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The design and use of cluster randomised controlled trials in evaluating injury prevention interventions: part 1. Rationale, design and informed consent
  1. Carolyn DiGuiseppi1,2,
  2. Carol Coupland3
  1. 1Colorado School of Public Health, University of Colorado Denver, Aurora, Colorado, USA
  2. 2Colorado Injury Control Research Center, Fort Collins, Colorado, USA
  3. 3Division of Primary Care, University of Nottingham, Nottingham, UK
  1. Correspondence to Carolyn DiGuiseppi, Department of Epidemiology, 13001 East 17th Place, Campus Box B-119, Aurora, CO, USA; Carolyn.DiGuiseppi{at}

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Definition and rationale

Cluster randomised trials (CRCTs), sometimes called group randomised, field, community-based or place-based trials, involve the random allocation of existing groups of individuals to study arms. Group (‘cluster’) size can vary, ranging from families or classrooms to clinics or communities. Because many injury prevention interventions (eg, community education, mass media and legislation) are delivered to groups, CRCTs are an important methodology for evaluation studies in this field.

Members of clusters tend to respond to interventions in ways that are more similar to others in the same cluster than to members of different clusters, because, first, like people choose to join the same cluster (eg, schools, churches); second, cluster members have common exposures (eg, living on a busy street); and, third, cluster members interact with each other in ways that influence their responses (eg, sharing information).1 Thus, in a CRCT, participant outcomes are usually correlated within clusters, which affects both sample size requirements and statistical analysis. Even minimal intracluster correlation can substantially increase required sample size (see accompanying paper in this issue2). Except in rare instances when there is no intracluster correlation, CRCTs will therefore have reduced statistical efficiency relative to trials that individually randomise the same number of people.3

Because CRCTs are more complex to design, implement and analyse than individually randomised controlled trials, as we discuss below and in our companion paper,2 alternative designs should be carefully considered and use of a clustered design justified. Justifications fall broadly into two categories: scientific and logistical.4

Scientific justification

Cluster-level intervention and action

The intervention is delivered to and affects groups of people rather than, or in addition to, individuals. For example, one experimental school-based violence prevention programme established a local task force …

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  • Funding Dr DiGuiseppi is funded in part through Grant No R49-CCR811509 from the Centers for Disease Control and Prevention.

  • Competing interests None.

  • Provenance and peer review Commissioned; externally peer reviewed.

  • i At the end of each section, we provide guidelines and examples for reporting the issue discussed, based on a published extension of CONSORT guidelines for the reporting of individually randomised controlled trials that addresses unique aspects of reporting CRCTs.42

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