Points to consider when designing studies to improve outcome in people with inflammatory arthritis

Understanding work participation is important, but the way in which this is defined and measured in clinical trials is not always the same, which has made it hard to compare data.

EULAR set up a taskforce to draft points to consider when designing studies that use work participation as a measure. The taskforce included doctors, experts and patients from 11 countries. They used the published evidence to draw up a set of points to consider.

Two overarching principles and nine points to consider were developed. The principles say that work participation is important for people with inflammatory arthritis, their families and society as a whole. They also point out that there are unique methodological aspects around designing, analysing and reporting studies with work participation as an outcome that require attention.

The points focus on identifying contextual factors upfront and account for them in analyses, as well as accounting for links between different work outcome domains and changes in work status over time. They also advise presenting results as means as well as proportions of patients reaching predefined meaningful categories. This helps people using the data to make comparisons between studies. Finally, they suggest that volume of productivity loss should be explicitly stated when costs are an outcome.

EULAR's current strategy states that 'by 2023, EULAR's activities and related advocacy will have increased participation in work by people with rheumatic and musculoskeletal diseases. EULAR hope that using these points to consider when designing new studies will improve the quality of data available about work in people with inflammatory arthritis, enabling comparisons across studies and the production of good-quality meta-analyses that can inform clinical practice and management for people with these diseases.

Journal reference:

Boonen, A., 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. doi.org/10.1136/annrheumdis-2020-219523.


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