Markers for early detection of cancer: statistical guidelines for nested case-control studies.
Markers for early detection of cancer: statistical guidelines for nested case-control studies.
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DOI：
10.1186/1471-2288-2-4
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发表时间：
2002-01-01
影响因子：
4
通讯作者：
Srivastava, Sudhir
中科院分区：
文献类型：
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作者：
Baker, Stuart G;Kramer, Barnett S;Srivastava, Sudhir
背景：最近许多长期的前瞻性研究都涉及到血液或组织标本的连续采集和储存。这刺激了巢式病例对照研究，包括测试一些标本中可能预测癌症的各种标志物。到目前为止，在统计设计和分析这些study.METHODS：制定统计指南，我们认为的目的，类型的偏见，并提取额外的信息的机会。（1）为了解释得最清楚，统计应该基于假阳性率和真阳性率-而不是优势比或相对风险（2）为了避免过度诊断偏倚，应根据症状而不是筛查来诊断病例。(3)为了尽量减少选择偏倚，研究人群和目标筛选人群的对照条件范围应相同。(4)为了提取额外的信息，阳性检测的标准应基于单个标志物的组合和标志物水平随时间的变化。(5)为避免过度拟合，应在同一研究的随机供试样本中评价训练样本中形成的阳性标志物组合标准，如可能，还应在另一项研究的验证样本中评价。(6)识别生物标志物的真阳性率和假阳性率类似于乳腺X线摄影，训练，测试和验证样本应包括至少110个随机选择的受试者没有癌症和70个受试者与cancer.CONCLUSION：这些指南确保良好的实践中的设计和分析巢式病例对照研究的早期检测生物标志物。
BACKGROUND: Recently many long-term prospective studies have involved serial collection and storage of blood or tissue specimens. This has spurred nested case-control studies that involve testing some specimens for various markers that might predict cancer. Until now there has been little guidance in statistical design and analysis of these studies.METHODS: To develop statistical guidelines, we considered the purpose, the types of biases, and the opportunities for extracting additional information.RESULTS: The following guidelines: (1) For the clearest interpretation, statistics should be based on false and true positive rates - not odds ratios or relative risks (2) To avoid overdiagnosis bias, cases should be diagnosed as a result of symptoms rather than on screening. (3) To minimize selection bias, the spectrum of control conditions should be the same in study and target screening populations. (4) To extract additional information, criteria for a positive test should be based on combinations of individual markers and changes in marker levels over time. (5) To avoid overfitting, the criteria for a positive marker combination developed in a training sample should be evaluated in a random test sample from the same study and, if possible, a validation sample from another study. (6) To identify biomarkers with true and false positive rates similar to mammography, the training, test, and validation samples should each include at least 110 randomly selected subjects without cancer and 70 subjects with cancer.CONCLUSION: These guidelines ensure good practice in the design and analysis of nested case-control studies of early detection biomarkers.