Pritzker School of Medicine, University of Chicago, Chicago, Illinois, USA.
American College of Cardiology, Washington, District of Columbia, USA.
J Am Med Inform Assoc. 2022 Jan 12;29(2):348-353. doi: 10.1093/jamia/ocab224.
Data on the safety and effectiveness of contraception among women with rare diseases are critical and sorely lacking. To fill this gap, we propose a national, patient-driven database that tracks contraceptive safety and effectiveness among women with rare diseases. We built a pilot database focusing on women with cystic fibrosis in 3 phases: (1) database design input from patients and experts, (2) merging of contraceptive survey data with relevant clinical outcomes from the Cystic Fibrosis Foundation Patient Registry (CFFPR), and (3) forming a data guide to facilitate accessible output data. We successfully linked 62 contraceptive survey variables with 362 relevant clinical outcome variables for 150 patients. This pilot represents a breakthrough in linking contraceptive data to disease-specific outcomes and informs how to build a national, patient-driven contraceptive database for women with rare diseases.
有关罕见病女性避孕安全性和有效性的数据至关重要，但却严重缺乏。为了填补这一空白，我们建议建立一个全国性的、由患者驱动的数据库，以跟踪罕见病女性的避孕安全性和有效性。我们分三个阶段建立了一个专注于囊性纤维化女性的试点数据库：（1）从患者和专家处获取数据库设计输入，（2）将避孕调查数据与囊性纤维化基金会患者注册中心（CFFPR）的相关临床结果相合并，（3）形成一个数据指南，以方便获取输出数据。我们成功地将 62 个避孕调查变量与 150 名患者的 362 个相关临床结果变量相联系。这个试点代表着将避孕数据与特定疾病结果联系起来的一个突破，并为如何为罕见病女性建立一个全国性的、由患者驱动的避孕数据库提供了信息。
