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.