Journal Article

Comments, suggestions, and criticisms of the Pragmatic Explanatory Continuum Indicator Summary-2 design tool: a citation analysis

Shiely, Frances, Taljaard, Monica, Willis, Andrew, Loudon, Kirsty, Zwarenstein, Merrick, Howie, Alison, Treweek, Shaun

2024

Overview

The pragmatic explanatory continuum indicator summary (PRECIS) tool, initially published in 2009 and revised in 2015, was created to assist trialists to align their design choices with the intended purpose of their randomised controlled trial (RCT): either to guide real-world decisions between alternative interventions (pragmatic) or to test hypotheses about intervention mechanisms by minimising sources of variation (explanatory). There have been many comments, suggestions, and criticisms of PRECIS-2. This summary will be used to facilitate the development of to the next revision, which is PRECIS-3. We used Web of Science to identify all publication types citing PRECIS-2, published between May 2015 and July 2023. Citations were eligible if they contained ‘substantive’ suggestions, comments, or criticism of the PRECIS-2 tool. We defined ‘substantive’ as comments explicitly referencing at least one PRECIS-2 domain or a concept directly linked to an existing or newly proposed domain. Two reviewers independently extracted comments, suggestions, and criticisms, noting their implications for the update. These were discussed among authors to achieve consensus on the interpretation of each comment and its implications for PRECIS-3. The search yielded 885 publications, and after full-text review, 89 articles met the inclusion criteria. Comments pertained to new domains, changes in existing domains, or were relevant across several or all domains. Proposed new domains included assessment of the comparator arm and a domain to describe blinding. There were concerns about scoring eligibility and recruitment domains for cluster trials. Suggested areas for improvement across domains included the need for more scoring guidance for explanatory design choices. Published comments recognise PRECIS-2's success in aiding trialists with pragmatic or explanatory design choices. Enhancing its implementation and widespread use will involve adding new domains, refining domain definitions, and addressing overall tool issues. This citation review offers valuable user feedback, pivotal for shaping the upcoming version of the PRECIS tool, PRECIS-3. •The paper summarises user feedback from trialists relating to the pragmatic explanatory continuum indicator summary (PRECIS)-2 design tool and points toward considerations, which may be needed to develop and refine the next version of the tool.•Developers should consider adding assessments of blinding and comparator arm design decisions.•Further detail should be given to guide explanatory approaches to design decisions to address the current imbalance, which favors a more pragmatic approach.•Further consideration and research is needed to supplement these review findings to provide guidance for the use of the PRECIS tool for retrospective assessment of design choices.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Applicability / Citation analysis / Clinical medicine / Decision making / Design / Explanatory trial / External validity / Humans / Internal Medicine / Intervention / Medical research / Patients / Pragmatic Clinical Trials as Topic - methods / Pragmatic Clinical Trials as Topic - standards / Pragmatic trial / Pragmatism / Randomized controlled trial / Randomized Controlled Trials as Topic - methods / Randomized Controlled Trials as Topic - standards / Research Design - standards / Stakeholders / Trial intention / Underserved populations