January 23, 2018
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EULAR recommends core data set to enable standardized, collaborative RA research

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A EULAR task force recently published recommendations for a core data set of 21 parameters for observational research and clinical care for rheumatoid arthritis, intended to support standardized data collection and improve comparability across different studies.

“To facilitate collaborative research, standardizing items (‘what to collect’) and their instruments (‘how to collect’) across studies and data collections is critical,” Helga Radner, MD, of the Medical University Vienna, and colleagues wrote. “Although guidelines on data reporting and outcome measures have been developed, such core sets have so far pertained to randomized control trials and trial extension studies in [RA], and have not been vetted against the feasibility of data collection in routine clinical care or against the needs of observational research.”

To develop a core set for data collection in RA research, EULAR established a task force including a 90-member pan-European expert panel, a 10-member steering committee, a working group of 15 experts from 11 European countries and the United States, two co-conveners, a methodologist and a patient partner. Their goal was to establish a core set that would help harmonize data collection in observational studies, act as a common data model and serve as a standard template for data collection in clinical care.

The task force conducted a hierarchical literature review of published articles from 67 European RA registers, identifying 47 prospective core set items and 125 instruments for how to collect them. The 90-member expert panel then completed an online survey rating the importance of each of the 47 items and their relevant instruments, ultimately choosing 29 for inclusion. The list of core set data items was further refined through two face-to-face meetings of the working group, online ratification and a second online survey.

The EULAR task force ultimately ratified a list of 21 core set data items, accompanied by recommendations for how to collect them. According to the published recommendations, the 21 items are: age, gender, disease duration, diagnosis of RA, BMI, smoking, swollen or tender joints, patient and evaluator global, pain, quality of life, function, composite scores, acute phase reactants, serology, structural damage, treatment and comorbidities.

“In summary, through a multistep, multistakeholder and evidence-based process, this task force has developed an RA core set that may harmonize data collection in future observational studies, act as a common data model against which existing databases can be mapped and serve as a template for standardized data collection in routine clinical practice to support the generation of research-quality data,” Radner and colleagues wrote. “This effort, which will continue to be updated and revised after evaluation of its implementation, may serve as an example for other conditions beyond RA.” – by Jason Laday

Disclosure: The researchers report no relevant financial disclosures.