Abstract
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.
TRIAL REGISTRATION: ClinicalTrials.org NCT05154084; https://clinicaltrials.gov/ct2/show/NCT05154084.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42254.
| Original language | English |
|---|---|
| Article number | e42254 |
| Number of pages | 15 |
| Journal | JMIR Research Protocols |
| Volume | 12 |
| DOIs | |
| Publication status | Published - 15 Jun 2023 |
Bibliographical note
AcknowledgmentsWe would like to acknowledge the input and expertise of our protocol external peer reviewers: Christopher Blick, Ashish Kamat, Jim Catto, Hugh Mostafid, Richard Sylvester, and John McGrath. This study was supported by the Rosetrees Trust grant CF1\100002, the Urology Foundation, Action Bladder Cancer UK, Karl Storz agreement, Photocure agreement, Medac Pharma agreement, and the British Journal of Urology International Charity. None of the study funders had any academic input to the study design analysis or reporting. This study was sponsored by British Urology Researchers in Surgical Training.
Funding Information:
We would like to acknowledge the input and expertise of our protocol external peer reviewers: Christopher Blick, Ashish Kamat, Jim Catto, Hugh Mostafid, Richard Sylvester, and John McGrath. This study was supported by the Rosetrees Trust grant CF1\100002, the Urology Foundation, Action Bladder Cancer UK, Karl Storz agreement, Photocure agreement, Medac Pharma agreement, and the British Journal of Urology International Charity. None of the study funders had any academic input to the study design analysis or reporting. This study was sponsored by British Urology Researchers in Surgical Training.
Funding Information:
This study has received funding from 3 industry sources—Karl Storz, Photocure, and Medac Pharma. Funds were provided as unrestricted grants with no influence on the design, analysis, or reporting of the study. PM is a designer and chief investigator for the Scot BC Quality OPS clinical project.
Publisher Copyright:
©Kevin Gallagher, Nikita Bhatt, Keiran Clement, Eleanor Zimmermann, Sinan Khadhouri, Steven MacLennan, Meghana Kulkarni, Fortis Gaba, Thineskrishna Anbarasan, Aqua Asif, Alexander Light, Alexander Ng, Vinson Chan, Arjun Nathan, David Cooper, Lorna Aucott, Gautier Marcq, Jeremy Yuen-Chun Teoh, Patrick Hensley, Eilidh Duncan, Beatriz Goulao, Tim O'Brien, Matthew Nielsen, Paramananthan Mariappan, Veeru Kasivisvanathan.
Data Availability Statement
The data sets generated and analyzed during this study are not publicly available due to a need to maintain anonymity of the included sites as set out in the study agreement but are available from the corresponding author on reasonable request. All statistical code will be made available upon request.Keywords
- TURBT
- Bladder cancer
- quality improvement
- performance feedback
- TRANSURETHRAL RESECTION
- urology
- oncology
- recurrence
- surgery
- surgical
- quality indicator
- performance
- evaluation
- feedback
Access to Document
- Gallagher_JMIRRP_Audit_Feedback_and_VOR
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