Background
Non-communicable disease (NCD) is the largest cause of mortality in the majority of low- and middle-income countries (LMICs) causing 68% of all deaths worldwide [
1]. Almost three quarters of NCD deaths, and 82% of premature NCD deaths, occur in LMICs [
1]. This presents a significant challenge to health services in LMICs, where the focus has traditionally been on treating acute conditions [
2]. Refocusing towards chronic disease requires LMICs to make major health systems changes, including to care services at primary and community levels and prevention services [
3]. Such services must include ways of following up patients on a regular basis, and referral systems allowing upward-referral and, more problematically, referral back, to ensure appropriate tertiary and community care. Health worker skills need to be re-oriented to support ongoing relationships with patients, with a focus on interpersonal skills to encourage lifestyle behaviour change [
4], currently rarely available in low-resource settings [
5]. This will involve substantial investment [
6].
In Bangladesh the burden of NCDs now surpasses infectious diseases, and accounts for 61% of all adult deaths [
7]. Approximately 12 million people, 32% of women and 19% of men, aged 35 years or older have hypertension [
8]; while overall 7 million people, 7.4% of individuals aged > 15, have diabetes [
9]. Very few patients with hypertension and diabetes are treated according to internationally recommended guidelines, and mostly only in specialist clinics such as Diabetic Association of Bangladesh (BADAS) hospitals/health centres, and other privately-managed specialist clinics that are too expensive for most, especially the poor [
10].
Although Bangladesh has adopted national strategic plans for the prevention and treatment of NCDs [
11,
12], progress has been limited [
13]. Health workers in the primary health-care system are not yet trained in NCD treatment [
14], the number of trained personnel in secondary and tertiary care services is inadequate, biochemical investigations required for accurate diagnosis are currently only available on a fee-for-service basis and the provision of basic drugs for treatment is limited and sporadic [
10]. In addition, despite having a national essential drugs policy that includes a list of essential drugs for use in public health services, drugs for treating diabetes and Cardiovascular Diseases (CVDs) are not on the list [
14]. A lack of clear institutional responsibilities, an absence of dedicated financing and competing priorities have been identified as barriers to implementing strategic plans for NCDs [
14].
In response, the Government has taken several policy decisions including establishing a separate operational plan for NCDs [
10], and establishing an NCD ‘corner’ (an NCD clinic room within the Upazila Health Complex), running in parallel with existing services at selected Upazila Health Complexes (UHCs) [
1]. UHCs are sub-district level primary care facilities with 31 or 50 beds, posts for nine doctors, ten nurses and 23 other staff, and having 270,000 catchment population. An UHC usually has in-patient department, an out-patient department and a family planning unit which together provide basic promotive, preventive, and curative services including comprehensive emergency obstetric care (EOC) services, gynaecology, anaesthesia, nursing and basic laboratory facilities. Despite the initiative of establishing NCD corners at UHCs, the majority of NCD corners are not fully functional due to non-availability of drugs, dedicated and appropriately trained staff and adequate systems for maintaining long-term individual patient records.
To support enactment of the NCD strategy, we initiated a project to develop and support implementation of a diabetes and hypertension case management package, in close collaboration with the Government of Bangladesh. We developed an evidence-based package [
15] for use by UHC doctors to diagnose and treat hypertension, type 2 diabetes, chronic obstructive pulmonary disease (COPD) and bronchial asthma, ischemic heart disease, and eye problems; and to diagnose, but not treat, cancers. A key principle within our study was to ensure the intervention was embedded within the government health system, and was therefore scalable. This meant that no additional drugs or equipment, beyond that already available within the government health system were provided.
The objectives of the study reported here were to test the package’s appropriateness, feasibility and acceptability regarding hypertension and diabetes patient management in two NCD clinics within two primary-care level UHCs. We also assessed adherence to clinical protocol for management of diabetes and hypertension.
Methods
Study design
We used a convergent mixed methods design [
16]. We first assessed the quality of hypertension and diabetes patient management using a quantitative composite outcome indicator. We then carried out qualitative in-depth interviews (IDIs) with doctors and patients to understand our quantitative findings, and to understand challenges to achieving appropriate patient management in the NCD clinics.
Setting
We purposively selected UHC NCD clinics for this feasibility study. The government-prescribed essential service package (ESP) at UHC level includes maternal health, nutrition, family planning and treatment of common diseases. UHCs are typically staffed with nine doctors including four specialists (gynecologist, surgery, anesthetist, pediatrics); nurses; medical assistants; sanitary inspectors; health inspectors; family planning inspectors; health assistants; technologists; and family welfare visitors/midwives.
Due to the small number of UHCs with functioning NCD clinics with an assigned doctor, necessary equipment and drugs, we were only able to select two UHCs, one in Dhaka division and one in Chittagong division. UHC1 (Dhaka division) had 7 doctors and 11 nurses and saw 150–200 patients per day; 3 private clinics operated in close proximity to the UHC. UHC2 (Chittagong) had 7 doctors and 9 nurses, and saw 280–300 patients per day; two specialist diabetes clinics provided by BIRDEM (Bangladesh Institute of Research and Rehabilitation of Diabetes, Endocrine and Metabolic Disorders), and around 30 private clinics, operated in close proximity.
Study participants
For our quantitative study, eligible adults were aged 18 and over, newly diagnosed with diabetes and/or hypertension and not on drug treatment at the point of enrolment. We also excluded anyone found at diagnosis to have sufficiently complicated or severe disease that they required referral to the district specialist.
For our qualitative study we included patients with diabetes and/or hypertension and doctors from the NCD clinic and outpatient departments in the two UHCs. NCD doctors identified patients with diabetes and/or hypertension, who we interviewed after their routine consultation. While the sample was dependent on which patients were available on the day, the researchers aimed to interview both men and women, young and old.
Intervention
CVD and diabetes management was primarily informed by International Diabetes Federation (IDF) [
17] and World Health Organisation (WHO) guidelines [
18]. A national technical working group of medical specialists in diabetes, CVD, oncology and respiratory health advised on the content of the package, ensuring its relevance to the Bangladesh health system. The package included a case management desk guide for NCD doctors; guidelines for nurses or paramedics to provide life style education on diet, exercise and tobacco cessation; a lifestyle education leaflet for patients; an individual patient treatment record card for clinicians in the NCD clinic to record ongoing treatment; a booklet for patients to record follow-up dates, drugs prescribed and instructions how to take drugs; and a training guide to be used during nationwide training by clinical specialists to all NCD doctors and nurses. All materials can be found here on our Communicable Disease-Health Service Delivery (COMDIS-HSD) website [
19].
We were able to integrate training on our NCD package within the existing government training programme for UHC staff, intended to set up the NCD clinics across the country. The NCD specialist doctor and three out-patient doctors from each UHC attended the training. Our research team supported the delivery of the first batch of training provided to four UHCs, including one of our study UHCs (UHC1). The training was conducted from 21 to 23 April 2015. At our suggestion, nurses were initially included in the training, but due to doctors’ concerns over the level of prior knowledge required, it was decided that future training would only be provided to UHC doctors. The training comprised 12 sessions, four of which covered diabetes and hypertension: details are available from the authors. In brief, the intervention followed the following structure. Out-patient doctors who saw patients with suspected symptoms or clear risk factors for hypertension or type 2 diabetes referred them to the NCD corner doctor. The NCD doctor diagnosed patients according to the appropriate management guidelines in the desk guide. The patient was then asked to return for follow-up after 15 days. The NCD doctor completed the individual patient NCD card to record treatment and follow up dates. During the 3-month study period, patients were advised to return for three follow up visits.
Outcomes
We assessed the quality of hypertension and diabetes patient management using a binary indicator of whether a patient was appropriately managed over a 3-month period following diagnosis with type 2 diabetes and/or hypertension. We classified a patient as appropriately managed (as defined in the desk guide) if:
1)
they were diagnosed with type 2 diabetes and/or hypertension according to the procedure specified in the desk guide: for diabetes, random blood glucose (RBG) and fasting blood glucose (FBG) tests performed and RBG ≥11.1 mmol/L and FBG ≥7 mmol/L, and blood pressure (BP) checked twice; and for hypertension, (BP) checked twice and systolic BP > 140 mmHg and/or diastolic BP > 90 mmHg, and FBG taken or RBG (and if high then FBG taken); and
2)
treatment was initiated with the appropriate drugs, if required (and variations recorded and justified); and
3)
if at diagnosis the patient was found to have sufficiently complicated or severe disease that they required referral, as defined in the NCD desk guide, they were referred to the district specialist; or if referral was not required then referral to the district specialist did not occur; and
4)
education and counselling was provided on the disease, treatment, adherence, and lifestyle behaviour change (as indicated by a record of attending the NCD nurse for counselling); and
5)
they were given a follow-up appointment.
A deviation from the initial planned definition of appropriate management occurred, related to checking whether BP had been measured twice. While the desk guide stated two BP measurements must be taken, the patient treatment card did not specify the need, or provide a place to record the second result. As a result, none of the clinicians recorded two BP results on the patient card. Given this limitation, we adapted our outcome measure to specify appropriate diagnosis as requiring only one recorded BP.
We also created six additional outcomes to explore specific components of patient treatment quality. Five outcomes were the separate (binary) indicators that together formed the appropriate management outcome, as defined above: 1) appropriate diagnosis, 2) appropriate drug initiation, 3) appropriate referral, 4) provision of education and counselling, and 5) provision of a follow-up appointment. The final outcome was a binary indicator of whether a patient was provided with a drug that was not on the Essential Medicines List.
Data collection procedures
All data was collected between 10th August and 31st December 2015 by researchers at the ARK Foundation. All quantitative data on the management of diabetes and hypertension were collected from the patient record card developed by the research team. One fieldworker was appointed in each UHC to collect data from the treatment card. Fieldworkers received training on data collection tools and procedures from the research team. IDIs were conducted by researchers from ARK, one with experience in qualitative research and two more junior researchers. Interviews were audio-recorded, translated into English and transcribed within two days by the interviewers.
Analysis
We summarised patient characteristics. Outcomes were summarised as percentages with 95% confidence intervals calculated using the Wilson score interval method [
20]. All analyses were performed using R (version 3.2.2). These quantitative analyses were used to inform development of the qualitative analysis.
Interviews were translated, transcribed verbatim and analysed thematically using the Framework approach [
21]. IDI transcripts were coded to identify facilitators and barriers to implementation and acceptability of the intervention to patients. All of the transcripts were first checked for accuracy by the researcher who conducted the interview. Transcripts were coded by two ARK researchers and a sample of transcripts were independently coded by a third experienced qualitative researcher. We adopted the following stages of Framework analysis: familiarisation, constructing a thematic framework, indexing and charting, mapping and interpretation. NVivo 11 and Excel 2010 software packages were used for qualitative data analysis.
Ethics
Ethical approval was received by both Bangladesh and the United Kingdom (UK) ethics committees. Written informed consent was obtained from all participants at recruitment. The information sheet was read out to all participants and those who were illiterate provided a thumb print to indicate consent.
Sample size
We estimated that to obtain a 95% Confidence Interval (CI) at most ±10% for outcome of appropriate management, assuming at least 45% of patients were categorized as appropriately managed, required a sample size of 95. To adjust for a cluster size of 20, and an assumed intra-cluster correlation coefficient of 0.05, we estimated a sample size of 190 was needed.
Discussion
There were many problems implementing NCD care: shortages of staff, appropriate medication and diagnostic equipment; and challenges delivering interactive training with hands-on practice. These implementation deficiencies meant patients were unwilling to attend for diagnosis or follow-up and doctors were unwilling to provide follow-up appointments. Challenges with the provision of quality training [
23] to the NCD doctors and nurses may partially explain problems with appropriate diagnosis and management. A common issue was that a second BP measurement was not taken (or not recorded) prior to diagnosing hypertension. One high BP may be due to anxiety, and if not confirmed in a repeat measurement may lead to over-diagnosis of hypertension. In addition, patients diagnosed with diabetes rarely had their BP checked (or recorded). These quality of care issues will need to be addressed through revision of training exercises and supervision/ monitoring.
The challenges of encouraging patient lifestyle behaviour change using nurses within NCD corners were evident. Ensuring proper training was a particular issue. This may be due to lifestyle change being given low priority and the hierarchical nature of the Bangladesh health system [
24]. Given the scale of the NCD epidemic in Bangladesh and other South Asian countries, support to patients to change their lifestyles for secondary prevention is key [
25]. Encouraging patients’ active involvement (‘self-management’) is particularly important given the constraints the health system faces appropriately managing patients within primary care [
3].
Despite these limitations, the NCD clinics appropriately managed approximately half of patients with diabetes and/or hypertension, failure being largely due to an incomplete diagnostic process (e.g. missing hypertension in a diabetic), or not giving a follow-up appointment. While there is still clearly great room for improvement, this study shows a relatively simple intervention can begin to provide appropriate care to a large proportion of patients, for whom previously there was no suitable care available within this setting. A key principle in our study was to embed the intervention into government practice to facilitate scale-up. This approach has led to dissemination of our materials along with training to doctors at 50 NCD clinics across Bangladesh.
While our study was not powered to look at gender differences, evidence from other studies indicates that women are less likely than men to be appropriately diagnosed for CVD [
26]. Further exploration of this issue in future studies is recommended.
Limited number of facilities and inadequate sample size are major limitations of the study. Care should be taken extrapolating the findings of this study, due to the small number of sites, and their potential lack of representativeness. Nonetheless, the qualitative findings provide a clear indication of practitioners’ experiences in attempting to establish a comprehensive NCD clinic. While NCDs have gained increased focus within Ministries of Health, operationalising NCD policies so that drugs, equipment and training are available in primary care clearly remains a challenge. Once facilities are fully functional in their delivery of NCD services, future research should focus on evaluating the effectiveness of the intervention across a representative range of sites.
To provide good NCD care, a trained doctor must be permanently stationed at the NCD clinic, together with a nurse to provide health education, and a regular supply of essential NCD drugs, diagnostic and recording equipment. In addition, to meet the challenges of implementing complex NCD care to ensure appropriate management, training must contain a substantial practical element. Advice on lifestyle behaviour change is vital if patients are to be able to manage their condition and avoid complications. Appropriate and available provision of lifestyle behaviour change counselling requires due recognition of the roles of nursing staff, and training to enable them to deliver this part of the intervention.
Acknowledgements
We would like to thank Dr. Bishwajit Bhowmik, Diabetic Association of Bangladesh (BADAS) for his technical guidance in developing the intervention package. We also thank the staff and patients of the clinics in this study for their involvement.