Process for domain selection: Similarity between OMERACT group activities and elements of FDA process.
| Elements of FDA Recommendation2 | Case 1: RAID10 Gossec, et al | Case 2: RAPP-PI10a | Case 3: Fatigue as a domain of interest in RA | Case 4: Q Sort18 |
|---|---|---|---|---|
| Outline hypothesized concepts and potential claims | x | x | x | x |
| Determine intended population | x | x | x | x |
| Determine intended application/characteristics (type of scores, mode and frequency of administration) | x | x | x | |
| Perform literature/expert review | x | x | x | |
| Develop hypothesized conceptual framework | x | x | ||
| Place PRO within preliminary endpoint model | ||||
| Document preliminary instrument development | x | x | ||
| Obtain patient input | x | x | x | x |
| Generate new items | x | x | x | |
| Select recall period, response options and format | x | x | x | |
| Select mode/method of administration/data collection | x | x | x | |
| Conduct patient cognitive interviewing | x | x | x | x |
| Pilot test draft instrument | x | x | ||
| Document content validity | x | x | x | x |
| Confirm conceptual framework with scoring rule | x |
PRO: patient-reported outcomes; RAPP-PI: Rheumatoid Arthritis Patient Priorities for Pharmaceutical Intervention; RAID: Rheumatoid Arthritis Impact of Disease.