Ying-Ying Leung1, Richard Holland2, Ashish J Mathew3, Christine Lindsay4, Niti Goel5, Alexis Ogdie6, Ana-Maria Orbai7, Pil Hojgaard8, Jeffrey Chau9, Laura C Coates10, Vibeke Strand11, Dafna D Gladman12, Robin Christensen13, William Tillett14, Philip Mease15. 1. Department of Rheumatology and Immunology, Singapore General Hospital, Duke-NUS Medical School, The Academia, level 4, 20 College Road, 169856, Singapore. Electronic address: katyccc@hotmail.com. 2. Concord Repatriation General Hospital, Sydney, Australia. 3. Centre for Prognosis Studies in Rheumatic Diseases, Division of Rheumatology, Department of Medicine, University of Toronto, Toronto, Ontario Canada; Department of Clinical Immunology & Rheumatology, Christian Medical College, Vellore, India; The Copenhagen Center for Arthritis Research, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark. 4. Patient Research Partner, Prosper, TX USA. 5. Patient Research Partner, Duke University School of Medicine, Durham, NC, USA. 6. Medicine and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. 7. Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. 8. Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. 9. Patient Research Partner, Hong Kong. 10. National Institute for Health Research Clinician Scientist, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom. 11. Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA. 12. University of Toronto, Krembil Research Institute, Psoriatic Arthritis Program, University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada. 13. Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen & Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark. 14. Royal National Hospital for Rheumatic Diseases, University of Bath, Bath, United Kingdom. 15. Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, WA, USA.
Abstract
OBJECTIVES: Physical function (PF) is a core domain to be measured in randomized controlled trials (RCTs) of psoriatic arthritis (PsA), yet the discriminative performance of patient reported outcome measures (PROMs) for PF in RCTs has not been evaluated systematically. In this systematic review, we aimed to evaluate the clinical trial discrimination of PF-PROMs in PsA RCTs. METHODS: We searched PubMed and Scopus databases in English to identify all original RCTs on biological and targeted synthetic disease modifying anti-rheumatic drugs (DMARDs) conducted in PsA. We assessed quality in each article using the OMERACT good method checklist. Effect sizes (ES) for the PF-PROMs were calculated and appraised using a priori hypotheses. Evidence supporting clinical trial discrimination for each PF-PROM was summarized to derive recommendations. RESULTS: 35 articles from 31 RCTs were included. Four PF-PROMs had data for evaluation: HAQ-Disability Index (DI), HAQ-Spondyloarthritis (S), and Short Form 36-item Health Survey Physical Component Summary (SF-36 PCS) and Physical Functioning domain (SF-36 PF). As anticipated, higher ES values were observed for intervention groups than the control groups. Across all studies, for HAQ-DI, the median ES were -0.73 and -0.24 for intervention and control groups, respectively. Whereas for SF-36 PCS, the median ES were 0.77 and 0.23. For intervention and control groups, respectively. CONCLUSION: Clinical trial discrimination was supported for HAQ-DI and SF-36 PCS in PsA with low risk of bias; and for SF-36 PF and HAQ-S with some caution. More studies are required for HAQ-S.
OBJECTIVES: Physical function (PF) is a core domain to be measured in randomized controlled trials (RCTs) of psoriatic arthritis (PsA), yet the discriminative performance of patient reported outcome measures (PROMs) for PF in RCTs has not been evaluated systematically. In this systematic review, we aimed to evaluate the clinical trial discrimination of PF-PROMs in PsA RCTs. METHODS: We searched PubMed and Scopus databases in English to identify all original RCTs on biological and targeted synthetic disease modifying anti-rheumatic drugs (DMARDs) conducted in PsA. We assessed quality in each article using the OMERACT good method checklist. Effect sizes (ES) for the PF-PROMs were calculated and appraised using a priori hypotheses. Evidence supporting clinical trial discrimination for each PF-PROM was summarized to derive recommendations. RESULTS: 35 articles from 31 RCTs were included. Four PF-PROMs had data for evaluation: HAQ-Disability Index (DI), HAQ-Spondyloarthritis (S), and Short Form 36-item Health Survey Physical Component Summary (SF-36 PCS) and Physical Functioning domain (SF-36 PF). As anticipated, higher ES values were observed for intervention groups than the control groups. Across all studies, for HAQ-DI, the median ES were -0.73 and -0.24 for intervention and control groups, respectively. Whereas for SF-36 PCS, the median ES were 0.77 and 0.23. For intervention and control groups, respectively. CONCLUSION: Clinical trial discrimination was supported for HAQ-DI and SF-36 PCS in PsA with low risk of bias; and for SF-36 PF and HAQ-S with some caution. More studies are required for HAQ-S.