Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: Collaborative research is compromised by heterogeneity of data collection in observational rheumatoid arthritis (RA) databases. Therefore a EULAR taskforce has been convened to develop a minimum core dataset (MCD) of data items (i.e. Ôwhat to collectÕ) and instruments for data collection (i.e. Ôhow to collectÕ) to 1) harmonize future data collection 2) act as a common data model to which existing databases can be mapped 3) serve as a template for standardized data collection for RA research in routine clinical practice.
Methods: The task force comprised a study steering committee, a task force working group and a pan-European expert panel. The project involved a multi-step process (Figure): 1) a hierarchical literature review to identify data items and instruments of existing RA cohorts and registers 2) an online survey to capture information on perceived importance of extracted items and instruments for possible inclusion 3) two face-to-face (F2F) meetings of the working group with discussion and voting on content (items) and structure (instruments) of the MCD. The voting of the F2F meetings were confirmed and consolidated by a ratification survey and work performed by the steering group between the two F2F meetings.
Results: Published articles from 67 different European registers and cohorts were included for data extraction. The number of patients recruited in each register ranged from 130 to more than 50,000. A total of 40 different items and 125 instruments were identified in literature; 7 items felt to be missing were added by the steering group. A total of 90 experts from 28 different European countries, including patients (18%), health professionals (18%), physicians (55%) and researchers or other experts (10%) participated in the online survey. 27/47 (57%) items were regarded to be important for inclusion in a MCD by >80% of responders. At the first F2F meeting 22/47 items were voted to be INCLUDED, 24/47 to be EXCLUDED in a MCD; for 2 items no consensus was reached. Ratification survey and second F2F meeting revealed consensus to include 21/47 items and their instruments (Table). Remaining work in the task force pertains to instruments for two items (ÔglucocorticoidsÕ and ÔcomorbiditiesÕ).
Conclusion: Based on the multistep process, a first draft of a MCD was developed which has to be tested for feasibility in clinical settings and applicability to answer important research questions. Figure: Flowchart of the multistep process of the project Table: Content of minimum core dataset
|INCLUDED ITEM||PROPOSED INSTRUMENTS|
|AGE||date of birth|
|DIAGNOISIS OF RA||rheumatologist reported diagnosis of RA|
|DISEASE DURATION||date of diagnosis|
|SMOKING||current / previous / never|
|BMI||weight / height|
|COMPOSITE SCORE||Clinical disease activity index (CDAI), simplified disease activity index (SDAI), disease activity score 28 joints (DAS28) EULAR and ACR response|
|TENDER JOINT COUNT||28 joint count|
|SWOLLEN JOINT COUNT||28 joint count|
|PATIENT GLOBAL||capture: 1) global assessment of disease activity, 2)related to arthritis,3) today and use of visual analogue scale (VAS) or numeric rating scale (NRS)|
|EVALUATOR GLOBAL||capture: 1) global assessment of disease activity, 2)related to arthritis,3) today and use of VAS or NRS|
|PAIN||capture: 1) pain, 2)related to arthritis, 3) last week and use of VAS or NRS|
|PHYSICAL FUNCTION||Health assessment questionnaire (HAQ)|
|ACUTE PHASE REACTANTS||C-reactive protein (CRP) AND erythrocyte sedimentation rate (ESR)|
|SEROLOGY||Rheumatoid factor AND ACPA|
|ONGOING/MOST RECENT DMARD||1) type of DMARD, 2) start and stop date, 3) reason for discontinuation (if applicable)|
|DMARD HISTORY||name of previous DMARD(s) (including biological, conventional synthetic and targeted synthetic DMARDs)|
|HEALTH RELATED QUALITY OF LIFE||Euro-Qol-5D (if available cost-free)|
|X-RAY HANDS AND FEET||presence of erosions on X-RAY Yes/No|
|COMORBIDITIES||To be identified|
|GLUCOCORTICOIDS||To be identified|
To cite this abstract in AMA style:Radner H, Nikiphorou E, Chatzidionysiou K, Gossec L, Hyrich KL, Zăbălan C, van Eijk-Hustings YJ, Williamson P, Dixon WG, Askling J. Towards Harmonized Data Collection in Rheumatoid Arthritis (RA): The EULAR Task Force for Standardizing a Minimum Data Collection for RA Observational Research [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/towards-harmonized-data-collection-in-rheumatoid-arthritis-ra-the-eular-task-force-for-standardizing-a-minimum-data-collection-for-ra-observational-research/. Accessed June 22, 2021.
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