COVID19 Clinical Predictors and Outcomes- Research Project
Study title: COVID-19, clinical predictors and evolution of disease in hospitalised and intensive care patients.
HRA National Research Ethics reference: 20/SC/0220
Sponsor: St George’s University Hospitals NHS Foundation Trust (JRES ref 2020.0115)
About this project
St George’s University Hospitals NHS Foundation Trust is setting up a collaborative project on COVID-19. This project will involve doctors and researchers from different specialities who will collaborate to investigate factors associated with severity and mortality in patients with COVID-19, and to improve treatment.
This project proposes to make use of clinical data collected routinely at St. George’s University Hospital during the course of patients’ admission and that is already available to the clinical team responsible for the patients’ care. The project will focus on data collected for all patients admitted to St. George’s University Hospital between 01 December 2019 and 30 April 2022.
Different specialities (e.g. respiratory, intensive care, infectious diseases) will need to approach the same overall aim from different perspectives, so several sub-studies will be derived from these data. Although all sub-studies will use different parts of the data derived from admissions, all will be non-interventional and will be using clinical non-identifiable data.
The care and treatment patients receive will not be modified by any study under this project. This project has been approved by the Health Research Authority Research Ethics Committee.
How will patients’ data be used.
The studies under this project will use only clinical data related to the patient’s admission that is collected routinely by the team responsible for patients’ care. These data will be taken from patients’ medical records.
The use of identifiable information (hospital ID number and name) will only be required for merging different hospital datasets. Only authorized persons will have access to the identifiable data. Any identifiable information will be removed and anonymized before conducting any analysis, so patients will not be able to be identified in any ensuing reports or publications.
Research or NHS staff who do not need to know patients’ identifiable information (including GPs) will not be able to see these data. All data will be anonymised and have a code number instead. We will keep all information safe and secure.
Once we have finished the study, we will keep some of the data for a period of 10 years, so we can check the results. All reports and publications will be written in a way that no-one can work out that you took part in the study.
This study will not provide any direct benefit for you as your care and treatment will not be modified/affected in anyway, but we hope that the findings in this study will help improve the management and treatment of COVID-19 in the near future.
Anonymised routinely collected information in medical records can be used to support medical research aimed at the patient and societal benefit as long as it is supported by the Health Research Authority Research Ethics Committee.
Do I have to take part?
All patients have the right at any time to object to the use of their information for any purpose other than their own direct care. Patients can choose one of two types of opt-out:
- National – opt-out of research and data sharing at a national level through the National Data Opt-out Programme at https://digital.nhs.uk/services/national-data-opt-out.
Once the opt-out is communicated, but no further processing of data will take place.