Background/Purpose: Robust data on the outcomes of pregnancy and influence of drug exposure in various inflammatory rheumatic diseases (IRD) are needed. Joint analyses of data from different databases could overcome the issue of small study sizes in single databases. A prerequisite for collaborative analyses would be a common core data set, collected by every collaborator. The objective was to develop a core data set for observational research to measure pregnancy course and outcomes of women with IRD.

Methods: The European Network of Pregnancy registers in rheumatology (EuNeP) consists of scientists who run pregnancy registers, namely EGR2 (France), RePreg (Switzerland), REVNATUS (Norway) and Rhekiss (Germany). During a face-to-face meeting involving all principal investigators of the 4 registers, the scope and core areas of the core data set have been developed according to COS-STAD recommendations¹ by consensus. Furthermore, the steps for developing a core data set, the consensus process and cut offs, as well as participants to be invited have been determined.

Results: The scope was defined as follows: ‘To develop a standardized core data set for data collection in prospective observational research and clinical care of pregnant women with IRD. All interventions the women receive will be covered. Patients should be enrolled at the earliest possible moment during pregnancy, and data should ideally be collected once every trimester’. Three core areas were described: ‘Maternal information’ (including demographics, comorbidities and IRD disease characteristics), ‘Treatment’ (including medications of IRD and other health conditions) and ‘Pregnancy’ (including prior and actual pregnancy(ies), delivery and infant outcomes).

An initial list of data items possibly relevant for pregnancy registers will be generated based on (I) data items already collected by registers participating in EuNeP, (II) a systematic literature search and (III) results of a survey among patient representatives regarding their needs during pregnancy. Consensus about the importance of each data item to be included in a final core data set will be reached by applying a 2-step Delphi survey. For each item, the importance must be rated on a numeric scale from 1 to 9 (1-3 = low importance, 4-6 = important but not critical, 7-9 = critical importance). Any data item achieving at least 70% of responses as critical will be included in the core data set. Participants involved in the Delphi survey will be (a) the steering committee of EuNeP, (b) a working group of at least 30 experts in the areas of rheumatology, internal medicine, epidemiology and other health professions, and (c) patient representatives.

So far, the protocol has been set up and finalized, the literature search is currently performed. The first step of the Delphi survey will be presumably undertaken in mid-2018, preliminary results are expected to be available at time of the ACR congress.

Conclusion: A core data set which standardizes the data collection of pregnancy registers in rheumatology will facilitate collaborative analyses of different data sources.

¹Kirkham et al., PLoS Med. 2017 Nov 16;14(11):e1002447.

This work was supported by a research grant from FOREUM Foundation for Research in Rheumatology.

« Back to 2018 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/defining-a-standardized-core-data-set-for-pregnancy-registers-in-rheumatic-diseases-an-european-approach/