OBJECTIVES: Several @entity1 -reported outcome (PRO) instruments have been validated in @entity5427 . This study aims to evaluate several measurement properties of such PROs in a broad axial @entity11028 (axSpA) population, including both @entity5427 and non-radiographic axSpA (nr-axSpA) subpopulations. METHODS: PROs assessed were @entity615 , @entity1 global assessment of disease activity, BASDAI, BASFI and the 36-item Short Form Health Survey. A literature review and both clinician and @entity1 qualitative interviews provided information on instrument content validity. Reliability (test-retest and internal consistency), construct validity (PROs, clinical-outcome correlations and known-groups validity) and PRO responsiveness were assessed. Data from the RAPID-axSpA trial (NCT01087762) investigating certolizumab pegol efficacy in axSpA, including relevant subpopulations, were utilized. RESULTS: Concepts identified for the broad axSpA population by both clinician and @entity1 interviews were consistent with those identified through literature review of @entity5427 . All PROs demonstrated reliability in the RAPID-axSpA population (n = 325), with test-retest intraclass correlation coefficients and internal consistency Cronbach's a >0.8. Validity was supported by agreement between PROs and clinician-rated measures; except for the 36-item Short Form Health Survey Mental Components Summary, correlations between PROs and physician global assessment of disease activity ranged from 0.28 to 0.42 for week 0 and from 0.53 to 0.65 for week 24. PRO measures showed good sensitivity to change (effect size >0.8) at weeks 12 and 24 for responders. No variations in measurement properties were noted between the subpopulations. CONCLUSION: This study indicates that both content validity and measurement properties of PRO instruments utilized in @entity5427 are preserved in the broad axSpA population.

Are XXXX -reported outcome instruments for ankylosing spondylitis fit for purpose for the axial spondyloarthritis @entity1 ? A qualitative and psychometric analysis.

@entity1 :: ('9606', 'Species') :: ['patient'] @entity11028 :: ('729238', 'Gene') :: ['SpA'] @entity5427 :: ('MESH:D017204', 'Disease') :: ['AS'] @entity615 :: ('MESH:D001416', 'Disease') :: ['total and nocturnal back pain']
@entity1 :: (9606,Species) :: ['patient']
