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EULAR recommendations for a core data set for pregnancy registries in rheumatology

Author

Ann Rheum Dis. 2020 Oct 14;annrheumdis-2020-218356.doi: 10.1136/annrheumdis-2020-218356. Online ahead of print.

Yvette Meissner 1, Rebecca Fischer-Betz 2, Laura Andreoli 3 4, Nathalie Costedoat-Chalumeau 5 6, Diederik De Cock 7, Radboud J E M Dolhain 8, Frauke Forger 9, Doreen Goll 10, Anna Molto 11 12, Catherine Nelson-Piercy 13 14, Rebecca Özdemir 15, Luigi Raio 16, Sebastian Cruz Rodríguez-García 17, Savino Sciascia 18, Marianne Wallenius 19 20, Astrid Zbinden 9, Angela Zink 21, Anja Strangfeld 21

Author Information

1 Epidemiology and Health Care Research, German Rheumatism Research Center Berlin, Berlin, Germany y.meissner@drfz.de.

2 Department for Rheumatology and Hiller Research Institute, Heinrich Heine University Düsseldorf, Dusseldorf, Germany.

3 Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.

4 Unit of Rheumatology and Clinical Immunology, ASST Spedali Civili di Brescia, Brescia, Italy.

5 Internal Medicine Department, Referral Center for Rare Autoimmune and Systemic Diseases, Hospital Cochin, Paris, France.

6 CRESS, INSERM, INRA, Université de Paris, Paris, France.

7 Department of Development and Regeneration KU, KU Leuven, Leuven, Belgium.

8 Medical Centre, Department of Rheumatology, Erasmus University Rotterdam, Rotterdam, Netherlands.

9 Department of Rheumatology, Immunology and Allergology, Inselspital University Hospital Bern, Bern, Switzerland.

10 Patient research partner, Berlin, Germany.

11 Rheumatology Department, Hospital Cochin, Paris, France.

12 U-1153, INSERM, University of Paris, Paris, France.

13 Obstetric Medicine Service, Queen Charlotte's and Chelsea Hospital, London, UK.

14 Department of Women and Children's Health, Guy's and St Thomas' NHS Foundation Trust, London, UK.

15 Patient research partner, Duisburg, Germany.

16 Department of Obstetrics and Gynaecology, Inselspital University Hospital Bern, Bern, Switzerland.

17 Rheumatology Department, Hospital Universitario de la Princesa, Madrid, Spain.

18 Dipartimento di Malattie Rare, Immunologiche, Ematologiche ed Immunoematologiche. Centro di Ricerche di Immunopatologia e Documentazione su Malattie Rare (CMID). Struttura Complessa a Direzione Universitaria di Immunologia Clinica, Ospedale Torino Nord Emergenza San G. Bosco ed Università di Torino, Torino, Italy.

19 Institute of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.

20 Norwegian National Advisory Unit on Pregnancy and Rheumatic Diseases, Dept of Rheumatology, St Olavs Hospital University Hospital in Trondheim, Trondheim, Norway.

21 Epidemiology and Health Care Research, German Rheumatism Research Center Berlin, Berlin, Germany.

Abstract

Background and objective: There is an urgent need for robust data on the trajectories and outcomes of pregnancies in women with inflammatory rheumatic diseases (IRD). In particular when rare outcomes or rare diseases are to be investigated, collaborative approaches are required. However, joint data analyses are often limited by the heterogeneity of the different data sources.To facilitate future research collaboration, a European League Against Rheumatism (EULAR) Task Force defined a core data set with a minimum of items to be collected by pregnancy registries in rheumatology covering the period of pregnancy and the 28-day neonatal phase in women with any underlying IRD.

Methods: A stepwise process included a two-round Delphi survey and a face-to-face meeting to achieve consensus about relevant items.

Results: A total of 64 multidisciplinary stakeholders from 14 different countries participated in the two rounds of the Delphi process. During the following face-to-face meeting of the EULAR Task Force, consensus was reached on 51 main items covering 'maternal information', 'pregnancy' and 'treatment'. Generic instruments for assessment are recommended for every item. Furthermore, for the five most frequent IRDs rheumatoid arthritis, spondyloarthritis, juvenile idiopathic arthritis, systemic lupus erythematosus and other connective tissue diseases, disease-specific laboratory markers and disease activity measurements are proposed.

Conclusion: This is the first consensus-based core data set for prospective pregnancy registries in rheumatology. Its purpose is to stimulate and facilitate multinational collaborations that aim to increase the knowledge about pregnancy course and safety of treatment in women with IRDs during pregnancy.