SAT0350 Content and face validity and feasibility of five candidate instruments for psoriatic arthritis randomised controlled trials: results from the psa omeract core set workshop at the grappa 2017 annual meeting

Abstract

BackgroundThe Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) – Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Core Set working group is developing a core instrument set to guide selection of outcome measures (instruments) for PsA randomised controlled trials (RCTs) and longitudinal observational studies (LOS). Candidate instrument measurement properties are being appraised in systematic literature reviews by working group members.ObjectivesAppraise the content and face validity (domain match) and feasibility of PsA instruments with GRAPPA stakeholders using the OMERACT Filter 2.1 instrument selection process1.MethodsThe PsA Core set workshop held at the GRAPPA 2017 annual meeting comprised an introductory plenary session and breakout group discussions. Working group members facilitated six breakout groups, with two patient research partners (PRPs) per group, discussing pre-selected domain-instrument pairs. Participants individually reviewed the instrument(s). After group discussion, they completed anonymised paper-based OMERACT questionnaires examining domain match and feasibility, with votes for each aspect of domain match and feasibility centralised by instrument. A final vote (show of hands) on whether the assigned instrument met the requirements for domain match and feasibility using the OMERACT traffic-light scoring system was taken. Consensus was defined as more than 70% agreement, and majority as more than 50% agreement within a group. Consensus represents stronger evidence than majority agreement.ResultsThere were 145 participants across all breakout groups and 116 returned completed questionnaires. Anonymized votes are summarised across groups and instruments in figure 1. More than 70% in the respective breakout groups endorsed the PsA instrument 66 swollen and 68 tender joint count (66/68 SJC/TJC) as a good match with the target domain of arthritis, a subset of MSK disease activity, FACIT-Fatigue as a good match with fatigue, and PsAID12 as a good match with HRQoL. There was consensus or majority agreement for all feasibility questions for the 66/68 SJC/TJC, HAQ-DI and PsAID9 and PsAID12. For the SPARCC enthesitis index only one item in both domain match and feasibility did not reach majority agreement.Abstract SAT0350 – Figure 1GRAPPA stakeholders’ ratings for OMERACT domain match and feasibility for 6 PsA instrumentsConclusionsThe first two steps of the OMERACT Filter 2.1 instrument selection process for five candidate instruments have been completed. The first set of candidate instruments selected to undergo the next phase of the OMERACT Filter 2.1, construct validity and discrimination appraisal are 66/68 SJC/TJC, SPARCC enthesitis index, PsAID9, PsAID12, HAQ-DI and FACIT-Fatigue. Additional PsA instruments will undergo the OMERACT selection process.Reference[1] Boers M, Kirwan JR, Tugwell P, et al. The OMERACT Handbook. Accessed 8 January 2018. https://www.omeract.org/resources.Disclosure of InterestNone declared

Endorsement of the 66/68 Joint Count for the Measurement of Musculoskeletal Disease Activity: OMERACT 2018 Psoriatic Arthritis Workshop Report

“…Domain match and feasibility for the SJC66/TJC68 were addressed at GRAPPA 2017 in a breakout group discussion, and following the meeting, among working group members using a Web-based survey. During the GRAPPA meeting, content validity and feasibility were addressed within a small group with clinicians, 2 patients, and a patient advocate; the voting sheets were completed by 22 people 12 . There was consensus (20/22, 91%) among the group that the SJC66/TJC68 was a match for the MSK disease activity/peripheral arthritis domain and that there was adequacy of content and no redundancies.…”

PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials

“…Second, during the GRAPPA 2017 annual meeting COMPACT workshop, one breakout group was dedicated to PsAID12. Facilitators provided the HRQOL domain description, the PsAID12 questionnaire and scoring method; participants then anonymously completed each item of the OMERACT domain match and feasibility questionnaires (11). Third, the working group voted on domain match and feasibility.…”

“…There was unanimous green vote for PsAID12 feasibility. At the GRAPPA 2017 annual meeting 24 stakeholders voted majority amber for PsAID12 domain match, and majority green for feasibility (11). Twenty-two working group members voted: 17 (82%) green for domain match and 20 (91%) green for feasibility; the rest of the working group votes were amber.…”

Evidence for Psoriatic Arthritis Impact of Disease (PsAID12) as Core Instrument to Measure Health-Related Quality of Life in Psoriatic Arthritis: A Systematic Review of Psychometric Properties

“…The PsAID12 content validity (domain match and feasibility) were assessed in a face-to-face meeting with 12 PsA PRPs, and a multistakeholder breakout group at the GRAPPA PsA core instrument set workshop. 17 In the face-to-face meeting and breakout group, facilitators provided the HRQoL domain description, the PsAID12 questionnaire, and scoring method; participants then anonymously completed each item of the OMERACT domain match and feasibility questionnaires. 13 A working group vote on domain match was also collected, with 22 working group members voting (50% rheumatologists, 23% patients, 13.5% industry, and 4.5% each dermatologists/ trainees/methodologists).…”

“…Four studies evaluated feasibility of PsAID12 17,20,24,26 and reported high feasibility. Two studies evaluated completion rate and demonstrated !99% completion rate for a paperbased questionnaire.…”