NHS Digital Data Release Register - reformatted

The Nuffield Department Of Surgical Sciences - Nds projects

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

MR1004 - ARTERIAL REVASCULARISATION TRIAL ( ART ) — DARS-NIC-147755-C5H4X

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)

Purposes: No (Academic)

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

When:DSA runs 2019-09-01 — 2020-08-31 2017.12 — 2017.05.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF OXFORD

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Members and Postings Report
  4. MRIS - Scottish NHS / Registration
  5. MRIS - Flagging Current Status Report
  6. Civil Registrations of Death
  7. Demographics
  8. Emergency Care Data Set (ECDS)
  9. Hospital Episode Statistics Accident and Emergency (HES A and E)
  10. Hospital Episode Statistics Admitted Patient Care (HES APC)
  11. Hospital Episode Statistics Critical Care (HES Critical Care)
  12. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The data supplied by the NHS IC to Royal Brompton Hospital and Harefield Trust will be used only for the approved Medical Research project.

Yielded Benefits:

The study has provided unique long term information on the efficacy and safety of bilateral internal thoracic artery grafts for CABG, as well as a valuable high quality database to understand factors that influence long term outcomes after CABG and how these may be improved.

Expected Benefits:

The ART study will provide evidence from the first randomised trial for the use of bilateral IMA during CABG surgery. It will provide evidence for patients, doctors and policy-decision makers on the optimum treatment for patients undergoing CABG surgery.

ART is funded by the British Heart Foundation (2004-2014), Medical Research Council (2004-2014) and National Institute of Health Research (2014-2017) to compare 10-year survival after bilateral versus single internal thoracic artery grafting, and secondary outcomes of the composite of death, myocardial infarction or stroke, quality of life and health economic measures. Follow up to ten years is expected to be completed in 2017. This study will provide unique long term information on the efficacy and safety of bilateral internal thoracic artery grafts for CABG, as well as a valuable high quality database to understand factors that influence long term outcomes after CABG and how these may be improved.

All of this information will be used directly to improve the care of patients with advanced coronary artery disease undergoing coronary artery bypass graft surgery. Since coronary artery bypass graft surgery is a common operation and if the use of bilateral internal thoracic arteries lead to improved long term survival this could offer substantial health benefits to patients. Furthermore, the health economic component of ART will provide evidence to policy makers on the relative costs and benefits of performing coronary artery bypass surgery.

Outputs:

The University of Oxford intend to publish finding in high impact and disease specific medical journals as well as present findings at scientific sessions and conferences. Safety data at one year have been published and an interim analysis of five year follow-up results was presented at the American Heart Association Scientific Sessions in November 2016 and published simultaneously in the New England Journal of Medicine.

There has also been a number of other publications, for example;

1. Taggart DP, Altman DG, Gray AM, Lees B, Nugara F, Yu LM, Campbell H, Flather M; ART Investigators. Randomized trial to compare bilateral vs. single internal mammary coronary artery bypass grafting: 1-year results of the Arterial Revascularisation Trial (ART). Eur Heart J. 2010 Oct;31(20):2470-81

2. Taggart DP, Altman DG, Gray AM, Lees B, Gerry S, Benedetto U, Flather M; ART Investigators.. Randomized Trial of Bilateral versus Single Internal-Thoracic-Artery Grafts. N Engl J Med. 2016 Dec 29;375 (26):2540-9 4. Taggart DP, Altman DG, Gray AM, Lees B, Nugara F, Yu LM, Flather M; ART Investigators.

3. Effects of on-pump and off-pump surgery in the Arterial Revascularization Trial. Eur J Cardiothorac Surg. 2015 Jun;47(6):1059- 65 5. Benedetto U, Altman DG, Gerry S, Gray A, Lees B, Pawlaczyk R, Flather M, Taggart DP; Arterial Revascularization Trial investigators.

4. Pedicled and skeletonized single and bilateral internal thoracic artery grafts and the incidence of sternal wound complications: Insights from the Arterial Revascularization Trial. J Thorac Cardiovasc Surg. 2016 Jul;152(1):270-6 6. Benedetto U, Altman DG, Gray AM, Lees B, Gerry S, Flather M, Taggart DP on behalf of the ART investigators. Impact of dual antiplatelet therapy after coronary artery bypass surgery on 1 year outcomes in the Arterial Revascularization Trial (ART). Eur J Cardiothoracic Surgery (accepted 2017) 7.

5. Taggart DP, Altman DG, Gray A M, Lees B, Gerry S, Benedetto U, Flather M,for the ART Investigators. Randomized trial of bilateral versus single internal- thoracic-artery grafts. N Engl J Med 2016;375:2540-2549

It is proposed that once all patients have completed their 10 year follow up (scheduled 2017), the survival data will be analysed and form the basis of a manuscript to be published in a peer-review medical journal(s) as soon as possible after the end of the study .

In addition to further outputs in peer review medical journals and conferences, the ART study team will prepare information for participants once the 10 year analysis has been performed and the findings published (anticipated date: end 2017/beginning 2018).

All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

Processing:

A cohort of 1837 patients has been flagged by NHS Digital for the ART study. The ART study has informed patient consent for their entire cohort. The data from the UK patients on date of death and cause of death will contribute towards the analysis of the primary outcome of the ART study which is survival at 10 years.

Sensitive and identifiable data (including Date of Death and Cause of Death) will be transferred from NHS Digital to the ART study on a quarterly basis.

Data will be stored by the University of Oxford (Nuffield Department of Surgical Sciences). The data will be held electronically in a file that is only accessible by nominated ART study personnel working at the University of Oxford.

Only authorised ART study personnel at the University of Oxford will have access to the patient ID and patient data from NHS Digital.

The data will not be shared with 3rd parties and will only used for the purposes described in this agreement.

All ONS terms and conditions described in the special conditions section of this agreement will be adhered to.

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).