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Health Services Research Unit Participant information sheet v 15.5.2018 Health Services Research Unit Nuffield Department of Population Health Richard Doll Building, Old Road Campus, Headington, Oxford OX3 7LF Telephone 01865 289424 or email [email protected] Telephone 01865 289432 or email [email protected] Pretesting the PDQ-Carer in electronic format Ethics Approval Reference: RS56991/REE001 1. What is the purpose of this research? Researchers in the Health Services Research Unit (HSRU) at the University of Oxford have recently developed the Parkinson’s Disease Carer Questionnaire (PDQ-Carer) in order to measure the effects of being a carer for someone with Parkinson’s disease. The PDQ-Carer is being transferred to an electronic format so it can be used on personal computers, laptops, tablet computers and smart phones. We are conducting interviews with a small number of carers for people with Parkinson’s disease to assess its usability and acceptability, to ensure that it can be used successfully online. 2. Why have I been invited to take part? You are being approached because you are an informal carer for someone with Parkinson’s who is a member of Parkinson’s UK and your local branch or the Research Support Network is helping to promote the project. For this research what is meant by ‘informal carer’ is a family member or friend who provides help and support to a person with Parkinson’s disease but is not paid for it. We are looking for between six and ten informal carers to complete an online questionnaire and be interviewed about it. You must be over 18 years old, living in the UK, have access to the internet and use your computer or other electronic device to complete the online questionnaire. 3. Do I have to take part? No. You can ask questions about the study before deciding whether or not to participate. If you do agree to participate, you may withdraw yourself and your data from the study at any time, without giving a reason and without penalty, by advising the researchers of this decision. If you decide to withdraw, please let us know within two weeks of the interview so any data you have contributed can be destroyed before it is anonymised 4. What will happen to me if I take part in the research? If you are happy to take part in the research, please email us to arrange a time and place (ideally at your home) for a one-off meeting during which you will complete the PDQ-Carer online using your smart phone, tablet, laptop or personal computer. Ahead of the meeting you will receive an email with a link and instructions to follow to access the PDQ-Carer. You will be asked to wait until the researcher is with you before accessing it. On arrival, we will outline what we are doing and give you the chance to ask any questions. This may take up to 10 minutes. You will be asked if you are willing to have the discussion audio recorded as this will provide an accurate record of any discussion about the PDQ-Carer. If you are still happy to take part, you will be asked to begin the PDQ-Carer online. When you have finished we will ask some questions about completing it. You will also be asked whether you have any suggestions about how to make it more user-friendly. You can choose not to discuss your responses to the questions if you feel that it may make you uncomfortable. We expect the whole process will take approximately 30-45 minutes. Participation is voluntary. All the information you give will remain strictly confidential and will be seen only by members of the research team. Page 1 of 2 5. Are there any potential risks in taking part? There are no risks in taking part. However, if you feel that issues have been brought up that need to be addressed you should contact your GP or healthcare provider. Are there any benefits in taking part? There will be no direct benefit to you from taking part in this research, but you will be helping the researchers to test the usability of the PDQ-Carer online. 6. What happens to the data provided? The research data will be confidential. It will be stored in password protected files in a secure place at the Health Services Research Unit at the University of Oxford. Access to data will be restricted to members of the research team. Your personal details (name, email address and telephone number) will be used only for this study and will not be kept beyond the conclusion of the study unless you have stated you wish to be contacted about future projects. The audio files will be confidential. They will be stored in password protected files and deleted from recording devices. A member of the research team will listen to and transcribe the audio files before deleting them. Your responses will be anonymised two weeks after the interview. The transcript will be stored in a locked cabinet in a locked private office at the HSRU at the University of Oxford. Data will be accessed only by members of the research team and will be destroyed after a period of 5 years. 7. Will the research be published? The study is likely to lead to an international conference presentation. Results will be published online and in an updated copy of the PDQ User Manual. If you wish to receive a copy of the results please give your name and address to the researcher after the cognitive interview. 8. Who is organising and funding the research? The research is internally funded by the Health Services Research Unit (HSRU), Nuffield Department of Population Health, University of Oxford. The names of the HSRU researchers involved in the study are Professor Crispin Jenkinson, Dr David Morley, Dr Laura Kelly and Mrs Sarah Dummett. 9. Who has reviewed this study? This study has been reviewed by, and received ethics clearance through, the University of Oxford Central University Research Ethics Committee (Reference number RS56991/REE001). 10. Who do I contact if I have a concern about the study or I wish to complain? If you have a concern about any aspect of this project, please speak to the relevant researcher (Dr David Morley, telephone 01865 289432) who will do his best to answer your query. The researcher should acknowledge your concern within 10 working days and give you an indication of how they intend to deal with it. If you remain unhappy or wish to make a formal complaint, please contact the relevant chair of the Research Ethics Committee at the University of Oxford who will seek to resolve the matter in a reasonably expeditious manner: Chair, Medical Sciences Inter-Divisional Research Ethics Committee; Email: [email protected]; Address: Research Services, University of Oxford, Wellington Square, Oxford OX1 2JD 11. Further Information and Contact Details If you would like to discuss the research with someone beforehand (or if you have questions afterwards), please contact: Dr David Morley Health Services Research Unit, Nuffield Department of Population Health Richard Doll Building, Old Road Campus, Headington, Oxford Telephone: 01865 289432 Email: [email protected] Page 2 of 2 .
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