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 @entity1 . 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 @entity308 score, the Warwick @entity1 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, @entity130 , hospitalisation) to 0.09 (maternal smoking), with most being < 0.04 (for example, maternal @entity308 , breast feeding, general health, @entity221 , 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 @entity1 health outcomes. Using such a design, approximately 40 practices would be sufficient to evaluate the effect of an intervention on maternal @entity308 , sleeping, and behavioural problems, and non-routine visits to the general practitioner.

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

@entity1 :: ('9606', 'Species') :: ['infants', 'child'] @entity308 :: ('MESH:D003866', 'Disease') :: ['depression', 'Edinburgh postnatal depression'] @entity221 :: ('MESH:D005334', 'Disease') :: ['minor illness'] @entity130 :: ('MESH:D014947', 'Disease') :: ['accidental injury']
@entity1 :: (9606,Species) :: ['child']
