Integrating Diabetic Retinopathy Into Mainstream Health System in Bangladesh
Phase: NA
Conditions: Diabetic Retinopathy
Sponsor: Hiroshima University



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ANNEXURE - C 
FORMAT FOR SUBMISSION OF A RESEARCH PROPOSAL FOR 
ETHICAL APPROVAL 
 
Project Title: Integrating Diabetic Retinopathy into Mainstream 
Health System in Bangladesh 
 
SUMMARY:  
 
Diabetes mellitus is a leading cause of death and disability.1,2 Diabetic 
Retinopathy (DR) is an eye disease that affects the eyesight of about 21.3% 
patients with diabetes in Bangladesh in a way that is irreversible because of 
the nature of the disease.18 According to International Diabetes Federation 
Diabetes Atlas (5th Edition), in 2011 there were approximately 8.4 million 
people in the age bracket 20-79 suffering from diabetes in Bangladesh, and 
this number is projected to double to 16.8 million by 2030. Based on these 
statistics, and also according to a nationally published report, the number of 
persons with DR is estimated to be about 1.8 million in Bangladesh.10 
 
Taking measures to delay vision loss in patients with diabetes is more cost-
effective than its treatment.16 Timely and effective referral of DR cases to an 
Ophthalmologist is very important in the prevention of this disease.16 The 
objective of this study is to identify reasons of DR referral procedure 
compliance and non-compliance among registered diabetic patients in a 
diabetic clinic and recommend effective strategies to enhance the referral 
system.   
 
The first phase of study is cross-sectional. Second phase of study is a 
Randomized Controlled Trial (intervention group to receive home-based 
health education and control group to receive standard care). The number of 
registered diabetic patients of Barishal DAB hospital who were referred to 
an Eye Consultant at a tertiary hospital following basic eye screening from 
September 2017 – August 2018 is N = 390 and they are all eligible for 
inclusion in the first phase of the study. This group (N = 390) will be divided 
into compliant and non-compliant patients. Both groups will be interviewed 
to understand motivation factors for compliance and de-motivating factors 
for non-compliance.  
 
In the second phase of the study, the non-compliant group (N=300) will be 
divided further into intervention and control groups following computational 
Randomized Controlled Trial method. The intervention group will receive 
relevant health education messages on Diabetic Retinopathy and 
information about the days and times when eye care services are provided at 
the tertiary hospital (i.e. service availability information). They will be 
provided with telephonic reminders at Days 7, 30 and 90 after the health 
education. Then, after a gap of one month from the last telephonic reminder, 
both control and intervention groups will be interviewed again. In this way 
this study will conclude whether the health education session is an effective 
way of improving compliance rate of referred DR patients.  
 
In-depth Interviews will be conducted with patients (compliant and non-

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compliant) and service providers. All questionnaires will be pre-tested in the 
study location. All participants will read and sign a Bengali consent form 
where confidentiality issues, study procedures, modalities, and participants’ 
right to refuse to answer/withdraw without monetary/non-monetary losses 
will be outlined in details. SPSS software will be used for data entry and 
analysis. Multiple Logistic Regression, along with other tests, will be used to 
identify variables that significantly influence successful referrals.  
 
The outcome of this research will be shared with service providers managing 
diabetes as well as those providing eye care services in public and private 
sectors, academicians, scholars, experts, research institutions, policy makers 
and other stakeholders – with the aim to share reasons of compliance/non-
compliance and recommend strategies to improve referrals. Ultimately, 
through this study trial, recommended strategies and best practices may be 
adopted, and replicated in other diabetic hospitals to integrate DR into 
mainstream health system effectively. 
 
 
INTRODUCTION: 
 
Diabetes is a non-communicable chronic disease associated with abnormally 
high levels of the glucose in the blood. One of the many complications of 
diabetes is Diabetic Retinopathy (DR), which results in vision problems in 
patients suffering from diabetes for many years. 
 
DR is the fifth leading cause of global blindness, affecting an estimated 1.8 
billion people and responsible for 4.8% of all causes of blindness.1 According 
to International Diabetes Federation (IDF) Atlas, Bangladesh is a least 
developed country (LDC) with a disproportionately high proportion of people 
having diabetes. Among all people living with diabetes in the 48 LDCs, about 
40% live in Bangladesh, which makes it one of the top 10 countries suffering 
from diabetes.1 In Bangladesh, approximately 6.1% of the population aged 
20-79 years has diabetes, with approximately 46% of these undiagnosed. 
According to International Diabetes Federation Diabetes Atlas (5th Edition), 
in 2011 there were approximately 8.4 million people in the age bracket 20-79 
suffering from diabetes in Bangladesh, and this number is projected to 
double to 16.8 million by 2030. Diabetic Retinopathy (DR) and Diabetic 
Macular Edema (DME) are common complications of diabetes that can result 
in vision loss – the estimated number of people with DR in Bangladesh is 
about 1.8 million (21.3% of the diabetic patients).18  
 
From a patient perspective there is little or no integration between the eye 
health sector and the diabetes sector. In Bangladesh, care for diabetes-
related eye disease is available in very few tertiary level health facilities. 
There is currently no eye health care available for people with diabetes or 
those suffering from DR, at the community clinics, primary health care 
centers or secondary health care centers (The Fred Hollows Foundation, 
2015). 
 
An effective referral system ensures a close relationship between all levels of 
the health system and helps to ensure people receive the best possible care 
closest to home. It also assists in making cost-effective use of hospitals and 
primary health care services. A good referral system can help to ensure: 

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patients receive optimal care at the appropriate level, hospital facilities are 
used optimally and cost-effectively, patients who most need specialist 
services can access them in a timely way, primary health services are well 
utilized and their reputation is enhanced. A referral system at all levels is 
used as a means to facilitate flow of patient referrals among healthcare 
providers. It is an important activity in any healthcare system for it is a 
critical component of quality clinical care. If practiced efficiently, it can 
contribute to high standards of care by improving patient outcomes and 
decreasing costs through optimal use of medical services. An optimal referral 
process should be in place for the effectiveness, safety and efficiency of high 
standard medical care. 
  
DR Screening is very important, because early stages of the disease lack 
symptoms – when symptoms occur the disease already requires treatment.17 
DR Screening centers may have to refer patients in a timely and effective 
manner to a DR treatment center. Early detection and timely referral are 
critical for timely interventions to prevent further deterioration of vision. In 
the case of DR, an effective referral system is crucial for the success of the 
disease management. This is because patient knowledge, awareness and 
perceived benefit of receiving DR Management services is very low, the world 
over, and more so in Bangladesh. Therefore, in order to make sure that DR 
Management is effectively integrated into mainstream public health in 
Bangladesh, it is vital to address one of the most challenging components of 
DR management, which is, strengthening referral system for patients having 
DR. If a patient is not made aware about possible consequences of negligence, 
is not properly counseled to undertake treatment and is not made aware of 
the existing referral pathway, the patient will in all probability forego 
treatment, since the perceived benefit of DR treatment is low among patients 
who lack symptoms.  
 
Bangladesh National strategy: The Bangladesh National Eye Care Plan 
(2016-2020) has just recently incorporated DR management for the first time, 
indicating the government’s commitment to manage DR through Public 
Private Partnership at all levels of the health system. 2 Bangladesh is also a 
signatory of Vision 2020, which is a global initiative for the elimination of 
avoidable blindness, a joint program of the World Health Organization 
(WHO) and the International Agency for the Prevention of Blindness (IAPB). 
Being a signatory of this initiative means that Bangladesh has pledged to 
work towards “A world in which no one is needlessly blind and where those 
with unavoidable vision loss can achieve their full potential”. Given the DR 
disease burden in Bangladesh, effectively managing DR becomes important 
to fulfill these commitments. The prevalence of DR among people with 
diabetes is 27% in Bangladesh which is quite a concerning situation.  
 
 
 
 
 
 
 
 
 

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The Research Question is:  
How can we increase the number of successful referrals of Diabetic 
Retinopathy patients from a diabetes clinic (DAB center) to an Eye 
Consultant located at a tertiary hospital?  
 
OBJECTIVE:  
 
General Objective:  The general objective is to recommend health education 
messages regarding DR and intervention strategies to benefit people who are 
at risk of developing DR or has already developed DR. 
 
Specific Objective: The specific objective is to investigate the effect of a health 
education intervention on patients with probable Diabetic Retinopathy who 
did not attend eye screening appointment with an Eye Consultant following 
referral from a diabetes clinic.   
 
• 
Primary Outcome: Increase in Successful Referrals from 35% to 55% (among 
non-compliant patients, i.e. those who do not avail appointment with an Eye 
Consultant at a tertiary hospital after being detected with probable DR at a 
diabetic hospital)  
 
• 
Secondary Outcome: Increase in knowledge of Diabetic Retinopathy and 
service availability (intervention vs. control groups) 
 
RATIONALE:  
 
A diabetic clinic should ideally be a one-stop-care center that offers holistic 
care for people with diabetes.15 DR patients may be diagnosed or 
undiagnosed persons with diabetes. Before a person is screened or treated 
for DR, ideally that person must first be diagnosed with diabetes, and 
brought under comprehensive diabetes care management. Comprehensive 
diabetes care management includes management of diseases of organs 
including kidneys, heart, tooth, brain and eyes. Yet many undiagnosed 
persons with diabetes who suffer from DR may also walk into eye clinics, 
requiring urgent attention. In such cases, it is best to manage DR first and 
then refer the patient to a diabetes clinic, so that patient can be brought 
under comprehensive diabetes management. Controlling and managing 
diabetes will ensure that the DR condition of patient does not deteriorate.  
Management of diabetes ensures that DR is controlled or prevented. It is a 
well-established fact that prevention of DR is more cost-effective than its 
treatment. In order to delay the onset of DR, it is important that referred DR 
patients from Barisal DAB Center promptly uptakes services at the referred 
facility, i.e. the tertiary hospital. Referred patients should ideally avail 
advanced DR management and treatment options without further loss of 
time.  
 
Diabetes clinics are one-stop-care-center for most registered patients with 
diabetes.  Barisal DAB center is visited by thousands of diabetic patients 
each year. According to International Diabetes Federation, the national 
prevalence of DR among people with diabetes is 27%.  It is estimated that 
27% of these patients has Diabetic Retinopathy who are now able to undergo 

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basic eye screening for probable DR at the Barisal DAB. These are eye 
patients who are at risk of losing their vision. However, when they are 
referred to an Eye Consultant of a tertiary hospital for advanced DR 
screening and management, most than referred patients to not avail services 
in the tertiary hospital, due to lack of awareness, motivation and other 
barriers. These ‘non-compliant’ patients maybe assumed to ‘drop out’ of the 
health system (The Fred Hollows Foundation Bangladesh, 2018).  
 
In the study locations:  
 
Sher-e-Bangla Medical College and Hospital (SBMC&H) has been providing 
eye care services for a long time to the community, and has recently started 
to provide eye care services to those suffering from Diabetic Retinopathy. 
Their services include eye screening and treatment for DR patients. The Eye 
Consultant in this hospital has received reputed international training. Most 
patients who came to seek DR management services at SBMC&H in 2017 
and 2018 are registered diabetic patients of the Barishal DAB center who are 
referred from Barisal DAB center to SBMC&H (The Fred Hollows 
Foundation Bangladesh, 2018).  
 
Barisal DAB center provides diabetes management services to registered 
diabetic patients, and has in recent year started to provide eye care services 
to those suffering from DR (The Fred Hollows Foundation Bangladesh, 2017). 
Their services include screening for probable DR cases. The medical 
personnel in this hospital has received training to screen for probable DR 
cases, and then refer these probable cases to an Eye Consultant for advance 
screening and management (preferably at SBMC&H since it provides DR 
treatment). From the patient record in the year 2017 and 2018, it has been 
found that most referred patients of Barishal DAB center do not avail their 
appointment at the referred facility (identified as non- compliant patients). 
These non-compliant patients are probable priority DR patients who need 
immediate medical attention (this risk group also has diabetes for more than 
5 years, and/or a family history of diabetes, and/or a higher range of Body 
Mass Index along with worsening eye conditions) (The Fred Hollows 
Foundation Bangladesh, 2018).  
 
Chances are these same diabetic patients (who have once before been 
referred from Barisal DAB center to an Eye doctor) will visit Barisal DAB 
center in future again for continued management of diabetes and other 
complication management. These high-risk patients can be followed-up with, 
 
Total Population 
Adult (over 20 yrs) population 
Probable 
number 
of 
persons 
with 
diabetes 
(6.1% of 
the total 
popn) 
Probable 
number 
of 
persons 
with DR 
(27% of 
persons 
with 
diabetes) 
District 
Male 
Female 
Total 
Male 
Female 
Total 
Barisal 
Sadar 
1,137,210 
1,187,110 
2,324,320 
627,740 
655,279 
1,283,019 
782,46 
21,131 

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regarding their appointment at SBMC&H (The Fred Hollows Foundation 
Bangladesh, 2018). This is because timely referral is critical for DR patients, 
in order to delay further deterioration of their vision, and DR patients need 
to complete the referral cycle in a prompt manner. That is, the number of 
successful referrals (or completed referrals) is an important indicator.  
From a patient perspective, the referral pathway should be clear and specific. 
Patients require specific information about the referred facility, such as days 
and times of services, how to travel to the referred facility, and so on. 
Through the health education component in this research, patients will be 
provided with this type of information, which will help them decide when and 
how to access tertiary level care. In this way, the non-compliance rate may 
be minimized.   
 
This research will thus focus around the issue of ‘DR patient referral 
management’ in an in-depth manner, which has not been previously covered 
in any research in Bangladesh. This research will highlight health education 
messages and possible health education delivery strategies, targeting DR 
patients. This may then be incorporated and integrated into the existing 
health care delivery. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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METHODOLOGY:  
 
Study design: The following chart summarizes the study design. The first 
phase of study is cross-sectional. The second phase of study is a Randomized 
Controlled Trial (intervention group to receive home-based health education 
and control group to receive standard care).  
 
 
 
• 
Variables used in study: Education, Occupation, Income, Age, Sex, District 
of residence, DR Stage, time taken to travel to health facility, knowledge of 
DR, source of information on DR, accompanying person, decision maker, 
information received at diabetes clinic, counseling received at diabetes clinic, 
follow up/reminder calls about appointment with Eye Consultant, clarity 
about referral procedure (place/time/location/how to get there), satisfaction 
with health facilities, understanding of non-compliance on vision.   
 
• 
Study Population: Registered diabetic patients who are/will be detected with 
probable DR and referred for specialty DR services at Sher-e-Bangla Medical 
College and Hospital (both groups will be studied – those who uptake services 
and those who do not, i.e. compliant and non-compliant patients) 
• 
Inclusion criteria: All diabetic patients registered at Barisal DAB who are 
referred to SBMC&H for DR management (screening/treatment), following 

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basic eye screening, from September 2017 – August 2018 (i.e. during these 
12 months) are eligible for inclusion in this study. Also, patients have to be 
atleast 18 years of age and will provide informed consent to be included in 
the research study. In addition to these criteria, in the 2nd phase of the study 
(RCT), only those patients will be included who did not undergo a Dilated 
Fundus Examination (DFE) in last 12 months.   
• 
Exclusion criteria:  Diabetic patients registered at Barisal DAB who are not 
referred to SBMC&H for DR management (screening/treatment), from 
September 2017 – August 2018 (i.e. during these 12 months) are excluded 
from this study. Also, patients below 18 years of age and those who do not 
provide informed consent to be included in the research study, are excluded 
from the study. In addition to these criteria, for the 2nd phase of the study 
(RCT), those patients who have undergone a Dilated Fundus Examination 
(DFE) in last 12 months will also be excluded from this study.    
• 
Primary Outcome: Increase in Referral Rate (among non-compliant patients, 
i.e. those who do not avail appointment with an Eye Consultant at a tertiary 
hospital after being detected with probable DR at a diabetic hospital) 
• 
Secondary Outcome: Increase in knowledge of Diabetic Retinopathy  
• 
Statistical basis of the sample size: We assumed that the intervention 
would result in an improvement of referral from 35% to 55% (i.e. 20% 
improvement). Thus to detect a difference of 20% in the referral with 
90% power and type 1 error 0.05, the sample would be 125 in each 
group {sample size = [(p1xq1 + p2q2)/(p2-p1)2] X factor for alpha and 
beta; where p1 is the percentage of the existing referral, q1 is 1-p1, 
p2 is the percentage of the expected referral from intervention; q2 is 
1-p2, alpha is the type 1 error and beta if the type 2 error and factor 
for alpha beta with 90% power is 10.5}. Considering that for RCT 
study, single arm sample size is 125, this means both arm sample size 
= 125X2 = 250. Taking drop-out rate to be 20% (more than standard 
10% because patients have already gone back home few months ago 
and it may be difficult to convince them to make the journey to the 
tertiary care hospital) the total sample size is 300 for the RCT study.   
• 
All diabetic patients registered at Barisal DAB who were referred to Barisal 
Sher-e-Bangla Medical College and Hospital after screening for probable DR 
(at the DAB clinic) from September 2017 – August 2018 are eligible for 
inclusion in this study. The total number of referred patients referred from 
September 2017 – August 2018 is N=390 based on hospital monthly data 
(from September 2017 – August 2018). All patients will be interviewed (both 
compliant and non-compliant patients).   
• 
Recruitment strategy: All patients referred by DAB to a tertiary hospital 
from September 2017 – August 2018 following basic eye screening will be 
interviewed (both compliant and non-compliant patients), i.e. N=390. Both 
compliant and non-compliant patients will be studied. Interviews will be 
conducted to inform on the reasons for compliance and non-compliance.  
• 
Methods of Data Collection: In-depth Interviews (IDI) with all patients. 
Patient phone numbers are recorded in hospital database. They will be 
contacted for consent for interview appointment and their detailed addresses 
will be noted for house visit. After completion of informed consent forms, face-
to-face interviews with patients and Face-to-face interviews with service 
providers will be completed.   
• 
Pre-testing: All the different sets of Questionnaires will be pre-tested in the 
study location which is Barisal district. The pre-test will be conducted on 

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both compliant and non-compliant patients. Feedback will be used to make 
any slight modifications, rearrangement of question sequence, changes in 
question wording or pattern, as and where needed. Since no sensitive 
questions are being asked to participants, it is expected that there will be no 
significant changes in the questionnaire that has been prepared.   
• 
Data Interpretation: Responses to questions will be coded and entered into 
SPSS software, which will then be used to analyze and interpret data.   
• 
Statistical Analysis: Frequency distributions will be used to analyze the 
demographic characteristics of the study population. Multiple Logistic 
Regression method will be used to identify variables that significantly 
influence successful and unsuccessful referrals among compliant and non-
compliant patients. For the RCT study among non-compliant patients to find 
impact of health education intervention, the primary outcome (successful 
referral rate – defined as attendance at referred facility) and secondary 
outcome (increase in knowledge of Diabetic Retinopathy and service 
availability) will be compared between both arms. For continuous measures 
the t-test will be used and for categorical outcomes, chi-square test will be 
use, when comparing the two arms (i.e. intervention and control groups). 
 
• 
Utilization of Results:  
The outcome of the research will be shared with service providers managing 
diabetes as well as eye care services, in public and private sectors, 
academicians, scholars, experts, research institutions, policymakers and 
other stakeholders. Researcher will arrange a dissemination seminar where 
government officials and INGO Forum members (working on eye health) will 
be present. Journalists will be invited to this event to publish findings in 
Bengali and English national dailies. She will present this research proposal, 
chapters from the Thesis as well as modified excerpts from the Thesis in 
various international and national platforms, conferences, symposiums and 
public health consortiums. Researcher will publish chapters from the thesis 
in peer-reviewed Public Health journals. 
Findings will help to strengthen the referral system of diabetic patients from 
DAB clinics to an Eye facility. This research will focus around the issue of 
‘patient referral’ in DR management in an in-depth manner, which has not 
been previously covered in any research in Bangladesh to the best of 
researcher’s knowledge. Therefore, strategies of strengthening the referral 
system of eye patients from DAB to an eye facility will be established.  
• 
Facilities : (Resources, equipment, chemicals, subjects (human, animal) etc. 
required for the study): 
o Facilities Available : 1 computer, SPSS software, participants 
o Additional Facilities Required : None 
 
 
 
 
 
 
 

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Flow-chart 
The following flow chart describes the sequence of tasks within the timeframe  
 
 
Ethical implications 
 
There are no reasonable foreseeable (or expected) risks in this study as there will be 
no medical interventions. Participants will be made aware about the confidentiality 
issues, study procedures, modalities, and their rights to refuse to answer/withdraw 
at any point without any monetary/non-monetary loss. 
This study is anonymous.  Investigator will not be collecting or retaining any 
information about patient identity. The records of this study will be kept strictly 
confidential. Publications will not contain any information that may make it 
possible to identify participants. 
Participants will not receive any monetary benefits for participating in this study. 
They will be informed about this before the start of the survey. They will be required 
to sign a detailed consent form that they can read in Bengali and have a witness 
sign. One copy of this will be provided to the participant.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DEC 2018
•pre-
intervention 
survey
•intervention  
for non-
compliant 
patients
•no 
intervention 
for control 
gorup
JAN 2019
• First telephonic 
follow-up on 
Day 7 after pre-
intervention 
suevey
• second 
telephonic 
follow-up on 
Day 30 after 
pre-
intervention 
suevey
FEB 2019
• waiting and 
observatory 
period
MAR 2019
• Third 
telephonic 
follow-up on 
Day 90 after 
the pre-
intervention 
survey
APR 2019
• 1 month 
window 
period
• during this 
time, patients 
are expected 
to visit Eye 
Consultant as 
a result of 
health 
education 
interventions
MAY 2019
•conduct 
post-
interventi
on survey 
for 
interventi
on and 
control 
groups 
JUNE 2019
•data coding 
and analysis
•produce 
report
•organize 
diseminatio
n session

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223 http://dx.doi.org/10.1016/S0140-6736(12)61689-4pmid: 23245608. 
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Available: http://www.idf.org/atlasmap/atlasmap. Accessed 2018. 
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impairment: 2010 
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Forecast, October 2011 
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has-6m-diabetic-patients 
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impairment: 2010 
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13. The Fred Hollows Foundation Bangladesh. (2017). Internal report: 
unpublished.  
14. The Fred Hollows Foundation Bangladesh. (2018). Internal report: 
unpublished.  
15. Lawton, J. , Parry, O. , Peel, E. and Douglas, M. (2005), Diabetes service 
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experiences and views. Diabetic Medicine, 22: 1246-1251. 
doi:10.1111/j.1464-5491.2005.01619.x 
16. Javitt JC, Aiello LP. Cost-effectiveness of detecting and treating diabetic 
retinopathy. Ann Intern Med. 1996;124(1:Pt 2):t-9. 
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18. Akhter A , Fatema K , Ahmed SF , et al . Prevalence and associated 
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and without diabetes. Ophthalmic Epidemiol 2013;20:220–7 
 
Budget:  
The total budget for this study is BDT forty-five thousand only (Tk 45,000/). 
For detailed breakdown, please refer to Appendix E.