A model-based approach to estimating the prevalence of disease combinations in South Africa.

BACKGROUND: The development of strategies to better detect and manage patients with multiple long-term conditions requires estimates of the most prevalent condition combinations. However, standard meta-analysis tools are not well suited to synthesising heterogeneous multimorbidity data. METHODS: We developed a statistical model to synthesise data on associations between diseases and nationally representative prevalence estimates and applied the model to South Africa. Published and unpublished data were reviewed, and meta-regression analysis was conducted to assess pairwise associations between 10 conditions: arthritis, asthma, chronic obstructive pulmonary disease (COPD), depression, diabetes, HIV, hypertension, ischaemic heart disease (IHD), stroke and tuberculosis. The national prevalence of each condition in individuals aged 15 and older was then independently estimated, and these estimates were integrated with the ORs from the meta-regressions in a statistical model, to estimate the national prevalence of each condition combination. RESULTS: The strongest disease associations in South Africa are between COPD and asthma (OR 14.6, 95% CI 10.3 to 19.9), COPD and IHD (OR 9.2, 95% CI 8.3 to 10.2) and IHD and stroke (OR 7.2, 95% CI 5.9 to 8.4). The most prevalent condition combinations in individuals aged 15+ are hypertension and arthritis (7.6%, 95% CI 5.8% to 9.5%), hypertension and diabetes (7.5%, 95% CI 6.4% to 8.6%) and hypertension and HIV (4.8%, 95% CI 3.3% to 6.6%). The average numbers of comorbidities are greatest in the case of COPD (2.3, 95% CI 2.1 to 2.6), stroke (2.1, 95% CI 1.8 to 2.4) and IHD (1.9, 95% CI 1.6 to 2.2). CONCLUSION: South Africa has high levels of HIV, hypertension, diabetes and arthritis, by international standards, and these are reflected in the most prevalent condition combinations. However, less prevalent conditions such as COPD, stroke and IHD contribute disproportionately to the multimorbidity burden, with high rates of comorbidity. This modelling approach can be used in other settings to characterise the most important disease combinations and levels of comorbidity.

Assessing the Policy Landscape for Salt Reduction in South-East Asian and Latin American Countries - An Initiative Towards Developing an Easily Accessible, Integrated, Searchable Online Repository.

Background: High dietary salt intake is an avoidable cause of hypertension and associated cardiovascular diseases (CVDs). Thus, salt reduction is recommended as one of the most cost-effective interventions for CVD prevention and for achieving the World Health Organization's (WHO) 25% reduction in premature non-communicable disease (NCD) mortality by 2025. However, current and comprehensive information about national salt reduction policies and related actions across different regions are difficult to access and impede progress and monitoring. Objectives: As an initial step to developing an online repository of salt reduction policies and related actions, and to track nation-wise progress towards the WHO's 25 by 25 goal, we aimed to identify and assess salt reduction policies and actions in select countries from two of the top five most populous regions of the world- the South-East Asia and Latin America. Methods: We conducted a literature review to identify national and regional salt reduction policies in the selected South-East Asian and Latin American countries, from January 1990-August 2020, available in English and Spanish. We also contacted selected WHO country offices (South-East Asian region) or relevant national authorities (Latin America) to gain access to unpublished documents. Results: In both regions, we found only a few dedicated stand-alone salt reduction policies: Bhutan, Sri-Lanka and Thailand from South East Asia and Costa Rica from Latin America. Available polices were either embedded in other national health/nutritional policy documents/overall NCD policies or were unpublished and had to be accessed via personal communication. Conclusions: Salt reduction policies are limited and often embedded with other policies which may impede their implementation and utility for tracking national and international progress towards the global salt reduction target associated with the 25 by 25 goal. Developing an online repository could help countries address this gap and assist researchers/policymakers to monitor national progress towards achieving the salt reduction target.

Intervention development of a brief messaging intervention for a randomised controlled trial to improve diabetes treatment adherence in sub-Saharan Africa.

BACKGROUND: Brief messaging interventions, including Short Message Service (SMS) text-messages, delivered via mobile device platforms, show promise to support and improve treatment adherence. To understand how these interventions work, and to facilitate transparency, we need clear descriptions of the intervention development process. METHOD: We describe and reflect on the process of designing and pretesting an evidence- and theory-informed brief messaging intervention, to improve diabetes treatment adherence in sub-Saharan Africa. We followed the stepwise approach recommended by the Medical Research Council, United Kingdom (MRC UK) Framework for Development and Evaluation of Complex Health Interventions and guidance for mobile health intervention development. RESULTS: We used a four-phase, iterative approach that first generated primary and secondary evidence on the lived experience of diabetes, diabetes treatment services and mobile-phone use. Second, we designed a type 2 diabetes-specific, brief text-message library, building on our previous hypertension text-message library, as well as drawing on the primary and secondary data from phase one, and on expert opinion. We then mapped the brief text-messages onto behaviour change (COM-B) theoretical constructs. Third, we refined and finalised the newly developed brief text-message library through stakeholder consultation and translated it into three local languages. Finally, we piloted the intervention by pre-testing the automated delivery of the brief text-messages in the trial sites in Malawi and South Africa. The final SMS text Adherence suppoRt for people with type 2 diabetes (StAR2D) intervention was tested in a randomised controlled trial in Malawi and South Africa (trial registration: ISRCTN70768808 ). CONCLUSION: The complexity of public health interventions requires that we give more attention to intervention development work. Our documentation and reflection on the StAR2D intervention development process promotes transparency, replicability, assessment of intervention quality, and comparison with other studies.

Implementation barriers for mHealth for non-communicable diseases management in low and middle income countries: a scoping review and field-based views from implementers.

Background: Mobile health (mHealth) has been hailed as a potential gamechanger for non-communicable disease (NCD) management, especially in low- and middle-income countries (LMIC). Individual studies illustrate barriers to implementation and scale-up, but an overview of implementation issues for NCD mHealth interventions in LMIC is lacking. This paper explores implementation issues from two perspectives: information in published papers and field-based knowledge by people working in this field. Methods: Through a scoping review publications on mHealth interventions for NCDs in LMIC were identified and assessed with the WHO mHealth Evidence Reporting and Assessment (mERA) tool. A two-stage web-based survey on implementation barriers was performed within a NCD research network and through two online platforms on mHealth targeting researchers and implementors. Results: 16 studies were included in the scoping review. Short Message Service (SMS) messaging was the main implementation tool. Most studies focused on patient-centered outcomes. Most studies did not report on process measures and on contextual conditions influencing implementation decisions. Few publications reported on implementation barriers. The websurvey included twelve projects and the responses revealed additional information, especially on practical barriers related to the patients' characteristics, low demand, technical requirements, integration with health services and with the wider context. Many interventions used low-cost software and devices with limited capacity that not allowed linkage with routine data or patient records, which incurred fragmented delivery and increased workload. Conclusion: Text messaging is a dominant mHealth tool for patient-directed of quality improvement interventions in LMIC. Publications report little on implementation barriers, while a questionnaire among implementors reveals significant barriers and strategies to address them. This information is relevant for decisions on scale-up of mHealth in the domain of NCD. Further knowledge should be gathered on implementation issues, and the conditions that allow universal coverage.

Mobile Messaging Support Versus Usual Care for People With Type 2 Diabetes on Glycemic Control: Protocol for a Multicenter Randomized Controlled Trial.

BACKGROUND: Health outcomes for people treated for type 2 diabetes could be substantially improved in sub-Saharan Africa. Failure to take medicine regularly to treat diabetes has been identified as a major problem. Resources to identify and support patients who are not making the best use of medicine in low- and middle-income settings are scarce. Mobile phones are widely available in these settings, including among people with diabetes; linked technologies, such as short message service (SMS) text messaging, have shown promise in delivering low-cost interventions efficiently. However, evidence showing that these interventions will work when carried out at a larger scale and measuring the extent to which they will improve health outcomes when added to usual care is limited. OBJECTIVE: The objective of this trial is to test the effectiveness of sending brief, automated SMS text messages for improving health outcomes and medication adherence in patients with type 2 diabetes compared to an active control. METHODS: We will carry out a randomized trial recruiting from clinics in two contrasting settings in sub-Saharan Africa: Cape Town, South Africa, and Lilongwe, Malawi. Intervention messages will advise people about the benefits of their diabetes treatment and offer motivation and encouragement around lifestyle and use of medication. We allocated patients, using randomization with a minimization algorithm, to receive either three to four intervention messages per week or non-health-related messages every 6 weeks. We will follow up with participants for 12 months, measuring important risk factors for poor health outcomes and complications in diabetes. This will enable us to estimate potential health benefits, including the primary outcome of hemoglobin A1c (HbA1c) levels as a marker for long-term blood glucose control and a secondary outcome of blood pressure control. We will record the costs of performing these activities and estimate cost-effectiveness. We will also use process evaluation to capture the collection of medication and assess the reception of the intervention by participants and health care workers. RESULTS: Recruitment to the trial began in September 2016 and follow-up of participants was completed in October 2018. Data collection from electronic health records and other routinely collected sources is continuing. The database lock is anticipated in June 2019, followed by analysis and disclosing of group allocation. CONCLUSIONS: The knowledge gained from this study will have wide applications and advance the evidence base for effectiveness of mobile phone-based, brief text messaging on clinical outcomes and in large-scale, operational settings. It will provide evidence for cost-effectiveness and acceptability that will further inform policy development and decision making. We will work with a wide network that includes patients, clinicians, academics, industry, and policy makers to help us identify opportunities for informing people about the work and raise awareness of what is being developed and studied. TRIAL REGISTRATION: ISRCTN Registry ISRCTN70768808; http://www.isrctn.com/ISRCTN70768808 (Archived by WebCite at http://www.webcitation.org/786316Zqk). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12377.

The role of context in implementation research for non-communicable diseases: Answering the 'how-to' dilemma.

INTRODUCTION: Understanding context and how this can be systematically assessed and incorporated is crucial to successful implementation. We describe how context has been assessed (including exploration or evaluation) in Global Alliance for Chronic Diseases (GACD) implementation research projects focused on improving health in people with or at risk of chronic disease and how contextual lessons were incorporated into the intervention or the implementation process. METHODS: Using a web-based semi-structured questionnaire, we conducted a cross-sectional survey to collect quantitative and qualitative data across GACD projects (n = 20) focusing on hypertension, diabetes and lung diseases. The use of context-specific data from project planning to evaluation was analyzed using mixed methods and a multi-layered context framework across five levels; 1) individual and family, 2) community, 3) healthcare setting, 4) local or district level, and 5) state or national level. RESULTS: Project teams used both qualitative and mixed methods to assess multiple levels of context (avg. = 4). Methodological approaches to assess context were identified as formal and informal assessments, engagement of stakeholders, use of locally adapted resources and materials, and use of diverse data sources. Contextual lessons were incorporated directly into the intervention by informing or adapting the intervention, improving intervention participation or improving communication with participants/stakeholders. Provision of services, equipment or information, continuous engagement with stakeholders, feedback for personnel to address gaps, and promoting institutionalization were themes identified to describe how contextual lessons are incorporated into the implementation process. CONCLUSIONS: Context is regarded as critical and influenced the design and implementation of the GACD funded chronic disease interventions. There are different approaches to assess and incorporate context as demonstrated by this study and further research is required to systematically evaluate contextual approaches in terms of how they contribute to effectiveness or implementation outcomes.

Text2PreventCVD: protocol for a systematic review and individual participant data meta-analysis of text message-based interventions for the prevention of cardiovascular diseases.

INTRODUCTION: Text message interventions have been shown to be effective in prevention and management of several non-communicable disease risk factors. However, the extent to which their effects might vary in different participants and settings is uncertain. We aim to conduct a systematic review and individual participant data (IPD) meta-analysis of randomised clinical trials examining text message interventions aimed to prevent cardiovascular diseases (CVD) through modification of cardiovascular risk factors (CVRFs). METHODS AND ANALYSIS: Systematic review and IPD meta-analysis will be conducted according to Preferred Reporting Items for Systematic review and Meta-Analysis of IPD (PRISMA-IPD) guidelines. Electronic database of published studies (MEDLINE, EMBASE, PsycINFO and Cochrane Library) and international trial registries will be searched to identify relevant randomised clinical trials. Authors of studies meeting the inclusion criteria will be invited to join the IPD meta-analysis group and contribute study data to the common database. The primary outcome will be the difference between intervention and control groups in blood pressure at 6-month follow-up. Key secondary outcomes include effects on lipid parameters, body mass index, smoking levels and self-reported quality of life. If sufficient data is available, we will also analyse blood pressure and other secondary outcomes at 12 months. IPD meta-analysis will be performed using a one-step approach and modelling data simultaneously while accounting for the clustering of the participants within studies. This study will use the existing data to assess the effectiveness of text message-based interventions on CVRFs, the consistency of any effects by participant subgroups and across different healthcare settings. ETHICS AND DISSEMINATION: Ethical approval was obtained for the individual studies by the trial investigators from relevant local ethics committees. This study will include anonymised data for secondary analysis and investigators will be asked to check that this is consistent with their existing approvals. Results will be disseminated via scientific forums including peer-reviewed publications and presentations at international conferences. TRIAL REGISTRATION NUMBER: CRD42016033236.

Improving treatment adherence for blood pressure lowering via mobile phone SMS-messages in South Africa: a qualitative evaluation of the SMS-text Adherence SuppoRt (StAR) trial.

BACKGROUND: Effective use of proven treatments for high blood pressure, a preventable health risk, is challenging for many patients. Prompts via mobile phone SMS-text messaging may improve adherence to clinic visits and treatment, though more research is needed on impact and patient perceptions of such support interventions, especially in low-resource settings. METHOD: An individually-randomised controlled trial in a primary care clinic in Cape Town (2012-14), tested the effect of an adherence support intervention delivered via SMS-texts, on blood pressure control and adherence to medication, for hypertensive patients. ( TRIAL REGISTRATION: ClinicalTrials.gov NCT02019823). We report on a qualitative evaluation that explored the trial participants' experiences and responses to the SMS-text messages, and identified barriers and facilitators to delivering adherence support via patients' own mobile phones. Two focus groups and fifteen individual interviews were conducted. We used comparative and thematic analysis approaches to identify themes and triangulated our analysis amongst three researchers. RESULTS: Most participants were comfortable with the technology of using SMS-text messages. Messages were experienced as acceptable, relevant and useful to a broad range of participants. The SMS-content, the respectful tone and the delivery (timing of reminders and frequency) and the relational aspect of trial participation (feeling cared for) were all highly valued. A subgroup who benefitted the most, were those who had been struggling with adherence due to high levels of personal stress. The intervention appeared to coincide with their readiness for change, and provided practical and emotional support for improving adherence behaviour. Change may have been facilitated through increased acknowledgement of their health status and attitudinal change towards greater self-responsibility. Complex interaction of psycho-social stressors and health service problems were reported as broader challenges to adherence behaviours. CONCLUSION: Adherence support for treatment of raised blood pressure, delivered via SMS-text message on the patient's own phone, was found to be acceptable, relevant and helpful, even for those who already had their own reminder systems in place. Our findings begin to identify for whom and what core elements of the SMS-text message intervention appear to work best in a low-resource operational setting, issues that future research should explore in greater depth.

Efficacy of a text messaging (SMS) based intervention for adults with hypertension: protocol for the StAR (SMS Text-message Adherence suppoRt trial) randomised controlled trial.

BACKGROUND: Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care. METHODS/DESIGN: The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data are collected on non-participants. DISCUSSION: The StAR trial uses a novel, low cost system based on widely available mobile phone technology to deliver the SMS-based intervention, manage communication with patients, and measure clinically relevant outcomes. The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-resource setting. TRIAL REGISTRATION: NCT02019823.