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1

Audit Report

Prostate Cancer Quality Performance Indicators

Clinical Audit Data: 01 July 2016 to 30 June 2017

Mr Grenville Oades MCN Clinical Lead Tom Kane MCN Manager David New Information Officer

West of Scotland Cancer Network Urological Cancer Managed Clinical Network

West of Scotland Cancer Network Final – Prostate Cancer MCN QPI Audit Report v1.0 27/08/2018 2

CONTENTS

EXECUTIVE SUMMARY 3

1. INTRODUCTION 11

2. BACKGROUND 11

2.1 NATIONAL CONTEXT 12

2.2 WEST OF SCOTLAND CONTEXT 12

3. METHODOLOGY 14

4. RESULTS AND ACTION REQUIRED 14

4.1 DATA QUALITY 14

4.2 PERFORMANCE AGAINST QUALITY PERFORMANCE INDICATORS (QPIS) 15

ACKNOWLEDGEMENT 43

ABBREVIATIONS 44

REFERENCES 45

APPENDIX: NHS BOARD ACTION PLANS 48


Executive Summary

Introduction This report contains an assessment of the performance of West of Scotland (WoS) urological cancer services using clinical audit data relating to patients diagnosed with prostate cancer in the twelve months between 01 July 2016 and 30 June 2017. Results are measured against the Prostate Cancer Quality Performance Indicators1 (QPIs). Data definitions2 and measurability criteria3 to accompany the Prostate Cancer QPIs are available from the ISD website. Twelve months of data were measured against the Prostate Cancer QPIs for the fifth consecutive year. A process of formal review was carried out after Year 3 of comparative reporting. The revised Prostate Cancer QPIs1 were published in July 2016 and are valid for patients diagnosed on or after 01 July 2015. Annual comparisons have been made where indicators have remained comparable following formal review. QPIs 11 and 12 are reported on for the first time within this report.

Background Prostate cancer is the most common cancer in males with approximately 3250 cases diagnosed in Scotland each year between 2012 and 20164. It is ranked as the fourth most commonly diagnosed cancer in Scotland after lung, breast and colorectal cancers5.

Methodology The clinical audit data presented in this report was collected by clinical audit staff in each NHS Board in accordance with an agreed dataset and definitions. The data was entered locally into the electronic Cancer Audit Support Environment (eCASE): a secure centralised web-based database. Data relating to patients diagnosed between 01 July 2016 and 30 June 2017 was downloaded from eCASE on 28 March 2018. Analysis was performed centrally by the West of Scotland Cancer Network (WoSCAN) Information Team and the timescales agreed took into account the patient pathway to ensure that a complete treatment record was available for each case. Initial results of the analysis were provided to local NHS Boards to check for inaccuracies or obvious gaps before final analysis was carried out. Final results were disseminated for NHS Board verification in line with the regional audit governance process, to ensure that the data was an accurate representation of service in each area.

Results Overall case ascertainment for WoS is high at 109.5% which indicates excellent capture of cases through audit. Case ascertainment figures however are provided for guidance and are not an exact measurement as it is not possible to compare directly with the same cohort. The Prostate Cancer Quality Performance Indicators (QPIs 1 to 8, and 11 to 13) summary of results is set out overleaf. QPIs 9 and 10 have been archived and are no longer reported. Where the number of cases meeting the denominator criteria for any indicator is between one and four, the percentage calculation has not been shown to avoid any unwarranted variation associated with small numbers


and to minimise the risk of disclosure. Results impacted by this are denoted with a dash (-). An asterisk (*) is applied to indicate a denominator of zero.


PROSTATE Quality Performance Indicator (QPI)

Performance by Board

QPI target AA FV GGC Lan WoS

QPI 1: Biopsy Procedure – Proportion of patients with prostate cancer who undergo TRUS prostate biopsy for histological diagnosis where a minimum of 10 cores are received by pathology.

90%

73.4% < 98.3% > 95.2% > 97.3% < 93.0% <

94 128 117 119 440 462 180 185 831 894

QPI 2 (i): Radiological Staging – Patients with intermediate risk prostate cancer, who are suitable for radical treatment, should be evaluated for locally advanced, nodal or bony metastatic disease (MRI).

95%

- 100.0% = 98.5% < 100.0% = 99.2% <

- - 34 34 65 66 18 18 119 120

QPI 2 (ii): Radiological Staging – Patients with high risk prostate cancer, who are suitable for radical treatment, should be evaluated for locally advanced, nodal or bony metastatic disease (MRI and bone scan).

95%

100.0% = 95.0% < 94.5% > 97.0% > 95.7% >

34 34 38 40 208 220 96 99 376 393

QPI 3: Pathology Reporting – Proportion of patients who undergo needle biopsy where the pathology report contains a full set of data items (as defined by the Scottish Urological Pathologists dataset).

90%

98.0% > 99.4% > 100.0% > 99.5% > 99.6% >

144 147 163 164 600 600 211 212 1118 1123

QPI 4(i): Multi-Disciplinary Team Meeting (MDT). Proportion of patients with non-metastatic prostate cancer (TanyNanyM0) discussed at the MDT before definitive treatment.

95%

100.0% > 99.2% > 95.6% > 89.8% < 95.4% >

139 139 131 132 517 541 202 225 989 1037

QPI 4(ii): Multi-Disciplinary Team Meeting (MDT). Proportion of patients with metastatic prostate cancer (TanyNanyM1) discussed at the MDT within 4 weeks of commencing treatment.

95%

65.1% < 98.2% > 88.6% > 96.1% > 88.9% >

28 43 56 57 195 220 74 77 353 397

QPI 5: Surgical Margins – Proportion of patients with pathologically confirmed, organ confirmed (stage pT2) prostate cancer who undergo radical prostatectomy in which tumour is present at the margin, i.e. positive surgical margin.

Analysed by HOSPSURG

< 20%

* * 3.3% < - 3.2% <

* * * * 2 61 - - 2 62

QPI 6: Volume of Cases per Surgeon – Number of radical prostatectomy procedures performed by a surgeon over a one year period (SMR01 data).

50 minimum

2 NOT MEETING

NA 7 NOT

MEETING 1 NOT

MEETING





QPI 7(i): Hormone Therapy – Proportion of patients with metastatic prostate cancer who are treated with immediate hormone therapy (31 days) (LHRH agonist monotherapy, maximum androgen blockade or bilateral orchidectomy).

95%

100.0% > 93.6% < 90.9% > 98.7% > 93.9% >

43 43 44 47 190 209 75 76 352 375

QPI 7(ii): Hormone Therapy – Proportion of patients with metastatic prostate cancer who are treated with immediate hormone therapy (31 days) and docetaxel chemotherapy.

70%

0.0% 20.5% 21.4% 13.7% 17.1%

0 43 9 44 42 196 10 73 61 356

QPI 8(i): Post surgical incontinence - Proportion of prostate cancer patients with post surgical incontinence approximately 1 year (between 10 and 14 months) after radical prostatectomy (i) > 0 pads per day


< 20%

- - 0.0% < - 0.0% <

- - - - 0 118 - - 0 124

QPI 8(ii): Post surgical incontinence - Proportion of prostate cancer patients with post surgical incontinence approximately 1 year (between 10 and 14 months) after radical prostatectomy (ii) > 1 pad per day


< 10%

- - 0.0% < - 0.0% <

- - - - 0 118 - - 0 124

QPI 11(i): Early Management of Active Surveillance - Proportion of men with prostate cancer under active surveillance who undergo multiparametric MRI within 6 months of diagnosis.

95%

100.0% 0.0% 0.0% 1.7% 15.2%

23 23 0 17 0 60 1 58 24 158

QPI 11(ii): Early Management of Active Surveillance – Proportion of men with prostate cancer under active surveillance who undergo prostate re-biopsy within 14 months of diagnosis.

75%

0.0% 72.2% 40.4% 38.6% 37.8%

0 21 13 18 21 52 17 44 51 135





QPI 12: 30 Day Mortality following Chemotherapy – Proportion of patients with prostate cancer who die within 30 days of chemotherapy.

<5%

* 8.3% 2.0% 0.0% 2.8%

* * 2 24 2 99 0 19 4 142

QPI 13: Clinical Trials Access - Proportion of patients diagnosed with prostate cancer who are consented for a clinical trial/research study.

15%

3.4% 16.1% 6.5% 0.7% 5.9%

8 234 25 155 49 757 2 284 84 1430

Meets/exceeds QPI target Figures below percentage performance denote the numerator and denominator values.

Does not meet QPI target (-) dash denotes a denominator of less than 5. (*) denotes a denominator of zero. Figures have been removed to ensure confidentiality.

> Indicates increase on previous year’s figure ‡ The denominator for Clinical Trials Access QPI uses 5-year cancer registry average (2012 – 2016).

< Indicates decrease from previous year’s figure

= Indicates no change from previous year

Indicates no comparable measure from previous year


Conclusions and Action Required Cancer audit has underpinned much of the regional development and service improvement work of the MCN and the regular reporting of activity and performance have been fundamental in assuring the quality of care delivered across the region. Following the development of Quality Performance Indicators, this has now become an established national programme to drive continuous improvement and ensure equity of care for patients across Scotland. The continual commitment of West of Scotland Boards has provided accurate data for reporting performance against the majority of Prostate Cancer QPIs from which yearly comparisons in the service provision across WoS Boards can be made. Further improvements with regard to data recording and completeness are required in order to report against all Prostate Cancer QPIs accurately. Overall, results from the fifth year of Prostate Cancer QPI analysis are encouraging and, for those QPIs that remained comparable where the target was not met at a regional level, improved WoS performance has been demonstrated. It is evident however that NHS Boards have found some targets challenging and there remains some issues surrounding data recording and completeness. The audit report has identified actions relating to data capture, specifically with regard to SMR01 data as well as continence for patients following radical prostatectomy. However, it is recognised that case ascertainment and data capture is generally of a high standard. Additional areas relating to service provision have been identified as requiring action, particularly with regard to ensuring patients are discussed at MDT prior to treatment or within a suitable time period once treatment has been commenced. As well as ensuring that patients are given the appropriate imaging within the optimum time period. Each Board was asked to complete a Performance Summary Report and document areas for improvement where performance was below the QPI target. NHS Boards are asked to develop local Action/Improvement Plans in response to the findings presented in the report.

Action required:

QPI 1: Biopsy Procedure

MCN to initiate regional discussion and propose required changes to the QPI ahead of any future national review.

QPI 2: Radiological Staging

NHS Greater Glasgow and Clyde to review the radiology referral process and reporting requirements for MRI scans.

NHS Greater Glasgow and Clyde to ensure that all patients meeting the high risk criteria are given an isotope bone scan.


QPI 4: Multi-Disciplinary Team (MDT) Meeting

NHS Lanarkshire to provide clarification on reasons behind advancing non metastatic prostate cancer patients to treatment prior to MDT and provide feedback on any planned remedial action.

NHS Ayrshire and Arran to provide detailed feedback on cases not meeting the target for part (ii) and provide details of any planned remedial action.

NHS Greater Glasgow and Clyde to ensure that all patients with metastatic disease are discussed at MDT within 4 weeks of first treatment and receive investigations promptly after diagnosis.

QPI 6: Volume of Cases per Surgeon

NHS Greater Glasgow and Clyde to work with coding department to improve the accuracy of SMR01 data.

NHS Ayrshire and Arran to provide feedback where surgeons have performed single cases.

QPI 7: Hormone Therapy and Docetaxel Chemotherapy

NHS Ayrshire and Arran to provide further explanation to the MCN into the QPI result for 7(ii) and potential differences in clinical approach.

NHS Greater Glasgow and Clyde to ensure there is clear documentation to explain any delays in the treatment pathway for all affected patients.

MCN to initiate regional discussion with regards to any required changes to the QPI ahead of any future national review.

QPI 8: Post-surgical Incontinence

NHS Greater Glasgow and Clyde to improve data capture of pad use through use of the long form ICIQ questionnaire.

NHS Greater Glasgow and Clyde to keep surgical outcomes under careful review to assess the impact of robotic surgery.

QPI 11: Early Management of Active Surveillance

NHS Greater Glasgow and Clyde to provide education on active surveillance protocol to all relevant staff.

MCN to initiate regional discussion with regards to any required QPI changes ahead of any future national review.

QPI 12: 30 Day Mortality following Chemotherapy

NHS Forth Valley to provide feedback on all cases of mortality.

QPI 13: Clinical Trials Access

MCN to identify potential barriers to trial recruitment and encourage clinicians to consider all patients for clinical trials.


A summary of actions for each NHS Board has been included within the Action Plan templates in the Appendix. Completed Action Plans should be returned to WoSCAN within two months of publication of this report.

Progress against these plans will be monitored by the MCN Advisory Board and any service or clinical issue which the Advisory Board considers not to have been adequately addressed will be escalated to the NHS Board Territorial Lead Cancer Clinician and Regional Lead Cancer Clinician. Additionally, progress will be reported annually to the Regional Cancer Advisory Group (RCAG) by NHS Board Territorial Lead Cancer Clinicians and MCN Clinical Leads, and nationally on a three-yearly basis to Healthcare Improvement Scotland as part of the governance processes set out in CEL 06 (2012).


1. Introduction This report contains an assessment of the performance of West of Scotland (WoS) urological cancer services using clinical audit data relating to patients diagnosed with prostate cancer in the twelve months between 01 July 2016 and 30 June 2017. Results are measured against the Prostate Cancer Quality Performance Indicators1 (QPIs), the original version of which were implemented for patients diagnosed on or after 01 July 2012. Data definitions2 and measurability criteria3 to accompany the Prostate Cancer QPIs are available from the ISD website. Twelve months of data were measured against the Prostate Cancer QPIs for the fifth consecutive year. In order to ensure the success of the National Cancer QPIs in driving quality improvement in cancer care across NHS Scotland, a process of formal review was carried out after Year 3 of comparative reporting. Tumour-specific Regional Clinical Leads undertook a key role in determining the extent of the review required for each tumour type. The revised Prostate Cancer QPIs1 were published in July 2016 and are valid for patients diagnosed on or after 01 July 2015. Annual comparisons have been made where indicators have remained comparable following formal review. Future reports will continue to compare clinical audit data in successive years to illustrate trends. QPIs 11 and 12 are new QPIs implemented at formal review. As these new QPIs included new data items, one year’s worth of data was required to be collected before they could be reported on. They will be reported on for the first time within this year’s report (Year 5).

2. Background Four NHS Boards across the WoS serve the 2.49 million population6. From this population, approximately 1430 men were diagnosed with prostate cancer annually between 2012 and 20167. The configuration of the Multidisciplinary Teams (MDTs) in the region is set out below and each MDT convenes on a weekly basis.

MDT Constituent Hospitals

Ayrshire & Arran (AA) Crosshouse Hospital, Ayr Hospital

Greater Glasgow and Clyde (GGC)

(i) Gartnavel General Hospital, Glasgow Royal Infirmary, Queen Elizabeth University Hospital, Vale of Leven

(ii) Royal Alexandra Hospital, Inverclyde Royal Hospital

Forth Valley (FV) Forth Valley Royal Hospital

Lanarkshire (Lan) Monklands District General, Wishaw General Hospital, Hairmyres Hospital


2.1 National Context Prostate cancer is the most common cancer in males with approximately 3250 cases diagnosed in Scotland each year between 2012 and 20164. It is ranked as the fourth most commonly diagnosed cancer in Scotland after lung, breast and colorectal cancers5. Since the start of the 1990s, there has been an overall increase in the incidence of prostate cancer. This is mainly due to the use of PSA testing, with particularly steep increases in incidence seen at the time of the implementation of PSA testing during the 1990s8. There has recently been a decrease in incidence with a 3.5% reduction from 2006 to 2016. However, partly due to the ageing population, incidence of prostate cancer is expected to rise in the coming years. A 35% increase in the incidence of prostate cancer has been projected from 2008-12 to 2023-279. Relative survival for prostate cancer is increasing10. Table 1 shows the percentage change in one-year and five-year age-standardised survival rates for patients diagnosed in 1987-1991 compared to those diagnosed in 2007-2011. Table 1: Relative age-standardised survival for prostate cancer in Scotland at 1 year and 5 years (2007-2011) showing percentage change from 1987-1991 to 2007-2011

10

Relative survival at 1 year (%) Relative survival at 5 years (%)

2007-2011 % change 2007-2011 % change

Prostate Cancer 96.0 % + 11.3% 84.0 % + 31.0 %

The significant increase in five-year survival rates may in part be due to the increased use of PSA testing in Scotland since the 1990s. As the PSA test enables some invasive prostate cancers to be detected earlier, this leads to an increase in survival time even in cases where a patient’s life is not necessarily extended by treatment11. 2.1.1 Service Redesign There have been major changes in the delivery of some aspects of prostate cancer services since the commencement of QPI reporting in 2012. At the National Planning Forum (NPF) in September 2015 it was agreed that each region should undertake a review of adult urology services as previous analysis demonstrated that surgery for prostate cancer varied markedly across Scotland with a split of open and laparoscopic operations between high and low volume centres12. The provision of radical prostatectomy surgery had also changed with the implementation of robotic surgery in Scotland and the changing pathways to support this. Scotland has now moved towards robotically-assisted prostatectomy surgery in three major high-volume centres in Aberdeen, Glasgow and Edinburgh. Regional service redesign commenced in the WoS in April 2016 and almost all of the radical prostatectomies performed in the WoS are now robotically assisted and take place at Queen Elizabeth University Hospital in Glasgow.

2.2 West of Scotland Context Prostate cancer is the most common urological cancer and accounts for approximately half of all urological cancer diagnoses in the West of Scotland. A total of 1566 cases of prostate cancer were recorded through audit as diagnosed in the WoS between 01 July 2016 and 30 June 2017. The number and percentage of patients diagnosed within each NHS Board is presented in Figure 1. As the largest WoS Board, 53.9% of all new cases of prostate cancer were diagnosed in NHS Greater


Glasgow and Clyde (NHSGGC) which is slightly higher than population estimates for this Board (46.4% of WoS population, 2015 mid-year estimates6). Figure 1: Proportion of patients diagnosed with prostate cancer by NHS Board of diagnosis, July 2016 to June 2017.

AA FV GGC Lan WoS

No. of new diagnoses 212 203 844 307 1566

% of WoS Total 13.5% 13.0% 53.9% 19.6%

The majority of men diagnosed with prostate cancer are in the older age groups with more than three quarters (76.6%) of new diagnoses occurring in males aged 65 and over. Figure 2 illustrates the distribution of the number of patients diagnosed within each age group for the WoS. Figure 2: Number of men diagnosed with prostate cancer in WoS within each age group, July 2016 to June 2017.

Age group <45 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 ≥85

No. of diagnoses 2 4 43 104 214 318 355 264 169 93

AA13.5%

FV13.0%GGC

53.9%

Lan19.6%

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100

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400

<45 45-49 50-54 55-60 60-64 65-69 70-74 75-79 80-84 85+

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Age group (years)


3. Methodology The clinical audit data presented in this report was collected by clinical audit staff in each NHS Board in accordance with an agreed dataset and definitions. The data was entered locally into the electronic Cancer Audit Support Environment (eCASE): a secure centralised web-based database. Data relating to patients diagnosed between 01 July 2016 and 30 June 2017 was downloaded from eCASE on 28 March 2018. Analysis was performed centrally by the West of Scotland Cancer Network (WoSCAN) Information Team and the timescales agreed took into account the patient pathway to ensure that a complete treatment record was available for each case. Initial results of the analysis were provided to local NHS Boards to check for inaccuracies or obvious gaps before final analysis was carried out. Final results were disseminated for NHS Board verification in line with the regional audit governance process, to ensure that the data was an accurate representation of service in each area.

4. Results and Action Required 4.1 Data Quality Audit data quality can be assessed in the first instance by estimating the proportion of expected patients that have been identified through audit. Case ascertainment is calculated as the number of new cases identified by the audit as a proportion of the number of cases reported by the National Cancer Registry (provided by Information Services Division, National Services Scotland). Cancer Registry figures were extracted from ACaDMe (Acute Cancer Deaths and Mental Health), a system provided by Information Services Division (ISD). An average of the previous five years’ figures is used to take account of annual fluctuations in incidence within NHS Boards. Figure 3: Case ascertainment by NHS Board for patients diagnosed with prostate cancer, July 2016 to June 2017.

AA FV GGC Lan WoS

Cases from audit 212 203 844 307 1566

ISD Cases (2012-2016 average) 234 155 757 284 1430

% Case ascertainment 90.6% 131.0% 111.5% 108.1% 109.5%

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AA FV GGC Lan WoS

Ca

se

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rta

inm

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)

NHS Board of diagnosis


Overall case ascertainment for WoS is high at 109.5% which indicates excellent capture of cases through audit. Case ascertainment figures however are provided for guidance and are not an exact measurement as it is not possible to compare directly with the same cohort. Case ascertainment for each WoS Board is illustrated in Figure 3. There is variation in percentage case ascertainment across the Boards ranging from 90.6% to 131.0% and a case ascertainment above 100% would suggest that overall numbers are increasing in a region; however regional variation in the use of PSA testing makes it difficult to interpret geographical variations in incidence8. The capture of Tumour, Nodal and Metastases (TNM) staging data, which is recorded in line with the TNM Classification of Malignant Tumours (Seventh Edition)13, has shown continued improvement over the last few years in most WoS Boards. This data is required for the measurement of QPIs 2 (i) and (ii), QPI 4 (i) and (ii) and QPI 7 and incomplete data may affect results as the clinical metastases field is required to determine whether cases should be included for measurement against these QPIs.

4.2 Performance against Quality Performance Indicators (QPIs) Results of the analysis of Prostate Cancer Quality Performance Indicators (QPIs 1 to 8, and 11 to 13) are set out in the following sections. QPIs 9 and 10 were archived and are no longer reported. Graphs and charts have been provided where this aids interpretation and, where appropriate, numbers have also been included to provide context. Where possible, and with consideration given to any changes after formal review, results for patients diagnosed in Year 5 have been presented alongside the previous years’ results to illustrate trends. Data (both graphically and in tabular format) are presented by location of diagnosis, location of treatment, or by operating surgeon, with some criteria given as an overall West of Scotland representation. Specific regional and NHS Board actions have been identified to address issues highlighted through the data analysis. Where the number of cases meeting the denominator criteria for any indicator is between one and four, the percentage calculation has not been shown on any associated charts or tables. This is to avoid any unwarranted variation associated with small numbers and to minimise the risk of disclosure. Any charts or tables impacted by this are denoted with a dash (-). Any commentary provided by NHS Boards relating to the impacted indicators will however be included as a record of continuous improvement. An asterisk (*) is applied to indicate a denominator of zero and to distinguish between this and a 0% performance.

Note: NHS Ayrshire and Arran made some data updates after the final data analysis. Original results have been included within charts and tables however the amended figures provided by NHS Ayrshire and Arran have been noted under each table.


QPI 1: Biopsy Procedure A definitive diagnosis of prostate cancer depends on the histopathological verification of adenocarcinoma in prostate biopsy cores or surgical specimens. The European Association of Urologists (EAU) recommends that for an initial diagnosis, a core biopsy of 10 – 12 systemic transrectal or transperineal peripheral zone biopsies should be performed under ultrasound-guided imaging14. QPI 1 states that 90% of patients who undergo transrectal ultrasound guided (TRUS) biopsy should have a minimum of 10 cores received by pathology. The tolerance within this target is to account for patients where, due to clinical suspicion, a smaller number of cores will suffice to enable a histological diagnosis. It also accounts for situations where patients may become unwell during the procedure resulting in the procedure being abandoned1.

QPI 1: Procedure for performing prostate biopsy should be optimised.

Numerator: Number of patients with prostate cancer who undergo TRUS biopsy where a minimum of 10 cores are received by pathology.

Denominator: All patients with prostate cancer who undergo TRUS biopsy of the prostate.

Exclusions: Patients enrolled in clinical trials

Patients with advanced (T4NanyMany) or metastatic disease (TanyNanyM1)

Target: 90%

Figure 4: The proportion of patients where a minimum of 10 cores were received by pathology following TRUS biopsy of the prostate.

QPI 1 Performance (%) Numerator Denominator Not recorded

numerator Not recorded exclusions

Not recorded denominator

AA‡ 73.4% 94 128 31 0 0

FV 98.3% 117 119 0 0 0

GGC 95.2% 440 462 0 7 0

Lan 97.3% 180 185 0 0 0

WoS 93.0% 831 894 31 7 0

‡NHS Ayrshire and Arran corrected result 76.6% (111/145)

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AA FV GGC Lan WoS

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Year 1 Year 2 Year 3 Year 4 Year 5 QPI Target


NHS Forth Valley, NHS Greater Glasgow and Clyde and NHS Lanarkshire all met the 90% target. NHS Ayrshire and Arran did not meet the target with a performance of 73.4% (corrected result 76.6%). The overall performance for the WoS met the target with 93.0%. NHS Ayrshire and Arran stated that a biopsy system utilising MRI fusion is used within the Board which may not be applicable to this QPI. TRUS biopsy is only used within the Board area where there is a clinically obvious tumour on examination.

Action required:



QPI 2: Radiological Staging Several factors have been shown to predict the risk of recurrence of prostate cancers and these have been used to classify localised prostate cancer into the risk groups below. QPI 2 (i) and (ii), based on the radiological staging of prostate cancer, refers to patients within these specific risk categories. Table 3: Localised Prostate Cancer Risk Categories

1

Low Risk Clinical Stage T1 – T2a and Gleason Score ≤ 6 and PSA at diagnosis < 10 ng/mL

Intermediate Risk Clinical Stage T2b or Gleason Score 7 or PSA at diagnosis 10 – 20 ng/mL

High Risk Clinical Stage ≥T2c or Gleason Score 8 – 10 or PSA at diagnosis > 20 ng/mL

Local staging is of importance in helping guide both patient and clinician towards a treatment decision. Although digital rectal examination (DRE), PSA level and needle biopsy histology help predict the likelihood of organ confined disease, this is on a population rather than an individual patient basis therefore it is important that patients are staged using Magnetic Resonance Imaging (MRI) and bone scan1. Results from these imaging tests could alter the management of some patients and further evaluate whether or not a patient is suitable for radical treatment. Patients found to have bone metastases may not be suitable for radical treatment.

QPI 2: Patients with intermediate or high risk prostate cancer, who are suitable for radical treatment, should be evaluated for locally advanced, nodal or bony metastatic disease.

Numerator: (i) Number of patients with intermediate-risk prostate cancer undergoing radical treatment who have an MRI of the prostate.

(ii) Number of patients with high-risk prostate cancer undergoing radical treatment who have an MRI of the prostate and an isotope bone scan (or alternative whole body MRI evaluation).

Denominator: All patients with (i) intermediate or (ii) high-risk prostate cancer undergoing radical treatment.

Exclusions: Patients who are unable to undergo an MRI scan

Patients who refuse MRI

Target: 95%


Figure 5: The proportion of patients with intermediate-risk prostate cancer undergoing radical treatment that have an MRI of the prostate, Year 2 to Year 5.

QPI 2(i) Performance (%) Numerator Denominator Not recorded



AA - - - - - -

FV 100.0% 34 34 0 0 0

GGC 98.5% 65 66 0 0 1

Lan 100.0% 18 18 0 0 0

WoS 99.2% 119 120 0 0 1

All Boards shown above met the 95% target. The NHS Ayrshire and Arran performance is not shown due to small numbers. The overall performance for the WoS was 99.2%. Figure 6: The proportion of patients with high-risk prostate cancer undergoing radical treatment that have an MRI of the prostate and isotope bone scan (or alternative whole-body MRI evaluation), Year 2 to Year 5.

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AA FV GGC Lan WoS

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Year 2 Year 3 Year 4 Year 5 QPI Target

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QPI 2(ii) Performance (%) Numerator Denominator Not recorded



AA‡ 100.0% 34 34 0 0 0

FV 95.0% 38 40 0 0 0

GGC 94.5% 208 220 0 0 1

Lan 97.0% 96 99 0 0 0

WoS 95.7% 376 393 0 0 1


NHS Ayrshire and Arran, NHS Forth Valley and NHS Lanarkshire all met the 95% target. NHS Greater Glasgow and Clyde fell just short of the target with 94.5%. The overall performance for the WoS was 95.7%. NHS Greater Glasgow and Clyde have provided detailed clinical feedback on all cases not meeting the target. A small number of cases received a bone scan out with the 6 week window. NHS Greater Glasgow and Clyde will explore the possibility of having staging information included in all MRI reports to aid clinicians to arrange appropriate imaging for each patient. The MDT has been encouraged to highlight patients who have not had the required imaging. A number of patients with high risk T stage but low risk PSA and Gleason scores did not receive a bone scan. NHS Greater Glasgow and Clyde must ensure that this cohort of patients receives a bone scan in the future.

Action required:




QPI 3: Pathology Reporting To help plan treatment for men diagnosed with prostate cancer, prognostic information from the needle biopsy is necessary1. The use of datasets improves the completeness of data in pathology reports and a minimum prostate cancer dataset has been agreed for Scotland based on the Royal College of Pathologists most recent Standard and Guideline for Prostate Cancer15. The target for this QPI has been set at 90% and the tolerance within the target is designed to account for situations where it is not possible to report all components of the dataset due to specimen size.

QPI 3: All surgical pathology reports for prostate needle biopsies should contain full pathology information to inform treatment decision making.

Numerator: Number of patients with prostate adenocarcinoma where needle biopsy pathology reports contains all data items (as defined in the Scottish Urological Pathologists dataset).

Denominator: All patients with prostate adenocarcinoma who undergo prostate needle biopsy.

Exclusions: None

Target: 90%

Figure 7: The proportion of patients with prostate adenocarcinoma whose needle biopsy pathology reports contain all data items as defined in the Scottish Urological Pathologists dataset.




AA‡ 98.0% 144 147 0 0 0

FV 99.4% 163 164 0 0 0

GGC 100.0% 600 600 0 0 0

Lan 99.5% 211 212 0 0 0

WoS 99.6% 1118 1123 0 0 0


All Boards comfortably met the 90% target. The overall performance for the WoS was 99.6%.

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Year 1 Year 2 Year 3 Year 4 Year 5 QPI Target


QPI 4: Multi-Disciplinary Team (MDT) Meeting Evidence suggests that patients with cancer managed by a multidisciplinary team have a better outcome. There is also evidence that the multidisciplinary management of patients increases their overall satisfaction with their care. Discussion prior to definitive treatment decisions being made provides reassurance that patients are being managed appropriately1. The MDT QPI was introduced in 2014 for patients diagnosed with prostate cancer and was subsequently split into parts (i) and (ii) following formal review. This was to account for patients with metastatic disease who often start hormone treatment immediately and therefore prior to MDT discussion. QPI 4(ii) stipulates that these cases should be discussed within 4 weeks of first treatment.

QPI 4: Multidisciplinary Team (MDT) Meeting

Description: Proportion of patients with (i) non-metastatic prostate cancer discussed prior to definitive treatment (ii) metastatic prostate cancer discussed within 4 weeks (28 days) of treatment.

Numerator: Number of patients discussed (i) prior to definitive treatment (ii) within 4 weeks of first treatment.

Denominator: All patients diagnosed with (i) non-metastatic (ii) metastatic prostate cancer.

Exclusions: Patients who died before first treatment.

Target: 95%

Figure 8: Proportion of patients diagnosed with (i) non-metastatic prostate cancer that are discussed prior to definitive treatment.




AA‡ 100.0% 139 139 0 0 0

FV 99.2% 131 132 0 1 7

GGC 95.6% 517 541 0 0 0

Lan 89.8% 202 225 0 0 0

WoS 95.4% 989 1037 0 1 7


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NHS Ayrshire and Arran, NHS Forth Valley and NHS Greater Glasgow and Clyde met the 95% target. NHS Lanarkshire fell short of the target with 89.8%. The overall WoS performance met the target with 95.4%. NHS Lanarkshire reviewed cases not meeting the target and noted that the majority of patients were commenced on treatment prior to MDT discussion as it was felt inappropriate to withhold cancer treatment until after MDT. Further information is required from NHS Lanarkshire to clarify why this action was taken on this particular patient cohort.

Figure 9: Proportion of patients diagnosed with metastatic prostate cancer discussed within 4 weeks (28 days) of first treatment.




AA‡ 65.1% 28 43 0 0 0

FV 98.2% 56 57 0 1 7

GGC 88.6% 195 220 0 0 0

Lan 96.1% 74 77 0 0 0

WoS 88.9% 353 397 0 1 7


NHS Forth Valley and NHS Lanarkshire met the 95% target with 98.2% and 96.1% respectively. NHS Greater Glasgow and Clyde fell short of the target with 88.6%. NHS Ayrshire and Arran were significantly short of the target with 65.1%. The overall performance for the WoS was below target at 88.9%. NHS Ayrshire and Arran reviewed cases and noted that patients either started treatment before MDT or refused treatment. NHS Greater Glasgow and Clyde have provided feedback on cases not meeting the target. In the majority of cases, treatment was started immediately on clinical diagnosis and staging investigations and/or biopsy were required prior to MDT discussion. Clinicians will be reminded of the QPI requirement and the consequent need to arrange prompt investigations. A small number of cases were not discussed for appropriate reasons.

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NHS Board of Diagnosis



Action required:





QPI 5: Surgical Margins Radical prostatectomy, the total removal of the prostate, is the primary curative surgical procedure for prostate cancer. Radical prostatectomy reduces the number of deaths and the risk of metastases in men with prostate cancer, however sometimes the tumour cannot be completely removed and the disease can recur. QPI 5 measures the proportion of patients with pathologically-confirmed, organ-confined (pT2) prostate cancer who undergo radical prostatectomy in which tumour is present at the margin and states that this should account for less than 20% of patients. It should be noted that the target was changed from < 25% to < 20% at formal review, thus making the target more challenging.

QPI Title: Organ confined prostate cancers which are surgically treated with radical prostatectomy should be completely excised.

Numerator: Number of patients with stage pT2 prostate cancer who underwent radical prostatectomy in which tumour is present at the margin.

Denominator: All patients with stage pT2 prostate cancer who underwent radical prostatectomy.

Exclusions: None

Target: < 20%

Figure 10: The proportion of patients with organ-confined (pT2) prostate cancer that underwent radical prostatectomy in which tumour is present at the margin.

(-) Data is not shown; denominator is less than 5. (*) Not applicable; denominator is zero




AA‡ * * * * * *

FV * * * * * *

GGC 3.3% 2 61 0 0 0

Lan - - - - - -

WoS 3.2% 2 62 0 0 0

(-) Data is not shown; denominator is less than 5. (*) denotes a denominator of zero.


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NHS Board of surgery

Year 1 Year 2 Year 3


Previous Target

- - * - * * * -


There were no cases included in this QPI from NHS Forth Valley. NHS Lanarkshire met the target but figures are not shown due to small numbers. NHS Ayrshire and Arran met the target (corrected result) with 11.1%. NHS Greater Glasgow and Clyde posted the best performance of all five years with 3.3%, well within the 20% target. The WoS performance was also the best to date with 3.2%.



It is preferable for radical prostatectomies to be performed in institutions that perform the procedure routinely. Studies have shown the rates of post-operative and late urinary complications following radical prostatectomy are significantly reduced if the procedure is performed in a high-volume hospital and by a surgeon who performs a large number of such procedures1. Within the last two years, provision of radical prostatectomy surgery has changed across Scotland with the implementation of robotically-assisted surgery in three high-volume centres. Regional service redesign commenced in the WoS in April 2016 and most procedures are now robotically assisted and take place at Queen Elizabeth University Hospital (QEUH) in Glasgow. For robotic assisted radical prostatectomy it has been suggested that individual surgeons should undertake a minimum of 50-100 cases per annum1. The target was therefore increased following formal review and QPI 6 states that surgeons performing radical prostatectomies should perform a minimum of 50 procedures per year.

QPI Title: Surgery should be performed by surgeons who perform the procedure routinely.

Specifications: Number of radical prostatectomies performed by each surgeon in a given year.

Exclusions: None

Target: Minimum of 50 procedures per surgeon in a 1 year period.

ISD has provided information from The General/Acute Inpatient and Day Case dataset (SMR01) to calculate the number of prostatectomies being carried out by each surgeon between 01 July 2016 and 30 June 2017. This data has been utilised as it will capture patients who may have been on active surveillance for a number of years and are only now undergoing treatment with radical prostatectomy. It should be noted that SMR01 data does not allow for credit to be allocated to each surgeon where operations are performed by two consultants. Table 5: SMR01 data provided by ISD - The number of radical prostatectomies performed per surgeon between 01 July 2016 and 30 June 2017.

QPI 6 No. of Operating Surgeons No. of Procedures No. of Surgeons Meeting

Target

AA 2 2 0

FV NA NA NA

GGC 8 170 1

Lan 1 9 0

WoS 13 181 1

Operation Codes

M61.1 M61.2 M61.3 M61.4 M61.9

Total excision of prostate and capsule of prostate Retropubic prostatectomy Transvesical prostatectomy Perineal prostatectomy Unspecified open excision of prostate

Only one surgeon from NHS Greater Glasgow and Clyde met the target. This was the only surgeon to meet the target in the West of Scotland. NHS Greater Glasgow and Clyde have provided feedback where surgeons have not reached the minimum number of procedures. A number of reasons were highlighted including surgeon retiring, surgeon in post for part of audit period and surgeons in training to perform robotic surgery. Two surgeons were included due to local coding errors, the details of which have been explained in the


feedback received. NHS Greater Glasgow and Clyde stated that surgical volumes will be kept under review. NHS Lanarkshire stated that there are around 10-20 open prostatectomies carried out within the Board each year, and that this reflects the regionalisation of the service within the West of Scotland. One surgeon performs all of the procedures on selected high grade cases after careful consultation and MDT support.

Action required:




QPI 7: Hormone Therapy and Docetaxel Chemotherapy The function of hormone therapy on prostate cancer is to stop testosterone feeding prostate cancer and encouraging growth16. Androgen Deprivation Therapy (ADT) blocks the production of androgens including testosterone, with the aim of slowing the growth of prostate cancer cells. There is evidence for symptom palliation and possible survival benefit in symptomatic metastatic patients, and for prolonged progression-free survival in asymptomatic patients with metastatic prostate cancer1. Androgen blockade can be administered in one of three ways: 1) orchidectomy; 2) injection of a luteinising hormone-releasing hormone (LHRH) agonist or antagonist; and 3) oral anti-androgen or oestrogen tablets in combination with an orchidectomy or LHRH agonist15. QPI 7(i) measures the proportion of patients with metastatic disease (TanyNanyM1) that undergo any of the above hormone therapy treatments within 31 days of discussion at MDT. QPI 7 was updated following QPI formal review and part (ii) was added to measure those patients undergoing immediate hormone therapy in combination with Docetaxel chemotherapy. Docetaxel chemotherapy has shown evidence of improved survival when given in conjunction with hormone therapy and therefore should be offered to men who are suitably fit as part of their care1. As QPI 7(ii) requires the measurement of new data values previously not recorded, this will be reported for patients diagnosed on or after 01 July 2016.

QPI 7: Patients with metastatic prostate cancer should undergo immediate hormone therapy and chemotherapy where appropriate.

Numerator: Number of patients with metastatic prostate cancer who undergo immediate management with (i) hormone therapy or (ii) hormone therapy and Docetaxel chemotherapy.

Denominator: All patients presenting with metastatic prostate cancer (TanyNanyM1).

Exclusions: Patients documented to have refused immediate hormone therapy

Patients documented to have refused chemotherapy (ii) only

Patients enrolled in clinical trials

Target: (i) 95% (ii) 70%

Figure 11: The proportion of patients presenting with metastatic prostate cancer treated with immediate hormone therapy (LHRH agonist monotherapy, dual androgen blockade or bilateral orchidectomy).

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AA‡ 100.0% 43 43 0 0 0

FV 93.6% 44 47 0 0 7

GGC 90.9% 190 209 0 0 0

Lan 98.7% 75 76 0 0 0

WoS 93.9% 353 375 0 0 7

‡ NHS Ayrshire and Arran corrected result 97.9% (46/47)

NHS Ayrshire and Arran and NHS Lanarkshire both met the 95% target with 100.0% and 98.7% respectively. NHS Forth Valley and NHS Greater Glasgow and Clyde were both short of the target with 93.6% and 90.9% respectively. The WoS performance was just below target with 93.9%.

NHS Forth Valley stated that a small number of patients missed the target by a matter of days. All cases were reviewed locally and the Board concluded that patients were managed in a clinically appropriate manner.

NHS Greater Glasgow and Clyde highlighted a number of factors impacting on results including patient choice, patient fitness, patient mortality and further investigation/referral required before treatment. In a small number of cases there was no clear documented reason for delay. Figure 12: The proportion of patients presenting with metastatic prostate cancer treated with immediate hormone therapy and Docetaxel chemotherapy.




AA‡ 0.0% 0 43 0 0 0

FV 20.5% 9 44 0 0 7

GGC 21.4% 42 196 1 1 0

Lan 13.7% 10 73 0 0 0

WoS 17.1% 61 356 1 1 7


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No Boards within the WoS met the 70% target. The overall performance for the WoS was 17.1%.

NHS Forth Valley, NHS Greater Glasgow and Clyde and NHS Lanarkshire have provided detailed clinical feedback on cases not meeting the target. Reasons noted included patient fitness and comorbidities; patient suitability for treatment and patient choice. NHS Forth Valley went on to state that all cases with metastatic disease will have potential suitability for chemotherapy specifically recorded at MDT. NHS Greater Glasgow and Clyde commented that the target is very challenging given the patient cohort and suggested that some adjustment to the QPI may be necessary.

Action required:





QPI 8: Post-surgical Incontinence Urinary incontinence, especially over the long term, is significant and is associated with poor quality of life. This therefore requires to be minimised in men undergoing surgery for prostate cancer1. This QPI is reported one year behind to allow capture of all eligible patients (i.e. to account for the 10 – 14 month time lag). Data presented below therefore refers to patients diagnosed in Years 1-4. Minor changes were implemented following formal review and exclusions now account for patients undergoing adjuvant radiotherapy within 12 months of surgery rather than 6 months. Post-surgical incontinence now requires to be measured using a validated tool, either The Expanded Prostate Cancer Index Composite (EPIC) Urinary Assessment or the Incontinence Questionnaire (ICIQ).

QPI Title: Post-surgical incontinence for patients with prostate cancer should be minimised.

Numerator: Number of patients with prostate cancer undergoing radical prostatectomy with post-surgical incontinence at 1 year (10-14 months) post radical prostatectomy;

8(i) More than 0 pads per day

8(ii) More than 1 pad per day

Denominator: All patients with prostate cancer undergoing radical prostatectomy.

Exclusions: Patients who undergo salvage prostatectomy

Patients who receive adjuvant radiotherapy within 6 months of surgery

Target: 8(i) < 20%

8(ii) < 10% Figure 13: The proportion of patients with prostate cancer undergoing radical prostatectomy with post-surgical incontinence by Board of surgery - QPI 8 (i) > 0 pads per day.




AA - - - - - -

FV - - - - - -

GGC 0.0% 0 118 118 0 0

Lan - - - - - -

WoS 0.0% 0 124 119 0 0

(-) Data is not shown; denominator is less than 5.

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- - - -


Figure 14: The proportion of patients with prostate cancer undergoing radical prostatectomy with post-surgical incontinence by Board of surgery - QPI 8 (ii) > 1 pad per day




AA - - - - - -

FV - - - - - -

GGC 0.0% 0 118 118 0 0

Lan - - - - - -

WoS 0.0% 0 124 119 0 0

(-) Data is not shown; denominator is less than 5. The majority of cases in this QPI have been from NHS Greater Glasgow and Clyde with very small numbers originating from other Boards in the WoS. This reflects the regionalisation of prostatectomy procedures. All Boards showed a 0% rate for incontinence in both parts of this QPI. However, in the vast majority of cases, continence status was “not recorded”. In NHS Greater Glasgow and Clyde, 100% of cases were “not recorded”. NHS Greater Glasgow and Clyde provided feedback on the performance and stated that this was due to the new requirement of this QPI, that pad use must be documented using a validated tool. A short form ICIQ (International Consultation on Incontinence Questionnaire) has been in use but this does not record pad use. The long form ICIQ records pad use and will be used in future. NHS Greater Glasgow and Clyde conducted a review of clinical records in order to assess pad use. Performance was found to be poorer compared to previous years. This is thought to be associated with the transition of performing the majority of surgeries robotically, and improvement is expected to be seen with future patient cohorts. The Board will continue to monitor surgical outcomes to assess the introduction of robotic surgery. Action required:



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QPI 11: Early Management of Active Surveillance Different treatment options are available for men with low risk prostate cancer including surgery, radiotherapy and also active surveillance. Active surveillance as a treatment option can reduce overtreatment and therefore reduce potential adverse effects from radical treatments as well as being beneficial in terms of healthcare costs. It is recommended that men who are undergoing active surveillance should have a multiparametric MRI performed at enrolment of active surveillance if not previously performed. A prostate re-biopsy should also be performed at the end of one year of active surveillance1.

QPI Title: Men under active surveillance for prostate cancer should undergo appropriate investigations at the clinically relevant timings.

Numerator: Number of patients with prostate cancer under active surveillance who undergo:

11(i) multiparametric MRI within 6 months of diagnosis

11(ii) prostate re-biopsy within 14 months of diagnosis.

Denominator: All patients with prostate cancer under active surveillance.

Exclusions: 11(i)

Patients unable to undergo an MRI scan.

Patients who refuse MRI.

11(ii)

Patients who undergo radical treatment within 14 months of diagnosis.

Patients who refuse biopsy.

Target: (i) 95% (ii) 75%

Figure 15: The proportion of patients with prostate cancer under active surveillance who undergo multiparametric MRI within 6 months of diagnosis.

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QPI 11(i) Performance (%) Numerator Denominator

Not recorded numerator

Not recorded exclusions


AA‡ 100.0% 23 23 0 0 0

FV 0.0% 0 17 0 0 0

GGC 0.0% 0 60 0 0 0

Lan 1.7% 1 58 0 0 0

WoS 15.2% 24 158 0 0 0


NHS Ayrshire and Arran met the target with 100.0%. All other Boards were significantly short of the 95% target. The overall performance for the WoS was 15.2%. Boards have provided feedback on cases not meeting the target. Most cases failed as MRI scans were performed without contrast. NHS Greater Glasgow and Clyde stated that a number of cases failed as the MRI scan was carried out prior to diagnosis. NHS Greater Glasgow and Clyde commented that advice from Radiology and referral to the NICE guidelines suggests that the use of contrast is not useful in this context. Definition/measurability issues with this QPI have been raised with ISD and are currently under review. Figure 16: The proportion of patients with prostate cancer under active surveillance who undergo prostate re-biopsy within 14 months of diagnosis.

QPI 11(ii) Performance (%) Numerator Denominator

Not recorded numerator

Not recorded exclusions


AA‡ 0.0% 0 21 0 0 0

FV 72.2% 13 18 0 0 0

GGC 40.4% 21 52 0 0 0

Lan 38.6% 17 44 0 0 0

WoS 37.8% 51 135 0 0 0


NHS Forth Valley was just short of the 75% target with a performance of 72.2%. All other Boards in the WoS were significantly short of the target. All Boards have reviewed cases and provided clinical feedback on cases not meeting the target including patient choice and contraindication to re-biopsy. A number of patients received a repeat

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biopsy out with the 14 month window. A number of patients received MRI only without re-biopsy, and NHS Ayrshire and Arran stated that MRI is used preferentially rather than re-biopsy within the Board area. However, it should be noted that NICE guidelines still recommend that biopsy should be repeated at one year17. NHS Greater Glasgow and Clyde stated that a small number of patients received no follow up investigations at one year. Education around the requirements of active surveillance protocol will be conducted within the Board. Action required:




QPI 12: 30 Day Mortality following Chemotherapy Outcomes of treatment, including treatment related morbidity and mortality should be regularly assessed. Treatment should only be undertaken in individuals that may benefit from that treatment, that is, treatments should not be undertaken in futile situations. This QPI is intended to ensure treatment is given appropriately, and the outcome reported on and reviewed1.

QPI Title: 30 day mortality following chemotherapy for prostate cancer.

Numerator: Number of patients with prostate cancer who undergo chemotherapy that die within 30 days of treatment.

Denominator: All patients with prostate cancer who undergo chemotherapy.

Exclusions: No exclusions.

Target: <5%

Figure 17: Proportion of patients with prostate cancer undergoing chemotherapy that die within 30 days of treatment.




AA * * * * * *

FV 8.3% 2 24 0 0 0

GGC 2.0% 2 99 1 0 1

Lan 0.0% 0 19 0 0 0

WoS 2.8% 4 142 1 0 1

NHS Greater Glasgow and Clyde and NHS Lanarkshire met the target of <5%. NHS Forth Valley exceeded the target with 8.3%. The WoS performance was within target at 2.8%. There were no patients from NHS Ayrshire and Arran included in this QPI. NHS Forth Valley has provided some feedback on cases not meeting the target. Further detail is required for clarification. Action required:

NHS Forth Valley to provide feedback on all cases of mortality.

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*


QPI 13: Clinical Trials Access Clinical trials are necessary to demonstrate the efficacy of new therapies and other interventions. Evidence suggests improved patient outcomes when hospitals are actively recruiting patients into clinical trials1. Clinicians are therefore encouraged to enter patients into well designed trials and to collect longer term follow up data. High accrual activity into clinical trials is used as a goal of an exemplary clinical research site. The measurement of this QPI focuses on those patients who have consented in order to reflect the intent to join a clinical trial and demonstrate the commitment to recruit patients. Often patients can be prevented from enrolling within a trial due to stratification of studies and precise inclusion criteria identified during the screening process. The clinical trials QPI is measured utilising Scottish Cancer Research Network (SCRN) data and ISD incidence data, as is the methodology currently utilised by the Chief Scientist Office (CSO) and the National Cancer Research Institute (NCRI). The principal benefit of this approach is that this data is already collected utilising a robust mechanism1.

QPI 13: All patients should be considered for participation in available clinical trials/research studies, wherever eligible.

Description: Proportion of patients diagnosed with prostate cancer who are consented for a clinical trial/research study.

Numerator: Number of patients diagnosed with prostate cancer consented for a clinical/research study.

Denominator: All patients with prostate cancer.

Exclusions: No exclusions

Target: 15%

Figure 18: Proportion of patients consented for and recruited into clinical trials for prostate cancer by NHS Board of residence, 2017.

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Consented Target 15% Recruited

N D % N D %

AA 8 234 3.4% 7 234 3.0%

FV 25 155 16.1% 21 155 13.5%

GGC 49 757 6.5% 41 757 5.4%

Lan 2 284 0.7% 2 284 0.7%

WoS Total 84 1430 5.9% 71 1430 5.0%

N: Number of patients enrolled in trials

D: Cancer registry data (5-year average)

%: Percentage of patients enrolled in clinical trials.

NHS Forth Valley met the 15% target with a performance of 16.1%. All other Boards within the WoS were short of the target. The overall performance for the WoS was 5.9%. Feedback suggests that there is a lack of available trials within the region which is reflected in the QPI performance. Boards will continue to assess patient suitability for inclusion in clinical trials. Action required:



Table 6: List of clinical trials for prostate cancer carried out at Beatson West of Scotland Cancer Centre (BWoSCC) and other WoS hospital sites showing the number of patients recruited into each clinical trial in 2017.

Short Title Full Project Title 2017

Consented Recruited

UK Genetic Prostate Cancer Study

UK Genetic Prostate Cancer Study - -

STAMPEDE Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy

36 31

PATCH Prostate Adenocarcinoma: TransCutaneous Hormones. A randomised-controlled trial of transcutaneous oestrogen patches versus LHRH analogues in prostate cancer.

16 14

TOPARP TOPARP: Phase II Trial of Olaparib in Patients with Advanced Castration Resistant Prostate Cancer

- -

ProCAID An open label phase I/randomised, double-blind phase II study in metastatic castration resistant Prostate Cancer of AZD5363 in combination with Docetaxel and prednisolone chemotherapy (ProCAID)

- -

MAdCaP A phase I/randomised phase II trial of abiraterone acetate with or without R05503781 in patients with metastatic Castrate Resistant Prostate Cancer (mCRPC) who have not previously received docetaxel

- -

EMBARK: MDV3100-13 Phase 3, Enzalutamide, non metastatic prostate cancer

A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy

9 6

TITAN JNJ-56021927 A Phase 3 Randomized, Placebo-controlled, Double-blind Study of JNJ-56021927 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects with Low Volume Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

- -

SPECTRE Combined SuPpression of cholEsterol bioavailability and androgen deprivation therapy to treat CastraTion Resistant prostatE cancer

7 -

KEYNOTE-199 – Phase II Trial of MK-3475 in Subjects with mCRPC with Prior Chemotherapy

Phase II Trial of Pembrolizumab (MK-3475) in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated with Chemotherapy (KEYNOTE-199)

- -

AQUARiUS Prospective Multi-country Observational Study to Investigate the Impact of Abiraterone Acetate and Enzalutamide on Health-related Quality of Life, Patient-reported Outcomes, and Medical Resource Use in Metastatic Castration-resistant Prostate Cancer Patients

- -

NCRN – 3041: ODM-201 in men with high risk non-metastatic castration resistant prostate cancer

A multinational, randomised, double blind, placebo controlled, phase III efficacy and safety study of ODM-201 in men with high risk non-metastatic castration resistant prostate cancer

5 5

Open-label Extension Study for Participants with Prostate Cancer

A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

- -

TOTAL 91 78

Source: SCRN data (-) dash denotes a denominator of less than 5.


5. Conclusions Cancer audit has underpinned much of the regional development and service improvement work of the MCN and the regular reporting of activity and performance have been fundamental in assuring the quality of care delivered across the region. Following the development of Quality Performance Indicators, this has now become an established national programme to drive continuous improvement and ensure equity of care for patients across Scotland. The continual commitment of West of Scotland Boards has provided accurate data for reporting performance against the majority of Prostate Cancer QPIs from which yearly comparisons in the service provision across WoS Boards can be made. Further improvements with regard to data recording and completeness are required in order to report against all Prostate Cancer QPIs accurately. Overall, results from the fifth year of Prostate Cancer QPI analysis are encouraging and, for those QPIs that remained comparable where the target was not met at a regional level, improved WoS performance has been demonstrated. It is evident however that NHS Boards have found some targets challenging and there remains some issues surrounding data recording and completeness. The audit report has identified actions relating to data capture, specifically with regard to SMR01 data as well as continence for patients following radical prostatectomy. However, it is recognised that case ascertainment and data capture is generally of a high standard. Additional areas relating to service provision have been identified as requiring action, particularly with regard to ensuring patients are discussed at MDT prior to treatment or within a suitable time period once treatment has been commenced. As well as ensuring that patients are given the appropriate imaging within the optimum time period.

Action required:

QPI 1: Biopsy Procedure


QPI 2: Radiological Staging



QPI 4: Multi-Disciplinary Team (MDT) Meeting








QPI 7: Hormone Therapy and Docetaxel Chemotherapy




QPI 8: Post-surgical Incontinence



QPI 11: Early Management of Active Surveillance



QPI 12: 30 Day Mortality following Chemotherapy

NHS Forth Valley to provide feedback on all cases of mortality. QPI 13: Clinical Trials Access


The MCN will actively take forward regional actions identified and NHS Boards are asked to develop local Action/Improvement Plans in response to the findings presented in the report. A summary of actions for each NHS Board has been included within the Action Plan templates in the Appendix. Completed Action Plans should be returned to WoSCAN within two months of publication of this report. Progress against these plans will be monitored by the MCN Advisory Board and any service or clinical issue which the Advisory Board considers not to have been adequately addressed will be escalated to the NHS Board Territorial Lead Cancer Clinician and Regional Lead Cancer Clinician. Additionally, progress will be reported annually to the Regional Cancer Advisory Group (RCAG), by NHS Board Territorial Lead Cancer Clinicians and MCN Clinical Leads, and nationally on a three-yearly basis to Healthcare Improvement Scotland as part of the governance processes set out in CEL 06 (2012).


Acknowledgement This report has been prepared using clinical audit data provided by the following NHS Boards in the WoSCAN area: NHS Ayrshire & Arran NHS Forth Valley NHS Greater Glasgow and Clyde NHS Lanarkshire

We would like to thank all members and active participants in the cancer network for their continued support of the MCN, and the many hospitals that are committed to making the audit succeed. We also acknowledge the efforts of the clinical effectiveness staff, nurses, and other service users for their work in ensuring the data are available to enable analysis to take place each year. Without their considerable efforts this level of progress would not be possible.


Abbreviations

AA NHS Ayrshire & Arran

ACaDMe Acute Cancer Deaths and Mental Health

ADT Androgen Deprivation Therapy

CEL(06) Chief Executive Letter

CSO Chief Scientist Office

CT Computed Tomography (scan)

DRE Digital Rectal Examination

EAU European Association of Urologists

eCASE Electronic Cancer Audit Support Environment

ERSPC European Randomised Study of Screening for Prostate Cancer

FV NHS Forth Valley

FVRH Forth Valley Royal Hospital

GGC NHS Greater Glasgow and Clyde

GMC General Medical Council

HIS Healthcare Improvement Scotland

ICD-10 WHO International Classification of Diseases

ICIQ International Consultation on Incontinence Questionnaire

ISD Information Services Division

Lan NHS Lanarkshire

LHRH Luteinising Hormone-Releasing Hormone

MCN Managed Clinical Network

MDT Multidisciplinary Team

MRI Magnetic Resonance Imaging

NCQSG National Cancer Quality Steering Group

NCRI National Cancer Research Institute

NHSGGC NHS Greater Glasgow and Clyde

PSA Prostate Specific Antigen

QEUH Queen Elizabeth University Hospital

QPI(s) Quality Performance Indicator(s)

RCAG Regional Cancer Advisory Group

SCRN Scottish Cancer Research Network

SMR(01) Scottish Morbidity Records

TNM Tumour, Nodes, Metastases (staging system)

TRUS Transrectal Ultrasound Guided Biopsy

WoS West of Scotland

WoSCAN West of Scotland Cancer Network


References

1. Healthcare Improvement Scotland. Prostate Cancer Quality Performance Indicators, v3.0; May 2012 (updated July 2016) [Accessed on: 12

th June 2018] Available at:

http://www.healthcareimprovementscotland.org/our_work/cancer_care_improvement/programme_resources/cancer_qpis.aspx

2. Information Services Division. National Data Definitions for the Minimum Core Data Set for Prostate

Cancer. Prostate v3.0; June 2012 (updated November 2016) [Accessed on: 12th June 2018] Available

at: http://www.isdscotland.org/Health-Topics/Cancer/Cancer-Audit/#qpi

3. Information Services Division. Prostate Cancer. Measurability of Quality Performance Indicators v3.0; June 2012 (updated November 2016) [Accessed on: 12

th June 2018] Available at:

http://www.isdscotland.org/Health-Topics/Cancer/Cancer-Audit/#qpi

4. Information Services Division, Cancer Statistics, Male genital organ cancers. Annual Incidence. [Accessed on: 10

th July 2018]. Available at: http://www.isdscotland.org/Health-Topics/Cancer/Cancer-

Statistics/Male-Genital-Organs/#prostate

5. Information Services Division. Cancer in Scotland, June 2004 (updated April 2017) [Accessed on: 12h

June 2018]. Available at: http://www.isdscotland.org/Health-Topics/Cancer/Cancer-Statistics/

6. ScotPHO, Public Health Information for Scotland. Mid 2015 Population Estimates Scotland. [Accessed on: 12

th June 2018] Available at: https://www.nrscotland.gov.uk/statistics-and-data/statistics/statistics-

by-theme/population/population-estimates/mid-year-population-estimates/mid-2015-and-corrected-mid-2012-to-mid-2014/list-of-tables

7. Information Services Division, Cancer Statistics, Summary statistics for male genital organ cancers.

[Accessed on: 12h June 2018]. Available at: http://www.isdscotland.org/Health-Topics/Cancer/Cancer-

Statistics/Male-Genital-Organs/#prostate

8. ScotPHO, Public Health Information for Scotland. Prostate cancer: introduction, May 2015. [Accessed on: 10

th July 2018] Available at: http://www.scotpho.org.uk/health-wellbeing-and-disease/cancer-

prostate/introduction

9. Information Services Division. Cancer Incidence Projections for Scotland 2013-2027, August 2015. [Accessed on 10

th July 2018]. Available at: https://www.isdscotland.org/Health-

Topics/Cancer/Publications/2015-08-18/2015-08-18-Cancer-Incidence-Projections-Report.pdf

10. ISD, NHS National Services Scotland. Trends in Cancer Survival in Scotland, 1983-2007. August 2010. [Accessed on: 12

h June 2018] Available at: http://www.isdscotland.org/Health-Topics/Cancer/Cancer-

Statistics/Survival_summary_8307.pdf?1

11. National Cancer Institute, Prostate-Specific Antigen (PSA) Test, July 2012. [Accessed on: 10th July

2017] Available at: http://www.cancer.gov/cancertopics/factsheet/detection/PSA

12. Information Services Division. Prostate Cancer Quality Performance Indicators; Patients diagnosed during July 2012 to June 2015, December 2016 [Accessed on: 10

th July 2018] Available at:

http://www.isdscotland.org/Health-Topics/Quality-Indicators/Publications/2016-12-13/2016-12-13-Prostate-QPI-Report.pdf

13. Sobin LH, Gospodarowicz MK, Wittekind Ch. UICC (Union for International Cancer Control). TNM

Classification of Malignant Tumours. Seventh Edition. Wiley-Blackwell; 2009.

14. Mottet N, Bastian PJ, Bellmunt J, et al. The European Association of Urologists, Guidelines on Prostate Cancer, April 2014. [Accessed on: 10

th July 2018] Available at: http://uroweb.org/wp-

content/uploads/1607-Prostate-Cancer_LRV3.pdf





http://www.isdscotland.org/Health-Topics/Cancer/Cancer-Statistics/Male-Genital-Organs/#prostate


http://www.isdscotland.org/Health-Topics/Cancer/Cancer-Statistics/

https://www.nrscotland.gov.uk/statistics-and-data/statistics/statistics-by-theme/population/population-estimates/mid-year-population-estimates/mid-2015-and-corrected-mid-2012-to-mid-2014/list-of-tables





http://www.scotpho.org.uk/health-wellbeing-and-disease/cancer-prostate/introduction

http://www.scotpho.org.uk/health-wellbeing-and-disease/cancer-prostate/introduction

https://www.isdscotland.org/Health-Topics/Cancer/Publications/2015-08-18/2015-08-18-Cancer-Incidence-Projections-Report.pdf

https://www.isdscotland.org/Health-Topics/Cancer/Publications/2015-08-18/2015-08-18-Cancer-Incidence-Projections-Report.pdf

http://www.isdscotland.org/Health-Topics/Cancer/Cancer-Statistics/Survival_summary_8307.pdf?1

http://www.isdscotland.org/Health-Topics/Cancer/Cancer-Statistics/Survival_summary_8307.pdf?1

http://www.cancer.gov/cancertopics/factsheet/detection/PSA



http://uroweb.org/wp-content/uploads/1607-Prostate-Cancer_LRV3.pdf

http://uroweb.org/wp-content/uploads/1607-Prostate-Cancer_LRV3.pdf


15. Royal College of Pathologists, Dataset for histopathology reports for prostatic carcinoma (2nd

Edition), October 2009. [Accessed on: 10

th July 2018] Available at:

http://www.rcpath.org/publications-media/publications/datasets/prostate

16. National Cancer Institute, Hormone Therapy for Prostate Cancer, July 2012 [Accessed on 10th July

2018] Available at: http://www.cancer.gov/cancertopics/factsheet/Therapy/hormone-therapy-prostate

17. National Institute for Health and Care Excellence, Prostate Cancer: Diagnosis and Management, January 2014 [Accessed on 14

th August 2018]. Available at:

https://www.nice.org.uk/guidance/cg175/chapter/Key-priorities-for-implementation

http://www.rcpath.org/publications-media/publications/datasets/prostate

http://www.cancer.gov/cancertopics/factsheet/Therapy/hormone-therapy-prostate

https://www.nice.org.uk/guidance/cg175/chapter/Key-priorities-for-implementation


Copyright

The content of this report is © copyright WoSCAN unless otherwise stated.

Organisations may copy, quote, publish and broadcast material from this report without payment and

without approval provided they observe the conditions below. Other users may copy or download

material for private research and study without payment and without approval provided they observe

the conditions below.

The conditions of the waiver of copyright are that users observe the following conditions:

Quote the source as the West of Scotland Cancer Network (WoSCAN).

Do not use the material in a misleading context or in a derogatory manner.

Where possible, send us the URL.

The following material may not be copied and is excluded from the waiver:

The West of Scotland Cancer Network logo.

Any photographs.

Any other use of copyright material belonging to the West of Scotland Cancer Network requires the

formal permission of the Network.


Appendix: NHS Board Action Plans A summary of actions for each NHS Board has been included within the following Action Plan templates. Completed Action Plans should be returned to WoSCAN within two months of publication of this report.

Action / Improvement Plan KEY (Status)

Area: NHS Ayrshire & Arran

1 Action fully implemented

Action Plan Lead: 2 Action agreed but not yet implemented

Date: 3 No action taken (please state reason)

QPI No.

Action Required Health Board Action Taken Timescales

Lead Progress/Action Status Status (see Key) Start End

Ensure actions mirror those detailed in Audit Report.

Detail specific actions that will be taken by the NHS Board.

Insert date

Insert date

Insert name of responsible lead for each specific action.

Provide detail of action in progress, change in practices, problems encountered or reasons why no action taken.

Insert No. from key above.

4(ii) Provide detailed feedback on cases not meeting the target and provide details of any planned remedial action.

6 Provide feedback where surgeons have performed single cases.

7(ii) Provide further explanation to the MCN into the QPI result and potential differences in clinical approach.



Area: NHS Greater Glasgow and Clyde




QPI No.





Insert date

Insert date




2 Review the radiology referral process and reporting requirements for MRI scans.

2 Ensure that all patients meeting the high risk criteria are given an isotope bone scan.

4 Ensure that all patients with metastatic disease are discussed at MDT within 4 weeks of first treatment and receive investigations promptly after diagnosis.

6 Work with coding department to improve the accuracy of SMR01 data.

7 Ensure there is clear documentation to explain any delays in the treatment pathway for all affected patients.

8 Improve data capture of pad use through use of the long form ICIQ


QPI No.





Insert date

Insert date




questionnaire.

8 Keep surgical outcomes under careful review to assess the impact of robotic surgery.

11 Provide education on active surveillance protocol to all relevant staff.



Area: NHS Forth Valley




QPI No.





Insert date

Insert date




12 Provide feedback on all cases of mortality.


Action / Improvement Plan

KEY (Status)

Area: NHS Lanarkshire




QPI No.





Insert date

Insert date




4 Provide clarification on reasons behind advancing non metastatic prostate cancer patients to treatment prior to MDT and provide feedback on any planned remedial action.


Action / Improvement Plan

KEY (Status)

Area: MCN




QPI No.





Insert date

Insert date




1 MCN to initiate regional discussion and propose required changes to the QPI ahead of any future national review.

7 MCN to initiate regional discussion with regards to any required changes to the QPI ahead of any future national review.

11 MCN to initiate regional discussion with regards to any required QPI changes ahead of any future national review.

13 MCN to identify potential barriers to trial recruitment and encourage clinicians to consider all patients for clinical trials.

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