Clinical Practice Guidelines in Pediatric and Newborn Medicine: Implications for Their Use in Practice T.

Allen Merritt, Donald Palmer, David A. Bergman and Patricia H. Shiono Pediatrics 1997;99;100-114 DOI: 10.1542/peds.99.1.100

The online version of this article, along with updated information and services, is located on the World Wide Web at: http://www.pediatrics.org/cgi/content/full/99/1/100

PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since 1948. PEDIATRICS is owned, published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois, 60007. Copyright 1997 by the American Academy of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.

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REVIEW ARTICLE Clinical Practice Guidelines in Pediatric and Newborn Medicine: Implications for Their Use in Practice
T. Allen Merritt, MD*; Donald Palmer, PhD; David A. Bergman, MD; and Patricia H. Shiono, PhD
ABSTRACT. Clinical practice guidelines are becoming pervasive in pediatrics and newborn medicine. They have spanned a wide range of primary care practice parameters from treating otitis media with effusion, to performing complex surgery for congenital heart disease, and management of respiratory distress syndrome and coordinating discharge from the neonatal intensive care unit. Administrators believe that using clinical practice parameters reduces health care costs, improves quality of care, and limits malpractice liability. Practice parameters and guidelines have grown in use because powerful intereststhird-party payers, insurers, and health maintenance organizations, as well as hospital administrators bent on reducing variable costs of care and contracting for capitated care champion their development, implementation, and monitoring. Economic credentialing of physicians with excessive variances without risk-adjusting for other than average patients is problematic and remains unchecked partly because of the fundamental characteristics of the evolving health care industry in which costs are more easily measured than quality. For highly autonomous physicians this standardization of medical decision making may represent a difficult transition into corporate practice by realigning traditional values of the doctor-patient relationship. However, because guidelines are almost certainly here to stay, pediatricians and neonatologists need to think critically about how their content and method of implementation, monitoring, and modification may influence medical teaching and decision making in the future. If guidelines are introduced primarily as a cost savings or containment tool that ignores the impact on the quality of care and restricts necessary care for infants and children, especially those with chronic illness or who are developmentally at risk, then neonatologists and pediatricians must be quick and determined to challenge the potentially damaging use of practice parameters or guidelines. Furthermore, there are many medicolegal implications of guideline implementation that may not favor physicians and leave to hospitals, insurers, and ultimately the courts decisions regarding evidence-based practice. In this review article, we pay special attention to the guidelines developed in newborn medicine. We discuss why and how guidelines are developed and critically evaluate the available evidence describing potential benefits and drawbacks of guidelines in general. There are legal implications to the implementation of guidelines, and guidelines may increase provider susceptibility to malpractice allegations. Neonatologists and pediatricians should critically analyze the following questions when guidelines are being developed: Are clinical practice parameters the most effective means to reduce the costs of health care, or improve the quality of health care services while reducing the need for and protecting physicians from malpractice suits? Or do clinical practice guidelines more closely resemble an audit system developed by health care organizations, insurers, and others including government-sponsored health care to appease powerful interestswith limited evidence for promise and perhaps potential negative cost, quality, and malpractice liability implications? In pediatric and newborn medicine there is limited evidence that guidelines have achieved the desired goals and further analysis of their process of care and the costs of implementation is warranted. Pediatrics 1997;99:100 114; practice guidelines.
ABBREVIATIONS. TQM, total quality management; CQI, continuous quality improvement; CPM, critical pathway methodologies; NICU, neonatal intensive care unit; ALOS-hospital, average length of stay for hospital days; ALOS-ICU, average length of stay for intensive care unit days; NeoMap, neonatal multidisciplinary action plan; DRG, diagnosis-related group; HMO, health maintenance organization.

From the *Division of Neonatology, Oregon Health Sciences University, Portland, Oregon and Visiting Scholar, Packard Foundation, Center for the Future of Children, Los Altos, California; the Graduate School of Management, Department of Sociology, and Center for Health Services Research in Primary Care, University of California, Davis; the Practice and Quality of Care, Lucile Salter Packard Childrens Hospital of Stanford, Palo Alto, California; and the Center for the Future of Children, David and Lucile Packard Foundation, Los Altos, California. Dr Bergman is the Vice President of the Practice and Quality of Care, Lucile Salter Packard Childrens Hospital of Stanford, Palo Alto, California. Received for publication Jul 10, 1996; accepted Sep 4, 1996. Reprint requests to (T.A.M.) Division of Neonatology, Department of Pediatrics, Oregon Health Sciences University, and St Charles Medical Center, 2500 NE Neff Rd, Bend, OR 97701 and Central Oregon Pediatric Associates, 2200 Professional Ct, Bend, OR 97701. PEDIATRICS (ISSN 0031 4005). Copyright 1997 by the American Academy of Pediatrics.

Economists have long believed that competition under perfect market conditions provides the best way to select the most efficient and effective way to organize the production of goods and the delivery of services in an industry.1 When perfect market conditions exist, firms that provide high quality at low cost have a competitive edge over those that are less efficient or whose quality leads to consumer dissatisfaction. However, sociologists who study organizations are increasingly recognizing that when market conditions are imperfect, and particularly when the costs and quality of goods and services are difficult to measure, competition is not effective in determining which forms activity takes and in assuring that low-cost, high-quality products (providers) survive and prosper while their high-cost, lower-quality alternatives fail.2 Under such circumstances, which are

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typical of most public sector industries (eg, education) and private sector industries that are experiencing significant restructuring, organizational leaders search their environments for likely models of effective organizing. Models used by successful organizations outside the industry, in particular by organizations in sectors that are pressuring the industry for change, are favored. Once adopted by leading organizations, imported models spread throughout the industry in a ritualistic way. That is, they acquire a taken for granted legitimacyshaping activities throughout the industry in the absence of (and sometimes, even in the face of negative) evidence regarding their efficacy from a cost or quality standpoint. This sort of process may be underway today in the health care industry, and the explosion of interest in clinical practice guidelines may be one consequence. In the 1980s, large industrial corporations as well as the national and state governments (principally third-party payers), motivated by the desire to limit the growth of health care expenditures, began to apply pressure that materialized in public policy initiatives and industry realignments.3,4 The result has been the evolution of a managed care system, in which health care services are provided on a capitated basis, that has progressively replaced the traditional fee-for-service structure, in which health care services are provided for direct reimbursement. The market for health care services under the evolving managed care system is far from perfect. Importantly, while health care researchers have made great efforts to develop measures of health care costs and quality, actual progress has been disappointingly slow. Thus, it is not surprising that as the health care reform movement gained momentum and political clout, health care delivery organizations began to import models of organizing production and service delivery from large industrial corporations one driving force behind health care reform. In particular, models for standardizing and formalizing service provision often incorporated as parts of Total Quality Management (TQM) and Continuous Quality Improvement (CQI) programs began to proliferate through health care provider organizations and the organizations accrediting health care institutions. Clinical practice guidelines are one means of standardizing and formalizing the practice of medicine that have been implemented in conjunction with TQM and CQI programs. Indeed, implementation of practice guidelines has been advocated as the method to improve cost management and to restrain the growth in aggregate health care expenditures.5 Payers are now using guidelines or derivative tools (including medical review, audit, and utilization review) in various ways to reduce health care expenditures. Quality improvement and protection against malpractice suits are typically cited as attendant benefits. And the proliferation of journal articles focused on optimal means of implementing practice guidelines (as opposed to analyzing their potential effects), suggests that guidelines may be acquiring a taken for granted legitimacy among health insurer and provider organizations, nursing administrators, govern-

mental agencies, practicing physicians, and medical researchers. In this article, we present an overview of clinical practice guidelines. Our presentation paints an overall picture of practice guidelines, while acknowledging variation in the authors, definitions, forms, and purposes of specific guidelines, and paying special attention to guidelines developed for perinatal-neonatal medicine. It also elaborates the accepted method for developing and implementing practice guidelines. We then present a comprehensive review of clinical practice guidelines developed for perinatal-neonatal medicine. Finally, we critically evaluate the potential benefits and drawbacks of clinical practice guidelines in general. Two questions motivate this analysis. Are clinical practice guidelines truly effective means to reduce the costs of health care, improve the quality of health services, and protect physicians from malpractice suits? Or do they more closely resemble an audit system adopted by health care organizations to appease powerful interests with limited promise and perhaps potential negative cost, quality, and malpractice liability implications?
A BRIEF OVERVIEW OF CLINICAL PRACTICE GUIDELINES The Authors and Definition of Clinical Practice Guidelines

Many groups have authored clinical practice guidelines. Guidelines have been developed by medical professional societies (eg, the American College of Physicians, the American Academy of Pediatrics), public sector agencies (eg, National Institutes of Health Office of Medical Applications of Research, Agency for Health Care Policy and Research, Centers for Disease Control and Prevention, United States Preventive Services Task Force, Health Care Financing Administration) and research organizations (RAND Corporation). Health care insurers (eg, Blue Shield, Foundation Health, Prudential HealthCare) have created, disseminated, and implemented practice guidelines for the providers with which they contract. Increasingly, health maintenance organizations (eg, Kaiser Permanente) and individual hospitals are developing or adapting their own guidelines, using local expertise and custom in codifying the practice policies and procedures used by their health care professionals. The Institute of Medicine defines clinical practice guidelines as systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.6,7 A variety of other terms have been used to denote guidelines in general, as well as to refer to specific varieties of guidelines. The American Medical Association,8 the American Academy of Neurology Quality Standards Subcommittee,9 and the American Academy of Pediatrics (C. T. Herrerias, personal communication, June 6, 1996) prefer the term practice parameters, and distinguish these statements from practice policies in their recommendations of care patterns, options, and standards to their membership. Brook and others from the
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RAND Corporation speak of appropriateness indicators.10 12 Coffey and co-workers have coined the terms care maps and critical pathways, which refer to protocols that stipulate the optimal sequencing and timing of interventions by physicians, nurses, and other disciplines for a particular diagnosis or procedure, designed to minimize delays and reduce resource utilization and to maximize the quality of care.12 Physician-directed diagnostic and therapeutic plans, commonly called critical pathway methodologies (CPM), have also been used in the hospital setting,13 often in conjunction with TQM and CQI programs.14,15 Finally, proprietary groups have copyrighted names such as clinical maps,16 care maps (NeoMaps or NeoPaths),17 and licensed the use of the treatment recipes to multiple institutions accompanied by multidisciplinary training workshops.
THE FOCUS OF PRACTICE GUIDELINES

Clinical practice guidelines vary in their specificity. Some are highly precise, such as those pertaining to childhood immunization schedules18 and the discharge of term and premature infants from hospital,19,20 while others are more general, such as those providing health supervision of infants, children, and adolescents.21,22 Guidelines also vary with respect to their content. Some focus on education, such as those written to help patients and their parents anticipate the progression of asthma.23 Others pertain to screening, diagnosis, and treatment, such as guidelines for laboratory assessment and therapeutic interventions associated with newborn screening programs, and identification of infants delivered of mothers with group B streptococcus colonization,24 or jaundiced term infants at 24 hours.25 Finally, guidelines differ in the audiences to which they are directed. Some (in particular, those written by professional associations) target physicians, while others (in particular, those developed by local institutions and proprietary groups) target nurses and other nonphysician health personnel. Guidelines have even been developed for consumers (patients or parents), such as those written for accident prevention, the treatment of otitis media with effusion in young children, and the management of pain in connection with operative or medical procedures, pediatric trauma, and cancer.26 28 Aside from immunization schedules and developmental health assessment, the major guidelines developed for pediatric patients have been directed toward injury prevention and emergency medical service planning,29 and the management of sickle cell anemia,30 chronic asthma,21 management of diarrhea31 and thrombophilia-related treatments.32
THE PURPOSE OF PRACTICE GUIDELINES

The most frequently stated purpose of clinical practice guidelines is the synthesis of evidence-based medical decision making to reduce inappropriate variation in clinical practice patterns. Wennberg and Gittlesohn33,34 reported as early as 1973 and again in 1990 that there are marked variations in the use of surgical procedures among hospital service areas
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and among physicians. Over the intervening years, a large body of evidence has confirmed that both patterns of care and patient outcomes vary among geographical areas and hospitals in ways not explainable by differences in case mix of the populations being served. In addition to large differences in utilization rates for surgical procedures, diagnostic services, and hospital admissions, there is also wide variation in hospital mortality for a number of medical conditions.35 Similar variations exist in neonatal medicine with respect to neonatal intensive care unit (NICU) outcomes. Indeed, data from two sources, the VermontOxford Neonatal Database36 and the National Institute of Child Health and Human Development Neonatal Research Network,37 document substantial variation among neonatal intensive care units in the use of a number of postnatal interventions and procedures, and in terms of outcomes. Methods of delivery room management, use of phototherapy, exchange transfusions, indwelling vascular catheters, and parenteral nutrition all exhibited considerable variation among National Institute of Child Health and Human Development Network centers even within 250-g birth weight categories. The persistence of such variation within relatively narrow birth weight categories suggests that differences in medical methods and outcomes among NICU centers is due in large part to differences in practice styles among units. On one hand, many daily practices in NICUs (the art of neonatology) have never been appropriately addressed using rigorous clinical trial methodology. On the other hand, there is a gap between advances in medical knowledge and the application of new information and technologies in provider settings. And this gap, which has widened rather than narrowed in recent years, is partly attributable to an overreliance on randomized clinical trials to continuously improve all aspects of neonatal care. The reduction of inappropriate practice variation through the implementation of clinical practice guidelines is sought for three reasons. First, and perhaps most important to clinicians, it may increase the quality of health care. Insofar as guidelines are based on the synthesis of science-based medicine, they may reduce the incidence of inappropriate (unnecessary and risky) care. In particular, guidelines may help block the premature introduction of new treatment methods or technologies that show promise but are ultimately of questionable efficacy. Further, as guidelines serve as a checklist reminding physicians of the elements of appropriate care, they may also improve the organization and completeness of clinical decision making. And insofar as guidelines are considered definitive of the standard of care in specific clinical areas, they promise to reduce physicians tendency to practice defensive medicine. Second, and also important to clinicians, the reduction of practice variation through the introduction of guidelines may reduce the incidence of medical malpractice suits. Because practice guidelines are premised on evidence-based medicine, the reduction of practice variation may reduce the incidence of inappro-

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priate care upon which malpractice suits are predicated. And insofar as guidelines are frequently interpreted by juries as definitive of the standard of care in a clinical area, they may serve as an affirmative defense against allegations of medical malpractice. Finally, and foremost in the minds of third-party payers, insurers, and provider organization administrators, the reduction of practice variation through the implementation of guidelines may reduce health care costs. If guidelines can reduce the provision of inappropriate care and the inefficient provision of appropriate care, they can eliminate the costs associated with both.
THE NORMATIVE MODEL OF GUIDELINE DEVELOPMENT

All advocates of clinical practice guidelines agree that guidelines should be based on reliable and reproducible evidence obtained from randomized controlled trials, or (in the absence of such evidence) on the judgments of noted experts in relevant disciplines. Further, guidelines should incorporate a statement regarding the strength of the scientific evidence and reasoning supporting them (including information on the quality of the evidence and research methods used in scientific experiments and explication of the logic underpinning expert opinion upon which guidelines are based). Most guideline proponents maintain that guidelines should be developed using a multidisciplinary approach, which includes all members of the health care team caring for patients, as well as the patients and families for whose ultimate benefit guidelines are presumably written. Indeed, the Institute of Medicine committees have stressed the importance of involving nonclinicians, such as representatives of patients and consumer groups, in some way. This latter review is especially important when (a) the understanding and compliance of patients with complex medical regimens is a significant factor in successful outcomes or (b) responsibility for day-to-day actions rests mostly with patients, or, in the case of technology-dependent childrentheir parents. Advocates also stipulate that guidelines should be clinically applicable. They should provide a clear description of the clinical state or condition for which care is being guided, as well as the patient population to which the guidelines apply. This should permit determination of how compelling a particular course of action is for a particular patient under a given clinical state or circumstance. Clinical practice guidelines should contain three basic elements: a desired patient outcome, short-term clinical measures and target values that correlate with this desired outcome, and specific approaches for achieving both the target values and the outcome. Insofar as guidelines are developed to improve quality and reduce costs, they should also offer projections of the relevant health outcomes and the costs of alternative courses of care. Further, most proponents recognize that although guidelines are geared to standardize care, they need to remain flexible enough to permit a degree of patient-specific departures from specified prevention,

diagnostic, and treatment protocols. They should identify predictable variances from the guideline based on historical reference data about frequency of selected adverse responses, complication rates, and other population-based morbidities. Several proponents maintain that multidisciplinary teams should modify national guidelines to take into account local conditions. This can increase both guideline applicability and physician buy-ina problem of growing concern.38 Finally, guidelines should be reviewed periodically to evaluate whether they are being appropriately and faithfully implemented, are having the desired effect on clinical outcomes, and are incorporating recent advances in medical knowledge. Documentation of procedures, patients being included, changing quality of evidence, and updated analyses are essential for guidelines to be meaningful. Because from the clinicians standpoint, the overriding purpose of guideline implementation is to improve the quality of health care, a broad range of patient-related outcomes and quality of life measures should be included in the evaluation of the effectiveness of guideline implementation. Survival, frequency of various morbidities, duration of hospitalization, resource utilizationall of which are important to physiciansare alone insufficient for evaluating the impact of guidelines on individual patients care. There must also be inclusion of the parents or patients perception of quality.
GUIDELINES IN PERINATAL AND NEONATAL MEDICINE

Although a few studies report cost reduction and quality improvement effects of clinical practice guidelines, most observers characterize available evidence on this score as inconclusive at best.39 Evaluation of available evidence is complicated by two aspects of existing research. First, studies vary considerably in their methodological rigor. Most problematic, many use pretest/posttest designs that do not adequately control for factors other than guideline implementation that may be responsible for observed effects. Second, existing studies vary considerably in the outcomes measured. Many focus primarily on measures related to costs (such as hospital length of stay) or physician behavior (such as compliance with prescribed preventative, diagnostic, or treatment regimes) that have ambiguous relationships to the quality of clinical outcomes.40,41 The neonatal resuscitation program of the the American Academy of Pediatrics/American Heart Association42 regarding guidelines for delivery room resuscitation is an example of guidelines based on current evidence-based medicine directed toward multiple providers to a specialized clinical situation immediate management of the infant at delivery, and has been shown to improve infant responses during delivery room management. Skilled application of these guidelines has led to improved resuscitation practices by those with certified skills. The article by the American Academy of Pediatrics Provisional Committee for Quality Improvement and Subcommittee on Hyperbilirubinemia entitled Practice Pa103

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rameter: Management of Hyperbilirubinemia in the Healthy Term Newborn25 received widespread publication and implementation, although these guidelines were the subject of several criticisms regarding their application. Table 1 summarizes multiple guidelines in perinatal-neonatal medicine and the organization(s) promulgating their use. Table 2 outlines a series of questions to be addressed when evaluating a guidelines process, content, and outcomes.
GUIDELINE FOR WHICH THERE IS EVIDENCE-BASED MEDICINE

One of the best studied guidelines for perinatalneonatal care evolved from a National Institutes of Health Consensus Development Conference, Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes.43 The resulting consensus statement provided scientific rationale for antenatal corticosteroids, citing evidence of decreased respiratory distress syndrome in infants of 29 to 34 weeks gestational age and reduction in intraventricular hemorrhage with improved survival among infants of 24 to 28 weeks gestational age. A more recent analysis has also supported the cost effectiveness of this antenatal therapy.44 In 1990, before this conference, use of corticosteroids for white low birth weight infants ranged from near 0% to 58% (mean 19%) among the 30 centers in the Vermont-Oxford Neonatal Network.45 In a follow-up study, Horbar et al46 found that the mean proportion use of prenatal glucocorticoids increased to 34% in 1993in part attributable to the findings in their database of improved outcomes among these infants and before the release of this conference report. After the release of these treatment recommendations, and an American College of Obstetricians and Gynecologists Committee Opinion,47 antenatal steroid use climbed even more dramatically. Similarly, selective management of women colonized with group B streptococci and their newborns were affected by expert opinion and provided an impetus for recently revised recommendations.24,48 Wirtschafter et al49,50 found that written guidelines and a focused educational program (ie, lectures and discussion regarding management techniques) produced an 8% improvement in the treatment of respiratory distress syndrome in infants and reduced variability in infant outcomes among several institutions in a health maintenance organization. It is not known whether (and if so, to what extent) the written guidelines (as compared with the educational program) were responsible for the improved patient outcomes. Several studies indicate that clinical practice guidelines can impact measures that are directly related to costs, such as length of stay in hospital. Turley et al13 reported evidence that clinical practice guidelines can reduce costs while preserving quality in the treatment of children with congenital heart disease. They contrasted 114 children treated at a University Medical Center with 172 children treated at Kaiser Permanente Medical Center in San Francisco, where a clinical practice guideline was in ef104

fect. All were operated on and treated by a single supervising cardiac surgeon. Preoperative clinical conditions using the New York Heart Association classification were matched, and associated conditions were reviewed for each matched pair. Average length of stay was compared both for hospital days (ALOS-hospital) and intensive care unit days (ALOSICU). ALOS-hospital stay was reduced by 43.8% using the physician-directed clinical pathway. ALOSICU was reduced by 37% (from 2.0 days in the university hospital to 1.25 at the Kaiser facility, where the pathway was used). The authors of this report stress that the critical pathways method was effective because the entire health care team, including parents, were actively involved in its use. Furthermore, they defined a transitional model of an interactive approach using a clinical nurse coordinator to insure adherence to all of the pathways elements and actively involving the family from preadmission to discharge. This radical outcome model attempted to anticipate both problems and opportunities to accelerate recovery by altering and upgrading the pathway design to conform to individual responses (placing a special emphasis on pain prevention using prophylactic analgesia). Outcome measures such as morbidity, readmission, and unscheduled clinic or emergency room visits were not different between the university hospital and Kaiser facility groups. Although methodological issues can be raised regarding differences in case-mix and risk severity, nonrandom allocation of patients, and differences in the time sequence among study participants, this report suggests that recovery can be hastened in a setting where a multidisciplinary health care team and the parents embrace clinical pathways and anticipate treatment issues. Neidig et al51 retrospectively evaluated 16 nonrandomly selected medical records of infants weighing 1.5 kg or more to discharge receiving neonatal intensive care (at a single center). Physician-delegated responsibilities leading to hospital discharge began 27% sooner and nursing care directed at discharge planning occurred 31% earlier when a pathway was used in care management, although there were delays in referral for discharge teaching by the neonatologists in some instances. Despite severe methodological problems (including small sample size taken from a single center), this study hints that earlier attention to details critical to informed discharge teaching of parents and conveyance of essential skills can be accelerated by a coordinated plan of care augmented by guidelines. Kurot and co-workers at the Schneiders Childrens Hospital found that NICU lengths of stay were significantly decreased in most gestational age categories, after their proprietary neoPath obtained from the Center for Case Management was implemented (M. C. Kurot, personal communication, March 24, 1996). However, because these nurse managers utilized a short-term pretest/posttest experimental design, it is not known whether, and to what extent the neoPath (as opposed to other interventions simultaneously instituted) were responsible for the observed improvement in this center. Further-

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TABLE 1. Professional Government Mandate Government Recommend Proprietary

Guidelines in Current Use by Neonatologists Institutional

ACOG ACOG ACOG AAP, AAFP CDC, AAP, ACOG AAP, BF, ACOG, AAFP AAP, ACOG, Bright Futures AAP, BF, ATA State laws or options State laws Most states Some states Wisconsin, Wyoming Some states Some states Some states Maine, New Hampshire Some states NIH, AHCPR, WHO All states All states Some states Two states Some states Some states Some states Maine, New Hampshire Some states State Laws USPHS expert panel NIH consensus CDC CDC CDC

Antenatal and/or Neonatal Therapy Maternal GBS detection Maternal anti D immunization Antenatal steroid treatment Maternal zidovudine treatment Neonatal zidovudine and PCP prophylaxis Gonnococal occular prophylaxis Maternal and neonatal GBS screening

Neonatal Screening Hemoglobinopathies PKU Hypothyroidism Galactosemia Cystic fibrosis Maple syrup urine disease Biotinidase deficiency Congenital adrenal hyperplasia Toxoplasmosis Tyrosinemia

School requirement Few state laws Few state laws

Guidelines for Treatment and Discharge Hepatitis B immunoglobulin prophylaxis Hepatitis B immunization DPT, OPV, HiB, and others Neonatal Resuscitation Program Guidelines for discharge of the healthy newborn Maternal stay after childbirth Guidelines for discharge Practice parameter for hyperbilirubinemia Vitamin K administration Screening for retinopathy of prematurity Screening for hearing among high-risk infants Health care supervision and anticipatory guidance ACOG, ACIP, AAP, ACP ACOG, ACIP, AAP, ACP AAP, CDC, Bright Futures AAP, AHA AAP, ACOG, Oregon Pediatric Society ACOG, AAP California Association of Neonatologists AAP AAP AAP ASHA, AAONS, Bright Futures AAP, Bright Futures

CDC

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AHCPR Various Various

NICU Care Paths, Maps, Guidelines By Gestational Age, Birth Weight, Disease Process, or for Early Discharge Normal Newborn

Many local guidelines Many local guidelines

Abbreviations: GBS, group B streptococcus; ACOG, American College of Obstetricians and Gynecologists; USPHS, United States Public Health Service; NIH, National Institutes of Health; CDC, Centers for Disease Control and Prevention; PCP, Pneumocystis carinii pneumonia; AAP, American Academy of Pediatrics; AAFP, American Academy of Family Physicians; BF, Bright Futures; AHCPR, Agency for Health Care Policy and Research; WHO, World Health Organization; PKU, phenylketonuria; ATA, American Thyroid Association; ACIP, Advisory Committee for Immunization Practices; ACP, American College of Physicians; DPT, diphtheria-tetanus-pertussis vaccine; OPV, oral polio vaccine; HiB, Haemophilus influenzae type b vaccine; AHA, American Heart Association; ASHA, American Speech-Language-Hearing Association; AAONS, American Academy of Otolaryngology Head and Neck Surgery; NICU, neonatal intensive care unit.

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TABLE 2. comes

Evaluation of Guideline Process, Content, and Out-

Assessing Clinical Practice Guidelines I. Are the guideline recommendations current and valid? A. Has the clinical problem been adequately defined, and have all the critical decisions and outcomes been clearly defined and specified? B. How was the guideline promoglated? What methods were used to identify, select,and systematically assess the clinical data in order to codify the appropriate evidence (metaanalysis of randomized clinical trials, historical practice, expert opinion)? C. Was an explicit and logical process used to consider the relative values of different endpoints when the guidelines are implemented? D. Do the guidelines incorporate the most current data and are they time-limited? E. Have the guidelines been evaluated prospectively, and what are the differences since implementation? II. What does the guideline recommend? A. Are practical, clinically relevant recommendations made? B. What are the anticipated results of the recommendations, and is the effect going to be similar for all patient groups when other risk-adjusted factors are considered? C. Have the outcomes been selected by peer review of the evidence for all patient groups or categories? D. How much uncertainty in terms of desirable and undesirable outcomes is there when the guidelines are implemented for different groups or categories of patients? III. Will implementation of the guideline actually improve the health of your patient? A. Do patients (or parents) understand the desired outcome for the proposed intervention? B. Are physicians, nurses, and others in the health care team committed to consistent implementation of the guideline? IV. Will value be added to patient care? A. Will quality be improved and costs lowered, or will cost considerations outweigh the perceived improvement in quality? B. What is the anticipated variance rate in implementation of the guideline and how will it be reported? C. How will these variance outcomes be compared with those adhering more rigidly to the guideline? V. Are there economic or legal imperatives imposed by the guidelines? A. In whose interest is the guideline primarily directed? Physicians, patients, quality of care, or cost of care? B. Will the guideline be asserted as an affirmative defense in the case of variances or an undesirable outcome? Adapted in part from Hayward RSA, Wilson MC, Tunis SR, et al. Users guides to the medical literature. JAMA. 1995;274:570 574.

periods, one before and the other after guideline introduction. Using her NeoMAP system, infants in DRG #386 had a reduction in hospital stay of 2 days while those in DRG #387 had an increase of 2.1 days. Neither difference was statistically significant. Infants in both DRG categories demonstrated improved neurobehavioral organization, with a reduction in the number of days until nippling of all feedings, but neither of these improvements were statistically significant. After discharge, infants in both DRG #386 and #387 who were managed using the NeoMAPs experienced a 2.8% increase in hospital readmission. Neither parents satisfaction with care nor nurses satisfaction with work was enhanced using this practice guideline. While considerable variation existed in both DRGs, there was no favorable impact on the cost of care. Those in DRG #386 experienced an increase in mean cost of care while those in DRG #387 experienced a decrease, but again neither difference was statistically significant. Thompson and Maringer53 recently reported that use of guidelines emphasizing nursing interventions that altered care plans for infants with apnea and bradycardia episodes, feeding intolerance, and advanced retinopathy of prematurity shortened NICU stay by 8% and reduced charges by 14%.
GUIDELINES FOR WHICH SUPPORT IS INCOMPLETE AND/OR CONTROVERSIAL

more, some neonatologists from this institution expressed an opinion that introduction of the guidelines had limited impact on better coordinating clinical care by physicians (K. King and D. Davidson, personal communication, March 23, 1996). Another similar proprietary clinical guideline was implemented with less success. Jones52 evaluated the implementation of a Neonatal Multidisciplinary Action Plan (NeoMAP) in Orlandos Florida Hospital in connection with infants in diagnosis-related groups (DRG) [DRG #386 extremely premature or respiratory distress and DRG #387: prematurity with major problems]. Her NeoMAP system was composed of gestational age-specific multidisciplinary care guidelines centered around the infant, nurse, and health care team. Jones contrasted outcomes in two 7-month
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In 1961 the American Academy of Pediatrics recommended the practice of vitamin K administration.54 Along with the Canadian Paediatric Society, the Fetus and Newborn Committee of the American Academy of Pediatrics reviewed their previous recommendation in 199355 because of concerns that intramuscular administration of vitamin K might be associated with childhood cancer.56,57 After rigorous reanalysis of multiple studies, Brousson and Klein recently reported that intramuscularly administered vitamin K is the most effective method of preventing hemorrhagic disease, although a three-dose oral regimen may be an acceptable alternative.58 The clinical and economic significance of jaundice in healthy term infants has also been a matter of great concern. A practice parameter promulgated by the American Academy of Pediatrics provides recommendations for the evaluation and treatment of neonatal hyperbilirubinemia in certain infants offering recommendations regarding evaluation and treatment.30 However, critics question the evidence cited in defense of the guidelines and express concern regarding potential misapplication. Unlike many other professional organization-derived guidelines, no formal pilot studies were undertaken to measure the impact of this guideline in particular, on early discharge, rates and duration of phototherapy, and frequency of kernicterus among infants with hyperbilirubinemia treated according to the recommendations in the guideline. Recently, managed care providers have begun to implement their own guidelines. Perhaps most wellknown are those pertaining to the curtailment of services to mothers and newbornsin particular, those mandating discharge at 24 hours or earlier

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when delivery occurs via the vaginal route. On the basis of limited clinical trials, early and earlier discharge guidelines have become a method of economically limiting benefits and services to mothers and their infants in situations where extensive home support and direct access to physicians after discharge are available. However, increased frequency of readmission to hospital for dehydration, hyperbilirubinemia, sepsis, and diminished implementation or shorter duration of breastfeeding led the American Academy of Pediatrics and several state legislatures to develop guidelines and laws ensuring sufficient hospital stays for both women and their babies after vaginal delivery or cesarean section,20 and recent federal law has also put an end to drive-through deliveries. Efforts by managed care providers to reduce lengths of stay for premature infants have also gained momentum after an initial small randomized trial of early discharge with intense follow-up.59 In this model there was extensive home follow-up of discharged premature infants with trained neonatal nurses; however, the economic interests of insurers and health care planners were motivating factors not the health care interests of infants and their parents. In California, the presumed economically-driven movement by insurers to develop guidelines that permit the discharge of premature infants before their stability or before the time needed for parenting education (or to deny payment for the last several days of a premature infants hospitalization when these activities were a focus), led the California Association of Neonatologists to develop professional guidelines for the appropriate discharge of premature infants and to file them with appropriate regulatory agencies.19
OTHER WIDELY ACCEPTED GUIDELINES IN USE

parameters, maps, or paths directing patient care throughout the NICU stay have not been shown either improve health care quality or reduce the costs of care. Therefore, there is insufficient evidence to warrant the current fervor for their widespread adoption, and the diversion of resources for their more universal application.
EFFICIENCY AND EFFECTIVENESS ISSUES The Balance Between Cost Reduction and Quality Improvement

Mandated screening programs are common in the United States despite the relative rarity of conditions being screened (hypothyroidism, metabolic disorders, hemoglobinopathies, etc). Some recommendations (neonatal ocular prophylaxis, etc) are widely believed to have significantly reduced the risk for neonatal infectious disease.60 62 Newer recommendations of zidovudine and prophylaxis agains Pneumocystis carinii pneumonia has been shown to improve the health of human immunodeficiency virus-exposed infants.63 65 These recommendations and the treatment of infants delivered of mothers with hepatitis B with hepatitis B immunoglobulin and vaccination and other immunizations are widely believed to have significantly reduced the risk for serious pediatric infectious diseases. Overall, data are sparse and rather unconvincing regarding the implementation of multidisciplinary practice guidelines in the NICU; guidelines based on considerable evidence for the prevention and treatment of infectious disease in mothers and their infants and hemorrhagic disease of the newborn, screening metabolic disease, hypothyroidism, hemoglobinopathies, vision and hearing impairment have dramatically improved infant outcomes and should be embraced by all. However, evidence that practice

In TQM and CQI theory, the minimization of costs and maximization of quality are pursued simultaneously. Each possible configuration of a health care products cost and quality is definitive of the different values it can represent to consumers. In a free market with full information, competition selects the optimal combination of quality and cost in the minds of consumersthe optimal combination being, by definition, the health care product of greatest value. However, several features of the managed care environment may cause cost reduction considerations to dominate quality improvement concerns in the crafting and implementation of clinical practice guidelines to an extent not anticipated and endorsed by the major health care industry constituentsthe consumers. First, all of those involved in their environment (insurers, provider organizations, third-party payers, and ultimately consumers) find it difficult to measure the cost and quality of health care services. Thus, market processes can not guarantee that the optimal combination of cost and quality are produced for health care consumers. Freed from specific market imperatives, health care industry decision makers exercise substantial discretion in crafting the balance of cost and quality in delivered services. Because in many cases cost reduction can only occur at the expense of quality, the problem is an ethical one. The fact that, in the era of managed care, key decision makers are frequently nonphysicians third-party payers, insurers, or middle-level managers in provider organizationsincreases the chances that cost considerations will outweigh quality concerns. Nonphysicians lack the work experience and professional training that instill in physicians the overriding importance of patient health interests in medical decision making.66 Second, although it is difficult to measure both the cost and quality of health care services, it is easier to measure costs than quality. This may generate topdown pressure to restrain costs at the expense of quality. Managers of insurance companies and provider organizations who are responsible for their organizations strategic focus may emphasize cost reduction because winning in the marketplace primarily hinges on the costs at which they deliver their products. Indeed, this appears to be the case even in the public sector, where pressures to reduce costs come from bureaucratic rather than market sources. Grogan et al67 found that Medicare carriers exclusively used guidelines to identify and punish providers who provided overly sufficient care, to motivate
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providers in general to lower costs. Seldom, if ever, did carriers use guidelines to identify providers who provided insufficient care to motivate them to deliver higher quality care. Emerging data suggest that private sector insurers are primarily interested in managing the cost rather than quality of care, as major contracts have been awarded to providers with lower bids who had poor track records for quality.68 The relative ease with which costs can be measured also generates an internal preoccupation with cost reduction, even among those further down the organizational hierarchy who are insulated from direct market pressures. It is axiomatic in organizational theory that subunits tend to monitor and orient behavior around those outcomes that are easiest to measure.69 It has been observed that this can lead supervisors to reward subordinate behaviors that violate organizational goals, when the measurable outcomes upon which rewards and punishments are contingent are unrelated to or at odds with goal attainment.70 If this is the case in the health care sector, we would expect to find that provider organizations discipline and release physicians for failure to meet cost standards more frequently than they do for failure to meet quality standards. Recent experience and some impressionistic evidence suggests that this may be the case.71
THE PROSPECTS FOR COST REDUCTION OR QUALITY IMPROVEMENT

There is reason to believe that the practice of medicine does not readily lend itself to the degree of codification embodied in some clinical practice guidelines. In the language of organizational sociology, the health care industry is characterized by nonuniform inputs (ie, patients with nominally similar conditions differing from one another in important ways) and nonroutine technologies (ie, knowledge about appropriate medical practice is still very much in the process of development and refinement). It is widely recognized that two patients with the same specific diagnosis (eg, assigned to the same DRG) may possess very different multiple associated risk factors, which can be expected to result in variations in response to therapy. The fact that the core technologies of medicine are not routine are suggested by the fact that clinical practice guidelines focused on the same subject (eg, the release of newborns from the hospital) but written by different groups (eg, professional associations and provider organizations) often conflict with one another. For example, previously the guidelines issued for the management of pregnant women in whom group B streptococci have been isolated in the latter phases of pregnancy differ depending on whether the clinician follows recommendations from American College of Obstetrics and Gynecology or the American Academy of Pediatrics (these guidelines have been revised and a joint guideline released by the Centers for Disease Control and Prevention, May 31, 1996). Similarly, there are two guidelines for the treatment of depression, one by the American Psychiatric Association and one by the Agency for Health Care Policy and
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Research of the United States Public Health Service that have areas of contradiction. Also in the language of organizational sociology, clinical guidelines standardize and formalize medical practice. That is, they specify in writing detailed procedures for preventing, diagnosing, and treating specific patient conditions. However, organizational theory recognizes that standardization and formalization undermine performance when inputs are nonuniform and technologies are nonroutine.72 Inappropriate standardization and formalization can amplify costs and undercut quality across the board, as organizational participants (in this case physicians) devote time and energy to comply with preset procedures that are not appropriate for inputs (in this case, patients) whose characteristics depart from those of the modal case (in this case, the average patient) for which standardized and formalized procedures (in this case, clinical practice guidelines) are typically written. Thus, many physicians indicate that they believe that practice guidelines will actually increase rather than reduce costs.73 Indeed, like any innovation, the development and implementation of clinical practice guidelines (in some cases, orchestrated by expensive consulting firms) alone is likely to be a costly process. Interestingly, at least one observer has puzzled out loud about the reasons why TQM and CQI techniques such as clinical practice guidelines have not been as successful in medicine as they have been in the industrial setting.74 Perhaps this is because the industrial settings in which TQM and CQI have been so successfully implemented conform more closely than the health care setting to the uniform inputs/routine technology preconditions. There are several ways in which the proponents of clinical practice guidelines have implicitly responded to this limitation on guideline effectiveness. On one hand, they advocate restricting guidelines to those conditions for which patient variation is small and inconsequential and about which medical knowledge is relatively complete. However, in practice, guidelines have been written in connection with conditions where one and in some cases both conditions fail to be met.75 In particular, numerous guidelines have been criticized for having been written in the absence of evidence from randomized clinical trials.76 On the other hand, some guideline proponents advocate writing even more detailed guidelines (ie, even more standardized and formalized procedures) to take into account the inherent variation in medical inputs and uncertainties of medical technologies and to provide timelines and precedents for all activities.77 But as Perrow78 has documented in connection with the nuclear power industry, escalating attempts to standardize and formalize organizational processes in sectors that have nonuniform inputs and nonroutine technologies can lead to catastrophic failures. Under these circumstances, preoccupation with adherence to complex preprogrammed if/then decision trees (in this case, complex clinical guidelines) can divert attention from salient signals in the environment.

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Some clinical practice guideline proponents have advocated building into guidelines flexibility to accommodate patient input variation and medical technology uncertainties. However, there is reason to worry that such flexibility, even if written into guidelines, will not be implemented. This is because guidelines are often implemented in inflexible ways. Increasingly, physicians are hired, compensated, disciplined, and terminated by provider organizations on the basis of their adherence to guidelines. Adherence may be monitored directly. More often, though, it is measured indirectly by comparing a physicians resource utilization rate (eg, number of tests conducted, patients referred, procedures performed) with the utilization rate of a comparison group of physicians who used the guideline.79 However, utilization reviews seldom take into account a physicians case-mix (ie, their guideline conformity and resource utilization scores are not risk-adjusted). Thus, physicians may feel compelled to treat all their patients as if they are average, even though the particular adverse case-mix requires otherwise. This constraint may be particularly pernicious in situations where physicians are informed midway through a review period of their failure to keep pace with utilization targets. It must take a particularly scrupulous and principled physician to maintain what he/she believes are appropriate quality standards in the face of evidence that they are on the path to censure, economic credentialing, and exclusion from provider groups for implied resource overutilization.80
LEGAL ISSUES

The Legal Status of Clinical Practice Guidelines Physician Licensure and the Corporate Practice Doctrine

Clinical practice guidelines may run afoul of physician licensure criteria and the corporate practice doctrine.85 In all states, only physicians are licensed to practice medicine. Insurers as well as provider organizations and their subunits (eg, hospitals) are ineligible for such licensure, insofar as they are not natural persons and fail to meet the statutory requirements of a medical degree, good character, and passage of a licensing examination.86 Further, in all states except in Nebraska and Missouri, the corporate practice doctrine stipulates that a licensed physician may not accept direction or instructions regarding the diagnosis or treatment of ailments from a corporation or an individual who is not licensed to practice medicine.87,88 Thus, physician liscensure rules and the corporate practice doctrine may be violated in cases where a corporation (eg, an insurer, health maintenance organization (HMO), or other provider organization) or its agents (eg, lay administrators) develop and enforce clinical practice guidelines that specify procedures and treatment paradigms that must be followed by a physician. For example, the restriction of treatment options offered patients because of membership in one or another provider groupsuch as that documented in recent testimonials and lay press accounts89may violate the corporate practice doctrine.
Tortious Interference

A variety of legal issues arise from the use of clinical practice guidelines. The tendency of provider organizations is to view guidelines as binding directives and the courts interpret guidelines as standards of care. Many practice guideline authors (especially physician-authors) view guidelines as decision aides to help physicians apply existing general medical knowledge for the prevention, diagnosis, and treatment of conditions for particular patients in specific circumstances. This accords with the traditional model of health care, in which physicians are granted autonomy in making treatment decisions about individual patients. However, third-party payers, insurers, and provider organizations may implement guidelines as if they are rules, which physicians must follow to gain or retain employment and to obtain favorable malpractice insurance rates.81 Further, courts may interpret guidelines as definitive of the standard of care in a clinical area, which is the yardstick against which a physicians practice is judged when establishing his/her culpability in malpractice suits. Legal issues related to clinical practice guidelines have recently been comprehensively reviewed82 84 and this review draws heavily from these articles. Issues of the legal status of various guidelines and the liabilities posed by their use (or nonuse) and their use in affirmative defense in malpractice allegations are reviewed.

Clinical practice guidelines may also violate the tortious interference doctrine. Any individual or corporation interfering in a contractual relationship may be liable for damages under the tortious interference doctrine. The tortious interference doctrine has been applied in the health care sector when the actions of a corporation, such as a hospital or insurer, directly interfered in the physician-patient relationship.90
Economic Credentialing

Finally, it may be illegal to use adherence to clinical practice guidelines as a basis for physician credentialing. For example, a group of physicians won a restraining order against a hospital that suspended their privileges for inappropriate use of lung scans, and excessive use of diagnostic tests, pacemakers, and pulmonary angiograms, which resulted in hospitalizations 51% longer and 31% more costly than those of other staff members.91 Although the appellate court reversed this decision, its justification focused on the quality of care delivered by the doctors and not the cost of that care. It is unclear if denying a physician privileges based primarily on economic reasons would be a violation of hospital bylaws. If so, fair hearing proceedings would permit the physician to justify his/her choice of testing and treatments. Of course, the likelihood that credentialing on the basis of deviation from guidelines would be judged illegal will hinge largely on whether or not clinical practice guidelines can be successfully characterized as quality improvement as opposed to cost containment tools.
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CLINICAL PRACTICE GUIDELINES AND PROVIDER ORGANIZATION LIABILITY

As provider organizations, such as hospitals, use guidelines as managerial tools to influence the behavior of previously autonomous physicians, their exposure to liability may increase. First, provider organizations that actively develop and implement guidelines that lead to patient injury or to adverse patient outcomes may be held liable for such injuries and adverse outcomes.92 Institutions that assume the physicians role by promulgating a plan of care may be held to the same standard as a practicing physician (and if so, they will be expected to exercise the same degree of care and skill as would be expected of a qualified practitioner). If a clinical practice guideline is interpreted as promulgating a plan of care and this plan of care is deficientin particular, if the guideline does not incorporate up-to-date scientific informationthe adopting organization can be found guilty for negligently instituting a deficient standard. A related liability issue may arise when hospitals or parent organizations promulgate guidelines in an attempt to control costs by regulating the decisions of their medical staff. If hospitals or parent organizations provide inducements or penalties that unduly influence physician decision making and medical judgments, they can be held either solely or jointly liable in a malpractice case.93,94 Second, provider organizations may be held liable for inadequately enforcing an acceptable standard. As indicated above, courts may consider practice guidelines definitive of the standards of care in the areas to which they pertain. In particular, juries may not have the expertise to distinguish a mere quality tool from a professional standard of care, even though written disclaimers to the contrary are often incorporated in guidelines. Because hospitals have a duty to their patients to monitor physician competence, plaintiffs could argue that physician noncompliance with critical guidelines put the hospital on notice of quality concerns regarding the specific physician. If a hospital fails to monitor the data generated and fails to correct quality inadequacies indicated by the data, the hospital may be found liable under the corporate negligence doctrine.95 Finally, clinical practice guidelines may increase the likelihood that hospitals and more encompassing parent organizations are held liable for the negligent acts of physicians, when they result in a reasonable appearance that complying physicians are agents of these organization. In todays managed care environment, in which medical school faculty become affiliated with hospital entities, and other community practitioners and clinics join to form larger health systems, it is increasingly likely that patients will come to believe that physicians are acting as agents or employees of the hospitals and the more encompassing parent organizations. When this is the case, the court may judge the hospital and/or health system to be vicariously liable for any negligent acts of the physicians associated with them. In Kashishian v Port96 the court held that a hospital may be vicariously liable for the negligent acts of physicians who
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are independent contractors. The court identified three elements that must be present to find apparent agency: (a) the hospital must have acted in a manner that would lead a reasonable person to believe that the negligent physician was an agent of the hospital; (b) the hospital must have had knowledge of and acquiesced to any acts of the physician that created the appearance of authority; and (c) the plaintiff must have acted in reliance on the physicians or the hospitals conduct consistent with ordinary care and prudence by following the recommendations of the medical staff and/or medical center personnel and/or health system employee. Increasingly, practice guidelines are developed by teams of administrators and nurses in association with selected hospital medical staff, printed on forms with hospital names and logos, entered into the medical record, and disseminated to patients to serve educational purposes and to increase patient awareness of expected outcomes on a day-to-day basis. The dissemination of such guidelines, especially if they depict a patient-specific plan of care, may lead patients to reasonably believe that their physicians are acting as agents of the hospital or other provider organization with apparent authority. And if guideline-based medical care is found deficient, the hospitals with which offending physicians are associated may be found liable.
CLINICAL PRACTICE GUIDELINES AND PHYSICIAN MALPRACTICE LIABILITY

Theoretically, clinical practice guidelines have the potential to reduce the practice of defensive medicine, lower the incidence of medical negligence, offer fair arbitration, and thus help to contain the costs of medical malpractice. Insofar as practice guidelines improve the quality of clinical decision making and improve outcomes, they should reduce the number of dissatisfied patients or parents interested in pressing malpractice suits. Further, insofar as guidelines are definitive of the standard of care, they make more explicit the criteria physicians must meet to satisfy the court regarding appropriate practice. Under common law in most states, a practice parameter may be introduced as evidence of the standard of care, provided that it is relevant to the clinical issues involved and meets certain indicators of reliability.97,98 Two states, Maine and Minnesota, offer a safe haven for physicians adhering to approved guidelines of their use as inculpatory evidence. Thus, adherence to relevant and reliable guidelines should signal compliance with accepted standards of care and should constitute important exculpatory evidence for defendants in malpractice suits. Hence, guidelines may improve the fairness and predictability of malpractice litigation by reducing the variability in standards of care determined by courts. Adherence to clinical practice guidelines should be of greatest exculpatory value in connection with conditions and treatments where standards of care fluctuate rapidly over time, such as the group B streptococci recommendations, childhood immunization, childhood injury prevention, and management of hyperbilirubinemia. Finally, insofar as there should

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be fewer frivolous malpractice suits filed, and reduced risk of inappropriate judgments, the costs associated with malpractice litigation should decline. However, even when adherence to guidelines is used as exculpatory evidence, it may not be decisive for two reasons. Courts may not consider reliable guidelines to be definitive of the standard of care in particular circumstances. Because courts tend to be resource-expansive, this is most likely to occur in connection with guidelines that were written largely to curtail costs and that do not include all valid treatment options. For example, in Wickline v State of California99 a patient sued the payer for premature discharge from hospital, which led to the amputation of the patients leg. The court found that the standard of care was met, but issued a strong policy statement that physicians bear the responsibility of medical treatment decisions; the standard of care must be based on medical judgment, not on economic decisions by third-party payers. The burden of delivering appropriate care, even if it requires departure from existing clinical practice guidelines, may be a heavy one to bear. Physicians are increasingly rewarded or punished (sometimes economically credentialed or decredentialed) based on their adherence to guidelines. In some cases, departure from HMO guidelines suggesting limits on care may result in forfeiture of compensation altogether (eg, when a patients plan does not cover a particular type of treatment) such as presented by the Employee Retirement Income Security Act (ERISA) which preemepts states from regulating ERISA-governed HMO plans, and prevent patients from obtaining relief in instances of negligent care practices by corporate decisions to limit care. Second, the court may even disregard relevant and reliable guidelines motivated by quality considerations, if it deems them deficient in light of current medical knowledge. Courts tend to be retrospective, appearing in some cases to penalize physicians for not following treatments which, only with the benefit of hindsight, could have avoided injury to the patient. For example, the court expanded the acceptable standard of care on the basis that the test for detecting glaucoma was cheap, safe, and accuratenot withstanding that the customary practice was not to test patients younger than 40.100 Of course, if adherence to clinical guidelines can help immunize physicians from malpractice liability, failure to comply with guidelines can expose them to liability. Indeed, there is evidence that practice guidelines are used more for inculpatory purposes (by plaintiffs) than they are used for exculpatory purposes by defendants physicians. Hyams et al101 surveyed two malpractice insurance companies and 960 randomly selected malpractice attorneys to ascertain the frequency and nature of the use of practice guidelines in litigation. Seventeen of 259 claims between 1990 and 1992 involved practice guidelines; 12 of which were used to implicate the defendant physicians) and only 4 of which were used as exculpatory evidence for the defendant physicians. Malpractice attorneys report that once a suit is initiated, practice guidelines are more likely to be used for

inculpatory (54%) than for exculpatory (23%) purposes, and 30.9% reported that clinical guidelines influenced their decision to bring at least one lawsuit during the previous year. Thus, physicians may find themselves between a legal rock and a hard place. On the one hand, they may feel compelled to depart from existing guidelines, for fear of being judged by the court to have not met the standard of care for a particular patient in a particular circumstance. On the other hand, they may feel compelled to comply with existing guidelines, even when they believe the guidelines are inappropriate for a particular patient in a particular circumstance, for fear of being judged to have failed to meet the standard of care for the average patient. Whether it is legally wise for physicians to adhere to or depart from existing clinical practice guidelines depends on whether courts can be expected to rule that guidelines are definitive of the standard of care. And whether courts will, in fact, rule that practice guidelines are definitive of the standard of care in particular areas is still a matter of some uncertainty. At the moment, though, physicians would do well to remain wary of insurers versions of guidelines, which are primarily focused on cost reduction under the guise of quality improvement. As summarized by Brennan, guidelines are not working in the physicians favor . . . they are more often used against physicians than in their defense.102 And, as summarized by Garnick et al103 to think . . . that inserting practice guidelines into the existing litigation process will generate large savings in the near future is overly optimistic.
CONCLUSION

Clinical practice guidelines are becoming pervasive in medical practice, from the primary care pediatrician treating otitis media, to the cardiac surgeon repairing congenital heart disease. This is largely because powerful interests bent on reducing the cost of health carethird-party payers (ie, the government and large industrial corporations), insurers, health maintenance organizations, and hospital administrators champion their development and implementation. And the interests of these powerful actors are partly a product of fundamental characteristics of the evolving health care industry, in which costs are more easily measured than quality, and the bottom line has become the holy grail. HMO administrators and others have embraced the industrization of health care providers and through the use of practice guidelines with little empirical evidence of quality enhancement or significant cost savings without substantial impairment in patient wellbeing. For traditionally highly autonomous physicians, this standardization of medical decision making may be a bitter pill to swallow. However, practice guidelines are almost certainly here to staya natural concomitant of the transition to corporate medicine. Thus, physicians need to move beyond blanket rejection of practice guidelines (as threats to their autonomy) and begin to think critically about how the content and method of implementation of guidelines
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may influence medical practice in the future. In this article, we raise questions about the reality, as opposed to the abstract promise, of clinical practice guidelines. Current evidence supports the relative emphasis clinical practice guidelines place on cost reduction as opposed to quality improvement. We believe that the promise guidelines hold for the reduction of costs and the improvement of quality irrespective of the relative emphasis they place on one rather than the other objective requires considerably more study using valid methodologies before they are embraced by the neonatology community. Finally, we point out possible legal barriers to guideline implementation and indicate how guidelines may actually increase provider organization and physician susceptibility to medical malpractice suits. Like many observers, we think that clinical practice guidelines can fulfill their promise to reduce health care costs, improve quality, and limit medical malpractice liabilityassuming they are (1) developed primarily as a tool for providing complete preventative care and more thoughtful and precise medical decision making, (2) based on scientifically rigorous clinical studies and the consensus of expert opinion when definitive evidence from clinical trials is lacking, and (3) implemented as general and flexible suggestions about appropriate practice styles. More specific suggestions can and have been made regarding means to sidestep the legal pitfalls that guidelines present; however, adherence to clinical guidelines could eliminate some of the incentives for physicians to practice using decision making that reduces the risk of malpractice liability. Unfortunately, in many cases, guidelines are implemented primarily as mechanisms to reduce costs (in particular, by limiting therapeutic choice), without substantial supportive evidence justifying the protocols they stipulate. Further, in many cases, guideline compliance is imposed on physicians and other health care providers backed up by potent economic sanctions. Practice guidelines developed and implemented in this way may be problematic from a quality improvement, malpractice liability limiting, and even a cost containment standpoint. Further, ultimately, guidelines ask (indeed, in some cases require) physicians to capitulate in the erosion of their professional autonomy as well as to surrender their role as patient advocateto the end of becoming faithful health care provider organization employees. For these reasons, and perhaps most importantly to safeguard patient welfare, critical analysis of clinical practice guidelines seems in order. The costs of developing, specifiying, disseminating, evaluating, and continuously updating widely accepted guidelines for a myriad diseases and processes in perinatal-neonatal medicine will be costly and present data may not support this investment. Physicians should view practice guidelines in the same way that they view new drugs or treatment modalities by demanding evidence of efficacy and cost savings before widespread implementation. Furthermore, neonatologists must be vigilant of off-label uses of guidelines and vigorously prosecute offenders when such
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abuses materialize. When guidelines are introduced primarily as economic or care restrictive tools for infants or children, neonatologists and pediatricians must be quick and determined to challenge this pernicious use. Guidelines should be carefully scrutinized for their clinical efficacy before they are disseminated, implemented, and embraced. And policymakers need our input and direction regarding the appropriate scope and content of practice guidelinesin particular, as they are incorporated as parts of TQM and CQI programs. Although clinical practice guidelines possess substantial promise for improving the efficiency and effectiveness of health care service provisions, they also pose a number of clear and present dangers to which neonatologists and pediatricians must respond.
ACKNOWLEDGMENTS
Appreciation is expressed to Lucy Carter, JD, at the Packard Foundation for review of the legal sections. Lynette FannonLamkin was especially helpful in obtaining references and Lexis citations used in preparing this manuscript. Discussions with Richard Behrman, MD, and Jeffrey Horbar, MD, regarding the overall impact of guidelines were very enlightening, as were discussions with James Hanson, MD, consultant to the Agency for Health Care Policy and Research, and Howard Bauchner, MD, of Boston University School of Medicine.

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ENTRUSTED BY NATURE (IN BRITAIN)

A mother who refused to let her dying son have a liver transplant won a landmark battle for parents rights yesterday. Three appeal court judges ruled that the care of children was entrusted by nature to parents rather than doctors. They said the law could not enforce an operation for the 15-month-old boy, even though doctors say he may live only a short time without it.

Harding L. Parents win right to let son die. Daily Mail October 25, 1996.

Submitted by Student

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Clinical Practice Guidelines in Pediatric and Newborn Medicine: Implications for Their Use in Practice T. Allen Merritt, Donald Palmer, David A. Bergman and Patricia H. Shiono Pediatrics 1997;99;100-114 DOI: 10.1542/peds.99.1.100
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