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. 2017 Sep 29;18(1):444.
doi: 10.1186/s13063-017-2174-2.

Clinical features of Parkinson's disease patients are associated with therapeutic misconception and willingness to participate in clinical trials

Emmi Reijula  1   2 , Anna-Maija Pietilä  3   4 , Arja Halkoaho  5 , Tuomas Selander  5 , Kirsti Martikainen  6 , Reetta Kälviäinen  7   8 , Tapani Keränen  5   9
Affiliations

Clinical features of Parkinson's disease patients are associated with therapeutic misconception and willingness to participate in clinical trials

Emmi Reijula et al. Trials. .

Abstract

Background: Clinical trials (CTs) are the "gold standard" to ensure the development of new effective treatments in medicine. A study was conducted to assess knowledge of, and attitudes toward, clinical trials among patients with Parkinson's disease (PD), along with factors that motivate them to participate.

Methods: A 50-item questionnaire on the views of patients with PD about CTs was developed. It included statements that the respondents assessed on a Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"). The questionnaire was mailed to a random sample (n = 2000) of members of the patient organization the Finnish Parkinson Association. In all, 708 response forms were returned, of which 681 were accepted after exclusion (a 34% response rate).

Results: In general, attitudes of patients with PD toward CTs were positive. Older subjects and patients with lower education levels had inadequate knowledge of general issues related to CTs. Older age, low level of education, and lower number of PD medications were significant predictors for failure to understand the nature and purpose of clinical research. Additionally, significant positive correlation was found between education level and willingness to participate in CTs.

Conclusions: Patients with PD have important gaps in their knowledge of methodological issues associated with CTs. The oldest subjects and those with a low level of education have the greatest information needs. Investigators should pay more attention to ensuring the comprehensibility of the information provided to potential CT participants.

Keywords: Clinical trials; Parkinson’s disease; Therapeutic misconception.

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Conflict of interest statement

Ethics approval and consent to participate

Ethics Committee approval was obtained from the Research Ethics Committee of the University of Eastern Finland (Statement 24/2014). To respect privacy of the study participants the questionnaires were returned anonymously; thus, a separate informed consent document was not used.

Consent for publication

Not applicable.

Competing interests

Kirsti K Martikainen has received lecture fees from Boehringer-Ingelheim; lecture and consultant’s fees from Orion Pharma, H. Lundbeck, and UCB Pharma; and travel/accommodation/meeting expenses from NordicInfu Care, all of these unrelated to this work. Reetta Kälviäinen has received speaker’s honoraria from Eisai, UCB, and Orion; honoraria for membership of advisory boards from Eisai, Fenno Medical, GW Pharmaceuticals, Pfizer, Sage Therapeutics, and UCB; and research support for her institute from the Academy of Finland, UCB, and Eisai. None of the other authors have any potential conflicts of interest to disclose.

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