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Paul S Appelbaum - One of the best experts on this subject based on the ideXlab platform.
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reducing Therapeutic Misconception a randomized intervention trial in hypothetical clinical trials
PLOS ONE, 2017Co-Authors: Paul P Christopher, Paul S Appelbaum, Debbie Truong, Karen Albert, Louise Maranda, Charles W LidzAbstract:Background Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as Therapeutic Misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces Therapeutic Misconception without significantly reducing willingness to participate in hypothetical clinical trials. Methods This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing Therapeutic Misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were Therapeutic Misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10–50), and willingness to participate in the clinical trial. Results 154 participants completed the study (age range, 23–87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic Misconception was significantly lower (p = 0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017). Willingness to participate in the hypothetical trial was not significantly different (p = 0.603) between intervention (52.1%, 95% CI [40.2% to 62.4%]) and control (56.3%, 95% CI [45.3% to 66.6%] groups. Conclusions An enhanced educational intervention augmenting traditional informed consent led to a meaningful reduction in Therapeutic Misconception without a statistically significant change in willingness to enroll in hypothetical clinical trials. Additional study of this intervention is required in real-world clinical trials.
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Variations in Unrealistic Optimism between Acceptors and Decliners of Early Phase Cancer Trials
Journal of Empirical Research on Human Research Ethics, 2017Co-Authors: Lynn A. Jansen, Paul S Appelbaum, Daruka Mahadevan, William M. P. Klein, Neil D. Weinstein, Motomi Mori, Catherine Degnin, Daniel P. SulmasyAbstract:Research has found that patient-subjects in early phase cancer trials exhibit unrealistic optimism regarding the risks and possible benefits of trial participation. Unrealistic optimism is associated with Therapeutic Misconception and failures to appreciate research-related information. This is the first study to assess whether those who decline to participate in these trials also exhibit unrealistic optimism. It is also the first study to assess whether there are significant differences in appreciation of research-related risks/benefits and Therapeutic Misconception between these two groups. We approached 261 patients at two academic medical centers who were offered enrollment in a Phase I, II, or I/II cancer trial (between 2012 and 2016). Two hundred thirty-three patients agreed to enroll in an early phase cancer trial, 171 of whom agreed to be interviewed for the study. Twenty-eight patients declined the offer to enroll, 15 of whom agreed to be interviewed for the study. Subjects participated in a structured face-to-face interview with a research associate trained to administer the study questionnaires. Acceptors demonstrated a significantly higher level of unrealistic optimism than decliners ( p < .05). Decliners had significantly less Therapeutic Misconception than acceptors (3.37 [ SD = 0.85] vs. 3.79 [ SD = 0.77], p = .042). There was a significant difference on one of the appreciation questions between acceptors and decliners ( p = .009). Comparative assessment of acceptors and decliners to early phase cancer trials casts light on whether unrealistic optimism is consequential for the decision to participate in these trials. The different levels of unrealistic optimism exhibited by these groups suggest that it may be a factor that affects the decision to participate.
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how not to test the prevalence of Therapeutic Misconception
Journal of Medical Ethics, 2016Co-Authors: Paul S AppelbaumAbstract:Almost 35 years ago, my colleagues and I first reported a new phenomenon: the decisions of many freshly enrolled research subjects appeared to be based on confusion between the nature of research and of ordinary treatment.1 We called the phenomenon ‘Therapeutic Misconception’ (TM), and noted that it was characterised by inaccurate beliefs about the degree of individualisation of treatment and likelihood of benefit associated with enrolment in a clinical trial. Since that original paper, dozens of studies from around the world have confirmed the existence of TM and its substantial prevalence, with rates of some degree of TM approaching or exceeding 50% in many studies.2 The concept of TM has become a given in the world of research ethics. Commonly accepted concepts, of course, are prime targets for academic revisionism, so it is not a surprise to see an article like that by Kim et al in this issue of JME .3 Indeed, Kim et al have embarked on a series of studies aimed at challenging the idea that TM is a major concern in consent to research. This is not the place to comment on the project as a whole, but the study reported here exemplifies its problems. It is based on the notion that “the apparent prevalence of TM indicates [sic] a form of measurement error”, that …
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Dispositional optimism and Therapeutic expectations in early-phase oncology trials.
Cancer, 2016Co-Authors: Lynn A. Jansen, Paul S Appelbaum, Daruka Mahadevan, William M. P. Klein, Neil D. Weinstein, Motomi Mori, Racky Daffe, Daniel P. SulmasyAbstract:BACKGROUND Prior research has identified unrealistic optimism as a bias that might impair informed consent among patient-subjects in early-phase oncology trials. However, optimism is not a unitary construct; it also can be defined as a general disposition, or what is called dispositional optimism. The authors assessed whether dispositional optimism would be related to high expectations for personal Therapeutic benefit reported by patient-subjects in these trials but not to the Therapeutic Misconception. The authors also assessed how dispositional optimism related to unrealistic optimism. METHODS Patient-subjects completed questionnaires designed to measure expectations for Therapeutic benefit, dispositional optimism, unrealistic optimism, and the Therapeutic Misconception. RESULTS Dispositional optimism was found to be significantly associated with higher expectations for personal Therapeutic benefit (Spearman rank correlation coefficient [r], 0.333; P
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why is Therapeutic Misconception so prevalent
Cambridge Quarterly of Healthcare Ethics, 2015Co-Authors: Charles W Lidz, Paul S Appelbaum, Laura B Dunn, Karen Albert, Eve Overton, Ekaterina PivovarovaAbstract:: Therapeutic Misconception (TM)-when clinical research participants fail to adequately grasp the difference between participating in a clinical trial and receiving ordinary clinical care-has long been recognized as a significant problem in consent to clinical trials. We suggest that TM does not primarily reflect inadequate disclosure or participants' incompetence. Instead, TM arises from divergent primary cognitive frames. The researchers' frame places the clinical trial in the context of scientific designs for assessing intervention efficacy. In contrast, most participants have a cognitive frame that is personal and focused primarily on their medical problems. To illustrate this, we draw on interview material from both clinical researchers and participants in clinical trials. We suggest that reducing TM requires encouraging subjects to adjust their frame, not just add information to their existing frame. What is necessary is a scientific reframing of participation in a clinical trial.
Daniel K Nelson - One of the best experts on this subject based on the ideXlab platform.
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Therapeutic Misconception in early phase gene transfer trials
Social Science & Medicine, 2006Co-Authors: Gail E Henderson, Larry R Churchill, Nancy M P King, Michele M Easter, Catherine Zimmer, Arlene M Davis, Barbra Bluestone Rothschild, Benjamin S Wilfond, Daniel K NelsonAbstract:Many subjects in early phase clinical trials expect to benefit in some way from the research intervention. It is understandable that people hope for improvement in their condition, no matter what the evidence. Yet unreasonable expectation of medical benefit may reflect problems with informed consent: Investigators may not disclose clearly that direct medical benefit from an early phase experimental intervention is unlikely or impossible, or subjects may not appreciate the differences between treatment and research. This paper presents findings from recent interviews with researchers and subjects and analysis of consent forms in early phase gene transfer research, a cutting-edge technology often called 'gene therapy'. We use three variables to construct a composite measure of Therapeutic Misconception TM, tapping Misconceptions about the purposes of early phase research and the potential for direct medical benefit in these trials. Our multivariate model demonstrates the importance of both subject- and study-level factors as predictors of this TM index: education, disease type, and communication by study personnel about the likelihood of benefit. We hope that this work will deepen the discussion of how to define and measure TM, and refine the specification of factors that are related to subjects' TM.
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1078 Therapeutic Misconception in early phase gene transfer trials
Molecular Therapy, 2005Co-Authors: Gail E Henderson, Larry R Churchill, Nancy M P King, Michele M Easter, Catherine Zimmer, Arlene M Davis, Barbra Bluestone Rothschild, Benjamin S Wilfond, Daniel K NelsonAbstract:Many subjects in early phase clinical trials are motivated by the expectation that they will benefit in some way from the research intervention. This may be especially true when there is a diagnosis of terminal illnesses for which standard treatments have been exhausted, or when scientific and lay publications promote an exciting new technology such as |[ldquo]|gene therapy|[rdquo]|. It is understandable that people may hope for improvement in their condition, no matter what the evidence. Yet unreasonable expectation of medical benefit from early phase trials may signal a breakdown of informed consent, stemming from investigators' failure to explain that direct medical benefit from an early phase experimental intervention is unlikely or even impossible, or from subjects' misunderstanding of the purposes of such research. Appelbaum and Lidz first described the Therapeutic Misconception (TM) as the mistaken belief |[ldquo]|that the research, like the therapy [subjects] have received previously, is designed and will be executed in a manner of direct benefit to them|[rdquo]|. Empirical studies have clearly documented the presence of TM, but they have not defined or measured it in the same way, nor have they captured its complexity. Attempts to define the predictors of TM suffer from similar methodological problems. Few studies include both subject and study level variables, and only one jointly assesses their contribution through multivariate analysis. In this paper, we address some of the problems in the analysis of TM by using data from recent interviews with researchers and subjects and analysis of consent forms in early phase gene transfer research (GTR). We present a new approach to TM measurement that combines three indicators of unrealistic expectations. We then examine predictors of subjects' TM with a multivariate model. Our findings demonstrate the effects of both subject and study level factors on TM, and suggest ways that subjects' TM might be identified and reduced.
Charles W Lidz - One of the best experts on this subject based on the ideXlab platform.
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reducing Therapeutic Misconception a randomized intervention trial in hypothetical clinical trials
PLOS ONE, 2017Co-Authors: Paul P Christopher, Paul S Appelbaum, Debbie Truong, Karen Albert, Louise Maranda, Charles W LidzAbstract:Background Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as Therapeutic Misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces Therapeutic Misconception without significantly reducing willingness to participate in hypothetical clinical trials. Methods This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing Therapeutic Misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were Therapeutic Misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10–50), and willingness to participate in the clinical trial. Results 154 participants completed the study (age range, 23–87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic Misconception was significantly lower (p = 0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017). Willingness to participate in the hypothetical trial was not significantly different (p = 0.603) between intervention (52.1%, 95% CI [40.2% to 62.4%]) and control (56.3%, 95% CI [45.3% to 66.6%] groups. Conclusions An enhanced educational intervention augmenting traditional informed consent led to a meaningful reduction in Therapeutic Misconception without a statistically significant change in willingness to enroll in hypothetical clinical trials. Additional study of this intervention is required in real-world clinical trials.
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an exploratory study of Therapeutic Misconception among incarcerated clinical trial participants
AJOB empirical bioethics, 2016Co-Authors: Paul P Christopher, Michael D Stein, Sandra A Springer, Josiah D Rich, Jennifer E Johnson, Charles W LidzAbstract:ABSTRACTBackground: Therapeutic Misconception, the misunderstanding of differences between research and clinical care, is widely prevalent among non-incarcerated trial participants. However, little attention has been paid to its presence among individuals who participate in research while incarcerated. Methods: This study examined the extent to which 72 incarcerated individuals may experience Therapeutic Misconception about their participation in one of six clinical trials, and its correlation with participant characteristics and potential influences on research participation. Results: On average, participants endorsed 70% of items suggestive of Therapeutic Misconception. The tendency toward Therapeutic Misconception was significantly higher among African Americans and Latinos compared to Whites, among older and less educated participants, and among enrollment in a substance-abuse-related trial; it was also correlated with a belief that the trial was the only way to obtain needed treatment. Conclusions: T...
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why is Therapeutic Misconception so prevalent
Cambridge Quarterly of Healthcare Ethics, 2015Co-Authors: Charles W Lidz, Paul S Appelbaum, Laura B Dunn, Karen Albert, Eve Overton, Ekaterina PivovarovaAbstract:: Therapeutic Misconception (TM)-when clinical research participants fail to adequately grasp the difference between participating in a clinical trial and receiving ordinary clinical care-has long been recognized as a significant problem in consent to clinical trials. We suggest that TM does not primarily reflect inadequate disclosure or participants' incompetence. Instead, TM arises from divergent primary cognitive frames. The researchers' frame places the clinical trial in the context of scientific designs for assessing intervention efficacy. In contrast, most participants have a cognitive frame that is personal and focused primarily on their medical problems. To illustrate this, we draw on interview material from both clinical researchers and participants in clinical trials. We suggest that reducing TM requires encouraging subjects to adjust their frame, not just add information to their existing frame. What is necessary is a scientific reframing of participation in a clinical trial.
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Therapeutic Misconception in research subjects development and validation of a measure
Clinical Trials, 2012Co-Authors: Paul S Appelbaum, Laura B Dunn, Karen Albert, Milena D Anatchkova, Charles W LidzAbstract:BackgroundTherapeutic Misconception (TM), which occurs when research subjects fail to appreciate the distinction between the imperatives of clinical research and ordinary treatment, may undercut th...
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Therapeutic Misconception and the limits of ethnography. A commentary on Timmermans and McKay
Social Science & Medicine, 2009Co-Authors: Charles W LidzAbstract:Comment on: Soc Sci Med. 2009 Dec;69(12):1784-90
Gail E Henderson - One of the best experts on this subject based on the ideXlab platform.
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why we should continue to worry about the Therapeutic Misconception
Journal of Clinical Ethics, 2013Co-Authors: Larry R Churchill, Nancy M P King, Gail E HendersonAbstract:: In a recent article in The Journal of Clinical Ethics, David Wendler argues that worries about the Therapeutic Misconception (TM) are not only misconceived, but detract from the larger agenda of a proper informed consent for subjects involved in clinical research.1 By contrast, we argue that Wendler mischaracterizes those who support TM research, and that his arguments are fragmentary, often illogical, and neglect a critical difference between clinical care and clinical research. A clear explanation about the chief aim of research is, in fact, what gives the other elements in a consent process their meaning. We argue that informed consent must be both trial-specific and context-sensitive, and that concern about the TM is needed now more than ever.
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clinical trials and medical care defining the Therapeutic Misconception
PLOS Medicine, 2007Co-Authors: Gail E Henderson, Charles W Lidz, Steven Joffe, Larry R Churchill, Nancy M P King, Michele M Easter, Arlene M Davis, Christine Grady, Nancy E Kass, Franklin G MillerAbstract:A key component of informed consent to participate in medical research includes understanding that research is not the same as treatment.
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Therapeutic Misconception in early phase gene transfer trials
Social Science & Medicine, 2006Co-Authors: Gail E Henderson, Larry R Churchill, Nancy M P King, Michele M Easter, Catherine Zimmer, Arlene M Davis, Barbra Bluestone Rothschild, Benjamin S Wilfond, Daniel K NelsonAbstract:Many subjects in early phase clinical trials expect to benefit in some way from the research intervention. It is understandable that people hope for improvement in their condition, no matter what the evidence. Yet unreasonable expectation of medical benefit may reflect problems with informed consent: Investigators may not disclose clearly that direct medical benefit from an early phase experimental intervention is unlikely or impossible, or subjects may not appreciate the differences between treatment and research. This paper presents findings from recent interviews with researchers and subjects and analysis of consent forms in early phase gene transfer research, a cutting-edge technology often called 'gene therapy'. We use three variables to construct a composite measure of Therapeutic Misconception TM, tapping Misconceptions about the purposes of early phase research and the potential for direct medical benefit in these trials. Our multivariate model demonstrates the importance of both subject- and study-level factors as predictors of this TM index: education, disease type, and communication by study personnel about the likelihood of benefit. We hope that this work will deepen the discussion of how to define and measure TM, and refine the specification of factors that are related to subjects' TM.
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1078 Therapeutic Misconception in early phase gene transfer trials
Molecular Therapy, 2005Co-Authors: Gail E Henderson, Larry R Churchill, Nancy M P King, Michele M Easter, Catherine Zimmer, Arlene M Davis, Barbra Bluestone Rothschild, Benjamin S Wilfond, Daniel K NelsonAbstract:Many subjects in early phase clinical trials are motivated by the expectation that they will benefit in some way from the research intervention. This may be especially true when there is a diagnosis of terminal illnesses for which standard treatments have been exhausted, or when scientific and lay publications promote an exciting new technology such as |[ldquo]|gene therapy|[rdquo]|. It is understandable that people may hope for improvement in their condition, no matter what the evidence. Yet unreasonable expectation of medical benefit from early phase trials may signal a breakdown of informed consent, stemming from investigators' failure to explain that direct medical benefit from an early phase experimental intervention is unlikely or even impossible, or from subjects' misunderstanding of the purposes of such research. Appelbaum and Lidz first described the Therapeutic Misconception (TM) as the mistaken belief |[ldquo]|that the research, like the therapy [subjects] have received previously, is designed and will be executed in a manner of direct benefit to them|[rdquo]|. Empirical studies have clearly documented the presence of TM, but they have not defined or measured it in the same way, nor have they captured its complexity. Attempts to define the predictors of TM suffer from similar methodological problems. Few studies include both subject and study level variables, and only one jointly assesses their contribution through multivariate analysis. In this paper, we address some of the problems in the analysis of TM by using data from recent interviews with researchers and subjects and analysis of consent forms in early phase gene transfer research (GTR). We present a new approach to TM measurement that combines three indicators of unrealistic expectations. We then examine predictors of subjects' TM with a multivariate model. Our findings demonstrate the effects of both subject and study level factors on TM, and suggest ways that subjects' TM might be identified and reduced.
Michele M Easter - One of the best experts on this subject based on the ideXlab platform.
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clinical trials and medical care defining the Therapeutic Misconception
PLOS Medicine, 2007Co-Authors: Gail E Henderson, Charles W Lidz, Steven Joffe, Larry R Churchill, Nancy M P King, Michele M Easter, Arlene M Davis, Christine Grady, Nancy E Kass, Franklin G MillerAbstract:A key component of informed consent to participate in medical research includes understanding that research is not the same as treatment.
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Therapeutic Misconception in early phase gene transfer trials
Social Science & Medicine, 2006Co-Authors: Gail E Henderson, Larry R Churchill, Nancy M P King, Michele M Easter, Catherine Zimmer, Arlene M Davis, Barbra Bluestone Rothschild, Benjamin S Wilfond, Daniel K NelsonAbstract:Many subjects in early phase clinical trials expect to benefit in some way from the research intervention. It is understandable that people hope for improvement in their condition, no matter what the evidence. Yet unreasonable expectation of medical benefit may reflect problems with informed consent: Investigators may not disclose clearly that direct medical benefit from an early phase experimental intervention is unlikely or impossible, or subjects may not appreciate the differences between treatment and research. This paper presents findings from recent interviews with researchers and subjects and analysis of consent forms in early phase gene transfer research, a cutting-edge technology often called 'gene therapy'. We use three variables to construct a composite measure of Therapeutic Misconception TM, tapping Misconceptions about the purposes of early phase research and the potential for direct medical benefit in these trials. Our multivariate model demonstrates the importance of both subject- and study-level factors as predictors of this TM index: education, disease type, and communication by study personnel about the likelihood of benefit. We hope that this work will deepen the discussion of how to define and measure TM, and refine the specification of factors that are related to subjects' TM.
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1078 Therapeutic Misconception in early phase gene transfer trials
Molecular Therapy, 2005Co-Authors: Gail E Henderson, Larry R Churchill, Nancy M P King, Michele M Easter, Catherine Zimmer, Arlene M Davis, Barbra Bluestone Rothschild, Benjamin S Wilfond, Daniel K NelsonAbstract:Many subjects in early phase clinical trials are motivated by the expectation that they will benefit in some way from the research intervention. This may be especially true when there is a diagnosis of terminal illnesses for which standard treatments have been exhausted, or when scientific and lay publications promote an exciting new technology such as |[ldquo]|gene therapy|[rdquo]|. It is understandable that people may hope for improvement in their condition, no matter what the evidence. Yet unreasonable expectation of medical benefit from early phase trials may signal a breakdown of informed consent, stemming from investigators' failure to explain that direct medical benefit from an early phase experimental intervention is unlikely or even impossible, or from subjects' misunderstanding of the purposes of such research. Appelbaum and Lidz first described the Therapeutic Misconception (TM) as the mistaken belief |[ldquo]|that the research, like the therapy [subjects] have received previously, is designed and will be executed in a manner of direct benefit to them|[rdquo]|. Empirical studies have clearly documented the presence of TM, but they have not defined or measured it in the same way, nor have they captured its complexity. Attempts to define the predictors of TM suffer from similar methodological problems. Few studies include both subject and study level variables, and only one jointly assesses their contribution through multivariate analysis. In this paper, we address some of the problems in the analysis of TM by using data from recent interviews with researchers and subjects and analysis of consent forms in early phase gene transfer research (GTR). We present a new approach to TM measurement that combines three indicators of unrealistic expectations. We then examine predictors of subjects' TM with a multivariate model. Our findings demonstrate the effects of both subject and study level factors on TM, and suggest ways that subjects' TM might be identified and reduced.