Pivotal evaluation of the accuracy of a biomarker used for classification or prediction: standards for study design.
Pivotal evaluation of the accuracy of a biomarker used for classification or prediction: standards for study design.
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关键评估用于分类或预测的生物标志物的准确性：研究设计标准。
DOI：
10.1093/jnci/djn326
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发表时间：
2008-10-15
影响因子：
10.3
通讯作者：
Potter, John D.
中科院分区：
文献类型：
--
作者：
Pepe, Margaret S.;Feng, Ziding;Janes, Holly;Bossuyt, Patrick M.;Potter, John D.
生物标志物评价的研究方法落后于评价治疗性治疗的研究方法。虽然生物标志物的开发有一个阶段性的方法，并且有报告研究结果的指南，但尚未制定一套连贯和全面的研究设计指南。我们描述了一个巢式病例对照研究设计，涉及前瞻性标本收集前，结果确定从一个研究队列，是相关的临床应用。在研究队列中随机选择的病例患者和对照受试者的标本上以盲法测定生物标志物。我们分别描述了与临床背景、生物标志物性能标准、生物标志物检测和研究规模相关的设计方面。该设计可应用于旨在用于疾病诊断、筛查或预后的生物标志物的研究。如果遵循这些严格的标准，生物标志物研究文献中普遍存在的偏见将被消除。
Research methods for biomarker evaluation lag behind those for evaluating therapeutic treatments. Although a phased approach to development of biomarkers exists and guidelines are available for reporting study results, a coherent and comprehensive set of guidelines for study design has not been delineated. We describe a nested case–control study design that involves prospective collection of specimens before outcome ascertainment from a study cohort that is relevant to the clinical application. The biomarker is assayed in a blinded fashion on specimens from randomly selected case patients and control subjects in the study cohort. We separately describe aspects of the design that relate to the clinical context, biomarker performance criteria, the biomarker test, and study size. The design can be applied to studies of biomarkers intended for use in disease diagnosis, screening, or prognosis. Common biases that pervade the biomarker research literature would be eliminated if these rigorous standards were followed.
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影响因子：
4
作者：
Baker, Stuart G;Kramer, Barnett S;Srivastava, Sudhir
通讯作者：
Srivastava, Sudhir
影响因子：
10.3
作者：
Kerlikowske, K;Molinaro, A;Waldman, F
通讯作者：
Waldman, F
影响因子：
105.7
作者：
Knottnerus, JA;van Weel, C;Muris, JWM
通讯作者：
Muris, JWM
影响因子：
2.1
作者：
Feng, Z;Prentice, R;Srivastava, S
通讯作者：
Srivastava, S
影响因子：
5
作者：
Janes, Holly;Pepe, Margaret S.
通讯作者：
Pepe, Margaret S.