Step in protocol development | Process(es) | Outcome |
---|---|---|
Metric selection | Literature review | 18 metrics aligned with prior literature, evidence-based guidelines, and stakeholder input developed to test 6 hypotheses relevant to treatment of OUD in pregnancy |
Expert consultation | ||
Stakeholder engagement | ||
Profile development | Adaptation from prior studies | 2 regionally, culturally representative profiles created |
Expert consultation | ||
Stakeholder engagement | ||
Pilot calls | USP training | Callers familiarized with protocol dialogue and refinements made to training guide to reflect sampling context |
Metric capture/Refinement of post-visit data entry forms | Reliable metric capture obtained | |
Fidelity checks | Qualitative fidelity observed across USPs |