MR730 - Bespoke data linkage

This Data Sharing Agreement permits the retention and processing of the data provided under previous iterations of this Agreement.

The following describes the purposes for which the data was disseminated under previous versions of this Data Sharing Agreement:

The University of Birmingham requires Current Status and Cause of Death data for use in the BAFTA 2 study. This study will be undertaken in Birmingham Clinical Trials Unit which sits within the University Of Birmingham's Institute of Applied Health Research. The University of Birmingham set up Birmingham Clinical Trials Unit to undertake health research in response to calls from a variety of funders including the National Institute of Health Research. The University of Birmingham responded to a call for research in this area.

BAFTA 2 is a follow up study to the BAFTA project that was closed 8 years ago (MR730). The aim of the study is to investigate the longer term effects of anticoagulation in terms of overall mortality and risk of stroke and cardiovascular events. The University also aims to report the longer term adherence to anticoagulation therapy in this age group. All patients that were involved in the original study are patients that the University aim to collect data from (1440).

The original cohort of patients has been used and no new patients have been recruited. Therefore, the University of Birmingham has permission from CAG to gain access to these records without further consent; it was decided that the consent originally given met the guidelines for collecting this additional data.

In the original BAFTA trial, the average length of follow up was 2.7 years, and the average age on entry to the study was 81, With the increasing numbers of very elderly people in the UK, it is of great relevance to understand whether the benefits of anticoagulation persist in this very elderly group. The long term follow up of the BAFTA cohort offers the opportunity to explore this.

This follow up study will provide invaluable information about the long term outcomes for this population. Additionally, with the introduction of new anticoagulants, such as rivaroxaban, this data will assist the University in addressing the cost effectiveness of the new anticoagulants by providing answers on long term harms and benefits that will be important for economic modelling.

The data will be used to establish who is now deceased and the cause of death. The mortality data will also be used to establish overall mortality rate. The cohort size is 1440 individuals

No new data will be supplied under this Agreement.

Data will only be accessed by individuals within Birmingham Clinical Trials Unit who have the authorisation from the Professor of Biostatistics and Deputy Unit Director, to access the data for the purposes described, all of whom are substantive employees of the University of Birmingham. The core dataset will only be accessed by two individuals within Birmingham Clinical Trials Unit. They will produce pseudonymised subsets of the data that will be accessed by the statisticians from Birmingham Clinical Trials Unit in the University of Birmingham. Access to the data supplied by NHS Digital, including subsets, will be restricted to substantive employees of the University of Birmingham.

Only the named researchers employed by the University of Birmingham will have access to these data. No third parties will be accessing the data and it will not be made available to anyone outside of the University of Birmingham. Researchers from the University of Cambridge will assist with preparing the algorithms for the analysis of the database holding the combined BAFTA 2 data. These algorithms will be designed by the University of Cambridge against a database with the same field architecture as the BAFTA 2 database but which only contains dummy data. Once these analysis algorithms are correct they will be passed to researchers in the University of Birmingham who will run them against the database which contains the BAFTA 2 data supplied by NHS Digital. The University of Cambridge will not analyse or process any data in relation to this study and are only supplying the algorithm that will be used by Personnel from The University of Birmingham.

Once downloaded onto the secure University of Birmingham servers dedicated to hold data supplied by NHS Digital, any necessary decryption will take place. A member of the IT team from Birmingham Clinical Trials unit will ensure that the data provided only contains the Unique Study ID and no other identifiers. Any analysis of data for BAFTA2 will only be undertaken on this pseudonymised data set.

There will be no requirement nor attempt to re-identify individuals from the data.

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 not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

The original BAFTA trial led to publications in a number of journals, including Lancet, BMJ, and Stroke.

As well as these papers, the results arising from BAFTA have been presented at numerous international conferences.

The University would anticipate that this further analysis of long-term outcomes would lead to publications in similar high impact journals and are expecting to publish towards the end of the 2019. The analysis would have an immediate impact on policy, as it would help clinicians and their very elderly patients reach informed decisions about whether or not to continue anticoagulation. The University will present the data at relevant conferences, e.g. Society for Academic Primary Care (SAPC), UK Stroke Forum (UKSF), and make the results available to The National Institute for Health and Care Excellence (NICE) and alert relevant charities, such as the Stroke Association, of the findings.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide. Record level information will not be released to any third party.

The original BAFTA trial was a landmark study that has had significant impact on management of stroke prevention in older people and has been incorporated into national guidelines. The original trial provided key data on the safety and effectiveness of anticoagulation in people over the age of 75 in atrial fibrillation (a major cause of stroke in this age group). This follow up study will provide invaluable information about the long term outcomes for this population. Additionally, with the introduction of new anticoagulants, such as rivaroxaban, this data will assist the University in addressing the cost effectiveness of the new anticoagulants by providing answers on long term harms and benefits that will be important for economic modelling.

As well as being incorporated into national guidelines, and providing data on the safety and effectiveness of anti-coagulation in people over the age of 75 in atrial fibrillation (a major cause of stroke in this age group), a number of publications have arisen from the original BAFTA study, thus allowing its findings to have an impact on health care globally.