Summary of case studies.
| Case Study | Full Title | What are the outcome domains you are currently working with? | Why did you decide not to use the existing Core Set? | What contextual factors did you consider? | How did you make these decisions? |
|---|---|---|---|---|---|
| OA Hand | Osteoarthritis of the hand | Domains identified in OMERACT 3; depending on the setting: pain, (physical) function and patient global assessment for symptom modifying trials and extra imaging for structure modifying trials | In the selection process patients were not involved and there was limited attention for different settings, study populations, different hand OA subsets and the co-occurrence of OA at other joint sites | Different hand OA subsets (thumb base OA, interphalangeal OA, erosive OA) and generalized OA; additionally: esthetic damage, inflammation, and thumb base prosthesis suggested | Discussions and Delphi exercises within a group of hand OA experts; work in progress; |
| Flare in RA | Flares in rheumatoid arthritis | Pain; physical function; tender joints; swollen joints; patient global; assessor global; laboratory measures fatigue; Stiffness; participation; self-management | A priori decision to use “bottom-up” approach to identify domains [literature review, qualitative studies (Ref. 14) with patients, expert input] to ensure all potential domains considered; domains ultimately recommended: existing RA core set plus domains initially identified by patients and then prioritized by both groups | Area of application (RCT, LOS, clinical practice), disease duration, duration in current (low) disease activity state, comorbid conditions, knowledge/experience with self-management strategies, individual context, environment | Domains identified through iterative 3 stage Delphi process of > 200 patients and health care providers (Ref. 15); Domains with > 70% agreement as important or essential in measuring flare by either patients or HCP were considered “Core” |
ANCA: antineutrophil cytoplasmic antibodies; RCT: randomized controlled trials; LOS: longitudinal observational studies; HCP: healthcare professional.