谁说得更好？对MedWatch“免费声明”中措辞差异的测试，用于消费者在直接面向消费者的电视广告中报告副作用。
Who Said It Better? A Test of Wording Differences in the MedWatch "Toll-Free Statement" for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements.
作者信息
Aikin Kathryn J, O'Donoghue Amie C, Sullivan Helen W, Betts Kevin R, Squire Claudia
机构信息
1 US Food and Drug Administration, Silver Spring, MD, USA.
2 RTI International, Durham, NC, USA.
出版信息
Ther Innov Regul Sci. 2016 Mar;50(2):169-173. doi: 10.1177/2168479015596023.
BACKGROUND
A toll-free statement alerting consumers how to report side effects to the US Food and Drug Administration (FDA) is required for both prescription drug labeling and direct-to-consumer (DTC) print ads. Because of different regulatory requirements between these materials (the Toll-free Number for Reporting Adverse Events on Labeling for Human Drug Products Rule [TFNR] versus the FDA Amendments Act [FDAAA], respectively), the wording of this statement differs. We studied how statement wording for reporting side effects to FDA in DTC television ads affects comprehension of product risks and benefits, comprehension of and memory for the toll-free statement, and perceived statement clarity.
METHODS
Participants viewed 1 of 8 mock prescription drug television ads that varied the wording and placement of the toll-free statement, and then responded to a questionnaire.
RESULTS
The FDAAA statement was more noticeable, clear, and more participants were able to recall and recognize its correct purpose. Comprehension of product risk and benefit information did not differ based on statement wording.
CONCLUSIONS
Findings suggest that the FDAAA toll-free statement wording is superior to that of the TFNR.
背景
处方药标签和面向消费者的直接宣传印刷广告均需提供免费声明，告知消费者如何向美国食品药品监督管理局（FDA）报告副作用。由于这些材料存在不同的监管要求（分别为《人用药品标签上报告不良事件的免费电话规则》[TFNR]与《FDA修正法案》[FDAAA]），该声明的措辞有所不同。我们研究了在面向消费者的电视广告中向FDA报告副作用的声明措辞如何影响对产品风险和益处的理解、对免费声明的理解与记忆以及声明的清晰度。
方法
参与者观看了8个模拟处方药电视广告中的1个，这些广告在免费声明的措辞和位置上有所不同，然后回答一份问卷。
结果
FDAAA声明更引人注目、更清晰，更多参与者能够回忆并识别其正确用途。对产品风险和益处信息的理解不因声明措辞而有所不同。
结论
研究结果表明，FDAAA免费声明的措辞优于TFNR。
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