EULAR recommends first core data set for pregnancy registries in rheumatology
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EULAR has released its first consensus-based recommendations for a core data set for prospective pregnancy registries in rheumatology, with a total of 51 items covering maternal information and treatment.
“In recent years, several European pregnancy registries have been established in rheumatology to prospectively collect and analyze data on pregnant women with different inflammatory rheumatic diseases (IRD),” Yvette Meissner, MSc, of the German Rheumatism Research Center Berlin, and colleagues wrote in the Annals of the Rheumatic Diseases. “However, certain research issues, for example, studying the pregnancy course in rare diseases, require even larger study populations, often exceeding the number of patients available in each registry, making collaborative analyses desirable.”
“Combined analysis of data from different sources requires a certain degree of homogeneity among the data collected,” they added. “A recent comprehensive survey of four registries working together in the European Network of Pregnancy Registries in Rheumatology (EuNeP) showed similar study designs in terms of prospective data collection, inclusion of patients with IRD before or during early pregnancy, and reporting of data in each trimester of pregnancy. However, major differences were found in the details of data collection, for example, in the instruments used to measure disease activity.”
To define a core data set for registries and observational studies that prospectively collect information about pregnant women with rheumatic diseases, EULAR convened an 18-member task force. Members included Meissner, as a fellow, three EMEUNET members, two patient research partners and one health professional.
The task force used a stepwise process, including a two-round Delphi survey and a face-to-face meeting in January 2019, to establish a consensus regarding relevant items. A total of 73 experts, including 17 members of the task force, were invited via email to participate in the Delphi vote. Among the invited, 65 participated in round one and 64 voted in round two. Of the participants in both Delphi rounds, 69% were women. In addition, 84% were rheumatologists, 5% each were obstetricians and epidemiologists, and 3% each were patients and midwives. A total of 14 countries were represented.
The task force and expert stakeholders reached a consensus on 51 core items, covering three topics: “maternal information,” “pregnancy” and “treatment.” Maternal information items include age, height, education level, weight before pregnancy, alcohol and smoking status, disease characteristics and prevalent comorbidities. The “pregnancy” topic includes items such as obstetrical history, pregnancy course, delivery outcome and neonatal outcomes. Lastly, the treatment items include drugs used 12 months prior to conception, rheumatic treatments used during and after pregnancy, and all other drugs used during pregnancy.
The task force recommended generic instruments for assessment on every item. In addition, for rheumatoid arthritis, spondyloarthritis, juvenile idiopathic arthritis, systemic lupus erythematosus and other connective tissue diseases, the task force proposed disease-specific laboratory markers and disease activity measurements.
“This EULAR Task Force proposes a core data set with a minimum of items to be collected by pregnancy registries in rheumatology,” Meissner and colleagues wrote. “Our aim was to facilitate collaborative research and joint data analyses.”
“As the design of registries may vary considerably between countries and will be influenced by the different health care systems, this common data set was deliberately kept short and simple, concentrating on the most important information that is needed for meaningful joint analyses,” they added. “We hope that this proposal will be useful when establishing new registries and also increase the willingness of rheumatologists, other health care professionals and patients to contribute to the registries and provide the necessary data.”
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