ImportanceIn the US, access to medication abortion using history-based (no-test) eligibility assessment, including through telehealth and mailing of mifepristone, has grown rapidly. Additional evidence on the effectiveness and safety of these models is needed.ObjectiveTo evaluate whether medication abortion with no-test eligibility assessment and mailing of medications is as effective as in-person care with ultrasonography and safe overall.Design, Setting, and ParticipantsProspective, observational study with noninferiority analysis. Sites included 4 abortion-providing organizations in Colorado, Illinois, Maryland, Minnesota, Virginia, and Washington from May 2021 to March 2023. Eligible patients were seeking medication abortion up to and including 70 days’ gestation, spoke English or Spanish, and were aged 15 years or older.ExposureStudy groups reflected the model of care selected by the patient and clinicians and included: (1) no-test (telehealth) eligibility assessment and mailing of medications (no-test + mail) (n = 228); (2) no-test eligibility assessment and pickup of medications (no-test + pickup) (n = 119); or (3) in-person with ultrasonography (n = 238).Main Outcomes and MeasuresEffectiveness, defined as a complete abortion without the need for repeating the mifepristone and misoprostol regimen or a follow-up procedure, and safety, defined as an abortion-related serious adverse event, including overnight hospital admission, surgery, or blood transfusion. Outcomes were derived from patient surveys and medical records. Primary analysis focused on the comparison of the no-test + mail group with the in-person with ultrasonography group.ResultsThe mean age of the participants (N = 585) was 27.3 years; most identified as non-Hispanic White (48.6%) or non-Hispanic Black (28.1%). Median (IQR) gestational duration was 45 days (39-53) and comparable between study groups (P = .30). Outcome data were available for 91.8% of participants. Overall effectiveness was 94.4% (95% CI, 90.7%-99.2%) in the no-test + mail group and 93.3% (95% CI, 88.3%-98.2%) in the in-person with ultrasonography group in adjusted models (adjusted risk difference, 1.2 [95% CI, −4.1 to 6.4]), meeting the prespecified 5% noninferiority margin. Serious adverse events included overnight hospitalization (n = 4), blood transfusion (n = 2), and emergency surgery (n = 1) and were reported by 1.1% (95% CI, 0.4%-2.4%) of participants, with 3 in the no-test + mail group, 3 in the in-person with ultrasonography group, and none in the no-test + pickup group.Conclusions and RelevanceThis prospective, observational study found that medication abortion obtained following no-test telehealth screening and mailing of medications was associated with similar rates of complete abortion compared with in-person care with ultrasonography and met prespecified criteria for noninferiority, with a low prevalence of adverse events.

中文翻译：

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无测试远程医疗和面对面药物流产的比较


重要性在美国，使用基于病史（无检测）资格评估（包括通过远程医疗和邮寄米非司酮）进行药物流产的机会迅速增加。需要关于这些模型的有效性和安全性的更多证据。目的评估无检测资格评估和邮寄药物的药物流产是否与超声检查的面对面护理一样有效且总体安全。设计、设置和参与者具有非劣效性分析的前瞻性观察性研究。这些地点包括 2021 年 5 月至 2023 年 3 月期间位于科罗拉多州、伊利诺伊州、马里兰州、明尼苏达州、弗吉尼亚州和华盛顿州的 4 个提供堕胎的组织。符合条件的患者在妊娠 70 天（包括 70 天）之前寻求药物流产，会说英语或西班牙语，并且年龄在 15 岁或以上。暴露研究组反映了患者和临床医生选择的护理模式，包括：（1） 无检测（远程医疗）资格评估和药物邮寄（无检测 + 邮件）（n = 228）;（2） 免检测资格评估和取药（免检测 + 取药） （n = 119）;或 （3） 亲自进行超声检查 （n = 238）。主要结局和测量有效性，定义为完全流产，无需重复米非司酮和米索前列醇方案或后续手术，安全性，定义为与流产相关的严重不良事件，包括过夜住院、手术或输血。结果来自患者调查和医疗记录。初步分析侧重于无检测 + 邮件组与面对面超声组的比较。结果参与者的平均年龄 （N = 585） 为 27.3 岁;大多数被确定为非西班牙裔白人 （48.6%）或非西班牙裔黑人 （28.1%）。中位 （IQR） 妊娠期为 45 天 （39-53），研究组间相当 （P = .30）。91.8% 的参与者可获得结果数据。在调整后的模型中，无检测 + 邮件组的总体有效性为 94.4%（95% CI，90.7%-99.2%），面对面超声检查组的总体有效性为 93.3%（95% CI，88.3%-98.2%）（调整后的风险差，1.2 [95% CI，-4.1 至 6.4]），达到预先设定的 5% 非劣效性边际。严重不良事件包括过夜住院 （n = 4）、输血 （n = 2） 和紧急手术 （n = 1），由 1.1% （95% CI，0.4%-2.4%） 的参与者报告，其中 3 例在无检测 + 邮件组中，3 例在现场超声检查组中，无检测 + 拾取组。结论和相关性这项前瞻性观察性研究发现，与超声检查面对面护理相比，在无测试远程医疗筛查和邮寄药物后获得的药物流产与相似的完全流产率相关，并且符合预先指定的非劣效性标准，不良事件的发生率较低。