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Table 1 Proposed design for a randomized trial of azithromycin for the long-term management of asthma. Seven of nine PRECIS-2 [98] domains are recommended as pragmatic and two as explanatory

From: Infection-mediated asthma: etiology, mechanisms and treatment options, with focus on Chlamydia pneumoniae and macrolides

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.

  1. aPRECIS-2 grades on a scale from 1 (extremely explanatory) to 5 (extremely pragmatic). Column 2 presents recommendations for which end of the spectrum is emphasized