Open this publication in new window or tab >> Department of Rheumatology, Instituto de Investigation Sanitaria San Carlos, Hospital Clinico Universitario San Carlos, Madrid, Spain.
Mobility Program Clinical Research Unit, St Michael's Hospital Li Ka Shing Knowledge Institute, Toronto, Ontario, Canada.
Neil Betteridge Associates, London, UK.
Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Pain and Rehabilitation Center.
Department of Epidemiology and Data Science; Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, Amsterdam, The Netherlands.
Patients with Arthritis and Rheumatism (PARE) working group, European League Against Rheumatism, Zurich, Switzerland.
PEPITES teams, Pierre Louis Institute for Epidemiology and Public Health, Inserm UMR 1136, Paris, France; Rheumatology Dept, Pitié Salpetriere Hospital, Sorbonne University; Assistance Publique- Hôpitaux de Paris, Paris, Fance.
APEMAC, Université de Lorraine, Nancy, France; CIC Epidémiologie Clinique, CHRU Nancy, Inserm, Université de Lorraine, Nancy, France.
Portuguese League Against Rheumatic Diseases (LPCDR) and Comprehensive Health Research Centre (CHRC), Lisbon, Portugal; People with Arthritis and Rheumatism (PARE), European League Against Rheumatism, Zurich, Switzerland.
Centre for Rheumatic Diseases, King’s College of London, London, UK; Rheumatology Department, King’s College Hospital, London, UK.
Health Economics Research Center, University Research and Innovation Center, Óbuda University, Budapest, Hungary.
Rheumatology Department, Centro Hospitalar de Lisboa Ocidental EPE Hospital de Egas Moniz, Lisboa, Portugal; NOVA Medical School, Lisboa, Portugal.
Erasmus School of Health Policy & Management and iMTA, Institute for Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, The Netherlands.
Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK; Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Manchester, UK.
MRC Versus Arthritis Centre for Musculoskeletal Health and Work, MRC Life course Epidemiology Unit, Southampton General Hospital, Southampton, UK.
Department of Clinical sciences, Lund University, Lund, Sweden; Department of Rheumatology, Skåne University Hospital, Lund, Sweden.
Department of Epidemiology and Data Science, Amsterdam Public Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands; Department of Rheumatology and immunology, AI&I, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Dept of Rheumatology, KU Leuven University Hospitals Leuven, Leuven, Belgium; Skeletal Biology and Engineering Research Centre, KU Leuven Department of Development and Regeneration, Leuven, Belgium.
Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; Rheumatology, Zuyderland Medical Centre Heerlen, Heerlen, The Netherlands.
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2021 (English) In: Annals of the Rheumatic Diseases, ISSN 0003-4967, E-ISSN 1468-2060, Vol. 80, no 9, p. 1116-1123, article id annrheumdis-2020-219523Article in journal (Refereed) Published
Abstract [en] BACKGROUND: Clinical studies with work participation (WP) as an outcome domain pose particular methodological challenges that hamper interpretation, comparison between studies and meta-analyses.
OBJECTIVES: To develop Points to Consider (PtC) for design, analysis and reporting of studies of patients with inflammatory arthritis that include WP as a primary or secondary outcome domain.
METHODS: The EULAR Standardised Operating Procedures were followed. A multidisciplinary taskforce with 22 experts including patients with rheumatic diseases, from 10 EULAR countries and Canada, identified methodologic areas of concern. Two systematic literature reviews (SLR) appraised the methodology across these areas. In parallel, two surveys among professional societies and experts outside the taskforce sought for additional methodological areas or existing conducting/reporting recommendations. The taskforce formulated the PtC after presentation of the SLRs and survey results, and discussion. Consensus was obtained through informal voting, with levels of agreement obtained anonymously.
RESULTS: Two overarching principles and nine PtC were formulated. The taskforce recommends to align the work-related study objective to the design, duration, and outcome domains/measurement instruments of the study (PtC: 1-3); to identify contextual factors upfront and account for them in analyses (PtC: 4); to account for interdependence of different work outcome domains and for changes in work status over time (PtC: 5-7); to present results as means as well as proportions of patients reaching predefined meaningful categories (PtC: 8) and to explicitly report volumes of productivity loss when costs are an outcome (PtC:9).
CONCLUSION: Adherence to these EULAR PtC will improve the methodological quality of studies evaluating WP.
Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2021
Keywords ankylosing, arthritis, health care, outcome and process assessment, psoriatic, rheumatoid, spondylitis
National Category
Clinical Medicine
Identifiers urn:nbn:se:liu:diva-177215 (URN) 10.1136/annrheumdis-2020-219523 (DOI) 000686232600020 () 33832966 (PubMedID) 2-s2.0-85104032349 (Scopus ID)
Note Funding: European League Against Rheumatism [EPI021]; NIHR Manchester Biomedical Research CentreNational Institute for Health Research (NIHR); Versus ArthritisVersus Arthritis [20380]
2021-06-222021-06-222025-02-18 Bibliographically approved