Measuring the adherence to NICE guidelines for the cystoscopic follow up of NMIBC
BAUS ePoster online library. Simeen S. 11/10/20; 304270; PCU-2 Disclosure(s): Poster presentation was displayed at ASIT International Surgical Conference in Birmingham in March 2020 (No oral presentation).
Sarah Simeen
Sarah Simeen
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Measuring the adherence to NICE guidelines for the cystoscopic follow up of NMIBC
Simeen S 1, Walklett S 1, Ellis R 1, Bodiwala D 1
King's Mill Hospital, United Kingdom

Introduction
Bladder cancer is the 10th most common cancer in the UK, with approximately 10, 300 new cases in the UK each year. In their lifetime, 1 in 50 males and 1 in 133 females in the UK will be diagnosed with bladder cancer (Cancer Research UK, 2015). Of these new diagnoses, around 75% are non-muscle invasive bladder cancers (NMIBC) (Kamat, Bağcıoğlu and Huri, 2017). In light of its significant prevalence in the UK population, compliance with guidelines created from best available evidence is important in ensuring patient safety by identifying patients who are at higher risk of recurrence and following them up accordingly. It also identifies low risk patients and prevents such cases with no recurrences from being followed up for prolonged periods. Such a trend would cumulatively have financial repercussions to the NHS.

NICE published its guideline 'Bladder cancer: diagnosis and management' (NICE Guideline, 2015) to aid clinicians in their decision-making. The guideline considers prognostic factors such as grade, size, solitary/multi-focal lesion, previous recurrences and hence the predicted behaviour of these tumours and uses this information to create risk categories. This audit looked at the publication's guidance regarding follow up of NMIBC specifically. Literature describes a risk-adapted approach, which aims to minimize the therapeutic burden of NMIBC with its high recurrence rates without missing progressing tumours (Kassouf et al 2016).

A US national retrospective cohort study (Schroeck et al 2018) on early stage bladder cancer looked at the extent to which such risk-aligned surveillance is adhered. They found that patients undergo cystoscopic surveillance at comparable frequencies regardless of risk. From observation it seemed practice within our department was similar, notably in terms of prolonged follow up of low risk cancers with no recurrences. It is important to understand barriers to better compliance and implement methods to overcome them.

Aims
• To measure the adherence to NICE guidelines for the cystoscopic follow up of NMIBC.

Methods
Data was collected from hospital digital records over a 5-month period. This yielded 100 patients who were under cystoscopic surveillance post resection of histologically confirmed NMIBC. Each case was allocated into the low, medium or high-risk groups in accordance with NICE guidance (Figure 1). The frequency and interval of follow up was then compared to the appropriate guidance for that patients risk category (Figure 2).

Results
The audit assessed a fairly even spread of patients across all 3 risk categories, with the intermediate risk category being the least represented at 27% of the whole sample (low and high risk were 35% and 38% respectively).

Figure 3 demonstrates the compliance rates per risk category. 30 out of the 35 (85.7%) patients in the low risk group were non-compliant with NICE guidance, 15 out of 27 (55.6%) in the intermediate risk group, and 17 out of the 38 (44.7%) patients in the high-risk group were non-compliant. Figure 4 explores this further, demonstrating the distribution of non-compliant cases per category, which were over- versus under-investigated. 100% of the non-compliant cases in both the low risk and intermediate risk categories were over-investigated, receiving an increased frequency of cystoscopies.

Amalgamating all 3 risk categories, figure 5 illustrates that out of the 100 patients, 38% of patients received the appropriate frequency of surveillance cystoscopies, 51% received an increased frequency and 11% received less than the recommended surveillance. Notably the high-risk group accounted for the 11% patients who were under investigated.

Discussion

The data collection was limited by the information available on the electronic records. It was often observed that key descriptive components such as size and foci of tumours were missing from the clinical information sent with the specimen for histology. This has implications on risk stratification, as diameter of less than 3 cm as opposed to over 3 cm is decisive of whether a tumour is low risk or high risk respectively (Figure 1).

The compliance pattern suggests that it is the low risk group who account in the majority for the lack of overall adherence to the guideline, with higher compliance rates in the high-risk group. The deviation from the suggested surveillance in the low and intermediate risk groups always represented an increase in surveillance rates when compared to the amount of surveillance cystoscopies suggested by the guideline. Out of the non-compliant cases two sub-groups emerged, those who had received more cystoscopies and those who received less cystoscopies. A cost analysis of the deviation took place. A total of 100 additional cystoscopies were carried out over the data collection period. The data suggests that a total of 22 cystoscopies were missed if the guideline was to be followed without variation. The net result of these variations resulted in 78 additional cystoscopies conducted over the period. The projected cost of each cystoscopy is £227, the resultant cost being £17,706 in total over the 5-month period. The figure accounts purely for the cystoscopy itself and does not take into account the associated costs of an increased number of cystoscopies, for example need for extra clinics and staff.

In addition to the higher financial cost, performing additional cystoscopies increases the risk of procedure-related complications such as infection and stricture disease, as well as patient discomfort.

Evidence supports the implementation of risk-aligned surveillance in aiding in the prevention of both overuse among low-risk patients, and underuse among high-risk patients. Although there are National clinical guidelines readily available, implementation and its success may be impeded by multiple challenges (Schroeck, Smith and Shelton, 2018). One such challenge could be fear of recurrence on discharge. This highlights the importance of collaboration of care between primary and secondary care and the patient, including patient education and high suspicion index by GP on finding blood on urine dip in absence of infection.

There are multiple national and international guidelines for the management of NMIBC. For example both the UK's NICE guidance and the European Association of Urologists (EAU) are in agreement on the risk stratified cystoscopic surveillance of NMIBC, but differ on advised frequency of intervals. For low risk NMIBC, their advice aligns in recommending cystoscopy at 3 months post initial resection then again at 12 months. NICE then go on to suggest discharge back to GP in primary care if there has been no recurrence within this time. This based on evidence that if a low risk NMIBC recurs after the first year it will typically recur the same grade and stage so will present similiarly. In contrast EAU recommends annual follow up for a further 5 years in low risk NMIBC. This stemming from current evidence that also suggests recurrence rates after 5 years tumour free are low (Leiblich et al, 2018). This study's findings of offering prolonged cystoscopic surveillance in the lower risk groups could suggest that we are offering a service more similar to what the EAU proposes.

Conclusions
The audit suggests there is room for improvement in compliance to the NICE guidance. It highlights the tendency to prolong surveillance of patients, performing a higher frequency of cystoscopies than suggested by NICE guidance. A much higher compliance rate was observed in the high-risk group. The audit does highlight that patient safety is maintained, and ultimately it is down to the clinical judgement of the surgeon, basing each decision on the individual patient. This study poses an interesting question as to whether clinicians in the UK are following the NICE guidance for cystoscopic surveillance of NMIBC or whether they are offering a service more similar to what the EAU proposes, and if so then why?

Recommendations
It is important to raise awareness to an appropriate audience, and the study findings have been presented and discussed at our trust Clinical Governance Meeting, attended by those who carry out cystoscopic surveillance. The display of NICE guidance information in the cystoscopy room is recommended. These changes will ensure that everyone within the department responsible for cystoscopies, including trainees, is aware of the NICE guidance.

The issue of absence of important risk stratification variables prevents full-optimised use of the guidance. It is considered here that the implementation of a standardised proforma would overcome this issue, improve record keeping and ensure correct risk categorisation.

Once these recommendations have been implemented for an appropriate time interval, a re-audit should be conducted to assess for improvement in compliance with the implemented change.

References:Cancer Research UK. (2020). Bladder cancer statistics. [online] Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bladder-cancer#heading-Zero [Accessed 24 Feb. 2020].

Kamat, A., Bagcioglu, M. and Huri, E. (2017). What is new in non-muscle-invasive bladder cancer in 2016?. Turkish Journal of Urology, 43(1), pp.9-13.

Kassouf, W., Traboulsi, S., Schmitz-Dräger, B., Palou, J., Witjes, J., van Rhijn, B., Grossman, H., Kiemeney, L., Goebell, P. and Kamat, A. (2016). Follow-up in non-muscle-invasive bladder cancer—International Bladder Cancer Network recommendations. Urologic Oncology: Seminars and Original Investigations, 34(10), pp.460-468.

Leiblich, A., Bryant, R., McCormick, R. and Crew, J. (2018). The management of non-muscle-invasive bladder cancer: A comparison of European and UK guidelines. Journal of Clinical Urology, 11(2), pp.144-148.

NICE Guideline (2015). Bladder cancer: diagnosis and management. [ebook] Available at: https://www.nice.org.uk/guidance/ng2/resources/bladder-cancer-diagnosis-and-management-of-bladder-cancer-51036766405 [Accessed 10 Feb. 2020].

Schroeck, F., Smith, N. and Shelton, J. (2018). Implementing risk-aligned bladder cancer surveillance care. Urologic Oncology: Seminars and Original Investigations, 36(5), pp.257-264.

Schroeck, F., Lynch, K., Chang, J., MacKenzie, T., Seigne, J., Robertson, D., Goodney, P. and Sirovich, B. (2018). Extent of Risk-Aligned Surveillance for Cancer Recurrence Among Patients With Early-Stage Bladder Cancer. JAMA Network Open, 1(5), p.e183442.
Measuring the adherence to NICE guidelines for the cystoscopic follow up of NMIBC
Simeen S 1, Walklett S 1, Ellis R 1, Bodiwala D 1
King's Mill Hospital, United Kingdom

Introduction
Bladder cancer is the 10th most common cancer in the UK, with approximately 10, 300 new cases in the UK each year. In their lifetime, 1 in 50 males and 1 in 133 females in the UK will be diagnosed with bladder cancer (Cancer Research UK, 2015). Of these new diagnoses, around 75% are non-muscle invasive bladder cancers (NMIBC) (Kamat, Bağcıoğlu and Huri, 2017). In light of its significant prevalence in the UK population, compliance with guidelines created from best available evidence is important in ensuring patient safety by identifying patients who are at higher risk of recurrence and following them up accordingly. It also identifies low risk patients and prevents such cases with no recurrences from being followed up for prolonged periods. Such a trend would cumulatively have financial repercussions to the NHS.

NICE published its guideline 'Bladder cancer: diagnosis and management' (NICE Guideline, 2015) to aid clinicians in their decision-making. The guideline considers prognostic factors such as grade, size, solitary/multi-focal lesion, previous recurrences and hence the predicted behaviour of these tumours and uses this information to create risk categories. This audit looked at the publication's guidance regarding follow up of NMIBC specifically. Literature describes a risk-adapted approach, which aims to minimize the therapeutic burden of NMIBC with its high recurrence rates without missing progressing tumours (Kassouf et al 2016).

A US national retrospective cohort study (Schroeck et al 2018) on early stage bladder cancer looked at the extent to which such risk-aligned surveillance is adhered. They found that patients undergo cystoscopic surveillance at comparable frequencies regardless of risk. From observation it seemed practice within our department was similar, notably in terms of prolonged follow up of low risk cancers with no recurrences. It is important to understand barriers to better compliance and implement methods to overcome them.

Aims
• To measure the adherence to NICE guidelines for the cystoscopic follow up of NMIBC.

Methods
Data was collected from hospital digital records over a 5-month period. This yielded 100 patients who were under cystoscopic surveillance post resection of histologically confirmed NMIBC. Each case was allocated into the low, medium or high-risk groups in accordance with NICE guidance (Figure 1). The frequency and interval of follow up was then compared to the appropriate guidance for that patients risk category (Figure 2).

Results
The audit assessed a fairly even spread of patients across all 3 risk categories, with the intermediate risk category being the least represented at 27% of the whole sample (low and high risk were 35% and 38% respectively).

Figure 3 demonstrates the compliance rates per risk category. 30 out of the 35 (85.7%) patients in the low risk group were non-compliant with NICE guidance, 15 out of 27 (55.6%) in the intermediate risk group, and 17 out of the 38 (44.7%) patients in the high-risk group were non-compliant. Figure 4 explores this further, demonstrating the distribution of non-compliant cases per category, which were over- versus under-investigated. 100% of the non-compliant cases in both the low risk and intermediate risk categories were over-investigated, receiving an increased frequency of cystoscopies.

Amalgamating all 3 risk categories, figure 5 illustrates that out of the 100 patients, 38% of patients received the appropriate frequency of surveillance cystoscopies, 51% received an increased frequency and 11% received less than the recommended surveillance. Notably the high-risk group accounted for the 11% patients who were under investigated.

Discussion

The data collection was limited by the information available on the electronic records. It was often observed that key descriptive components such as size and foci of tumours were missing from the clinical information sent with the specimen for histology. This has implications on risk stratification, as diameter of less than 3 cm as opposed to over 3 cm is decisive of whether a tumour is low risk or high risk respectively (Figure 1).

The compliance pattern suggests that it is the low risk group who account in the majority for the lack of overall adherence to the guideline, with higher compliance rates in the high-risk group. The deviation from the suggested surveillance in the low and intermediate risk groups always represented an increase in surveillance rates when compared to the amount of surveillance cystoscopies suggested by the guideline. Out of the non-compliant cases two sub-groups emerged, those who had received more cystoscopies and those who received less cystoscopies. A cost analysis of the deviation took place. A total of 100 additional cystoscopies were carried out over the data collection period. The data suggests that a total of 22 cystoscopies were missed if the guideline was to be followed without variation. The net result of these variations resulted in 78 additional cystoscopies conducted over the period. The projected cost of each cystoscopy is £227, the resultant cost being £17,706 in total over the 5-month period. The figure accounts purely for the cystoscopy itself and does not take into account the associated costs of an increased number of cystoscopies, for example need for extra clinics and staff.

In addition to the higher financial cost, performing additional cystoscopies increases the risk of procedure-related complications such as infection and stricture disease, as well as patient discomfort.

Evidence supports the implementation of risk-aligned surveillance in aiding in the prevention of both overuse among low-risk patients, and underuse among high-risk patients. Although there are National clinical guidelines readily available, implementation and its success may be impeded by multiple challenges (Schroeck, Smith and Shelton, 2018). One such challenge could be fear of recurrence on discharge. This highlights the importance of collaboration of care between primary and secondary care and the patient, including patient education and high suspicion index by GP on finding blood on urine dip in absence of infection.

There are multiple national and international guidelines for the management of NMIBC. For example both the UK's NICE guidance and the European Association of Urologists (EAU) are in agreement on the risk stratified cystoscopic surveillance of NMIBC, but differ on advised frequency of intervals. For low risk NMIBC, their advice aligns in recommending cystoscopy at 3 months post initial resection then again at 12 months. NICE then go on to suggest discharge back to GP in primary care if there has been no recurrence within this time. This based on evidence that if a low risk NMIBC recurs after the first year it will typically recur the same grade and stage so will present similiarly. In contrast EAU recommends annual follow up for a further 5 years in low risk NMIBC. This stemming from current evidence that also suggests recurrence rates after 5 years tumour free are low (Leiblich et al, 2018). This study's findings of offering prolonged cystoscopic surveillance in the lower risk groups could suggest that we are offering a service more similar to what the EAU proposes.

Conclusions
The audit suggests there is room for improvement in compliance to the NICE guidance. It highlights the tendency to prolong surveillance of patients, performing a higher frequency of cystoscopies than suggested by NICE guidance. A much higher compliance rate was observed in the high-risk group. The audit does highlight that patient safety is maintained, and ultimately it is down to the clinical judgement of the surgeon, basing each decision on the individual patient. This study poses an interesting question as to whether clinicians in the UK are following the NICE guidance for cystoscopic surveillance of NMIBC or whether they are offering a service more similar to what the EAU proposes, and if so then why?

Recommendations
It is important to raise awareness to an appropriate audience, and the study findings have been presented and discussed at our trust Clinical Governance Meeting, attended by those who carry out cystoscopic surveillance. The display of NICE guidance information in the cystoscopy room is recommended. These changes will ensure that everyone within the department responsible for cystoscopies, including trainees, is aware of the NICE guidance.

The issue of absence of important risk stratification variables prevents full-optimised use of the guidance. It is considered here that the implementation of a standardised proforma would overcome this issue, improve record keeping and ensure correct risk categorisation.

Once these recommendations have been implemented for an appropriate time interval, a re-audit should be conducted to assess for improvement in compliance with the implemented change.

References:Cancer Research UK. (2020). Bladder cancer statistics. [online] Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bladder-cancer#heading-Zero [Accessed 24 Feb. 2020].

Kamat, A., Bagcioglu, M. and Huri, E. (2017). What is new in non-muscle-invasive bladder cancer in 2016?. Turkish Journal of Urology, 43(1), pp.9-13.

Kassouf, W., Traboulsi, S., Schmitz-Dräger, B., Palou, J., Witjes, J., van Rhijn, B., Grossman, H., Kiemeney, L., Goebell, P. and Kamat, A. (2016). Follow-up in non-muscle-invasive bladder cancer—International Bladder Cancer Network recommendations. Urologic Oncology: Seminars and Original Investigations, 34(10), pp.460-468.

Leiblich, A., Bryant, R., McCormick, R. and Crew, J. (2018). The management of non-muscle-invasive bladder cancer: A comparison of European and UK guidelines. Journal of Clinical Urology, 11(2), pp.144-148.

NICE Guideline (2015). Bladder cancer: diagnosis and management. [ebook] Available at: https://www.nice.org.uk/guidance/ng2/resources/bladder-cancer-diagnosis-and-management-of-bladder-cancer-51036766405 [Accessed 10 Feb. 2020].

Schroeck, F., Smith, N. and Shelton, J. (2018). Implementing risk-aligned bladder cancer surveillance care. Urologic Oncology: Seminars and Original Investigations, 36(5), pp.257-264.

Schroeck, F., Lynch, K., Chang, J., MacKenzie, T., Seigne, J., Robertson, D., Goodney, P. and Sirovich, B. (2018). Extent of Risk-Aligned Surveillance for Cancer Recurrence Among Patients With Early-Stage Bladder Cancer. JAMA Network Open, 1(5), p.e183442.
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