Background Desire for improvement in one's illness and having one's own doctor functioning as a researcher are thought to promote therapeutic misconception (TM), a phenomenon in which research subjects are said to conflate research with treatment.
Purpose To examine whether subjects’ therapeutic motivation and own doctor functioning as researcher are associated with TM.
Methods We interviewed 90 persons with advanced Parkinson's disease (PD) enrolled or intending to enrol in sham surgery controlled neurosurgical trials, using qualitative interviews. Subjects were compared by motivation (primarily therapeutic vs primarily altruistic or dually motivated by altruistic and therapeutic motivation), and by doctor status (own doctor as site investigator vs not) on the following: understanding of purpose of study; understanding of research procedures; perception of chance of direct benefit; and recollection and perceptions concerning the risks.
Results 60% had primarily therapeutic motivation and 44% had their own doctor as the site investigator, but neither were generally associated with increased TM responses. Overall level of understanding of purpose and procedures of research were high. Subjects responded with generally high estimates of probability of direct benefit, but their rationales were personal and complex. The therapeutic-motivation group was more sensitive to risks. Five (5.6%) subjects provided incorrect answers to the question about purpose of research, and yet, showed excellent understanding of research procedures.
Conclusions In persons with PD involved in sham surgery clinical trials, being primarily motivated by desire for direct benefit to one's illness or having one's own doctor as the site investigator were not associated with greater TM responses.
- Research Ethics
- Gene Therapy/Transfer
- Clinical trials
- Policy Guidelines/Inst. Review Boards/Review Cttes.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Read the full text or download the PDF:
Other content recommended for you
- Sham neurosurgery in patients with Parkinson's disease: is it morally acceptable?
- An investigation of patients’ motivations for their participation in genetics-related research
- Therapeutic optimism in the consent forms of phase 1 gene transfer trials: an empirical analysis
- Are patients with amyotrophic lateral sclerosis at risk of a therapeutic misconception?
- Phase I oncology trials: why the therapeutic misconception will not go away
- For love and money: the need to rethink benefits in HIV cure studies
- Understanding the ‘therapeutic misconception’ from the research participant’s perspective
- Understanding people’s ‘unrealistic optimism’ about clinical research participation
- Non-completion and informed consent
- Sham surgery controls: intracerebral grafting of fetal tissue for Parkinson’s disease and proposed criteria for use of sham surgery controls