EULAR Points to Consider (PtC) for designing, analysing and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis
(2021) In Annals of the Rheumatic Diseases 80(9). p.1116-1123- 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... (More)
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.
(Less)
- author
- organization
- publishing date
- 2021
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- ankylosing, arthritis, health care, outcome and process assessment, psoriatic, rheumatoid, spondylitis
- in
- Annals of the Rheumatic Diseases
- volume
- 80
- issue
- 9
- article number
- 20219523
- pages
- 1116 - 1123
- publisher
- BMJ Publishing Group
- external identifiers
-
- scopus:85104032349
- pmid:33832966
- ISSN
- 0003-4967
- DOI
- 10.1136/annrheumdis-2020-219523
- language
- English
- LU publication?
- yes
- id
- 5d1abe9e-4f39-43fa-8dda-79d44e31559e
- date added to LUP
- 2021-04-23 07:56:11
- date last changed
- 2024-04-20 05:13:51
@article{5d1abe9e-4f39-43fa-8dda-79d44e31559e,
abstract = {{<p>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. </p>}},
author = {{Boonen, Annelies and Putrik, Polina and Marques, Mary Lucy and Alunno, Alessia and Abasolo, Lydia and Beaton, Dorcas and Betteridge, Neil and Bjørk, Mathilda and Boers, Maarten and Boteva, Boryana and Fautrel, Bruno and Guillemin, Francis and Mateus, Elsa F. and Nikiphorou, Elena and Péntek, Márta and Pimentel Santos, Fernando and Severens, Johannes L. and Verstappen, Suzanne M.M. and Walker-Bone, Karen and Wallman, Johan Karlsson and Ter Wee, Marieke M. and Westhovens, René and Ramiro, Sofia}},
issn = {{0003-4967}},
keywords = {{ankylosing; arthritis; health care; outcome and process assessment; psoriatic; rheumatoid; spondylitis}},
language = {{eng}},
number = {{9}},
pages = {{1116--1123}},
publisher = {{BMJ Publishing Group}},
series = {{Annals of the Rheumatic Diseases}},
title = {{EULAR Points to Consider (PtC) for designing, analysing and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis}},
url = {{http://dx.doi.org/10.1136/annrheumdis-2020-219523}},
doi = {{10.1136/annrheumdis-2020-219523}},
volume = {{80}},
year = {{2021}},
}