Delivery of optimum health care is predicated on the availability of high-quality clinical evidence in relevant populations, best realised by randomised controlled trials (RCTs). However, this evidence is typically generated by RCTs using costly, stand-alone, non-reusable systems which are usually separate from clinical care, have rigorous inclusion and exclusion criteria, and are conducted under ideal conditions (explanatory RCTs). These lack external validity and may not be applicable to broader populations. We also know, that much of the evidence we rely on to make health care decisions is not of high quality through the use of inappropriate designs, unrepresentative or small samples, incorrect analysis methods or faulty interpretation.
Pragmatic RCTs are a key part of the solution; these large-scale trials are embedded within routine clinical care. But, trial teams need guidance on making their trials more pragmatic. PRECIS-2 (Pragmatic Explanatory Continuum Indicator Summary-2) is a tool that provides this guidance. It consists of the PRECIS-2 wheel and table, both embedded in an information package (PRECIS-2 Toolkit). First published in 2009 and updated to PRECIS-2 in 2015 through extensive consultation, it requires another update, because trial design has changed significantly in the intervening period, and users of PRECIS-2 have made recommendations for its improvement.
The purpose of our study is to develop the next generation PRECIS-3 tool by: systematically reviewing the existing use of PRECIS-2; engaging with users and non-users of PRECIS-2 to elicit suggestions for improvement; conducting user interface design testing to assess usability; prospectively 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.
