Consent in clinical trials: What do patients know?

Hereu, Pilar; Pérez, Elena Cónde; Fuentes, Inma; Vidal, Xavier; Suñé, Pilar; Arnau, Josep Maria

doi:10.1016/j.cct.2010.05.004

Cited by 30 publications

(30 citation statements)

References 12 publications

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“…TM was found in a pilot study among 12 of 15 Egyptian outpatients [11], and in 70% of people who had consented to research participation for themselves or their children in France [12]. In addition, there are many studies illustrating failures on the part of research subjects to comprehend one or another aspect of clinical research (e.g., unproven experimental treatment, randomization, use of placebo) that seem likely to contribute to TM, e.g., [13]-[16]. …”

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confidence: 99%

Therapeutic misconception in research subjects: Development and validation of a measure

et al. 2012

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Background Therapeutic misconception (TM), which occurs when research subjects fail to appreciate the distinction between the imperatives of clinical research and ordinary treatment, may undercut the process of obtaining meaningful consent to clinical research participation. Previous studies have found TM is widespread, but progress in addressing TM has been stymied by the absence of a validated method for assessing its presence. Purpose The goal of this study was to develop and validate a theoretically grounded measure of TM, assess its diagnostic accuracy, and test previous findings regarding its prevalence. Methods 220 participants were recruited from clinical trials at 4 academic medical centers in the U.S. Participants completed a 28-item Likert-type questionnaire to assess the presence of beliefs associated with TM, and a semi-structured TM interview designed to elicit their perceptions of the nature of the clinical trial in which they were participating. Data from the questionnaires were subjected to factor analysis and items with poor factor loadings were excluded. This resulted in a 10-item scale, with 3 strongly correlated factors and excellent internal consistency; the fit indices of the model across 10 training sets were consistent with the original results, suggesting a stable factor solution. Results The scale was validated against the TM interview, with significantly higher scores among subjects coded as displaying evidence of TM. ROC analysis based on a 10-fold internal cross-validation yielded AUC=.682 for any evidence of TM. When sensitivity (0.72) and specificity (0.61) were both optimized, Positive Predictive Value was 0.65 and Negative Predictive Value was 0.68, with a Positive Likelihood Ratio of 1.89, and a Negative Likelihood Ratio of 0.47. 50.5% (n=101) of participants manifested evidence of TM on the TM interview, a somewhat lower rate than in most previous studies. Limitations The predictive value of the scale compared with the “gold standard” clinical interview is modest, although similar to other instruments based on self-report assessing states of mind rather than discrete symptoms. Thus, although the scale can offer evidence of which subjects are at risk for distortions in their decisions and to what degree, it will not allow researchers to conclude definitively that TM is present in a given subject. Conclusions The development of a reliable and valid TM scale, even with modest predictive power, should permit investigators in clinical trials to identify subjects with tendencies to misinterpret the nature of the situation and to provide additional information to them. It should also stimulate research on how best to decrease TM and facilitate meaningful informed consent to clinical research.

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confidence: 99%

Therapeutic misconception in research subjects: Development and validation of a measure

et al. 2012

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“…Instead, we found that results of studies conducted in the west are consistent with our own. A study reported that over half of subjects were unaware that adverse effects could occur during their participation 6. Two reports regarding cancer clinical trials also showed that more than half of the participants did not recognise potential risks associated with the trial 7 9.…”

Section: Discussionmentioning

confidence: 99%

“…Nevertheless, several studies have raised the concern that participants in various clinical trials often show deficient comprehension of the trials in which they are enrolled 5 6. Furthermore, some studies have reported considerable misunderstanding by participants, particularly therapeutic misconception, which is defined as overestimating the benefits of participating in clinical research while underestimating the possible risks 7–9…”

Section: Introductionmentioning

confidence: 99%

Discrepancy between participants' understanding and desire to know in informed consent: are they informed about what they really want to know?

Koh

Goh

et al. 2011

J Med Ethics

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“…An influential strain in the bioethics literature on clinical trials is devoted to revealing research participants' failure to appreciate that research and health care serve fundamentally different goals (Featherstone and Donovan, 2002;Brown et al, 2004;Bergenmar et al, 2008;Sand et al, 2008;Hereu et al, 2010;McCann et al, 2010;Behrendt et al, 2011;Sanchini et al, 2013). To explain this phenomenon, Appelbaum et al's concept of "therapeutic misconception" (Appelbaum et al, 1987;Lidz et al, 2004) is often evoked (Miller, 2000;Featherstone and Donovan, 2002;Miller and Rosenstein, 2003;Canvin and Jacoby, 2006).…”

Section: From Principles To Practice: Moral Friction In Clinical Resementioning

confidence: 99%

Beyond the ‘therapeutic misconception’: Research, care and moral friction

Wadmann

Hoeyer

2014

BioSocieties

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In research ethics regulation, health care and research are depicted as serving distinct goals, and policies are in place to prevent what is seen as patients' misconceived understanding of research as health care. On the basis of ethnographic research in four Danish hospitals in conjunction with a cardiovascular drug trial in patients with chronic disease, we argue that the objectives of health care and research often merge in mutually constitutive practices. We build on observations of trial activities, interviews with physician-investigators, research nurses, patient-participants and trial sponsors and a survey of the patient-participants. We found an organization of clinical drug trials allowing extraordinary care relationships to form, which makes trial participation attractive for patients and allows information to flow more freely. However, the research-care intermingling generates moral concerns for those involved. We conceptualize these concerns as a productive moral friction resulting from research staff caring too much for patients. We identify four situations in which friction arises: when care-giving comes to replace specialist contact, when caring for individuals appears unfair for the collective, when care motives may be doubted and when patients invent their own ways of helping staff in order to reciprocate their care. We conclude that the presentation of the research-care tension as an ethical dilemma is misleading and even part of the problem that must be dealt with by those involved.

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Consent in clinical trials: What do patients know?

Cited by 30 publications

References 12 publications

Therapeutic misconception in research subjects: Development and validation of a measure

Therapeutic misconception in research subjects: Development and validation of a measure

Discrepancy between participants' understanding and desire to know in informed consent: are they informed about what they really want to know?

Beyond the ‘therapeutic misconception’: Research, care and moral friction

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