PATIENT INFORMATION SHEET Study name: CT morphology of lung parenchyma pre and post bariatric surgery: correlation with pulmonary function.

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1 Version Hammersmith Hospital Du Cane Rd London W12 0HS Tel: PATIENT INFORMATION SHEET Study name: CT morphology of lung parenchyma pre and post bariatric surgery: correlation with pulmonary function. Introduction You are invited to take part in a Research Study. Before you decide whether or not to take part, it is important for you to understand what it will involve. Please take time to read the following information carefully, and discuss it with others if you wish. It describes the purpose, procedures, benefits, potential risks and precautions of the study. Ask us if there is anything that is not clear, or if you would like more information. Take time to decide whether or not you wish to take part. If you decide not to take part in the study, you will not have to give a reason why and your future medical care will not be affected. 1. What is the Study? The study is assessing the lung structure with Computed Tomography (CT) scans and lung function before and after weight loss surgery. 2. What is the purpose of this study? The purpose of this study is to examine the effects of weight loss on the lungs using limited CT scans and lung function. A limited CT scan is when only 3 sections of the chest are obtained when breathing in and 3 sections breathing out, which is a much smaller radiation dose than a standard CT scan where the whole of the lung is included. 3. Do I have to take part? No. It is up to you whether to take part or not. If you decide to participate, you will be requested to sign a consent form after you have read this information sheet and discussed it. Even if you decide to take part, you may withdraw at any time without giving a reason. Your decision to take part or not to take part will not affect the standard treatment you receive. 4. What will happen if I agree to take part in the study? If you agree to take part in this study, you will initially be asked questions to make sure that you qualify for this study. These will include whether you have any respiratory symptoms,

2 previous drug treatments and details of previous occupations, pet keeping and smoking history. Once you have entered the study, a limited CT will be done with lung function tests (blowing into machines) before you have surgery and you will be asked to come back to the hospital for limited CT scan and lung function tests 6 months after surgery. 5. What are the side effects of taking part? The lung function tests are not associated with any side effects. The limited CT scans use Xrays (ionizing radiation). As with all exposure to ionizing radiation, there is a small risk of developing cancer. This is greatest in children and young people. However, everyone is exposed to ionizing radiation on a daily basis (background radiation dose) and the additional radiation dose from taking part in the study will be 9 weeks of background radiation, which constitutes a minimal risk for the development of a cancer (1in 20,000 risk). 6. How will my lifestyle be affected if I take part in the study? When deciding whether to take part in this study, consider if the tests and extra hospital visit listed above will affect your work and family schedules. We can arrange the CT scan and lung function tests on the same day as your pre-assessment visit for surgery. You will also have to visit the hospital once 6 months after the surgery. We will make a payment of 50 for your time and travel expenses. 7. What happens during CT scanning? On the day of your surgery pre-assessment at Charing Cross, you will also come to the Xray department at Charing Cross Hospital. We will then ask you to lie comfortably on your back on the scanner and a CT scan will be done. A CT uses X-rays to look at the lungs in detail. There will not be any needles or injections. You will be asked to take a breath in and hold your breath and also breathe out. The total duration of the scan will be less than 5 minutes. 8. What are the benefits of taking part in the study? Taking part in this study may not have direct medical benefit for you. The study will not provide any information that may benefit you, but it may be interesting for you to see how weight loss affects your lungs. It may help others in the future, by providing information about how excess weight affects the lungs and breathing. Information from this study will help doctors learn more about the effects of obesity on the lungs. 9. What are the other possible disadvantages of taking part? The disadvantages of taking part in this study are associated with the use of Xrays in CT scans. You will also be exposed to extra radiation by taking part in this study. This will be due to the CT scan. The maximum amount of radiation you will be exposed to if you take part in the study will be similar to that received by a person living in the UK over a period of 9 weeks as a result of background radioactivity in the atmosphere. We will be happy to discuss this indepth if you have any further questions on radiation exposure. 10. What will happen after the study? When you have had your surgery, you will need to come in for a follow-up visit approximately 6 months later. You will undergo a second CT scan and lung function tests. Your participation in the study will then be complete with no further tests or visits to hospital.

3 11. What if I become pregnant? If you are pregnant, you will not qualify to take part in the study. If you should get pregnant during this study, please let your doctor know immediately. We will withdraw you from the study immediately. All women who could become pregnant will be asked to sign a section of the consent form to confirm they are not pregnant or agree to a pregnancy test. 12. Who is organising and funding the research? Dr Susan Copley, Consultant Radiologist is organising the study. Mr Ahmed (Consultant Surgeon) and Dr Jonathan Cousins (Consultant Anaesthetist) are also involved. The study is funded by a Bursary from the Royal College of Radiologists (UK). 13. What if something goes wrong? The scans will be reviewed on the day of the study by an experienced consultant Radiologist (Dr Susan Copley). If a serious medical condition is identified your hospital Consultant (Mr Ahmed) and your GP will be informed by telephone. Imperial College London Healthcare NHS Trust s research is covered by the standard NHS Hospital Indemnity for negligent or wrongful harm and this is provided under clinical negligence scheme for Trusts clinical risk management NHS Litigation Authority (NHSLA) for NHS Trusts in England Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform the Investigator (Dr Sue Copley, ext 34954). The normal National Health Service complaint complaints mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Imperial AHSC Joint Research Office. 14. Will my participation in the study be kept confidential? If you decide to take part in the study, you give us permission to use information about you. This permission continues until the study is over, including the length of time that we must keep records about the study. We will keep all information confidential. Your medical information will be combined with information about other people in the study. Information will be labelled with a code number, and will not include your name or other information that directly identifies you. When you sign this consent form, you agree to have your personal and medical information used as described here. With your permission, we will inform your GP about your involvement in this study. What will happen to the results of the research study? We the study doctor and your specialists plan to publish the results of this study in a scientific journal so that the information will be available to all. You will not be in any way identifiable from images or use of data. Please let us know if you or your family wish to see a copy of the published report and we can send it to you by mail.

4 15. Who has reviewed the study? This study has been reviewed and approved by the Camden and Islington Research Ethics Committee London. The Imperial College Healthcare NHS Trust hospital research and development committee have also given approval. The Imperial College Healthcare NHS Trust Imaging Research Committee has given approval. 16. Who should I call if I have any questions? You can talk with the study doctor Dr Susan Copley on or about any questions or concerns you have about this study. Call the study doctor if you change your mind and decide that you no longer want to take part. Thank you for taking time to read this information leaflet.

5 Patient Consent Form REC Ref: JROHH0269 Study Investigator: Dr Susan Copley Participant ID Number Title of project: CT morphology of lung parenchyma pre and post bariatric surgery: correlation with pulmonary function. Please complete this section by initialling the boxes and signing at the bottom of the page. 1. I confirm that I have read and understand the information sheet dated (version 2) for the above study. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily. 2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. 3. I understand that relevant sections of my medial notes and data collected during the study may be looked at by responsible individuals from the NHS Trust and regulatory authorities. I give permission for these individuals to have access to my records. 4. [Females only] I confirm I am not pregnant. 5. [Females only] If I cannot confirm I am not pregnant, I agree to undergo a pregnancy test prior to the CT scan. 6. I agree to take part in the above study 7. I agree to my GP being informed of my participation in the study 8..Please inform me when the results of the study are published

6 Name of participant Date Signature Name of person taking consent Date Signature Name of lead researcher Date Signature (if different from above) Data Protection Act 1998: This research project is registered for data protection and the requirements of the ACT apply in full. The information held will be used for medical research purposes only and will be stored and disposed of in a secure manner. Original signed consent form to be kept in study file, one copy for patient and one copy for hospital notes.

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