EULAR recommendations for a core data set for pregnancy registries in rheumatology.
- Meissner Y Epidemiology and Health Care Research, German Rheumatism Research Center Berlin, Berlin, Germany y.meissner@drfz.de.
- Fischer-Betz R Department for Rheumatology and Hiller Research Institute, Heinrich Heine University Düsseldorf, Dusseldorf, Germany.
- Andreoli L Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
- Costedoat-Chalumeau N Internal Medicine Department, Referral Center for Rare Autoimmune and Systemic Diseases, Hospital Cochin, Paris, France.
- De Cock D Department of Development and Regeneration KU, KU Leuven, Leuven, Belgium.
- Dolhain RJEM Medical Centre, Department of Rheumatology, Erasmus University Rotterdam, Rotterdam, Netherlands.
- Forger F Department of Rheumatology, Immunology and Allergology, Inselspital University Hospital Bern, Bern, Switzerland.
- Goll D Patient research partner, Berlin, Germany.
- Molto A Rheumatology Department, Hospital Cochin, Paris, France.
- Nelson-Piercy C Obstetric Medicine Service, Queen Charlotte's and Chelsea Hospital, London, UK.
- Özdemir R Patient research partner, Duisburg, Germany.
- Raio L Department of Obstetrics and Gynaecology, Inselspital University Hospital Bern, Bern, Switzerland.
- Rodríguez-García SC Rheumatology Department, Hospital Universitario de la Princesa, Madrid, Spain.
- Sciascia S 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.
- Wallenius M Institute of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.
- Zbinden A Department of Rheumatology, Immunology and Allergology, Inselspital University Hospital Bern, Bern, Switzerland.
- Zink A Epidemiology and Health Care Research, German Rheumatism Research Center Berlin, Berlin, Germany.
- Strangfeld A Epidemiology and Health Care Research, German Rheumatism Research Center Berlin, Berlin, Germany.
- 2020-10-15
Published in:
- Annals of the rheumatic diseases. - 2020
antirheumatic agents
autoimmune diseases
biological therapy
epidemiology
health care
outcome assessment
English
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.
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.
- Language
-
- English
- Open access status
- hybrid
- Identifiers
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- DOI 10.1136/annrheumdis-2020-218356
- PMID 33055080
- Persistent URL
- https://folia.unifr.ch/global/documents/207945
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