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3. Methodology
3.1 Study site
The study was conducted in the General Medicine units of Kasturba Hospital,
Manipal

3.2 Study design

This was a Cross-sectional Observational study carried out among diabetic
patients admitted in the medicine wards of Kasturba Hospital.

3.3 Study duration

For prescription pattern data were collected from 2008 to 2010 (three years)

3.4 Sample size

For prescription pattern: Alternative diabetic patients admitted in medicine
wards during 2008 to 2010 were selected for the study.

For cost of illness:

Based on sample size calculation using formulae

Z2 P 1 P
n
Where, n=sample size d2
Z= 1.96(From Z distribution Table at =5% level)
P= Diabetes patient in medicine wards/ total admission X 100
d=0.05(5%)

Based on the estimation, sample size arrived for cost of illness assessment
was 100 and 116 patients data was analyzed to make up for any data
incompleteness in case profiles for both diabetic cases and as well as
diabetics with complications.

3.5 Ethical approval

Ethical approval was obtained from the Institutional Ethics Committee (IEC) of
Kasturba Hospital, Manipal. (Appendix-I)
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3.6 Study criteria

The study group consisted of all the Type 2 Diabetes Mellitus patients
admitted in various Medicine Units during the year 2008-2010 and who met
the following criteria.

Inclusion criteria
Patients admitted in the Medicine Units who are diagnosed to have
Type 2 Diabetes irrespective of age and sex.
Type 2 diabetic patients with and without complications
Type 2 diabetic patients with other comorbidities

Exclusion Criteria
Patients who were excluded from the study were:
Diabetic patients who were admitted in the wards other than
medicine department.
Patients who were discharged against medical advice.
Patients data were insufficient

3.7 Sources of data

1. Patient case/medical record
2. Hospital drug list(formulary)
3. Hospital billing data
4. Daily admission list maintained by medical records department

Patient case records: This includes the following information

Patient demographics
Patient history notes.
Drug treatment charts.
Report of Diagnostic and Interventional procedures.
Laboratory investigations report.
Discharge summary.
Progress chart.
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3.8 Study Material

3.8.1 Patient Data Collection Form:
In order to record necessary data from the sources mentioned above, a
separate Patient Data Collection Form was designed based on the data
required for the study. It was designed in order to record the treatment
pattern, which includes; Demography of patient, Date of admission and
discharge, Complaints on admission, Medical and Medication history,
Diagnosis, Investigation report and Interventional procedure, Physical
findings, Treatment details, Progress Report, Discharge Medication
(Appendix-II).

3.8.2 Cost of Illness(COI) questionnaire:

To collect the data for COI questionnaire was prepared by referring text books
and articles to document relevant cost involved in the treatment of the diabetic
patients. It includes demographic of the patients like age, sex, educational
information and occupation. It also contains direct medical cost like cost of
drugs, investigations, consultation, interventions and hospitalization and direct
nonmedical cost like transportation and days lost from work (Appendix-III).

3.9 Operational Modality

3.9.1Collection of Data:
a) For prescription pattern
Kasturba Hospital is multidisciplinary tertiary care hospital. There are seven
units in the medicine department. Patients admitted (alternative patients) in
each of the unit with type 2 diabetes as per study criteria, are included in the
study. Patient data is collected prospectively over a period of three years
(2008-2010). For data collection each patients data were reviewed and Data
were documented in the CRF form prepared for study purpose. These
diabetic patients are followed up from day of admission to day of discharge.
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1. Collected data for type 2 diabetic patients were evaluated using SPSS
version 20 as follows:
Age group wise distribution of the patients.
Gender wise distribution of the patients.
Various characteristics of the diabetic patients like average age of the
patients, number of days admission, history of diabetes , total number
of drugs during discharge, total number of diabetic drugs at discharge
and total number of hypertensive drugs at discharge
Diabetic patients are classified as only diabetic, diabetic with
hypertensive, diabetic with hyperlipidemia and diabetic with
hypertension and hyperlipidemia together for the purpose of analyzing
prescription pattern
Status of various complications of diabetis with its subclassifications
Status of comorbidities present along with type 2 diabetes
Status of various laboratory investigations during admission time like
blood sugar levels, glycatedHb levels, lipid profile and renal function
tests.
Study the prescription pattern of antidiabetic like monotherapy, dual
therapy, three drug combinations, four drug combinations and five drug
combinations and various type of drug combinations
Prescription pattern of individual class of drugs used in the treatment of
the type 2 diabetic patients.
Trends in prescription of antidaibeticdrugs .
2. Type 2 diabetes with Hypertension:
From above data, data relevant for diabetes with hypertensive patients was
separated and evaluated following parameters using SPSS 20 Version
Prevalence of hypertension in type 2 diabetes
Age group wise distribution of diabetes patients with hypertension
Gender wise distribution of diabetes patients with hypertension
Status of duration of hypertension history of the patients
Status of blood pressure as per JNCVII classification during admission
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Prescription pattern of anti-hypertensives in type 2 diabetic patients as

monotherapy, dual therapy, triple therapy, four drug combinations and
five drug combinations.
Use pattern of individual class of anti-hypertensives
Trends in prescribing anti-hypertensives in diabetic patients
Age wise prescribing antihypertensive trend
3. Type 2 diabetic patients with hyperlipidemia
Use pattern of lipid lowering agents in type 2 diabetic patients were
evaluated
4. Use pattern of antiplatelet agents in type 2 diabetic patients were
evaluated.

b) Cost of Illness of type 2 diabetic patients with and without

complications:
As per the sample size calculation 116 each (100Plus) of diabetic patients
with (any) and without complications admitted in medicine wards in 2011 who
were ready to give consent(Appendix-IV to VI) were interviewed and relevant
datas were documented in COI questionnaire and evaluated for following
parameters.

1. Demography of the type 2 diabetic patients with and without complications

Gender wise patient distribution
Age group wise patients distribution
Body Mass Index(BMI) status of the patients
Educational status of the patients
Occupation of the patients
Year of diagnosis of diabetes
Regarding place of residence(urban/rural)
2. Drugs used in the treatment of these patients
3. Complications status of diabetic patients with complications
4. Various direct medical, direct non-medical costs and total cost involved in
the diabetes care.
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3.9.2Statistical analysis:
All the data were presented as descriptive statistics using SPSS version 20,
as statistical software. The Cochran-Armitage test was used to assess the
statistical significance of trends over time(2008-2010). Mann-whitney U test is
used to assess the statistical significant difference between the total costs
involved in the treatment of diabetes alone and diabetes with complications.
P-value< 0.05 was considered statistically significant.