Answers are grounded in this paper and cite their sources.
Randomised trials are difficult and costly.Like most things that are hard, the effort expended is only worth it because we hope to make a difference.Sadly, the benefit to potential users such as patients, healthcare professionals and policy makers is often smaller than it should be because trial design decisions reduced the relevance of the trial to users.PRECIS-2 is a tool designed to help trialists match their design decisions to the information needs of those they hope will use the trial results.PRECIS-2 was developed in collaboration with over 80 international trialists, methodologists and others to produce a tool that supports improved design insight for trialists.PRECIS-2 has a wheel format with nine design domains including Eligibility, Recruitment, Setting and Primary outcome.One domain -Organisation -is explicitly aimed at making trialists consider the resource requirements their intervention will place on health care systems if it were to be rolled out into routine care, the intention being to think about implementation at the design stage.The highly visual presentation makes inconsistent decision-making immediately obvious; it also highlights differences of opinion between trial team members.The IDEAL framework was created to improve the quality of research in surgery.It is proposed that PRECIS-2 could be part of this framework to design these complex intervention trials.We will present the tool, explain how to use it and show examples of how it has been used already.This work is part of the Trial Forge initiative to improve trial efficiency.
No takes yet. Share an insight, caveat, or question.
Agha et al. (2016) studied this question.
Synapse has enriched 10 related papers. Consider them for comparative context: