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Reassessing the measurement and presence of therapeutic misconception in a phase 1 setting
Author(s) -
Abernethy Eli R.,
Campbell Gavin P.,
Hianik Rachel S.,
Thomson Mary Catherine,
Blee Shan M.,
Sibold Hannah C.,
Dixon Margie D.,
Switchenko Jeffrey M.,
Pentz Rebecca D.
Publication year - 2021
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.33746
Subject(s) - medicine , family medicine , clinical trial , pathology
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%).

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