NHS Digital Data Release Register - reformatted

Oxford University Hospitals NHS Foundation Trust projects

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

MR1460 - OxValve - Survival following a diagnosis of Valvular Heart Disease in a primary care population (OxValve-Survive) — DARS-NIC-135294-P7L0F

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research study, No - data flow is not identifiable, Identifiable, Anonymised - ICO Code Compliant, No (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (NHS Trust)

Sensitive: Sensitive

When:DSA runs 2019-07-23 — 2022-07-22 2018.10 — 2022.09.

Access method: One-Off, Ongoing

Data-controller type: OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. MRIS - Flagging Current Status Report
  2. MRIS - Cause of Death Report
  3. MRIS - Cohort Event Notification Report
  4. Civil Registration - Deaths
  5. Demographics
  6. Civil Registrations of Death

Objectives:

The main function of the heart is to pump blood around the body. There are four main valves in the heart which ensure the blood travels in the right direction. If the valves become narrowed or leaky, this can mean the heart functions less efficiently.

Valvular heart disease (VHD) occurs when one or more valves does not form properly before birth (congenital) or if they are damaged (acquired) during life. In the developing world, infections such as rheumatic fever are still prevalent and can cause valve damage. In the UK and other developed countries, the most common cause of VHD is degeneration - wear and tear - over time.

When the heart valves don’t work properly, the heart muscle may need to work harder to cope. If valves become narrowed (stenosis), more pressure is needed to force the blood through them, and if they become leaky (regurgitation), more blood flows back into the heart chamber and needs to be pumped out again.

Over time, VHD can cause the heart to stop working properly. Some people may experience symptoms such as breathlessness, chest pain or passing out, while for others, problems with their valves will not cause them any difficulties. The treatment for severe VHD is surgery but this has risks. Identifying people who need to have an operation to deal with symptoms, or prevent future problems, and are well enough to have the procedure, is important.

The burden of VHD in the community population was poorly understood and therefore a cardiology team at the Oxford University Hospital NHS Foundation Trust embarked on finding out how common VHD was in the older population. In 2009, the team started the OxValve study with the aim of screening people age 65 years and over from primary care to determine how many participants had VHD. The study received ethical approval from the Southampton and South West Hampshire Research Ethics Committee (REC ref. no. 09/H0502/58) under consent versions 1 to 7 which was used to recruit 4,009 participants in total between 2009 and May 2016. Each participant underwent detailed examination including echocardiography to establish the presence, and severity, of VHD.

The findings of the first 2,500 participants were reported in the European Heart Journal in 2016. VHD was found in 1,269 participants (51% of the cohort). Most VHD was mild with only 159 participants having a new diagnosis of clinically significant disease (12.5% of those with VHD, 6.4% of the OxValve cohort). The cohort is currently undergoing a 5 year follow up where participants are asked if they are willing to be rescreened.

The long-term outlook for people with VHD is not fully understood. It is not known how long people with VHD, detected at screening, live for and whether they die from heart-related problems or something else. The OxValve-Survive study aims to report the survival rates of people in the OxValve cohort with and without VHD. The study will provide estimates of one, five and ten year survival, and the cause of death.

The cardiology team at Oxford University Hospital NHS Foundation Trust are in working partnership with the Nuffield Department of Primary Care Health Sciences (NDPCHS) at the University of Oxford working with the primary care team at NDPCHS which is leading on the primary care theme of the OxValve programme. Only individuals at the NDPCHS will do the data linkage and analysis for the data received from NHS Digital. The reason for this is that NDPCHS have expertise in survival analysis and experience with mortality linkage. The original OxValve team (at Oxford University Hospitals NHS Foundation Trust) will not be involved in processing the data for this purpose and will have no access to the data in its raw form. Oxford University Hospitals NHS Foundation Trust will only have access to aggregated reports with small numbers suppressed in line with the HES Analysis Guide.

Yielded Benefits:

The findings have been presented at the British Society of Cardiology conference. The OxValve study (at NDPCHS) are currently drafting a manuscript for submission to a peer-reviewed journal.

Expected Benefits:

The number of people with VHD in the community population of the UK was previously unknown. OxValve has given reliable prevalence estimates and is following participants up. However, the number of people in the cohort who have died, and their cause of death, remains unknown. This is important information to understand the natural trajectory of the disease and whether VHD found at screening is associated with higher mortality, or not.

A better understanding of prognosis could help inform patients, clinicians and commissioners. The limited data on survival for people with VHD can make discussions on outlook between patients and clinicians more challenging. Accurate mortality data linked to a well-phenotyped cohort could improve clinicians understanding of likely survival rates and causes of death for people with VHD. Commissioners of healthcare are also likely to be interested in the findings to allow them to provide appropriate surgical and palliative care services for this population.

Identification of risk factors for death in people with VHD may allow targeted treatment of modifiable risk factors. The findings from the study are likely to be relevant to other European countries where the prevalence VHD and risk factors for death are likely to be comparable.

Further scientific benefits include the contribution of the project to future systematic reviews and meta-analyses of risk factors for the prognosis of VHD. The findings of the study may also lead to future randomized controlled trials of treatments, and of interventions aimed to target risk factors, to improve the prognosis of these patients.

Outputs:

The OxValve-Survive study will report the one and five year survival rates of participants with and without VHD, and report the most common causes of death.

The findings will be presented at a relevant conference such as the Annual Scientific Meeting of the Society for Academic Primary Care or the British Cardiovascular Society Annual Conference. The choice of conference will depend on the timing of completion of the statistical analyses and deadline for submission of the abstract. Dissemination of the findings of the project at either of these meetings, will inform frontline clinicians that interact with these patients on a daily basis. This project will help to provide an evidence base to inform decisions that are likely to improve the quality of care for patients with VHD in the UK and similar countries.

The findings of this project will also be published in a peer reviewed scientific journal approximately one year after receiving the mortality data i.e., before the end of 2019. Target journals will include the British Medical Journal, European Heart Journal and the British Journal of General Practice. Depending on obtaining the necessary funding, the aim will be to publish open-access.

The findings of this project will also be disseminated through the OxValve study website, the Nuffield Department of Primary Care Health Sciences website, and through relevant social media channels. Through these platforms, clinicians, academics, media, patients, and the public will be reached.


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

Processing:

The original OxValve study dataset is held at Oxford University Hospital NHS Foundation Trust. A copy of the full OxValve dataset is also held by NDPCHS at the University of Oxford and this dataset will be linked with the civil registration mortality data via NHS Digital. This contains the data of individuals who consented to participate in the study from 2009 onwards. Individuals recruited in the first year using consent materials version 1.1 did not give sufficient consent for their personal data to be shared with a body such as NHS Digital for the purpose of accessing their mortality data and no data will be requested about these individuals unless they provided additional consent subsequently.

The primary care team at NDPCHS based at University of Oxford will send NHS Digital; name, date of birth, NHS number, and the pseudonymised study ID for all participants who gave sufficiently informed consent. NHS Digital will match and flag the cohort and will return Mortality data (including Date and Cause of death) linked to the study ID. This data will be linked into the main OxValve study database at NDPCHS which only contains the clinical data (i.e. information collected at the screening appointment such as outcomes of ECGs, blood tests and self-reporting information). OxValve identifiers are stored separately. The data will not be linked with any other data and only the linkages described above are permitted under this Agreement.

The data will be stored on a restricted access network drive, with access restricted by password to the authorised user of the data only. Both the PC and network drive are on a secure part of the main University network with EAL4+ compliant perimeter firewalls. The wider University network is monitored and secured by the University OxCERT team. The local network and PCs are operated under the departments Information Security and Information Governance policies.

The data will be used exclusively for the purposes of the study specified hereby at University of Oxford only. The data will not be made accessible to any other 3rd parties, including Oxford University Hospitals NHS Foundation Trust.

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).

The Data will only be used for the purposes described in this Agreement.

Project 2 — DARS-NIC-148156-N8FNR

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

Purposes: ()

Sensitive: Sensitive, and Non Sensitive

When:2017.06 — 2017.05.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Bespoke
  4. MRIS - Scottish NHS / Registration
  5. MRIS - Flagging Current Status Report

Objectives:

The data supplied by the NHS IC to John Radcliffe Infirmary will be used only for the approved Medical Research Project in MR174.

Outcomes in acute/general medical inpatients in the Hospital Episode Statistics — DARS-NIC-07787-Z1W1X

Type of data: information not disclosed for TRE projects

Opt outs honoured: N, Anonymised - ICO Code Compliant (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012, Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii)

Purposes: No (NHS Trust)

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

When:DSA runs 2019-01-01 — 2020-12-31 2017.12 — 2016.08.

Access method: One-Off

Data-controller type: OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Civil Registration (Deaths) - Secondary Care Cut
  3. HES:Civil Registration (Deaths) bridge
  4. Civil Registrations of Death - Secondary Care Cut
  5. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

To identify whether there is any evidence from existing electronic health record data to support the key prescriber concern that early antibiotic review leading to reduced antimicrobial usage will cause greater rates of treatment failure/mortality.

The Antibiotic Reduction & Konservation (ARK) programme’s overarching aim is to reduce the incidence of serious infections caused by antibiotic-resistant bacteria in the future, through substantially and safely reducing antibiotic use in hospitals now. The programme has three specific research questions
(i) how can antibiotic prescription ‘review & revise’ strategies be implemented optimally to reduce antibiotic use safely within hospitals?
(ii) can a feasible inexpensive package of interventions that increase prescriber compliance with ‘review & revise’, and patient acceptability of shorter antibiotic therapy durations driven by ‘review & revise’ be built?
(iii) are ‘review & revise’ strategies cost-effective across a range of scenarios reflecting plausible associations between antibiotic use now and future resistance leading to loss of antibiotic options?

The goal of reducing total antibiotic burden in acute/general medical inpatients by at least 15% will be addressed through 6 work-packages. WP1-WP3 will provide underpinning data for design and piloting in WP4 of a ‘review & revise’ intervention package for inpatients/carers and healthcare professionals. WP5 will evaluate its effectiveness and safety, and WP6 will conduct health-economic evaluations. This request for data is for observational analysis as part of WP2.

Yielded Benefits:

As above, results from the planned analyses generated to date have contributed to the development of the ARK intervention which is currently undergoing evaluation in a large cluster-randomised trial. Continuing access to the data is required to complete the write up of the results for publication in a peer-reviewed manuscript, and to appropriately address queries which will inevitably arise from reviewers.

Expected Benefits:

This analysis would inform the development of a behavioural intervention to reduce antibiotic usage in acute/general medical inpatients. If the behaviour intervention reduces antibiotic use without changing patient outcomes, then it would be immediately ready for NHS deployment. It would be freely available to the NHS (under the terms of the contract with NIHR).

Providing that the results do not suggest that substantial harm could result from reducing antibiotic use (in which case the whole Programme Grant will be reviewed by the funders and the Programme Steering Committee), the results will be used, together with other published studies, to inform the development of a ‘review &revise’ behavioural intervention package for inpatients/carers and healthcare professionals aimed at reducing antibiotic usage. This behavioural intervention will then be tested in a large cluster-randomised stepped-wedge trial during years 3-5 of the Programme Grant.

Outputs:

The results of these analyses will be published in a peer-reviewed medical journal - no record-level data will be an output and any small numbers will be suppressed in line with the HES analysis guide. These analyses are comparing Trust-level outcome data with Trust-level antibiotic usage (see protocol for further details). Therefore, even though the Trust will make every attempt to adjust for case-mix and other factors that could influence outcomes and antibiotic usage, such adjustments may be imperfect, and any residual association does not necessarily imply causation. Interpretation of results from these analyses will explicitly highlight this. Standardly, such biases can occur in either direction, making it impossible to work out whether effects observed in observational studies are optimistic or conservative; hence, the need to rely on randomised controlled trials for unbiased inference regarding intervention effects. However, a priori, in this specific context of adults admitted to acute general/medical specialities, it is highly likely that any residual bias is primarily in one direction, namely that “less sick” individuals (at lower risk of the various clinical outcomes) have lower antibiotic exposure. Given this, not observing harm in these observational analyses is necessary to conclude that no harm would be associated with an intervention to reduce antibiotic use in this group of patients. If one observes evidence for harm from this observational analysis, after adjustment for as many confounders as possible, this would seriously undermine the rationale for the proposed trial within the larger Programme Grant, necessitating high-level review of the larger project.

It is expected that a publication will be submitted to a medical journal within 1 year of receiving the data from HSCIC. The Trust will also disseminate findings through the patient and public engagement activities ongoing within ARK and the Oxford Biomedical Research Centre within which key team members also work. The Trust are requesting for the data to be retained for 12 months from the date of provision, to allow for queries during the publication process.

Processing:

Case-mix adjusted outcomes in patients admitted to acute/general medicine will be compared with Trust-level antibiotic usage data from the English Surveillance Programme for Antimicrobial Utilisation and Resistance (ESPAUR), in an observational ecological (Trust-level) analysis. Hospital-level data will be used as a proxy for consumption in acute/general medicine as speciality-level data is not yet available in ESPAUR. Four outcomes will be considered:
• Mortality by 14 and 30 days after admission (in and out of hospital) (binary indicator)
• Admission to intensive care unit or high-dependency unit within this admission (identified from number of days of high-dependency/augmented care within each spell)
• Length of stay of the admission spell, both to actual discharge date and date medically ready for discharge
• Re-admission (non-elective) within 30 days of discharge (regardless of re-admission speciality)

Antibiotic use will be considered at the level of each Trust in terms of defined daily doses (DDDs: a World Health Organisation system for standardising antibiotic usage), overall and by drug class, per quarter, per year and over the 5 year study period. Broad spectrum will be defined as: co-amoxiclav; meropenem; second (eg cefuroxime), third (e.g. ceftriaxone ceftazidime) or fourth (e.g. cefepime) generation cephalosporins; quinolones; piperacillin/tazobactam.

The following potential confounders will be adjusted for age at admission (years); gender; ethnicity; index of multiple deprivation (IMD) score; Clinical Classifications Software (CCS) group of primary diagnosis code; Charlson co-morbidity score (calculated from secondary diagnosis codes associated with the first consultant episode within each spell, or the second consultant episode if the first is A&E); immunosuppression (calculated from the secondary diagnosis codes); intended management (admitted overnight, not admitted overnight, etc.); patient classification (actual management: admitted overnight, not admitted overnight etc.); admission day of the week, day of the year; calendar year; admission method; admission source; number of admissions (excluding as day case) in the previous year.

The null hypothesis is that there is no association between Trust-level antibiotic usage and outcomes in patients admitted to acute/general medicine.

The analysis will be conducted by medical statisticians only. Any individual using the data for such analysis will be either employed by the Trust or by the University of Oxford, with an honorary contract with the Trust in place. The data will be stored and processed on an NHS server housed within the Oxford University Hospitals NHS Trust (OUH), within the NHS N3 firewall. A database manager/software engineer will process the data onto the NHS server.
No third parties will store, process or access record-level data.