Information for patients

We are doing this study to check whether consent forms in several different languages can improve access to research for patients having surgery. We will also compare the accuracy and completeness of diversity (protected characteristics) data collection using different methods such as in your medical records, as part of questionnaires and by asking you questions.

You have been invited because you are going to have surgery and are taking part in a study where your demographic information will be collected. You may be invited to take part in other PROTECT platform studies if you are eligible.

No. It is up to you to decide whether or not you would like to take part in the study. If you decide to take part, you will be asked to sign a consent form. You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. If you decide not to take part, or later to withdraw, this will not affect any part of the care you receive.

We will ask you to consent to be a part of the PROTECT Trial. The consent materials will either be in a traditional paper format or an electronic format, and presented at random in multiple languages. Information such as sex, ethnicity, partnership status, disability, pregnancy status, religion, sexual orientation and gender and gender identity will be collected from you as part of the PROTECT trial, and you can refuse to answer any questions if you do not want to. We will use this information to see what method of data collection accurately captures diversity data in clinical trials.

The information we collect may improve how we collect diversity information for patients taking part in clinical trials.

There are no disadvantages in taking part in this study, only information available to us will be collected.

If you decide not to take part, or later to withdraw, this will not affect any aspects of the care you receive. You are free to stop taking part at any time without giving a reason. If you decide to withdraw from the PROTECT-DIVERSITY study, you will remain part of the PROTECT platform, unless you tell us otherwise. Please refer to the main PROTECT Platform Participant Information Sheet, under section ‘What will happen if I don’t want to carry on with the study?’.

You can find out how we will use your information by referring to the relevant sections in the PROTECT Participant Information Sheet. 

The study is funded by the British Journal of Anaesthesia and the Academy of Medical Sciences.

Once the study is complete, we will prepare and publish a scientific report. The results will be available to the hospitals that took part in the study. We may share information relating to the study in scientific meetings and it may be published in scientific journals. The results including a plain English summary of the findings will be published on the PROTECT website and you will be able to request a copy by contacting the study team via email: protect-admin@qmul.ac.uk