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

Annelies Boonen*, Polina Putrik, Mary Lucy Marques, Alessia Alunno, Lydia Abasolo, Dorcas Beaton, Neil Betteridge, Mathilda Bjørk, Maarten Boers, Boryana Boteva, Bruno Fautrel, Francis Guillemin, Elsa F. Mateus, Elena Nikiphorou, Márta Péntek, Fernando Pimentel Santos, JL (Hans) Severens, Suzanne M.M. Verstappen, Karen Walker-Bone, Johan Karlsson WallmanMarieke M. Ter Wee, René Westhovens, Sofia Ramiro

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

14 Citations (Scopus)


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.

Original languageEnglish
Article number20219523
Pages (from-to)1116-1123
Number of pages8
JournalAnnals of the Rheumatic Diseases
Issue number9
Publication statusPublished - 1 Sept 2021

Bibliographical note

Funding Information:
Funding This study was funded by European League Against Rheumatism (EPI021); SMMV is supported by the NIHR Manchester Biomedical Research Centre and Versus Arthritis (grant number 20380).

Funding Information:
Competing interests AB: research grants from Abbvie and Celgene and honoraria for consultancy or speakers honoraria from UCB, Biogen, Sandoz, Eli Lilly and Galapagos (all to her department); EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, AbbVie and Lilly; FPS: research grant from AbbVie, Novartis; consultancy or speaking fees: AbbVie, Angelini, AstraZeneca, Biogen, Eli Lilly, Laboratórios Vitória, MSD, Novartis, Tecnimed, UCB; SR: research grant from MSD; consultancy or speaking fees: AbbVie, Eli Lilly, MSD, Novartis, Sanofi, UCB; JKW: consultancy fees from Celgene, Eli Lilly, Novartis; RW: consultancy and speakers bureau Celltrion and Galapagos/Gilead.

Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.


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