NHS Digital Data Release Register - reformatted
University of Nottingham
Opt outs honoured: Y
Basis: Health and Social Care Act 2012
Format: Anonymised - ICO code compliant Non Sensitive
How often: Ongoing
When: unknown — 11/2016
HSCIC Id: DARS-NIC-376367-M5V9H-v0.0
Data: Hospital Episode Statistics Accident and Emergency
Data: Hospital Episode Statistics Admitted Patient Care
Data: Hospital Episode Statistics Critical Care
Data: Hospital Episode Statistics Outpatients
Data: MRIS - Cohort Event Notification Report
Data: MRIS - Cause of Death Report
Data: MRIS - Cause of Death Report
Data: MRIS - Cohort Event Notification Report
Data: Office for National Statistics Mortality Data
Data: Hospital Episode Statistics Admitted Patient Care
Data: MRIS - Flagging Current Status Report
Data: MRIS - Scottish NHS / Registration
Data: MRIS - Cohort Event Notification Report
Data: MRIS - Cause of Death Report
Data: MRIS - Personal Demographics Service
Data: MRIS - Cause of Death Report
Data: MRIS - Cohort Event Notification Report
Output: The trial will proceed until there are 87 adjudicated cases and will then be analysed to test the hypothesis that H.pylori eradication reduces the incidence of peptic ulcer bleeding. The main primary outputs of the analysis will be scientific papers/posters covering both the medical and procedural aspects of the study. The University of Nottingham intends to publish the results of the HEAT Study in a major scientific journal (such as The Lancet), and will also present details of the study at relevant scientific meetings. For example, the methodology for the study presented at the Digestive Diseases Federation Conference in London in June 2015 and at the United Gastroenterology Week Conference in Barcelona in October 2015.
The final results of the study, for which the HSCIC data will be used, will be expected in early 2017 for publication in The Lancet, and these results would be presented at BSG national (and potentially international) meetings. As this study is endpoint-driven, the University of Nottingham require hospitalisation / ulcer bleed data regularly throughout the course of the study, as this will help to determine a more accurate end date, based on event rates. There will also be a report for the funder and sponsor at the end of the trial, which is currently due in September 2017.
All outputs from the study would only include aggregated summaries, with small numbers suppressed in line with the HES Analysis Guide and no patient-level identifiable data would be used.
Activities: Suitable patients identified from GP records are invited to participate. Those who respond are invited to attend a screening visit at their GP practice. Following consent they undergo a brief baseline health assessment and perform a H. pylori breath test. H. pylori positive patients will be randomised to receive eradication treatment or matching placebo. Treatment is dispatched to the patients by post.
The trial data are owned by University of Nottingham but managed and held under contract by TCR Nottingham on the HEAT database. The HEAT database is stored on an N3 server within the N3 network based at Nottinghamshire Health Informatics Service (formally King’s Mill Hospital Data Centre). Authorised University of Nottingham staff can access the data via remote access to the server but the data is not removed from the server. TCR Nottingham manages all access permissions which are set on a per-person basis. Only relevant members of the study team would have access to the data provided by HSCIC. TCR Nottingham provides two levels of access to the data for staff at University of Nottingham: (i) the full identifiable data is accessible only to 2 individuals for the purpose of facilitating follow-up contact, and (ii) data stripped of identifiers except for initials and study screening number is assessable to the research team and only this level of data is used in analyses.
The practice of retaining initials is to mitigate risks of quality errors arising from transposition errors if using only a study screening number. This is consistent with established operating procedures within the University based on published opinion of what is classed as identifiable data. The methodology has been reviewed by the Ethics Committee and study sponsor with both supporting the approach. The University is satisfied that amongst up to 40,000 patients, the use of initials would not render an individual at risk of reidentification by those accessing the data.
All patient follow-up is electronic. Patients make no follow up visits but can notify trial office of any relevant [or indeed irrelevant] events. Follow up data is obtained by interrogation of GP electronic records and by routine linkage via the HSCIC to ONS data on deaths and from HES data. The University of Nottingham will be making several sequential applications for data from the HSCIC to support follow up activities.
GP records will be interrogated 6-12-monthly by searching for relevant read codes to identify any hospital admission possibly due to acute GI bleeding, as well as current health and prescribing information. These will be cross-checked against HES. The study uses all routinely available data to detect events. As HES data is transmitted to GPs in the form of a discharge summary, it is likely that the primary hospital data will contain detail that does not appear in the GP record but that is not known. The main purpose in collecting from both sources is to minimise the chance of missing information but a secondary analysis of the trial includes an assessment of whether electronic interrogation of GP practice records is a reliable form of patient follow-up. The trial will not directly link GP records and HES data. At individual patient level, the HES data will be compared with the HEAT database to determine the extent of discrepancies between the detail in the HES data and the data derived from the GP records.
The primary endpoint for this trial is a hospitalisation for an ulcer bleed therefore; details of hospitalisation that trial patients experience are required from the HSCIC to ensure that no potential endpoints are missed. Data on hospitalisations will be reviewed and, if it is deemed that a potential endpoint has occurred, then further details will be collected (directly from the source) and the event will be adjudicated by a blinded Adjudication Committee (like the trial subjects and investigators (see above)) members of the committee do not know the identity of each subject’s randomised treatment.
The University of Nottingham require all the fields within HES because as part of the secondary analysis of this study, a health economic analysis will be performed comparing many quality of life factors in both arms of the trial (e.g. the cost effective benefit of intervention; length of hospital stay types of services accessed, and other related medical events). For the secondary analysis HES data on all reasons for admissions are required in order to study the impact on other health conditions. To inform the economic analysis it is important to consider the route of admission (elective investigation versus emergency).
Data minimisation has been considered and as part of that process, a health economist has reviewed the list of fields available from HES and confirmed which are required.
Objective: Helicobacter Eradication Aspirin Trial (HEAT) is a large double-blind (i.e. neither subject nor trialist knows the identity of their randomised treatment), placebo-controlled randomised multi-centre study set in primary care. There are three primary objectives:
1. Medical: To test the hypothesis that a one week course of Helicobacter pylori (H. pylori) eradication in patients using aspirin ≤325mg daily will reduce the incidence of subsequent adjudicated peptic ulcer bleeding that results in hospitalisation.
2. Economic: To test the hypothesis that the intervention has a positive net monetary benefit.
3. Methodological: To establish a methodology for large simple outcomes studies using electronically extracted Primary Care follow-up data, to reduce costs to a level that enables outcomes studies of clinically important questions to be done without the need for industry support.
The data is required as part of the process of endpoint detection. This is a large ultra-simple trial which attempts to use electronic data sources to capture possible trial endpoints (primary endpoint admission to hospital with peptic ulcer bleeding). Other sources of data will be via electronic scrutiny of GP records, ONS mortality data and patient alerts. Cases deemed to have possibly reached an endpoint will have detailed hospital data collated and an Adjudication Committee will evaluate whether patients have had a definite or probable ulcer bleed using the criteria of the TARGET study.
Study patients give permission for subsequent scrutiny of their records and any death certification. GP data are repetitively uploaded to a bespoke database/management system which has also been prepared to detect and store disease and procedure codes from HES. Permissions are also already in place for access to all the major hospitals where the trial is being conducted (Southampton & the South West, London, Nottingham & East Midlands / South Yorkshire, Durham and the North, Oxford and South East, Birmingham and the West Midlands) to allow nurse access to gather information on possible cases.
Benefits: The cost of admission and hospital stay for a bleeding peptic ulcer is likely to be approximately £15,000 for the population that will be analysed. Based on calculations for patients participating in the proposed trial (assuming all ultimately undergo eradication treatment) the trial would lead to the projected prevention of 585 hospitalisations at a saving of approximately £5.85 million, and prevention of ~59 deaths, potentially making the trial itself a cost effective therapeutic intervention. Though cost savings in relation to the trial particpants is not the primary purpose of the study, these figures are illustrative of potential savings should the trial results have the expected impact on NHS policy.
If the hypothesis of the trial is correct, patients would benefit medically from the study, and the NHS would make significant cost savings. The results would be presented to NICE and other policy makers, who may deem that any patient taking aspirin regularly (25% of over 65 years) should be breath tested, and their H. pylori eradicated if present, as the University of Nottingham believe this will halve the bleeding risk for patients.
Objective: The TARDIS trial will assess the safety and efficacy of intensive antiplatelet therapy, as compared with guideline antiplatelet therapy in patients at high-risk of stroke recurrence.The TARDIS trial will assess the safety and efficacy of intensive antiplatelet therapy, as compared with guideline antiplatelet therapy in patients at high-risk of stroke recurrence.
Objective: The data supplied will be used only for the approved medical research project MR1105 - SNAP (Nicotine replacement therapy in pregnancy)
Source: NHS Digital.