Description and Rating Anchors for Each PRECIS-2 Domain*
| PRECIS-2 Domain | Domain Description* | Completely Explanatory (PRECIS-2 anchor = 1) | Equally Explanatory/Pragmatic (PRECIS-2 anchor = 3) | Completely Pragmatic (PRECIS-2 anchor = 5) |
|---|---|---|---|---|
| 1) Eligibility Criteria | Who is selected to participate in the trial? | Sample much more narrow than representative population (meets USPSTF or CMS guidelines) | Most “typical” participants included some exclusions that limit study population | Sample representative of population expected to receive intervention in usual care setting (meets USPSTF or CMS guidelines) |
| 2) Recruitment Path | How are participants recruited in the trial? | General advertising without relevance to usual care population, recruitment requires extra effort | Some extra effort/resources used to recruit beyond usual care | Participants recruited unobtrusively during clinic visits |
| 3) Setting | Where is the trial being done? | Few or one clinical sites that are not at all representative of usual care site | More than one clinical sites that is partially representative of usual care | Multiple sites nearly identical to usual care |
| 4) Organization | What expertise and resources are needed to deliver the intervention? | Intervention requires many extra hours of staff time or infrastructure | Intervention requires some extra time of infrastructure | Intervention integrated into usual care and requires no extra time or resources |
| 5) Flexibility (delivery by staff) | How should the intervention be delivered? | Intervention is protocol-driven with extensive oversight from clinicians | Intervention allows flexibility at discretion of clinician | Intervention oversight and follow-up managed by clinician |
| 6) Flexibility (adherence) | What measures are in place to make sure participants adhere to the intervention? | Close monitoring to maximize participant adherence | Few strategies to monitor and increase adherence | Methods to maximize adherence within realm of usual care (i.e., send reminders) |
| 6) Follow-up | How closely are participants followed-up? | Frequent visits for data collection during intervention period | Some added visits for data collection during intervention | No additional visits than what would be completed in usual care |
| 7) Primary Outcome | How relevant is it to participants? | Measures/terms collected not relatable to participants/society and requires additional training to measure | Measures/terms somewhat understandable to participants/society and can be assessed in usual care | Measures/terms understood by participants/society and easy to assess |
| 8) Primary Analysis | To what extent are all data included? | Analysis excludes data from individuals with poor adherence or missing data (“per protocol analysis”) | Data from all study participants included but rigor slightly reduced | Data from all participants included with imputation if needed |
Abbreviations: CMS, Centers for medicare and medicaid services; PRECIS, PRagmatic Explanatory Continuum Indicator Summary.
*Domain descriptions are from Loudon, et al. BMJ, 2015.19