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Complex interventions are needed to effectively tackle non-communicable diseases. However, complex interventions can contain a mix of effective and ineffective actions. Process evaluation (PE) in public health research is of great value as it could clarify the mechanisms and contextual factors associ­ated with variation in the outcomes, better identify effective components, and inform adaptation of the intervention. The aim of this paper is to demonstrate the value of PE through five case studies that span the research cycle. The interven­tions include using digital health, salt reduction strategies, use of fixed dose combinations, and task shifting. Insights of the methods used, and the implications of the PE findings to the project, were discussed. PE of complex interventions can refute or confirm the hypothesized mechanisms of action, thereby enabling intervention refinement, and identifying implementation strategies that can address local contextual needs, so as to improve service delivery and public health outcomes.

BACKGROUND India has 66 million people with diabetes, of which a large proportion do not receive adequate care. The Primary Health Centres across rural and urban areas serve as platforms for continuum of care and early detection of diabetes in the population. The untapped potential of frontline health care workforce can act as a means to bridge the gaps of service demands. OBJECTIVE We aim to develop and evaluate a technology-enabled system-level intervention based around the community health workers [Accredited Social Health Activists (ASHA)] and primary-care physicians, and mobile tablet-based clinical decision support system to improve the identification and management of individuals with diabetes and cardiovascular disease (CVD) in primary care settings in India. METHODS A cluster-randomized trial in sixteen villages/peri-urban areas in Andhra Pradesh and Haryana will test the preliminary effectiveness of this intervention. An independent evaluation will compare the difference in the proportion of participants with diabetes having a 0.5% reduction in HBA1c (measured at baseline and end-line) in intervention and usual-care arm. Qualitative interviews of physicians, ASHA, and community members will ascertain the intervention acceptability and feasibility. RESULTS A total of 1785 adults over 30 years (females: 53.2%; median age: 50 years) were screened. ASHAs achieved 100% completeness of data for all anthropometric, blood-pressure, and blood-glucose measures. At baseline, 63% of the participants were overweight/obese, 27.8% had elevated blood-pressure, 20.3% were at high-risk for CVD, and 21.3% had elevated blood-glucose. Half of the individuals with diabetes were newly diagnosed. CONCLUSIONS Transfers of simple clinical procedures from physicians to non-physician health workers, with the help of technology, can support the provision of healthcare in under-served communities. The preliminary findings suggest that community health workers can successfully screen and refer patients with diabetes and/or CVD to physicians in the Indian primary healthcare system. The proposed model can be adapted for larger trial sand tested for other commonly prevalent disease conditions. CLINICALTRIAL

Background: Women with recent gestational diabetes mellitus (GDM) have increased risk of developing type 2 diabetes mellitus (T2DM). We aimed to determine whether a resource- and culturally-appropriate lifestyle intervention could prevent glycaemic deterioration in South Asia. Methods: This was an open-label parallel-group randomised trial. Women with GDM from 19 urban hospitals in India, Sri Lanka and Bangladesh underwent an oral glucose tolerance test (OGTT) 3-18 months post-partum. Those without T2DM were randomised to a 12-month lifestyle intervention focused on diet and physical activity or usual care. The primary outcome was the proportion with worsening category of glycaemia based on OGTT using American Diabetes Association criteria: 1) normal glucose tolerance to pre-diabetes (impaired fasting glucose and/or impaired glucose tolerance) or T2DM; or 2) pre-diabetes to T2DM. Secondary outcomes included new-onset T2DM, and change in body weight. Findings: 1823 women underwent OGTT at a median of 6·9 months post-partum. After excluding 162 (8·9%) with T2DM, 1612 (37·5% with pre-diabetes and 62·5% with normoglycaemia) were randomised between November 2017 and January 2020. Baseline mean age was 30·9 years (SD 4·9), mean BMI was 26·6 kg/m 2 (SD 4·7). Among participants randomised to the intervention, 79·7% were exposed to all programme content although pandemic lockdowns impacted the delivery model. After 14·5 months median follow-up, 1308 (81·2%) participants had primary outcome data. The intervention, compared to usual care, did not reduce worsening glycaemic status (25·5% vs. 27·1%; hazard ratio, 0·92 [95% CI: 0·76‒1·12]) or any secondary outcome. There was no evidence of heterogeneity of intervention effect by baseline characteristics. Interpretation: A large proportion of South Asian women in urban centres develop dysglycaemia soon after a GDM-affected pregnancy. A low-intensity lifestyle intervention, substantially modified due to the COVID-19 pandemic, did not prevent subsequent deterioration in glycaemic status. Alternate or additional approaches are needed, especially among high-risk individuals. Trial Registration: Clinical Trials Registry of India (CTRI/2017/06/008744), Sri Lanka Clinical Trials Registry (SLCTR/2017/001) and ClinicalTrials.gov (NCT03305939). Funding: Global Alliance for Chronic Disease grants from the Indian Council of Medical Research (NO.58/1/1/GACD/NCD-II) and Australian National Health and Medical Research Council (1093171). Additional funding was received from USV Pharmaceuticals Ltd. and Lupin Pharmaceuticals Ltd. for sub-studies (data not reported here). Declaration of Interest: None to declare. Ethical Approval: The study protocol was approved by Human Research Ethics Committees of the All India Institute of Medical Sciences (India), icddr,b (Bangladesh), Faculty of Medicine, University of Kelaniya (Sri Lanka) and the University of Sydney (Australia)

Additional file 2: Table 1. CONSORT 2010 checklist of information to include when reporting a cluster randomised trial. Table 2. Extension of CONSORT for abstracts1,2 to reports of cluster randomised trials.

Additional file 1. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.

Aim: To refine and contextually adapt a postpartum lifestyle intervention for prevention of type 2 diabetes mellitus (T2DM) in women with prior gestational diabetes mellitus (GDM) in Bangladesh, India, and Sri Lanka.Materials and Methods: In-depth interviews (IDIs) and focus group discussions (FGDs) were conducted with women with current diagnosis of GDM, and health care professionals involved in their management, to understand relevant local contextual factors for intervention optimization and implementation. This paper describes facilitators and barriers as well as feedback from participants on how to improve the proposed intervention. These factors were grouped and interpreted along the axes of the three main determinants of behavior–capability, opportunity, and motivation. IDIs and FGDs were digitally recorded, transcribed, and translated. Data-driven inductive thematic analysis was undertaken to identify and analyze patterns and themes.Results: Two interrelated themes emerged from the IDIs and FGDs: (i) The lifestyle intervention was acceptable and considered to have the potential to improve the existing model of care for women with GDM; and (ii) Certain barriers such as reduced priority of self-care, and adverse societal influences postpartum need to be addressed for the improvement of GDM care. Based on the feedback, the intervention was optimized by including messages for family members in the content of the intervention, providing options for both text and voice messages as reminders, and finalizing the format of the intervention session delivery.Conclusion: This study highlights the importance of contextual factors in influencing postpartum care and support for women diagnosed with GDM in three South Asian countries. It indicates that although provision of postpartum care is complex, a group lifestyle intervention program is highly acceptable to women with GDM, as well as to health care professionals, at urban hospitals.

OBJECTIVE The extent to which diabetes (DM) practice guidelines, often based on evidence from high-income countries (HIC), can be implemented to improve outcomes in low- and middle-income countries (LMIC) is a critical challenge. We carried out a systematic review to compare type 2 DM guidelines in individual LMIC versus HIC over the past decade to identify aspects that could be improved to facilitate implementation. RESEARCH DESIGN AND METHODS Eligible guidelines were sought from online databases and websites of diabetes associations and ministries of health. Type 2 DM guidelines published between 2006 and 2016 with accessible full publications were included. Each of the 54 eligible guidelines was assessed for compliance with the Institute of Medicine (IOM) standards, coverage of the cardiovascular quadrangle (epidemiologic surveillance, prevention, acute care, and rehabilitation), translatability, and its target audiences. RESULTS Most LMIC guidelines were inadequate in terms of applicability, clarity, and dissemination plan as well as socioeconomic and ethical-legal contextualization. LMIC guidelines targeted mainly health care providers, with only a few including patients (7%), payers (11%), and policy makers (18%) as their target audiences. Compared with HIC guidelines, the spectrum of DM clinical care addressed by LMIC guidelines was narrow. Most guidelines from the LMIC complied with less than half of the IOM standards, with 12% of the LMIC guidelines satisfying at least four IOM criteria as opposed to 60% of the HIC guidelines (P < 0.001). CONCLUSIONS A new approach to the contextualization, content development, and delivery of LMIC guidelines is needed to improve outcomes.

Highlights The Global Alliance for Chronic Disease Hypertension Program created an innovative network of researchers. The network facilitated collaboration, learning, and opportunities for growth for researchers. Challenges included at times “too many” opportunities, which took away from core research. Access to experts such as health policymakers and decision makers was invaluable.

Background The Indian National Program for Cardiovascular Disease, Diabetes, Cancer and Stroke (NPCDCS) was introduced to provide non-communicable disease (NCD) care through primary healthcare teams including Accredited Social Health Activists (ASHAs). Since ASHAs are being deployed to provide NCD care on top of their regular work for the first time, there is a need to understand the current capacity and challenges faced by them. Methods A desktop review of NPCDCS and ASHA policy documents was conducted. This was followed by group discussions with ASHAs, in-depth interviews with their supervisors and medical officers and group discussions with community members in Guntur, Andhra Pradesh, India. The multi-stakeholder data were analysed for themes related to needs, capacity, and challenges of ASHAs in providing NCD services. Results This study identified three key themes—first, ASHAs are unrecognised as part of the formal NPCDCS service delivery team. Second, they are overburdened, since they deliver several NPCDCS activities without receiving training or remuneration. Third, they aspire to be formally recognised as employees of the health system. However, ASHAs are enthusiastic about the services they provide and remain an essential link between the health system and the community. Conclusion ASHAs play a key role in providing comprehensive and culturally appropriate care to communities; however, they are unrecognised and overburdened and aspire to be part of the health system. ASHAs have the potential to deliver a broad range of services, if supported by the health system appropriately. Trial registration The study was registered with “Clinical Trials Registry – India” (identifier CTRI/2018/03/012425).

Background: Polypills, fixed-dose combinations of blood pressureelowering drug(s), and statin, with or without aspirin, improve the use of these recommended drugs in patients with or at high risk of cardiovascular disease. However, in India, there has been poor uptake of polypills despite market availability.Objectives: This study sought to assess availability and cost of polypills and explore barriers and facilitators to their use in the state of Andhra Pradesh in India.Methods: A mixed-methods study was conducted. Availability and cost of polypills as well as individual component drugs was assessed through a survey of pharmacies across urban, urban slum, and rural regions in state of Andhra Pradesh in India. In-depth interviews with stakeholders at each level of the health system explored barriers and facilitators to use of polypills.Results: Overall, 30 pharmacies were surveyed (10 in each of urban, urban slum, and rural region). In urban region, 2 pharmacies stocked polypills (without aspirin) costing 121 Indian rupees (INR) per 10 pills, and 1 other pharmacy stocked a polypill (with aspirin) costing 24 INR per 10 pills. All pharmacies stocked a wide range of component drugs as separate pills with combined cost of the cheapest angiotensin-converting enzyme inhibitor, statin, and aspirin INR 124 per 10 pills. Patients were willing to use polypills if prescribed by their doctor, and pharmacies were willing to stock polypills if there was market demand. For prescribers, key barriers included perceptions that current polypills contained outdated drugs and inadequate flexibility in prescribing.Conclusions: In a market in which polypill use is licensed, their availability and use is very low. Lack of prescription of polypills was the predominant barrier to polypill use; therefore, making polypills with drugs that are more acceptable and at different available strengths, in conjunction with broader prescriber education and training, may improve their use.HighlightsIn India, where polypills are licensed, their availability and use are very low.A major barrier to the use of polypills is the lack of prescriptions from prescribers.Polypills with evidence-based drugs that are acceptable to prescribers are likely to improve their use.

Importance Cardiovascular diseases (CVDs) are the leading cause of disease burden in Indonesia. Implementation of effective interventions for CVD prevention is limited. Objective To evaluate whether a mobile technology–supported primary health care intervention, compared with usual care, would improve the use of preventive drug treatment among people in rural Indonesia with a high risk of CVD. Design, Setting, and Participants A quasi-experimental study involving 6579 high-risk individuals in 4 intervention and 4 control villages in Malang district, Indonesia, was conducted between August 16, 2016, and March 31, 2018. Median duration of follow-up was 12.2 months. Residents 40 years or older were invited to participate. Those with high estimated 10-year risk of CVD risk (previously diagnosed CVD, systolic blood pressure [BP] >160 mm Hg or diastolic BP >100 mm Hg, 10-year estimated CVD risk of 30% or more, or 10-year estimated CVD risk of 20%-29% and a systolic BP >140 mm Hg) were followed up. Interventions A multifaceted mobile technology–supported intervention facilitating community-based CVD risk screening with referral, tailored clinical decision support for drug prescription, and patient follow-up. Main Outcomes and Measures The primary outcome was the proportion of individuals taking appropriate preventive CVD medications, defined as at least 1 BP-lowering drug and a statin for all high-risk individuals, and an antiplatelet drug for those with prior diagnosed CVD. Secondary outcomes included mean change in BP from baseline. Results Among 22 635 adults, 3494 of 11 647 in the intervention villages (30.0%; 2166 women and 1328 men; mean [SD] age, 58.3 [10.9] years) and 3085 of 10 988 in the control villages (28.1%; 1838 women and 1247 men; mean [SD] age, 59.0 [11.5] years) had high estimated risk of CVD. Of these, follow-up was completed in 2632 individuals (75.3%) from intervention villages and 2429 individuals (78.7%) from control villages. At follow-up, 409 high-risk individuals in intervention villages (15.5%) were taking appropriate preventive CVD medications, compared with 25 (1.0%) in control villages (adjusted risk difference, 14.1%; 95% CI, 12.7%-15.6%). This difference was driven by higher use of BP-lowering medication in those in the intervention villages (1495 [56.8%] vs 382 [15.7%]; adjusted risk difference, 39.4%; 95% CI, 37.0%-41.7%). The adjusted mean difference in change in systolic BP from baseline was −8.3 mm Hg (95% CI, −10.1 to −6.6 mm Hg). Conclusions and Relevance This study found that a multifaceted mobile technology–supported primary health care intervention was associated with greater use of preventive CVD medication and lower BP levels among high-risk individuals in a rural Indonesian population.

Objectives A diagnosis of hypertensive disorders during pregnancy (HDPs) or gestational diabetes mellitus (GDM) is highly predictive of women at increased risk of developing chronic hypertension, Type 2 diabetes, and cardiovascular disease. This study investigates perceptions of women and healthcare providers in rural India regarding these long‐term risks. Design Qualitative study using modified grounded theory. Setting Two states in rural India: Haryana and Andhra Pradesh. Population Pregnant and postpartum women, community health workers (CHWs), primary care physicians, obstetricians, laboratory technicians, and healthcare officials. Methods In‐depth interviews and focus group discussions explored: (1) priorities for high‐risk pregnant women; (2) detection and management of HDPs and GDM; (3) postpartum management, and (4) knowledge of long‐term sequelae of high‐risk conditions. A thematic analysis was undertaken. Results Seven focus group discussions and 11 in‐depth interviews (n = 71 participants) were performed. The key priority area for high‐risk pregnant women was anaemia. Blood pressure measurement was routinely embedded in antenatal care; however, postpartum follow up and knowledge of the long‐term complications were limited. GDM was not considered a common problem, although significant variations and challenges to GDM screening were identified. Knowledge of the long‐term sequelae of GDM with regard to an increased risk of Type 2 diabetes and cardiovascular disease among doctors was minimal. Conclusions There is a need for improved education, standardisation of testing and postpartum follow up of HDPs and GDM in rural Indian settings. Funding SN is supported by an MRC Clinical Research Training Fellowship (MR/R017182/1). The George Institute for Global Health Global Women's Health programme provided financial support for the research assistant and fieldwork costs in India. Tweetable abstract Improved education and postpartum care of women with hypertension and diabetes in pregnancy in rural India are needed to prevent long‐term risks., Tweetable abstract Improved education and postpartum care of women with hypertension and diabetes in pregnancy in rural India are needed to prevent long‐term risks.

BackgroundThe brunt of cardiovascular disease (CVD) burden globally now resides within low- and middle-income countries, including Indonesia. However, little is known regarding cardiovascular health in Indonesia. This study aimed to estimate the prevalence of elevated CVD risk in a specific region of Indonesia.MethodsWe conducted full household screening for cardiovascular risk factors among adults aged 40 years and older in 8 villages in Malang District, East Java Province, Indonesia, in 2016-2017. 10-year cardiovascular risk scores were calculated based on the World Health Organization/International Society of Hypertension's region-specific charts that use age, sex, blood pressure, diabetes status and smoking behaviour.ResultsAmong 22,093 participants, 6,455 (29.2%) had high cardiovascular risk, defined as the presence of coronary heart disease, stroke or other atherosclerotic disease; estimated 10-year CVD risk of ≥ 30%; or estimated 10-year CVD risk between 10% to 29% combined with a systolic blood pressure of > 140 mmHg. The prevalence of high CVD risk was greater in urban (31.6%, CI 30.7-32.5%) than in semi-urban (28.7%, CI 27.3-30.1%) and rural areas (26.2%, CI 25.2-27.2%). Only 11% and 1% of all the respondents with high CVD risk were on blood pressure lowering and statins treatment, respectively.ConclusionsHigh cardiovascular risk is common among Indonesian adults aged ≥40 years, and rates of preventive treatment are low. Population-based and clinical approaches to preventing CVD should be a priority in both urban and rural areas.

Background Cardiovascular diseases (CVD) are rising in India resulting in major health system challenges. Methods Eighteen primary health centre (PHC) clusters in rural Andhra Pradesh were randomised over three, 6-month steps to an intervention comprising: (1) household CVD risk assessments by village-based community health workers (CHWs) using a mobile tablet device; (2) electronic referral and clinical decision support for PHC doctors; and (3) a tracking system for follow-up care. Independent data collectors screened people aged ≥ 40 years in 54 villages serviced by the PHCs to create a high CVD risk cohort (based on WHO risk charts and blood pressure thresholds). Randomly selected, independent samples, comprising 15% of this cohort, were reviewed at each 6-month step. The primary outcome was the proportion meeting systolic blood pressure (SBP) targets (

© 2016 Diabetes UK Aim: To investigate the distribution of and risk factors for dysglycaemia (Type 2 diabetes and prediabetes) in women with previous gestational diabetes mellitus in India. Methods: All women (n = 989) from two obstetric units in New Delhi and Hyderabad with a history of gestational diabetes were invited to participate, of whom 366 (37%) agreed. Sociodemographic, medical and anthropometric data were collected and 75-g oral glucose tolerance test were carried out. Results: Within 5 years (median 14 months) of the pregnancy in which they were diagnosed with gestational diabetes, 263 (72%) women were dysglycaemic, including 119 (32%) and 144 (40%) with Type 2 diabetes and prediabetes, respectively. A higher BMI [odds ratio 1.16 per 1-kg/m2 greater BMI (95% CI 1.10, 1.28)], presence of acanthosis nigricans [odds ratio 3.10, 95% CI (1.64, 5.87)], postpartum screening interval [odds ratio 1.02 per 1 month greater screening interval 95% CI (1.01, 1.04)] and age [odds ratio 1.10 per 1-year older age 95% CI (1.04, 1.16)] had a higher likelihood of having dysglycaemia. The American Diabetes Association-recommended threshold HbA1c value of ≥ 48 mmol/mol (6.5%) had a sensitivity and specificity of 81.4 and 90.7%, respectively, for determining the presence of Type 2 diabetes postpartum. Conclusion: The high post-pregnancy conversion rates of gestational diabetes to diabetes reported in the present study reinforce the need for mandatory postpartum screening and identification of strategies for preventing progression to Type 2 diabetes. Use of the American Diabetes Association-recommended HbA1c threshold for diabetes may lead to significant under-diagnosis.

Amid massive health system disruption induced by the coronavirus disease 2019 (COVID-19) pandemic, the need to maintain and improve essential health services is greater than ever. This situation underscores the importance of the primary health care (PHC) revitalization agenda articulated in the 2018 Astana Declaration. The objective was to synthesize what was already known about strengthening PHC in low- and middle- income countries prior to COVID-19. We conducted a secondary analysis of eleven reviews and seven evidence gap maps published by the Primary Health Care Research Consortium in 2019. The 2020 World Health Organization Operational framework for primary health care was used to synthesize key learnings and determine areas of best practice. A total of 238 articles that described beneficial outcomes were analysed (17 descriptive studies, 71 programme evaluations, 90 experimental intervention studies and 60 literature reviews). Successful PHC strengthening initiatives required substantial reform across all four of the framework’s strategic levers – political commitment and leadership, governance and policy, funding and allocation of resources, and engagement of communities and other stakeholders. Importantly, strategic reforms must be accompanied by operational reforms; the strongest evidence of improvements in access, coverage and quality related to service delivery models that promote integrated services, workforce strengthening and use of digital technologies. Strengthening PHC is a “hard grind” challenge involving multiple and disparate actors often taking years or even decades to implement successful reforms. Despite major health system adaptation during the pandemic, change is unlikely to be lasting if underlying factors that foster health system robustness are not addressed.

IntroductionThe development of type 2 diabetes mellitus disproportionately affects South Asian women with prior gestational diabetes mellitus (GDM). The Lifestyle InterVention IN Gestational diabetes (LIVING) Study is a randomised controlled trial of a low-intensity lifestyle modification programme tailored to women with previous GDM, in India, Bangladesh and Sri Lanka, aimed at preventing diabetes/pre-diabetes. The aim of this process evaluation is to understand what worked, and why, during the LIVING intervention implementation, and to provide additional data that will assist in the interpretation of the LIVING Study results. The findings will also inform future scale-up efforts if the intervention is found to be effective.Methods and analysisThe Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) methodological approach informed the evaluation framework. Michie’s Behaviour Change Theory and Normalisation Process Theory were used to guide the design of our qualitative evaluation tools within the overall RE-AIM evaluation framework. Mixed methods including qualitative interviews, focus groups and quantitative analyses will be used to evaluate the intervention from the perspectives of the women receiving the intervention, facilitators, site investigators and project management staff. The evaluation will use evaluation datasets, administratively collected process data accessed during monitoring visits, check lists and logs, quantitative participant evaluation surveys, semistructured interviews and focus group discussions. Interview participants will be recruited using maximum variation purposive sampling. We will undertake thematic analysis of all qualitative data, conducted contemporaneously with data collection until thematic saturation has been achieved. To triangulate data, the analysis team will engage in constant iterative comparison among data from various stakeholders.Ethics and disseminationEthics approval has been obtained from the respective human research ethics committees of the All India Institute of Medical Sciences, New Delhi, India; University of Sydney, New South Wales, Australia; and site-specific approval at each local site in the three countries: India, Bangladesh and Sri Lanka. This includes approvals from the Institutional Ethics Committee at King Edwards Memorial Hospital, Maharaja Agrasen Hospital, Centre for Disease Control New Delhi, Goa Medical College, Jawaharlal Institute of Postgraduate Medical Education and Research, Madras Diabetes Research Foundation, Christian Medical College Vellore, Fernandez Hospital Foundation, Castle Street Hospital for Women, University of Kelaniya, Topiwala National Medical College and BYL Nair Charitable Hospital, Birdem General Hospital and the International Centre for Diarrhoeal Disease Research. Findings will be documented in academic publications, presentations at scientific meetings and stakeholder workshops.Trial registration numbersClinical Trials Registry of India (CTRI/2017/06/008744); Sri Lanka Clinical Trials Registry (SLCTR/2017/001) and ClinicalTrials.gov Registry (NCT03305939); Pre-results.

AimTo evaluate the feasibility and potential effectiveness of a lifestyle intervention (diet and physical activity) among women with history of gestational diabetes mellitus (GDM), delivered by trained facilitators.MethodsFifty-six normoglycaemic or prediabetic women with prior GDM were recruited at mean of 17 months postpartum. Socio-demographic, medical and anthropometric data were collected. Six sessions on lifestyle modification were delivered in groups (total four groups, with 12–15 women in each group). Pre and post intervention (6 months) weight, body mass index (BMI), waist circumference, 75 g oral glucose tolerance test, blood pressure (BP) and lipid parameters were compared.ResultsThe intervention was feasible, with 80% of women attending four or more sessions. Post-intervention analyses showed a significant mean reduction of 1.8 kg in weight, 0.6 kg/m2 in BMI and 2 cm in waist circumference. There was also a significant drop of 0.3 mmol/L in fasting plasma glucose, 0.9 mmol/L in 2 h post glucose load value of plasma glucose, 3.6 mmHg in systolic BP, and 0.15 mmol/L in triglyceride levels. Changes in total cholesterol, low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol and diastolic BP were non-significant.ConclusionsThis study showed feasibility of the lifestyle intervention delivered in group sessions to women with prior gestational diabetes.

Background Non-optimal blood pressure (BP) levels are a major cause of disease burden globally. We describe current BP and treatment patterns in rural India and compare different approaches to BP lowering in this setting. Methods All individuals aged ≥40 years from 54 villages in a South Indian district were invited and 62,194 individuals (84%) participated in a cross-sectional study. Individual 10-year absolute cardiovascular disease (CVD) risk was estimated using WHO/ISH charts. Using known effects of treatment, proportions of events that would be averted under different paradigms of BP lowering therapy were estimated. Results After imputation of pre-treatment BP levels for participants on existing treatment, 76·9% (95% confidence interval, 75.7–78.0%), 5·3% (4.9–5.6%), and 17·8% (16.9–18.8%) of individuals had a 10-year CVD risk defined as low ( 160/100 mmHg), respectively. Compared to the 19.6% (18.4–20.9%) of adults treated with current practice, a slightly higher or similar proportion would be treated using an intermediate (23·2% (22.0–24.3%)) or high (17·9% (16.9–18.8%) risk threshold for instituting BP lowering therapy and this would avert 87·2% (85.8–88.5%) and 62·7% (60.7–64.6%) more CVD events over ten years, respectively. These strategies were highly cost-effective relative to the current practice. Conclusion In a rural Indian community, a substantial proportion of the population has elevated CVD risk. The more efficient and cost-effective clinical approach to BP lowering is to base treatment decisions on an estimate of an individual’s short-term absolute CVD risk rather than with BP based strategy. Clinical trial registration Clinical Trials Registry of India CTRI/2013/06/003753, 14 June 2013. Electronic supplementary material The online version of this article (10.1186/s12889-018-6142-x) contains supplementary material, which is available to authorized users.

Background Discrete choice experiment (DCE) is a quantitative technique which helps determine preferences from a definite set of choices. DCEs have been widely used to inform health services in high-income country settings and is gradually being used in low and middle-income countries (LMICs). There are challenges in deploying this method in LMIC settings due to the contextual, cultural and language related barriers. Most DCEs are conducted using paper-based tools. With mobile technology readily accessible across LMICs, we developed an Android-based platform to conduct a DCE among community health workers (CHWs) in rural India. Methods This paper describes the development of a DCE for low-literacy community health workers (CHWs) in low-resourced setting on an Android platform. We illustrate the process of identifying realistic and locally relevant attributes, finalising the tool and cognitively testing it among respondents with an average of 10 years of education using ‘think aloud’ and ‘verbal probing’ techniques. The Android application was tested in two rounds, first by the research team and second, by the CHWs. The ‘think aloud’ and ‘verbal probing’ techniques were essential in assessing the comprehension of the CHWs to the DCE choices. Results The CHWs did not take much time to familiarize themselves with the Android application. Compared to the paper based DCE, the time required for data collection using the Android application was reduced by 50%. We found the Android-based app to be more efficient and time saving as it reduced errors in data collection, eliminated the process of data entry and presented the data for analysis in real time. Conclusion Electronic administration of DCE on Android computer tablets to CHWs with basic education is more efficient, time-saving than paper-based survey designs once the application is provided. It is feasible to use technology to develop and implement DCEs among participants with basic education in resource poor settings.

Aim This study aims to determine whether a resource- and culturally appropriate lifestyle intervention programme in South Asian countries, provided to women with gestational diabetes (GDM) after childbirth, will reduce the incidence of worsening of glycaemic status in a manner that is affordable, acceptable and scalable. Methods Women with GDM (diagnosed by oral glucose tolerance test using the International Association of the Diabetes and Pregnancy Study Groups criteria) will be recruited from 16 hospitals in India, Sri Lanka and Bangladesh. Participants will undergo a repeat oral glucose tolerance test at 6 ± 3 months postpartum and those without Type 2 diabetes, a total sample size of 1414, will be randomly allocated to the intervention or usual care. The intervention will consist of four group sessions, 84 SMS or voice messages and review phone calls over the first year. Participants requiring intensification of the intervention will receive two additional individual sessions over the latter half of the first year. Median follow-up will be 2 years. The primary outcome is the proportion of women with a change in glycaemic category, using the American Diabetes Association criteria: (i) normal glucose tolerance to impaired fasting glucose, or impaired glucose tolerance, or Type 2 diabetes; or (ii) impaired fasting glucose or impaired glucose tolerance to Type 2 diabetes. Process evaluation will explore barriers and facilitators of implementation of the intervention in each local context, while trial-based and modelled economic evaluations will assess cost-effectiveness. Discussion The study will generate important new evidence about a potential strategy to address the long-term sequelae of GDM, a major and growing problem among women in South Asia. (Clinical Trials Registry of India No: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry No: SLCTR/2017/001; and ClinicalTrials.gov Identifier No: NCT03305939).

BackgroundWith the exponential increase in mobile phone users in India, a large number of public health initiatives are leveraging information technology and mobile devices for health care delivery. Given the considerable financial and human resources being invested in these initiatives, it is important to ascertain their role in strengthening health care systems. ObjectiveWe undertook this review to identify the published mobile health (mHealth) or telemedicine initiatives in India in terms of their current role in health systems strengthening. The review classifies these initiatives based on the disease areas, geographical distribution, and target users and assesses the quality of the available literature. MethodsA search of the literature was done to identify mHealth or telemedicine articles published between January 1997 and June 2017 from India. The electronic bibliographic databases and registries searched included MEDLINE, EMBASE, Joanna Briggs Institute Database, and Clinical Trial Registry of India. The World Health Organization health system building block framework was used to categorize the published initiatives as per their role in the health system. Quality assessment of the selected articles was done using the Cochrane risk of bias assessment and National Institutes of Health, US tools. ResultsThe combined search strategies yielded 2150 citations out of which 318 articles were included (primary research articles=125; reviews and system architectural, case studies, and opinion articles=193). A sharp increase was seen after 2012, driven primarily by noncommunicable disease–focused articles. Majority of the primary studies had their sites in the south Indian states, with no published articles from Jammu and Kashmir and north-eastern parts of India. Service delivery was the primary focus of 57.6% (72/125) of the selected articles. A majority of these articles had their focus on 1 (36.0%, 45/125) or 2 (45.6%, 57/125) domains of health system, most frequently service delivery and health workforce. Initiatives commonly used client education as a tool for improving the health system. More than 91.2% (114/125) of the studies, which lacked a sample size justification, had used convenience sampling. Methodological rigor of the selected trials (n=11) was assessed to be poor as majority of the studies had a high risk for bias in at least 2 categories. ConclusionsIn conclusion, mHealth initiatives are being increasingly tested to improve health care delivery in India. Our review highlights the poor quality of the current evidence base and an urgent need for focused research aimed at generating high-quality evidence on the efficacy, user acceptability, and cost-effectiveness of mHealth interventions aimed toward health systems strengthening. A pragmatic approach would be to include an implementation research component into the existing and proposed digital health initiatives to support the generation of evidence for health systems strengthening on strategically important outcomes.

BACKGROUND With the exponential increase in mobile phone users in India, a large number of public health initiatives are leveraging information technology and mobile devices for health care delivery. Given the considerable financial and human resources being invested in these initiatives, it is important to ascertain their role in strengthening health care systems. OBJECTIVE We undertook this review to identify the published mobile health (mHealth) or telemedicine initiatives in India in terms of their current role in health systems strengthening. The review classifies these initiatives based on the disease areas, geographical distribution, and target users and assesses the quality of the available literature. METHODS A search of the literature was done to identify mHealth or telemedicine articles published between January 1997 and June 2017 from India. The electronic bibliographic databases and registries searched included MEDLINE, EMBASE, Joanna Briggs Institute Database, and Clinical Trial Registry of India. The World Health Organization health system building block framework was used to categorize the published initiatives as per their role in the health system. Quality assessment of the selected articles was done using the Cochrane risk of bias assessment and National Institutes of Health, US tools. RESULTS The combined search strategies yielded 2150 citations out of which 318 articles were included (primary research articles=125; reviews and system architectural, case studies, and opinion articles=193). A sharp increase was seen after 2012, driven primarily by noncommunicable disease–focused articles. Majority of the primary studies had their sites in the south Indian states, with no published articles from Jammu and Kashmir and north-eastern parts of India. Service delivery was the primary focus of 57.6% (72/125) of the selected articles. A majority of these articles had their focus on 1 (36.0%, 45/125) or 2 (45.6%, 57/125) domains of health system, most frequently service delivery and health workforce. Initiatives commonly used client education as a tool for improving the health system. More than 91.2% (114/125) of the studies, which lacked a sample size justification, had used convenience sampling. Methodological rigor of the selected trials (n=11) was assessed to be poor as majority of the studies had a high risk for bias in at least 2 categories. CONCLUSIONS In conclusion, mHealth initiatives are being increasingly tested to improve health care delivery in India. Our review highlights the poor quality of the current evidence base and an urgent need for focused research aimed at generating high-quality evidence on the efficacy, user acceptability, and cost-effectiveness of mHealth interventions aimed toward health systems strengthening. A pragmatic approach would be to include an implementation research component into the existing and proposed digital health initiatives to support the generation of evidence for health systems strengthening on strategically important outcomes.

BACKGROUND Communities in rural Andhra Pradesh may be at increasing risk of diabetes. In the present study we analyzed three cross-sectional studies over 9 years to estimate the changing prevalence of dysglycemia (diabetes and prediabetes). METHODS The 2005 study sampled 4535 individuals from 20 villages, the 2010 study sampled 4024 individuals from 14 villages, and the 2014 project of 62 254 individuals sought to include all adults aged 40-85 years from 54 villages. Blood glucose levels were estimated using a hand-held device in 2005 and 2014 and using HbA1c dried blood spots in 2010. RESULTS In primary analyses restricted to assays based on fasting samples (2005, n = 3243; 2014, n = 749), the prevalence estimates for dysglycemia were 53.7% (95% confidence interval [CI] 51.8%-55.7%) in 2005 and 62.0% (95% CI 58.5%-65.4%) in 2014 (P < 0.001). Over the same period, mean body mass index (BMI) increased from 22.2 to 24.3 kg/m2 (mean difference 2.1 kg/m2 ; 95% CI 2.0-2.2 kg/m2 ; P < 0.001). In secondary analyses using data from all participants (2005, n = 4535; 2010, n = 4024; 2014, n = 62 254), regardless of measurement technique, the estimated prevalence of dysglycemia was 53.9% (95% CI 52.0%-55.9%) in 2005, 50.5% (95% CI 46.1%-54.9%) in 2010, and 41.3% (95% CI 40.9%-41.7%) in 2014 (P < 0.001). CONCLUSIONS The prevalence of dysglycemia was high at every assessment using every measurement method. Dysglycemia in this population is most likely to have risen with the rise in BMI. The decline in prevalence suggested by the secondary analyses was likely due to confounding from the different assessment methods.

With the rapid adoption of mobile devices, mobile health (mHealth) offers the potential to transform health care delivery, especially in the world's poorest regions. We systematically reviewed the literature to determine the impact of mHealth interventions on health care quality for non-communicable diseases in low- and middle-income countries and to identify knowledge gaps in this rapidly evolving field. Overall, we found few high-quality studies. Most studies narrowly focused on text messaging systems for patient behavior change, and few studies examined the health systems strengthening aspects of mHealth. There were limited literature reporting clinical effectiveness, costs, and patient acceptability, and none reporting equity and safety issues. Despite the bold promise of mHealth to improve health care, much remains unknown about whether and how this will be fulfilled. Encouragingly, we identified some registered clinical trial protocols of large-scale, multidimensional mHealth interventions, suggesting that the current limited evidence base will expand in coming years.

Elevated blood pressure, a major risk factor for ischemic heart disease, heart failure, and stroke, is the leading global risk for mortality. Despite global efforts to combat hypertension, it continues to exert a significant health and economic burden on low- and middle-income country (LMIC) populations, thereby triggering the need to address the problem by way of novel approaches. The Global Alliance for Chronic Diseases has funded 15 research projects related to hypertension control in low-resource settings worldwide. These research projects have developed and evaluated several important innovative approaches to hypertension control, including: community engagement, salt reduction, salt substitution, task redistribution, mHealth, and fixed-dose combination therapies. In this paper, we briefly review the rationale for each of these innovative approaches, as well as summarize the experience of some of the research teams in these respective areas. Where relevant, we also draw upon the wider literature to illustrate how these approaches to hypertension control are being implemented in LMICs. The studies outlined in this report demonstrate innovative and practical methods of implementing for improving hypertension control in diverse environments and contexts worldwide.

Background: Member states of the WHO, including India, have adopted a target 30% reduction in mean population salt consumption by 2025 to prevent noncommunicable diseases. Our aim was to support this initiative by summarizing existing data that describe mean salt consumption in India. Method: Electronic databases – MEDLINE via Ovid, EMBASE, CINAHL and the Cochrane Database of Systematic Reviews – were searched up to November 2015 for studies that reported mean or median dietary salt intake in Indian adults aged 19 years and older. Random effects meta-analysis was used to obtain summary estimates of salt intake. Results: Of 1201 abstracts identified, 90 were reviewed in full text and 21 were included: 18 cross-sectional surveys (n = 225 024), two randomized trials (n = 255) and one case–control study (n = 270). Data were collected between 1986 and 2014, and reported mean salt consumption levels were between 5.22 and 42.30 g/day. With an extreme outlier excluded, overall mean weighted salt intake was 10.98 g/day (95% confidence interval 8.57–13.40). There was significant heterogeneity between the estimates for contributing studies (I2 = 99.97%) (P homogeneity ≤0.001), which was likely attributable to the different measurement methods used and the different populations studied. There was no evidence of a change in intake over time (P trend = 0.08). Conclusion: The available data leave some uncertainty about exact mean salt consumption in India but there is little doubt that population salt consumption far exceeds the WHO-recommended maximum of 5 g per person per day.

Background We believe that it is important that governments understand the reliability of the mortality data which they have at their disposable to guide policy debates. In many instances, verbal autopsy (VA) will be the only source of mortality data for populations, yet little is known about how the accuracy of VA diagnoses is affected by the reliability of the symptom responses. We previously described the effect of the duration of time between death and VA administration on VA validity. In this paper, using the same dataset, we assess the relationship between the reliability and completeness of symptom responses and the reliability and accuracy of cause of death (COD) prediction. Methods The study was based on VAs in the Population Health Metrics Research Consortium (PHMRC) VA Validation Dataset from study sites in Bohol and Manila, Philippines and Andhra Pradesh, India. The initial interview was repeated within 3–52 months of death. Question responses were assessed for reliability and completeness between the two survey rounds. COD was predicted by Tariff Method. Results A sample of 4226 VAs was collected for 2113 decedents, including 1394 adults, 349 children, and 370 neonates. Mean question reliability was unexpectedly low (kappa = 0.447): 42.5 % of responses positive at the first interview were negative at the second, and 47.9 % of responses positive at the second had been negative at the first. Question reliability was greater for the short form of the PHMRC instrument (kappa = 0.497) and when analyzed at the level of the individual decedent (kappa = 0.610). Reliability at the level of the individual decedent was associated with COD predictive reliability and predictive accuracy. Conclusions Families give coherent accounts of events leading to death but the details vary from interview to interview for the same case. Accounts are accurate but inconsistent; different subsets of symptoms are identified on each occasion. However, there are sufficient accurate and consistent subsets of symptoms to enable the Tariff Method to assign a COD. Questions which contributed most to COD prediction were also the most reliable and consistent across repeat interviews; these have been included in the short form VA questionnaire. Accuracy and reliability of diagnosis for an individual death depend on the quality of interview. This has considerable implications for the progressive roll out of VAs into civil registration and vital statistics (CRVS) systems. Electronic supplementary material The online version of this article (doi:10.1186/s12963-016-0104-2) contains supplementary material, which is available to authorized users.

Background One key contextual feature in Verbal Autopsy (VA) is the time between death and survey administration, or recall period. This study quantified the effect of recall period on VA performance by using a paired dataset in which two VAs were administered for a single decedent. Methods This study used information from the Population Health Metrics Research Consortium (PHMRC) Study, which collected VAs for “gold standard” cases where cause of death (COD) was supported by clinical criteria. This study repeated VA interviews within 3–52 months of death in PHMRC study sites in Andhra Pradesh, India, and Bohol and Manila, Philippines. The final dataset included 2113 deaths interviewed twice and with recall periods ranging from 0 to 52 months. COD was assigned by the Tariff method and its accuracy determined by comparison with the gold standard COD. Results The probability of a correct diagnosis of COD decreased by 0.55 % per month in the period after death. Site of data collection and survey module also affected the probability of Tariff Method correctly assigning a COD. The probability of a correct diagnosis in VAs collected 3–11 months after death will, on average, be 95.9 % of that in VAs collected within 3 months of death. Conclusions These findings suggest that collecting VAs within 3 months of death may improve the quality of the information collected, taking the need for a period of mourning into account. This study substantiates the WHO recommendation that it is reasonable to collect VAs up to 1 year after death providing it is accepted that probability of a correct diagnosis is likely to decline month by month during this period. Electronic supplementary material The online version of this article (doi:10.1186/s12963-016-0105-1) contains supplementary material, which is available to authorized users.

A cross-sectional study was conducted in the year 2008 among 174 children in observation homes in Hyderabad, India, to estimate the distribution of inhalant (whitener) use among this population. Data were collected using an instrument developed for this purpose. About 61% of the children were boys and their mean age was 12.2 years (range 5-18 years). Whitener use was found in 35% of the children along with concurrent use of other substances. Peer pressure was the commonest cause reported for initiating substance use. The high prevalence is an important concern for the Indian policymakers given the large number of street children in Indian cities.

Task-shifting to non-physician health workers (NPHWs) has been an effective model for managing infectious diseases and improving maternal and child health. There is inadequate evidence to show the effectiveness of NPHWs to manage cardiovascular diseases (CVDs). In 2012, the Global Alliance for Chronic Diseases funded eight studies which focused on task-shifting to NPHWs for the management of hypertension. We report the lessons learnt from the field. From each of the studies, we obtained information on the types of tasks shifted, the professional level from which the task was shifted, the training provided and the challenges faced. Additionally, we collected more granular data on ‘lessons learnt ’ throughout the implementation process and ‘design to implementation’ changes that emerged in each project. The tasks shifted to NPHWs included screening of individuals, referral to physicians for diagnosis and management, patient education for lifestyle improvement, follow-up and reminders for medication adherence and appointments. In four studies, tasks were shifted from physicians to NPHWs and in four studies tasks were shared between two different levels of NPHWs. Training programmes ranged between 3 and 7 days with regular refresher training. Two studies used clinical decision support tools and mobile health components. Challenges faced included system level barriers such as inability to prescribe medicines, varying skill sets of NPHWs, high workload and staff turnover. With the acute shortage of the health workforce in low-income and middle-income countries (LMICs), achieving better health outcomes for the prevention and control of CVD is a major challenge. Task-shifting or sharing provides a practical model for the management of CVD in LMICs.

Cause list for PHMRC VA study by module. (DOCX 13Â kb)

Odds ratios from logistic regressions 1, 2 and 3 showing the effects of recall period on correct assignment for verbal autopsy pairs for adults only. Results of logistic regression models analyzing predictors of correct assignment for adults only. (DOCX 14Â kb)

List of target causes for the VA for adults, children and neonates. (DOCX 12Â kb)

Summary of the sample size of VA respondents and their relationship to the decedent, by module. (DOCX 13Â kb)

15 p., Background The Global Alliance for Chronic Diseases comprises the majority of the world’s public research funding agencies. It is focussed on implementation research to tackle the burden of chronic diseases in low- and middle-income countries and amongst vulnerable populations in high-income countries. In its inaugural research call, 15 projects were funded, focussing on lowering blood pressure-related disease burden. In this study, we describe a reflexive mapping exercise to identify the behaviour change strategies undertaken in each of these projects. Methods Using the Behaviour Change Wheel framework, each team rated the capability, opportunity and motivation of the various actors who were integral to each project (e.g. community members, non-physician health workers and doctors in projects focussed on service delivery). Teams then mapped the interventions they were implementing and determined the principal policy categories in which those interventions were operating. Guidance was provided on the use of Behaviour Change Wheel to support consistency in responses across teams. Ratings were iteratively discussed and refined at several group meetings. Results There was marked variation in the perceived capabilities, opportunities and motivation of the various actors who were being targeted for behaviour change strategies. Despite this variation, there was a high degree of synergy in interventions functions with most teams utilising complex interventions involving education, training, enablement, environmental restructuring and persuasion oriented strategies. Similar policy categories were also targeted across teams particularly in the areas of guidelines, communication/marketing and service provision with few teams focussing on fiscal measures, regulation and legislation. Conclusions The large variation in preparedness to change behaviour amongst the principal actors across these projects suggests that the interventions themselves will be variably taken up, despite the similarity in approaches taken. The findings highlight the importance of contextual factors in driving success and failure of research programmes. Forthcoming outcome and process evaluations from each project will build on this exploratory work and provide a greater understanding of factors that might influence scale-up of intervention strategies.

Background.India has few mental health professionals to treat the large number of people suffering from mental disorders. Rural areas are particularly disadvantaged due to lack of trained health workers. Ways to improve care could be by training village health workers in basic mental health care, and by using innovative methods of service delivery. The ongoing Systematic Medical Appraisal, Referral and Treatment Mental Health Programme will assess the acceptability, feasibility and preliminary effectiveness of a task-shifting mobile-based intervention using mixed methods, in rural Andhra Pradesh, India.Method.The key components of the study are an anti-stigma campaign followed by a mobile-based mental health services intervention. The study will be done across two sites in rural areas, with intervention periods of 1 year and 3 months, respectively. The programme uses a mobile-based clinical decision support tool to be used by non-physician health workers and primary care physicians to screen, diagnose and manage individuals suffering from depression, suicidal risk and emotional stress. The key aim of the study will be to assess any changes in mental health services use among those screened positive following the intervention. A number of other outcomes will also be assessed using mixed methods, specifically focussed on reduction of stigma, increase in mental health awareness and other process indicators.Conclusions.This project addresses a number of objectives as outlined in the Mental Health Action Plan of World Health Organization and India's National Mental Health Programme and Policy. If successful, the next phase will involve design and conduct of a cluster randomised controlled trial.

Communities in rural Andhra Pradesh may be at increasing risk of diabetes. In the present study we analyzed three cross-sectional studies over 9 years to estimate the changing prevalence of dysglycemia (diabetes and prediabetes).The 2005 study sampled 4535 individuals from 20 villages, the 2010 study sampled 4024 individuals from 14 villages, and the 2014 project of 62 254 individuals sought to include all adults aged 40-85 years from 54 villages. Blood glucose levels were estimated using a hand-held device in 2005 and 2014 and using HbA1c dried blood spots in 2010.In primary analyses restricted to assays based on fasting samples (2005, n = 3243; 2014, n = 749), the prevalence estimates for dysglycemia were 53.7% (95% confidence interval [CI] 51.8%-55.7%) in 2005 and 62.0% (95% CI 58.5%-65.4%) in 2014 (P0.001). Over the same period, mean body mass index (BMI) increased from 22.2 to 24.3 kg/mThe prevalence of dysglycemia was high at every assessment using every measurement method. Dysglycemia in this population is most likely to have risen with the rise in BMI. The decline in prevalence suggested by the secondary analyses was likely due to confounding from the different assessment methods.

KEN 13 Assessment. Optimizing Linkage and Retention to Hypertension Care in Rural Kenya (KEN 13).

Background: Cardiovascular disease (CVD) is a major cause of premature morbidity and mortality globally, and is responsible for 27% of all deaths in India. The rise in CVD burden is largely due to an increase in the prevalence of CVD risk factors and a relative lack of resources devoted for CVD care. Health systems in India face substantial challenges to meet the growing epidemic. Innovative solutions addressing health system challenges and reliable information about the CVD risk factor prevalence and management have the potential to influence strategies for the development of CVD prevention programs in India. Methods: 1. Morbidity data from the SMARThealth India study involving around 62000 participants from 54 villages was analysed to describe the CVD burden and treatment patterns in a rural community of Andhra Pradesh, India 2. The morbidity data from the SMARThealth India study and the Andhra Pradesh Rural Health Initiative (APRHI) study were compared to estimate the trend in blood pressure (BP) distribution and management in the last decade in a rural community of Andhra Pradesh 3. A comprehensive literature review was conducted to describe the role of mHealth in improving healthcare quality for non-communicable diseases in low- and middle-income countries 4. A novel community mHealth intervention model for provision of CVD care to the rural communities was developed and preliminarily evaluated using a mixed methods approach in 11 villages of Andhra Pradesh, India Findings: Approximately 40% of all adults aged 40 years and above in a rural region of Andhra Pradesh, India had hypertension, of which, around 50% were aware of their diagnosis, 48% were on prescribed BP lowering therapy and 26% had their BP controlled. The proportions having low, intermediate and high 10-year CVD risk were 77•7%, 5•4% and 16•9%, respectively. Comparison of two cross-sectional studies, 10 years apart, in the same region showed a 4% increase in the prevalence of hypertension although there was a reduction in mean systolic BP by 1.6 mmHg. Upon comparison of the projected outcomes from current BP treatment patterns with those from an absolute risk approach, it was found that around one-half of those on BP lowering treatment are at low risk and around one half of individuals at high risk are actually taking their BP lowering drugs. Modeling the BP treatment pattern showed that in comparsion to current use of BP lowering medications (20%) in general population, a similar number of people would be treated using an intermediate (22%) or high (17%) risk threshold for instituting BP lowering drug therapy. However, compared to current practice, such risk-based strategies for BP lowering could avert 92% and 65% more CVD events over 10 years, respectively making it an efficient clinical approach to BP lowering. The literature review concluded that though mHealth are currently being used in low-and middle-income countries for patient level behavior change, there is a lack of literature for research on end-to-end healthcare systems where multi-faceted strategies including mHealth are taken to improve patient care. An innovative systems oriented approach using mHealth, task shifting, and risk-based strategies for BP lowering was developed and found to be feasible to implement in a rural setting and acceptable to the rural community, non-physician health workers and primary care physicians. Conclusion: India is undergoing a rapid epidemiological transition. A substantial proportion of a rural Indian population has elevated CVD risk with large gaps in CVD management. An innovative multifaceted mHealth platform for CVD care using efficient clinical approaches is feasible to be implemented in these settings. More research is required to develop an innovative, sustainable and scalable strategy in order to achieve the goals for reducing 25% of CVD by 2025, a target set at the 65th World Health Assembly.

The rise of chronic disease and failure in the implementation of adequate prevention strategies places a heavy burden on the health systems of low- and middle-income countries. Despite vast interest in mobile health (mHealth) technologies, there is a lack of evidence for the clinical impact and scalability of mHealth tools for managing chronic diseases in a resource-constrained setting. This paper outlines the development and field evaluation of an mHealth solution in the form of a clinical decision support (CDS) tool. The CDS tool was tailored for use by healthcare providers within a primary care setup in rural India to perform screening and management of cardiovascular disease (CVD) risk. The CDS tool was designed prior to, and during an agile development phase that comprehensively engaged end-users namely primary health centre (PHC) physicians and rural non-physician healthcare workers (NPHWs). Lessons learnt from a pilot implementation are presented to help inform strategies for large-scale evaluation of mHealth technology in resource-constrained settings.

Shortened PHMRC VAI. (DOCX 133 kb)