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. 2017 Nov 10;18(1):532.
doi: 10.1186/s13063-017-2267-y.

Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains

Paula Darby Lipman  1 , Kirsty Loudon  2 , Leanora Dluzak  3 , Rachael Moloney  4 , Donna Messner  4 , Catherine M Stoney  5
Affiliations

Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains

Paula Darby Lipman et al. Trials. .

Abstract

Background: There continues to be debate about what constitutes a pragmatic trial and how it is distinguished from more traditional explanatory trials. The NIH Pragmatic Trials Collaborative Project, which includes five trials and a coordinating unit, has adopted the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS-2) instrument. The purpose of the study was to collect PRECIS-2 ratings at two points in time to assess whether the tool was sensitive to change in trial design, and to explore with investigators the rationale for rating shifts.

Methods: A mixed-methods design included sequential collection and analysis of quantitative data (PRECIS-2 ratings) and qualitative data. Ratings were collected at two annual, in-person project meetings, and subsequent interviews conducted with investigators were recorded, transcribed, and coded using NVivo 11 Pro for Windows. Rating shifts were coded as either (1) actual change (reflects a change in procedure or protocol), (2) primarily a rating shift reflecting rater variability, or (3) themes that reflect important concepts about the tool and/or pragmatic trial design.

Results: Based on PRECIS-2 ratings, each trial was highly pragmatic at the planning phase and remained so 1 year later in the early phases of trial implementation. Over half of the 45 paired ratings for the nine PRECIS-2 domains indicated a rating change from Time 1 to Time 2 (N = 24, 53%). Of the 24 rating changes, only three represented a true change in the design of the trial. Analysis of rationales for rating shifts identified critical themes associated with the tool or pragmatic trial design more generally. Each trial contributed one or more relevant comments, with Eligibility, Flexibility of Adherence, and Follow-up each accounting for more than one.

Conclusions: PRECIS-2 has proved useful for "framing the conversation" about trial design among members of the Pragmatic Trials Collaborative Project. Our findings suggest that design elements assessed by the PRECIS-2 tool may represent mostly stable decisions. Overall, there has been a positive response to using PRECIS-2 to guide conversations around trial design, and the project's focus on the use of the tool by this group of early adopters has provided valuable feedback to inform future trainings on the tool.

Keywords: Effectiveness trials; Mixed methods; PRECIS-2 tool; Pragmatic trials; Trial design.

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Conflict of interest statement

Ethics approval and consent to participate

The Westat IRB reviews all studies involving research on human subjects. Exemption from IRB review was received from the Chair of the Westat Institutional Review Board (IRB) on 23 October 2014 (FWA 00005551). According to [45 CFR 46.101(b5)] and a letter received on 16 October 2014, from Denise Bonds, Medical Officer, NHLBI; this research involves a program evaluation and, therefore, is exempt from IRB review.

Westat is conducting an evaluation of the methods and processes that contribute to successful, pragmatic, low-cost clinical trials. The work involves monitoring the design/planning of these trials and, in years 2–5, the implementation of the trials. As members of this cooperative agreement, all investigators consented to participate in these activities and, specifically, provided oral consent prior to the conduct of the interviews as reported in this submission.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
PRECIS-2 principal investigator (PI) plots by study trial (trial planning phase – Time 1)
See this image and copyright information in PMC

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