NHS Digital Data Release Register - reformatted

London North West University Healthcare NHS Trust

Project 1 — DARS-NIC-131964-Q6L1J

Opt outs honoured: Y

Sensitive: Non Sensitive

When: 2018/03 — 2018/05.

Repeats: One-Off

Legal basis: Health and Social Care Act 2012, Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012)

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Admitted Patient Care
  • Office for National Statistics Mortality Data

Objectives:

The National Clinical Audit of Specialist Rehabilitation following Major Injury (NCASRI) was commissioned in 2015 by the Health Care Quality Improvement Partnership (HQIP), and funded by NHS England as part of its National Clinical Audit and Patient Outcomes Programme (NCAPOP). King's College London provide HQIP with advice on the audit and have submitted the application for data on behalf of HQIP. It is HQIP who determine the purpose and are acting as Data Controllers. It is a three-year programme which will determine the scope, provision, quality and efficiency of specialist rehabilitation services across England and improve the quality of care for adults with complex rehabilitation needs following Major Trauma. Outcomes and quality of care will be evaluated in accordance with standards and recommendations laid out in national documents from the Department of Health and NHS England (NHSE), the British Society of Rehabilitation Medicine (BSRM) and the National Institute of Clinical Excellence (NICE). An organisational audit, mapping the current rehabilitation service provision and performance against the standards were reported on after the first year of the audit (July 2015 – June 2016). The second year of the NCASRI audit focused on a prospective clinical audit of new patients presenting within NHS Major Trauma Centres (MTCs) who have complex needs and receive specialist rehabilitation (July 2016 – August 2017). The focus of the second year of the audit has involved tracking of patients identified as having complex rehabilitation needs when they leave the Major Trauma Centre to determine: a) whether they received the specialist rehabilitation they were referred for and b) what the outcomes were. The final and third year of the audit will combine aspects of year one and two and also include a feasibility study looking at the viability of tracking patients using NHS Digital data for patients that were referred to rehabilitation but were not admitted. The data that NHS Digital will provide is being requested to answer the feasibility component of the audit only. The aim of the feasibility study is to identify the pathway and outcomes for patients who require specialist rehabilitation on discharge from MTCs, but who do not subsequently attend. HES and ONS data obtained through this request will help to describe the pathways that patients may follow if they are not admitted to a rehabilitation centre. Unfortunately, due to lack of capacity within the specialist rehabilitation services, many patients who still have complex rehabilitation needs at the point of discharge from MTCs are repatriated to their local district general hospitals or trauma units to wait for a specialist rehabilitation bed to become available. Many patients may never actually get to those rehabilitation services, but the reasons why are unknown. Some patients may improve spontaneously to a level where their needs can be met by their local non-specialist rehabilitation services, but others simply 'get lost' in the system. This feasibility element of the audit wishes to explore if it is possible to track where patients are (using HES, HRG (Health Resource Group) and ONS data), and once they are tracked, identify reasons for admission, e.g. rehabilitation or other acute care. The general NHS information systems collate little or no information about rehabilitation following trauma. However, there are now well-established specialist national databases, although not linked, that systematically collect a wide range of clinical data on patients following major trauma. These are: 1. TARN's database that collects identifiable patient level data on the acute care phase (including information about rehabilitation needs gathered through a ''rehabilitation prescription") for all patients admitted to MTCs across England that meet certain requirements. 2. UKROC's database collates clinical information on needs, input and outcomes for all episodes of in- patient specialist rehabilitation in England. Data linkage between the Trauma Audit Research Network (TARN) and UKROC (UK Rehabilitation Outcomes Collaborative) datasets is underway to identify the patients common to both datasets using their NHS number. The Trauma Audit Research Network (TARN) was founded by the University of Manchester and Salford Royal NHS Trust in 1989 when research showed that there were preventable trauma deaths in the UK. TARN is based at the University of Manchester which is on the same site as Salford Royal NHS Trust. TARN is thus a university run network processing NHS patient data. TARN helps hospitals to collect and evaluate data on their trauma care (treatment of serious injuries such as head injuries, chest injuries and broken limbs) and how they rate in comparison with other Trusts. It then advises NHS Trusts on how the care could be improved. TARN provides a standard measure of the process at each stage on the patient pathway, thus measuring the performance of the system. The results depend on seniority of staff, speed of service and the number of survivors per caseload or the right patient at the right place at the right time. All Major Trauma Centres have to submit data to TARN database to incentivise compliance and good quality trauma care in England. An NHS England best practice tariff is attached to each patient for whom data is submitted. The UK specialist Rehabilitation Outcomes Collaborative (UKROC) database was established originally through an NIHR-funded Programme Grant as the national clinical data set for specialist rehabilitation and to inform tariff development under the Payment by Results Programme. It is based at Northwick Park Hospital - London North West Healthcare NHS Trust. Since 2012 it has provided the NHSE commissioning dataset for specialist rehabilitation and now has over 30,000 recorded case episodes. In addition to activity and contract monitoring, it provides quarterly national bench-marking reports on quality and outcomes. The UKROC dataset comprises: • Demographics – age, gender, diagnosis • Commissioning data – CCG, funding source etc • Processing data (dates of assessment, admission, discharge; waiting times from referral to admission, length of stay) • Discharge destination • Clinical information - collected using a series of validated tools on o individual needs for rehabilitation (complexity), o the inputs provided to meet those needs and o outcomes in terms of gains in functional independence and cost-efficiency. UKROC systematically collates episode data for all patients admitted for in-patient specialist rehabilitation across England. This includes all 65 designated Level 1 and 2 rehabilitation services, as well as a number of other rehabilitation providers offering ‘slow-stream’ rehabilitation in the context of specialist nursing homes or other community-based services. Rehabilitation units receive banded tariffs depending on the complexity of the patients they admit as well as the staffing and resource requirements to treat patients. This is known as the different ‘levels’ of rehabilitation units. Level 1 Rehabilitation Centres (Tertiary ‘specialised’ rehabilitation services) are high cost / low volume services, which provide for patients with highly complex rehabilitation needs that are beyond the scope of their local and district specialist services. These are normally provided in co-ordinated service networks planned over a regional population of 1-5 million through specialised commissioning arrangements. These services are sub-divided into: • Level 1a - for patients with high physical dependency • Level 1b - mixed dependency • Level 1c - mainly walking wounded patients with cognitive/behavioural disabilities. Level 2 Rehabilitation Centres (Local/district specialist rehabilitation services) are typically planned over a district-level population of 350-500K, and are led or supported by a consultant trained and accredited in Rehabilitation medicine (RM), working both in hospital and the community setting. The specialist multidisciplinary rehabilitation team provides advice and support for local general rehabilitation teams. Level 3 Rehabilitation (Within each locality): Local non-specialist rehabilitation teams provide general multi-professional rehabilitation and therapy support for a range of conditions within the context of acute services (including stroke units), intermediate care or community services. The NHSE Service Specification for specialist rehabilitation identifies four categories of rehabilitation need (A,B,C,D) and three levels of specialist rehabilitation services (1, 2 and 3) • The majority of post trauma patients will have category C or D needs which can be met by their local general rehabilitation services. • A small number with more complex needs (category B) require the skills and facilities of a local specialist (Level 2) rehabilitation service and • A very small number of patients with highly complex needs (Category A) may require treatment in a tertiary (Level 1) regional service. The TARN database already collects NHS numbers, however until recently the UKROC database only collected de-identified data which made it impossible to link these data-sets in order to track patients from the acute care centres into specialist rehabilitation. There was thus no way of knowing whether patients who are identified as requiring specialist rehabilitation as they leave the MTCs actually receive it, and if they do, what their outcomes are. In order to better understand the outcome of MTC patients that received rehabilitation, section 251 permission was applied for to enable data linkage between MTC data, collected in the TARN database, and UKROC data. Section 251 permission was granted on the 10th January 2017 to collect confidential patient information for: NHS number, dates of birth and gender within the UKROC database in order to link the UKROC and TARN data-sets for the NCASRI programme. A proportion of patients that are captured in the TARN database, and require specialist in-patient rehabilitation on leaving the MTC, will not subsequently attend a specialist rehabilitation unit and thus not be captured by UK ROC. The aim of the feasibility component of the audit is to explore if HES, ONS and HRG data could provide more information on this small cohort of patients that need specialist in-patient rehabilitation but never receive this. This small cohort of patients are the cohort that will be the subject of this application for data and it is anticipated that this cohort of patients will be finalised by March 2018. For the feasibility component of the audit: HES data is required to: • Identify inpatient admissions to other in-patient services other than specialist rehabilitation. • Identify where patients (that required rehabilitation) went from MTCs but did not arrive at rehabilitation. • The search would seek admission and discharge dates for any inpatient treatment in the 6 months after leaving the MTCs. • Collecting dates of admission/discharge to non-specialist services in the 6 months after leaving the MTC will identify whether patients can be traced through HES data, and whether this has the potential to furnish useful information about the alternate care pathways for future audit cycles. • HES data will be processed through a Casemix Grouper to generate both the core HRGs and the unbundled HRGs for the records to determine reason for admission for patients. ONS data is required to: • Identify which patients may have died and thus did not arrive at rehabilitation. • The month and year of death would be obtained by searching ONS mortality data using the NHS number, gender and date of birth, to identify any patients who have subsequently died. Overall, the NCASRI programme aims to determine the scope, provision, quality and cost-efficiency of specialist rehabilitation services for adults with complex needs following major injury across England.

Expected Benefits:

Overall, the NCASRI programme aims to determine the scope, provision, quality and cost-efficiency of specialist rehabilitation services for adults with complex needs following major injury across England. It will provide high quality comparative data on service provision and outcomes across different providers, mapped onto national quality standards for rehabilitation from the National Service Framework for Long Term Conditions (NSF for LTC), the British Society of Rehabilitation Medicine (BSRM), NHS England and NICE. The feasibility study will identify if it is possible to use HES, HRG and ONS data to identifying the pathway and outcomes from existing data sources for patients who require specialist rehabilitation on discharge from MTCs, but do not subsequently attend. It is anticipated that it will be challenging to derive meaningful data, such as the number and duration of episodes of in-patient treatment with (HRG) VC codes as it is well known that rehabilitation is not coded very well in HRGs. This in itself will be useful to feed back to NHSE, suggesting more rigorous coding in the future. Meaningful data could be used to highlight any inequalities that may exist between patient care and outcome. Where possible, comparative data will be presented for each MTC which may highlight inequality in pathways of rehabilitation, depending on the data retrieved from DARS. If there is sufficient data, then recommendations could be made where inequity of access to rehabilitation are identified. This activity is in the patient, carers, and public interest so that UKROC can facilitate improvements in specialist rehabilitation services.

Outputs:

The data will allow an analysis and description of outcomes of major trauma patients such as those who do not receive rehabilitation or death to presentation characteristics and process information. This will be linked with data collected in the TARN database and the UKROC database such as early implementation of the rehabilitation prescription, prompt referral and transfer times to rehabilitation, and appropriate levels of specialist input. The outcomes of the linkage will be presented in a report to HQIP in June 2018. This will be the final report submitted to HQIP at the end of the three year funded audit period. Two previous annual reports were delivered to HQIP. The first report focused on the access and organisation of specialist rehabilitation and major trauma in England and compliance with standards as set out by several national organisations. The second year report reflected on the challenges of prospective data collection and reported on some interim analysis of prospective data collected by major trauma centres. The final report will report on all data collected during the first year of data collection as well as compliance to standards and the outcome of the feasibility study. The report will be published nationally through NCAPOP in printed form and on the NCASRI website. Expected publication date is Autumn 2018. Local data will be shared with contributing providers (including Major Trauma Networks and commissioning bodies ( NHSE and CCGs). Any data provided to trusts will only be in the form of aggregated outputs with small numbers suppressed - no data provided directly from NHS Digital will be provided to trusts. Results of the feasibility study will be available on-line and will also be presented at the NHSE Disability and Rehabilitation Clinical Advisory Group. Results will also be presented at selected conferences. All outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guide.

Processing:

For the purpose of the feasibility component of the audit, TARN will send to NHS Digital a cohort of patients (cohort size 2500). The cohort of patients will be created by using a prior linkage which is covered under a separate Section 251. TARN data will be linked to UKROC data – the patients identified in the TARN data as having complex Cat A or B needs who did NOT subsequently receive specialist rehabilitation (as identified through the UK ROC data base) will now form the target population to create the cohort that will be sent to NHS Digital and is the subject of the agreement. 1. TARN will send a list of these patients to NHS Digital using a study ID (TARN ID), NHS number, DOB and gender. 2. NHS Digital will return the requested data set to the NCASRI team with the TARN ID and no other identifiers. Only Month and Year of Death is requested from the ONS Mortality data. 3. The HES and ONS data will then be analysed by the NCASRI team for descriptive analysis of patient pathways and outcomes. Analysis will: 3.1 Identify any patients who have died in the period from the ONS-Mortality dataset – these will be excluded from the denominator of patients who should have received rehabilitation. 3.2 Linked HES data will be used for the remaining patients to examine the proportion who were admitted to other in-patient services during the period. Where possible Healthcare Resource group (HRG) codes we will be used to determine: • The total number of episodes for acute care and the duration in hospital care. • The number and duration of episodes of in-patient treatment with (HRG) VC codes, indicating admission solely for rehabilitation related to trauma (VC06Z (brain injury), VC08Z (spinal injury), VC14Z (amputation), VC24Z (other musculoskeletal), VC30Z (burns), VC36Z (other trauma) in services not registered with and reporting to UKROC (eg Level 3 services). 3.3 Results and reporting will include information on the proportion of eligible patients who, after discharge from the MTC: • appear to have received further acute care and/or rehabilitation in other services • appear to have had no further in-patient treatment • patients who have died Data will only be handled by the NCASRI team members who are substantive employees of London North West Healthcare NHS Trust, Northwick Park Hospital. Data provided by NHS Digital will only be stored on secure servers based at London North West Healthcare NHS Trust. Parts of the audit, and a proportion of funding is managed and subcontracted to King’s College London but staff employed directly and only through them will not be involved in the data analysis, processing, or storage of the data provided by NHS Digital. All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data). There will be no requirement nor attempt to re-identify individuals from the data. All processing of ONS data will be in line with ONS standard conditions. The data from NHS Digital will not be used for any other purpose other than that outlined in this agreement. Linkage of data will only be for the purpose of this Agreement and not for any other purpose. There will be no attempts to re-link any of the data for any other purposes not stated in this agreement. There will be no attempt to re-identify any of the data. All processing of ONS data will be in line with ONS standard conditions. All outputs will be restricted to aggregate data with small numbers supressed in line with the HES analysis guide.


Project 2 — DARS-NIC-148269-0WSH2

Opt outs honoured: Y, No - consent provided by participants of research study

Sensitive: Sensitive

When: 2016/04 (or before) — 2019/01.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Informed Patient consent to permit the receipt, processing and release of data by NHS Digital

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration
  • MRIS - Members and Postings Report

Objectives:

Investigation of genetic and environmental factors underlying cardiovascular disease – the London Life Sciences Population (LOLIPOP) Study. The primary aims of the LOLIPOP study are to identify the genetic and environmental factors underlying the two fold increased risk of cardiovascular disease amongst UK Indian Asians compared with European whites. Data access is restricted to those named in section 7 of this agreement. Any changes will be notified to the NHS IC. The LOLIPOP study is a prospective population cohort comprising ~18,000 Indian Asian and ~12,000 European white men and women living in West London. Consenting subjects complete a questionnaire (recording current, past and family medical history, cardiovascular risk factors, current medications, alcohol and cigarette consumption) have measurements of height, weight, waist hip ratio and blood pressure, as well as a 12 lead ECG. Fasting blood samples are collected for routing haematology and biochemistry (including blood lipids). Aliqouts of plasma, serum and DNA are stored for future analyses. Baseline assessments are complete. We now plan to undertake follow-up to identify incident cardiovascular events, using death certification, hospital discharge coding and local cardiac databases. We ask the Information Centre to flag research participants, and inform LOLIPOP investigators of participants who have died along with the cause of death. Flagging should continue for 20+ years. Possible cardiovascular events, including deaths, will be verified against source data where possible. This will be done through review of hospital, primary care and coroners records.

Expected Benefits:

The LOLIPOP study is a prospective population cohort comprising ~18,000 Indian Asian and ~12,000 European white men and women living in West London. Consenting subjects complete a questionnaire (recording current, past and family medical history, cardiovascular risk factors, current medications, alcohol and cigarette consumption) have measurements of height, weight, waist hip ratio and blood pressure, as well as a 12 lead ECG. Fasting blood samples are collected for routing haematology and biochemistry (including blood lipids). Aliqouts of plasma, serum and DNA are stored for future analyses. Baseline assessments are complete. We now plan to undertake follow-up to identify incident cardiovascular events, using death certification, hospital discharge coding and local cardiac databases. We ask the Information Centre to flag research participants, and inform LOLIPOP investigators of participants who have died along with the cause of death. Flagging should continue for 20+ years. Possible cardiovascular events, including deaths, will be verified against source data where possible. This will be done through review of hospital, primary care and coroners records.

Outputs:

The LOLIPOP study is a prospective population cohort comprising ~18,000 Indian Asian and ~12,000 European white men and women living in West London. Consenting subjects complete a questionnaire (recording current, past and family medical history, cardiovascular risk factors, current medications, alcohol and cigarette consumption) have measurements of height, weight, waist hip ratio and blood pressure, as well as a 12 lead ECG. Fasting blood samples are collected for routing haematology and biochemistry (including blood lipids). Aliqouts of plasma, serum and DNA are stored for future analyses. Baseline assessments are complete. We now plan to undertake follow-up to identify incident cardiovascular events, using death certification, hospital discharge coding and local cardiac databases. We ask the Information Centre to flag research participants, and inform LOLIPOP investigators of participants who have died along with the cause of death. Flagging should continue for 20+ years. Possible cardiovascular events, including deaths, will be verified against source data where possible. This will be done through review of hospital, primary care and coroners records.

Processing:

No contact will be made with any individual(s) that could be identified from the information supplied, except as specified in the protocol and associated letters agreed between the Ealing Hospital NHS Trust, Uxbridge Road, Middx UB1 3HW and the NHS IC. Use of these Datasets are for the sole purpose set out above. The Data must not be shared with any other organisation or named individual not explicitly referred to within this agreement. If the information referred to herein is subject to an FOI or other request to share the Data, then agreement from the NHS IC must be sought before undertaking this. The Dataset must not be shared with any third party in the format in which it is provided to you by the NHS IC. Information tools derived from this Dataset will not be provided to any organisations without the specific consent of the NHS IC. Any publications derived from this Data by any party must be subject to ONS confidentiality guidance on the release of Health Statistics: http://www.ons.gov.uk/about/consultations/closed-consultations/disclosure-review-for-health-statistics---consultation-on-guidance/


Project 3 — DARS-NIC-148406-2YXPR

Opt outs honoured: Yes - patient objections upheld (Section 251)

Sensitive: Sensitive

When: 2018/06 — 2018/12.

Repeats: One-Off

Legal basis: Health and Social Care Act 2012 – s261(7), National Health Service Act 2006 - s251 - 'Control of patient information'.

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report

Yielded Benefits:

The assessment of familial risk of colorectal cancer has evolved over the last 30 years since the Family Cancer Clinic was first established by the Imperial Cancer Research Fund at St Mark’s Hospital in 1986. In 1986 individuals with an empiric lifetime risk of developing colorectal cancer that was assessed as 1 in 10 or greater were offered five yearly colonoscopy from the age of 25. As a result of analysing the prospective results of colonoscopic surveillance in different empiric risk groups and the introduction of molecular genetic testing we have redefined risk groups and adapted surveillance protocols with some individuals requiring more frequent colonoscopy and others less frequent colonoscopy. This has led to a much more appropriate use of valuable NHS resources. As examples of the developments that have been made: 1. Individuals with inherited genetic conditions such as Lynch syndrome may now be diagnosed by molecular genetic testing. The outcome of surveillance has been analysed in Lynch syndrome gene-carriers and it has been shown that interval cancers occur with five yearly surveillance and that more frequent colonoscopy with two yearly surveillance is required . 2. In contrast, individuals who used to be assessed as having a 1 in 10 empiric risk or greater but whose families have now been shown not have Lynch syndrome on molecular genetic testing (Familial colorectal cancer type x) have now been shown to be at lower risk and surveillance is now started with five yearly colonoscopy at 35 instead of 25 years of age. 3. In the past individuals with a single first-degree relative who had been diagnosed with colorectal cancer at an age of 45 years or less were thought to be a high risk. However, prospective surveillance has shown that if they do not have Lynch syndrome they are at low moderate risk and only require a one-off colonoscopy at age 55 rather than five yearly colonoscopy from the age of 25 which they would have been offered in the past.

Objectives:

The London North West University Healthcare NHS Trust (LNWUHNT) requires notifications of cancer registrations and mortality data for use in a service evaluation of its surveillance of patients with a family history of colorectal and other cancers. The service evaluation focuses on a cohort of patients who have a family history of colorectal cancer and have been referred to the Family Cancer Clinic at St Mark’s Hospital (part of LNWUHNT) for assessment of their risk of developing colorectal cancer and for colonoscopic surveillance if this is felt to be appropriate. The service evaluation is undertaken to assess whether the colonoscopic surveillance is effective in preventing colorectal cancer and is undertaken by the Family Cancer Clinic team within St Mark’s Hospital with statistical support from a statistician at Queen Mary University of London (QMUL). The Family Cancer Clinic Bobby Moore Database is a dedicated clinical and research database that has been funded by a Cancer Research UK Infrastructure Grant and is hosted on the servers of LNWUHNT. The previous database was hosted by Imperial College London (ICL). ICL still has an embargoed data set to which no new data is being added. This will be destroyed once it has been confirmed that all of the data has been successfully transferred to the new database at LNWUHNT. The new database is currently undergoing some modifications. The database was funded by Cancer Research UK but that organisation has no other involvement. The Family Cancer Clinic at St Mark’s Hospital is referred patients with a family history of colorectal and other cancers to assess their risk of developing colorectal cancer. The team in the Family Cancer Clinic reviews the family history of each patient, constructs a pedigree and confirms cancers that have occurred in the family by obtaining death certificates and cancer registrations. They arrange genetic testing, if appropriate. The patient’s risk is then assessed and colonoscopic surveillance arranged if it is assessed as being appropriate. The great majority of the surveillance that the team recommends is colonoscopic but they may also recommend ultrasound, gastroscopy and breast screening in some cases. The vast majority of surveillance is undertaken at St Mark's Hospital but some patients, if they live far away, elect to have their surveillance performed locally and to have the results are sent to the team at St Mark’s Hospital. There are 2,958 individuals who have had at least one colonoscopy of whom 2,254 have had two or more. The Family Cancer Clinic at LNWUHNT maintains the Bobby Moore Database with information on the outcome of surveillance and any cancer diagnoses. They require data from NHS Digital about its patients who are undergoing colonoscopic surveillance for familial risk of colorectal cancer to ensure that there is complete ascertainment of cases of cancer. The data from NHS Digital is used to verify the information already held on the Bobby Moore Database. The aim of the service evaluation is to see if surveillance is successful in preventing cases of colorectal and other cancers. It also allows an assessment of whether there are other causes of death that occur more frequently than expected in the cohort. When the cohort was originally flagged in 2003, the team discovered no additional cases of colorectal cancer that it was not already aware of from the clinical care of their patients. However, when the team has previously submitted papers for publication on the outcome of surveillance for familial risk of cancer the journal’s reviewers have asked for the cohort to be flagged for cancer and mortality notifications to ensure that the team is not over estimating the benefits of surveillance. In addition to service evaluation, associated research is being undertaken with the following aims: • To ensure best practice in offering appropriate surveillance to individuals at increased risk of colorectal cancer due to a strong family history of colorectal cancer. • To quantify the risk of colorectal cancer associated with different family histories and individual characteristics including molecular genetic testing of patients' tumours and germline DNA. • To understand the natural history of colorectal neoplasia and effectiveness of colonoscopy in different groups. Surveillance of individuals with a family history of colorectal cancer is a huge clinical burden for the NHS and prospective evidence is required to develop evidence-based surveillance guidelines. The flagged data is to ensure that the Family Cancer Clinic at LNWUHNT has a complete data set of cancer registrations and deaths.

Expected Benefits:

The assessment of familial risk of colorectal cancer has evolved over the last 30 years since the Family Cancer Clinic was first established by the Imperial Cancer Research Fund at St Mark’s Hospital. It is now possible to diagnose inherited genetic conditions such as Lynch syndrome by molecular genetic testing and to organise colonoscopic surveillance in family members who are gene-carriers. The team has analysed the outcome of surveillance in this group and shown that that interval cancers occur and more frequent colonoscopy every one or two years is required. The team has shown that there is group of patients with a strong family history of colorectal cancer (Familial Colorectal Cancer type x / Non Lynch Familial Colorectal Cancer) in whom interval cancers do not occur and less frequent colonoscopy from a later age of onset is required. Dissemination of the findings through publications and directly impacting NICE and European guidelines is beneficial to health care and health care users. Primarily, identifying groups at higher risk of cancers enables effective and appropriate surveillance leading to prevention and earlier detection of cancers. Identifying groups at lower risk of cancers means that people who are not at high risk are not over-investigated leading to less inconvenience and less concern for such individuals. The team will analyse the outcome of colonoscopic surveillance in the current cohort of patients. The team will publish the outcomes in various genetic and familial risk groups. This data will be used to help develop updated National and European guidelines for the management of familial risk of colorectal cancer. This will allow surveillance to be targeted at those individuals in whom it is most appropriate with significant potential savings in cost to the NHS.

Outputs:

The team at St Mark’s has previously published papers on the outcome of colonoscopic surveillance for familial risk of colorectal cancer: Dove-Edwin I, Adams J, Sasieni P, Thomas HJW. The prevention of colorectal cancer by colonoscopic surveillance in individuals with a family history of colorectal cancer: a sixteen year prospective follow-up study. Br Med J 2005; 331: 1047-9 Dove-Edwin I, de Jong A, Lipton L, Adams J, Mesher D, Lipton L, Sasieni P, Vasen HFA, Thomas HJW. Prospective results of surveillance colonoscopy in autosomal dominant colorectal cancer families with and without Lynch syndrome. Gastroenterology 2006; 130: 1995-2000 Mesher D, Dove-Edwin I, Sasieni P, Vasen H, Bernstein I, Royer-Pokora B, Morak M, German HNPCC Consortium, Lalloo F, Evans DG, Forsberg A, Lindblom A, Thomas H. A pooled analysis of the outcome of prospective colonoscopic surveillance for familial colorectal cancer. In J Cancer 2014; 134: 939-47 These papers have contributed to the development of National and European evidence-based guidelines on the management of familial risk of colorectal cancer: Cairns SR, Scholefield JH, Steele RJ, Dunlop MG, Thomas HJW, Evans DG, Eaden JA, Atkin WP, Saunders BP, Lucassen A, Jenkins P, Fairclough PD, Woodhouse CR; British Society of Gastroenterology: Association of Coloproctology for Great Britain and Ireland. Guidelines for colorectal cancer screening and surveillance in moderate and high risk groups (update from 2002) Gut 2010; 59: 666-689 Vasen HFA, Blanco I, Atkan-Collan K, Gopie JP, Alonso A, Aretz S, Bernstein I, Bertario L, Burn J, Capella G, Colas C, Engel C, Frayling IM, Genuardi M, Heinimann K, Hes FJ, Hodgson SV, Karagiannis JA, Lalloo F, Lindblom A, Mecklin J-P, Moller P, Myrhoj T, Nagengast FM, Parc Y, Ponz de Leon M, Renkonen-Sinisalo L, Sampson JR, Sotormorken A, Sijmons RH, Tejpar S, Thomas HJW, Rahner N, Wijnen JT, Jarvinen HJ, Moslein G. Revised guidelines for the clinical management of Lynch syndrome (HNPCC): recommendations by a group of European experts. Gut 2013; 62: 812-23 The entire dataset has not been analysed since 2006 and it is anticipated that there are now over 30,000 patient-years of follow-up that is available for analysis. The team aims to analyse this data and to submit a new paper to a prestigious peer reviewed journal in 2018. The individual leading this work is a member of a committee of the British Society of Gastroenterology which is currently revising and updating their 2010 guidelines for NICE. He is also involved in developing gene-specific surveillance guidelines with the European Hereditary Tumour Group.

Processing:

In 2003, St Mark’s Hospital provided identifiers to the Medical Research team in the Office for National Statistics (ONS) which provided a ‘flagging’ / patient tracking service. The service has since transferred to NHS Digital which continued to provide the patient tracking service. NHS Digital provides quarterly notifications of cancer registrations and deaths including cause of death to the Family Cancer Clinic team at St Mark’s Hospital. The team uses the data to ensure that its own data set on the Bobby Moore Database is accurate and complete. Where there are differences between the data provided by NHS Digital and the data in the Bobby Moore Database, the Database is updated to include the latest data from NHS Digital. Where the data from NHS Digital matches the Database, no further action is taken. The data set received from NHS Digital is then destroyed. The Bobby Moore Database is housed on the LNWUHNT servers. The Bobby Moore Database is only accessed by individuals within the Family Cancer Clinic team all of whom are substantive employees of the LNWUHNT or hold an honorary contract with the LNWUHNT. One such individual is employed by Imperial College London at St Mark’s Hospital and is an Honorary Consultant Physician at LNWUHNT and also an NHS Consultant Physician at Imperial College Healthcare NHS Trust. Pseudonymised data is extracted from the Bobby Moore Database and securely transferred to Queen Mary University of London (QMUL). That data is stored on QMUL servers with access restricted to one statistician who analyses the data specifically and solely to analyse the outcome of colonoscopic surveillance in different familial risk groups and in different genetic conditions. This data is mostly data collected from other sources but may include pseudonymised cancer or death data provided by NHS Digital where there were discrepancies between NHS Digital data and the Bobby Moore Database. The data supplied to QMUL contains no field indicating whether cancer or death information was provided by the clinical team at St Mark’s or by NHS Digital. The copy of the dataset at Imperial College London (ICL) is stored on ICL servers and will only be accessed if required to verify successful transfer of the database to LNWUHNT. Once it has been confirmed that the data was successfully transferred, the copy at ICL will be securely destroyed. It is expected that destruction will take place before the end of May 2018. ONS terms and conditions relating to the data being shared under this agreement will be adhered to.