The therapeutic misconception (TM) may lead to unrealistic expectations of outcomes in clinical trials for muscular dystrophies. Regardless of whether informed consent is achieved, hope, promise and expectations all influence how information is interpreted. It is unclear whether TMs represent a breach of the consent process and/or whether they may represent effective ways of coping with the prognosis of serious, life-threatening conditions. We do not know to what extent and how we can modify TM, and at what cost to participant wellbeing. This project will engage the "Duchenne/Becker muscular dystrophy community" (parents, affected adolescents and adults, clinician investigators, and biopharmaceutical leaders) to explore adaptive and maladaptive elements of the therapeutic misconception when considering and participating in a clinical trial. The study will use a community-based participatory research approach to help ensure that the scope of questions and interpretation is informed by a diverse set of experiences and perceptions. The result will be a considerable contribution to the literature about TM, including efforts to develop measures to evaluate TM;and the development of target(s) for intervention that are: focused on wellbeing rather than extinguishing TM, are acceptable to the community, and can be tested in a downstream intervention study. Specifically, the study aims to use qualitative approaches to obtain from families and researchers an in-depth assessment of the concept, scope, and sources of TM, as well as adaptive and maladaptive elements of TM. Concurrently we will analyze written sources of information about clinical trials to identify potential sources of therapeutic misconceptions. The data from those studies will be used to create a quantitative survey to obtain generalizable information about TM. We will further engage the community to use the data from the three analyses to develop a set of feasible targets and design an intervention that would reduce maladaptive and negative outcomes of TM and improve family wellbeing when evaluating and participating in clinical trials

Public Health Relevance

The therapeutic misconception (TM) may lead to unrealistic expectations of outcomes in future clinical trials for muscular dystrophies. It is unclear to what extent TMs represent a breach of the informed consent process, and/or whether TM may represent an effective way of coping with the prognosis of serious, life-threatening conditions. This project includes qualitative and quantitative studies to inform about the scope, sources, and nature of TM and will result in a considerable contribution to the literature about TM and the development of target(s) for intervention that are: focused on wellbeing rather than extinguishing TM, acceptable to the community, and can be tested in a downstream intervention study.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21NS077286-02
Application #
8339888
Study Section
Special Emphasis Panel (ZRG1-HDM-S (02))
Program Officer
Odenkirchen, Joanne
Project Start
2011-09-30
Project End
2014-06-30
Budget Start
2012-09-01
Budget End
2014-06-30
Support Year
2
Fiscal Year
2012
Total Cost
$145,000
Indirect Cost
$20,000
Name
Parent Project Muscular Dystrophy
Department
Type
DUNS #
021721225
City
Middletown
State
OH
Country
United States
Zip Code
45042