The efficacy of interventions to prevent type 2 diabetes among women with recent gestational diabetes mellitus-A living systematic review and meta-analysis.

BACKGROUND: While previously considered a transient condition, with no lasting adverse impact, gestational diabetes mellitus (GDM) is now a well-established risk factor for developing type 2 diabetes mellitus (T2DM). The risk of developing T2DM appears to be particularly high in the first few years after childbirth, providing a compelling case for early intervention. This review provides an up-to-date systematic review and meta-analysis to assess the effectiveness of interventions to reduce incidence of T2DM in women with a recent history of GDM. METHODS: The search was conducted on October 20, 2023 with an annual surveillance planned for the next 5 years to maintain a living systematic review. The inclusion criteria were randomized controlled trials of any type in women within 5 years of GDM-complicated pregnancy that reported outcomes of T2DM diagnosis or measures of dysglycemia with a follow-up of at least 12 months. RESULTS: Seventeen studies met our inclusion criteria and have been included in this review. There were 3 pharmacological and 14 lifestyle interventions. Intervention was not associated with significant reduction in the primary outcome of T2DM (risk ratio, 0.78; 95% confidence interval [CI]: 0.43-1.41; p = 0.41; I2 = 79%) compared with the control group (placebo or usual care). However, meta-analysis of the four studies reporting hazard ratios suggested a reduction in diabetes incidence (hazard ratio, 0.68; 95% CI: 0.48-0.97; p = 0.03; I2 = 31%). CONCLUSION: This review provides equivocal evidence about the efficacy of interventions to reduce the risk of T2DM in women within 5 years of GDM-complicated pregnancy and highlights the need for further studies, including pharmacotherapy.

Rationale, Design, and Intervention Development of a Mobile Health-Led Primary Care Program for Management of Type 2 Diabetes in Rural Thailand: Protocol for a SMARThealth Diabetes Study.

BACKGROUND: Noncommunicable diseases (NCDs), particularly diabetes and chronic kidney diseases, pose a significant health burden in Thailand, especially among socioeconomically disadvantaged populations. The existing primary health care system faces challenges in providing optimal care for NCDs due to inadequate primary care workforce. The SMARThealth program offers a technology-based solution to enhance NCD management through task-sharing among nonphysician health care workers. OBJECTIVE: This study aims to adapt and implement the SMARThealth Diabetes program in rural Thailand to improve diabetes management. The main objectives are to (1) adapt, validate, and integrate the SMARThealth Diabetes program for improving the management of type 2 diabetes mellitus at the primary health care level; and (2) to determine the feasibility and acceptability of the SMARThealth Diabetes program in rural communities of Thailand. METHODS: A pragmatic, type 2 hybrid effectiveness or implementation, parallel-group cluster randomized controlled trial of 12 months duration and involving 51 subdistrict health offices in rural communities of Kamphaeng Phet province, Thailand, will be conducted. The intervention arm will receive the SMARThealth Diabetes program, including workforce restructuring, clinical decision support system, and continuous performance monitoring, while the control arm will continue with usual practice. Data will be collected using the SMARThealth platform and will be stored on a server in Thailand. The primary outcome measure will be the change in mean hemoglobin A1c (HbA1c) measured at randomization and 12 months from randomization between the intervention and control clusters. Secondary outcomes will include the difference in change in albuminuria status, estimated glomerular filtration rate, systolic blood pressure, and low-density lipoprotein cholesterol level. The analysis for change in HbA1c between baseline and end of study will be performed using linear mixed models. Any imbalances between the 2 arms will be addressed by sensitivity analyses. Additionally, a mixed methods process evaluation will be conducted to assess the implementation process, that will include in-depth interviews and focus group discussions, in addition to the quantitative data collected during the implementation process. The qualitative data will be thematically analyzed to explore factors that promote or inhibit the implementation and maintenance of the program. RESULTS: The data collection commenced in November 2022, and the results will be ready for publication by the first quarter of 2025. Effectiveness of the intervention package will be assessed by change in mean HbA1c measures, and detailed feasibility, barriers, and enablers for the implementation of the intervention will be documented through a detailed process evaluation. CONCLUSIONS: The study protocol outlines a novel approach to enhancing diabetes management in rural Thailand through digital technology-based interventions that will facilitate task-sharing among health care workers. This can help inform future strategies for improving NCD care in low-resource settings globally. TRIAL REGISTRATION: Thai Clinical Trials Registry TCTR20200322006; https://www.thaiclinicaltrials.org/show/TCTR20200322006. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59266.

Mental Health Care Support in Rural India: A Cluster Randomized Clinical Trial.

Importance: More than 150 million people in India need mental health care but few have access to affordable care, especially in rural areas. Objective: To determine whether a multifaceted intervention involving a digital health care model along with a community-based antistigma campaign leads to reduced depression risk and lower mental health-related stigma among adults residing in rural India. Design, Setting, and Participants: This parallel, cluster randomized, usual care-controlled trial was conducted from September 2020 to December 2021 with blinded follow-up assessments at 3, 6, and 12 months at 44 rural primary health centers across 3 districts in Haryana and Andhra Pradesh states in India. Adults aged 18 years and older at high risk of depression or self-harm defined by either a Patient Health Questionnaire-9 item (PHQ-9) score of 10 or greater, a Generalized Anxiety Disorder-7 item (GAD-7) score of 10 or greater, or a score of 2 or greater on the self-harm/suicide risk question on the PHQ-9. A second cohort of adults not at high risk were selected randomly from the remaining screened population. Data were cleaned and analyzed from April 2022 to February 2023. Interventions: The 12-month intervention included a community-based antistigma campaign involving all participants and a digital mental health intervention involving only participants at high risk. Primary health care workers were trained to identify and manage participants at high risk using the Mental Health Gap Action Programme guidelines from the World Health Organization. Main Outcomes and Measures: The 2 coprimary outcomes assessed at 12 months were mean PHQ-9 scores in the high-risk cohort and mean behavior scores in the combined high-risk and non-high-risk cohorts using the Mental Health Knowledge, Attitude, and Behavior scale. Results: Altogether, 9928 participants were recruited (3365 at high risk and 6563 not at high risk; 5638 [57%] female and 4290 [43%] male; mean [SD] age, 43 [16] years) with 9057 (91.2%) followed up at 12 months. Mean PHQ-9 scores at 12 months for the high-risk cohort were lower in the intervention vs control groups (2.77 vs 4.48; mean difference, -1.71; 95% CI, -2.53 to -0.89; P < .001). The remission rate in the high-risk cohort (PHQ-9 and GAD-7 scores <5 and no risk of self-harm) was higher in the intervention vs control group (74.7% vs 50.6%; odds ratio [OR], 2.88; 95% CI, 1.53 to 5.42; P = .001). Across both cohorts, there was no difference in 12-month behavior scores in the intervention vs control group (17.39 vs 17.74; mean difference, -0.35; 95% CI, -1.11 to 0.41; P = .36). Conclusions and Relevance: A multifaceted intervention was effective in reducing depression risk but did not improve intended help-seeking behaviors for mental illness. Trial Registration: Clinical Trial Registry India: CTRI/2018/08/015355.

Core outcome sets for trials of interventions to prevent and to treat multimorbidity in adults in low and middle-income countries: the COSMOS study.

INTRODUCTION: The burden of multimorbidity is recognised increasingly in low- and middle-income countries (LMICs), creating a strong emphasis on the need for effective evidence-based interventions. Core outcome sets (COS) appropriate for the study of multimorbidity in LMICs do not presently exist. These are required to standardise reporting and contribute to a consistent and cohesive evidence-base to inform policy and practice. We describe the development of two COS for intervention trials aimed at preventing and treating multimorbidity in adults in LMICs. METHODS: To generate a comprehensive list of relevant prevention and treatment outcomes, we conducted a systematic review and qualitative interviews with people with multimorbidity and their caregivers living in LMICs. We then used a modified two-round Delphi process to identify outcomes most important to four stakeholder groups (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals and policymakers) with representation from 33 countries. Consensus meetings were used to reach agreement on the two final COS. REGISTRATION: https://www.comet-initiative.org/Studies/Details/1580. RESULTS: The systematic review and qualitative interviews identified 24 outcomes for prevention and 49 for treatment of multimorbidity. An additional 12 prevention and 6 treatment outcomes were added from Delphi round 1. Delphi round 2 surveys were completed by 95 of 132 round 1 participants (72.0%) for prevention and 95 of 133 (71.4%) participants for treatment outcomes. Consensus meetings agreed four outcomes for the prevention COS: (1) adverse events, (2) development of new comorbidity, (3) health risk behaviour and (4) quality of life; and four for the treatment COS: (1) adherence to treatment, (2) adverse events, (3) out-of-pocket expenditure and (4) quality of life. CONCLUSION: Following established guidelines, we developed two COS for trials of interventions for multimorbidity prevention and treatment, specific to adults in LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs. PROSPERO REGISTRATION NUMBER: CRD42020197293.

Global lessons on delivery of primary healthcare services for people with non-communicable diseases: convergent mixed methods.

OBJECTIVE: To extract key lessons on primary healthcare (PHC) service delivery strategies for non-communicable diseases (NCD) from the work of researchers funded by the Global Alliance for Chronic Diseases (GACD). DESIGN: A convergent mixed methods study that extracted data using a standardised template from research projects funded by the GACD that focused on PHC. The strategies implemented in these studies were mapped onto the PHC Performance Initiative framework. Semistructured qualitative interviews were conducted with researchers from purposefully selected projects to understand the strategies and contextual factors in more depth. SETTING: PHC contexts from low or middle-income countries (LMIC) as well as vulnerable groups within high-income countries. Projects came from all regions of the world, particularly East Asia and Pacific, sub-Saharan Africa, South Asia, Latin America and Caribbean. PARTICIPANTS: The study extracted data on 84 research projects and interviewed researchers from 16 research projects. RESULTS: Research projects came from all regions of the world, and mainly focused on diabetes (35.3%), hypertension (28.3%) and mental health (27.6%). Mapped onto the PHC Performance Initiative framework: 49.4% focused on high-quality PHC (particularly the comprehensiveness of NCD care, 41.2%); 41.2% on the availability of PHC services (particularly the competence of healthcare workers, 36.5%); 35.3% on population health management (particularly community-based services, 35.3%); 34.1% on facility organisation and management (particularly team-based care, 20.0%) and 31.8% on access (particularly digital technology, 23.5%). Most common strategies were task shifting and training to improve the comprehensiveness of NCD care through community-based services. Contextual factors related to inputs: infrastructure, equipment and medication, workforce (particularly community health workers), finances, health information systems and digital technology. CONCLUSION: Key strategies and contextual factors to improve PHC service delivery for NCDs in LMICs were identified. These strategies should combine with other strategies to strengthen the PHC system as a whole, while improving care for NCDs.

Development of a risk prediction model for postpartum onset of type 2 diabetes mellitus, following gestational diabetes; the lifestyle InterVention in gestational diabetes (LIVING) study.

AIMS: This study aimed to develop a prediction model for identifying a woman with gestational diabetes mellitus (GDM) at high risk of type 2 diabetes (T2DM) post-birth. METHODS: Utilising data from 1299 women in the Lifestyle Intervention IN Gestational Diabetes (LIVING) study, two models were developed: one for pregnancy and another for postpartum. Key predictors included glucose test results, medical history, and biometric indicators. RESULTS: Of the initial cohort, 124 women developed T2DM within three years. The study identified seven predictors for the antenatal T2DM risk prediction model and four for the postnatal one. The models demonstrated good to excellent predictive ability, with Area under the ROC Curve (AUC) values of 0.76 (95% CI: 0.72 to 0.80) and 0.85 (95% CI: 0.81 to 0.88) for the antenatal and postnatal models, respectively. Both models underwent rigorous validation, showing minimal optimism in predictive capability. Antenatal model, considering the Youden index optimal cut-off point of 0.096, sensitivity, specificity, and accuracy were measured as 70.97%, 70.81%, and 70.82%, respectively. For the postnatal model, considering the cut-off point 0.086, sensitivity, specificity, and accuracy were measured as 81.40%, 75.60%, and 76.10%, respectively. CONCLUSIONS: These models are effective for predicting T2DM risk in women with GDM, although external validation is recommended before widespread application.

Antenatal oral glucose tolerance test abnormalities in the prediction of future risk of postpartum diabetes in women with gestational diabetes: Results from the LIVING study.

OBJECTIVES: To explore associations between type and number of abnormal glucose values on antenatal oral glucose tolerance test (OGTT) with postpartum diabetes in South Asian women diagnosed with gestational diabetes (GDM) using International Association of the Diabetes and Pregnancy Study Groups criteria. METHODS: This post-hoc evaluation of the Lifestyle Intervention IN Gestational Diabetes (LIVING) study, a randomized controlled trial, was conducted among women with GDM in the index pregnancy, across 19 centers in Bangladesh, India, and Sri Lanka. Postpartum diabetes (outcome) was defined on OGTT, using American Diabetes Association (ADA) criteria. RESULTS: We report data on 1468 women with GDM, aged 30.9 (5.0) years, and with median (interquartile range) follow-up period of 1.8 (1.4-2.4) years after childbirth following the index pregnancy. We found diabetes in 213 (14.5%) women with an incidence of 8.7 (7.6-10.0)/100 women-years. The lowest incidence rate was 3.8/100 women years, in those with an isolated fasting plasma glucose (FPG) abnormality, and highest was 19.0/100 women years in participants with three abnormal values. The adjusted hazard ratios for two and three abnormal values compared to one abnormal value were 1.73 (95% confidence interval [CI], 1.18-2.54; p = .005) and 3.56 (95% CI, 2.46-5.16; p < .001) respectively. The adjusted hazard ratio for the combined (combination of fasting and postglucose load) abnormalities was 2.61 (95% CI, 1.70-4.00; p < .001), compared to isolated abnormal FPG. CONCLUSIONS: Risk of diabetes varied significantly depending upon the type and number of abnormal values on antenatal OGTT. These data may inform future precision medicine approaches such as risk prediction models in identifying women at higher risk and may guide future targeted interventions.

Implementation of mobile-health technology is associated with five-year survival among individuals in rural areas of Indonesia.

There is an urgent need to focus on implementing cost-effective health interventions and policies to reduce the burden of cardiovascular disease in Indonesia. This study aims to evaluate whether a mobile technology-supported primary health care intervention, compared with usual care, would reduce the risk of all-cause mortality among people in rural Indonesia. Data were collected from 11,098 participants in four intervention villages and 10,981 participants in four control villages in Malang district, Indonesia. The baseline data were collected in 2016. All the participants were followed for five years, and the mortality data were recorded. Cox proportional hazard model was used to examine the association between the intervention and the risk of all-cause mortality, adjusted for the covariates, including age, gender, educational attainment, employment and marital status, obesity and the presence of diabetes mellitus. During the five-year follow-up, 275 participants died in intervention villages, compared with 362 in control villages. Participants residing in intervention villages were at 18% (95%CI = 4 to 30) lower risk of all-cause mortality. Higher education attainment and being married are associated with lower risks of all-cause mortality among respondents who lived in the control villages, but not among those living in the intervention villages. A mobile technology-supported primary health care intervention had the potential to improve the five-year survival among people living in villages in an upper-middle income country.

The incidence and risk factors of postpartum diabetes in women from Bangladesh, India and Sri Lanka (South Asia) with prior gestational diabetes mellitus: Results from the LIVING study.

AIM: To study, the incidence and risk factors for postpartum diabetes (DM), in women with gestational diabetes mellitus (GDM) from South Asia (Bangladesh, India and Sri Lanka), followed for nearly two years after delivery. METHODS: Women with prior GDM diagnosed using IADPSG criteria were invited at 19 centres across Bangladesh, India and Sri Lanka for an oral glucose tolerance test (OGTT) following childbirth, and were enrolled in a randomized controlled trial. The glycaemic category (outcome) was defined from an OGTT based on American Diabetes Association criteria. RESULTS: Participants (n = 1808) recruited had a mean ± SD age of 31.0 ± 5.0 years. Incident DM was identified, between childbirth and the last follow-up, in 310 (17.1 %) women [incidence 10.75/100 person years], with a median follow-up duration of 1.82 years after childbirth. Higher age, lower education status, higher prior pregnancy count, prior history of GDM, family history of DM, and postpartum overweight/obese status were significantly associated with incident DM. Women in Bangladesh had a higher cumulative incidence of DM [16.49/100 person years] than in Sri Lanka [12.74/100 person years] and India [7.21/100 person years]. CONCLUSIONS: A high incidence of DM was found in women with prior GDM in South Asia, with significant variation between countries. Women from Bangladesh had a significantly higher pregnancy count, family history of DM and overweight/obese status, despite having significantly lower age, which could be responsible for their higher rates of DM. Registration of this study: The study was registered with the Clinical Trials Registry of India (CTRI/2017/06/008744), Sri Lanka Clinical Trials Registry (SLCTR/2017/001), and ClinicalTrials.gov (NCT03305939).

SMARThealth PRegnancy And Mental Health study: protocol for a situational analysis of perinatal mental health in women living in rural India.

Introduction: The situation for women experiencing mental health problems during pregnancy and postpartum in rural India is critical: a high burden of disease, a high estimated number of women are undiagnosed and untreated with mental health problems, a substantial gap in research on women's perinatal health, and severe stigma and discrimination. The SMARThealth Pregnancy study is a cluster randomised trial using a digital intervention to identify and manage anaemia, hypertension, and diabetes in the first year after birth in rural India. Within this study, the SMARThealth Pregnancy and Mental Health (PRAMH) study is a situational analysis to understand mental health problems during pregnancy and in the first year following birth in this population. Methods/design: This situational analysis aims to analyse and to assess the context of perinatal mental health, health services, barriers, facilitators, and gaps in Siddipet district of Telangana state in India, to develop an implementation framework for a future intervention. A tested, standardised situational analysis tool will be adapted and applied to perinatal mental health in rural India. A desktop and policy review will be conducted to identify and analyse relevant mental health and pregnancy care policies at the national and state levels. We will conduct in-depth interviews with policymakers, planners, mental health professionals and other experts in perinatal mental health (n = 10-15). We will also conduct focus group discussions with key stakeholders, including women with perinatal mental health problems, their families and carers, and community health workers (n = 24-40). A theory of change workshop with key stakeholders will be conducted which will also serve as a priority setting exercise, and will clarify challenges and opportunities, priorities, and objectives for a pilot intervention study. The analysis of qualitive data will be done using thematic analysis. Based on the data analysis and synthesis of the findings, an implementation framework will be developed to guide development, testing and scale up of a contextually relevant intervention for perinatal mental health. Discussion: The situational analysis will help to establish relationships with all relevant stakeholders, clarify the context and hypotheses for the pilot intervention and implementation.

A community-based intervention to improve screening, referral and follow-up of non-communicable diseases and anaemia amongst pregnant and postpartum women in rural India: study protocol for a cluster randomised trial.

BACKGROUND: Medical complications during pregnancy, including anaemia, gestational diabetes mellitus and hypertensive disorders of pregnancy place women are at higher risk of long-term complications. Scalable and low-cost strategies to integrate non-communicable disease screening into pregnancy care are needed. We aim to determine the effectiveness and implementation components of a community-based, digitally enabled approach, "SMARThealth Pregnancy," to improve health during pregnancy and the first year after birth. METHODS: A pragmatic, parallel-group, cluster randomised, type 2 hybrid effectiveness-implementation trial of a community-based, complex intervention in rural India to decrease anaemia (primary outcome, defined as haemoglobin < 12g/dL) and increase testing for haemoglobin, glucose and blood pressure (secondary outcomes) in the first year after birth. Primary Health Centres (PHCs) are the unit of randomisation. PHCs are eligible with (1) > 1 medical officer and > 2 community health workers; and (2) capability to administer intravenous iron sucrose. Thirty PHCs in Telangana and Haryana will be randomised 1:1 using a matched-pair design accounting for cluster size and distance from the regional centre. The intervention comprises (i) an education programme for community health workers and PHC doctors; (ii) the SMARThealth Pregnancy app for health workers to support community-based screening, referral and follow-up of high-risk cases; (iii) a dashboard for PHC doctors to monitor high-risk women in the community; (iv) supply chain monitoring for consumables and medications and (v) stakeholder engagement to co-develop implementation and sustainability pathways. The comparator is usual care with additional health worker education. Secondary outcomes include implementation outcomes assessed by the RE-AIM framework (reach, effectiveness, adoption, implementation, maintenance), clinical endpoints (anaemia, diabetes, hypertension), clinical service delivery indicators (quality of care score), mental health and lactation practice (PHQ9, GAD7, EuroQoL-5D, WHO IYCF questionnaire). DISCUSSION: Engaging women with screening after a high-risk pregnancy is a challenge and has been highlighted as a missed opportunity for the prevention of non-communicable diseases. The SMARThealth Pregnancy trial is powered for the primary outcome and will address gaps in the evidence around how pregnancy can be used as an opportunity to improve women's lifelong health. If successful, this approach could improve the health of women living in resource-limited settings around the world. TRIAL REGISTRATION: ClinicalTrials.gov NCT05752955. Date of registration 3 March 2023.

A Mobile Clinical Decision Support System for High-Risk Pregnant Women in Rural India (SMARThealth Pregnancy): Pilot Cluster Randomized Controlled Trial.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death in women in India. Early identification is crucial to reducing deaths. Hypertensive disorders of pregnancy (HDP) and gestational diabetes mellitus (GDM) carry independent risks for future CVD, and antenatal care is a window to screen and counsel high-risk women. In rural India, community health workers (CHWs) deliver antenatal and postnatal care. We developed a complex intervention (SMARThealth Pregnancy) involving mobile clinical decision support for CHWs and evaluated it in a pilot cluster randomized controlled trial (cRCT). OBJECTIVE: The aim of the study is to co-design a theory-informed intervention for CHWs to screen, refer, and counsel pregnant women at high risk of future CVD in rural India and evaluate its feasibility and acceptability. METHODS: In phase 1, we used qualitative methods to explore community priorities for high-risk pregnant women in rural areas of 2 diverse states in India. In phase 2, informed by behavior change theory and human-centered design, we used these qualitative data to develop the intervention components and implementation strategies for SMARThealth Pregnancy in an iterative process with end users. In phase 3, using mixed methods, we evaluated the intervention in a cRCT with an embedded qualitative substudy across 4 primary health centres: 2 in Jhajjar district, Haryana, and 2 in Guntur district, Andhra Pradesh. RESULTS: SMARThealth Pregnancy embedded a total of 15 behavior change techniques and included (1) community awareness programs; (2) targeted training, including point-of-care blood pressure and hemoglobin measurement; and (3) mobile clinical decision support for CHWs to screen women in their homes. The intervention focused on 3 priority conditions: anemia, HDP, and GDM. The evaluation involved a total of 200 pregnant women, equally randomized to intervention or enhanced standard care (control). Recruitment was completed within 5 months, with minimal loss to follow-up (4/200, 2%) at 6 weeks postpartum. A total of 4 primary care doctors and 54 CHWs in the intervention clusters took part in the study. Fidelity to intervention practices was 100% prepandemic. Over half the study population was affected by moderate to severe anemia at baseline. The prevalence of HDP (2.5%) and GDM (2%) was low in our study population. Results suggest a possible improvement in mean hemoglobin (anemia) in the intervention group, although an adequately powered trial is needed. The model of home-based care was feasible and acceptable for pregnant or postpartum women and CHWs, who perceived improvements in quality of care, self-efficacy, and professional recognition. CONCLUSIONS: SMARThealth Pregnancy is an innovative model of home-based care for high-risk pregnant women during the transitions between antenatal and postnatal care and adult health services. The use of theory and co-design during intervention development facilitated acceptability of the intervention and implementation strategies. Our experience has informed the decision to initiate a larger-scale cRCT. TRIAL REGISTRATION: ClinicalTrials.gov NCT03968952; https://clinicaltrials.gov/ct2/show/NCT03968952. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.3389/fgwh.2021.620759.

Variation in Price of Cardiovascular and Diabetes Medicine in Indonesia, and Relationship with Quality: A Mixed Methods Study in East Java.

Lower-middle income Indonesia, the world's fourth most populous country, has struggled to contain costs in its mandatory, single-payer public health insurance system since the system's inception in 2014. Public procurement policies radically reduced prices of most medicines in public facilities and the wider market. However, professional associations and the press have questioned the quality of these low-cost, unbranded generic medicines. We collected 204 samples of four cardiovascular and one antidiabetic medicines from health facilities and retail outlets in East Java. We collected amlodipine, captopril, furosemide, simvastatin, and glibenclamide, sampling to reflect patients' likelihood of exposure to specific brands and outlets. We recorded sales prices and maximum retail prices and tested medicines for dissolution and percentage of labeled content using high-performance liquid chromatography. We conducted in-depth interviews with supply chain actors. All samples, including those provided free in public facilities, met quality specifications. Most manufacturers make both branded and unbranded medicines. Retail prices varied widely. The median ratio of price to the lowest price for an equivalent product was 5.1, and a few brands sold for over 100 times the minimum price. Prices also varied between outlets for identical products because retail pharmacies set prices to maximize profit. Because very-low-cost medicines were universally available and of good quality, we believe richer patients who chose to buy branded products effectively protected medicine quality for poorer patients in Indonesia because manufacturers cross-subsidize between branded and unbranded versions of the same medicine.

Continuity of CVD treatment during the COVID-19 pandemic: evidence from East Java, Indonesia.

BACKGROUND: In Indonesia, the world's fourth most populous country, cardiovascular diseases (CVDs) are a leading cause of death and disability. Government efforts to reduce the burden of CVD include a community-based prevention and early detection programme, and the provision of medicines to prevent cardiovascular events. Disruptions to medicine supply chains, service provision, and movement during the COVID-19 pandemic potentially threatened the continuity of these efforts. We investigated the distribution and dispensing of common CVD medicines in Malang district, East Java, before the pandemic and early in its course. METHODS: From January to October 2020, we collected monthly data on stock levels, sales or dispensing volumes, and price for five common CVD medicines (amlodipine, captopril, furosemide, glibenclamide and simvastatin), from a public and a private distributor, and from public health facilities (n = 4) and private pharmacies (n = 2). We further complied monthly data on patient numbers in two primary health centres. We tracked changes in stocks held and volumes dispensed by medicine type and sector, comparing the three months before the local COVID-19 response was mobilised with the subsequent seven months. We conducted interviews with pharmacists (n = 12), community health workers (n = 2) and a supply chain logistics manager to investigate the reasons for observed changes, and to learn details of any impacts or mitigation measures. RESULTS: The pandemic affected demand more than supply, causing medicine stocks to rise. Restricted service provision, lock-down measures and fear of infection contributed to a sharp drop in patient numbers and dispensing volumes in the public sector. Meanwhile private sector sales, especially of lower-priced CVD medicines, rose. Community health workers attributed some poor health outcomes to interruption in regular patient check-ups; this interruption was aggravated by formal mitigation policies. CONCLUSIONS: Fears that COVID-19 would interrupt medicine availability were unfounded in East Java. Public sector patients may have compensated for reduced service access by switching to private pharmacies. Mitigation policies that ignored administrative procedures were not effective.

Protocol for a cross-sectional study on COVID-19 vaccination programmes in primary health care.

BACKGROUND: An integrated primary health care approach, where primary care and public health efforts are coordinated, is a key feature of routine immunisation campaigns. AIM: The aim of the study is to describe the approach used by a diverse group of international primary health care professionals in delivering their coronavirus disease 2019 (COVID-19) vaccination programmes, as well as their perspectives on public health and primary care integration while implementing national COVID-19 vaccination programmes in their own jurisdictions. SETTING: This is a protocol for a study, which consists of a cross-sectional online survey disseminated among a convenience sample of international primary health care professional through member-based organisations and professional networks via email and online newsletters. METHODS: Survey development followed an iterative validation process with a formative committee developing the survey instrument based on study objectives, existing literature and best practices and a summative committee verifying and validating content. RESULTS: Main outcome measures are vaccination implementation approach (planning, coordination service deliver), level or type of primary care involvement and degree of primary care and public health integration at community level. CONCLUSION: Integrated health systems can lead to a greater impact in the rollout of the COVID-19 vaccine and can ensure that we are better prepared for crises that threaten human health, not only limited to infectious pandemics but also the rising tide of chronic disease, natural and conflict-driven disasters and climate change.Contribution: This study will provide insight and key learnings for improving vaccination efforts for COVID-19 and possible future pandemics.

Protocol for the implementation and evaluation of a community-based behavior change intervention to reduce dietary salt intake in India.

Excess dietary salt intake is well established as a leading cause of high blood pressure and associated cardiovascular disease, yet current salt intake in India is nearly 11 g per day, more than twice World Health Organization maximum recommended intake of 5 g per day. Although dietary survey data from India indicate that the main sources of dietary salt are salt added during cooking at home, and few salt reduction efforts have focused on interventions at the household level. As a result, there is little evidence of the effectiveness of behavior change programs to reduce salt intake at the household level. The study aims to develop and implement a community based behavioral change intervention to reduce salt intake delivered by front line community-based health volunteers; and evaluate the preliminary effectiveness, acceptability, and feasibility of delivering a salt reduction behavior change program and potential to support future scale-up. The study is a pre-post intervention design, and outcomes will be evaluated from a random sample of 1500 participants from 28 villages in two primary health centers in Siddipet, Telangana. Primary outcome is change in salt-related KAB (knowledge, attitude, and behavior) score, and secondary outcomes will be changes in salt intake measured by 24 h urinary sodium excretion and change in scores using the subscales of the COM-B ("capability", "opportunity", "motivation" and "behavior") tool. Findings will be used to inform future public health policies to support implementation of scalable community-based interventions to reduce salt intake and control hypertension, the leading-cause of death in India.

A study of the quality of cardiovascular and diabetes medicines in Malang District, Indonesia, using exposure-based sampling.

BACKGROUND: The WHO has warned that substandard and falsified medicines threaten health, especially in low and middle-income countries (LMICs). However, the magnitude of that threat for many medicines in different regions is not well described, and high-quality studies remain rare. Recent reviews of studies of cardiovascular and diabetes medicine quality recorded that 15.4% of cardiovascular and 6.8% of diabetes samples failed at least one quality test. Review authors warn that study quality was mixed. Because they did not record medicine volume, no study reflected the risk posed to patients. METHODS AND FINDINGS: We investigated the quality of five medicines for cardiovascular disease and diabetes in Malang district, East Java, Indonesia. Our sample frame, based on dispensing volumes by outlet and price category, included sampling from public and private providers and pharmacies and reflected the potential risk posed to patients. The content of active ingredient was determined by high-performance liquid chromatography and compared with the labelled content. Dissolution testing was also performed.We collected a total of 204 samples: amlodipine (88); captopril (22); furosemide (21); glibenclamide (21) and simvastatin (52), comprising 83 different brands/products. All were manufactured in Indonesia, and all samples met specifications for both assay and dissolution. None was suspected of being falsified. CONCLUSIONS: While we cannot conclude that the prevalence of poor-quality medicines in Malang district is zero, our sampling method, which reflects likely exposure to specific brands and outlets, suggests that the risk to patients is very low; certainly nothing like the rates found in recent reviews of surveys in LMICs. Our study demonstrates the feasibility of sampling medicines based on likely exposure to specific products and underlines the dangers of extrapolating results across countries.

Community prevalence and dyad disease pattern of multimorbidity in China and India: a systematic review.

BACKGROUND: Driven by the increasing life expectancy, China and India, the two most populous countries in the world are experiencing a rising burden of multimorbidity. This study aims to explore community prevalence and dyad patterns of multimorbidity in China and India. METHODS: We conducted a systematic review of five English and Chinese electronic databases. Studies involving adults 18 years or older at a community level, which reported multimorbidity prevalence and/or patterns were included. A modified Newcastle-Ottawa Scale was used for quality assessment. Despite large heterogeneity among reported studies, a systematic synthesis of the results was conducted to report the findings. RESULTS: From 13 996 studies retrieved, 59 studies met the inclusion criteria (46 in China, 9 in India and 4 in both). The median prevalence of multimorbidity was 30.7% (IQR 17.1, 49.4), ranging from 1.5% to 90.5%. There was a large difference in multimorbidity prevalence between China and India, with median prevalence being 36.1% (IQR 19.6, 48.8) and 28.3% (IQR 8.9, 56.8), respectively. Among 27 studies that reported age-specific prevalence, 19 studies found multimorbidity prevalence increased with age, while 8 studies observed a paradoxical reduction in the oldest age group. Of the 34 studies that reported sex-specific prevalence, 86% (n=32) observed a higher prevalence in females. The most common multimorbidity patterns from 14 studies included hypertensive diseases combined with diabetes mellitus, arthropathies, heart diseases and metabolic disorders. All included studies were rated as fair or poor quality. CONCLUSION: Multimorbidity is highly prevalent in China and India with hypertensive diseases and other comorbidities being the most observed patterns. The overall quality of the studies was low and there was a lack of representative samples in most studies. Large epidemiology studies, using a common definition of multimorbidity and national representative samples, with sex disaggregation are needed in both countries. PROSPERO REGISTRATION NUMBER: CRD42020176774.

Going digital: opportunities and barriers in the use of technology for health research.

Digital health refers to the use of novel information com-munication technologies in healthcare. The use of these technologies could positively impact public health and health outcomes of populations by generating timely data, and facili-tating the process of data collection, analysis, and knowledge translation. Using selected case studies, we aim to describe the opportunities and barriers in the use of technology applied to health-related research. We focus on three areas: strategies to generate new data using novel data collection methods, strategies to use and analyze existing data, and using digital health for health-related interventions. Exemplars from seven countries are provided to illustrate activity across these areas. Although the use of health-related technologies is increasing, challenges remain to support their adoption and scale-up -especially for under-served populations. Research using digital health approaches should take a user-centered design, actively working with the population of interest to maximize their uptake and effectiveness.