NHS Digital Data Release Register - reformatted

Institute of Cancer Research

🚩 Institute of Cancer Research received multiple copies of from the same dataset, in the same month, both with optouts respected and with optouts ignored. Institute of Cancer Research may not have compared the two datasets, but the identifiers are consistent between datasets and NHS Digital does not know what their recipients actually do.

Project 1 — DARS-NIC-226323-X4L5B

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/04 (or before) — 2016/08.

Repeats: Ongoing

Legal basis: 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

Objectives:

As part of the ARTISTIC trial, between 2001-09, 24510 women underwent HPV testing with genotyping. This project concerns long-term follow-up of this unique cohort through notification of cancer and death. The aim is to evaluate the long-term value of HPV testing as a primary screening strategy. Cervical screening intervals of 6-10 years following a negative HPV test are now being considered and which demonstrates the importance of long-term data on cohorts such as ARTISTIC. The universal introduction of primary HPV testing in the NHS cervical screening programme will require several practical decisions on test method and frequency with large effects on costs, staff time and patient acceptability, as well as on effectiveness of cancer prevention. Our findings will add to the body of evidence to allow policy -makers to improve the cervical screening programme in the UK (and around the world). The results will be presented at international HPV conferences and published in peer-reviewed journals. In addition, anonymised individual data (including events notified through this flagging process) has been pooled with 3 other European trials in order to evaluate the efficacy of HPV testing for preventing invasive cervical cancer (to be published in the Lancet shortly). In screened cohorts, invasive cervical cancer is so rare that pooling data with other large studies is the best way to evaluate this.


Project 2 — DARS-NIC-148118-VCXW9

Opt outs honoured: No - consent provided by participants of research study (Reasonable Expectation, Consent (Reasonable Expectation))

Sensitive: Sensitive

When: 2016/04 (or before) — 2019/09.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(7)

Categories: Identifiable

Datasets:

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

Objectives:

The study aims to find genes which predispose to prostate cancer, and to determine whether variation in risk genes influence the prognosis of individuals with prostate cancer. 31 regions of the genome have now been associated with prostate cancer (the majority found by our research group), and we can now begin to analyse what effects these “risk regions” have on prostate cancer aggressiveness and outcome. Our aims are to find new genetic markers to identify who might be at risk of developing prostate cancer in the future; to be able to more accurately target appropriate treatments to those patients who are most likely to have aggressive disease and to develop new drug treatments for prostate cancer. This has the potential to be able to target screening to those who would benefit from this manoeuvre and the potential to improve survival. (see point 10)

Expected Benefits:

The UKGPCS has been running since 1992, and gained MREC approval in 2003. The study is UK wide and currently 162 hospitals recruit prostate cancer patients with young onset or familial prostate cancer into the study. The Royal Marsden Hospital has ethical approval to recruit prostate cancer patients of any age to the study. Currently there are 10,491 patients consented to the study, and the target is 21,000 by the end of 2012. Each consented patient gives a blood sample, and a family history questionnaire, and we obtain clinical data from their consultant. Not all patients have given consent to re contact them and we do not have current addresses for many of the participants, some of whom were recruited more than 10 years ago.

Outputs:

The study aims to find genes which predispose to prostate cancer, and to determine whether variation in risk genes influence the prognosis of individuals with prostate cancer

Processing:

Standard time-to-event analysis will be used to test for association between genotype and prognosis. Time at risk will begin on the date of diagnosis, with time under observation beginning on date of blood sample receipt. Follow-up will be censored on the date of death from any cause, or, if death did not occur, on the date of the end of the study. We already have genotype data, date of diagnosis and date of blood receipt for all our cases. We therefore request death certificate data to enable us to obtain date of death and cause of death for those men in UKGPCS who have died. (see point 12)


Project 3 — DARS-NIC-148096-PT589

Opt outs honoured: No - consent provided by participants of research study (Consent (Reasonable Expectation))

Sensitive: Sensitive

When: 2016/04 (or before) — 2019/09.

Repeats: Ongoing, One-Off

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c)

Categories: Identifiable

Datasets:

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

Yielded Benefits:

The study is one of the major cohort studies worldwide focussed on cancer, and has produced over 100 scientific peer-reviewed publications (see section 5.c), many of them heavily used and cited (thousands of citations). These include contributions to discovery of the majority of the single nucleotide polymorphisms (SNPs) that are known to affect the risk of breast cancer, and many affecting risks of endometrial cancer, ovarian cancer and melanoma. These are the major discoveries in cancer genetics of the last 5-10 years that enable improved risk prediction and counselling for patients in clinics and their families. The ICR has published data showing that the previous literature has generally underestimated the risks of breast cancer from hormone replacement therapy (HRT), used by very large numbers of women around the menopause: this is vital in giving more accurate estimation of risks for patients and their doctors weighing the risks and benefits of taking HRT – a major public health issue. The ICR has developed, using the study data, a new, improved measure of family history of breast cancer incidence, to enable improved advice to women in clinics about their risk of breast cancer if members of their close family have had the disease, with greater precision and power than previously used measures. These outputs and uses demonstrate clearly the feasibility and public benefit.

Objectives:

Purpose The data supplied by the NHS IC to Institute of Cancer Research will be used only for the approved Medical Research Project identified above.

Expected Benefits:

Finding the causes of cancer is important to enabling its prevention and identifying high risk groups for screening and early detection. Cancer now accounts for 26% of deaths in women in England, so is a major public health problem. Breast cancer is the most common cancer in women in the UK and worldwide. The Generations Cohort study was set up in 2003, to investigate the causes of breast cancer with exceptional focus, size and comprehensiveness, and also to investigate the causes of other cancers and causes of death in women. Epidemiological evidence indicates that the aetiology of breast cancer involves genetic, behavioural and environmental factors, probably with interactions between these, and that the behavioural/environmental factors act at several different stages of life, probably starting before birth, and continuing to the menopause and beyond. Many of the likely causal factors are complex ones that are difficult or impossible to measure in retrospect – for instance serum concentrations of hormones at various ages – but more accurate investigation of these is crucial to understanding the causes of this cancer and hence its prevention. To investigate these factors optimally needs a study in which information about them, and how they change through life, is collected prospectively in a large cohort of women, with long term follow-up for breast cancer. For aspects such as the relationship of serum concentrations of IGF1 and of sex hormones to risk of subsequent breast cancer, this is essentially the only design that can give valid data. Such a study design is also the optimal one to assess gene-environment interactions affecting the risk of breast cancer. The cohort design has similar strengths for investigation of other major cancers and causes of death. The Generations cohort is one of the largest and most comprehensive in the world to investigate the causes of breast cancer, and provide risk prediction data to enable personalised screening and prophylaxis. It is also investigating breast cancer and ovarian cancer pathology and survival. The study has exceptional detail, size and power to provide new information on the causes and genetics of breast cancer and other major diseases of women in the UK. The objective is to enable preventive measures for these diseases and to give information for patients and their families, doctors and other health professionals advising patients, the public, and policy makers, and for health promotion campaigns, on risk factors for these diseases and potential measures to reduce the risks, including targeted measures based on genetic and other factors. The study is also providing new data for personalised risk prediction, and on pathology and survival from cancer to aid diagnosis and treatment/ follow-up.

Outputs:

The planned outputs will include several hundred published papers in peer-reviewed scientific journals, submitted over the next 40 years, on the causes and risks of cancer incidence and cause-specific mortality, and on cancer pathology and survival, in women (see below for examples). The research is funded primarily by Breast Cancer Now, as the major part of a programme of breast cancer-related peer-reviewed research funded by them, and has produced many high-profile publications listed below, so PHE can be assured that it will continue to do so with longer follow-up and hence more valuable results. The extended follow-up will enable analyses on a growing spectrum of less-common conditions as greater numbers of cancers and deaths accumulate, and enable increasingly long-term risks to be assessed. The ICR will publicise the results to patients and society more widely by press releases and blogs, to professional standard, from the Institute’s and Breast Cancer Now’s very active communications departments, information sent to Breast Cancer Now (the major UK breast cancer charity) supporters and patient groups and put on the Study website, and by talks given to patient and lay groups as well as to appropriate medical and scientific conferences, meetings and seminars. The study has now produced >100 papers in peer-reviewed journals, many in the leading research journals for their specialities, on aetiology and genetics and hence prevention and patient counselling of cancer and its risk factors. Over the next 40 years the study is expected to produce several hundred more papers in peer reviewed journals, on aetiology and genetics, and hence patient counselling, on cancer and its risk factors and on other diseases. It is planned that during 2019 papers will be published on, among other topics, the relation of breast cancer risk to weight change (important for preventive messages on losing weight); the relation of breast cancer risk to shift work (an important public health issue given the large number of female shift workers and whether their shift work is affecting their cancer risk); breast cancer risks in relation to recent pregnancies (important because these temporarily raise risk, but it needs to be discovered how much and for how long after the pregnancy) and several papers on the genetic risks of female reproductive related cancer risks (important to genetic counselling of patients and their families).

Processing:

The study is of cohort design, recruiting volunteer women from the general population of the UK aged 18 years and older, who have completed an extensive questionnaire about breast cancer risk factors, given a blood sample, and given informed consent for follow-up via national routine data systems. Over 110,000 women have been recruited since 2003 with active recruitment stopping in 2009. Participants still continue to join the study, however these are not in great numbers. A cohort study is methodologically the most rigorous study design that can be undertaken of long-term cancer and mortality risks. Follow-up is primarily by 3-yearly questionnaires. It is planned that collection of exposure and follow-up data will continue for at least 40 years. In addition periodic newsletters are sent to participants with a reply slip for notification of changes in address and, with signed informed consent, the ICR also uses flagging at NHS Digital to provide follow-up data, including cancer registrations and causes of death. The ICR supplies cohort identifiers to NHS Digital and the participants’ entries are then flagged on NHS Digital’s computer system. Only identifiers of participants with whom the ICR has lost contact or who have self-reported cancers and/or who are believed to have died are supplied to NHS Digital for flagging. Otherwise, the ICR continues to collect information directly from the participants. 41,695 participants had been flagged prior to September 2018. Approximately 800 additional participants who meet the above criteria will be flagged at fixed points each year. ICR will supply identifying details of these additional participants to NHS Digital for the purpose of flagging. Under this Agreement, the ICR is not permitted to flag new participants recruited during or since 2015 (at which point guidance NHS Digital issued new guidance on consent). For flagged participants NHS Digital reports details of the cancer diagnoses and/or the details of deaths (date and cause) and also reports exits from registration with the NHS (e.g. if a participant emigrates). NHS Digital has supplied this data to the ICR on a regular basis over many years. These data are used only for analyses for the approved medical research project identified above. Analyses are conducted of risk factors for breast cancer and other cancers and causes of death mainly by standard cohort analyses methods (Breslow & Day, 1987), but also in nested case-control analyses for exposure variables (e.g. various assays) that can only practically be obtained on this basis. Identifiable data are required to ensure accurate linkages of individual participants’ data. Access to the identifiable data is restricted to ICR researchers with authorisation from the Chief Investigator, who is the Head of the ICR’s Epidemiology Team. The data will be accessed and analysed solely at ICR for the analyses described above, which are the purpose of the study and the purpose of obtaining the data from 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 – i.e. employees, agents and contractors of the Data Recipient who may have access to the data).


Project 4 — DARS-NIC-147923-P5DTX

Opt outs honoured: Y

Sensitive: Sensitive

When: 2017/03 — 2017/05.

Repeats: Ongoing

Legal basis: Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , 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 NHS IC to Institute of Cancer research will only be used for the approved Medical Research Project.


Project 5 — DARS-NIC-147749-3SSRF

Opt outs honoured: Y

Sensitive: Sensitive

When: 2017/03 — 2017/05.

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

Objectives:

The data supplied by the NHS IC to Institute of Cancer Research will be used only for the approved Medical Research Project identified above.


Project 6 — DARS-NIC-147748-XD18S

Opt outs honoured: Yes - patient objections upheld (Section 251 NHS Act 2006)

Sensitive: Sensitive

When: 2017/03 — 2019/09.

Repeats: Ongoing, One-Off

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 , National Health Service Act 2006 - s251 - 'Control of patient information'.

Categories: Identifiable

Datasets:

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

Yielded Benefits:

Previous outputs from this study have been widely used for care of the relevant patients, as evidenced by the exceptionally high citation rates of the papers (in square brackets below): Swerdlow et al., Cancer incidence and mortality in patients with insulin-treated diabetes: a UK cohort study. Br J Cancer 2005;92:2070-5 [151 citations], Laing et al., Mortality from heart disease in a cohort of 23,000 patients with insulin-treated diabetes. Diabetologia 2003; 46:760-5 [645 citations], Laing et al., Mortality from cerebrovascular disease in a cohort of 23 000 patients with insulin-treated diabetes. Stroke 2003;34:418-21 [152 citations], dos Santos Silva et al., Birthweight and other pregnancy outcomes in a cohort of women with pre-gestational insulin-treated diabetes mellitus, Scotland, 1979-95. Diabet Med 2005;22:440-7 [38 citations], Laing et al., The British Diabetic Association Cohort Study, II: cause-specific mortality in patients with insulin-treated diabetes mellitus. Diabet Med 1999;16:466-71 [387 citations], Laing et al., The British Diabetic Association Cohort Study, I: all-cause mortality in patients with insulin-treated diabetes mellitus. Diabet Med 1999;16:459-65 [176 citations], Swerdlow et al., Mortality of South Asian patients with insulin-treated diabetes mellitus in the United Kingdom: a cohort study. Diabet Med 2004;21:845-51 [26 citations], Laing et al., Psychosocial and socioeconomic risk factors for premature death in young people with type 1 diabetes. Diabetes Care 2005;28:1618-23 [69 citations].

Objectives:

The data supplied will be used only for the approved Medical Research Project - MR400 - Cohort Study of People with Insulin Treated Diabetes

Expected Benefits:

Diabetes mellitus is the most common metabolic abnormality in Western populations. The health care costs and implications are very large. It occurs through two different primary disease processes, type I (insulin-dependent) and type II (non-insulin dependent), with different patient characteristics. Type I diabetes largely starts in childhood, and is one of the major childhood chronic diseases. With the introduction of insulin treatment in 1922, survival beyond a year or two became possible, but this entailed serious long-term consequences for risks of several major chronic diseases, especially cardiovascular diseases. Because modern treatments have led to greatly improved survival of patients with diabetes, the issue of long-term side-effects of the disease has become an important one for information and advice to patients and (for children) to their parents. It is also important to clinicians deciding about treatment of diabetes and the balance of benefit vs. side-effects and complications, and to the Health Service, because of the costs accruing for continued follow-up and care of these patients and the planning required to take account of long-term consequences and to plan strategies, where possible, for their prevention and early detection. The risks of cancer are also of major importance to patients and their families, and to clinical practice and health service planning, because cancer is one of the major causes of morbidity and death in the UK and type I diabetes requires lifelong treatment and follow-up. Data on very long term risks are limited, however. The metabolic and hormonal antecedents and consequences of diabetes, and the treatments for it, might also affect the risk of cancer and this is important to know in order to guide screening regimens, enable early diagnosis, and follow-up. Most studies of cancer risks in patients with diabetes have related to type II diabetes, however, for which interpretation is uncertain because of potential confounding by obesity and alcohol consumption. Pancreatic cancer risk has been found raised, but there is uncertainty about the direction of causation, because pancreatic cancer can cause diabetes. The aetiology of type I diabetes is not related to obesity or alcohol use, and the diabetes generally occurs well before the ages at which pancreatic cancer is prevalent. Studies of cancer risk in patients with type I diabetes, however, have generally been relatively small. ICR therefore inaugurated 25 years ago a long-term cohort study of mortality and cancer incidence in 29,500 patients in the UK with insulin-treated diabetes. It is much the largest cohort study of such patients in the world with such long follow-up, and is providing unique information, currently with up to 35 years follow-up, but in the future with longer follow-up, on the long-term consequences of diabetes and the extent to which duration of diabetes and age at onset are risk factors for mortality and morbidity. The ICR is not aware of other published cohort studies with information on these latter variables. The study is important to inform parents of children with diabetes, patients themselves, those treating the patients, and the health service, on the long-term consequences and prognosis of this chronic disease, which consumes considerable health service resources. Overall the study will enable patients, their parents and clinicians to undertake more-informed discussion and decision-making about the patient’s risk of long-term morbidity and mortality, and therefore understand risks better and embark on a more personalised care pathway. In particular:- 1. The study will provide information on relative and absolute risks of the full spectrum of long-term site-specific cancer incidence and cause-specific mortality, and on life expectancy, which will provide a more informed knowledge base from which patients can ascertain their personal risks of developing a range of late effects through life than has previously been possible, and enable them to take into account the age at which they developed diabetes and the duration that has elapsed since. This is important for patients to be able to make fully informed decisions on their care and for clinical decisions on long-term care and will enable follow-up and screening schedules tailored to their personal risks and hence potentially to more patient-centred and effective follow-up, earlier diagnosis of adverse events, and improved outcomes. 2. By improving knowledge of risk complications, the results should contribute to consensus and guidelines for management of long-term hazards to improve outcomes, e.g. via screening tools and standardising of follow-up schedules. 3. The data provided would also provide important information for health service resource distribution and costings, to plan long-term management of this life-long condition, which gives rise to considerable health service provision costs, economically and effectively. 4. Improve understanding of disease aetiology and hence prevention by, for instance, illuminating the relation of cancer risks to duration of diabetes, and examining the relation of diabetes complications to age of onset of diabetes.

Outputs:

The planned outputs will include several published papers in high-profile peer-reviewed scientific journals, submitted over the next 2-3 years, and subsequently further papers with longer follow-up over the next 20 years on the risks of cancer incidence and cause-specific mortality in patients with type I diabetes, with analyses subdivided by age at onset of diabetes, duration since onset, and attained age (see below for examples). The research was initially funded by the British Diabetic Association. It has produced several high-profile publications (references in section 5d. iii), so NHS Digital can be assured that it will do so again with longer follow-up and hence more valuable results. The extended follow-up will also enable analyses of less-common outcomes for which the ICR was unable to publish stable results in its previous round of analyses because of limited numbers of cancers and deaths, and for which there are currently no published analyses available for long durations, to inform patients, their parents and clinicians on risks. It will also enable far longer-term risks to be assessed (up to 45 years follow-up from study entry) than has previously been possible. ICR will publicise the results to patients, their parents, and society more widely by press releases and blogs, to professional standard, from the Institute’s very active communications department, information sent to patient-centred charities (notably Diabetes UK) and help groups and put on the ICR’s website, and by talks given to patient and lay groups as well as to appropriate medical speciality (paediatric endocrinology and genetics) conferences, meetings and seminars.

Processing:

The cohort identifiers were supplied to ONS (then OPCS) many years ago and the participants’ entries were flagged on NHS Digital’s computer system. A cohort study, by definition, follows people with exposure information already collected (in this instance diagnostic information) to ascertain their subsequent risks of morbidity and/or mortality. ICR already holds the exposure (diagnostic) data and follow-up data up to the present (sent by NHS Digital and predecessor organisations over the last >20 years) and needs continuing follow-up data on cancer incidence, mortality and other losses to follow-up to enable analyses of cancer incidence and cause-specific mortality risks over longer periods for the benefit of current and future patients, and their health care. No new data will be shared with NHS digital. NHS Digital supplies quarterly data to the ICR. These data are used only for analyses for the approved medical research project identified above. The data are not linked to other datasets other than the clinical source data and the ONS/NHS Digital data. Identifiable data are required to ensure accurate linkages of individual patients’ data. After the data sent by NHS Digital have been linked, the analysis is conducted on pseudo-anonymised files. The data will be accessed and analysed by the authorised Approved Researchers at ICR, in order to produce the analyses described above, which are the purpose of the study and the purpose of obtaining the data from NHS Digital. Data will only be accessed by individuals within the ICR who have authorisation from the Principal Investigator of the study, to access the data for the purpose(s) described, all of whom are substantive employees of the Institute of Cancer Research. 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 - i.e. employees, agents and contractors of the Data Recipient who may have access to that data).