Cluster randomised trials in maternal and child health: implications for power and sample size.

BACKGROUND Interventions based in the community can be evaluated by randomising clusters, such as general practices, rather than individuals, as in conventional randomised trials. This increases the sample size needed because of intracluster correlation. AIMS To estimate sample size requirements for cluster randomised trials of interventions based in general practice directed at common health problems affecting mothers and infants. METHODS Data were collected from a pilot trial of the effect of Citizen's Advice Bureau services involving six general practices. Outcome measures included the Edinburgh postnatal depression score, the Warwick child health and morbidity profile, number of visits to the general practitioner, and two questionnaires delivered at the beginning and end of the study. Intracluster correlation coefficients and inflation factors (the ratio of the sample size required for a cluster randomised trial to that required for an individually randomised trial) were calculated. RESULTS Intracluster correlation coefficients ranged from 0 (sleeping problems, accidental injury, hospitalisation) to 0.09 (maternal smoking), with most being < 0.04 (for example, maternal depression, breast feeding, general health, minor illness, behavioural problems, and visits to the general practitioner). Assuming 50 cases/practice, cluster randomised trials require sample sizes up to 3 times greater than individually randomised trials for most health outcomes measured. CONCLUSIONS These data enable sample sizes to be estimated for cluster randomised trials into a range of maternal and child health outcomes. Using such a design, approximately 40 practices would be sufficient to evaluate the effect of an intervention on maternal depression, sleeping, and behavioural problems, and non-routine visits to the general practitioner.