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患者对直接面向消费者的电视广告中肿瘤临床试验终点的理解。

Patient Understanding of Oncology Clinical Trial Endpoints in Direct-to-Consumer Television Advertising.

机构信息

Office or Prescription Drug Promotion, US Food and Drug Administration, Silver Spring, MD, USA.

Center for Communication & Media Impact, RTI International, Research Triangle Park, NC, USA.

出版信息

Oncologist. 2023 Jul 5;28(7):e542-e553. doi: 10.1093/oncolo/oyad064.

Abstract

BACKGROUND

This study examined how people interpret overall survival (OS), overall response rate (ORR), and progression-free survival (PFS) endpoints in the context of direct-to-consumer television ads. Although there is little research on this topic, initial evidence suggests that people can misinterpret these endpoints. We hypothesized that understanding of ORR and PFS would be improved by adding a disclosure ("We currently do not know if [Drug] helps patients live longer") to ORR and PFS claims.

METHODS

We conducted 2 online studies with US adults examining television ads for fictional prescription drugs indicated to treat lung cancer (N = 385) or multiple myeloma (N = 406). The ads included claims about OS, ORR with and without a disclosure, or PFS with and without a disclosure. In each experiment, we randomized participants to view 1 of 5 versions of a television ad. After viewing the ad twice, participants completed a questionnaire that measured understanding, perceptions, and other outcomes.

RESULTS

In both studies, participants correctly differentiated between OS, ORR, and PFS via open-ended responses; however, participants in the PFS conditions (versus ORR conditions) were more likely to make incorrect inferences about OS. Supporting the hypothesis, adding a disclosure made expectations around living longer and quality-of-life improvements more accurate.

CONCLUSION

Disclosures could help reduce the extent to which people misinterpret endpoints like ORR and PFS. More research is needed to establish best-practice recommendations for using disclosures to improve patient understanding of drug efficacy without changing their perception of the drug in unintended ways.

摘要

背景

本研究考察了人们如何在直接面向消费者的电视广告中理解总生存期 (OS)、总缓解率 (ORR) 和无进展生存期 (PFS) 终点。尽管关于这个主题的研究很少,但初步证据表明,人们可能会误解这些终点。我们假设,通过在 ORR 和 PFS 声明中添加披露(“我们目前尚不清楚 [药物] 是否有助于患者延长寿命”),可以提高对 ORR 和 PFS 的理解。

方法

我们在美国成年人中进行了两项在线研究,研究了针对肺癌(N=385)或多发性骨髓瘤(N=406)的虚构处方药的电视广告。这些广告包括关于 OS、有和没有披露的 ORR 以及有和没有披露的 PFS 的声明。在每个实验中,我们随机分配参与者观看 5 个电视广告版本中的 1 个。观看广告两次后,参与者完成了一份调查问卷,该问卷测量了理解、看法和其他结果。

结果

在两项研究中,参与者通过开放式回答正确地区分了 OS、ORR 和 PFS;然而,在 PFS 条件下(与 ORR 条件相比),参与者更有可能对 OS 做出不正确的推断。这一假设得到了支持,添加披露可以使关于寿命延长和生活质量改善的期望更加准确。

结论

披露可以帮助减少人们误解 ORR 和 PFS 等终点的程度。需要进一步研究,以确定使用披露来提高患者对药物疗效的理解而不改变他们对药物的看法的最佳实践建议。

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