Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception.

BACKGROUND: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment. AIM: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials (parent studies). PATIENTS AND METHODS: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient subjects based on this questionnaire. RESULTS: A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good (69-97%), and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease. CONCLUSION: The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators.

Participation of French general practitioners in end-of-life decisions for their hospitalised patients.

BACKGROUND AND OBJECTIVE: Assuming the hypothesis that the general practitioner (GP) can and should be a key player in making end-of-life decisions for hospitalised patients, perceptions of GPs' role assigned to them by hospital doctors in making withdrawal decisions for such patients were surveyed. DESIGN: Questionnaire survey. SETTING: Urban (districts located near Paris) and rural (southern France) areas. PARTICIPANTS: GPs. RESULTS: The response rate was 32.2% (161/500), and it was observed that 70.8% of respondents believed that their participation in withdrawal decisions for their hospitalised patients was essential, whereas 42.1% believed that the hospital doctors were sufficiently skilled to make withdrawal decisions without input from the GPs. Most respondents were found to believe that they had the necessary skills (91.9%) and enough time (87.6%) to participate in withdrawal decisions. The last case of treatment withdrawal in hospital for one of their patients was described by 40% (65/161) of respondents, of whom only 40.0% (26/65) believed that they had participated actively in the decision process. The major factors in the multivariate analysis were the GP's strong belief that his or her participation was essential (p = 0.01), information on admission of the patient given to the GP by the hospital department (p = 0.007), rural practice (p = 0.03), visit to the patient dying in hospital (p = 0.02) and a request by the family to be kept informed about the patient (p = 0.003). CONCLUSION: Strong interest was evinced among GPs regarding end-of-life issues, as well as considerable experience of patients dying at home. As GPs are more closely corrected to patients' families, they may be a good choice for third-party intervention in making end-of-life decisions for hospitalised patients.