Information for participants (primarily focused at UK participants)
You are being invited to take part in a research study which aims to help improve the care of patients who undergo surgery in the future. Before you decide, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully. Talk to others about the study if you wish. Ask us if there is anything that is not clear or if you would like more information.
ISOS is a study which is simply recording information about patients undergoing surgery and the care they receive. This information will help us to understand how surgical patients are treated across different healthcare systems worldwide.
This study is taking place in hundreds of hospitals around the world for one week during the spring of 2014. We have chosen you because you are having surgery and will stay in hospital overnight during that week. In the United Kingdom more than 150 hospitals have registered to take part.
No. It is up to you to decide to join the study and your participation is voluntary. You will be asked to sign a consent form if you decide to participate. If you change your mind afterwards you may leave the study at any time – please contact firstname.lastname@example.org if you would like to do this.
You will not receive any additional treatments or medicines as part of this study. The study simply involves collecting a small amount of information about your treatment during and after surgery. Patients will be followed up until they leave hospital. We will then follow your health status for three years using an NHS database formerly called the Health and Social Care Information Centre (HSCIC), now known as NHS Digital. Your personal information will be shared with NHS Digital to facilitate this (name, date of birth and postcode). Data will be transferred through secure methods to NHS Digital, and no information about the operation or other data collected during the ISOS study will be shared with NHS Digital. They will return the date of death of patients who have died in the three years after surgery.
No. The care you receive will be exactly the same as if the study was not taking place.
We will record details including your name, age and hospital number, which will allow us to find your information in the NHS database. We will also collect information about your surgery, anaesthesia and your treatment afterwards. The study will combine information collected during your hospital admission with civil registration data (Date of Death and Cause of Death) supplied by NHS Digital on behalf of the Office for National Statistics (ONS)
A trained member of NHS staff will collect the information. They are required to adhere to strict codes of confidentiality.
The information collected about you will be stored on a secure database. Statisticians will analyse the information to understand the care of patients having surgery around the world. Your data is retained for 20 years in line with research regulations.
The information is held on a secure computer system and the study has been approved under the Data Protection Act by the lead site, Barts Health NHS Trust.
You will not benefit directly from the study but your participation will help patients undergoing surgery in the future.
No. There are no disadvantages of taking part and no changes to your treatment.
This study was reviewed by the Yorkshire & The Humber - Humber Bridge Research Ethics Committee (REC). This committee are a group of people who oversee the ethical conduct of research studies. These people are not part of the study team.
Last updated: 13th March, 2017
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