Renal study: Privacy notice

Researchers are analysing de-identified routine patient records to learn more about risks of life-threatening infections in end-stage renal disease.

Overview

This privacy notice outlines the purpose of this research project and how we will collect and use the data. It also describes how to get further information and what to do if you do not want to be part of the study.

You have the right to access any personal information held about you, to have your information processed fairly and lawfully and the right to privacy. These rights are upheld by law and outlined in the Data Protection Act 2018 and the General Data Protection Regulation (GDPR).

You can find general information about how patient data are used in research at the links below:

Purpose of the research

Antibiotic-resistant infections are a global threat, but some groups of people are more vulnerable to them because of particular chronic illnesses. Renal disease is one of them. Renal impairment and renal replacement therapy (such as haemodialysis) are associated with increased risks of infection, which requires frequent antibiotic treatment. Renal patients are also more frequently exposed to healthcare environments and procedures from which drug-resistant infections may be acquired.

This means patients with renal impairment may be more likely to develop life-threatening antibiotic-resistant infection. Yet, epidemiological evidence of this remains imperfect, particularly when it comes to understanding how the risk and severity of such infections varies between different types of renal patients.

To address this gap in knowledge, this study will examine de-identified electronic health records from Queen Elizabeth Hospital Birmingham, one of the UK’s major renal centres. The study objectives are to measure the rate and factors associated with (a) antibiotic prescribing for renal patients admitted to hospital and (b) antibiotic-resistant infections during renal patient admissions.

By producing new evidence, researchers hope to learn about potential areas where drug-resistant infections could be prevented, for instance by strengthening infection control procedures, or by reconsidering the way antibiotics are used in treating patients.

Information collected for this research

We have a data sharing agreement with University Hospital Birmingham NHS Foundation Trust which authorises us to hold a subset of de-identified hospitalisation record for adults aged 18 years who were treated for chronic kidney disease between 2010 and 2021.

This information contains records of:

  • patient sex, ethnic group and 10-year age group
  • inpatient admissions, procedures, diagnoses, antibiotics prescribed and administered
  • outpatient dialysis appointments
  • clinical observations (vitals)
  • clinical investigations (microbiology sample testing, blood tests, renal function)
  • month and year of death
  • specialist information on chronic kidney disease (disease stage, type of care, risk factors)

These records are held on certified secure computer network known as the UCL Data Safe Haven, and are considered to be kept sufficiently safe and restricted so that researchers can analyse them without risking to breach confidentiality and data protection.

The legal basis for processing personal data for this purpose data at UCL falls under Article 6(1)(e) of the General Data Protection Regulations (GDPR), i.e. “a task carried out in the public interest”. It also falls under Article 9(2)(j), “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes”.

Ethical approval for this research was granted by a Health Research Authority Research Ethics Committee (reference REC 20/NE/0215).

Outputs from the research

This study will search for risk factors associated with the risk of drug-resistant infections among:

  • demographics (age, sex, ethnicity)
  • co-morbidities
  • frequency and class of antibiotics used
  • time (drug-resistant infections are increasing nationally)
  • receipt of transplant
  • receipt of renal replacement therapy (dialysis)
  • chronic kidney disease stage and renal function
  • use of intravenous lines.

Findings will be published an in academic journal.

This research will help researchers understand how the incidence and type of drug-resistant infections vary in different types of patients, and inform the design of more sophisticated research studies into interventions to prevent, track or treat such infections.

This research will help Queen Elizabeth Hospital clinicians better understand infectious trends and consider how to improve patient care both for admitted patients and patients undergoing dialysis.

Finally, this research will contribute towards strengthening evidence on healthcare acquired infections. This is important to inform wider healthcare and government policy on the prevention and treatment of antibiotic resistance nationally, since drug-resistant infection can transmit to other patients.

Data storage and retention

Data will be stored until 31 August 2021 on secure servers at University College London. All records will then be erased.

Your rights

Records held for this research programme are pseudonymised: researchers are not able to identify which records may belong to you. As a consequence, it is not possible for researchers themselves to grant usual data protection rights.

However, University Hospitals Birmingham NHS Foundation Trust is able to uphold your rights, for instance if you do not want your information to be used by the University College London research team. You can contact University Hospitals Birmingham NHS Foundation Trust’s Data Protection Officer at the address below:

Information Governance Team
3rd Floor, Nuffield House
Mindelsohn Way
Birmingham
B15 2TH
Email: InformationGovernance@uhb.nhs.uk

Who can I contact?

This research is led by Dr Laura Shallcross at University College London (UCL) and Dr Martin Gill at University Hospitals Birmingham. If you have questions or concerns about the study please contact:

Dr Laura Shallcross
UCL Institute of Health Informatics 222 Euston Road
London
NW1 2DA
Email: l.shallcross@ucl.ac.uk

How can I complain?

University College London sponsors this study and is acting as Joint Data Controller. If you wish to complain about our use of personal data, please send an email with the details of your complaint to the Data Protection Office so that we can look into the issue and respond to you. You also have the right to lodge a complaint with the Information Commissioner’s Office (ICO) (the UK data protection regulator).

For further information on your rights and how to complain to the ICO, please refer to the ICO website.

Details about the project

Full title: Antibiotic prescribing and resistance patterns in renal inpatients

IRAS project: 277662

UHB R&D reference: RRK6981

HRA Research Ethics Committee reference: REC 20/NE/0215

When was this privacy notice last updated?

This privacy notice was last updated in December 2020 and may be amended from time to time.



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