EULAR Points to Consider (PtC) for designing, analysing and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis
EULAR Points to Consider (PtC) for designing, analysing and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis
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.
1116-1123
Boonen, Annelies
c32bd0a4-48b2-45f9-9ab3-5ff0074b7f32
Putrik, Polina
1d018d5d-b4ec-4d72-be2f-e144e0d049f9
Marques, Mary Lucy
e3ec71c2-4a5c-45a9-a4ae-7a6cf34c9805
Walker-Bone, Karen
ad7d1336-ed2c-4f39-ade5-da84eb412109
12 August 2021
Boonen, Annelies
c32bd0a4-48b2-45f9-9ab3-5ff0074b7f32
Putrik, Polina
1d018d5d-b4ec-4d72-be2f-e144e0d049f9
Marques, Mary Lucy
e3ec71c2-4a5c-45a9-a4ae-7a6cf34c9805
Walker-Bone, Karen
ad7d1336-ed2c-4f39-ade5-da84eb412109
Boonen, Annelies, Putrik, Polina and Marques, Mary Lucy
,
et al.
(2021)
EULAR Points to Consider (PtC) for designing, analysing and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis.
Annals of the Rheumatic Diseases, 80 (9), .
(doi:10.1136/annrheumdis-2020-219523).
Abstract
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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Accepted/In Press date: 23 March 2021
e-pub ahead of print date: 8 April 2021
Published date: 12 August 2021
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Local EPrints ID: 485341
URI: http://eprints.soton.ac.uk/id/eprint/485341
ISSN: 0003-4967
PURE UUID: 25fe2087-cbcc-4280-a15d-28fee956246a
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Date deposited: 04 Dec 2023 17:52
Last modified: 17 Mar 2024 02:50
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Author:
Annelies Boonen
Author:
Polina Putrik
Author:
Mary Lucy Marques
Corporate Author: et al.
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