For parents & guardians

PRESSURE is a research study that compares the clinical and cost-effectiveness of permissive blood pressure targets with usual care in critically ill children with hypotension.

PRESSURE is sponsored by Cambridge University Hospitals NHS Foundation Trust and managed by the Intensive Care National Audit & Research Centre (ICNARC) Clinical Trials Unit. PRESSURE is funded by the National Institute for Health Research (NIHR) – Health Technology Assessment Programme

With consent, we will collect information on each child’s progress from their medical notes and the national databases of NHS patient records, including the child’s name, date of birth, their NHS number, any relevant health data and parents/guardians’ contact details. One year later, ICNARC will send a short questionnaire to parents and guardians to find out how their child is doing. All information collected will securely submitted to ICNARC and be kept secure and confidential at all times. If consent is not granted, we will collect a minimised anonymised dataset for monitoring safety and important outcomes

ICNARC will follow-up on your child’s well-being by requesting some important health information, including survival and hospital stay data, from national databases held by  Paediatric Intensive Care Audit Network (PICANet), NHS Digital and Digital Health and Care Wales (organisations that manages access to national database of NHS records).

For information from PICANet, your child will be assigned a PICANet ID number to retrieve the information, keeping their identity anonymous at all times. To obtain important information from NHS digital, the PRESUSRE trial team will send your child’s date of birth, postcode, NHS number and unique trial number (required to ensure you can be identified in the database correctly) to them using a secure password protected online file exchange service. An authorised person from NHS Digital will then link the identifiers to the national records and securely send back the relevant data for storage on the secure PRESSURE trial database. The same process will be carried out with Digital Health and Care Wales.

All data is kept under a secure password protected database, owned by an authorised contractor called Exponential-e. Only authorised members of ICNARC and the participating PICUs are able to access this. At ICNARC regular backups of your data are undertaken to avoid data loss. Once the study is finished, statisticians from ICNARC will analyse the information to find out which treatment was most effective. A member of our team based at the London School of Hygiene and Tropical Medicine will help with some of the analyses but will only have access to pseudonymised data and will not be able to identify any of the participants

At the end of the study, ICNARC will keep identifiable information (personal data) about your child for no longer than one year after the study has finished (unless you have agreed otherwise) and the rest of the research data will be kept for up to 10 years. It will not be possible to identify any person who has taken part in the study in any reports or articles

ICNARC process data for this study under the legitimate interest legal basis. This is because ICNARC is a registered charity and the data processing described here is to support scientific and statistical research. Your rights to access, change or move your child’s information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw your child from the study, we will keep the information that we have already obtained. To safeguard you and your child’s rights, we will use the minimum personally identifiable information possible. There is no automated decision making or profiling.

If, when you consented for your child to take part, you indicated that you did not want us to either obtain the information from NHS Digital or Digital Health and Care Wales or to send you a questionnaire, we will not process data for these purposes.

More information about PRESSURE is available on this website. If you have any other questions or wish to opt out or withdraw, please contact:

Robert Darnell         Trial Manager             pressure@icnarc.org        0207 269 9271

Dr David Inwald      Chief Investigator       di260@cam.ac.uk

ICNARC’s overarching privacy notice, and details of our Data Protection Officer, is available here.

If you have a complaint about our use of your information, you can contact the Information Commissioner’s Office via their website or write to them at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF