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Identifying Effectiveness in 'The Old Old' : Principles and Values in the Age of Clinical Trials

机译：识别“老者”中的有效性：临床试验时代的原则和价值

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This article explores some implications of the increasing reliance on clinical trials in contemporary health care, particularly health care payers' efforts to use them in the so-called fourth hurdle decisions. How do these agencies manage medical uncertainty given the desire to produce clear guidelines for clinicians? Their solutions take account of trials in at least two ways, reflecting broader debates about the meaning of these medical experiments. Trials can be read as either "proofs of protocol"-straightforward guides to action with individual drugs in specific populations-or "proofs of principle"-where extrapolation is made possible through an appeal to underlying biological mechanisms. These contrasting readings of trials are illustrated with reference to guidelines on heart disease prevention/cholesterol reduction using statins among the elderly in North America and the United Kingdom. Uncertainty in these cases does not lead to inertia but solutions use different fixed points to aid navigation, including both physiological principles and moral values.
机译：本文探讨了当代医疗保健中越来越依赖临床试验的某些含义，尤其是医疗保健付款人在所谓的第四关决策中使用它们的努力。考虑到需要为临床医生制定明确的指南，这些机构如何处理医疗不确定性？他们的解决方案至少以两种方式考虑了试验，这反映了有关这些医学实验意义的广泛辩论。可以将试验理解为“协议的证明”（针对特定人群使用单个药物的直接指导）或“原理的证明”（其中通过吸引潜在的生物学机制进行推断）。参考北美和英国老年人使用他汀类药物预防心脏病/降低胆固醇的指南，说明了这些对比试验结果。在这些情况下，不确定性不会导致惯性，但是解决方案使用不同的固定点来辅助导航，包括生理原理和道德价值。

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