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«Sithara S Pillai Dissertation submitted in partial fulfillment of the requirement for the award of the degree of Master of Public Health Achutha ...»

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Sithara S Pillai

Dissertation submitted in partial fulfillment of the

requirement for the award of the degree of

Master of Public Health

Achutha Menon Centre for Health Science Studies,

Sree Chitra Tirunal Institute for Medical Sciences and Technology Thiruvananthapuram, Kerala, India October 2012 Acknowledgments I am grateful to God Almighty for giving me life and the strength to go through this course successfully.

I would like to convey my sincere gratitude and appreciation to my guide Dr V. Raman Kutty for his unreserved assistance in doing this research. His encouragement, support and guidance from the initial to the final level enabled me to build up an understanding of the subject. This thesis would not have been as standardized as it is now without his great support.

This research would not have been possible without the support of Dr G. Vijaya Kumar and his team at Medical Trust Hospital, Kulanada, Panthalam.

I would like to acknowledge the Kerala state council for science, technology and environment for funding the project.

I extend my sincere thanks to Dr. Sankara Sarma, Dr. K.R. Thankappan and Dr. Mala Ramanathan for their inputs while analyzing the data.

I would like to thank all other faculty of Achutha Menon Centre for Health Science Studies for providing me their valuable suggestions to improve the study.

Finally I would like to convey my heartfelt thanks to my caring husband for his support throughout the study period.

Certificate I hereby certify that the work embodied in this dissertation entitled “Impact of diabetic foot ulcer on health related quality of life and employment among rural diabetic population” is a bonafide record of original research work undertaken by Ms. Sithara S Pillai, in partial fulfilment of the requirement for the award of the “Master of Public Health” degree under my guidance and supervision.

Dr. V. Raman Kutty, Professor, Achutha Menon Centre for Health Science Studies Sree Chitra Tirunal Institute for Medical Sciences and Technology Thiruvananthapuram, Kerala October 2012 Declaration I declare that the work embodied in this dissertation entitled “Impact of diabetic foot ulcer on health related quality of life and employment among rural diabetic population” is the result of my original field research. It has not been submitted to any other university or institution for the award of a degree.

Sithara S Pillai Master of Public Health scholar Achutha Menon Centre for Health Science Studies Sree Chitra Tirunal Institute for Medical Sciences and Technology Thiruvananthapuram, Kerala October 2012

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To my husband Vivek Venugopal for his encouragement and support throughout the study;

To my parents Sasidharan Pillai and Rethnamma S Pillai for the value of education they instilled in me.

Abstract Background: With a diabetic prevalence of 8.6% India is ranked at the top with respect to the burden of diabetes. HRQL (Health related quality of life) information is necessary to measure the effectiveness of the treatment, patient management and policy decisions.

Diabetic foot ulcer is an important complication of diabetes and increasingly affects the working population. Evidence on HRQL, employment related factors and expenditure related factors is extremely rare in Kerala- particularly among rural diabetic population. This study was conducted with an objective to measure the health related quality of life among diabetic patients with healed and unhealed foot ulcer in the rural population.

Method: A cross sectional survey among 118 diabetic foot ulcer patients (mean years of age was 57.66 ± 7.71; 66.9% were males) selected randomly from the patients attending the outpatient department of a major diabetic care centre. Information was collected on sociodemographic variables, disease and treatment related factors, family life, employment and expenditure using a pre-tested structured interview schedule. The twenty nine item DFS- SF was used to measure the health related quality of life, after validation of the scale among the same rural diabetic population. For the working population the economic loss was calculated by total value of man days lost.

Results: The mean ± SD of total HRQL score for healed and unhealed group is 74.86 ± 12.11 and 59.92 ± 15.41 respectively. After adjusting for ulcer duration and sex the difference between the mean scores was 16.75 (95% CI = [-22.66, -10.81]). Median value of total man days lost was 26000 Rs with a range of 450 to 720000 Rs.

Conclusion: The mean HRQL score is significantly different between healed and unhealed groups even after adjustment for other predictors. There is a considerable economic burden imposed on households by diabetic foot ulcer which warrants greater attention to this condition. A multidisciplinary approach is needed to reduce the social and economic consequences of diabetic foot ulcer.

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Glossary of abbreviations Abstract Chapter 1: Introduction and review of literatures

1.1. Introduction

1.2. Background

1.3. Prevalence studies 1.3.1. Global scenario 1.3.2. Indian scenario 1.3.3. South India or Kerala scenario

1.4. Pathways to foot ulceration

1.5. Treatment modalities

1.6. Health related quality of life (HRQL)

1.7. Translation and validation of diabetic foot ulcer scale short form (DFS -SF) 1.7.1. The procedure of validation

1.8. Studies on impact on employment

1.9. Family consequences studies

1.10. Expenditure or economic impact studies

1.11. Diabetes education – Prevention and care of foot ulcer Chapter 2: Rationale and objectives of the study

2.1. Rationale for the study

2.2. Objectives of the study 2.2.1. Major objectives 2.2.2. Minor objectives Chapter 3: Methodology

3.1 Operational definitions

3.2. Formative research 3.2.1. Conceptual framework

3.3. Study design

3.4. Translation and validation of the DFS – SF 3.4.1. Linguistic validation 3.4.2. Measures of reliability and validity 3.4.3. Study setting 3.4.4. Sample size 3.4.5. Sample selection procedures 3.4.6. Data collection techniques 3.4.7. Data analysis

3.5. Cross sectional survey 3.5.1. Study setting 3.5.2. Sample size 3.5.3. Sample selection procedures 3.5.4. Sample selection criteria 3.5.5. Data collection techniques 3.5.6. Data storage and cleaning 3.5.7. Variables under the study – Definitions and characteristics 3.5.8. Data analysis 3.5.9 Analysis of HRQL score 3.5.10. Analysis of employment characteristics 3.5.11. Family characteristics 3.5.12. Direct medical expenditure

3.6. Case study research 3.6.1. Study setting 3.6.2. Sample size 3.6.3. Sample selection procedure 3.6.4. Data collection technique 3.6.5. Data analysis

3.7. Ethical considerations Chapter 4: Results

4.1. Scale validation 4.1.1. Assessment of reliability Temporal stability Internal consistency 4.1.2. Assessment of validity

4.2. Cross sectional survey 4.2.1. Socio demographic and clinical characteristics of the study sample 4.2.2. HRQL measurement 4.2.3. Employment related characteristics 4.2.4. Family life related characteristics 4.2.5. Quantum and pattern of direct medical expenditure

4.3. Case study research

Chapter 5: Discussion

5.1. Scale validation

5.2. Cross sectional survey 5.2.1. Sample characteristics 5.2.2. HRQL measured using DFS –SF 5.2.3. Impact on employment related characteristics 5.2.4. Impact on family life 5.2.5. Quantum and pattern of direct medical expenditure

5.3. Qualitative analysis

5.5. Strengths and limitations of the study 5.5.1. Strengths 5.5.2. Limitations Chapter 6: Conclusion and recommendations References Annexure 1. Guidelines for formative research Annexure 2. Diabetic Foot Ulcer Scale-Short Form Annexure 3. Diabetic Foot Ulcer Scale – Short Model (Back translated version) Annexure 4. Report on cognitive debriefing of the translated version of DFS - SF Annexure 5. SF-36v2™ Health Survey Annexure 6. Consent form for referring patient for participating in the study Annexure 7. Interview schedule Annexure 8. R functions used for sample size estimation and data analysis Annexure 9. Guidelines for Case study research – Individual patient discussion Annexure 10. Participant information sheet Annexure 11. Informed consent for Interview Annexure 12. Informed consent for case study

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Table 3.1: Predictor variables Table 3.

2: Outcome variables Table 3.3: Frame work used for analysis Table 4.1: Internal consistency for different domains of the score Table 4.2: Correlation matrix with SF 36 Vs DFS-SF Table 4.3: Socio demographic characteristics of the study sample Table 4.4: Disease characteristics of the study sample Table 4.5: Socio demographic and clinical characteristics in the two groups Table 4.6: Results of two factor ANOVA for Sub scale 1 – Leisure score Table 4.7: Results of two factor ANOVA for Sub scale 2 – Physical health score Table 4.8: Results of two factor ANOVA for Sub scale 3 – Daily activities score Table 4.9: Results of two factor ANOVA for Sub scale 4 – Emotions score Table 4.10: Results of two factor ANOVA for Sub scale 5 – Treatment score Table 4.11: Linear model of HRQL score on major predictors Table 4.12: ANCOVA showing adjusted difference in mean HRQL scores between healed and unhealed group Table 4.13: Employment related characteristics of the study sample Table 4.14: Estimates of the employment related characteristics Table 4.15: Results of Wilcoxon rank sum test to find out the predictors of total value of man days lost Table 4.16: Direct medical expenditure related characteristics

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Fig. 1 Causal pathways to foot ulceration Fig. 2 Conceptual framework Fig. 3 Deductive themes used for case study analysis Fig. 4 Mean HRQL score with 95% CIs comparing healed and unhealed groups in five

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‘Need for national campaign to encourage physicians to remove patient’s shoes and socks and to examine the feet’ - Paul Brand (1914–2003) who added science to the art of foot care

1.1. Introduction Diabetes mellitus is one of the major chronic non communicable diseases that affect millions globally. Evidence shows that diabetes has become a major epidemic in newly industrialised and developing nations. With a diabetic prevalence of 8.6 percent, India is ranked at the top with respect to the burden of diabetes.1 Diabetes is a serious health problem that needs special attention and public health interventions in the 21st century.

Sandeep et al from the Madras Diabetes Research foundation summarize the situation of diabetes in India as follows: “Diabetes in India is no longer a disease of the affluent.

Studies have shown that poor diabetics are more prone to complications as they have less access to quality health care. This presents an alarming picture as the poor would find it more difficult to cope with the diabetes epidemic”.2 Diabetes has been classified as Type1 and Type 2. In Type 1, the person’s body is unable to produce insulin and he/she requires a continuous supply of insulin as treatment, whereas in Type 2, the person’s body cells fail to use the produced insulin or there may be some insufficiency of insulin.3 Uncontrolled blood glucose level for a long duration can damage heart and blood vessels, eyes, kidneys and nerves. People with diabetes are also prone to infections. In most of the high income countries diabetes has became a primary cause for cardio vascular diseases, blindness, kidney failure and lower limb amputation.1 The nerve and blood vessel damage due to the uncontrolled diabetes leads to a variety of foot problems. These conditions worsen in the presence of infection and lead to ulcer formation. This eventually increases the risk of a person for lower limb

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that among people without diabetes.4 Effective control over blood glucose level, blood pressure and cholesterol can delay or even prevent the development of diabetes related complications.1

1.2. Background Diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin, or when the body cannot effectively use the insulin that it produces.

Hyperglycaemia, or raised blood sugar, is a common effect of uncontrolled diabetes. Over a period of time, this leads to serious damage to many body systems, especially to nerves and blood vessels.5 Globally, the number of diabetics in 2011 is 366.2 million and the projected value for 2030 is 551.8 million. The prevalence of Type 2 diabetes is increasing all over the world and nearly 80 percent of the people with diabetes live in low and middle income countries. Around 4.6 million deaths in 2011 is attributed to diabetes.1 Population based studies across the world show that the incidence of Type 2 diabetes mellitus is increasing among young adults. This will lead to an increase in the prevalence of micro and macro vascular complications associated with diabetes.6 The large and growing population of India and the high prevalence of diabetes among its population have increased the burden of diabetes in India.7 In a review in the year 2000, Andrew J.M. Boulton stated that “The hallmark of diabetic foot problems in India is gross infection: major contributing factors for its late presentation include the frequency of barefoot gait, attempts at home surgery, trust in faith healers, often undetected diabetes, rodents nibbling at insensitive feet while the patients sleep on the floor, maggots pouring out of open wounds and red ants swarming inside the dressing ”.8

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