What is the C3 Study?
The C3 Study is designed to study the occurrence of heart rhythm problems, heart attacks and strokes that occur in those who survive a period of critical illness. We hope to identify who is at risk using the data that is already collected whilst you are in hospital.
Why is this important?
We do not have a good understanding of how things that happen during an ICU admission are related to long-term outcomes. This study will investigate one important group of conditions that are common after an ICU admission – strokes and diseases of the heart and blood vessels.
This research will help us identify high risk patients who could be considered for certain treatments that may reduce their long-term risks.
Is my health care data being used in the study?
In order to have the best chance of answering the study’s questions, we need large amounts of data (around a hundred thousand admissions to ICU).
In studies of this size, individual patient consent is often not feasible. In these cases, the Confidentiality Advisory Group (CAG) may permit the use of confidential patient information, providing adequate safeguards are in place and the use of the data is justifiable.
The Confidentiality Advisory Group (CAG) is an independent body which provides expert advice on the use of confidential patient information. The key purpose of the CAG is to protect and promote the interests of patients and the public, while at the same time facilitating appropriate use of confidential patient information for purposes beyond direct patient care.
Directly identifiable data will not be held in the study database
With permission from the CAG and the Oxford Research Ethics Committee, we are collecting data from the following sites (from 2006 to 2023):
- Oxford University Hospitals NHS Trust
- John Radcliffe hospital AICU
- Churchill hospital CICU
- Royal Berkshire NHS Trust
- Royal Berkshire ICU
- Imperial College Healthcare NHS Trust
- St Mary’s AICU
- Hammersmith Hospital GICU and CICU
- Charing Cross CXH ITU
- Kings College Hospitals NHS Trust
- Christine Brown Critical Care Unit (CCU)
- Frank Stansil CCU
- Liver Intensive Therapy Unit (ITU)
- Jack Steinberg CCU
Are you using my data without consent?
The NHS Act 2006 and the Regulations enable the common law duty of confidentiality to be temporarily lifted so that confidential patient information can be transferred to an applicant without the discloser being in breach of the common law duty of confidentiality.
In practice, this means that the person responsible for the information (the data controller) can, if they wish, disclose the information to the applicant without being in breach of the common law duty of confidentiality. They must still comply with all other relevant legal obligations e.g. the Data Protection Act 1998.
Approval also provides reassurance that we (the C3 study team) have undergone an independent review of our purposes and governance arrangements. Examples include:
- The activity must be a medical purpose as defined in s251 (12) of the NHS Act 2006
- The activity must be in the public interest or in the interests of improving patient care
- The activity must be compliant with the provisions of the Data Protection Act 1998
- All applications must undergo an annual review to evidence whether support is still necessary
I would rather my data isn’t used for this research. How do I opt out?
You are free to choose if data from your health records is shared for research and planning.
NHS Digital will inform us (by pseudo-anonymous study ID) which patients have opted out. This will be a continuous process from enrolment until the study ends.
Records that are flagged as opted-out within each site will not be extracted. If we are informed by NHS Digital of patients completing the opt-out after data extraction, these data will be removed and future records relating to these patients will not be extracted. We will also remove records from the study (in the same manner) if patients contact the study directly.
Participating sites will be asked to display the NHS opt-opt and Your Data Matters poster in their follow-up clinic area. We will also generate a business card sized notification which can be put into the information packs that patients in follow-up clinics receive. This will display the study logo, contact details and website address.
Your data matters
The study openly support the ICO Your data matters campaign. The aim is to increase the public’s trust and confidence in how their data is used and made available. We also support the NHS implementation of this campaign that has direct relevance to the study using data for patient benefit.