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The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about the development of clinical practice guidelines

机译:美国传染病学会莱姆指南:关于临床实践指南发展的警示故事

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摘要

Flawed clinical practice guidelines may compromise patient care. Commercial conflicts of interest on panels that write treatment guidelines are particularly problematic, because panelists may have conflicting agendas that influence guideline recommendations. Historically, there has been no legal remedy for conflicts of interest on guidelines panels. However, in May 2008, the Attorney General of Connecticut concluded a ground-breaking antitrust investigation into the development of Lyme disease treatment guidelines by one of the largest medical societies in the United States, the Infectious Diseases Society of America (IDSA). Although the investigation found significant flaws in the IDSA guidelines development process, the subsequent review of the guidelines mandated by the settlement was compromised by a lack of impartiality at various stages of the IDSA review process. This article will examine the interplay between the recent calls for guidelines reform, the ethical canons of medicine, and due process considerations under antitrust laws as they apply to the formulation of the IDSA Lyme disease treatment guidelines. The article will also discuss pitfalls in the implementation of the IDSA antitrust settlement that should be avoided in the future.
机译:有缺陷的临床实践指南可能会损害患者的护理。编写治疗指南的专家小组的商业利益冲突尤其成问题,因为专家小组成员的议程可能会相互冲突,从而影响准则的建议。从历史上看,指南面板上没有针对利益冲突的法律补救措施。但是,在2008年5月,美国最大的医学学会之一美国传染病学会(IDSA)对康涅狄格州的莱姆病治疗指南的发展进行了一项具有开创性的反托拉斯调查。尽管调查发现IDSA指南制定过​​程中存在重大缺陷,但是由于IDSA审查过程的各个阶段缺乏公正性,后来对和解授权的指南进行了审查。本文将探讨最近对准则改革的呼吁,医学的道德规范以及根据反托拉斯法制定的IDSA莱姆病治疗准则所依据的正当程序考虑因素之间的相互作用。本文还将讨论IDSA反托拉斯解决方案实施中的陷阱,将来应避免这种情况。

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