Harris Karen Eloise, Lavin Philip Todd, Akin Mark Donnell, Papagiannakis Emmanouil, Denardis Sara
Department of Obstetrics and Gynecology, College of Medicine, University of Central Florida, Gainesville, FL 32605, USA.
Boston Biostatistics Research Foundation, Framingham, MA 01702-6105, USA.
Oncol Lett. 2020 Oct;20(4):17. doi: 10.3892/ol.2020.11878. Epub 2020 Jul 16.
The present study compared two methods for the detection of severe cervical dysplasia in women with atypical squamous cells of underdetermined significance (ASC-US) cytology; digital colposcopy with adjunctive dynamic spectral imaging (DSI) and conventional colposcopy. IMPROVE-COLPO was a two-arm cross-sectional study of US community-based colposcopy. The active (prospective) arm of this study recruited patients examined by digital colposcopy and adjunctive DSI. Preceding consecutive patients that had been examined with conventional methods were used as historical controls in the retrospective arm of the study after being matched in number to those in the prospective arm by a colposcopist. In the present study, the primary measure was the number of women detected with cervical intraepithelial neoplasia (CIN) grade 3 or worse (CIN3+) following punch biopsy. The study included 1,353 retrospective and 1,226 prospective patients eligible for this analysis who were examined by 146 colposcopists in 42 community-based clinics. The patient baseline characteristics were comparable between the two arms. The average number of biopsies taken per patient was higher among the prospective arm patients (including standard and DSI-assisted biopsies) compared with the retrospective arm control patients (1.21 vs. 0.97 respectively). Biopsy detected 31 patients with CIN3+ [2.29%; 95% confidence interval (CI), 1.56-3.24] in the retrospective arm, and 48 patients with CIN3+ (3.92%; 95% CI, 2.90-5.16) in the prospective arm. The difference in the number of patients detected with CIN3+ in the two arms of the study was 1.62% (95% CI, 0.30-3.04; P=0.022), which corresponds to a 70.9% relative increase in the prospective compared with the retrospective arm. Biopsy appeared less efficient in detecting patients with CIN3+ in the retrospective arm compared with the prospective arm. However, there was no statistically significant difference between the retrospective arm and the prospective arm in terms of: i) Biopsies taken (over the entire population) per patient detected with CIN3+ (42.2 in the retrospective arm vs. 30.8 in the prospective arm; P=0.164) and ii) positive predictive value of using biopsies to identify patients with CIN3+ (2.83 vs. 3.92; P=0.118). Adoption of digital colposcopy with DSI increased the number of biopsies collected from ASC-US patients compared with retrospective controls of standard colposcopy and detected a significantly higher number of patients who were CIN3+. The number of additional biopsies taken in the prospective arm compared with the retrospective arm was too small to explain the increased detection of patients with CIN3+ observed in the prospective arm, suggesting that biopsies in the prospective arm were better at identifying CIN3+.
本研究比较了两种用于检测意义不明确的非典型鳞状细胞（ASC-US）细胞学女性患者严重宫颈发育异常的方法；数字阴道镜检查联合辅助动态光谱成像（DSI）和传统阴道镜检查。IMPROVE-COLPO是一项基于美国社区阴道镜检查的双臂横断面研究。本研究的主动（前瞻性）组招募了接受数字阴道镜检查和辅助DSI检查的患者。在研究的回顾性组中，由阴道镜医师将数量与前瞻性组匹配后，此前接受传统方法检查的连续患者用作历史对照。在本研究中，主要测量指标是在活检后检测出宫颈上皮内瘤变（CIN）3级或更严重（CIN3+）的女性数量。该研究纳入了1353例回顾性患者和1226例前瞻性患者进行此分析，这些患者由42家社区诊所的146名阴道镜医师进行检查。两组患者的基线特征具有可比性。与回顾性组对照患者相比，前瞻性组患者（包括标准活检和DSI辅助活检）每位患者的平均活检次数更高（分别为1.21次和0.97次）。回顾性组活检检测出31例CIN3+患者[2.29%；95%置信区间（CI），1.56 - 3.24]，前瞻性组检测出48例CIN3+患者（3.92%；95%CI，2.90 - 5.16）。研究两组中检测出CIN3+的患者数量差异为1.62%（95%CI，0.30 - 3.04；P = 0.022），这相当于前瞻性组相对于回顾性组相对增加了70.9%。与前瞻性组相比，回顾性组活检在检测CIN3+患者方面似乎效率较低。然而，回顾性组和前瞻性组在以下方面无统计学显著差异：i）每例检测出CIN3+的患者（在整个人口中）的活检次数（回顾性组为42.2次，前瞻性组为30.8次；P = 0.164）以及ii）使用活检识别CIN3+患者的阳性预测值（分别为2.83和3.92；P = 0.118）。与标准阴道镜检查的回顾性对照相比，采用数字阴道镜检查联合DSI增加了ASC-US患者的活检数量，并检测出显著更多的CIN3+患者。前瞻性组与回顾性组相比额外进行的活检数量太少，无法解释前瞻性组中观察到的CIN3+患者检测增加的情况，这表明前瞻性组的活检在识别CIN3+方面更好。
