Schneeweiss S, Kriegmair M, Stepp H
Department of Epidemiology, Harvard University School of Public Health, Boston, Massachusetts, USA.
J Urol. 1999 Apr;161(4):1116-9.
We demonstrate a simple yet comprehensive method to evaluate the sensitivity of endoscopic procedures when no gold standard is available.
In 208 consecutive patients with superficial bladder cancer 328 endoscopies were performed to compare the sensitivity of white light and 5-aminolevulinic acid induced fluorescence endoscopy. Both procedures were performed during the same session.
The maximum interval of observable sensitivity for 5-aminolevulinic acid induced fluorescence endoscopy ranged between 78 and 97.5%, and the best estimate for sensitivity based on realistic assumptions was 93.4% (95% confidence intervals 90 to 97.3). The best sensitivity estimate for white light endoscopy was 46.7% (95% confidence intervals 39.4 to 54.3, maximum range 47.2 to 53%).
This method to determine the maximum possible range of sensitivity estimates for endoscopic procedures without a gold standard is easily applied. Depending on the assumptions a range of reasonable scenarios can be constructed and the corresponding sensitivities can be reported. This approach gives fast and valid results, and could further indicate the diagnostic superiority of 5-aminolevulinic acid induced fluorescence compared to white light endoscopy.
我们展示了一种简单而全面的方法，用于在没有金标准的情况下评估内镜检查程序的敏感性。
对208例连续性浅表性膀胱癌患者进行了328次内镜检查，以比较白光内镜和5-氨基乙酰丙酸诱导荧光内镜的敏感性。两种检查均在同一次检查中进行。
5-氨基乙酰丙酸诱导荧光内镜可观察到的敏感性最大区间为78%至97.5%，基于实际假设的敏感性最佳估计值为93.4%（95%置信区间90%至97.3%）。白光内镜的最佳敏感性估计值为46.7%（95%置信区间39.4%至54.3%，最大范围47.2%至53%）。
这种在没有金标准的情况下确定内镜检查程序敏感性估计最大可能范围的方法易于应用。根据假设，可以构建一系列合理的情况并报告相应的敏感性。这种方法能快速得出有效结果，并可进一步表明5-氨基乙酰丙酸诱导荧光与白光内镜相比的诊断优势。
