NHS Digital Data Release Register - reformatted

Wolfson Institute of Preventive Medicine

Project 1 — DARS-NIC-147743-W4JNH

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/04 (or before) — 2016/11.

Repeats: Ongoing

Legal basis: Section 251 approval is in place for the flow of identifiable data

Categories: Identifiable

Datasets:

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

Objectives:

The data supplied by the HSCIC to Wolfson Institute of Preventive Medicine will be used only for the approved medical research project - MR170 Women with Benign Breast Disease


Project 2 — DARS-NIC-148066-2B6LS

Opt outs honoured: N

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2016/08.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

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

Objectives:

To determine the value of preventive angioplasty (a procedure in which fine balloons are positioned and expanded within coronary arteries) to dilate all identified significantly narrowed coronary arteries among patients having therapeutic angioplasty to treat a myocardial infarction; ie angioplasty limited to unblocking the artery causing the myocardial infarction. The primary aim is to determine whether preventive angioplasty undertaken at the time of treating the artery responsible for the myocardial infarction reduces the incidence of the combined endpoint of coronary death, non−fatal myocardial infarction and refractory angina. The secondary aims are: 1. To determine and quantify the safety of preventive angioplasty among patients undergoing therapeutic angioplasty for an acute myocardial infarction. 2. To undertake an economic evaluation comparing the cost to the NHS of preventive PCI. 3. To undertake a quality of life assessment in patients randomised to each treatment strategy.


Project 3 — DARS-NIC-148229-QC5WK

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/09 — 2018/09.

Repeats: Ongoing

Legal basis: Section 251 approval is in place for the flow of identifiable data, Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007

Categories: Identifiable

Datasets:

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

Objectives:

The data supplied by the NHS IC to Wolfson Institute of Preventative Medicine will be used only for the approved Medical Research Project MR710.


Project 4 — DARS-NIC-148331-5F2FS

Opt outs honoured: Y, No - data flow is not identifiable (Does not include the flow of confidential data)

Sensitive: Sensitive

When: 2016/04 (or before) — 2019/03.

Repeats: Ongoing, One-Off

Legal basis: Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Other - GDPR does not apply solely to the deceased

Categories: Identifiable, Anonymised - ICO code compliant

Datasets:

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

Yielded Benefits:

The BUPA study has been a very valuable research resource providing evidence to support a range of public health interventions. Early work providing evidence on the link between passive smoking and both lung cancer and heart disease was extremely influential in the government deciding to ban passive smoking from public places (The dose-response relationship between cigarette consumption, biochemical markers and risk of lung cancer,). Additional work on the effect of tar yield of cigarettes also influenced the move to low tar cigarettes. (Mortality in relation to tar yield of cigarettes: a prospective study of four cohorts, Relative intakes of tar, nicotine, and carbon monoxide from cigarettes of different yields.) The BUPA study was also one of the first studies to establish the link between serum cholesterol and subsequent heart disease (Systematic underestimation of association between serum cholesterol concentration and ischaemic heart disease in observational studies: data from the BUPA study) and the link between serum homocysteine and subsequent heart disease (Homocysteine and ischemic heart disease: results of a prospective study with implications regarding prevention.) and between apolipoproteins and heart disease (Apolipoproteins and ischaemic heart disease: implications for screening.). All these findings have implications for screening for heart disease and will improve the prevention of the 73,000 deaths from heart disease that occur in the UK each year. The BUPA study has also provided information on screening for cancers, with the finding that Insulin-like growth factors are not useful in screening for cancer (Insulin-like growth factors and cancer: no role in screening. Evidence from the BUPA study and meta-analysis of prospective epidemiological studies.) and that PSA is useful in screening for prostate cancer (Prospective observational study to assess value of prostate specific antigen as screening test for prostate cancer.), but that free PSA is not (Adding free to total prostate-specific antigen levels in trials of prostate cancer screening).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. In summary data from the BUPA cohort have been of considerable importance in the field of epidemiology and preventive medicine; particularly in the field of cancer prevention and cardiovascular disease prevention. There have been over 50 publications, the last one as recently as April 2017 (Wald DS et al. Mortality from aortic stenosis: prospective study of serum calcium phosphate. J Int Med 2017;281:407-411).

Objectives:

1) To carry out a prospective epidemiological study of the association between carboxyhaemoglobin COHG levels and motality from lung cancer and ischaemic heart disease (IHD). 2) To inestigate the interrelationships of COHG levels with risk factor of IHD and estimate their value in predicting IHD.

Expected Benefits:

The Wolfson Institute's work on establishing the link between passive smoking and lung cancer and heart disease using the BUPA database was extremely influential in the government deciding to ban passive smoking from public places. This clearly affects the health of the whole population. The BUPA study established the link between Prostate-Specific Antigen (PSA) and the risk of developing prostate cancer in men (Prospective observational study to assess value of prostate specific antigen as screening test for prostate cancer; Nov 1995.). The Wolfson Institute is currently collaborating with Professor Hans Lilja (Oxford University) and Dr Brian Shine trying to improve methods of screening for prostate cancer to avoid over-treating men with prostate cancer. This collaboration consists of Oxford providing the technical expertise on stored serum analysis, the Wolfson Institute analysing the results and discussing the interpretation of these with Oxford. Individual patient data is not released to Oxford. Prostate cancer is the most common male cancer and over 41,000 men in the UK are diagnosed with it each year. If a new screening test is developed this would improve the outlook not only for the 41,000 men diagnosed with prostate cancer every year in the UK , but also it would avoid large numbers of men becoming extremely anxious due to being told they are at a high risk of prostate cancer by less accurate screening tests. Aortic stenosis is a serious heart condition with no known means of prevention. Death follows symptoms of heart failure in most cases unless the valve is surgically replaced. Aortic stenosis is caused by the build up of calcium (a mineral found in the blood) on the aortic valve (flaps of tissue which regulates blood flow) leading to obstruction of blood flow from the heart. Recent work on analysing data from the BUPA study on men with aortic stenosis suggests that lowering plasma phosphate or calcium could prevent calcium phosphate deposition on heart valves. (Mortality from aortic stenosis: prospective study of serum calcium and phosphate,2017). This work provided sufficient evidence for the MRC to fund a randomised trial as a pilot trial to determine whether the progression of aortic stenosis can be prevented using sevelamer. If this is successful it will radically change the management of patients with aortic stenosis, potentially removing the necessity of surgery.

Outputs:

The main aims of the study were: 1. To continue a prospective epidemiological study of the association between COHb levels and mortality from coronary heart disease and lung cancer. This was achieved with over 22,000 men being recruited into the BUPA cohort from 1975 to 1982. 2. To investigate the interrelationships of COHb levels with risk factors of CHD, and estimate their value in predicting CHD. This was achieved with the following papers being published : a.Carbon monoxide in breath in relation to smoking and carboxyhaemoglobin levels; May 1981. b. Serum cotinine levels in pipe smokers: evidence against nicotine as cause of coronary heart disease; Oct 1981. 3. To clarify some of the conflicting observations concerning the relationship between risk of lung cancer and coronary heart disease in relation to self-described inhaling habits. The following papers have been published: a. Prospective study of effect of switching from cigarettes to pipes or cigars on mortality from three smoking related diseases; June 1997. b. The dose-response relationship between cigarette consumption, biochemical markers and risk of lung cancer; 1997. 4. To store serum and urine samples from men recruited into the study so that substances which may be markers of or aetiologically linked to lung cancer or coronary heart disease can be measured in these samples on a case-control basis after being notified of deaths. This has been achieved – the BUPA cohort information and blood samples have been securely stored for over 40 years (since 1976). Research on a case-control basis continues to be performed on these data , evidenced by the following 9 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. b.Chlamydia pneumoniae infection and mortality from ischaemic heart disease: large prospective study; July 2000. c.Adding free to total prostate-specific antigen levels in trials of prostate cancer screening; Feb 2000. d. Homocysteine and ischemic heart disease: results of a prospective study with implications regarding prevention; April 1998. e. Helicobacter pylori infection and mortality from ischaemic heart disease: negative result from a large, prospective study; Nov 1997. f. Prospective observational study to assess value of prostate specific antigen as screening test for prostate cancer; Nov 1995. g. Serum albumin and mortality in the BUPA study. British United Provident Association; Feb 1994. h. Apolipoproteins and ischaemic heart disease: implications for screening; Jan 1994. I. Association between infection with Helicobacter pylori and risk of gastric cancer: evidence from a prospective investigation; June 1991. QMUL are currently analysing data concerning the prediction of the occurrence of clinically detected prostate cancer during the following 30 years. It is expected that the results from this study will be finalised in 2019. The value of the BUPA cohort is that any new hypothesis can be investigated extremely quickly as the data and serum samples are all stored at the Wolfson Institute of Preventive Medicine which is part of Queen Mary University London. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide

Processing:

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. This agreement will only flow pseudonymised data back to QMUL. The Study no longer hold any identifiers for the cohort. NHS Digital will share back to QMUL the following, BUPA unique member ID and month and year of DOB along with exits/re-entries, Cancer registration details (not registration number as this is identifiable) and fact/date/cause of death. The data will not be linked to any other information about the participants. QMUL have already collected all information required about the cohort and will not be linking to any additional datasets. The data on mortality received will be coded and stored in the BUPA cohort database on a secure fire-walled server at the Wolfson Institute of Preventive Medicine. The data can be accessed only via passwords by three members of staff who are all substantive employees of the QMUL. 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 substantive employees of Queen Mary University London and one member of the team who is working under an honorary contract at QMUL. 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.


Project 5 — DARS-NIC-148484-PSL6Q

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/04 (or before) — 2017/05.

Repeats: Ongoing

Legal basis: Section 251 approval is in place for the flow of identifiable data, 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: Identifiable

Datasets:

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

Objectives:

The aim of this study is to determine the effect on mortality from breast cancer of mammographic screening in women starting ages 40-41, compared with starting at age 50 as in the current national breast cancers diagnosed in the trial population to predict outcomes. Data Access is restricted to those names in section 7 of this agreement. Any changes will be notified to the HSCIC