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Investigating

the use of Hospital Episode

Statistics data to measure variation in

Performance and Quality in Colorectal Surgery

Miss Elaine Burns BSc.Edin Hons (Anatomical Sciences) MBCHB MRCS (Glasg)

DIVISION OF SURGERY, DEPARTMENT OF SURGERY AND CANCER,

IMPERIAL COLLEGE LONDON

Doctor of Philosophy (PhD) 2012

Supervisors: Mr Omar Faiz, Dr Paul Aylin, Professor the Lord Ara Darzi of Denham

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Table of Contents

Abstract ........................................................................................................................................... 12

Acknowledgements ..................................................................................................................... 14

Publications and presentations resulting from this thesis ............................................ 17

Statement of Contribution and Declaration of Originality ............................................. 23

Chapter 1- Introduction ............................................................................................................. 24

Hypothesis .................................................................................................................................. 29

Aim ................................................................................................................................................ 29

Chapter 2- What is surgical quality and how do we measure it? ................................. 30

Introduction ............................................................................................................................... 30

The demand for high-quality healthcare ......................................................................... 30

The definition of surgical quality ....................................................................................... 31

Reporting of surgical performance and quality ............................................................ 32

Measuring quality in surgery ............................................................................................... 36

Risk-adjustment and statistical considerations in quality measurement ............ 47

Measurement of quality in colorectal surgery ............................................................... 51

Chapter 3- Data sources for quality measurement. .......................................................... 59

Routinely collected datasets ................................................................................................ 59

Clinical databases .................................................................................................................... 62

National Surgical Quality Improvement Program ........................................................ 63

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Advantages and disadvantages of routinely collected data ...................................... 64

Systematic review of accuracy of routinely collected data ........................................ 69

Variation from HES data ........................................................................................................ 91

HES data and Colorectal surgery ......................................................................................... 96

Chapter 4- Materials and Methods ...................................................................................... 100

Hospital Episode Statistics (HES) .................................................................................... 100

HES Coding ............................................................................................................................... 101

Risk adjustment ..................................................................................................................... 103

Outcome measures ............................................................................................................... 108

Ethical considerations ......................................................................................................... 109

Statistical considerations ................................................................................................... 109

Volume ...................................................................................................................................... 110

Chapter 5- Variation in patient factors .............................................................................. 111

Introduction ............................................................................................................................ 111

Aim ............................................................................................................................................. 112

Methods .................................................................................................................................... 112

Results ...................................................................................................................................... 113

Summary .................................................................................................................................. 123

Chapter 6- Variation in Structural factors ........................................................................ 124

Introduction ............................................................................................................................ 124

Aim ............................................................................................................................................. 125

Methods .................................................................................................................................... 126

Results ...................................................................................................................................... 127

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Summary .................................................................................................................................. 142

Chapter 7- Variation in process factors ............................................................................. 144

Introduction ............................................................................................................................ 144

Aim ............................................................................................................................................. 147

Methods .................................................................................................................................... 147

Results ...................................................................................................................................... 149

Summary .................................................................................................................................. 160

Chapter 8- Variation in outcome factors ........................................................................... 161

Introduction ............................................................................................................................ 161

Aim ............................................................................................................................................. 162

Methods .................................................................................................................................... 163

Results ...................................................................................................................................... 172

Defining novel outcome measures from HES and assessing variation in these

measures 172

Variation in established colorectal outcome measures 197

The impact of process factors on outcome 209

Summary .................................................................................................................................. 210

Chapter 9- Reducing variation in outcome following colorectal surgery in

England- the role of volume in determining outcome .................................................. 212

Introduction ............................................................................................................................ 212

Aims ........................................................................................................................................... 221

Methods .................................................................................................................................... 221

Volume considerations 225

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Results ...................................................................................................................................... 233

Does a relationship exist between consultant team or Trust volume and outcome

following colorectal cancer surgery? 233

Is there a relationship between total resection workload (i.e. benign and malignant)

and outcome? 248

Is volume relationship mitigated in part by structural factors? 252

Is there a relationship between surgeon laparoscopic caseload and outcome?

252

Is there a relationship between caseload and outcome in subspecialist care?

260

Summary .................................................................................................................................. 265

Chapter 10- Discussion ........................................................................................................... 267

Main findings .......................................................................................................................... 267

Role of caseload in determining outcome .................................................................... 268

Quality improvement ........................................................................................................... 277

New outcome measures ...................................................................................................... 280

Laparoscopic versus open approaches .......................................................................... 287

Study limitations ................................................................................................................... 291

Conclusion ............................................................................................................................... 297

References ................................................................................................................................... 298

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

List of figures

Figure 3.1: Schematic of inclusion following literature search. 74

Figure 5.1: Variation in admission type (elective and emergency) by Trust for all colorectal

resections (percentage of elective admission with 95% confidence interval error bars). 114

Figure 5.2: Variation in Trust diagnosis for all colorectal resections by Trust of all patients

undergoing a colorectal resection. 115

Figure 5.3 Variation in type of resection per Trust of all patients undergoing a colorectal resection.

116

Figure 5.4: Variation in Charlson scoring per Trust of all patients undergoing a colorectal

resection. 118

Figure 5.5: Variation in social deprivation by Trust of all patients undergoing a colorectal

resection 119

Figure 5.6: Variation in patient age by Trust of all patients undergoing a colorectal resection 120

Figure 6.1: Variation in total volume of colorectal resection over the study period (8 years) by 156

individual NHS Trust 130

Figure 6.2: Variation in elective colorectal cancer resection caseload per consultant team per year

over the study period. 133

Figure 6.3: Increase in mean consultant team elective colorectal cancer caseload over time with

95% confidence interval error bars. 135

Figure 6.4: The percentage of patients undergoing RPC in each provider volume category (LV, MV,

HV) from 1996 to 2008 140

Figure 6.5: The percentage of patients undergoing RPC in each surgeon volume category (LV, MV,

HV) from 2000 to 2008 141

Figure 7.1: Funnel plot of consultant team caseload and APE rates amongst patients with rectal

cancer 150

Figure 7.2: Funnel plot of NHS Trust caseload and APE rates amongst patients with rectal cancer

151

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Figure 7.3: Overall percentage APE use amongst rectal cancer patients over time 152

Figure 7.4: Uptake of laparoscopic approach for all elective resections and elective colorectal

cancer resections 154

Figure 7.5: Variation in minimal access surgery rate amongst patients undergoing an elective

colorectal resection across SHA in 2007 158

Figure 8.1: Funnel plot of adjusted reoperation rates for elective colorectal resectional procedures

for individual consultant teams by volume of elective surgery. 180

Figure 8.2: Funnel plot of adjusted reoperation rates for both emergency and elective colorectal

resectional procedures for individual NHS Trusts by volume. 181

Figure 8.3: Variation in incisional hernia rates following colorectal resection for each NHS Trust

with 95% confidence intervals 189

Figure 8.4: Variation in adhesion rates following colorectal resection for each NHS Trust with 95%

confidence intervals 190

Figure 8.5: Funnel plot of pouch failure rates by NHS Trust. 196

Figure 8.6: Variation in 30 day mortality following colorectal resection for each NHS Trust with

95% confidence intervals 200

Figure 8.7: Mean readmission rates following colorectal resection with 95% confidence intervals

per NHS Trust. 202

Figure 8.8: Variation in LOS amongst colorectal resection patients by NHS Trust with 95%

confidence intervals. 205

Figure 9.1: Funnel plot of adjusted 30-day mortality and Trust caseload. 240

Figure 9.2: Funnel plot of Trust postoperative return to theatre rates and caseload. 241

Figure 9.3: Funnel plot of consultant team caseload and 30-day postoperative mortality 242

Figure 9.4: Funnel plot of adjusted consultant team return to theatre rates and caseload. 243

Figure 9.5: Confidence intervals of odds ratios of 30 day mortality following rectal cancer

resection at incremental increases in rectal cancer surgical caseload to demonstrate critical

volume of surgery (increments of 5). 246

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Figure 9.6: Confidence intervals of odds ratios of 30 day mortality following rectal cancer

resection at incremental increases in rectal cancer surgical caseload to demonstrate critical

volume of surgery (increments of 2.5). 247

Figure 9.7: Confidence intervals of odds ratios of 30 day mortality following cancer resection at

incremental increases in total surgical caseload to demonstrate critical volume of surgery

(increments of 10). 250

Figure 9.8: Confidence intervals of odds ratios of 30 day mortality following cancer resection at

incremental increases in total surgical caseload to demonstrate critical volume of surgery

(increments of 5). 251

Figure 9.9: Increase in number of consultant teams using the minimal access approach from 2002

to 2008 with dates of publication of randomised control trials and guidelines. 253

Figure 9.10: Kaplan Meier curve showing variation in failure rates according to institutional

volume groups 263

Figure 9.11: Funnel plot showing provider volume and failure rates following RPC 264

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

List of Tables

Table 2.1: Advantages and disadvantages of quality metrics classified according to the Donabedian

approach. 38

Table 3.1: Advantages and disadvantages of HES data 65

Table 3.2: Assessment of quality of studies examining data accuracy of routinely collected data in

comparison to case note review 73

Table 3.3: Summary of included studies examining data accuracy of routinely collected data in

comparison to case note review 78

Table 3.4: Summary of included studies comparing routinely collected data with clinical registries

80

Table 5.1: Patient characteristics and type of surgery for all patients undergoing colorectal

resection. 117

Table 5.2: Characteristics of patients undergoing RPC between 1996 and 2008 122

Table 6.1: Patient characteristics and type of surgery for all patients undergoing colorectal

resection. 128

Table 6.2: Patient characteristics and type of surgery for all patients undergoing colorectal cancer

resection. 132

Table 6.3: Patient characteristics in each institutional volume category operated on between 1996

and 2008 * 137

Table 6.4: Patient characteristics in each surgeon volume category of pouch patients operated on

between 2000 and 2008* 138

Table 7.1: Number of elective laparoscopic colorectal cancer resections by SHA in 2007. 156

Table 7.2: Multiple logistic regression of use of minimal access surgery in elective colorectal

cancer resection including those patients undergoing resection in 2007. 157

Table 7.3: Pouch laparoscopic use by volume category 160

Table 8.1: OPCS codes used to define reoperations following colorectal resection 165

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
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Table 8.2: Patient characteristics and type of surgery by approach for patients undergoing a

colorectal resection. 173

Table 8.3: Reoperation following colorectal resections for patients undergoing laparoscopic and

open procedures. 175

Table 8.4: Patient characteristics of those patients who necessitated a reoperation in the

postoperative period. 177

Table 8.5: Multiple regression analysis for reoperation and laparotomy amongst elective and

emergency patients. 178

Table 8.6: Descriptives of elective patients undergoing colorectal resection between 2002 and

2008 included for analysis of medium term adhesion and herniae rates. 184

Table 8.7: Rates of re-intervention for adhesions and incisional hernia repairs following

laparoscopic and open resection at one, two and three year post surgery. 186

Table 8.8: Multiple regression analysis of operative reintervention for incisional hernia and

adhesion 187

Table 8.9: Characteristics of restorative proctocolectomy patients who experienced failure

(372/5771) compared with those who did not 192

Table 8.10: Unifactorial and Multiple Cox regression analysis for pouch failure 194

Table 8.11: Variation in 30 day and 365 day mortality amongst elective and emergency colorectal

resection patients (unadjusted analysis). 198

Table 8.12: Variation in 30 day and 365 day mortality amongst elective and emergency colorectal

resection patients (multiple regression analysis). 199

Table 9.1:Previous research examining surgical provision and impact of caseload on outcome

using HES data. 218

Table 9.2: OPCS codes used to classify colorectal resection. 223

Table 9.3: Volume thresholds for elective colorectal resection. 227

Table 9.4: Volume categories and number of patients in each category for restorative

proctocolectomy. 229

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Table 9.5: Patient characteristics and type of surgery by approach for patients undergoing an

elective colorectal resection. 234

Table 9.6: Unadjusted outcome of elective colorectal cancer resection according to volume

categories. 237

Table 9.7: Multiple regression of 30-day postoperative mortality, 28-day unplanned readmission,

reoperation and length of stay for elective colorectal cancer resection. 238

Table 9.8: Patient characteristics of all patients undergoing an elective resection. 255

Table 9.9: Patient characteristic of cancer patients undergoing a laparoscopic elective colorectal

resection between 2002 and 2008 in each volume category. 256

Table 9.10: Outcome following elective laparoscopic colorectal cancer resection in each volume

category. 258

Table 9.11: Multiple logistic regression for reoperation, 30 day medical morbidity, 365 day

medical morbidity and LOS for patients undergoing an elective laparoscopic colorectal cancer

resection. 259

Table 9.12: Outcome of RPC according to institutional volume and surgeon volume 261

Table 9.13: Linear regression analysis for the logarithmic transformation of length of stay (LOS)

with institutional and surgeon volume considered separately for pouch surgery 262

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Abstract

This thesis provides a comprehensive overview of general and subspecialist colorectal

surgery in England. It examines variation in provision and outcome of colorectal surgery in

structure, process and outcome factors at the patient, consultant team and NHS Trust levels.

Finally, this thesis examines the potential role of increasing surgical caseload to reduce any

demonstrable variation and improve outcome. To address these questions, current issues in

surgical quality as well as the coding accuracy reported in the published literature have been

reviewed. Colorectal resection and the more specialised procedure of restorative

proctocolectomy were examined from the Hospital Episode Statistics dataset. Novel

outcome measures were derived using longitudinal analysis. Regression analysis was used to

understand the predictors of process factors and outcome measures.

I have defined new outcome measures and demonstrated considerable variation in these new

measures and in more traditional accepted measures in both general and subspecialist

colorectal surgery from routinely collected datasets. Routinely collected data offer an

exciting potential data source for measuring performance and quality. If data accuracy can be

assured, measures such as reoperation may be used alongside established measures of quality

in a meaningful way to benchmarking performance of surgical providers. The methods

described in this thesis can be applied to a broad range of surgical specialties.

Though volume may have a role in determining outcome and reducing variation in

subspecialist colorectal surgery, it is by no means the panacea to improve quality across all

providers in general colorectal care. The impact of volume on outcome in more general

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

colorectal surgery is less clear. Though centralisation is likely to have benefits, further

evidence of the optimum way to implement such changes is needed rather than

indiscriminately increasing volume across all providers for general colorectal surgical care.

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Acknowledgements

This PhD was undertaken in the Department of Surgery and Cancer in St Marys Hospital

under the supervision of Mr Omar Faiz, Dr Paul Aylin and Professor Ara Darzi.

I am indebted to Omar Faiz for his excellent supervision throughout my PhD. As well as

finding a mentor, I have learnt many skills from him that will stand me in good stead

throughout the rest of my career.

Paul Aylin has been an amazing supervisor. He has always been supportive and a welcome

ear to listen to my PhD moans.

Id like to thank Professor Darzi for his support clinically and career wise, for giving me this

wonderful opportunity and for helping me achieve my career and research goals.

Without the statistical support and advice from Dr Alex Bottle, this PhD would not have been

possible. I am also grateful for the support of all members of the Dr Foster unit. Id like to

acknowledge Professor John Nicholls who has provided invaluable insights throughout this

research.

Id like to thanks the others who have helped me survive and enjoy research. Ravi

Mamidanna and Alex Almoudaris were fantastic collaborators in our burgeoning reseach

group. The current and previous residents of the Room 1029 have provided laughs, joy, tea

and wine at times of need. Thanks guys.

Finally but definitely not least, I like to acknowledge and sincerely thank my parents, Mary

and Martin, the rest of my family, my flatmate Caroline, and all my friends for keeping me

sane throughout this journey. They have been a constant source of distraction and happiness

and have gone way beyond the call of duty to support me in the last three years,

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Abbreviations

AAA Abdominal Aortic Aneursym

ACPGBI Association of Coloproctologists of Great Britain and Ireland

ACS American College of Surgeons

APE Abdominoperineal Excision

AUGIS The Association of Upper Gastrointestinal Surgeons of Great Britain

and Ireland

CRM Circumferential Resection Margin

EBHR Evidence-Based Hospital Referral

ERP Enhanced Recovery Programmes

HES Hospital Episode Statistics

IBD Inflammatory Bowel Disease

IPAA Ileal anal-pouch anastomosis

ICU Intensive Care Unit

IQR Interquartile Range

LOS Length of Stay

NBOCAP National Bowel Cancer Audit Project

NHS National Health Service

NICE National Institute for Health and Clinical Excellence

NSQIP National Surgical Quality Improvement Programme

PbR Payment by Results

PROMS Patient Reported Outcome Measures

RCT Randomised Control Trial

RPC Restorative proctocolectomy

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

SEER Surveillance Epidemiology and End Results

SHA Strategic Health Authority

SD Standard Deviation

UK United Kingdom

US United States

VA Veterans Affairs

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Publications and presentations resulting from this thesis

Publications directly resulting from thesis (See Appendices)

Burns EM, Bottle A, Aylin P, Darzi A, Nicholls RJ, Faiz O. Variation in reoperation after

colorectal surgery in England as an indicator of surgical performance: retrospective analysis

of Hospital Episode Statistics. BMJ. 2011 Aug 16;343:d4836

Burns EM, Rigby E, Mamidanna R, Bottle A, Aylin P, Ziprin P, Faiz OD.

Systematic review of discharge coding accuracy. J Public Health (Oxf). 2011 Jul 27.

Burns EM, Bottle A, Aylin P, Clark SK, Tekkis PP, Darzi A, Nicholls RJ, Faiz O. Volume

analysis of outcome following restorative proctocolectomy. Br J Surg. 2011 Mar;98(3):408-

17.

Burns EM, Mamidanna R, Currie A, Bottle A, Aylin P, Darzi A, Faiz OD. The role of

caseload in determining outcome following laparoscopic colorectal cancer resection. (Under

review Colorectal Dis 2012)

Burns EM, Currie A, Bottle A, Aylin P, Faiz O. An evaluation of incisional hernia and

adhesion-related outcomes following laparoscopic and open colorectal surgery in England.

Br J Surg. 2012 Nov 12. [Epub ahead of print]

Burns EM, Aylin P, Bottle A, Faiz O. Defining and measuring quality in surgery. (Under

review Postgraduate Medical Journal 2011)

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Burns EM, Bottle A, Almoudaris A, Mamidanna R, Aylin P, Darzi A, Nicholls RJ, Faiz OD.

The role of volume in elective colorectal surgery (under review BMJ 2012)

Associated with work from thesis

Burns EM, Naseem H, Bottle A, Lazzarino AI, Aylin P, Darzi A, Moorthy K, Faiz O.

Introduction of laparoscopic bariatric surgery in England: observational population cohort

study. BMJ. 2010 Aug 26;341:c4296

Almoudaris AM, Burns EM, Bottle A, Aylin P, Darzi A, Faiz O. A colorectal perspective

on voluntary submission of outcome data to clinical registries. Br J Surg. 2011 Jan;98(1):132-

9.

Burns EM, Faiz O. Evolution of the surgeon--volume, patient outcome relationship. Ann

Surg. 2010 May;251(5):991-2

Burns EM, Faiz O. Response to Khani et al., centralization of rectal cancer surgery

improves long-term survival. Colorectal Dis. 2010 Oct;12(10):1054.

Burns EM, Mayer EK, Faiz O. Surgeon volume does not predict outcomes in the setting of

technical credentialing: results from a randomized trial of colon cancer. Ann Surg. 2009

May;249(5):866;

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Faiz O, Haji A, Burns E, Bottle A, Kennedy R, Aylin P. Hospital stay amongst patients

undergoing major elective colorectal surgery: predicting prolonged stay and readmissions in

NHS hospitals. Colorectal Dis. 2011 Jul;13(7):816-22.

Faiz O, Brown T, Bottle A, Burns EM, Darzi AW, Aylin P. Impact of hospital institutional

volume on postoperative mortality after major emergency colorectal surgery in English

National Health Service Trusts, 2001 to 2005. Dis Colon Rectum. 2010 Apr;53(4):393-401.

Mamidanna R, Burns EM, Bottle A, Aylin P, Stonell C, Hanna GB, Faiz O. Reduced risk of

medical morbidity and mortality in patients selected for laparoscopic colorectal resection in

England: A population based study. Arch Surg 2011 Nov 21.

Almoudaris AM, Burns EM, Mamidanna R, Bottle A, Aylin P, Vincent C, Faiz O. Value of

Failure To Rescue as a marker of the standard of care following reoperation for

complications after colorectal resection. Br J Surg. 2011 Dec; 98 (12): 1775-83.

Presentations

Burns EM, Mamidanna R, Currie A, Bottle A , Darzi A, Faiz OD The role of caseload in

determining outcome following laparoscopic colorectal cancer resection. European Society of

Coloproctology Copenhagen 2011.

Burns EM, Currie A, Bottle A, Aylin P, Darzi A, Faiz O. Minimal Access colorectal surgery

is associated with fewer subsequent adhesion-related admissions and operations than the

conventional approach. European Society of Coloproctology Copenhagen 2011.

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Burns EM, Bottle A, Aylin P, Darzi A, Faiz O. Does surgeon or institution volume influence

abdominoperineal excision rate? European Society of Coloproctology Copenhagen 2011.

Burns EM, Bottle A, Aylin P, Darzi A, Faiz O. Does surgeon or institution volume influence

abdominoperineal excision rate? Tripartite Colorectal meeting Cairns 2011.

Burns EM, Bottle A, Aylin P, Darzi A, Faiz O. The role of surgeon volume in Colorectal

Cancer Surgery. Tripartite Colorectal meeting Cairns 2011.

Burns EM, Bottle A, Aylin P, Darzi A, Nicholls RJ, Faiz O. Variation in return to theatre

following colorectal surgery in England an indication of inequality of surgical

performance? Tripartite Colorectal meeting Cairns 2011.

Currie A, Burns EM, Darzi A, Faiz O, Ziprin P. Has shortened surgical training led to poorer

colorectal cancer outcomes? Tripartite Colorectal meeting Cairns 2011.

Burns EM, Bottle A, Aylin P, Darzi A, Faiz O. Return to theatre in Crohns Disease in the

biological era. European Society of Coloproctology Sorrento 2011.

Burns EM, Bottle A, Aylin P, Darzi AW, Faiz O. The impact of reoperation following

colorectal resection on postoperative mortality. European Society of Coloproctology Sorrento

2011.

Burns EM, Bottle A, Aylin P, Darzi A, Faiz OD. Does surgeon or institution volume

influence abdominoperineal excision rate? Association of Coloproctology of Great Britain

and Ireland Birmingham 2011.

Burns EM, Bottle A, Aylin P, Darzi A, Faiz OD. The impact of surgeon volume in colorectal

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

cancer surgery. Association of Coloproctology of Great Britain and Ireland Birmingham

2011.

Burns EM, Bottle A, Aylin P, Darzi A, Nicholls RJ, Faiz OD. Variation in return to theatre

following colorectal surgery in England an indication of inequality of surgical

performance? Association of Coloproctology of Great Britain and Ireland Birmingham 2011.

Burns EM, Bottle A, Aylin P, Tekkis PP, Clark S, Darzi AW, Nicholls RJ, Faiz O. National

Outcomes Following Restorative Proctocolectomy In England. Association of Great Britain

and Ireland Liverpool 2010.

Burns E, Naseem H, Aylin P, Faiz O, Moorthy K. Trends in Laparoscopic Bariatric Surgery

and Comparisons of Outcomes with Open Surgery: a National study in England 2000-2008.

Association of Great Britain and Ireland Liverpool 2010.

Burns EM, Bottle A, Aylin P, Tekkis PP, Clark S, Darzi AW, Nicholls RJ, Faiz O.

Examining Differences In Postoperative Outcomes Between Hospitals with differing surgical

caseload following Restorative Proctocolectomy. Association of Great Britain and Ireland

Liverpool 2010.

Burns EM, Bottle A, Aylin P, Tekkis PP, Clark SK, Darzi AW, Nicholls RJ, Faiz O.

Examining differences in case selection between surgeons with differing surgical caseload in

pouch surgery. Association of Great Britain and Ireland Liverpool 2010.

Burns E, Bottle A, Aylin P, Faiz O, Moorthy K. The role of volume in Bariatric Surgery.

Association of Great Britain and Ireland Liverpool 2010.

Burns E, Bottle A, Aylin P, Faiz O, Moorthy K. National Outcomes following Bariatric

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Surgery in England. Association of Great Britain and Ireland Liverpool 2010.

Burns EM, Bottle A, Jing SS, Aylin P, Darzi AW, Faiz O. National Provision Of

Laparoscopic Pouch Surgery In England. Association of Coloproctology of Great Britain and

Ireland Bournemouth 2010.

Burns EM, Bottle A, Aylin P, Tekkis PP, Clark SK, Darzi AW, Nicholls RJ, Faiz O.

National Outcomes Following Restorative Proctocolectomy In England. Association of

Coloproctology of Great Britain and Ireland Bournemouth 2010.

Burns EM, Bottle A, Aylin P, Tekkis PP, Clark SK, Darzi AW, Nicholls RJ, Faiz O.

Examining differences in case selection between surgeons with differing surgical caseload in

pouch surgery. Association of Coloproctology of Great Britain and Ireland Bournemouth

2010.

Burns EM, Bottle A, Aylin P, Tekkis PP, Clark SK, Darzi AW, Nicholls RJ, Faiz O.

Examining Differences In Postoperative Outcomes Between Hospitals with differing surgical

caseload in restorative proctocolectomy. Association of Coloproctology of Great Britain and

Ireland Bournemouth 2010.

Burns E, Bottle A, Aylin P, Kennedy R H, Hanna G, Faiz O. Disparity in use of laparoscopy

for colon cancer in England. Association of Great Britain and Ireland Glasgow 2009.

Faiz O, Haji A, Burns E, Bottle A, Kennedy R, Darzi AW, Aylin P. Hospital stay amongst

patients undergoing major elective colorectal surgery: predicting prolonged stay and

readmissions in NHS hospitals. Association of Great Britain and Ireland Glasgow 2009.

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Burns E, Aylin P, Kennedy R H, Hanna G, Faiz O. Disparity in use of laparoscopy for colon

cancer in England. Association of Coloproctology of Great Britain and Ireland Harrogate

2009.

Faiz O, Brown T, Bottle A, Burns EM, Darzi AW, Aylin P. The influence of hospital

provider volume on postoperative mortality and intestinal continuity rates after major

emergency colorectal surgery in England. Association of Coloproctology of Great Britain and

Ireland Harrogate 2009.

Faiz O, Haji A, Burns E, Bottle A, Kennedy R, Darzi AW, Aylin P. Hospital stay amongst

patients undergoing major elective colorectal surgery: predicting prolonged stay and

readmissions in NHS hospitals. Association of Coloproctology of Great Britain and Ireland

Harrogate 2009.

Statement of Contribution and Declaration of originality

The work contained in this thesis is my own and was performed by myself. In the process of

carrying out this work, other individuals were involved. My supervisors, Mr O Faiz, Dr P

Aylin and Professor A Darzi provided direction and advice with conception, design and

editing of the studies included in this thesis. In addition, Dr A Bottle aided with data cutting

of the pouch database, statistical support and editing of the other chapters. Specifically in

Chapter 4, Dr E Rigby and Mr R Mamidanna acted as second and third reviewer for the

articles included in the systematic review of coding accuracy and helped with the drafting

and editing fo the final manuscript (See appendix). Mr A Almoudaris compiled the structural

data that were analysed by myself in Chapters 6 and 9. Though I carried out the analysis and

interpretation of the data, R Mamidanna derived the algorithm and provided the data for

defining medical morbidity in Chapter 8 and 9. All other work is appropriately referenced.

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Chapter 1- Introduction

Variation in the utilization of health care services that cannot be explained by variation in

patient illness or patient preferences.

Jack Wennberg (Dartmouth Atlas of Variation)

Over the last seventeen years, since the publication of the Calman Hine report, there has been

an increasing recognition that variation exists within the National Health Service (NHS)

(Expert Advisory Group on Cancer to the Chief Medical Officers of England and Wales,

1995). There has been a consequent impetus towards uniform practice across England and

Wales. The report, High quality care for all: NHS next stage review, went further in making

quality and standard setting central to the future of healthcare in the NHS in England (Darzi,

2008).

Variation in healthcare has been previously demonstrated in both the NHS and in other

healthcare systems such as in the United States (US). Patient factors such as ethnicity and

socioeconomic deprivation have been demonstrated to have a negative impact on both access

to services and outcome following treatment (Bagger et al., 2008, Smith et al., 2006).

Variation at an institutional level also exists. NHS Trusts vary in terms of the provision of

services and other structural factors such as caseload. These factors may or may not impact

on the healthcare provided and consequent outcome. In the NHS, Primary Care Trusts (PCT)

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

commission services from Acute Trusts. PCTs differ in terms of which procedures that they

will or will not permit leading to the suggestion of a postcode lottery (Henderson, 2009) i.e.

where the services available for individual patients depend on their geographical location.

It is generally agreed that there is unacceptable regional variation in NHS services throughout

England (Darzi, 2008). This variation persists in surgical practice. Geographical disparities

have been examined using routinely collected hospital data in England. Dixon et al, found

marked variation in age and sex adjusted total hip and knee replacement rates (Dixon et al.,

2006). As a first step to improving quality in clinical care, this variation must be described

and demonstrated. Such descriptions can be used to direct quality initiatives. The NHS has

begun to publicly report this variation in the NHS Atlas of Variation (NHS Atlas). This Atlas

is similar to the Dartmouth Atlas in the US (Dartmouth Atlas of Variation). It describes

variation in a range of variables including bariatric surgery, spending on cancer and stroke

care.

Colorectal surgery

Colorectal surgery represents a significant portion of the elective and emergency general

surgical workload. In the financial year 2007/2008, there were over 35,000 admissions for

colorectal resections in England. It is a diverse speciality encompassing a wide range of

diseases including colorectal cancer, inflammatory bowel disease and diverticular disease.

Given the ageing population, the workload of this speciality is likely to increase over time.

One study predicted a 42% increase in the number of colonic resections between 2000 and

2020 in the US (Liu et al., 2004).


25
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Colorectal surgery is associated with marked morbidity (Alves et al., 2005) and, in the

emergency setting a significant risk of mortality (Faiz et al., 2010a). Considerable variation

between institutional and individual colorectal surgical practice and outcome has been

demonstrated previously (Morris et al., 2008, McArdle and Hole, 1991). Such variability is

increasingly unacceptable to clinicians, healthcare managers, commissioners and patients.

Describing this variation in performance is an important step to allow quality assessment and

subsequent improvement.

In the United Kingdom (UK), nationwide administrative data that include all patients

admitted to National Health Service (NHS) hospitals are collected. The current availability

and comprehensive coverage of these datasets makes them an attractive potential source for

measuring performance. Reducing variation to improve outcome is desirable. Several quality

improvement measures have been suggested to improve outcome. These include centralising

services, increasing individual provider caseload, clinician revalidation or surgeon

credentialing to ensure adequate technical proficiency. Surgeon credentialing involves

assessing surgeons as competent in performing a particular operation or set of interventions.

Revalidation represents a regulatory process incorporating regular audit and assessment to

ensure clinicians meet nationally agreed standards (General Medical Council, 2010). This

process may reduce variation within the health service and improve outcome. For

revalidation to be effective, reliable performance measures are necessary. In the US, in

addition to outcome measures such as mortality, length of stay and readmission, other

measures have been used to examine variation in colorectal surgery such as return to theatre

and complication rates (Billingsley et al., 2007, Billingsley et al., 2008, Morris et al., 2007a).

26
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

As yet colorectal reoperation rates have not been examined at a national level using UK

based data.

Previous studies have demonstrated variation in colorectal surgical practice in England.

Using Hospital Episode Statistics (HES) data, Tilney and colleagues found considerable

inter-centre variation in Abdominoperineal Excision (APE) rates (Tilney et al., 2008). Using

HES data linked to cancer registry data, Morris and co workers suggested that surgeon-to-

surgeon variation in the use of APE persisted despite case mix adjustment (Morris et al.,

2008). As well as differences at an institutional level both these studies found increased rates

of APE use amongst those patients from more socially deprived areas. Tilney and colleagues

in a study using a clinical database also found a relationship between lower socioeconomic

status and increased rates of APE use (Tilney et al., 2009).

Alongside colorectal excisional surgery, it is necessary to describe variation following more

specialist surgery. Restorative proctocolectomy (RPC) or ileal pouch anal anastomosis

surgery (IPAA) is widely accepted as the operation of choice for patients with Ulcerative

Colitis (UC) or Familial Adenomatous Polyposis (FAP) who require colectomy. It is one of

the most challenging operations in colorectal surgery and requires a high level of both

technical skill and clinical acumen in choosing the appropriate patients to undergo the

procedure. There have been many large series from single institutions describing outcome

following RPC in the UK and US (Fazio et al., 1995, Tulchinsky et al., 2003, Chapman et al.,

2005). Published audits of outcome at a national level are, however, limited. One previous

study examined outcome following RPC using the UK National Ileal pouch registry (Tekkis
27
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

et al., 2010). This audit took place over thirty years with ten contributing centres in the UK.

Examination of variation in outcome or the role of surgeon or institutional caseload in

determining outcome was beyond the remit of this study. Kennedy and colleagues examined

the role of caseload in determining volume using administrative data in a single region in

Canada (Kennedy et al., 2006). This study found increased reoperation and failure rates

amongst lower volume institutions. The results of this study may not be applicable to the UK

setting. Furthermore this study did not examine the role of individual surgeons caseload in

determining outcomes.

This thesis seeks to assess whether it is feasible, given accurate data, to measure performance

and quality in surgery from HES data. As part of assessing the HES databases use to

measure performance and quality, we review current issues in surgical quality and existing

measures of quality. This thesis will examine variation in structure, process and outcome

measures at the NHS Trust, and consultant team levels. This thesis, however, goes further in

seeking to ascertain whether this variation can be negated through increasing institutional or

surgeon caseload.

28
Hypothesis

There is variation in colorectal surgical performance and quality that can be measured using a

national routinely collected dataset.

Aim

1. Define current issues in surgical quality and performance with particular reference to

colorectal surgery

2. Examine current variation in colorectal surgery and contributing factors to this

variation from routinely collected datasets

3. Derive new possible measures of colorectal surgical performance from routinely

collected datasets

4. Explore use of administrative datasets to benchmark performance and quality in

colorectal surgery

5. Assess the role of caseload in reducing any apparent variation.

29
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Chapter 2- What is surgical quality and how do we measure it?

Introduction

Healthcare accounts for a significant proportion of government and individual spending. In

the US, in 2008, total healthcare expenditure was $2.4 trillion -17% of the Gross Domestic

Product (2009d). In the UK in 2009 healthcare was responsible for 102.6 billion of public

spending (www.ukspending.co.uk, 2009). Policy-makers, healthcare funders and patients

demand high quality medical care to justify current spending levels in a period of financial

austerity. Central to efficiency in healthcare is a fundamental need to demonstrate quality of

service provision. Although it is useful to speak about improving quality in broad terms,

what does quality in healthcare actually mean?

This chapter seeks to define surgical quality, discuss the reasons for measuring quality, and

describe existing quality metrics.

The demand for high-quality healthcare

In the report, Crossing the Quality Chasm: A New Health System for the 21st Century, the

Committee on Quality of Healthcare from the Institute of Medicine in America recognised

that there was a significant gap between current healthcare performance and the quality that

is possible (Committee on Quality Health Care in America, 2001). This document advocated

redesign of the American healthcare system in order to achieve superior quality (Committee

on Quality Health Care in America, 2001). In England, the 2008 government report, High

quality care for all: NHS next stage review outlined the vision for the future of the NHS.

30
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

This document, along with the NHS Constitution, (NHS Constitution, 2009) and the recently

formed National Quality Board, underline the health services commitment to delivering a

high quality service for all patients (National Quality Board). Other countries similarly

overtly promote high quality healthcare. Australia, for example, has a well established

Commission on Safety and Quality in Healthcare. This commission has wide-ranging remit to

drive quality improvement, disseminate knowledge and publicly report performance against

national standards (Australian Commission on Safety and Quality in Healthcare, 2009).

The definition of surgical quality

The definition of quality in surgical care is debated. It should reflect all aspects of care; not

just outcome including mortality and morbidity but also patient centred factors such as

patient experience and postoperative quality of life. The National Institute of Medicine in the

US defines quality as the degree to which health services for individuals and populations

increase the likelihood of desired health outcomes and are consistent with current

professional knowledge (Institute of Medicine, 1990). This definition recognises the need for

care to meet current standards and the requirement for healthcare professionals to deliver up

to date treatment. The above description of quality does not however define desired health

outcomes.

Surgical quality is deeply intertwined, but not synonymous, with both performance and

safety. Performance is the way in which a person or organisation functions whereas quality

is a measure of excellence. Safe practice must be followed to deliver quality care. High

quality service provision requires excellent clinical performance. Improving safety is a focus

31
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

for many quality initiatives. As such, quality initiatives may begin with improving surgical

safety. The World Health Organisation (WHO) recognised the need for global action to

improve safety in surgery with the Safe Surgery Saves Lives initiative. The latter resulted in a

simple checklist that could be used globally in many types of surgery to attempt to reduce

adverse events. Initial pilot studies demonstrated that this checklist resulted in a 47%

reduction in mortality after its introduction (Haynes et al., 2009). It also illustrated that such a

simple intervention can be applied internationally irrespective of differences in healthcare

systems.

Reporting of surgical performance and quality

Since Florence Nightingale, attempts have been made to measure performance and make

comparisons between institutions. Nightingale together with William Farr first openly

published hospital mortality rates in 1857 (Spiegelhalter, 1999). They used these statistics to

galvanise public opinion to improve quality in poorly performing institutions. Similarly,

Ernest Codman encouraged the public reporting of surgical outcome in the early 1900s

(Neuhauser, 2002). Both Nightingale and Codman were however subject to criticism for their

methods - most notably because their data did not account for variation in case-mix.

Even today controversy exists regarding the use of publicly reported outcome measures

(Mohammed et al., 2009). One frequently cited concern is that surgeons may be less willing

to operate on high-risk patients if outcomes are openly reported (Schneider and Epstein,

1996). The Cardiac Surgery Reporting System has been collecting and publishing risk-

adjusted cardiac surgery mortality data for New York State since 1989 (Chassin et al., 1996).

32
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Initial analyses suggested that, three years following the introduction of the public reporting

scheme, mortality after cardiac surgery decreased by 41% (Hannan et al., 1994). Some

authors, however, questioned whether this decrease in mortality reflected true improvements

in quality. Omoigui suggested that the apparent improvements may have occurred as a result

of changes in surgical case-mix (Omoigui et al., 1996). This study examined the referral

pattern of patients from New York to the Cleveland clinic in Ohio from 1989 to 1993. The

482 patients referred from New York were sicker than the other referral cohorts in the clinic

and had higher risk scores than those patients who remained in New York. Relative to the

Ohio referral group, those referred from New York State had an increased risk of mortality

[odds ratio of 1.7 (Confidence Interval 1.1-2.7), p=0.030]. Chassin and co-workers refuted

the data in the Omoigui study by arguing that the time period used by Omiogui and

colleagues was premature given that the first publicly reported outcomes were issued in late

1989 (Chassin et al., 1996). In addition, the referral numbers to the Cleveland clinic were

small in comparison to the total number of procedures performed in the comparable period in

New York. Ghali and colleagues argued that the dramatic improvement in mortality seen in

New York was not necessarily due to the reporting of outcome data (Ghali et al., 1997). Ghali

found a similar reduction in mortality despite the absence of statewide reporting in

Massachusetts. It is unknown whether this reflects a baseline improvement in mortality due

to medical advances or whether the positive effects from New York State diffused to other

regions. The concern that public reporting of outcome measures can lead to a change in

surgical case mix was further contested in a recent study reviewing surgical practice

following the publication of cardiac surgery mortality data in the UK (Bridgewater et al.,

2007). This study observed an increase in the number and proportion of high-risk patients

undergoing cardiac surgery after the introduction of public reporting of cardiac surgical

33
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

outcome. Despite concerns regarding the potential hazards of public reporting of outcome

data, this type of programme is likely to take on a wider role especially in the UK given

patients right to choose their treatment location (NHS Constitution, 2009). Hibbard and co-

investigators studied the effects on hospital performance of public reporting of quality of care

data versus reports for internal consumption and finally no feedback. Hibbard found that

public reporting and to a lesser extent internal feedback led to not only increased quality

improvement activity but also to improvements in performance in poorer performing

hospitals (Hibbard et al., 2005). The use of public reporting of outcome measures for quality

improvement purposes, however, remains questionable. A recent systematic review found

that although public reporting leads to quality improvement activity at a hospital level, it is

unclear whether this increase in activity translates into genuine improvements in quality

(Fung et al., 2008).

An alternative to public reporting is the production of reports for internal monitoring. The

National Surgical Quality Improvement Programme (NSQIP) provides an example of an

intervention that uses risk-adjusted quality metrics to drive quality improvement

(ACS/NSQIP 2009). This programme started amongst the Veterans Affairs (VA) hospitals,

following a legal mandate in 1985 for the VA to report their risk-adjusted outcomes

benchmarked against national figures (Davis et al., 2007). The VA was in a unique position

to create risk-adjusted models and began to inform sophisticated outcome measure reporting

through their own progressive information technology systems and centralised organisation.

Using this monitoring system the VA created NSQIP to encourage surgical quality

monitoring across all VA hospitals. With support of the American College of Surgeons

(ACS), this system is now disseminating to private hospitals as a means of reporting

34
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

outcomes. The ACS/NSQIP system uses a combination of semi-annual reports, ad hoc

reports and online reporting to feedback to individual hospitals. The reports are designed for

internal review rather than for public reporting, and are used as a basis to identify areas where

quality improvement initiatives can be implemented to improve outcomes and track the

results from such initiatives. Internal reporting of outcome data for quality measurement and

improvement is used in the UK based initiative, Dr Foster Intelligence. This is an online tool

that is used for timely analysis of outcome data through case mix adjusted cumulative sum

charts at a provider level to allow early identification of potentially poor performance and

prompt remedial action to improve the quality of care (Bottle and Aylin, 2008).

Irrespective of whether external or internal reporting is favoured, performance measurement

in surgery demands identification of appropriate and measurable outcomes that can be

accurately risk-adjusted and used to distinguish between good and substandard performance.

The risk-adjustment model should only adjust for those factors that are outside the control of

the system being measured. In the case of repair of fracture neck of femur, when assessing

surgical technique in isolation, adjustment should be made for the preoperative clinical state

of the patient as this is beyond the control of a surgeons technical skills. In contrast, for a

hospital level assessment, adjustment should be made for the state of the patient at admission,

but not for the degree of medical stabilisation prior to surgery or preoperative care as this will

impact on their survival, and is within the control of the system.

Mortality, although useful and relevant in elective cardiac and some abdominal surgery, is an

insensitive quality measure for most other elective procedures. As such, it is necessary to

define what constitutes appropriate quality measures for various surgical specialities.

35
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Outcome measures are not necessarily the best way of defining surgical quality. Iezzoni

described outcome as the sum of patient factors, effectiveness of care and also random

variation between individual patients and providers (Iezonni, 2003). It follows that

institutional or surgeon-specific performance may be determined by random variation if

complete reliance on outcome measurement alone is used to define and benchmark quality in

surgery.

Measuring quality in surgery

The Agency for Healthcare Research and Quality defines a quality measure as a mechanism

that enables the user to quantify the quality of a selected aspect of care by comparing it to a

criterion (Center for Health Policy Studies, 1995). A useful quality metric is reproducible,

easily measured over time, objective, reliable and relevant to clinicians, health service

providers and patients (Bergman et al., 2006). These metrics must reflect the complexity of

the underlying processes and be resistant to the gaming effect where an organisation

manipulates a particular metric rather than improving the overall quality (Smith, 1995).

When used for comparison between surgeons or providers, a metric should be adjusted to

reflect variation in case mix, and be shown to be a valid proxy of overall quality.

Furthermore, the National Quality Forum in the US, in outlining their proposed criteria for

quality metrics, suggested that metrics should address a high impact area of healthcare, be

evidence based, relevant, feasible, reliable and credible. The measure should be usable by

the intended audience and be useful to distinguish between good and poor quality. In

addition, the National Quality Forum underlines the importance of risk-adjusting metrics

where possible. Using the Donabedian approach, (Donabedian, 1980) quality metrics may be

36
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

subdivided according to whether they represent structural, process or outcome measures

(Table 2.1).

37
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Table 2.1: Advantages and disadvantages of quality metrics classified according to the
Donabedian approach.

Factor Example Advantages Disadvantages


Structural Surgical caseload Easily measured May not reflect changes in
outcomes
Can be improved through Over simplistic
system changes
Process Number of lymph Reflect agreed standards of Need to be directly related to
nodes harvested in care improved outcomes to be
oncological colorectal useful
resections
Reduce inequality in care Restrict the provision of
when used effectively individualised patient care
Usually not available from
routine data
Outcome Postoperative mortality Easily understood by Usually infrequent events
healthcare professionals and
patients
Can be collected through Can be crude measures of
existing data sources quality
Can be risk-adjusted to reflect
case-mix

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Structural factors

Structural factors reflect characteristics that relate to the surgeon or the organisation.

Examples of structural factors include the number of subspecialist surgeons at an institution,

the nursing-to-patient ratios, the number of surgical beds, (Brook et al., 1996) and the

operative volume carried out at a given institution. Structural measures are potentially

attractive quality metrics as they are easily measured. The impact of operative volume, or

caseload, of a given procedure on performance has been subject to significant scrutiny

(Dimick et al., 2005). Indeed, a relationship between poor operative outcome and both low

surgeon or low institution volume has been demonstrated for a range of surgical procedures,

(Luft et al., 1979, Begg et al., 1998) including pancreatic resection, (Sosa et al., 1998,

Bentrem and Brennan, 2005) coronary artery bypass grafting, (Hannan et al., 2003, Wu et al.,

2004) orthopaedic, (Katz, 2001) and vascular surgery (Killeen et al., 2007, Holt et al., 2007a,

Holt et al., 2007b). The Leapfrog Group, an American alliance aimed at using employer

purchasing power to improve surgical quality and outcomes, has used the volume-outcome

relationship to determine payment and referral policy. (Leapfrog Group, 2007) For seven

elective procedures the alliance promotes Evidence-Based Hospital Referral (EBHR) that is

largely centred on hospital caseload. Surgical volume as a proxy measure of quality is also

being used in the English healthcare system to justify centralisation of upper gastrointestinal

cancer services with the aim of improving quality. Regional oesophagogastric cancer centres

in England should presently serve a population base of greater than 1 million people and

perform a minimum of 100 oesophageal and gastric cancer resections per year (Department

of Health, 2001). Volume as a quality metric is also being applied to colorectal surgery in the

UK. It is currently recommended that a colorectal surgeon should carry out a minimum of

twenty colorectal cancer operations per year (NICE, 2004). However, some surgeons argue

39
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

that the volume-outcome relationship may represent an oversimplification. It is possible that

volume identifies and remedies the problem associated with poor performers carrying out low

surgical volumes. However, this comes at the expense of surgeons who demonstrate good

performance but with low surgical caseload. A recent study, based on data from Clinical

Outcomes of Surgical Therapy randomised control trial, highlighted the possible role of

credentialing (i.e. establishing the proficiency of surgeons at a given technique) in

determining quality (Larson et al., 2008). This may account for good outcomes amongst

some low-volume surgeons. Discriminating between the relative independent impact of

credentialing and volume in determining quality within surgery requires further research

given the growing emphasis being placed upon caseload in service planning in many

countries. In addition to surgical caseload, outcomes following complex surgery have been

found to improve with better staffing in intensive care units and optimum nurse-to-patient

ratios (Dimick et al., 2001).

Process measures

Structural measures yield little information regarding the actual care received by individual

patients. In contrast, process measures seek to reflect the interactions that lead to effective

care. Process metrics frequently measure adherence to treatment standards or guidelines. As

quality metrics, these measures are attractive as they can be standardised and provide

information about the areas in which quality improvement may be focused. Surgical-specific

process measures are currently being sought both in the US and UK (ACS/NSQIP 2009, Care

Quality Indicators, 2009). The American Society of Clinical Oncology have derived a range

of surgical quality process measures for breast and colorectal cancer (Desch et al., 2008).

These metrics include provision of Tamoxifen or Aromatase Inhibitor in breast cancer, lymph

40
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

node harvest for colonic and rectal cancer resection and the timing of radiotherapy and

chemotherapy for breast and colorectal cancer. They aim to reflect the quality of operative

treatment as well as adjuvant care.

Process measures should, however, be directly linked to outcome to confirm their use as a

valid quality marker. This however can prove difficult (Evans et al., 2001). Pitches and

colleagues in a systematic review concluded that there was little relationship between process

measures and mortality. This conclusion was controversial as 51% (26/51) studies included in

their review did demonstrate such a relationship (Pitches et al., 2007). Exclusion of outlying

institutions from individual studies negated any relationship. Recently, there has also been a

growing appreciation of the variable use of some clinical processes in the perioperative

period such as early nutrition, (Fearon et al., 2005) epidural analgesia, (Gendall et al., 2007)

as well as goal-directed fluid administration (Noblett et al., 2006). Protocols, such as

enhanced recovery programmes (ERP), which incorporate a number of processes that are

each independently associated with high-quality care, have been shown to be clinically

effective at accelerating recovery in patients undergoing colorectal surgery (King et al., 2006,

Wind et al., 2006). More importantly, implementation of evidence-based care through ERPs

may also facilitate standardization of high-quality postoperative care and thus improve

outcome.

A single process measure is unlikely to capture all the main aspects of quality and may only

capture a fraction of the variation in outcome. This requires the combined use of several

measures, which can be problematic. One option is to use the proportion of patients for whom

all the evidence-based processes have been followed. However, providers adhering well to

41
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

one process may adhere very poorly to another, even in the same group of patients (Peterson

et al., 2006). Combining measures into one, for example by the use of a composite measure

(like a star rating system), requires a set of weights for this combination, and the choice of

composite measure has been shown to affect the relative performance (rankings) of hospitals

(Jacobs et al., 2005). An often-quoted advantage for process measures is that they do not

require case mix adjustment because the protocol to which they relate should be followed in

all patients. While this is true in theory, in practice the sicker and disadvantaged patients have

been suggested to have such protocols followed less often than other patients (Peterson et al.,

2006). Other than poorer standards of care, possible reasons for this could include greater

levels of contra-indications and patient refusal.

In addition to clinical processes, effective teamwork is associated with superior outcomes in

many different industries, including healthcare. Team working has certainly been associated

with better outcomes in intensive care units, (Shortell, 1991) and primary care (Bower et al.,

2003). Furthermore, it is central both to the delivery of healthcare and to its improvement.

Group information processes such as multi-disciplinary ward rounds have also been found to

be associated with lower mortality and morbidity rates, (Gurses and Xiao, 2006, Plantinga et

al., 2004) as well as a reduced incidence of prescription errors (Leape et al., 1999). In

addition, in the surgical context, Young and colleagues found that low-morbidity hospitals

had higher levels of team communication and coordination (Young et al., 1998). These

examples all suggest that teamwork is a critical mediator for the delivery of both safe and

high quality surgical care.

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Outcome

Outcome measures are frequently used as quality metrics as they can be collected from

existing data sources. They seek to reflect the endpoint of the cumulative processes of a

patients care. Furthermore they may be objective (e.g. mortality) or subjective (e.g. patient

reported outcomes). When outcome measures represent either rarely occurring events (such

as postoperative mortality, surgical site infection rates (Fry, 2008), reoperation rates (Morris

et al., 2007a), or leak rates following elective gastrointestinal surgery), these can represent

blunt instruments with which to measure quality. Moreover, use of inaccurate data,

inadequate case-mix adjustment or even chance variation between patient outcomes may lead

to difficulty in interpretation of performance ranking. In turn, this may invalidate, or render

erroneous, subsequent service or policy decision-making.

Given that measures such as mortality and anastomotic leaks are infrequent events in most

surgical populations, consideration should be given to the sample sizes required to judge

whether outcome differences reflect true variation in performance or whether they reflect

patient factors or chance alone. Singh and co-workers calculated the necessary population

sizes required to detect underperformance using mortality as the outcome measure in radical

cystectomy (Singh et al., 2003). They found that, given an acceptable mortality rate of 3.5%,

a cohort of 211 patients would be necessary to demonstrate that a surgeon with an 8%

mortality rate was underperforming rather than this high mortality being due to chance or

case mix. Depending on the specialty, this may represent several years worth of patients.

Given the large number of patients required to detect significant variation in performance, it

may be necessary to combine performance indicators to derive a meaningful composite

measure that reflects quality. Superiority of empirically derived composite measures over

43
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

individual surgical quality indicators has recently been shown in the context of explaining

variation in mortality after aortic valve replacement surgery (Staiger et al., 2009).

Postoperative mortality represents one of the most commonly used surgical outcome

measures of quality. It has been used to examine performance in vascular surgery, (Holt et

al., 2008b) urology (Chalasani et al., 2009), and, following the Bristol inquiry, it has been

used to monitor cardiothoracic surgery outcomes in the UK (Keogh and R, 2003, Keogh et

al., 2004). Postoperative mortality represents an outcome measure that is easily collected,

can be validated and risk adjusted (Keogh et al., 2004). Although it is an important measure

of outcome, it is however a crude quality measure that, as mentioned previously, is relevant

only to a small number of high risk procedures where this outcome occurs routinely (Califf

and Peterson, 2009). As previously stated, public reporting of mortality data has raised the

concern that surgeons will either reject high risk patients or refer them elsewhere. In addition,

for mortality rates to be genuinely useful as a comparative measure they must be corrected

for case-mix differences and thus far risk adjustment has proved to be imperfect (also see

later section below) (Landon et al., 2003). Knowing that your unit has a high mortality rate is

not the same as knowing why that rate is high and how to reduce it.

Postoperative mortality is an example of an objective outcome metric. It does not however

reflect the patient experience, subsequent life expectancy or offer a subjective measure of

satisfaction. Patient Reported Outcome Measures (PROMs) are instruments that measure

patients illness experience. In the UK, it has been mandatory from April 2009 to collect

general and disease-specific PROMs before and following certain elective procedures

including inguinal hernia repair, varicose vein surgery, unilateral knee replacements and

44
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

unilateral hip replacements (Department of Health, 2009). Work is planned to assess the

degree of risk adjustment required for these measures.

Specific measures assess the impact of a single disease or system on a patients wellbeing.

Disease-specific questionnaires include the Oxford knee score for patients undergoing total

knee replacements, (Dawson et al., 1998) and European organisation for research and

treatment of cancer (EORTC QLQ CR38) questionnaire, which is the most commonly used

disease-specific measure in colorectal cancer patients (Gujral et al., 2008). Generic measures

such as EuroQol 5D and SF-36 evaluate the overall quality of life irrespective of underlying

pathology. PROMs highlight the importance of considering quality from the patients

perspective. It may be argued that, as the healthcare user, the patients view of the impact of

a treatment is the most significant measure of quality.

The relationship between structures, processes and surgical outcomes is complex. NSQIP has

made an attempt to understand the latter relationship (ACS/NSQIP, 2009). Risk-adjusted

outcome data that were routinely collected from the VA hospital sites were analysed against

observations made during site visits (Daley et al., 1997), as well as responses on a survey of

structure and care processes from the same sites (Schifftner et al., 2007). The results were

mixed. The researchers found that risk-adjusted morbidity bore close correlation with

observations of the quality of care observed during the site visits. However, the survey

responses did not demonstrate this association between outcomes and processes of care.

Regardless of the slightly conflicting findings of these studies, what is important is that the

NSQIP has made an attempt to explain how variability in the structure of surgical teams and

the use of care processes may explain some of the variability in outcomes identified across

45
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

surgical units. Furthermore, perhaps their findings from the site visits suggest that the ideal

approach to measuring quality involves quantifying a combination of structural and process

measures as well as outcomes. Lilford and colleagues argue that while outcome measures are

useful, for internal consumption, to monitor trends within an organisation, process measures

may be more fair to make comparisons across organisations (Lilford et al., 2004). The

collective appraisal of all these factors might permit a more global appraisal of surgical

service quality and allow fair comparisons to be made across institutions.

In addition to choosing the appropriate quality measures to examine, the timing and

population to which to apply these measures needs to be ascertained. Due to ease of

collection, outcome measures are often defined as in hospital complications. Post-discharge

complications require dedicated resources to collect. Bilimoria and colleagues found that

inclusion of post-discharge complications did change the outlier status of some institutions

(Bilimoria et al., 2010a). The additional expense of collecting such variables is likely to

preclude inclusion of out of hospital events in performance monitoring unless linkage to other

datasets such as general practice databases is performed. Surgical practice can be broadly

divided into emergency and elective admissions. For some conditions, such as colorectal

cancer some emergency admissions will represent a failure to diagnose a condition at an early

enough stage. Many existing outcome measures focus on elective practice. Emergency

admissions tend to have poorer outcome and involve a different care pathway than elective

admission. Institutions may perform well in elective surgery but poorly in emergency surgery

(Ingraham et al., 2011).

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Risk-adjustment and statistical considerations in quality measurement

Variation in measured performance is not solely due to variation in the quality of care. For

performance measures to be meaningful and reliable, adequate risk adjustment is essential

(Shuhaiber, 2002, Krumholz et al., 2006). Ptok and colleagues demonstrated, using German

data, that risk adjustment largely negated apparent marked differences in unadjusted

mortality rates between two providers emphasising the need to account for patient factors in

any comparisons (Ptok et al., 2011). The literature is awash with scoring systems that attempt

to account for patient-related variation. One of the simplest systems is the American Society

of Anaesthesiologists Classification (ASA). This is a tool to assess the physical status of a

patient prior to undergoing surgery (Davenport et al., 2006). This system has the benefit of

being easily applied but is subjective with low inter-observer reliability (Mak et al., 2002).

The NSQIP risk-adjustment system is the most commonly used robust scoring system in the

US. It contains 60 clinical variables and was developed and validated from procedures

performed in VA hospitals (Khuri et al., 1997, Khuri et al., 1998). Use of ASA alone for risk

adjustment has been compared with the use of all the NSQIP variables for adjustment

(Davenport et al., 2006). Although ASA was a strong predictor of morbidity or mortality,

using the all the NSQIP variables to risk adjust improved prediction. In addition, the authors

cautioned against the use of ASA given its subjective nature. The NSQIP methodology is

widely used in the US NSQIP quality improvement programme (2009a). It, however, requires

input of a large number of variables making it complex and less user friendly. The

Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity

(POSSUM) is a British scoring system that contains only 12 physiological and 6 operative

variables and is used to predict mortality in surgical patients (Copeland et al., 1991). This

system has been validated for patients undergoing vascular and colorectal surgery (Midwinter

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

et al., 1999, Sagar et al., 1994, Al-Homoud et al., 2004). POSSUM has been used previously

to risk-adjust mortality and morbidity when benchmarking surgeon performance (Sagar et al.,

1996). POSSUM is useful both because of its reduced number of variables and it takes into

account the impact of surgical as well as patient factors. The Portsmouth POSSUM (P-

POSSUM) and Colorectal-POSSUM (Cr-POSSUM) are adaptations of this system (Prytherch

et al., 1998, Tekkis et al., 2004).

Despite the apparent validity of many existing risk adjustment methods, surgeons remain

reluctant to have their performance measured following risk adjustment using these systems.

In a questionnaire of American surgeons in hospitals involved in the roll-out of the NSQIP

programme to the private sector, Neuman and co-workers determined that only 46% of

surgeons believed that surgeon-specific outcomes should be reported (Neuman et al., 2009).

Furthermore, only 24% of respondents felt that the NSQIP risk-adjustment system should be

used to determine pay for performance.

The statistical methods used to differentiate performance between providers or healthcare

professionals have been the subjects of much debate. To assist policy and decision-making,

these methods must serve two purposes. Firstly, statistical methods must enable appropriate

discrimination between good and poor performers for a particular quality metric. In addition,

they should enable sequential monitoring to rapidly identify temporal changes in quality. The

use of league tables, funnel plots and control charts for these purposes are described below.

Bilimoria and colleagues used the NSQIP database to compare several methods of identifying

outliers at the hospital level in general and colorectal surgery (Bilimoria et al., 2010b).

Included outcome measures were 30 day mortality and complications. They compared

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

identification of outliers using a standard logistic regression with a confidence intervals set at

90%, 95% and 99% with hierarchical analysis and rankings based on quintiles or quartiles.

Each method yielded a difference number of outliers for mortality and morbidity.

Hierarchical and single level logistic regression analyses offered similar numbers of outliers.

This study did not assess techniques such as funnel plots or control charts.

League tables and caterpillar plots have been used to describe performance data within

healthcare. Caterpillar plots have however been criticised as they can be difficult to interpret,

do not take into account the issues of multiple testing and cannot be used for sequential

testing (Mohammed and Deeks, 2008). Furthermore, by their nature, these plots do invite the

user to rank institutions. This may be hazardous if not appropriately adjusted for case-mix

differences. Moreover, a minimum volume of cases appropriate to the performance outcome

being measured is required for meaningful analysis. Specifically, poor performance at low

volume levels can occur by chance and this method fails to permit its distinction from

genuinely substandard care. Funnel plots were originally described as a means of identifying

publication bias in meta-analyses (Egger et al., 1997), but Speigelhalter first suggested using

funnel plots to examine performance between institutions (Spiegelhalter, 2002). Mayer and

colleagues have recently published a comprehensive review on the use of funnel plots in

surgery (Mayer et al., 2009b). Funnel plots have been used to compare outcomes in patients

undergoing interventions including cardiac, (Stark et al., 2001) and upper gastro-intestinal

surgery (Tekkis et al., 2003a). They represent a graphical presentation of outcome data

adjusted for caseload. Aberrant institutions, or outliers, represent those that demonstrate

variation outside the common cause variation i.e. special cause variation, thereby

prompting further investigation (Marshall et al., 2004). Their principal disadvantage,

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

however, is their inability to efficiently represent sequential changes in performance over

time. Control charts (and recently cumulative funnel plots (Kunadian et al., 2008)) have been

used in recent years to overcome this problem. They were first devised by Shewhart to

improve quality in the industrial setting (Shewhart, 1939). Along with a curve expressing the

average, limits denoting the upper and lower control ceilings are illustrated. Several different

control charts are in use in healthcare, (Thor et al., 2007) including charts based on a

cumulative sum (CUSUM) technique (Aylin et al., 2003). These charts can detect sustained

minor differences between the observed performance and the benchmark and trigger an alarm

when the set control limit or threshold is breached. A systematic review of the statistical

process control approach in healthcare found that control charts were useful in many settings

including surgery, primary care as well as in the monitoring of chronic disease in individual

patients (Thor et al., 2007). These charts have been used retrospectively to detect aberrant or

unexpected performance such as that seen following the Bristol cardiac paediatric surgery

case, (Mohammed et al., 2001) and in the Shipman case (Mohammed et al., 2001, Aylin et

al., 2003). In the latter, Aylin and co-investigators, used the CUSUM chart to examine

primary care data to investigate General Practitioners with significantly high patient mortality

(Aylin et al., 2003). Using this chart, they concluded that Dr Shipman would have been

identified as demonstrating special cause variation, potentially prompting earlier

investigation of his practice. Similarly, a recent article by Coory and colleagues examined 30-

day in-hospital mortality rates following admission for acute myocardial infarction using

administrative data (Coory et al., 2008). This study aimed to compare funnel plots with

sequential monitoring using control charts. Although when using the funnel plots no outliers

were identified above the three standard deviation threshold, on the control charts 5 of the 18

hospitals were flagged as having a relative risk increase of 75% or greater. The authors

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

suggested that control charts allowed earlier identification of potential problems permitting

more timely investigation of units. As with all statistical methods, however, control charts do

have certain disadvantages. Firstly, the threshold settings for the control limits require careful

consideration. If the alarm is triggered frequently, then the chart is likely to be discredited

(Lim, 2003). Secondly, as these charts were designed for the high-volume industrial setting,

they do require a certain case load to permit their use as an effective performance monitoring

technique (Lim, 2003). Finally, due to imperfect risk-adjustment methods, the triggering

alarm may not represent true poor performance but rather variation due to alternative factors.

Measurement of quality in colorectal surgery

Several quality measures have been suggested in colorectal surgery (Almoudaris et al.,

2010a). These may also be divided into structure, process and outcome measures according to

the Donabedian approach. An exhaustive list of possible measures is not within the remit of

this chapter. However, the important or frequently used measures are summarized below.

Structure

Role of caseload

Similar to other areas of surgery, volume has been suggested as a quality measure and a

means of improving quality in colorectal surgery. There is an abundance of literature

suggesting a relationship between surgeon and hospital caseload and complex surgical

procedures such as oesophagectomy (Bilimoria et al., 2008a), abdominal aortic aneurysm

repair (Holt et al., 2007a) and cardiothoracic procedures (Hannan et al., 2003). The volume

outcome relationship in colorectal surgery is less clear. Research has focused on the

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in Colorectal Surgery

relationship of caseload with a variety of outcome measures following mostly cancer surgery

with few studies looking at the volume outcome relationship in other diseases such as

inflammatory bowel disease and diverticular disease. A myriad of volume thresholds have

been suggested using a plethora of different methodologies. In the US, a high volume

hospital has been defined as anything from 25 colorectal procedures per year to over 125

procedures per year (Rabeneck et al., 2004, Bilimoria et al., 2008a). Given the lack of

consensus as to what constitutes a high volume surgeon or hospital, it is difficult to draw

meaningful conclusions from the literature. For colonic surgery, some studies have found a

relationship between hospital volume and mortality (Ko et al., 2002, Hannan et al., 2002,

Birkmeyer et al., 2002, Callahan et al., 2003, Ho et al., 2006, Schrag et al., 2000, Schrag et

al., 2003) while others have failed to find such a relationship (Morris and Platell, 2007,

Billingsley et al., 2007).

The Association of Coloproctology of Great Britain and Ireland (ACPGBI) have proposed a

minimum volume per surgeon of 20 colorectal cancer cases per year (2007). This is based on

an audit of colorectal cancer outcome amongst surgeons in the northern region of England

(Borowski et al., 2007). In this study high volume surgeons were considered as those who

performed more than 18.5 elective and emergency colorectal cancer resection per year. High

volume surgeon caseload correlated with higher rate of restorative surgery and reduced

perioperative mortality. Few other studies corroborated Borowski and colleagues initial study

thresholds. Though the same study group, three years later, categorised a high volume

surgeon as those that performed greater than 40 procedures per year. At these volume

thresholds, operative and long term survival was better amongst higher volume surgeons

(Borowski et al., 2010). Both McGrath and colleagues in an Australian study and Hermanek

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and colleagues in a German study, using greater than seventeen resections per year and

fifteen per year respectively to define the high volume threshold, failed to find an association

between colorectal surgeon caseload and outcome (McGrath et al., 2005, Hermanek and

Hohenberger, 1996). In the volume literature a variety of approaches have been taken for

volume. Some of these have been statistical and some have used a priori thresholds to define

volume groups. Of the statistically defined methods, most studies have divided the patients

or providers into equal groups. Studies have divided providers into three (tertiles) (Harmon

et al., 1999, Miller et al., 2004, Simunovic et al., 2000, Harling et al., 2005, Meyerhardt et al.,

2003), four (quartiles) (Borowski et al., 2010, Borowski et al., 2007, Kee, 1999, Rogers et al.,

2006) or five (quintiles) (Bilimoria et al., 2008a) groups. Some studies though have treated

volume as a continuous measure (Ho et al., 2006, Ko et al., 2002, Panageas et al., 2003,

Schrag et al., 2000).

In modern day colorectal practice, some questions regarding the role of caseload remain

unanswered.

1. Is there a relationship between hospital and surgeon volume and quality of care or

have we negated this by specialised care?

2. If such a relationship exists, which is the critical factor, the surgeon or the hospital

volume?

3. Furthermore, if such a relationship exists, what is the optimal provider volume for

best care?

4. If hospital volume is important, are there hospital characteristics such as radiology

services that are significant in this volume effect?

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
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5. Is overall resection volume important or just cancer volume? Can an Inflammatory

Bowel Disease (IBD) surgeon perform and offer quality perioperative care for cancer

resections

We seek to begin to answer these questions in subsequent chapters.

Processes

Lymph node yield

Lymph node yield has been proposed as a marker of surgical quality. Guidelines suggest that

at least 12 regional lymph nodes are removed and pathologically examined for resected colon

cancer. Identification of at least 12 lymph nodes has been strongly correlated with colorectal

surgical training and surgeon case volume (Dillman et al., 2009, Miller et al., 2004).

However, in the US less than 40% of institutions achieved identification of more than 12

lymph nodes in at least 75% of their cancer resections (Bilimoria et al., 2008d). Furthermore,

Wong and colleagues failed to find an association between hospital lymph node yield and

patient survival and other process measures such as use of adjuvant chemotherapy (Wong et

al., 2007). A systematic review, however, suggested that lymph node yield correlated with

survival for stage II and stage III disease (Chang et al., 2007). In addition, lymph node yield

may be a useful measure of institutional quality as it reflects both the surgeons technical skill

and the pathologists ability to identify lymph nodes in the resected specimen. Its use for

assessing individual surgeons may consequently be limited.

Use of laparoscopy in colorectal resections

NICE guidelines in 2006 suggested that laparoscopic colorectal cancer resection should be

offered to suitable patients where the surgeon has the necessary skill to perform such a

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

resection (NICE, 2006). One study suggested that laparoscopy improved the quality of rectal

resections in rectal cancer (Gouvas et al., 2009). Variation in use of laparoscopy may reflect

patient characteristics but also surgeon and institutional factors such as age of surgeon,

innovation or size of institution. Use of laparoscopy should be tailored to individual patients

but wide variation between providers will reflect more than differences in case mix.

Abdominoperineal excision (APE) rate

Considerable variability in surgical techniques employed between individual surgeons has

been observed (McArdle and Hole, 1991). APE involves resection of the rectum along with

the anal sphincters necessitating a permanent colostomy. Anterior resection with or without a

covering ileostomy has been suggested to be oncologically superior to APE (How et al.,

2011). Tilney and co-workers suggested use of abdominoperineal excision (APE) versus

restorative anterior resection for rectal cancer as a surrogate marker for surgical quality in

elective rectal surgery (Tilney et al., 2008). A recent systematic review found that anterior

resection was associated with reduced tumour perforation and circumferential resection

margin (CRM) involvement as well as improved survival and local recurrence rates (How et

al., 2011). Morris and co-workers, examined variation in APE rates across the English NHS

using administrative data linked to cancer registry data (Morris et al., 2008). This study found

significant variation in the use of APE in rectal cancer across the health service in England

re-emphasising the potential of APE rates as a quality measure. It is important to state that

not all rectal cancers are amenable to excision by anterior resection nor have substantial

differences in postoperative quality of life been noted between anterior resection and APE

(Cornish et al., 2007). The Association of Coloproctology of Great Britain and Ireland

(ACPGBI) have recommended that the number of resectable rectal cancers treated by APE

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

should be less than 30% of rectal cancer resections (ACPGBI, 2007). Process measures like

APE rates and the quality of surgical excision by histological examination of the plane of

surgical dissection can be used to measure aspects of surgical quality in rectal cancer

treatment (Quirke, 2003).

Participation in National Audit

Participation in National Audit is central to good clinical practice and governance in all

specialties including colorectal surgery (NBOCAP, 2004). Registries exist for colorectal

cancer and restorative proctocolectomy. These registries aim to improve quality through

national audit. Indeed, Almoudaris and colleagues found that those organisations that did not

submit to the National Bowel Cancer Audit Project (NBOCAP) had higher mortality rates

than those that did submit (Almoudaris et al., 2011). The reasons for this discrepancy are

unclear. The infrastructure necessary to allow submission may reflect a better organized

institution with improved care processes and therefore better outcome.

Outcome

Mortality

Mortality is a quality measure that has been historically relied upon and one of the most

widely recognised measures of surgical quality (Morris et al., 2011b). In the elective setting,

postoperative mortality following colorectal surgery occurs infrequently making it an

insensitive alert to poor performance and requiring many cases to meaningfully identify

outliers. A long audit period is required for it to be statistically stable. Commonly used

definitions such as all cause mortality and 30 day in hospital mortality do not discriminate

between all deaths and those that are potentially preventable. Finally, many failures in care

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in Colorectal Surgery

do not always lead to death. The effect of public reporting of mortality data in colorectal

surgery is unknown.

Length of stay and readmission

One of the main determinants of the cost of an admission is the length of in hospital stay

(LOS). Optimum length of stay is desirable from the provider and patients viewpoints.

Programmes have been designed to reduce length of stay such as ERP (Wind et al., 2006).

Considerable variation in LOS across institutions has been demonstrated following colorectal

surgery in England and in the US (Cohen et al., 2009, Faiz et al., 2011b). Fry and colleagues

suggested that prolonged length of stay correlates well with adverse events and is a good

quality measure (Fry et al., 2009). Though prolonged LOS has been proposed as a useful

quality measure that can be used to drive quality improvement, caution should be applied

when assessing individual surgeons with this metric. LOS is not always within the surgeons

control and may reflect other factors such as availability of rehabilitation services and

coordination of discharge planning.

Readmission has become increasingly important with the suggestion that providers will not

receive reimbursement for emergency readmissions after surgery. This will be especially

significant in the context of the ERP where shorter LOS may be offset by increased

readmissions. Distal bowel resection, benign diagnosis, young age, and social deprivation

were predictors of readmission following colorectal cancer resection (Faiz et al., 2011b).

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
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Reoperation

Postoperative reoperation has been suggested as a useful quality marker in the United States

for general surgery (Birkmeyer et al., 2001), more recently for colorectal surgery (Morris et

al., 2007a, Merkow et al., 2009) and in the UK for vascular surgery (Holt et al., 2009a).

Reoperations following colorectal surgery are undertaken mostly for surgical morbidity such

as postoperative bleeding or anastomotic leaks. Reoperation is associated with poor clinical

outcome including higher risk of early death and local recurrence as well as poorer overall

survival (Mirnezami et al., 2011). A small single centre study found that approximately 50%

of reoperations could be a result of technical failure (Isbister, 1998). In a review of quality

indicators using the Delphi technique a multidisciplinary team suggested that anastomotic

leak following surgery should be an outcome measure used to assess surgeon quality

(Gagliardi et al., 2005). This review prioritized 30 day mortality as an outcome measure but

did not prioritize readmission, LOS or unplanned return to theatre. From administrative data

it is likely that a substantial portion of reoperations represent anastomotic leaks. A measure

such as reoperation, when taken alongside other accepted measures such as mortality,

potentially offers a sensitive and relevant marker of surgical quality.

Quality in surgery and specifically in colorectal surgery is a broad subject. Defining and

measuring surgical quality is aimed towards improving quality of care experienced by

patients. This thesis seeks to derive new possible measures from routinely collected data to

allow measurement of quality and performance benchmarking if data accuracy can be

assured.

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Chapter 3- Data sources for quality measurement.

Irrespective of the structural, process or outcome metrics employed to appraise quality, data

sources are necessary from which to derive these measures. These sources need to be reliable

for the specified use and relevant to the purpose or group to which the metrics are being

directed. In broad terms current external data sources, i.e. beyond individual surgeon or

departmental audit, include routinely collected administrative data sets and clinical registry

data.

Routinely collected datasets

Routinely collected datasets are primarily collected for administrative reasons. In the US,

they are used for insurance and billing purposes. In the UK, administrative datasets are used

for hospital reimbursement through the Payment by Results system and for healthcare

management purposes as well as being increasingly used to audit hospital performance by

agencies such as the Care Quality Commission (Care Quality Commission, 2009).

In the UK, there are four separate routinely collected datasets for England, Scotland, Wales

and Northern Ireland. The Hospital Episode Statistics (HES) is the dataset for England. The

Information Services Division Scotland (ISD) database is the routinely collected database in

Scotland. The HES dataset comprises data for every hospital admission that takes place in

England. These data can be used to examine regional procedure rates and outcome measures

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

such as inpatient mortality and length of hospital stay but, through linkage to other national

datasets, can also be used to measure other outcome such as out of hospital mortality. These

outcome measures have been used to compare inter-centre variability (Jarman et al., 1999).

HES data have been collected since 1987 from all inpatient admissions in NHS trusts in

England. The database contains clinical information about primary and secondary diagnoses,

procedures and patient level information such as age group, gender, postcode and ethnicity.

The database contains information on waiting list time, date and mode of admission. The

main unit of the dataset is the Finished Consultant Episode (FCE). The FCE is defined as the

period of admitted patient care under a consultant or allied healthcare professional within an

NHS trust (www.hesonline.nhs.uk). Each episode has an assigned primary diagnosis and up

to 20 secondary diagnoses which are currently coded using International Classification of

Disease (10th revision) (ICD-10) with procedures categorised with up to 24 procedure fields,

coded using the Office of Population Censuses and Surveys Classification of Surgical

Operations and Procedures (4th revision) (OPCS-4).

HES data have been linked to other national datasets such as the Office of National Statistics

and the Cancer Registry for additional clinical and outcome information such as out of

hospital mortality and tumour staging (HES/ONS methodology, 2002, Morris et al., 2008).

HES have been previously used to examine outcome measures such as mortality, unplanned

readmission and length of stay. Complications such as reoperation have been published and

used to benchmark hospital performance using American administrative data (Birkmeyer et

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

al., 2001, Morris et al., 2007a). Such a measure has not been previously reported using a UK

administrative dataset for colorectal surgery. Recently, Holt and colleagues examined re-

interventions on the index admission following abdominal aortic aneurysm repairs (Holt et

al., 2009a).

In the US, there is no single nationwide dataset. Administrative databases are, however,

maintained by state and federal governments as well as private health insurers. Three

examples of such databases maintained in the US are described below. Medicare, a federal

initiative, has since 1965 provided health insurance for those over 65 years of age and people

with disabilities and end stage renal failure (Iezonni, 2003). In 2000, Medicare served 39

million people - 14% of the US population (DeParle, 2000). Separate from Medicare, the

Department of Veterans Affairs (VA) provides patient care for veterans and their dependants.

As stated previously the VA have dedicated substantial efforts to improving information

capture for performance monitoring through NSQIP (ACS/NSQIP, 2009). Medicaid

represents another major US healthcare provider that is a combined state and federal

program, (Iezonni, 2003) which provides cover to those with disabilities as well as long-term

care for older people. In 1998 Medicaid provided coverage for more than 15% of the US

population (DeParle, 2000).

Unlike American datasets, HES data cover all of England and therefore afford a national

overview of practice and outcome. Routinely collected datasets in the US employ ICD-9-CM

diagnosis coding whereas in the UK ICD-10 is used. The codes used to denote procedures

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also differ. These differences can lead to difficulties in translating clinical indicators from

the US to UK (Bottle and Aylin, 2009, Raleigh et al., 2008).

Clinical databases

To examine inter-institutional variation in surgical provision and outcome, large databases

are required. These databases may be clinical or routinely collected datasets. The largest UK

colorectal clinical dataset is the National Bowel Cancer Audit Project (NBOCAP) database.

This dataset was originally set up under the auspices of the Association of Coloproctology of

Great Britain and Ireland (ACPGBI). This audit project is administered by ACPGBI and the

National Clinical Audit Support Programme. It has previously been used to examine

variation in surgical practice for colorectal cancer, to describe outcome following colorectal

resections for cancer and derive predictive models of mortality (Tilney et al., 2009, Tan et al.,

2007, Tekkis et al., 2003b). Furthermore annual reports are produced describing national

process measures such as APE rates, circumferential margin clearance rates, permanent

stoma rates and use of laparoscopy as well as outcome measures such as postoperative

mortality. However, not all NHS Trusts submit data to this audit and data completeness

remains problematic (NBOCAP, 2009). Case ascertainment was estimated at 69% in the

latest report (NBOCAP, 2009).

Clinical databases contain data relevant to a specific clinical condition or procedure. Data are

usually collected through voluntary submission from clinicians or institutions and cover a

wide range of clinical information concerning patient demographics, treatment and outcome.

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Often these databases are set up under the auspices of specialist societies with an interest in a

particular condition or procedure. A clinician or allied healthcare professional usually

submits the data. This attempts to ensure the accuracy of the data and also gives clinicians a

sense of ownership of the data. Furthermore, outcome data can be tailored to the specific

disease or condition for example quality of life data or data on postoperative function.

Submission to these datasets is not mandatory (Almoudaris et al., 2011). Bias may be present

or perceived as those who have feel that they deliver optimum care maybe more likely to

submit data. This makes comparisons between clinicians or institutions using these datasets

problematic. Moreover, as these datasets are often under the direction of specialist societies

rather than direct government control, there is a question of how to investigate those

clinicians or institutions that appear to be outliers.

National Surgical Quality Improvement Program

The National Surgical Quality Improvement Program (NSQIP) is endorsed by the American

College of Surgeons and is a large scale audit project involving all Veteran affiliated

hospitals. This program is also being rolled out across many private hospitals (2009a). The

aim of this audit is to use benchmarked internal data feedback to facilitate quality

improvement. Each hospital submits data collected by a trained research nurse. This audit

uses a sampling technique rather than collecting data about all patients admitted to

participating hospitals. Much work has been performed to refine the risk adjustment of the

data to facilitate bench marking between institutions (Khuri et al., 1998, Khuri et al., 1997).

NSQIP has been extensively used for population based studies in a broad range of surgical

specialties (Abedi et al., 2009, Lancaster and Hutter, 2008, Campbell et al., 2008, Bilimoria

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et al., 2008b, Bilimoria et al., 2008c). In the US, NSQIP data are considered the gold standard

(Fink, 2009). However data collection is expensive, time consuming and selective requiring

additional trained staff (Kaafarani and Rosen, 2009).

The cost of maintaining HES data has been estimated at 1 per record with clinical registry

data costing up to 60 per record (Raftery et al, 2005). Given the low cost and universal

nature of routinely collected data, they offer an attractive potential source of benchmarking

performance and quality in healthcare.

Advantages and disadvantages of routinely collected data

Table 3.1 summarises the advantages and disadvantages of using HES data. Despite the

advantages of size, low cost (per record) and ease of collection, routinely collected datasets

do have weaknesses. In keeping with their administrative origins they collect limited clinical

information and the data input is by non-clinicians. The routinely collected databases do not

currently collect subjective measures of performance that might afford patient-centred

performance benchmarking. In England, the independent healthcare regulator, the Healthcare

Commission, which has recently been reorganised into the Care Quality Commission, carries

out yearly patient surveys designed to systematically gather patients opinions regarding the

care that they have received (Care Quality Commission, 2009). These surveys cover a broad

range of enquiry into a patients experience. The Care Quality Commission uses the results of

this survey as part of a global assessment of performance when rating healthcare providers.

To date these have been not been linked to the HES dataset.

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Table 3.1: Advantages and disadvantages of HES data

Advantages of HES data Disadvantages of HES data


Inexpensive Non clinicians coding data may reduce accuracy
Non clinicians coding data may ensure objectivity of coding
National Data quality concerns
Inclusive of all practitioners, diseases and
Lack of clinically relevant information
conditions
Many years of data Limited outcome and process measures
Linked episodes for longitudinal analysis
Potential linkage to other data sources

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The accuracy of coding is variable. Campbell and co-workers, in a systematic review of UK

administrative data published in 2001, found a median accuracy for coding of 91% for

diagnostic codes and 69.5% for procedure codes (Campbell et al., 2001). There have been

system changes since this review. Some authors suggest that the quality of HES data is not

yet sufficiently robust to use for public reporting of routine activity and outcome monitoring.

However, predictive models derived from HES data have been shown to be as accurate as

those derived from vascular, cardiac and colorectal clinical registry data for predicting

mortality for three common procedures (Aylin et al., 2007a). Aylin and colleagues compared

risk prediction models derived from HES for isolated coronary artery bypass graft (CABG),

abdominal aortic aneurysm repair (AAA repair) and colorectal cancer resection to those

published from the national cardiac surgery database, the national vascular database and the

colorectal cancer database. Good agreement, measured by Receiver Operating Characteristic

score, was found between the models derived from HES and those derived from clinical

registries (CABG HES 0.77 Clinical registry 0.78, ruptured AAA repair HES 0.66 Clinical

registry 0.65, unruptured AAA repair HES 0.74 Clinical registry 0.70 and colorectal cancer

resection HES 0.80 Clinical registry 0.78) (Aylin et al., 2007a). At a national level HES has

been shown to be more comprehensive, and at least as accurate, as the Association of

Coloproctology of Great Britain and Ireland (ACPGBI) colorectal cancer database and the

National Vascular database (Garout et al., 2008, Aylin et al., 2007b). Garout and colleagues

compared case volume and postoperative mortality for patients undergoing colorectal cancer

resection with the ACPGBI database.(Garout et al., 2008) HES reported 12% more

procedures than ACPGBI in 2001-2002 in Trusts than submitted to the database. ACPGBI

reported 5.8% mortality with 5.6% reported on HES. It must be stressed that the definitions

of mortality differed between HES and the ACPGBI database. 30 day in hospital mortality

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in Colorectal Surgery

was available on HES whereas in and out of hospital mortality was reported on the ACPGBI

database. Aylin and colleagues similarly compared volume and mortality for patients

undergoing a range of vascular procedures including AAA repair, carotid endarterectomy and

infrainguinal bypass (Aylin et al., 2007b). For those Trusts that submitted data to both

databases, 8461 more cases were reported on HES (HES 16923 and Vascular database 8462).

When only the consultant teams that were known to submit data to the registry were included

in the analysis, HES still had 2141 more cases than the vascular registry. Amongst these

patients, there were no differences in mortality between the two datasets. Westaby and

colleagues compared congenital heart surgery as reported on HES with that reported on the

central cardiac audit database (CCAD) (Westaby et al., 2007). The authors reported that the

HES database included less cases and underestimated mortality when compared to CCAD.

However, similar to the study by Garout and colleagues (Garout et al., 2008), the definition

of mortality differed between the two databases with the CCAD recording in and out of

hospital mortality whereas just in hospital mortality is available on HES. Furthermore,

Westaby looked at a wider range of procedures and the coding differed between studies

leading to the discrepancies in the included procedures and hence numbers.

There have been changes in the use of routinely collected data with the introduction of

Payment By Results (PbR scheme). This is an initiative directing healthcare funding based

on information drawn from coding data. An individual Trusts payment is based on the

activity carried out at the hospitals within the Trust. Tariffs are adjusted for case mix. Each

episode of patient care gets coded into a tariff, the Healthcare Resource Group (HRG). It is

this HRG that determines hospital payment. A clinical audit programme was carried out for

the first time in all acute NHS trusts in 2007-08, including over 50,000 episodes equating to

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73 million under the PbR scheme (Audit Commission, 2008). Results of the audit showed

that errors in coding were having a significant impact on payment accuracy. Average error in

Healthcare Resource Group (HRG) coding was 9.4% with a range of 0.3% to 52% across

trusts reflecting a gross error of 3.5 million or 5% of the sample size. Although the net

financial impact was close to zero, there were a number of cases where the net local financial

impact was significant. The NHS operating framework for 2008-09 calls on organisations to

focus on clinical coding in the drive for world class patient care (Department of Health,

2007). The focus on accurate coding alongside the link to financial reimbursement may have

improved coding accuracy.

Prior to the reliance on routinely collected hospital data for identification of substandard

performance at either an institutional or surgeon level, validation of the data source, as well

as of the metric that is being used to denote the quality of a given care pathway, is a pre-

requisite. It is difficult to quantify coding accuracy and in particular amongst surgical

patients. The Audit Commision report assesses a sample of case notes across all Trusts. The

focus is not exclusively on surgical patients. In order to attempt to answer this question in the

modern day setting with current information technology system, the focus on data accuracy

and following the introduction of the PbR scheme, a systematic review of data accuracy

recorded in the existing literature was performed. The primary objective of this study is to

identify and review studies investigating the accuracy of hospital episode data. Secondary

objectives are to investigate factors influencing variation in coding errors.

The accuracy of routinely collected data can be assessed against various standards. In this

review the gold standard is assumed to be where coding is compared to that derived from

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

independent assessment of the case notes. This requires reliable data within the case notes.

In some studies, where indicated, coding is compared to other sources such as clinical

registry data. Each system is subject to possible inaccuracy as the data quality depends on

those inputting the data. In addition, registries may not use OPCS or ICD 10 to code data

further introducing inherent differences. Therefore, in this review, studies that use clinical

registry data are considered separately from case note review studies.

Systematic review of accuracy of routinely collected data

Methods

The measurement tool for assessment of multiple systematic reviews (AMSTAR), which

consists of 11 items for assessing methodological quality of systematic reviews was

employed (Shea et al., 2007).

Literature Search

We searched PubMed, EMBASE, The Cochrane Database and Ovid. Studies assessing the

accuracy of hospital coding data from Great Britain were identified. Studies published from

1989 to present were included.

Search terms included

1. Scottish Morbidity Record, OCD, SMR, OPCS, ICD (MeSH), HES, HAA

2. Classification, nomenclature (includes vocabulary controlled)(MeSH), Medical

records (MesH), Medical records, computerised (MeSH), Medical Record Linkage

(MeSH), Registries (MeSH), Forms and record control, clinical coding.

3. Accuracy (Ti/Ab), Quality (Ti/Ab)

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
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4. Limit year 1989 to present

5. Great Britain

6. 5 and 6

7. 1 and 3

8. 2 and 3

9. 1 and 2 and 3

10. 6 and (7 or 8 or 9)

Using the search term PEDW did not yield any further relevant articles.

References of the articles identified were also hand searched for further relevant articles. In

addition, expert knowledge of potential further sources such as the Audit Commission was

used to ensure as comprehensive a review of available sources as possible.

Review selection criteria

Studies from the electronic searches were reviewed independently by myself and another

researcher. Discrepancies between selected papers were assessed by another researcher for

inclusion and agreed through consensus. All papers assessing accuracy of hospital coding

data were included and no restrictions were made on the type of study.

Inclusion criteria

Included studies had to:

1. Compare routinely collected hospital coding data with independent review of hospital

notes or discharge summaries

2. Examine ICD and/or OPCS codes

3. Measure data quality against published standards and rules

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4. Be based in Great Britain

5. Be published in the English language

6. Be published after 1989

7. Have identifiable accuracy rates

Quality assessment

Papers were assessed using a pre-defined checklist of quality criteria derived from Crombie

(Crombie, 1996) and utilised by Campbell et al (Campbell et al., 2001) in a previous review

of discharge coding accuracy. Quality criteria were as follows:

1. Random sampling of episodes. This was coded as yes if random sampling was

explicitly stated or all episodes from a defined time period were obtained; no if

sampling was mentioned, but not random and unclear when the sampling strategy

was not outlined.

2. At least 90% of episodes sampled were available for analysis. This was coded as

yes if the percentage was greater than 90%; no if the percentage was less than 90%

and unclear when the percentage was not recorded or able to be calculated from the

data.

3. Trained coders were utilised. This was coded as yes when coders training or

experience was specifically mentioned; no when coders were stated as clinicians or

untrained and unclear when the training of coders was not mentioned.

4. Inter- and intra-coder reliability rates were reported. This was coded as yes when

rates were recorded; no when no record of reliability rates was made and unclear

when reliability was discussed but not explicitly stated.

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5. Awareness of codes at time of discharge. This was coded as no - unaware when

coders were blinded to the original coding of a procedure or diagnosis; yes - aware

when coders were aware of the original diagnoses when recoding case notes or

discharge summaries or unclear when awareness of coders to previous coding was

not noted.

Reported accuracy rates refer to the primary diagnosis and main procedure code. Accuracy is

defined as the percentage agreement between coding allocated through independent

assessment of hospital notes or discharge summaries and that recorded on the routinely

collected dataset. The overall diagnosis and procedures accuracies were calculated where

applicable. In those studies that assessed the accuracy of both the procedure and diagnosis, if

stated in the paper the overall accuracy was used to contribute to calculation of the median

overall accuracy of the studies. If not stated in the paper, the diagnostic and procedure

accuracies were considered separately. Some studies report three or four level accuracy. The

accuracy level reported is that described by the authors of the individual studies as stated in

Table 3.2. The clinicians diagnosis at discharge was taken to be the standard against which

the accuracy was measured.

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Investigating*the*use*of*Hospital*Episode*Statistics*data*to*measure*variation*in*Performance*and*Quality*in*Colorectal*Surgery*
*

Table 3.2: Assessment of quality of studies examining data accuracy of routinely collected data in comparison to case note review
Data source 90% Coder
Random Trained Coder Definition of
First Author Reference Year sampled Awareness
sampling coders reliability Accuracy
available of codes
Sellar C (Sellar et al., 1990) 1990 Registry and Case note No Yes Unclear No Yes, aware Unclear
Smith SH (Smith et al., 1991) 1991 Case note review Yes Yes No No Unclear Unclear
Yeoh C (Yeoh and Davies, 1993) 1993 Case note review Yes No Unclear Yes No, unaware Unclear
Panayiotou B (Panayiotou, 1993) 1993 Case note review Unclear Yes Yes No Yes, aware Three digit
Cleary R (Cleary et al., 1994) 1994 Case note review Unclear Unclear Yes Yes Unclear Four digit
Drennan Y (Drennan, 1994) 1994 Case note review Yes Yes Yes No No, unaware Unclear
Gibson N (Gibson and Bridgman, 1998) 1998 Case note review Yes No Unclear No Unclear Four digit
Dixon J (Dixon et al., 1998) 1998 Case note review Yes Yes Yes Yes Unclear Four digit
Kirkman M.A (Kirkman et al., 2009) 2009 Discharge summary Yes Unclear Unclear No Unclear Four digit
Reddy-Kolanu GR (Reddy-Kolanu and Hogg, 2009) 2009 Case note review Yes Yes Yes No Unclear Unclear
Nouraei SA (Nouraei et al., 2009) 2009 Case note review Yes Yes Yes Unclear Unclear Four digit
Mitra I (Mitra et al., 2009) 2009 Case note review Yes Unclear Yes No Unclear Four digit
Beckley (Beckley et al., 2009) 2010 Case note review Yes Unclear Yes No Unclear Unclear
Audit Commission (Audit Commission, 2010) 2010 Case note review Yes Unclear Yes Unclear Unclear Four digit
Murchison J (Murchison et al., 1991) 1991 Case note review No Yes Unclear No Unclear Unclear
Park RH (Park et al., 1992) 1992 Case note review No Yes No No Unclear Unclear
McGonigal G (McGonigal et al., 1992) 1992 Case note review No Yes No No Yes, aware Four digit
Pears J (Pears et al., 1992) 1992 Case note review Unclear No Unclear Unclear No, unaware Four digit
Samy AK (Samy et al., 1994) 1994 Case note review Yes Unclear Unclear Unclear Unclear Unclear
Dornan S (Dornan et al., 1995) 1995 Case note review Yes Yes Yes No Yes, aware Unclear
Harley K (Harley and Jones, 1996) 1996 Case note review Yes Yes Yes No Unclear Three digit
Case note review and
Davenport RJ (Davenport et al., 1996) 1996 No Yes Unclear No Yes, aware Unclear
Local registry
Kohli HS (Kohli and Knill-Jones, 1992) 2009 Case note review Yes Yes Unclear No Yes, aware Four digit
Hasan M (Hasan et al., 1995) 1995 Case note review Yes Yes Yes No Unclear Four digit
Colville RJ (Colville et al., 2000) 2000 Operation note review Yes Yes No No No, unaware Four digit

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Investigating*the*use*of*Hospital*Episode*Statistics*data*to*measure*variation*in*Performance*and*Quality*
in*Colorectal*Surgery*
*

Results

69 potential studies were identified by the searches. Of these, 37 studies were excluded.

Figure 3.1 shows the reason for exclusion of these studies.

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in Colorectal Surgery

Figure 3.1: Schematic of inclusion following literature search.

7
750 initial

results

681 excluded on review of title


and abstract

69 papers
37 papers excluded when full papers
reviewed
- 7 letters
- 13 non HES data
- 12 did not include accuracy
- 1 study was not UK based
- 2 reviews
- 2 outpatient data

32 papers

25 case note 7 clinical registry

review

75

S
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Of the 32 included studies, 25 studies compared the data accuracy of routinely collected data

with case or operation notes (Colville et al., 2000, Davenport et al., 1996, Dixon et al., 1998,

Dornan et al., 1995, Gibson and Bridgman, 1998, Harley and Jones, 1996, Hasan et al., 1995,

Kirkman et al., 2009, Kohli and Knill-Jones, 1992, McGonigal et al., 1992, Mitra et al., 2009,

Murchison et al., 1991, Nouraei et al., 2009, Panayiotou, 1993, Park et al., 1992, Pears et al.,

1992, Reddy-Kolanu and Hogg, 2009, Samy et al., 1994, Sellar et al., 1990, Smith et al.,

1991, Yeoh and Davies, 1993, Cleary et al., 1994, Audit Commission, 2010, Beckley et al.,

2009) and seven studies contrasted routinely collected data with clinical registry data (Jen et

al., 2008, Mukherjee et al., 1991, Raza et al., 1999, Milburn et al., 2007, Garout et al., 2008,

Aylin et al., 2007b, Westaby et al., 2007).

Tables 3.3 and 3.4 summarise the details of the included studies that examined the data

accuracy using case note review and registry data respectively. Of the papers that compared

routinely collected data accuracy with case note review, 14 papers (56%) used English

datasets (Cleary et al., 1994, Kirkman et al., 2009, Gibson and Bridgman, 1998, Yeoh and

Davies, 1993, Panayiotou, 1993, Sellar et al., 1990, Reddy-Kolanu and Hogg, 2009, Smith et

al., 1991, Dixon et al., 1998, Nouraei et al., 2009, Mitra et al., 2009, Audit Commission,

2010, Beckley et al., 2009), nine (37.5%) examined Scottish data (Murchison et al., 1991,

Park et al., 1992, Kohli and Knill-Jones, 1992, McGonigal et al., 1992, Dornan et al., 1995,

Samy et al., 1994, Pears et al., 1992, Harley and Jones, 1996, Davenport et al., 1996) and two

studies used Welsh data (Colville et al., 2000, Hasan et al., 1995). 20 of these papers

assessed the accuracy of diagnostic coding (Cleary et al., 1994, Colville et al., 2000,

Davenport et al., 1996, Dixon et al., 1998, Dornan et al., 1995, Gibson and Bridgman, 1998,

Hasan et al., 1995, Kirkman et al., 2009, Kohli and Knill-Jones, 1992, McGonigal et al.,

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1992, Murchison et al., 1991, Nouraei et al., 2009, Panayiotou, 1993, Park et al., 1992, Pears

et al., 1992, Samy et al., 1994, Sellar et al., 1990, Yeoh and Davies, 1993) and nine papers

assessed the accuracy of procedure coding (Colville et al., 2000, Dixon et al., 1998, Harley

and Jones, 1996, Mitra et al., 2009, Nouraei et al., 2009, Reddy-Kolanu and Hogg, 2009,

Smith et al., 1991, Drennan, 1994). The majority of studies that assessed diagnostic coding

accuracy used ICD9 (11 studies) exclusively. However, four studies examined ICD10 and

three studies with long study periods used a combination of ICD9 and ICD8. A version of

the OPCS4 coding system was used in seven of the nine studies that examined procedure

coding. The remaining two studies assessed the use of the OPCS3 or an unspecified version

of the OPCS coding system.

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Table 3.3: Summary of included studies examining data accuracy of routinely collected data in comparison to case note review
Number of
Country First Author Reference Year Diagnosis/Procedure included Study dates Coding system Setting Data accuracy
cases sampled
England Sellar C (Sellar et al., 1990) 1990 Deliberate self poisoning 1980-1985 ICD8, ICD9 488 Single hospital Diagnosis 95.7%
England Smith SH (Smith et al., 1991) 1991 Joint replacements 1988 OPCS3 139 3 hospitals Procedure 85.0%
(Yeoh and Davies, 37 1990, Diagnosis 54.1% 1990
England Yeoh C 1993 Paediatric diagnoses 1990, 1991 ICD Single acute hospital
1993) 117 1991 Diagnosis 84.6% 1991
England Panayiotou B (Panayiotou, 1993) 1993 Cerebrovascular disease Unspecified ICD9 117 Single acute hospital Diagnosis 76.0%
All general medicine and
England Cleary R (Cleary et al., 1994) 1994 1990-1991 ICD 501 2 acute hospitals Diagnosis 51.0%
general surgery diagnoses
Urology, Cardiothoracics, OPCS4.2 Diagnosis 68.0%
England Drennan Y (Drennan, 1994) 1994 1990-1991 2044 4 acute hospitals
Cardiology, General Surgery ICD9 Procedure 83.0%
(Gibson and
England Gibson N 1998 General Surgery diagnosis 1995 ICD10 298 Single acute hospital Diagnosis 71.0%
Bridgman, 1998)
Diagnosis 1252 Diagnosis 50.5%
England Dixon J (Dixon et al., 1998) 1998 All 1991-1993 OPCS4, ICD9 2 hospitals
Procedure 416 Procedure 65.9%
ICH 978 Diagnosis ICH 95.9%
England Kirkman M.A (Kirkman et al., 2009) 2009 Haemorrhagic stroke 2002-2007 ICD10 4 acute hospitals
SAH 1169 Diagnosis SAH 96.1%
(Reddy-Kolanu and Hospital day surgery
England Reddy-Kolanu GR 2009 ENT procedures 2008 OPCS4 79 Procedure 69.6%
Hogg, 2009) unit
Diagnosis 96.2%
England Nouraei SA (Nouraei et al., 2009) 2009 Otolaryngology procedures 2007-2008 OPCS4, ICD9 1250 Single acute hospital
Procedure 85.1%
Head and Neck Surgery
England Mitra I (Mitra et al., 2009) 2009 2006 OPCS 34 Single acute hospital Procedure 52.6%
procedures
England Beckley (Beckley et al., 2009) 2009 Urological procedures 2007 ICD10, OPCS4 500 Single acute hospital Procedure 83.4%
Overall 87.0%
(Audit Commission,
England Audit Commission 2010 All diagnoses 2009-2010 ICD10, OPCS4 unknown Multiple hospitals Diagnosis 87.0%
2010)
Procedure 90.0%
ENT- Ears Nose and Throat
SAH- Subarachnoid Haemorrhage
ICH- Intracerebral Haemorrhage
ICD- International Classification of Disease
OPCS- Office of Population, Censuses and Surveys (OPCS) classification of interventions and procedures
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality in Colorectal Surgery

Table 3.3: Summary of included studies examining data accuracy of routinely collected data in comparison to case note review contd

Number of
Country First Author Reference Year Diagnosis/Procedure included Study dates Coding system Setting Data accuracy
cases sampled
All NHS Overall 93.7%
Scotland Murchison J (Murchison et al., 1991) 1991 Inflammatory Bowel Disease 1968-1983 ICD8, ICD9 255 hospitals in Crohns 95.5%
Scotland Ulcerative Colitis 91.0%
Scotland Park RH (Park et al., 1992) 1992 Wilson's disease 1974-1989 ICD8, ICD9 40 All Scotland Diagnosis 87.50%
Gastrointestinal Diagnosis, Co- Multiple
Scotland Kohli HS (Kohli and Knill-Jones, 1992) 1992 1987 ICD9 778 Diagnosis 73.6%
existing Arthritis hospitals
Scotland McGonigal G (McGonigal et al., 1992) 1992 Dementia 1974-1988 ICD 196 Single hospital Diagnosis 93%
Paediatric and general medical 52 paediatric Paediatric diagnosis 67.0%
Scotland Pears J (Pears et al., 1992) 1992 Unspecified ICD9 Single hospital
diagnoses 100 medical Medical diagnosis 54.0%
Abdominal Aortic Aneurysm
Scotland Samy AK (Samy et al., 1994) 1994 1979-1991 ICD9 500 Unclear Diagnosis 97.80%
diagnosis
Upper Gastrointestinal
Scotland Dornan S (Dornan et al., 1995) 1995 1989-1991 ICD9 3447 Single hospital Diagnosis 58.40%
diagnoses
Multiple Diagnosis 89.2%,
Scotland Harley K (Harley and Jones, 1996) 1996 All diagnoses 1992, 1994 ICD9, OPCS4 17959
hospitals Procedure 88.2%
Scotland Davenport RJ (Davenport et al., 1996) 1996 Stroke Unclear ICD9 566 Single hospital Diagnosis 94.2%
Wales Hasan M (Hasan et al., 1995) 1995 Cerebrovascular disease 1993 ICD9 166 Single hospital Diagnosis 74.0%
Overall 78.0%
Wales Colville RJ (Colville et al., 2000) 2000 Plastic surgery procedures 1998 OPCS4 50 Single hospital Diagnosis 62.0%
Procedure 98.0%
ENT- Ears Nose and Throat
SAH- Subarachnoid Haemorrhage
ICH- Intracerebral Haemorrhage
ICD- International Classification of Disease
OPCS- Office of Population, Censuses and Surveys (OPCS) classification of interventions and procedures

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Table 3.4: Summary of included studies comparing routinely collected data with clinical registries
Country First Author Reference Year Diagnosis/Procedure Study Coding Comparison registry Measure used Setting % Data recorded on
considered dates system HES versus Registry
England Jen MH (Jen et al., 2008) 2008 Clostridium Difficile, 2004- ICD10 HPA mandatory Numbers Multiple Clostridium
Orthopaedic Surgical Site 2005 reporting registry included on hospitals DifficileHPA 93121
infection (SSI) each database HES 36757
SSI HPA 1191
HES 1045
England Mukherjee AK (Mukherjee et al., 1991 Ovarian Neoplasm 1979- ICD9 Ovarian Tumour Case inclusion Multiple Ovarian Tumour
1991) 1983 Registry and Regional hospitals Registry 685
Cancer Registry HAA 611
England Garout M (Garout et al., 2008) 2008 Colorectal Cancer 2001- OPCS4 National Clinical Patient volume Multiple ACPGBI registry 6, 617
2002 Registry and outcome hospitals cases
HES 7, 516 cases
Comparable mortality
rates
England Aylin P (Aylin et al., 2007b) 2007 Vascular procedures 2001- OPCS4 National Clinical Patient volume Multiple NVD 8,462 cases
2003 Registry and outcome hospitals HES 16,923 cases
Comparable mortality
England Westaby S (Westaby et al., 2007 Cardiac paediatric 2000- OPCS4 National Clinical Case inclusion Multiple CCAD 1745 HES 2182
2007)* procedures 2002 Registry hospitals Mortality- HES 4.2% vs
CCAD 6.4%
Scottish Raza Z (Raza et al., 1999) 1999 Vascular procedures 1994 ICD9, Local vascular Operative Single Local vascular database
OPCS4 database accuracy hospital 840 cases
ISD 793 cases
Scottish Milburn JA (Milburn et al., 2007) 2007 General, paediatric and 2003- ICD10, Local database Accuracy of Multiple Clinically acceptable
vascular surgery 2004 OPCS4 diagnosis and hospitals match Diagnosis 86.9%,
procedure Procedure 84.0%
coding
HPA- Health Protection Agency
ICD- International Classification of Disease
OPCS- Office of Population, Censuses and Surveys (OPCS) classification of interventions and procedures
ACPGBI- Association of Coloproctology of Great Britain and Ireland
NVD- National Vascular Database
HES- Hospital Episode Statistics
CCAD Central Cardiac Audit Database ISD- Information and Statistics Division
* Definition of 30 mortality and breadth of included procedures varied between HES and CCAD

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Papers comparing routinely collected data with case note review

- Study quality

The studies varied according to the size of included admissions from 34-17,959 admissions

with a median of 298 admissions (Table 3.3). Table 3.2 summarises the quality assessment

for each of these studies. 17 studies stated that their samples were random. 16 studies

assessed greater than 90% of the case notes selected for sampling. Only ten studies stated

that trained coders were used and only three studies assessed inter-coder reliability. Six

studies stated that the coders performing case note review were blinded to the original codes.

Table 3.2 states the level of accuracy where stated assumed for each study.

- Accuracy

The overall median accuracy was 83.2% (IQR 67.3%-92.1%). The median diagnostic

accuracy was 80.3% (IQR 63.3%-94.1%) with a median procedure accuracy of 84.2% (IQR

68.7%-88.7%).

Payment by results (PbR) was introduced in 2004. When we compared those studies that

included data prior to the introduction of PBR and those afterwards, there were no differences

in the overall accuracy of codes [Overall accuracy pre-PbR 77.0% (IQR 66.2%-89.0%)

versus post-PbR 86.1% (IQR 73.1%-96.1%),p=0.207] or the accuracy of procedure codes

(p=0.602) but the accuracy of the primary diagnosis improved from 73.8% (IQR 59.3%-

92.1%) to 96.0% (IQR 89.3%-96.25) (p=0.020). There were no differences in overall

accuracy between those datasets that examined accuracy across multiple hospitals and those

that looked at single sites (p=0.252). When studies examining Scottish data were compared

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

with those assessing English data, there were no differences in overall, procedure or

diagnosis accuracy (p=0.292, p=0.245 and p=0.742 respectively).

Those studies that used random sampling for case selection had lower median accuracy

[Median random accuracy 83.1.0% (IQR 68.0%-88.2%) vs Median non random 93.7% (IQR

90.3%-95.0%), p=0.033].

Papers comparing routinely collected data with clinical registry data

Seven studies compared routinely collected data with clinical registry (Jen et al., 2008,

Mukherjee et al., 1991, Raza et al., 1999, Milburn et al., 2007, Garout et al., 2008, Aylin et

al., 2007b, Westaby et al., 2007). Five of these studies compared HES data with national

registry data (Aylin et al., 2007b, Garout et al., 2008, Jen et al., 2008, Mukherjee et al., 1991,

Westaby et al., 2007). Three of these studies compared number of procedures and mortality

against surgical society clinical registries (Aylin et al., 2007b, Garout et al., 2008, Westaby et

al., 2007).

A further study examined rates of Clostridium Difficile reported on HES database against

those reported to the Health Protection Agency (HPA) (Jen et al., 2008). Reporting cases of

Clostridium Difficile to the HPA is mandatory. Murkherjee and colleagues compared rates of

ovarian neoplasms against a local registry and histopathology dataset (Mukherjee et al.,

1991). Two further Scottish studies compared ISD data against local databases or registries

(Milburn et al., 2007, Raza et al., 1999). Table 3.4 summarises these studies and shows the

number of procedures recorded on the registries versus those recoded on administrative

datasets.

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The HES dataset recorded twice as many procedures as compared with the National Vascular

disease (NVD) registry (HES n=16923 and NVD n=8462) with slightly higher death rates

recorded on HES (HES 18% and NVD 15%) (Aylin et al., 2007b). Garout and colleagues

found a higher number of colorectal procedures reported on HES than on the Association of

Coloproctology of Great Britain and Ireland (ACPGBI) colorectal cancer database (HES

n=7516 and ACPGBI n=6617) with comparable overall mortality at a national level [HES

418 (5.6%) vs ACPGBI 383 (5.8%), p=0.416] (Garout et al., 2008). Westaby and colleagues,

however, found a higher number of reported infant cardiothoracic procedures on the Central

Cardiac Audit Database (CCAD) than on HES (HES n=1745 and CCAD n=2182).(Westaby

et al., 2007) The reported mortality was lower on HES than on the CCAD [HES n=74 (4.2%)

vs CCAD n=139 (6.4%)]. However, the two datasets differed in the types of procedures

included in the analysis with all procedures included in the CCAD and a limited number

included in the HES data analysis. In addition the definition of 30 day mortality differed

between datasets, with HES recording only those deaths in hospital and the CCAD including

all deaths in and out of hospital. Thus, the comparison was inhibited by the different coding

systems and difficulty in defining the same procedures and outcomes.

Discussion

Main findings of the study

Data accuracy has been a concern for clinicians, managers and central government for several

years (Audit Commission, 2002). Steps have been taken to improve quality with the Care

Quality Commission mandating yearly audits of individual Trust data quality (Care Quality

Commission, 2009). This study examines the accuracy of administrative data in the United

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in Colorectal Surgery

Kingdom in the published literature from 1989 to the present day. Overall accuracy was 83%

with accuracy for procedure coding (84.2%) found to be higher than that of primary diagnosis

coding (80.3%). Accuracy of diagnostic coding has been shown to have improved

substantially in recent years.

Implications of data accuracy

Questions should be asked as to whether an accuracy of 83%, or 87% when the most recent

data from the Audit commission are considered (Audit Commission, 2010), is reasonable to

allow the data to be used for research, service planning, financial reimbursement, or

performance and quality assessment. Currently there is no consensus as to what is an

acceptable level of data accuracy. The ultimate goal would be a data accuracy of 100%. The

greatest data accuracy recorded was 98% in the study of abdominal aortic aneurysms (Samy

et al., 1994). This may be a more realistic target. The involvement of clinicians in coding has

been proposed to achieve this improvement in accuracy (Williams JG, 2002). Yeoh and

Davis initially examined changes in accuracy after clinicians became responsible for coding.

They found over a one-year period the accuracy increased from 54% to 85% (Yeoh and

Davies, 1993). Though, given such a low initial coding accuracy, it may be argued that there

were serious flaws in coding in earlier years, questioning the applicability of this research to

other trusts. Nouraei and colleagues observed that use of a clinician coding multi-

disciplinary team (MDT) in Ear Nose Throat (ENT) surgery resulted in a change to 24.1% of

records and an increase in departmental revenue of 443,371 (4.8 times the cost of

maintaining such an MDT) (Nouraei et al., 2009). This suggests that clinician involvement

may be a cost effective means of improving data quality and improving hospital

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reimbursement. Greater education is needed amongst clinicians about clinical coding and its

uses.

The majority of studies included in this review defined inaccurate coding as inaccurate four

digit coding (Table 3.2). Both OPCS and ICD10 mostly use four digit codes to signify

procedures and diagnoses respectively. The first letter refers to the chapter in which the code

is contained and the subsequent two or three numbers refer to a related group of diseases or

procedures and then specific disease or procedure within that group. For example, ICD10

code K35.0 refers to Acute appendicits with generalised peritonitis. The K chapter is any

disease of the digestive system and K35 group is all acute appendicitis. It may be that for

some purposes the chapter and group of diseases (e.g. K35) or three digit code may be

sufficient. Cleary and colleagues reported an accuracy of 51% at the four digit level but 90%

at the three digit level suggesting that many inaccuracies occur with four digit coding (Cleary

et al., 1994). For some uses, three letter accuracy may be sufficient and therefore the coding

accuracy will be higher than that described in this study.

The accuracy reported in this study is lower than that reported by Campbell and colleagues in

their original systematic review (Campbell et al., 2001). In this review the accuracy of coding

was variable but with a median of 90%. The current study contains a larger number of more

recent studies. It is difficult to assess how applicable these figures are to general accuracy

rates in the NHS or whether they reflect a degree of publication bias. Clinical studies that

demonstrate good data accuracy may not be published with the aim of assessing data

accuracy but focus on examining a particular clinical condition. Such articles may not be

included in this analysis. Similarly, some articles that demonstrate poor data accuracy may

have originally been conceived to look at a particular condition thereby skewing our results

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towards a lower overall accuracy rate. The latest audit of data quality from the Audit

Commission concluded that the accuracy of data coding was improving each year suggesting

that there may be a discrepancy between data accuracy figures published in the literature and

the real life data accuracy figures (Audit Commission, 2010).

If we accept that the overall accuracy (87%) that was reported by the Audit Commission,

what are the possible uses of administrative data within the NHS? Epidemiological and

outcome based research are areas for which HES has been used (Bottle and Aylin, 2009, Faiz

et al., 2008a, Faiz et al., 2008b, Faiz et al., 2010a, Mayer et al., 2010, Faiz et al., 2011b). It is

difficult to quantify the potential impact of this level of accuracy on research. An assumption

is made in this research that there are no systematic inaccuracies that may bias the studies. A

study that examines for example the impact of an explanatory variable on outcome assumes

that the level of inaccuracy will be the same across that explanatory variable. The impact of

this will be impossible to measure without a large NHS wide survey of all Trust accuracies

across specialties. Such a study would be expensive to undertake for merely academic

purposes but may be possible through data collected by the Audit Commission National

Audit. It is important that the current focus on improving data quality continues despite the

proposed disbandment of the Audit Commission following the recent Government Spending

review.

Administrative data are used to determine individual Trust reimbursement. Several studies

and the Audit Commission report examined the effect of data inaccuracy on reimbursement

(Audit Commission, 2010, Nouraei et al., 2009, Beckley et al., 2009). Potential savings for

the individual Trusts are considerable. One study estimated that inaccurate coding could lead

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to losses of up to 10% of a departments profits (Beckley et al., 2009). Indeed, it is in the

interests of Trusts to maximise their financial returns. By optimising coding practices, these

gains can be made. Though it is important that the data are still as accurate as possible as

there may be a temptation to use codes associated with the greatest financial return. Such

gaming may be avoided. In conjunction with outcome based research, administrative data

offer an attractive source for quality measurement and performance benchmarking. Poor

quality data collection may reflect more widespread system failures within Trusts or

departments. Those Trusts with more inaccurate data maybe judged to be worse by these

data than they actually are. In performance measurement, outlier status using administrative

data can serve as a prompt for further investigation rather than a definitive assertion of poor

performance. Caution should therefore be exercised regarding the reliability of identification

of outliers from routinely collected data.

The introduction of PbR led to an improvement in data accuracy though there is likely to be

econtinuing variation in accuracy rates. Factors such as efficiency of support systems in a

hospital, differences in case mix or prevalent diseases between units, organisational culture or

management structure may further underlie this variation. However, further work is required

to assess the impact of these factors.

This review seeks to assess data accuracy in Great Britain but increasingly routinely collected

and registry data are being used to draw international comparisons of performance (Coleman

et al., 2011). It is essential that when using both administrative and clinical registry

databases that country to country variations in these datasets are well understood, for

example databases may not be comprehensive or may be only inclusive of patients treated at

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centres of excellence with an interest in data collection. Attempts should be made in each

country to address the issues of data accuracy outlined in this study in order to ensure that the

data maybe meaningfully used to explore national and provider differences.

Clinical registry versus administrative databases

Clinical registries are purpose built databases for prospective data collection. In contrast to

the inclusive mandatory administrative datasets, clinical registries are mostly voluntary.

Given this voluntary nature, they will not include all patients with a given condition nor will

all the datafields be complete for each patient (NBOCAP, 2009). These databases contain

tailored data fields that allow collection of disease specific clinically relevant data. As to be

expected, two studies found HES and registry data to be largely comparable for mortality

with larger patient volumes recorded on HES (Aylin et al., 2007b, Garout et al., 2008). Four

studies, however, found fewer cases recorded on the administrative database than in the

clinical registries (Westaby et al., 2007, Jen et al., 2008, Mukherjee et al., 1991, Raza et al.,

1999). The reasons for this discrepancy are uncertain. It may represent poor coding on the

HES dataset. However, there was considerable variation in the coding and classifications

used in the two datasets. For example, the definition of mortality and included procedures

differed between the the HES and CCAD datasets in the study by Westaby and colleagues

(Westaby et al., 2007). Such comparisons therefore are unlikely to be comparing like with

like. Though registries contain useful clinically meaningful data, they are more expensive to

set up and maintain and require enthusiastic clinicians to support data submission. Costs of

maintaining HES data have been estimated at 1 per record with clinical registry data costing

up to 60 per record (Raftery et al., 2005). Though useful in discrete conditions or for

specific treatments, they do not have the breadth of national administrative datasets. They

may also not fully reflect the range of procedures performed even within a given specialty as

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clinicians may favour the entry of interesting or complex cases over more straignforward

cases.

Limitations of this study

The accuracy of routinely collected data is infrequently published. This review includes

studies from an extended time period. The historical nature of the data limits the

applicability of the accuracy to the current time. Though our review was as broad as

possible, some studies that have not referenced accuracy in the title or abstract or that have

not been referenced in other articles will not have been included in the study. The accuracy

of coding may be just one aspect of a paper and therefore not included in the title or abstract.

Such papers will not have been included in this study. It is difficult to quantify the impact of

such bias on the results of this study.

The studies included in this systematic review are heterogeneous. They vary in methods used

to assess accuracy, the diagnoses and procedures included and the personnel involved in

assessing the data quality. As a result of this heterogeneity, meta-analysis was not possible.

Indeed due to the small number of papers, limited statistical analysis was possible. Few

studies looked at accuracy in recent years following the introduction of PbR and concerted

efforts to improve data quality such as the National Audit Office reports and the focus by the

Care Quality Commission. There was a wide range of data accuracies reported in the

literature. This may reflect considerable variation in practice across the NHS. It may also

reflect the differences in methodologies used in the included studies. Inter-coder reliability

was rarely stated in these studies. Only 68% of the studies used random sampling and only

48% of the studies stated that trained coders were used. Methods of identifying case records

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for review varied across studies. Some studies used local databases (Milburn et al., 2007,

Sellar et al., 1990) or all admissions in a defined period with or without a specific diagnosis

or under a certain physician (Yeoh and Davies, 1993, Nouraei et al., 2009, Dixon et al., 1998,

Harley and Jones, 1996, Reddy-Kolanu and Hogg, 2009, Colville et al., 2000, Hasan et al.,

1995, Kirkman et al., 2009, Kohli and Knill-Jones, 1992, Samy et al., 1994, Cleary et al.,

1994, Murchison et al., 1991, Panayiotou, 1993, Audit Commission, 2010, Pears et al., 1992,

Drennan, 1994, Beckley et al., 2009) to identify the base denominator of included patients.

Finally there may be publication bias in the literature. Studies with accuracy rates at the

extremes of the spectrum may be preferentially reported. Though given the wide range of

accuracies reported preference for the low or high end of the spectrum is likely to be limited.

The overall accuracy reported in this study may not be applicable to individual NHS Trusts as

there will be Trust to Trust differences in accuracy rates. Some Trusts will have more

reliable data than others. This may have significant implications regarding performance

benchmarking. In addition, some diagnoses or procedures maybe better coded than others so

there is likely to be differences in accuracy between conditions.

Accuracy rates of administrative data coding have improved in recent years in the NHS.

This may relate to the introduction of pro rata financial reimbursement for financial activity.

This review suggests that data accuracy is high enough to facilitate its use in most

circumstances. Wide variation in reported accuracy may reflect variation in individual trusts

coding suggesting that care should be exercised when using these data for clinician and

institution benchmarking. Identification of apparent unacceptable institution or individual

performance using administrative data may serve as a prompt for further investigation and

should be interpreted with caution.

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Variation from HES data

Variation in the provision or outcome in England has been demonstrated previously in other

disciplines.

Clinician variation

Bloor and colleagues used HES data to explore variation in consultant activity and the link

between consultant activity and type of contract (Bloor et al., 2004). Consultant surgeons

with discretionary salary points and those with maximum part-time contracts had higher

activity than other consultant surgeons.

Management variation

Preference for particular procedures differs geographically in the HES dataset. In 1996,

Mulholland and colleagues described threefold difference in the rate of vaginal to abdominal

hysterectomy by regional health authority (Mulholland et al., 1996).

Bragg and colleagues used maternity data collected on HES to assess the existing variation in

caesarean section rates across England (Bragg et al., 2010). This study suggested that there

was considerable variation in both the patient characteristics across units and also the

adjusted section rates suggesting that there is considerable variation at the patient level and

the unit level. More variation existed amongst emergency patients.

Other authors have found significant geographical variation in the provision of elective

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surgery. Two studies suggested that there is considerable regional variation in the provision

of hip and knee joint replacements (Dixon et al., 2006, Judge et al., 2009). Keenan and

colleagues showed marked geographical variation in cataract and glaucoma surgery rates by

local authority with rates of cataract surgery varying from 172 to 548 procedures per 100000

population (Keenan et al., 2007) (Keenan et al., 2009b). This variation was also associated

with social deprivation indices.

Khan and colleagues found that despite an overall exponential increase in plastic surgery,

there was a 4.6 fold difference in plastic surgery rates across health authorities (Khan et al.,

2010). Some of this variation may be explained by case mix and variation in coding but the

possibility of real differences in healthcare access must be explored.

Geographical variation has also been described in lower limb amputation rates with

unadjusted rates varying between 3.9 per 100,000 and 7.2 per 100,000 of the population in

different SHAs (Moxey et al., 2010). 30 day in hospital mortality following major amputation

also differed by SHA between 20.2 and 14.0%.

Variation over time

In addition, HES data have been used to explore trends in disease activity and admissions

over time in epilepsy (Bruce et al., 2004), circumcision rates (Cathcart et al., 2006),

ophthalmic and retinal surgery (Clarke and Fraser, 2006, El-Amir et al., 2009, Fraser and

Wormald, 2008, Keenan et al., 2007, Keenan et al., 2009a, Keenan et al., 2009b), oral

surgery (Dhariwal et al., 2002, Moles and Ashley, 2009), obesity surgery (Ells et al., 2007,

Burns et al, 2010), road collisions (Gill et al., 2006), infectious diseases (Hayward et al.,

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2008, Trotter et al., 2008), urology (Hussain et al., 2008), hepatobiliary disease (Kang et al.,

2003a, Thomson et al., 2008, Tinto et al., 2002), appendicitis (Kang et al., 2003b), vascular

surgery (Kanwar et al., 2010, McCaslin et al., 2007, Moxey et al., 2010), plastic

surgery(Khan et al., 2010), orthopaedics (McColl et al., 1998, Wu et al., 2011), drug

reactions (Patel et al., 2007), gynaecology (Reid, 2007) and deliberate self harm (Wilkinson

et al., 2002).

Variation in outcome

Callery and colleagues used HES data to assess variation in paediatric readmission rates in

North West English NHS Trusts. Even amongst the small number of included hospitals, there

was demonstrable variation in readmission rates (Callery et al., 2010).

Holt and colleagues showed considerable variation in mortality following elective AAA

repair. Thirty hospitals had a significantly greater mortality than elsewhere and three of these

hospitals had over twice the mortality of the rest of England (Holt et al., 2008b).

Patient differences- variation and social deprivation

HES data have been used to explore the association between social deprivation and surgical

provision and outcome in several specialties including orthopaedics (Cookson et al., 2007,

Judge et al., 2010) and oncology (Raine et al., 2010).

Cookson and colleagues explored the impact of social deprivation and provision of total hip

replacements (Cookson et al., 2007). During the ten year study period, social deprivation

appeared to play a diminishing role in determining access to total hip replacement. Judge and

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colleagues corroborated this finding and suggested that social deprivation was associated

with access to both total hip and total knee replacements (Judge et al., 2010).

Raine and colleagues analysed admissions with rectal, breast and lung cancer in patients over

50 years of age from 1999 to 2006 (Raine et al., 2010). Elective procedures and anterior

resection for rectal cancer and breast conserving surgery for breast were deemed preferential

to other procedures in this study. Patients form areas of greater social deprivation underwent

lower levels of preferred procedures. Given that variation in stage of disease at presentation

impacts on choice of surgical procedure, the absence of staging data in this dataset is a

significant flaw.

Gilbert and colleagues demonstrated that patients from more socially deprived areas admitted

with a fall were less likely to return to their home than more affluent patients (Gilbert et al.,

2010).

Gender

Filipovic and colleagues explored gender differences in the provision of and outcome

following AAA repair for ruptured AAA (Filipovic et al., 2007). Women underwent fewer

repairs and had a higher mortality than men.

Management of disease

David and colleagues examined current management in gallbladder disease across England

(David et al., 2008). They concluded that the provision of early laparoscopic cholecystectomy

in 2003-2004 was suboptimal with a higher rate of open procedures and a low rate of

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cholecystectomy on the initial admission.

Furthermore, HES data have been used to examine clinical outcome from comparative

procedures such as laparoscopic and open surgery (Faiz et al., 2008b, Faiz et al., 2008c,

Burns et al., 2010) open versus endovascular aneurysm repair (Holt et al., 2010) and to

demonstrate the safety of certain procedures (West and Card, 2010).

Health policy

Farrar and colleagues used HES data to explore the impact of PbR on hospital practice

(Farrar et al., 2009). Day case rates increased and there was a trend towards increased

hospital activity following the introduction of PbR.

Propper and colleagues examined the possible impact of patient choice on distances travelled

from a patients home to hospital (Propper et al., 2007). Patients from more affluent areas

travelled greater distances to hospitals. Propper suggested that more affluent patients may

benefit from patient choice more as they are more willing to travel to remote hospitals.

Holt and colleagues examined the feasibility of reconfiguring vascular services to centralize

hospitals. They postulated that services could be concentrated in 48 centres from the current

242 institutions offering vascular services. They proposed that there would be a significant

reduction in elective mortality without increasing patient travel significantly. This model was

unable to account for resultant changes in emergency services but was the first study to

provide an evidence base to predict impact of such a widespread change in practice (Holt et

al., 2008a).

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HES data have also been used to examine the impact of public health initiatives such as the

introduction of the smoking ban in public places on the population. It is difficult to find a

causal link but this study did find a decrease in admissions for myocardial infarction after the

introduction of the smoking ban (Sims et al., 2010).

These studies suggest that HES data can be used to not only look at variation in disease but to

assess the impact of health policy interventions and also attempt to predict the effect of future

policies.

HES data and Colorectal surgery

Provision

Specifically in colorectal surgery, HES data have been used to examine provision and

outcome of certain procedures. Day case colorectal surgery has been shown to be

underutilised and Faiz and colleagues have suggested that increases in day case rates can

significantly improve hospital efficiency (Faiz et al., 2008a).

Hartmanns procedure was originally described in 1921 by Henri Hartmann for resection of

an obstructing colonic tumour (Hartmann, 1923). The procedure involves resection of an

affected segment of sigmoid colon, leaving a rectal stump and necessitates stoma formation.

This stoma may be reversed at a subsequent procedure. A systematic review has suggested

that primary resection and anastomosis in nonelective diverticular disease may be associated

with a lower mortality than the Hartmanns procedure (Constantinides et al., 2006a). Primary

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anastomosis is also more frequently used by colorectal specialist in the emergency setting

(Constantinides et al., 2006b). David and colleagues examined use of Hartmanns procedure

and subsequent reversal in England (David et al., 2009). They found that only 23.3% of

patients who had a Hartmanns procedure underwent a reversal during the study period.

Using similar methodology, David and colleagues also explored reversal of stoma rates

following anterior resection with covering ileostomy and found that 75% of patients had a

reversal of ileostomy (David et al., 2010). This study may overestimate the number of

patients who were reversed following surgery, as some patients may not have been actively

coded with an additional stoma formation code.

HES data have also been used to explore possible causes of fluctuations in disease.

Sonnenberg found that fluctuations in admissions for viral and bacterial intestinal infection

mirrored admissions for Crohns disease (Sonnenberg, 2008). He suggested a possible causal

link between intestinal infections and exacerbations of Crohns disease. This highlights an

area for further research but cannot definitely establish such a link due to other possible

confounders not present on the HES dataset.

Colorectal outcome

HES data have been used to examine mortality, following colorectal resection, in the

emergency setting (Faiz et al., 2010c) and among the elderly population (Faiz et al., 2011a).

In the emergency setting, postoperative mortality at thirty days was high (13.3% following

colorectal cancer resection and 15.4% following diverticular resection). Furthermore, one

year mortality rose to 34.7% and 22.6% for cancer and diverticular resections respectively

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(Faiz et al., 2010c). There is significant mortality rates in elderly patients following elective

colonic surgery with those patients over 85 years of age having approximately 2.5 times the

risk of death than those aged 75-79 years of age (Faiz et al., 2011a). Morris and colleagues

identified significant NHS Trust variation in 30 day mortality rates using cancer registry

linked HES data (Morris et al., 2011b). In a previous study using a similar dataset, Morris

and colleagues examined variation in APE rates for rectal cancer (Morris et al., 2008). It has

been suggested that APE rates should be below 30% of a surgeons rectal cancer caseload

(ACPGBI, 2007).

Readmission and LOS following elective colorectal surgery was investigated by Faiz and

colleagues (Faiz et al., 2011b). Colonic resection resulted in a shorter LOS than for rectal

resection with stomas increasing the duration of inpatient stay. Furthermore there was a

decrease in LOS of two days from 1996 to 2006. LOS and readmission varied by disease

type, age, social deprivation. Use of laparoscopy led to a shorter LOS.

Kang and colleagues described early trends in diverticular admission between 1989 and 2000

(Kang et al., 2003c). Jeyarajah and colleagues examined later trends in admission for

diverticular disease and predictors of outcome (Jeyarajah et al., 2009). They found an

increasing number of admissions for diverticular disease from 1996 to 2006. The majority of

admissions were nonelective. Admissions increased in the elderly populations. An

emergency admission, increasing age and co-morbidity were associated with poorer outcome.

Faiz and colleagues used HES data to compare outcome following laparoscopic and open

elective colorectal resections with selection for laparoscopy being associated with lower

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perioperative and one year mortality and a reduced length of stay (Faiz et al., 2009).

Policy implications

The impact of introducing guidelines has been explored using HES data. The use of

laparoscopic colorectal resection increased despite initial NICE guidelines preferring open

surgery (Green et al., 2009). The effect of subsequent guidelines recommending

laparoscopic colorectal resection is unclear from this study (2006).

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Chapter 4- Materials and Methods

Hospital Episode Statistics (HES)

The HES database is an administrative dataset of routinely collected data that collates patient

level information from all English NHS Trusts. It includes all NHS and private patients

admitted to NHS hospitals. Its core component is the Finished Consultant Episode (FCE).

This reflects a period of uninterrupted inpatient care under a single consultant team or allied

health care professional. Episodes may be linked together to form a single admission or

spell. If a patient is transferred to a different Trust during this time then these admissions are

linked into a single superspell.

Each admission contains a primary diagnosis and up to 20 secondary diagnoses, categorised

according to the International Classification of Disease (10th revision) (ICD-10), (WHO) and

up to 24 procedure fields coded using the Office of Population Censuses and Surveys

Classification of Surgical Operations and Procedures (4th Revision) (OPCS-4.4) and codes

appropriate to the year of admission prior to OPCS-4.4 revision (Connecting for health,

2009). The OPCS-4 codes consist of four character codes. The first letter denotes the chapter

of the classification. The next two digits represent the section of the chapter and the final

digit represents the specific procedure within that chapter for example H04 Total excision of

colon and rectum represents the exact code within this section. H042 Panproctocolectomy

S and anastomosis of ileum to anus and creation of pouch HFQ can be found in

chapter H Lower Digestive tract, section H04 Total excision of colon and rectum and

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represent an ileoanal pouch procedure or restorative proctocolectomy. Prior to April 2007

there were up to twelve operation fields and four prior to April 2002. OPCS classifications

have undergone several iterations since its inception. OPCS 4.2 was valid until 31st March

2006. From April 2006 to March 2007, use of OPCS 4.3 became mandatory. From April

2007 to March 2009, OPCS 4.4 came into effect and finally since April 2009 OPCS 4.5 has

been use.

Diagnostic coding has used the ICD-10 since 1995. Similar to OPCS coding, diagnosis codes

are four characters with the letter and first two digits representing the relevant section and the

final digit specifying the exact classification. There are currently 20 diagnostic fields. Prior

to April 2007, there were fourteen fields and seven prior to April 2002.

In this study all codes were verified locally with the Imperial College NHS Trust coders, with

the published literature and where appropriate with the central National Clinical

Classifications helpdesk (National Coding Service).

HES Coding

Colorectal resection

OPCS codes

Right sided resection right hemicolectomy (H07)

extended right hemicolectomy and transverse colectomy (H06,

H08)

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Left sided resection left hemicolectomy (H09)

sigmoid colectomy (H10)

Hartmanns procedure (H33.5) in emergency studies

total colectomy panproctocolectomy (H04.1, H04.3, H04.8, H04.9)

total colectomy (H05)

colectomy of unspecified site (H11)

Rectal resection anterior resection

(H33.2, H33.3, H33.4, H33.6, H33.7, H33.8, H33.9)

abdominoperineal excision (APE) (H33.1)

Hartmanns procedure (H33.5) in elective studies

ICD10 codes

Malignant disease C18 C19 C20 C21 C26

Ulcerative colitis (UC), K51

Crohns disease, K50

Diverticular disease. K57

Further details about secondary coding is given in the relevant chapter.

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Restorative proctocolectomy

OPCS codes

H042 Total excision of colon and rectum, Panproctocolectomy and

anastomosis of ileum to anus and creation of pouch however further

qualified

H043 Total excision of colon and rectum, Panproctocolectomy and

anastomosis of ileum to anus not elsewhere classified

G725 Other connection of ileum, Anastomosis of ileum to anus and creation

of pouch however further qualified

ICD10 codes

Individual diagnoses were recoded into major diagnostic categories according to ICD 10 code

as follows: K51- Ulcerative colitis (UC), K50 - Crohns disease, C18 C19 C20 C21

C26 D37- Malignant disease, D010 D12-Benign colorectal tumours. The remaining

codes were classified as other diagnosis

Risk adjustment

Charlson comorbidity score

The Charlson co-morbidity index is derived from the secondary diagnosis codes as a marker

of co-morbidity. Charlson and colleagues used data collected in a cohort study in 1984 of

medical patients admitted to New York hospital to create a comorbidity index. This index

was then validated against a cohort of breast cancer patients to test its ability to predict

mortality (Charlson et al., 1987). They produced a weighted index of 19 conditions that took

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account not only of the number of comorbid conditions but also the relative severity of these

conditions using the relative risk of death from each condition.

Given that this index was validated amongst breast cancer patients, validation was required

for other specialities and for its use in administrative datasets. Ouellette and colleagues

validated the Charlson score for colorectal cancer patients (Ouellette et al., 2004). They

retrospectively reviewed patients undergoing a laparotomy for colorectal cancer over 4 years.

Higher scores correlated with longer length of stay, overall mortality and perioperative

mortality. DHoore and colleagues applied the Charlson index successfully to predict

mortality amongst patients with ischaemic heart disease, congestive heart failure, stroke or

bacterial pneumonia using administrative databases (D'Hoore et al., 1993). The area under

the receiver-operating curve was 0.83. They also examined the use of Charlson scoring to

predict mortality amongst patients admitted with ischaemic heart disease using an

administrative database in Quebec, Canada (D'Hoore et al., 1996). The authors found that the

Charlson index could be successfully applied to an administrative dataset to predict mortality.

In addition to the United States and Canada, the Charlson index has been applied to data in

other countries including Australia and Europe (Lu et al., 2011, Faiz et al., 2008b, Faiz et al.,

2010a, Pasternak et al., 2010, Thygesen et al., 2011). The original adaptations of Charlson

used the ICD-9 coding systems but subsequent studies were able to adapt it to the ICD10

version used on HES (Sundararajan et al., 2004). Nuttall and colleagues demonstrated that

Charlson scoring could be applied to English data using the HES dataset to predict short term

outcome and mortality following urological cancer surgery (Nuttall et al., 2006). Charlson

scoring has been used previously to predict postoperative complications following colorectal

and other surgical procedures (Kemp and Finlayson, 2008, Arrigo et al., 2011).
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Charlson scoring uses the secondary diagnosis fields present on HES to take account of other

comorbidities. Other scores such as the Physiological and Operative Severity Score for the

Enumeration of Mortality and Morbidity (POSSUM) scoring system (Copeland et al., 1991),

Portsmouth POSSUM (Prytherch et al., 1998) or colorectal POSSUM (Tekkis et al., 2004)

may provide greater risk adjustment. The variables required to derive these more specialised

comorbidity measures are not, however, available on the HES dataset.

The Charlson score has been categorised for the colorectal and pouch datasets. This

categorisation was used to improve power and make the scores more clinically meaningful.

The categories were chosen according to the relationship with mortality with each score.

The categories were as follows:

Colorectal resection

1. Those patients with a score of zero

2. Those patients with a score of between one and four

3. Those patients with a score greater than or equal to five.

Pouch procedure

1. Those patients with a score of less than or equal to two

2. Those patients with a score of greater than two.

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Carstairs index of deprivation

The Carstairs index of deprivation is a small-area deprivation score at the ward level and is

derived from the patients postcode contained in the HES dataset (Carstairs and Morris,

1989). This score is based on four factors derived from national census data. These factors

include overcrowding, unemployment, social class, and car ownership and are combined into

an unweighted score of the four variables. Patients are divided into quintiles according to the

Carstairs score. Other measures of social deprivation specifically designed for use in health

include the Townsend score and the Jarman score (Morris and Carstairs, 1991). The

Townsend and Carstairs indices are highly correlated. In a review of indices by Carstairs and

Morris, the Carstairs index was highly correlated with health measures such as the

standardized mortality ratio and permanent sickness (Morris and Carstairs, 1991). This score

is commonly used in outcome research using HES data to assess the impact of social

deprivation on health (Bagger et al., 2008, Al Murri et al., 2004, Pagano et al., 2009, Wu et

al., 2011, Mayer et al., 2011, Lazzarino et al., 2011). The inclusion of car ownership in the

score may not be relevant in all geographical locations such as larger cities.

Risk adjustment also included gender, admission status, diagnosis, type of resection and

where applicable use of laparoscopy.

Admission status was determined according to the ADMIMETH variable present on HES

and was coded as elective or emergency.

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Diagnosis was determined firstly by the primary diagnosis DIAG1. If DIAG1 did not

contain a diagnosis of colorectal cancer, diverticular disease or inflammatory bowel disease,

DIAG2 and DIAG3 were interrogated for these diagnoses. If not present, the diagnosis

was categorised as other. For analysis of pouch procedures, inflammatory bowel disease was

further categorised into Ulcerative colitis and Crohns disease.

Resection type for studies including emergency and elective admissions are categorised into

the following categories according to the OPCS codes above:

Right sided resections include right hemicolectomy, extended right hemicolectomy and

transverse colectomy.

Left sided resections include left hemicolectomy, sigmoid colectomy and Hartmanns

procedure.

Total colectomy includes panproctocolectomy and total colectomy and colectomy of

unspecified site

Rectal resection includes anterior resection and abdominoperineal excision (APE).

For those including elective or cancer procedures only then resections are categorised into the

following categories:

Right sided resections include right hemicolectomy, extended right hemicolectomy and

transverse colectomy.

Left sided resections include left hemicolectomy, sigmoid colectomy

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Total colectomy includes panproctocolectomy and total colectomy and colectomy of

unspecified site

Rectal resection includes anterior resection, abdominoperineal excision (APE) and

Hartmanns procedure.

Outcome measures

Some outcome measures are readily available on HES. These include 30 day in hospital

mortality, 365 day all cause mortality, 28 day readmission and length of stay. Other outcome

measures may be derived from HES data using longitudinal analysis. The methodology for

these measures is outlined in the relevant chapters.

30 day in hospital mortality is defined as death from any cause within hospital within 30 days

of admission. This does not include out of hospital deaths or death on a subsequent

admission.

365 day all cause mortality is defined as deaths within 365 days for any cause in and out of

hospital and are derived through linkage between HES records and the Office of National

Statistics.(HES/ONS methodology, 2002) Due to delays in linkage, this measure is only

available for patients admitted between 1st April 2000 and 31st March 2005.

Readmission is defined as readmission to the same Trust or any other trust in England within

28 days of discharge from hospital.

Length of stay (LOS) is the time in days that a patient remains in hospital during the primary

admission. A patient admitted and discharged on the same day would have an LOS of zero

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Ethical considerations

We have approval under Section 251 (formerly Section 60) granted by the National

Information Governance Board for Health and Social Care (formerly the Patient Information

Advisory Group). We have approval from the South East Research Ethics Committee.

Statistical considerations

Categorical variables were investigated using the Chi-squared test. Logistic regression

analysis was used to investigate the independent role of explanatory variables on outcome.

Linear regression was used to investigate LOS. LOS underwent logarithmic transformation

and back exponentiation for analysis. Cox regression analysis was used to explore the

independent predictors for time dependent outcome (pouch failure).

Statistical analyses were carried out using SPSS Version 16.0 to 18.0 as applicable

(Statistical Package for Social Sciences, SPSS, Chicago, Illinois, USA). Multilevel

modelling was performed using MLwiN Version 2.1 (2009) from the Centre for Multilevel

Modelling, University of Bristol (Rabash et al., 2010). Further details on the multilevel

models constructed are included in the relevant chapters.

For tests of significance, a p value of <0.05 was considered significant. For non-parametric

variables the median and interquartile range (IQR) are given.

Funnel plots with exact Poisson control limits were constructed using the web tool-

http://www.erpho.org.uk/topics/tools/funnel.aspx

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Volume

In this thesis volume has been considered in a number of ways according to the appropriate

dataset. This is discussed further in the relevant chapters.

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Chapter 5- Variation in patient factors

Introduction

When measuring performance and quality amongst providers, it is important to account for

differences in case mix amongst individual consultant teams and NHS Trusts. There may be

considerable variation in characteristics of patients operated on by different providers. In fact,

previous research has suggested that much of the variation seen in healthcare is at the patient

level (Osler et al., 2011). Osler and colleagues sought to assess the impact of patient and

hospital factors in a population of patients undergoing surgery for colorectal cancer in

Denmark on mortality. They suggested that, though hospitals varied significantly in

mortality, only 4.3% (based on the intraclass correlation) of the variation in mortality was

accounted for at the hospital level. The remaining variation was at the patient level. Friese

and colleagues showed that patient factors such as type of admission and cancer stage

differed significantly amongst National Cancer Institutes in the US (Friese et al., 2010). In

this study, failure to rescue rates were lower amongst the National Cancer Institutes than in

other studies. Some of these differences are likely to be due to the population differences of

those treated in these centres. Prior to discussing variation amongst providers, it is important

to acknowledge that there may be variation in patient factors among these providers. When

assessing variation at a provider level, consideration of patient level differences is important.

Datasets vary in the degree of risk adjustment possible from the included information. As

routinely collected datasets are not specifically designed for such comparative purposes,

some desirable factors are absent. Disease severity scoring is not contained within the HES

database. In particular, cancer stage, Hinchley grade or severity of inflammatory bowel

disease are not present in this database. Institutions that may have a specialist interest in

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advanced cancer or severe inflammatory bowel disease surgery may appear erroneously as

outliers on this database. This information may be available in the future through linkage

with other datasets such as cancer registries, which would allow improved risk stratification.

Identification of outlier status on such a routinely collected dataset should never be

considered as definitely signifying poor performance without further investigation to confirm

data accuracy and case mix.

This chapter serves to provide an important introduction to the datasets used in this research

and to assess the variation in patient factors across Trusts in both general colorectal and more

specialized colorectal surgery.

Aim

This chapter aims to describe variation in patient characteristics across providers amongst

colorectal resections and pouch patients.

Methods

All patients undergoing a colorectal resection between 2000 and 2008 on the HES database

were included in assessing variation in patients undergoing colorectal surgery.

When more specialized surgery was examined, all elective patients undergoing a pouch

procedure between 1996 and 2008 were included. The earlier study years were included due

to the small number of patients undergoing this procedure across England. Diagnoses were

assigned according to the ICD10 diagnoses described in the methods and in more detail

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below as appropriate. Those Trusts performing less than ten colorectal procedures during the

study period were omitted from the graphs describing variation in case mix (n=20 Trust,

n=37 patients).

Ethnicity was coded according to the HES classification. The following classes were

grouped together

1. White included British (White), Irish (White), Any other White background

2. Black included Caribbean (Black or Black British), African (Black or Black British),

Any other Black background

3. Indian subcontinent included Indian (Asian or Asian British), Pakistani (Asian or

Asian British), Bangladeshi (Asian or Asian British), Any other Asian background

4. Chinese (other ethnic group)

Figures 5.1 to 5.6 summarise the differences in patient characteristics across Trust. The total

height represents the total caseload with each coloured bar representing the number of

procedures belonging to that category within an institutions caseload. Where appropriate,

caterpillar plots show the mean percentage for that variable with the 95% confidence

intervals in each Trust.

Results

Colorectal resection

Of the 246,420 patients managed by Trusts performing greater than or equal to 10 resections

between 2000 and 2008, 158,812 (64.4%) patients underwent an elective resection. Trusts

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varied considerably in the proportion of procedures that were coded to an emergency

admission with a range of 52% to 100% elective workload. The Trust with a 100% elective

workload was of low volume with just 16 included resections over the eight-year study

period. Figure 5.1 shows the variation in the proportion of elective and emergency

admissions per Trust.

Figure 5.1: Variation in admission type (elective and emergency) by Trust for all colorectal
resections (percentage of elective admission with 95% confidence interval error bars).
1

0.9
Percentage elective caseload

0.8

0.7

0.6

0.5

0.4

0.3
RGC
RXH

RGR
RW3

RMP
RXC

RD1
RR1
RWW
RA9
RK5
RTH
RHM
RVR
RAE

RTR
RFF
RJC
RWJ
RJD
RGM
RQ6

RHW
REM
RAS

RGN

NHS Trusts

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Figure 5.2: Variation in Trust diagnosis for all colorectal resections by Trust of all patients
undergoing a colorectal resection.

4000

3500

3000

2500
Other

2000 DD
IBD
1500
Cancer

1000

500

0
Individual NHS Trusts

The most common diagnosis was that of colorectal cancer with a median percentage caseload

59.0% (IQR 55.3%-62.0%) per Trust. Figure 5.2 shows the variation between Trusts

according to diagnoses.

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Figure 5.3 Variation in type of resection per Trust of all patients undergoing a colorectal
resection.

4000

3500

3000

2500

Total
2000
Rectal
1500
Left

1000 Right

500

0
RN3
RWE

RWA
RTD
RXC
RTR

RXR
RWG
RNL

RR7

RE9
RXL
RWY

RA7
RM2

RC1
RA4

RC3
RJF

RBQ
RXH

RFW
RLQ
RNS
RNQ
RVV

Individual NHS Trusts

Figure 5.3 demonstrates the variation in type of resection that patients undergo in each Trust.

Right sided resections were the most common procedure undertaken (Table 5.1).

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Table 5.1: Patient characteristics and type of surgery for all patients undergoing colorectal
resection.
Elective
All procedures
N (%)
158842
Elective admission * (64.5%)

Resection type** right sided 80908 (32.8)


left sided 73162 (29.7)
rectal 68925 (28.0)
total 23462 (9.5)

Diagnosis Colorectal cancer 144536 (58.6)


IBD 20672 (8.4)
Diverticular disease 33034 (13.4)
other 48215 (19.6)

Age 17-54 475668 (19.3)


55-69 78867 (32.0)
70-79 75900 (30.8)
>79 44022 (17.9)

Charlson score 0 158265 (64.2)


1-4 23157 (9.4)
5 65035 (26.4)

Carstairs 1 (least deprived) 46647 (18.9)


deprivation
index*** 2 55290 (22.4)
3 53870 (21.9)
4 49139 (19.9)
5 (most deprived) 41318 (16.8)

Gender Male 124982 (50.7)


Female 121475 (49.3)

*150 patients did not have an admission status recorded


** Rectal resections included Hartmanns procedure
*** 193 patients did not have a Carstairs deprivation score recorded

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Figure 5.4: Variation in Charlson scoring per Trust of all patients undergoing a colorectal
resection.
4000

3500

3000

2500

2000 Charlson >4

1500 Charlson 1-4


Charlson 0
1000

500

0
RN3
RWE

RWA
RTD
RXC
RTR

RXR
RWG
RNL

RNS

RE9
RXL
RWY

RNQ
RR7
RA7
RM2

RC1
RA4
RJF

RFW
RC3
RBQ
RXH
RVV

RLQ

Individual NHS Trust

The majority of patients had low comorbidity scores as measured by the Charlson score.

Figure 5.4 shows the variation in Charlson scores by NHS trust.

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Figure 5.5: Variation in social deprivation by Trust of all patients undergoing a colorectal
resection
4000

3500

3000

2500
QUINTILE 5
2000 QUINTILE 4
QUINTILE 3
1500
QUINTILE 2

1000 QUINTILE 1

500

0
RN1
RWE
RX1
RXP
RHU
RJE

RVR
REM

RRF

RBD

RNJ
RW3

RM4
RPY
RYJ

RLN
RWH

RQ8

NT8
RNQ
RRK

RBT

5QT

Individual NHS Trust

Trusts varied in the degree of affluence of their patient populations as shown in Figure 5.5.

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Figure 5.6: Variation in patient age by Trust of all patients undergoing a colorectal resection

4000

3500

3000

2500

>79
2000
70-79

1500 55-69
17-54
1000

500

0
RN3
RWE

RWA
RTD
RXC
RTR

RXR
RWG
RNL

RR7

RE9
RXL
RWY

RA7
RM2

RC1
RA4

RC3
RJF

RBQ
RXH

RFW
RLQ
RNS
RNQ
RVV

Individual NHS Trusts

There was less variation in age of patients between Trusts as shown in Figure 5.6.

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Restorative proctocolectomy

Of patients undergoing primary RPC, 55.4% (3198) were male. The median age of the entire

population was 38 years (IQR 28-50 years, n=5771) (Table 1). 4723 (81.8%) patients had no

associated co-morbidity (Charlson score = 0). Table 5.2 summarises the characteristics of

patients undergoing RPC included in this study. 87.7% (5063/5771) were assigned

diagnostic codes relating to the principal diagnostic categories listed in Table 5.2. The

remaining 12.3% (708/5771) were assigned to 154 separate primary diagnoses. The most

frequent codes in the other diagnostic category were; K914 and Z432 [Attention to

stoma (250/5771)]; K528 and K529 [Non infective gastroenteritis and colitis

(n=70/5771)]; K660 [Adhesions (n=22/5771)]; K572, K573 and K579 [Diverticular

disease (n=17/5771)]; Q431 [Hirschsprung's disease (12/5771)] and K566 [Obstruction

(9/5771)]. The number of RPCs carried out each year remained stable throughout the study

period. In 1996, 465 RPC were performed compared with 483 in 2007 (p=0.252).

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Table 5.2: Characteristics of patients undergoing RPC between 1996 and 2008
Age Median 38 years
Frequency (percent)
<17 years 216 (3.7)
17-39 years 2882 (49.9)
40-59 years 1993 (34.5)
>59 years 680 (11.8)
Total 5771 (100)

Gender Male:Female 3198:2573

Charlson comorbidity score Frequency (percent)


0-2 5633 (97.6)
>2 138 (2.4)
Total 5771 (100)

Carstairs deprivation score Frequency (percent)


1 least deprived 1226 (21.2)
2 1322 (22.9)
3 1214 (21)
4 1063 (18.4)
5 most deprived 926 (16.0)
Unclassified 20 (0.3)
Total 5771 (100.0)

Diagnosis Frequency (percent)


UC 3934 (68.2)
Malignancy 619 (10.7)
Crohns disease 381 (6.6)
Benign 129 (2.2)
Other diagnosis 708 (12.3)
Total 5771 (100)

Ethnicity Frequency (percent)


White 2907 (50.4)
Indian subcontinent 176 (3.0)
Black 38 (0.7)
Chinese 4 (0.1)
Other/Unknown 2646 (45.8)
Total 5771 (100)

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Summary

Variation exists at the patient level. This variation is particularly marked in terms of levels of

social deprivation, admission status and diagnosis. This variation in case mix may impact on

outcome. It is important when considering benchmarking performance and quality that this

variation is understood and accounted for as much as possible.

Patient factors, such as social deprivation, are often not amenable to alteration by the surgical

team and NHS Trust. It is therefore important to focus on the variation in factors that are

within the control of the NHS Trusts and consultant teams whilst acknowledging the

differences in patient factors that may impact on outcome.

In the following chapters, variation in NHS trust and consultant team structural factors such

as level of activity alongside process factors such as use of laparoscopy are described.

Following this, the differences in outcome that can be explained by variation at the patient,

and in structural and process factors are described as well as the variation in outcome that is

yet to be explained.

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Chapter 6- Variation in Structural factors

Introduction

Patients represent one level when considering quality and performance measurement in

health care. Structural factors have been used as quality indicators in the US with some

healthcare funders stipulating that minimum surgical caseloads are required for

reimbursement (Leapfrog Group, 2007). In the UK, government bodies and surgical societies

have proposed minimum populations and volume of surgery for certain oncological

procedures. The Department of Health suggested centralizing Upper Gastrointestinal and

Hepato-biliary care in 2001 (Department of Health, 2001). The Association of Upper

Gastrointestinal Surgeons of Great Britain and Ireland (AUGIS, 2010) have subsequently

proposed a minimum of 15-20 oesophago-gastric resections per year per surgeon in units of

4-6 surgeons (AUGIS, 2010). In the same report, AUGIS propose that each surgeon should

perform 12-16 pancreatic resections surgeon and 15-25 liver resections (10-15 major) per

year (AUGIS, 2010). The ACPGBI has also proposed minimum volume of colorectal cancer

resections of at least twenty elective and emergency colorectal cancer resection per year

(ACPGBI, 2007). The evidence base for this figure of twenty procedures is unclear. No such

minimum volumes have been suggested for benign surgery such as for IBD.

Measurement of caseload and stipulation of a minimum volume for certain procedures is an

attractive way of improving quality. Once initial restructuring issues are overcome, it would

be an easy measure to monitor as a surrogate for quality. However, its place is not

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recognized across the board and increasing caseload indiscriminately without sufficient

evidence may have detrimental effects.

Both surgeon and hospital caseload may affect the quality of care offered in a hospital.

Institutional factors such as provision of critical care beds including size of Intensive Care

Unit (ICU), access to emergency theatres or nurse to patient ratios may affect the quality of

care experienced by patients. Little research has focused on variation in these structural

factors across NHS units.

This chapter seeks to establish if variation in structural factors, activity and infrastructure,

exists across England in both general and more specialized colorectal surgery.

Aim

This chapter aims to

1. Explore the variation in activity across surgeons and institution in colorectal surgery

in England.

2. Assess how activity has altered over time

3. Assess how many consultant teams meet the threshold of twenty cancer resections per

year in England.

4. Explore variation in institution infrastructure across these units.

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Methods

Inclusions

1. All patients undergoing colorectal resection in England with a further analysis of

those patients undergoing a resection for cancer between 2000 and 2008.

2. Patients undergoing a restorative proctocolectomy for any diagnosis.

The consultant code was not used for emergency admissions. Analysis of whether consultant

teams met the twenty threshold suggested by the ACPGBI is based, therefore, on the elective

caseload. The elective caseload is used to predict overall caseload based on the relative

overall percentage of elective to emergency cancer procedures. As 75% of cancer resections

are elective, the cut off of fifteen elective colorectal resections per year per consultant team

was examined in lieu of the twenty suggested by the ACPGBI.

Institutional Infrastructural data

Data regarding the infrastructure available within NHS Trusts were derived from

http://www.performance.doh.gov.uk/hospitalactivity/data_requests/index.htm. Data were

averaged across the years where infrastructure data were available. Data concerning

radiology services including Computer Tomography (CT) scanning, Magnetic Resonance

Imaging (MRI), fluoroscopy and ultrasound scanning (USS) were averaged by the number of

beds per year. Critical care beds included high dependency (HDU) beds, Intensive Care Unit

(ICU) beds. Numbers of critical care beds are the number per Trust bed per year multiplied

by 100. These data were non parametric. Correlations were, therefore, performed using

Spearmanns correlation.

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Results

All Colorectal resections

Between 1st April 2000 and 31st March 2008, 246457 patients who underwent a primary

colorectal resection in 175 English Trusts were included. 158842 (64.5%) patients

underwent resection during an elective admission and 35.5% (87465) represented emergency

admissions. 150 patients had no record of their admission status. Table 6.1 summarises the

characteristics of elective and emergency patients undergoing resection included in this

study. Those Trusts that undertook greater than or equal to ten procedures during the study

period performed a median of 187 procedures per year (IQR 132-257 cases per year, n=156

Trusts).

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Table 6.1: Patient characteristics and type of surgery for all patients undergoing colorectal
resection.
Elective Emergency p
n (%) n (%)

Resection type* right sided 45856 (28.9) 34957 (40.0)


left sided 38317 (24.1) 34823 (39.8)
<0.001
rectal 63315 (39.9) 5604 (6.4)
total 11354 (7.1) 12081 (13.8)

Diagnosis Cancer 111023 (69.9) 33489 (38.3)


IBD 11442 (7.2) 9201 (10.5)
<0.001
Diverticular disease 14113 (8.9) 18914 (21.6)
Other 22264 (14.0) 25861 (29.6)

Age 17-54 27522 (17.3) 20020 (22.9)


55-69 54944 (34.6) 23907 (27.3)
<0.001
70-79 51316 (32.3) 24581 (28.1)
>79 25060 (15.8) 18957 (21.7)

Charlson score 0 54574 (65.2) 54574 (62.4)


1-4 14836 (9.3) 8312 (9.5) <0.001
5 40443 (25.5) 24579 (28.1)

Carstairs 1 (least deprived) 31391 (19.8) 15224 (17.4)


deprivation 2
37045 (23.3) 18220 (20.8)
index**
<0.001
3 34910 (22.0) 18931 (21.6)
4 30679 (19.3) 18427 (21.1)
5 (most deprived) 24680 (15.5) 16608 (19.0)

Gender Male 84151 (53.0) 40815 (46.7)


<0.001
Female 74691 (47.0) 46650 (53.3)

*Left sided resections included Hartmanns procedure


** 192 patients did not have Carstairs deprivation scores recorded

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6731 consultant teams were coded as having managed these elective and emergency patients.

For the analysis of variation at a consultant team level only elective patients were included.

3716 consultant teams were coded to managing 158842 elective patients. Of these 1557

performed greater than or equal to five resections over the study period. These consultant

teams managed a median of 13 procedures per year (IQR 3-33 cases per year, n=1557

consultant teams). Figure 6.1 shows the variation in all colorectal resection by NHS Trust

over the study period.

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Figure 6.1: Variation in total volume of colorectal resection over the study period (8 years)
by 156 individual NHS Trust
4000

3500

3000

2500

2000

1500 Total Trust volume

1000

500

0
5P5
RV4
RCU

RAP

RMP
RN7
RC9
RM2

RNS
RVY

RWW
RNL
RKB

RTR
RWF

RF4
RXP
RQQ
RBQ

RLN

RVV
RAX

Individual NHS Trust

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Cancer resections

Between 1st April 2000 and 31st March 2008, 144536 patients underwent an emergency or

elective colorectal resection for cancer in 160 NHS Trusts. Of these, 111023 (76.8%)

patients were coded to an elective admission and 33489 (23.2%) patients were coded to an

emergency admission. 26 patients did not have a valid admission status. 3651 consultant

teams were coded as having managed these elective and emergency patients. The consultant

code was not used for emergency patients. For elective patients, 2175 consultant teams

managed 111023 cancer patients undergoing resection. 1155 consultant teams performed

between 5 and 465 elective procedures over this period. 149 hospital providers performed

between 87 and 2161 colorectal resections over the eight-year study period. In those Trusts

that performed more than or equal to ten procedures over the study period, the median Trust

elective and emergency volume per year was 112 procedures (IQR 81-153 cases per year,

n=149 Trusts) with a median consultant team volume of 16 elective cancer cases per year

(IQR 5-28 cases per year, n=1155 consultant teams). Table 6.2 summarises the characteristic

of elective and emergency cancer patients included in this study. Figure 6.2 shows the

variation in elective cancer resection caseload per consultant team during the study period.

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Table 6.2: Patient characteristics and type of surgery for all patients undergoing colorectal
cancer resection.
Elective Emergency p
n (%) n (%)

Resection type* right sided 33283 (30.0) 17506 (52.3)


left sided 17552 (15.8) 5337 (15.9)
<0.001
rectal 56546 (50.9) 8117 (24.2)
total 3642 (3.3) 2529 (7.6)

Age 17-54 10550 (9.5) 3146 (9.4)


55-69 39080 (35.2) 9509 (28.4)
<0.001
70-79 40373 (36.4) 11222 (33.5)
>79 21020 (18.9) 9612 (28.7)

Charlson score 0 66243 (59.7) 16414 (49.0)


1-4 10053 (9.1) 2542 (7.6) <0.001
5 34727 (31.3) 14533 (34.1)

Carstairs 1 (least deprived) 22169 (20.0) 5961 (17.8)


deprivation 2
26202 (23.6) 7129 (21.3)
index**
<0.001
3 24593 (22.2) 7322 (21.9)
4 21167 (19.1) 6963 (20.8)
5 (most deprived) 16806 (15.1) 6101 (18.2)

Gender Male 63676 (57.4) 16715 (49.9)


<0.001
Female 47347 (42.6) 16774 (50.1)

* Rectal resections included Hartmanns procedure


** 99 patients did not have a Carstairs deprivation score recorded

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Figure 6.2: Variation in elective colorectal cancer resection caseload per consultant team per
year over the study period.
500
450
400
350
300
250
200
150
100
50
0
Individual consultant teams

Each band of colour represents the volume performed in an individual year by each
consultant team with the total height representing the total volume of elective cancer
resections performed within the study period.

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Changes in activity over time

There was no correlation between year of surgery and total provider resection activity or total

cancer resection activity after exclusion of those very low volume trusts [r=0.051, p=0.071

and r=0.043, p=0.134 respectively]. There was a small correlation between consultant team

elective cancer caseload per year and year of surgery [r=0.095, p<0.001]. As shown in

figure 6.3, the mean resection volume per year rose from 14.6 cases in 2000 per consultant

team to 18.8 cases per consultant team in 2007. The number of consultant teams reduced

over this period from 930 consultant teams in 2000 to 812 consultant teams in 2007

(r=-0.937, p=0.001).

Guideline of twenty cancer resection per year

75% of the overall cancer workload were admitted as elective admissions. To explore,

therefore, the twenty resection threshold suggested by the ACPGBI, the cut off of 15 elective

colorectal resections per year were examined per consultant team. Even with this lower

threshold, only 267 consultant teams met the threshold of 15 cancer resections in each year

that they performed resections.

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Figure 6.3: Increase in mean consultant team elective colorectal cancer caseload over time
with 95% confidence interval error bars.

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Pouch procedures

Between 1st April 1996 and 31st March 2008, 5771 patients underwent primary elective RPC

in 154 English NHS Trusts. 154 hospital providers performed between 1 and 611 primary

RPCs over the twelve-year study period. The twenty highest volume institutions carried out

49.4% (n=2848) of the total number. The median institution volume was 22 cases (IQR 11-39

cases, n=154 NHS trusts). 3878 (67.2%) procedures were assigned 499 individual consultant

team codes. Individual consultant team codes were only available from April 2000 to March

2008 and thus the surgeon volume spans only eight of the twelve years. Over this period,

individual consultants performed between 1 and 134 primary pouch procedures. Ninety-one

percent carried out 20 or fewer RPCs over the eight years and the median surgeon volume

was 4 cases (IQR 1-9 cases, n=499 surgeons) over eight years.

Patients undergoing pouch procedures were categorised according to the volume of primary

procedures carried out by their named consultant team or institution during the study period.

In the first instance these categories were apportioned in two ways as described in the

methodology section: categories A to C and into low volume (LV), medium volume (MV)

and high volume (HV). The latter were assigned to tertiles derived from ranking individual

patients. The characteristics of patients in each group are outlined in Table 6.3 and Table 6.4.

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Table 6.3: Patient characteristics in each institutional volume category operated on between 1996 and 2008 *
1-14 procedures 15-31 procedures 32 procedures 1-39 procedures 40-100 procedures 101 procedures
A B C P value LV MV HV P value
Age
<17 years 31/402 (7.7) 23/1068 (2.2) 162/4301 (3.8) 66/1964(3.4) 61/1916 (3.2) 89/1891 (4.7)
17-39 years 192/402 (47.8) 524/1068 (49.1) 2166/4301 (50.4) 988/1964 (50.3) 947/1916 (49.4) 947/1891 (50.1)
p<0.001 p=0.208
40-59 years 131/402 (32.6) 391/1068 (36.6) 1471/4301 (34.2) 680/1964 (34.6) 672/1916 (35.1) 641/1891 (33.9)
>59 years 48/402(11.9) 130/1068 (12.2) 502/4301 (11.7) 230/1964 (11.7) 236/1916 (12.3) 214/1891 (11.3)
Gender
Male:Female 217:185 612:456 2369:1932 p=0.355 1090:874 857:1059 842:1049 p=0.988
Charlson comorbidity score
0-2 392/402 (97.5) 1047/1068 (98.0) 4194/4301 (97.5) 1918/1964 (97.7) 1862/1916 (97.2) 1853/1891 (98.0)
p=0.602 p=0.259
>2 10/402 (2.5) 21/1068 (2.0) 107/4301 (2.5) 46/1964 (2.3) 54/1916 (2.8) 38/1891 (2.0)
Carstairs deprivation score
1 72/402 (17.9) 209/1068 (19.6) 945/4301 (22.0) 387/1964 (19.7) 389/1916 (20.3) 450/1891 (23.8)
2 83/402 (20.6) 247/1068 (23.1) 992/4301 (23.1) 467/1964 (23.8) 440/1916 (23.0) 415/1891 (21.9)
3 75/402 (18.7) 260/1068 (24.3) 879/4301 (20.4) 413/1964 (21.0) 407/1916 (21.2) 394/1891 (20.8)
p<0.001 p=0.016
4 86/402 (21.4) 213/1068 (19.9) 764/4301 (17.8) 380/1964 (19.3) 348/1916 (18.2) 335/1891 (17.7)
5 84/402 (20.9) 138/1068 (12.9) 704/4301 (16.4) 314/1964 (16.0) 319/1916 (16.6) 293/1891 (15.5)
Unclassified 2/402 (0.5) 1/1068 (0.1) 17/4301 (0.4) 3/1964 (0.2) 13/1916 (0.7) 4/1891 (0.2)
Diagnosis
UC 239/402 (59.5) 745/1068 (69.8) 2959/4301 (68.6) 1328/1964 (67.6) 1290/1916 (67.3) 1316/1891 (69.6)
Malignancy 52/402 (12.9) 94/1068 (8.8) 473/4301 (11.0) 193/1964 (9.8) 208/1916 (10.9) 218/1891 (11.5)
Crohns disease 12/402 (3.0) 27/1068 (2.5) 90/4301 (2.1) p=0.001 52/1964 (2.6) 43/1916 (2.2) 34/1891 (1.8) p=0.002
Benign 33/402 (8.2) 57/1068 (5.3) 291/4301 (6.8) 134/1964 (6.8) 110/1916 (5.7) 137/1891 (7.2)
Other diagnosis 66/402 (16.4) 145/1068 (13.6) 497/4301 (11.6) 257/1964 (13.1) 265/1916 (13.8) 186/1891 (9.8)
Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality in Colorectal Surgery

Table 6.4: Patient characteristics in each surgeon volume category of pouch patients operated on between 2000 and 2008*
1-2 procedures 3-6 procedures 7 procedures 1-10 procedures 11-28 procedures 29 procedures
A B C P value LV MV HV P value
Age
<17 years 18/266 (6.8) 24/554 (4.3) 98/3058 (3.2) 66/1331 (5.0) 27/1329 (2.0) 47/1218 (3.9)
p<0.001 p<0.001
17-39 years 88/266 (33.1) 276/554 (49.8) 1555/3058 (50.9) 610/1331 (45.8) 712/1329 (53.6) 597/1218 (49.0)
40-59 years 97/266 (36.5) 191/554 (34.5) 1067/3058 (34.9) 471/1331 (35.4) 443/1329 (33.3) 441/1218 (36.2)
>59 years 63/266 (23.7) 63/554 (11.4) 338/3058 (11.1) 184/1331 (13.8) 147/1329 (11.1) 133/1218 (10.9)
Gender
Male:Female 153:113 301:253 1722:1336 p=0.614 758:573 751:578 667:551 p=0.505
Charlson comorbidity score
0-2 253/266 (95.1) 540/554 (97.5) 2990/3058 (97.8) 1290/1331 (96.9) 1303/1329 (98.0) 1190/1218 (97.7)
p=0.026 p=0.158
>2 13/266 (4.9) 14/554 (2.5) 68/3058 (2.2) 41/1331 (3.1) 26/1329 (2.0) 28/1218 (2.3)
Carstairs deprivation score
1 least deprived 51/266 (19.2) 123/554 (22.2) 656/3058 (21.5) 282/1331 (21.2) 261/1329 (19.6) 287/1218 (23.6)
2 49/266 (18.4) 133/554 (24.0) 721/3058 (23.6) 305/1331 (22.9) 319/1329 (24.0) 279/1218 (22.9)
3 54/266 (20.3) 118/554 (21.3) 633/3058 (20.7) 274/1331 (20.6) 272/1329 (20.5) 259/1218 (21.3)
p=0.333 p=0.594
4 54/266 (20.3) 95/884 (17.1) 554/3058 (18.1) 243/1331 (18.3) 250/1329 (18.8) 210/1218 (17.2)
5 most deprived 57/266 (21.4) 85/554 (15.3) 489/3058 (16.0) 225/1331 (16.9) 225/1329 (16.9) 181/1218 (14.9)
Unclassified 1/266 (0.4) 0/554 (0.0) 5/3058 (0.2) 2/1331 (0.2) 2/1329 (0.2) 2/1218 (0.20
Diagnosis
UC 138/266 (51.9) 356/554 (64.3) 2129/3058 (69.6) 834/1331 (62.7) 957/1329 (72.0) 832/1218 (68.3)
Malignancy 50/266 (18.8) 66/554 (11.9) 307/3058 (10.0) 169/1331 (12.7) 108/1329 (8.1) 146/1218 (12.0)
Crohns disease 12/266 (4.5) 9/554 (1.6) 72/3058 (2.4) p<0.001 37/1331 (2.8) 36/1329 (2.7) 20/1218 (1.6) p<0.001
Benign 14/266 (5.3) 34/554 (6.1) 197/3058 (6.4) 87/1331 (6.5) 67/1329 (5.0) 91/1218 (7.5)
Other diagnosis 52/266 (19.5) 89/554 (16.1) 353/3058 (11.5) 204/1331 (15.3) 161/1329 (12.1) 129/1218 (10.6)
*The number of procedures in the surgeon categories refers to those carried out over the period from 2000 to 2008.

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Changes in activity over time

The number of procedures performed per year remained stable with 471 procedures

performed in 2000 and 483 performed in 2007. During this time the number of consultant

teams performing RPC rose from 166 in 2000 to 224 in 2007 [r=0.953, p<0.001]. As shown

in figures 6.4 and 6.5 the number of patients operated in low volume centres and by low

volume consultant teams increased (p<0.001 for both providers).

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Figure 6.4: The percentage of patients undergoing RPC in each provider volume category
(LV, MV, HV) from 1996 to 2008

45.0%

40.0%

35.0%

30.0%
% of patients

25.0%

LV
20.0%
MV
15.0%
HV
10.0%

5.0%

.0%

Year of surgery

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Figure 6.5: The percentage of patients undergoing RPC in each surgeon volume category
(LV, MV, HV) from 2000 to 2008

50.0%

45.0%

40.0%

35.0%
% of patients

30.0%

25.0% LV
MV
20.0%
HV
15.0%

10.0%

5.0%

.0%
2000/01 2001/02 2002/03 2003/04 2004/05 2005/06 2006/07 2007/08
Year of surgery

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Institution infrastructure

Data on structural characteristics was available for 154 NHS Trusts. These data were missing

for two Trusts that performed ten procedures over the study period but no Trusts performing

pouch procedures.

The median inpatient bed number per institution was 733 (IQR 476-1005 beds). The median

critical bed number per 100 inpatient beds was 0.91 (IQR 0.72-1.26 beds). The median

number of CT scans, MRI and Ultrasound scans performed per inpatient bed was 15.86 (IQR

12.75-20.13), 6.57 (IQR 4.84-8.64) and 29.58 (IQR 23.85-37.73) respectively.

Unsurprisingly, larger institutions did perform more resections (r=0.800, p<0.001) and more

pouch procedures (r=0.407, p<0.001). The caseload of pouch procedures weakly correlated

with radiology services [number of CT scans performed per bed per year (Spearman Rho test

r=0.166, p=0.047), number of MRI performed per bed per year (Spearman Rho test r=0.232,

p<0.001), ultrasound scans performed per year (Spearman Rho test r=0.675, p=-0.035)]. The

caseload of RPC did correlate with number of critical care beds (Spearman Rho test r=0.336,

p<0.001) and theatres available (Spearman Rho test r=0.590, p<0.001). Overall resection

caseload correlated with theatre number but no other factors (Spearman Rho test r=0.0743,

p<0.001).

Summary

There was large variation in the activity of both Trusts and Consultant teams performing

colorectal resections and the more specialized procedure of pouch surgery. A low number of

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consultant teams performing colorectal resections consistently met with the adapted volume

threshold suggested by the ACPGBI. General colorectal caseload is increasing time

suggesting some centralisation of sevices is already taking place in England. The availability

of critical care facilities correlated with increased activity of more specialised pouch surgery.

Given these differences in structural factors and at a patient level, variation is likely to exist

in process factors and outcome amongst individual consultant teams and across institutions.

The next chapters seek to describe the variation in process factors and outcome measure as

well as investigate ways of reducing such variation.

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Chapter 7- Variation in process factors

Introduction

Structural measures are used to assess some aspects of quality of care. Measuring quality in

care needs a multifaceted approach. Process measures are often used as surrogate measures

of quality (Donabedian, 1980). They have been shown to directly influence outcome (Rubin

et al., 2001). Process measures reflect the care given across a patient population. These

measures are often applicable to the whole population and therefore occur with a higher

frequency than some outcome measures. In addition, by identifying areas where process

measures are poorly applied, it may be easier to pinpoint where care is lacking and what can

be done to improve quality and hence direct quality improvement programmes.

Process measures are often comprised of perioperative medication or assessment such as

preoperative staging magnetic resonance imaging in rectal cancer. Such measures are

difficult to derive from routinely collected datasets and require bespoke data collection.

Process measures such as choice of procedures are more easily collected using routinely

collected datasets. These measures are, however, more complex. The decision-making about

the most appropriate surgical intervention requires a significant amount of information such

as comorbid conditions, knowledge of the disease process itself and previous surgical history.

Some of this information is present on the routinely collected datasets but by no means all. It

is not possible to ascertain from the dataset whether the treatment selected for an individual

patient is the most appropriate treatment. There is, however, some guidance as to the

preferred treatments across a patient population. The ACPGBI have suggested that APE

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rates should be less than 30% (ACPGBI, 2007). This level recognises that in some patients.

APE is the most appropriate operation. For the majority of patients, however, restorative

surgery is preferable.

A valid process measure should correlate with other measures of quality or there should be a

general consensus that it represents such a valid measure. APEs for rectal cancer have been

suggested to have worse outcome than anterior resection. An APE necessitates a permanent

stoma. Tekkis and colleagues, in a study using ACPGBI bowel cancer audit project data,

found that circumferential margin involvement was significantly higher in patients selected

for APE when compared with those that underwent anterior resection (APE 16.7% and

anterior resection 7.5%) (Tekkis et al., 2005b). Following adjustment for Dukes stage and

whether the procedure was intended to be curative, APE continued to be associated with a

higher circumferential margin involvement [OR 3.3 (2.0-5.4)]. Haward and colleagues, using

the Northern and Yorkshire Cancer registry, demonstrated a survival advantage at 5 years

following anterior resection over APE (Haward et al., 2005). This may be improving over

time with a focus on improving rectal cancer outcome. Using HES data between 1996 and

2004, Tilney and colleagues found a reduction in use of APE over time but also suggested

that significant variation in institutional APE rates remained (Tilney et al., 2008). It should be

noted that this study included all patients assigned to a diagnosis code of colorectal cancer

rather than the ICD10 code of rectal cancer specifically. Morris and colleagues also found

that there were significant variations in England in APE rates amongst NHS Trusts and

suggested that steps needed to be taken to reduce such variation (Morris et al., 2008). Morris

et al, specifically used the C20 ICD10 diagnosis for rectal cancer and excluded other

cancers including those of the rectosigmoid. More recently, Nicholson and colleagues found

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significant inter centre variation in APE rates in Scotland with APE rates ranging from 38%

to 20% (Nicholson et al., 2011). Unlike previous authors, Nicholson et al found that this

inter-centre variation was not statistically significant. Any apparent unexplainable variation

in APE at a consultant team or institution level is undesirable.

It should be acknowledged that not all patients are amenable to undergoing an anterior

resection instead of APE. Patients may also choose to have an APE over an anterior

resection. Indeed, in those with very low rectal tumours or where anal sphincter function is

impaired, an APE may be impossible to avoid. Moreover, a Cochrane review in 2005 found

no difference in quality of life following APE and anterior resection (Pachler and Wille-

Jorgensen, 2005).

Increasingly, laparoscopy is being seen as the treatment of choice for colorectal resection for

most but not all patients. Minimally invasive surgery has been shown to be beneficial for

colorectal cancer surgery in randomised control trials (Lacy et al., 1995, Guillou et al., 2005,

Jayne et al., 2007, Jayne et al., 2010, Veldkamp et al., 2005). NICE guidelines suggested that

it should be offered in appropriate patients with colorectal cancer (NICE, 2006). It should be

stressed however that not all patients are suitable for laparoscopy and some procedures are

less technically challenging than others. However, given the NICE guidelines, it would be

reasonable to expect a similar level of use across NHS Trusts and geographical regions.

Some surgeons with highly specialized caseloads will continue to practice exclusively open

surgery but this does not apply to the majority. Given the apparent benefits and guidelines

for its use, laparoscopy may represent a useful process measure in the future for colorectal

resection. Its role in more specialised surgery such as RPC is less certain.

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This chapter focuses on the potential process measures of APE rate and use of minimally

invasive surgery. These measures are potentially ascertainable from the HES dataset and both

restorative and minimally invasive surgery have been associated with favorable patient

outcome.

Aim

This chapter seeks to explore variation in two measurable process measures amongst patients

undergoing colorectal surgery in England. Specifically, variation in APE rate and use of

minimally invasive surgery are examined at a consultant team and institutional level with use

of minimally invasive surgery being further assessed at a regional level.

Methods

Process measures examined were APE rate and use of the minimally invasive approach for

colorectal resection and pouch surgery.

APE rate

Elective rectal cancer resection patients were included in the APE study if they were assigned

to an ICD10 code of rectal cancer C20. To reduce the implications of possible erroneous

coding, rectosigmoid tumours C19 and anal cancers C21 were excluded when assessing

APE rate. This approach was previously used by Morris and colleagues (Morris et al., 2008).

Providers (individual consultant teams and NHS Trusts) were assigned an APE rate

according to the number of elective APE assigned to the provider divided by the total number

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of elective rectal cancer resections assigned to the provider. It is not possible to ascertain,

from HES, height from the anal verge for these patients.

Risk adjustment included comorbidity, age, social deprivation, use of laparoscopy, year of

surgery and gender.

Use of laparoscopy

All elective resections between 2002 and 2008 were included in the analysis. The study

began in 2002 as this was considered to be the year in which the minimal access approach for

colorectal resection began to be more widely disseminated.

Given that the NICE guidelines apply to and randomized control trials only included cancer

patients, subgroup analysis was performed including only the elective cancer resections.

For the regional comparison of rates of use of the minimal access approach, only elective

colorectal cancer resections in the study year 2007-2008 were included. This last study year

available on the dataset was felt to be the most appropriate comparison across regions as the

NICE guidelines for colorectal cancer resections were introduced in 2006. In this analysis,

patients were coded into regions according to their Strategic Health Authority (SHA). This

was overlayed onto a map of England.

Risk adjustment included comorbidity, age, use of laparoscopy, social deprivation, year of

surgery, type of resection and gender.

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Given the more recent use of the minimal access approach for pouch surgery, use of the

minimal access approach for all or part of restorative proctocolectomy was examined

separately. As more specialised high volume pouch surgeons may be more likely to make use

of laparoscopy, the role of activity in determining laparoscopic rate was assessed. Caseload

was considered as a categorical variable in tertiles according to the total pouch volume over

this study period.

Results

Variation in APE use

36714 patients who underwent an elective resection for rectal cancer were included. Figure

7.1 shows the variation in APE rate by consultant teams. 3.2% of teams (28/880) had

adjusted APE rates abovw the 3rd SD control limits. Figure 7.2 shows the variation in

adjusted APE rate by NHS Trusts. Of the 149 Trusts, 14 Trusts (9.4%) above the 3rd SD

control limits. There was a slight reduction in APE rates over time from 28.5% (1328/4663)

in 2000/1 to 24.7% (1187/3609) in 2007/08 as shown in figure 7.3.

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Figure 7.1: Funnel plot of consultant team caseload and APE rates amongst patients with
rectal cancer

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Figure 7.2: Funnel plot of NHS Trust caseload and APE rates amongst patients with rectal
cancer

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
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Figure 7.3: Overall percentage APE use amongst rectal cancer patients over time

p<0.001

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Use of laparoscopy in colorectal resection

Of the 121117 elective patients undergoing a resection between 2002 and 2008 included in

this analysis, 84620 underwent an elective resection for colorectal cancer. The overall

laparoscopy rate between 2002 and 2008 was 8.1% (9871/121117) and 7.7% (6554/84620)

for all elective resections and for cancer resections respectively. Between 2000 and 2008, the

use of laparoscopy increased exponentially for both cancer resections and total resections as

shown in Figure 7.4.

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Figure 7.4: Uptake of laparoscopic approach for all elective resections and elective colorectal
cancer resections

25%

20%
Percentage use of laparoscopy

15%

10% Total elective resection


Elective cancer resection

5%

0%

Year of surgery

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
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Regional use of minimal access approach

15246 patients who had undergone an elective colorectal cancer resection in 2007 were

included. Of these, 20.1% (3060/15246) patients were selected for the laparoscopic

approach. Table 7.1 shows the total number of cancer resections by each SHA. There was

significant variation in the percentage of colorectal resections selected for laparoscopy in

each SHA. This varied from 10.1% to 29.7% by SHA as shown in Figure 7.5. Following

adjustment for age, gender, level of comorbidity, social deprivation, and type of resection,

SHA continued to be a significant predictor of selection for the minimal access approach as

shown in Table 7.2.

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Table 7.1: Number of elective laparoscopic colorectal cancer resections by SHA in 2007.

Laparoscopic Total number of


SHA
Procedures resections
1 218 (10.1%) 2155
2 177 (13.0%) 1359
3 204 (12.9%) 1580
4 188 (19.5%) 965
5 401 (21.9%) 1831
6 299 (22.9%) 1304
7 365 (24.7%) 1475
8 478 (25.1%) 1908
9 399 (25.6%) 1556
10 331 (29.7%) 1113

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Table 7.2: Multiple logistic regression of use of minimal access surgery in elective colorectal
cancer resection including those patients undergoing resection in 2007.

Univariate Multivariate
Odds Odds
95% C.I. p 95% C.I. p
Ratio Ratio
Age 0.204
17-54 1.00
55-69 1.01 0.87 1.18 0.855
70-79 1.11 0.95 1.28 0.182
>79 1.10 0.94 1.29 0.254
Carstairs 0.394
deprivation 1 (least deprived) 1.00
index 2 1.07 0.95 1.20 0.298
3 1.01 0.89 1.14 0.890
4 0.95 0.84 1.08 0.451
5 (most deprived) 1.02 0.89 1.17 0.765
Gender Female vs male 1.13 1.03 1.21 0.008 1.04 0.95 1.12 0.412
Charlson <0.001 <0.001
score of co- 0 1.00 1.00
morbidity 1-4 0.93 0.83 1.06 0.281 0.96 0.85 1.09 0.517
5 0.76 0.69 0.83 <0.001 0.78 0.71 0.85 <0.001
Strategic <0.001 <0.001
Health 1 1.00 1.00
Authority 2 1.33 1.08 1.64 <0.001 1.32 1.07 1.63 0.011
3 1.32 1.08 1.61 0.008 1.29 1.05 1.58 0.015
4 2.15 1.74 2.66 0.008 2.14 1.73 2.64 <0.001
5 2.49 2.08 2.8 <0.001 2.46 2.06 2.94 <0.001
6 2.64 2.19 3.20 <0.001 2.59 2.14 3.14 <0.001
7 2.92 2.43 3.51 <0.001 2.87 2.39 3.45 <0.001
8 2.97 2.50 3.54 <0.001 2.97 2.49 3.54 <0.001
9 3.06 2.56 3.67 <0.001 3.04 2.54 3.65 <0.001
10 3.76 3.11 4.55 <0.001 3.71 3.06 4.49 <0.001
Type of <0.001 <0.001
resection right sided 1.00 1.00
left sided 0.91 0.81 1.03 0.141 0.95 0.83 1.07 0.001
Rectal 0.77 0.71 0.84 <0.001 0.76 0.69 0.83 <0.001
Total 0.42 0.31 0.58 <0.001 0.41 0.30 0.57 <0.001

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Figure 7.5: Variation in minimal access surgery rate amongst patients undergoing an elective
colorectal resection across SHA in 2007

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Use of minimal access approach for pouch surgery

2946 primary pouch procedures were performed between 2002 and 2008 in England. 2.7%

(81/2946) were performed using laparoscopic assistance (at least in part). 41 consultant

teams in 33 institutions performed these laparoscopically assisted procedures. Table 7.3

shows the differences in use of laparoscopy in each pouch volume category.

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Table 7.3: Pouch laparoscopic use by volume category

Surgeon Procedure Laparoscopy P value


volume group number rate

A 1-2 3.6% (9/248)


procedures
B 3-6 4.3% (25/562)
procedures p=0.022

C >6 2.2% (24/2136)


procedures

Summary

This chapter confirms the considerable variation in APE use amongst colorectal cancer

patients at a consultant team and NHS trust level with decreased use of APE over time. The

use of the minimal access approach has increased significantly since 2002 for elective

colorectal cancer resection and its use is beginning to disseminate for laparoscopically

assisted pouch surgery. There is considerable geographical variation in the use of minimal

access surgery for colorectal cancer resection despite the introduction of NICE guideline

endorsing this form of surgery.

This and previous chapters have demonstrated variation at a patient level and in structure and

process measures. Such factors are likely to have an impact on outcome and be potentially

addressable to improve the quality of care. The next chapter establishes whether this variation

translates in variation in outcome and derives a new measure necessary to answer this

question.

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Chapter 8- Variation in outcome factors

Introduction

In the previous chapters, variation at a patient level and in structure and process factors in

colorectal surgery was demonstrated. Significant variation was observed between providers

in terms of patient case mix, differences in activity, use of laparoscopy and selection of rectal

cancer patients for APE. It is important to consider whether these differences translate into

genuine variation in outcome. On the HES dataset, certain outcome measures are readily

available. These include in-hospital mortality, length of stay and 28 day readmission. Other

measures such as all cause one-year mortality (available for procedures carried out between

1st April 2000 to 31st March 2004) are derived from HES linkage to the Office of National

Statistics dataset.(HES/ONS linkage methodology, 2002)

These measures have limitations. Mortality is a quality measure that has been historically

relied upon. It is uncommon, especially in elective surgical practice. Its use for quality and

performance benchmarking is therefore limited. A long audit period is required for it to be

statistically stable. Failures in the quality of performance may not necessarily lead to death.

To fully exploit the HES database, further outcome measures in addition to these traditional

measures are required. Using longitudinal analysis, it may be possible to derive new

measures. These measures may be short term, medium term or longer term. Derivation of

these measures will allow a more comprehensive assessment of the HES datasets use to

investigate variation in colorectal surgery. In this thesis, 28-day reoperation following

colorectal resection is explored as a possible short term outcome measure. Adhesion and

incisional herniae rates and pouch failure are examined as medium term measures and a long

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term outcome measure respectively. These measures were chosen as they allowed

exploration of the diverse uses of HES data. In addition, they are clinically meaningful. It is

also likely that process factors such as laparoscopy and caseload may have an impact on these

outcome measures. Finally, some of these measures such as reoperation may prove valuable

measures of surgical performance when used alongside other established measures such as

mortality if data accuracy can be assured. Certainly, postoperative return to theatre

(reoperation) has been suggested as a useful quality marker in the US for general surgery

(Birkmeyer et al., 2001) and more recently for colorectal surgery (Morris et al., 2007a). In the

UK, it has also been described using HES data in the vascular context (Holt et al., 2009a).

When variation in subspecialised surgery is examined, procedure specific measures are

required including failure following restorative proctocolectomy.

This chapter will describe the derivation and variation in new outcome measures

(reoperation, adhesion, hernia and pouch failure rates). It will also look at variation in

established measures such as mortality. Finally, the impact of process factors (laparoscopy

and APE) on outcome will be examined.

Aim

This chapter seeks to

1. Demonstrate the derivation and potential use of novel colorectal specific short term

outcome metrics (28-day reoperation rates)

2. Demonstrate the derivation and potential use of novel colorectal specific medium

term outcome metrics (adhesion and incisional herniae rates)

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3. Demonstrate the derivation and potential use of novel colorectal specific long term

outcome metrics (pouch failure rates)

4. Assess differences in outcome at a patient level and according to structure and process

factors.

5. Describe existing variation in outcome in general and subspecialised colorectal (i.e.

ileal pouch) surgery.

6. Assess the impact of process factors (laparoscopy and APE) on outcome at a patient

level.

Methods

Short-term complications - Reoperation

Database inclusions and variable coding: all adult patients undergoing primary colorectal

resections were included from 1 April 2000 to 31 March 2008. Any patient who underwent a

colorectal resection between 1996 and 2000 was excluded from the analysis. The first

resection that the patient underwent between 2000 and 2008 was considered as the primary

resection.

Definition: Reoperation was defined as any reoperation for an intra abdominal procedure or

wound complication on the index admission or on a subsequent admission to hospital within

28 days of the initial resection. Reoperation rates were classified according to type of

operation. These were divided into laparotomy (considered as a reopening of abdomen,

washout of abdomen, small bowel resection, further colorectal resection, open procedure for

intra-abdominal abscess, division of adhesions and formation of stoma), stoma complications

(considered as an operation on a stoma excluding closure of stoma and stoma formation),

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wound complications requiring reoperation, and other reasons for reoperation were

considered as other. The codes used to define these procedures are shown in Table 8.1.

Any procedure code on the initial admission or within 28 days of the index procedure were

examined and the relevant intra abdominal or wound complications were identified and

included.

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Table 8.1: OPCS codes used to define reoperations following colorectal resection

Reoperation classification OPCS code


Laparotomy Reopening of abdomen T301 T302 T303 G281 G288 G332 G352 G362 G351
G532 G385 G633 H168 H622 T301 T302 T303 T308
T309 T331 T411 T414 T418 T419 T428 T431 T432
T361 T362 T365 T368 T369 T488 T384 T388 T398
T554 M372 P253 P258
Open procedure for abscess T341 T342 T343
Washout T461 T462 T463 T468 T469 T348 T349 H625
Small bowel operation G611 G692 G693 G694 G698 G699 G702 G712 G713
G714 G721 G723 G725 G731 G734 G738 G762 G763
G768 G784 G786 G788 G822 G828 G513 G584 G588
G589 G638 T374 G488 G674 G728 G781 G782 G824
G535 G538 G591 G634 G715
Colorectal resection H041 H051 H053 H058 H059 H061 H063 H062 H064
H068 H071 H072 H073 H074 H078 H079 H081 H082
H083 H084 H085 H088 H091 H092 H093 H094 H095
H098 H099 H101 H102 H103 H104 H105 H089 H108
H109 H298 H305 H308 H331 H332 H333 H334 H335
H336 H338 H339 H111 H112 H113 H114 H115 H118
H119 H122 H131 H135 H193 H198 H199 H624 H628
H161 H138 G722 H176 H178 H192 H478 H479 H299
Division of early adhesions T412 T413 T415 T423
Formation of stoma G741 G742 G743 G749 G748 H151 H152 H158 H159
Stoma complication H141 H142 H148 H149 H153 H155 H156 H163 G739
G751 G752 G754 G755 G758 G759 G601 G602 G608
G618 G733 G711 G718 G729 G789
Wound complication S608 S068 S069 S089 S242 S571 S573 S572 S574
S575 S577 S578 S579 T282 T283 S424 S428 T288
T289 S472 S474 S478 S421 S422 S423 S429 S434
S438 S476 S352 S358 S359 T313 T315 T316 T318
T774 T963 S628 S132 S152
Other Spleen/liver injury J692 J699 J724 J728 J021 J042 J183 J212 J241 J181
J185
Urological procedures M062 M151 M131 M132 M138 M168 M212 M218
M162 M193 M221 M264 M359 M373 M378 M379
M202 M258 M274 M335 M021 M025 M651 M763
M764 M191 M228 M136 M292
Repair of incisional hernia T252 T253 T259 T262 T272 T273 T278 T279 T312
EUA/operation on rectum H412 H418 H419 H464 H468 H469 H541 H568 H444
H448 Q552
Perineal operation N242 N248 N249 P111 P131 P138 H531 H558 H581
H582 H583 H588 H589

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Medium term complications

Database inclusions and variable coding: all patients older than 17 undergoing primary

colorectal resection were included from 1 April 2002 to 31 March 2008. The first resection

that the patient underwent between 2002 and 2008 was considered as the primary resection.

Any patient undergoing a colorectal resection between 1996 and 2002 were excluded from

this study.

For medium term complications, subsequent admissions were analysed for up to three years

following the initial resection. An admission with diagnosis in any field with an ICD10 code

of Incisional hernia and adhesions were included or a relevant operative code. Those

admissions where an operative intervention occurred were considered in the regression

analysis. The following codes were included:

Incisional hernia: ICD10 diagnosis codes: K43 Ventral hernia, K45 Other abdominal hernia,

K46 Unspecified abdominal hernia.

OPCS codes: T25 Primary repair of incisional hernia, T26 Repair of recurrent incisional

hernia, T27 Repair of other hernia of abdominal wall.

Adhesions: ICD10 diagnosis codes: K565 Intestinal adhesions [bands] with obstruction,

Peritoneal adhesions [bands] with intestinal obstruction, K566, Other and unspecified

intestinal obstruction K660 Peritoneal adhesions, N994 Postprocedural pelvic peritoneal

adhesions.

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OPCS codes: T412- Division of band of peritoneum, T413 Freeing of adhesions of

peritoneum, T415 Freeing of extensive adhesions of peritoneum, T423 Endoscopic division

of adhesions of peritoneum, T361 Omentectomy, Y181 Freeing of adhesions of organ.

Resections were categorised according to the site of resection (OPCS coding) as follows:

Right sided resection which included right hemicolectomy (H07) and extended right

hemicolectomy and transverse colectomy (H06, H08).

Left sided resection that included left hemicolectomy (H09), sigmoid colectomy (H10) and

Hartmanns procedure (H33.5).

Subtotal colectomy, panproctocolectomy (H04.1, H04.3, H04.8, H04.9) and total colectomy

(H05) and colectomy of unspecified site (H11) were considered together.

Rectal resection including anterior resection (H33.2, H33.3, H33.4, H33.6, H33.7, H33.8,

H33.9) and abdominoperineal resection (APE H33.1)

A laparoscopic procedure was considered to be any procedure associated with OPCS codes

Y50.8, Y75 or Y71.4. Y71.4 (failed minimal access) was introduced in 2006.

Procedures coded to failed minimal access were considered in the laparoscopic group for

analysis.

Individual diagnoses were recoded into major diagnostic categories according to ICD10 code

as follows: C18 C19 C20 C21 C26-Malignant disease, K51- Ulcerative colitis

(UC), K50 - Crohns disease, and K57 Diverticular disease.

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The remaining codes were classified as other. Patients were grouped into four age cohorts:

17-54, 55-69 and 70-79 and >79 years according to age at time of surgery. Charlson score

was considered in three categories 0, 1-4 and 5. A hospital trust may comprise several sites.

Due to mergers, Trust codes were unified to reflect their status as of April 2008.

Long term complication- Pouch failure

Database inclusions and variable coding: all primary elective RPCs were included from 1st

April 1996 to 31st March 2008. The Office of Population Censes and Surveys classification of

Surgical Operations and Procedures 4th revision (OPCS) codes are included as follows:

H042 Total excision of colon and rectum, Panproctocolectomy and

anastomosis of ileum to anus and creation of pouch however further

qualified

H043 Total excision of colon and rectum, Panproctocolectomy and

anastomosis of ileum to anus not elsewhere classified

G725 Other connection of ileum, Anastomosis of ileum to anus and creation

of pouch however further qualified

Patients were excluded if their first procedure, during the study period, was for revision

surgery.

Definition: Failure was defined as excision of the ileal reservoir or formation of ileostomy

with no subsequent reversal. If a patient had undergone both ileostomy formation and a

subsequent excision, the first date was selected as the pouch failure date. Failure rates are

presented for all patients.

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The codes used to define pouch failure and stoma formation and reversal are shown below.

OPCS codes used to define Excision of pouch

H661 Excision of ileoanal pouch

H468 Other specified operation on rectum

H331 Excision of rectum, Abdominoperineal excision of

rectum and end colostomy

H335 Excision of rectum, Rectosigmoidectomy and closure

of rectal stump and exteriorisation of bowel,

H338 Excision of rectum, Other specified, H339 Excision

of rectum, Unspecified.

OPCS codes used to define pouch revision:

H662 Revision of ileo-anal pouch

OPCS codes used to define reversal of ileostomy

G753 Attention to artificial opening into ileum, Closure of

ileostomy

G732 Attention to connection of ileum, Closure of

anastomosis of ileum,

H154 Other exteriorisation of colon, Closure of colostomy,

G733 Attention to connection of ileum, Resection of

ileostomy.

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OPCS codes used to define Ileostomy formation

G741 Continent ileostomy,

G742 Temporary ileostomy,

G743 Defunctioning ileostomy,

G748 Other specified,

G749 Other unspecified,

G751 Refashioning of ileostomy.

Of note both the H661 and H662 codes were first introduced in 2006

Individual diagnoses were recoded into major diagnostic categories according to ICD 10

code.

ICD-10 codes used to categorise primary diagnoses

K51 Ulcerative colitis (UC)

K50 Crohns disease

C18 C19 C20 C21 C26 D37 Malignant disease

D010 D12 Benign colorectal tumours

The remaining codes were classified as other diagnosis. Patients were grouped into four age

cohorts: <17, 17-39, 40-59 and >59 years according to age at time of surgery. We considered

that a Charlson score of greater than two would describe the more comorbid patient and those

patients with a score of less than or equal to two would represent those patients with few or

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no comorbidities. Mortality at 30 days increased significantly in those patients with a

Charlson score of three.

Outcome variables: 30 day in-hospital and 365 day total postoperative mortality (for all

causes in both cases) were ascertained. Patients from the study years prior to 2000 and after

March 2005 were excluded from the analysis of 365 day mortality. Length of stay (LOS) is

the time (days) spent in hospital during the primary admission for RPC; a patient admitted

and discharged on the same day would have an LOS of zero. Median length of stay [+/-

interquartile range (IQR)] is referred to in unadjusted analyses. Readmission refers to

emergency (unplanned) readmission to hospital within 28 days for any reason.

Statistical methodology: Categorical variables were investigated using the Chi-squared test.

Logistic regression analysis was used to investigate bivariate variables. Factors with a

significance level of 0.1 on univariate analysis were included in the regression analyses.

Statistical analyses were carried out using SPSS Version 18.0 (Statistical Package for Social

Sciences, SPSS, Chicago, Illinois, USA). For tests of significance, p value of <0.05 was

considered significant. For non-parametric variables, the median and interquartile ranges

(IQR) are given. Funnel plots were constructed using the web tool:

http://www.erpho.org.uk/topics/tools/funnel.aspx. To reduce the potential impact of coding

errors and capture the true Trust and consultant team colorectal resection caseload for the

construction of the funnel plots, only trusts who performed greater than 10 resections and

consultant teams who performed greater than or equal to five resections over the period were

included.

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Results

Defining novel outcome measures from HES and assessing variation in these
measures
Reoperation

Demographics

Between 1st April 2000 and 31st March 2008, 246469 patients who underwent a primary

colorectal resection in 175 English NHS Trusts were included. 158847 (64.4%) patients

underwent resection during an elective admission and 35.5% (87472/246269) represented

emergency admissions. 150 patients had no record of their admission status. Table 8.2

summarises the characteristics of elective and emergency patients undergoing resection

included in this study and the relative numbers of elective patients undergoing open and

laparoscopic procedures.

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Table 8.2: Patient characteristics and type of surgery by approach for patients undergoing a
colorectal resection.

Elective Emergency
(n=158847) (n=87472)
Laparoscopic All approaches
approach Open approach p*
n (%) n (%) n (%)

Resection type right sided 3627 (35,8) 42229 (28.4) <0.001 34962 (40.0)
left sided 2237 (22.1) 36085 (24.3) 34825 (39.8)
rectal 3836 (37.9) 59479 (40.0) 5604 (6.4)
total 431 (4.3) 10923 (7.3) 12081 (13.8)
Total 10131 (6.4) 148716 (93.6) 87472 (100)

Diagnosis Colorectal cancer 6673 (65.9) 104352 (70.2) <0.001 33493 (38.3)
IBD 758 (7.5) 10684 (7.2) 9201 (10.5)
Diverticular disease 1051 (10.4) 13063 (8.8) 18915 (21.6)
other 1649 (16.3) 20617 (13.9) 25863 (29.6)
Total 10131 (6.4) 148716 (93.6) 87472 (100)

Age 17-54 1957 (19.3) 25568 (17.2) <0.001 20021 (22.9)


55-69 3409 (33.6) 51536 (34.7) 23909 (27.3)
70-79 3096 (30.6) 48221 (32.4) 24582 (28.1)
>79 1669 (16.5) 23391 (15.7) 18960 (21.7)
Total 10131 (6.4) 148716 (93.6) 87472 (100)

Charlson score 0 6908 (68.2) 96658 (65.0) <0.001 54581 (62.4)


1-4 1172 (11.6) 13665 (9.2) 8312 (9.5)
5 2051 (20.2) 38393 (25.8) 24579 (28.1)
Total 10131 (6.4) 148716 (93.6) 87472 (100)

Carstairs 1 (least deprived) 2285 (22.6) 29107 (19.6) <0.001 15225 (17.4)
deprivation index 2 2456 (24.2) 34589 (23.3) 18221 (20.8)
3 2216 (21.9) 32694 (22.0) 18932 (21.6)
4 1770 (17.5) 28910 (19.4) 18427 (21.1)
5 (most deprived) 1398 (13.8) 23285 (15.7) 16612 (19.0)
Total** 10126 (6.4) 148585 (93.6) 87417 (100)

Gender Male 4920 (48.6) 79234 (53.3) <0.001 40819 (46.7)


Female 5211 (51.4) 69482 (46.7) 46653 (53.3)
Total 10131 (6.4) 148716 (93.6) 87472 (100)

* p value refers to the comparison in patient demographics between the elective laparoscopic
versus open groups.
** 55 emergency patients and 137 (6 laparoscopic and 131 patients in the open group)
patients did not have social deprivation status recorded.

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The overall postoperative reoperation rate for all patients undergoing colorectal resection

irrespective of admission status was 6.5% (15986/246469). 13227 (82.7%) of these required

a reoperation on their primary admission. The remaining 2759 patients underwent a

subsequent admission that necessitated a reoperation. Emergency patients experienced

slightly higher rates of reoperation than elective [7.0% (6156/87472) vs 6.2% (9819/158847),

p<0.001]. A total of 11536 (4.7%) patients underwent re-laparotomy following colorectal

resection. 0.6% (1560/246469) experienced a subsequent stoma-related complication

requiring surgery. 3861 (1.6%) had a wound complication necessitating reoperation. Table

8.3 shows the procedures included as reoperations.

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Table 8.3: Reoperation following colorectal resections for patients undergoing laparoscopic
and open procedures.

Elective Emergency
Laparoscopic Open Total All
p*
approach approach elective approaches
n (%) n (%) n (%) n (%)
Any reoperation 718 (7.1) 9413 (6.1) 9819 (6.2) <0.001 6156 (7.0)

Laparotomy Overall 541 (5.3) 6601 (4.4) 7142 (4.5) <0.001 4387 (5.0)
Reopening of 1733 (2.0)
129 (1.3) 2488 (1.7) 2617 (1.6) 0.002
abdomen
Open procedure for 264 (0.3)
31 (0.3) 432 (0.3) 463 (0.3) 0.779
abscess
Washout 127 (1.3) 1358 (0.9) 1485 (0.9) 0.001 1015 (1.2)
Small bowel 644 (0.7)
105 (1.0) 861 (0.6) 966 (0.6) <0.001
operation
Colorectal resection 166 (1.6) 1495 (1.0) 1661 (1.0) <0.001 944 (1.1)
Division of early 381 (0.4)
47 (0.5) 713 (0.5) 760 (0.5) 0.827
adhesions
Formation of stoma 241 (2.4) 2355 (1.6) 2596 (1.6) <0.001 1202 (1.4)

Stoma complication 50 (0.5) 654 (0.4) 704 (0.4) 0.430 856 (1.0)

Wound complication 145 (1.4) 2098 (1.4) 2243 (1.4) 0.866 1616 (1.8)

Other Spleen/liver injury 4 (0.0) 86 (0.1) 90 (0.1) 0.453 80 (0.1)


Urological 97 (0.1)
11 (0.1) 181 (0.1) 192 (0.1) 0.713
procedures
Repair of incisional 30 (0.0)
36 (0.4) 48 (0.0) 84 (0.0) <0.001
hernia
EUA/operation on 101 (0.1)
32 (0.3) 383 (0.3) 415 (0.3) 0.266
rectum
Perineal operation 18 (0.2) 402 (0.3) 396 (0.2) 0.077 56 (0.1)
*p value refers to the comparison in patient demographics between the laparoscopic versus
open groups.

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Patient characteristics and reoperation

Table 8.4 demonstrates the characteristics of elective and emergency patients who required

reoperation. Table 8.5 describes the predictors of reoperation in patients undergoing

colorectal resection. Table 8.5 also includes multiple regression analyses for patients

undergoing re-intervention for laparotomy specifically. On multiple regression analysis,

younger age, a diagnosis of inflammatory bowel disease, increasing co-morbidity, male

gender, rectal and subtotal resection, the laparoscopic approach and emergency admission

status were independent predictors of both reoperation and laparotomy following surgery

(Table 8.5). Increasing social deprivation predicted a higher reoperation rate but was not

significant for laparotomy rate.

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Table 8.4: Patient characteristics of those patients who necessitated a reoperation in the
postoperative period.

Elective Emergency
Reoperation No reoperation Reoperation No reoperation
n (%) n (%) p n (%) n (%) p
Resection Right sided 1974 (4.3) 43882 (95.7) <0.001 2181 (6.2) 32781 (93.8) <0.001
type Left sided 2284 (6.0) 36038 (94.0) 2546 (7.3) 32279 (92.7)
Rectal 4659 (7.4) 58656 (92.6) 428 (7.6) 5176 (92.4)
Subtotal/total 902 (7.9) 10452 (92.1) 1001 (8.3) 11080 (91.7)
Diagnosis Colorectal cancer 6566 (5.9) 104459 (94.1) <0.001 1983 (5.9) 31510 (94.1) <0.001
IBD 782 (6.8) 10660 (93.2) 739 (8.0) 8462 (92.0)
Diverticular 845 (6.0) 13269 (94.0) 1335 (7.1) 17580 (92.9)
Other 1626 (7.3) 20640 (92.7) 2099 (8.1) 23764 (91.9)
Age 17-54 1847 (6.7) 25678 (93.3) <0.001 1570 (7.8) 18451 (92.2) <0.001
55-69 3576 (6.5) 51369 (93.5) 1868 (7.8) 22041 (92.2)
70-79 3218 (6.3) 48099 (93.7) 1805 (7.3) 22777 (92.6)
>79 1178 (4.7) 23882 (95.3) 913 (4.8) 18047 (95.2)
Charlson 0 5880 (5.7) 97686(94.3) <0.001 3725 (6.8) 50856 (93.2) 0.001
score 1-4 974 (6.6) 13863 (93.4) 576 (6.9) 7736 (93.1)
5 2965 (7.3) 37479 (92.7) 1855 (7.5) 22724 (92.5)

1 (least deprived) 1849 (5.9) 29543 (94.1) <0.001 1037 (6.8) 14188 (93.2) 0.044
2 2175 (5.9) 34870 (94.1) 1221 (6.7) 17000 (93.3)
Carstairs 3 2161 (6.2) 32749 (93.7) 1319 (7.0) 17613 (93.0)
4 1929 (6.3) 28751 (93.1) 1353 (7.3) 17074 (92.7)
5 (most deprived) 1697 (6.9) 22986 (93.1) 1223 (7.4) 15389 (92.6)
Gender Male 6080 (7.2) 78074 (92.8) <0.001 3164 (7.8) 37655 (92.2) <0.001
Female 3739 (5.0) 70954 (95.0) 2992 (6.6) 43661 (93.6)

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Table 8.5: Multiple regression analysis for reoperation and laparotomy amongst elective and
emergency patients.

Co factors All reoperation Laparotomy


Odds Odds
95% CI p value 95% CI p
ratio ratio
Age <0.001 <0.001
17-54 1.00 1.00
55-69 0.98 0.94 1.03 0.474 0.94 0.89 0.99 0.022
70-79 0.96 0.91 1.01 0.109 0.93 0.88 0.99 0.013
>79 0.70 0.66 0.74 <0.001 0.68 0.63 0.73 <0.001
Diagnosis <0.001 <0.001
Colorectal Cancer 1.00 1.00
Inflammatory Bowel
1.33 1.24 1.42 <0.001 1.18 1.09 1.28 <0.001
Disease
Diverticular Disease 1.12 1.06 1.18 <0.001 1.04 0.97 1.11 0.280
Other 1.40 1.34 1.46 <0.001 1.35 1.28 1.42 <0.001
Charlson
<0.001 <0.001
score
0 1.00 1.00
1-4 1.10 1.04 1.17 0.001 1.01 0.94 1.08 0.768
5 1.34 1.29 1.39 <0.001 1.35 1.29 1.41 <0.001
Gender female vs male 0.75 0.73 0.78 <0.001 0.74 0.71 0.77 <0.001
Social Deprivation <0.001
1 Least deprived 1.00
2 1.00 0.95 1.05 0.973
3 1.06 1.01 1.11 0.032
4 1.09 1.04 1.15 0.001
5 Most deprived 1.14 1.08 1.20 <0.001
Site of resection <0.001 <0.001
Right sided 1.00 1.00
Left sided 1.31 1.25 1.37 <0.001 1.18 1.12 1.25 <0.001
Rectal 1.63 1.56 1.71 <0.001 1.37 1.29 1.44 <0.001
Total 1.44 1.35 1.52 <0.001 1.37 1.28 1.47 <0.001
Surgical Laparoscopy versus
1.11 1.03 1.20 0.006 1.16 1.06 1.26 0.001
approach open
Admission Emergency vs
1.21 1.17 1.26 <0.001 1.16 1.11 1.21 <0.001
status Elective
Year of
(continuous variable) 1.03 1.03 1.04 <0.001 1.03 1.02 1.04 <0.001
surgery

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Variation in reoperation between surgeon and Trusts

Exclusion of trust and surgeon codes that failed to meet the minimum volume inclusion

criteria equated to 19 Trusts [37 patients (0.02%)] and 4185 consultant codes [6853 patients

(2.8%)] respectively. 72.2% of patients excluded in the analysis of surgeon codes were

assigned to an emergency admission.

For included consultant teams elective reoperation rates varied between 0% and 80%.

Variation between Trusts was between 0% and 17%. Figures 8.1 and 8.2 show funnel plots of

the adjusted reoperation rates amongst consultant teams and NHS Trusts respectively. Wide

variation in reoperation rates can be observed across all volume caseloads.

Twenty-two of the 156 included Trusts had adjusted reoperation rates outside (i.e. above) the

99.8% control limit, which corresponds to 3 standard deviations above the mean. For 156

Trusts, 0.16 Trust outliers at this threshold could be expected to arise through chance alone,

assuming a purely binomial distribution for the reoperations. Eleven (0.7%) of the 1557

included consultant teams had elective reoperation rates above the 99.8% control limit and

1.6 consultant team outliers at this threshold could be expected through chance alone. Even

at a high caseload there was however significant variation in both the Trust and surgeon team

reoperation rates. There was a five-fold difference in highest and lowest (14.9% vs 2.8%)

elective reoperation rates amongst surgical teams performing greater than 500 procedures.

There was a threefold difference in reoperation rates in Trusts performing over 2500

procedures throughout the study period (11.5% vs 3.7%).

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Figure 8.1: Funnel plot of adjusted reoperation rates for elective colorectal resectional
procedures for individual consultant teams by volume of elective surgery.

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in Colorectal Surgery

Figure 8.2: Funnel plot of adjusted reoperation rates for both emergency and elective
colorectal resectional procedures for individual NHS Trusts by volume.

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Laparoscopy and reoperation

Overall, for both elective and emergency patients, those who had a resection attempted using

a minimal access approach had a marginally higher rate of reoperation than those having an

open approach [Laparoscopic 7.0% (799/11359), open 6.5% (15187/235110), p=0.015].

Table 8.2 shows the reasons for reoperation for elective laparoscopic and open groups.

Correlation with other outcome measures

Elective and emergency patients who experienced a complication requiring reoperation

during their initial admission had a prolonged median LOS [elective patients: reoperation 27

days (IQR 17-43 days, n=7873); No reoperation 11 days (9-16 days, n=150974), p<0.001;

emergency patients: reoperation 34 days (IQR 21-55 days, n=5401); No reoperation 17 days

(11-28 days, n=82071, p<0.001] and a higher rate of postoperative mortality [elective

patients: reoperation 938/7873 (11.9%), no reoperation 4399/150974 (2.9%), p<0.001;

emergency patients: reoperation 1251/5346 (23.4%), no reoperation 12511/82126 (15.2%),

p<0.001]. One year mortality was available from April 2000 to March 2004. Those elective

and emergency patients who experienced a complication requiring reoperation either on the

index admission or a subsequent admission within 28 days of surgery demonstrated an

increased one year mortality [elective patients: reoperation 1353/57546 (23.9%), no

reoperation 10162/89800 (11.3%), p<0.001; emergency patients: reoperation 1477/3693

(40.0%), no reoperation 15030/50822 (29.6%), p<0.001]. Elective patients who required an

reoperation on the index admission had a higher emergency readmission rate within 28 days

of discharge following this index admission (reoperation 947/7873 (12.0%), no reoperation

13777/150974 (9.1%), p<0.001].

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Medium term outcomes

Incisional hernia and adhesion rates

Variation at a patient level

187148 patients were included between 1st April 2002 and 31st March 2008. Table 8.6 shows

the characteristic of these patients. Patients were followed up until three years or the end of

the study period. The median follow up was 987 days (IQR 406-1095, n=187148).

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Table 8.6: Descriptives of elective patients undergoing colorectal resection between 2002 and
2008 included for analysis of medium term adhesion and herniae rates.

Laparoscopic Open
approach approach p value
n (%) n (%)
Resection type right sided 4137 (37.6) 57888 (32.9) <0.001
left sided 2462 (22.4) 52327 (29.7)
rectal 3860 (35.0) 48978 (27.8)
total 554 (5.0) 16942 (9.6)
Diagnosis Colorectal cancer 6938 (63.0) 102310 (58.1) <0.001
IBD 931 (8.5) 14671 (8.3)
Diverticular disease 1217 (11.1) 23955 (13.6)
other 1927 (17.5) 35199 (20.0)
Age 17-54 2315 (21.0) 33990 (19.3) <0.001
55-69 3567 (32.4) 56696 (32.2)
70-79 3273 (29.7) 53569 (30.4)
>79 1858 (16.9) 31880 (18.1)
Charlson score 0 7514 (68.2) 110546 (62.8) <0.001
1-4 1271 (11.5) 17688 (10.0)
5 2228 (20.2) 47901 (27.2)
Carstairs 1 (least deprived) 2425 (22.1) 33608 (19.1) <0.001
deprivation index 2 2666 (24.2) 39549 (22.5)
3 2410 (21.9) 38550 (21.9)
4 1935 (17.6) 34866 (19.8)
5 (most deprived) 1561 (14.2) 29420 (16.7)
Admission status Elective 9871(89.6) 111246 (63.3) <0.001
Emergency 1140 (10.4) 64777 (36.8)
Gender Male 5344 (48.5) 89648 (50.9) <0.001
Female 5669 (51.5) 86487 (49.1)

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Incisional herniae rates

During the study period, 4.7% (8885/187148) patients were admitted with a diagnosis of

incisional hernia or underwent a procedure for repair of an incisional hernia. 80.6%

(7160/8885) of these patients underwent an operative repair of hernia. This equates to 3.8%

of all patients undergoing colorectal resection. Patients selected for the laparoscopic approach

had higher rates of operative intervention for incisional hernia than those selected for the

open approach [laparoscopic 4.2% (465/11013) vs open 3.8% (6695/176135), p=0.025].

Table 8.7 shows the readmissions requiring operative intervention for incisional hernia and

adhesions in the laparoscopic and open groups. On multiple regression analysis, use of

laparoscopy was not a predictor of operative repair for incisional herniae [OR 1.09 (CI 0.99-

1.21), p=0.079]. Table 8.8 shows the multiple regression analysis for operative

reintervention for incisional hernia.

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Table 8.7: Rates of re-intervention for adhesions and incisional hernia repairs following
laparoscopic and open resection at one, two and three year post surgery.

Laparoscopic
Open Approach p value
approach
Incisional hernia
repair
One year 1.5% (163/11013) 0.9% (1655/176135) <0.001
Two year 3.6% (394/11013) 2.9% (5029/176135) <0.001
Three year 4.2% (465/11013) 3.8% (6688/176135) 0.024

Division of
adhesions
One year 1.5% (160/11013) 1.8% (3208/176135) 0.005
Two year 2.5% (270/11013) 3.0% (5351/176135) <0.001
Three year 2.8% (305/11013) 3.6% (6325/176135) <0.001

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Table 8.8: Multiple regression analysis of operative reintervention for incisional hernia and
adhesion
Incisional hernia repair Division of adhesions
Odds Odds
95% C.I. p value 95% C.I. p value
Ratio Ratio
Laparoscopic vs
Surgical approach 1.09 0.99 1.21 0.083 0.80 0.71 0.90 <0.001
open
Charlson score of <0.001 <0.001
co-morbidity 0 1.00 1.00
1-4 0.98 0.91 1.06 0.617 0.99 0.91 1.08 0.817
5 0.63 0.59 0.68 <0.001 0.86 0.80 0.91 <0.001
Age <0.001 <0.001
17-54 1.00 1.00
55-69 1.09 1.03 1.17 0.007 0.75 0.71 0.80 <0.001
70-79 0.79 0.73 0.84 <0.001 0.49 0.46 0.53 <0.001
>79 0.28 0.25 0.32 <0.001 0.26 0.23 0.28 <0.001
Year of surgery <0.001 0.001
2002 1.00 1.00
2003 1.14 1.04 1.24 0.005 1.07 0.98 1.17 0.155
2004 1.23 1.13 1.34 <0.001 1.15 1.05 1.26 0.003
2005 1.42 1.30 1.54 <0.001 1.27 1.17 1.39 <0.001
2006 1.39 1.28 1.51 <0.001 1.27 1.16 1.38 <0.001
2007 1.12 1.03 1.22 0.012 1.22 1.11 1.33 <0.001
Gender Female vs Male 0.78 0.74 0.82 <0.001 1.13 1.07 1.19 <0.001
Emergency vs
Admission status 1.07 1.01 1.13 0.027 1.49 1.41 1.58 <0.001
Elective
Diagnosis <0.001 <0.001
Cancer 1.00 1.00
IBD 1.11 0.99 1.23 0.072 1.31 1.19 1.44 <0.001
Diverticular Disease 2.18 2.04 2.34 <0.001 1.08 1.00 1.17 0.045
Other 1.21 1.13 1.30 <0.001 0.94 0.88 1.01 0.088
Carstairs Index of social deprivation 0.001
1 (least deprived) 1.00
2 0.98 0.91 1.06 0.570
3 0.97 0.90 1.04 0.379
4 0.93 0.86 1.00 0.060
5 (most deprived) 0.83 0.76 0.90 <0.001
Type of resection <0.001 <0.001
right sided 1.00 1.00
left sided 1.45 1.35 1.55 <0.001 1.89 1.76 2.04 <0.001
rectal 1.70 1.59 1.83 <0.001 1.95 1.80 2.10 <0.001
total 1.02 0.92 1.13 0.667 1.92 1.76 2.10 <0.001
Reoperation 1.56 1.44 1.69 <0.001 2.16 2.00 2.32 <0.001

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Adhesion related admissions

During the study period, 8.1% (15125/187148) patients were admitted with a diagnosis of

adhesions or underwent a procedure for division of adhesions. Of these patients, 43.9%

(6637/15125) required an operative intervention for division of adhesions. Overall, 3.5% of

patients undergoing colorectal resection required division of adhesions within 3 years of their

primary procedure. Patients selected for a laparoscopic procedure had lower rates of

admissions with a diagnosis of adhesion [laparoscopic 6.3% (692/11013) open 8.2%

(14433/176135), p<0.001] and lower rates of reintervention for adhesions than those

undergoing an open procedure [laparoscopic 2.8% (305/11013) open 3.6% (6332/176135),

p<0.001]. On multiple regression analysis, patients selected for a laparoscopic procedure had

lower adhesion rates [OR 0.80 (CI 0.71-0.90), <0.001]. Table 8.8 shows the multiple

regression analysis for operative reintervention for adhesion rates.

For those patients admitted with adhesions, similar numbers in the laparoscopic and open

groups required surgical reintervention [laparoscopic 44.1% (305/692) open 43.9%

(6332/14433), p=0.916].

Patients who suffered a complication requiring reoperation in the postoperative period were

more likely to have operative reintervention for adhesions than those who did not experience

a complication in the postoperative period [reoperation 13.1% (1639/12481) No reoperation

7.7% (13486/174667), p<0.001].

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Variation at an institutional level of incisional hernia and adhesion rates

Incisional hernia rates varied between 0 and 9% at an institutional level. Adhesion rates

varied marginally greater at an institutional level between 0 and 14%. Figures 8.3 and 8.4

show the variation in incisional hernia and adhesional hernia rate respectively.

Figure 8.3: Variation in incisional hernia rates following colorectal resection for each NHS
Trust with 95% confidence intervals

Adhesion

rate

(%)

NHS Trust

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in Colorectal Surgery

Figure 8.4: Variation in adhesion rates following colorectal resection for each NHS Trust
with 95% confidence intervals

Adhesion

rate

(%)

NHS Trust

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Longer term outcome measures

Pouch failure rates

Variation at a patient level

Of the entire patient series, 6.4% (372/5771) patients experienced failure during the study

period. The median follow up period was 65 (IQR 28-106) months of 5731. 40 patients were

excluded due to incomplete data about the timing of surgery. The median time to failure was

9.4 months (IQR 2.5-23.4 months) and 59% of failure (221/372) occurred in the first year

after surgery. 5.8% (339/5771) of patients underwent an indefinite ileostomy and 1.1%

(65/5771) an excision of the pouch. 33 patients were coded to both excision of pouch and

formation of ileostomy. Only four patients were given the revision of ileostomy code but

this was only introduced in 2006. 57.6% (3322/5771) of patients underwent a definite

subsequent reversal of the ileostomy following the pouch procedure. Of these 5.5%

(182/3322) experienced failure with 29 patients being coded to having an excision of pouch

and 168 patients having a further ileostomy performed without subsequent reversal during the

study period. Table 8.9 summarises the characteristics of patients who experienced failure.

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Table 8.9: Characteristics of restorative proctocolectomy patients who experienced failure


(372/5771) compared with those who did not

Patients who Patients who did not


experienced failure experience failure
Age Median 40 years Median 38 years
Frequency (percent) Frequency (percent)
<17 years 7 (1.9) 209 (3.9)
17-39 years 169 (45.4) 2713 (50.3)
40-59 years 156 (41.9) 1837 (34.0)
>59 years 40 (10.8) 640 (11.9)
Total 372 (100) 5399 (100.0)
Gender Male:Female 199:173 (53.5:46.5) 2999:2400 (55.5:44.5)
Charlson comorbidity
Frequency (percent) Frequency (percent)
score
0-2 361 (97.0) 5272 (97.6)
>2 11 (3.0) 127 (2.4)
Total 372 (100) 5399 (100.0)
Carstairs deprivation score Frequency (percent) Frequency (percent)
1 least deprived 61 (16.4) 1165 (21.6)
2 81 (21.8) 1241 (23.0)
3 91 (24.5) 1123 (20.8)
4 73 (19.6) 990 (18.3)
5 most deprived 63 (16.9) 863 (16.0)
Unclassified 3 (0.8) 17 (0.8)
Total 372 (100.0) 5399 (100.0)
Diagnosis Frequency (percent) Frequency (percent)
UC 254 (68.3) 3680 (68.2)
Malignancy 39 (10.5) 580 (10.7)
Crohns disease 10 (2.7) 119 (2.2)
Benign 23 (6.2) 358 (6.6)
Other diagnosis 46 (12.4) 662 (12.3)
Total 372 (100) 5399 (100.0)

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Patients aged between 40 and 60 years were most likely to experience failure [Age 40-59

7.8% (156/1993), 17-39 years 5.9% (169/2882), 60 5.9% (40/680), <17 3.2% (7/216),

p=0.008]. There was no relationship between diagnosis (p=0.974), level of comorbidity

[(Charlson score), p=0.460], social deprivation (p=0.118) or gender (p=0.441) and failure in

unadjusted analyses. In Cox regression analysis, age and higher provider volume were

associated reduced pouch failure (Table 8.10). The role of volume will be discussed further

in the following chapter.

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Table 8.10: Unifactorial and Multiple Cox regression analysis for pouch failure

Unifactorial analysis Multiple Regression analysis

Odds 95% CI for Odds 95% CI for


p p
Ratio Odds Ratio Ratio Odds Ratio

Cofactor Lower Upper Lower Upper


Gender
Female (compared with
1.07 0.87 1.31 0.520
male)
Diagnosis 0.948
UC 1.00
Malignant disease 0.98 0.70 1.37 0.882
Crohns disease 1.25 0.66 2.35 0.490
Benign disease 0.92 0.60 1.41 0.707
Other diseases 1.04 0.76 1.42 0.831
Age cohort 0.008 0.009
Age <17* 1.00 1.00
Age 17- 39 years 1.84 0.86 3.92 0.114 1.80 0.85 3.84 0.127
Age 40-59 years 2.50 1.17 5.32 0.018 2.44 1.14 5.20 0.021
Age >59 years 1.87 0.84 4.18 0.127 1.82 0.81 4.06 0.145
Charlson comorbidity score
Charlson 2 * 1.00
Charlson 3 1.31 0.72 2.39 0.378
Carstairs index 0.112
1 least deprived* 1.00
2 1.24 0.89 1.73 0.203
3 1.51 1.09 2.09 0.013
4 1.39 0.99 1.96 0.056
5 Most deprived 1.39 0.97 1.97 0.070
6 Unclassified 2.95 0.93 9.41 0.067
Provider Volume 0.015 0.018
LV 1-39 procedures* 1.00 1.00
MV 40-100 procedures 1.04 0.82 1.32 0.720 1.04 0.82 1.32 0.741
HV >100 procedures 0.73 0.56 0.95 0.018 0.73 0.57 0.95 0.019
Consultant team volume 0.451
LV 1-11 procedures* 1.00
MV 12-28 procedures 1.01 0.73 1.38 0.976
HV >28 procedures 0.83 0.59 1.16 0.277
*reference group

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Considerable variation in Trust failure rates was demonstrated in the funnel plot shown in

Figure 8.5.

Patients who had a longer LOS for the primary procedure and those readmitted within 28

days after discharge following the primary procedure were significantly more likely to

experience failure [Readmitted within 28 days: failure rate 9.9% (125/1269), not readmitted

within 28 days: failure rate 5.5% (247/4502), p<0.001. The median LOS of those who

experienced failure was 13.5 days (IQR 10-21 days, n=372) compared with 12 days (IQR 9-

15 days, n=5329) for those who did experience failure, p<0.001].

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Figure 8.5: Funnel plot of pouch failure rates by NHS Trust.

*An institution performing a single procedure during the study period with a 100% failure rate was excluded.

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Variation in established colorectal outcome measures

Variation in colorectal resection outcome - Mortality

Variation at a patient level

Of the elective colorectal resection patients, 3.4% (5337/158842) died in hospital within 30

days of admission. The 365 day elective mortality (available from April 2000 to March 2005

only) was 12.1% (11515/95341). The 30 day mortality [15.7% (13761/87465), p<0.001] and

365 day mortality [30.3% (16505/54508), p<0.001] were both higher for patients coded to an

emergency admission. Table 8.11 shows the variation in 30 day and 365 day mortality

amongst colorectal resection patients.

There was a slight reduction in one year mortality and 30 day mortality over time for both

emergency and elective surgery (Table 8.11).

Patients with increasing age, a diagnosis of cancer, the open approach and increasing social

deprivation and increasing comorbidity had higher 30 day and 365 day mortality (Table

8.11).

Table 8.12 shows the multiple regression analysis for both 30 day and 365 day mortality. An

open approach, increasing comorbidity, increasing age, earlier study year, female gender, an

emergency admission, increasing social deprivation were independent predictors of an

increased 30 day and 365 day mortality.

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Table 8.11: Variation in 30 day and 365 day mortality amongst elective and emergency
colorectal resection patients (unadjusted analysis).
30 day mortality 365 day mortality
Elective Emergency Elective Emergency
n (%) p n (%) p n (%) p n (%) p
Surgical Open 5163 (3.5) 13672 (15.9) 11423 (12.2) 16428 (30.3)
approach Use of 174 (1.7) <0.001 89 (7.3) <0.001 92 (5.3) <0.001 77 (22.2) 0.001
laparoscopy

Resection type right sided 1642 (3.6) 4639 (13.3) 3717 (14.0) 6635 (30.7)
left sided 909 (3.0) 6189 (17.8) 1969 (10.3) 6684 (30.8)
<0.001 <0.001 <0.001 <0.001
rectal 2310 (3.2) 667 (11.9) 5086 (12.0) 944 (27.0)
total 476 (4.2) 2266 (18.8) 743 (10.2) 2242 (29.2)

Diagnosis Colorectal 3732 (3.4) 4699 (14.0) 8975 (13.5) 7789 (35.1)
cancer
IBD 105 (0.9) 508 (5.5) 166 (2.3) 529 (9.1)
<0.001 <0.001 <0.001 <0.001
Diverticular 392 (2.8) 3101 (16.4) 556 (6.5) 2915 (25.0)
disease
other 1108 (5.0) 5453 (21.1) 1818 (13.7) 5272 (34.5)

Age 17-54 173 (0.6) 587 (2.9) 683 (4.1) 1044 (8.5)
55-69 939 (1.7) 2500 (10.5) 2871 (8.8) 3515 (23.9)
<0.001 <0.001 <0.001 <0.001
70-79 2208 (4.3) 4859 (19.8) 4640 (14.9) 5914 (37.1)
>79 2017 (8.0) 5815 (30.7) 3321 (22.5) 6032 (50.8)

Charlson score 0 1845 (1.8) 5833 (10.7) 4711 (7.4) 7332 (20.9)
1-4 540 (3.6) <0.001 1461 (17.6) <0.001 867 (11.4) <0.001 1359 (30.0) <0.001
5 2952 (7.3) 6467 (26.3) 5937 (24.9) 7814 (52.4)

Carstairs 1 (least 855 (2.7) 1932 (12.7) 1939 (10.6) 2452 (26.3)
deprivation deprived)
index 2 1127 (3.0) 2642 (14.5) 2504 (11.4) 3295 (29.0)
3 1213 (3.5) <0.001 2977 (15.7) <0.001 2538 (12.1) <0.001 3571 (30.3) <0.001
4 1112 (3.6) 3171 (17.2) 2399 (12.8) 3746 (32.2)
5 (most 1029 (4.2) 3031 (18.3) 2130 (14.0) 3426 (33.1)
deprived)

Gender Male 3317 (3.9) 5915 (14.5) 6632 (13.1) 7392 (29.1)
<0.001 <0.001 <0.001 <0.001
Female 2020 (2.7) 7846 (16.8) 4883 (10.9) 9113 (31.4)

Year of Surgery 2000 718 (3.7) 1730 (16.4) 2442 (12.7) 3292 (31.2)
2001 676 (3.7) 1744 (15.8) 2297 (12.5) 3344 (30.4)
2002 691 (3.6) 1752 (16.2) 2326 (12.2) 0.001 3327 (30.7) 0.032
2003 644 (3.6) 1769 (16.1) 2214 (11.5) 3256 (30.7)
<0.001 <0.001
2004 692 (3.6) 1793 (16.1) 226 (11.6) 3286 (29.5)
2005 686 (3.3) 1743 (15.2)
2006 634 (3.0) 1707 (15.9)
2007 596 (2.7) 1523 (14.1)
*Includes patients admitted between 2000 and 2005 for a resection.

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Table 8.12: Variation in 30 day and 365 day mortality amongst elective and emergency
colorectal resection patients (multiple regression analysis).
30 day mortality 365 day mortality*
Odds Odds
95% C.I. p 95% C.I. p
Ratio Ratio
Laparoscopic vs
Surgical approach 0.56 0.49 0.63 <0.001 0.56 0.47 0.66 <0.001
open
Charlson score of <0.001 <0.001
co-morbidity 0 1.00 1.00
1-4 1.62 1.54 1.72 <0.001 1.44 1.37 1.52 <0.001
5 3.04 2.93 3.15 <0.001 3.59 3.48 3.70 <0.001
Age <0.001 <0.001
17-54 1.00 1.00
55-69 3.16 2.91 3.43 <0.001 2.29 2.16 2.43 <0.001
70-79 7.01 6.48 7.59 <0.001 4.11 3.89 4.36 <0.001
>79 13.94 12.86 15.10 <0.001 7.16 6.75 7.60 <0.001
Year of surgery <0.001 0.001
2000 1.00 1.00
2001 0.94 0.88 1.00 0.063 0.96 0.91 1.00 0.046
2002 0.93 0.88 0.99 0.030 0.93 0.89 0.97 0.001
2003 0.92 0.86 0.98 0.008 0.89 0.85 0.93 <0.001
2004 0.92 0.86 0.98 0.007 0.87 0.83 0.91 <0.001
2005 0.84 0.79 0.89 <0.001
2006 0.84 0.79 0.90 <0.001
2007 0.73 0.68 0.78 <0.001
Gender Female vs Male 0.88 0.85 0.91 <0.001 0.92 0.89 0.95 <0.001
Emergency vs
Admission status 3.85 3.71 4.00 <0.001 2.99 2.89 3.09 <0.001
Elective
Diagnosis <0.001 <0.001
Cancer 1.00 1.00
IBD 1.10 1.00 1.21 0.054 0.50 0.45 0.54 <0.001
Diverticular Disease 1.62 1.54 1.70 <0.001 0.84 0.80 0.88 <0.001
Other 2.53 2.44 2.64 <0.001 1.54 1.48 1.60 <0.001
Carstairs Index of social deprivation <0.001 <0.001
1 (least deprived) 1.00 1.00
2 1.09 1.04 1.15 0.001 1.06 1.01 1.11 0.013
3 1.21 1.15 1.28 <0.001 1.13 1.08 1.19 <0.001
4 1.32 1.25 1.39 <0.001 1.22 1.67 1.28 <0.001
5 (most deprived) 1.51 1.43 1.60 <0.001 1.36 1.30 1.43 <0.001
Type of resection <0.001 <0.001
right sided 1.00 1.00
left sided 1.23 1.19 1.29 <0.001 1.04 1.00 1.08 0.050
rectal 0.88 0.84 0.93 <0.001 0.78 0.75 0.82 <0.001
total 1.90 1.80 2.01 <0.001 1.40 1.33 1.48 <0.001
*Includes patients admitted between 2000 and 2005 for a resection.

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Variation at an institutional level

Figure 8.6 shows the variation in unadjusted mortality rates per NHS Trust for patients

undergoing a colorectal resection.

Figure 8.6: Variation in 30 day mortality following colorectal resection for each NHS Trust
with 95% confidence intervals

30 day

mortality

(%)

NHS Trust

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Variation in colorectal resection outcome amongst patients- Readmission and length of stay

Readmission

The overall readmission rate for patients undergoing colorectal resection was 9.2%

(22737/246457). There were no differences in readmission rates between elective and

emergency admissions [elective 9.3% (14724/158842) emergency 9.1% (7991/87465),

p=0.272].

Readmission rates varied little from 8% to 13% per NHS Trust. Figure 8.7 shows this

variation in readmission rates.

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Figure 8.7: Mean readmission rates following colorectal resection with 95% confidence
intervals per NHS Trust.

Readmission

(%)

NHS Trust

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LOS

Variation at a patient level

The mean logarithm LOS with back exponentiation was 14.3 days (SD 2.0) with emergency

admissions having a longer LOS than elective admissions [elective 12.6 (1.8), emergency

17.9 (2.3), p<0.001]. Table 8.13 shows the variation in LOS for elective and emergency

colorectal resection with patient characteristics.

Selection for the open approach, increasing age, comorbidity and social deprivation, female

gender, and a diagnosis of IBD were predictors for prolonged LOS (Table 8.13).

Variation at an institutional level

There was limited variation in LOS at an institutional level (Figure 8.8). In this graph, the

Trust with the longest LOS only performed 10 resections during the study period.

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Table 8.13: Univariate and Multiple regression analysis of log LOS with back

exponentiation.

Univariate Multivariate
Relative Relative
95% C.I. p 95% C.I. p
risk risk
Laparoscopic vs
Surgical approach
open 0.60 0.59 0.61 <0.001 0.71 0.70 0.72 <0.001
Charlson score of
co-morbidity 0 1.00 1.00
1-4 0.89 0.89 0.90 <0.001 0.94 0.93 0.94 <0.001
5 0.88 0.98 1.00 0.013 1.01 1.00 1.02 0.030
Age
17-54 1.00 1.00
55-69 1.09 1.08 1.09 <0.001 1.15 1.14 1.16 <0.001
70-79 1.25 1.24 1.26 <0.001 1.32 1.30 1.33 <0.001
>79 1.40 1.39 1.41 <0.001 1.44 1.43 1.46 <0.001
Year of surgery 0.97 0.97 0.97 <0.001 0.98 0.97 0.98 <0.001
Gender Female vs Male 1.03 1.02 1.03 <0.001 1.01 1.01 1.02 <0.001
Emergency vs
Admission status
Elective 1.43 1.42 1.43 <0.001 1.43 1.42 1.44 <0.001
Diagnosis
Cancer 1.00 1.00
IBD 1.03 1.02 1.04 <0.001 1.12 1.11 1.13 <0.001
Diverticular Disease 1.08 1.07 1.09 <0.001 0.96 0.95 0.97 <0.001
Other 1.04 1.03 1.04 <0.001 0.99 0.98 0.99 <0.001
Carstairs Index of social deprivation
1 (least deprived) 1.00 1.00
2 1.04 1.03 1.05 <0.001 1.03 1.02 1.03 <0.001
3 1.09 1.08 1.02 <0.001 1.06 1.05 1.07 <0.001
4 1.13 1.12 1.14 <0.001 1.09 1.08 1.10 <0.001
5 (most deprived) 1.19 1.18 1.21 <0.001 1.15 1.14 1.16 <0.001
Type of resection <0.001
right sided 1.00 1.00
left sided 1.16 1.15 1.17 <0.001 1.15 1.15 1.16 <0.001
rectal 1.05 1.04 1.06 <0.001 1.22 1.21 1.23 <0.001
total 1.31 1.30 1.32 <0.001 1.30 1.28 1.31 <0.001

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Figure 8.8: Variation in LOS amongst colorectal resection patients by NHS Trust with 95%
confidence intervals.
80

70
*
60

50
LOS (days)

40

30

20

10

0
RLU

RX1
RBZ
RCB

RTF
RH8
RCF
RWP

RTD
RVL
RWW

RFF

RJL

RJ7
RMC

RYJ

RAL
RWJ

RQX
NT8

RNH
RHQ
RGQ

RTK
RGT

RVV

NHS Trust
95% CIs

*low volume Trust performing ten elective and emergency procedures

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Variation in established outcome amongst pouch patients

Twenty-eight (0.5%) patients died in hospital within 30 days of admission. The 365 day

mortality (available from April 2000 to March 2005 only) was 1.5% (35/2395). The 30-day

mortality was greater in patients over 60 years [age: 1-16 years=0.5% (1/216), 17-39

years=<0.1% (1/2882), 40-59 years=0.3% (5/1993) and 60 years=3.1% (21/680), p<0.001].

Unsurprisingly, a higher 365 day mortality was also observed in patients over 60 years [age:

1-16 years=1.2% (1/82), 17-39 years=0.5% (6/1172), 40-59 years=1.2% (10/846) and 60

years and over=6.1% (38/295), p<0.001]. Both the 30 day in hospital mortality and 365 day

mortality were significantly higher in patients with a Charlson score 3 [30 day mortality:

Charlson2 0.4% (22/5663), Charlson3 4.3% (6/138) p<0.001; 365 mortality: Charlson2

1.1% (25/2338), Charlson3 17.5% (10/57) p<0.001]. The 30-day mortality of patients over

60 years was 2.5% (15/607) with a Charlson score of 2 and 8.2% (6/73) with a Charlson

score of 3, (p=0.007). In patients aged 60 years or over, the 365 day mortality was 4.5%

(12/264) and 19.4% (4/31) for Charlson scores of 2 and 3 (p=0.001).

Patients with a diagnosis of malignant disease had a higher 30 day and 365 day mortality than

patients in other diagnostic categories [30 day mortality; malignancy=1.8% (11/617), UC=

0.1% (4/3934), Crohns disease= 0.0% (0/129), benign = 0.0% (0/381), other diagnosis

1.8% (13/708), p<0.001; 365 day mortality: malignancy=6.6% (19/287), UC = 0.5%

(8/1593), Crohns disease= 1.8% (1/55), benign = 0.0% (0/153), other diagnosis 2.3%

(7/307), p<0.001]. Within the category of other, diverticular disease and Hirschsprungs

disease demonstrated higher mortality at 30 days [30 day mortality; attention to stoma=0.4%

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(1/250), noninfective gastroenteritis=1.4% (1/70), adhesions=0% (0/22), diverticular disease=

11.8% (2/17), Hirschsprung's disease=8.3% (1/12), obstruction=0% (0/9), p=0.001].

Age (p<0.001), diagnosis (p<0.001), comorbidity (p=0.019) and social deprivation (p=0.046)

were positively associated with 30 day postoperative mortality on multivariate logistic

regression. Diagnosis (p=0001) and the comorbidity index (p<0.001) were independently

associated with 365 day mortality on multiple logistic regression. A Charlson score>2 had an

odds ratio of 19.69 (C.I. 8.95-43.29, p<0.001) compared to a Charlson score of 2. A

diagnosis of malignancy had odds ratio of 8.28 (CI 3.23-21.27, p<0.001) compared with a

diagnosis of UC.

Length of stay and 28-day readmissions:

The median length of stay (LOS) following RPC was 12 days (IQR: 9-15 days, n=5771). In

total, 1269 (22.0%) patients were readmitted within 28-days of discharge. Median LOS

increased with advancing age [age 16 years: 10 days (IQR 8-13 days, n=216); age 17-39

years: 11 days (IQR 9-14 days, n=2882); age 40-59 years: 12 days (IQR 10-16 days,

n=1993); age 60 years: 14 days (IQR 10-20 days, n=680), p<0.001]. It was significantly

longer in patients with significant comorbidity [Charlson score 2: 12 days (IQR 9-15 days,

n=5633); Charlson score 3: 15 days (IQR 11-22 days, n=138), p<0.001)]. The median LOS

for female patients was less than for males [female 11 days (IQR 9-15 days, n= 2573): male

12 days (IQR 9-16 days, n=3198 (p=0.054)]. A malignant diagnosis was associated with a

significantly longer median inpatient stay [malignant = 13 days (IQR 11-18 days, n=617);

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UC= 11.5 days (IQR 9-15 days, n=3934); benign tumour diagnosis = median stay 11 days

(IQR 9-15 days, n=383); Crohns disease= 11 days (IQR 9-15 days, n=129); other

diagnosis= 11 days (IQR 9-15 days, n=708), p<0.001].

Social deprivation was associated with a one day increase in median LOS [Carstairs 1 (least

deprived) =11 days (IQR 9-15 days, n=1226), Carstairs 2=11 days (IQR 9-15 days,n=1322),

Carstairs 3=12 days (IQR 9-16 days,n=1214), Carstairs 4=12 days (IQR 9-15 days, n=1063),

Carstairs 5 (most deprived)=12 days (IQR 9-16 days, n=926, Unclassified=12 days (IQR 10-

17 days n=20), p<0.001]. During the study period there was a reduction in LOS from 12 to 10

days (p<0.001).

Readmissions within 28-days were greater amongst females [female 25.5% (656/2573); male

19.2% (613/3198), p<0.001]. Patients with a diagnosis of malignancy were significantly less

likely to be readmitted within 28 days [malignant diagnosis=16.3% (101/619), benign tumour

diagnosis=23.1% (88/381), Crohns disease= 24.8% (32/129), UC=22.9% (899/3934), other

diagnosis 21.0% (149/708), p=0.007]. Readmissions within 28 days increased over the study

period from 18.1% in 1996 to 28.6% in 2007 (p=0.003). Gender was an independent

predictor for readmission on multivariate regression analysis with women being more likely

to be readmitted [odds ratio 1.44 (CI 1.27-1.64), p<0.001].

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Table 9.11 shows the linear regression analysis for LOS following a primary RPC.

Increasing co-morbidity, later discharge year, younger age and both high provider and

surgeon caseload were independent predictors of a shorter LOS.

The differences in infrastructure amongst outliers for mortality and reoperation will be

discussed in the following chapter.

The impact of process factors on outcome


Use of laparoscopy and outcome

Thus far in this thesis, selection for laparoscopy has been associated with reduced mortality

(Table 8.12) and a shorter LOS (Table 8.13). These improved perioperative outcome may be

offset by a possible small increase in reoperation rate (Table 8.5). In the medium term,

selection for the minimal access approach may be associated with a reduced adhesion rate

(table 8.8).

Outcome from laparoscopic restorative proctocolectomy in the early years of its introduction

2,946 primary pouches procedures were performed between 1st April 2002 and 31st March

2008. 2.7% (81/2946) were performed with laparoscopic assistance by 41 surgeons in 33

institutions. There were no differences in terms of patient age, gender, diagnosis, level of

comorbidity or social deprivation between those selected for the open and laparoscopic

technique (p=0.137, p=0.185, p=0.164, p=0.965, and p=0.576 respectively). No deaths were

recorded at 1-year following laparoscopic procedures. A higher proportion of patients were

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readmitted within 28-days following laparoscopic compared with open surgery [34.6%

(28/81) versus 23.6% (676/2885) respectively, p=0.022]. Hospital stay was shorter following

laparoscopic pouch surgery compared with the conventional technique [10 days (IQR=7-15

days,n=81) versus 11 days (IQR=8-15 days,n=2865) respectively, p=0.020].

Rectal procedures-APE and outcome

36,714 patients who underwent an elective resection coded to a primary diagnosis of rectal

cancer were included. Of these, 26.1% (9574/36714) had an APE resection. 63.3%

(23224/36714) of rectal cancer patients were coded to an anterior resection. 7.4%

(2722/36714) of patients were coded to a Hartmanns procedure. More patients who

underwent APE were from areas of higher social deprivation [Carstairs score 5 (most

deprived) APE 17.3% (1655/9574), Other procedure 14.8% (4021/27140), p<0.001]. Patients

selected for APE had a lower 30-day mortality and 28-day unplanned readmission rate [30-

day mortality - APE 2.7% (256/9574), Other procedure 3.3% (896/27140), p=0.002, 28 day

readmission - APE 9.9% (948/9574), Other procedure 11.6% (3152/27140), p<0.001].

Patients undergoing APE had a higher return to theatre rate in the postoperative period [APE

10.0% (957/9574), Other procedure 7.8% (2130/27140), p<0.001].

Summary

We have shown that it is possible to derive new outcome measures from HES data using

longitudinal analysis. The methodology underpinning these novel measures is widely

applicable to other surgical specialities. Significant variation in these measures has been

demonstrated amongst patients and providers. In addition we have shown the interplay

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between process (in terms of APE rate and use of laparoscopy) and outcome measures in

general colorectal surgery and in the more specialised pouch procedure.

This thesis reports national reoperation rates following major colorectal resection in England.

Reoperation represents a new possible performance measure that can be derived from

existing data sources. Moreover, we have demonstrated the feasibility of using routinely

collected data to benchmark institutional and surgeon reoperation rates on a national scale.

We have demonstrated substantial variation in reoperation rates between providers of

colorectal services as well as in pouch surgery. In an equal healthcare system such as the

NHS, quality improvement is necessary to reduce unwanted variation in outcome.

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Chapter 9- Reducing variation in outcome following colorectal surgery in

England- the role of volume in determining outcome

Introduction

The previous chapters have demonstrated considerable variation in patient characteristics

managed by providers. Chapter 6 showed that the activity of general colorectal (index

procedure colorectal resection) and more specialised colorectal surgery (index procedure

RPC) varies considerably amongst providers. Chapter 7 showed differences in terms of

process factors including use of laparoscopy and APE rates amongst providers. Chapter 8

described variation in outcome measure (reoperation, adhesion and incisional hernia rates and

more specialised colorectal outcome in terms of pouch failure, mortality and LOS).

Demonstration of variation and some of the underlying variation will not in itself lead to an

improvement in patient care. There is an increasing vogue towards centralising elective

surgical services through generally increasing surgical caseload and thereby improve the

quality of surgical provision. It may be that increasing caseload may be an effective strategy

for reducing the demonstrable variation. This study examines whether increasing caseload

in general colorectal as well as in more specialised colorectal procedures reduces this

variation and therefore could be used to improve outcome and patient care.

In the US, several studies have demonstrated improved outcome at both a surgeon and

institution level (Hodgson et al., 2003, Schrag et al., 2002, Billingsley et al., 2007).

However, not all studies have shown a clear benefit to higher caseload (Faiz et al., 2010a). In

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the UK, the relationship between volume and outcome in elective colorectal cancer surgery

has not been explored at a national level.

Using a regional dataset, Borowski and colleagues demonstrated lower perioperative

mortality, lower anastomotic leak rate and higher use of restorative rectal surgery amongst

higher volume surgeons in the North of England (Borowski et al., 2007, Borowski et al.,

2010). However, an earlier study using the North West cancer registry failed to find such an

association between volume and improved outcome (Parry et al., 1999). Morris and

colleagues in two studies, using regional cancer registry data and HES data, found higher use

of APE amongst higher volume surgeons for rectal cancer (Morris et al., 2010, Morris et al.,

2008). Though APE is the appropriate procedure of choice in some patients with low rectal

cancers, APE has been associated with poorer oncological outcome (Wibe et al., 2004,

Haward et al., 2005). The ACPGBI suggest that surgeons who performed elective colorectal

cancer procedures should perform at least twenty elective or emergency cancer resections per

year (ACPGBI, 2007). This guideline places the emphasis on colorectal cancer resections. It

has not been addressed in studies whether a surgeon that performs a high volume of

resections for diverticular disease or inflammatory bowel disease may have equivalent

outcome to a high volume cancer surgeon. Given the considerable reconfiguration of surgical

services required to centralise one of the most common colorectal procedures and possible

disadvantages to patients, it is necessary to ensure that adequate evidence of the advantages

of higher surgical volume at the national level exists prior to undertaking such a

reconfiguration.

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Minimally invasive techniques have revolutionised colorectal surgical practice. Colorectal

patients undergoing laparoscopic surgery have reduced postoperative pain, a shorter length of

stay and a quicker return to normal levels of activity (Abraham et al., 2004, Schwenk et al.,

2005, Faiz et al., 2009). Furthermore, oncological data have suggested equivalent outcome

following laparoscopic surgery and the open approach for colorectal cancer (Jayne et al.,

2010, Jayne et al., 2007, Bonjer et al., 2007). The relationship between caseload and outcome

following the laparoscopic approach is, however, not well understood. The learning curve

for laparoscopic colorectal surgery is long and complex (Tekkis et al., 2005c, Schlachta et al.,

2001, Finlayson and Birkmeyer, 1997). Yasunaga and colleagues demonstrated that increased

surgeon caseload volume in laparoscopic colectomy was associated with shorter operating

times, but had no significant impact on postoperative complication rates nor was hospital

volume associated with post-operative morbidity (Yasunaga et al., 2009). This study used

self-reported data from the Japanese Surgical Society website. Voluntary reporting to clinical

registries may be associated with some degree of bias (Almoudaris et al., 2010b). Using

administrative data, Kuwabara and colleagues reported that hospital volume of laparoscopic

colectomy was not associated with increasing risk of post-operative complications(Kuwabara

et al., 2009). Using data from the Clinical Outcomes of Surgical Therapy (COST) study,

Larson showed that high surgeon volume had shorter operating times, longer distal resection

margins and greater lymph node yields, but no difference in terms of complications,

conversion rates or 5-year survival (Larson et al., 2008). Prior to inclusion in this study

surgeons were credentialed to establish a minimum volume and competency. The Colon

Cancer Laparoscopic or Open Resection (COLOR) study group investigated the impact of

hospital volume on outcome in a trial population of colonic cancer patients (Kuhry et al.,

2005). Hospitals with high volume practice demonstrated shorter operating times, fewer

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in Colorectal Surgery

conversions to the open approach, shorter length of stay and a reduced number of

complications. These data are from clinical trials where surgeon participants are generally

expert or in the case of the COST trial credentialed prior to inclusion. In contrast to

purpose-built clinical databases or trial data, routinely collected data have been used to

investigate the volume-outcome relationship in surgery in the United States and Holland

(Birkmeyer et al., 2002, van Lanschot et al., 2001).

General colorectal surgery, including colorectal resection, makes up the mainstay of

colorectal practice. More specialised surgery, such as pouch surgery, often involves smaller

numbers and has increased complexity. The role of volume in reducing variation in practice

and outcome in subspecialised surgery may be different than for general colorectal surgery.

Such a relationship may be magnified and therefore ought to be explored separately.

Restorative proctocolectomy with ileal reservoir (RPC) described in 1978 (Parks and

Nicholls, 1978) has become the operation of choice for patients with ulcerative colitis (UC)

requiring surgery and for some with familial adenomatosis polyposis (FAP). Various

modifications of the operation including experimentation with various pouch configurations

(Utsunomiya et al., 1980, Nicholls and Lubowski, 1987, Fonkalsrud et al., 1988) have been

made over the last thirty years.

Several studies have reported the short and long-term outcome following RPC (Hueting et al.,

2005, Tulchinsky et al., 2003). Despite its widespread acceptance and use, considerable

postoperative morbidity has been reported in a large series, with more than 60% of patients

experiencing complications (Fazio et al., 1995). Surgical results have improved with

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in Colorectal Surgery

increased operative experience (Fleshman et al., 1988, Marcello et al., 1993, Tekkis et al.,

2005a).

The United Kingdom (UK) National Inflammatory Bowel Disease (IBD) Audit in 2006

reported that institutional median volume was four RPCs performed per year (IBD Audit,

2006). The low volumes carried out by most individual surgeons has resulted in little

published information from low volume centres. One approach to achieving the sample sizes

required for the meaningful analysis of outcome is to use either national clinical registry

and/or national administrative datasets. The UK National Ileal Pouch registry has collected

data from participating units since 2004 (Tekkis et al., 2009). In 2006, ten units had

submitted their data on 2491 patients. There was a failure rate of 7.7% over a median follow

up period of 53 months after a primary procedure. This rose to 27% following salvage

surgery. It was unclear whether surgical caseload was related to failure or function including

urgency or incontinence (Tekkis et al., 2009). For technically challenging surgery with

difficult decision making, one can hypothesis that higher surgical caseload will translate into

improved outcomes. With such low activity levels reported in previous audit, is there a role

for centralising services into dedicated pouch centres?

Variation in patient factors, structural factors, processes and outcome amongst providers has

been demonstrated previously. How can these differences be negated to improve patient

care? Is increasing surgical caseload amongst surgeons and Trusts one feasible means of

improving outcome? If such a volume relationship does exist, to which colorectal services

should it apply and at what level?

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in Colorectal Surgery

HES data have been used previously to examine current activity and the role of volume in

determining outcome in other specialties including upper gastrointestinal and hepatobiliary

surgery(Al-Sarira et al., 2007, Leigh et al., 2009, Pal et al., 2008), urology (Hanchanale et al.,

2010, Judge et al., 2007, Mayer et al., 2010, Mayer et al., 2009a, McCabe et al., 2005,

McCabe et al., 2007, Nuttall et al., 2005), vascular surgery (Holt et al., 2007a, Holt et al.,

2007b) (Holt et al., 2009b, Jibawi et al., 2006) and orthopaedics (Judge et al., 2006). Table

9.1 summarises the findings of these studies.

Using the outcome measures demonstrated for general colorectal surgery derived in Chapter

8 (reoperation) and for more specialised colorectal procedures (pouch failure), alongside

established measures such as mortality, it will be feasible to examine the role of caseload in

improving outcome and reducing variation. Furthermore, it may be possible to investigate

the role of volume in reducing variation in process factors such as APE.

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Table 9.1:Previous research examining surgical provision and impact of caseload on outcome using HES data.
First author Publication Study Speciality Diagnosis and Procedure Definition of volume Findings
year year
Al-Sarira(Al-Sarira et al., 2007) 2007 1997- Upper Cancer Hospital volume Fewer centres performing surgery
2004 gastrointestinal Oesophagectomy Quintiles per year Increasing number of procedures in
1-9, 10-19, 20-29, 30-39, 40 high volume centres
Pal(Pal et al., 2008) 2008 1999- Upper All diagnoses Hospital volume Reduced unadjusted mortality in higher
2005 gastrointestinal Quartiles over study (6 years) volume centres for oesophagectomy and
pancreaticoduodenectomy
HV LV p value
Oesophagectomy, 1-66, 66-122, 132-231, 235-368 4.0% 7.8% 0.007
Gastrectomy, 1-44, 45-68, 69-100, 101-244 6.7% 5.6% NS
Pancreaticoduodenectomy 1-43, 46-77, 81-144, 173-317 3.8% 6.5% 0.016
Liver resection 1-197, 211-301, 318-503, 589-685 2.0% 3.1% NS
Leigh(Leigh et al., 2009) 2009 1998- Upper Cancer Hospital volume 30 day mortality Low volume compared
2003 gastrointestinal Oesophagectomy Low volume <100 cases over study to high volume OR 1.62 (1.38-1.91)
High volume 100 cases over study 90 day mortality Low volume compared
Cardiothoracic versus General to high volume OR 1.55 (1.35- 1.77)
Surgeon
Nuttall(Nuttall et al., 2005) 2005 1995- Urology Radical cystectomy Mean volumes per year No evidence for centralisation during
2002 study period.
McCabe(McCabe et al., 2005) 2005 1998- Urology Radical cystectomy Minimum threshold per hospital 11 procedures per year
2003
McCabe(McCabe et al., 2007) 2007 1998- Urology Radical cystectomy Minimum threshold per surgeon 8 procedures per year
2003
Judge(Judge et al., 2007) 2007 1997- Urology Prostate cancer Hospital volume Reduced LOS and readmissions in high
2004 Radical prostatectomy Quintiles per year volume
114, 1522, 2332, 3345, 4693 No significant relationship between
mortality and complications
Mayer(Mayer et al., 2009a) 2009 2000- Urology Radical cystectomy Minimal case volume as per Increase in number of centres reaching
2007 Radical prostatectomy recommendations (50 cases per volume threshold.
year)
Hachanale(Hanchanale et al., 2010) 2010 1998- Urology Prostate Cancer Surgeon and hospital volume High volume surgeons and hospitals
2005 Radical prostatectomy High and low volume based on 50th had lower mortality and a shorter LOS
centile per year
26 for hospital and 16 for surgeon

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Table 9.1:Previous research examining surgical provision and impact of caseload on outcome using HES data contd.
First author Publication Study Speciality Diagnosis and Procedure Definition of volume Findings
year year
Mayer(Mayer et al., 2010) 2010 2000- Urology Radical cystectomy Surgeon and hospital volume Higher mortality amongst medium
2007 Tertiles per year volume institutions
2-10, 20-16, 16 No surgeon volume relationship
Mayer(Mayer et al., 2011) 2011 2000- Urology Radical cystectomy Hospital and surgeon volume Low volume institution had lower
2007 Tertiles per year reintervention rate.
High volume surgeons had reduced
early reinterventions (OR, 0.68; 95%
CI, 0.510.91;P=0.01)
Jibawi(Jibawi et al., 2006) 2006 1997- Vascular Open AAA repair Minimum threshold 14 procedures per year
2002
Holt(Holt et al., 2007a) 2007 2000- Vascular Open AAA repair Hospital volume Reduced mortality and shorter LOS for
2005 Quintiles over study (5 years) elective and non ruptured urgent
0-7.2 repairs.
7.3-12.6 There was no relationship for ruptured
12.7-19.4 repairs.
19.5-32
>32
Holt(Holt et al., 2007b) 2007 2000- Vascular Extra-cranial atherosclerotic Hospital volume Reduced mortality in high volume
2005 arterial disease Quintiles per year centres in elective procedures OR
Carotid Endarterectomy 1-9.4, 9.5-17.2, 17.3-34.6, 34.7- 0.898 (0.808-0.99)
52.2, 52.3-95.6 Decreased LOS in higher volume
centres for elective and emergency
admissions (p<0.001)
No relationship with complications
Holt(Holt et al., 2009b) 2009 2005- Vascular AAA Hospital volume 13% reduction in odds mortality for
2007 Endovascular AAA repair Quintiles per year each additional 20 cases performed.
Judge(Judge et al., 2006) 2006 1997- Orthopaedic Total knee (TKR) and total Hospital volume Trend for more procedures in higher
2002 hip (THR) arthroplasty Five clinically sensible categories volume centres
per year Low volume Trusts have higher
150, 51100, 101250, 251500, mortality for THR OR 1.98 (1.133.47)
>500 and TKR OR 1.72 (0.763.89)
Hospital orthopaedic training status Reduced LOS following THR and

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TKR but no difference in readmission


or revision rates
Training centres had reduced mortality
following THR and possible reduced
revision rate following TKR, reduced
readmission following THR and TKR
but no difference in LOS for THR or
TKR.

NS- Non significant


OR- Odds Ratio

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Aims

This chapter aims to

1. Assess whether there is a relationship between surgeon or hospital caseload and

elective colorectal cancer resection outcome using national data.

2. Assess the relevance of the suggested threshold of twenty colorectal cancer resections

per annum in determining postoperative outcome.

3. Address whether overall elective resection volume (i.e. inclusion of benign and

malignant) impacts on outcome.

4. Evaluate the role of caseload in determining rectal resection outcome and choice of

surgery for rectal cancer (APE rate).

5. To explore whether a volume tipping point can be identified, if a volume outcome

relationship is demonstrated.

6. Explore the role of volume in determining outcome from more specialised colorectal

care in particular following laparoscopic surgery and restorative proctocoloectomy.

Methods

Colorectal resections

Database inclusions and variable coding: all adult patients undergoing primary elective

colorectal resections were included from 1st April 2000 to 31st March 2008. Any patients who

underwent a colorectal resection between 1996 and 2000 were excluded from the analysis.

The first resection that the patient underwent between 2000 and 2008 was considered as the

primary resection.

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Surgical procedures were categorised as follows:

Right-sided resections that included right hemicolectomy and extended right hemicolectomy

and transverse colectomy

Left-sided resections that included left hemicolectomy and sigmoid colectomy

Rectal resections included anterior resection, Hartmanns procedures and abdominoperineal

resection (APE)

Subtotal colectomy, panproctocolectomy and total colectomy and colectomy of unspecified

site were considered together.

OPCS codes for each procedure is shown in Table 9.2.

Colorectal resection

A laparoscopic procedure was considered as any procedure associated with OPCS codes

Y50.8, Y75 or Y71.4. Y71.4 (failed minimal access) was introduced in 2006. Patients

coded to the failed minimal access code were considered in the laparoscopic group for further

analysis.

The Charlson score was considered in three categories 0, 1-4 and 5. The postoperative

mortality within each of these groups was similar.

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Table 9.2: OPCS codes used to classify colorectal resection.

Type of resection Procedure OPCS code

Right sided resections Right hemicolectomy H07

Extended right hemicolectomy and transverse H06, H08

colectomy

Left sided resections left hemicolectomy sigmoid colectomy H09

Hartmanns procedure (if not associated with H10

rectal cancer diagnosis) H33.5

Rectal resection anterior resection H33.2, H33.3, H33.4, H33.6, H33.7,

H33.8, H33.9

abdominoperineal resection (APE) H33.1

Hartmanns procedure (if associated with H33.5

rectal cancer diagnosis)

total colectomy panproctocolectomy H04.1, H04.3, H04.8, H04.9

total colectomy H05

colectomy of unspecified site H11

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Restorative Proctocolectomy

Database inclusions and variable coding: all primary elective RPCs were included from 1st

April 1996 to 31st March 2008. They were denoted by the following OPCS codes:

H042 Total excision of colon and rectum, Panproctocolectomy and

anastomosis of ileum to anus and creation of pouch however further

qualified

H043 Total excision of colon and rectum, Panproctocolectomy and

anastomosis of ileum to anus not elsewhere classified

G725 Other connection of ileum, Anastomosis of ileum to anus and creation

of pouch however further qualified

Individual diagnoses were recoded into major diagnostic categories according to ICD 10 code

as follows: K51- Ulcerative colitis (UC), K50 - Crohns disease, C18 C19 C20 C21

C26 D37- Malignant disease, D010 D12-Benign colorectal tumours. The remaining

codes were classified as other diagnosis (the latter are described below). Patients were

grouped into four age cohorts: <17, 17-39, 40-59 and >59 years according to age at time of

surgery. We considered that a Charlson score of greater than three would include the more

comorbid patient and those patients with a score of less than or equal to two would represent

those patients with few or no comorbidities Mortality at 30 days increased significantly in

those patients with a Charlson score of 3 and small numbers of patients with high Charlson

scores, Charlson score was grouped into two clinically relevant categories: 2 and >2.

Ethnicity was coded according to the HES dataset classification: white, black, Indian

subcontinent, unknown and other.

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Volume considerations
Colorectal Resection volume

In order to examine the role of volume, colorectal caseload is considered in several ways.

The first approach divides caseload into three tertiles according to the volume of elective

colorectal cancer resection performed by the consultant team or Trust per year giving three

groups of approximately equal numbers of consultant teams or Trusts. The volume per year

was found by averaging the total volume over the study period by the number of years in

which the relevant consultant code or Trust code was present. The second approach explores

the proposed threshold suggested by the Association of Coloproctology of Great Britain and

Ireland (ACPGBI) of twenty colorectal cancer resections per year (ACPGBI, 2007) As this

guideline refers to both elective and emergency cases, both were included to determine

volume thresholds. When analysing abdominoperineal resection rates, consultant teams and

Trusts were divided into tertiles according to their rectal cancer caseload per year. The

volume per year was found by averaging the total elective rectal cancer volume over the

study period by the number of years in which the relevant consultant code or Trust code was

present. Due to mergers, Trust codes were unified to reflect their status as of April 2008. A

hospital Trust may comprise several sites. The tertile approach was chosen as when

compared with a continuous or quintile approach, this model for reoperation and 30-day

mortality had the lowest Deviance Information Criterion statistic (Spiegelhalter et al., 2002).

Table 9.3 shows the volume thresholds for each means of exploring colorectal resection

volume.

To minimise the effects of erroneous coding, only those Trusts that performed ten or more

procedures and those consultant teams that performed greater than 4 procedures over the

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study period were included. In addition, those patients with unquantified deprivation scoring

were excluded. In total this excluded 1762 patients.

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Table 9.3: Volume thresholds for elective colorectal resection.


Number of
Volume Thresholds Procedures per year %
patients

Consultant Team
Volume
LV 1.0-7.4 procedures 5693 5.2
MV 7.5-20.7 procedures 27295 25.1
HV >20.7 procedures 76273 69.8
Total 109261 100.0
Guideline surgeon
<20 procedures 21164 19.4
volume
20 procedures 88097 80.6
Total 109261 100.0
Consultant Team Rectal surgery volume
rLV 1-3.4 procedures 1774 4.8
rMV 3.5-7.8 procedures 9710 26.4
rHV >7.8 procedures 25230 68.7
Total 36714 100.0
Institutional volume
LV 1-68.9 procedures 19478 17.8
69.0-103.5
MV 34243 31.3
procedures
HV >103.5 procedures 55540 50.8
Total 109261 100.0
Institutional Rectal surgery volume
rLV 1-21.6 procedures 6140 16.7
rMV 21.7-37.8 procedures 14328 39.0
rHV >37.8 procedures 16246 44.3
Total 36714 100.0

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Pouch Case Volume

In an attempt to investigate comprehensively the role between outcome and volume in pouch

surgery three separate methodological approaches to categorical handling of surgical volume

were utilised. First, hospital and surgeon volume was categorised into three groups following

ranking of institutions and surgeons according to volume and then dividing the ranking into

three equal groups, A, B and C. This technique yielded a similar number of institutions (or

surgeons) in each group but inequality in the number of patients in each group. Secondly, we

determined volume tertiles by ranking patients according to aggregated surgeon or

institutional caseload to give three volume categories including: low volume (LV), medium

volume (MV) and high volume (HV). Each volume tertile contained equal numbers of

patients and tertile ranges were calculated separately for both surgeon and institution. The

caseloads resulting from the latter two approaches are shown in Table 9.4.

The consultant code was only available from April 2000 to March 2008. Therefore the

surgeon volume category spans eight study years and the institutional provider volume spans

twelve study years. To evaluate further the role of extreme volumes on outcome, a third

pragmatic approach was used. In this method centres where fewer than twelve procedures

were performed over the study period (i.e. less than one a year, ExtLV) were compared with

centres with a higher caseload (equal to or more than one procedure a month, ExtHV). The

remaining patients were designated in the ExtMV category. Lastly, institutional pouch

volume was investigated graphically as a continuous variable by charting it against

unadjusted failure rates in a funnel plot.

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Table 9.4: Volume categories and number of patients in each category for restorative
proctocolectomy.
Number of Number of Percentage Number of
Volume category procedures per year patients of patients providers

Institutional A 1-14 procedures 0.1-1.2 402/5771 7.0 55 trusts


B 15-31 procedures 1.3-2.6 1068/5771 18.5 48 trusts
C 32 procedures 2.7 4301/5771 74.5 51 trusts

Low volume 1-39 procedures 0.1-3.3 1964/5771 34.0 117 trusts


Medium volume 40-100 procedures 3.3-8.3 1816/5771 33.2 28 Trusts
High volume 101 procedures 8.4 1891/5771 33.8 9 trusts

Surgeon A 1-2 procedures 0.1-0.3 266/3878 6.9 209 surgeons


B 3-6 procedures 0.4-0.8 554/3878 14.3 126 surgeons
C 7 procedures 0.9 3058/3878 78.9 164 surgeons

Low volume 1-10 procedures 0.1-1.3 1331/3878 34.3 397 surgeons


Medium volume 11-28 procedures 1.4-3.5 1329/3878 34.3 78 surgeons
High volume 29 procedures 3.6 1218/3878 31.4 24 surgeons

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Outcome variables

30-day in-hospital mortality was ascertained. Length of stay (LOS) is the time (in days) spent

in hospital during the primary admission for colorectal resection; a patient admitted and

discharged on the same day would have a LOS of zero. Readmission refers to emergency

(unplanned) readmission to hospital within 28 days for any reason. Reoperation was defined

as any return to theatre for an intra abdominal procedure or wound complication on the index

admission or on a subsequent admission to hospital within 28 days of the initial resection.

30 day medical morbidity and 365 day medical morbidity were defined as the presence of

relevant acute postoperative diagnosis code or as a primary code on a subsequent admission

within 30 and 365 days respectively (Mamidanna et al., 2011). The relevant ICD10 codes

were as follows: angina (I20), myocardial infarction (I21, I22), ischaemic heart disease (I24,

I25), congestive cardiac failure (I50), atrial fibrillation / flutter when not present

preoperatively (AF) (I48), pneumonia (J12-J16, J18, J22, J69, J95, J98), pleural effusion

(J90-J91, J948), respiratory failure (J80, J96) and other respiratory complications (J41-J46,

J81), deep vein thrombosis (I80), pulmonary embolism (I26), acute ischaemic stroke (I63,

I64), sequelae of stroke (I69), renal failure (N17, N18, N19, N990). 28 day readmission

refers to any unplanned readmission within 28 days. Length of stay (LOS) is the time (in

days) spent in hospital during the primary admission; a patient admitted and discharged on

the same day would have an LOS of zero.

Pouch failure was defined as excision of the ileal reservoir or formation of ileostomy with no

subsequent reversal. If a patient had undergone both ileostomy formation and a subsequent

excision, the first date was selected as the pouch failure date. Failure rates are presented for

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in Colorectal Surgery

all patients and for a subgroup of patients who underwent definite initial ileostomy reversal

(i.e. those patients who regained intestinal continuity). Not all patients are actively coded as

having a stoma alongside RPC. It is unclear whether the coding for ileostomy reversal is

accurate, and therefore all pouch failures were considered for the statistical analyses.

Excision of pouch was defined by the following codes following advice from professional

coders: H661 Excision of ileoanal pouch, H468 Other specified operation on rectum,

H331 Excision of rectum, Abdominoperineal excision of rectum and end colostomy,

H335 Excision of rectum, Rectosigmoidectomy and closure of rectal stump and

exteriorisation of bowel, H338 Excision of rectum, Other specified, H339 Excision of

rectum, Unspecified. The following code was used to denote pouch revision: H662

Revision of ileo-anal pouch. Of note both the H661 and H662 codes were first introduced

in 2006.

The following codes were used to define reversal of ileostomy: G753 Attention to

artificial opening into ileum, Closure of ileostomy G732 Attention to connection of ileum,

Closure of anastomosis of ileum, H154 Other exteriorisation of colon, Closure of

colostomy, G733 Attention to connection of ileum, Resection of ileostomy. Ileostomy

formation was defined by the following codes: G741 Continent ileostomy, G742

Temporary ileostomy, G743 Defunctioning ileostomy, G748 Other specified, G749

Other unspecified, G751 Refashioning of ileostomy.

To assess the point at which the addition of cases no longer led to improved outcome or

reduced APE rate, 5 and 2.5 cases were added to the total caseload until there was no

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reduction in mortality or APE rate. If such a transition point was found, this was termed the

tipping point.

Statistical methodology

Categorical variables were investigated using the Chi-squared test. Correlation analysis was

performed using the Pearson correlation test or Spearmans Rho test for parametric or non-

parametric respectively. Logistic regression analysis was used to investigate the independent

role of age, gender, primary diagnosis, Charlson comorbidity score, Carstairs index of social

deprivation, provider volume, consultant volume and discharge year on postoperative

mortality and 28 day readmission rates. Linear regression was used to investigate the

independent role of age, gender, primary diagnosis, Charlson score, Carstairs index of social

deprivation, provider volume, consultant volume and discharge year on LOS. Cox regression

analysis was used to explore the independent role of age, gender, primary diagnosis, Charlson

score, Carstairs index of social deprivation, provider volume, consultant volume and

discharge year and time to failure. Hospital volume was considered in the Cox regression

model with consultant status considered separately for examining the impact of volume on

pouch failure. For those patients who experienced failure, the pouch survival time was

calculated as either the time in months from the date of RPC to the date of the procedure that

denoted pouch failure. The patients who did not experience failure were considered to have

an intact pouch until the end of the study period (31st March 2008) unless they died within

365 days of RPC. Patients known to have died within 365 days of RPC were considered to

have an intact pouch until 365 days after RPC. Factors with a significance level of 0.1 on

univariate analysis were included in the regression analyses.

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Multilevel logistic regression analysis was used to investigate postoperative mortality,

readmission and reoperation rate for colorectal resection taking account clustering of patients

within consultant teams and teams within hospitals. Multilevel modelling was carried out

using MLWin Version 2.21 (Rabash et al., 2010).

Statistical analyses were carried out using SPSS Version 16.0 (Statistical Package for Social

Sciences, SPSS, Chicago, Illinois, USA). For tests of significance, a p value of <0.05 was

considered significant. For non-parametric variables the median and interquartile range (IQR)

are given. Funnel plots were respectively constructed using the web tool:

http://www.erpho.org.uk/topics/tools/funnel.aspx

Results

Does a relationship exist between consultant team or Trust volume and outcome
following colorectal cancer surgery?
Demographics

The numbers of patients in each volume category are shown in Table 9.3.

Patient characteristics and volume

Of the elective colorectal cancer resections, 6.1% (6634/109261) were selected to have their

procedure laparoscopically. Table 9.5 shows the characteristics of patients operated on by

consultant teams and institutions with varying caseload. Higher volume consultant teams

performed more rectal procedures and demonstrated greater use of laparoscopy. Higher

volume consultant teams managed fewer patients from areas of increased social deprivation.

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Table 9.5: Patient characteristics and type of surgery by approach for patients undergoing an
elective colorectal resection.
Consultant Team Volume Guideline surgeon volume Institution volume

LV MV HV P value <20 20 P value LV MV HV P value

Resection 2335 7963 22080 6912 25466 5626 10048 16704


right sided <0.001 <0.001 <0.001
type (41.0) (29.2) (28.9) (32.7) (28.9) (28.9) (29.3) (30.1)

1300 4603 11326 3948 13281 3178 5393 8658


left sided
(22.8) (16.9) (14.8) (18.7) (15.1) (16.3) (15.7) (15.6)

1850 13740 40517 9534 46573 10024 17608 28475


rectal
(32.5) (50.3) (53.1) (45.0) (52.9) (51.5) (51.4) (51.3)

subtotal/ 208 989 2350 770 2777 650 1194 1703


total (3.7) (3.6) (3.1) (3.6) (3.2) (3.3) (3.5) (3.1)

Surgical Laparoscopic 118 1803 4713 1057 5577 1475 1863 3296
<0.001 <0.001 <0.001
Approach approach (2.1) (6.6) (6.2) (5.0) (6.3) (7.6) (5.4) (5.9)

70.1 69.4 69.7 69.6 69.7 69.3 69.6 69.8


Age Mean (SD) <0.001 0.013 <0.001
(11.3) (11.2) (11.1) (11.3) (11.4) (11.4) (11.1) (11.0)

Charlson 3311 16531 45562 12734 52670 11552 20095 33757


0 <0.001 0.224 <0.001
score (58.2) (60.6) (59.7) (60.2) (59.8) (59.3) (58.7) (60.8)

445 2632 6873 1961 7989 1903 3245 4802


1-4
(7.8) (9.6) (9.0) (9.3) (9.1) (9.8) (9.5) (8.6)

1937 8132 23838 6469 27438 6023 10903 16981


5
(34.0) (29.8) (31.3) (30.6) (31.1) (30.9) (31.8) (30.6)

Carstairs 1 (least 1044 4542 16257 3826 18017 3641 6972 11230
<0.001 <0.001 <0.001
deprivation deprived) (18.3) (16.6) (21.3) (18.1) (20.5) (18.7) (20.4) (20.2)

1304 5732 18808 4530 21314 4018 8231 13595


2
(22.9) (21.0) (24.7) (21.4) (24.2) (20.6) (24.0) (24.5)

1195 6061 16963 4543 19676 4040 7630 12549


3
(21.0) (22.2) (22.3) (21.5) (22.3) (20.7) (22.3) (22.6)

1086 5687 14067 4205 16635 3902 6516 10422


4
(19.1) (20.8) (18.4) (19.9) (18.9) (20.0) (19.0) (18.8)

5 (most 1064 5273 10178 4060 12455 3877 4894 7744


deprived) (18.7) (19.3) (13.3) (19.2) (14.1) (19.9) (14.3) (13.9)

2540 11552 32368 12084 50717 8374 14484 23602


Gender Male 0.004 0.212 0.289
(44.6) (42.3) (42.4) (57.1) (57.6) (43.0) (42.3) (42.5)

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Outcome and volume

Of the elective patients, 3.3% (3602/109261) died in hospital within 30 days of admission.

8.6% (9450/109261) had an unplanned readmission within 28 days of discharge from

hospital. 5.9% (6469/109261) had a surgical complication requiring a re-intervention in the

postoperative period. The mean length of stay for elective colorectal cancer resections was

12.7 days (SD 1.76). Volume is considered as a continuous and a categorical variable.

Continuous

In unadjusted analysis, higher consultant team volume was correlated with reduced mean

postoperative mortality [Correlation coefficient=-0.013, p<0.001 (Spearmans Rho test)],

increasing mean readmission rate [Correlation coefficient=0.018, p<0.001 (Spearmans Rho

test)] but reduced LOS [Correlation coefficient=-0.037 p<0.001 (Pearson correlation

following logarithmic transformation)]. Correlation of consultant team volume and mean

reoperation rate [Correlation coefficient=-0.005, p=0.072 (Spearmans Rho test)] did not

meet significance.

Following adjustment in multilevel hierarchical analysis, hospital or consultant team cancer

resection volume was not a significant predictor of postoperative mortality (p=0.160 and

p=0.595 respectively, DIC=28091), reoperation (p=0.419 and p=0.464 respectively,

DIC=48149), readmission (p=0.366 and p=0.322 respectively, DIC=63630) or LOS (Trust

p=0.484 and consultant team p=0.448, DIC= 4267).

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Categorical

When considered as a categorical variable, we divided caseload into three tertiles according

to the volume of elective colorectal cancer resection performed by the consultant team or

Trust per year giving three groups of approximately equal numbers of consultant teams or

Trusts.

We also assessed the impact of consultant teams performing greater than or equal than twenty

elective and emergency cancer procedures on outcome.

As described in Table 9.6, in unadjusted analysis consultant teams who perform greater than

twenty procedures per year had slightly higher readmission rates but a marginally shorter

LOS. Table 9.6 shows unadjusted postoperative outcome according to volume categories. As

shown in Table 9.6, in unadjusted analysis higher volume consultant teams had a lower 30-

day mortality and shorter LOS but a higher 28-day readmission rate. Higher volume Trusts

had slightly lower reoperation rates and shorter LOS. However, in regression analysis, higher

volume consultant teams and institutions have a shorter LOS as shown in Table 9.7.

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Table 9.6: Unadjusted outcome of elective colorectal cancer resection according to volume
categories.
Length of in hospital
30 day mortality 28 day Readmission Reoperation stay
N (%) P value N (%) P value N (%) P value Mean (SD) P value
LV 223 (3.9) 0.012 436 (7.7) 0.023 306 (5.4) 0.113 13.47 (1.73) <0.001
Consultant
Team MV 859 (3.1) 2384 (8.7) 1660 (6.1) 13.06 (1.77)
Volume
HV 2520 (3.3) 6630 (8.7) 4503 (5.9) 12.54 (1.75)
0.744 13.33 (1.75) <0.001
Guideline <20 721 (3.4) 0.318 1735 (8.2) 0.009 1243 (5.9)
surgeon
2881 (3.3) 12.57 (1.76)
volume 20 7715 (8.8) 5226 (5.9)

LV 656 (3.4) 0.399 1710 (8.8) 0.725 1229 (6.3) 0.008 13.47 (1.73) <0.001
Institutional
MV 1155 (3.4) 2937 (8.6) 1936 (5.7) 13.06 (1.77)
volume
HV 1791 (3.2) 4803 (8.6) 3304 (5.9) 12.55 (1.75)

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Table 9.7: Multiple regression of 30-day postoperative mortality, 28-day unplanned readmission, reoperation and length of stay for elective
colorectal cancer resection.
30-day mortality 28-day Readmission Reoperation Length of in hospital stay APE for rectal cancer*
Odds Confidence Odds Confidence Odds Confidence Odds Confidence Odds Confidence
P value P value P value P value P value
Ratio intervals Ratio intervals Ratio intervals Ratio intervals Ratio intervals
Resection right sided* 1.00 1.00 1.00 1.00
type left sided 0.95 0.85 1.06 0.338 1.06 0.99 1.14 0.104 1.19 1.09 1.31 <0.001 1.09 1.08 1.10 <0.001
rectal 1.13 1.04 1.22 0.003 1.45 1.38 1.53 <0.001 1.95 1.83 2.09 <0.001 1.28 1.27 1.29 <0.001
total 1.69 1.43 2.01 <0.001 1.55 1.38 1.74 <0.001 2.03 1.77 2.33 <0.001 1.34 1.32 1.37 <0.001
Surgical Lap vs open
0.66 0.55 0.79 <0.001 1.04 0.95 1.13 0.423 1.27 1.15 1.41 <0.001 0.72 0.71 0.73 <0.001 0.96 0.85 1.09 0.539
Approach approach
Age 1.09 1.09 1.10 <0.001 0.99 0.99 0.99 <0.001 1.00 0.99 1.00 0.001 1.01 1.01 1.01 <0.001 1.00 0.99 1.00 0.002
Charlson 0* 1.00 1.00 1.00 1.00 1.00
score 1-4 1.85 1.63 2.09 <0.001 1.21 1.13 1.30 <0.001 1.16 1.06 1.27 0.001 1.06 1.05 1.08 <0.001 1.04 0.96 1.13 0.379
5 3.32 3.08 3.58 <0.001 1.10 1.05 1.15 <0.001 1.31 1.24 1.38 <0.001 1.09 1.09 1.09 <0.001 0.89 0.85 0.94 <0.001
Carstairs 1* 1.00 1.00 1.00 1.00 1.00
deprivation 2 1.02 0.91 1.14 0.705 0.99 0.92 1.05 0.679 1.01 0.94 1.10 0.378 1.02 1.02 1.03 <0.001 1.12 1.04 1.21 0.002
3 1.14 1.02 1.27 0.022 1.00 0.94 1.07 0.901 1.05 0.97 1.14 0.113 1.06 1.05 1.07 <0.001 1.16 1.08 1.25 <0.001
4 1.21 1.08 1.36 0.001 1.09 1.02 1.17 0.011 1.08 1.00 1.17 0.032 1.09 1.08 1.10 <0.001 1.29 1.20 1.48 <0.001
5 1.35 1.21 1.52 <0.001 1.19 1.11 1.28 <0.001 1.11 1.01 1.20 0.012 1.15 1.14 1.16 <0.001 1.34 1.22 1.48 <0.001
Female vs
Gender 0.61 0.57 0.66 <0.001 0.84 0.80 0.88 <0.001 0.66 0.63 0.70 <0.001 1.00 0.99 1.01 0.976 0.89 0.85 0.94 <0.001
Male
Consultant LV* 1.00 1.00 1.00 1.00 1.00
Team MV 0.90 0.77 1.05 0.194 1.00 0.90 1.12 0.955 0.98 0.86 1.11 0.385 0.99 0.98 1.00 0.187 0.93 0.83 1.04 0.204
Volume HV 0.94 0.81 1.09 0.423 1.01 0.91 1.12 0.827 0.95 0.84 1.07 0.210 0.95 0.94 0.97 <0.001 0.78 0.70 0.87 <0.001
Institution LV* 1.00 1.00 1.00 1.00 1.00
volume MV 0.98 0.89 1.08 0.686 0.99 0.93 1.06 0.790 0.90 0.83 0.97 0.002 0.98 0.97 0.99 <0.001 1.05 0.98 1.13 0.134
HV 0.96 0.87 1.05 0.377 1.01 0.95 1.07 0.795 0.96 0.90 1.03 0.127 0.96 0.95 0.97 <0.001 0.96 0.90 1.03 0.248
* Caseload of rectal surgeon volume refers to volume of procedures for rectal cancer only.

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Figure 9.1 and figure 9.2 show the variation in mortality and reoperation rates with institution

caseload. Four and ten NHS Trusts are above the upper control limit (corresponding to 3

standard deviations) for mortality and reoperation respectively. For consultant teams, there

are two and six outliers for mortality and return to theatre rates respectively (Figure 9.3 and

figure 9.4). 0.3 Trusts and 2.3 Consultant teams would be expected through chance alone.

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Figure 9.1: Funnel plot of adjusted 30-day mortality and Trust elective colorectal cancer
caseload.

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Figure 9.2: Funnel plot of Trust postoperative return to theatre rates and elective colorectal
cancer caseload.

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Figure 9.3: Funnel plot of consultant team elective colorectal cancer caseload and 30-day
postoperative mortality

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Figure 9.4: Funnel plot of adjusted consultant team return to theatre rates and elective
colorectal cancer caseload.

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Is there a relationship between operative volume and rectal cancer surgery?

Rectal procedures

36,714 patients who underwent an elective resection coded to a primary diagnosis of rectal

cancer were included. Of these, 26.1% (9574/36714) had an APE resection. 63.3%

(23224/36714) of rectal cancer patients were coded to an anterior resection. 7.4%

(2722/36714) of patients were coded to a Hartmanns procedure. More patients who

underwent APE were from areas of higher social deprivation [Carstairs score 5 (most

deprived) APE 17.3% (1655/9574), Other procedure 14.8% (4021/27140), p<0.001]. Patients

selected for APE had a lower 30-day mortality and 28-day unplanned readmission rate [30-

day mortality - APE 2.7% (256/9574), Other procedure 3.3% (896/27140), p=0.002, 28 day

readmission - APE 9.9% (948/9574), Other procedure 11.6% (3152/27140), p<0.001].

Patients undergoing APE had a higher return to theatre rate in the postoperative period [APE

10.0% (957/9574), Other procedure 7.8% (2130/27140), p<0.001].

When considered as a continuous variable, increasing consultant team caseload of rectal

surgery and of all elective surgery were associated with reduced APE rate [0.97 per

additional patient caseload (0.95-0.98), p=0.002 and 0.98 per addition 5 total elective patients

(0.97-0.99), p=0.003 respectively]. There was no relationship between total Trust caseload or

Trust rectal surgery volume and APE rate (p=0.421 and p=0.401 respectively).

Table 9.3 shows the number of rectal procedures in each volume category for consultant

teams and Trust when volume is categorised using the tertile approach to both volume.

Lower volume rectal consultant teams and Trusts performed higher volume of APE in the

unadjusted analysis [rLV consultant teams 30.4% (540/1774), rMV consultant teams 28.5%

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
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(2768/9710), rHV consultant teams 24.8% (6266/18964), p<0.001, rLV Trusts 27.0%

(1659/6140), rMV Trusts 26.8% (3836/14328), rHV Trusts 25.1% (4079/16246), p=0.001].

Given the likely relationship between consultant team caseload and APE rate, the critical

threshold over which outcome improved was explored. To this end, the impact of the

addition of 5 and 2.5 extra procedures to a given surgeons caseload was compared. Figure

9.5 and figure 9.6 show these comparisons. These figures suggest that 7.5 procedures per

year is the point at which there is a significant difference in APE rate.

In multiple regression analysis of APE versus other surgery for elective rectal cancer patients,

in addition to increased co morbidity, social deprivation, increasing age and male gender,

patients treated by lower volume rectal consultant teams were more likely to undergo APE

than higher volume consultant teams as shown in Table 9.7.

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Figure 9.5: Confidence intervals of odds ratios of 30 day mortality following rectal cancer
resection at incremental increases in rectal cancer surgical caseload to demonstrate critical
volume of surgery (increments of 5).

1.4

1.2

1
Odds Ratio

0.8

0.6

0.4

0.2

0
0-5 vs 5-10 5-10 vs 10-15 10-15 vs 15-20 15-20 vs >20
Volume categories

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Figure 9.6: Confidence intervals of odds ratios of 30 day mortality following rectal cancer
resection at incremental increases in rectal cancer surgical caseload to demonstrate critical
volume of surgery (increments of 2.5).

1.4

1.2

1
Odds ratio

0.8

0.6

0.4

0.2

0
0-2.5 vs 2.5-5.0 vs 5.0-7.5 vs 7.50-10.0 vs 10.0-12.5 vs 12.5-15.0 vs 15.0-17.5 vs 17.5-20.0 vs
2.5-5.0 5.0-7.5 7.5-10 10.0-12.5 12.5-15.0 15.0-17.5 17.5-20.0 >20.0
Volume categories

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Is there a relationship between total resection workload (i.e. benign and


malignant) and outcome?

Although the cancer resection volume does not appear to be a significant impact on outcome,

does total resection volume a significant impact on outcome? Does a high volume IBD

surgeon who, in consequence, does lower volume of cancer work, have similar outcome to a

high volume cancer surgeon?

In total, 155,169 patients who underwent elective colorectal resection were included. Of these

3.1% (4861/155169) died in hospital within 30 days. 6.1% (9505/155169) experienced a

complication requiring reoperation. Of these patients, 9.3% (14372/155169) required

readmission. The median LOS was 12 days (9-16 days).

Following multiple regression analysis, consultant team volume (for each increase in 5

procedures per year) was an independent predictor [OR 0.96 (0.95-0.98), p=0.001] for lower

postoperative death but Trust volume (for each increase in 10 procedures per year) failed to

predict postoperative death [OR 1.00 (1.00-1.01), p=0.309].

Consultant team and Trust volume were not predictors of reoperation [OR 0.99 (0.98-1.00),

p=0.236 and OR 1.00 (1.00-1.01), p=0.319, respectively] or readmission [OR 1.00 (1.00-

1.01), p=0.257 and OR 1.00 (1.00-1.00), p=0.350, respectively].

Given the relationship between total resection volume and consultant team elective cancer

mortality, figures 9.7 and 9.8 demonstrate the likely cut off threshold for consultant team

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

total resection volume. The cut-off threshold appears to be between 5 and 10 procedures per

year.

To assess whether total caseload is important in determining cancer resection outcome, we

performed a multiple regression model with total resection caseload as a binary variable (less

than or equal to 7.5 or greater than 7.5. A total elective consultant team caseload of greater

than 7.5 procedures per year was associated with reduced postoperative death following

elective colorectal cancer resections [OR 0.80 (0.68-0.94), p=0.002].

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Figure 9.7: Confidence intervals of odds ratios of 30 day mortality following cancer resection
at incremental increases in total surgical caseload to demonstrate critical volume of surgery
(increments of 10).

1.8

1.6

1.4

1.2
Odds ratio

0.8

0.6

0.4

0.2

0
0.1-10.0 vs 10.1-20.0 vs 20.1-30.0 vs 30.1-40.0 vs 40.1-50.0 vs 50.1-60.0 vs 60.1-70.0 vs
10.1-20.0 20.1-30.0 30.1-40.0 40.1-50.0 50.1 - 60.0 60.1-70.0 70.1-80.0
Volume categories

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Figure 9.8: Confidence intervals of odds ratios of 30 day mortality following cancer resection
at incremental increases in total surgical caseload to demonstrate critical volume of surgery
(increments of 5).

1.4

1.2

1
Odds Ratio

0.8

0.6

0.4

0.2

0
0.1-5.0 vs 5.1-10.0 10.1-15.0 15.1-20.0 20.1-25.0 25.1-30.0 30.1-35.0 35.1-40.0 40.1-45.0
5.1-10.0 vs vs vs vs vs vs vs vs
10.1-15.0 15.1-20.0 20.1-25.0 25.1-30.0 30.1-35.0 35.1-40.0 40.1-45.0 45.1-50.0
Volume Categories

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in Colorectal Surgery

Is volume relationship mitigated in part by structural factors?


Those consultant teams performing less than 7.5 cases per year work in hospitals with a

lower median number of inpatient beds per Trust [873 beds (IQR 571-1138) vs 915 beds

(IQR 662-1196), p=0.036], with a slightly reduced median number of theatres per inpatient

bed [2.16 (IQR 1.76-2.41) vs 2.21 (IQR 1.86-2.51), p=0.024], and slightly lower median

number of critical care beds per inpatient beds [1.90 (IQR 1.59-2.64) vs 1.97 (IQR 1.60-

3.18), p=0.026]. There were no differences in terms of median CT, MRI, USS or fluoroscopy

use (p=0.605, p=0.127, p=0.491 and p=0.156 respectively).

Is there a relationship between surgeon laparoscopic caseload and outcome?


Between 2002 and 2008, 84620 patients underwent an elective colorectal cancer resection.

Of these 7.7% (6554/84620) were selected for the laparoscopic approach. These procedures

were performed by 495 consultant teams who performed between 1 and 29 elective

laparoscopic cancer cases per year with a median of 10 cases per year (IQR 6-15 cases,

n=6554). There was an increase in number of surgeons selecting patients for the laparoscopic

approach from 2002 to 2008. In 2002, 41 consultant teams performed laparoscopic

resections whereas in 2007 there were 398 consultant teams (Figure 9.9).

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Figure 9.9: Increase in number of consultant teams using the minimal access approach from
2002 to 2008 with dates of publication of randomised control trials and guidelines.
450
400
Number of consultant teams

NICE
350 guidelines
300
250
200 COST study
150
Braga et al
100 Lacy et al
50
0
2002 2003 2004 2005 2006 2007
Year of Surgery

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Table 9.8 shows the characteristics of the elective colorectal cancer patients (2002-2008)

included in this analysis. As shown in Table 9.9, high volume surgeons operated on more

patients from affluent areas than other surgeon teams. Higher and medium volume surgeons

operated on more patients with rectal disease. The patients were similar in other

characteristics across surgeon volume categories.

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Table 9.8: Patient characteristics of all patients undergoing an elective colorectal cancer
resection between 2000 and 2002.

Characteristic

Resection type right sided 44527 (28.7)


left sided 29564 (19.1)
rectal 70269 (45.3)
total 10809 (7.0)
Laparoscopic
Surgical Approach 10046 (6.5)
approach
Age Mean (SD) 66.5 (14.0)
Charlson score 0 101353 (65.3)
1-4 14530 (9.4)
5 39286 (25.3)
Carstairs deprivation 1 (least deprived) 30745 (19.8)
2 36319 (23.4)
3 34197 (22.0)
4 29942 (19.3)
5 (most deprived) 23966 (15.4)
Gender Male 82443 (53.1)

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Table 9.9: Patient characteristic of cancer patients undergoing a laparoscopic elective


colorectal cancer resection between 2002 and 2008 in each volume category.

Low Medium High volume


volume volume
1-8 9-16 >16
procedures procedures per procedures per
per year year year p
n (%) n (%) n(%)

Resection type right sided 843 (38.1) 730 (33.8) 744 (34.1) <0.001
left sided 438 (19.8) 322 (14.9) 323 (14.8)
rectal 884 (40.0) 1067 (49.4) 1093 (50.0)
total 45 (2.0) 41 (1.9) 24 (1.1)

Age 17-54 192 (8.7) 201 (9.3) 199 (9.1) 0.849


55-69 753 (34.1) 741 (34.3) 723 (33.1)
70-79 813 (36.8) 780 (36.1) 786 (36.0)
>79 452 (20.5) 438 (20.3) 476 (21.8)

Charlson score 0 1393 (63.0) 1299 (60.1) 1374 (62.9) 0.143


1-4 251 (11.4) 240 (11.1) 245 (11.2)
5 566 (25.6) 621 (28.7) 565 (25.9)

Carstairs 1 (least deprived) 449 (20.3) 491 (22.7) 527 (24.1) <0.001
deprivation index 2 533 (24.1) 528 (24.4) 542 (24.8)
3 482 (21.8) 465 (21.5) 519 (23.8)
4 376 (17.0) 396 (18.3) 370 (16.9)
5 (most deprived) 370 (16.7) 279 (12.9) 224 (10.3)

Gender Male 1149 (52.0) 1172 (54.3) 1172 (53.7) 0.296


Female 1061 (48.0) 988 (45.7) 1012 (46.3)

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Of these patients, 2.0% (133/6554) patients died in hospital within 30 days. 7.2% (472/6554)

had a surgical complication necessitating reoperation. 14.2% (930/6487) experienced a

medical complication within 30 days of the procedure and 15.6% (1020/6487) within one

year of the procedure. 9.7% (639/6554) required an unplanned readmission within 28 days.

The median LOS was 8 days (IQR 5-12 days, n=6554). Table 9.10 shows the unadjusted

outcome across volume categories. In unadjusted analyses, lower volume consultant teams

have lower reoperation rates. High volume consultant teams had the lowest medical

morbidity rates with the shortest LOS. Medium volumes teams have the highest medical

morbidity rates. Table 9.11 shows the multiple regression analysis for reoperation, 30 day

medical morbidity, 365 day medical morbidity and LOS. Medium volume consultant teams

had higher medical morbidity rates with high volume consultant teams having shorter LOS

than other providers. There were no statistically significant differences following regression

in reoperation rates across volume providers.

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Table 9.10: Outcome following elective laparoscopic colorectal cancer resection in each
volume category.

Medium
Low volume High volume
volume
1-8 9-16 >16
procedures procedures procedures P value
per year per year per year
30 day in
2.1% 1.8% 2.2%
hospital 0.515
(46/2210) (38/2160) (49/2184)
mortality
6.1% 7.5% 8.0%
Reoperation 0.044
(135/2210) (163/2160) (174/2184)
30 day medical 13.6% 16.1% 13.3%
0.018
morbidity (296/2175) (344/2138) (290/2174)
365 day medical 14.9% 17.7% 14.6%
0.008
morbidity (324/2175) (379/2138) (317/2174)
9.2% 10.3% 9.8%
Readmission 0.506
(204/2210) (222/2160) (213/2184)
8 days 8 days 7 days
LOS <0.001
(6-12 days) (5-11 days) (5-11 days)

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality in Colorectal Surgery

Table 9.11: Multiple logistic regression for reoperation, 30 day medical morbidity, 365 day medical morbidity and LOS for patients undergoing
an elective laparoscopic colorectal cancer resection.
Reoperation 30 day medical morbidity 365 day medical morbidity LOS
Odds Odds Odds Relative
95% C.I. p 95% C.I. p 95% C.I. p 95% C.I. p
Ratio Ratio Ratio Risk
0.209 0.057 0.032
Surgeon volume
LV 1.00 1.00 1.00 1.00
MV 0.83 0.66 1.05 0.121 1.16 0.97 1.38 0.109 1.15 0.98 1.37 0.101 0.94 0.90 0.97 <0.001
HV 1.00 0.80 1.26 0.975 0.94 0.78 1.13 0.520 0.93 0.78 1.11 0.394 0.90 0.87 0.93 <0.001
Age <0.001 <0.001
17-54 1.00 1.00 1.00
55-69 2.58 1.64 4.05 <0.001 2.42 1.61 3.63 <0.001 1.11 1.05 1.17 <0.001
70-79 4.70 3.01 7.33 <0.001 4.09 2.75 6.09 <0.001 1.28 1.21 1.35 <0.001
>79 6.81 4.34 10.69 <0.001 5.52 3.67 8.28 <0.001 1.54 1.45 1.64 <0.001
Charlson score <0.001 <0.001 <0.001
0 1.00 1.00 1.00 1.00
1-4 1.13 0.83 1.54 0.424 1.54 1.23 1.93 <0.001 1.55 1.26 1.93 <0.001 1.09 1.04 1.14 0.001
5 1.40 1.14 1.74 0.002 2.34 2.01 2.74 <0.001 2.28 1.96 2.65 <0.001 1.13 1.09 1.17 <0.001
0.009 0.002
Carstairs
1 1.00 1.00 1.00
deprivation index
2 0.96 0.77 1.19 0.695 0.97 0.78 1.20 0.765 1.06 1.01 1.10 0.011
3 1.11 0.90 1.39 0.334 1.17 0.95 1.44 0.146 1.06 1.02 1.11 0.005
4 1.21 0.96 1.51 0.109 1.33 1.07 1.66 0.010 1.11 1.06 1.16 <0.001
5 1.46 1.15 1.85 0.002 1.46 1.15 1.84 0.002 1.19 1.14 1.26 <0.001
Type of <0.001 0.003 0.003
resection right sided 1.00 1.00 1.00 1.00
left sided 1.45 1.07 1.97 0.017 0.75 0.61 0.94 0.011 0.76 0.61 0.93 0.009 1.11 1.06 1.16 <0.001
rectal 2.03 1.61 2.54 <0.001 0.84 0.72 0.99 0.032 0.85 0.73 0.99 0.031 1.25 1.21 1.30 <0.001
total 2.20 1.15 4.22 0.018 2.07 1.03 4.15 0.042 2.01 1.02 3.95 0.044 1.35 1.20 1.51 <0.001
Gender Female vs male 0.75 0.65 0.87 <0.001 0.76 0.66 0.88 <0.001 0.97 0.94 1.00 0.069
Year of surgery 1.07 1.00 1.14 0.038 1.09 1.03 1.17 0.006 0.95 0.94 0.96 <0.001

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Is there a relationship between caseload and outcome in subspecialist care?


To investigate the impact of surgeon and hospital caseload on outcome following RPC,

patients were categorised according to the volume of primary procedures carried out by their

named consultant team or institution during the study period. In the first instance these

categories were apportioned in two ways as described in the methodology section: categories

A to C and into low volume (LV), medium volume (MV) and high volume (HV). The latter

were assigned to tertiles derived from ranking individual patients.

Table 9.4 shows the number of patients in categories A to C and LV, MV and HV. Table

9.12 shows the unadjusted outcome amongst these volume categories. On multiple Cox

regression analysis, patient age and institutional volume were independent predictors of

failure (Table 8.9 for univariate and Cox regression of failure). The study year in which was

surgery undertaken was not significantly associated with failure on univariate Cox regression

(p=0.220). Table 9.13 shows the multiple linear regression analysis for LOS of patients

undergoing pouch procedures. Higher volume consultant team and hospital volume was a

predictor of shortened length of stay. Figure 9.10 shows a Kaplan-Meier curve

demonstrating differences in adjusted failure over time between provider volume categories

(HV, MV, LV). Figure 9.11 is a funnel plot illustrating the unadjusted failure rates

according to hospital provider volume. There is one institution outside two standard

deviations on the funnel plot.

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Investigating*the*use*of*Hospital*Episode*Statistics*data*to*measure*variation*in*Performance*and*Quality*in*Colorectal*Surgery*
*

Table 9.12: Outcome of RPC according to institutional volume and surgeon volume

Institutions Surgeons
Low Medium High Low Medium High
volume volume volume A B C volume volume volume A B C
Frequency Frequency Frequency P Frequency Frequency Frequency P Frequency Frequency Frequency P Frequency Frequency Frequency P
(%) (%) (%) value (%) (%) (%) value (%) (%) (%) value (%) (%) (%) value

30 day 10/1964 11/1916 7/1891 2/402 3/1068 23/4301 5/1331 3/1329 3/1218 3/266 2/554 6/3058
mortality (0.5) (0.6) (0.4) 0.684 (0.5) (0.3%) (0.5%) 0.627 (0.4) (0.2) (0.2) 0.806 (1.1) (0.4) (0.2) 0.032

365 day 10/793 15/796 10/806 5/144 3/446 27/1805 17/712 12/836 6/847 5/133 8/298 22/1964
mortality (1.3) (1.9) (1.2) 0.514 (3.5) (0.7) (1.5) 0.050 (2.4) (1.4) (0.7) 0.022 (3.8) (2.7) (1.1) 0.008

Readmission 459/1964 404/1916 406/1891 90/402 247/1068 932/4301 319/1331 335/1329 264/1218 62/266 146/554 710/3058
rate (23.4) (21.1) (21.5) 0.183 (22.4) (23.1) (21.7) 0.577 (24.0) (25.2) (21.7) 0.106 (23.3) (26.4) (23.2) 0.276

Pouch 133/1964 140/1916 99/1891 30/402 70/1068 272/4301 74/1331 78/1329 63/1218 19/266 25/554 171/3058
Failure (6.8) (7.3) (5.2) 0.026 (7.5) (6.6) (6.3) 0.665 (5.6) (5.9) (5.2) 0.745 (7.1) (4.5) (5.6) 0.296

Median Median Median Median Median Median Median Median Median Median Median Median
stay in stay in days stay in days stay in days stay in days stay in days stay in days stay in days stay in days stay in days stay in days stay in days
days (IQR) (IQR) (IQR) (IQR) (IQR) (IQR) (IQR) (IQR) (IQR) (IQR) (IQR) (IQR)
Length of
stay 12 (9-16) 12 (9-15) 11 (9-15) <0.001 12 (9-16) 12 (9-16) 12 (9-15) 0.026 11 (9-16) 11 (8-15) 11 (9-15) 0.004 13 (9-19) 11 (9-15) 11 (9-15) <0.001

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Table 9.13: Linear regression analysis for the logarithmic transformation of length of stay
(LOS) with institutional and surgeon volume considered separately for pouch surgery
Institution volume Surgeon volume
95% Confidence
OR p value OR 95% Confidence interval p value
interval
Gender
Female (compared with male) 0.99 0.97 1.02 0.605 0.99 0.96 1.02 0.543

Diagnosis
UC (reference)*
Malignant disease 1.00 0.95 1.05 0.868 0.99 0.93 1.05 0.687
Crohns disease 1.01 0.92 1.10 0.899 0.97 0.87 1.08 0.582
Benign disease 0.98 0.93 1.03 0.426 0.99 0.92 1.05 0.656
Other diseases 0.96 0.92 1.00 0.039 0.97 0.93 1.02 0.305

Age cohort
Age <17 (reference)*
Age 17- 39 years 1.06 0.99 1.14 0.078 1.10 1.00 1.20 0.040
Age 40-59 years 1.19 1.11 1.28 <0.001 1.23 1.13 1.35 <0.001
Age >59 years 1.30 1.20 1.34 <0.001 1.33 1.21 1.48 <0.001

Charlson comorbidity score


Charlson 2 (reference)*
Charlson 3 1.23 1.12 1.34 <0.001 1.36 1.22 1.53 <0.001

Quintile of deprivation
(Carstairs index)
1 (reference) least deprived*
2 1.02 0.98 1.06 0.380 1.01 0.97 1.06 0.559
3 1.10 1.06 1.14 <0.001 1.08 1.03 1.13 0.002
4 1.09 1.04 1.13 <0.001 1.09 1.04 1.15 0.001
5 Most deprived 1.13 1.08 1.17 <0.001 1.14 1.07 1.20 <0.001
6 Unclassified 1.06 0.85 1.31 0.623 1.01 0.68 1.52 0.951

Discharge Year 0.98 0.98 0.98 <0.001 0.97 0.96 0.98 <0.001

Provider Volume/Consultant
team volume
LV (reference)*
MV 0.96 0.93 0.99 0.006 0.92 0.88 0.95 <0.001
HV 0.93 0.90 0.96 <0.001 0.93 0.90 0.97 0.001
*odds ratios and confidence intervals have been exponentiated after regression analysis.

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Figure 9.10: Kaplan Meier curve showing variation in failure rates according to institutional
volume groups

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

Figure 9.11: Funnel plot showing provider volume and failure rates following RPC

100

90

80

70
Percentage pouch failure rate

Data
60
Upper 3SD
50 limit
Upper 2SD
limit
40

30

20

10

0
0 100 200 300 400 500 600
Provider volume

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Investigating the use of Hospital Episode Statistics data to measure variation in Performance and Quality
in Colorectal Surgery

The impact of very high and low volume groups

To examine further the role of volume on outcome, we studied the differences in hospitals

with very low ( 1 /year) and very high ( 12/year) volumes (ExtLV and ExtHV). The

failure rate was significantly higher amongst patients treated in very low (7.8%) compared

with very high (5.3%) volume centres on both univariate [ExtLV centres (reference) p=0.032

ExtMV centres odds ratio 0.81 (CI 0.53-1.24, p=0.333) ExtHV odds ratio 0.61 (CI 0.38-0.96,

p=0.034)] and multiple Cox analyses [p=0.039]. On univariate analysis, however, low

volume centres were not associated with higher 30-day mortality, 365 day mortality, LOS or

the readmission rate (p=0.618, p=0.490, p=0.757, p=0.546 respectively).

Summary

This chapter explores the role of surgeon and institution volume in determining postoperative

outcome in colorectal surgery in the England. Chapter 6 demonstrated marked variation in

activity amongst surgeons. This chapter aimed to explore whether these differences in

activity translate into differences in outcome. In addition, it aims to differentiate whether it is

the total caseload that is important or whether only the cancer caseload needs to be accounted

for. Caseload has been examined previously using many different methodologies. This

chapter seeks to establish which of these methodologies is the most useful means of

examining volume. If caseload is significant, is it significant at the surgeon or the hospital

level and what is the tipping point underpinning the volume outcome relationship? Finally

we aimed to assess whether the volume outcome relationship is present in more specialised

surgery such as rectal surgery, restorative proctocolectomy and laparoscopy.

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Following adjustment in multiple regression analysis, there were no differences in outcome

across consultant team or institution cancer resection caseload in terms of postoperative

mortality, reoperation rate or readmission rate when colorectal cancer resection volume was

considered. The absence of such a relationship held true irrespective of the methodology

used to examine caseload. Higher volume consultant teams had a shorter LOS. Though

higher volume Trusts in unadjusted analysis had a shorter LOS, this was not significant

following adjustment.

Higher consultant team total resection volume is associated with improved postoperative

mortality and reduced LOS following cancer resection but not with other measures such as

reoperation and readmission. The tipping point or cutoff appears to be low an approximately

7.5 elective resections per year (Figure 9.8). Pouch and rectal surgery appear to have a

relationship with caseload with higher volume pouch centres having lower pouch failure rates

and consultant teams performing less than 7.5 rectal cancer resections per year having lower

APE rates. No relationship was evident between laparoscopic cancer outcome and

laparoscopic caseload.

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Chapter 10- Discussion

Main findings

This thesis has described variation in colorectal surgery across patients and providers at

structure, process and outcome levels and demonstrated that it is feasible to measure new

perioperative outcome measures such as reoperation, and longer term measures such as

adhesion and pouch failure rates. The aim of describing such variation and defining potential

quality measures is to identify ways of quality improvement and the extent to which the HES

dataset can be used for such purposes. Increasing individual surgeon and institutions

caseload is one possible way of improving quality. This thesis explores the role of volume in

determining postoperative outcome and variation in process factors to identify areas in which

this may or may not be an effective strategy. Volume appears to play a role in determining

outcome in more specialised surgery such as pouch surgery. When examining short-term

postoperative outcome such as reoperation and mortality following colorectal cancer

resection, the relationship is less clear. It is likely that beyond a small number of resections,

the addition of extra cases confers no further short term benefits. This thesis has

corroborated previous research suggesting that higher volume centres perform fewer APE

with the threshold being approximately 7.5 elective rectal resections per year per consultant

team. Though centralising services has other benefits, indiscriminately increasing caseload

may not translate into tangible improvements in surgical quality. Finally, alongside other

established measures, such as mortality, reoperation is a possible measure of quality

following colorectal resectional surgery.

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Role of caseload in determining outcome

We have seen significant variation across providers in terms of process measures such as

APE rates and use of laparoscopy and outcome including reoperation rates and pouch failure.

Such variation in an equitable healthcare system such as the NHS is undesirable and steps

should be focused on improving quality and reducing this variation. One suggested means of

improving patient outcome is to increase a providers caseload, either at an institutional or

surgeon level, and therefore through increased experience improve outcome. However, this

may involve not only considerable restructuring of the way we deliver surgical care but also

increased inconvenience to patients such as longer distances to travel, losing the association

and relationship with their local hospital and increasing numbers leading to a strain on

existing stretched infrastructure in tertiary hospitals functioning at maximum capacity. It is

important, therefore, to have evidence of the potential efficacy of such a change in policy

prior to increasing caseload. The value of centralization and increasing caseload has been

demonstrated in vascular surgery (Holt et al., 2009b, Holt et al., 2007a) and in other general

surgical specialties such as for oesophagectomy and hepatobiliary surgery (Finks et al., 2011)

but does such an association exist for colorectal surgery in the UK and for which procedures?

There is some evidence in the UK regarding the impact of volume on outcome in colorectal

suregry. As stated in Chapter 9, Borowski and colleagues in two papers explored the impact

of surgeon and hospital volume on outcome following colorectal cancer resection (Borowski

et al., 2010, Borowski et al., 2007). Both of these studies used data from the Northern Region

Colorectal Cancer Audit Group registry. In the earlier work published in 2007, the authors

designated a high volume surgeon as one performing greater than 18.5 emergency and

elective colorectal cancer procedures per year (Borowski et al., 2007). Higher volume

surgeons were more likely to perform potentially restorative surgery for rectal cancer [OR

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1.53 (1.10-2.12), p=0.012]. Hartmanns procedure was considered as nonrestorative.

Following elective resection, higher volume surgeons had a significantly lower mortality [OR

0.58 (1.06-1.90), p<0.001]. No such association was seen for emergency surgery. Though

there was no association with anastomotic leak when volume was considered as a categorical

variable, when volume was analysed as a continuous variable, increasing volume was

associated with reduced leaks [OR 0.91 per ten patients (0.83-1.00), p=0.049]. Higher

volume surgeons were also more likely to be colorectal specialist. In the more recent study

by Borowski and colleagues published in 2010, high volume surgeons were those that

performed more than 40 procedures per year (Borowski et al., 2010). High volume

institutions were categorised as those performing annually more than 109 procedures per year

(Borowski et al., 2010). In this second study, such very high volume surgeons were found to

have reduced anastomotic leak rate [OR 0.59 (0.37-0.93), p=0.024] and reduced perioperative

death [OR 0.66 (0.51-0.85), p=0.002] compared with low volume surgeons. There were no

differences in longer term outcome. Smith and colleagues examined data from the Wessex

registry over a three year study period. Specialisation, as defined by membership of the

ACPGBI, was highly correlated with volume of colorectal cancer surgery (Smith et al.,

2003). The authors concluded that specialisation played more of a role in determining

outcome than volume. Volume and specialisation were not included, however, in the same

model. It is therefore difficult to unpick from this study whether volume or specialisation is

the predominant factor. Morris and colleagues explored the use of APE following rectal

cancer excision and specialisation using the Northern and Yorkshire cancer registry dataset

from 1998 to 2005 (Morris et al., 2011a). They employed a cut-off of seven rectal cancer

cases per year to define a high volume surgeon. These high volume surgeons were

considered as specialists. In this study the annual median rectal cancer caseload was two

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cases per year with only 76 of the 276 included consultants meeting the threshold of seven

cases per year. There was a 5mm difference in tumour height in APEs operated on by

different groups with lower tumours being operated by the higher volume specialists. Little

has been done in the UK to explore the relationship between volume and more specialied

colorectal surgery such as pouch surgery.

This is the first study to examine nationally the role of volume in England in determining

outcome following elective colorectal resection for cancer and for all diagnoses. We

examined nationally the role of caseload in determining APE rate and sought to begin to

provide an evidence base for a minimum threshold of rectal surgery. Furthermore, we looked

at the role of volume in laparoscopic colorectal surgery. Finally we examined the impact of

caseload at an institutional and consultant team level on outcome following restorative

proctocolectomy. This is the first worldwide study to examine such a relationship.

Volume and colorectal resection

In previous international literature, the finding of an association between mortality and

surgeon volume has been mixed with some studies finding a similar correlation as

demonstrated in this study while other studies fail to find a volume outcome relationship

(Schrag et al., 2003, Hannan et al., 2002, Callahan et al., 2003, Rogers et al., 2006). A

systematic review suggested that there was evidence for colonic cancer but not in studies

examining rectal or colorectal outcome (Iversen et al., 2007). Given the ambiguity in the

literature, the current study offers an important addition to the volume outcome debate. The

definition of a high volume surgeon or institution in any branch of medicine is problematic

with no clear consensus across the literature as to what should constitute a high volume

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practitioner or institution. Guidance has been offered by the ACPGBI in relation to cancer

work but not for benign pathology (ACPGBI, 2007). Studies from the United States

examining caseload tend to have much lower numbers considered as high volume than

research from elsewhere. (Rogers et al., 2006, Boudourakis et al., 2009, Billingsley et al.,

2008, Schrag et al., 2003). Studies have wide variation in the thresholds chosen for each

volume category. For the purposes of this thesis, volume was interrogated using several

different statistical and clinically meaningful ways. The Deviance Information Criterion

(DIC) was used to compare multilevel logistic regression models for 30 day mortality and

reoperation. The model with the smaller statistic was chosen. The DIC statistic was

proposed by Spiegelhalter and colleagues to be the Bayesian equivalent of the Akaike

Information Criterion Statistic (AIC) (Spiegelhalter et al., 2002). The model with the lowest

DIC statistic included a tertile approach to volume. This gave three roughly equal groups of

providers (institutions and surgical teams). The upper limit of a high volume surgical team

was 20.7 cases per year. This included only elective cancer cases. Furthermore it only

included primary resections so further resections in a subsequent year within the dataset were

excluded. Though a level of 20.7 cases is seemingly low to be a high volume surgeon, overall

elective colorectal cancer cases constituted 111023 cases, less than half of the dataset so the

true overall volume of these consultant teams may be more in the region of at least 41 cases

when elective and emergency practice is considered or appoximately 28 cancer resection.

This level is in fact higher than the 18.5 elective and emergency cases threshold set by

Borowskis earlier work (Borowski et al., 2007). When colorectal cancer cases were looked

at in isolation, no relationship was found between surgeon volume and outcome even if

volume was considered as a continuous variable. However, when total elective caseload i.e.

for all diagnoses was considered as a continuous variable, higher volume surgeons did appear

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to have an improved 30 day mortality rate. The tipping point appears to be quite low at 7.5

procedures per year. Similar methodology to attempt to define a tipping point for thresholds

in the volume outcome debate has been employed previously by Ananthakrishnan and

colleagues and Ross and colleagues (Ananthakrishnan et al., 2008, Ross et al., 2010).

Ananthakrishnan examined outcome in patients admitted with IBD from the Nationwide

dataset in the US (Ananthakrishnan et al., 2008). They use the same methodology used in this

study as a sensitivity analysis in IBD. Ross and colleagues examined the role of caseload in

determining mortality following myocardial infarction, heart failure and pneumonia (Ross et

al., 2010). They sought to define a high volume institution through the addition of 25 cases

and assessing where additional cases made no further impact on outcome.

In England the lack of an apparent volume outcome relationship when cancer alone is

considered may reflect the working practices in this country such as elective colorectal cancer

surgery being increasingly provided by colorectal specialists (Morris et al., 2007b) or the

increasing influence of the multidisciplinary team in surgeon decision making (Augestad et

al., 2010). Chapter 6 demonstrated an increase in resection activity amongst colorectal

resection surgeons suggesting that there has been some organic centralisation of services.

Chapter 8 does demonstrate significant variation in outcome from elective colorectal cancer

surgery across NHS Trusts and surgeons in England as shown in the funnel plots, Figures 9.1

to 9.5. There are outliers at both low and high volumes suggesting that there are other

differences in providers not explained by volume alone. Centralisation of services may have

unwanted consequences such as impact on emergency services and training. It is also not

clear what the appropriate caseload is to maximise the benefits and reduce these possible

unwanted effects of centralisation. This thesis has attempted to answer this question by

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examining the total volume of surgery but this may be too simplistic an approach. It maybe

that there are added longer term oncological benefits of increasing caseload that have not

been assessed in this study. Indiscriminate centralisation of services may not, however,

produce improvements in quality. It may be more beneficial to increase caseload amongst

those high performing providers. Centralisation to those providers who already demonstrate

good outcome may combine the benefits of increasing caseload with technical and non

technical proficiency to improve quality and outcome. Though a relationship was not

apparent with colorectal cancer resection, the impact of caseload may be more apparent in

newer techniques or for more specialised procedures. Therefore, the role volume was

examined for laparoscopic colorectal surgery and restorative proctocolectomy as a more

specialised procedure.

Volume and Laparoscopy

High volume laparoscopic consultant teams were associated with a shorter length of stay [OR

0.88 (0.85-0.91), p<0.0001] when compared with lower volume consultant teams. In this

analysis, low volume was considered as those that performed less than 7 procedures per year

and high volume teams were those that performed more than 12 procedures per year. These

numbers reflect practice in England. Larson and colleagues using data from the COLOR

study used the cut-off points of five and ten procedures per year to define a low volume and

high volume surgeon respectively (Larson et al., 2008). The latter study only examined

outcome from colonic surgery and was limited to those patients that were enrolled in the trial.

Therefore those surgeon thresholds were probably artificially lower than the true caseload of

the included surgeons. Even assuming the thresholds used by Larson and colleagues were

higher than those used in this study, they still did not demonstrate an impact of volume on

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outcome following laparoscopic surgery. Yasunaga and colleagues examined volume in

terms of the total number of laparoscopic colectomies performed throughout the career of the

surgeon (Yasunaga et al., 2009). Therefore, it is difficult to draw comparisons with the

current study. In Yasunagas study even surgeons performing greater than 200 procedures

during their career did not have lower postoperative complications.

The current study has, however, demonstrated differences in the case mix of differing volume

surgeons. Low volume consultant teams performed more right sided and left sided resections

than other volume surgeons. Laparoscopic rectal resections are technically more challenging

than colonic resections with a higher postoperative complication rate. The preference for left

and right sided resection may be due to low volume surgeons selecting the technically easier

cases for the laparoscopic approach. This may explain why medium volume surgeons

demonstrated the highest medical morbidity following surgery. In effect, medium volume

surgeons may not be as selective as the lower volume surgeons. As the data for this study are

derived from an administrative database, scoring of the complexity of surgery is not available

or feasible. The analysis has been risk adjusted for type of resection and to an extent for

patient comorbidity, but cancer stage is not available on this dataset.

Volume and restorative proctocolectomy

The median volume of pouch procedures carried out in England per year by individual

surgeons was extremely small. Approximately half of all procedures were performed at

centres that had carried out 22 or fewer operations during the twelve-year period of the study.

Moreover, ninety percent of the surgeons performing these complex operations had carried

out approximately two procedures per year (20 procedures over eight years).

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These findings are in line with the results of the recent IBD audit in England reported by the

UK IBD Audit steering group (IBD Audit, 2007). This body had suggested that hospitals

with a low volume of pouch surgery should consider referring to hospitals with a larger

volume. The present study has, in addition, demonstrated an increase throughout the study

period in the number of low volume hospitals performing pouch surgery (Figure 6.4). It has

also highlighted differences in case selection amongst surgeons with varying caseload in

terms of age and diagnosis. Most importantly a high hospital caseload is associated with a

lower adjusted failure rate. This finding supports the work by Kennedy and colleagues who

using Canadian administrative datasets, found that large surgical caseloads (defined as low

volume 10 procedures, medium volume 11-100, high volume>100 over approximately 6.5

years in this study) were associated with reduced reoperation and failure rates (Kennedy et

al., 2006).

In this study we used three different approaches for categorising the caseload of an institution

or surgeon. The first two were based on statistical techniques to create three groups of

providers or patients respectively. The procedure thresholds obtained using these statistical

approaches were small and may not have adequately discriminated between higher volume

more specialised and lower volume centres.

For these reasons we also used a more pragmatic approach to examining volume. From a

clinical standpoint this was a much more intuitive way of analysing the apparent benefits of

higher volume more specialised centres and surgeons. However, there was no a priori

evidence for the chosen cut off points but it resulted in the observation that failure was

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associated with lower volume centres irrespective of whether statistical or clinical thresholds

were used to define institutional volume.

Significant differences in case selection amongst high and low volume providers were

observed. Low volume providers (those in Category A) operate on more patients with

malignancy and Crohns disease than other providers. Importantly, these differences may not

only reflect surgeon experience but also the experience of others such as histopathologists in

establishing the correct preoperative diagnosis and multidisciplinary decision-making.

The study has found clear differences in outcome between different volume providers

following pouch surgery in terms of failure at an institutional level and one year mortality at

a surgeon level. The relative risk reduction of pouch failure between LV and HV providers

was 27% on adjusted analysis. When extremes of volume are considered, this increases to

39%. The absolute reduction in the failure rates between the LV and HV categories (6.8%

and 5.2% respectively) is small. In such a procedure as RPC, function is extremely important

with failure being the extreme endpoint of poor function. Thus small differences in failure

rates may reflect large differences in function in patients operated by institutions with varying

caseloads.

Given the complexity of case selection for pouch surgery, the procedure itself and subsequent

care, it might seem reasonable that these patients receive subspecialist expertise. Various

studies have suggested that patients undergoing colorectal surgery for both inflammatory

bowel disease and colorectal cancer at high-volume centres demonstrate better outcomes

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(Birkmeyer et al., 1999, Hannan et al., 2002, Melville et al., 1994, Porter et al., 1998).

Although centralization has not formally occurred in colorectal surgery, the UK IBD audit

group recommended that low-volume centres should refer complex procedures, such as

pouch surgery, to high volume centres (IBD Audit, 2007). The increasing reliance on the

volume-outcome relationship is being used to drive quality improvement via

subspecialisation. Given the relatively small numbers of RPCs performed annually in

England and the small number of very high volume centres combined with the proposed

establishment of recognised inflammatory bowel disease units, adequate training will become

increasingly difficult for surgical trainees. This aspect will need to be allowed for and

integrated into any proposals for centralising surgical services. It may be that centralisation

may be a more effective means of improving quality for more specialised procedures such as

restorative proctoclectomy. However, further work is needed to examine the relationship

between caseload and elective cancer oncological outcome.

The role of caseload in determining postoperative outcome and process factors appears to be

more magnified for subspecialist surgery. Increasing volume per se may not have the desired

effect on improving outcome across colorectal surgery. Prior to indiscriminate centralisation

further evidence is needed to support such a change in general colorectal services. There may

be other global ways to use data such as HES to improve the quality of care.

Quality improvement

Increasing volume is one possible way of improving quality but may not be effective across

the breadth of colorectal surgery. Other possible approaches include national and

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institutional performance benchmarking. A system similar to NSQIP would be feasible if data

accuracy can be assured. Some argue that as the data begin to be used to benchmark quality,

it will consequently improve as institutions submit more accurate data to meet the need to

demonstrate quality. Methodology such as that proposed by this research could be used as

part of this benchmarking. Caution should be exercised in public reporting of data pending

further ratification of risk adjustment methods and data accuracy.

Centralisation to centres of excellence may be an alternative means of improving quality

rather than indiscriminate centralising to all higher caseload units. Funders of healthcare

will need to establish criteria for defining a centre of excellence and then concentrate

referrals to these institutions (Birkmeyer and Birkmeyer, 2006). This may be possible under

the proposed changes to the NHS. HES data may be used to form one part of the assessment

if data accuracy can be assured. Alternatively, pay for performance initiatives reward high-

performing institutions and potentially penalise those where service quality is substandard

(Birkmeyer and Birkmeyer, 2006). These systems have been already suggested in England

with the proposal to withhold payment for unplanned readmissions. Through monetary

incentives, these initiatives may provide a stimulus for rapid quality improvement. It should

be noted however that there is, as yet, limited evidence to show that this method leads

directly to improved quality. There is some overlap between pay for performance and the

centre of excellence model. The Leapfrog programme, discussed previously, uses a

combination of the centre of excellence and pay for performance strategies (Leapfrog

Group, 2007). As stated, this type of programme utilises evidence-based hospital referral to

enhance service quality. In addition, it uses a range of other process and outcome measures

such as thromboembolic prophylaxis, safety culture and pressure ulcer rates to determine

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reward payments. Hospitals opt to participate in this type of programme to attain referrals and

rewards. These programmes require clear definition and universal consensus regarding the

criteria used to denote high performance.

Another strategy is the pay for participation model. It provides a monetary incentive for

providers to enrol in a quality improvement programme. A successful example of this type of

initiative was the Michigan Surgical Quality Collaborative (Englesbe et al., 2007), that

instituted a data-based quality improvement programme. The costs to the funder of this

incentive based programme are projected to be recouped through a modest reduction in

complications. Englesbe and colleagues made a successful business case for the pay for

participation programme, estimating that only a 1.8% reduction in complication rates was

sufficient to offset the programme costs (Englesbe et al., 2007). Providers opt to participate in

the data based quality improvement programmes, the costs of which are met by funders. The

provider benefits through improving quality and patient care in their organisation and the

funder reaps long-term benefits through reduced costs from lower complications rates. This

model does, however, have disadvantages. Certainly, it is difficult to organise and often

requires one funder to possess a dominant market share for the business case to be viable

(Birkmeyer and Birkmeyer, 2006). Of note, in these initiatives, individual provider data are

not made available for either payer or public consumption (Englesbe et al., 2007). In

addition, this model would require a complete overhaul in the way in which NHS services are

delivered.

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The proposed revalidation of clinicians through the General Medical Council may offer

benefits to patients. A need to demonstrate satisfactory outcome may actually improve

outcome through audit.

All these strategies require data and defined measures of quality. This thesis, therefore,

sought to explore methodologies that could be used to derive new measures from HES data

and assess HES data utility and versatility.

New outcome measures

Reoperation as a potential quality marker

The reoperation rates of 6.5% (7.0% following an emergency resection and 6.2% following

an elective resection) described in this thesis are consistent with those found by previous

studies from the American SEER and the National Surgical Quality Improvement Programme

data (Morris et al., 2007a, Billingsley et al., 2008, Bilimoria et al., 2008b). Morris and

colleagues, in a study of SEER-Medicare linked data, found that 5.7% of colon cancer

resections and 6.5% of rectal resections required a postoperative procedure (Morris et al.,

2007a). Male gender also conferred an increased risk of reoperation in the study by Morris

and colleagues. Cancer stage in this study was not a significant predictor of reoperation

following adjustment. Merkow and colleagues examined 23098 elective patients undergoing

a colorectal procedure recorded on the ACS NSQIP database. 5.7% of patients required a

reoperation (Merkow et al., 2009). In this study the range of reoperation rates amongst

hospitals varied from 0% to 38.1%. Using a similar ACS NSQIP dataset, Bilimoria and

colleagues examined reoperation rates following elective laparoscopic and open colonic

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cancer resections (Bilimoria et al., 2008b). Reoperation rates (5.5% for a laparoscopic and

5.8% for an open resection, p=0.79) were similar in the laparoscopic and open groups.

Bilimorias study, however, only included elective colonic cancer resection and excluded

other indications for surgery and emergency presentations. Delaney and colleagues

examining NSQIP data found a similar small but statistically significant increase in

reoperation rates following laparoscopy (Delaney et al., 2008).

The methodology to derive reoperation rates from the UK administrative dataset employed in

this study reflects a valid way of investigating postoperative outcome. Data from individual

hospitals are submitted centrally from local institution administrative computer systems.

Thus these systems could be potentially used for real time monitoring of postoperative

outcome in a reproducible and feasible way through existing institution databases. As

clinical coders enter the data and not the clinical team caring for the patient, the data have a

degree of objectivity. Moreover, the data represent an opportunity to report the outcome of

all resections performed by all surgeons in the entire country.

Increasing socioeconomic deprivation is associated with higher reoperation rates and has

shown to be a factor in determining the type of surgery that patients undergo. As shown in

table 9.7 and corroborated by work by Tilney and colleagues and Morris and colleagues,

patients from areas of increased social deprivation are more likely to undergo an

abdominoperineal resection than other patients (Tilney et al., 2009, Morris et al., 2008).

Tilney and colleagues, from HES data, demonstrated that though the APE rates were

reducing over time, patients from more socially deprived areas were 50% more likely to

undergo an APE than those from the least socially deprived areas (Tilney et al., 2008).

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Furthermore, using NBOCAP clinical registry data, Tilney and colleagues showed that

patients from the most socially deprived areas had an excess of APEs (Tilney et al., 2009). In

the study by Tilney et al, there were no differences in APE rates between patients with Dukes

C tumours and those with Dukes A and B. Social deprivation has also been correlated with

poorer survival after treatment of colorectal cancer especially following surgical resection

(Wrigley et al., 2003, Faiz et al., 2009). These disparities in outcome may reflect severity of

disease at presentation or other unquantified characteristics but some of this variation will

reflect inequalities in access to care according to socioeconomic background. The observed

increase in reoperation rates with increasing socioeconomic deprivation suggests that further

work is required to redress this inequality through quality improvement and early detection of

disease.

Although older patients have been shown to have poorer postoperative mortality (Faiz et al.,

2011a) and increased morbidity such as postoperative medical complications, older patients

have not been found to have higher reoperation rates (Bentrem et al., 2009). Bentrem and

colleague found that, despite increased medical morbidity and mortality in those over 75

years of age, reoperation rates did not increase in the older age group (Bentrem et al., 2009).

This may reflect increased rates of stoma formation to avoid the disasterous consequences of

an anastomotic leak, more conservative surgery or a reluctance of surgeons to take older

patients back to theatre following surgery. Older patients may not be fit for a further

procedure or may die before returning to theatre following a complication. Further research is

required to target decision-making amongst surgeons treating patients in this age group.

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Reoperation is associated with other markers of poor postoperative outcome such as mortality

and prolonged LOS. Patients with a complication necessitating a reoperation are three times

more likely to die in the postoperative period than other patients. Furthermore, reoperation is

associated with poorer long term outcome including higher risk of local recurrence and lower

overall survival (Mirnezami et al., 2011). An anastomotic leak following rectal resection

increased the risk of local recurrence by 100% [OR 2.05 (1.51-2.8), p=0.0001](Mirnezami et

al., 2011). One study found that surgical complications had long-term effect on quality of life

(measured at one year postoperatively) following colorectal cancer resection (Anthony et al.,

2003). This study however included medical and surgical morbidity in the definition of a

complication. Further work is needed to establish whether a reoperation in itself leads to

poorer postoperative quality of life. We have demonstrated that patients requiring a return to

theatre for complication have increased risks of adhesions and incisional hernia. Patients

experiencing such a complication are twice as likely to require adhesionolysis and have a

50% increased risk of having an incisional hernia repair. This correlation has been

demonstrated previously (Hesselink et al., 1993, Parker et al., 2001, Rotholtz et al., 2008).

From this work it is suggested that reoperation is a possible measure of surgical quality and is

feasible to measure from HES data. The incidence is in line with published literature. In

addition, chapter 8 demonstrates variation at NHS Trust and Consultant team level. Using

funnel plots, significant outliers (for both high and low rates) were identified for reoperation.

At a patient level, reoperation correlates with other markers of poor outcome including

mortality. Certainly a reoperation rate of zero is not desirable. If reoperation was used in

isolation to measure performance of Trusts and Surgeons then it may be tempting to not

reoperate where clinically indicated. Reoperation should therefore be taken as one of a

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toolkit of measures alongside other measures such as mortality. Prior to its use as an

individual measure of performance, further understanding of what range of reoperation is

acceptable is required. In addition, data quality must be assured. This may be performed

through an iterative process where Trusts and surgeons are given the opportunity to correct

their individual data prior to any publication. Finally, the risk adjustment afforded by clinical

registries and administrative datasets is inadequate. Therefore, a high outlier status should

serve as a prompt for further scrutiny rather than a definitive label of poor performance.

The methodology underpinning this measure is widely applicable to other surgical

specialities. If coding accuracy can be assured reoperation rates, along with existing quality

measures such as mortality, could offer a powerful means of benchmarking the quality of

surgical care.

Medium term complications

As demonstrated by reoperation, it is possible to measure short term complications. Chapter

8 also explored the feasibility of measure medium term outcome measures. This is the first

population-based epidemiological survey to examine the national rates of incisional hernia

and adhesions following colorectal resection in England. This study suggests that use of the

minimally invasive approach in colorectal surgery results in fewer adhesion-related

admissions and reoperations with comparable rates of incisional hernia following colorectal

surgery between these approaches. At an institutional level, there was less variation in these

medium measures than in short term outcome measures such as reoperation.

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The occurrence of adhesions and incisional hernia in this study are similar to the findings

from other studies. The overall incisional hernia rates of 4.7% are in keeping with data from a

recent Cochrane review (Kuhry et al., 2008). The rate following laparoscopic surgery of 4.2%

is in the centre of the range in published series (0.55-7%) (Duepree et al., 2003, Lumley et

al., 2002, Regadas et al., 1998, Skipworth et al., 2010). The high admission rate for adhesions

(8.1%) and adhesiolysis rate (3.5%) reiterate the importance of this issue as recognised by

other authors (Bhardwaj and Parker, 2007, Parker et al., 2004, Parker et al., 2007). The rate

of post-operative adhesions requiring admission or operation rate in our population-based

study was higher than the 2.7% reported by the CLASICC group (Taylor et al., 2010). The

CLASICC study was underpowered to analyse these outcomes. One advantage of using HES

data is that it includes all patients admitted to NHS hospitals and thus it allows analysis of a

large number of patients. Furthermore, it includes all surgeons, not just those enthusiasts that

submit data to clinical trials. Those patients undergoing emergency surgery, unsurprisingly,

have increased risks of adhesions and incisional hernia (Hesselink et al., 1993, Parker et al.,

2001, Rotholtz et al., 2008).

Rectal procedures may be at increased risk of developing incisional herniae. Desouza and

colleagues (Desouza et al.) compared the occurrence of incisional hernia following

laparoscopic colorectal surgery with differing types of specimen removal. They found that

Pfannensteil incisions significantly reduced the risk of incisional hernia when compared to

midline extraction wounds and conventional open laparotomy. They undertook, however, all

their minimally invasive surgery using the hand-assisted approach, which theoretically may

obviate the reduced tissue handling benefits of the laparoscopic approach. In addition, they

excluded port-site and parastomal hernias, which may significantly have biased their

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outcomes. As opposed to an intention to treat basis, they coded all their converted cases to

the conventional midline laparotomy approach.

The increasing risk of incisional herniae and adhesions over the period of this study merits

further investigation. The increased adhesion rate may be due to more accurate clinical

coding but the problem of adhesions following colorectal surgery has been increasingly noted

in the surgical literature (Menzies and Ellis, 1990, Parker et al., 2007). Parker and colleagues

issued a call for action on adhesions to the colorectal community and advocated adhesion

reduction strategies including the use of anti-adhesion agents (Parker et al., 2007). Whilst this

study could not make an assessment of the anti-adhesion strategies used, the evidence

surrounding the impact of the anti-adhesion meshes and solutions requires further

elucidation. A systematic review has suggested that some solutions may reduce the

development of adhesions postoperatively (Kumar et al., 2009). Little work has however

investigated the long term development of clinically relevant adhesions or necessity for

admission with adhesional bowel obstruction. Further work is necessary to evaluate the

longer term clinical benefits of such anti-adhesion strategies.

Pouch failure

Individual procedures may have more pertinent outcome measures than those that are

applicable to general colorectal surgery. Pouch failure is an important end point for patients

undergoing such surgery. Derivation of such a measure demonstrates the feasibility of

examining more long term outcome measures as well as tailoring the measures to individual

procedures on HES.

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The failure rate observed compares favourably with the rates of 3-12 percent reported from

large single centre case series (Fazio et al., 1995, Tulchinsky et al., 2003, Delaney et al.,

2003, Chapman et al., 2005, Gemlo et al., 1992, Setti Carraro et al., 1994). Despite

refinement in surgical technique over time, failure did not significantly decrease during the

study period. The period of follow up may have been too short to capture any such trend, as

improvement of technique and experience in the more recent years may not be reflected in

reduced failure for some years to come. In an analysis of patients entered on the UK

National Pouch Registry, Tekkis and colleagues found that failure increased from 5.3% at

five years to 16.1% at ten years follow up (Tekkis et al., 2009).

The diagnosis was not found to be a predictor of pouch failure, although it should be stated

that there is not a code in the ICD-10 classification for indeterminate colitis. This may be

coded to either UC or Crohns disease or it may be included in the non-infective colitis

category. The lack of an apparent relationship between pouch failure and diagnosis may

reflect discrepancies in the coding of inflammatory bowel disease. Failure rates do vary

significantly across NHS Trusts and amongst consultant teams. The rates varied from over

20% in some small volume centres to less than 3% in higher volume centres. Such variation

in rates is unlikely to be solely attributable to variation in case mix or aberrant coding. It is

therefore important to assess what steps can be taken to reduce such undesirable variation.

Laparoscopic versus open approaches

One focus of this thesis has been the interplay between process factors i.e. use of laparoscopy

and outcome. The patient reported benefits of laparoscopic colorectal surgery have been

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in Colorectal Surgery

documented (Braga et al., 2002, Lacy et al., 2002, Veldkamp et al., 2005, Jayne et al., 2007,

Braga et al., 2005). There have been several randomised control trials (RCT) that have

explored the efficacy and safety of laparoscopic colorectal surgery. Lacy and colleagues

reported the first RCT (the Barcelona trial) of 219 patients investigating laparoscopic surgery

for colonic cancer.(Lacy et al., 2002). They found reduced morbidity following laparoscopic

surgery than open (12% vs 31%, p=0.001) and equivalent postoperative mortality rates,

although the reoperation rates were not recorded in this study. Cancer related survival was

higher in the laparoscopic group. The Clinical Outcomes of Surgical Therapy Study Group

(COST) study published its findings in 2004 (2004a). In a study of 872 colonic cancer

patients, the postoperative complication rates (21% vs 20%, p=0.64), mortality (<1% and 1%,

p=0.40) and cancer recurrence rates were similar in the open and laparoscopically assisted

groups (16% vs 18%, p=0.32). The colon cancer laparoscopic or open resection (COLOR), a

North American and European RCT, in 2005 reported comparable morbidity and mortality in

the laparoscopic and open surgical groups (2004a). However in this study the reintervention

rate was not significantly higher in the laparoscopic group than in the open group (7% vs 5%,

p=013). The conventional versus laparoscopic assisted surgery in patients with colorectal

cancer (MRC CLASICC trial) reported the short term outcome in 2005 (Guillou et al., 2005).

In this study of 794 patients, 268 patients were allocated to open surgery and 526 to

laparoscopic surgery. The laparoscopic group and open groups had similar overall

complication rates (32% versus 33%). The three year and five year results reported no

difference in overall survival (Jayne et al., 2007, Jayne et al., 2010).

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These studies report different outcome measures and include a total of 3133 patients. It is

possible that these trials are underpowered to examine more subtle variation in outcome

following laparoscopic surgery.

We have shown that elective patients selected for a laparoscopic approach experienced higher

reoperation rates. 7.1% of elective laparoscopic patients underwent a reoperation following

the primary resection. Though Bilmoria and colleagues did not demonstrate a difference in

reoperation rates following colonic cancer resections (lap 5.5% and open 5.8%, p=0.79)

(Bilimoria et al., 2008b), a later study by Delaney and colleagues also using NSQIP data

examined outcome following colectomy for all diagnoses (Delaney et al., 2008). This study

found a similar small increase in the adjusted reoperation rate following laparoscopic

resection when compared with the open approach (OR=1.78, p=0.002). When examining

reoperation rates following laparoscopic colorectal cancer surgery, the reoperation rates

demonstrated in this study are higher than those previously published from the American

College of Surgeons National Surgical Quality Improvement Program (NSQIP) data or trial

data (Bilimoria et al., 2008b, Hewett et al., 2008, Schwenk et al., 2005). The latter studies,

however, mostly included only colonic procedures. Laparoscopic rectal procedures were

twice as likely to experience a reoperation following surgery (table 9.11) than right sided

resections. The increased reoperation rates may also reflect the learning curve by English

surgeons taking up laparoscopic surgery or the impact of widening practice from dedicated

enthusiasts to the more general colorectal surgeons. Importantly, surgeon caseload did not

impact on postoperative reoperation rates. Broadly, this implies that low volume laparoscopic

surgeons are not associated with higher serious surgical morbidity rates than colleagues

exposed to greater activity. It is unclear whether this increase in reoperation represents a

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truly higher incidence of surgical complications requiring reoperation or whether a surgeons

propensity for reoperation is increased following the laparoscopic approach.

We have demonstrated a reduction in clinically important adhesions following the

laparoscopic approach. This confirms the findings from single-centre observational

studies.(Dowson et al., 2008, Lumley et al., 2002, Duepree et al., 2003). However, the

laparoscopic approach is not without risk for adhesion development. The SCAR-2 study

examining pelvic gynaecological surgery documented similar adhesion-related risk regardless

of the surgical approach (Lower et al., 2004).

From 2002 to 2008, the number of consultant teams practising minimal access colorectal

surgery increased. This increase corresponded with the publication of several randomised

control trials in 2002 and 2004 ratifying the safety of the laparoscopic approach for cancer

surgery (Braga et al., 2002, Lacy et al., 2002, 2004a). The National Institute of Clinical

Excellence (NICE) introduced its guidelines on laparoscopic colorectal cancer surgery in

2006 (NICE, 2006), by which point there had already been a significant expansion in the

number of surgeons offering the minimal access approach. In England, the National Training

Programme for Laparoscopic Colorectal Surgery began in 2008 with the aim to increase the

number of colorectal surgeons trained to independently perform laparoscopic colorectal

surgery. This program in conjunction with the NICE guidelines is likely to increase further

the number of surgeons performing laparoscopic colorectal surgery.

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Study limitations

Reoperation

The advantage of this administrative dataset is that it provides a comprehensive overview of

current colorectal practice in England. By including all patients admitted to NHS hospitals in

England, any submission bias is avoided. There are several limitations, common to all

included studies that merit discussion.

HES dataset

The dataset, although prospectively collected, includes all patients undergoing surgery

without standardisation of treatment and selection bias of procedure or management by

individual surgeons or trusts cannot be excluded. HES data lack clinical information such as

disease severity that would allow a more refined risk adjustment for comparison of

institutions or surgeons.

Data accuracy has been frequently questioned. Extensive comparisons between the HES

dataset and other data sources have suggested the reliability of HES data for clinical outcome

analysis (Aylin et al., 2001, Poloniecki et al., 2004, Aylin et al., 2007a, Aylin et al., 2007b,

Garout et al., 2008). The systematic review sought to quantify the data accuracy published in

this thesis. This demonstrated an overall accuracy of 83.2% with a diagnostic accuracy of

80.3% and a procedure accuracy of 84.2%. Accuracy, however, is likely to be improving. A

recent Audit Commission assessment of coding accuracy suggested recent improvement in

coding accuracy with a procedure accuracy of 90% and diagnostic accuracy of 87% (Audit

Commission, 2010). Derivation of the reoperation rates in this study relies on the secondary

procedure codes. The accuracy of secondary codes may be less than that of the primary

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codes but this is difficult to ascertain from the published literature. The Charlson score is

based on secondary diagnosis coding and was used to adjust for comorbidity in the included

studies. It has been used previously for colorectal cancer patients and shown to be valid

(Ouellette et al., 2004). The Charlson score has also been used to adjust for comorbidity in

predicting surgical complications in the United States (Kemp and Finlayson, 2008). A more

comprehensive explanation of the Charlson scoring system is given in Chapter 4. Trusts may

vary in the accuracy to which they record secondary procedures or diagnosis codes. Some of

the inter trust variability seen in these studies may reflect differences in local coding

practices.

Coding

The OPCS code for conversion of a minimal access to an open procedure was introduced in

2006. Cases converted prior to the introduction of this code will not have been captured as

conversions and may have been included in the open group of patients prior to 2006. The

current study used the OPCS codes Y75 (introduced in 2006) and Y50.8 to designate a

laparoscopic procedure. From these codes, it is not possible to know how much of the

procedure was performed laparoscopically and how many procedures were converted to the

open approach. In addition, it is not possible to ascertain if they were hand assisted or how

much of the operation was completed laparoscopically. Therefore, analysis was performed

on an intention to treat basis.

For this analysis where emergency patients were included, patients coded to a Hartmanns

procedure (H33.5) were included in the left sided group. The majority of these cases had a

diagnosis of diverticular disease. It was therefore felt that these resections were more likely

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to be sigmoid resections rather than true rectal resections. However, when elective

procedures were considered, Hartmanns procedures were included in the rectal group.

Up to April 2006 specific codes for pouch revision did not exist and the reliability with which

pouch revisional procedures can be identified is unclear. However, the coding used prior to

2006 was similar to the coding for pouch excision with the addition of the Y71.3 revisional

operation code. Thus revisional procedures prior to 2006 will be captured in the pouch

excision group.

The anonymised consultant codes refer to the consultant in charge of the patients care. It is

not possible to determine who the operating surgeon is or their level of experience. It is

difficult therefore to assess the learning curve of the operating surgeon rather than the

consultant team.

The dataset is not able to code for parastomal hernia, which may be coded with other ventral

hernia, which will artificially increase the incisional hernia incidence. As operative codes are

more likely to be accurate than diagnosis codes, the study may not be as specific in

identifying incisional hernias or adhesions that did not require admission or operation.

The ICD10 code for rectal cancer excluded cancers coded to a rectosigmoid diagnosis (C19).

It is not possible to ascertain height from the anal verge for rectal cancers.

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Reoperation

Surgical complications that do not require reoperation such as wound infection treated by

antibiotics are not included in this study. Interventional radiological procedures such as

image-guided drain insertion are also not included. Thus the total surgical morbidity that

may have an impact on outcome including length of stay and mortality will be

underestimated in this study. Surgeons may differ in their threshold for taking patients back

to theatre reflecting differences in surgeon level reoperation rates. Furthermore, surgeons

may have a lower threshold for performing a diagnostic laparoscopy in patients who

underwent a minimal access procedure, elevating the apparent reoperation rate.

Each patient will undergo different preoperative decision-making and differ in their

postoperative management according to the clinician in charge of their care. Different

surgeons will have different selection criteria for the laparoscopic approach.

Medium term complications

The clinical severity of a hernia is not conveyed within this administrative database. The

clinical impact of a limited port-site hernia is likely to differ from that of a large midline

laparotomy herniation. This is important as at the consultant level one surgeon may operate

on the more difficult cases. Moreover, data such as length of incision or previous surgery are

not included in this dataset. We cannot, therefore, say with absolute certainty that any

herniae or adhesions are secondary to the colorectal resection admission included in this

study. Though patients undergoing a resection in at least the six years prior to the study

period have been excluded, other operations such as gynaecological procedures may have

been undertaken. Furthermore, our dataset only examines inpatient admissions so any

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patient who has an incisional hernia conservatively treated on an outpatient basis will not be

included in this dataset.

Cancer stage or disease severity are not included in the dataset so have not been included in

the risk adjustment models. This would be pertinent as cases for more advanced disease are

more likely to have been converted from laparoscopic to open with the inherent risks of

incisional hernia development. The dataset has no coding for the use of anti-adhesion

strategies as discussed earlier.

The dataset does not contain long-term mortality data. Therefore, patients in both groups are

assumed to be alive at three years or the end of the study period. It is therefore not possible

to assess the competing risk in each group. This may account in part for the reduced

reoperation for adhesions and hernia rates seen in the elderly population. Long term survival

is likely to be similar following laparoscopic and open colorectal cancer resections (Buunen

et al., 2009, Kuhry et al., 2008). Therefore the impact of an excess mortality in the

laparoscopic or open group is likely to be limited.

Restorative proctocolectomy

Overall pouch failure rates are consistent with those described in other studies suggesting that

the current data are valid (Gemlo et al., 1992, Setti Carraro et al., 1994). It was not feasible to

ascertain type of actual RPC that was performed (whether handsewn or stapled) nor other

potentially important variables such as severity of disease and steroid usage at the time of

surgery. Furthermore, it was not possible to evaluate clinical outcomes such as poor

functional outcome or other complications such as pouchitis or late-presenting pelvic sepsis.

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in Colorectal Surgery

Volume

Hospital provider volume in this study refers to the volume of surgery carried out in a

particular NHS Trust during the study period. An NHS Trust may contain multiple sites on

which colorectal surgery is performed. These are, however, overseen by the same surgical

team and patients should therefore have access to the same services across sites.

Furthermore, the consultant code used to differentiate between surgeons denotes an

individual consultant team under whose care a patient is operated upon. The consultant may

not carry out every single procedure but maintains responsibility for patient care. The grade

of surgeon performing the procedure is not known. Given the complexity of the surgery it is

likely that the vast majority of operations would be carried out by or under the direct

supervision of the responsible consultant. This is more likely in the elective setting.

Therefore, at a consultant team level only elective patients were included. The patients

named consultant surgeon is responsible for the care of the patient, and therefore must ensure

that clinicians of an appropriate level and competency undertake a patients management. If

the level of trainee supervision varied between different volume centres or teams then this

may impact on the providers outcome. However, it is not possible to investigate this from

this dataset.

The resection volume only includes a patients primary resection so may underestimate

slightly the consultant teams volume. Furthermore, only elective resections were included.

Consultant teams may have a variable emergency workload.

In the analysis of APE rate, only the primary operation was examined. We did not assess

how many patients who underwent an anterior resection were defunctioned or how many had

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intestinal continuity restored on a subsequent admission. It is important to recognise that for

some patients an APE is the most appropriate management strategy. Without more detailed

data on tumour stage and height, it is difficult to draw meaningful conclusions. However,

such wide variation in practice would not be expected through patient factors alone.

Conclusion

This thesis provides a comprehensive overview of general and subspecialist colorectal

surgery in England. We have demonstrated considerable variation in colorectal surgery and

defined new outcome measures from routinely collected datasets. Routinely collected data

offer an exciting potential data source for measuring performance and quality, as they are

cost effective and comprehensive. If data accuracy can be assured, measures such as

reoperation may be used alongside established measures of quality in a meaningful way to

benchmarking performance of providers. The methods described in this thesis can be applied

to a broad range of surgical specialties. Furthermore, the variation described in this thesis is

a starting point to develop quality improvement initiatives to reduce unwanted variation in

healthcare. Though volume has a role in determining outcome and reducing this variation in

some aspects of subspecialist colorectal surgery, it is by no means the panacea to improve

quality across all providers. Thought must be given to centralising services to the optimum

providers rather than indiscriminately increasing volume. Further work is required to

examine other outcome measures such as oncological factors and also to unpick the features

that make an excellent provider irrespective of whether they have a high or low volume

caseload. These positive aspects of an institution may then be replicated elsewhere to

improve quality of care for the majority of colorectal surgical patients.

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