If you are happy with the information here, please continue to the next page of the survey.
You are invited to take part in a research study. Before you decide whether to take part it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully. Talk to others about the study if you wish. Contact me if there is anything that is not clear or if you would like more information. Take time to decide whether you wish to take part.
What is the purpose of the study?
This study aims to explore the feelings and attitudes of SCAD sufferers who experience chest pain due to a SCAD induced heart attack. We will use this information to develop a user-friendly personal patient device that can measure troponin levels in the blood. Troponin is a protein that is released in the blood during a heart attack. The hope is that access to such a device will help patients with SCAD to make an informed decision as to whether it is necessary to seek emergency treatment when experiencing chest pain or whether the pain is simply a symptom of their condition and not an indicator of anything more serious.
Why have I been asked to take part?
You have been asked to take part because you have experienced a heart attack caused by SCAD and as a result experience chest pain. You may or may not have experience using similar devices or other at-home medical devices, this is not essential to be a part of this study - any thoughts or insights you could offer would be valuable.
Do I have to take part?
No, it is up to you to decide whether to take part. If you do decide to take part, you will be asked to sign an online consent form and you will be emailed a copy of this information sheet to keep. If you agree to take part, you are still free to withdraw at any time and without giving a reason. Deciding not to take part or withdrawing from the study will not affect your routine medical care or your legal rights.
What will happen if I take part?
If you agree to participate, you will take part in an in person or online interview. After you sign the consent form, a researcher from Edinburgh Napier University will contact you to arrange a convenient time and format for you to take part in an interview. During the interview, you will be asked about your experience with chest pain caused by SCAD and how you manage this. You will be asked whether you feel that the proposed device would change how you respond to your chest pain, your experience (if any) of using existing devices (e.g. device to measure your blood sugar) and if there is anything specific you feelwould be beneficial in this potential new device. The interview will be audio recorded using Microsoft Teams and then a written copy of the conversation will be made. The written copy will be securely stored, and the audio recording will be deleted. We will remove your name and any other data that might identify you. The interview is expected to last for between 30- 45 minutes.
If you attend in person, there will be an opportunity to use an already existing clinical troponin measurement device called the Siemens Atellica VTLI (see image below). This is completely voluntary and will not have any effect on you participation or contribution to the study. The researcher leading the interview will be fully trained in the use of this device and the appropriate hygiene and safety measures will be in place. Should you choose to use the device, it will consist of a finger prick test which may cause slight discomfort but will be very quick.
What are the possible benefits of taking part?
You will not get a direct benefit from taking part in the study. The findings might help to improve future management on post SCAD chest pain.
What are the possible disadvantages and risks of taking part?
We do not think that there are any disadvantages, however if you agree to participate, you will be required to give up some time to take part in an interview lasting a maximum of 45 minutes.
Will my taking part in the study be kept confidential?
All the information we collect during the research will be kept confidential and there are strict laws which safeguard your privacy at every stage.
How will we use information about you?
Only the research team will have access to your name or contact details. Your data will have a code number instead. Once we have finished the study, we will remove this linked code number which makes your data anonymous. We will write our results in a way that no-one can work out that you took part in the study.
What are your choices about how your information is used?
If you decide you no longer want to take part, you can request that your information is withdrawn from the study up until the analysis is complete. You can request this by contacting Madeleine Holifield – 2554967H@student.gla.ac.uk.
What are your choices about how your information is used?
You can find out more about how we use your information from our privacy notice. This is included in this information pack.
What happens when the study is finished?
When the study is finished, anonymised data will be stored by Edinburgh Napier University. These anonymised data may be made available to other researchers for further analysis once the results of the research have been published. This would only be after an official request, consideration of suitability for sharing, and subject to a data sharing agreement between Edinburgh Napier University and the researcher requesting the data. The data will be stored for at least 10 years. Consent forms which contain your identifiable information will be kept for a maximum of 6 years.
What will happen to the results of the study?
The data will be analysed and written up within an MEng dissertation project and the findings may be published in healthcare journals and presented at conferences. However, it will not be possible to identify any individual participant from these reports or publications. Quotes may be used in the presentation findings but names will be replaced with pseudonyms so these will not be identifiable to an individual.
Who is organising the research and why?
The principal investigator organising the study is Madeleine Holifield, a Biomedical Engineering Masters student at the University of Glasgow with a special interest in cardiovascular medical devices used in this area. The project is being conducted as part of my MEng Dissertation.
Who has reviewed the study?
A favourable ethical opinion has been obtained the School of Health and Social Care Research and Integrity Committee at Edinburgh Napier University.
Researcher contact details:
If you have further questions about the study, please contact: Madeleine Holifield – 2554967H@student.gla.ac.uk
Professor Lis Neubeck is the supervisor for the project and can be contacted at l.neubeck@napier.ac.uk
Independent contact details:
If you would like to discuss this study with an independent person please contact: Dr Sheona McHale, Research Fellow (Edinburgh Napier University) at s.mchale@napier.ac.uk
