RT Journal Article
SR Electronic
T1 EULAR Points to Consider (PtC) for designing, analysing and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 1116
OP 1123
DO 10.1136/annrheumdis-2020-219523
VO 80
IS 9
A1 Annelies Boonen
A1 Polina Putrik
A1 Mary Lucy Marques
A1 Alessia Alunno
A1 Lydia Abasolo
A1 Dorcas Beaton
A1 Neil Betteridge
A1 Mathilda Bjørk
A1 Maarten Boers
A1 Boryana Boteva
A1 Bruno Fautrel
A1 Francis Guillemin
A1 Elsa F Mateus
A1 Elena Nikiphorou
A1 Márta Péntek
A1 Fernando Pimentel Santos
A1 Johannes L Severens
A1 Suzanne M M Verstappen
A1 Karen Walker-Bone
A1 Johan Karlsson Wallman
A1 Marieke M ter Wee
A1 René Westhovens
A1 Sofia Ramiro
YR 2021
UL http://ard.bmj.com/content/80/9/1116.abstract
AB 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.Data sharing not applicable as no datasets generated and/or analysed for this study. No datasets were generated and/or analysed for this study.