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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 .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 , 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. (shrink)

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Increases in international travel and migratory flows have enabled infectious diseases to emerge and spread more rapidly than ever before. Hence, it is increasingly easy for local infectious diseases to become global infectious diseases (GIDs). National governments must be able to react quickly and effectively to GIDs, whether naturally occurring or intentionally instigated by bioterrorism. According to the World Health Organisation, global partnerships are necessary to gather the most up-to-date information and to mobilize resources to tackle GIDs when necessary. Communicable (...) disease control also depends upon national public health laws and policies. The containment of an infectious disease typically involves detection, notification, quarantine and isolation of actual or suspected cases; the protection and monitoring of those not infected; and possibly even treatment. Some measures are clearly contentious and raise conflicts between individual and societal interests. In Europe national policies against infectious diseases are very heterogeneous. Some countries have a more communitarian approach to public health ethics, in which the interests of individual and society are more closely intertwined and interdependent, while others take a more liberal approach and give priority to individual freedoms in communicable disease control. This paper provides an overview of the different policies around communicable disease control that exist across a select number of countries across Europe. It then proposes ethical arguments to be considered in the making of public health laws, mostly concerning their effectiveness for public health protection. (shrink)

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Increasing geographical mobility and international travel augment the ease and speed by which infectious diseases can spread across large distances. It is therefore incumbent upon each state to ensure that immunisation programmes are effective and that herd immunity is achieved. Across Europe, a range of immunisation policies exist: compulsion, the offer of financial incentives to parents or healthcare professionals, social and professional pressure, or simply the dissemination of clear information and advice. Until recently, immunisation against particular communicable diseases was compulsory (...) in Italy. The Italian National Vaccination Plan paved the way for regions to suspend the sanctions associated with compulsory vaccinations for children when certain criteria are met—for example when immunisation coverage is high and when effective monitoring/surveillance systems are in place—and thus marked a milestone in the move from compulsory to voluntary immunisation. The forthcoming NVP for 2008–10 confirms the liberal approach to vaccination in Italy as it entrusts to the regions responsibility for the achievement and maintenance of herd immunity. This paper reviews the arguments for and against compulsory and voluntary immunisation in relation to the Italian NVP and in the context of the diverse immunisation policies that exist across Europe. It concludes with cautious support for the NVP and an associated shift from compulsory to voluntary immunisation in Italy, and draws similarities between issues concerning regional variation in immunisation policy in Italy and national variation in immunisation policy across Europe and beyond. (shrink)

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