Table 1 Application of PRagmatic Explanatory Continuum Indicator Summary (PRECIS)-2 Criteria to the OPTIMIZE Study
Domain | Criteria for scoring | Score | Rationale |
|---|---|---|---|
Eligibility criteria | To what extent are the trial participants similar to those who would receive this intervention in usual care? | 4 | The eligibility criteria are similar to those that would be used in clinical decision making; assessments/screening are clinically available and routinely used |
Recruitment path | How much extra effort is made to recruit participants than what is done in usual care settings to engage patients? | 3 | Recruiting from the electronic health record as a health system would to identify an at-risk population; use targeted invitation letters and incentives |
Setting | How different are the resources, intervention provider expertise, and organization of care delivery in the trial from usual care? | 4 | Care is provided in the usual care settings; providers have been trained specifically for the study |
Organization of intervention | How different are the settings for the trial from usual care settings? | 3 | Organization is identical to usual care; Back Pain Navigators serve a coordinating care role |
Flexibility of experimental intervention–delivery | How different from usual care are the resources, intervention provider expertise, and organization of care delivery in the trial? | 4 | Allow flexibility per clinical judgement; there are intervention protocols, fidelity measurements, and engagement activities |
Flexibility of experimental intervention–adherence | Is the intervention delivery in the trial more or less flexible compared with usual care? | 2 | Great effort is made to ensure that participants attend the first intervention appointment |
Follow-up | How intense is the measurement and follow-up of trial participants compared with the typical follow-up of patients in usual care? | 2 | Assessments at baseline, week 10, and months 6 and 12 are outside of usual care; incentives are offered for completion |
Outcome | To what extent is the trial’s primary outcome directly relevant to the participants? | 5 | Outcomes are highly relevant to participants and to providers |
Analysis | To what extent will all data be included in the analysis of the primary outcome? | 5 | Intention-to-treat analysis is planned, using data from all randomized participants |