Ralph Lauren J, Ehrenreich Katherine, Kaller Shelly, Gurazada Tanvi, Biggs M Antonia, Blanchard Kelly, Hauser Debra, Kapp Nathalie, Kromenaker Tammi, Moayedi Ghazaleh, Gil Jessica Pinckney, Perritt Jamila B, Raymond Elizabeth, Taylor DeShawn, White Kari, Valladares Ena Suseth, Williams Sigrid, Grossman Daniel
Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA.
Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA.
Am J Obstet Gynecol. 2025 Jul;233(1):44.e1-44.e15. doi: 10.1016/j.ajog.2025.01.008. Epub 2025 Jan 9.
With increasingly restricted access to facility-based abortion in the United States, pregnant people are increasingly relying on models of care that use history-based or no-test approaches for eligibility assessment. Minimal research has examined the accuracy of abortion patients' self-assessment of eligibility for medication abortion using their health history. This step is necessary for ensuring optimal access to history-based or no-test models, as well as potential over-the-counter access.
This study aimed to examine the accuracy of pregnant people's eligibility for medication abortion as determined using their self-reported health history, compared with clinician assessments using ultrasound and other tests.
In this diagnostic accuracy study, we recruited people seeking medication or procedural abortion from 9 abortion facilities, aged ≥15 years, English- or Spanish-speaking, and with no prior ultrasound conducted at the recruitment facility. Before ultrasound, we surveyed participants on medication abortion eligibility, including estimated gestational duration, medical history, contraindications, and ectopic pregnancy risk factors such as pain and bleeding symptoms. We compared patients' eligibility based on self-reported history with subsequent clinician assessment, focusing on overall diagnostic accuracy, or area under the receiver operating characteristic curve, sensitivity, specificity, and proportion with discordant patient and clinician eligibility assessment, using 77 days as the upper gestational duration limit.
Overall, 22.1% of 1386 participants were ineligible for medication abortion according to clinician assessment. Overall diagnostic accuracy of self-assessment was acceptable (area under the receiver operating characteristic curve=0.65; 95% confidence interval, 0.63-0.67), with sensitivity of 92.2% (88.6-94.9) and specificity of 37.8% (34.9-40.7). Very few participants (n=24; 1.7%) self-assessed as eligible when the clinician deemed them ineligible; many more (n=672; 48.5%) self-assessed as ineligible when the clinician deemed them eligible. The most common patient-reported contraindications included unexplained pain (55.5%), gestational duration >77 days (36.5%), and anemia (29.0%). On its own, unexplained pain had poor sensitivity in identifying those with clinician concern for ectopic pregnancy (41.7%; 95% confidence interval, 15.2-72.3). Removing unexplained pain as a screening criterion resulted in higher accuracy (0.71; 95% confidence interval, 0.69-0.74) (P<.001).
History-based screening protocols are highly effective at ensuring that few people receive medication abortion when ineligible. However, a sizable group screens as ineligible when they are in fact eligible, suggesting a need for more specific screening questions.
在美国，随着基于医疗机构的堕胎服务获取渠道日益受限，孕妇越来越依赖基于病史或无需检查的护理模式进行资格评估。极少有研究考察堕胎患者根据自身健康史自我评估药物流产资格的准确性。这一步骤对于确保基于病史或无需检查的模式以及潜在的非处方获取途径能够实现最佳准入至关重要。
本研究旨在比较孕妇根据自我报告的健康史确定的药物流产资格准确性与临床医生使用超声及其他检查进行评估的结果。
在这项诊断准确性研究中，我们从9家堕胎机构招募了寻求药物流产或手术流产的人员，年龄≥15岁，讲英语或西班牙语，且在招募机构未进行过超声检查。在进行超声检查之前，我们就药物流产资格对参与者进行了调查，包括估计孕周、病史、禁忌证以及异位妊娠风险因素，如疼痛和出血症状。我们将基于患者自我报告病史的资格与随后临床医生的评估进行比较，重点关注总体诊断准确性，即受试者操作特征曲线下面积、敏感性、特异性以及患者与临床医生资格评估不一致的比例，以77天作为孕周上限。
总体而言，根据临床医生评估，1386名参与者中有22.1%不符合药物流产资格。自我评估的总体诊断准确性尚可（受试者操作特征曲线下面积 = 0.65；95%置信区间，0.63 - 0.67），敏感性为92.2%（88.6 - 94.9），特异性为37.8%（34.9 - 40.7）。当临床医生认为不符合资格时，极少有参与者（n = 24；1.7%）自我评估为符合资格；而当临床医生认为符合资格时，更多参与者（n = 672；48.5%）自我评估为不符合资格。患者报告的最常见禁忌证包括不明原因疼痛（55.5%）、孕周>77天（36.5%）和贫血（29.0%）。单独来看，不明原因疼痛在识别临床医生关注的异位妊娠患者方面敏感性较差（41.7%；95%置信区间，15.2 - 72.3）。去除不明原因疼痛作为筛查标准后，准确性更高（0.71；95%置信区间，0.69 - 0.74）（P <.001）。
基于病史的筛查方案在确保极少不符合资格的人获得药物流产方面非常有效。然而，有相当一部分人被筛查为不符合资格，而实际上他们是符合资格的，这表明需要更具针对性的筛查问题。
