THE SCOTTISH GOVERNMENT HEALTH DIRECTORATES



Scottish Cancer Taskforce

National Cancer Quality Steering Group

Prostate Cancer

Clinical Quality Performance Indicators

Engagement Document

October 2019

Contents Page

1. National Cancer Quality Programme 4

1.1 Quality Assurance and Continuous Quality Improvement 4

2. Quality Performance Indicator Development Process 4

3. QPI Formal Review Process 5

4. Format of the Quality Performance Indicators 5

5. Supporting Documentation 6

6. Prostate Cancer Risk Categorisation 6

7. Quality Performance Indicators for Prostate Cancer 7

QPI 1: Biopsy Procedure 7

QPI 2: Radiological Staging 8

QPI 3: Pathology Reporting 9

QPI 4: Multi-Disciplinary Team (MDT) Meeting 10

QPI 5: Surgical Margins 11

QPI 6: Volume of Cases per Surgeon 12

QPI 7: Hormone Therapy and Docetaxel Chemotherapy 13

QPI 8: Post Surgical Incontinence 15

QPI 11: Management of Active Surveillance 16

QPI 12: 30 Day Mortality following Systemic Anti-Cancer Therapy 17

QPI 13: Clinical Trial and Research Study Access 18

QPI 14: Diagnostic Pre-biopsy Multi-parametric MRI (mpMRI) 19

QPI 15: Low Burden Metastatic Disease 21

8. Survival 22

9. Areas for Future Consideration 22

9.1 Post Radiotherapy Toxicity / Post Surgical Incontinence 22

10. Governance and Scrutiny 23

10.1 National 23

10.2 Regional – Regional Cancer Networks 23

10.3 Local – NHS Boards 23

11. How to participate in the engagement process 23

11.1 Submitting your comments 24

11.2 Engagement feedback 24

11. References 25

12. Appendices 27

Appendix 1: QPI Development Process 27

Appendix 2: Prostate Cancer QPI Development Group Membership (2012) 29

Appendix 3: Prostate Cancer QPI Formal Review Group Membership (2016) 30

Appendix 4: Prostate Cancer QPI Formal Review Group Membership (2019) 31

Appendix 5: 3 Yearly National Governance Process & Improvement Framework for Cancer Care 32

Appendix 6: Regional Annual Governance Process and Improvement Framework for Cancer Care 33

Appendix 7: Glossary of Terms 34

1. National Cancer Quality Programme

Beating Cancer: Ambition and Action (2016)1 details a commitment to delivering the national cancer quality programme across NHSScotland, with a recognised need for national cancer QPIs to support a culture of continuous quality improvement. Addressing variation in the quality of cancer services is pivotal to delivering improvements in quality of care. This is best achieved if there is consensus and clear indicators for what good cancer care looks like.

Small sets of cancer specific outcome focussed, evidence based indicators are in place for 19 different tumour types. These are underpinned by patient experience QPIs that are applicable to all, irrespective of tumour type. These QPIs ensure that activity is focused on those areas that are most important in terms of improving survival and individual care experience whilst reducing variation and supporting the most effective and efficient delivery of care for people with cancer. QPIs are kept under regular review and are responsive to changes in clinical practice and emerging evidence.

A programme to review and update the QPIs in line with evolving evidence is in place as well as a robust mechanism by which additional QPIs will be developed over the coming years.

1.1 Quality Assurance and Continuous Quality Improvement

The ultimate aim of the programme is to develop a framework, and foster a culture of, continuous quality improvement, whereby real time data is reviewed regularly at an individual Multi Disciplinary Team (MDT)/Unit level and findings actioned to deliver continual improvements in the quality of cancer care. This is underpinned and supported by a programme of regional and national comparative reporting and review.

NHS Boards are required to report against QPIs as part of a mandatory, publicly reported, programme at a national level. A rolling programme of reporting is in place, with approximately three national tumour specific reports published annually. National reports include comparative reporting of performance against QPIs at MDT/Unit level across NHSScotland, trend analysis and survival. This approach helps to overcome existing issues relating to the reporting of small volumes in any one year.

In the intervening years tumour specific QPIs are monitored on an annual basis through established Regional Cancer Network and local governance processes, with analysed data submitted to Information Services Division (ISD) for inclusion in subsequent national reports. This approach ensures that timely action is taken in response to any issues that may be identified through comparative reporting and systematic review.

2. Quality Performance Indicator Development Process

The QPI development process was designed to ensure that indicators are developed in an open, transparent and timely way. The development process can be found in appendix 1.

The Prostate Cancer QPI Development Group was convened in October 2010, chaired by Professor Robert Masterton (Executive Medical Director, NHS Ayrshire and Arran). Membership of this group included clinical representatives drawn from the three regional cancer networks, Healthcare Improvement Scotland, ISD and patient/carer representatives. Membership of the development group can be found in appendix 2.

3. QPI Formal Review Process

As part of the National Cancer Quality Programme a systematic national review process has been developed, whereby all tumour specific QPIs published are subject to formal review following 3 years analysis of comparative QPI data.

Formal review of the Prostate Cancer QPIs was undertaken for the first time in December 2015. A Formal Review Group was convened, chaired by Dr Hilary Dobson (Chair, National Cancer Quality Steering Group). Membership of this group included Clinical Leads from the three Regional Cancer Networks. Membership of this group can be found in appendix 3.

The 2nd Cycle of Formal Review commenced in May 2019 following reporting of 6 years of QPI data. This cycle of review is more selective and focussed on ensuring the ongoing clinical relevance of the QPIs. A Formal Review Group was convened in September 2019, with Mr James Mander, Consultant General & Colorectal Surgeon and Regional Lead Cancer Clinician, SCAN appointed as Clinical Advisor/Chair to the group. Membership of this group can be found in appendix 4.

The formal review process is clinically driven with proposals for change sought from specialty specific representatives in each of the Regional Cancer Networks. . Formal review meetings to further discuss proposals will be arranged where deemed necessary. The review builds on existing evidence using expert clinical opinion to identify where new evidence is available and a full public engagement exercise will take place where significant revisions have been made or new QPIs developed.

During formal review QPIs may be archived and replaced with new QPIs. Triggers for doing so include significant change to clinical practice, targets being consistently met by all Boards and publication of new evidence. Where QPIs have been archived, for those indictors which remain clinically relevant, data will continue to be collected to allow local / regional analysis of performance as required.

Any new QPIs have been developed in line with the following criteria:

• Overall importance – does the indicator address an area of clinical importance that would significantly impact on the quality and outcome of care delivered?

• Evidence based – is the indicator based on high quality clinical evidence?

• Measurability – is the indicator measurable i.e. are there explicit requirements for data measurement and are the required data items accessible and available for collection?

4. Format of the Quality Performance Indicators

QPIs are designed to be clear and measurable, based on sound clinical evidence whilst also taking into account other recognised standards and guidelines.

• Each QPI has a short title which will be utilised in reports as well as a fuller description which explains exactly what the indicator is measuring.

• This is followed by a brief overview of the evidence base and rationale which explains why the development of this indicator was important.

• The measurability specifications are then detailed; these highlight how the indicator will actually be measured in practice to allow for comparison across NHSScotland.

• Finally a target is indicated, which dictates the level each unit should be aiming to achieve against each indicator.

In order to ensure that the chosen target levels are the most appropriate and drive continuous quality improvement as intended they are kept under review and revised as necessary, if further evidence or data becomes available.

Rather than utilising multiple exclusions, a tolerance level has been built into the QPIs. It is very difficult to accurately measure patient choice, co-morbidities and patient fitness therefore target levels have been set to account for these factors. Further detail is noted within QPIs where there are other factors which influenced the target level.

Where ‘less than’ () levels.

5. Supporting Documentation

A national minimum core dataset and a measurability specification document have been developed in parallel with the indicators to support the monitoring and reporting of Prostate Cancer QPIs. These were implemented for all patients diagnosed with prostate cancer on, or after, 1st July 2019.

6. Prostate Cancer Risk Categorisation

Several factors are known to predict the risk of recurrence of prostate cancer; these factors are used to classify localised prostate cancer into risk categories2. Some of the Prostate Cancer QPIs (section 7) refer to specific risk categories which are detailed in the table below.

|Low Risk |Clinical Stage T1 – T2a[1] |

| |and Gleason score ≤ 6 |

| |and PSA[2] at diagnosis 20 ug/l |

Table 1: Localised Prostate Cancer Risk Categories

7. Quality Performance Indicators for Prostate Cancer

QPI 1: Biopsy Procedure

|Revisions: |This QPI has been archived – the measure is no longer considered relevant in the current format |

| |due to a change in clinical practice where multi-parametric MRI is performed prior to biopsy. A|

| |new QPI on pre-biopsy MRI has therefore been developed – see QPI 14. |

QPI 2: Radiological Staging

|QPI Title: |Patients with high risk prostate cancer, who are suitable for radical treatment, should be |

| |evaluated for locally advanced, nodal or bony metastatic disease. |

|Description: |Proportion of patients with high risk prostate cancer undergoing radical treatment who have had |

| |Magnetic Resonance Imaging (MRI) and bone scan staging. |

|Rationale and Evidence: |Local staging is of importance in helping guide both patient and clinician towards a treatment |

| |decision. |

| | |

| |Whilst digital rectal examination, Prostate Specific Androgen (PSA) level and needle biopsy |

| |histology together help predict the likelihood of organ-confined disease, this is on a |

| |population rather than individual patient basis. In addition, needle biopsies are prone to |

| |sampling error. |

| | |

| |Therefore the management of a patient predicted to have organ confined disease by the above |

| |parameters who unexpectedly on MRI has definite capsular, seminal vesicle, nodal or bony |

| |involvement (or a predominant anterior tumour not palpable or reached by biopsy) may be |

| |radically changed by that MRI result. Similarly, patients predicted to have significant risk of|

| |locally advanced disease may be considered suitable for radical treatment if the MRI shows |

| |organ-confined disease. Clearly patients found to have bone metastases are by definition not |

| |suitable for radical treatment3,4,5. |

| | |

| |Patients with high-risk prostate cancer should have MRI to assess the extent of disease ahead of|

| |radical treatment2. |

|Specifications: |Numerator: |Number of patients with high risk prostate cancer undergoing radical |

| | |treatment who have an MRI of the prostate and isotope bone scan (or |

| | |alternative whole body MRI evaluation). |

| |Denominator: |All patients with high risk prostate cancer undergoing radical treatment.|

| | | |

| |Exclusions: |Patients unable to undergo an MRI scan: |

| | |Pacemaker or other MRI incompatible implanted device. |

| | |Cerebral aneurysm clip. |

| | |Metal in eye. |

| | |Claustrophobia. |

| | |Unable to fit bore of scanner. |

| | |Too heavy for MRI table. |

| | |Patients who refuse MRI. |

| | |Patients with T2c tumours (with no other high risk factors). |

|Target: |95% |

| | |

| |The tolerance within this target is to account for other situations where patients are deemed |

| |clinically unsuitable or unfit to undergo MRI. In addition, it reflects those patients in which|

| |prostate cancer is an incidental finding at surgery. |

|Revision(s): |Specification (i) archived – all regions / healthboards are consistently meeting and exceeding the|

| |95% target (>3 years). |

| |Specification (ii) – exclusion added for patients with T2c tumours (with no other risk factors). |

QPI 3: Pathology Reporting

|Revisions: |This QPI has been archived – all regions are consistently meeting / exceeding the target for |

| |this QPI. Pathology reporting with full information is now considered standard practice. |

QPI 4: Multi-Disciplinary Team (MDT) Meeting

|QPI Title: |Patients should be discussed by a multidisciplinary team prior to definitive treatment. |

|Description: |Proportion of patients with prostate cancer who are discussed at MDT meeting before |

| |definitive treatment. |

| | |

| |Please note: The specifications of this QPI are separated to ensure clear measurement of |

| |patients with: |

| | |

| |Non-metastatic prostate cancer (TanyNanyM0); and |

| |Metastatic prostate cancer (TanyNanyM1). |

|Rationale and Evidence: |Evidence suggests that patients with cancer managed by a multi-disciplinary team have a |

| |better outcome. There is also evidence that the multidisciplinary management of patients |

| |increases their overall satisfaction with their care6. |

| | |

| |Discussion prior to definitive treatment decisions being made provides reassurance that |

| |patients are being managed appropriately. |

| | |

| |For patients presenting with metastatic disease it is often clinically appropriate to |

| |commence hormone therapy immediately, i.e. prior to MDT discussion, therefore specification |

| |(ii) has been developed to account for this cohort of patients. |

|Specification (i): |Numerator: |Number of patients with non-metastatic prostate cancer (TanyNanyM0) |

| | |discussed at the MDT before definitive treatment. |

| |Denominator: |All patients with non-metastatic prostate cancer (TanyNanyM0). |

| |Exclusions: |Patients who died before first treatment. |

|Specification (ii): |Numerator: |Number of patients with metastatic prostate cancer (TanyNanyM1) |

| | |discussed at the MDT within 6 weeks of commencing treatment. |

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

| |Exclusions: |Patients who died before first treatment. |

|Target: |95% |

| | |

| |The tolerance within this target accounts for situations where patients require treatment |

| |urgently, or where prostate cancer is an incidental finding at surgery. |

|Revision(s): |Specification (ii) – timeframe has been revised to within 6 weeks of commencing treatment (from 4 |

| |weeks) to allow for relevant staging whilst still ensuring there is appropriate time to see |

| |oncology for discussion and commencement of early adjuvant therapies. |

QPI 5: Surgical Margins

|QPI Title: |Organ confined prostate cancers which are surgically treated with radical prostatectomy should |

| |be completely excised. |

|Description: |Proportion of patients with pathologically confirmed, organ confined (stage pT2) prostate cancer|

| |who undergo radical prostatectomy in which tumour is present at the margin, i.e. positive |

| |surgical margin. |

|Rationale and Evidence: |Positive surgical margin is an independent prognostic factor in adversely impacting biochemical |

| |recurrence free (PSA failure) period and progression free survival7. |

|Specifications: |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: | ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download