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.
abstract: 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.
authors.affiliation: Clinical Operational Research Unit, University College London, UK. c.pagel@ucl.ac.uk
authors.forename: Christina
authors.initials: C
authors.lastname: Pagel
authors.forename: Audrey
authors.initials: A
authors.lastname: Prost
authors.forename: Sonia
authors.initials: S
authors.lastname: Lewycka
authors.forename: Sushmita
authors.initials: S
authors.lastname: Das
authors.forename: Tim
authors.initials: T
authors.lastname: Colbourn
authors.forename: Rajendra
authors.initials: R
authors.lastname: Mahapatra
authors.forename: Kishwar
authors.initials: K
authors.lastname: Azad
authors.forename: Anthony
authors.initials: A
authors.lastname: Costello
authors.forename: David
authors.initials: D
authors.lastname: Osrin
mesh_terms: D001459:Bangladesh / Q000453:epidemiology; D016000:Cluster Analysis; D003153:Community Health Services / Q000191:economics / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D003906:Developing Countries / Q000191:economics*; D005260:Female; D006302:Health Services Research; D006801:Humans; D007194:India / Q000453:epidemiology; D007226:Infant Mortality; D007231:Infant, Newborn; D050498:Live Birth; D008295:Malawi / Q000453:epidemiology; D008427:Maternal Health Services / Q000191:economics / Q000706:statistics & numerical data*; D008428:Maternal Mortality; D011247:Pregnancy; D011634:Public Health / Q000191:economics / Q000706:statistics & numerical data*; D012107:Research Design; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome