James Beard

The effect of increased coverage of participatory women's groups on neonatal mortality in Bangladesh : A cluster randomized trial

IMPORTANCE Community-based interventions can reduce neonatal mortality when health systems are weak. Population coverage of target groups may be an important determinant of their effect on behavior and mortality. A womens group trial at coverage of 1 group per 1414 population in rural Bangladesh showed no effect on neonatal mortality, despite a similar intervention having a significant effect on neonatal and maternal death in comparable settings. OBJECTIVE To assess the effect of a participatory womens group intervention with higher population coverage on neonatal mortality in Bangladesh. DESIGN A cluster randomized controlled trial in 9 intervention and 9 control clusters. SETTING Rural Bangladesh. PARTICIPANTS Women permanently residing in 18 unions in 3 districts and accounting for 19 301 births during the final 24 months of the intervention. INTERVENTIONS Womens groups at a coverage of 1 per 309 population that proceed through a participatory learning and action cycle in which they prioritize issues that affected maternal and neonatal health and design and implement strategies to address these issues. MAIN OUTCOMES AND MEASURES Neonatal mortality rate. RESULTS Analysis included 19 301 births during the final 24 months of the intervention. More than one-third of newly pregnant women joined the groups. The neonatal mortality rate was significantly lower in the intervention arm (21.3 neonatal deaths per 1000 live births vs 30.1 per 1000 in control areas), a reduction in neonatal mortality of 38% (risk ratio, 0.62 [95% CI, 0.43-0.89]) when adjusted for socioeconomic factors. The cost-effectiveness was US

Electronic data capture in a rural African setting: evaluating experiences with different systems in Malawi

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The effect of participatory women's groups on birth outcomes in Bangladesh: does coverage matter? Study protocol for a randomized controlled trial

393 per year of life lost averted. Cause-specific mortality rates suggest reduced deaths due to infections and those associated with prematurity/low birth weight. Improvements were seen in hygienic home delivery practices, newborn thermal care, and breastfeeding practices. CONCLUSIONS AND RELEVANCE Womens group community mobilization, delivered at adequate population coverage, is a highly cost-effective approach to improve newborn survival and health behavior indicators in rural Bangladesh. TRIAL REGISTRATION isrctn.org Identifier: ISRCTN01805825.

Cause-specific neonatal mortality: analysis of 3772 neonatal deaths in Nepal, Bangladesh, Malawi and India

Background As hardware for electronic data capture (EDC), such as smartphones or tablets, becomes cheaper and more widely available, the potential for using such hardware as data capture tools in routine healthcare and research is increasing. Objective We aim to highlight the advantages and disadvantages of four EDC systems being used simultaneously in rural Malawi: two for Android devices (CommCare and ODK Collect), one for PALM and Windows OS (Pendragon), and a custom-built application for Android (Mobile InterVA – MIVA). Design We report on the personal field and development experience of fieldworkers, project managers, and EDC system developers. Results Fieldworkers preferred using EDC to paper-based systems, although some struggled with the technology at first. Highlighted features include in-built skip patterns for all systems, and specifically the ‘case’ function that CommCare offers. MIVA as a standalone app required considerably more time and expertise than the other systems to create and could not be customised for our specific research needs; however, it facilitates standardised routine data collection. CommCare and ODK Collect both have user-friendly web-interfaces for form development and good technical support. CommCare requires Internet to build an application and download it to a device, whereas all steps can be done offline with ODK Collect, a desirable feature in low connectivity settings. Pendragon required more complex programming of logic, using a Microsoft Access application, and generally had less technical support. Start-up costs varied between systems, and all were considered more expensive than setting up a paper-based system; however running costs were generally low and therefore thought to be cost-effective over the course of our projects. Conclusions EDC offers many opportunities for efficient data collection, but brings some issues requiring consideration when designing a study; the decision of which hardware and software to use should be informed by the aim of data collection, budget, and local circumstances.

Methods and challenges in measuring the impact of national pneumococcal and rotavirus vaccine introduction on morbidity and mortality in Malawi

BackgroundProgress on neonatal survival has been slow in most countries. While there is evidence on what works to reduce newborn mortality, there is limited knowledge on how to deliver interventions effectively when health systems are weak. Cluster randomized trials have shown strong reductions in neonatal mortality using community mobilisation with womens groups in rural Nepal and India. A similar trial in Bangladesh showed no impact. A main hypothesis is that this negative finding is due to the much lower coverage of womens groups in the intervention population in Bangladesh compared to India and Nepal. For evidence-based policy making it is important to examine if womens group coverage is a main determinant of their impact. The study aims to test the effect on newborn and maternal health outcomes of a participatory womens group intervention with a high population coverage of womens groups.MethodsA cluster randomised trial of a participatory womens group intervention will be conducted in 3 districts of rural Bangladesh. As we aim to study a womens group intervention with high population coverage, the same 9 intervention and 9 control unions will be used as in the 2005-2007 trial. These had been randomly allocated using the districts as strata. To increase coverage, 648 new groups were formed in addition to the 162 existing groups that were part of the previous trial. An open cohort of women who are permanent residents in the union in which their delivery or death was identified, is enrolled. Women and their newborns are included after birth, or, if a woman dies during pregnancy, after her death. Excluded are women who are temporary residents in the union in which their birth or death was identified. The primary outcome is neonatal mortality in the last 24 months of the study. A low cost surveillance system will be used to record all birth outcomes and deaths to women of reproductive age in the study population. Data on home care practices and health care use are collected through interviews.Trial registrationISRCTN: ISRCTN01805825

Impact of the 13-Valent Pneumococcal Conjugate Vaccine on Clinical and Hypoxemic Childhood Pneumonia over Three Years in Central Malawi: An Observational Study

Objective Understanding the causes of death is key to tackling the burden of three million annual neonatal deaths. Resource-poor settings lack effective vital registration systems for births, deaths and causes of death. We set out to describe cause-specific neonatal mortality in rural areas of Malawi, Bangladesh, Nepal and rural and urban India using verbal autopsy (VA) data. Design We prospectively recorded births, neonatal deaths and stillbirths in seven population surveillance sites. VAs were carried out to ascertain cause of death. We applied descriptive epidemiological techniques and the InterVA method to characterise the burden, timing and causes of neonatal mortality at each site. Results Analysis included 3772 neonatal deaths and 3256 stillbirths. Between 63% and 82% of neonatal deaths occurred in the first week of life, and males were more likely to die than females. Prematurity, birth asphyxia and infections accounted for most neonatal deaths, but important subnational and regional differences were observed. More than one-third of deaths in urban India were attributed to asphyxia, making it the leading cause of death in this setting. Conclusions Population-based VA methods can fill information gaps on the burden and causes of neonatal mortality in resource-poor and data-poor settings. Local data should be used to inform and monitor the implementation of interventions to improve newborn health. High rates of home births demand a particular focus on community interventions to improve hygienic delivery and essential newborn care.

Methodological challenges in measuring vaccine effectiveness using population cohorts in low resource settings.

Highlights • Evaluation of vaccine impact and effectiveness is critically important but methodologically challenging.• Challenges include achieving unbiased ascertainment of vaccine status, and non-vaccine-attributable decline in morbidity and mortality.• Use of multiple sites together with diverse evaluation methods provides more robust evaluation.

Can We Predict Oral Antibiotic Treatment Failure in Children with Fast-Breathing Pneumonia Managed at the Community Level? A Prospective Cohort Study in Malawi.

Background The pneumococcal conjugate vaccine’s (PCV) impact on childhood pneumonia during programmatic conditions in Africa is poorly understood. Following PCV13 introduction in Malawi in November 2011, we evaluated the case burden and rates of childhood pneumonia. Methods and Findings Between January 1, 2012-June 30, 2014 we conducted active pneumonia surveillance in children <5 years at seven hospitals, 18 health centres, and with 38 community health workers in two districts, central Malawi. Eligible children had clinical pneumonia per Malawi guidelines, defined as fast breathing only, chest indrawing +/- fast breathing, or, ≥1 clinical danger sign. Since pulse oximetry was not in the Malawi guidelines, oxygenation <90% defined hypoxemic pneumonia, a distinct category from clinical pneumonia. We quantified the pneumonia case burden and rates in two ways. We compared the period immediately following vaccine introduction (early) to the period with >75% three-dose PCV13 coverage (post). We also used multivariable time-series regression, adjusting for autocorrelation and exploring seasonal variation and alternative model specifications in sensitivity analyses. The early versus post analysis showed an increase in cases and rates of total, fast breathing, and indrawing pneumonia and a decrease in danger sign and hypoxemic pneumonia, and pneumonia mortality. At 76% three-dose PCV13 coverage, versus 0%, the time-series model showed a non-significant increase in total cases (+47%, 95% CI: -13%, +149%, p = 0.154); fast breathing cases increased 135% (+39%, +297%, p = 0.001), however, hypoxemia fell 47% (-5%, -70%, p = 0.031) and hospital deaths decreased 36% (-1%, -58%, p = 0.047) in children <5 years. We observed a shift towards disease without danger signs, as the proportion of cases with danger signs decreased by 65% (-46%, -77%, p<0.0001). These results were generally robust to plausible alternative model specifications. Conclusions Thirty months after PCV13 introduction in Malawi, the health system burden and rates of the severest forms of childhood pneumonia, including hypoxemia and death, have markedly decreased.

Impact of a participatory intervention with women's groups on psychological distress among mothers in rural Bangladesh: Secondary analysis of a cluster-randomised controlled trial

Highlights • We discuss methodological challenges for evaluating vaccine effectiveness using cohorts.• No single set of definitions or analytical approach can address all possible biases.• Careful consideration of denominator, exposure and outcome definitions is needed.• Sensitivity analyses are crucial to examine assumptions and explore subtle relationships.

Non-treatment of children with community health worker-diagnosed fast-breathing pneumonia in rural Malawi: exploratory subanalysis of a prospective cohort study

Background Pneumonia is the leading cause of infectious death amongst children globally, with the highest burden in Africa. Early identification of children at risk of treatment failure in the community and prompt referral could lower mortality. A number of clinical markers have been independently associated with oral antibiotic failure in childhood pneumonia. This study aimed to develop a prognostic model for fast-breathing pneumonia treatment failure in sub-Saharan Africa. Method We prospectively followed a cohort of children (2–59 months), diagnosed by community health workers with fast-breathing pneumonia using World Health Organisation (WHO) integrated community case management guidelines. Cases were followed at days 5 and 14 by study data collectors, who assessed a range of pre-determined clinical features for treatment outcome. We built the prognostic model using eight pre-defined parameters, using multivariable logistic regression, validated through bootstrapping. Results We assessed 1,542 cases of which 769 were included (32% ineligible; 19% defaulted). The treatment failure rate was 15% at day 5 and relapse was 4% at day 14. Concurrent malaria diagnosis (OR: 1.62; 95% CI: 1.06, 2.47) and moderate malnutrition (OR: 1.88; 95% CI: 1.09, 3.26) were associated with treatment failure. The model demonstrated poor calibration and discrimination (c-statistic: 0.56). Conclusion This study suggests that it may be difficult to create a pragmatic community-level prognostic child pneumonia tool based solely on clinical markers and pulse oximetry in an HIV and malaria endemic setting. Further work is needed to identify more accurate and reliable referral algorithms that remain feasible for use by community health workers.