Department of Gynecology and Obstetrics, Aarhus University Hospital, Aarhus, Denmark.
Department of Gynecology and Obstetrics, Randers Regional Hospital, Skovlyvej 15, 8390, Randers, Denmark.
BMC Womens Health. 2021 Jan 12;21(1):21. doi: 10.1186/s12905-020-01169-1.
Colposcopy serves as a subjective examination of the cervix with low sensitivity to detect cervical intraepithelial dysplasia (CIN) grade 2 or worse (CIN2 +). Dynamic spectral imaging (DSI) colposcopy has been developed to provide an objective element to cervix examinations and has been proven to increase sensitivity of detecting CIN2 + . We aimed to assess the performance of the DSI color map and compared it to histological diagnoses of cervical biopsies in determining the CIN grade present.
Women were included in a consecutive, prospective manner at Randers Regional Hospital, Denmark. Women were eligible to participate if they were referred for colposcopy due to abnormal cervical smear (threshold: ≥ ASCUS) or follow-up after previously diagnosed CIN. All women had four biopsies taken, one directed by colposcopists alone prior to viewing the DSI color map, one directed by the worst color on the respective DSI color map, and two additional biopsies. All biopsies were analyzed separately. We calculated sensitivity, specificity, positive predictive values, and negative predictive values (NPVs) with 95% confidence intervals (CIs).
A total of 800 women were recruited. Of these, 529 (66.1%) were eligible for inclusion. The sensitivity of the DSI color map was found to be 48.1% (95% CI 41.1-55.1) in finding CIN grade 2 or worse (CIN2 +) when compared to the histological diagnosis of the DSI directed biopsy. This was 42.5% (95% CI 36.7-48.5) when compared to the final histological diagnosis of all four cervical biopsies and with an NPV of 53.5% (95% CI 50.5-56.5).
The worst color indicated by the DSI map might not consistently reflect the true grade of cervical dysplasia present. Thus, even though the DSI color map indicates low-grade changes, colposcopists should still consider taking biopsies from the area as high-grade changes might be present.
NCT04249856, January 31 2020 (retrospectively registered).
阴道镜检查是一种对宫颈进行主观检查的方法，其对检测宫颈上皮内瘤变（CIN）2 级或更高级别（CIN2+）的敏感性较低。动态光谱成像（DSI）阴道镜检查的目的是为宫颈检查提供客观元素，并已被证明可提高检测 CIN2+的敏感性。我们旨在评估 DSI 彩色图谱的性能，并将其与宫颈活检的组织学诊断进行比较，以确定存在的 CIN 分级。
在丹麦兰德斯地区医院，以连续、前瞻性的方式纳入女性。如果女性因宫颈涂片异常（阈值：≥ASCUS）或先前诊断为 CIN 后的随访而被转诊行阴道镜检查，则有资格参加。所有女性均行 4 处活检，1 处由阴道镜医师单独在查看 DSI 彩色图谱之前取材，1 处取材自相应 DSI 彩色图谱上的最差颜色，另外 2 处活检。所有活检均单独进行分析。我们计算了敏感性、特异性、阳性预测值和阴性预测值（NPV），置信区间（CI）为 95%。
共纳入 800 名女性，其中 529 名（66.1%）符合纳入标准。与 DSI 定向活检的组织学诊断相比，DSI 彩色图谱在发现 CIN 2 级或更高级别（CIN2+）时的敏感性为 48.1%（95%CI 41.1-55.1）。与所有 4 处宫颈活检的最终组织学诊断相比，其敏感性为 42.5%（95%CI 36.7-48.5），NPV 为 53.5%（95%CI 50.5-56.5）。
DSI 图谱上指示的最差颜色可能并不能始终反映宫颈上皮内瘤变的真实分级。因此，即使 DSI 彩色图谱显示低级别变化，阴道镜医师仍应考虑从该区域取材，因为可能存在高级别病变。
NCT04249856，2020 年 1 月 31 日（回顾性注册）。
