[Show abstract][Hide abstract] ABSTRACT: Approximately 6000 men die every year from ruptured abdominal aortic aneurysm in England and Wales. Randomised clinical trials and a large pilot study have shown that ultrasound screening of men aged 65 years can prevent about half of these deaths. However, there is a significant perioperative morbidity and mortality from interventions to repair the detected aneurysm. This paper explores the ethical issues of screening men for abdominal aortic aneurysm. It is concluded that a population screening programme for abdominal aortic aneurysm offers a clear balance of good over harm. It is therefore ethically justified, as long as men are given adequate information at every stage of the process. Each man has the right to be properly informed, regardless of whether he accepts the invitation to be screened and, if an aneurysm is detected, whether or not he accepts treatment.
[Show abstract][Hide abstract] ABSTRACT: The optimal choice of regulatory approach for securing patient safety is an important problem. In this review article, we show how insights from the field of regulatory studies can provide a conceptual apparatus for analysis of important problems in the regulation of medicine and healthcare. Design-based regulation operates through technical constraints that are self-executing. Technology, by concretising rules about proper behaviour and conduct, not only functions as a regulatory instrument, but may also encode particular values and versions of rationality. As debates in the broader area of "code" or "design"-based regulation, including the crime prevention context have highlighted, design-based approaches may have significant social, political and ethical implications. Though design-based regulation can be an attractive solution where there is widespread agreement about what constitutes good medical practice, it is considerably more problematic where there is contestation about what constitutes an error and who owns the definition of an error. Design-based regulation involves challenges to professional agency and authority, and engages with wider debates about the regulation of the medical profession. It is vital that the introduction of patient safety technology is sensitive to the values and motives that get encoded in design.
Social Science [?] Medicine 08/2010; 71(3):502-9.
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