SMOKING STUDY - MEN ATTENDING BUPA MEDICAL CENTRE

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Objective for processing

This BUPA cohort study was set up to look at risk factors for cancer and cause specific mortality, with an emphasis on the risks of smoking. St George’s Hospital Medical School requires access to NHS England data for the purpose of the following research project: The Smoking Study – Men Attending BUPA Medical Centre. The purpose of this request is: The following is a summary of the aims of the research project provided on behalf of St George’s Hospital Medical School: (a) to receive an extension to continue to hold data from the death certificates and cancer notifications of men who are part of the BUPA research cohort. This cohort consisted of 22,000 men aged 35-64 years who attended the British United Provident Association (BUPA) medical centre in London for a comprehensive medical examination between 1975 and 1982. The data on mortality and cancers has been used to conduct both cohort and case control studies resulting in over 32 papers being published in peer review journals. The areas of research covered have included the health effects of active and passive smoking, screening, cancer and nutrition, cancer and infection, serum cholesterol in relation to Ischaemic Heart Disease (IHD) and cancer, apolipoproteins, blood pressure and stroke, cardiovascular screening and osteoporosis. Currently there is no funding to process the data, but it is planned to apply for future grants to enable research into risk factors for mortality, mainly from ischemic heart disease or cancer from this valuable cohort to continue. ''This BUPA cohort study was set up to look at risk factors for cancer and cause specific mortality, with an emphasis on the risks of smoking. b) The data controller has changed from Queen Mary University of London to St George’s, University of London (SGUL), because the Principal Investigatory Professor of the study retired and the new Principal Investigatory Professor (and only member of SGUL staff with access to the data) is employed by SGUL. “St George’s Hospital Medical School wishes to continue to hold data from the death certificates and cancer notifications of men who are part of the BUPA research cohort. This cohort consisted of 22,000 men aged 35-64 years who attended the British United Provident Association (BUPA) medical centre in London for a comprehensive medical examination between 1975 and 1982. The data on mortality and cancers has been used to conduct both cohort and case control studies resulting in over 32 papers being published in peer review journals. The areas of research covered have included the health effects of active and passive smoking, screening, cancer and nutrition, cancer and infection, serum cholesterol in relation to Ischaemic Heart Disease (IHD) and cancer, apolipoproteins, blood pressure and stroke, cardiovascular screening, and osteoporosis. Currently there is no funding to process the data, but the intention is to apply for future grants to enable research into risk factors for mortality, mainly from ischemic heart disease or cancer from this valuable cohort to continue. The ''The original purposes of the study were: [3 paragraphs unchanged] 4. To store serum and urine samples from men recruited into the [21 words unchanged] measured in these samples on a case-control basis after being notified of deaths. deaths.'' The following NHS England data are stored: • Civil Registration Mortality • Cancer Registration • Demographics The level of the data is: • Pseudonymised The data is minimised as follows: • Limited to a study cohort of approximately 22,000 patients who consented to participate. • Limited to data between May 1976 and February 2019. [1 paragraph unchanged] The General Data Protection Regulation Article 6 (1) (e) and Article 9 (2) (j) are the legal basis for the processing and storage of the data (though no data processing will be conducted under this extension). The Health and Social Care Act 2012 s261 (1) and s261 (2)(b)(ii) is the legal basis for dissemination of the pseudonymised data (no data to be released under this current agreement). St George’s Hospital Medical School is the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above. The lawful basis for processing personal data under the UK GDPR is: Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. The lawful basis for processing special category data under the UK GDPR is: Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

Processing activities

NHS Digital supplied historically the date and cause of death to QMUL. This mortality data was linked to other clinical information on these men using the study ID numbers. QMUL used this information to create case-control data sets where cases include all men who have died from a specific cause and the controls are those men who have not died from that cause. Risk factors for the disease are then examined amongst these case control data sets. Dates of death and birth were not used – only age at death and age at time of collecting the clinical information. SGUL is the new data controller and all existing data will be transferred to SGUL. NHS Digital and predecessor service providers previously received the cohort identifiers and provided the relevant records from the Mortality, Cancer Registration and Demographics data to Queen Mary University London (QMUL). This agreement will not flow any data back to SGUL. QMUL linked that data with other clinical information on the cohort using the study ID numbers. QMUL used this information to create case-control data sets where cases include all men who had died from a specific cause and the controls were those men who had not died from that cause. Risk factors for the disease were then examined amongst these case control data sets. Dates of death and birth were not used – only age at death and age at time of collecting the clinical information. The data will not be linked to any other information about the participants. SGUL have already collected all information required about the cohort and will not be linking to any additional data sets. QMUL transferred the complete dataset to St George’s Hospital Medical School and St George’s Hospital Medical School replaced QMUL as the controller for the data. The data on mortality that has been received has been coded and stored in the BUPA cohort database in the SGUL DASH server. DASH is an isolated, self-contained remote desktop environment which conforms to IG Toolkit / ISO27001 auditing and security requirements. The data is currently on a unix server in a secure area of SGUL. The server has been physically moved but not yet connected to a computer. Physical connection to a computer will only occur upon approval of this DSA. The data will not be transferred to any other location. The data can be accessed only via two factor authentication by the Principal Investigatory Professor who is a substantive employee of SGUL. No identifying information is released. The data will not be linked to any other information about the participants. Data will only be accessed and processed by one substantive employee of SGUL. QMUL no longer stores nor has access to the data. 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. No new data will be provided to St George’s Hospital Medical School under this Data Sharing Agreement (DSA). The data will be stored on servers at St George’s Hospital Medical School. The data will not be linked to any other information about the participants. St George’s Hospital Medical School have already collected all information required about the cohort and will not be linking to any additional data sets. Under this DSA, the data will be stored and not otherwise processed. The data will not leave England at any time. The data can be accessed only via two factor authentication by the Principal Investigatory Professor who is a substantive employee of St George’s Hospital Medical School.

Expected output

[3 paragraphs unchanged] This was achieved with the following papers being published : published: [7 paragraphs unchanged] This has been achieved – the BUPA cohort information and blood samples [9 words unchanged] 1976). Research on a case-control basis continues to be performed on these data , data, evidenced by the following 9 10 publications: - a.Insulin-like growth factors and cancer: no role in screening. Evidence from the BUPA study and meta-analysis of prospective epidemiological studies; July 2006. a. Multi-marker risk-based screening for prostate cancer; Jan 2022. b.Chlamydia pneumoniae infection and mortality from ischaemic heart disease: large prospective study; July 2000. b. Insulin-like growth factors and cancer: no role in screening. Evidence from the BUPA study and meta-analysis of prospective epidemiological studies; July 2006. c.Adding free to total prostate-specific antigen levels in trials of prostate cancer screening; Feb 2000. c. Chlamydia pneumoniae infection and mortality from ischaemic heart disease: large prospective study; July 2000. d. Homocysteine and ischemic heart disease: results of a prospective study with implications regarding prevention; April 1998. d. Adding free to total prostate-specific antigen levels in trials of prostate cancer screening; Feb 2000. e. Helicobacter pylori infection and mortality from ischaemic heart disease: negative result from a large, prospective study; Nov 1997. e. Homocysteine and ischemic heart disease: results of a prospective study with implications regarding prevention; April 1998. f. Prospective observational study to assess value of prostate specific antigen as screening test for prostate cancer; Nov 1995. f. Helicobacter pylori infection and mortality from ischaemic heart disease: negative result from a large, prospective study; Nov 1997. g. Serum albumin and mortality in the BUPA study. British United Provident Association; Feb 1994. g. Prospective observational study to assess value of prostate specific antigen as screening test for prostate cancer; Nov 1995. h. Apolipoproteins and ischaemic heart disease: implications for screening; Jan 1994. h. Serum albumin and mortality in the BUPA study. British United Provident Association; Feb 1994. I. Association between infection with Helicobacter pylori and risk of gastric cancer: evidence from a prospective investigation; June 1991. i. Apolipoproteins and ischaemic heart disease: implications for screening; Jan 1994. No data processing is currently occurring, but if additional funds are obtained data analysis conducted by researchers at SGUL will recommence. The value of the BUPA cohort is that any new hypothesis can be investigated extremely quickly as the data provides 40 years follow-up. j. Association between infection with Helicobacter pylori and risk of gastric cancer: evidence from a prospective investigation; June 1991. The data was used in the recent study "Wald NJ, Bestwick JP, Morris JK. Multi-marker risk-based screening for prostate cancer. Journal of Medical Screening. 2022;29(2):123-133" which was a nested case-control study and showed that screening performed up to every 5 years from age 55 using a new multi-marker risk-based screening algorithm for future prostate cancer achieves a high DR and a much lower FPR than using PSA alone, resulting in reductions in overdiagnosis and overtreatment. No data processing is currently occurring, but if additional funds are obtained data analysis conducted by researchers at SGUL will recommence. The value of the BUPA cohort is that any new hypothesis can be investigated extremely quickly as the data provides 40 years follow-up, as demonstrated by the recent publication. [1 paragraph unchanged]

Expected measurable benefits

No data processing is currently occurring, but if additional funds are obtained data analysis conducted by researchers at SGUL will recommence. No new benefits are expected. This DSA permits the secure retention of data for the purpose of recreating trial analysis and auditing.

Benefits reported

[2 paragraphs unchanged] The BUPA study has also provided information on screening for cancers, with [23 words unchanged] from the BUPA study and meta-analysis of prospective epidemiological studies.) and that PSA Prostate-specific antigen (PSA) is useful in screening for prostate cancer (Prospective observational study to assess [17 words unchanged] (Adding free to total prostate-specific antigen levels in trials of prostate cancer screening).Prostate screening). The recent study (Multi-marker risk-based screening for prostate cancer; 2022) has derived an algorithm which will improve screening compared to using PSA alone. Prostate cancer is the second most commonest cause of death from cancer in men and therefore any improvements in screening will impact on the lives of large numbers of men . men. Aortic stenosis is a serious heart condition with no known means of [10 words unchanged] unless the valve is surgically replaced. Aortic stenosis is caused by the build up build-up of calcium (a mineral found in the blood) on the aortic valve [95 words unchanged] management of patients with aortic stenosis, potentially removing the necessity of surgery. In summary data from the BUPA cohort have been and continue to be of considerable importance in the field of epidemiology and preventive medicine; particularly [13 words unchanged] will enable future similar studies to be performed in funding becomes available.