INFECTIVE ENDOCARDITIS AFTER
TRANSCATHETER HEART VALVE REPLACEMENT
Why are we doing this research?
Guy’s and St Thomas’ NHS Foundation Trust (GSTT) are conducting research into a rare complication of heart valve replacement, infective endocarditis. This occurs when the replacement valve becomes infected, requiring antibiotics or valve surgery. We are specifically interested in patients who have developed infective endocarditis after transcatheter valve implantation (TVI), where the valve is replaced without open heart surgery. We want to understand how many patients develop this complication, which patients are affected, and to look at which treatments are most effective.
Whose data is used in the research?
GSTT will access limited clinical information on patients who have developed infective endocarditis after TVI. We will receive some data that does not identify you, but will also receive NHS Number, which means that all this data does identify a specific person.
We also have permission to receive data on patients who have received other types of valve replacement surgery. For these patients we will receive the same data as above but without the NHS Number. This data is pseudonymised, as it does not directly identifiable an individual person. Pseudonymised data could however identify a person if combined with other data. For that reason, GSTT has robust controls about how the data is used to ensure that this does not happen.
The data that GSTT will receive comes from NHS Digital. They will use identifiable data, supplied by the National Institute for Cardiovascular Outcomes (NICOR) from three of their audits; the National Cardiac Surgery Audit, the UK TAVI registry and the National Congenital Heart Disease Audit, to link to hospital data.
What data will be used for this research?
GSTT will receive from NHS Digital data relating to patients visits to hospital. This data is called Hospital Episode Statistics (HES). HES is data collected about all hospital admissions, out patients and accident and emergency and includes clinical information about diagnoses and operations. For this research GSTT are requesting admitted patient care data from HES.
Once NHS Digital have linked the data they will supply GSTT with information about the hospital admissions of both the TVI patients and non-TVI patients. Neither of these HES datasets will contain name, address or date of birth. However, for TVI patients it will contain NHS Number and this will be used to request further clinical information from their operating consultant. This will include;
- Use of prophylactic antibiotics
- Diagnostic imaging tests and results (echocardiography/CT/MRI)
- Microbiology results (blood culture/valve explant)
- Clinical management of patients diagnosed with TVI-IE (antibiotic regimen & duration/surgery)
- Details of complications of infective endocarditis
Once we have this information GSTT will securely destroy the NHS number. GSTT do not need to have data that directly identifies individual patients to conduct the analysis, but we do require the NHS number to provide to the clinicians to obtain the extra information bulleted above. GSTT would never use the NHS number to try to re-identify people themselves.
Once GSTT has securely deleted the NHS number, we will have pseudonymised data to use in our research and any publications following our analysis will contain aggregated data only.
Guy’s and St Thomas’ NHS Foundation Trust are the sole Data Controller for the data used in this research.
Guys and St Thomasâ€™ Foundation Trust will not share this data with any other organisation, other than what has already been described.
What can I do if I don’t want to be included in this research?
If you have had infective endocarditis after TVI in England and are happy to be included in this study there is no requirement to contact us.
If you have had infective endocarditis after TVI and DO NOT want to be included in this research please contact us by email to email@example.com or by writing to;
Professor Bernard Prendergast
6th Floor, East Wing
St. Thomas Hospital
Westminster Bridge Road
London SE1 7EH
and we will remove you from our database. Your decision about whether or not to allow your information to be used in this research will not affect your health treatment.
How can I find more information?
If you would like further information or would like to be kept informed of our results please contact firstname.lastname@example.org