Key findings about the quality of care for people with Lung Cancer in England incorporating headline and completeness data from Wales

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1 National Lung Cancer Audit Key findings about the quality of care for people with Lung Cancer in England incorporating headline and completeness data from Wales Report for the audit period 2005 Prepared in association with: Healthcare Commission Royal College of Physicians FOR HEALTH AND SOCIAL CARE

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3 National Lung Cancer Audit Key findings about the quality of care for people with Lung Cancer in England incorporating headline and completeness data from Wales Report for the audit period of 88

4 LUCADA First Annual Report: This is the first annual report from the Lung Cancer Audit (LUCADA). The National Lung Cancer Audit began with a small group of early users in England in January After this initial testing phase the audit was opened up to all hospitals in England with steadily increased levels of participation throughout the rest of 2004 and This first annual report presents the findings collected on registrations with a date first seen during It includes data on levels of participation, data quality and completeness and a basic analysis of the demographic data. The report also includes some data from the parallel Welsh Lung Cancer Audit. The overall aim of the audit is to provide comparative data about the incidence, nature and treatment of lung cancer, from this information differences in incidence and outcome can be explored with the ultimate aim of improving patient care and outcomes. Printed copies of this report can be ordered from The Information Centre for health and social care s Contact Centre or quoting document reference For further information about this report, or contact: National Clinical Audit Support Programme The Information Centre for health and social care 1 Trevelyan Square Boar Lane Leeds LS1 6AE 4 of 88

5 Contents 1 Acknowledgements 6 2 Foreword 7 3 Executive Summary England 8 Participation 8 Data Field Completeness 8 Headline Reports 9 Wales 9 Participation 9 Headline Reports 9 Uses of Audit Data 9 Recommendations 10 4 Background 10 to lung cancer 10 to mesothelioma 11 to the audit 12 5 Details of the Audit/Introduction 14 Management Arrangements 14 Documentation for Users 14 Access to the LUCADA Database 14 Audit Progress 15 Methods of Capturing and 15 Uploading Data Performance of the Helpdesk 15 Compliance with Standards 15 6 Methods and Approaches/ 16 Rollout of the Audit Methodology 16 Clinical Aspects 16 Casemix Factors 16 Exclusions 17 Determining Organisations Managing 17 Lung Cancer and Mesothelioma Rollout 17 Events 17 Presentations 17 Website 17 Data Standards 17 Priority outputs and headline 17 indicators 7 Pitfalls 18 Responsibilities 18 Completeness of Data 18 Organisational Codes 18 8 Reports and Analyses 18 Data Completeness 18 Headline indicators 19 Demography and Casemix 20 Stage at Time of Decision 24 to Treat Performance Status at Time of 26 Decision to Treat Co-morbidity 28 Lung Function 30 Incidence of Lung Cancer by 30 Deprivation Index Staging and Diagnosis Process 32 Source of Referral to 32 Specialist Team Patient Pathway 33 Treatment 37 Non-small cell 37 Other Cancers 39 All Lung Cancer 39 Excluding Confirmed Small Cell Carcinoma Small Cell 40 Mesothelioma 41 Outcomes 42 Clinical Trials 42 Survival 42 9 Uses of Information from LUCADA Issues and Recommendations Future Work Conclusions 46 Appendix 1 Participation and 47 Recruitment 1a England 47 1b Wales 56 Appendix 2 Data Completeness 57 2a Case Ascertainment by Cancer 57 Network England 2b Case Ascertainment by Cancer 58 Network Wales 2c Data Completeness England 59 2d Data Completeness Wales 69 2e English Data with no date first seen 70 recorded Appendix 3 National Lung Cancer Audit 71 Dataset/User manual Appendix 4 LUCADA Priority Outputs 77 Appendix 5 Notes on Coding 80 Classifications Appendix 6 Contributing 81 Organisations Glossary 82 References 86 5 of 88

6 1. Acknowledgements The National Lung Cancer Audit was commissioned and sponsored by the Healthcare Commission and developed in partnership with the Clinical Effectiveness and Evaluation Unit at the Royal College of Physicians (RCP). Throughout the development and rollout, a number of key individuals have provided considerable contribution. These include the LUCADA project team: Mick Peake and Nic Chanarin, Clinical leads Alastair Mason, Chair Roz Stanley, Project Manager Steve Dean, Senior Project Manager (Cancer Audits) Kimberley Greenaway, Project Manager, National Bowel Cancer Audit Kerry Agar, Project Support Officer Kate Sweetlove, previous Project Manager Natasha Hinds-Payne, previous Project Support Officer The following groups have supported the audit; the Joint Information Group (JIG); the LUCADA User Group; and The Intercollegiate Lung Cancer Group (ICLCG). NHS Connecting For Health and previously the NHSIA, provided support and technical infrastructure. We would particularly like to acknowledge Phil Moores, Simon Netley and Darren Reddick for their support to users, and Julian van Tienhoven, Tim Rickwood and David Stump for their technical support, development and maintenance work. The data from Wales included in this report was submitted by Informing Healthcare who thank the lung teams in all 12 Welsh Trusts, without whose considerable efforts this contribution would not have been possible. The analysis for this report was undertaken by the Cancer Registries and special thanks must be given to Ruth Jack and Henrik Møller at Thames Cancer Registry and Catherine Thomson at West Midlands Cancer Registry. We would like to acknowledge Nick Worner, and Louise Phillips for their incisive and constructive comments during the report compilation. Above all we would like to thank the early adopters for the significant work carried out at the inception of the LUCADA Project, the tireless support of many of the Cancer Networks, and the individual users for their contribution which has enabled this first national annual report. 6 of 88

7 2. Foreword 2a Prof. Mike Richards National clinical audits are an important tool for driving up the quality of care delivered in routine clinical practice. The LUCADA audit of patients with lung cancer is one of the first nationwide audits in the field of cancer. LUCADA is of particular importance both because of the burden of lung cancer in this country and because of concerns regarding low surgical intervention rates and poor five-year survival rates. I would like to commend all those who have driven this audit forward and all those working within hospital teams who have contributed data. The findings show that recruitment of hospitals has been broadly in line with initial projections. However, there are no grounds for complacency. To have maximal input on quality of care, all NHS Trusts will need to participate and to enter data on all newly diagnosed patients. For meaningful comparisons between Trusts it will be essential to increase the proportion of patients for when stage, performance status and co-morbidity are recorded. This report provides some very useful baseline data against which progress will be monitored in future years. 2b Mick Peake Although the establishment of the National Lung Cancer Audit programme has taken the effort and cooperation of a large number of individuals and organisations over a significant period of time, the crucial day-to-day collection of detailed patient-related data in busy clinical settings requires the efforts and commitment of a very large number of people. Without the efforts of these doctors, nurses, audit staff, MDT co-ordinators, data clerks, etc, there would be no data to analyse. We would like to extend our profound appreciation to all these staff who, we know only too well, are working under great pressure from many other quarters. We hope that this report, the first of many, will begin to give them a taste of the fruits of their efforts, which we all hope will help in the ultimate aim of improving the outcomes for patients with lung cancer and mesothelioma. Mick Peake Clinical Project Lead, National Lung Cancer Audit; Associate Director; Clinical Effectiveness and Evaluation Unit, Royal College of Physicians. Prof. Mike Richards National Cancer Director 7 of 88

8 3. Executive Summary LUCADA First Annual Report The overall aim of the audit is to provide comparative data about the incidence, nature, geographical distribution and treatment of lung cancer, from this information differences in incidence and outcome can be explored with the ultimate aim of improving patient care and outcomes. This is a summary of the first annual report covering patients with a date first seen recorded in England in 2005, the first full year since the audit s launch. Comparative headline and completeness data from the parallel Welsh Lung Cancer Audit is also included. Comparison of the headline indicators between the English and Welsh data in this publication might suggest a higher standard of care for Welsh patients. However, there are differences in data collection and completeness which must be taken into account in making direct comparison. The principal of these is the method of data retrieval for LUCADA. In England, this is based on a dataset created with the primary aim of supporting the audit and uptake by Trusts has been variable with approximately 40 per cent of cases registered in In Wales the audit data is extracted from a National Summary Electronic Cancer Patient Record (CaNISC), which is used for lung cancer patients by all Trusts in Wales and as a result 71 per cent of patients are included when using the equivalent baseline to the English data. The majority of Welsh Trusts also use CaNISC to provide cancer waittime data for The Wales Assembly Government and this also encourages patient registration. Poor participation in the current audit by some of the large treatment centres in England in 2005 has resulted in under-recording of treatment. These results emphasise the need for all the hospitals within the English cancer networks to contribute data to LUCADA. 3.1 England Participation A total of 23,529 new cases of lung cancer and mesothelioma had been recorded on the LUCADA system by the end of June 2006 of these 10,920 cases had a date first seen in 2005 In England 77 per cent of the 200 Trusts eligible for participation in the audit had submitted some data by the end of June of the 34 English Cancer Networks had full participation (all trusts within a network entering some data) by June A further 7 networks had all but one hospital participating in the audit Some major cancer centres have yet to submit data to the audit. Although 77 per cent of hospitals submitting data exceeds the original recruitment target of 75 per cent, effort is needed to continue to recruit all eligible Trusts by the end of There are a number of issues which make participation difficult, particularly the lack of local resources to collect and input data. Some of these problems have been made worse by conflicting priorities for NHS trusts including the reporting of cancer waiting times data. This was exacerbated by the change to weekly reporting in the latter half of Data field completeness Within the LUCADA database key fields are monitored for the standard of data completion. Some of these fields can be completed by entering the option of unknown. The completeness score is shown excluding unknown where applicable. Field Completeness including unknown Completeness excluding unknown (actual completeness) (actual completeness) Date of diagnosis 92 per cent n/a Histological completeness 78 per cent n/a (including clinical diagnosis) Discussed at MDT indicated (includes yes and no) 86 per cent n/a Treatment recorded 66 per cent n/a Stage 51 per cent 47 per cent Performance status 66 per cent 53 per cent Co-morbidity 67 per cent 46 per cent Stage and performance status and co-morbidity 37 per cent 24 per cent Figure 3.1.2: Data Field Completeness (data collected from England) 8 of 88

9 3.1.3 Headline reports 12,784 patient records were submitted to LUCADA during This is approximately 40 per cent of the expected number of cases for this period. Of these, 10,920 were suitable for detailed analysis. Of these 10,920 records: 64 per cent of patients had a histological and/or cytological diagnosis recorded The histological confirmation rate is probably a good surrogate marker of the overall standard of a lung cancer service, the optimal rate perhaps being per cent. It is not possible at this stage to determine if the observed shortfall reflects standards of care or is a result of incomplete data 78 per cent of patients had been reviewed by a multi-disciplinary team (MDT) National guidance recommends that this proportion should be 100 per cent 9 per cent of patients underwent a surgical resection Hospital Episode Statistics (HES) and other data from the UK are consistent with this, but it is low by international standards. The data also shows wide variations in surgical resection rates within England 43 per cent of patients had received anti-cancer treatment. This excludes palliative care and active monitoring This is in line with published data available from the UK but again is low in comparison to international standards. 3.2 Wales Participation In Wales all 12 acute NHS trusts submitted data for Following local validation, data was uploaded to the main LUCADA database from the central Wales electronic cancer record, Cancer Network Information System Cymru (CaNISC) Headline reports 1,596 records were submitted during This is approximately 89 per cent of the expected number of cases for this period Please note that the Welsh Cancer Intelligence and Surveillance Unit baseline figures represent only the registrations made by trusts, the all Wales lung cancer incidence for 2004 registered from all sources is 2,248. Thus on a direct comparison to English data, case ascertainment is 71 per cent for Wales. Of these 1,596 records: 75 per cent of patients had a histological and/or cytological diagnosis The histological confirmation rate is probably a good surrogate marker of the overall standard of a lung cancer service, the optimal rate perhaps being per cent. It is not possible at this stage to determine if the observed shortfall reflects standards of care or is a result of incomplete data 90 per cent of patients had been reviewed by a multi-disciplinary team (MDT) National guidance recommends that this proportion should be 100 per cent 59 per cent of patients had received anti-cancer treatment This is in line with published data available from the UK but again is low in comparison to international standards The proportion of Welsh patients undergoing surgical resection is unavailable for this report. 3.3 Uses of Audit Data The advantage of the LUCADA database is that it collects more detailed information about the care provided than is available from existing sources of data such as the Cancer Registries and Hospital Episode Statistics (HES). The dataset was developed to be clinically relevant and therefore has professional ownership. It is also able to provide comparative reports to local service providers within a short timescale including tools to produce summary reports for each of the variables recorded. These reporting tools were revised in 2005, allowing users to review their own information benchmarked against the national average on a real-time basis Annual Health Check and Peer Review Information about participation in the audit is being provided to the Healthcare Commission for use in the Annual Health Check in England and is being used in the Peer Review process. Information on audit participation and data completeness is likely to be used for 2006 and the first risk-adjusted clinical indicators are likely to be included in 2007 for those hospitals whose 2006 data are of sufficient quality. Discussions with the Cancer Peer Review Team are underway to explore the best use of LUCADA data in the next round with a view to including more detailed assessment on activity, performance and outcomes National Institute of Clinical Excellence (NICE) Guidance Two of the key recommendations of the NICE guidance on the diagnosis and treatment of lung cancer are specifically addressed by the audit: Proportion of patients receiving chemotherapy in advanced stage non-small cell lung cancer 9 of 88

10 Proportion of lung cancer patients discussed at an MDT. Other NICE recommendations can also be measured, but a wider range of the recommendations are being addressed through further development of the audit during Future uses of data As the quantity and quality of data from LUCADA improves it has the potential to help better inform the public, to improve the standards of Peer Review and to significantly contribute to research in this field. With comprehensive coverage of the country, the audit will provide feedback to healthcare providers and purchasers using up-to-date information on activity, performance and outcomes which can be used for benchmarking, planning and prioritisation of service improvements. Since the data will be riskadjusted, it will have the clinical credibility required to change practice. Information of this quantity and timeliness has never been available for cancer services on a large scale anywhere in the world before. This audit therefore has the potential for bringing about major changes in practice which could impact on key outcomes such as survival. 3.4 Recommendations All hospitals and trusts involved in any part of the patient pathway for lung cancer should take steps to ensure their full participation in the audit for the 12- month period ending December 2006 thus ensuring that: Their complete data are included in the National Lung Cancer Audit analysis and reporting Their audit participation is taken into account in the Healthcare Commission s Annual Health Check Hospitals and networks are able to use their contribution to the audit as evidence in Peer Review They can identify where improvements in patient care are needed. Further recommendations from the audit are: All patients should be managed by a specialist multi-disciplinary team Every patient diagnosed with lung cancer or mesothelioma should be entered on the LUCADA database Local services should be using the histological confirmation rate as a prime marker of the overall quality of their services; those with a low value should ensure that this is not due to poor data quality and then take appropriate action Good data on activity performance and outcomes are essential components of clinical governance The public should have access to accurate and risk-adjusted clinical information. The second annual report in 2007 will include comparative risk adjusted analyses with identification of hospitals and Cancer Networks. This will provide insights into the variations in performance and outcomes of lung cancer care. These comparisons will only be robust and meaningful if the level of data completeness for the year ending 2006 is a great improvement on that in Background 4.1 Lung Cancer What is lung cancer and how common is it? Lung cancer is a term covering a collection of several different forms of malignant tumour arising in the lungs and major airways. Overall, it is the commonest cause of death from cancer in the Western world, with around 33,000 deaths per annum in England and Wales. In men, deaths from lung cancer outnumber those from the next most common cancer, prostate, by around 2:1 and in women, lung cancer deaths either exceed or are very close to the numbers that result from breast cancer. One person dies from lung cancer in the UK almost every 15 minutes Relationship to smoking It is estimated that around 90 per cent of lung cancers in men and 85 per cent in women are related to the victims smoking habit. However, there are between 3,000 and 4,000 lung cancer deaths occur each year in individuals who have never smoked - greater than the number of deaths from cervical cancer, ovarian cancer, endometrial cancer, lymphoma and leukaemia. A proportion of these deaths are related to passive smoking. Approximately one in 6 lifelong smokers will die of lung cancer Prognosis Overall the current outcomes for lung cancer patients are not good, with the median survival of all patients being around 6 months and no more than per cent enjoying long-term survival even in the very best of hands. However, if detected at an early stage, there is a high chance of long-term survival with surgery or radical radiotherapy. Previous 10 of 88

11 studies have shown, however, that approximately two-thirds of patients have metastatic disease (i.e. it has spread to other organs) by the time they get to specialist care and no more than 20 per cent have potentially surgically resectable tumours. Compounding this is the fact that because of the average age of onset of lung cancer (approximately 70 years) and the fact that the majority of patients are smokers, there is a high incidence of comorbidities in this population. The most common include Chronic Obstructive Pulmonary Disease (COPD) and Ischaemic Heart Disease - both of which may render the patients unfit for radical treatment including surgery Symptoms One of the reasons why lung cancer patients do not get to see a specialist earlier in the course of their disease is that the symptoms are very often nonspecific. They include persistent cough, the coughing of blood (haemoptysis), breathlessness, chest pain, fatigue and weight loss. Given that the majority of patients are smokers and several of these symptoms are common in smokers in general, it is understandable that both patients and clinicians may not recognise the early symptoms of the disease for what they are. Even though lung cancer is a common disease, a GP is only likely to see 1-2 new cases per year, making it even more difficult to identify patients early. In fact many of those patients that do have operable disease are discovered to have an abnormal x-ray incidentally when having the examination for some other purpose Pathways of care Both the referral and management pathways for lung cancer patients are complex making the identification of the entire patient population and the collection of a comprehensive dataset very difficult. One study demonstrated over 70 different care pathways in a detailed audit of nearly 500 patients in Yorkshire (Melling et al, 2002). Despite the publication of referral guidelines for suspected cancer patients (NHS Exec. 2000; NICE 2004), no more than 50 per cent of patients are referred directly from their GPs to a lung cancer specialist with the suspicion of a diagnosis of the disease; the rest come through a wide variety of routes such as Accident and Emergency Departments, urgent admission to general and elderly medicine wards and following referral as an out-patient to another specialist department. Most patients are now referred to a specialist department at some stage of their care and it is stated policy (National Cancer Plan DH, 2001) that such patients should be discussed at a multi-disciplinary team (MDT) meeting. The majority of trusts and hospitals who receive such referrals and host such MDT meetings do not have, on site, facilities for the full range of potential treatments such as thoracic surgery, chemotherapy and radiotherapy and so, of necessity, the majority of patients are managed by more than one trust. There are also a proportion of patients who have to travel to another Cancer Network to receive a particular form of treatment. In summary, there are a number of reasons why collecting complete data on lung cancer patients is difficult. They include: No more than half of the patients are identified as likely to be suffering from lung cancer at the time of referral to secondary care A proportion of patients will never have their lung cancer confirmed by a tissue diagnosis, making the simple search of pathology records inadequate to identify the entire patient population The majority of patients are managed by more than one trust, with some being managed by more than one network - making collection of data for the whole care pathway difficult unless all institutions are engaged in the audit process Not all relevant data are available at one particular time - for example, although the MDT meeting is an ideal time and place to collect a great deal of data, not everything will be available there, particularly treatment and other outcome data A small proportion of patients are not referred to secondary care. 4.2 Mesothelioma What is mesothelioma? Mesothelioma is a cancer which principally affects the lining of the lungs (pleura) and the lining of the abdominal cavity (peritoneum). Over 90 per cent of cases with a known first site are pleural mesothelioma What causes mesothelioma? Mesothelioma has a strong association with exposure to asbestos dust. It is believed that nearly all deaths caused by mesothelioma are linked to asbestos exposure. There is a long lag time between exposure to asbestos and the development of mesothelioma; this varies from a minimum of 10 years to a maximum of 60 years after exposure, the median time being of the order of 30 years. Cases of mesothelioma in the UK usually occur in people who have worked in environments where they have been exposed to asbestos. 11 of 88

12 4.2.3 Epidemiology Mesothelioma is a relatively uncommon tumour; in the UK in 2003, there were 1,796 new cases of mesothelioma of which 85 per cent (1,521) were men and 15 per cent (275) were women. There is wide variation in the frequency of this tumour around the UK with the standardised mortality ratio (SMR) in men varying from 593 to 16 (the average SMR is, by definition 100) (HSE). There are therefore many areas of the country where the number of new cases diagnosed each year by clinical teams will be in single figures Prognosis Mesothelioma is almost universally fatal and treatments have only a modest affect on survival in the vast majority of patients. Most published studies have reported a median survival of between 7 and 9 months Symptoms and pathways of care The symptoms of mesothelioma are, as with lung cancer, fairly non-specific. They include breathlessness, chest pain, fatigue and weight loss. Such symptoms in a male patient with an appropriate occupational history should at least trigger an early chest x-ray. The guidelines for urgent referral of patients with suspected lung cancer (NHS Exec. 2000; NICE 2004) cover mesothelioma patients as well as those with suspected lung cancer. It is very largely the same teams who manage lung cancer patients who manage those with mesothelioma. Although the range of effective treatments for mesothelioma is more limited than for lung cancer, there are still many patients who are referred across trust and network boundaries for their care. 4.3 The Audit Background The National Lung Cancer Audit has been established on a formal basis following a Department of Health sponsored snapshot audit of lung cancer services in the mid 1990 s. It is one of the first projects of national comparative audit aimed at helping clinicians and managers to improve the quality and outcomes of their services. The audit was originally referred to as LUCADA (Lung Cancer Data) from which the associated data collection system now takes it name Survival Survival from lung cancer in the UK is poorer than that reported from the USA and most of Europe; similarly the proportion of patients receiving radical, potentially curative treatments (particularly surgery) are low in the UK. Some of the variation can be explained by differences in the definition and range of the populations studied, but it is unlikely that these factors can explain most of the very wide range reported. There are also huge ranges in treatment and survival rates in the UK and some studies have demonstrated a clear correlation between active treatment rates and outcomes. These facts emphasise the serious need to raise the overall standards of care and to reduce regional variations within the UK. UK data are largely derived from the Cancer Registries and the particular strength of their data are the robust analysis of incidence and survival. In the most recently published national performance indicator data which relates to patients with lung cancer diagnosed in England between 1993 and 1995, the 5 year survival rate varied from 2.2 per cent to 8.8 per cent - the mean being 5.5 per cent (compared to a reported European average of around 10 per cent) (NHS Executive, National Performance Indicators for the NHS, London, Department of Health 2000a). Data derived from Hospital Episode Statistics (HES) show a four-fold difference in surgical resection rates across trusts in England and a study in the south east of England showed a three-fold range of active treatment rate (Jack R et al Brit. J. Cancer, 2003; 88; ). Thus, improving outcomes in the worst performing areas to those of the best has the potential to at least double the overall 5 year survival rate in the UK without any advances in treatment Risk adjustment Although survival is the easiest endpoint to measure, in lung cancer (where even in the best hands, the majority of patients have incurable disease) high quality, rapid palliation is also vital as is the experience of care for patients and their families. Such endpoints are more difficult to measure at a national level, but there is some evidence that services that provide high quality diagnostic, staging and treatment facilities (which can be more easily measured - e.g. histological confirmation rate), are more likely to deliver quality care in these other less tangible areas. What is not known is the extent to which the differences in survival can be explained by regional variations in: Configuration of services Management policies (including diagnosis, staging and treatment) The actual standards of specialist treatments (e.g. the availability of specialist thoracic surgeons and oncologists) 12 of 88

13 Casemix factors such as: I stage at presentation II social deprivation (and its possible association with late presentation to medical care) III co-morbidity IV performance status. An understanding of these factors will be gained through risk-adjustment of the data from this National Lung Cancer Audit. With comprehensive cover of the country, the audit will provide feedback to healthcare providers and purchasers using up-todate information on activity, performance and outcomes which can be used for benchmarking, planning and prioritisation of service improvements. Since the data will be risk-adjusted, it will have the clinical credibility required to change practice. Information of this quantity and timeliness has never been available for cancer services on a large scale anywhere in the world before. This audit therefore has the potential for bringing about major changes in practice which could impact on key outcomes such as survival Advantages of LUCADA The advantages of LUCADA is that it collects more detailed information about the care provided than is available from existing sources of data such as the Cancer Registries and Hospital Episode Statistics (HES). The dataset was developed to be clinically relevant, and therefore has professional ownership. It is also able to provide comparative reports to local service providers within a short timescale Clinical benefits The potential clinical benefits can be summarised thus: The ability to identify the strengths and weaknesses of local, regional and national services for patients with lung cancer and mesothelioma. Increased clinical ownership of, and pride in, their services. The ability to plan and prioritise service developments in this field, covering such issues as: Service improvement initiatives Improved outcomes for patients: Improved survival (potentially a doubling of overall long-term survival rates) Greater consistency of care both within and between regions Improved palliation of symptoms A reduction in use of inappropriate treatments Better information on service quality and outcomes, making choice more meaningful A better experience of care The establishment of performance and outcome benchmarks which can help inform future guideline development and monitor their implementation A major resource for research with the potential for linkages with many high quality research programmes Uses of data The audit uses data on activity, performance and key outcomes for all patients with lung cancer using a subset of the National Cancer Dataset (NCDS) in order to provide evidence to explain properly the differences in survival rates and treatment and from this to determine the actions that may be required to tackle these differences. The audit supports a number of national initiatives including: National Standard for Better Health C5 about participation in audit Cancer Peer Review NICE lung cancer guidelines Healthcare Commission trust assessment process (Annual Health Check) Progress Following a period of data collection from four early adopter sites beginning in January 2004, a programme of national rollout began in June As of June 2006, there are over 23,500 patient records submitted to LUCADA from almost fourfifths of eligible trusts representing all of the English Cancer Networks. Investment priorities Re-configuration of services Manpower planning Training requirements 13 of 88

14 4.3.8 Stakeholders The National Lung Cancer Audit is commissioned by the Healthcare Commission and developed and delivered through a collaborative arrangement including: The Information Centre for health and social care Royal College of Physicians NHS Connecting For Health Department of Health Cancer Registries Patient representatives User representatives. 5. Details of the Audit/Introduction 5.1 Management Arrangements The National Lung Cancer Audit is commissioned by the Healthcare Commission which has committed funding for at least a further three years, currently until 2008/09. The LUCADA Implementation Group is responsible for the running of the project. The Group involves staff from: The Information Centre for health and social care s National Clinical Audit Support Programme (NCASP), who provide overall management support and manage thirteen of the national clinical audits commissioned by the Healthcare Commission The Clinical Evaluation and Effectiveness Unit (CEEU) of the Royal College of Physicians, who provide clinical direction and information input The LUCADA Joint Information Group (JIG) which is responsible for the development of data standards, risk-adjusted analysis and information formats The LUCADA Users Group which is responsible for providing user feedback with particular reference, to the dataset its associated documentation and the practical problems associated with the collection of high quality clinical data on an ongoing basis. 5.2 Documentation for Users The documents about LUCADA that have been produced for users are: Data manual (user guide) (extensively revised in 2005 and outlined in appendix 3) Quick start guide which contains simple instructions to help users with the system Guides to constitution and format of an upload file. These three documents are available on the LUCADA pages of the NCASP section of The IC website: cs/lungcancer/default.asp?om=m1 5.3 Access to the LUCADA Database Access to the LUCADA Database is via the Open Exeter system and requires access to an NHSnet connection and Internet Explorer version 6 or above. Access to the system is via a password which must be applied for using the Open Exeter clinical audit user certification forms. Further details can be obtained via the Open Exeter website at: https://www.openexeter.nhs.uk/nhsia/index.jsp The NHS Connecting For Health systems and service delivery, who provide software development and helpdesk support The Cancer Registries who provide input on issues relating to data quality and analysis The Healthcare Commission The Department of Health Cancer Policy Team The Implementation Group relates to three other bodies: The Intercollegiate Lung Cancer Group (ICLCG) which provides strategic clinical advice and is responsible for approving LUCADA s information formats and public reports 14 of 88

15 5.4 Audit Progress During 2005 The NCASP website was redesigned The data manual was re-written Software updates were released to improve the audit, many of these following user recommendations The helpdesk maintained a good standard of performance During 2006 Completion of consultation on further development of the audit Development and implementation of Phase 2 data collection (for release in spring 2007) Detailed analysis of 2005 data Planning of improved analysis and reporting tools, and development for future. Migration into the Secondary Uses Service (SUS) jointly developed by NHS Connecting For Health and The Information Centre for health and social care. It is intended to continue quarterly software releases, which do not entail major changes to the dataset and system, through The release of version 2.0 which will introduce more significant amendments and additions will be in spring Many of the changes needed have been identified by users and the user group will continue to be the major forum for identifying the requisite software changes. Major changes under consideration for version 2.0 include: A data item relating to why first choice treatment was not given which incorporates the current comorbidity field and record patients who refused treatment or died before it could be given New data items to record information on PET scanning and bronchoscopy and CT guided needle biopsies Improved capture of data relating to mesothelioma Capability of recording more treatment options including multi-modality therapy. The Secondary Uses Service (SUS), being developed as part of the National Programme for Information Technology (NPfIT), jointly developed by NHS Connecting For Health and The Information Centre for health and social care, is intended in the future as a common analytical tool for use in areas such as commissioning and audit. SUS will have the potential to link data from a variety of sources such as the national clinical audits, cancer waiting times, registries and HES. NCASP are closely involved with this national initiative. 5.5 Methods of Capturing and Uploading Data There are marked differences between users in the sophistication of their IT systems and this has led to the development of a number of technical solutions to capture the LUCADA data: Direct data entry into the LUCADA application Upload from a local system either at hospital, trust or network level. Direct data entry software is available as a webbased application, where on entry of the NHS number, patient details are verified through the Open Exeter System. The user can then confirm that the patient details are correct before entering further information. Records can also be uploaded from local systems using csv or XML files. These files may be generated from either commercially supplied or locally developed clinical databases. Contact has been made with the leading commercial suppliers to encourage them to ensure that their systems can capture the LUCADA dataset. 5.6 Performance of the Helpdesk The LUCADA helpdesk is provided by NHS Connecting For Health (CFH) systems and service delivery through a Service Level Agreement with NCASP. It provides the IT infrastructure and associated technical and user support for the service. Monthly statistics facilitate performance monitoring of this service and the performance of the helpdesk has been good throughout the year. The helpdesk is available from 09:00 to 17:00 hours Monday to Friday excluding Public Holidays and all calls are given a priority depending on the business impact or level of inconvenience being caused. Suggestions for changes to the system can be raised through the login screen of LUCADA. These are reviewed by the User Group and Implementation Group and considered for inclusion. The helpdesk can be contacted at: 5.7 Compliance with Standards National systems of data collection, such as clinical audits, need to comply with: Data standards Confidentiality and privacy standards. 15 of 88

16 The Information Standards Board (ISB), part of the Information Centre for health and social care is responsible for approving national datasets. The LUCADA dataset received conditional approval at Operational Standard level in It is anticipated that a Dataset Change Notice (DSCN) will be issued following full approval. The Patient Information Advisory Group (PIAG) has provided support under section 60 of the Health and Social Care Act 2001, for the use of patient identifiable data for this and other NCASP audits. 6. Methods and Approaches/ Rollout of the Audit 6.1 Methodology Since the National Lung Cancer Audit was one the first of its kind, there was the need to establish a methodology which has (in parallel with the National Head and Neck Cancer Audit) become established as a generic approach for the National Clinical Audit Support Programme (NCASP) cancer audits. It includes the following items: Establishment of data items needed to answer the specific issues identified as of central clinical importance by a representative expert panel (the Intercollegiate Lung Cancer Group), derived wherever possible from a subset of the National Cancer Dataset (NCDS) Establishment of, and agreement to, the main questions that the project would address derived from the aims of the National Services Framework (NSF) for cancer Agreement of a project plan and timetable including: funding issues roles and responsibilities of partner organisations process for recruitment and support of participating centres Development of a model for the processes of local data collection, central collation and analysis (including issues of security and confidentiality to meet Caldicott Guardian requirements) Development of methodology for quality assurance of data Definition of processes to oversee data collection, transmission and collation Responsibilities for data analysis and interpretation Reporting format, timing and procedures. 6.2 Clinical Aspects In the planning and rollout of the LUCADA application, it was recognised that there was a need for local organisations to commit resources to enable regular and timely data collection. Using the relevant National Cancer Dataset (NCDS) elements together with a small number of additional data items, the LUCADA Project Team aimed to identify the following from the contributing centres: All patients diagnosed with lung cancer or mesothelioma across the NHS in England and Wales (registered by the component hospitals, trusts and Cancer Networks) The route of presentation (e.g. from a GP, following an emergency admission) The population denominator (i.e. the expected number of new cases per annum) derived via the Cancer Registries. This is needed to reflect workload, completeness of cases identified and distribution of cases Casemix factors (see below) Whether patients have been managed by a multidisciplinary team The primary treatment for the cancer Death related to treatment Survival via date of death. 6.3 Casemix Factors The Lung Cancer Audit examines key casemix factors in detail for the first time on a large scale. Previous data sources (e.g. the Cancer Registries) have historically been unsuitable for understanding the variations in treatment and outcomes in lung cancer patients. The key casemix factors collected within LUCADA are: Age Sex Deprivation index (derived from postcode) Co-morbidity - For the purpose of this audit comorbidity is defined as co-morbidity of such severity as to rule out a radical treatment that would otherwise be the preferred option 16 of 88

17 Performance status Disease stage at time of decision to treat. 6.4 Exclusions from the Audit Lung metastases from another cancer site Combination treatments (i.e. chemoradiotherapy) Second treatments (except prophylactic cranial irradiation in small cell carcinoma). 6.5 Determining Organisations Managing Lung Cancer and Mesothelioma Lead clinicians and managers from all 34 English Cancer Networks were contacted and asked to provide names of the cancer centres, trusts and hospitals involved in the care of lung cancer and mesothelioma patients. From the replies received, 151 trusts were identified as contributing to the care of this patient group. Subsequently some trusts have chosen to submit data at hospital level thus increasing the number of potential participating organisations to around 200. This figure will continue to vary as hospitals and trusts rationalise their approach to both data submission and patient care. In Wales all 12 acute trusts are involved in the care of patients with lung cancer and mesothelioma. Data are stored on a central, all-wales electronic cancer patient record which provides the information submitted to LUCADA. 6.6 Lung Cancer Audit Rollout Following an early adopters stage, rollout of the audit started in June A major activity of 2005 was the encouragement of all Cancer Networks and their eligible trusts to start the submission of data to LUCADA. The work has involved face-to face contacts, national workshops and presentations at national meetings. 6.9 Website The NCASP section of The IC website (www.icservices.nhs.uk/ncasp/pages/audit_topics/lu ngcancer) was completely redesigned in 2005 to help facilitate participation in the audit and is updated regularly. It contains background and progress information and details of how to join the audit Priority Outputs and Headline Indicators The priority outputs are the major end points for analysis and are described in detail in appendix 5. These priority outputs were developed and agreed by the Intercollegiate Lung Cancer Group (ICLCG) having been chosen as the most important clinical indicators within the dataset. These priority outputs have the potential to answer questions which will result in improved patient outcomes. Subsequently, a small set of headline indicators were derived as key performance indicators. These headline indicators are: Number of cases recorded by place first seen as a proportion of the estimated lung cancer population served Percentage of patients for whom there has been a histological and/or cytological diagnosis Percentage of patients who have been reviewed by an MDT Percentage of patients who undergo surgical resection Percentage of patients who have any active anticancer treatment. 6.7 Events run by LUCADA Team In 2005, the LUCADA team ran two workshops in the spring in Bradford and London with over 120 people attending. 6.8 Presentations given by LUCADA Team An important component of the communication strategy has been to seek out opportunities to encourage people to participate in LUCADA at both national and local level. Members of the audit team spoke at four national and three regional conferences during 2005; ten Cancer Networks were also visited. Members of the team have given at least 17 invited lectures on the subject of the audit over the last 2 years. 17 of 88

18 7. Pitfalls 7.1 Responsibility One of the major and ongoing challenges for the National Lung Cancer Audit is identifying who is responsible for individual patient care. Whilst the single most important managing unit for the patient is the multi-disciplinary team (MDT) at which the patient is first seen, the care of the patient may include several hospitals, trusts or indeed networks. Due to the complexity of the patient pathway in lung cancer it is imperative that all organisations involved in the pathway submit data to LUCADA. Without full national participation, there will be many partial records which will weaken the impact of the audit program s conclusions. Comprehensive data are needed to produce risk-adjusted outputs. All organisations must take responsibility for ensuring that all data on all patients are entered onto the database. 7.2 Completeness of Data The importance of this is clearly illustrated when the data for 2005 is analysed. Of the 12,784 patients records submitted 1,864 could not be used in the analysis because no place first seen or date first seen was recorded. This situation arises when a patient record is first created by a hospital treating a patient who was first seen in another hospital and then referred on for treatment without original appointment data. For a risk-adjusted analysis to be done complete data in all the key variables (age, postcode, sex, comorbidity, performance status and stage) is required. Of the 10,920 patients less than 37 per cent had complete data on all the required items It is possible to record not known in many of the fields. If not known is recorded this is interpreted differently from if the data item is just not completed. If data completeness is examined excluding both the not known responses and not completed items then completeness for a riskadjusted analysis falls to only 24 per cent It is going to be a huge challenge to improve this data completeness for the next annual report which will look at the data for Organisational Codes Another major issue for the audit is large number of organisation codes available to trusts. An organisation may have several hospital level codes as well as a trust level code. It is important that all organisations clearly define which codes they intend to use and are consistent in their approach to this. Without such discipline records end up fragmented across many (often similar) location codes rendering meaningful online analysis almost impossible. 8. Reports and Analyses 8.1 Data Completeness - Casemix Factors Data completeness is a major factor in the quality of data recorded. If large quantities of data are incomplete it may be impossible to draw meaningful conclusions from any subsequent data analysis. Actual completeness Actual completeness is the proportion of records in which a valid data value is entered, but excludes not known and not recorded from the completeness score. The completeness for individual data items when not known or not recorded is included is described in appendix 2e. Data on actual completeness relates to 10,920 patients entered onto the LUCADA database with a date first seen in These patients were those included in the dataset at 17 July Some hospitals had included only very small numbers of patients, in some cases this was as little as one patient and there is a worry about how representative the data on such small numbers will be. The term overall completeness means that values of unknown are included whilst actual completeness excludes values entered onto the database as unknown Actual completeness of presence or absence of co-morbidity Overall of the 10,920 patients with a date first seen recorded 4,999 (46 per cent) had recorded a valid known co-morbidity code Actual completeness of performance status Overall of the 10,920 patients with a date first seen recorded 5,811 (53 per cent) had recorded a valid known performance status Actual completeness of stage Overall of the 10,920 patients with a date first seen recorded 5,088 (47 per cent) had recorded a valid known stage Overall completeness (including not known) of risk-adjusted variables: stage, comorbidity and performance status Overall of the 10,920 patients with a date first seen recorded 4,053 (37 per cent) had a valid code (including unknown ) for all of these variables Actual Completeness (i.e. excluding not known) of risk-adjusted variables: stage, comorbidity and performance status Overall of the 10,920 patients with a date first seen recorded 2,625 (24 per cent) had a valid response recorded for all of stage, co-morbidity and performance status. 18 of 88

19 Comment The standard of data completeness for these key fields needs to improve in 2006 for the data to be of a high enough standard for risk-adjusted analysis. The target for 2006 is for actual completeness to reach 66 per cent for key Casemix fields. 8.2 Headline Indicators The National Lung Cancer Audit uses five headline indicators to reflect or measure the key standards of care for lung cancer patients at a high level. In this report data for headline indicators relates to 10,920 patients entered on the LUCADA database with a date first seen in These patients were those included in the dataset at 17 July Some trusts had included only very small numbers of patients, in some cases this was as little as one patient and there is a worry about how representative the data on such small numbers will be Number of cases recorded by place first seen as a proportion of the estimated lung cancer population served 12,784 patient records were submitted to LUCADA during 2005, this is approximately 40 per cent of the expected number of cases for this period. Of these 10,920 were suitable for detailed analysis. Because estimated number figures have not yet been agreed by all individual organisations participating in LUCADA it is not yet possible to illustrate this by place first seen. However participation by Cancer Network is shown in appendix 2a Proportion of patients who have specific anti-cancer treatment (surgery, drug treatment, teletherapy or brachytherapy) as first treatment recorded Overall of the 10,920 patients with a date first seen recorded 4,620 patients (42 per cent) had a specific anti-cancer treatment (surgery, drug treatment, teletherapy or brachytherapy) as the first treatment recorded. It is not possible to determine if this is a true reflection of the standards of care because of the high proportion of incomplete records Proportion of patients in whom there is a histological and/or a cytological diagnosis. Overall of the 10,920 patients with a date first seen recorded 7,141 patients (65 per cent) had a histological and/or a cytological diagnosis. Of sites with at least 25 patients with a date first seen recorded (10,272 patients) the median per cent of patients with a histological and/or a cytological diagnosis is 72 per cent (interquartile range: 54 per cent-82 per cent). % of patients Histological/Cytological diagnosis Place first seen Number of patients Figure: 8.2.3: Proportion of patients in whom there is a histological and/or a cytological diagnosis for sites with at least 25 patients with a date first seen recorded The rate of histological confirmation has been suggested as marker of the quality of a cancer service with an optimum rate of perhaps around per cent. There is wide variation between hospitals with a median per cent of 72 per cent and a huge range of data. Some hospitals are showing a reported confirmation rate of 0 per cent but this is likely to represent missing data. Over a quarter of hospitals recorded histological confirmation rates greater than 82 per cent but some of this may represent selective reporting of only complete or better cases Proportion of patients who have been reviewed by an MDT. Overall of the 10,920 patients with a date first seen recorded 8,472 patients (78 per cent) had been reviewed by an MDT. Of sites with at least 25 patients with a date first seen recorded (10,272 patients) the median per cent of patients reviewed by an MDT is 85 per cent (interquartile range: 70 per cent- 94 per cent) Number of patients 19 of 88

20 % of patients Reviewed by MDT Place first seen Number of patients Figure: 8.2.4: Proportion of patients who have been reviewed by an MDT for sites with at least 25 patients with a date first seen recorded The NICE target for the proportion of patients with lung cancer reviewed by an MDT is 100 per cent. Peer Review suggests a less ambitious target of 95 per cent. The median per cent of 85 per cent falls below these targets. 25 per cent of hospitals managed to record a value greater than 94 per cent and thus show that the target set by Peer Review is achievable. Data at the extreme ends of this graph should be treated with caution as an MDT review of 0 per cent is likely to reflect missing data and some of the 100 per cent reporting may be selected counting of the best cases Proportion of patients who underwent surgical resection. Overall of the 10,920 patients with a date first seen recorded 930 patients (9 per cent) had surgical resection recorded. Comment 50 0 Number of patients Fig shows the number of new patients broken down by diagnostic category Definition of non-small cell lung cancer Non-small cell lung cancer (NSCLC) is a term that covers several different cell types of lung carcinomas which together make up over 80 per cent of malignant tumours in the thorax. The vast majority of these cancers are either squamous cell carcinomas or adenocarcinomas and although there are some significant differences in the clinical patterns of the sub-types, the treatment for all non-small cell lung cancer is similar. Surgical resection is the treatment of choice provided the tumour is of limited stage and the patient is fit enough to undergo surgery. In a significant minority of patients it is not possible to confirm the cell type by histological or cytological means and by convention these patients are also grouped with patients with non-small cell lung cancer. There is thus a variety of ways to describe the proportion of patients having different types of treatment. In this report treatment has been expressed as percentages for (a) those with confirmed NSCLC and (b) for those patients who do not have small cell lung cancer (or mesothelioma) - thus this group includes the confirmed NSCLC patients and all the other cancers, including those with only a clinical diagnosis, carcinoid tumours and those where data are missing or not known. This latter group has been called All lung cancers excluding confirmed Small Cell Carcinoma. It is hoped that this will provide a more accurate picture of the care of lung cancer patients at a population-based level. Estimated number of cases for ,200 Approximately 40 per cent of the annual incidence of lung cancer in England was recorded on LUCADA in 2005, therefore clinical conclusions for the whole population must not be drawn from this report. For the cases recorded on LUCADA, data completeness is very variable, which again makes clinical interpretation of these results difficult. To produce clinically relevant and risk-adjusted reports on the 2006 data, the data completeness in terms of both the total number of cases recorded and the quality of data for those cases must improve. 8.3 Demography and Casemix Small Cell Carcinoma 1,098 (10 per cent) Confirmed Non-Small Cell Carcinoma 4,320 (40 per cent) Cases submitted to LUCADA in ,784 (41.2 per cent of estimated total) Cases included in analysis 10,920 (35 per cent of total) Other clinical diagnosis only 2,219 (20 per cent) Other (histologically confirmed) 1,336 (12 per cent) Patients excluded - no date first seen recorded 1,864 (14.5 per cent of submitted cases) Other (data incomplete) 1,488 (13.5 per cent) Mesothelioma 459 (4 per cent) The following analyses have been done on all cases of lung cancer recorded in LUCADA by trusts in England defined by a date first seen occurring between 1 January 2005 and 31 December During this period 12,784 patients were registered. All lung cancers excluding confirmed small cell carcinoma Figure 8.3.1: Demography and Casemix 20 of 88

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