Randomized Trial of Risk Information Formats in Direct-to-Consumer Prescription Drug Advertisements
Randomized Trial of Risk Information Formats in Direct-to-Consumer Prescription Drug Advertisements
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DOI：
10.1177/0272989x11413289
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发表时间：
2011-11-01
影响因子：
3.6
通讯作者：
Sullivan, Helen W.
中科院分区：
文献类型：
--
作者：
Aikin, Kathryn J.;O'Donoghue, Amie C.;Sullivan, Helen W.
背景联邦法规规定，处方药和生物制品的印刷广告必须提供关于每种广告产品的副作用、禁忌症和有效性的“简要”信息的真实陈述。“目前一些满足简短摘要要求的方法，尽管从监管的角度来看是足够的，但在用于面向消费者的促销活动时，可能会导致广告难以阅读和理解。Objective.探讨如何改进简要摘要。设计作者进行了一项实验研究，检查了300名消费者的（购物中心的访客曾被告知他们超重）对4种不同的简短摘要格式的理解和偏好：传统的（来自专业标签的风险部分的简单语言版本），问题和答案（问答;以问题的形式列出标题），重点介绍（来自修订的专业标签的摘要部分）和处方药事实框（类似于当前的非处方药事实标签）。结果这种形式产生了几种影响。例如，观看药物事实格式的参与者能够更好地回忆起风险（P < .01），并报告比那些看到传统格式的参与者更有信心执行任务（P < .01）。注意到偏好的差异;例如，药物事实格式排名最高，其次是Q&A格式，传统格式，最后是亮点格式，P < 0.001。结论.总的来说，这些数据表明，在简短摘要中传达信息的传统方法既不是最容易理解的，也不是消费者最喜欢的。这些数据为决策者和研究人员提供了重要的信息，说明格式在消费者理解摘要方面的作用。
Background. Federal regulations specify that print advertisements for prescription drugs and biological products must provide a true statement of information "in brief summary" about each advertised product's 'side effects, contraindications, and effectiveness." Some of the current approaches to fulfilling the brief summary requirement, although adequate from a regulatory perspective, result in ads that may be difficult to read and understand when used in consumer-directed promotion. Objective. To explore ways in which the brief summary might be improved. Design. The authors conducted an experimental study that examined 300 consumers' (mall visitors ever told that they were overweight) understanding of and preference for 4 different brief summary formats: traditional (a plain-language version of the risk sections from professional labeling), question and answer (Q & A; with headings framed in the form of questions), highlights (a summary section from revised professional labeling), and prescription drug facts box (similar to the current over-the-counter drug facts label). Results. The format had several effects. For instance, participants who viewed the drug facts format were better able to recall risks (P < .01) and reported greater confidence to perform the tasks (P < .01) than those who saw the traditional format. Differences in preference were noted; for example, the drug facts format was ranked highest, followed by the Q&A format, the traditional format, and finally the highlights format, P < 0.001. Conclusions. Taken together, these data suggest that the traditional method of conveying information in the brief summary is neither the most comprehensible nor the most preferred by consumers. These data provide policy makers and researchers with important information regarding the role of format in consumers' understanding of the brief summary.