Table 1.

Research agenda for the OMERACT Vasculitis Working Group.

DomainIssuePotential Solution
Health-Related Quality of Life (HRQOL)Usefulness of the SF-36 as an outcome measure for AAVAnalysis of SF-36 from randomized controlled trials and observational cohorts
Role of organ-specific instrumentsPilot 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 scoresEvaluate scoring approaches in ongoing studies
Potential use of HRQOL data for health economics assessmentEvaluate EuroQol-5D in ongoing studies
Patient-reported outcomes (PRO)Item generation and selectionPatient focus groups
PROMIS NIH Toolbox for certain items, such as fatigue, sleep
Item reduction, item weighting, and overall revision of the instrumentDelphi exercise with patients with vasculitis
Need for vasculitis type-specific instruments/modulesPilot general vasculitis instrument and vasculitis type-specific instrument
Validation of new PRO instrumentUse in randomized controlled trials
Comparison of PRO and HRQOLCompare PRO and HRQOL data within same patient cohort
DamageItem selectionCompile items from data in ongoing studies
Item weightingWeighting informed expert rankings and trial data
Need for vasculitis type-specific instrumentComparison of VDI to AVID in ongoing studies; data from CDA
Disease activityWeighting of itemsDetermine data-driven weights using global assessment scores, medium-term outcomes (3-12 months), physician treatment decisions, relapse risk, death
Discrepancies between instrumentsHarmonization, 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 vasculitisDisease-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.