作者投稿
专家审稿
编辑办公
邮件订阅
RSS
-
摘要: 新的诊断方法在临床开展之前, 必须经由严格设计的诊断试验准确性研究进行评价。诊断试验准确性研究设计包括应用PICOS(P:Patient; I:Intervention; C:Comparison; O:Outcome; S:Study design)原则构建研究问题、确定诊断金标准、选择具有代表性的研究对象、估算样本量、同步盲法比较诊断试验与金标准结果、确立最佳截点值、评价诊断准确性以及遵循诊断准确性研究报告规范进行论文报告8个方面。诊断试验的准确性指标包括灵敏度、特异度、预测值和似然比。其中, 诊断试验的似然比可帮助医生从验前概率获得验后概率。当医疗环境与研究环境相似、收治患者符合研究入组标准时, 应用诊断试验研究的似然比有助于对目标疾病进行诊断与鉴别诊断。Abstract: New diagnostic methods must be evaluated by rigorously designed diagnostic accuracy studies before clinical implementation. Designing a diagnostic accuracy study includes 8 procedures:constructing the research question with the PICOS (P:Patient; I:Intervention; C:Comparison; O:Outcome; S:Study design)framework, identifying an appropriate gold standard, choosing a representative patient sample, estimating the sample size, interpreting results of diagnostic tests and the gold standard blind to the other, setting up the optimal threshold, evaluating the diagnostic accuracy, and finally drafting a report according to the standards for reporting diagnostic accuracy. The accuracy of diagnostic tests includes sensitivity, specificity, predictive value (PV), and likelihood ratio (LR). The LR estimated by diagnostic tests can move clinicians from the pretest probability to a posttest probability. If the clinical setting is similar to that of the study and the patient meets all eligibility criteria of the study, the LR may facilitate the diagnostic process in clinical practice.
-
Key words:
- diagnostic test /
- study design /
- clinical practice
利益冲突 无 -
表 1 诊断试验四格表
诊断试验 金标准诊断 合计 有病 无病 阳性 真阳性(a) 假阳性(b) a+b 阴性 假阴性(c) 真阴性(d) c+d 合计 a+c b+d a+b+c+d a.真阳性，指金标准诊断为“有病”且诊断试验结果是“阳性”的例数；b.假阳性，指金标准诊断为“无病”但诊断试验结果是“阳性”的例数；c.假阴性，指金标准诊断为“有病”但诊断试验结果是“阴性”的例数；d.真阴性，指金标准诊断为“无病”且诊断试验结果是“阴性”的例数 
下载: 导出CSV
-
[1] Yerushalmy J. Statistical problems in assessing methods of medical diagnosis, with special reference to X-ray techniques[J]. Public Health Rep, 1947, 62:1432-1449. doi: 10.2307/4586294 [2] Vecchio TJ. Predictive value of a single diagnostic test in unselected populations[J]. N Engl J Med, 1966, 274:1171-1173. doi: 10.1056/NEJM196605262742104 [3] Grimes DA, Schulz KF. Refining clinical diagnosis with likelihood ratios[J]. Lancet, 2005, 365:1500-1505. doi: 10.1016/S0140-6736(05)66422-7 [4] Sackett DL, Haynes RB. The architecture of diagnostic research[J]. BMJ, 2002, 324:539-541. doi: 10.1136/bmj.324.7336.539 [5] Lijmer JG, Mol BW, Heisterkamp S, et al. Empirical evidence of design-related bias in studies of diagnostic tests[J]. JAMA, 1999, 282:1061-1066. doi: 10.1001/jama.282.11.1061 [6] Glasziou P, Irwig L, Deeks JJ. When should a new test become the current reference standard?[J]. Ann Intern Med, 2008, 149:816-822. doi: 10.7326/0003-4819-149-11-200812020-00009 [7] Worster A, Carpenter C. Incorporation bias in studies of diagnostic tests:how to avoid being biased about bias[J]. CJEM, 2008, 10:174-175. doi: 10.1017/S1481803500009891 [8] Weiss NS. Control definition in case-control studies of the efficacy of screening and diagnostic testing[J]. Am J Epidemiol, 1983, 118:457-460. doi: 10.1093/oxfordjournals.aje.a113650 [9] Whiting PF, Rutjes AW, Westwood ME, et al. A systematic review classifies sources of bias and variation in diagnostic test accuracy studies[J]. J Clin Epidemiol, 2013, 66:1093-1104. doi: 10.1016/j.jclinepi.2013.05.014 [10] Rutjes AW, Reitsma JB, Di Nisio M, et al. Evidence of bias and variation in diagnostic accuracy studies[J]. CMAJ, 2006, 174:469-476. doi: 10.1503/cmaj.050090 [11] Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics[J]. J Biomed Inform, 2014, 48:193-204. doi: 10.1016/j.jbi.2014.02.013 [12] Simel DL, Samsa GP, Matchar DB. Likelihood ratios with confidence:sample size estimation for diagnostic test studies[J]. J Clin Epidemiol, 1991, 44:763-770. doi: 10.1016/0895-4356(91)90128-V [13] Whiting P, Rutjes AW, Reitsma JB, et al. Sources of variation and bias in studies of diagnostic accuracy:a systematic review[J]. Ann Intern Med, 2004, 140:189-202. doi: 10.7326/0003-4819-140-3-200402030-00010 [14] Leeflang MM, Rutjes AW, Reitsma JB, et al. Variation of a test's sensitivity and specificity with disease prevalence[J]. CMAJ, 2013, 185:E537-E544. doi: 10.1503/cmaj.121286 [15] Akobeng AK. Understanding diagnostic tests 1:sensitivity, specificity and predictive values[J]. Acta Paediatr, 2007, 96:338-341. doi: 10.1111/j.1651-2227.2006.00180.x [16] Akobeng AK. Understanding diagnostic tests 2:likelihood ratios, pre- and post-test probabilities and their use in clinical practice[J]. Acta Paediatr, 2007, 96:487-491. doi: 10.1111/j.1651-2227.2006.00179.x [17] Bossuyt PM, Reitsma JB, Bruns DE, et al. Towards complete and accurate reporting of studies of diagnostic accuracy:the STARD initiative[J]. BMJ, 2003, 326:41-44. doi: 10.1136/bmj.326.7379.41 [18] Bossuyt PM, Reitsma JB, Bruns DE, et al. STARD 2015:an updated list of essential items for reporting diagnostic accuracy studies[J]. BMJ, 2015, 351:h5527. http://www.bmj.com/content/351/bmj.h5527 [19] 王波, 詹思延.如何撰写高质量的流行病学研究论文第三讲诊断试验准确性研究的报告规范——STARD介绍[J].中华流行病学杂志, 2006, 27:909-912. http://d.wanfangdata.com.cn/Periodical/zhlxbx200610020 [20] 朱一丹, 李会娟, 武阳丰.诊断准确性研究报告规范(STARD)2015介绍与解读[J].中国循证医学杂志, 2016, 16:730-735. http://www.wanfangdata.com.cn/details/detail.do?_type=perio&id=zgxzyx201606017 [21] 孙凤.医学研究报告规范解读[M].北京:北京大学医学出版社, 2015:181-188. [22] Whiting P, Rutjes AW, Reitsma JB, et al. The development of QUADAS:a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews[J]. BMC Med Res Methodol, 2003, 3:25. doi: 10.1186/1471-2288-3-25 [23] Whiting PF, Rutjes AW, Westwood ME, et al. QUADAS-2:a revised tool for the quality assessment of diagnostic accuracy studies[J]. Ann Intern Med, 2011, 155:529-536. doi: 10.7326/0003-4819-155-8-201110180-00009 [24] Schunemann HJ, Oxman AD, Brozek J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies[J]. BMJ, 2008, 336:1106-1110. https://core.ac.uk/display/77296584 [25] Richardson WS. Where do pretest probabilities come from?[J]. Evid Based Med, 1999, 4:68-69. http://www.onacademic.com/detail/journal_1000038118494510_f71d.html [26] Fagan TJ. Letter:Nomogram for Bayes theorem[J]. N Engl J Med, 1975, 293:257. http://europepmc.org/abstract/med/1143310 [27] Shi X, Zhang L, Zhang Y, et al. Utility of T-Cell Interferon-gamma Release Assays for Etiological Diagnosis of Classic Fever of Unknown Origin in a High Tuberculosis Endemic Area-a pilot prospective cohort[J]. PLoS One, 2016, 11:e0146879. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4718655/ -
点击查看大图
图(3) / 表(1)
计量
- 文章访问数: 1273
- HTML全文浏览量: 525
- PDF下载量: 477
- 被引次数: 0
