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PARTICIPANT INFORMATION SHEET Title of Project: Fractured Vision: Optometric Examination of Patients Following Stroke

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PARTICIPANT INFORMATION SHEET Title of Project: Fractured Vision: Optometric Examination of Patients Following Stroke Dr Chris Markham PhD FHEA MHCPC Head of School School of Health Sciences and Social Work University of Portsmouth James Watson West 2 King Richard 1st Road Portsmouth PO1 2FR United Kingdom T: +44 (0)23 9284 4440 E: [email protected] PARTICIPANT INFORMATION SHEET Title of Project: Fractured vision: Optometric examination of patients following stroke Name and Contact Details of Researcher(s): Mr Malcolm Maciver, School of Health Sciences and Social Work, University of Portsmouth, James Watson West, PO1 2DT. [email protected] Name and Contact Details of Supervisor (if relevant): Dr C Markham, Head of School, School of Health Sciences and Social Work, University of Portsmouth, James Watson West, PO1 2DT. [email protected] Ethics Committee Reference Number: SFEC 2017-113 Invitation We would like to invite you to take part in our research study. Joining the study is entirely up to you, before you decide we would like you to understand why the research is being done and what it would involve for you. The following notes outline what is involved in the study, and how much time this should take. Should you have any questions or wish clarification on part of the study please don’t hesitate to contact the principal investigator, Malcolm Maciver, on [email protected]. The principal investigator is a qualified optometrist and PhD researcher at the University of Portsmouth, he is also involved with the delivery of the Masters in Optometry programme at the University of Portsmouth, leading two units on the MOptom course programme. Study Summary This study is designed to create a standardised eye examination battery for patients that present with a history of stroke. In many cases these patients have complex visual needs and some practitioners are hesitant to conduct examinations and provide vision care. This results in many patients having difficulty accessing primary eye care services within the community. You have been contacted as we are looking for eye care or healthcare professionals with experience in the provision of visual care to brain injured patients. This study will consist of a series of 3 questionnaires which aims to develop a standard visual test battery for use on patients who have suffered a stroke. Each questionnaire should take around 30-40 minutes to complete and will be completed online. What is the purpose of the study? With an ageing population, stroke is becoming increasingly prevalent within western society. Many individuals who have suffered a stroke develop complex visual problems subsequent to their injury. In many cases primary care optometrists are the first eye care professionals to encounter these patients. Current guidance for the provision of care to patients following stroke is limited, This study is a Delphi Study to develop a standard vision test battery that could be used by the primary care optometrist in clinical practice. The Delphi Study is a method used to find a group consensus using tiered questionnaires with feedback to participants at each step. This study consists of a series of questionnaires issued to multiple experts within the field. After each questionnaire is answered, the grouped (anonymous) results of the previous questionnaire are returned to participants with the next questionnaire. This multi-step method with grouped results is used to develop a consensus. Why have I been invited? You have been invited to this study as you are a vision or healthcare professional with a specialist interest in the provision of visual care to patients with acquired brain injury. This study will consist of a small group of around 18-20 vision and healthcare professionals with a specialist interest in acquired brain injury. You have been approached to participate as you have been identified as an expert within this area, either through your publication(s), professional reputation or by recommendation by professional and non-governmental bodies. Do I have to take part? No, taking part in this research is entirely voluntary. It is up to you to decide if you want to volunteer for the study. We will describe the study in this information sheet. Completion of the questionnaire will be considered as consent at each stage of the study. What will happen to me if I take part? If you decide to take part you will be sent a questionnaire at three different points in time. These questionnaires will ask you about your thoughts on the visual examination of patients who have had a stroke. The first questionnaire should take around 30-40 minutes to complete. Subsequent questionnaires will be based on the (group) responses to the previous iteration, these will be issued with the anonymous group results of the previous questionnaire. The second and third questionnaire will take a similar period of time to complete. Expenses and payments This study is not funded, there are no expenses or payments for participation in this study. Anything else I will have to do? It is requested that participants do not discuss the contents or nature of this study with other eye care providers until after the submission of the final questionnaire. What data will be collected and / or measurements taken? The primary data from this study will be that collected from the questionnaires. Participant’s contact data will be held by the principal investigator (see later). Data from questionnaires will be anonymised at collection by the online survey platform. Data will be collected using the online survey platform BOS. What are the possible disadvantages, burdens and risks of taking part? The major burden of taking part is time. This study will consist of three questionnaires at different time points which may take upto two hours of your time to complete. What are the possible advantages or benefits of taking part? Participation in this study will give you the opportunity to consider the views of other experienced eye care providers views on the visual assessment of patients following stroke. This will give the opportunity to reflect on your provision of eye care to patients following stroke in your practice. Will my taking part in the study be kept confidential? All participant personal data will remain confidential. Anonymisation of participants from one another is a key feature of the method used within this study. All contact details that could be used to identify you as a participant within this study will be kept securely on an encrypted password protected file on the University of Portsmouth’s N drive. Passwords / encryption access will be held by the principal investigator only. The data, when made anonymous, may be presented to others at academic conferences, or published as a project report, academic dissertation or in academic journals or book. Anonymous data, which does not identify you, may be used in future research studies approved by an appropriate research ethics committee. The raw data, which would identify you, will not be passed to anyone outside the study team without your express written permission. The exception to this will be any regulatory authority which may have the legal right to access the data for the purposes of conducting an audit or enquiry, in exceptional cases. These agencies treat your personal data in confidence. The raw data will be retained for up to 10 years. When it is no longer required, the data will be disposed of securely or destroyed.in line with the University of Portsmouth’s records management policy: http://www.port.ac.uk/departments/services/corporategovernance/recordsmanagement/uop_retention/ http://www.port.ac.uk/accesstoinformation/policies/researchandknowledgetransferservices/filetodownlo ad,189755,en.pdf What will happen if I don’t want to carry on with the study? As a volunteer you can stop any participation in the study at any time, or withdraw from the study at any time before, without giving a reason if you do not wish to. As all data collected within this study is anonymised at collection, should you withdraw from the study all data collected up until the point of withdrawal will be retained and included in the study. Once the research has been completed, and the data analysed, it will not be possible for you to withdraw your data from the study. What if there is a problem? If you have a query, concern or complaint about any aspect of this study, in the first instance you should contact the principal investigator Mr Malcolm Maciver ([email protected]). If there is a complaint please contact the supervising academic Dr Chris Markham ([email protected]) with details of the complaint. The contact details for both the principal investigator and supervisor are detailed on page 1. If your concern or complaint is not resolved by the researcher or their supervisor, you should contact the following member of Staff: Dean of Science Prof Sherria Hoskins Faculty of Science 023 9284 3007 University of Portsmouth [email protected] St Michael’s Building White Swan Road Portsmouth PO1 2DT If the complaint remains unresolved, please contact: The University Complaints Officer 023 9284 3642 [email protected] Who is funding the research? This research is unfunded. This study is supported by the University of Portsmouth. None of the researchers or study staff will receive any financial reward by conducting this study, other than their normal salary / bursary as an employee / student of the University. Who has reviewed the study? Research involving human participants is reviewed by an ethics committee to ensure that the dignity and well-being of participants is respected. This study has been reviewed by the Science Faculty Ethics Committee and been given favourable ethical opinion. Thank you Thank you for taking time to read this information sheet and for considering volunteering for this research.
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