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  • Boonen, AnneliesDivision of Rheumatology, Maastricht University Medical Centre+ Internal Medicine, Maastricht, The Netherlands; Universiteit Maastricht Care and Public Health Research Institute, Maastricht, The Netherlands (author)

EULAR Points to Consider (PtC) for designing, analysing and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis

  • Article/chapterEnglish2021

Publisher, publication year, extent ...

  • 2021-04-08
  • BMJ Publishing Group Ltd,2021
  • electronicrdacarrier

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  • LIBRIS-ID:oai:DiVA.org:liu-177215
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-177215URI
  • https://doi.org/10.1136/annrheumdis-2020-219523DOI
  • https://lup.lub.lu.se/record/5d1abe9e-4f39-43fa-8dda-79d44e31559eURI

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  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Funding: European League Against Rheumatism [EPI021]; NIHR Manchester Biomedical Research CentreNational Institute for Health Research (NIHR); Versus ArthritisVersus Arthritis [20380]
  • 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.

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  • Putrik, PolinaDivision of Rheumatology, Maastricht University Medical Centre+ Internal Medicine, Maastricht, The Netherlands; Universiteit Maastricht Care and Public Health Research Institute, Maastricht, The Netherlands (author)
  • Marques, Mary LucyRheumatologist, Leiden University Medical Center, Leiden, The Netherlands; Rheumatology, Centro Hospitalar e Universitario de Coimbra EPE, Coimbra, Portugal (author)
  • Alunno, AlessiaRheumatology Unit, University of Perugia Department of Medicine, Perugia, Italy (author)
  • Abasolo, LydiaDepartment of Rheumatology, Instituto de Investigation Sanitaria San Carlos, Hospital Clinico Universitario San Carlos, Madrid, Spain (author)
  • Beaton, DorcasMobility Program Clinical Research Unit, St Michael's Hospital Li Ka Shing Knowledge Institute, Toronto, Ontario, Canada (author)
  • Betteridge, NeilNeil Betteridge Associates, London, UK,Neil Betteridge Associates Limited (author)
  • Björk, Mathilda,1977-Linköping University,Linköpings universitet,Medicinska fakulteten,Avdelningen för prevention, rehabilitering och nära vård,Region Östergötland, Smärt och rehabiliteringscentrum(Swepub:liu)matth80 (author)
  • Boers, MaartenDepartment of Epidemiology and Data Science; Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, Amsterdam, The Netherlands,Amsterdam UMC - Vrije Universiteit Amsterdam (author)
  • Boteva, BoryanaPatients with Arthritis and Rheumatism (PARE) working group, European League Against Rheumatism, Zurich, Switzerland (author)
  • Fautrel, BrunoPEPITES 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,Institut Pierre Louis d’Epidémiologie et de Santé Publique (author)
  • Guillemin, FrancisAPEMAC, Université de Lorraine, Nancy, France; CIC Epidémiologie Clinique, CHRU Nancy, Inserm, Université de Lorraine, Nancy, France,University Hospital of Nancy (author)
  • Mateus, Elsa FPortuguese 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 (author)
  • Nikiphorou, ElenaCentre for Rheumatic Diseases, King’s College of London, London, UK; Rheumatology Department, King’s College Hospital, London, UK (author)
  • Péntek, MártaHealth Economics Research Center, University Research and Innovation Center, Óbuda University, Budapest, Hungary (author)
  • Pimentel Santos, FernandoRheumatology Department, Centro Hospitalar de Lisboa Ocidental EPE Hospital de Egas Moniz, Lisboa, Portugal; NOVA Medical School, Lisboa, Portugal,NOVA University Lisbon (author)
  • Severens, Johannes LErasmus School of Health Policy & Management and iMTA, Institute for Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, The Netherlands (author)
  • Verstappen, Suzanne M MCentre 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 (author)
  • Walker-Bone, KarenMRC Versus Arthritis Centre for Musculoskeletal Health and Work, MRC Life course Epidemiology Unit, Southampton General Hospital, Southampton, UK (author)
  • Wallman, Johan KarlssonLund University,Lunds universitet,Lund Arthritis Research Group (LARG),Forskargrupper vid Lunds universitet,Lund University Research Groups,Department of Clinical sciences, Lund University, Lund, Sweden; Department of Rheumatology, Skåne University Hospital, Lund, Sweden(Swepub:lu)med-jnk (author)
  • Ter Wee, Marieke MDepartment 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 (author)
  • Westhovens, RenéDept of Rheumatology, KU Leuven University Hospitals Leuven, Leuven, Belgium; Skeletal Biology and Engineering Research Centre, KU Leuven Department of Development and Regeneration, Leuven, Belgium,Catholic University of Leuven (author)
  • Ramiro, SofiaRheumatology, Leiden University Medical Center, Leiden, The Netherlands; Rheumatology, Zuyderland Medical Centre Heerlen, Heerlen, The Netherlands (author)
  • Division of Rheumatology, Maastricht University Medical Centre+ Internal Medicine, Maastricht, The Netherlands; Universiteit Maastricht Care and Public Health Research Institute, Maastricht, The NetherlandsRheumatologist, Leiden University Medical Center, Leiden, The Netherlands; Rheumatology, Centro Hospitalar e Universitario de Coimbra EPE, Coimbra, Portugal (creator_code:org_t)

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  • In:Annals of the Rheumatic Diseases: BMJ Publishing Group Ltd80:9, s. 1116-11230003-49671468-2060

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