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[多元评估模型是否有理论依据?随机临床试验的局限性]

[Is there a rationale for pluralistic evaluation models? Limitations of randomized clinical trials].

作者信息

Kienle Gunver S

机构信息

Institut für angewandte Erkenntnistheorie und medizinische Methodologie, Bad Krozingen.

出版信息

Z Arztl Fortbild Qualitatssich. 2005;99(4-5):289-94.

Abstract

Randomized clinical trials (RCTs) are believed to deliver the highest level of clinical evidence, and other types of evidence are rarely integrated in therapy assessments. Under ideal circumstances, RCTs are perfect tools of therapy evaluation; however, in clinical reality they suffer from a variety of limitations. Their prioritization can distort public health regulation because of commercial bias, career bias, bias of large numbers, mediocrity bias, and bias of therapy preferences; also, they can lead to discrepancies between clinical research and routine medical practice, to ethical problems, and to divergent and asymmetrical results. Moreover, the seemingly simple therapy assessment based on RCT results bears the danger of their endorsement and misuse by non-medical personnel, especially bureaucrats. To meet the demands of the complex reality of medical care, the physician's judgment should be methodologically professionalized and re-integrated into the process of generating medical knowledge; fixed hierarchies of medical evidence should be de-emphasized in favor of information syntheses from different types of (quality assessed) evidence.

摘要

随机临床试验(RCTs)被认为能提供最高水平的临床证据,而其他类型的证据在治疗评估中很少被整合。在理想情况下,随机临床试验是治疗评估的完美工具;然而,在临床实际中,它们存在各种局限性。由于商业偏见、职业偏见、数量偏见、平庸偏见和治疗偏好偏见,对它们的优先考虑可能会扭曲公共卫生监管;此外,它们可能导致临床研究与常规医疗实践之间的差异、伦理问题以及结果的分歧和不对称。此外,基于随机临床试验结果的看似简单的治疗评估存在被非医疗人员(尤其是官僚)认可和滥用的风险。为了满足医疗保健复杂现实的需求,医生的判断应在方法上实现专业化,并重新融入医学知识的生成过程;应淡化医学证据的固定等级制度,转而支持来自不同类型(经过质量评估)证据的信息综合。

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