Improving access to adjuvant intravesical therapy for non-muscle invasive bladder cancer in a community hospital.
Key Words: Bladder cancer, non-muscle invasive bladder cancer, adjuvant intravesical therapy, performance improvement, community hospital practice patterns, mitomycin-C, BCG.
Bladder cancer is the fifth most commonly diagnosed cancer in the United States (National Cancer Institute [NCI], 2015). Bladder cancer incidence is about four times higher in men than in women, and almost two times higher in white men than in black men (American Cancer Society [ACS], 2015). Connecticut has the highest incidence rate of bladder cancer (27.3 cases per 100,000/year) among the nine national Surveillance Epidemiology and End Results (SEER) areas (NCI, 2011). In 2012, there were approximately 49,000 newly diagnosed cases nationally, with early stage cancers (Ta, Tis, T1) accounting for approximately 35,000 (71%) of the new cases (National Cancer Data Base [NCDB], Commission on Cancer, 2015).
Our facility is a 275-bed, not-for-profit, acute care community hospital located in central Connecticut. Our service area covers a total population of over 265,000 and includes urban, suburban, and rural portions of the state. Our affiliated urologists are members of a single private practice group of four board-certified urologists.
The New England states, along with Ohio and Nevada, have the highest bladder cancer rates in the country. Connecticut's bladder cancer rate has been trending upward since 1981 (NCI, 2015). For this reason, we wanted to ascertain that all patients receive optimal treatment and the best chance to minimize recurrence and progression of bladder cancer. A nurse-led performance improvement project was initiated to assess current treatment patterns for early stage, non-muscle invasive bladder cancers to determine whether treatment guidelines were being followed and if improvements might be needed. The study was limited to non-muscle invasive disease in an effort to maximally impact practice patterns related to the cancers treated within our system. Patients diagnosed with muscle-invasive disease are referred to tertiary care centers for treatment.
Treatment of early stage bladder cancer (Ta, Tis, and T1, both low- and high-grade) with intravesical therapy is aimed at minimizing morbidity and improving survival. Both qualitative and quantitative studies have been done to assess the practice patterns of urologic surgeons for compliance with "best practice" guidelines, such as those established by National Comprehensive Care Network (NCCN), the American Urological Association (AUA), and European Association of Urology (EAU), for early stage bladder cancer. These guidelines vary slightly, but all recommend a single dose of intravesical chemotherapy after transurethral resection of bladder cancer (TURBT) (see Table 1).
Chamie et al. (2011) studied quality of care, as well as adherence to established guidelines for treating high grade, non-invasive bladder cancer patients. These researchers found that of the 4,545 subjects analyzed over a 10-year period, only one received treatment that was adherent to all recommended measures, and that non-adherence to practice guidelines resulted from a combination of patient related factors (i.e., age and co-morbid conditions) and surgeon-related factors (i.e., personal choice related to use of surveillance cystoscopy, urine cytology, imaging, and intravesical treatment). Review of treatment interventions noted that perioperative mitomycin-C use was lowest in the northeast, with highest use in patients treated by a "medium to high" volume surgeon. Bacillus Calmette-Guerin (BCG) use was lowest in patients of advanced age ([greater than or equal to] 75) and highest in the south and northeast, and in patients diagnosed at stage T1. Overall findings revealed that practice patterns vary widely between providers, geographic location, and patient subsets. The authors concluded, "The findings of the current study serve to alert patients and providers to the wide gap between guideline recommended care and routine practice" (Chamie et al., 2011, p. 5400).
Nielsen et al. (2011) found that self-reported use of intravesical therapy by urologists was higher than use reported by claims-based analysis. In this study, as with prior studies, "practice type and years in practice were significantly associated with variation in practices. Further research is needed to reconcile these findings with administrative claims data" (Nielsen et al., 2011, p. 967).
In looking at national practice patterns of a sample of 259 United States-based urologists, Cookson et al. (2012) also found wide variations in practice patterns related to the use of intravesical therapy for treatment of non-muscle invasive disease. Of the 1,010 eligible patients, only 59.6% received some form of intravesical treatment during initial treatment, and 66% of the urologists surveyed in this study never used intravesical postoperative chemotherapy (Cookson et al., 2012).
National practice guidelines are ambiguous, which leads to practice variations. Hollingsworth et al. (2011) discuss that "the data underlying contemporary guidelines for the management of patients with early stage disease are limited" (p. 1112). They note that although there is evidence intravesical therapy can reduce recurrence and progression of disease, other aspects of the national guidelines, such as frequency of surveillance cystoscopy, and imaging have not been as rigorously studied and are more open to individual interpretation. Suggestion is made of increasing "well-designed clinical trials for early stage bladder cancer" or at least an "alternative approach to developing a base of evidence" to guide best practices (Hollingsworth et al., 2011, p. 1112).
Echoing the findings of these prior studies, Burks et al. (2012) reviewed practice patterns of five Urological Surgery Quality Collaborative practices regarding use of intravesical therapy after TURBT for clinical stage Ta/T1. Of 696 patients who met criteria as ideal for intravesical treatment, there was significant variation in its use, resulting in only 264 (37.9%) being treated with immediate intravesical therapy (Burks et al., 2012). This review of physician champion practice patterns (after prospectively screening charts to assure ideal patient selection) still revealed significant non-compliance with use of intravesical therapy for many of the same reasons found in prior studies.
In summary, practice patterns for non-muscle invasive disease vary widely, with differences not only by provider, but by geographic location and years in practice. Additionally, national guidelines are ambiguous, leaving room for individual interpretation on a case-by-case basis.
Quality/Performance Improvement Method
The quality improvement (QI) method for our project is Define-Measure-Analyze-Improve-Control (DMAIC), which is a data-driven methodology used to improve and optimize processes and designs. DMAIC is a well-known and well-accepted project methodology that focuses on improving existing processes.
Based on the literature and guidelines review, the following questions were used to guide the assessment of current practice for patients with non-muscle invasive bladder cancer:
* Are our newly diagnosed, non-invasive bladder cancer patients treated according to NCCN guidelines?
* What are our practice patterns at Middlesex Hospital regarding the use of adjuvant intravesical BCG, and mitomycin-C, for early stage bladder cancer?
* Did NCCN guideline adherence improve after re-education of the surgeons?
Using a combination of chart review and data pulled from cancer registry, data were collected on all newly diagnosed patients between 2010 and 2011. Data collected included name/date of birth, date of TURBT, surgeon, pathology stage and grade, patients receiving mitomycin-C at time of surgery, adjuvant BCG x 6 cycles, mitomycin-C, and BCG, no adjuvant treatment, date of recurrence, date of last follow up, and date of death.
For 2010 and 2011, 87 patients were diagnosed with non-muscle invasive bladder cancer (Ta, T1). All patients underwent a TURBT as first line treatment (see Table 2).
Our QI interventions consisted of re-education of our urologists after the review of the 20102011 data. Because our urologists are a private practice group, we initially reviewed the NCCN guidelines for early stage bladder cancer during our monthly Urology Case Conference. We also provided physicians with copies of the full NCCN (2012) bladder cancer guidelines, and a laminated copy of the NCCN guidelines for early stage bladder cancer attached to a small white board so physicians could refer to this while providing patient education via drawings and writing of key points during the cancer talk.
After re-education of the physicians, there were 54 patients in 2012 and 48 patients in 2013 diagnosed with non-muscle invasive disease (see Tables 3 and 4).
Patient data were reviewed in 2012 and 2013 to determine if re-education efforts regarding guidelines improved guideline adherence patterns. The patients reviewed were broken down by year (2012: N = 54, 2013: N= 48).
Comparison was then made between those who received the adjuvant treatment options of intravesical BCG, mitomycin-C, or BCG and mitomycin versus those who received no adjuvant treatment.
As shown in Figure 1, adjuvant treatment use over time revealed less likelihood over time to use BCG alone. After reeducation of the physicians, there was an increase in use of the combined treatment of mitomycin and BCG. However, if only one adjuvant treatment is used, it is most likely to be mitomycin (BCG was previously more common). Additionally, after the reeducation of the physicians in 2011, the number of patients receiving no adjuvant treatment dropped significantly, only to then increase slightly in 2013. Upon chart review this was related to patient condition after postoperative patient assessment. A positive impact on practice pattern has occurred because use of both treatments has become more common since the first analysis.
Figure 2 compares Middlesex Hospital data (2010-2012) to data of the same stage and adjuvant treatment type from the National Cancer Database, Community Cancer Center Data. (NCDB). During the data period reviewed for Stage 0 disease, both Middlesex and NCDB data show use of mitomycin alone as the treatment of choice. For Stage 1, it is replaced by BCG.
We continue to review the NCCN and AUA treatment guidelines annually. Guidelines will also be monitored for new updates on a regular basis. The guidelines and any new information will be discussed during Urology Case Conference held monthly. The 2014 and 2015 data will be reviewed when available to assess the stability of the interventions.
Improvement Process Findings
Our treatment of early stage bladder cancer mirrors the current NCCN (2015) guidelines. The NCCN guidelines recommend the options of mitomycin or BCG, as well as observation alone in some cases. Additionally, our practice patterns mirror national treatment patterns as referenced by the NCDB and review of the literature. As a result of this improvement project, more patients are receiving adjuvant treatment for early stage bladder cancer.
Practice Changes and Recommendations
Ongoing education related to evidence based national guidelines should be provided to physicians who are diagnosing and treating non-muscle invasive bladder cancer patients. The method of education must be concise and adaptable to physician needs, with sensitivity to time commitment and practicality/usefulness of educational materials provided. A plan must be in place that incorporates providing updates and changes as new information becomes available.
Re-education of our physicians was a relatively easy process as we currently reserve part of our monthly Urology Case Conference time for educational purposes. Partnering with the physicians for the purpose of reeducation helps to strengthen the relationship between the Cancer Center and the private practice group. It has been cost-effective as the only hard supply costs incurred were those of the white boards, laminating supplies, and nursing time. This project facilitates better decision making by physicians regarding adjuvant intravesical treatment, which is supported by evidence-based guidelines. This early intervention has been shown to decrease recurrence and disease progression, which may lead to improved patient outcomes.
Treatment of early stage bladder cancer is variable by provider. Many factors contribute to the variance among clinicians regarding the use of adjuvant treatment, which treatment is most effective or best to use, or whether no adjuvant treatment should be given. More research must be conducted on patient outcomes based on surveillance protocols and on the various adjuvant treatment interventions. Until then, there will continue to be variability in how urologists treat non-muscle invasive bladder cancer. As nurses, it is essential to advocate for adherence to and implementation of best practices for our patient population. Inter-professional teamwork, collaboration, and education can help overcome some of the existing harriers.
American Cancer Society (ACS). (2015). What are the key standards about bladder cancer? Retrieved from http:// www.cancer.org/cancer/bladder cancer/detailedguide/bladder-cancerkey-statistics
American Urological Association (AUA). (2007). Guidelines for the management of nonmuscle invasive bladder cancer. Retrieved from http://www. auanet.org/education/guidelines/ bladder-cancer.cfm
Burks, E, Liu, A., Suh, R., Schuster, T., Bradford, T., Moylan, D., ... Miller, D. (2012). Understanding the use of immediate intravesical chemotherapy for patients with bladder cancer. The Journal of Urology, 188, 2108-2113.
Chamie, K., Saigal, C., Lai, J., Hanley, J., Setodji, C., Konety, B., & Litwin, M.; Urologic Diseases in America Project.
(2011) . Compliance with guidelines for patients with bladder cancer. Cancer, 117(23), 5392-5401. doi:10. 1002/cncr.26198
Cookson, M., Chang, S., Oefelein, M., Gallagher, J., Schwartz, B., & Heap, K. (2012). National practice Patterns for immediate postoperative instillation of chemotherapy in nonmuscle invasive bladder cancer. The Journal of Urology, 187, 1571-1576. doi:10. 1016/j.juro.2011.12.056
European Association of Urology (EAU). (2015). Guidelines on non-muscle invasive bladder cancer (Ta, T1, and CIS). Retrieved from http://uroweb. org/wp-content/uploads/EAUGuidelines-Non-muscle-invasive-Bladder -Cancer-2015-vl.pdf
Hollingsworth, J., Zhang, Y., Miller, D., Skolarus, T., Wood, D., Lee, C., ... Hollenbeck, B. (2011). Identifying better practices for early-stage bladder cancer. Medical Care, 49, 1112-1117.
National Cancer Data Base, Commission on Cancer. (2015). Diagnosis year by first course treatment of urinary bladder cancer diagnosed in 2000-2012. Retrieved from http://oliver.facs.org/ BMPub/BMR_report_1st2.cfm ?CFID=109760&CFTOKEN=llb7f43 25e4ccfbd-A60D4743-CAC6-8B60A5003C712D5D92EF
National Cancer Institute (NCI). (2011). SEER cancer statistics factsheets: Bladder cancer. Bethesda, MD: Author. Retrieved from: http://seer. cancer.gov/statfacts/html/urinb.html
National Cancer Institute (NCI). (2015). SEER cancer statistics factsheets: Bladder cancer. Bethesda, MD: Author. Retrieved from http://seer. cancer.gov/statfacts/html/urinb.html
National Comprehensive Cancer Network (NCCN). (2012). NCCN guidelines V. 2.2012: Bladder cancer. Retrieved from http://www.nccn.org/profession als/physican_gls/pdf/bladder/pdf
National Comprehensive Cancer Network (NCCN). (2015). NCCN guidelines 1.2015: Bladder cancer. Retrieved from http://www.nccn.org/profession als/physician_gls/pdf/bladder.pdf
Nielsen, M., Smith, A., Pruthi, R., Guzzo, T., Amiel, G., Shore, N., & Lotan, Y. (2012). Reported use of intravesical therapy for non-muscle-invasive bladder cancer (NMIBC): Results from the Bladder Cancer Advocacy Network (BCAN) survey. British Journal of Urology International, 110, 967-972. doi:10.1111/j.l464-410x.2012.11060x
Dorothy Carvalho, BSN, RN, OCN, CURN, is the Urology Nurse Navigator, Middlesex Hospital Cancer Center, Middletown, CT.
Table 1. Comparison of Adjuvant Treatment Recommendations by the AUA, EAU, and NCCN, for Ta, Tis, and T1 Bladder Cancers American Urological European Association National Association (AUA) of Urology (EAU) Comprehensive Cancer (2007) (2015) Network (NCCN) (2015) Low-grade Ta bladder Low-risk tumors: Ta low grade. cancer. Primary, solitary, Ta, no CIS. Recommendation: An One immediate Observation vs. initial single dose instillation of single dose of intravesical chemotherapy. intravesical chemotherapy may be chemotherapy within administered 24 hours of TURBT immediately and/or induction postoperatively. intravesical chemotherapy. Multifocal and-or Intermediate risk Ta--high grade. large volume, tumors: all cases histologically between low and high. confirmed, low-grade Ta, or recurrent low- grade Ta bladder cancer. Recommendation: An One immediate Intravesical induction course of instillation of chemotherapy, BCG intravesical therapy chemotherapy followed (preferred) or with Bacillus by further mitomycin or Calmette-Guerin (BCG) instillations of observation. or mitomycin-C is either chemotherapy recommended for the or BCG for a maximum treatment of these of 1 year. patients with the goal of preventing or delaying recurrence. Option: Maintenance High/risk tumors: T1, T1--low grade. BCG or mitomycin-C HG/G3, CIS, multiple may be considered. and recurrent and large (greater than 3 cm) Histologically TaG1G2 tumors. (All Strongly advise confirmed high/grade of these conditions repeat TURBT, if Ta, T1, and/or must be present.) residual disease--BCG carcinoma in situ or cystectomy. bladder cancer. Standard: For Intravesical full T1--high grade. patients with lamina dose BCG propria invasion (T1) instillations for 1 but without to 3 years or muscularis propria in cystectomy (in the specimen, repeat highest risk tumors). resection should be performed prior to additional intravesical therapy. Recommendation: An Cystectomy, if no induction course of residual disease--BCG BCG followed by or mitomycin or maintenance therapy observation. is recommended for treatment of these patients. Option: Cystectomy Any Tis. should be considered for initial therapy BCG. in select patients. Table 2. Pre-Intervention Data (2010-2011) Patient Population Male Female N 2010-2011 61 26 87 Mean Age 78 62 Stage (low and high grade) Ta 48 16 T1 13 10 Table 3. Post-Intervention Data (2012) Patient Population Male Female N 2012 45 9 54 Mean Age 76 72 Stage (low and high grade) Ta 29 5 T1 16 4 Table 4. Post-Intervention Data (2013) Patient Population Male Female N 2013 41 7 48 Mean Age 71 71 Stage (low and high grade) Ta 27 4 T1 14 3
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|Title Annotation:||Quality/Performance Improvement|
|Author:||Carvalho, Dorothy R.|
|Date:||Nov 1, 2015|
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