01386nas a2200229   4500000000100000008004100001260001700042653004100059653003400100100001300134700001400147700001500161700001300176700001400189700001800203245006500221856005500286300000900341490000800350520078400358022001401142       2015                            d  c05/2015bBMJ10aGeneral Earth and Planetary Sciences10aGeneral Environmental Science1 aLoudon K1 aTreweek S1 aSullivan F1 aDonnan P1 aThorpe KE1 aZwarenstein M00aThe PRECIS-2 tool: designing trials that are fit for purpose  uhttps://www.bmj.com/content/350/bmj.h2147.full.pdf  a1-110 v3503 a<p>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.</p>
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