{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T15:43:15Z","timestamp":1792424595257,"version":"4.5.0"},"reference-count":28,"publisher":"American Medical Association (AMA)","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Intern Med"],"abstract":"\n Importance<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To determine whether patients are more knowledgeable about medication abortion after reviewing and signing the PAF.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n 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\u2009=\u2009301 control) or after (n\u2009=\u2009292 exposed) receiving and signing the PAF. Data were analyzed December 2025 to August 2026.<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n 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, \u22120.04 to 0.39). Nearly everyone knew to contact a \u201cprovider\u201d if they \u201cwere to have an infection (590 [99%]) or heavy bleeding that soaked through 2 full-size sanitary pads per hour for 2 hours (566 [96%]).\u201d 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%]).<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT07604675<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamainternmed.2026.5197","type":"journal-article","created":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T15:30:25Z","timestamp":1792423825000},"source":"Crossref","is-referenced-by-count":0,"title":["Mifepristone Patient Agreement Form and Medication Abortion Knowledge"],"prefix":"10.1001","author":[{"given":"M. Antonia","family":"Biggs","sequence":"first","affiliation":[{"name":"Advancing New Standards in Reproductive Health; University of California, San Francisco, Oakland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine","family":"Ehrenreich","sequence":"additional","affiliation":[{"name":"Advancing New Standards in Reproductive Health; University of California, San Francisco, Oakland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shelly","family":"Kaller","sequence":"additional","affiliation":[{"name":"Advancing New Standards in Reproductive Health; University of California, San Francisco, Oakland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren","family":"Ralph","sequence":"additional","affiliation":[{"name":"Advancing New Standards in Reproductive Health; University of California, San Francisco, Oakland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Grossman","sequence":"additional","affiliation":[{"name":"Advancing New Standards in Reproductive Health; University of California, San Francisco, Oakland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2026,10,19]]},"reference":[{"issue":"1","key":"ioi260062r1","doi-asserted-by":"publisher","first-page":"175","DOI":"10.1097\/AOG.0000000000000603","article-title":"Incidence of emergency department visits and complications after abortion.","volume":"125","author":"Upadhyay","year":"2015","journal-title":"Obstet Gynecol"},{"issue":"11","key":"ioi260062r4","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2025.42096","article-title":"Mifepristone access through community pharmacies when regulated as a routine prescription medication.","volume":"8","author":"Nethery","year":"2025","journal-title":"JAMA Netw 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