Information for Patients
Why have I been invited to take part in the Sunflower Study?
The hospital you have been referred to, as you are experiencing problems with your gallbladder, is taking part in the Sunflower Study. One of the possible treatments for patients with gallbladder problems is surgery. The study is looking at whether testing for bile duct stones before gallbladder surgery is necessary or not. We realise that your treatment may not yet have been decided, but if you are referred for gallbladder surgery you may be invited to take part in this study. We are therefore providing you with this informationto help you consider whether you’d like to take part in the study should you have gallbladder surgery. If you are referred for surgery, a member of the team will talk to you about this study once you have spoken to the surgeon.
What will I have to do if I take part?
You will need to take the time to read and understand what the study would involve. You can speak to the research team at your hospital who will answer any questions you may have. If you decide to take part, you will be asked to sign a consent form. So that the study can evaluate the information given to participants about the study, we may ask your permission to audio-record these consultations. If so, you will be given a separate information sheet that describes this in more detail. If you agree to your consultation being audio-recorded, we will ask you to sign a separate consent form.
We will put everyone who takes part in the study into one of two groups. To try to make sure the groups are the same to start with, people will be put into a group randomly so that neither you or the study team will select which group you will be in. One group will have the scan to test for bile duct stones before their gallbladder surgery and the other group will not. The group that have the scan will be half the size of the group who do not, to limit the number of scans performed in the study. Whichever group you are put into, the care you will receive is considered part of standard routine care that takes place all over the NHS, and every other aspect of your care will be the same.
If you are in the group of people having a scan to test for bile duct stones, you will be given an appointment at your hospital to have the scan before your gallbladder surgery either as an outpatient or an inpatient depending on whether you are already staying in hospital.
We will collect information about your medical history before your gallbladder surgery and will review your progress until you are discharged home. We will also collect information about any hospital admissions you make for between 1-4 years after your operation, depending on when you joined the study. To collect this information, the study will use some data about you which will be routinely collected by healthcare providers whenever you have hospital treatment. For patients in England, this data is held by NHS Digital. Some data held about you by NHS Digital, including hospital episodes, diagnostic imaging and mortality data, will be sent to researchers working on the study. For patients in other nations of the UK, the same data will be sent by the relevant organisations.
In order to record how you are feeling before and after your operation, you may be asked to complete questionnaires. Not all participants will be asked to do this, and it will be decided at random. This is because we do not need all participants to fill in questionnaires to have enough information to answer this part of the research question. If you are selected, we will ask you to complete the questionnaires at the time you start the study, at the time of your gallbladder surgery, and approximately 3, 6 and 12 months after joining the study. Some participants will also complete questionnaires 18 months after joining the study. You can choose to do them by post or electronically (online). The questionnaires give us information about your health; for example, how you are feeling, what activities you can perform and how much pain you are feeling. They shouldn’t take more than approximately 10 minutes to complete.
What alternatives are there to taking part?
If you decide not to take part in the study, you will receive the usual care provided in your hospital, which may or may not include having a scan.
What are the possible benefits of taking part?
We cannot promise that the study will help you, but we hope that the results from this study may help benefit the NHS and improve the management of future patients.
What is there is a problem?
If you have any concerns or questions about this study, please contact the research team (email@example.com or 0117 342 2526 / 07929 771395)
If you have concerns about the way you have been treated during the study or wish to make a formal complaint, you may wish to contact the Patient Advice and Liaison Service (PALS).
We have no reason to believe that you will be placed at any greater risk to your health by taking part in this study. However, if something goes wrong and you are harmed during the study there are no special compensation arrangements. If anything goes wrong because of taking part in the study due to negligence, the NHS trust responsible will compensate you. Negligence includes, for example, if injury was caused by a deviation from the study protocol by a researcher. The normal NHS complaints mechanisms will still be available to you.
Will my taking part in the study be kept confidential?
Leeds Teaching Hospitals NHS Trust is the Sponsor for this study and University Hospitals Bristol NHS Foundation Trust is where the study coordination team at Clinical Trials and Evaluation Unit, Bristol Trials Centre (BTC), are based. Both organisations will use information from you and your medical records in order to undertake this study and will act as the joint data controllers for this study. This means that they are responsible for looking after your information and using it properly. Your local hospital site and the central coordinating team in Bristol will keep identifiable information about you for 5 years after the study has finished.
Your local recruiting hospital will collect information from you and your medical records for this research study and will transfer it securely to the coordination team at BTC in accordance with our instructions. All your data will be stored securely on an NHS server.
Your local recruiting hospital and BTC will use your name and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. They may also check your address against NHS records to ensure that the details they have for you are up to date.Occasionally, other members of NHS staff or research staff at your local recruiting hospital may need to check your medical records but this will only be done by researchers bound by the same rules of confidentiality as all NHS staff. The confidentiality of your medical records will be respected at all times. All the information collected will be stored in a purpose built and secure database. Individuals from the Sponsor and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Your local recruiting hospital and BTC will keep your name and contact details confidential. The only people in the coordinating centre who will have access to information that identifies you will be people who need to contact you as part of the Sunflower Study or audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name or contact details.
Any information about you will only be used for the purposes of this research unless you give permission for it to be used in future ethically approved studies. You can still take part in the Sunflower Study if you do not want your data to be used for other studies. If you do consent to your data being stored for use in future studies, any identifiable information will be stored on secure NHS servers. Stored identifiable information will not be passed on to any third party. Information collected about you without any identifiers will only be shared with researchers who have ethical approval for their research.
We may also need to contact your GP to obtain information relevant to our research. To enable us to do this, we will ask for your consent for your GP to be informed that you are participating in this study.
What if new information becomes available?
If we get new information about the management of bile duct stones, your doctor will let you know and discuss whether you want to continue in the study.
What will happen if I don’t want to carry on with the study?
You are free to withdraw from the study at any time without giving a reason and this decision will not affect your rights. You may be happy to continue with the questionnaires (if applicable), or you may want to withdraw from the study completely. This will be discussed with you at the time of withdrawal.
You can withdraw in writing, by telephone, or in person by contacting your local research team or the study coordinating centre (firstname.lastname@example.org or 0117 342 2526 / 07929 771395).
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. This means that we won’t be able to let you see or change the data we hold about you. If you withdraw from the study, we will keep and use the information about you that we have already obtained.
If you choose to stop taking part in the study, we would like to continue collecting information about your health from your hospital and routine data sources, without contacting you. If you do not want this to happen, tell us and we will stop. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information by reading the Bristol Trials Centre Privacy Notice or by contacting the SUNFLOWER team.
Who is organising and reviewing the study?
This study has been reviewed by an independent Research Ethics Committee, who protect your safety, rights, wellbeing and dignity. Leeds Teaching Hospitals NHS Trust has overall responsibility for the study. The study is managed by BTC. This study is funded by the National Institute for Health Research – Health Technology Assessment Programme (16/142/04).
It is unlikely that any insurance would be affected by taking part in this study, but you should consider this before consenting and seek advice if necessary.
The NHS provide general advice on surgery. The UK Clinical Research Collaboration produce a booklet called ‘Understanding Clinical Trials’ which provides general information on clinical research, and can also be requested by email from email@example.com