title: Therapeutic misconception correlates with willingness to participate in clinical drug trials among patients with epilepsy; need for better counseling.
abstract: OBJECTIVE
  To ensure the development of new effective treatments in medicine, clinical trials (CTs) need to be conducted. The study was aimed at assessing knowledge of and attitudes toward clinical drug trials among patients with epilepsy, along with factors that motivate them to participate in CTs. Use of this information could improve recruitment for future trials and enhance their quality.
  
  
  METHODS
  A 45-item questionnaire on the views of patients with epilepsy 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=1875) of members of the Finnish Epilepsy Association aged at least 18 years. In all, 342 questionnaires were returned, and 325 were accepted after exclusion.
  
  
  RESULTS
  The analysis indicates that the general attitudes of patients with epilepsy toward CTs are positive. Most of the patients with epilepsy saw participation in clinical trials as indispensable to new treatments becoming available. Retired respondents and persons who had developed epilepsy when young had inadequate knowledge of general issues related to CTs. Level of education and number of antiepileptic medications (AEDs) were significant predictors for failure to understand the nature and purpose of clinical research - i.e., for therapeutic misconception (TM). Additionally, strong correlation was found between TM and respondents' willingness to participate in clinical trials.
  
  
  CONCLUSIONS
  The new treatments are often studied in patients with a high risk of TM and impaired comprehension of general procedures associated with CTs. Clinically, it may be worthwhile for the investigators to be able to recognize vulnerable individuals and pay special attention to the information provided on the purposes and methods of the trial, to contribute to high-quality AED studies.
authors.affiliation: University of Eastern Finland, Faculty of Health Sciences, Kuopio, Finland. Electronic address: emmii@student.uef.fi.
authors.forename: Emmi
authors.initials: E
authors.lastname: Reijula
authors.affiliation: Kuopio University Hospital, Science Service Center, Kuopio, Finland. Electronic address: arja.halkoaho@kuh.fi.
authors.forename: Arja
authors.initials: A
authors.lastname: Halkoaho
authors.affiliation: University of Eastern Finland, Faculty of Health Sciences, Kuopio Social and Health Care Services, Kuopio, Finland. Electronic address: anna-maija.pietila@uef.fi.
authors.forename: Anna-Maija
authors.initials: AM
authors.lastname: Pietilä
authors.affiliation: Kuopio University Hospital, Science Service Center, Kuopio, Finland. Electronic address: tuomas.selander@kuh.fi.
authors.forename: Tuomas
authors.initials: T
authors.lastname: Selander
authors.affiliation: NeuroCenter, Kuopio University Hospital, Kuopio, Finland; Faculty of Health Sciences, School of Medicine, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland. Electronic address: reetta.kalviainen@kuh.fi.
authors.forename: Reetta
authors.initials: R
authors.lastname: Kälviäinen
authors.affiliation: Kuopio University Hospital, Science Service Center, Kuopio, Finland; National Institute for Health and Welfare, Helsinki, Finland. Electronic address: tapani.keranen@thl.fi.
authors.forename: Tapani
authors.initials: T
authors.lastname: Keränen
mesh_terms: D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000523:psychology*; D003376:Counseling; D004341:Drug Evaluation; D004827:Epilepsy / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D009042:Motivation; D010358:Patient Participation / Q000523:psychology*; D036301:Qualitative Research; D012306:Risk; D011795:Surveys and Questionnaires; D055990:Therapeutic Misconception; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000927:Anticonvulsants
keywords: Clinical trials; Epilepsy; Therapeutic misconceptions