Core Outcome Measures in Effectiveness Trials

2017 EULAR recommendations for a core data set to support observational research and clinical care in rheumatoid arthritis

General Information

Abstract:
Personalised medicine, new discoveries and studies on rare exposures or outcomes require large samples that are increasingly difficult for any single investigator to obtain. Collaborative work is limited by heterogeneities, both what is being collected and how it is defined. To develop a core set for data collection in rheumatoid arthritis (RA) research which (1) allows harmonisation of data collection in future observational studies, (2) acts as a common data model against which existing databases can be mapped and (3) serves as a template for standardised data collection in routine clinical practice to support generation of research-quality data. A multistep, international multistakeholder consensus process was carried out involving voting via online surveys and two face-to-face meetings. A core set of 21 items ('what to collect') and their instruments ('how to collect') was agreed: age, gender, disease duration, diagnosis of RA, body mass index, smoking, swollen/tender joints, patient/evaluator global, pain, quality of life, function, composite scores, acute phase reactants, serology, structural damage, treatment and comorbidities. The core set should facilitate collaborative research, allow for comparisons across studies and harmonise future data from clinical practice via electronic medical record systems.

Authors:
Radner, H. Chatzidionysiou, K. Nikiphorou, E. Gossec, L. Hyrich, K. L. Zabalan, C. van Eijk-Hustings, Y. Williamson, P. R. Balanescu, A. Burmester, G. R. Carmona, L. Dougados, M. Finckh, A. Haugeberg, G. Hetland, M. L. Oliver, S. Porter, D. Raza, K. Ryan, P. Santos, M. J. van der Helm-van Mil, A. van Riel, P. von Krause, G. Zavada, J. Dixon, W. G. Askling, J.

Publication

Journal:
Ann Rheum Dis
Volume:
77
Issue:
4
Pages:
476 - 479
Year:
2018
DOI:
Further Study Information

Date:
2015 - 2016
Funding source(s):
T his project was funded by a EULAR project grant

Health Area

Disease Category
Rheumatology

Disease Name
Rheumatoid arthritis

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Not specified

Method(s)

Literature review
Semi structured discussion
Survey

A multistep, international multistakeholder consensus process was carried out involving voting via online surveys and two face-to-face meetings


Stakeholders Involved

Clinical experts
Consumers (patients)
Epidemiologists
Methodologists
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice
COS for registry
Minimum dataset

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