Research agenda for the OMERACT Vasculitis Working Group.
| Domain | Issue | Potential Solution |
|---|---|---|
| Health-Related Quality of Life (HRQOL) | Usefulness of the SF-36 as an outcome measure for AAV | Analysis of SF-36 from randomized controlled trials and observational cohorts |
| Role of organ-specific instruments | Pilot such instruments in ongoing studies and compare to generic tool such as SF-36; evaluate addition of organ-specific tools to SF-36 | |
| Individual domain vs composite scores | Evaluate scoring approaches in ongoing studies | |
| Potential use of HRQOL data for health economics assessment | Evaluate EuroQol-5D in ongoing studies | |
| Patient-reported outcomes (PRO) | Item generation and selection | Patient focus groups |
| PROMIS NIH Toolbox for certain items, such as fatigue, sleep | ||
| Item reduction, item weighting, and overall revision of the instrument | Delphi exercise with patients with vasculitis | |
| Need for vasculitis type-specific instruments/modules | Pilot general vasculitis instrument and vasculitis type-specific instrument | |
| Validation of new PRO instrument | Use in randomized controlled trials | |
| Comparison of PRO and HRQOL | Compare PRO and HRQOL data within same patient cohort | |
| Damage | Item selection | Compile items from data in ongoing studies |
| Item weighting | Weighting informed expert rankings and trial data | |
| Need for vasculitis type-specific instrument | Comparison of VDI to AVID in ongoing studies; data from CDA | |
| Disease activity | Weighting of items | Determine data-driven weights using global assessment scores, medium-term outcomes (3-12 months), physician treatment decisions, relapse risk, death |
| Discrepancies between instruments | Harmonization, standardization of tools, new single instrument | |
| Definition of disease states (e.g., remission, relapse, low-disease activity, high-disease activity) | Longterm cohort studies | |
| Inclusion of other forms of vasculitis | Disease-specific evaluations; generic vasculitis instruments plus vasculitis type-specific modules |
SF-36: Medical Outcomes Survey Short Form 36 Questionnaire; PROMIS: Patient-Reported Outcomes Measurement System; NIH: US National Institutes of Health; VDI: Vasculitis Damage Index; AVID: ANCA Vasculitis Index of Damage; CDA: Combined Damage Assessment.