Epidemiology and Health Services Research, German Rheumatism Research Centre Berlin, Berlin, Germany.
Department of Rheumatology and Clinical Immunology, Charité University Medicine, Berlin, Germany.
Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5867. doi: 10.1002/pds.5867.
In pharmacoepidemiology, robust data are needed to judge the impact of drug treatment on pregnancy, pregnancy outcomes and breast-fed infants. As pregnant and breastfeeding women are usually excluded from randomised clinical trials, observational studies are required. One of those data sources are pregnancy registers specifically developed to focus on certain diseases or disease groups. The German Rhekiss register investigates pregnancies in women with chronic inflammatory rheumatic diseases (IRD). Rhekiss is a nationwide, multicentre, longitudinal study, in which women aged 18 years or older with an underlying IRD can be enrolled by a rheumatologist either when planning a pregnancy or in the first half of pregnancy. Data are collected prospectively at regular follow-up visits. Rheumatologists and patients provide information in a web-based system before conception (if enrolment was at the time of pregnancy planning), during and after pregnancy. A smartphone app is available for patients. Maternal and clinical information, general laboratory markers, treatment with antirheumatic and other drugs, adverse events, items related to course and outcome of pregnancy and the health of the child are uniformly assessed for all diseases. Individual information on the IRD includes classification criteria, diagnosis-specific laboratory parameters, clinical parameters and validated instruments to measure disease activity or damage. Furthermore, patient-reported outcome measures are captured. A total of 2013 individual patients have been enrolled in the register, and data on 1801 completed pregnancies are available. In summary, Rhekiss is a comprehensive and complex register that can answer various research questions about pregnancy in women with chronic IRDs.
在药物流行病学中，需要有可靠的数据来判断药物治疗对妊娠、妊娠结局和母乳喂养婴儿的影响。由于孕妇和哺乳期妇女通常被排除在随机临床试验之外，因此需要进行观察性研究。其中一种数据源是专门为关注某些疾病或疾病群体而开发的妊娠登记处。德国 Rhekiss 登记处调查患有慢性炎症性风湿病 (IRD) 的女性的妊娠情况。Rhekiss 是一项全国性、多中心、纵向研究，18 岁或以上患有潜在 IRD 的女性可以由风湿病学家在计划怀孕时或怀孕的前半段时间入组。数据通过定期随访前瞻性收集。风湿病学家和患者在怀孕前（如果是在怀孕计划时入组）、怀孕期间和之后通过基于网络的系统提供信息。患者还可以使用智能手机应用程序。所有疾病均统一评估母婴临床信息、一般实验室标志物、抗风湿药物和其他药物治疗、不良事件、与妊娠过程和结局相关的项目以及儿童健康状况。IRD 的个体信息包括分类标准、诊断特异性实验室参数、临床参数和用于测量疾病活动或损害的经过验证的工具。此外，还捕获了患者报告的结果测量指标。该登记处共入组了 2013 名个体患者，其中 1801 例完成妊娠的数据可用。总之，Rhekiss 是一个全面而复杂的登记处，可以回答有关患有慢性 IRD 的女性妊娠的各种研究问题。
