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

<p>Abstract</p> <p>Background</p> <p>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...

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Main Authors: Mahapatra Rajendra, Colbourn Tim, Das Sushmita, Lewycka Sonia, Prost Audrey, Pagel Christina, Azad Kishwar, Costello Anthony, Osrin David
Format: Article
Language:English
Published: BMC 2011-06-01
Series:Trials
Online Access:http://www.trialsjournal.com/content/12/1/151
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author Mahapatra Rajendra
Colbourn Tim
Das Sushmita
Lewycka Sonia
Prost Audrey
Pagel Christina
Azad Kishwar
Costello Anthony
Osrin David
author_facet Mahapatra Rajendra
Colbourn Tim
Das Sushmita
Lewycka Sonia
Prost Audrey
Pagel Christina
Azad Kishwar
Costello Anthony
Osrin David
author_sort Mahapatra Rajendra
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusions</p> <p>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.</p>
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spelling doaj.art-6bc5c8a586d14b8d8120b55e7388ba942022-12-22T01:37:40ZengBMCTrials1745-62152011-06-0112115110.1186/1745-6215-12-151Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implicationsMahapatra RajendraColbourn TimDas SushmitaLewycka SoniaProst AudreyPagel ChristinaAzad KishwarCostello AnthonyOsrin David<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusions</p> <p>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.</p>http://www.trialsjournal.com/content/12/1/151
spellingShingle Mahapatra Rajendra
Colbourn Tim
Das Sushmita
Lewycka Sonia
Prost Audrey
Pagel Christina
Azad Kishwar
Costello Anthony
Osrin David
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
Trials
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url http://www.trialsjournal.com/content/12/1/151
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