Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: Results and methodological implications
Pagel C.,University College London |
Prost A.,University College London |
Lewycka S.,University College London |
Das S.,Society for Nutrition |
And 5 more authors.
Trials | Year: 2011
Background: Public health interventions are increasingly evaluated using cluster-randomised trials in which groups rather than individuals are allocated randomly to treatment and control arms. Outcomes for individuals within the same cluster are often more correlated than outcomes for individuals in different clusters. This needs to be taken into account in sample size estimations for planned trials, but most estimates of intracluster correlation for perinatal health outcomes come from hospital-based studies and may therefore not reflect outcomes in the community. In this study we report estimates for perinatal health outcomes from community-based trials to help researchers plan future evaluations.Methods: We estimated the intracluster correlation and the coefficient of variation for a range of outcomes using data from five community-based cluster randomised controlled trials in three low-income countries: India, Bangladesh and Malawi. We also performed a simulation exercise to investigate the impact of cluster size and number of clusters on the reliability of estimates of the coefficient of variation for rare outcomes.Results: Estimates of intracluster correlation for mortality outcomes were lower than those for process outcomes, with narrower confidence intervals throughout for trials with larger numbers of clusters. Estimates of intracluster correlation for maternal mortality were particularly variable with large confidence intervals. Stratified randomisation had the effect of reducing estimates of intracluster correlation. The simulation exercise showed that estimates of intracluster correlation are much less reliable for rare outcomes such as maternal mortality. The size of the cluster had a greater impact than the number of clusters on the reliability of estimates for rare outcomes.Conclusions: The breadth of intracluster correlation estimates reported here in terms of outcomes and contexts will help researchers plan future community-based public health interventions around maternal and newborn health. Our study confirms previous work finding that estimates of intracluster correlation are associated with the prevalence of the outcome of interest, the nature of the outcome of interest (mortality or behavioural) and the size and number of clusters. Estimates of intracluster correlation for maternal mortality need to be treated with caution and a range of estimates should be used in planning future trials. © 2011 Pagel et al; licensee BioMed Central Ltd.
Nair N.,Ekjut |
Tripathy P.,Ekjut |
Costello A.,University College London |
Prost A.,University College London
International Journal of Gynecology and Obstetrics | Year: 2012
Research conducted over the past decade has shown that community-based interventions can improve the survival and health of mothers and newborns in low- and middle-income countries. Interventions engaging women's groups in participatory learning and action meetings and other group activities, for example, have led to substantial increases in neonatal survival in high-mortality settings. Participatory interventions with women's groups work by providing a forum for communities to develop a common understanding of maternal and neonatal problems, as well as locally acceptable and sustainable strategies to address these. Potential partners for scaling up interventions with women's groups include government community health workers and volunteers, as well as organizations working with self-help groups. It is important to tailor scale-up efforts to local contexts, while retaining fidelity to the intervention, by ensuring that the mobilization of women's groups complements other local programs (e.g. home visits), and by providing capacity building for participatory learning and action methods across a range of nongovernmental organizations and government stakeholders. Research into scale-up mechanisms and effectiveness is needed to inform further implementation, and prospective surveillance of maternal and neonatal mortality in key scale-up sites can provide valuable data for measuring impact and for advocacy. There is a need for further research into the role of participatory interventions with women's groups to improve the quality of health services, health, and nutrition beyond the perinatal period, as well as the role of groups in influencing non-health issues, such as women's decision-making power. © 2012 International Federation of Gynecology and Obstetrics.
Prost A.,University College London |
Colbourn T.,University College London |
Seward N.,University College London |
Azad K.,Perinatal Care Project |
And 28 more authors.
The Lancet | Year: 2013
Background: Maternal and neonatal mortality rates remain high in many low-income and middle-income countries. Different approaches for the improvement of birth outcomes have been used in community-based interventions, with heterogeneous effects on survival. We assessed the effects of women's groups practising participatory learning and action, compared with usual care, on birth outcomes in low-resource settings. Methods: We did a systematic review and meta-analysis of randomised controlled trials undertaken in Bangladesh, India, Malawi, and Nepal in which the effects of women's groups practising participatory learning and action were assessed to identify population-level predictors of effect on maternal mortality, neonatal mortality, and stillbirths. We also reviewed the cost-effectiveness of the women's group intervention and estimated its potential effect at scale in Countdown countries. Findings: Seven trials (119 428 births) met the inclusion criteria. Meta-analyses of all trials showed that exposure to women's groups was associated with a 37% reduction in maternal mortality (odds ratio 0·63, 95% CI 0·32-0·94), a 23% reduction in neonatal mortality (0·77, 0·65-0·90), and a 9% non-significant reduction in stillbirths (0·91, 0·79- 1·03), with high heterogeneity for maternal (I2=58·8%, p=0·024) and neonatal results (I2=64·7%, p=0·009). In the meta-regression analyses, the proportion of pregnant women in groups was linearly associated with reduction in both maternal and neonatal mortality (p=0·026 and p=0·011, respectively). A subgroup analysis of the four studies in which at least 30% of pregnant women participated in groups showed a 55% reduction in maternal mortality (0·45, 0·17-0·73) and a 33% reduction in neonatal mortality (0·67, 0·59-0·74). The intervention was cost effective by WHO standards and could save an estimated 283 000 newborn infants and 41 100 mothers per year if implemented in rural areas of 74 Countdown countries. Interpretation: With the participation of at least a third of pregnant women and adequate population coverage, women's groups practising participatory learning and action are a cost-effective strategy to improve maternal and neonatal survival in low-resource settings. © 2013. World Health Organization. Published by Elsevier Ltd/Inc/BV. All rights reserved.
Seward N.,Institute of Child Health |
Osrin D.,Institute of Child Health |
Li L.,Institute of Child Health |
Costello A.,Institute of Child Health |
And 8 more authors.
PLoS Medicine | Year: 2012
Background: Sepsis accounts for up to 15% of an estimated 3.3 million annual neonatal deaths globally. We used data collected from the control arms of three previously conducted cluster-randomised controlled trials in rural Bangladesh, India, and Nepal to examine the association between clean delivery kit use or clean delivery practices and neonatal mortality among home births. Methods and Findings: Hierarchical, logistic regression models were used to explore the association between neonatal mortality and clean delivery kit use or clean delivery practices in 19,754 home births, controlling for confounders common to all study sites. We tested the association between kit use and neonatal mortality using a pooled dataset from all three sites and separately for each site. We then examined the association between individual clean delivery practices addressed in the contents of the kit (boiled blade and thread, plastic sheet, gloves, hand washing, and appropriate cord care) and neonatal mortality. Finally, we examined the combined association between mortality and four specific clean delivery practices (boiled blade and thread, hand washing, and plastic sheet). Using the pooled dataset, we found that kit use was associated with a relative reduction in neonatal mortality (adjusted odds ratio 0.52, 95% CI 0.39-0.68). While use of a clean delivery kit was not always accompanied by clean delivery practices, using a plastic sheet during delivery, a boiled blade to cut the cord, a boiled thread to tie the cord, and antiseptic to clean the umbilicus were each significantly associated with relative reductions in mortality, independently of kit use. Each additional clean delivery practice used was associated with a 16% relative reduction in neonatal mortality (odds ratio 0.84, 95% CI 0.77-0.92). Conclusions: The appropriate use of a clean delivery kit or clean delivery practices is associated with relative reductions in neonatal mortality among home births in underserved, rural populations. Please see later in the article for the Editors' Summary. © 2012 Seward et al.
Tripathy P.,Ekjut |
Nair N.,Ekjut |
Sinha R.,Ekjut |
Rath S.,Ekjut |
And 15 more authors.
The Lancet Global Health | Year: 2016
Background: A quarter of the world's neonatal deaths and 15% of maternal deaths happen in India. Few community-based strategies to improve maternal and newborn health have been tested through the country's government-approved Accredited Social Health Activists (ASHAs). We aimed to test the effect of participatory women's groups facilitated by ASHAs on birth outcomes, including neonatal mortality. Methods: In this cluster-randomised controlled trial of a community intervention to improve maternal and newborn health, we randomly assigned (1:1) geographical clusters in rural Jharkhand and Odisha, eastern India to intervention (participatory women's groups) or control (no women's groups). Study participants were women of reproductive age (15-49 years) who gave birth between Sept 1, 2009, and Dec 31, 2012. In the intervention group, ASHAs supported women's groups through a participatory learning and action meeting cycle. Groups discussed and prioritised maternal and newborn health problems, identified strategies to address them, implemented the strategies, and assessed their progress. We identified births, stillbirths, and neonatal deaths, and interviewed mothers 6 weeks after delivery. The primary outcome was neonatal mortality over a 2 year follow up. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN31567106. Findings: Between September, 2009, and December, 2012, we randomly assigned 30 clusters (estimated population 156519) to intervention (15 clusters, estimated population n=82702) or control (15 clusters, n=73817). During the follow-up period (Jan 1, 2011, to Dec 31, 2012), we identified 3700 births in the intervention group and 3519 in the control group. One intervention cluster was lost to follow up. The neonatal mortality rate during this period was 30 per 1000 livebirths in the intervention group and 44 per 1000 livebirths in the control group (odds ratio [OR] 0.69, 95% CI 0·53-0·89). Interpretation: ASHAs can successfully reduce neonatal mortality through participatory meetings with women's groups. This is a scalable community-based approach to improving neonatal survival in rural, underserved areas of India. Funding: Big Lottery Fund (UK). © 2016 Tripathy et al. Open Access article distributed under the terms of CC BY.