@article{98816, keywords = {General Earth and Planetary Sciences, General Environmental Science}, author = {Loudon K and Treweek S and Sullivan F and Donnan P and Thorpe KE and Zwarenstein M}, title = {The PRECIS-2 tool: designing trials that are fit for purpose}, abstract = {
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.
}, year = {2015}, journal = {BMJ}, volume = {350}, pages = {1-11}, month = {05/2015}, publisher = {BMJ}, issn = {1756-1833}, url = {https://www.bmj.com/content/350/bmj.h2147.full.pdf}, doi = {10.1136/bmj.h2147}, language = {Eng}, }