Advancing New Standards in Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, Oakland, California; Ibis Reproductive Health, Cambridge, Massachusetts; Black Women for Wellness, Los Angeles, California; the National Asian Pacific American Women's Forum, Chicago, Illinois; Advocates for Youth, Washington, DC; the National Network of Abortion Funds, Boston, Massachusetts; International Planned Parenthood, London, United Kingdom; the Red River Women's Clinic, Fargo, North Dakota; the Pegasus Health Justice Center, Dallas, Texas; Physicians for Reproductive Health, New York, New York; Gynuity Health Projects, Tacoma, Washington; California Latinas for Reproductive Justice, Los Angeles, California; and the Steve Hicks School of Social Work and Department of Sociology, University of Texas at Austin, Austin, Texas.
Obstet Gynecol. 2022 Jun 1;139(6):1111-1122. doi: 10.1097/AOG.0000000000004757. Epub 2022 May 2.
To 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.
We 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.
We 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%.
Overall, 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.
开发一种米非司酮和米索前列醇复方药物的药品标签原型，并进行标签理解研究，以评估对关键标签概念的理解。
我们遵循美国食品和药物管理局的指导意见，组建了一个多学科专家团队，并进行了认知访谈，以开发一种药物流产用的药品标签原型。为了评估标签理解，我们制定了 11 个主要和 13 个次要沟通目标，与使用指征、资格、剂量方案、禁忌症、警告信号、副作用以及识别治疗失败风险相关，并制定了相应的目标表现阈值（80-90%的准确率）。我们通过社交媒体招募了年龄在 12-49 岁之间的有子宫的人，进行了个体结构化视频访谈。参与者审查了药品标签，并回答问题，以评估他们对每个沟通目标的理解。在转录和编码访谈后，我们根据年龄和读写能力组估计了正确回答的比例和确切的二项式 95%置信区间。
我们共采访了 851 人（计划采访 1507 人）；844 人的回答符合分析条件，其中 35.7%（n=301）的参与者年龄在 12-17 岁之间。总体样本在与使用指征、使用资格、剂量方案和禁忌症相关的 11 个主要沟通目标中的 10 个（93-99%正确）方面达到了表现标准；年轻人达到了 9 个，读写能力有限的人达到了 11 个表现标准中的 8 个。只有 79%（95%CI 0.76-0.82）的总体样本理解，如果在服用米索前列醇后不久出现少量或无出血，应联系医疗保健专业人员，这未达到预设的 85.0%的阈值。
总体而言，高水平的理解表明，在没有临床监督的情况下，人们可以理解药物流产产品的大多数关键药品标签概念，并建议进行微小修改。
