Table 3 Pragmatism of the trial design scored using the PRECIS-2 tool
PRECIS-2 Domain | Pragmatic Score range from 1 (very explanatory) to 5 (very pragmatic) | Description |
|---|---|---|
Eligibility Criteria | 5 (very pragmatic) | Anyone with PD or DLB psychosis likely to be a candidate for either medication in routine care |
Recruitment | 4 (rather pragmatic) | Usual appointments at diverse clinics, some advertising used |
Setting | 3 (equally pragmatic and explanatory) | Local academic center, multiple clinics, diverse socioeconomic backgrounds |
Organization | 4 (rather pragmatic) | No extra training for prescription management, 1:1 training for the trial protocol with the principal investigator, utilize extra research staff for record keeping and study management |
Flexibility (Delivery) | 5 (very pragmatic) | Medication prescribed per routine care at prescriber’s full discretion |
Flexibility (Adherence) | 5 (very pragmatic) | Medication managed per routine care |
Follow-up | 4 (rather pragmatic) | Mostly at routine appointments, some additional contact for outcome collection |
Primary Outcome | 4 (rather pragmatic) | NPI-Q not used in routine care, but is easily administered and targets psychosis severity |
Primary Analysis | 5 (very pragmatic) | Intention-to-treat using all available data |
