Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains.
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.
['Lipman|Paula Darby|PD|http://orcid.org/0000-0002-2522-9691', 'Loudon|Kirsty|K|', 'Dluzak|Leanora|L|', 'Moloney|Rachael|R|', 'Messner|Donna|D|', 'Stoney|Catherine M|CM|']
D004608:Eligibility Determination D023381:Endpoint Determination D019983:Guideline Adherence D006801:Humans D018579:Patient Selection D017410:Practice Guidelines as Topic D064792:Pragmatic Clinical Trials as Topic D012107:Research Design D009626:Terminology as Topic D013997:Time Factors
Pragmatic trials Trial design PRECIS-2 tool Effectiveness trials Mixed methods