Importance While the US Food and Drug Administration requires medication abortion patients to review and sign a patient agreement form (PAF) under its Risk Evaluation and Mitigation Strategy program, there is limited research examining whether the PAF improves patient knowledge. Objective To determine whether patients are more knowledgeable about medication abortion after reviewing and signing the PAF. Design, Setting, and Participants People receiving mifepristone and misoprostol medications (15 years or older and proficient in English or Spanish) were recruited from 5 facilities in California, Colorado, Illinois, Kansas, and Minnesota (January to October 2025). After receiving standard clinic counseling and the mifepristone medication guide, patients were randomized into 2 study groups and then completed a survey either before (n = 301 control) or after (n = 292 exposed) receiving and signing the PAF. Data were analyzed December 2025 to August 2026. Intervention The control group completed the survey before receiving the PAF and any PAF-related counseling. The exposed group received and signed the PAF and any PAF-related counseling and then completed a knowledge survey. Main Outcomes and Measures Overall medication abortion knowledge (correct response to 12 items regarding when to seek medical care, effectiveness, administration, potential serious risks, and side effects) and responses to each individual knowledge item. Results A total of 593 participants (mean [SD] age, 26.9 [5.8] years; 44 Asian/Pacific Islander [7%], 132 Black [22%], 181 Hispanic [31%], and 159 White [27%] individuals) completed knowledge items (301 control [51%]; 292 exposed [49%]). Across participant characteristics, study groups only differed significantly in reported abortion history. In adjusted analyses, participants answered a mean (95% CI) of 10.37 (10.26-10.48) of 12 knowledge items consistently with the PAF with no study group differences (control: difference, 10.26; exposed: difference, 10.44; adjusted difference, 0.18; 95% CI, -0.04 to 0.39). Nearly everyone knew to contact a "provider" if they "were to have an infection (590 [99%]) or heavy bleeding that soaked through 2 full-size sanitary pads per hour for 2 hours (566 [96%])." The items with answers that were least often concordant with the PAF included how often the treatment does not work (320 [54%]) and taking misoprostol 24 to 48 hours after mifepristone (458 [77%]). Conclusions and Relevance The randomized clinical trial found that patient knowledge about medication abortion following standard counseling was high. Exposure to the required PAF did not result in a clinically meaningful increase in medication abortion knowledge. The findings raise questions about the PAF requirement from the US Food and Drug Administration, as it does not appear to be useful. Trial Registration ClinicalTrials.gov Identifier: NCT07604675.
This case report describes a man in his 60s who presented with recurrent palpitations associated with dyspnea and a ringing sensation in his ears for the preceding 24 hours.
Importance While the US Food and Drug Administration requires medication abortion patients to review and sign a patient agreement form (PAF) under its Risk Evaluation and Mitigation Strategy program, there is limited research examining whether the PAF improves patient knowledge. Objective To determine whether patients are more knowledgeable about medication abortion after reviewing and signing the PAF. Design, Setting, and Participants People receiving mifepristone and misoprostol medications (15 years or older and proficient in English or Spanish) were recruited from 5 facilities in California, Colorado, Illinois, Kansas, and Minnesota (January to October 2025). After receiving standard clinic counseling and the mifepristone medication guide, patients were randomized into 2 study groups and then completed a survey either before (n = 301 control) or after (n = 292 exposed) receiving and signing the PAF. Data were analyzed December 2025 to August 2026. Intervention The control group completed the survey before receiving the PAF and any PAF-related counseling. The exposed group received and signed the PAF and any PAF-related counseling and then completed a knowledge survey. Main Outcomes and Measures Overall medication abortion knowledge (correct response to 12 items regarding when to seek medical care, effectiveness, administration, potential serious risks, and side effects) and responses to each individual knowledge item. Results A total of 593 participants (mean [SD] age, 26.9 [5.8] years; 44 Asian/Pacific Islander [7%], 132 Black [22%], 181 Hispanic [31%], and 159 White [27%] individuals) completed knowledge items (301 control [51%]; 292 exposed [49%]). Across participant characteristics, study groups only differed significantly in reported abortion history. In adjusted analyses, participants answered a mean (95% CI) of 10.37 (10.26-10.48) of 12 knowledge items consistently with the PAF with no study group differences (control: difference, 10.26; exposed: difference, 10.44; adjusted difference, 0.18; 95% CI, −0.04 to 0.39). Nearly everyone knew to contact a “provider” if they “were to have an infection (590 [99%]) or heavy bleeding that soaked through 2 full-size sanitary pads per hour for 2 hours (566 [96%]).” The items with answers that were least often concordant with the PAF included how often the treatment does not work (320 [54%]) and taking misoprostol 24 to 48 hours after mifepristone (458 [77%]). Conclusions and Relevance The randomized clinical trial found that patient knowledge about medication abortion following standard counseling was high. Exposure to the required PAF did not result in a clinically meaningful increase in medication abortion knowledge. The findings raise questions about the PAF requirement from the US Food and Drug Administration, as it does not appear to be useful. Trial Registration ClinicalTrials.gov Identifier: NCT07604675
