News Release

NEW: Points to consider in research

Observational data are increasingly used to analyse the safety and effectiveness of new therapies in different subgroups.

Peer-Reviewed Publication

European Alliance of Associations for Rheumatology (EULAR)

EULAR, the European Alliance of Associations for Rheumatology has published new points to consider when analysing and reporting comparative effectiveness research using observational data in rheumatology. These complement previously published points to consider on how to use observational data to analyse and report safety data in biologic registers and report clinical trial extension studies. A EULAR task force was set up to draft the points. The group included healthcare professionals, rheumatologists, epidemiologists, statisticians, patients, and social science researchers.

The group developed three overarching principles and ten points to consider. The points do not carry the same weight of supporting clinical evidence as EULAR recommendations, but the agreement between task force members was very high. The principles focus on the definition of treatment effectiveness as how well a treatment performs in routine clinical settings. They also acknowledge that observational data traditionally have several limitations, including confounding and missing data, and note that robust and transparent epidemiological and statistical methods increase the trustworthiness of results gained from observational data.

The points to consider expand on current STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines regarding the importance of describing missing data patterns. Similar to STROBE guidelines, they are relevant not only to rheumatic and musculoskeletal diseases, but can be used in most medical fields where cohort studies are used to assess effectiveness – especially of chronic disease treatments.

It is thought that EULAR is the first non-governmental organisation representing patients, healthcare professionals and scientific societies to date has developed recommendations for comparative effectiveness studies.

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