NHS Digital Data Release Register - reformatted

Addenbrooke's Hospital projects

75 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

🚩 Addenbrooke's Hospital was sent multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. Addenbrooke's Hospital may not have compared the two files, but the identifiers are consistent between datasets, and outside of a good TRE NHS Digital can not know what recipients actually do.

ADDITION: Anglo-Dutch-Danish study of Intensive Treatment In peOple with screeN-detected diabetes (MR798) — DARS-NIC-147750-8GS7S

Type of data: information not disclosed for TRE projects

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

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 , Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7), National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Academic)

Sensitive: Sensitive, and Non Sensitive

When:DSA runs 2018-12-01 — 2021-11-30 2017.09 — 2021.09.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF CAMBRIDGE

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Scottish NHS / Registration
  4. Civil Registration - Deaths
  5. Demographics
  6. MRIS - Flagging Current Status Report
  7. MRIS - Members and Postings Report
  8. Civil Registrations of Death

Objectives:

The data supplied by the NHSIC to MRC Epidemiology Unit will be used only for the approved Medical Research Project MR798

Yielded Benefits:

The ADDITION study has already provided useful information about screening for diabetes: • Screening for diabetes does not make people feel anxious, depressed or falsely reassured. • The health status of ADDITION participants was improved five years after diagnosis e.g. there were important reductions in levels of blood pressure, cholesterol and blood glucose over the five years of the study. • Earlier diagnosis and treatment of diabetes has contributed to lower than expected rates of heart attacks and premature death, which are now similar to those in the general population without diabetes. There have been more than 35 publications from the UK alone feeding into the academic discourse on the treatment of diabetes: the full list can be seen here, http://addition.au.dk/publications/, but some example papers are: Patient-centred care, health behaviours and cardiovascular risk factor levels in people with recently diagnosed type 2 diabetes: 5 year follow-up of the ADDITION-plus trial cohort. Dambha-Miller H, Cooper AJM, Simmons RK, Kinmonth AL, Griffin SJ. BMJ Open 2016;6(1):e008931. Medication burden in the first 5 years following diagnosis of type 2 diabetes: findings from the ADDITION-UK trial cohort. Black JA, Simmons RK. BMJ Open Diabetes Res Care. 2015 Oct 1;3(1):e000075. doi: 10.1136/bmjdrc-2014-000075. eCollection 2015 Cardiovascular risk reduction following diagnosis of diabetes by screening: one-year results from the ADDITION-Cambridge trial cohort. Charles M, Simmons RK, Williams KM, Roglic G, Sharp SJ, Kinmonth AL, Wareham NJ, Griffin SJ. Brit J Gen Pract 2012;62:294-295. Are people with negative screening tests falsely reassured? A parallel group cohort study embedded in the ADDITION (Cambridge) randomised controlled trial. Paddison CAM, Eborall HC, Sutton S, French DP, Vasconcelos J, Prevost AT, Kinmonth AL, Griffin SJ. BMJ 2009;339:b4535. Patients’ experiences of screening for type 2 diabetes: prospective qualitative study embedded in the ADDITION (Cambridge) randomised controlled trial. Eborall HC, Davies R, Kinmonth AL, Griffin S, Lawton J. BMJ 2007;335:490-493. Findings from the study have also been presented at GP forums, policy briefings and major international conferences.

Expected Benefits:

a) Type 2 diabetes is frequently asymptomatic, with the true onset occurring several years before diagnosis. While detection of the condition may be improving, around 30-50% of people with diabetes remain undiagnosed, and when patients are diagnosed, around 20-30% have evidence of diabetic complications. Long-term follow-up of the ADDITION study will inform the management of newly diagnosed patients and to establish the size and nature of the benefits of detecting and treating diabetes earlier.

NHS digital data will inform the long term follow up and allow study of mortality events in participants across the ADDITION cohort. This will add to the evidence of treatment and screening options for diabetes and will influence NHS policy makers and clinician decisions nationally on the best way to care for this population.

The data will also be used to inform the cost-utility analysis. Completeness of information on the health outcomes, including death, is crucial to enable a true cost to the NHS to be determined and hence influence implementation decisions on the course of treatment for the population. This could lead to reductions in NHS spending on treatments without proven effectiveness or to invest in treatments that will generate savings in the future through reduced NHS service use.

b) ADDITION-Cambridge has existing responsibility for organisation and delivery of diabetes care both locally and nationally (e.g. guideline development, managed care networks, expert review group for diabetes QOF indicators, National Screening Committee Advisory Group, UK Department of Health Vascular screening programme) and therefore have established mechanisms for influencing policy and practice in these and related fields.

c) Results from this study will help inform care early in the course of the disease and will provide information on whether people in middle-age should be offered screening for diabetes in the UK and worldwide .

d) It is estimated that 1 in 16 UK adults has (diagnosed or undiagnosed) type 2 diabetes, and this creates a substantial burden of suffering and health service use. Treatment of type 2 diabetes and related complications (cardiovascular disease, amputation, blindness, kidney failure) accounts for 10% of the NHS budget. This is expected to rise as the number of people in the UK who have type 2 diabetes is estimated to rise to 6.25 million by 2035.
Type 2 diabetes is frequently asymptomatic, with the true onset occurring several years before diagnosis.

Outputs:

The following outputs have been produced:
The ADDITION Europe study has so far led to the publication of 76 papers in peer-reviewed scientific journals, with a further 4 under review or in press. Data from ADDITION has also contributed to 12 PhD theses and 52 oral presentations or posters at international conferences. The primary analysis of 5 year outcomes was published in the Lancet (Griffin et al. (2011). Lancet, 378 (9786), 156167).
Participant dissemination events have continued throughout the past 10 years, including public meetings and annual newsletters.
The following outputs will be produced:
The results of the 10 year analysis will be submitted to this or a similar leading medical journal by December 2018 (subject to the completion of the processing activities described above). Findings were presented at the annual meeting of the European Association for the Study of Diabetes (EASD) in September 2016. Throughout 2018, secondary analyses including cost-utility analysis and mechanistic analyses will be published in leading medical or disease-specific peer-reviewed journals such as the Lancet, BMJ, Diabetalogia, Diabetes Care, and International Journal of Obesity. All publications will be open access, in line with the University of Cambridge open-access policy, and can be accessed by clinicians, academics, policy makers and interested members of the public.
A simplified version of the findings will be issued to participants and GP practices that took part as part of our annual newsletter. Lay-summary findings are also published on the organisation’s website.
All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

No personal identifiable data will be released or published.

Processing:

Data Flow & What data is provided
a) NHS Digital already hold a file from the University of Cambridge containing identifiers of participants (less any that object to data linkage) recruited in Cambridge. This includes:
STUDY_ID
NHS number
Date of Birth
Sex
Postcode
The cohort will then be linked to mortality data and will be extracted for each participant. No additional filters will be applied to the data, nor any additional derived fields provided.
b) The University of Cambridge will use the Study ID to link the data previously disseminated (i.e. data the University of Cambridge holds). By means of this re-identification, the mortality data to be disseminated is therefore considered Identifiable.
c) The data will be downloaded at the University of Cambridge MRC Epidemiology Unit and transferred immediately to an independent, physically-separated network that is isolated from public network systems and can only be accessed locally, with a managed access system including both password and procedural controls. This other network is still on the Unit premises but is known as the private network where all of the Unit's patient data is stored. It is not connected to the internet and can only be accessed by being at the Unit. Access to this network must be approved by both local senior management and the ADDITION study CI and access will only be granted for the purpose described. All study team members accessing the data have a contract with the Unit. Pseudonymised data may be released from the Unit’s physically separate server onto the Unit's main network, and may be accessed on site or by remote access.

The data will not be made available to any third parties. All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

Mortality data sets are requested in this application. Previously received quarterly update of mortality data since 2006 (previously from ONS). Data is requested going forward for the duration of the Data Sharing Agreement.

All mortality outcomes are of relevance, no filters will be applied. It is essential to be able to identify which participant data relates to, to enable the study to link mortality outcome data with measures that were taken as part of their screening for ADDITION.

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 2 — DARS-NIC-148297-0XFP3

Type of data: information not disclosed for TRE projects

Opt outs honoured: N

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)

Purposes: ()

Sensitive: Sensitive, and Non Sensitive

When:2017.09 — 2017.05.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report

Objectives:

The data supplied by the NHS IC to Addenbrookes Hospital will be used only for the approved Medical Research Project MR835.

MR1098 - The time-course and mechanisms underlying age-related changes in arterial stiffness — DARS-NIC-148376-YBRWP

Type of data: information not disclosed for TRE projects

Opt outs honoured: N, Identifiable (Consent (Reasonable Expectation))

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), Health and Social Care Act 2012 – s261(2)(c); Informed Patient consent to permit the receipt, processing and release of data by NHS Digital

Purposes: No (NHS Trust Site)

Sensitive: Non Sensitive, and Sensitive, and Non-Sensitive

When:DSA runs 2022-01-06 — 2022-06-30 2016.09 — 2016.11.

Access method: Ongoing, One-Off

Data-controller type: CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST, UNIVERSITY OF CAMBRIDGE

Sublicensing allowed: No

Datasets:

  1. MRIS - Cohort Event Notification Report
  2. MRIS - Cause of Death Report
  3. MRIS - Scottish NHS / Registration
  4. MRIS - Flagging Current Status Report
  5. MRIS - Members and Postings Report
  6. MRIS - Personal Demographics Service

Objectives:

The data supplied by the NHS IC to Addenbrooke's Hospital will be used only for the approved Medical Research Project MR 1098.

Yielded Benefits:

Addenbrookes Hospital to confirm details of of yielded benefits on re-submission

Expected Benefits:

This Agreement permits the secure retention of the data only and no other processing.


Addenbrookes Hospital to confirm on re-submission

Outputs:

This Agreement permits the secure retention of the data only and no other processing.

No new outputs will be produced under this Data Sharing Agreement.


Addenbrookes Hospital to confirm on re-submission.

Processing:

The data previously supplied by the NHS IC to Addenbrooke’s Hospital will be used only for the approved Medical Research Project for the Research Project The Time-Course And Mechanisms For Health And Social Care Underlying Age-Related Changes In Arterial Stiffness.

Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement.

The information will, be processed in accordance with the principles and conditions set out in the Data Protection Act 1998 and with proper safeguards to ensure confidentiality. The data will be held in a secure environment where any access can be traced. NHS Digital will have the right to audit the security arrangements put in place.
Users of the data supplied are obliged to abide by all relevant legislation, regulations, codes of practice, guidance and any further requirements imposed on them when accessing the shared information.
The data is categorised as Classified and will be treated by the NHS IC in accordance with NHS IC protocols for the transfer and use of NHS Classified Data.

Historic Transfer of Data between the NHS IC and the Addenbrookes Hospital:

Data Depot
• The Data was sent to Addenbrookes Hospital via the secure online Data Depot (file transfer system, used for exchanging files between the IC and external parties) to a Permitted User at Addenbrookes Hospital. The Data is encrypted to 128-bit AES when transmitted from the IC.
• For a new Permitted User at Addenbrookes Hospital taking responsibility for arrangements under this Agreement, NHS Digital will provide login details.
• For an existing Permitted User at Addenbrookes Hospital taking responsibility for arrangements under this Agreement, a notification e-mail will be sent informing that the data is available.
• The named person must not share the password with any other person at any time.

Data will be retained for 10 years.


Customer to confirm on re-submission

Project 4 — DARS-NIC-148198-8KJMN

Type of data: information not disclosed for TRE projects

Opt outs honoured: N

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)

Purposes: ()

Sensitive: Sensitive, and Non Sensitive

When:2017.09 — 2016.11.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report

Objectives:

The data supplied by the NHS IC to Addenbrooke Hospital will be used only for the approved MR634 study.