An examination of loss to follow-up and potential bias in outcome ascertainment in a study of direct-to-patient telemedicine abortion in the United States.

OBJECTIVES: To examine associations between factors associated with loss to follow-up and effectiveness in the TelAbortion project, which provided medication abortion by direct-to-patient telemedicine and mail in the United States. STUDY DESIGN: The study population for this descriptive analysis included abortions among participants enrolled in the TelAbortion study with data present in a web-based database tool from November 2018 to September 2021 who were mailed a medication package. The analysis included information on abortions across nine sites. In this analysis, we used generalized estimating equations to examine factors associated with loss to follow-up and effectiveness. RESULTS: Of the 1831 abortions included in this analysis, 1553 (84.8%) were classified as having complete follow-up and 278 (15.2%) were classified as lost to follow-up. In a multivariable analysis, factors significantly associated with loss to follow-up included history of medical abortion, education, gestational age, study site, and whether the TelAbortion was performed pre- or post-COVID-19 onset (p < 0.05). The rate of treatment failure (i.e., abortions resulting in continuing pregnancy or uterine evacuation) reported in this study was 5.1%. The only covariate associated with both loss to follow-up and treatment failure was higher gestational age. However, using gestational age to impute missing abortion outcomes did not substantially change the estimated failure rate. CONCLUSIONS: Abortions that were lost to follow-up differed substantially from those with complete follow-up, which could bias the effectiveness estimate. However, imputing outcomes based on available and appropriate pretreatment data did not substantially affect the estimate. This finding is encouraging, although it does not exclude the possibility of bias due to unmeasured factors. IMPLICATIONS: Significant differences between abortion cases with complete follow-up and those lost to follow-up provide insights into abortion cases that may be at a higher risk for being lost. The low treatment failure rate indicates that the telemedicine provision of medication abortion is effective.

Expansion of a direct-to-patient telemedicine abortion service in the United States and experience during the COVID-19 pandemic.

OBJECTIVE: To present updated evidence on the safety, efficacy and acceptability of a direct-to-patient telemedicine abortion service and describe how the service functioned during the COVID-19 pandemic. STUDY DESIGN: We offered the study at 10 sites that provided the service in 13 states and Washington DC. Interested individuals obtained any needed preabortion tests locally and had a videoconference with a study clinician. Sites sent study packages containing mifepristone and misoprostol by mail and had remote follow-up consultations within one month by telephone (or by online survey, if the participant could not be reached) to evaluate abortion completeness. The analysis was descriptive. RESULTS: We mailed 1390 packages between May 2016 and September 2020. Of the 83% (1157/1390) of abortions for which we obtained outcome information, 95% (1103/1157) were completed without a procedure. Participants made 70 unplanned visits to emergency rooms or urgent care centers for reasons related to the abortion (6%), and 10 serious adverse events occurred, including 5 transfusions (0.4%). Enrollment increased substantially with the onset of COVID-19. Although a screening ultrasound was required, sites determined in 52% (346/669) of abortions that occurred during COVID that those participants should not get the test to protect their health. Use of urine pregnancy test to confirm abortion completion increased from 67% (144/214) in the 6 months prior to COVID to 90% (602/669) in the 6 months during COVID. Nearly all satisfaction questionnaires (99%, 1013/1022) recorded that participants were satisfied with the service. CONCLUSIONS: This direct-to-patient telemedicine service was safe, effective, and acceptable, and supports the claim that there is no medical reason for mifepristone to be dispensed in clinics as required by the Food and Drug Administration. In some cases, participants did not need to visit any facilities to obtain the service, which was critical to protecting patient safety during the COVID-19 pandemic. IMPLICATIONS: Medical abortion using telemedicine and mail is effective and can be safely provided without a pretreatment ultrasound. This method of service delivery has the potential to greatly improve access to abortion care in the United States.