Clinical Trials and Medical Care: Defining the Therapeutic Misconception

et al. (2007) Clinical trials and medical care: Defining the therapeutic misconception. PLoS Med 4(11): e324. doi:10.1371/ journal.pmed.0040324 Clinical Trials and Medical Care: Defining the Therapeutic Misconception Gail E. Henderson 0 1 2 Larry R. Churchill 0 1 2 Arlene M. Davis 0 1 2 Michele M. Easter 0 1 2 Christine Grady 0 1 2 Steven Joffe 0 1 2 Nancy Kass 0 1 2 Nancy M. P. King 0 1 2 Charles W. Lidz 0 1 2 Franklin G. Miller 0 1 2 Daniel K. Nelson 0 1 2 Jeffrey Peppercorn 0 1 2 Barbra Bluestone Rothschild 0 1 2 Pamela Sankar 0 1 2 Benjamin S. Wilfond 0 1 2 Catherine R. Zimmer 0 1 2 What Is Therapeutic Misconception? 0 1 2 0 Gail E. Henderson , Arlene M. Davis, Michele M. Easter , Daniel K. Nelson, Jeffrey Peppercorn, Barbra Bluestone Rothschild, and Catherine R. Zimmer are with the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America. Larry R. Churchill is with Vanderbilt University , Nashville , Tennessee, United States of America. Christine Grady and Franklin G. Miller are with the Department of Clinical Bioethics, National Institutes of Health Clinical Center , Bethesda , Maryland, United States of America. Steven Joffe is with Harvard University , Boston , Massachusetts, United States of America. Nancy Kass is with Johns Hopkins University , Baltimore , Maryland, United States of America. Nancy M. P. King is with Wake Forest University , Winston-Salem , North Carolina, United States of America. Charles W. Lidz is with the University of Massachusetts, Wooster, Massachusetts, United States of America. Pamela Sankar is with the University of Pennsylvania, Philadelphia, Pennsylvania, United States of America. Benjamin S. Wilfond is with the University of Washington , Seattle, Washington , United States of America 1 Abbreviations: NBAC, National Bioethics Advisory Commission; TM , therapeutic misconception 2 Funding: Support for the development of this paper was provided by National Human Genome Research Institute grants R01 HG 02087 and P20 HG 03387. The opinions expressed are the views of the authors and do not necessarily reflect the policy of the United States National Institutes of Health, the Public Health Service, or the Department of Health and Human Services Summary Points - For over three decades, bioethics scholarship and research ethics guidelines have identified concerns about the boundaries between research and standard clinical care [1,2]. Ethicists have argued that informed consent to participate in research should include clarification of the differences between these two activities [310]. In 1982, Appelbaum and colleagues reported on findings from interviews with patients with psychiatric disorders that documented failure to appreciate the difference between research and treatment, labeling the phenomenon therapeutic misconception (TM) [3]. Despite considerable empirical research on TM in the intervening years, a consistent definition has not emerged in the literature. Without such a definition, meaningful empirical work to measure and assess the prevalence of TM, or to test interventions to reduce it, is difficult to conduct. Progress is further impeded when studies use measures that reflect inconsistent definitions of research and clinical care, which are fundamental to the definition of TM. Scholars who have contributed to this literature, including this papers authors, met at the University of North Carolina at Chapel Hill in September 2005 to address the debate on defining TM. The workshop included a University of North Carolina team funded to study TM in early-phase gene transfer research (R01 HG 02087) [1117] and others from the fields of medicine, oncology, public health, sociology, philosophy, anthropology, law, and bioethics. Following guidelines The Policy Forum allows health policy makers around the world to discuss challenges and opportunities for improving health care in their societies.  A key component of informed consent to participate in medical research is the understanding that research is not the same as treatment.  However, studies have found that some research participants do not appreciate important differences between research and treatment, a phenomenon called therapeutic misconception.  A consistent definition of therapeutic misconception is missing from the literature, and this hinders attempts to define its prevalence or ways to reduce it.  This paper proposes a new definition and describes how it can be operationalized. on scale development [18], we debated definitions based on the literature, evaluated questions that could be used in a TM scale, and participated in ongoing discussion during the following year. In this article, we summarize the controversies, propose a definition with specific dimensions, and describe how these dimensions can be operationalized to produce a valid measure of TM. Defining Therapeutic Misconception In Appelbaum and colleagues study [3], the patients interviewed were enrolled in clinical trials that involved randomization, non-treatment control groups and placebos, and double-blind procedures. The researchers found that many trial participants were unaware of study design implications, especially random assignment to a control or comparison group, often believing that they were assigned a medication based on what was best for them, personally. The authors concluded that those patients who are trial participants and who do not adequately appreciate the purpose and methods of research studies are ill-equipped to evaluate risks and benefits of study participation, and may fail to recognize how personal care may be compromised by research procedures [19]. Competing Interests: The authors have declared that no competing interests exist. Confusion about the purpose of research is integral to most definitions of TM. According to Appelbaum and colleagues, TM occurs when a research subject fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment, and therefore inaccurately attributes therapeutic intent to research procedures [6]. In 2001, the National Bioethics Advisory Commission (NBAC) defined TM similarly, as the belief that the purpose of a clinical trial is to benefit the individual patient rather than to gather data for the purpose of contributing to scientific knowledge [5]. In its report, NBAC called attention to the important distinction between the purpose of research as a knowledgegenerating activity and its broader consequences, which may include potential benefit from the intervention (direct benefit) or from other aspects of study participation (inclusion or collateral benefit) [20,21]. The report stated, It is not a misconception to believe that participants probably will receive good clinical care during research. But it is a misconception to believe that the purpose of clinical trials is to administer treatment rather than to conduct research [5]. Joffe and Miller [22], ci (...truncated)