NHS Digital Data Release Register - reformatted

Southampton General Hosptial projects

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

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y

Legal basis: Section 251 approval is in place for the flow of identifiable data

Purposes: ()

Sensitive: Non Sensitive

When:2017.09 — 2017.11.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

MRIS - List Cleaning Report

Objectives:

This study is the first to look at the outcome data of patients admitted to hospital with a fast heart rhythm and associated troponin rise. It will provide an insight to clinicians into how these patients are managed in hospital and what their outcome is. It is clear that at present clinicians do not have any guidance on how these patients should be managed and what affect different management strategies have on the outcome of these patients. The aim of this study is to provide information on how the different management strategies in these patients affects their outcome. This is a first step into analysis into this treatment and it is hoped that results produced from this research will lead to a further prospective randomised trial.

Currently when using the current blood test (troponin) for the diagnosing of a heart attack it has been shown that 61.6% of patients present with a suspected heart attack, however, only 10% of these patients will in fact have a proven heart attack. This can lead to the potential mismanagement of a very large proportion of patients who have been incorrectly been diagnosed with a heart attack. The patients with a fast heart rhythm play a significant part of this group that are incorrectly treated as having a heart attack. This study will show clinicians what the outcome is for this group of patients and what is the optimal management. At present there is a heterogeneous approach to managing these patients with no clear optimal strategy. It is hoped that this study will highlight which strategies result in a more favourable outcome for patients with the disorder. Although the patients selected for this study will not benefit from the study as it is a non-interventional retrospective observational study, the results of this study may well benefit the same cohort of patients who present with the condition in the future. This will be achieved through guiding clinicians as to what is the optimal management strategy, furthermore, the study may act as the foundation for a much larger definitive randomised control trial in the future.

The study will look at how patients with a fast heart rhythm and a raised high-sensitive troponin levels (HsTrop) are managed in the hospital and what impact this raised blood test has on their outcome. At present there is no clear consensus on how patients with a fast heart rhythm and raised HsTrop level should be managed, as such there is a mixed approach from clinicians managing these patients. Traditionally patients with a raised HsTrop level are labelled with having had a heart attack and managed as such. University Hospital Southampton NHS Foundation Trust are now aware that adopting this approach in all patients with a fast heart rhythm and raised HsTrop is in some cases harmful.

This data is required to complete initial work on the study, which will have the potential to form the basis of more powerful prospective observational studies that may well change how patients with the condition are managed in the future. Further data will be required at a later date (and requested under a separate application) for these additional studies.

Expected Benefits:

The aim of this study is to provide a comprehensive analysis of how patients with the condition are managed and how this affects their outcome. At present there is no guidance to clinicians on how these patients should be managed. This study will give a greater insight into this and has potential to form the basis of a larger prospective trial that may change the way patients with the condition are managed in the future.

The data is required for this study to provide the most accurate and reliable information on the outcome of these patients. The expected target date for initial benefit to the health care of these patients would be expected at 3-6 months from receiving the data through dissemination in a peer-reviewed journal that clinicians will be able to access and use to help guide the management of these patients.

This study is the first step in a larger project to provide clinicians with a guidance on how patients admitted with an arrhythmia and troponin rise should be managed. The survival rates that will be obtained from NHS Digital will allow investigators to find what management strategies provide benefit to this group of patients. If this is achieved it is hoped that further prospective randomised control trials will be instigated with a view to guiding clinicians on what are the optimal treatment strategies and potential result in efficiency savings. If this is achieved the researchers would hope that this will be reflected in guidelines such as those from NICE.

Outputs:

The requested data is being used to produce outputs as part of the first steps in this research. If the findings of this study do prove that in patients with an arrhythmia and troponin rise are better managed via a certain strategy then the next step would be a prospective randomised trial to prove that data from this study are in fact correct. This could lead to significant changes to how clinicians manage such patients and may be incorporated into NICE guidelines. This, however, is dependent on strong conclusions being drawn from this initial study and to do that UHS require the data from NHS Digital.

The University Hospital Southampton NHS Foundation Trust will endeavour to publish the data in well respected peer reviewed journals such as 'Heart' which is a cardiology subsidiary of the British Medical Journal. This would be expected to occur within 3-6 months of receiving the data. In order to achieve this level of output the data is required as it is the most reliable data on the outcome of the patients selected for this study. This is a retrospective study that will not affect the patients selected for this study but may influence how patients with the same condition are managed in the future.

Outputs from the study may also be made available through a patient newsletter and other patient centric communication, which will be made available on-line.

There is also a significant possibility that the results of this retrospective study will provide the basis for a larger prospective study that will change the way clinicians manage such patients in the future. The findings of this study and any subsequent studies that follow on may provide governing bodies such as NICE to review the findings and to begin to construct guidelines on how patients with arrhythmias and a troponin rise are managed in the future. In order to do this the study will need to have robust data from NHS Digital to influence clinical practice.

All outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guide.

Processing:

Only substantive employees of University Hospital Southampton NHS Foundation Trust will have access to the data and only for the purposes described in this document.

University Hospital Southampton NHS Foundation Trust (UHS) will provide NHS Digital with the NHS number and unique study ID of patients selected for this study (~800)

NHS Digital will return the unique study ID for each patient along with data relating to the removal of patients from the NHS, where the reason is classified as 'death'. This data is obtained from the Personal Demographics service and will supply the reason for removal from the NHS, in this case death and the date of this removal. This will provide the researchers with an indication of whether members of this cohort are alive or dead and the date they were removed from the NHS PDS system.

Death event, date and study member ID will be the only data to flow from NHS Digital to the researchers. Once it is received, the study ID will be used to match against the clinical data. The clinical data contains no direct identifiers and cannot directly identify the patients in the selected cohort. Identifiable data is kept completely separately and the researchers will not and have no requirement to, re-identify the cohort.

All work on this study will be done at UHS on trust computers that require a login and password to access.

The data on mortality status will allow the investigators to plot kaplan-curves for different treatment group and patient groups. This will then allow statistical analysis to determine if certain patient groups and treatment groups confer a different mortality rate. This is the first step to determine if the survival rate of patients admitted with a fast heart rate and troponin rises differ by patient groups. Currently there are no guidelines on how these patients with a troponin rise should be managed. Looking at mortality rates will allow the investigators to determine if any treatment alters this rate and what the optimal treatment strategy might be for these patients.

No contact will be made with the patients selected. The de-identified data will be stored on the Trust NHS computers, which require a login and password, for analysis. The data will only be used for this study.

The NHS Digital data is crucial to provide the most accurate information on the outcome of patients recruited to this study and will form the basis of a robust research study that will be submitted to peer reviewed journals.

The data from this study will not used for commercial purposes, not provided in record level form to any third party, and not used for direct marketing. No work on this study will be carried outside of UHS.

All outputs will be aggregated with small number suppressed in line with the HES analysis guide.