Participant Information Sheet

Transcription

1 Participant Information Sheet We would like to invite you to take part in a research study. This leaflet explains why the research is being done and what it involves. There is no rush to take part and there is plenty of time for questions. Discuss it with others if you wish. If you agree take part, you can withdraw any time you like with no hard feelings from anyone. The research is funded by the UK Medical Research Council, supported by the National Health Service. The study is being carried out at the Universities of Manchester, Nottingham and Cardiff. No drug treatments or drug companies are involved. Why is the study being done? Psychosis, such as occurs in schizophrenia and related disorders, affects over 1 in 100 of the population. Symptoms can be distressing and can cause long-term illness. It usually starts in the late teens and twenties and symptoms commonly come on quite slowly. The aim of this research is to follow up recent clues about what happens in the brain that leads to psychosis. Recent research suggests that brain cells, which communicate with each other using two related chemical messengers called glutamate and gaba, start communicating abnormally. In some people this may be because a form of mild inflammation takes place. In others, the gaba and glutamate problems could be due to what genes they inherited. We want to find out whether problems with gaba and glutamate communication is common in early psychosis and whether this settles down or changes in those who have had the illness for some years. Another question is whether gaba and glutamate problems are usually due to a mixture of inflammation and genes, or whether it s usually just one of them. When we know the answers, we will be better able to think about slowing or stopping the development of psychosis with completely new treatments for the early stages. We can measure genes and inflammation in simple blood samples. We will measure brain cell communication using a technique called magneto-encephalography (MEG) and this is being done in Nottingham and Cardiff. In all three centres we are measuring gaba and glutamate in brain using magnetic resonance spectroscopy (MRS). A special kind of MRS called C13MRS is used in Nottingham and Manchester to measure gaba and glutamate in more detail. In Manchester another kind of scanning called positron emission tomography (PET) is used to measure inflammation in the brain. We need to compare these measures in people with early psychosis or who have had symptoms for a number of years and people with no history of psychosis. MRC SPRING Participant Information Sheet Manchester; Version 6.1 (28/02/2016) Page 1 of 10

2 We are asking your help to find the answers to the questions about early and established psychosis. This would mean having several visits in which you will have a combination of 2-3 scans and tests that your centre is carrying out. Why have I been invited to take part in this study? For people with psychosis We are inviting you to participate because you are receiving NHS care for the treatment of psychosis and are aged between years old. Your clinical team thinks you may be eligible and interested to take part. We are inviting you to take part in an interview with one of the research workers to find out if you would be eligible for the study. For people without a history of mental illness We are inviting you to take part as a control participant, in other words as somebody who does not have a diagnosis of psychosis or past mental illness. You will be forming part of the comparison group to which we will compare the results from participants who do have a diagnosis of psychosis. Do I have to take part? It is up to you to decide whether or not to take part in the study. We will describe the study and go through this information leaflet, which you should keep. We will then ask you to sign a consent form to show you have agreed to take part. You are free to withdraw at any time, without giving a reason. If you decide not to take part, no pressure will be put upon you to continue and you will be treated with goodwill. If you are a patient and stop the study, you will carry on as normal with your regular clinical team. What will participation involve? If you agree to take part in the study, there will be 3-4 visits. These visits will take place at the NIHR/Welcome Trust Clinical Research Facility or Wolfson Molecular Imaging Centre. The visits are referred to as: Screening Imaging PET 12-month follow-up (patients only) MRC SPRING Participant Information Sheet Manchester; Version 6.1 (28/02/2016) Page 2 of 10

3 1. Screening Visit You will first take part in an interview with a research worker to find out if the study is suitable for you. If you are eligible and agree to participate, we (the research team), will carry out further checks including reviewing your medical and drug treatment case notes. We will arrange a basic medical examination, routine blood tests and blood pressure to make sure there is no medical reason why you should not take part. This will include a routine test which looks at your heart called an ECG. This is a quick test and is something you may have experienced if you have had a stay in hospital. We will also ask you some questions about any medical conditions you may have, and about your general physical health. We will take a research blood sample for inflammation measures (called cytokines) and genetic analysis. During this visit you will also carry out some standard tests of your thinking and reasoning skills. These assessments are widely used and are done at your own pace. We will give full instructions about the tasks before you do them. If you agree, after the visit we will inform your GP about you taking part in the study and your GP may provide information to us about any relevant medical problems you may have. In the unlikely situation where there is an abnormal test result (i.e. abnormalities in blood tests, or in the brain scans), we would inform your GP/Consultant of these findings. 2. Imaging Visit At your next visit we would like you to complete some standard questionnaires/interviews about some of the experiences you may have. We would like to audio record the interviews. The reason for this is so that we can concentrate on talking to you during the interview instead of writing things down. We can also use the recordings to help ensure that we are conducting the interviews and completing the questionnaires correctly. We will ensure that any identifiable data is removed from the recordings so it will never be possible to identify you. We would also like to video record these interviews to further help us become better at conducting these. The recordings will be kept securely and only members of the research team would be able to view them. If you wish not to be filmed, we will respect your wishes and not video record the interview. Once the study has finished the video interview can be erased at the end of the study. If you agree though, we would like to keep the interview stored securely so that other medical researchers with NHS contracts can use the interviews. These researchers would use the videos in the same way, to make sure they are getting their assessments of levels of symptoms right, by comparing their scores. These other researchers will not know who you are, since they will just be allowed to use this video for training purposes and nothing else. If you agree to be video-recorded but do not wish for your video to be used in other studies, we will destroy the video at the end of the SPRING Study, and nobody else other than those researchers working on the SPRING study will be allowed to view it. If you agree to have a video interview but change your mind at a later date, you can contact the Research team and ask for the video to be destroyed. You can ask for this during the duration of the SPRING study or in the future. Your decision will be accepted with no questions asked. During this visit we would also take images of your brain using different imaging techniques. There is no set order in which these scans are done. It may be that the scans will have to take place on separate days, or sometimes on the same day. We will discuss this with you. We briefly describe here each technique we would like to do and what would be involved: MRC SPRING Participant Information Sheet Manchester; Version 6.1 (28/02/2016) Page 3 of 10

4 Proton MRS (magnetic resonance spectroscopy) MRS takes place in a magnetic resonance imaging (MRI) scanner. This will enable us to take pictures of your brain and to also measure chemical levels. There are no dangers or side-effects of any kind using this type of scanner. No chemicals, injections, or blood samples are involved, and there is also no radiation. You lie with your head inside a short tunnel in a magnetic field. The machine makes quite a lot of noise so you wear padded earphones and there is a microphone. You can listen to music and hear or speak to the operator. Very occasionally people find this claustrophobic so you can press a button to come out if you don t want to continue. The proton MRS will take about 45 minutes in the scanner. Glucose MRS The Glucose MRS scan will take place in the same scanner as mentioned above (the proton MRS scan), so the procedure will be similar. This scan looks at how glucose is used by the brain. It involves giving a glucose infusion (administering glucose into a vein in the arm via a small tube placed in the vein called a cannula). We will closely monitor the levels of glucose in your blood stream during the scan to ensure the procedure is safe. This is done by taking a small sample of blood from another cannula placed in either in your arm, hand or foot. The infusion of glucose and the scan together will take approximately hours. Once the scan is completed we will provide a meal for you to eat and will take a few more small blood samples to ensure your blood glucose levels have returned to normal levels. Because we are giving you an infusion of glucose, it is important that you arrive to this visit without eating anything (fasted). A researcher will discuss with you how long you should be fasted for prior to the scan. This will probably involve an overnight fast. 3. PET (Positron Emission Tomography) visit Some people with psychosis have inflammation in their body that shows up on blood tests. However, it is unclear how this relates to the symptoms of psychosis. Measuring inflammation in the brain would help us determine its involvement in developing psychosis. We can measure inflammation in the brain with a type of brain scan called Positron Emission Tomography ( PET for short) using a radioactive marker called 11C- PK1195. The PET scan will take place on a separate day to the other scanning techniques. It will take place at the Wolfson Molecular Imaging Centre (WMIC) a University of Manchester research facility. For this scan you will have a cannula (a small plastic tube) inserted into a vein in your arm through which a blood sample will be taken to measure the level of cytokines (a marker of inflammation) in your blood. You will then be asked to lie on a bed with your head in a PET camera and the radioactive marker will be injected through the cannula in your arm. The scan will then take place and last about 75 minutes. After the scan we will take the cannula out of your arm Month follow-up (patients only) For patients with psychosis, after 12 months from finishing the study, we would like to see you again. At this visit we will repeat the questionnaires/interviews and the tests of thinking and reasoning skills. MRC SPRING Participant Information Sheet Manchester; Version 6.1 (28/02/2016) Page 4 of 10

5 What do I have to do? Agree to attend all appointments and to perform the assessments Bring a list of names and dose of any medications you take. Not to use alcohol or recreational drugs for 24hrs before each visit. If female, tell us if you are pregnant, trying to become pregnant or breast feeding. Tell us of certain medical conditions you may have such as a history of heart problems, head trauma, neurological disease, diabetes, or a blood-borne virus such as HIV or hepatitis C If you have taken part in any other clinical research project in the last month you may have to wait a month before taking part in the current study (For example, you have taking part as a participant in a research study that involved taking a drug; being paid an inconvenience allowance; having an invasive procedure (e.g. venepuncture >50ml, endoscopy). If you have taken part taken part in a research study that involved exposure to ionising radiation in the last 12months, you will have to speak with the researcher before taking part to see if the study is suitable for you. What will my blood samples be used for? Our research uses the samples and information you have provided to help understand psychosis better. We will measure the level of cytokines in your blood and relate this to measures of inflammation in the brain shown by the brain scan. We will also send blood samples for genetic analysis. We study the huge number of tiny genetic differences found between one person and another. We hope to find out if these tiny differences are related in any way to mental health problems and to the imaging and thinking/reasoning tasks done in the study. With your consent we will hold your samples so that they will be available for use by other researchers in the field under a system that strictly protects your confidentiality. The samples will be stored at Cardiff University. What are the possible disadvantages and risks of taking part? We have extensive experience of all our research tests and procedures and all have been used on very large numbers of patients in the UK and world-wide. It is essential that people find them acceptable otherwise research would fail. Nevertheless, it is possible you might find some questions too personal, upsetting or tiresome. If you do, we will treat this with respect and understanding. If you are currently undergoing treatment, this study does not include any changes to this and it should not have a negative impact on your mental health in any way. Blood and DNA sample Some people feel mild discomfort when giving a blood sample. Sometimes there is mild bruising afterwards. As we are taking a blood sample for genetic analysis, very rarely we may find a genetic risk factor which may have important implications for your future health or for the health of your family. In these rare MRC SPRING Participant Information Sheet Manchester; Version 6.1 (28/02/2016) Page 5 of 10

6 circumstances, we will take advice from a clinical geneticist (a specialist in this area) who may advise us to recontact you and/or your GP. In this case you may be offered the option to seek further advice through a genetic counselling service. However, there will be a space on the consent form for you to let us know if you would prefer for us not to contact you about such findings. If you don t want us to inform you of any findings, we would not contact your GP either. MRS The MRI scanner uses a large magnet to take pictures and there are no known risks unless you have any metal in your body which might be affected by the magnet. A checklist will be given to rule out the presence of metal objects. Some people can find the MRI scanner claustrophobic reassurance will be provided and staff will be there for support. You can also stop the scan at any time. Glucose MRS The glucose MRS scan will take place in the same MRI scanner at the MRS scan. Therefore the check for metal objects will also cover this scan. The glucose is given as an intravenous ( drip ) infusion of glucose during the scan through a cannula (small plastic tube) inserted into a vein in your arm, hand or foot. You might experience brief discomfort with the cannulation. It is a safe procedure however, and something you may have experienced if you have stayed in hospital. There is a small risk of developing a condition called thrombophlebitis at the site of a cannula, which means local inflammation and clotting of blood within a vein. Rarely this can lead to complications but most cases get better on their own. The risk of this is very low given the short amount of time the cannula will remain in the vein. This scan causes a mild increase in the level of glucose (sugar) in the blood. This could in theory trigger abnormal heart rhythms in people with certain rare heart conditions so we will check your ECG and blood pressure. PET The scan involves injecting a radioactive marker through a cannula (small plastic tube) in the vein. The same risks regarding the cannula would apply as for the Glucose MRS scan above. As this is a radioactive marker, you will receive a small dose of radioactivity as part of this study. We are all exposed to what is known as background radioactivity every day, mostly from natural sources of radiation in the earth. Low doses of radiation give us a small risk of developing cancer. However, risk comparisons show that radiation is a small risk when compared to the natural incidence of cancer (the number of people who would go on to develop cancer anyway), every day risks people take such as driving, and lifestyle factors such as smoking and alcohol consumption. Participating in this study will very slightly increase your chances of cancer death over your lifetime. However, this extra risk is very small (approximately 2 in 10,000). The total radiation exposure you will receive in this study is equivalent to one and a half years average background radiation in the UK, or the radiation you would receive from a single CT (computed tomography) scan of the head. This research study has been approved by ARSAC (Administration of Radioactive Substances Advisory Committee) which reviews all UK medical research involving the administration of radiation to humans. The radioactive drug is given in MRC SPRING Participant Information Sheet Manchester; Version 6.1 (28/02/2016) Page 6 of 10

7 an extremely low dose and no side effects are expected. For individuals who have received this drug in the past, no side effects have been observed. There will be no residual radiation once the scan is completed. What are the possible benefits of taking part? Your participation will help to identify the underlying cause of psychosis and may contribute to improving treatments for people with psychosis. However you are not expected to directly benefit from participating in this study. If you wish, at a later date we can provide an image of your brain as a souvenir. Will my taking part in the study be kept confidential? Yes, all information which is collected about you during the research will be kept strictly confidential and will conform to the Data Protection Act of 1998 with respect to data collection, storage and destruction. This covers any information from your NHS records that we collect to complete a research checklist and to note any relevant medical or other factors relevant to the research. We will not make photocopies of any part of your notes. Your name and address is not recorded with the research information, instead we use a code number to identify your research data. Research data will be stored on computers in an encrypted (i.e. scrambled) form that can only be read with a key held by one researcher. Blood samples taken for the cytokine and genetic analysis will only be labelled and identified via a unique ID and barcode with no personal details. Your GP will be notified of your participation in the study. If you are a patient we will also inform your care coordinator and psychiatrist. In order to book in your scans for this study, some of your data needs to be sent to the scanning centre(s). The data to be sent will include information such as your name, date of birth and so on, but it may also include information about your health or medical history. The information will only include the essential details needed to book your scans and carry them out safely, it will not be used for any other purpose. The data will be transferred and held securely at the scanning centre. The data will be kept as part of the scanning records until it is no longer required at which point it will be destroyed in line with University/Trust procedures. Authorised individuals from the University of Manchester, the scanning centre, NHS Trust or regulatory authorities may need to access the data collected as part of this study to make sure that the research is being carried out properly. With your permission, the information looked at will include your personal data. All the authorised individuals have a duty of confidentiality to you as a participant in this research. In the unlikely event that you have a loss of capacity to consent, the research team would retain any data collected and continue to use it confidentially in connection with the purposes for which consent is being sought. Research data that is collected during the study will be stored anonymously for 15 years. This is in accordance with regulatory procedures. Any personal identifiable data will be removed from your research data, so your confidentiality will be continued after the completion of the study. MRC SPRING Participant Information Sheet Manchester; Version 6.1 (28/02/2016) Page 7 of 10

8 What will happen if I do not want to carry on with the study? You can withdraw from the study at any time without giving a reason and without any consequence to your current or future treatment. No further data will be collected from the moment you withdraw. Any data that has been collected will be kept confidential but may be used in the subsequent analyses. What if I have any questions? If you have any questions or you have a concern about any aspect of the study, you can speak to any member of the research study team. See contact details below. What if there is a problem? If you have a concern about any aspect of this study, you should speak to the researchers who will do their best to answer your questions (see contact numbers below). Any complaint you have about the study will be resolved promptly, and information will be provided by phone or in writing to inform you of how the complaint has been addressed. If the research team is unable to resolve your concern and you remain unhappy, or you do not want to contact any of them directly and you may wish to make a complaint regarding the study, please contact a University Research Practice and Governance Coordinator on / or by to Research.Complaints@manchester.ac.uk. Otherwise, you can contact the National Health Service Patient Advice and Liaison Service (NHS-PALS), details of local PALS offices can be found at (PALS)/LocationSearch/363 The Universities involved in the study (Manchester, Cardiff, and Nottingham) are providing insurance cover for this research; in the event that something does go wrong as a result of taking part in this research, you may have grounds for claiming compensation but you may have to pay your legal costs. What will happen to the results of the research study? We aim to publish the results of the study in scientific journals but will also make them available to all participants in a non-scientific format. We do not expect the results to be available until after the end of the trial (2018). Involvement of GP/Consultant and Insurance We are asking for your consent to write to your GP/Consultant to let them know of your participation in the study. We may also need to access relevant information from your medical files for research purposes and we are asking your consent to access this information. If there are any abnormal test results (excluding genetic findings) that could impact on your health, we would inform your GP/Consultant. Similarly, if we have any significant concerns about your mental health, we would inform your GP and mental health team if you have one. If there are any genetic findings relevant to your health, we would only inform your GP/Consultant if you have consented to find out yourself. MRC SPRING Participant Information Sheet Manchester; Version 6.1 (28/02/2016) Page 8 of 10

9 If you have consented to find out about any genetic risk factors and this does occur, any genetic test results from the study do not have to be disclosed to insurance companies. This applies to any current policies you hold, as well as for future applications for life insurance or private medical cover. This is covered by the UK Government s Concordant and Moratorium on Genetics and Insurance. With regards to taking part in the study generally, if you have private medical insurance we would advise you to check in the terms and conditions of your policy that participating in the study will not affect your cover. If you are seeking life insurance / private medical cover in the future, you would need to inform them of any abnormal test results from the study such as a brain lesion. What about expenses? The amount you will be compensated is dependent on whether you complete the study. If you complete the study you will be compensated 210. If for whatever reason you do not complete the study, you will be compensated for the parts you did take part in. In addition you will be reimbursed for travel expenses for all study visits. Who is organising and funding the research? This study is funded by the Medical Research Council. It is organised by the University of Manchester, in collaboration with Cardiff University and the University of Nottingham, and in partnership with the following local NHS Trusts: Manchester Mental Health & Social Care Trust; Central Manchester University Hospitals NHS Foundation Trust; Greater Manchester West Mental Health NHS Foundation Trust; and Pennine Care NHS Foundation Trust. Who has reviewed the study? The study has been reviewed by the NRES Ethics Committee North West Lancaster (Ref. 14/NW/0298), the Administration of Radioactive Substances Advisory Committee (ARSAC Ref: 595/3856/31624), by the Sponsor (University of Manchester) and your local NHS Trust(s). The study is being carried out in Manchester, Nottingham and Cardiff. What should I do now? Think about what the study involves and discuss it with friends and family if you wish. If you or your relatives have any further questions, please contact any of the members of staff listed below. We will contact you soon, but will give you at least 24hrs to read this information sheet. Alternatively, you can contact us on one of the telephone numbers or addresses given below. MRC SPRING Participant Information Sheet Manchester; Version 6.1 (28/02/2016) Page 9 of 10

10 Contact for further information If you require further information about the study you may contact one of the following people: SPRING Study Team Phone: or or Website: Thank you very much for taking the time to read this information sheet MRC SPRING Participant Information Sheet Manchester; Version 6.1 (28/02/2016) Page 10 of 10