EULAR: Studies on work participation should identify contextual factors upfront
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Studies that feature work participation as an outcome in patients with inflammatory arthritis should identify key contextual factors — such as job type or social security system — upfront, according to new “points to consider” from EULAR.
Published in the Annals of the Rheumatic Diseases, the points to consider — nine of them in total — will help improve the methodological quality of studies examining work participation, wrote members of a EULAR task force.
“[Work participation (WP)] studies face challenges that have been repeatedly highlighted in reviews of studies with WP as an outcome domain,” Annelies Boonen, MD, PhD, of Maastricht University Medical Center, in the Netherlands, and colleagues wrote. “Identified issues relate to heterogeneity of definitions and measures to assess WP across studies. The role of contextual factors that modify or confound the outcome is often ignored. Sample size calculation specifically for the work outcomes and other methodological aspects are neglected and reporting of outcomes is often heterogeneous.”
“To overcome such limitations that hamper correct interpretation, guidance for conducting and reporting studies with WP as an outcome are a first step,” they added. “However, no such guidelines exist for studies on WP in [rheumatic and musculoskeletal diseases (RMDs)].”
To aid researchers in designing, analyzing and reporting studies of patients with inflammatory arthritis that include work participation as a primary or secondary outcome, EULAR established a 22-member multidisciplinary task force, led by Boonen and colleagues, that included experts and patients from 11 countries. Prior to drafting their points to consider, members of the task force identified methodologic areas of concern and conducted two systemic literature reviews to appraise the methodology across said areas.
Meanwhile, members surveyed professional societies and experts outside the task force for additional methodological areas or existing conducting and reporting recommendations. Members then developed the points to consider following a discussion and presentation of the literature review and survey results. A consensus was reached through informal voting, with agreement levels set anonymously.
The task force ultimately drafted and approved two overarching principles and nine points to consider. According to the overarching principles, work participation is key for patients with inflammatory arthritis and their families, as well as for “society as a whole.” In addition, the task force established that there are “unique methodological aspects” regarding studies with work participation as an outcome that require specific attention.
The nine points to consider are:
- Study duration and the choice of work participation outcome domains and measurement instruments should be considered in relation to the work-related study objective;
- The power to detect meaningful effects demand particular attention due to the fact that work participation outcomes may not apply to the entire study population;
- Outcome domains such as work status, absenteeism and presenteeism should be defined clearly and examined with validated instruments;
- Contextual factors, such as job type, that are highly likely to confound or modify work participation outcomes should be identified upfront, considered in the study design and accounted for in the analysis;
- Interdependence among various outcome domains should be accounted for in the analysis;
- Researchers should specify populations included in the analysis of each work participation outcome domain, with descriptions of their relevant characteristics;
- In longitudinal studies, researchers should regularly assess changes in work status;
- Researchers should consider reporting both aggregate results and the proportion of individuals based on predefined categories; and
- In studies analyzing the costs of work participation changes, the volume of work productivity — such as days or hours — should be reported.
“The nine [points to consider] aim to improve the quality of interventional and non-interventional studies and should eventually contribute to improving WP for patients with [inflammatory arthritis],” Boonen and colleagues wrote. “Specifically, adherence to these methodological considerations should lead to unbiased results and facilitate meta-analyses.”
“The task force would like to emphasize that while important, improvement of WP, employment, reduced sick leave or presenteeism should never be reached at the expense of long-term health or even life satisfaction,” they added. “Rather, the final goal should be to support patients in healthy and sustainable work, and days off work or adjustments in work productivity can be tools to reach this goal.”
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