Development, validation and dissemination of the PRECIS-3 tool to support the design of pragmatic randomised controlled trials: Towards making clinical trials part of routine clinical care

Randomised controlled trials (RCTs) have been proven to be the best means of acquiring clinical data for the provision of a wide variety of healthcare solutions. Conventional (explanatory) RCTs, however, are normally performed under ideal conditions in a scenario that is divorced from the clinical care of the participants. They are known to have a number of other limitations including high cost, non-reusability, restrictive eligibility criteria, and lack applicability to broader patient groups. Inappropriate choices in design, participant sampling, analysis, and data interpretation have often resulted in explanatory RCTs providing poor quality clinical evidence, of dubious use for good healthcare solutions.

Large scale randomised controlled trials (RCTs) that are embedded in routine health care (pragmatic RCTs) have emerged as a key improvement in how we gather evidence to find out what treatments and therapies are best for patients and the public. The development of standard guidelines for pragmatic RCT trial teams are at an earlier stage of evolution, and lag behind the trial design landscape. PRECIS-2 is such a guidance tool, first published in 2009 and updated in 2015. Many users have subsequently made recommendations for further development of this tool, given the changes that have occurred in trial design.

The purpose of this study is to develop the next generation PRECIS-3 tool by: reviewing the existing use of PRECIS-2; engaging with users and non-users of PRECIS-2 in a coordinated and structured manner to get suggestions for improvement; establishing usability for PRECIS-3; prospectively (forward) testing PRECIS-3 in pragmatic trials in critical care; updating the existing PRECIS-2 website including creating an additional section for patients and the public; and disseminating PRECIS-3 to ensure maximum use.

Wide dissemination and use of PRECIS-3 will increase applicability, utility and uptake of RCTs, systematic reviews, guidelines, and the care and clinical outcomes that follow.

Award Date

01 July 2022

Award Value

€370,000.00

Principal Investigator

Dr Frances Shiely

Host Institution

University College Cork

Scheme

Investigator Led Projects