Table 1.

Patient involvement in the OMERACT Vasculitis working group/VCRC-PCORI steering committee, and research projects.

Patient Involvement
  • Development of project protocol and materials

  • Regular progress evaluations and reviews of results

  • Development of interview prompts and cues

  • Semistructured exploratory interviews

  • Participation in breakout session at OMERACT 2014

  • Reporting of results*

Use of PROMIS Measures in AAVDevelopment of a Disease-specific PRO Instrument for AAVApplication of the ICF in AAV
  • Selection of PROMIS domains for use in the study

  • Selection of PROMIS domains and instruments for longitudinal study and randomized control trials

  • Pilot of PROMIS instruments

  • Testing and feedback on administration of PROMIS to research subjects

  • Review of preliminary data and analysis*

  • Design of ancillary studies*

  • Review of final PROMIS “toolbox” for use in clinical research in AAV*

  • Review of candidate questions

  • Review of freelisting data used to define relevant domains and shape PRO items

  • Cognitive interviews of candidate questionnaire items

  • Survey of ∼500 UK and US patients to determine scale structure and item reduction*

  • Participants in randomized controlled trial to further evaluate final questionnaire items*

  • Review of final instrument for use in future validation studies*

  • Involvement in analysis of interview transcripts

  • Designing a questionnaire for prioritizing the ICF categories identified at individual interviews

  • Participation in online exercise to prioritize the ICF categories identified at individual interviews

  • Participation in a consensus meeting to finalize the ICF Core Set for AAV*

  • * Future step. VCRC: Vasculitis Clinical Research Consortium; PCORI: Patient-Centered Outcomes Research Institute; PROMIS: Patient-reported Outcomes Measurement Information System; AAV: ANCA-associated vasculitis; PRO: patient-reported outcome; ICF: International Classification of Functioning, Disability and Health; ANCA: antineutrophil cytoplasmic antibody.