4.7 Article

The PRECIS-2 tool: designing trials that are fit for purpose

Journal

BMJ-BRITISH MEDICAL JOURNAL
Volume 350, Issue -, Pages -

Publisher

BMJ PUBLISHING GROUP
DOI: 10.1136/bmj.h2147

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Funding

  1. Chief Scientist Office (CSO) of Scotland [CZH/4/773]
  2. UK Medical Research Council
  3. University of Dundee
  4. Health Services Research Unit at the University of Aberdeen - CSO of the Scottish Government Health Directories
  5. Chief Scientist Office [CZH/4/773, NMAHP2, HSRU1] Funding Source: researchfish
  6. Medical Research Council [1415468] Funding Source: researchfish

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PRECIS is a tool to help trialists make design decisions consistent with the intended purpose of their trial. This paper gives guidance on how to use an improved, validated version, PRECIS-2, which has been developed with the help of over 80 international trialists, clinicians, and policymakers. Keeping the original simple wheel format, PRECIS-2 has nine domains-eligibility criteria, recruitment, setting, organisation, flexibility (delivery), flexibility (adherence), follow-up, primary outcome, and primary analysis-scored from 1 (very explanatory) to 5 (very pragmatic) to facilitate domain discussion and consensus. It is hoped PRECIS-2 will be valuable in supporting the explicit matching of design decisions to how the trial results are intended to be used

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