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A “yellow card” reporting system for sight loss in giant cell arteritis INFORMATION SHEET Your health records are being used in a research study on giant cell arteritis. The purpose of this leaflet is to explain why the research is being done and what steps are being taken to protect your anonymity in the study. Please talk to others about the study if you wish and ask us if there is anything that is not clear. What is the purpose of the study? Blindness can be a serious consequence of untreated giant cell arteritis. With proper, early treatment, this can be prevented in the majority of patients. Early treatment requires early recognition. The purpose of this study is to firstly estimate how many people are affected by sight loss in giant cell arteritis every year, and secondly to look at some characteristics of patients with giant cell arteritis to see if any patients are at particular risk of sight loss. We think this information would help target resources to allow us to recognise giant cell arteritis earlier. Why have I been registered in this study? You have been registered because you have been diagnosed with giant cell arteritis. We are interested in identifying all patients diagnosed with giant cell arteritis, with and without sight loss, in order to be as accurate as possible. Do I have to take part? You can choose not to take part in the study. You are free to withdraw at any time, without giving a reason. This will not affect the standard of care you receive, which will continue as it is normally provided. What will happen to me if I continue to take part? This is an observational study – in other words no change to your standard treatment will occur. Information relevant to this study, about yourself and your condition, will be recorded for later analysis. This will be information that is already recorded as part of your standard assessment. The information that is retained will be anonymised so that the researchers, who are based at a central site and are not directly involved with your care, will not be able to identify you. In detail, when you are first diagnosed, your doctor, or your local research team on your doctor’s behalf, will email an electronic “yellow card” to the central research team notifying them of your diagnosis. A request for further information about your case will then be made. The information collected will include: age, when you were referred and first seen, how long you had symptoms for, details about the symptoms you experienced, how you responded to treatment, what the findings of Sight Loss Reporting PIS V4 16.2.2015 (Modelled on ARCTU 2-part PIS template V1.0-10.08.2012) Page 1 of 4 the eye department were (if applicable), results of any scans performed, the medications you were taking, any risk factors you had for heart disease or stroke, a number approximately representing your socioeconomic background based on your home address, and the result of any biopsy performed. Will my taking part in this study be kept confidential? Yes. We will follow standard ethical and legal practice regarding confidentiality. All information which is collected about you during the course of the research will be kept strictly confidential. Access to your full record will be limited to your local clinical and research team. Anonymous information will be passed to the central research team. In order to preserve your anonymity your name, date of birth and address will be removed from the information when it is passed to the central research team based at Southend University Hospital, and the information collected will not be provided to anyone else. It will be stored securely and used only for the purpose of this study. Your normal clinical records will have an entry showing that you are being included in this study, but will otherwise be unaffected. What are the possible disadvantages and risks of taking part? Information about you will be recorded securely on a centrally held database. The risk of identifying you from this information will be minimised as much as possible, but it may be that people can identify who you are from the information held if they are already familiar with your case. This can include people who have already been involved in your medical care, or friends and relatives who are aware of some of your medical details and are also part of the research team. We do not foresee it to be possible to identify you based on information solely obtained from our database. What are the possible benefits of taking part? No direct benefit is foreseen to yourself by taking part. Communication between the different departments involved in your care would be encouraged by participation in this study, and it is expected that this would form part of your standard clinical care. What happens when the research study stops? The study will take place over a year and we estimate we will need to retain your data for another year after that in order to fully analyse it. After this we may archive the data obtained for up to 15 years in total. However If any further analysis not originally planned for this study is considered, it would only be after obtaining further ethical approval for that research. Sight Loss Reporting PIS V4 16.2.2015 (Modelled on ARCTU 2-part PIS template V1.0-10.08.2012) Page 2 of 4 What if relevant new information about my condition becomes available? Sometimes, in the course of a study, we may get new information about how your condition should be treated. If this happens, we may be able to identify if your own treatment should be changed from the records held about you. In this case your doctors will be informed. What will happen if I don’t want to carry on with the study? If you wish to withdraw from the study, the investigators will be notified and all or part of your record, depending on your wishes, will be deleted. This will not affect the information held in your normal clinical records. During the course of the study information about you will be analysed and shared among the group of investigators and collaborators. Eventually information about you may form the basis for a scientific publication accessible to the general public. It is very unlikely that it would be possible to personally identify you from records such as these, but withdrawing your data from an analysis after it has been performed and publicised would not be possible. What if there is a problem? If you have a concern about any aspect of this study, you can discuss it with the doctors looking after you who have registered you for the study. You can also contact the researchers at the following address: Professor B Dasgupta Research and Development Southend University Hospital NHS Foundation Trust Prittlewell Chase Westcliff-on-Sea Essex SS0 0RY. The information held centrally about individuals will be limited, and to fully address your queries we may need your permission to contact your doctor for further details. If you remain unhappy and wish to complain formally, you can do this through the Patient Advice and Liaison service, details of which are included at the end of this leaflet. Harm In the event that something does go wrong and you are harmed through this research, and this is due to someone‘s negligence, then you may have grounds for a legal action for compensation against Southend University Hospital NHS Trust, but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you (if appropriate). Sight Loss Reporting PIS V4 16.2.2015 (Modelled on ARCTU 2-part PIS template V1.0-10.08.2012) Page 3 of 4 What will happen to the results of the research study? We expect that, once fully analysed, the results of this study will be submitted for presentation at scientific meetings and publication in a scientific journal. The results will be publicly accessible, although you will not be personally identifiable. Who is organising and funding the research? This research is being organised through the Research and Development Department at Southend University Hospital NHS Trust. Funding from the charity Fight for Sight will contribute to the running of this study. No commercial organisations are providing financial support for this study. 12. Who has reviewed the study? All research in the NHS is looked at by independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by the London-Hampstead Research Ethics Committee. 13. Further information and contact details Further information about this research project can be obtained from the local investigating team at your hospital, led by: [insert local details] You can also discuss it with the doctors looking after your condition. If you are unhappy with any aspect of the way you are treated as part of this study you can discuss this with your hospital’s Patient advice and Liaison service, whose contact details are as follows: [insert local details] Sight Loss Reporting PIS V4 16.2.2015 (Modelled on ARCTU 2-part PIS template V1.0-10.08.2012) Page 4 of 4