Reassessing the measurement and presence of therapeutic misconception in a phase 1 setting
Reassessing the measurement and presence of therapeutic misconception in a phase 1 setting
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DOI：
10.1002/cncr.33746
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发表时间：
2021-06-23
期刊：
影响因子：
6.2
通讯作者：
Pentz, Rebecca D.
中科院分区：
文献类型：
--
作者：
Abernethy, Eli R.;Campbell, Gavin P.;Pentz, Rebecca D.
研究背景治疗误解（TM）是指研究对象未能将临床研究的目标与标准的个人护理区分开来。传统上，通过询问患者有关研究目的的问题来确定TM。然而，最近的研究质疑TM是否像报道的那样普遍，因为患者/研究人员对TM问题的解释存在差异。作者已经创建了一个接受这些进步的访谈工具，以更准确地确定TM的患病率。方法患者被问及试验的目的如下：1）“试验主要是为了帮助研究和获得知识吗？“2）“它主要是想帮助你作为一个人吗？（3）不知道。然后，参与者被问到他们认为这个问题在问什么：A）“我自己参与的意图是什么”，B）“研究的官方目的是什么”，或C）“不确定”。结果患者（n = 98）平均年龄60岁，大多数为白色（64%），家庭年收入≥ 60，000美元（61%），49%有大学学历。98例患者中有12例（12%）明确显示TM。这远远低于作者最初在类似队列中发现的68%。98例患者中有24例（24.5%）不清楚一个或两个问题是什么，无法分类。结论以前，如果患者回答试验的目的是为了使他或她受益，则认为他们患有TM。关于患者如何解释该问题的额外询问显示，只有12%的患者明确患有TM。治疗误解（TM）是指研究对象未能区分临床研究的目标与标准的个人护理。TM标志着对临床研究目的的基本误解，威胁到参与临床试验的有效知情同意。传统上，TM是通过询问患者他们的研究目的来确定的。然而，最近的研究质疑TM是否普遍存在，因为患者/研究人员对TM问题的解释存在差异。通过开发一种接受这些进步的访谈工具，我们报告了第1阶段设置（12%）中的TM估计值低于我们之前在类似队列中发现的TM估计值（68%）。
Background Therapeutic misconception (TM) refers to research subjects' failure to distinguish the goals of clinical research from standard personal care. TM has traditionally been determined by questioning the patient about the research study's purpose. Recent research, however, has questioned whether TM is as prevalent as reported due to discrepancies between patient/researcher interpretations of TM questions. The authors have created an interview tool receptive to these advancements to more accurately determine the prevalence of TM. Methods Patients were questioned about the trial's purpose as follows: 1) "Is the trial mostly intending to help research and gain knowledge?," 2) "Is it mostly intending to help you as a person?," or 3) "Don't know." Participants were then asked what they thought this question was asking: A) "What my own intentions are for participating," B) "What the official purpose of the research study is," or C) "Not sure." A patient exhibited TM by answering that the official trial purpose was to help him or her. Results Patients (n = 98) had a mean age of 60 years, were mostly White (64%), had a combined family annual income >=$60,000 (61%), and 49% had a college degree. Twelve of 98 patients (12%) definitely exhibited TM. This was much lower than the author's original finding of 68% in a similar cohort. Twenty-four of 98 patients (24.5%) were unclear about what one or both questions were asking and could not be categorized. Conclusions Previously, a patient was thought to have TM if they answered that the purpose of the trial was to benefit to him or her. An additional query about how patients interpreted that question revealed only 12% definitely had TM. Lay Summary Therapeutic misconception (TM) refers to research subjects' failure to distinguish the goals of clinical research from standard personal care. TM signals a basic misunderstanding of the purpose of clinical research, threatening valid informed consent to participate in clinical trials. TM has traditionally been determined by questioning patients about their research study's purpose. Recent research, however, has questioned whether TM is as prevalent due to discrepancies between patient/researcher interpretations of TM questions. By developing an interview-tool receptive to these advancements, we report a lower TM estimate in the phase 1 setting (12%) than we found previously in a similar cohort (68%).