A new approach to Health Benefits Package design: an application of the Thanzi La Onse model in Malawi.

An efficient allocation of limited resources in low-income settings offers the opportunity to improve population-health outcomes given the available health system capacity. Efforts to achieve this are often framed through the lens of "health benefits packages" (HBPs), which seek to establish which services the public healthcare system should include in its provision. Analytic approaches widely used to weigh evidence in support of different interventions and inform the broader HBP deliberative process however have limitations. In this work, we propose the individual-based Thanzi La Onse (TLO) model as a uniquely-tailored tool to assist in the evaluation of Malawi-specific HBPs while addressing these limitations. By mechanistically modelling-and calibrating to extensive, country-specific data-the incidence of disease, health-seeking behaviour, and the capacity of the healthcare system to meet the demand for care under realistic constraints on human resources for health available, we were able to simulate the health gains achievable under a number of plausible HBP strategies for the country. We found that the HBP emerging from a linear constrained optimisation analysis (LCOA) achieved the largest health gain-∼8% reduction in disability adjusted life years (DALYs) between 2023 and 2042 compared to the benchmark scenario-by concentrating resources on high-impact treatments. This HBP however incurred a relative excess in DALYs in the first few years of its implementation. Other feasible approaches to prioritisation were assessed, including service prioritisation based on patient characteristics, rather than service type. Unlike the LCOA-based HBP, this approach achieved consistent health gains relative to the benchmark scenario on a year- to-year basis, and a 5% reduction in DALYs over the whole period, which suggests an approach based upon patient characteristics might prove beneficial in the future.

Health workforce needs in Malawi: analysis of the Thanzi La Onse integrated epidemiological model of care.

BACKGROUND: To make the best use of health resources, it is crucial to understand the healthcare needs of a population-including how needs will evolve and respond to changing epidemiological context and patient behaviour-and how this compares to the capabilities to deliver healthcare with the existing workforce. Existing approaches to planning either rely on using observed healthcare demand from a fixed historical period or using models to estimate healthcare needs within a narrow domain (e.g., a specific disease area or health programme). A new data-grounded modelling method is proposed by which healthcare needs and the capabilities of the healthcare workforce can be compared and analysed under a range of scenarios: in particular, when there is much greater propensity for healthcare seeking. METHODS: A model representation of the healthcare workforce, one that formalises how the time of the different cadres is drawn into the provision of units of healthcare, was integrated with an individual-based epidemiological model-the Thanzi La Onse model-that represents mechanistically the development of disease and ill-health and patients' healthcare seeking behaviour. The model was applied in Malawi using routinely available data and the estimates of the volume of health service delivered were tested against officially recorded data. Model estimates of the "time needed" and "time available" for each cadre were compared under different assumptions for whether vacant (or established) posts are filled and healthcare seeking behaviour. RESULTS: The model estimates of volume of each type of service delivered were in good agreement with the available data. The "time needed" for the healthcare workforce greatly exceeded the "time available" (overall by 1.82-fold), especially for pharmacists (6.37-fold) and clinicians (2.83-fold). This discrepancy would be largely mitigated if all vacant posts were filled, but the large discrepancy would remain for pharmacists (2.49-fold). However, if all of those becoming ill did seek care immediately, the "time needed" would increase dramatically and exceed "time supply" (2.11-fold for nurses and midwives, 5.60-fold for clinicians, 9.98-fold for pharmacists) even when there were no vacant positions. CONCLUSIONS: The results suggest that services are being delivered in less time on average than they should be, or that healthcare workers are working more time than contracted, or a combination of the two. Moreover, the analysis shows that the healthcare system could become overwhelmed if patients were more likely to seek care. It is not yet known what the health consequences of such changes would be but this new model provides-for the first time-a means to examine such questions.

Population health outcomes in Nigeria compared with other west African countries, 1998-2019: a systematic analysis for the Global Burden of Disease Study.

BACKGROUND: Population-level health and mortality data are crucial for evidence-informed policy but scarce in Nigeria. To fill this gap, we undertook a comprehensive assessment of the burden of disease in Nigeria and compared outcomes to other west African countries. METHODS: In this systematic analysis, using data and results of the Global Burden of Diseases, Injuries, and Risk Factors Study 2019, we analysed patterns of mortality, years of life lost (YLLs), years lived with disability (YLDs), life expectancy, healthy life expectancy (HALE), and health system coverage for Nigeria and 15 other west African countries by gender in 1998 and 2019. Estimates of all-age and age-standardised disability-adjusted life-years for 369 diseases and injuries and 87 risk factors are presented for Nigeria. Health expenditure per person and gross domestic product were extracted from the World Bank repository. FINDINGS: Between 1998 and 2019, life expectancy and HALE increased in Nigeria by 18% to 64·3 years (95% uncertainty interval [UI] 62·2-66·6), mortality reduced for all age groups for both male and female individuals, and health expenditure per person increased from the 11th to third highest in west Africa by 2018 (US$18·6 in 2001 to $83·75 in 2018). Nonetheless, relative outcomes remained poor; Nigeria ranked sixth in west Africa for age-standardised mortality, seventh for HALE, tenth for YLLs, 12th for health system coverage, and 14th for YLDs in 2019. Malaria (5176·3 YLLs per 100 000 people, 95% UI 2464·0-9591·1) and neonatal disorders (4818·8 YLLs per 100 000, 3865·9-6064·2) were the leading causes of YLLs in Nigeria in 2019. Nigeria had the fourth-highest under-five mortality rate for male individuals (2491·8 deaths per 100 000, 95% UI 1986·1-3140·1) and female individuals (2117·7 deaths per 100 000, 1756·7-2569·1), but among the lowest mortality for men older than 55 years. There was evidence of a growing non-communicable disease burden facing older Nigerians. INTERPRETATION: Health outcomes remain poor in Nigeria despite higher expenditure since 2001. Better outcomes in countries with equivalent or lower health expenditure suggest health system strengthening and targeted intervention to address unsafe water sources, poor sanitation, malnutrition, and exposure to air pollution could substantially improve population health. FUNDING: The Bill & Melinda Gates Foundation.

Modeling Contraception and Pregnancy in Malawi: A Thanzi La Onse Mathematical Modeling Study.

Malawi has high unmet need for contraception with a costed national plan to increase contraception use. Estimating how such investments might impact future population size in Malawi can help policymakers understand effects and value of policies to increase contraception uptake. We developed a new model of contraception and pregnancy using individual-level data capturing complexities of contraception initiation, switching, discontinuation, and failure by contraception method, accounting for differences by individual characteristics. We modeled contraception scale-up via a population campaign to increase initiation of contraception (Pop) and a postpartum family planning intervention (PPFP). We calibrated the model without new interventions to the UN World Population Prospects 2019 medium variant projection of births for Malawi. Without interventions Malawi's population passes 60 million in 2084; with Pop and PPFP interventions. it peaks below 35 million by 2100. We compare contraception coverage and costs, by method, with and without interventions, from 2023 to 2050. We estimate investments in contraception scale-up correspond to only 0.9 percent of total health expenditure per capita though could result in dramatic reductions of current pressures of very rapid population growth on health services, schools, land, and society, helping Malawi achieve national and global health and development goals.

A qualitative study on the feasibility and acceptability of institutionalizing health technology assessment in Malawi.

OBJECTIVE: The objective of this study was to assess the feasibility and acceptability of institutionalizing Health Technology Assessment (HTA) in Malawi. METHODS: This study employed a document review and qualitative research methods, to understand the status of HTA in Malawi. This was complemented by a review of the status and nature of HTA institutionalization in selected countries.Qualitative research employed a Focus Group Discussion (FGD ) with 7 participants, and Key Informant Interviews (KIIs) with12 informants selected based on their knowledge and expertise in policy processes related to HTA in Malawi.Data extracted from the literature was organized in Microsoft Excel, categorized according to thematic areas and analyzed using a literature review framework. Qualitative data from KIIs and the FGD was analyzed using a thematic content analysis approach. RESULTS: Some HTA processes exist and are executed through three structures namely: Ministry of Health Senior Management Team, Technical Working Groups, and Pharmacy and Medicines Regulatory Authority (PMRA) with varyingdegrees of effectiveness.The main limitations of current HTA mechanisms include limited evidence use, lack of a standardized framework for technology adoption, donor pressure, lack of resources for the HTA process and technology acquisition, laws and practices that undermine cost-effectiveness considerations. KII and FGD results showed overwhelming demand for strengthening HTA in Malawi, with a stronger preference for strengthening coordination and capacity of existing entities and structures. CONCLUSION: The study has shown that HTA institutionalization is acceptable and feasible in Malawi. However, the current committee based processes are suboptimal to improve efficiency due to lack of a structured framework. A structured HTA framework has the potential to improve processes in pharmaceuticals and medical technologies decision-making.In the short to medium term, HTA capacity building should focus on generating demand and increasing capacity in cost-effectiveness assessments. Country-specific assessments should precede HTA institutionalization as well as recommendations for new technology adoptions.

Testing, tracing and isolation in compartmental models.

Existing compartmental mathematical modelling methods for epidemics, such as SEIR models, cannot accurately represent effects of contact tracing. This makes them inappropriate for evaluating testing and contact tracing strategies to contain an outbreak. An alternative used in practice is the application of agent- or individual-based models (ABM). However ABMs are complex, less well-understood and much more computationally expensive. This paper presents a new method for accurately including the effects of Testing, contact-Tracing and Isolation (TTI) strategies in standard compartmental models. We derive our method using a careful probabilistic argument to show how contact tracing at the individual level is reflected in aggregate on the population level. We show that the resultant SEIR-TTI model accurately approximates the behaviour of a mechanistic agent-based model at far less computational cost. The computational efficiency is such that it can be easily and cheaply used for exploratory modelling to quantify the required levels of testing and tracing, alone and with other interventions, to assist adaptive planning for managing disease outbreaks.

The Ebola crisis and people with disabilities' access to healthcare and government services in Liberia.

BACKGROUND: There has been little research on the impact of the 2014-2015 West African Ebola crisis on people with disabilities. This paper outlines the way in which the Ebola Virus Disease (EVD) outbreak in Liberia in 2015 highlighted existing inequalities and exclusion of people with disabilities and their households. METHODS: The results presented here are part of a larger ESRC/DFID-funded mixed methods research project in Liberia (2014-2017) which included a quantitative household survey undertaken in five counties, complemented by qualitative focus group discussions and interviews with people with disabilities and other key stakeholders. Uniquely, this research gathered information about people with disabilities' experience of the EVD outbreak, as well as additional socioeconomic and inclusion data, that compared their experience with non-disabled community members. RESULTS: Reflections by people with disabilities themselves show knowledge, preparation, and responses to the EVD epidemic was often markedly different among people with disabilities due to limited resources, lack of inclusion by many mainstream public health and medical interventions and pre-existing discrimination, marginalisation and exclusion. Interviews with other key stakeholder revealed a lack of awareness of disability issues or sufficient training to include this population systematically in both Ebola response activities and general health services. Key findings include the need to understand and mitigate direct and indirect health consequences of unequal responses to the epidemic, as well as the limited capacity of healthcare and social services to respond to people with disabilities. CONCLUSION: There are lessons to be learned from Ebola outbreak around inclusion of people with disabilities, relevant to the current COVID-19 pandemic. Now is the time to undertake measures to ensure that people with disabilities do not continue to be marginalised and excluded during global public health emergencies.

Understanding the roles of community health workers in improving perinatal health equity in rural Uttar Pradesh, India: a qualitative study.

BACKGROUND: Despite substantial reductions in perinatal deaths (stillbirths and early neonatal deaths), India's perinatal mortality rates remain high, both nationally and in individual states. Rates are highest among disadvantaged socio-economic groups. To address this, India's National Health Mission has trained community health workers called Accredited Social Health Activists (ASHAs) to counsel and support women by visiting them at home before and after childbirth. We conducted a qualitative study to explore the roles of ASHAs' home visits in improving equity in perinatal health between socio-economic position groups in rural Uttar Pradesh (UP), India. METHODS: We conducted social mapping in four villages of two districts in UP, followed by three focus group discussions in each village (12 in total) with ASHAs and women who had recently given birth belonging to 'higher' and 'lower' socio-economic position groups (n = 134 participants). We analysed the data in NVivo and Dedoose using a thematic framework approach. RESULTS: Home visits enabled ASHAs to build trusting relationships with women, offer information about health services, schemes and preventive care, and provide practical support for accessing maternity care. This helped many women and families prepare for birth and motivated them to deliver in health facilities. In particular, ASHAs encouraged women who were poorer, less educated or from lower caste groups to give birth in public Community Health Centres (CHCs). However, women who gave birth at CHCs often experienced insufficient emergency obstetric care, mistreatment from staff, indirect costs, lack of medicines, and referrals to higher-level facilities when complications occurred. Referrals often led to delays and higher fees that placed the greatest burden on families who were considered of lower socio-economic position or living in remote areas, and increased their risk of experiencing perinatal loss. CONCLUSIONS: The study found that ASHAs built relationships, counselled and supported many pregnant women of lower socio-economic positions. Ongoing inequities in health facility births and perinatal mortality were perpetuated by overlapping contextual issues beyond the ASHAs' purview. Supporting ASHAs' integration with community organisations and health system strategies more broadly is needed to address these issues and optimise pathways between equity in intervention coverage, processes and perinatal health outcomes.

Predictive value of pulse oximetry for mortality in infants and children presenting to primary care with clinical pneumonia in rural Malawi: A data linkage study.

BACKGROUND: The mortality impact of pulse oximetry use during infant and childhood pneumonia management at the primary healthcare level in low-income countries is unknown. We sought to determine mortality outcomes of infants and children diagnosed and referred using clinical guidelines with or without pulse oximetry in Malawi. METHODS AND FINDINGS: We conducted a data linkage study of prospective health facility and community case and mortality data. We matched prospectively collected community health worker (CHW) and health centre (HC) outpatient data to prospectively collected hospital and community-based mortality surveillance outcome data, including episodes followed up to and deaths within 30 days of pneumonia diagnosis amongst children 0-59 months old. All data were collected in Lilongwe and Mchinji districts, Malawi, from January 2012 to June 2014. We determined differences in mortality rates using <90% and <93% oxygen saturation (SpO2) thresholds and World Health Organization (WHO) and Malawi clinical guidelines for referral. We used unadjusted and adjusted (for age, sex, respiratory rate, and, in analyses of HC data only, Weight for Age Z-score [WAZ]) regression to account for interaction between SpO2 threshold (pulse oximetry) and clinical guidelines, clustering by child, and CHW or HC catchment area. We matched CHW and HC outpatient data to hospital inpatient records to explore roles of pulse oximetry and clinical guidelines on hospital attendance after referral. From 7,358 CHW and 6,546 HC pneumonia episodes, we linked 417 CHW and 695 HC pneumonia episodes to 30-day mortality outcomes: 16 (3.8%) CHW and 13 (1.9%) HC patients died. SpO2 thresholds of <90% and <93% identified 1 (6%) of the 16 CHW deaths that were unidentified by integrated community case management (iCCM) WHO referral protocol and 3 (23%) and 4 (31%) of the 13 HC deaths, respectively, that were unidentified by the integrated management of childhood illness (IMCI) WHO protocol. Malawi IMCI referral protocol, which differs from WHO protocol at the HC level and includes chest indrawing, identified all but one of these deaths. SpO2 < 90% predicted death independently of WHO danger signs compared with SpO2 ≥ 90%: HC Risk Ratio (RR), 9.37 (95% CI: 2.17-40.4, p = 0.003); CHW RR, 6.85 (1.15-40.9, p = 0.035). SpO2 < 93% was also predictive versus SpO2 ≥ 93% at HC level: RR, 6.68 (1.52-29.4, p = 0.012). Hospital referrals and outpatient episodes with referral decision indications were associated with mortality. A substantial proportion of those referred were not found admitted in the inpatients within 7 days of referral advice. All 12 deaths in 73 hospitalised children occurred within 24 hours of arrival in the hospital, which highlights delay in appropriate care seeking. The main limitation of our study was our ability to only match 6% of CHW episodes and 11% of HC episodes to mortality outcome data. CONCLUSIONS: Pulse oximetry identified fatal pneumonia episodes at HCs in Malawi that would otherwise have been missed by WHO referral guidelines alone. Our findings suggest that pulse oximetry could be beneficial in supplementing clinical signs to identify children with pneumonia at high risk of mortality in the outpatient setting in health centres for referral to a hospital for appropriate management.

Preconception health in England: a proposal for annual reporting with core metrics.

There is growing interest in preconception health as a crucial period for influencing not only pregnancy outcomes, but also future maternal and child health, and prevention of long-term medical conditions. Successive national and international policy documents emphasise the need to improve preconception health, but resources and action have not followed through with these goals. We argue for a dual intervention strategy at both the public health level (eg, by improving the food environment) and at the individual level (eg, by better identification of those planning a pregnancy who would benefit from support to optimise health before conception) in order to raise awareness of preconception health and to normalise the notion of planning and preparing for pregnancy. Existing strategies that target common risks factors, such as obesity and smoking, should recognise the preconception period as one that offers special opportunity for intervention, based on evidence from life-course epidemiology, developmental (embryo) programming around the time of conception, and maternal motivation. To describe and monitor preconception health in England, we propose an annual report card using metrics from multiple routine data sources. Such a report card should serve to hold governments and other relevant agencies to account for delivering interventions to improve preconception health.

Factors associated with healthcare seeking behaviour for children in Malawi: 2016.

OBJECTIVE: To characterise health seeking behaviour (HSB) and determine its predictors amongst children in Malawi in 2016. METHODS: We used the 2016 Malawi Integrated Household Survey data set. The outcome of interest was HSB, defined as seeking care at a health facility amongst people who reported one or more of a list of possible symptoms given on the questionnaire in the past two weeks. We fitted a multivariate logistic regression model of HSB using a forward step-wise selection method, with age, sex and symptoms entered as a priori variables. RESULTS: Of 5350 children, 1666 (32%) had symptoms in the past two weeks. Of the 1666, 1008 (61%) sought care at health facility. The children aged 5-14 years were less likely to be taken to health facilities for health care than those aged 0-4 years. Having fever vs. not having fever and having a skin problem vs. not having skin problem were associated with increased likelihood of HSB. Having a headache vs. not having a headache was associated with lower likelihood of accessing care at health facilities (AOR = 0.50, 95% CI: 0.26-0.96, P = 0.04). Children from urban areas were more likely to be taken to health facilities for health care (AOR = 1.81, 95% CI: 1.17-2.85, P = 0.008), as were children from households with a high wealth status (AOR = 1.86, 95% CI: 1.25-2.78, P = 0.02). CONCLUSION: There is a need to understand and address individual, socio-economic and geographical barriers to health seeking to increase access and use of health care and fast-track progress towards Universal Health Coverage.

OBJECTIF: Caractériser le comportement de recherche de santé (CRS) et déterminer ses prédicteurs chez les enfants du Malawi en 2016. MÉTHODES: Nous avons utilisé l'ensemble de données de l'Enquête intégrée de 2016 auprès des ménages du Malawi. Le résultat d'intérêt était le CRS, défini comme la recherche de soins dans un établissement de santé chez les personnes qui ont déclaré une ou plusieurs symptômes d'une liste de possibilités figurant sur le questionnaire, dans les deux dernières semaines. Nous avons appliqué un modèle de régression logistique multivariée du CRS en utilisant une méthode de sélection par étape, avec l'âge, le sexe et les symptômes entrés comme variables a priori. RÉSULTATS: Sur 5.350 enfants, 1.666 (32%) ont présenté des symptômes au cours des deux dernières semaines. Sur les 1.666, des soins ont été cherché pour 1.008 (61%) dans un établissement de santé. Les enfants âgés de 5 à 14 ans étaient moins susceptibles d'être emmenés dans des établissements de santé pour des soins de santé que ceux âgés de 0 à 4 ans. Avoir de la fièvre par rapport à ne pas en avoir et avoir un problème de peau par rapport à ne pas en avoir étaient associés à une probabilité accrue de CRS. Avoir un mal de tête par rapport à ne pas en avoir était associé à une probabilité plus faible d'accéder aux soins dans les établissements de santé (AOR = 0,50 ; IC95%: 0,26-0,96 ; P= 0,04). Les enfants des zones urbaines étaient plus susceptibles d'être emmenés dans des établissements de santé pour des soins de santé (AOR = 1,81 ; IC95%: 1,17-2,85 ; P= 0,008), tout comme les enfants de ménages ayant une position socioéconomique plus élevée (AOR = 1,96 ; IC95%: 1,13-3,40 ; P= 0,02). CONCLUSION: Il est nécessaire de comprendre et de surmonter les obstacles individuels, socioéconomiques et géographiques à la recherche de la santé pour accroître l'accès et l'utilisation des soins de santé et accélérer les progrès vers la couverture sanitaire universelle.

Mobile money use and social health insurance enrolment among rural dwellers outside the formal employment sector: Evidence from Kenya.

BACKGROUND: The study set out to explore whether mobile money use (mobile phone-based financial services) increased the probability of rural dwellers outside the formal employment sector of being enrolled in Kenya's social health insurance, the National Hospital Insurance Fund (NHIF). METHODS: We used data from the 2015 FinAccess Household Survey and analysed responses of 4282 rural individuals outside the formal employment sector. Probit and bivariate probit models were used and adjusted for mobile phone ownership, sex, age, age-squared, education, wealth quintile, bank account use, informal group membership, occupation, and health shocks. RESULTS: We found that 16.26% (95% CI, 14.58% to 18.10%) of mobile money users had NHIF cover as compared with 2.44% (95% CI, 1.83% to 3.23%) of nonusers. Importantly, mobile money use increased the probability of being enrolled in NHIF by 4.6% (95% CI, 2.1% to 7.1%) after controlling for confounders. Access to mobile money was associated with reduced travel time and lower transport costs, which are likely to be key mechanisms for increasing NHIF enrolment. CONCLUSION: By lowering transport costs and saving travel time, mobile money provides an easy means to pay social health insurance premiums thus incentivising its uptake among rural people outside of formal employment.

Intervention strategies to improve nutrition and health behaviours before conception.

The nutritional status of both women and men before conception has profound implications for the growth, development, and long-term health of their offspring. Evidence of the effectiveness of preconception interventions for improving outcomes for mothers and babies is scarce. However, given the large potential health return, and relatively low costs and risk of harm, research into potential interventions is warranted. We identified three promising strategies for intervention that are likely to be scalable and have positive effects on a range of health outcomes: supplementation and fortification; cash transfers and incentives; and behaviour change interventions. On the basis of these strategies, we suggest a model specifying pathways to effect. Pathways are incorporated into a life-course framework using individual motivation and receptiveness at different preconception action phases, to guide design and targeting of preconception interventions. Interventions for individuals not planning immediate pregnancy take advantage of settings and implementation platforms outside the maternal and child health arena, since this group is unlikely to be engaged with maternal health services. Interventions to improve women's nutritional status and health behaviours at all preconception action phases should consider social and environmental determinants, to avoid exacerbating health and gender inequalities, and be underpinned by a social movement that touches the whole population. We propose a dual strategy that targets specific groups actively planning a pregnancy, while improving the health of the population more broadly. Modern marketing techniques could be used to promote a social movement based on an emotional and symbolic connection between improved preconception maternal health and nutrition, and offspring health. We suggest that speedy and scalable benefits to public health might be achieved through strategic engagement with the private sector. Political theory supports the development of an advocacy coalition of groups interested in preconception health, to harness the political will and leadership necessary to turn high-level policy into effective coordinated action.

Understanding how, why, for whom, and under what circumstances opt-out blood-borne virus testing programmes work to increase test engagement and uptake within prison: a rapid-realist review.

BACKGROUND: Prisons represent a unique opportunity to diagnose blood-borne viruses. Opt-out testing is receiving increasing interest, as a result of mounting evidence to suggest that the manner in which a test offer is delivered, affects test uptake. Although the effectiveness of opt-out testing within the prison setting has been established, robust explanations are required for the variation in outcomes reported. METHODS: Rapid-realist review methodology was used to synthesise the literature on prison-based opt-out testing. The review was carried out in three phases. Phase one: An expert panel provided literature relevant to the implementation of opt-out testing within the English prison estate. Unstructured searches were also conducted to identify other social programmes where "opt-out" had been used to increase uptake. Phase two: a systematic search of six peer-review and five grey literature databases was carried out to identify empirical data on opt-out testing within the prison setting. Phase three: Additional non-exhaustive searches were carried out to identify literature that reinforced emergent concepts. The development of programme theory took place with each iteration and was validated in consultation with stakeholders. RESULTS: Programme theory was constructed for two outcomes: the proportion of intake offered a test and the proportion offered that accepted testing. The proportion of intake offered testing was influenced by the timing of the test offer, which was often delayed due to barriers to prisoner access. The decision to accept testing was influenced by concerns about confidentiality, fear of a positive diagnosis, a prisoner's personal interpretation of risk, discomfort with invasive procedures, trust in healthcare, and the fidelity of the opt-out offer. CONCLUSIONS: This review identified important implementation considerations that moderate the effectiveness of opt-out testing programmes. It also highlighted a lack of appreciation for the theoretical underpinnings of opt-out programmes and tension around how to implement testing in a manner that adheres to both default theory and informed consent. It is anticipated that results will be used to inform the design and implementation of subsequent versions of these programmes, as well as catalyse further in-depth analysis into their operation within the unique context of prison. REVIEW REGISTRATION: CRD42017068342 .

A cash-based intervention and the risk of acute malnutrition in children aged 6-59 months living in internally displaced persons camps in Mogadishu, Somalia: A non-randomised cluster trial.

BACKGROUND: Somalia has been affected by conflict since 1991, with children aged <5 years presenting a high acute malnutrition prevalence. Cash-based interventions (CBIs) have been used in this context since 2011, despite sparse evidence of their nutritional impact. We aimed to understand whether a CBI would reduce acute malnutrition and its risk factors. METHODS AND FINDINGS: We implemented a non-randomised cluster trial in internally displaced person (IDP) camps, located in peri-urban Mogadishu, Somalia. Within 10 IDP camps (henceforth clusters) selected using a humanitarian vulnerability assessment, all households were targeted for the CBI. Ten additional clusters located adjacent to the intervention clusters were selected as controls. The CBI comprised a monthly unconditional cash transfer of US$84.00 for 5 months, a once-only distribution of a non-food-items kit, and the provision of piped water free of charge. The cash transfers started in May 2016. Cash recipients were female household representatives. In March and September 2016, from a cohort of randomly selected households in the intervention (n = 111) and control (n = 117) arms (household cohort), we collected household and individual level data from children aged 6-59 months (155 in the intervention and 177 in the control arms) and their mothers/primary carers, to measure known malnutrition risk factors. In addition, between June and November 2016, data to assess acute malnutrition incidence were collected monthly from a cohort of children aged 6-59 months, exhaustively sampled from the intervention (n = 759) and control (n = 1,379) arms (child cohort). Primary outcomes were the mean Child Dietary Diversity Score in the household cohort and the incidence of first episode of acute malnutrition in the child cohort, defined by a mid-upper arm circumference < 12.5 cm and/or oedema. Analyses were by intention-to-treat. For the household cohort we assessed differences-in-differences, for the child cohort we used Cox proportional hazards ratios. In the household cohort, the CBI appeared to increase the Child Dietary Diversity Score by 0.53 (95% CI 0.01; 1.05). In the child cohort, the acute malnutrition incidence rate (cases/100 child-months) was 0.77 (95% CI 0.70; 1.21) and 0.92 (95% CI 0.53; 1.14) in intervention and control arms, respectively. The CBI did not appear to reduce the risk of acute malnutrition: unadjusted hazard ratio 0.83 (95% CI 0.48; 1.42) and hazard ratio adjusted for age and sex 0.94 (95% CI 0.51; 1.74). The CBI appeared to increase the monthly household expenditure by US$29.60 (95% CI 3.51; 55.68), increase the household Food Consumption Score by 14.8 (95% CI 4.83; 24.8), and decrease the Reduced Coping Strategies Index by 11.6 (95% CI 17.5; 5.96). The study limitations were as follows: the study was not randomised, insecurity in the field limited the household cohort sample size and collection of other anthropometric measurements in the child cohort, the humanitarian vulnerability assessment data used to allocate the intervention were not available for analysis, food market data were not available to aid results interpretation, and the malnutrition incidence observed was lower than expected. CONCLUSIONS: The CBI appeared to improve beneficiaries' wealth and food security but did not appear to reduce acute malnutrition risk in IDP camp children. Further studies are needed to assess whether changing this intervention, e.g., including specific nutritious foods or social and behaviour change communication, would improve its nutritional impact. TRIAL REGISTRATION: ISRCTN Registy ISRCTN29521514.

The Lancet Countdown: tracking progress on health and climate change.

The Lancet Countdown: tracking progress on health and climate change is an international, multidisciplinary research collaboration between academic institutions and practitioners across the world. It follows on from the work of the 2015 Lancet Commission, which concluded that the response to climate change could be "the greatest global health opportunity of the 21st century". The Lancet Countdown aims to track the health impacts of climate hazards; health resilience and adaptation; health co-benefits of climate change mitigation; economics and finance; and political and broader engagement. These focus areas form the five thematic working groups of the Lancet Countdown and represent different aspects of the complex association between health and climate change. These thematic groups will provide indicators for a global overview of health and climate change; national case studies highlighting countries leading the way or going against the trend; and engagement with a range of stakeholders. The Lancet Countdown ultimately aims to report annually on a series of indicators across these five working groups. This paper outlines the potential indicators and indicator domains to be tracked by the collaboration, with suggestions on the methodologies and datasets available to achieve this end. The proposed indicator domains require further refinement, and mark the beginning of an ongoing consultation process-from November, 2016 to early 2017-to develop these domains, identify key areas not currently covered, and change indicators where necessary. This collaboration will actively seek to engage with existing monitoring processes, such as the UN Sustainable Development Goals and WHO's climate and health country profiles. The indicators will also evolve over time through ongoing collaboration with experts and a range of stakeholders, and be dependent on the emergence of new evidence and knowledge. During the course of its work, the Lancet Countdown will adopt a collaborative and iterative process, which aims to complement existing initiatives, welcome engagement with new partners, and be open to developing new research projects on health and climate change.

Findings from a cluster randomised trial of unconditional cash transfers in Niger.

Unconditional cash transfers (UCTs) are used as a humanitarian intervention to prevent acute malnutrition, despite a lack of evidence about their effectiveness. In Niger, UCT and supplementary feeding are given during the June-September "lean season," although admissions of malnourished children to feeding programmes may rise from March/April. We hypothesised that earlier initiation of the UCT would reduce the prevalence of global acute malnutrition (GAM) in children 6-59 months old in beneficiary households and at population level. We conducted a 2-armed cluster-randomised controlled trial in which the poorest households received either the standard UCT (4 transfers between June and September) or a modified UCT (6 transfers from April); both providing 130,000 FCFA/£144 in total. Eligible individuals (pregnant and lactating women and children 6-<24 months old) in beneficiary households in both arms also received supplementary food between June and September. We collected data in March/April and October/November 2015. The modified UCT plus 4 months supplementary feeding did not reduce the prevalence of GAM compared with the standard UCT plus 4 months supplementary feeding (adjusted odds ratios 1.09 (95% CI [0.77, 1.55], p = 0.630) and 0.93 (95% CI [0.58, 1.49], p = 0.759) among beneficiaries and the population, respectively). More beneficiaries receiving the modified UCT plus supplementary feeding reported adequate food access in April and May (p < 0.001) but there was no difference in endline food security between arms. In both arms and samples, the baseline prevalence of GAM remained elevated at endline (p > 0.05), despite improved food security (p < 0.05), possibly driven by increased fever/malaria in children (p < 0.001). Nonfood related drivers of malnutrition, such as disease, may limit the effectiveness of UCTs plus supplementary feeding to prevent malnutrition in this context. Caution is required in applying the findings of this study to periods of severe food insecurity.

Impact evaluation of different cash-based intervention modalities on child and maternal nutritional status in Sindh Province, Pakistan, at 6 mo and at 1 y: A cluster randomised controlled trial.

BACKGROUND: Cash-based interventions (CBIs), offer an interesting opportunity to prevent increases in wasting in humanitarian aid settings. However, questions remain as to the impact of CBIs on nutritional status and, therefore, how to incorporate them into emergency programmes to maximise their success in terms of improved nutritional outcomes. This study evaluated the effects of three different CBI modalities on nutritional outcomes in children under 5 y of age at 6 mo and at 1 y. METHODS AND FINDINGS: We conducted a four-arm parallel longitudinal cluster randomised controlled trial in 114 villages in Dadu District, Pakistan. The study included poor and very poor households (n = 2,496) with one or more children aged 6-48 mo (n = 3,584) at baseline. All four arms had equal access to an Action Against Hunger-supported programme. The three intervention arms were as follows: standard cash (SC), a cash transfer of 1,500 Pakistani rupees (PKR) (approximately US$14; 1 PKR = US$0.009543); double cash (DC), a cash transfer of 3,000 PKR; or a fresh food voucher (FFV) of 1,500 PKR; the cash or voucher amount was given every month over six consecutive months. The control group (CG) received no specific cash-related interventions. The median total household income for the study sample was 8,075 PKR (approximately US$77) at baseline. We hypothesized that, compared to the CG in each case, FFVs would be more effective than SC, and that DC would be more effective than SC-both at 6 mo and at 1 y-for reducing the risk of child wasting. Primary outcomes of interest were prevalence of being wasted (weight-for-height z-score [WHZ] < -2) and mean WHZ at 6 mo and at 1 y. The odds of a child being wasted were significantly lower in the DC arm after 6 mo (odds ratio [OR] = 0.52; 95% CI 0.29, 0.92; p = 0.02) compared to the CG. Mean WHZ significantly improved in both the FFV and DC arms at 6 mo (FFV: z-score = 0.16; 95% CI 0.05, 0.26; p = 0.004; DC: z-score = 0.11; 95% CI 0.00, 0.21; p = 0.05) compared to the CG. Significant differences on the primary outcome were seen only at 6 mo. All three intervention groups showed similar significantly lower odds of being stunted (height-for-age z-score [HAZ] < -2) at 6 mo (DC: OR = 0.39; 95% CI 0.24, 0.64; p < 0.001; FFV: OR = 0.41; 95% CI 0.25, 0.67; p < 0.001; SC: OR = 0.36; 95% CI 0.22, 0.59; p < 0.001) and at 1 y (DC: OR = 0.53; 95% CI 0.35, 0.82; p = 0.004; FFV: OR = 0.48; 95% CI 0.31, 0.73; p = 0.001; SC: OR = 0.54; 95% CI 0.36, 0.81; p = 0.003) compared to the CG. Significant improvements in height-for-age outcomes were also seen for severe stunting (HAZ < -3) and mean HAZ. An unintended outcome was observed in the FFV arm: a negative intervention effect on mean haemoglobin (Hb) status (-2.6 g/l; 95% CI -4.5, -0.8; p = 0.005). Limitations of this study included the inability to mask participants or data collectors to the different interventions, the potentially restrictive nature of the FFVs, not being able to measure a threshold effect for the two different cash amounts or compare the different quantities of food consumed, and data collection challenges given the difficult environment in which this study was set. CONCLUSIONS: In this setting, the amount of cash given was important. The larger cash transfer had the greatest effect on wasting, but only at 6 mo. Impacts at both 6 mo and at 1 y were seen for height-based growth variables regardless of the intervention modality, indicating a trend toward nutrition resilience. Purchasing restrictions applied to food-based voucher transfers could have unintended effects, and their use needs to be carefully planned to avoid this. TRIAL REGISTRATION: ISRCTN registry ISRCTN10761532.

Effects of women's groups practising participatory learning and action on preventive and care-seeking behaviours to reduce neonatal mortality: A meta-analysis of cluster-randomised trials.

BACKGROUND: The World Health Organization recommends participatory learning and action (PLA) in women's groups to improve maternal and newborn health, particularly in rural settings with low access to health services. There have been calls to understand the pathways through which this community intervention may affect neonatal mortality. We examined the effect of women's groups on key antenatal, delivery, and postnatal behaviours in order to understand pathways to mortality reduction. METHODS AND FINDINGS: We conducted a meta-analysis using data from 7 cluster-randomised controlled trials that took place between 2001 and 2012 in rural India (2 trials), urban India (1 trial), rural Bangladesh (2 trials), rural Nepal (1 trial), and rural Malawi (1 trial), with the number of participants ranging between 6,125 and 29,901 live births. Behavioural outcomes included appropriate antenatal care, facility delivery, use of a safe delivery kit, hand washing by the birth attendant prior to delivery, use of a sterilised instrument to cut the umbilical cord, immediate wrapping of the newborn after delivery, delayed bathing of the newborn, early initiation of breastfeeding, and exclusive breastfeeding. We used 2-stage meta-analysis techniques to estimate the effect of the women's group intervention on behavioural outcomes. In the first stage, we used random effects models with individual patient data to assess the effect of groups on outcomes separately for the different trials. In the second stage of the meta-analysis, random effects models were applied using summary-level estimates calculated in the first stage of the analysis. To determine whether behaviour change was related to group attendance, we used random effects models to assess associations between outcomes and the following categories of group attendance and allocation: women attending a group and allocated to the intervention arm; women not attending a group but allocated to the intervention arm; and women allocated to the control arm. Overall, women's groups practising PLA improved behaviours during and after home deliveries, including the use of safe delivery kits (odds ratio [OR] 2.92, 95% CI 2.02-4.22; I2 = 63.7%, 95% CI 4.4%-86.2%), use of a sterile blade to cut the umbilical cord (1.88, 1.25-2.82; 67.6%, 16.1%-87.5%), birth attendant washing hands prior to delivery (1.87, 1.19-2.95; 79%, 53.8%-90.4%), delayed bathing of the newborn for at least 24 hours (1.47, 1.09-1.99; 68.0%, 29.2%-85.6%), and wrapping the newborn within 10 minutes of delivery (1.27, 1.02-1.60; 0.0%, 0%-79.2%). Effects were partly dependent on the proportion of pregnant women attending groups. We did not find evidence of effects on uptake of antenatal care (OR 1.03, 95% CI 0.77-1.38; I2 = 86.3%, 95% CI 73.8%-92.8%), facility delivery (1.02, 0.93-1.12; 21.4%, 0%-65.8%), initiating breastfeeding within 1 hour (1.08, 0.85-1.39; 76.6%, 50.9%-88.8%), or exclusive breastfeeding for 6 weeks after delivery (1.18, 0.93-1.48; 72.9%, 37.8%-88.2%). The main limitation of our analysis is the high degree of heterogeneity for effects on most behaviours, possibly due to the limited number of trials involving women's groups and context-specific effects. CONCLUSIONS: This meta-analysis suggests that women's groups practising PLA improve key behaviours on the pathway to neonatal mortality, with the strongest evidence for home care behaviours and practices during home deliveries. A lack of consistency in improved behaviours across all trials may reflect differences in local priorities, capabilities, and the responsiveness of health services. Future research could address the mechanisms behind how PLA improves survival, in order to adapt this method to improve maternal and newborn health in different contexts, as well as improve other outcomes across the continuum of care for women, children, and adolescents.