ArticleObstetrics and gynecology2022
Comprehension of an Over-the-Counter Drug Facts Label Prototype for a Mifepristone and Misoprostol Medication Abortion Product.
Article in Obstetrics and gynecology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed, 16 citations in OpenAlex.
- Examining the association between prior medical mistreatment and interest in and support for over-the-counter medication abortion among people seeking in-person abortion in the United States.BMC health services research · 2026Article
- A Scoping Review of Barriers to Accessing Abortions among Adolescents in the United States.Journal of pediatric and adolescent gynecology · 2026Article
- Imagining Coat-Hangers and Pills: A Qualitative Exploration of Abortion Beliefs and Attitudes in Hostile Policy Contexts in the United States.Perspectives on sexual and reproductive health · 2025Article
- Decreasing reproductive and abortion care barriers: findings on the student health center's role from a student survey.BMC women's health · 2023Article
- Self-Managed Abortion in the United States.Current obstetrics and gynecology reports · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 1 institution in 3 countries.
Funding
Abstract
objectiveTo develop a drug facts label prototype for a combination mifepristone and misoprostol product and to conduct a label-comprehension study to assess understanding of key label concepts.
methodsWe followed U.S. Food and Drug Administration guidance, engaged a multidisciplinary group of experts, and conducted cognitive interviews to develop a drug facts label prototype for medication abortion. To assess label comprehension, we developed 11 primary and 13 secondary communication objectives related to indications for use, eligibility, dosing regimen, contraindications, warning signs, side effects, and recognizing the risk of treatment failure, with corresponding target performance thresholds (80-90% accuracy). We conducted individual structured video interviews with people with a uterus aged 12-49 years, recruited through social media. Participants reviewed the drug facts label and responded to questions to assess their understanding of each communication objective. After transcribing and coding interviews, we estimated the proportion of correct responses and exact binomial 95% CIs by age and literacy group.
resultsWe interviewed 851 people (of 1,507 people scheduled); responses from 844 were eligible for analysis, and 35.7% (n=301) of participants were aged 12-17 years. The overall sample met performance criteria for 10 of the 11 primary communication objectives (93-99% correct) related to indications for use, eligibility for use, the dosing regimen, and contraindications; young people met nine and people with limited literacy met eight of the 11 performance criteria. Only 79% (95% CI 0.76-0.82) of the overall sample understood to contact a health care professional if little or no bleeding occurred soon after taking misoprostol, not meeting the prespecified threshold of 85.0%.
conclusionOverall, high levels of comprehension suggest that people can understand most key drug facts label concepts for a medication abortion product without clinical supervision and recommend minor modifications.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.