Effectiveness, cost-effectiveness, and positive externalities of integrated chronic care for adults with major depressive disorder in Malawi (IC3D): a stepped-wedge, cluster-randomised, controlled trial.

BACKGROUND: In low-income and middle-income countries, individuals with major depressive disorder often do not receive screening and treatment. We assessed effectiveness and cost-effectiveness of an integrated care model for treating major depressive disorder in Malawi, accounting for two sets of positive externalities: household benefits and improvements in comorbidities. METHODS: In this stepped-wedge, cluster-randomised, controlled trial, 14 health facilities in Neno District, Malawi, introduced screening, diagnosis, and treatment for people with major depressive disorder, using a stepped-care model of group Problem Management Plus and antidepressant therapy. Adults (ie, aged ≥18 years) residing in facility catchment areas, newly diagnosed with major depressive disorder, and actively enrolled in an integrated chronic care clinic were eligible for inclusion. People identified with high suicidal risk or psychotic symptoms were excluded. Health facilities were categorised into two strata (ie, health centres or secondary hospitals) and randomly allocated to one of five trial sequences, with intervention initiation staggered across sequences in 3-month periods. Participants were masked to trial sequence, data collectors were masked to treatment assignment, and the chief statistician was masked to treatment assignment until analysis. Services were delivered by counsellors and clinical officers at integrated chronic care clinics, and assessments took place at 3-month intervals over 27 months. Primary outcomes were changes in depressive symptom severity (measured with the Patient Health Questionnaire-9 [PHQ-9]), current depressive episode (PHQ-9 score of >10), and functioning (measured with the WHO Disability Assessment Schedule 2.0) over the 27-month period. Longitudinal mixed-effects regression analyses assessed outcomes from an intention-to-treat perspective. The trial was registered with ClinicalTrials.gov (NCT04777006) and is completed. FINDINGS: Between Sept 1, 2021, and April 28, 2022, we conducted 15 562 screenings, resulting in 506 (3%) adults identified with major depressive disorder and 487 (3%) enrolled (395 [81%] women and 92 [19%] men). Assignment to IC3D corresponded to a 2·60-point (95% CI -3·35 to -1·86; d -0·61) reduction in depressive symptoms and 1·69-point (-2·73 to -0·65; -0·27) improvement in functioning, reflecting a reduced odds of depression after treatment roll-out (adjusted odds ratio 0·62, 95% CI 0·51 to 0·74). INTERPRETATION: Integrated care for people with major depressive disorder and chronic health conditions is effective at reducing depressive symptoms, improving functioning, and reducing the odds of depression, and facilitates expansion of services through existing infrastructure. FUNDING: National Institute of Mental Health.

Critical care capacity and care bundles on medical wards in Malawi: a cross-sectional study.

INTRODUCTION: As low-income countries (LICs) shoulder a disproportionate share of the world's burden of critical illnesses, they must continue to build critical care capacity outside conventional intensive care units (ICUs) to address mortality and morbidity, including on general medical wards. A lack of data on the ability to treat critical illness, especially in non-ICU settings in LICs, hinders efforts to improve outcomes. METHODS: This was a secondary analysis of the cross-sectional Malawi Emergency and Critical Care (MECC) survey, administered from January to February 2020, to a random sample of nine public sector district hospitals and all four central hospitals in Malawi. This analysis describes inputs, systems, and barriers to care in district hospitals compared to central hospital medical wards, including if any medical wards fit the World Federation of Intensive and Critical Care Medicine (WFSICCM) definition of a level 1 ICU. We grouped items into essential care bundles for service readiness compared using Fisher's exact test. RESULTS: From the 13 hospitals, we analysed data from 39 medical ward staff members through staffing, infrastructure, equipment, and systems domains. No medical wards met the WFSICCM definition of level 1 ICU. The most common barriers in district hospital medical wards compared to central hospital wards were stock-outs (29%, Cl: 21% to 44% vs 6%, Cl: 0% to 13%) and personnel shortages (40%, Cl: 24% to 67% vs 29%, Cl: 16% to 52%) but central hospital wards reported a higher proportion of training barriers (68%, Cl: 52% to 73% vs 45%, Cl: 29% to 60%). No differences were statistically significant. CONCLUSION: Despite current gaps in resources to consistently care for critically ill patients in medical wards, this study shows that with modest inputs, the provision of simple life-saving critical care is within reach. Required inputs for care provision can be informed from this study.

Realigning noncommunicable disease monitoring with health systems priorities in the Africa region.

The African region of the World Health Organization (WHO) recently adopted a strategy aimed at more comprehensive care for noncommunicable diseases (NCDs) in the region. The WHO's World Health Assembly has also newly approved several ambitious disease-specific targets that raise the expectations of chronic care and plans to revise and update the NCD-Global Action Plan. These actions provide a critically needed opportunity for reflection and course correction in the global health response to NCDs. In this paper, we highlight the status of the indicators that are currently used to monitor progress towards global goals for chronic care. We argue that weak health systems and lack of access to basic NCD medicines and technologies have prevented many countries from achieving the level of progress required by the NCD epidemic, and current targets do little to address this reality. We identify gaps in existing metrics and explore opportunities to realign the targets with the pressing priorities facing today's health systems.

Community-facility linkage models and maternal and infant health outcomes in Malawi's PMTCT/ART program: A cohort study.

BACKGROUND: In sub-Saharan Africa, 3 community-facility linkage (CFL) models-Expert Clients, Community Health Workers (CHWs), and Mentor Mothers-have been widely implemented to support pregnant and breastfeeding women (PBFW) living with HIV and their infants to access and sustain care for prevention of mother-to-child transmission of HIV (PMTCT), yet their comparative impact under real-world conditions is poorly understood. METHODS AND FINDINGS: We sought to estimate the effects of CFL models on a primary outcome of maternal loss to follow-up (LTFU), and secondary outcomes of maternal longitudinal viral suppression and infant "poor outcome" (encompassing documented HIV-positive test result, LTFU, or death), in Malawi's PMTCT/ART program. We sampled 30 of 42 high-volume health facilities ("sites") in 5 Malawi districts for study inclusion. At each site, we reviewed medical records for all newly HIV-diagnosed PBFW entering the PMTCT program between July 1, 2016 and June 30, 2017, and, for pregnancies resulting in live births, their HIV-exposed infants, yielding 2,589 potentially eligible mother-infant pairs. Of these, 2,049 (79.1%) had an available HIV treatment record and formed the study cohort. A randomly selected subset of 817 (40.0%) cohort members underwent a field survey, consisting of a questionnaire and HIV biomarker assessment. Survey responses and biomarker results were used to impute CFL model exposure, maternal viral load, and early infant diagnosis (EID) outcomes for those missing these measures to enrich data in the larger cohort. We applied sampling weights in all statistical analyses to account for the differing proportions of facilities sampled by district. Of the 2,049 mother-infant pairs analyzed, 62.2% enrolled in PMTCT at a primary health center, at which time 43.7% of PBFW were ≤24 years old, and 778 (38.0%) received the Expert Client model, 640 (31.2%) the CHW model, 345 (16.8%) the Mentor Mother model, 192 (9.4%) ≥2 models, and 94 (4.6%) no model. Maternal LTFU varied by model, with LTFU being more likely among Mentor Mother model recipients (adjusted hazard ratio [aHR]: 1.45; 95% confidence interval [CI]: 1.14, 1.84; p = 0.003) than Expert Client recipients. Over 2 years from HIV diagnosis, PBFW supported by CHWs spent 14.3% (95% CI: 2.6%, 26.1%; p = 0.02) more days in an optimal state of antiretroviral therapy (ART) retention with viral suppression than women supported by Expert Clients. Infants receiving the Mentor Mother model (aHR: 1.24, 95% CI: 1.01, 1.52; p = 0.04) and ≥2 models (aHR: 1.44, 95% CI: 1.20, 1.74; p < 0.001) were more likely to undergo EID testing by age 6 months than infants supported by Expert Clients. Infants receiving the CHW and Mentor Mother models were 1.15 (95% CI: 0.80, 1.67; p = 0.44) and 0.84 (95% CI: 0.50, 1.42; p = 0.51) times as likely, respectively, to experience a poor outcome by 1 year than those supported by Expert Clients, but not significantly so. Study limitations include possible residual confounding, which may lead to inaccurate conclusions about the impacts of CFL models, uncertain generalizability of findings to other settings, and missing infant medical record data that limited the precision of infant outcome measurement. CONCLUSIONS: In this descriptive study, we observed widespread reach of CFL models in Malawi, with favorable maternal outcomes in the CHW model and greater infant EID testing uptake in the Mentor Mother model. Our findings point to important differences in maternal and infant HIV outcomes by CFL model along the PMTCT continuum and suggest future opportunities to identify key features of CFL models driving these outcome differences.

Increasing utilisation of perinatal services: estimating the impact of community health worker program in Neno, Malawi.

BACKGROUND: By 2015, Malawi had not achieved Millennium Development Goal 4, reducing maternal mortality by about 35% from 675 to 439 deaths per 100,000 livebirths. Hypothesised reasons included low uptake of antenatal care (ANC), intrapartum care, and postnatal care. Involving community health workers (CHWs) in identification of pregnant women and linking them to perinatal services is a key strategy to reinforce uptake of perinatal care in Neno, Malawi. We evaluated changes in uptake after deployment of CHWs between March 2014 and June 2016. METHODS: A CHW intervention was implemented in Neno District, Malawi in a designated catchment area of about 3100 women of childbearing age. The pre-intervention period was March 2014 to February 2015, and the post-intervention period was March 2015 to June 2016. A 5-day maternal health training package was delivered to 211 paid and supervised CHWs. CHWs were deployed to identify pregnant women and escort them to perinatal care visits. A synthetic control method, in which a "counterfactual site" was created from six available control facilities in Neno District, was used to evaluate the intervention. Outcomes of interest included uptake of first-time ANC, ANC within the first trimester, four or more ANC visits, intrapartum care, and postnatal care follow-up. RESULTS: Women enrolled in ANC increased by 18% (95% Credible Interval (CrI): 8, 29%) from an average of 83 to 98 per month, the proportion of pregnant women starting ANC in the first trimester increased by 200% (95% CrI: 162, 234%) from 10 to 29% per month, the proportion of women completing four or more ANC visits increased by 37% (95% CrI: 31, 43%) from 28 to 39%, and monthly utilisation of intrapartum care increased by 20% (95% CrI: 13, 28%) from 85 to 102 women per month. There was little evidence that the CHW intervention changed utilisation of postnatal care (- 37, 95% CrI: - 224, 170%). CONCLUSIONS: In a rural district in Malawi, uptake of ANC and intrapartum care increased considerably following an intervention using CHWs to identify pregnant women and link them to care.

Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers.

Public health and service delivery programmes, interventions and policies (collectively, 'programmes') are typically developed and implemented for the primary purpose of effecting change rather than generating knowledge. Nonetheless, evaluations of these programmes may produce valuable learning that helps determine effectiveness and costs as well as informing design and implementation of future programmes. Such studies might be termed 'opportunistic evaluations', since they are responsive to emergent opportunities rather than being studies of interventions that are initiated or designed by researchers. However, current ethical guidance and registration procedures make little allowance for scenarios where researchers have played no role in the development or implementation of a programme, but nevertheless plan to conduct a prospective evaluation. We explore the limitations of the guidance and procedures with respect to opportunistic evaluations, providing a number of examples. We propose that one key missing distinction in current guidance is moral responsibility: researchers can only be held accountable for those aspects of a study over which they have control. We argue that requiring researchers to justify an intervention, programme or policy that would occur regardless of their involvement prevents or hinders research in the public interest without providing any further protections to research participants. We recommend that trial consent and ethics procedures allow for a clear separation of responsibilities for the intervention and the evaluation.

Case study of a method of development of a selection process for community health workers in sub-Saharan Africa.

BACKGROUND: Choosing who should be recruited as a community health worker (CHW) is an important task, for their future performance partly depends on their ability to learn the required knowledge and skills, and their personal attributes. Developing a fair and effective selection process for CHWs is a challenging task, and reports of attempts to do so are rare. This paper describes a five-stage process of development and initial testing of a CHW selection process in two CHW programmes, one in Malawi and one in Ghana, highlighting the lessons learned at each stage and offering recommendations to other CHW programme providers seeking to develop their own selection processes. CASE PRESENTATION: The five stages of selection process development were as follows: (1) review an existing selection process, (2) conduct a job analysis, (3) elicit stakeholder opinions, (4) co-design the selection process and (5) test the selection process. Good practice in selection process development from the human resource literature and the principles of co-design were considered throughout. Validity, reliability, fairness, acceptability and feasibility-the determinants of selection process utility-were considered as appropriate during stages 1 to 4 and used to guide the testing in stage 5. The selection methods used by each local team were a written test and a short interview. CONCLUSIONS: Working with stakeholders, including CHWs, helped to ensure the acceptability of the selection processes developed. Expectations of intensiveness-in particular the number of interviewers-needed to be managed as resources for selection are limited, and CHWs reported that any form of interview may be stressful. Testing highlighted the importance of piloting with CHWs to ensure clarity of wording of questions, interviewer training to maximise inter-rater reliability and the provision of guidance to applicants in advance of any selection events. Trade-offs between the different components of selection process utility are also likely to be required. Further refinements and evaluation of predictive validity (i.e. a sixth stage of development) would be recommended before roll-out.

The Rohingya people of Myanmar: health, human rights, and identity.

The Rohingya people of Myanmar (known as Burma before 1989) were stripped of citizenship in 1982, because they could not meet the requirement of proving their forefathers settled in Burma before 1823, and now account for one in seven of the global population of stateless people. Of the total 1·5 million Rohingya people living in Myanmar and across southeast Asia, only 82 000 have any legal protection obtained through UN-designated refugee status. Since 2012, more than 159 000 people, most of whom are Rohingya, have fled Myanmar in poorly constructed boats for journeys lasting several weeks to neighbouring nations, causing hundreds of deaths. We outline historical events preceding this complex emergency in health and human rights. The Rohingya people face a cycle of poor infant and child health, malnutrition, waterborne illness, and lack of obstetric care. In December, 2014, a UN resolution called for an end to the crisis. We discuss the Myanmar Government's ongoing treatment of Rohingya through the lens of international law, and the steps that the newly elected parliament must pursue for a durable solution.

The predictive validity of the Living Goods selection tools for community health workers in Kenya: cohort study.

BACKGROUND: Ensuring that selection processes for Community Health Workers (CHWs) are effective is important due to the scale and scope of modern CHW programmes. However they are relatively understudied. While community involvement in selection should never be eliminated entirely, there are other complementary methods that could be used to help identify those most likely to be high-performing CHWs. This study evaluated the predictive validity of three written tests and two individual sections of a one-to-one interview used for selection into CHW posts in eight areas of Kenya. METHODS: A cohort study of CHWs working for Living Goods in eight local areas of Kenya was undertaken. Data on the selection scores, post-training assessment scores and subsequent on-the-job performance (number of household and pregnancy registrations, number of child assessments, proportion of on-time follow-ups and value of goods sold) were obtained for 547 CHWs. Kendall's tau-b correlations between each selection score and performance outcome were calculated. RESULTS: None of the correlations between selection scores and outcomes reached the 0.3 threshold of an "adequate" predictor of performance. Correlations were higher for the written components of the selection process compared to the interview components, with some small negative correlations found for the latter. CONCLUSIONS: If the measures of performance included in this study are considered critical, then further work to develop the CHW selection tools is required. This could include modifying the content of both tools or increasing the length of the written tests to make them more reliable, for if a test is not reliable then it cannot be valid. Other important outcomes not included in this study are retention in post and quality of care. Other CHW programme providers should consider evaluating their own selection tools in partnership with research teams.

Building a knowledge translation platform in Malawi to support evidence-informed health policy.

With the support of the World Health Organization's Evidence-Informed Policy Network, knowledge translation platforms have been developed throughout Africa, the Americas, Eastern Europe, and Asia to further evidence-informed national health policy. In this commentary, we discuss the approaches, activities and early lessons learned from the development of a Knowledge Translation Platform in Malawi (KTPMalawi). Through ongoing leadership, as well as financial and administrative support, the Malawi Ministry of Health has strongly signalled its intention to utilize a knowledge translation platform methodology to support evidence-informed national health policy. A unique partnership between Dignitas International, a medical and research non-governmental organization, and the Malawi Ministry of Health, has established KTPMalawi to engage national-level policymakers, researchers and implementers in a coordinated approach to the generation and utilization of health-sector research. Utilizing a methodology developed and tested by knowledge translation platforms across Africa, a stakeholder mapping exercise and initial capacity building workshops were undertaken and a multidisciplinary Steering Committee was formed. This Steering Committee prioritized the development of two initial Communities of Practice to (1) improve data utilization in the pharmaceutical supply chain and (2) improve the screening and treatment of hypertension within HIV-infected populations. Each Community of Practice's mandate is to gather and synthesize the best available global and local evidence and produce evidence briefs for policy that have been used as the primary input into structured deliberative dialogues. While a lack of sustained initial funding slowed its early development, KTPMalawi has greatly benefited from extensive technical support and mentorship by an existing network of global knowledge translation platforms. With the continued support of the Malawi Ministry of Health and the Evidence-Informed Policy Network, KTPMalawi can continue to build on its role in facilitating the use of evidence in the development and refinement of health policy in Malawi.

Service readiness for the management of non-communicable diseases in publicly financed facilities in Malawi: findings from the 2019 Harmonised Health Facility Assessment census survey.

INTRODUCTION: Non-communicable diseases (NCDs) are rising in low-income and middle-income countries, including Malawi. To inform policy-makers and planners on the preparedness of the Malawian healthcare system to respond to NCDs, we estimated NCD service readiness in publicly financed healthcare facilities in Malawi. METHODS: We analysed data from 564 facilities surveyed in the 2019 Harmonised Health Facility Assessment, including 512 primary healthcare (PHC) and 52 secondary and tertiary care (STC) facilities. To characterise service readiness, applying the law of minimum, we estimated the percentage of facilities with functional equipment and unexpired medicines required to provide NCD services. Further, we estimated permanently unavailable items to identify service readiness bottlenecks. RESULTS: Fewer than 40% of PHC facilities were ready to deliver services for each of the 14 NCDs analysed. Insulin and beclomethasone inhalers had the lowest stock levels at PHC facilities (6% and 8%, respectively). Only 17% of rural and community hospitals (RCHs) have liver and kidney diagnostics. STC facilities had varying service readiness, ranging from 27% for managing acute diabetes complications to 94% for chronic type 2 diabetes management. Only 38% of STC facilities were ready to manage chronic heart failure. Oral pain medicines were widely available at all levels of health facilities; however, only 22% of RCHs and 29% of STCs had injectable morphine or pethidine. Beclomethasone was never available at 74% of PHC and 29% of STC facilities. CONCLUSION: Publicly financed facilities in Malawi are generally unprepared to provide NCD services, especially at the PHC level. Targeted investments in PHC can substantially improve service readiness for chronic NCD conditions in local communities and enable STC to respond to acute NCD complications and more complex NCD cases.

Cost analysis for initiating an integrated package of essential non-communicable disease interventions (PEN-Plus) in Kondoa District Hospital, Tanzania: a time-driven activity-based costing (TDABC) study protocol.

INTRODUCTION: Non-communicable diseases (NCDs) constitute approximately 74% of global mortality, with 77% of these deaths occurring in low-income and middle-income countries. Tanzania exemplifies this situation, as the percentage of total disability-adjusted life years attributed to NCDs has doubled over the past 30 years, from 18% to 36%. To mitigate the escalating burden of severe NCDs, the Tanzanian government, in collaboration with local and international partners, seeks to extend the integrated package of essential interventions for severe NCDs (PEN-Plus) to district-level facilities, thereby improving accessibility. This study aims to estimate the cost of initiating PEN-Plus for rheumatic heart disease, sickle cell disease and type 1 diabetes at Kondoa district hospital in Tanzania. METHODS AND ANALYSIS: We will employ time-driven activity-based costing (TDABC) to quantify the capacity cost rates (CCR), and capital and recurrent costs associated with the implementation of PEN-Plus. Data on resource consumption will be collected through direct observations and interviews with nurses, the medical officer in charge and the heads of laboratory and pharmacy units/departments. Data on contact times for targeted NCDs will be collected by observing a sample of patients as they move through the care delivery pathway. Data cleaning and analysis will be done using Microsoft Excel. ETHICS AND DISSEMINATION: Ethical approval to conduct the study has been waived by the Norwegian Regional Ethics Committee and was granted by the Tanzanian National Health Research Ethics Committee NIMR/HQ/R.8a/Vol.IX/4475. A written informed consent will be provided to the study participants. This protocol has been disseminated in the Bergen Centre for Ethics and Priority Setting International Symposium, Norway and the 11th Muhimbili University of Health and Allied Sciences Scientific Conference, Tanzania in 2023. The findings will be published in peer-reviewed journals for use by the academic community, researchers and health practitioners.

Feasibility of continuous glucose monitoring in patients with type 1 diabetes at two district hospitals in Neno, Malawi: a randomised controlled trial.

OBJECTIVES: To assess the feasibility and change in clinical outcomes associated with continuous glucose monitoring (CGM) use among a rural population in Malawi living with type 1 diabetes. DESIGN: A 2:1 open randomised controlled feasibility trial. SETTING: Two Partners In Health-supported Ministry of Health-run first-level district hospitals in Neno, Malawi. PARTICIPANTS: 45 people living with type 1 diabetes (PLWT1D). INTERVENTIONS: Participants were randomly assigned to Dexcom G6 CGM (n=30) use or usual care (UC) (n=15) consisting of Safe-Accu glucose monitors and strips. Both arms received diabetes education. OUTCOMES: Primary outcomes included fidelity, appropriateness and severe adverse events. Secondary outcomes included change in haemoglobin A1c (HbA1c), acceptability, time in range (CGM arm only) SD of HbA1c and quality of life. RESULTS: Participants tolerated CGM well but were unable to change their own sensors which resulted in increased clinic visits in the CGM arm. Despite the hot climate, skin rashes were uncommon but cut-out tape overpatches were needed to secure the sensors in place. Participants in the CGM arm had greater numbers of dose adjustments and lifestyle change suggestions than those in the UC arm. Participants in the CGM arm wore their CGM on average 63.8% of the time. Participants in the UC arm brought logbooks to clinic 75% of the time. There were three hospitalisations all in the CGM arm, but none were related to the intervention. CONCLUSIONS: This is the first randomised controlled trial conducted on CGM in a rural region of a low-income country. CGM was feasible and appropriate among PLWT1D and providers, but inability of participants to change their own sensors is a challenge. TRIAL REGISTRATION NUMBER: PACTR202102832069874.

Correction: Decentralization and Integration of Advanced Cardiac Care for the World's Poorest Billion Through the PEN-Plus Strategy for Severe Chronic Non-Communicable Disease.

[This corrects the article DOI: 10.5334/gh.1313.].

Decentralization and Integration of Advanced Cardiac Care for the World's Poorest Billion Through the PEN-Plus Strategy for Severe Chronic Non-Communicable Disease.

Rheumatic and congenital heart disease, cardiomyopathies, and hypertensive heart disease are major causes of suffering and death in low- and lower middle-income countries (LLMICs), where the world's poorest billion people reside. Advanced cardiac care in these counties is still predominantly provided by specialists at urban tertiary centers, and is largely inaccessible to the rural poor. This situation is due to critical shortages in diagnostics, medications, and trained healthcare workers. The Package of Essential NCD Interventions - Plus (PEN-Plus) is an integrated care model for severe chronic noncommunicable diseases (NCDs) that aims to decentralize services and increase access. PEN-Plus strategies are being initiated by a growing number of LLMICs. We describe how PEN-Plus addresses the need for advanced cardiac care and discuss how a global group of cardiac organizations are working through the PEN-Plus Cardiac expert group to promote a shared operational strategy for management of severe cardiac disease in high-poverty settings.

Protocol for an evaluation of the initiation of an integrated longitudinal outpatient care model for severe chronic non-communicable diseases (PEN-Plus) at secondary care facilities (district hospitals) in 10 lower-income countries.

INTRODUCTION: The Package of Essential Noncommunicable Disease Interventions-Plus (PEN-Plus) is a strategy decentralising care for severe non-communicable diseases (NCDs) including type 1 diabetes, rheumatic heart disease and sickle cell disease, to increase access to care. In the PEN-Plus model, mid-level clinicians in intermediary facilities in low and lower middle income countries are trained to provide integrated care for conditions where services traditionally were only available at tertiary referral facilities. For the upcoming phase of activities, 18 first-level hospitals in 9 countries and 1 state in India were selected for PEN-Plus expansion and will treat a variety of severe NCDs. Over 3 years, the countries and state are expected to: (1) establish PEN-Plus clinics in one or two district hospitals, (2) support these clinics to mature into training sites in preparation for national or state-level scale-up, and (3) work with the national or state-level stakeholders to describe, measure and advocate for PEN-Plus to support development of a national operational plan for scale-up. METHODS AND ANALYSIS: Guided by Proctor outcomes for implementation research, we are conducting a mixed-method evaluation consisting of 10 components to understand outcomes in clinical implementation, training and policy development. Data will be collected through a mix of quantitative surveys, routine reporting, routine clinical data and qualitative interviews. ETHICS AND DISSEMINATION: This protocol has been considered exempt or covered by central and local institutional review boards. Findings will be disseminated throughout the project's course, including through quarterly M&E discussions, semiannual formative assessments, dashboard mapping of progress, quarterly newsletters, regular feedback loops with national stakeholders and publication in peer-reviewed journals.

Non-communicable disease burden among inpatients at a rural district hospital in Malawi.

BACKGROUND: The burden of non-communicable diseases (NCDs) is high in Malawi. However, resources and training for NCD care remain scarce, especially in rural hospitals. Current care for NCDs in the developing world focuses on the WHO's traditional 4 × 4 set. However, we do not know the full burden of NCDs outside of that scope, like neurological disease, psychiatric illness, sickle cell disease, and trauma. The goal of this study was to understand the burden of NCDs among inpatients in a rural district hospital in Malawi. We broadened our definition of NCDs beyond the traditional 4 × 4 set of NCDs, and included neurological disease, psychiatric illness, sickle cell disease, and trauma. METHODS: We conducted a retrospective chart review of all inpatients who were admitted to the Neno District Hospital between January 2017 and October 2018. We broke patients down by age, date of admission, type, and number of NCD diagnoses, and HIV status, and constructed multivariate regression models for length of stay and in-hospital mortality. RESULTS: Of 2239 total visits, 27.5% were patients with NCDs. Patients with NCDs were older (37.6 vs 19.7 years, p < 0.001) and made up 40.2% of total hospital time. We also found two distinct populations of NCD patients. The first were patients 40 years and older with primary diagnoses of hypertension, heart failure, cancer, and stroke. The second were patients under 40 years old with primary diagnoses of mental health conditions, burns, epilepsy, and asthma. We also found significant trauma burden, accounting for 40% of all NCD visits. In multivariate analysis, carrying a medical NCD diagnosis was associated with longer length of stay (coefficient 5.2, p < 0.001) and a higher risk of in-hospital mortality (OR 1.9, p = 0.03). Burn patients also had significantly longer length of stay (coefficient 11.6, p < 0.001). CONCLUSIONS: There is a significant burden of NCDs in a rural hospital in Malawi, including those outside of the traditional 4 × 4 set. We also found high rates of NCDs in the younger population (under 40 years of age). Hospitals must be equipped with adequate resources and training to meet this burden of disease.

Critical Care Units in Malawi: A Cross-Sectional Study.

Background: The global burden of critical illness falls disproportionately outside high-income countries. Despite younger patient populations with similar or lower disease severity, critical illness outcomes are poor outside high-income countries. A lack of data limits attempts to understand and address the drivers of critical care outcomes outside high-income countries. Objectives: We aim to characterize the organization, available resources, and service capacity of public sector critical care units in Malawi and identify barriers to improving care. Methods: We conducted a secondary analysis of the Malawi Emergency and Critical Care Survey, a cross-sectional study performed from January to February 2020 at all four central hospitals and a simple random sample of nine out of 24 public sector district hospitals in Malawi, a predominantly rural, low-income country of 19.6 million in southern Africa. Data from critical care units were used to characterize resources, processes, and barriers to care. Findings: There were four HDUs and four ICUs across the 13 hospitals in the Malawi Emergency and Critical Care Survey sample. The median critical care beds per 1,000,000 catchment was 1.4 (IQR: 0.9 to 6.7). Absent equipment was the most common barrier in HDUs (46% [95% CI: 32% to 60%]). Stockouts was the most common barriers in ICUs (48% [CI: 38% to 58%]). ICUs had a median 3.0 (range: 2 to 8) functional ventilators per unit and reported an ability to perform several quality mechanical ventilation interventions. Conclusions: Although significant gaps exist, Malawian critical care units report the ability to perform several complex clinical processes. Our results highlight regional inequalities in access to care and support the use of process-oriented questions to assess critical care capacity. Future efforts should focus on basic critical care capacity outside of urban areas and quantify the impact of context-specific variables on critical care mortality.

Training Mid-Level Providers to Treat Severe Non-Communicable Diseases in Neno, Malawi through PEN-Plus Strategies.

Background: Non-communicable diseases (NCDs) are a leading cause of worldwide morbidity and mortality, yet access to care in lower-income countries is limited. Rural communities, where poverty levels are high, feel the greatest burden. In Malawi, as elsewhere in the African region, it is particularly challenging for patients in rural districts to obtain care for locally endemic and severe NCDs such as type 1 diabetes, rheumatic heart disease, and sickle cell disease. The Package of Essential NCD Interventions - Plus (PEN-Plus) is a strategy to decentralize care for these severe conditions by enabling local clinicians at intermediate-care facilities to provide services otherwise available only through specialty clinics at central hospitals. Objectives: The primary objective of this study was to evaluate the impact of training mid-level providers to treat severe and chronic NCDs in newly established PEN-Plus clinics in Neno, Malawi. Methods: Our team developed a logic model to describe the anticipated impacts of the intervention on provider knowledge, patient recruitment, and care provision. We applied a retrospective review of routinely collected clinical and administrative data to assess changes along these hypothesized pathways. Findings: Didactic trainings improved provider test scores immediately following training (25-point improvement; p < 0.01), with demonstrated retention of knowledge after 6 months (21-point improvement, p < 0.01). Over 350 patients were enrolled in the first 18 months of program initiation. The PEN-Plus clinic led to significant improvement in the provision of medications and testing across a range of services. Conclusion: Mid-level providers can be successfully trained to treat severe NCDs with physician-guided education, mentorship, and supervision. The PEN-Plus clinic improved patient enrollment, the quality of clinical care and access to essential medications and laboratory supplies. These lessons learned can guide decentralization of NCD care to district hospitals in Malawi and expansion of PEN-Plus services in the African region.

The Malawi emergency and critical care survey: A cross-sectional national facility assessment.

BACKGROUND: Data on emergency and critical care (ECC) capacity in low-income countries (LICs) are needed to improve outcomes and make progress towards realizing the goal of Universal Health Coverage. METHODS: We developed a novel research instrument to assess public sector ECC capacity and service readiness in LICs. From January 20th to February 18th, 2020 we administered the instrument at all four central hospitals and a simple random sample of nine of 24 district hospitals in Malawi, a landlocked and predominantly rural LIC of 19·1 million people in Southern Africa. The instrument contained questions on the availability of key resources across three domains and was administered to hospital administrators and clinicians from outpatient departments, emergency departments, and inpatient units. Results were used to generate an ECC Readiness Score, with a possible range of 0 to 1, for each facility. FINDINGS: A total of 114 staff members across 13 hospitals completed interviews for this study. Three (33%) district hospitals and all four central hospitals had ECC Readiness Scores above 0·5 (p-value 0·070). Absent equipment was identified as the most common barrier to ECC Readiness. Central hospitals had higher median ECC Readiness Scores with less variability 0·82 (interquartile range: 0·80-0·89) than district hospitals (0·33, 0·23 to 0·50, p-value 0·021). INTERPRETATION: This is the first study to employ a systematic approach to assessing ECC capacity and service readiness at both district and central hospitals in Malawi and provides a framework for measuring ECC capacity in other LICs. Prior ECC assessments potentially overestimated equipment availability and our methodology may provide a more accurate approach. There is an urgent need for investments in ECC services, particularly at district hospitals which are more accessible to Malawi's predominantly rural population. These findings highlight the need for long-term investments in health systems strengthening and underscore the importance of understanding capacity in LIC settings to inform these efforts. FUNDING: Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital and Department of Emergency Medicine, Brigham and Women's Hospital.