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Extending CONSORT to include cluster trials

BMJ 2004; 328 doi: (Published 18 March 2004) Cite this as: BMJ 2004;328:654
  1. Michael J Campbell, professor of medical statistics (
  1. Institute of General Practice, School of Health and Related Research, University of Sheffield

    Welcome extension will help to understand trials better and reduce bias

    Anyone who has tried to appraise a randomised controlled trial critically will be aware of the frustration that arises when a key piece of information is missing. To understand the results of a randomised controlled trial a reader must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. The original and revised CONSORT (consolidated standards of reporting trials) statements were designed to help authors improve reporting by using a checklist and flow diagram and have been well cited.1 These have now been extended to include cluster trials (p 702).2 Cluster trials randomise interventions to groups of patients rather than to individual patients and have their own problems. Using the extended CONSORT statement should help reduce bias and help readers to understand a cluster trial's conduct and to assess thevalidity of its …

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