Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
University of New Mexico Comprehensive Cancer Center, Albuquerque, NM.
J Low Genit Tract Dis. 2023 Apr 1;27(2):113-119. doi: 10.1097/LGT.0000000000000721. Epub 2023 Jan 17.
Reproducibility of cervical biopsy diagnoses is low and may vary based on where the diagnostic test is performed and by whom. Our objective was to measure multilevel variation in diagnoses across colposcopists, pathologists, and laboratory facilities.
We cross-sectionally examined variation in cervical biopsy diagnoses within the 5 sites of the Population-Based Research Optimizing Screening through Personalized Regimens (PROSPR I) consortium within levels defined by colposcopists, pathologists, and laboratory facilities. Patients aged 18 to 65 years with a colposcopy with biopsy performed were included, with diagnoses categorized as normal, cervical intraepithelial neoplasia grade 1 (CIN1), grade 2 (CIN2), and grade 3 (CIN3). Using Markov Chain Monte-Carlo methods, we fit mixed-effects logistic regression models for biopsy diagnoses and presented median odds ratios (MORs), which reflect the variability within each level. Median odds ratios can be interpreted as the average increased odds a patient would have for a given outcome (e.g., CIN2 or CIN3 vs normal or CIN1) when switching to a provider with higher odds of diagnosing that outcome. The MOR is always 1 or greater, and a value of 1 indicates no variation in outcome for that level, with higher values indicating greater variation.
A total of 130,110 patients were included who received care across 82 laboratory facilities, 2,620 colposcopists, and 489 pathologists. Substantial variation in biopsy diagnoses was found at each level, with the most occurring between laboratory facilities, followed by pathologists and colposcopists. Substantial variation in biopsy diagnoses of CIN2 or CIN3 (vs normal or CIN1) was present between laboratory facilities (MOR: 1.26; 95% credible interval = 1.19-1.36).
Improving consistency in cervical biopsy diagnoses is needed to reduce underdiagnosis, overdiagnosis, and unnecessary treatment resulting from variation in cervical biopsy diagnoses.
宫颈活检诊断的重复性较低，其结果可能因检测地点和检测人员的不同而有所差异。本研究旨在评估阴道镜医师、病理学家和实验室在宫颈活检诊断中的多层次差异。
我们在Population-Based Research Optimizing Screening through Personalized Regimens（PROSPR I）联盟的 5 个研究点，对阴道镜检查和活检患者的宫颈活检诊断进行了横断面研究，分析了阴道镜医师、病理学家和实验室的诊断差异。纳入的研究对象为年龄在 18 至 65 岁之间，接受阴道镜检查和活检的患者，将诊断结果分为正常、宫颈上皮内瘤变 1 级（CIN1）、宫颈上皮内瘤变 2 级（CIN2）和宫颈上皮内瘤变 3 级（CIN3）。采用马尔可夫链蒙特卡罗法拟合混合效应逻辑回归模型，计算活检诊断的中位数优势比（MOR），以反映每个水平的变异性。MOR 可以解释为患者在特定结局（如 CIN2 或 CIN3 与正常或 CIN1）的转换中，其获得给定结果的几率增加的平均值。MOR 始终大于或等于 1，值为 1 表示该水平的结果没有变化，值越高表示差异越大。
共纳入了 130110 名患者，这些患者分别在 82 个实验室、2620 名阴道镜医师和 489 名病理学家处接受了治疗。在每个水平都发现了宫颈活检诊断的显著差异，其中实验室之间的差异最大，其次是病理学家和阴道镜医师。实验室之间的 CIN2 或 CIN3（与正常或 CIN1 相比）的活检诊断差异显著（MOR：1.26；95%可信区间：1.19-1.36）。
需要提高宫颈活检诊断的一致性，以减少因宫颈活检诊断差异而导致的诊断不足、过度诊断和不必要的治疗。
