Acute Leukaemia Quality Performance Indicators

Transcription

1 Acute Leukaemia Quality Performance Indicators Patients diagnosed between July 2014 and June 2017 Publication date 19 June 2018 An Official Statistics publication for Scotland

2 This is an Official Statistics Publication The Official Statistics (Scotland) Order 2008 authorises NHS National Services Scotland (the legal name being the Common Services Agency for the Scottish Health Service) to produce official statistics. All official statistics should comply with the UK Statistics Authority s Code of Practice which promotes the production and dissemination of official statistics that inform decision making. They can be formally assessed by the UK Statistics Authority s regulatory arm for National Statistics status. Find out more about the Code of Practice at: Find out more about official statistics at: 2

3 Contents Introduction... 4 Key Points... 7 Foreword from Acute Leukaemia Clinical Leads... 8 Results and Commentary Case Ascertainment Overall Performance Summary Quality Performance Indicators Clinical Trials List of Tables Contact Further Information Rate this publication Appendices Appendix 1 Background information Appendix 2 Acute Leukaemia QPIs Appendix 3 Acute Leukaemia Clinical Trials Appendix 4 Publication Metadata Appendix 5 Early access details Appendix 6 ISD and Official Statistics

4 Introduction The cancer strategy Beating Cancer: Ambition and Action published in March 2016 builds on the commitment made in the Better Cancer Care plan to 'develop a work programme which will define how we will take forward quality indicators for cancer services' by further supporting a culture of continuous quality improvement in cancer care across NHSScotland. The new cancer strategy states a commitment to improving data collection to advance the quality and delivery of care for cancer patients. To achieve this, the Scottish Cancer Taskforce established the National Cancer Quality Steering Group (NCQSG), which includes responsibility for: The development of small sets (approximately indicators) of tumour specific national quality performance indicators (QPIs) as a proxy measure of quality care. Overseeing the implementation of the national governance framework that underpins the reporting of performance against these national QPIs. The QPIs have been developed collaboratively with the three Regional Cancer Networks: North of Scotland Cancer Network (NOSCAN), South East Scotland Cancer Network (SCAN), West of Scotland Cancer Network (WoSCAN), Information Services Division (ISD), Healthcare Improvement Scotland, Scottish Cancer Coalition and the Scottish Government. The QPIs are published on the Healthcare Improvement Scotland website. These indicators, used to drive quality improvement in cancer care across NHSScotland are kept under regular review; NHS Boards will be required to report against QPIs as part of a mandatory national cancer quality programme. ISD support NHS Boards in improving the quality of local data collection and reporting through the production of data validation specifications, and measurability criteria for QPIs. The current data sets are outlined on the Cancer Audit website. A rolling programme of reporting is planned across many tumour sites. National reports will include comparative reporting of performance against QPIs at NHS Board level across NHS Scotland, trend analysis and survival analysis (where applicable). This approach will help overcome existing issues relating to the reporting of small volumes in any one year. This report assesses performance against 12 Acute Leukaemia QPIs using clinical audit data relating to patients diagnosed with acute leukaemia for the period from July 2014 to June

5 Data collection and analysis Acute Leukaemia QPI data for patients diagnosed between July 2014 and June 2017 were collected by NHS Boards, supported by the regional cancer networks, and then analysed against the Acute leukaemia measurability document. Aggregated analysed data were then submitted to ISD via a data collection template for collation to allow comparisons at NHS Board level. Data quality and completeness Small numbers: 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 (-). However, any commentary provided by NHS Boards relating to the impacted indicators will be included as a record of continuous improvement. Generally, the number of patients diagnosed with acute leukaemia each year is relatively low, therefore to minimise the impact of this, data have been aggregated over the 3 reporting years and, for some indicators, only a network breakdown is shown. Quality Assurance: The data quality team at ISD assessed a random sample of approximately 34% of Acute Leukaemia QPI records across mainland NHS Boards, with a date of diagnosis in year ending June The overall accuracy of recording of the sampled dataset was very high at 96.1% nationally. The accuracy of recording of individual data items ranged from 86% to 99% at Scotland level. The Data Quality team are working with Cancer networks to follow up findings from the assessment, clarify ambiguities in data definitions and further improve the quality of Acute Leukaemia QPI data. Baseline Review: Following baseline review of acute leukaemia QPIs data, some changes were made to measurability in order that the QPIs appropriately measured what they were intended to. These were positive changes and led to more focussed analysis in year 2. However, the alterations to measurability mean that year 1 and year 2 results may not be directly comparable for some QPIs. 5

6 Formal Review: In order to ensure the success of the National Cancer QPIs in driving quality improvement in cancer care across NHS Scotland it is critical that the QPIs continue to be clinically relevant and focus on areas which will result in improvements to the quality of patient care. It was proposed that a formal review of all QPIs should take place following 3 years national comparative reporting, with tumour specific Regional Clinical Leads undertaking a key role in determining the need and extent of the review required. For acute leukaemia, this review has already taken place; revised acute leukaemia QPIs for implementation from year 4 onwards will be published later in 2018, following public consultation. Any proposed changes to the QPIs as a result of this review will be noted in this report. Survival Analysis: For future tumour specific survival analyses, it has been agreed to use the Cancer Audit QPI dataset rather than the Cancer Registry dataset that has been used in the past. This should provide benefits in terms of improved accuracy and more specific and detailed analysis. Due to time limitations and availability of data in time for this release, therefore, it has been agreed to undertake acute leukaemia survival analysis at a later date. Historic survival analysis figures using Cancer Registry data are available here for reference. Age Groups: The QPI results presented in this report include only patients aged 16 years and over. It has been agreed at a national level that analysis of patients under the age of 16 years will not be included in published QPI reports, due to the very small numbers of patients involved. However, these data have been analysed and results supplied to clinical staff for consideration when identifying areas for improvement in the service. 6

7 Key Points There were 745 patients diagnosed with Acute Leukaemia in Scotland over the period July 2014 to June At a Scotland level, the target was met in nine of the seventeen indicators (i.e. including sub parts of some QPIs) with eight below target. For those QPIs where the target was not met across Scotland, some reasons and appropriate actions are provided in the report. 7

8 Foreword from Acute Leukaemia Clinical Leads The three Regional Cancer Networks (North of Scotland Cancer Network (NOSCAN), South East Scotland Cancer Network (SCAN), and West of Scotland Cancer Network (WoSCAN)) aim to promote the highest standards of cancer care and equity of access to cancer services across Scotland. The development and introduction of national Quality Performance Indicators (QPIs) across Scotland represents a major step forward for patients with Acute Leukaemia. The Acute Leukaemia QPIs were developed by clinical staff across the three Regional Cancer Networks in collaboration with Information Services Division, Healthcare Improvement Scotland, Scottish Cancer Coalition and the Scottish Government. The outcome focussed measures have facilitated national comparative analysis to identify areas of good practice and areas of variance. This is the first report of performance against the Acute Leukaemia QPIs at a national level and provides results from the first three years of QPI recording across the three Regional Cancer Networks. Due to the relatively low numbers of patients diagnosed with Acute Leukaemia, results are combined for all patients diagnosed within the three year period July June While this provides a more accurate indication of the quality of service provided by NHS Boards, results may mask improvements that may have taken place since the implementation of QPI reporting. The QPI results have shown that overall, the quality of Acute Leukaemia services across Scotland is good in many areas of care, for example for indicators relating to initial investigation, diagnosis, early deaths and deaths in remission. Notably, the National Allogeneic Haemopoietic Stem Cell Transplant Unit has highlighted that the improvement in uptake of tissue typing at the time of diagnosis (QPI 9) has helped to ensure that work to identify a donor can commence much earlier in the patient pathway, reducing the time from diagnosis to transplant. However, some challenges remain and these are outlined below: Access to clinical trials a number of the quality indicators for Acute Leukaemia consider whether patients have been entered into clinical trials, however it is only possible for patients to be recruited into trials if appropriate trials are available and patients meet the eligibility criteria for these. There were a range of clinical trials available during the period reported covering both Acute Myeloid Leukaemia and Acute Lymphoblastic Leukaemia, some of which recruited very well across the UK. However, recruitment into the current NCRI (LI-1) trial has been lower in some centres, primarily due to clinical concern that the novel treatment arms in the study may not provide benefits over standard of care. This can only be addressed if new drugs become available that show particular promise in this clinical setting. If that were the case then it is likely that recruitment would increase substantially. Further, for NHS Fife there have been issues with insufficient research infrastructure to support trials which led to a temporary suspension of recruitment to the main NCRI Acute Leukaemia trials. This has now been addressed and patient recruitment has recommenced so it is hoped that performance against this target will improve. 8

9 Data collection - Difficulties in collection of information in relation to the storage of genetic material and performance status (WHO / ECOG) of patients have affected the results of some QPIs in the West of Scotland. Actions have been identified to address these issues and it is anticipated that performance will improve going forward. In addition further actions have been identified by individual NHS Boards to help address other areas for improvement, for example resourcing of MDT meetings, and ensuring that all clinicians are mindful of the need for tissue typing of all relevant patients. A Formal Review of the Acute Leukaemia QPIs has taken place. As part of this review some amendments to the QPI definitions have been proposed, some targets made more challenging and a number of new indicators are being developed which may prove more challenging for NHS Boards to meet in future years. We are confident that implementation of these new QPIs will drive further quality improvement in Acute Leukaemia services across NHSScotland. Dr Huw Roddie Consultant Haematologist SCAN Clinical Lead for Acute Leukaemia Dr Dominic Culligan Consultant Haematologist, NHS Grampian NOSCAN Dr Grant McQuaker Consultant Haematologist WoSCAN Haemato-oncology MCN Clinical Lead 9

10 Results and Commentary Case Ascertainment Case ascertainment is a measure of data quality and is calculated by comparing the number of new patients captured by the cancer audit with a five year average of the numbers recorded on the cancer registry. A five year average is used for registry data as the information is not available until sometime after the year under examination. This is due to data collection and verification processes. As the number of cases will vary each year, it is possible for case ascertainment to be over or under 100%. Therefore, the figures presented should be seen as an indication only. The average case ascertainment across Scotland from July 2014 to June 2017 was 113%. 160 Estimated Case Ascertainment (%) 2014/ No. of Audit Records Diagnosed in 2014/17 Average No. of Cancer Registrations: Estimated Case Ascertainment % NOSCAN Grampian Highland Orkney Shetland Tayside Western Isles SCAN Borders Fife Lothian WoSCAN Ayrshire & Arran Dumfries & Galloway Forth Valley Greater Glasgow & Clyde Lanarkshire Scotland

11 Overall Performance Summary The tables below summarise the overall % performance across the country for each QPI. NOSCAN: D by Health Board of Diagnosis S by Health Board of Surgery 11

12 SCAN: D by Health Board of Diagnosis S by Health Board of Surgery 11

13 WoSCAN: D by Health Board of Diagnosis S by Health Board of Surgery No data matching QPI criteria Data not shown due to small numbers 12

14 2014/ / /16 Information Services Division Clinical Trials Summary Table by Scottish Cancer Research Network (SCRN) SCRN - North & East SCRN - South East SCRN - West* Clinical Trials - Interventional - > 7.5% 45.8% 30.1% 40.7% Clinical Trials - Translational - > 15% 2.3% 0.0% 0.0% *2014 data not supplied, data for 2015 & 2016 only Target not met Met or exceeded target 13

15 Quality Performance Indicators The following section includes a detailed summary of each of the twelve acute leukaemia QPIs outlining the variation at NHS Board level. Charts are colour coded by network and show 3 year aggregate data. Where performance at either level is shown to fall below the target, commentary from the relevant NHS Board is included to provide context to the variation. Information in this report is shown by Health Board of diagnosis. Further information at hospital level is available from the data tables, where applicable. QPI 1: Complete Diagnostic Panel Prior to patients undergoing intensive treatment for acute leukaemia the diagnosis must be established and prognostic markers obtained where relevant. A complete panel is required as findings from one test may alter the testing strategy for other techniques. A complete diagnostic panel is defined as: (i) Morphology; (ii) Immunophenotyping; (iii) Cytogenetics; and (iv) Storage of genetic material for routine diagnostic testing. Numerator: Number of patients with acute leukaemia undergoing treatment with curative intent where complete diagnostic panel undertaken. Denominator: All patients with acute leukaemia undergoing treatment with curative intent. Exclusions: No exclusions Target: 90% Across the 3 reporting years, there were 336 patients diagnosed in Scotland with Acute Leukaemia undergoing treatment with curative intent. For 245 of these patients (73%), a complete diagnostic panel was undertaken. This is below the 90% target and is driven by the performance in WoSCAN where all Boards were significantly below target; contrasting with the rest of the country where the target was consistently met. 14

16 QPI 1 Complete Diagnostic Panel by Health Board of Diagnosis - 3 Year Total % NHS Board/Region % Performance Numerator Denominator Grampian Highland Orkney * * * Shetland * * * Tayside Western Isles * * * NOSCAN Borders Fife Lothian SCAN Numerator Ayrshire & Arran Dumfries & Galloway Forth Valley Greater Glasgow & Clyde Lanarkshire WoSCAN Scotland Source: Cancer audit - Data not shown due to small numbers * No data matching QPI criteria Exclusion Denominator In WoSCAN, it was commented that the lack of a formal recording process for the storage of genetic material (as evidenced by the high not recorded figures) has contributed to the performance and appears to be a common problem in all Boards in the network. Therefore, this may not be a true reflection of the current practice as appropriate testing is taking place to diagnose patients in a timely manner, and may instead indicate a data recording issue. Improvements have since been made to the existing molecular reports and it is, therefore, expected that performance should improve from year 4 onwards. 15

17 QPI 2: Diagnostic Classification Management of patients with acute leukaemia is determined in part by diagnostic classification therefore it is essential that this is assigned and recorded to ensure most appropriate management, inform treatment decision making and determine clinical trial availability. Numerator: Number of patients with acute leukaemia who have a WHO classification assigned and recorded (either by MDT or reporting haematologist/ haematopathologist). Denominator: All patients with acute leukaemia. Exclusions: Patients receiving supportive care / palliation only. Target: 100% All acute leukaemia patients in Scotland across the 3 reporting years had a diagnostic classification assigned and recorded and, therefore, the target was consistently met. QPI 2 Diagnostic Classification by Health Board of Diagnosis - 3 Year Total %

18 NHS Board/Region % Performance Numerator Denominator Grampian Highland Orkney * * * Shetland * * * Tayside Western Isles * * * NOSCAN Borders Fife Lothian SCAN Numerator Exclusion Denominator Ayrshire & Arran Dumfries & Galloway Forth Valley Greater Glasgow & Clyde Lanarkshire WoSCAN Scotland Source: Cancer audit - Data not shown due to small numbers * No data matching QPI criteria At the formal review, post year 3, it was proposed that this QPI should be archived given that all Boards have consistently achieved the 100% target across the 3 years. 17

19 QPI 3: MDT Discussion 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. Numerator: Number of patients with acute leukaemia discussed at the MDT within 6 weeks of diagnosis. Denominator: All patients with acute leukaemia Exclusions: No exclusions. Target: 95% Of the 697 patients diagnosed with acute leukaemia during the reporting period, 85% (595 patients) were discussed at the MDT within 6 weeks of diagnosis. This is below the 95% target only NHS Grampian, NHS Tayside and NHS Dumfries & Galloway achieved this target. QPI 3 - MDT Discussion by Health Board of Diagnosis - 3 Year Total %

20 NHS Board/Region % Performance Numerator Denominator Numerator Grampian Highland Orkney * * * Shetland * * * Tayside Western Isles * * * NOSCAN Borders Fife Lothian SCAN Ayrshire & Arran Dumfries & Galloway Forth Valley Greater Glasgow & Clyde Lanarkshire WoSCAN Scotland Source: Cancer audit - Data not shown due to small numbers * No data matching QPI criteria Exclusion Denominator Across Scotland patients did not meet this QPI due to Some patients being discussed outwith the six week timescale. This has been exacerbated in NHS Grampian due to lack of pathologist availability at MDT and in WoSCAN due to lack of MDT admin support, although the latter has now been addressed. Patients who died before treatment In addition SCAN noted that some patients with a poor prognosis where MDT discussion would not have altered management did not meet the QPI while in NOSCAN some patients were already in remission and therefore discussion not considered necessary. At the formal review, it was proposed to change the timescale for patients discussed at the MDT meeting from 6 weeks to 8 weeks of diagnosis. 19

21 QPI 4: Minimal Residual Disease Marker Identification of a Minimal Residual Disease (MRD) marker must be done at diagnosis, to allow later measurement of disease levels. In this way more intensive treatments can be directed at patients who continue to harbour significant levels of leukaemic cells, while treatment intensity may be reduced for patients in whom no disease is detected. Numerator: Number of patients with ALL *, <25 years of age, undergoing treatment with curative intent who are assessed for the presence of MRD marker. Denominator: All patients with ALL, <25 years of age, undergoing treatment with curative intent. Exclusions: No exclusions Target: 90% * ALL Acute Lymphoblastic Leukaemia Due to the small numbers involved, this QPI is reported at regional network and national level only. At a national level, this QPI was met where 94% of patients in this group were assessed for the presence of the MRD marker. Only WoSCAN failed to achieve the target at regional level although there were very few patients. QPI 4 Minimal Residual Disease Marker by Health Board of Diagnosis - 3 Year Total NOSCAN SCAN WoSCAN Scotland 20

22 NHS Board/Region % Performance Numerator Denominator NOSCAN SCAN Numerator WoSCAN Scotland Source: Cancer audit - Data not shown due to small numbers * No data matching QPI criteria Exclusion Denominator The issue regarding small numbers was discussed at the formal review and the proposal was to archive this QPI. It was felt that the numbers over 3 years were too small to be meaningful and there was not enough evidence to expand the age group. 21

23 QPI 5(i): Early Deaths patients with Acute Myeloid Leukaemia Proportion of patients with acute leukaemia being treated with curative intent who die within 30 days of treatment. Treatment related mortality is a marker of the quality and safety of the whole service provided by the Multi Disciplinary Team (MDT). Outcomes of treatment, including treatment related morbidity and mortality should be regularly assessed. Numerator: Number of patients with AML being treated with curative intent who die within 30 days of treatment. Denominator: All patients with AML being treated with curative intent. Exclusions: No exclusions. Target: Patients under 16 years of age < 2% Patients aged between 16 and 60 years < 8% Patients over 60 years of age < 18% Due to the small numbers involved, this QPI is reported at regional network and national level only. Across the country during the 3 year period there were very few patients with AML, under 16 years of age, being treated with curative intent. Consequently, the data for this cohort is not shown due to small numbers. In the 16 to 60 age group, the target was met nationally with just less than 8% of patients with AML, undergoing curative treatment, who died within 30 days. QPI 5 (i) Early Deaths (Between 16 & 60) by Health Board of Diagnosis - 3 Year Total NOSCAN SCAN WoSCAN Scotland 22

24 NHS Board/Region % Performance Numerator Denominator NOSCAN Numerator Exclusion Denominator SCAN WoSCAN Scotland Source: Cancer audit - Data not shown due to small numbers * No data matching QPI criteria For the over 60 age group, the target was met by all regions. At national level, 10.5% of patients died within 30 days of curative treatment. QPI 5 (i) Early Deaths (Over 60) by Health Board of Diagnosis - 3 Year Total NOSCAN SCAN WoSCAN Scotland NHS Board/Region % Performance Numerator Denominator NOSCAN Numerator Exclusion Denominator SCAN WoSCAN Scotland Source: Cancer audit - Data not shown due to small numbers * No data matching QPI criteria All cases not meeting the target for this QPI were reviewed at the morbidity and mortality meetings and concluded that all patients were treated appropriately and no further action was required. 23

25 QPI 5(ii): Early Deaths patients with Acute Lymphoblastic Leukaemia Proportion of patients with acute leukaemia being treated with curative intent who die within 35 days of treatment. Treatment related mortality is a marker of the quality and safety of the whole service provided by the Multi Disciplinary Team (MDT). Outcomes of treatment, including treatment related morbidity and mortality should be regularly assessed. Numerator: Number of patients with ALL being treated with curative intent who die within 35 days of treatment. Denominator: All patients with ALL being treated with curative intent. Exclusions: No exclusions. Target: Patients aged between 16 and 60 years < 8% Patients over 60 years of age < 20% Despite reporting three year cumulative results, the numbers of patients with ALL in each age group remain very low and can have a significant effect on proportions. For each age group, the target was met at national and regional level. NHS Board/Region % Performance Numerator Denominator Numerator years of age NOSCAN SCAN WoSCAN Scotland Over 60 years of age NOSCAN SCAN WoSCAN Scotland Source: Cancer audit - Data not shown due to small numbers * No data matching QPI criteria Exclusion Denominator 24

26 All cases not meeting the target for this QPI were reviewed at the morbidity and mortality meetings and concluded that all patients were treated appropriately and no further action was required. QPI 6: Access to ATRA for Patients with Acute Promyelocytic Leukaemia Patients with suspected Acute Promyelocytic Leukaemia (APL) should undergo treatment with All Trans-Retinoic Acid (ATRA) within 1 day of diagnosis. Treatment with ATRA should be started immediately after a diagnosis of APL is suspected. It is important to consider diagnostic suspicion of APL as a medical emergency that requires several specific and simultaneous actions, including immediate commencement of ATRA therapy. Numerator: Number of patients with APL who receive ATRA within 1 day of diagnosis. Denominator: All patients with APL. Exclusions: No exclusions Target: 95% Due to the small numbers involved, this QPI is reported at regional network and national level only. Again the very small numbers of patients with APL over the 3 years may impact the proportions. At a national level, 92% of patients with APL received ATRA within 1 day of diagnosis against the 95% target. Of the three regional networks, only SCAN achieved target with 100% of patients receiving the treatment within 1 day of diagnosis. 100 QPI 6 Access to ATRA for Patients with Acute Promyelocytic Leukaemia by Network of Diagnosis - 3 Year Total NOSCAN SCAN WoSCAN Scotland 25

27 NHS Board/Region % Performance Numerator Denominator Numerator Exclusion NOSCAN SCAN WoSCAN Scotland Source: Cancer audit - Data not shown due to small numbers * No data matching QPI criteria Denominator In NOSCAN, patient fitness was a factor in not achieving the 95% target. In WoSCAN, after review, it was found that one patient was erroneously documented as not receiving the ATRA treatment within 1 day. Improvements in the data collection process have since been put in place. Additionally, given the small number of patients in the west of Scotland denominator relative to the other networks, work has commenced in WoSCAN to explore this further to identify and address any potential case ascertainment issues. Due to the small numbers it was proposed at the formal review to archive this QPI. 26

28 QPI 7: - Deaths in Remission Proportion of patients with acute leukaemia undergoing treatment with curative intent who die in first complete remission (CR), within 1 year of diagnosis. Outcomes of treatment, including treatment related mortality should be regularly assessed. This QPI measures the quality of supportive care provision and management of complications in patients treated with curative intent who achieve morphological remission following consolidation therapy. Numerator: Number of patients with acute leukaemia undergoing treatment with curative intent who achieve first CR and die within 1 year of diagnosis, whilst in CR. Denominator: All patients with acute leukaemia undergoing treatment with curative intent who achieve first CR. Exclusions: Patients undergoing bone marrow / stem cell transplant. Target: Patients 16 years of age and over <10% Due to the 1 year lag, this QPI reports on year 2 and 3 data only. Across the 2 year period the target of <10% of patients over 16 years of age dying in remission within 1 year of diagnosis was comfortably met across the country. QPI 7 Deaths in Remission (16 and over) by Health Board of Diagnosis - 3 Year Total <10% 0 27

29 NHS Board/Region % Performance Numerator Denominator Grampian Highland Orkney * * * Shetland * * * Tayside Western Isles * * * NOSCAN Borders * * * Fife Lothian SCAN Numerator Exclusion Ayrshire & Arran Dumfries & Galloway Forth Valley Greater Glasgow & Clyde Lanarkshire WoSCAN Scotland Denominator Source: Cancer audit - Data not shown due to small numbers * No data matching QPI criteria 28

30 QPI 8: Clinical Trials with Curative Intent Clinical trials are necessary to demonstrate the efficacy of new therapies and other interventions. Furthermore evidence suggests improved patient outcomes from participation in clinical trials. Non-participation in clinical trials does not affect quality of care. Numerator: Number of patients with acute leukaemia who are treated with curative intent enrolled in a clinical trial. Denominator: All patients with acute leukaemia who are treated with curative intent. Exclusions: Patients who refuse entry into a clinical trial Patients over 60 years of age. Target: Patients aged between 16 and 60 years of age - over 60% For patients aged between 16 and 60 being treated with curative intent, 52% were enrolled in a clinical trial during the 3 year period. With the exception of NHS Greater Glasgow & Clyde and NHS Lanarkshire, all other NHS Boards failed to meet the 60% target. QPI 8 Clinical Trials with Curative Intent (Between 16 & 60) by Health Board of Diagnosis - 3 Year Total %

31 NHS Board/Region % Performance Numerator Denominator Grampian Highland Orkney * * * Shetland * * * Tayside Western Isles * * * NOSCAN Borders Fife Lothian SCAN Numerator Exclusion Ayrshire & Arran Dumfries & Galloway Forth Valley Greater Glasgow & Clyde Lanarkshire WoSCAN Scotland Source: Cancer audit - Data not shown due to small numbers * No data matching QPI criteria Denominator Most NHS Board cited the lack of availability of clinical trials and patient eligibility as significant factors in not achieving target. 30

32 QPI 9: Tissue Typing for Transplant Patients with acute leukaemia treated with curative intent should have a specimen sent to the lab for tissue typing at diagnosis. Tissue typing should be performed in all patients with newly diagnosed acute leukaemia for whom allogeneic Haematopoietic Stem Cell Transplantation would be considered. Numerator: Number of patients with acute leukaemia between 16 and 65 treated with curative intent with a specimen sent to the lab for tissue typing at diagnosis. Denominator: All patients with acute leukaemia between 16 and 65 being treated with curative intent. Exclusions: No exclusions Target: 90% In Scotland, over the 3 year reporting period, 80% of patients with acute leukaemia - between the ages of 16 and 65 and being treated with curative intent - had a specimen sent to the lab for tissue typing at diagnosis. This is below the target of 90%. Only NHS Forth Valley met the target, with 100% of patients receiving tissue typing. QPI 9 Tissue Typing for Transplant by Health Board of Diagnosis - 3 Year Total %

33 NHS Board/Region % Performance Numerator Denominator Grampian Highland Orkney * * * Shetland * * * Tayside Western Isles * * * NOSCAN Borders Fife Lothian SCAN Numerator Ayrshire & Arran Dumfries & Galloway Forth Valley Greater Glasgow & Clyde Lanarkshire WoSCAN Scotland Exclusion Denominator Source: Cancer audit - Data not shown due to small numbers * No data matching QPI criteria In each NHS Board all patients not meeting the target were reviewed and most were found to be not suitable for tissue typing for various valid clinical reasons. The National Allogeneic Haemopoietic Stem Cell Transplant Unit in Glasgow, which is the national centre for stem cell transplants, noted that there was significant improvement in uptake of tissue typing over the 3 years resulting in significant clinical improvements. Specifically, it has helped to ensure that, for appropriate patients, the work to identify a donor can be started 4-6 weeks earlier in the patient pathway. This is a process that can, in some cases, take several months so this reduction in time to receiving the tissue typing sample can have a significant impact on time from diagnosis to transplant particularly for those with matched sibling donors. 32

34 QPI 10(i): Intensive Chemotherapy in Older Adults Patients with acute leukaemia over 60 years of age should be offered intensive chemotherapy, within the context of a clinical trial wherever possible, as this provides quality of life and survival benefit. Numerator: Number of patients with acute leukaemia 60 years of age and over with performance status (PS) 0-1 who receive intensive chemotherapy. Denominator: All patients with acute leukaemia 60 years of age and over with PS 0-1. Exclusions: No exclusions. Target: 20% Overall, in Scotland, 42% of patients in this group received intensive chemotherapy across the 3 years. All NHS Boards achieved target with the exception of NHS Borders and NHS Forth Valley although there were small numbers involved. There was a high proportion of notrecorded values for the denominator criteria and it is possible that some of these patients should have been included in the denominator. The not recorded data fields for the denominator relate to the patient s performance status. QPI 10 (i) Intensive Chemotherapy in Older Adults by Health Board of Diagnosis - 3 Year Total %

35 Numerator Denominator NHS Board/Region % Performance Numerator Denominator Exclusion Grampian Highland Orkney * * * Shetland * * * Tayside Western Isles * * * NOSCAN Borders Fife Lothian SCAN Ayrshire & Arran Dumfries & Galloway Forth Valley Greater Glasgow & Clyde Lanarkshire WoSCAN Scotland Lack of patient fitness for intensive treatment was cited by several NHS Boards as a significant reason for some patients not meeting the target. 34

36 QPI 10(ii): Intensive Chemotherapy in Older Adults (within clinical trials) Patients with acute leukaemia over 60 years of age should be offered intensive chemotherapy, within the context of a clinical trial wherever possible, as this provides quality of life and survival benefit. Numerator: Number of patients with acute leukaemia 60 years of age and over who receive intensive chemotherapy enrolled in a clinical trial. Denominator: All patients with acute leukaemia 60 years of age and over who receive intensive chemotherapy. Exclusions: Patients who refuse entry into a clinical trial. Target: 80% Of the 130 patients in Scotland aged over 60 with acute leukaemia receiving intensive chemotherapy during the three year period, 79 (61%) were enrolled in a clinical trial. None of the networks managed to achieve the 80% target. At the baseline review of year 1 data, it was noted that this QPI did not exclude patients who declined entry to a clinical trial whereas other QPIs did. This exclusion was added from year 2 onwards. QPI 10 (ii) Intensive Chemotherapy in Older Adults by Health Board of Diagnosis - 3 Year Total %

37 NHS Board/Region % Performance Numerator Denominator Grampian Highland Orkney * * * Shetland * * * Tayside Western Isles * * * NOSCAN Borders Dumfries & Galloway Fife Lothian Numerator Exclusion SCAN Ayrshire & Arran Forth Valley Greater Glasgow & Clyde Lanarkshire WoSCAN Scotland Denominator In each network, the lack of available clinical trials to recruit to was recognised as a factor in the performance of this QPI. 36

38 QPI 11: Clinical Trials with Non Curative Intent Patients with acute leukaemia who are suitable only for treatment with non-curative intent should be considered for participation in available clinical trials, wherever eligible. Numerator: Number of patients with acute leukaemia who are treated with non-curative intent enrolled in a clinical trial. Denominator: All patients with acute leukaemia who are treated with non-curative intent. Exclusions: Patients who refuse entry into a clinical trial. Target: 10% At Scotland level, the 10% target for enrolling patients in this group into clinical trials was narrowly missed over the 3 years. This is largely driven by the performance across SCAN where only 2% of patients met the criteria whereas the target was met in the other 2 regions. QPI 11 Clinical Trials with Non Curative Intent by Health Board of Diagnosis - 3 Year Total % 0 37

39 NHS Board/Region % Performance Numerator Denominator Grampian Highland Orkney * * * Shetland * * * Tayside Western Isles * * * NOSCAN Borders Fife Lothian SCAN Numerator Ayrshire & Arran Dumfries & Galloway Forth Valley Greater Glasgow & Clyde Lanarkshire WoSCAN Scotland Exclusion Denominator Again, the lack of availability of suitable clinical trials and patient eligibility was a contributing factor in the performance of this QPI across most NHS Boards. 38

40 QPI 12: Palliative Treatment For patients with acute leukaemia who are deemed ineligible for treatment with curative intent by the multi-disciplinary team treatment with palliative chemotherapy is recommended to optimise disease control while avoiding serious treatment-related toxicities. Evidence suggests palliative chemotherapy in this indication has an associated quality of life benefit for patients. Numerator: Number of patients with acute myeloid leukaemia who are suitable only for treatment with non-curative intent who receive palliative chemotherapy with either low dose cytarabine or azacytidine. Denominator: All patients with acute myeloid leukaemia who are suitable only for treatment with non-curative intent. Exclusions: Patients who refuse chemotherapy treatment. Patients with adverse cytogenetics. Target: 70% Just under half of the patients suitable only for non-curative intent treatment in Scotland during the reporting period received palliative chemotherapy. This is significantly less than the target of 70% which was only met by one NHS Board NHS Ayrshire & Arran. QPI 12 - Palliative Treatment by Health Board of Diagnosis - 3 Year Total %

41 Numerator Denominator NHS Board/Region % Performance Numerator Denominator Exclusion Grampian Highland Orkney * * * Shetland * * * Tayside Western Isles * * * NOSCAN Borders Fife Lothian SCAN Ayrshire & Arran Dumfries & Galloway Forth Valley Greater Glasgow & Clyde Lanarkshire WoSCAN Scotland The patients not meeting target were reviewed within each NHS Board and in many cases patient fitness due to age or co-morbidities meant they were not suitable for this treatment and received best supportive care instead. These results may potentially underestimate the number of patients treated with non-curative intent because clinical trials may use agents other than low dose chemotherapy. This was discussed at the formal review and it was proposed to widen the criteria to include patients treated with non-curative intent who are considered for an appropriate chemotherapy regimen. 40

42 Clinical Trials Access to Clinical Trials is a common issue for all cancer types; therefore, a generic QPI was developed to measure performance across the country. Further details on the development and definition of this QPI can be found here. Specifically for acute leukaemia, the QPI is defined as follows and Appendix A3 contains a list of acute leukaemia trials into which patients have been recruited in Scotland during the three year period ending December Information is shown by each Scottish Cancer Research Network (SCRN). Clinical Trials Access: Proportion of patients with acute leukaemia who are enrolled in an interventional clinical trial or translational research. All patients should be considered for participation in available clinical trials, wherever eligible. Numerator: Number of patients with acute leukaemia enrolled in an interventional clinical trial or translational research. Denominator: All patients with acute leukaemia. Exclusions: No exclusions. Target: Interventional clinical trials 7.5% Translational research 15% The aspiration is to enrol a minimum of 7.5% of patients into Interventional Clinical Trials and 15% into Translational research. Interventional Trials 50.0% % of Acute Leukaemia Patients Enrolled in Interventional Clinical Trials 45.0% 40.0% 35.0% 30.0% 25.0% 20.0% 2014/16 Target 15.0% 10.0% 5.0% 0.0% SCRN - North & East SCRN - South East SCRN - West* 41

43 2014/16 No of patients Av cancer Target Network enrolled registrations %Enrolled SCRN - North & East 7.5% % SCRN - South East 7.5% % SCRN - West* 7.5% % Translational Trials 16.0% % of Acute Leukaemia Patients Enrolled in Translational Clinical Trials 14.0% 12.0% 10.0% 8.0% 2014/16 Target 6.0% 4.0% 2.0% 0.0% SCRN - North & East SCRN - South East SCRN - West 2014/16 No of patients Av cancer Target Network enrolled registrations %Enrolled SCRN - North & East 15% % SCRN - South East 15% % SCRN - West* 15% % *Data for 2016 and 2017 has been provided by SCRN West, therefore west of Scotland results are not directly comparable to the other regions. These results demonstrate the general commitment across the country to increase recruitment to clinical trials. This QPI has been changed after formal review to monitor the number of patients consented for clinical trials with no split by trial type and a target of 15%. This will be in place for future reporting of this QPI. 42

44 List of abbreviations QPI - Quality Performance Indicator ISD - Information Services Division NOSCAN - North of Scotland cancer network WoSCAN - West of Scotland cancer network SCAN - South East Scotland cancer network MDT - Multidisciplinary team SCRN - Scottish Cancer Research Network 43

45 List of Tables Acute Leukaemia Data Tables File name File and size Excel 115 Kb 44

46 Contact John Connor Principal Information Analyst Colin Houston Senior Information Analyst Further Information Further information on Cancer Quality Performance Indicators can be found on the Cancer QPI section of the ISD website. The next release of this publication will be February Rate this publication Please provide feedback on this publication to help us improve our services. 45

47 Appendices Appendix 1 Background information The purpose of the cancer quality work programme and the roles and responsibilities of each organisation are outlined in Chief Executives Letter (CEL 06). This document also provides details of the data collection, quality assurance and governance processes that are critical to the reporting of QPIs. Appendix 2 Acute Leukaemia QPIs The table below shows the list of Acute Leukaemia QPIs applicable to this publication. Please note that revisions to these QPIs may have been made since the initial data collection refer to the Healthcare Improvement Scotland website for the latest version of these QPIs. QPI Numerator Denominator Exclusions Target QPI 1: Complete Diagnostic Panel Number of patients with acute leukaemia undergoing treatment with curative intent where complete diagnostic panel undertaken. All patients with acute leukaemia undergoing treatment with curative intent. No exclusions 90% QPI 2: Diagnostic Classification Number of patients with acute leukaemia who have a WHO classification assigned and recorded (either by MDT or reporting haematologist/ haematopathologist). All patients with acute leukaemia. Patients receiving supportive care / palliation only. 100% QPI 3: MDT Discussion Number of patients with acute leukaemia discussed at the MDT within 6 weeks of diagnosis. All patients with acute leukaemia. No exclusions 95% QPI 4: Minimal Residual Disease Marker Number of patients with ALL, <25 years of age, undergoing treatment with curative intent who are assessed for the presence of MRD marker. All patients with ALL, <25 years of age, undergoing treatment with curative intent. No exclusions 90% 46

48 QPI 5(i): Early Deaths patients with Acute Myeloid Leukaemia Number of patients with AML being treated with curative intent who die within 30 days of treatment. All patients with AML being treated with curative intent. No exclusions Patients under 16 years of age < 2% Patients aged between 16 and 60 years < 8% QPI 5(ii): Early Deaths patients with Acute Lymphoblastic Leukaemia Number of patients with ALL being treated with curative intent who die within 35 days treatment. Number of patients with ALL being treated with curative intent who die within 35 days treatment. No exclusions Patients over 60 years of age < 18% Patients under 16 years of age <2% Patients aged between 16 and to 60 years <8% Patients over 60 years of age < 20% QPI 6: Access to ATRA for Patients with Acute Promyelocytic Leukaemia Number of patients with APL who receive ATRA within 1 day of diagnosis. All patients with APL. No exclusions 95% QPI 7: Deaths in Remission Number of patients with acute leukaemia undergoing treatment with curative intent who achieve first CR and die within 1 year of diagnosis, whilst in CR. All patients with acute leukaemia undergoing treatment with curative intent who achieve first CR. Patients undergoing bone marrow / stem cell transplant. Patients under 16 years of age <4% Patients 16 years of age and over <10% QPI 8: Clinical Trials with Curative Intent QPI 9: Tissue Typing for Transplant Number of patients with acute leukaemia who are treated with curative intent enrolled in a clinical trial. Number of patients with acute leukaemia between 16 and 65 treated with curative intent with a specimen sent to the lab for tissue typing at diagnosis. All patients with acute leukaemia who are treated with curative intent. All patients with acute leukaemia between 16 and 65 being treated with curative intent. Patients who refuse entry into a clinical trial. Patients over 60 years of age. Patients under 16 years of age 80% Patients aged between 16 and 60 years of age over 60% No exclusions 90% QPI 10(i): Intensive Chemotherapy in Older Adults Number of patients with acute leukaemia 60 years of age and over with PS 0-1 who receive intensive chemotherapy. All patients with acute leukaemia 60 years of age and over with PS 0-1. No exclusions 20% 47

49 QPI 10(ii): Intensive Chemotherapy in Older Adults (within clinical trials) Number of patients with acute leukaemia 60 years of age and over who receive intensive chemotherapy enrolled in a clinical trial. All patients with acute leukaemia 60 years of age and over who receive intensive chemotherapy. Patients who refuse entry into a clinical trial. 80% QPI 11: Clinical Trials with Non Curative Intent Number of patients with acute leukaemia who are treated with non-curative intent enrolled in a clinical trial. All patients with acute leukaemia who are treated with non-curative intent. Patients who refuse entry into a clinical trial. 10% QPI 12: Palliative Treatment Number of patients with acute myeloid leukaemia who are suitable only for treatment with non-curative intent who receive palliative chemotherapy with either low dose cytarabine or azacytidine. All patients with acute myeloid leukaemia who are suitable only for treatment with noncurative intent. Patients who refuse chemotherapy treatment. Patients with adverse cytogenetics 70% Appendix 3 Acute Leukaemia Clinical Trials The list of clinical trials in use for acute leukaemia patients in Scotland across the Scottish Cancer Research Networks is shown below. Further details on these clinical trials are available from the relevant SCRN. Study Title SCRN - North & East SCRN - South East SCRN - West AML 19 AML 17 AML18 RAvVa LI-1 InCiTe Phase I study of KHK2823 in AML or MDS ROMAZA UKALL 14 UKALL 2011 PHAZAR FIGARO UKALL60+ Understanding and managing the coagulopathy of APL (Pilot Study) 48