Evidence map›Paper›PMID 21672223›Full record

Trial reportTrials2011

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

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 80 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02718222 nacompletednot on this mapstarted 2015, after this paper: background citation

Studying the Impact and Performance of Institutionalizing Immediate Post-partum IUD Services as a Routine Part of Antenatal Counseling and Delivery Room Services in Nepal, Sri Lanka, Tanzania

TypeinterventionalSponsorHarvard School of Public Health (HSPH)Ran2015 to 2018Enrolled140,258ConditionsContraceptionArmsPost-partum IUD
NCT03032276 naunknown statusnot on this mapstarted 2016, after this paper: background citation

Impact and Operational Assessment of an Integrated Safe Motherhood and Newborn Health Promotion Package: a Community-based Cluster Randomized Controlled Trial

TypeinterventionalSponsorInternational Centre for Diarrhoeal Disease Research, BangladeshRan2016 to 2022Enrolled50,400ConditionsNeonatal Death, Maternal DeathArmsSafe motherhood and newborn health promotion package
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  4. Early skin-to-skin contact for mothers and their healthy newborn infants.The Cochrane database of systematic reviews · 2016
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20 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Christina PagelClinical Operational Research Unit, University College London, UK. c.pagel@ucl.ac.uk
Audrey Prost
Sonia Lewycka
Sushmita Das
Tim Colbourn
Rajendra Mahapatra
Kishwar Azad
Anthony Costello
David Osrin

Funding

Wellcome Trust 081052/Z/06/ZWellcome Trust 091561
6 · The paper itself

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.

Indexed as

Cluster AnalysisHealth Services ResearchResearch DesignBangladeshCommunity Health ServicesData Interpretation, StatisticalDeveloping CountriesFemaleHumansIndiaInfant MortalityInfant, NewbornLive BirthMalawiMaternal Health ServicesMaternal Mortality

Identifiers

PMID21672223
PMCPMC3136407

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.