PDF(Pubmed)
Abstract：
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.
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.
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.
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.
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.
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.
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：这项研究调查了人们如何解释总生存期(OS)，总反应率（ORR），和无进展生存期(PFS)终点在直接面向消费者的电视广告的背景下。尽管关于这个主题的研究很少，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索赔中增加一项披露（“我们目前不知道[药物]是否有助于患者寿命更长”），可以改善对ORR和PFS的理解。
方法：我们对美国成年人进行了2项在线研究，以检查电视广告中虚构的处方药，这些处方药用于治疗肺癌（N=385）或多发性骨髓瘤（N=406）。这些广告包括关于操作系统的声明，ORR有或没有披露，或PFS，有或没有披露。在每个实验中,我们随机分配参与者观看电视广告的5个版本中的1个。看了两次广告后,参与者完成了一份测量理解的问卷，感知，和其他结果。
结果：在两项研究中，参与者正确区分了操作系统，ORR,和PFS通过开放式响应；然而，PFS条件(与ORR条件相比)的参与者更有可能对OS做出不正确的推断.支持这个假设，增加披露使人们对寿命更长和生活质量改善的期望更加准确。
结论：披露有助于降低人们对ORR和PFS等终点的误解程度。需要更多的研究来建立最佳实践建议，以使用披露来提高患者对药物疗效的理解，而不会以意想不到的方式改变他们对药物的看法。
方法：我们对美国成年人进行了2项在线研究，以检查电视广告中虚构的处方药，这些处方药用于治疗肺癌（N=385）或多发性骨髓瘤（N=406）。这些广告包括关于操作系统的声明，ORR有或没有披露，或PFS，有或没有披露。在每个实验中,我们随机分配参与者观看电视广告的5个版本中的1个。看了两次广告后,参与者完成了一份测量理解的问卷，感知，和其他结果。
结果：在两项研究中，参与者正确区分了操作系统，ORR,和PFS通过开放式响应；然而，PFS条件(与ORR条件相比)的参与者更有可能对OS做出不正确的推断.支持这个假设，增加披露使人们对寿命更长和生活质量改善的期望更加准确。
结论：披露有助于降低人们对ORR和PFS等终点的误解程度。需要更多的研究来建立最佳实践建议，以使用披露来提高患者对药物疗效的理解，而不会以意想不到的方式改变他们对药物的看法。
