Audit Report Acute Leukaemia Quality Performance Indicators

Transcription

1 Haemato-oncology Managed Clinical Network Audit Report Acute Leukaemia Quality Performance Indicators Clinical Audit Data: 01 July 2014 to 30 June 2017 Dr Mark Drummond Consultant Haematologist MCN Clinical Lead Heather Wotherspoon MCN Manager Julie McMahon Information Officer The content of this report is copyright WoSCAN unless otherwise stated.

2 Acute Leukaemia QPI Audit Report Addendum Contents Amendment Record This report has been issued and amended as follows: Revision Page 21 Description QPI 7 Remission deaths for patients with acute leukaemia receiving treatment with curative intent. NHS Forth Valley figure has been updated to show no deaths within the two year analysis period. The overall West of Scotland figure has been updated to reflect this amendment. Revision Date: 19 th July 2018 Signed: Carol Marshall Grant McQuaker WoSCAN Information Manager Consultant Haematologist and MCN Clinical Lead 2

3 CONTENTS EXECUTIVE SUMMARY 4 1. INTRODUCTION 7 2. BACKGROUND NATIONAL CONTEXT WEST OF SCOTLAND CONTEXT 8 3. METHODOLOGY RESULTS AND ACTION REQUIRED DATA QUALITY PERFORMANCE AGAINST QUALITY PERFORMANCE INDICATORS (QPIS) 12 ACKNOWLEDGEMENT 35 ABBREVIATIONS 36 REFERENCES 37 APPENDIX 1: NHS BOARD ACTION PLANS 39 3

4 Executive Summary Introduction This report contains an assessment of the performance of West of Scotland (WoS) acute leukaemia cancer services using clinical audit data relating to patients diagnosed with acute leukaemia between 1 st July 2014 and 30 th June Regular reporting of activity and performance is a fundamental requirement of a Managed Clinical Network (MCN) to assure the quality of care delivered across the region. The National Cancer Quality Steering Group (NCQSG) completed a programme of work in 2014 to develop national Quality Performance Indicators (QPIs) for all cancer types to enable national comparative reporting and drive continuous improvement for patients. In collaboration with the three Regional Cancer Networks and Information Services Division (ISD) the Acute Leukaemia QPIs were published by Healthcare Improvement Scotland (HIS) in April Data definitions and measurability criteria to accompany the cancer QPIs are available from the ISD website 2. In June 2017, Regional Cancer Clinical Leads Group (RCCLG) supported the recommendation from the Haemato-oncology MCN Clinical Lead to delay publication of the first acute leukaemia QPI audit report until 3 years worth of data was available for analysis, given the very low patient numbers. As an interim measure, performance summary reports were issued to WoS NHS Boards for management purposes only, identifying both local and regional actions. Outcomes from these actions have been noted within this report. ISD will publish a national comparative report in summer 2018 which will compare results across the three regional networks. In order to ensure success of the national cancer QPIs in driving quality improvement in cancer care across NHS Scotland it is critical that QPIs continue to be clinically relevant and focus on areas which will result in improvements to the quality of patient care. As part of the national process it was agreed that indicators would be formally reviewed following the availability of 3 years of comparative reporting. This clinically led review aims to identify potential refinements to the current QPIs and involves key clinicians from each of the Regional Cancer Networks. The review of acute leukaemia QPIs is due to start in April 2018 and the output of the review will be communicated in due course. Background The Haemato-oncology MCN was established in 2002 as a means of delivering equitable, high quality clinical care to all haemato-oncology patients across five NHS Boards; Ayrshire & Arran, Dumfries & Galloway, Forth Valley, Greater Glasgow and Clyde (GGC) and Lanarkshire covering a population of 2.6 million. Audit teams within the WoS and Dumfries & Galloway recorded 345 new leukaemia cases diagnosed between 1 July 2014 and 30 June The Haemato-oncology MCN continues to support and develop the clinical service for these patients and at present there are seven local Multi-disciplinary Team (MDTs) meetings held across the region which complement the function of the Regional Haemato-oncology MDT. The Network continues to benefit from enthusiastic engagement of a range of healthcare professionals and managers across the WoS. 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 1 st July 2014 and 30 th June 2017 was downloaded from ecase on 17 th January

5 Analysis was performed centrally by the (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 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. Cancer patients under the age of 16 years are treated in the Royal Children s Hospital in Glasgow, separately from the adult services. Although QPI audit data are collected for patients under 16, this group is excluded from published QPI figures. However regions may report these separately to their clinical groups for internal management purposes. Due to the small numbers involved in each year of analysis, cumulative three year data results have been presented for all QPIs. Results Results for each QPI are shown in detail in the main report and illustrate Board performance against each target and overall WoS performance for each performance indicator. Results are presented graphically and the accompanying tabular format also highlights any missing data and its possible effect on any of the measured outcomes. 5

6 Conclusions and Action Required Cancer audit has underpinned much of the regional development and service improvement work of WoSCAN 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 tumour-specific QPIs, this has now become an established national programme to drive continuous improvement and ensure equity of care for patients across Scotland. Collection of acute leukaemia QPI data has been challenging due to the complex nature of haematological malignancies and specifically their diagnosis and work-up. Diagnostic material can be processed in several labs across the region and it is difficult to pull data together for comprehensive diagnostic workup and effective audit. Moreover, many patients are intensively treated over several months and distilling the quality of their care into easily measurable parameters is extremely difficult to collect and interpret. The results presented within this report illustrate that many of the QPI targets set have been challenging for Boards to achieve and some variance has been noted across Boards. However, given the small numbers included within the measurement of the majority of indicators, percentages should be compared with caution. Where QPI targets were not met, NHS Boards have provided detailed commentary. In the main these indicate valid clinical reasons or that, in some cases, patient choice or co-morbidities have influenced patient management. This audit report has highlighted the need to improve data capture to enable more meaningful analysis of performance against QPIs in the coming years, specifically with regards to performance status (WHO/ECOG) and complete diagnostic panel. However overall case ascertainment and data capture has improved in the third year of data collection and analysis. The Haemato-oncology MCN will actively participate in the forthcoming Acute Leukaemia QPI formal review process, to ensure appropriate quality outcome measures are identified for this group of rare and complex tumours. NHS Boards are asked to develop local Action/Improvement Plans in response to the findings presented in the report. Actions required: QPI 1: Complete Diagnostic Panel Audit staff to follow guidance issued by the Haemato-oncology MCN Molecular Diagnostics Subgroup to facilitate data collection regarding storage of genetic material. QPI 6: Access to ATRA for Patients with Acute Promyelocytic Leukaemia NHS Ayrshire & Arran to provide detailed reasons for patient with acute promyelocytic leukaemia not undergoing treatment with All Trans-Retinoic Acid (ATRA). QPI 8: Clinical Trials with Curative Intent All Boards have a responsibility to ensure that all available clinical trials are open in a timely manner. Consideration should be given wherever possible to treat patients in a unit where clinical trials are available. QPI 10: Intensive Chemotherapy in Older Adults All Boards to ensure recording of performance status for all acute leukaemia cases. Completed Action Plans should be returned to WoSCAN within two months of publication of this report. The content of this report is copyright WoSCAN unless otherwise stated.

7 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 threeyearly 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) acute leukaemia cancer services using clinical audit data relating to patients diagnosed with acute leukaemia between 1 st July 2014 and 30 th June Regular reporting of activity and performance is a fundamental requirement of a Managed Clinical Network (MCN) to assure the quality of care delivered across the region. The National Cancer Quality Steering Group (NCQSG) completed a programme of work in 2014 to develop national Quality Performance Indicators (QPIs) for all cancer types to enable national comparative reporting and drive continuous improvement for patients. In collaboration with the three Regional Cancer Networks and Information Services Division (ISD) the Acute Leukaemia QPIs were published by Healthcare Improvement Scotland (HIS) in April Data definitions and measurability criteria to accompany the cancer QPIs are available from the ISD website 2. In June 2017, Regional Cancer Clinical Leads Groups (RCCLG) supported the recommendation from the Haemato-oncology MCN Clinical Lead to delay publication of the first acute leukaemia QPI audit report until 3 years worth of data was available for analysis, given the very low patient numbers. As an interim measure, performance summary reports were issued to WoS NHS Boards for management purposes only, identifying both local and regional actions. Outcomes from these actions have been noted within this report. In order to ensure success of the national cancer QPIs in driving quality improvement in cancer care across NHS Scotland it is critical that QPIs continue to be clinically relevant and focus on areas which will result in improvements to the quality of patient care. As part of the national process it was agreed that indicators would be formally reviewed following the availability of 3 years of comparative reporting. This clinically led review aims to identify potential refinements to the current QPIs and involves key clinicians from each of the Regional Cancer Networks. The review of acute leukaemia QPIs is due to start in April 2018 and the output of the review will be communicated in due course. 2. Background The Haemato-oncology MCN was established in 2002 as a means of delivering equitable, high quality clinical care to all haemato-oncology patients across five NHS Boards; Ayrshire & Arran, Dumfries & Galloway, Forth Valley, Greater Glasgow and Clyde (GGC) and Lanarkshire covering a population of 2.6 million. Membership includes 48 consultant haemato-oncologists, 3 clinical oncologists and a number of haemato-pathologists in addition to other professional groups involved in the multidisciplinary care of patients with blood cancer (haematological cancer). The Haemato-oncology MCN continues to support and develop the clinical service for approximately 1200 haemato-oncology patients per annum. The effective management of these patients throughout the region continues to rely on co-ordinated delivery of treatment and care that requires close collaboration of professions from a range of specialties. Currently, there are seven local Multi- 7

8 Number of Cases disciplinary Team (MDTs) meetings held across the West of Scotland (WoS) which complement the function of the Regional Haemato-oncology MDT. Table 1: WoS MDT Configuration MDT Ayrshire Clyde Dumfries & Galloway Forth Valley Lanarkshire North Glasgow South Glasgow Constituent Hospital Crosshouse Hospital, Ayr Hospital Royal Alexandra Hospital, Inverclyde Royal Hospital, Vale of Leven Dumfries and Galloway Royal Infirmary Forth Valley Royal Hospital Hairmyres Hospital, Wishaw General Hospital, Monklands and District General Hospital Beatson West of Scotland Cancer Centre, Transplant Team, Glasgow Royal Infirmary, Stobhill Hospital, Queen Elizabeth University Hospital, New Victoria Hospital 2.1 National Context Acute myeloid leukaemia (AML) and acute lymphoblastic leukaemia (ALL) account for less than 1% of all new cancer cases diagnosed in Scotland. Approximately 183 AML cases are diagnosed each year and approximately 34 ALL cases 3. Five year relative survival figures in Scotland for AML are 13% for males and 18% for females, which are similar to the European average of 15% for males and 18% for females. For ALL, relative survival rates are 37% for males and 42% for females compared to the European average of 39% for males and 40% for females West of Scotland Context A total of 345 new acute leukaemia cases were recorded through audit as diagnosed in the WoS between 1 July 2014 and 30 June The number of patients diagnosed within each analysis period and NHS Board is presented in Figure 1. Figure 1: Number of patients diagnosed with acute leukaemia by board of diagnosis. Year 1 Year 2 Year Ayrshire & Arran Forth Valley Lanarkshire GGC D&G Board of Diagnosis AA FV LAN GGC D&G WoS Year Year Year

9 < < Percentage of Cases Number of Cases Breakdown by cancer subtype is shown below in Figure 2 and illustrates that AML is the most common type of acute leukaemia in patients aged over 16 years of age in the WoS. Figure 2: Acute leukaemia by subtype of disease. 110 AML ALL Other Year 1 Year 2 Year 3 Year 1 Year 2 Year 3 AML ALL Other *Other category includes not assessable and blastic plasmacytoid dendritic cell neoplasm. Leukaemia Age and Gender Distribution Figure 3 illustrates the distribution of AML and ALL by age. The median age of AML patients was 71.5 years, with 75% of patients aged 60 years or over. The median age of ALL patients was 51.5 years, with 23% aged < 30 years, 43% aged years and 34% of patients aged > 60 years. Figure 3: Distribution of AML and ALL by age in the WoS July 2014 June 2017 AML ALL Age Range AML is recognised to be more common in males by all published epidemiological data (by a factor of ). WoS data indicates a 1.3 fold excess of AML in the male population (56.3%) compared to females (43.7%). Epidemiological data also report a similar pattern in ALL with T-ALL in particular Age Range 9

10 Proportion of Cases being more common in males. WoS data reflect this, noting a 63.8% occurrence in males and 36.2% in females. Treatment The type of first treatment administered is detailed in Figure 4 with 40% of patients receiving intensive chemotherapy and 22% of patients receiving low dose chemotherapy. Figure 4: AML Mode of First Treatment_ July 2014 June 2017 AML July June Intensive Chemotherapy Low dose chemotherapy Supportive Care Only Pt Died Other Figure 5 illustrates the percentage of AML patients receiving intensive therapy by age ( 60 years and > 60 years respectively). In the younger cohort, 82% of patients received intensive chemotherapy compared with 25% of patients in the >60 years age group. Figure 5: AML Intensive Treatment_ July 2014 June 2017 AML Treatment July 14 June 17 <=60 years of age AML Treatment July 14 June 17 >60 years of age Non Intensive, 14, 18% Intensive Chemotherapy, 54, 25% Intensive Chemotherapy, 63, 82% Non Intensive, 164, 75% 10

11 Proportion of cases Figure 6 illustrates the percentage of ALL patients receiving intensive therapy by age with over 95% of patients 60 years being treated intensively. Figure 6: ALL Intensive Treatment_ July 2014 June < >60 Age Group 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 recorded manually and entered locally into the electronic Cancer Audit Support Environment (ecase): a secure centralised webbased database. Data relating to patients diagnosed with acute leukaemia between 1 st July 2014 and 30 th June 2017 was downloaded from ecase at 2200 hrs on 17 th January Cancer audit is a dynamic process with patient data continually being revised and updated as more information becomes available. This means that apparently comparable reports for the same time period and cancer site may produce slightly different figures if extracted at different times. Analysis was performed centrally for the region by the 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 Boards to check for inaccuracies, inconsistencies or obvious gaps and a subsequent download taken upon which final analysis was carried out. The final data analysis was 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. Cancer patients under the age of 16 years are treated separately from the adult services. Although QPI audit data are collected for patients under 16, this group is excluded from published QPI figures due to the very low numbers. However regions may report these separately to their clinical groups for internal management purposes. Due to the small numbers involved in each year of analysis, cumulative three year data results have been presented for all QPIs. 11

12 4. Results and Action Required 4.1 Data Quality Quality of audit data can be assessed in the first instance by estimating the proportion of expected patients that have been identified through audit. Case ascertainment is calculated by the number of patients identified as diagnosed in a NHS Board through audit as a percentage of the incidence of cancer diagnosed in that NHS Board from Cancer Registry. Cancer Registry information is available some time after the year of interest as collection and verification of data is time intensive. For this reason, audit data cannot be compared directly to Cancer Registry data for the same year. The number of patients diagnosed each year will naturally vary. Cancer Registry figures used were extracted from Cancer Registry Scotland, a system provided by ISD via the standard reports available. Table 2 presents the case ascertainment for each NHS Board and for WoSCAN as a whole. Table 2: Case ascertainment by NHS Board for patients diagnosed with Acute Leukaemia, 01/07/2014 to 30/06/2017 Health Board of Diagnosis (01/07/ /06/2017) Audit Cancer Registry Average Case Ascertainment Ayrshire & Arran % GGC % Forth Valley % Lanarkshire % Dumfries & Galloway % WoS Total % 4.2 Performance against Quality Performance Indicators (QPIs) Results of the analysis of acute leukaemia QPIs are set out in the following sections. Graphs and charts have been provided where this aids interpretation and, where appropriate, numbers have also been included to provide context. Due to the small numbers involved in each year of analysis, cumulative three year data results have been presented for all QPIs. Data (both graphically and in tabular format) are presented by location of diagnosis or treatment, with some criteria given as an overall WoS 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. 12

13 Percentage of Cases 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. Diagnosis and classification is as per World Health Organisation (WHO) 2008, and thus requires morphological, flow-cytometric, cytogenetic and (in selected cases) molecular analysis. Diagnostic material must be obtained and analysed or stored prior to treatment. By incorporating these different testing modalities into the diagnostic pathway, accurate diagnosis and sub classification is possible. A complete panel is required as findings from one test may alter the testing strategy for other techniques 1. Title: Numerator: Patients with acute leukaemia should have complete diagnostic panel undertaken to inform appropriate management. 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% Figure 7: Proportion of patients with acute leukaemia who have complete diagnostic panel undertaken to inform appropriate management. Year 1 - Year Ayrshire & Arran Forth Valley Lanarkshire GGC D&G WoS QPI 1 Year 1- Year 3 Performance (%) Numerator Denominator Board of Diagnosis numerator exclusions denominator Year 1 (%) Year 2 (%) Year 3 (%) AA 65.6% % 90.9% 84.6% FV 25.0% % - Lan 33.3% % 5.9% 36.4% GGC 54.9% % 76.9% 27.3% D&G 53.8% % % WoS 49.4% % 55.6% 45.5% 13

14 Overall in the WoS 49.4% of patients diagnosed with acute leukaemia undergoing treatment with curative intent had complete diagnostic panel undertaken. This falls short of the target of 90% for this measure. No individual board achieved the QPI target with performance ranging from 25% in NHS Forth Valley to 65.6% in NHS Ayrshire & Arran. NHS Forth Valley commented that, after review of year 3 data, the four cases documented as not recorded had a complete diagnostic panel performed therefore the percentage for this QPI in year 3 should be 100%. Forth Valley has now put processes in place to improve validation of the data collected. Feedback from all WoS Boards primarily identifies a data collection issue regarding the storage of genetic material. The interim performance report issued following analysis of years 1 and 2 data identified a regional action to explore the feasibility of adding standardised text regarding the storage of genetic material to existing molecular reports to facilitate data capture. Molecular genetics now issue storage reports and advice has recently been issued by the Haemato-oncology MCN Molecular Diagnostics Subgroup, navigating audit staff through Clinical Portal and SCI store to capture the relevant data. Next year s results should therefore show an improvement against this target. NHS Lanarkshire noted that the Clinical Lead will remind all staff who perform bone marrow examinations to send molecular samples. NHSGGC commented that appropriate diagnostic tests are being carried out in a timely manner and noted that, going forward, an acute leukaemia diagnostic pathway currently being developed by the MCN will remind clinicians of the sample types to be sent. Action Required: Audit staff to follow guidance issued by the Haemato-oncology MCN Molecular Diagnostics Subgroup to facilitate data collection regarding storage of genetic material. 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 1. Title: Numerator: Patients with acute leukaemia should have a World Health Organisation classification recorded to facilitate appropriate management. 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% 14

15 Percentage of Cases Figure 8: Proportion of patients with acute leukaemia who have World WHO classification assigned and recorded (either by MDT or reporting haematologist/haematopathologist). Year 1 - Year Ayrshire & Arran Forth Valley Lanarkshire GGC D&G WoS QPI 2 Year 1- Year 3 Performance (%) Numerator Denominator Board of Diagnosis numerator exclusions denominator Year 1 (%) Year 2 (%) Year 3 (%) AA 100% % 100% 100% FV 100% % 100% Lan 100% % 100% 100% GGC 100% % 100% 100% D&G 100% % - 100% WoS 100% % 100% 100% As demonstrated in Figure 5, all NHS Boards achieved the QPI target with 100% of patients in the WoS having a WHO classification assigned and recorded (either by MDT or reporting haematologist/ haematopathologist). 15

16 Percentage of Cases 3: MDT Discussion 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 care 1. Title: Numerator: Patients with acute leukaemia should be discussed by a MDT at diagnosis. 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% Figure 9: Proportion of patients with acute leukaemia who are discussed at MDT meeting within 6 weeks of diagnosis. Year 1 - Year Ayrshire & Arran Forth Valley Lanarkshire GGC D&G WoS QPI 3 Year 1- Year 3 Performance (%) Numerator Denominator Board of Diagnosis numerator exclusions denominator Year 1 (%) Year 2 (%) Year 3 (%) AA 84.2% % 76.9% 84.0% FV 86.5% % 93.3% 100% Lan 82.9% % 72.4% 87.5% GGC 79.9% % 88.4% 77.3% D&G 95.2% % 83.3% 100% WoS 83.1% % 82.3% 84.8% Of the 344 patients across the region with acute leukaemia, 286 were discussed at the MDT within six weeks of diagnosis. This equates to 83.1% which is 11.9 percentage points below the 95% QPI target. There was very little change in WoS performance against this target over the 3 year period. Only NHS Dumfries & Galloway achieved the QPI target with a performance of 95.2%. Performance in other NHS Boards ranged from 79.9% in NHSGGC to 86.5% in NHS Forth Valley. 16

17 NHS Ayrshire & Arran commented that local review of cases was carried out. Reasons for cases not being discussed at MDT included cases that were discussed outwith the six week timescale, patients who died before treatment and cases where local or regional MDT outcomes were not recorded. NHS Ayrshire & Arran added that clinicians are aware that all cases should be brought to the local or regional MDT within six weeks of diagnosis. Work is currently being carried out to improve the recording of MDT outcomes. The aggregated 3 year result for NHS Forth Valley is noted as 86.5% just below the 90% target. However, NHS Forth Valley has shown continued improvement on performance over the duration of QPI measurement achieving 50% in year 1 to 100% in year 3. NHS Lanarkshire noted that the Clinical Lead will remind clinical staff that all newly diagnosed cases must be discussed at MDT regardless of previous malignancy e.g. myelodysplastic syndrome. NHSGGC commented that all patients will have been extensively discussed at the time of presentation both locally and with the laboratories providing diagnostic testing, and treatment will be started. A large proportion of patients with acute leukaemia are treated within a clinical trial and MDT decision making becomes more crucial after the first cycle of treatment, usually some 5-6 weeks after presentation. NHSGGC also noted that delay in formal MDT discussion was partly due to a lack of administrative support. It is anticipated that the recent appointment of an MDT Co-ordinator in NHSGGC will lead to an improvement in performance against this QPI target in next year s results. QPI 4: Minimal Residual Disease Marker (MRD) Treatment stratification based upon MRD analyses at particular time points has become standard of care in the treatment of patients within paediatric and young adult protocols (currently not clinically indicated in patients over 25 years of age). Identification of an 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 1. Title: Numerator: Patients with Acute Lymphoblastic Leukaemia (ALL) under the age of 25 receiving curative treatment should be assessed for the presence of MRD marker. 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% Due to the small numbers meeting the denominator criteria in each year of analysis individual region results cannot be presented. 3 year aggregated results for WoS give an overall performance of 85.7% with 6 out of 7 patients with ALL, under 25 years of age, undergoing treatment with curative intent being assessed for the presence of MRD marker. 17

18 QPI 5: Early Deaths Early death can be defined using the time point of 30/35 days following treatment as response status is normally evaluated within this timeframe. Differing time points are utilised for AML and ALL given different treatment regimens. Treatment related mortality is a marker of the quality and safety of the whole service provided by the MDT. Outcomes of treatment, including treatment related morbidity and mortality should be regularly assessed 1. Title: Numerator: Mortality rate following diagnosis of acute leukaemia. 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 aged between 16 and 60 years < 8% Patients over 60 years of age < 18% Table 3: Proportion of patients with AML being treated with curative intent who die within 30 days of treatment. QPI 5(i) Year 1- Year 3 Performance (%) Numerator Denominator Not recorded numerator Not recorded numerator (%) Not recorded exclusions Not recorded exclusions (%) Not recorded denominator a) AML years of age AA 0.0% % 0 0.0% 0 FV 0.0% % 0 0.0% 0 Lan 18.2% % 0 0.0% 0 GGC 8.7% % 0 0.0% 0 D&G WoSCAN 7.0% % 0 0.0% 0 b) AML >60 years of age AA 20.0% % 0 0.0% 0 FV na na na 0 0.0% 0 0.0% 0 Lan 13.0% % 0 0.0% 0 GGC 7.1% % 0 0.0% 0 D&G 0.0% % 0 0.0% 0 WoSCAN 10.7% % 0 0.0% 0 For AML patients aged between 16 and 60, 4 deaths within 30 days of curative treatment were noted resulting in a WoS performance of 7% against the <8% QPI target. Only NHS Lanarkshire did not achieve the QPI target with a performance of 18.2% however, the number of patients included in the denominator is low and this can have a considerable effect on proportions. NHS Lanarkshire commented that the Clinical Quality and Haematology lead reviewed the notes of cases not meeting this QPI, and concluded that no further action was required. Six deaths were recorded in the WoS for AML patients aged 60 years and above, that died within 30 days of treatment, resulting in a mortality rate of 10.7%, which is below the <18% target. Only NHS Ayrshire & Arran did not meet the QPI target with a performance of 20% however, as stated above the number of patients included in the denominator is low. NHS Ayrshire & Arran commented that all cases were discussed locally at the mortality and morbidity meeting and no issues were identified. 18

19 Title: Numerator: Mortality rate following diagnosis of acute leukaemia. 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% Table 4: Proportion of patients with ALL being treated with curative intent who die within 35 days of treatment. QPI 5(ii) Year 1- Year 3 Performance (%) Numerator Denominator Not recorded numerator Not recorded numerator (%) Not recorded exclusions Not recorded exclusions (%) Not recorded denominator a) ALL years of age AA % 0 0.0% 0 FV na na na 0 0.0% 0 0.0% 0 Lan % 0 0.0% 0 GGC 0.0% % 0 0.0% 0 D&G WoSCAN 4.0% % 0 0.0% 0 b) ALL >60 years of age AA % 0 0.0% 0 FV na na na 0 0.0% 0 0.0% 0 Lan % 0 0.0% 0 GGC 20.0% % 0 0.0% 0 D&G na na na 0 0.0% 0 0.0% 0 WoSCAN 20.0% % 0 0.0% 0 Despite three year cumulative results, numbers remain low and this can have a considerable effect on proportions. Overall in the WoS, 4% of ALL patients aged between 16 and 60 years, died within 35 days of curative treatment which is below the <8% QPI target. For ALL patients aged over 60 years of age, 2 deaths were noted within 35 days of curative treatment resulting in a performance of 20%, which meets the QPI target. Treatment related mortality is a proxy marker for patient selection, treatment decisions and day to day care. The results for QPI 5 illustrate that there are no concerns around these parameters in WoSCAN. 19

20 QPI 6: Access to ATRA for Patients with Acute Promyelocytic Leukaemia Treatment with All Trans-Retinoic Acid (ATRA) should be started immediately after a diagnosis of Acute Promyelocytic Leukaemia (APL) is suspected. In doubtful cases, ATRA should be commenced until a definitive result is available. The tolerance within the target is designed to account for situations where patients have co-morbidities or fitness levels which preclude treatment with ATRA 1. Title: Numerator: Patients with APL should undergo treatment with ATRA within 1 day of diagnosis. Number of patients with APL who receive ATRA within 1 day of diagnosis Denominator: All patients with APL. Exclusions: No exclusions. Target: 90% For the third consecutive year only a very small number of patients were included within the measurement of this QPI and therefore individual regional results cannot be presented at this time. At a regional level, aggregated 3 year data shows that 6 of 8 patients with APL received ATRA within 1 day of diagnosis resulting in a performance of 75% against the 90% target. NHS Forth Valley commented that after review it was found that the one patient documented as not meeting the QPI did in fact receive ATRA within one day of diagnosis therefore the percentage for this QPI should be 100%. NHS Forth Valley has put processes in place to improve data collection. Action required: NHS Ayrshire & Arran to provide detailed reasons for patient with acute promyelocytic leukaemia not undergoing treatment with All Trans-Retinoic Acid (ATRA). 20

21 QPI 7: Deaths in Remission 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 1. Title: Numerator: Remission deaths for patients with acute leukaemia receiving treatment with curative intent. Number of patients with acute leukaemia undergoing treatment with curative intent who achieve first complete remission and die within 1 year of diagnosis, whilst in complete remission. Denominator: All patients with acute leukaemia undergoing treatment with curative intent who achieve first complete remission. Exclusions: Patients undergoing bone marrow / stem cell transplant Target: <10% QPI 7 Year 1- Year 2 Performance (%) Numerator Denominator numerator exclusions denominator Year 1 (%) Year 2 (%) AA 0.0% % 0.0% FV 0.0% % 0.0% Lan 4.8% % 8.3% GGC 4.3% % 6.3% D&G 0.0% % 0.0% WoS 3.0% % 4.9% To ensure accurate reporting of this QPI, i.e. that all patients are included where a year has elapsed since their diagnosis, the patients reported here were diagnosed between 1 st July 2014 to 30 th June Year 3 results will be analysed in Year 4. In WoS, 2 of 66 patients with acute leukaemia who underwent treatment with curative intent and achieved first complete remission died within 1 year of diagnosis, whilst in complete remission. This represented 3.0% performance which meets the <10% target level. All boards met the QPI. The number of patients included in the denominator for QPI 7 is low, especially within the smaller WoS Boards, and this can have a considerable effect on proportions. 21

22 Percentage of Cases 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. Nonparticipation in clinical trials does not affect quality of care 1. Title: Numerator: Patients with acute leukaemia under 60 years of age who are suitable for treatment with curative intent should be considered for participation in available clinical trials, wherever eligible. Number of patients aged with acute leukaemia who are treated with curative intent enrolled in a clinical trial. Denominator: All patients aged with acute leukaemia who are treated with curative intent. Exclusions: Patients who refuse entry into a clinical trial and patients over 60 years of age. Target: 60% Figure 10: Proportion of patients with acute leukaemia aged with acute leukaemia who are treated with curative intent enrolled in a clinical trial. Year 1 - Year Ayrshire & Arran Forth Valley Lanarkshire GGC D&G WoS QPI 8 Year 1- Year 3 Performance (%) Numerator Denominator Board of Diagnosis numerator exclusions denominator Year 1 (%) Year 2 (%) Year 3 (%) AA 29.4% % 33.3% FV 30.0% % - Lan 61.5% % GGC 68.8% % 50.0% 93.3% D&G n/a WoS 57.6% % 40.5% 82.1% 22

23 It should be noted that despite the 3 year aggregated results numbers remain low across all boards which will have a greater effect on percentage values. Data has been restricted for NHS Dumfries & Galloway due to small numbers. Overall in the WoS, 57.6% of patients aged years with acute leukaemia treated with curative intent were enrolled in a clinical trial. This is only slightly short of the 60% target for this measure. NHS Lanarkshire, NHSGGC and NHS Dumfries & Galloway exceeded the QPI target with performance of 61.5%, 68.8% and 100% respectively. NHS Ayrshire & Arran commented that the QPI target was not achieved due to no clinical trials being open at the time of diagnosis. All clinicians are aware of available clinical trials and trials are offered to patients where appropriate. NHS Forth Valley stated that the clinical lead reviewed all cases which did not meet the QPI and at the time of the QPI audit the clinical trial AML 19 was not open. Action Required: All Boards have a responsibility to ensure that all available clinical trials are open in a timely manner. Consideration should be given wherever possible to treat patients in a unit where clinical trials are available. QPI 9: Tissue Typing for Transplant Human Leukocyte Antigen (HLA) typing should be performed in all patients with newly diagnosed acute leukaemia for whom allogeneic Haematopoietic Stem Cell Transplantation would be considered 1. Title: Patients with acute leukaemia treated with curative intent should have a specimen sent to the lab for tissue typing at diagnosis. 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% 23

24 Percentage of Cases Figure 11: Proportion 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. Year 1 - Year Ayrshire & Arran Forth Valley Lanarkshire GGC D&G WoS QPI 9 Year 1- Year 3 Performance (%) Numerator Denominator Board of Diagnosis numerator exclusions denominator Year 1 (%) Year 2 (%) Year 3 (%) AA 76.2% % 90.0% 100% FV 100% % - Lan 60.0% % 28.6% 85.7% GGC 85.7% % 84.2% 94.7% D&G 66.7% WoS 80.0% % 75.6% 94.6% Of the 115 patients aged between 16 and 65 years diagnosed with acute leukaemia and treated with curative intent, 92 had a specimen sent to the lab for tissue typing at diagnosis. This has resulted in an aggregated 3 year WoS performance of 80% against the 90% QPI target. However, performance against this target has increased steadily over the 3 year period, with the target achieved in year 3. The target was narrowly missed by NHS Lanarkshire in year 3, however all cases not meeting the QPI have been reviewed and valid clinical reasons identified. This regional improvement in uptake of tissue typing at the time of diagnosis has had a significant clinical impact. 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. 24

25 Percentage of Cases QPI 10: 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. Older age should not be a reason to withhold intensive therapy. Evidence suggests that intensive chemotherapy provides better quality of life and longer survival than supportive care only regardless of chronologic age 1. Title (i): Numerator: 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. Number of patients with acute leukaemia 60 years of age and over with 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% Figure 12: Proportion of patients with acute leukaemia 60 years of age and over with PS 0-1 who receive intensive chemotherapy. Year 1 - Year Ayrshire & Arran Forth Valley Lanarkshire GGC D&G WoS QPI 10(i) Year 1- Year 3 Performance (%) Numerator Denominator Board of Diagnosis numerator exclusions denominator Year 1 (%) Year 2 (%) Year 3 (%) AA 39.1% % 37.5% 55.6% FV 12.5% % - Lan 58.6% % 54.5% 50.0% GGC 33.3% % 45.5% 25.0% D&G 54.5% % - - WoS 41.4% % 37.8% 45.9% Overall in WoS, of the 116 patients with acute leukaemia aged 60 years and over with a performance status of 0-1, 48 received intensive chemotherapy, resulting in a performance of 41.4% which meets 25

26 Percentage of Cases the 20% QPI target. NHS Forth Valley were the only board not to meet the target with a performance of 12.5%, however numbers are low which will have a greater effect on percentage values. There was a high proportion of not-recorded values for the denominator criteria and it is possible that some of these patients should have been included in the denominator. Data fields which were not recorded for denominator relate to performance status. Action Required: All Boards to ensure recording of performance status for all acute leukaemia cases. Title (ii): Numerator: 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. 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% Figure 13: Proportion of patients with acute leukaemia 60 years of age and over with PS 0-1 who receive intensive chemotherapy enrolled in a clinical trial. Year 1 - Year Ayrshire & Arran Forth Valley Lanarkshire GGC D&G WoS QPI 10(ii) Year 1- Year 3 Performance (%) Numerator Denominator Board of Diagnosis numerator exclusions denominator Year 1 (%) Year 2 (%) Year 3 (%) AA 72.7% % FV n/a - - Lan 88.5% % 90.0% 87.5% GGC 30.0% % 14.3% 77.3% D&G 22.2% % WoS 58.8% % 60.9% 84.8% 26

27 Percentage of Cases It should be noted that despite the 3 year aggregated results numbers remain low across all boards which will have a greater effect on percentage values. Overall in the WoS, 58.8% of patients with acute leukaemia aged over 60 years receiving intensive chemotherapy were enrolled in a clinical trial. This falls short of the target of 80% for this measure. Only NHS Lanarkshire achieved the target with a performance of 88.5%. NHS Ayrshire & Arran reviewed all cases not meeting the QPI and commented that during the reporting period there were no clinical trials available locally to recruit patients to. NHS Ayrshire & Arran added that all clinicians are aware of clinical trials and patients are offered recruitment to trials where appropriate. NHSGGC stated that due to the very small numbers no clear conclusions could be drawn from the data. QPI 11: Clinical Trials with Non 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. Nonparticipation in clinical trials does not affect quality of care 1. Title: Numerator: 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. 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% Figure 14: Proportion of patients with acute leukaemia who are treated with non-curative intent enrolled in a clinical trial. Year 1 - Year Ayrshire & Arran Forth Valley Lanarkshire GGC D&G WoS Board of Diagnosis 27

28 QPI 11 Year 1- Year 3 Performance (%) Numerator Denominator numerator exclusions denominator Year 1 (%) Year 2 (%) Year 3 (%) AA 13.3% % 0.0% 0.0% FV 8.7% % 25.0% 0.0% Lan 14.3% % 0.0% 25.0% GGC 13.2% % 0.0% 11.8% D&G 0.0% % - n/a WoS 12.0% % 4.5% 9.3% Overall in the WoS, of the 142 patients with acute leukaemia treated with non curative intent, 17 were enrolled in a clinical trial, resulting in a performance of 12% therefore achieving the QPI target of 10%. NHS Ayrshire & Arran, NHS Lanarkshire and NHSGGC all exceeded the QPI with performance of 13.3%, 14.3% and 13.2% respectively. NHS Forth Valley were marginally below target achieving 8.7%, There were no patients meeting the QPI in NHS Dumfries & Galloway, however numbers are low therefore percentages should be viewed with caution. NHS Forth Valley noted several reasons why patients were not enrolled in a clinical trial including ineligibility, no trial available and no trial offered. 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. 1 Title: Numerator: Patients AML who are suitable only for treatment with non-curative intent should receive treatment with an appropriate palliative chemotherapy regimen. Number of patients with AML 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 AML who are suitable only for treatment with non-curative intent. Exclusions: Patients who refuse chemotherapy treatment and patients with adverse cytogenetics. Target: 70% 28

29 Percentage of Cases Figure 15: Proportion of patients with AML who are suitable only for treatment with non-curative intent who receive palliative chemotherapy with either low dose cytarabine or azacytidine. Year 1 - Year Ayrshire & Arran Forth Valley Lanarkshire GGC D&G WoS QPI 12 Year 1- Year 3 Performance (%) Numerator Denominator Board of Diagnosis numerator exclusions denominator Year 1 (%) Year 2 (%) Year 3 (%) AA 70.6% % 33.3% FV 31.6% % 50.0% 37.5% Lan 45.0% % 50.0% 62.5% GGC 50.0% % 40.0% 37.5% D&G n/a WoS 46.9% % 51.6% 42.1% Of the 98 patients with AML who were suitable for treatment with non curative intent, 46 received low dose chemotherapy equating to 46.9% performance against the 70% target. NHS Forth Valley, NHSGGC, and NHS Lanarkshire were all below target with performance of 31.6%, 50% and 45% respectively. Results are restricted for NHS Dumfries & Galloway due to small numbers. NHS Forth Valley reviewed cases not meeting the QPI and noted that patients received supportive care as agreed at MDT and therefore concluded that all patients were managed appropriately. NHS Lanarkshire provided valid clinical reasons for the 3 patients who did not meet this QPI. NHSGGC stated that small numbers of patients and patient choice may influence treatment given and skew results. 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 is not currently taken into account in the measurability for this QPI, however this will be considered as part of the forthcoming formal review process. 29

30 Clinical Trial Access QPI 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 1. Data definitions and measurability criteria to accompany the Clinical Trial QPI are available from the HIS website 1. 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 National Cancer Research Institute (NCRI). Utilising SCRN data allows for comparison with CSO published data and ensures capture of all clinical trials recruitment, not solely first line treatment trials, as contained in the clinical audit data. Given that a significant proportion of clinical trials are for relapsed disease this is felt to be particularly important in driving quality improvement. This methodology utilises incidence as a proxy for all patients with cancer. This may slightly over, or underestimate, performance levels, however this is an established approach currently utilised by NHS Scotland 1. The following definitions are used to distinguish between interventional clinical trials and translational research: Interventional Clinical Trial: A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. Translational Research: Translational research transforms scientific discoveries arising from laboratory, clinical, or population studies into clinical applications to reduce cancer incidence, morbidity, and mortality. QPI Title: Numerator: All patients should be considered for participation in available clinical trials wherever eligible. Number of patients with acute leukaemia enrolled in an interventional clinical trial or translational research. Denominator: All patients diagnosed with acute leukaemia. Exclusions: No exclusions. Target: Interventional 7.5% Translational 15% 30

31 % Performance Figure 16: Proportion of patients recruited into interventional clinical trials for leukaemia by NHS Board of residence Interventional trials Interventional trials Ayrshire & Arran Forth Valley Lanarkshire GGC D&G WoS NHS Board of Residence Interventional 2016 Interventional 2017 N D % N D % AA % % FV % % Lan % % GGC % % D&G % % WoS Total % % The denominator is the 5 year average of ISD incidence data for all acute leukaemias in WoS ( ). The target is to enrol a minimum of 7.5% of patients into interventional clinical trials. Overall in the WoS this was achieved with 39.3% of patients (n=44) in 2017 recruited to an interventional clinical trial. There were no patients recruited to translational clinical trials. These results demonstrate the widespread commitment across the region to increase recruitment to clinical trials. The Haemato-oncology MCN Clinical Trials Subgroup continues to strive towards embedding trials into day-to-day clinical practice to support the development of new treatments and improve patient outcomes. The MCN has produced disease-specific maps of open trials available across the region, which are accessible on the WoSCAN intranet site and are updated regularly. 31