Gatekeeping and trailblazing: The role of biomarkers in novel guidelines for diagnosing Alzheimer's disease
Gatekeeping and trailblazing: The role of biomarkers in novel guidelines for diagnosing Alzheimer's disease
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DOI：
10.1057/s41292-017-0065-0
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发表时间：
2018-03-01
期刊：
影响因子：
1.6
通讯作者：
Boenink, Marianne
中科院分区：
文献类型：
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作者：
Boenink, Marianne
在创新政策讨论中，临床实践指南通常被视为看门人：它们选择哪些新技术可以进入临床实践。然而，早期研究指出，在生物医学创新中，“希望政权”和“真理政权”是相互作用的。对未来发展的高期望可以通过改变评估标准纳入临床指南，从而共同塑造创新必须通过的“大门”。本文展示了诊断指南如何通过引入新的疾病词汇来以另一种方式体现希望，为新兴诊断技术铺平道路。我讨论了两套诊断阿尔茨海默病的指南：美国国家老龄化研究所和阿尔茨海默病协会发布的指南（2011 年），以及 DSM-5 中与诊断 AD 相关的部分（2013 年）。两者都充当看门人的角色，因为它们明确阻止在临床实践中使用生物标志物测试。然而，它们也充当了“开拓者”的角色，改变了阿尔茨海默病的概念，以便以后可以轻松地进行生物标志物测试。本文最后对其他诊断指南中可能存在的此类“开拓性”及其从伦理和社会角度的可接受性进行了一些反思。
In innovation policy discourse, clinical practice guidelines are often viewed as gatekeepers: they select which novel technologies may enter clinical practice. Earlier research has pointed out, however, that in biomedical innovation a 'regime of hope' and a 'regime of truth' interact. High expectations of future developments can feed into clinical guidelines by changing assessment criteria, thus co-shaping the 'gate' innovations have to pass. This paper shows how diagnostic guidelines can embody hope in yet another way, by introducing a novel disease vocabulary that paves the way for emerging diagnostic technologies. I discuss two sets of guidelines for diagnosing Alzheimer's disease: the guidelines issued by the American National Institute on Aging and the Alzheimer's Association (2011), and the parts of the DSM-5 related to diagnosing AD (2013). Both function as gatekeepers in that they explicitly discourage the use of biomarker testing in clinical practice. However, they also act as 'trailblazers', transforming the conceptualization of Alzheimer's disease in such a way that biomarker tests can be easily fitted in later on. The paper ends with some reflections on the potential presence of such 'trailblazing' in other diagnostic guidelines, and its acceptability from an ethical and societal point of view.