OP0326 DEVELOPMENT OF A STANDARDIZED MINIMAL CORE DATA SET FOR PREGNANCY REGISTERS IN RHEUMATOLOGY – RESULTS OF A EULAR TASK FORCE
Authors: Yvette Meißner, Rebecca Fischer-Betz, Laura Andreoli, Nathalie Costedoat-Chalumeau, Diederik De Cock, Radboud Dolhain, Frauke Förger, Doreen Goll, Anna Moltó, Rebecca Özdemir, Luigi Raio, Catherine Nelson-Piercy, Sebastian C Rodriguez-García, Savino Sciascia, Marianne Wallenius, Astrid Zbinden, Angela Zink, Anja Strangfeld
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> Results from individual data collections on drug safety during pregnancy and outcomes of pregnancy in patients with inflammatory rheumatic diseases (IRD) are often limited due to small number of cases. Joint data analyses from different data sources could solve this problem. <h3>Objectives</h3> The aim of this EULAR task force was to define a core data set to facilitate joint analysis of pregnancy registers in rheumatology. <h3>Methods</h3> Scope and core areas of the core data set have been developed according to COS-STAD recommendations<sup>1</sup> by consensus. An initial list of data items possibly relevant for pregnancy registers was generated based on (I) a systematic literature search, (II) data items already collected by European pregnancy registers and (III) a survey amongst patient representatives. Consensus about the importance of each data item to be included in a core data set was reached by applying a 2-round Delphi survey where each item was rated on a numeric scale (1-3 = low importance, 4-6 = important but not critical, 7-9 = critical importance). Any data item that was considered as 'critical important' by at least 70% of responders in Delphi round 2 was included in the core set. During a face-to-face meeting of the EULAR task force, the inclusion or exclusion of data items with no consensus was finally decided. <h3>Results</h3> 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 including the neonatal phase. 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. An additional visit should capture the neonatal phase'. Three core areas were described: 'Maternal information' (including demographics, IRD disease characteristics and comorbidities), 'Pregnancy' (including prior and current pregnancy(ies), delivery and neonatal outcomes) and 'Treatment' (including medication of IRD and other health conditions). 64 experts from 14 different European countries participated in the 2 rounds of Delphi (68% female; 84% physicians, 5% obstetricians, 5% epidemiologists, 3% patients, 3% midwives). Of the 148 data items, 85 were included in the final core set. The figure shows included items within the core areas. <h3>Conclusion</h3> The consensus process resulted in an extensive list of data items recommended by experts to be collected as a minimum by pregnancy registers in rheumatology. This core data set applies to all pregnant women irrespective of the underlying IRD. The EULAR task force plans to find consensus on additional disease specific advice. <h3>Reference</h3> [1] Kirkham et. al. PLoS med.2017;14(11):e1002447. <h3>Acknowledgement</h3> This work was supported by a research grant from FOREUM Foundation for Research in Rheumatology. <h3>Disclosure of Interests</h3> Yvette Meißner Speakers bureau: Pfizer, Rebecca Fischer-Betz Grant/research support from: GlaxoSmithKline and UCB Pharma for performing the LuLa-study., Laura Andreoli: None declared, Nathalie Costedoat-Chalumeau: None declared, Diederik De Cock: None declared, Radboud Dolhain Grant/research support from: UCB Pharma B.V, Frauke Förger: None declared, Doreen Goll: None declared, Anna Moltó: None declared, Rebecca Özdemir: None declared, Luigi Raio: None declared, Catherine Nelson-Piercy Consultant for: UCB, Speakers bureau: UCB, Sebastian C Rodriguez-García: None declared, Savino Sciascia: None declared, Marianne Wallenius: None declared, Astrid Zbinden: None declared, Angela Zink Speakers bureau: Speakers fees from AbbVie, Janssen, Pfizer, Roche, Sanofi, Anja Strangfeld Speakers bureau: Speakers fees from Bristol-Myers Squibb, MSD, Pfizer, Roche