Astrid van Tubergen1, Peter M Black2, Geoffroy Coteur3. 1. Department of Medicine, Division of Rheumatology, Maastricht University Medical Center, Maastricht, The Netherlands, a.van.tubergen@mumc.nl. 2. Clinical Outcome Assessments Consulting, ERT, Philadelphia, PA, USA and. 3. Global Health Outcomes Research, UCB Pharma, Brussels, Belgium.
Abstract
OBJECTIVES: Several patient-reported outcome (PRO) instruments have been validated in AS. This study aims to evaluate several measurement properties of such PROs in a broad axial SpA (axSpA) population, including both AS and non-radiographic axSpA (nr-axSpA) subpopulations. METHODS: PROs assessed were total and nocturnal back pain, patient global assessment of disease activity, BASDAI, BASFI and the 36-item Short Form Health Survey. A literature review and both clinician and patient 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 patient interviews were consistent with those identified through literature review of AS. All PROs demonstrated reliability in the RAPID-axSpA population (n = 325), with test-retest intraclass correlation coefficients and internal consistency Cronbach's α >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 AS are preserved in the broad axSpA population.
OBJECTIVES: Several patient-reported outcome (PRO) instruments have been validated in AS. This study aims to evaluate several measurement properties of such PROs in a broad axial SpA (axSpA) population, including both AS and non-radiographic axSpA (nr-axSpA) subpopulations. METHODS: PROs assessed were total and nocturnal back pain, patient global assessment of disease activity, BASDAI, BASFI and the 36-item Short Form Health Survey. A literature review and both clinician and patient 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 patient interviews were consistent with those identified through literature review of AS. All PROs demonstrated reliability in the RAPID-axSpA population (n = 325), with test-retest intraclass correlation coefficients and internal consistency Cronbach's α >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 AS are preserved in the broad axSpA population.
Authors: Victoria Navarro-Compán; James Cheng-Chung Wei; Filip Van den Bosch; Marina Magrey; Lisy Wang; Dona Fleishaker; Joseph C Cappelleri; Cunshan Wang; Joseph Wu; Oluwaseyi Dina; Lara Fallon; Vibeke Strand Journal: RMD Open Date: 2022-06
Authors: J Sieper; A Kivitz; A van Tubergen; A Deodhar; G Coteur; F Woltering; R Landewé Journal: Arthritis Care Res (Hoboken) Date: 2015-10 Impact factor: 4.794
Authors: Désirée van der Heijde; Maxime Dougados; Robert Landewé; Joachim Sieper; Walter P Maksymowych; Martin Rudwaleit; Filip Van den Bosch; Jürgen Braun; Philip J Mease; Alan J Kivitz; Jessica Walsh; Owen Davies; Lars Bauer; Bengt Hoepken; Luke Peterson; Atul Deodhar Journal: Rheumatology (Oxford) Date: 2017-09-01 Impact factor: 7.580
Authors: Mark C Hwang; Mona Martin; Kristina Harris; Philip Geerdts; Jeffrey L Stark; John Reveille Journal: Qual Life Res Date: 2020-07-01 Impact factor: 4.147
Authors: Maria A T van Wissen; Max M H Teuwen; Cornelia H M van den Ende; Thea P M Vliet Vlieland; Alfons A den Broeder; Wilbert B van den Hout; Wilfred F Peter; Dirkjan van Schaardenburg; Astrid M van Tubergen; Maaike G J Gademan; Salima F E van Weely Journal: Physiother Res Int Date: 2021-11-15