JMIR Publications

ABSTRACT

Background:

Non-muscle 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 with frequent repeat treatments. There is evidence that the quality of the initial surgical procedure (Transurethral resection of bladder tumour (TURBT)) and timely administration of postoperative bladder chemotherapy significantly reduces cancer recurrence rates and improves outcomes such as cancer progression and mortality. There is survey-based evidence that TURBT practice varies significantly across surgeons and sites[1]. 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, tumour, or adjuvant treatment factors, suggesting that how the surgery is performed may be a reason for the variation. This study primarily aims to determine if feedback of and education about surgical quality indicators can improve performance, and secondarily if this can reduce cancer recurrence rates. Planned secondary analyses of observational aim to determine what surgeon, operative, peri-operative institutional and patient factors are associated with better achievement of TURBT quality indicators and NMIBC recurrence rates.

Objective:

This study primarily aims to determine if feedback of and education about surgical quality indicators can improve performance, and secondarily if this can reduce cancer recurrence rates.

Methods:

This study is an observational, international, multi-centre study with an embedded cluster randomised trial of audit, feedback, and education. Sites will be included if they perform TURBT for NMIBC. The study has 4 phases. 1. Site registration and usual practice survey 2. Retrospective audit 3. Randomisation to audit, feedback, and education intervention or to no intervention. 4. Prospective audit. The study has 4 co-primary outcomes which are 4 evidence-based TURBT quality indicators: a surgical performance factor (detrusor muscle resection); an adjuvant treatment factor (intra-vesical chemotherapy administration); and two documentation factors (resection completeness and tumour features). A key secondary outcome is the early cancer recurrence rate. The intervention is an online surgical performance feedback dashboard with educational and practical resources for TURBT quality improvement (e-AF+E). It will include anonymous site and surgeon level peer-comparison, a performance summary and targets. The co-primary outcomes will be analysed at the site level whilst recurrence rate will be analysed at the patient level.

Results:

The study has 4 phases. 1. Site registration and usual practice survey 2. Retrospective audit 3. Randomisation to audit, feedback, and education intervention or to no intervention. 4. Prospective audit. The study has 4 co-primary outcomes which are 4 evidence-based TURBT quality indicators: a surgical performance factor (detrusor muscle resection); an adjuvant treatment factor (intra-vesical chemotherapy administration); and two documentation factors (resection completeness and tumour features). A key secondary outcome is the early cancer recurrence rate. The intervention is an online surgical performance feedback dashboard with educational and practical resources for TURBT quality improvement (e-AF+E). It will include anonymous site and surgeon level peer-comparison, a performance summary and targets. The co-primary outcomes will be analysed at the site level whilst recurrence rate will be analysed at the patient level.

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 ultimate goal is to gain incremental benefit across large numbers of patients using a simple and cheap intervention that will amount to large absolute benefits across the population of patients with NMIBC. Local and/or national ethical and institutional approvals or exemptions will be obtained at each participating site. The study results will be published in peer-reviewed journals and presented at national and international scientific congresses. Clinical Trial: The study is registered with clinicaltrials.org (NCT05154084).