An exploratory study of therapeutic misconception among incarcerated clinical trial participants

Christopher, Paul P.; Stein, Michael D.; Springer, Sandra A.; Rich, Josiah D.; Johnson, Jennifer E.; Lidz, Charles W.

doi:10.1080/23294515.2015.1058303

Cited by 3 publications

(3 citation statements)

References 39 publications

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“…These results illustrate a general ethical research challenge, namely participants' difficulties in understanding the nature of clinical trials, including the distinction between treatment in general and research participation. The term "therapeutic misconception" means that a research participant does not fully understand that the primary purpose of a trial is to produce knowledge for the benefit of future patients, as distinct from helping the patient with her current condition (30,(36)(37)(38)(39). These misconceptions might result in unrealistic expectations, and thus disappointment at the lack of help offered during the encounters with the data collectors.…”

Section: The Participantsmentioning

confidence: 99%

Control Group Design in a Complex Intervention Study: Challenges, Dilemmas and Possible Solutions

Mangset¹,

Kitzmüller²,

Evju³

et al. 2020

Preprint

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Background The use of a control group is one of the most critical components of an RCT. The control conditions may change over time and include assessment interviews and standard stroke treatment. Therefore, the control group should be monitored and described in as much detail as the intervention group. It is important to find ways to reduce the risk of study-induced influence on the members of the control group. The aim of this study was to explore the possible influence of the assessment interviews on the adjustment of the members of a control group in an RCT exploring psychosocial well-being following stroke. Methods Fifteen participants in the control group of the RCT, six women and nine men, aged 29-88 years, were interviewed in narrative semi-structured interviews. Ricoeur’s interpretation theory guided the analysis. Results The perceived influence of the assessment interviews on the control group varied considerably. Two different themes with subthemes were identified, describing the influence of the assessment interviews in the control group. Theme one described how participants emphasized the perceived influence of the assessment interviews that served as a safety net, enhanced their awareness and understanding, facilitated their adjustment after stroke, encouraged them to seek support, and allowed them to vent their disappointment of having been allocated to the control group. Theme two described participants’ experiences of handling their adjustment process on their own without describing any influence of the assessment interviews on their condition. These participants highlighted mild strokes, spontaneous recovery, setting own goals, support from family and friends and supporting research. Conclusions In view of the design challenges in RCTs, it seems important to explore in depth how to design assessment interviews with control group members without introducing risk of bias, and to uphold rigor and stringency in the trials.

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Section: The Participantsmentioning

confidence: 99%

Control Group Design in a Complex Intervention Study: Challenges, Dilemmas and Possible Solutions

Mangset¹,

Kitzmüller²,

Evju³

et al. 2020

Preprint

View full text Add to dashboard Cite

show abstract

“…12 Many studies have shown that the prevalence of therapeutic misconception is high among research participants. 13,14 Analysis of consent forms of Phase 1 gene transfer trials by Kimmelman et al, showed that the forms have been designed blurring the distinction between research and patient care. 15 Thus, the ICMR ethical guidelines mandate the inclusion of the term "research", and word the PIS in an unambiguous manner to prevent this possibility of therapeutic misconception.…”

Section: Discussionmentioning

confidence: 99%

A study to assess the completeness of informed consent documents for biomedical research on human participants submitted to the institutional ethics committee of a tertiary care hospital

Anandabaskar

Vimal

Dongre

et al. 2019

Int J Basic Clin Pharmacol

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Background: Informed consent is an essential pre-requisite for research on human participants. However, many studies have shown that informed consent documents (ICDs) are incomplete and lack many of the essential elements. The objective of the study was to assess the completeness of ICDs submitted to an institutional ethics committee (IEC) against the Indian Council of Medical Research (ICMR) ethical guidelines for biomedical research on human participants.Methods: This is a retrospective cross-sectional study. The ICDs submitted to the IEC during the period from January 2015 to December 2017 were reviewed for completeness, with the help of a checklist which is based ICMR ethical guidelines for biomedical research on human participants 2006.Results: A total of 212 ICDs were reviewed during the study period. More than 50% of the ICDs have clearly explained many of the essential elements like nature and purpose of the study (62.3%), voluntary participation (98.6%), procedures (68.9%), risks (71.2%), benefits (92.9%), alternative treatments (60.7%), maintaining confidentiality (99.1%), no loss of benefits on withdrawal from the study (87.8%) and contact details of principal investigator (99.5%). However, the other essential elements of the ICD are either not mentioned or not clearly explained.Conclusions: This study has shown that although majority of the ICDs submitted for review by the IEC have mentioned many of the essential elements, some of the elements like contact details of Chairman of IEC, future use of sample, compensation for trial related injury and provision of counseling for consent of genetics testing have not been stated.

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“…12 These findings were consistent with other studies that documented TM in over half of trial participants in clinical research. [14][15][16][17] Although it is clear that TM poses a threat to valid consent, an emerging body of literature has questioned whether the reported prevalence of TM among research participants is actually overestimated as a result of discrepancies between patient and research interviewer interpretation of TM questions. 13,[18][19][20] These studies suggest that patients interpreting a question differently than intended by the interviewer introduces a measurement error.…”

Section: Introductionmentioning

confidence: 99%

Reassessing the measurement and presence of therapeutic misconception in a phase 1 setting

Abernethy

Campbell

Hianik

et al. 2021

Cancer

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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.

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An exploratory study of therapeutic misconception among incarcerated clinical trial participants

Cited by 3 publications

References 39 publications

Control Group Design in a Complex Intervention Study: Challenges, Dilemmas and Possible Solutions

Control Group Design in a Complex Intervention Study: Challenges, Dilemmas and Possible Solutions

A study to assess the completeness of informed consent documents for biomedical research on human participants submitted to the institutional ethics committee of a tertiary care hospital

Reassessing the measurement and presence of therapeutic misconception in a phase 1 setting

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