Hassan Cesare, Piovani Daniele, Spadaccini Marco, Parigi Tommaso, Khalaf Kareem, Facciorusso Antonio, Fugazza Alessandro, Rösch Thomas, Bretthauer Michael, Mori Yuichi, Sharma Prateek, Rex Douglas K, Bonovas Stefanos, Repici Alessandro
Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy; Endoscopy Unit, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.
Department of Biomedical Sciences, Pieve Emanuele, Humanitas University, Rozzano, Italy.
Gastrointest Endosc. 2023 Feb;97(2):212-225.e7. doi: 10.1016/j.gie.2022.10.009. Epub 2022 Oct 13.
Adenoma detection rate (ADR) is still the main surrogate outcome parameter of screening colonoscopy, but most studies include mixed indications, and basic ADR is quite variable. We therefore looked at the control groups in randomized ADR trials using advanced imaging or mechanical methods to find out whether indications or other factors influence ADR levels.
Patients in the control groups of randomized controlled trials (RCTs) on ADR increase using various methods were collected based on a systematic review; this control group had to use high-definition white-light endoscopy performed between 2008 and 2021. Random-effects meta-analysis was used to pool ADR in control groups and its 95% confidence interval (CI) according to clinical (indication and demographic), study setting (tandem/parallel, number of centers, sample size), and technical (type of intervention, withdrawal time) parameters. Interstudy heterogeneity was reported with the I statistic. Multivariable mixed-effects meta-regression was performed for potentially relevant variables.
From 80 studies, 25,304 patients in the respective control groups were included. ADR in control arms varied between 8.2% and 68.1% with a high degree of heterogeneity (I = 95.1%; random-effect pooled value, 37.5%; 95% CI, 34.6‒40.5). There was no difference in ADR levels between primary colonoscopy screening (12 RCTs, 15%) and mixed indications including screening/surveillance and diagnostic colonoscopy; however, fecal immunochemical testing as an indication for colonoscopy was an independent predictor of ADR (odds ratio [OR], 1.6; 95% CI, 1.1-2.4). Other well-known parameters were confirmed by our analysis such as age (OR, 1.038; 95% CI, 1.004-1.074), sex (male sex: OR, 1.02; 95% CI, 1.01-1.03), and withdrawal time (OR, 1.1; 95% CI, 1.0-1.1). The type of intervention (imaging vs mechanical) had no influence, but methodologic factors did: More recent year of publication and smaller sample size were associated with higher ADR.
A high level of variability was found in the level of ADR in the control groups of RCTs. With regards to indications, only fecal immunochemical test-based colonoscopy studies influenced basic ADR, and primary colonoscopy screening appeared to be similar to other indications. Standardization for variables related to clinical, methodologic, and technical parameters is required to achieve generalizability and reproducibility.
腺瘤检出率（ADR）仍是结肠镜筛查的主要替代结局参数，但大多数研究纳入的适应证混杂，且基础ADR差异较大。因此，我们研究了使用先进成像或机械方法的随机ADR试验中的对照组，以了解适应证或其他因素是否会影响ADR水平。
基于系统评价收集了使用各种方法提高ADR的随机对照试验（RCT）对照组中的患者；该对照组必须采用2008年至2021年间进行的高清白光结肠镜检查。采用随机效应荟萃分析，根据临床（适应证和人口统计学）、研究设置（串联/平行、中心数量、样本量）和技术（干预类型、退镜时间）参数，汇总对照组的ADR及其95%置信区间（CI）。用I统计量报告研究间异质性。对潜在相关变量进行多变量混合效应荟萃回归分析。
纳入了80项研究中各自对照组的25304例患者。各对照组的ADR在8.2%至68.1%之间，异质性较高（I = 95.1%；随机效应合并值为37.5%；95%CI为34.6‒40.5）。初次结肠镜筛查（12项RCT，15%）与包括筛查/监测和诊断性结肠镜检查在内的混杂适应证之间的ADR水平无差异；然而，粪便免疫化学检测作为结肠镜检查的适应证是ADR的独立预测因素（比值比[OR]为1.6；95%CI为1.1‒2.4）。我们的分析证实了其他一些众所周知的参数，如年龄（OR为1.038；95%CI为1.004‒1.074）、性别（男性：OR为1.02；95%CI为1.01‒1.03）和退镜时间（OR为1.1；95%CI为1.0‒1.1）。干预类型（成像与机械）无影响，但方法学因素有影响：较新的发表年份和较小的样本量与较高的ADR相关。
在RCT对照组中，ADR水平存在高度变异性。关于适应证，只有基于粪便免疫化学检测的结肠镜检查研究影响基础ADR，初次结肠镜筛查似乎与其他适应证相似。需要对与临床、方法学和技术参数相关的变量进行标准化，以实现可推广性和可重复性。
