背景:非肌层浸润性膀胱癌(NMIBC)占膀胱癌的75%。这是常见的和昂贵的。高复发率以及需要定期进行侵入性监测和重复治疗,这对患者的预后和生活质量造成了成本和损害。有证据表明,初始外科手术(经尿道膀胱肿瘤电切术[TURBT])和术后膀胱化疗的质量显着降低了癌症复发率并改善了预后(癌症进展和死亡率)。有外科医生报告的证据表明,TURBT的做法在外科医生和地点之间差异很大。膀胱内化疗临床试验的证据有限,表明NMIBC复发率在不同部位之间差异显著,这不能通过患者的差异来解释。肿瘤,或辅助治疗因素,这表明手术的执行方式可能是这种变化的原因。
目的:这项研究的主要目的是确定对手术质量指标的反馈和教育是否可以提高性能,其次是否可以降低癌症复发率。计划的二次分析旨在确定哪些外科医生,Operative,围手术期,机构,和患者因素与更好地实现TURBT质量指标和NMIBC复发率相关。
方法:这是一个观察性的,国际,多中心研究,采用嵌入式整群随机审计试验,反馈,和教育。如果站点为NMIBC执行TURBT,则将包括这些站点。该研究分为四个阶段:(1)现场注册和常规实践调查;(2)回顾性审核;(3)随机审核,反馈,和教育干预或不干预;和(4)前瞻性审计。将在每个参与站点获得当地和国家的道德和机构批准或豁免。
结果:该研究有4个共同主要结果,这是4个基于证据的TURBT质量指标:手术性能因素(逼尿肌切除术);辅助治疗因素(膀胱内化疗);和2个文献因素(切除完整性和肿瘤特征)。一个关键的次要结果是早期癌症复发率。干预是基于Web的外科手术性能反馈仪表板,具有用于TURBT质量改进的教育和实践资源。它将包括匿名站点和外科医生级别的同行比较,性能总结,和目标。共同主要结果将在现场水平进行分析,而复发率将在患者水平进行分析。该研究于2020年10月获得资助,并于2021年4月开始收集数据。截至2023年1月,共有220家医院参与,超过15,000份患者记录。预计数据收集结束日期为2023年6月30日。
结论:本研究旨在使用分布式协作模型提供站点级别的基于网络的性能反馈干预,以提高内镜下膀胱癌手术的质量。该研究得到资助,并计划在2023年6月完成数据收集。
背景:ClinicalTrials.orgNCT05154084;https://clinicaltrials.gov/ct2/show/NCT05154084。
■DERR1-10.2196/42254。
BACKGROUND: Nonmuscle invasive bladder cancer (NMIBC) accounts for 75% of bladder cancers. It is common and costly. Cost and detriment to patient outcomes and quality of life are driven by high recurrence rates and the need for regular invasive surveillance and repeat treatments. There is evidence that the quality of the initial surgical procedure (transurethral resection of bladder tumor [TURBT]) and administration of postoperative bladder chemotherapy significantly reduce cancer recurrence rates and improve outcomes (cancer progression and mortality). There is surgeon-reported evidence that TURBT practice varies significantly across surgeons and sites. There is limited evidence from clinical trials of intravesical chemotherapy that NMIBC recurrence rate varies significantly between sites and that this cannot be accounted for by differences in patient, tumor, or adjuvant treatment factors, suggesting that how the surgery is performed may be a reason for the variation.
OBJECTIVE: This study primarily aims to determine if feedback on and education about surgical quality indicators can improve performance and secondarily if this can reduce cancer recurrence rates. Planned secondary analyses aim to determine what surgeon, operative, perioperative, institutional, and patient factors are associated with better achievement of TURBT quality indicators and NMIBC recurrence rates.
METHODS: This is an observational, international, multicenter study with an embedded cluster randomized trial of audit, feedback, and education. Sites will be included if they perform TURBT for NMIBC. The study has four phases: (1) site registration and usual practice survey; (2) retrospective audit; (3) randomization to audit, feedback, and education intervention or to no intervention; and (4) prospective audit. Local and national ethical and institutional approvals or exemptions will be obtained at each participating site.
RESULTS: The study has 4 coprimary outcomes, which are 4 evidence-based TURBT quality indicators: a surgical performance factor (detrusor muscle resection); an adjuvant treatment factor (intravesical chemotherapy administration); and 2 documentation factors (resection completeness and tumor features). A key secondary outcome is the early cancer recurrence rate. The intervention is a web-based surgical performance feedback dashboard with educational and practical resources for TURBT quality improvement. It will include anonymous site and surgeon-level peer comparison, a performance summary, and targets. The coprimary outcomes will be analyzed at the site level while recurrence rate will be analyzed at the patient level. The study was funded in October 2020 and began data collection in April 2021. As of January 2023, there were 220 hospitals participating and over 15,000 patient records. Projected data collection end date is June 30, 2023.
CONCLUSIONS: This study aims to use a distributed collaborative model to deliver a site-level web-based performance feedback intervention to improve the quality of endoscopic bladder cancer surgery. The study is funded and projects to complete data collection in June 2023.
BACKGROUND: ClinicalTrials.org NCT05154084; https://clinicaltrials.gov/ct2/show/NCT05154084.
UNASSIGNED: DERR1-10.2196/42254.