诊断试验准确性研究设计及临床应用 come the current reference standard? [JJ. Ann Intern Med y: the STARD initiative [J]. BM, 2003, 326: 41-44. 2008,149:816-82 [18 Bossuyt PM, Reitsma JB, Bruns DE, et al. STARD 2015 [7] Worster A, Carpenter C. Incorporation bias in studies of di- an updated list of essential items for reporting diagnostic ac- agnostic tests: how to avoid being biased about bias [J] curacy studies [J]. BMJ, 2015, 351: h5527. CJEM,2008,10:174-17 [19]王波,詹思延如何撰写高质量的流行病学研究论文第 [8] Weiss NS Control definition in case-control studies of the ef- 三讲诊断试验准确性研究的报告规范一 STARD介绍 ficacy of screening and diagnostic testing [J]. Am J Epide. [J].中华流行病学杂志,2006,27:909-912 iol,1983,118:457-460. [20]朱一丹,李会娟,武阳丰.诊断准确性研究报告规范 [9 Whiting PF, Rutjes AW, Westwood ME, et al. A systematic ( STARD)2015介绍与解读[J].中国循证医学杂志 review classifies sources of bias and variation in diagnostic 2016.16:730-735 test accuracy studies[J]. J Clin Epidemiol,2013,66:[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,2015:1 [10] Rutjes AW, Reitsma JB, Di Nisio M, et al. Evidence of bias [22] Whiting P, Rutjes AW, Reitsma JB, et al. The development [J].C 2006,174:469-476 diagnostic accuracy included in systematic reviews [J] [11] Hajian-Tilaki K. Sample size estimation in diagnostic test BMC Med Res methodol. 2003. 3. 25 studies of biomedical informatics [J]. J Biomed Inform, [23 Whiting PF, Rutjes AW, Westwood ME, et al. QUADAS-2 014,48:193-204. a revised tool for the quality assessment of diagnostic 12 Simel DL, Samsa GP, Matchar DB. Likelihood ratios with accuracy studies [J]. Ann Intern Med, 2011, 155 confidence: sample size estimation for diagnostic test studi [J].J Clin Epidemiol, 1991, 44: 763-770 [24 Schunemann H], Oxman AD, Brozek J, et al. Grading [13 Whiting P, Rutjes AW, Reitsma JB, et al. Sources of varia- tion and bias in studies of diagnostic accuracy: a systematic nostic tests and strategies [J]. BMJ, 2008, 336 review [J]. Ann Intern Med, 2004, 140: 189-202 1106·1110 [ 14] Leeflang MM, Rutjes AW, Reitsma JB, et al. Variation of a [25] Richardson WS. Where do pretest probabilities come from? test,'s sensitivity and specificity with dis [J]. Evid Based Med, 1999, 4: 68-69 CMAJ,2013,185:E537-E544 [26] Fagan TJ Letter: Nomogram for Bayes theorem [J]. N Engl [15] Akobeng AK. Understanding diagnostic tests 1: sensitivity JMed,1975,293:257 specificity and predictive values [J]. Acta Paediatr, 2007. [27] Shi X, Zhang L, Zhang Y, et al. Utility of T-Cell Interferon- 96:338-341. gamma Release Assays for Etiological Diagnosis of Classic [16] Akobeng AK. Understanding diagnostic tests 2 Fever of Unknown Origin in a High Tuberculosis Endemic ratios, pre- and post-test probabilities and the Area-a pilot prospective cohort [J]. PLos One, 2016 clinical practice [J]. Acta Paediatr, 2007, 96:487-49 ll:e0l46879. [17] Bossuyt PM, Reitsma JB, Bruns DE, et al. Towards complete and accurate reporting of studies of diagnostic accu- (收稿日期:2019-12-11) VoL. 1 No. 1 101诊断试验准确性研究设计及临床应用 Ｖｏｌ􀆰 １１ Ｎｏ􀆰 １ １０１ ｃｏｍｅ ｔｈｅ ｃｕｒｒｅｎｔ ｒｅｆｅｒｅｎｃｅ ｓｔａｎｄａｒｄ? [Ｊ]. Ａｎｎ Ｉｎｔｅｒｎ Ｍｅｄꎬ ２００８ꎬ １４９: ８１６￣ ８２２. [７] Ｗｏｒｓｔｅｒ Ａꎬ Ｃａｒｐｅｎｔｅｒ Ｃ. Ｉｎｃｏｒｐｏｒａｔｉｏｎ ｂｉａｓ ｉｎ ｓｔｕｄｉｅｓ ｏｆ ｄｉ￣ ａｇｎｏｓｔｉｃ ｔｅｓｔｓ: ｈｏｗ ｔｏ ａｖｏｉｄ ｂｅｉｎｇ ｂｉａｓｅｄ ａｂｏｕｔ ｂｉａｓ [ Ｊ]. ＣＪＥＭꎬ ２００８ꎬ １０: １７４￣ １７５. [８] Ｗｅｉｓｓ ＮＳ. Ｃｏｎｔｒｏｌ ｄｅｆｉｎｉｔｉｏｎ ｉｎ ｃａｓｅ￣ｃｏｎｔｒｏｌ ｓｔｕｄｉｅｓ ｏｆ ｔｈｅ ｅｆ￣ ｆｉｃａｃｙ ｏｆ ｓｃｒｅｅｎｉｎｇ ａｎｄ ｄｉａｇｎｏｓｔｉｃ ｔｅｓｔｉｎｇ [Ｊ]. Ａｍ Ｊ Ｅｐｉｄｅ￣ ｍｉｏｌꎬ １９８３ꎬ １１８: ４５７￣ ４６０. [９] Ｗｈｉｔｉｎｇ ＰＦꎬ Ｒｕｔｊｅｓ ＡＷꎬ Ｗｅｓｔｗｏｏｄ ＭＥꎬ ｅｔ ａｌ. Ａ ｓｙｓｔｅｍａｔｉｃ ｒｅｖｉｅｗ ｃｌａｓｓｉｆｉｅｓ ｓｏｕｒｃｅｓ ｏｆ ｂｉａｓ ａｎｄ ｖａｒｉａｔｉｏｎ ｉｎ ｄｉａｇｎｏｓｔｉｃ ｔｅｓｔ ａｃｃｕｒａｃｙ ｓｔｕｄｉｅｓ [ Ｊ]. Ｊ Ｃｌｉｎ Ｅｐｉｄｅｍｉｏｌꎬ ２０１３ꎬ ６６: １０９３￣ １１０４. [１０] Ｒｕｔｊｅｓ ＡＷꎬ Ｒｅｉｔｓｍａ ＪＢꎬ Ｄｉ Ｎｉｓｉｏ Ｍꎬ ｅｔ ａｌ. Ｅｖｉｄｅｎｃｅ ｏｆ ｂｉａｓ ａｎｄ ｖａｒｉａｔｉｏｎ ｉｎ ｄｉａｇｎｏｓｔｉｃ ａｃｃｕｒａｃｙ ｓｔｕｄｉｅｓ [ Ｊ]. ＣＭＡＪꎬ ２００６ꎬ １７４: ４６９￣ ４７６. [１１] Ｈａｊｉａｎ￣Ｔｉｌａｋｉ Ｋ. Ｓａｍｐｌｅ ｓｉｚｅ ｅｓｔｉｍａｔｉｏｎ ｉｎ ｄｉａｇｎｏｓｔｉｃ ｔｅｓｔ ｓｔｕｄｉｅｓ ｏｆ ｂｉｏｍｅｄｉｃａｌ ｉｎｆｏｒｍａｔｉｃｓ [ Ｊ]. Ｊ Ｂｉｏｍｅｄ Ｉｎｆｏｒｍꎬ ２０１４ꎬ ４８: １９３￣ ２０４. [１２] Ｓｉｍｅｌ ＤＬꎬ Ｓａｍｓａ ＧＰꎬ Ｍａｔｃｈａｒ ＤＢ. Ｌｉｋｅｌｉｈｏｏｄ ｒａｔｉｏｓ ｗｉｔｈ ｃｏｎｆｉｄｅｎｃｅ: ｓａｍｐｌｅ ｓｉｚｅ ｅｓｔｉｍａｔｉｏｎ ｆｏｒ ｄｉａｇｎｏｓｔｉｃ ｔｅｓｔ ｓｔｕｄｉｅｓ [Ｊ]. Ｊ Ｃｌｉｎ Ｅｐｉｄｅｍｉｏｌꎬ １９９１ꎬ ４４: ７６３￣ ７７０. [１３] Ｗｈｉｔｉｎｇ Ｐꎬ Ｒｕｔｊｅｓ ＡＷꎬ Ｒｅｉｔｓｍａ ＪＢꎬ ｅｔ ａｌ. Ｓｏｕｒｃｅｓ ｏｆ ｖａｒｉａ￣ ｔｉｏｎ ａｎｄ ｂｉａｓ ｉｎ ｓｔｕｄｉｅｓ ｏｆ ｄｉａｇｎｏｓｔｉｃ ａｃｃｕｒａｃｙ: ａ ｓｙｓｔｅｍａｔｉｃ ｒｅｖｉｅｗ [Ｊ]. Ａｎｎ Ｉｎｔｅｒｎ Ｍｅｄꎬ ２００４ꎬ １４０: １８９￣ ２０２. [１４] Ｌｅｅｆｌａｎｇ ＭＭꎬ Ｒｕｔｊｅｓ ＡＷꎬ Ｒｅｉｔｓｍａ ＪＢꎬ ｅｔ ａｌ. Ｖａｒｉａｔｉｏｎ ｏｆ ａ ｔｅｓｔ􀆳ｓ ｓｅｎｓｉｔｉｖｉｔｙ ａｎｄ ｓｐｅｃｉｆｉｃｉｔｙ ｗｉｔｈ ｄｉｓｅａｓｅ ｐｒｅｖａｌｅｎｃｅ [Ｊ]. ＣＭＡＪꎬ ２０１３ꎬ １８５: Ｅ５３７￣Ｅ５４４. [１５] Ａｋｏｂｅｎｇ ＡＫ. Ｕｎｄｅｒｓｔａｎｄｉｎｇ ｄｉａｇｎｏｓｔｉｃ ｔｅｓｔｓ １: ｓｅｎｓｉｔｉｖｉｔｙꎬ ｓｐｅｃｉｆｉｃｉｔｙ ａｎｄ ｐｒｅｄｉｃｔｉｖｅ ｖａｌｕｅｓ [Ｊ]. Ａｃｔａ Ｐａｅｄｉａｔｒꎬ ２００７ꎬ ９６: ３３８￣ ３４１. [１６] Ａｋｏｂｅｎｇ ＡＫ. Ｕｎｄｅｒｓｔａｎｄｉｎｇ ｄｉａｇｎｏｓｔｉｃ ｔｅｓｔｓ ２: ｌｉｋｅｌｉｈｏｏｄ ｒａｔｉｏｓꎬ ｐｒｅ￣ ａｎｄ ｐｏｓｔ￣ｔｅｓｔ ｐｒｏｂａｂｉｌｉｔｉｅｓ ａｎｄ ｔｈｅｉｒ ｕｓｅ ｉｎ ｃｌｉｎｉｃａｌ ｐｒａｃｔｉｃｅ [Ｊ]. Ａｃｔａ Ｐａｅｄｉａｔｒꎬ ２００７ꎬ ９６: ４８７￣ ４９１. [１７] Ｂｏｓｓｕｙｔ ＰＭꎬ Ｒｅｉｔｓｍａ ＪＢꎬ Ｂｒｕｎｓ ＤＥꎬ ｅｔ ａｌ. Ｔｏｗａｒｄｓ ｃｏｍｐｌｅｔｅ ａｎｄ ａｃｃｕｒａｔｅ ｒｅｐｏｒｔｉｎｇ ｏｆ ｓｔｕｄｉｅｓ ｏｆ ｄｉａｇｎｏｓｔｉｃ ａｃｃｕ￣ ｒａｃｙ: ｔｈｅ ＳＴＡＲＤ ｉｎｉｔｉａｔｉｖｅ [Ｊ]. ＢＭＪꎬ ２００３ꎬ ３２６: ４１￣ ４４. [１８] Ｂｏｓｓｕｙｔ ＰＭꎬ Ｒｅｉｔｓｍａ ＪＢꎬ Ｂｒｕｎｓ ＤＥꎬ ｅｔ ａｌ. ＳＴＡＲＤ ２０１５: ａｎ ｕｐｄａｔｅｄ ｌｉｓｔ ｏｆ ｅｓｓｅｎｔｉａｌ ｉｔｅｍｓ ｆｏｒ ｒｅｐｏｒｔｉｎｇ ｄｉａｇｎｏｓｔｉｃ ａｃ￣ ｃｕｒａｃｙ ｓｔｕｄｉｅｓ [Ｊ]. ＢＭＪꎬ ２０１５ꎬ ３５１: ｈ５５２７. [１９] 王波ꎬ 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ꎬ ２００６ꎬ ２７: ９０９￣ ９１２. [２０] 朱一丹ꎬ 李会娟ꎬ 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ꎬ ２０１６ꎬ １６: ７３０￣ ７３５. [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ꎬ ２０１５: １８１￣ １８８. [２２] Ｗｈｉｔｉｎｇ Ｐꎬ Ｒｕｔｊｅｓ ＡＷꎬ Ｒｅｉｔｓｍａ ＪＢꎬ 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 Ｍｅｔｈｏｄｏｌꎬ ２００３ꎬ ３: ２５. [２３] Ｗｈｉｔｉｎｇ ＰＦꎬ Ｒｕｔｊｅｓ ＡＷꎬ Ｗｅｓｔｗｏｏｄ ＭＥꎬ ｅｔ ａｌ. ＱＵＡＤＡＳ￣２: ａ ｒｅｖｉｓｅｄ ｔｏｏｌ ｆｏｒ ｔｈｅ ｑｕａｌｉｔｙ ａｓｓｅｓｓｍｅｎｔ ｏｆ ｄｉａｇｎｏｓｔｉｃ ａｃｃｕｒａｃｙ ｓｔｕｄｉｅｓ [ Ｊ ]. Ａｎｎ Ｉｎｔｅｒｎ Ｍｅｄꎬ ２０１１ꎬ １５５: ５２９￣ ５３６. [２４] Ｓｃｈｕｎｅｍａｎｎ ＨＪꎬ Ｏｘｍａｎ ＡＤꎬ Ｂｒｏｚｅｋ Ｊꎬ ｅｔ ａｌ. Ｇｒａｄｉｎｇ ｑｕａｌｉｔｙ ｏｆ ｅｖｉｄｅｎｃｅ ａｎｄ ｓｔｒｅｎｇｔｈ ｏｆ ｒｅｃｏｍｍｅｎｄａｔｉｏｎｓ ｆｏｒ ｄｉａｇ￣ ｎｏｓｔｉｃ ｔｅｓｔｓ ａｎｄ ｓｔｒａｔｅｇｉｅｓ [ Ｊ ]. ＢＭＪꎬ ２００８ꎬ ３３６: １１０６￣ １１１０. [２５] Ｒｉｃｈａｒｄｓｏｎ ＷＳ. Ｗｈｅｒｅ ｄｏ ｐｒｅｔｅｓｔ ｐｒｏｂａｂｉｌｉｔｉｅｓ ｃｏｍｅ ｆｒｏｍ? [Ｊ]. Ｅｖｉｄ Ｂａｓｅｄ Ｍｅｄꎬ １９９９ꎬ ４: ６８￣ ６９. [２６] Ｆａｇａｎ ＴＪ. Ｌｅｔｔｅｒ: Ｎｏｍｏｇｒａｍ ｆｏｒ Ｂａｙｅｓ ｔｈｅｏｒｅｍ [Ｊ]. Ｎ Ｅｎｇｌ Ｊ Ｍｅｄꎬ １９７５ꎬ ２９３: ２５７. [２７] Ｓｈｉ Ｘꎬ Ｚｈａｎｇ Ｌꎬ Ｚｈａｎｇ Ｙꎬ 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 Ｏｎｅꎬ ２０１６ꎬ １１: ｅ０１４６８７９. (收稿日期: ２０１９￣ １２￣ １１)