For this follow-up study, we will use an existing linkage between UKPDS participants and the ONS mortality dataset, provided by NHS Digital on behalf of ONS, sourced from Civil Registration Data. We will obtain mortality data (month and year of death) held by NHS Digital and NHS Scotland.
We will use this existing linkage to additionally link participants to hospital NHS electronic health records (hospital admissions, hospital out-patient, critical care and A&E attendances along with mental health information). This would involve sharing of confidential information to wider NHS organisations to facilitate linkage. This will allow us to compare rates of important health outcomes, including heart attacks, strokes, dementia and dementia, experienced by participants in different randomised groups.
We wish to follow-up the original participants in the original UKPDS cohort. The long term follow-up of the UKPDS has two main aims:
(1) To assess the effect of blood pressure lowering on dementia, major vascular diseases (such as heart attack and stroke) and death in people with diabetes; and
(2) To assess the effect of better glucose control on dementia, major vascular diseases (such as heart attack and stroke) and death in people with diabetes. This is because the lifetime benefit of these treatments is likely to have been underestimated in the trial follow-up.
People with higher blood pressure or diabetes have an increased risk of developing dementia, but there is no evidence that lowering either blood pressure or glucose reduces the risk of developing this debilitating condition. A randomised trial like UKPDS with very long follow-up is necessary, since dementia is an insidious condition which takes many years to develop, and which represents a unique opportunity to directly assess the effect of these treatments on dementia risk. This question is highly relevant. If we demonstrate that blood pressure lowering or glucose lowering prevents dementia, many more patients will be considered for blood pressure lowering thereby reducing the burden of disease posed by dementia.
To find out more about this long term follow-up please see UKPDS Long Term Follow-Up Protocol.
No, automated processing will not be used in this research project.
The data that we receive and analyse will be identified by an anonymised trial number only, and will not be identified by name, date of birth, NHS number or address. With the trial number, we will link to the original UKPDS database, and additionally biological information collected during the trial (i.e. blood tests). This information received from NHS Digital will be imported into a database held securely by the University of Oxford and used solely for academic research purposes. Before analysing this complete dataset (including information already provided by trial participants with information from NHS Digital) patient identifiers will be removed. We will use the minimum personally-identifiable information possible. To minimise any chance of re-identification, we are requesting the minimum required data for the analyses, ensuring the data is anonymised, and will keep the required data under review for analysis. We will not attempt to re-identify individuals. Any personal data that identifies you are collected and managed by the UKPDS team and will not be shared with anyone else, except to obtain health information about you from NHS Digital. Access to the study database is by unique combinations of usernames and passwords and only authorised study personnel can access information about participants. The University building is also secure with authorised swipe card access only. Importantly, whilst the information received is specific to each trial participant, no individual person will be identifiable in any publication arising from this work.
Any personal data that identifies you are collected and managed by the UKPDS team and will not be shared with anyone else, except to obtain health information about you from NHS Digital (see section above).
The University of Oxford is required to keep the information collected about you for at least 25 years after "end of the study" and perhaps longer if required by the law or other research needs. The "end of the study" is when the last health information is collected about study participants.
Anonymous results of the study may be made available to collaborators and relevant bone fide researchers according to the Diabetes Trials Unit and the Nuffield Department of Population Health (NDPH), University of Oxford data sharing policy: https://www.ndph.ox.ac.uk/about/data-access-policy
The University of Oxford, as sponsor, is the data controller. This means that we, as University of Oxford researchers, are responsible for looking after your information and using it properly. The University of Oxford is using your personal data for research purposes and will only process personal data as necessary to undertake research that is being carried out in the public interest. This is known under data protection law as our “legal basis”. The legal basis for the processing and storage of your personal data for the UKPDS Long Term Follow-up study and its sub-studies is that it is ‘a task in the public interest’ (Article 6 (1) (e) EU General Data Protection Regulation (GDPR)). In addition, a required condition under GDPR to process your special category (sensitive) personal data is met as it is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes (Article 9 (2) (j) GDPR).
Data protection regulation provides you with control over your personal data and how it is used. When you agree to your information being used in research, however, some of those rights may be limited in order for the research to be reliable and accurate.
Further information about your rights with respect to your personal data under the General Data Protection Regulation is available on the University of Oxford's Compliance webpage https://compliance.admin.ox.ac.uk/node/673106. If you would like to contact us directly for more information about how we process and protect data collected for research, please email: dtu@dtu.ox.ac.uk or call: 01865 857 240 or you can write to: UKPDS, Diabetes Trial Unit, University of Oxford, OCDEM Building, Churchill Hospital, Old Road, Headington, OX3 7LJ
Complaints
If you wish to raise a complaint on how we have handled your personal data, you can either contact the UKPDS study team via the contact details above or the University of Oxford's Data Protection Officer via email at: data.protection@admin.ox.ac.uk or by telephone on +44 (0) 1865 270285, who will investigate the matter. If you are not satisfied with our response or believe we are processing your data in a way that is not lawful you can complain to the Information Commissioner's Office (ICO) or call their helpline on 0303 123 1113.
It helps UKPDS to produce reliable results if we are able to follow-up as many participants as possible by accessing their electronic NHS records. If you decide you do not want your study data to be linked in this way you can withdraw from this follow-up without affecting your current medical care. This can be done by contacting the study team who would require your identifiers to then inform NHS Digital and other data sources that you no longer wish to be included. You are free to do this at any time and don’t have to give us a reason. If you have any questions, please contact the study team using the details below:
UKPDS
Diabetes Trials Unit
OCDEM Building
Churchill Hospital
Old Road
Headington
OX3 7LJ
Email: dtu@dtu.ox.ac.uk
Telephone: 01865 857240
The UKPDS Long-term Follow up study and its substudies have been reviewed and approved by the South East Scotland Research Ethics Service (18/SS/0127).
Reference number: 18/SS/0127
PRIVACY NOTICE UKPDS STUDY 25th November 2019 V6