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

Christina Pagel,Kishwar Azad,Rajendra Mahapatra,Sushmita Das,Sonia Lewycka,Audrey Prost,David Osrin,Anthony Costello,Tim Colbourn

doi:10.1186/1745-6215-12-151

Abstract

BackgroundPublic 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.MethodsWe 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.ResultsEstimates 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.ConclusionsThe 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.

Highlights

Public health interventions are increasingly evaluated using cluster-randomised trials in which groups rather than individuals are allocated randomly to treatment and control arms
We found large differences between our community-based mortality estimates and national Demographic and Health Survey (DHS) figures
Estimates from our community-based samples were generally lower than those reported in an analysis of intracluster correlation coefficient (ICC) for perinatal outcomes in hospitals conducted as part of the 2005 WHO Survey on Maternal and Perinatal Health using data from over 90 000 births in 120 facilities across eight Latin American countries

Summary

Introduction

Public health interventions are increasingly evaluated using cluster-randomised trials in which groups rather than individuals are allocated randomly to treatment and control arms. Public health interventions are increasingly evaluated using cluster-randomised controlled trials (cRCTs) in which groups rather than individuals are allocated randomly to treatment and control arms. Many contemporary public health interventions are large in scale, complex in nature, and ‘unblinded’ in design because they require the active involvement of participants. It is often more appropriate and feasible to implement them ‘with’ groups or communities rather than to apply them ‘to’ individuals. Current cRCTs include a UK study in which deprived areas of London have been randomised to receive interventions promoting healthy eating, physical activity and mental health [3], and, in India, a trial in which urban wards of Mumbai were randomly allocated to a community mobilisation intervention for improved maternal and newborn health [4]

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Results

Discussion

Conclusion