DOMAIN | Pragmatic or Explanatory?a | COMMENTS |
---|---|---|
Eligibility. Who is selected to participate in the trial? | Pragmatic | Exclusions only for safety; comorbidities included. |
Recruitment. How are participants recruited into the trial? | Pragmatic | Recruited from practice sites (emergency rooms, clinics). |
Setting. Where is the trial being done? | Pragmatic | Performed at the practice site. |
Organization. What expertise and resources are needed to deliver the intervention? | Pragmatic | No extraordinary expertize required. |
Flexibility: delivery. How should the intervention be delivered? | Pragmatic | Total weekly oral dose can be administered on any schedule desired. |
Flexibility: adherence. What measures are in place to make sure participants adhere to the intervention? | Explanatory | Adherence encouraged by frequent contacts by the research team and monitored by patient report and pill count. |
Follow-up. How closely are the participants followed-up? | Explanatory | 3-monthly study visits to collect non-routine information (e.g., spirometry, biomarkers, QOL) |
Primary outcome. How relevant is it to participants? | Pragmatic | Outcome is patient-centered (see text for discussion). |
Primary analysis. To what extent are all data included? | Pragmatic | Intention-to-treat. |