Table 1.

Process for domain selection: Similarity between OMERACT group activities and elements of FDA process.

Elements of FDA Recommendation2Case 1: RAID10 Gossec, et alCase 2: RAPP-PI10aCase 3: Fatigue as a domain of interest in RACase 4: Q Sort18
Outline hypothesized concepts and potential claimsxxxx
Determine intended populationxxxx
Determine intended application/characteristics (type of scores, mode and frequency of administration)xxx
Perform literature/expert reviewxxx
Develop hypothesized conceptual frameworkxx
Place PRO within preliminary endpoint model
Document preliminary instrument developmentxx
Obtain patient inputxxxx
Generate new itemsxxx
Select recall period, response options and formatxxx
Select mode/method of administration/data collectionxxx
Conduct patient cognitive interviewingxxxx
Pilot test draft instrumentxx
Document content validityxxxx
Confirm conceptual framework with scoring rulex
  • PRO: patient-reported outcomes; RAPP-PI: Rheumatoid Arthritis Patient Priorities for Pharmaceutical Intervention; RAID: Rheumatoid Arthritis Impact of Disease.