NHLBI TOPMed: Novel Risk Factors for the Development of Atrial Fibrillation in Women

The Women's Genome Health Study (WGHS) is a prospective cohort comprised of over 25,000 initially healthy female health professionals enrolled in the Women's Health Study, which began in 1992-1994. All participants in WGHS provided baseline blood samples and extensive survey data. Women who reported atrial fibrillation during the course of the study were asked to report diagnoses of AF at baseline, 48 months, and then annually thereafter. Participants enrolled in the continued observational follow-up who reported an incident AF event on at least one yearly questionnaire were sent an additional questionnaire to confirm the episode and to collect additional information. They were also asked for permission to review their medical records, particularly available ECGs, rhythm strips, 24-hour ECGs, and information on cardiac structure and function. For all deceased participants who reported AF during the trial and extended follow-up period, family members were contacted to obtain consent and additional relevant information. An end-point committee of physicians reviewed medical records for reported events according to predefined criteria. An incident AF event was confirmed if there was ECG evidence of AF or if a medical report clearly indicated a personal history of AF. The earliest date in the medical records when documentation was believed to have occurred was set as the date of onset of AF.

女性基因组健康研究（Women's Genome Health Study, WGHS）是一项前瞻性队列研究，其队列由25000余名初始健康的女性医疗从业者组成，这些参与者均纳入1992-1994年启动的女性健康研究（Women's Health Study）项目。所有该研究参与者均提供了基线血液样本与详尽的调查数据。研究期间报告心房颤动（atrial fibrillation, AF）的女性参与者，需分别在基线、随访48个月时上报AF诊断情况，此后每年均需定期报告。纳入持续观察性随访的参与者中，若至少在一份年度问卷中报告了新发AF事件，研究人员将向其发送额外问卷以确认该发作情况并收集补充信息。此外，研究人员还将征得其同意，查阅其医疗记录，尤其是现有心电图（electrocardiogram, ECG）、心律描记图、24小时心电图及心脏结构与功能相关信息。对于在试验及延长随访阶段报告过AF的已故参与者，研究人员将联系其家属以获取知情同意与相关补充信息。由医师组成的终点委员会将依据预先设定的标准，对报告的事件相关医疗记录进行审核。若存在AF的ECG证据，或医疗报告明确显示存在AF个人病史，则可确认新发AF事件。医疗记录中被认定为该事件发生的最早日期，将被定为AF发病日期。