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      The EPICS Trial: Enabling Parents to Increase Child Survival through the introduction of community-based health interventions in rural Guinea Bissau

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          Abstract

          Background

          Guinea-Bissau is a small country in West Africa with a population of 1.7 million. The WHO and UNICEF reported an under-five child mortality of 203 per 1000, the 10 th highest amongst 192 countries. The aim of the trial is to assess whether an intervention package that includes community health promotion campaign and education through health clubs, intensive training and mentoring of village health workers to diagnose and provide first-line treatment for children's diseases within the community, and improved outreach services can generate a rapid and cost-effective reduction in under-five child mortality in rural regions of Guinea-Bissau. Effective Intervention plans to expand the project to a much larger region if there is good evidence after two and a half years that the project is generating a cost-effective, sustainable reduction in child mortality.

          Methods/design

          This trial is a cluster-randomised controlled trial involving 146 clusters. The trial will run for 2.5 years. The interventions will be introduced in two stages: seventy-three clusters will receive the interventions at the start of the project, and seventy-three control clusters will receive the interventions 2.5 years after the first clusters have received all interventions if the research shows that the interventions are effective. The impact of the interventions and cost-effectiveness will be measured during the first stage.

          The package of interventions includes a community health promotion campaign and education through health clubs, and intensive training and mentoring of village health workers to diagnose and provide first-line treatment for common children's diseases within the community. It also includes improved outreach services to encourage provision of antenatal and post natal care and provide ongoing monitoring for village health workers.

          The primary outcome of the trial will be the proportion of children that die under 5 years of age during the trial. Secondary outcomes will include age at and cause of child deaths, neonatal mortality, infant mortality, maternal mortality, health knowledge, health seeking behaviour, morbidity and costs.

          Discussion

          The trial will be run by research and service delivery teams that act independently, overseen by a trial steering committee. A data monitoring committee will be appointed to monitor the outcome and any adverse effects.

          Trial Registration

          Current Controlled Trials ISRCTN52433336

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          Most cited references5

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          Community-based interventions for improving perinatal and neonatal health outcomes in developing countries: a review of the evidence.

          Infant and under-5 childhood mortality rates in developing countries have declined significantly in the past 2 to 3 decades. However, 2 critical indicators, maternal and newborn mortality, have hardly changed. World leaders at the United Nations Millennium Summit in September 2000 agreed on a critical goal to reduce deaths of children <5 years by two thirds, but this may be unattainable without halving newborn deaths, which now comprise 40% of all under-5 deaths. Greater emphasis on wide-scale implementation of proven, cost-effective measures is required to save women's and newborns' lives. Approximately 99% of neonatal deaths take place in developing countries, mostly in homes and communities. A comprehensive review of the evidence base for impact of interventions on neonatal health and survival in developing-country communities has not been reported. This review of community-based antenatal, intrapartum, and postnatal intervention trials in developing countries aimed to identify (1) key behaviors and interventions for which the weight of evidence is sufficient to recommend their inclusion in community-based neonatal care programs and (2) key gaps in knowledge and priority areas for future research and program learning. Available published and unpublished data on the impact of community-based strategies and interventions on perinatal and neonatal health status outcomes were reviewed. Evidence was summarized systematically and categorized into 4 levels of evidence based on study size, location, design, and reported impact, particularly on perinatal or neonatal mortality. The evidence was placed in the context of biological plausibility of the intervention; evidence from relevant developed-country studies; health care program experience in implementation; and recommendations from the World Health Organization and other leading agencies. A paucity of community-based data was found from developing-country studies on health status impact for many interventions currently being considered for inclusion in neonatal health programs. However, review of the evidence and consideration of the broader context of knowledge, experience, and recommendations regarding these interventions enabled us to categorize them according to the strength of the evidence base and confidence regarding their inclusion now in programs. This article identifies a package of priority interventions to include in programs and formulates research priorities for advancing the state of the art in neonatal health care. This review emphasizes some new findings while recommending an integrated approach to safe motherhood and newborn health. The results of this study provide a foundation for policies and programs related to maternal and newborn health and emphasizes the importance of health systems research and evaluation of interventions. The review offers compelling support for using research to identify the most effective measures to save newborn lives. It also may facilitate dialogue with policy makers about the importance of investing in neonatal health.
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            Ethical issues in the design and conduct of cluster randomised controlled trials.

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              Uniform requirements for manuscripts submitted to biomedical journals.

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                Author and article information

                Journal
                BMC Public Health
                BMC Public Health
                BioMed Central
                1471-2458
                2009
                3 August 2009
                : 9
                : 279
                Affiliations
                [1 ]Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London, UK
                [2 ]Effective Intervention, Centre for Economic Performance, London School of Economics, Houghton Street, London, UK
                [3 ]Effective Intervention, Bissau, Guinea-Bissau
                Article
                1471-2458-9-279
                10.1186/1471-2458-9-279
                2736942
                19650919
                3c10b0ee-c765-424b-8cbd-732f944b1c9e
                Copyright © 2009 Mann et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 15 June 2009
                : 3 August 2009
                Categories
                Study Protocol

                Public health
                Public health

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