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

Background-Interventions based in the community can be evaluated by randomi sing clusters, such as general practices, rather than individuals, as in co nventional 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 A dvice Bureau services involving six general practices. Outcome measures inc luded the Edinburgh postnatal depression score, the Warwick child health an d morbidity profile, number of visits to the general practitioner, and two questionnaires delivered at the beginning and end of the study. Intracluste r correlation coefficients and inflation factors (the ratio of the sample s ize required for a cluster randomised trial to that required for an individ ually randomised trial) were calculated. Results-Intracluster correlation coefficients ranged from 0 (sleeping probl ems, accidental injury, hospitalisation) to 0.09 (maternal smoking), with m ost being < 0.04 (for example, maternal depression, breast feeding, general health, minor illness, behavioural problems, and visits to the general pra ctitioner). Assuming 50 cases/practice, cluster randomised trials require s ample sizes up to 3 times greater than individually randomised trials for m ost health outcomes measured. Conclusions-These data enable sample sizes to be estimated for cluster rand omised trials into a range of maternal and child health outcomes. Using suc h 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.