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经尿道膀胱肿瘤切除术的质量控制指标:来自比利时嵌入式多中心前瞻性登记研究的结果。

Quality Control Indicators for Transurethral Resection of Bladder Tumor: Results from an Embedded Belgian Multicenter Prospective Registry.

机构信息

Department of Urology, University Hospitals Leuven, Leuven, Belgium.

Department of Urology, AZ Sint Blasius, Dendermonde, Belgium.

出版信息

Eur Urol Oncol. 2023 Aug;6(4):422-430. doi: 10.1016/j.euo.2022.11.005. Epub 2022 Dec 19.

Abstract

BACKGROUND

Quality control indicators (QCIs) can be used to objectively evaluate guideline adherence and benchmark quality among urologists and centers.

OBJECTIVE

To assess six QCIs for non-muscle-invasive bladder cancer (NMIBC) using a prospective registry of transurethral resection of bladder tumor (TURBT) procedures.

DESIGN, SETTING, AND PARTICIPANTS: Clinical data for TURBT cases were prospectively collected using electronic case report forms (eCRFs) embedded in the electronic medical record in three centers during 2013-2017. Pathological data were collected retrospectively. Patients with T0 disease or prior T2 disease were excluded.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

We assessed six QCIs: complete resection (CR) status, presence of detrusor muscle (DM), re-TURBT, single instillation of mitomycin C (MMC), start of bacillus Calmette-Guérin (BCG) therapy, and therapy ≤6 wk after diagnosis. We assessed the quality of reporting on QCIs and compliance with QCIs, compared compliance between centers and over time, and investigated correlation between compliance and recurrence-free survival (RFS).

RESULTS AND LIMITATIONS

Data for 1350 TURBT procedures were collected, of which 1151 were included for 907 unique patients. The distribution of European Association of Urology risk categories after TURBT was 271 with low risk, 464 with intermediate risk, and 416 with high risk. The quality of reporting for two QCIs was suboptimal, at 35% for DM and 51% for BCG. QCI compliance was 97% for CR, 31% for DM, 65% for MMC, 33% for re-TURBT, 39% for BCG, and 88% for therapy ≤6 wk after diagnosis. Compliance with all QCIs differed significantly among centers. Compliance with MMC and re-TURBT increased significantly over time, which could be attributed to one center. Compliance with MMC was significantly correlated with RFS. The main study limitation is the retrospective collection of pathology data.

CONCLUSIONS

A TURBT registry consisting of eCRFs to collect pathology and outcome data allowed assessment of QCIs for NMIBC. Our study illustrates the feasibility of this approach in a real-life setting. Differences in performance on QCIs among centers can motivate urologists to improve their day-to-day care for patients with NMIBC, and can thus improve clinical outcomes.

PATIENT SUMMARY

Our study demonstrates that quality control indicators for treatment of bladder cancer not invading the bladder muscle can be evaluated using electronic medical records. We assessed results for 1151 procedures in 907 individual patients to remove bladder tumors between 2013 and 2017 at three centers in Belgium. Compliance with the quality control indicators differed between centers, increased over time, and was correlated with recurrence of disease.

摘要

背景

质量控制指标 (QCIs) 可用于客观评估泌尿科医生和中心的指南依从性和质量基准。

目的

使用经尿道膀胱肿瘤切除术 (TURBT) 程序的前瞻性登记处评估非肌肉浸润性膀胱癌 (NMIBC) 的六个 QCIs。

设计、地点和参与者:在 2013 年至 2017 年期间,三个中心使用嵌入电子病历中的电子病例报告表 (eCRF) 前瞻性地收集 TURBT 病例的临床数据。回顾性收集病理数据。排除 T0 疾病或先前 T2 疾病的患者。

测量和统计分析

我们评估了六个 QCIs:完全切除 (CR) 状态、存在逼尿肌 (DM)、再次 TURBT、单次丝裂霉素 C (MMC) 灌注、卡介苗 (BCG) 治疗开始和诊断后 6 周内开始治疗。我们评估了 QCIs 的报告质量和遵守情况,比较了中心之间和随时间的遵守情况,并调查了遵守情况与无复发生存率 (RFS) 的相关性。

结果和局限性

共收集了 1350 例 TURBT 手术的数据,其中 1151 例纳入了 907 例独特的患者。TURBT 后欧洲泌尿外科学会风险分类的分布为低危 271 例、中危 464 例、高危 416 例。两个 QCIs 的报告质量不理想,DM 为 35%,BCG 为 51%。CR 的 QCI 依从率为 97%,DM 为 31%,MMC 为 65%,再次 TURBT 为 33%,BCG 为 39%,诊断后 6 周内治疗为 88%。各中心的 QCIs 依从性差异显著。MMC 和再次 TURBT 的依从性随时间显著增加,这可能归因于一个中心。MMC 的依从性与 RFS 显著相关。主要研究局限性是病理数据的回顾性收集。

结论

使用电子病历收集病理和结果数据的 TURBT 登记处允许评估 NMIBC 的 QCIs。我们的研究说明了在现实环境中采用这种方法的可行性。中心之间 QCIs 表现的差异可以促使泌尿科医生改善他们对 NMIBC 患者的日常护理,从而改善临床结果。

患者总结

我们的研究表明,可使用电子病历评估治疗膀胱肌肉未受侵犯的膀胱癌的质量控制指标。我们评估了 2013 年至 2017 年期间在比利时三个中心进行的 1151 例、907 名个体患者的 1151 例手术,以切除膀胱肿瘤。各中心的质量控制指标依从性不同,随时间增加,与疾病复发相关。

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