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Participant Information Sheet – Co-design stakeholder group
V2.0 12 Dec 2023
Name of Chief Investigator: Charlotte Massey, PhD Student
Research project title
Harnessing technology to support assessment and management of cough and secretion problems in people with MND: A mixed methods study to explore barriers and facilitators to support co-design of telemedicine tool
Introduction
Thank you for taking the time to read this information.
We are inviting you to take part in a research study which aims to understand the barriers and facilitators to providing effective cough and secretion management for people with Motor Neurone Disease (MND).
Before you decide whether to take part, it is important that you understand why the research is being done and what it will involve. Please read the following information carefully and discuss it with others if you wish. If you have questions, please contact us using the contact details at the bottom of this form.
What is the purpose of this project?
The aim of this research is to co-design a tool using technology to support management of cough and secretion issues in people with MND. It informs part of a larger study aiming to design a tool to support with these issues. See below figure for information of the whole project. The red box highlights which part of the project this is.
The exact form of the tool will be determined in an iterative approach by the research but examples of what this may look like might include option to remotely monitor symptoms or education and training resources. The information from Stage 1 will be taken forward on how best to translate this knowledge into improved services for patients by co-designing a tool to support management of these issues.
Why have I been invited to take part?
We are inviting you to take part in this study as you are a stakeholder involved in cough and secretion management in MND. A stakeholder is anyone who has an interest or concern in a topic. The range of stakeholders within this project are people living with MND, their caregivers, and all healthcare professionals involved. There are limited stakeholder slots available so it may not be possible to recruit everybody who shows an interest in this aspect of the study. We aim to recruit 8-15 stakeholders to participate throughout the process, as participants are able to leave the stakeholder group at any time, it is anticipated that recruitment my continue during the process.
Do I have to take part?
No. Participation in this study is entirely voluntary. You may withdraw from the study at any time and for any reason or no reason by stopping your participation in the stakeholder meetings. If you decide to take part, you will be asked to sign a consent form confirming you have understood what is involved, how your data will be used and your right to withdraw.
What will I have to do?
You will be asked to take part in a stakeholder group to allow us co-design a tool to support cough and secretion management in MND. These will be offered face to face or remotely and will be participant preference. The meetings will be audio recorded and we will ask your consent to do this.
There will be 6 stakeholder meetings over the course of 6-12 months. You can attend these face to face or virtually via video conferencing software. You may choose to enter or exit the stakeholder process at any point during the 6-12 months, even if the workshops have already started. Each meeting will take approximately 60-90 minutes. These will involve reviewing the themes from the first part of the research and coming together to identify the key areas to work on, designing and prototyping a tool to support with these areas highlighted.
What are the possible benefits of taking part?
There are no direct benefits for participation. However, your participation will help us understand more about the challenges of cough and secretion management and allow you to directly input into developing a tool to support this.
What are the possible disadvantages of taking part?
We expect there to be minimal burdens involved in taking part in the study. You will have to give up some of your time to attend the meetings. However, reasonable out-of-pocket travel expenses (e.g. a 2nd class rail ticket if you would like to participate face to face) will be reimbursed and you are able to leave and withdraw at any time during the meetings. You are also able to take part virtually if you are unable to attend in person. The Chief Investigator will check in with you during and at the end of the meetings.
Will my taking part in this project be kept confidential?
Yes. Your taking part in the research project will be kept confidential within the research team at Sheffield Teaching Hospitals NHS Foundation Trust. Any personal or identifying information, such as your name and contact details, will be stored securely and separately from the research data until the end of the study and then will be destroyed. The study team will use this information to able to send you the results of the study. We will keep all information about you safe and secure.
With your consent the meetings will be recorded on an encrypted, password protected recording device (if face to face) or using video conferencing software (if remote). The recording device will always be stored in a locked cupboard or safe.
Following the meetings, the recordings will be saved on secure University of Sheffield computer servers and then deleted from the recording device. The files will be encrypted and securely transferred to a professional transcription service to be transcribed in full to allow it to be analysed. Once the meetings have been transcribed the files will be deleted. Your data will be given a pseudo anonymised study ID (no-one outside the research team will be able to identify you from the data).
Only the Chief Investigator and her supervisors will have access to the computer folders containing the study data collected. Any information in the transcripts that may help identify you, the person with MND, your healthcare professionals or location will be deleted or anonymised by the Chief Investigator prior to analysis.
How will we use information about you?
Sheffield Teaching Hospitals NHS Foundation Trust is the sponsor for this study. We will need to use personal information from you for this research project. People will use this information to perform the research to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your personal details.
Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no one can work out that you took part in the study.
All the research data collected as part of this study will be held securely and in confidence at STH. It will be used only for the purpose of this research. The anonymised information will be stored securely for 5 years after the end of the study, after which will be destroyed.
Other researchers may find the data collected to be useful in answering future research questions. We will ask for your explicit consent for your data to be shared in this way. The anonymised data and the analysis will be uploaded and stored on ORDA (the secure University of Sheffield's data repository hub for managing and sharing research data) for 10 years after which it will be deleted. The anonymised data will be made available to other researchers on request.
What are your choices about how your information is used?
You can stop being part of the study at any time, without giving a reason. If you wish to withdraw your data after this point, we will keep the anonymised data that you have already provided.
We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
Where can you find out more about how your information is used?
You can find out more about how we use your information at:
at www.sth.nhs.uk/about-us/general-data-protection-regulations.
by asking one of the research team
What is the legal basis for processing my personal data?
According to data protection legislation, we are required to inform you that the legal basis in which we are applying to process your personal data is ‘is necessary for the performance of a task carried out in the public interest’ (Article 6(1)(e) and will comply with the requirements of the General Data Protection Regulation (GDPR), the UK Data Protection Act 2018, and the Common Law Duty of Confidentiality.
Further information, including details about how and why the University processes your personal information, how we keep your information secure, and your legal rights (including how to complain if you feel that your personal information has not been handled correctly), can be found in the University’s Privacy Notice https://www.sheffield.ac.uk/govern/data-protection/privacy/general.
What will happen to the results of this research?
The results of the study will be published in a peer-reviewed journal and may be presented at seminars and conferences. It will also be presented back to the MND community via the MNDA. Nobody will be able to identify you in any reports or publications.
When you agree to take part in a research study, anonymised information that you have submitted may be provided to researchers running other studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research.
This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research and cannot be used to contact you or affect your care.
What if something goes wrong?
This type of research is not considered to be harmful. In the unlikely event that you feel you have been harmed by taking part in this research, there are no special arrangements for compensation arrangements. If you are harmed due to someone's negligence, then you may have grounds for a legal action but you may have to pay for it.
If you have any cause to complain about any aspect of the way in which you have been approached or treated during the course of this study, the normal National Health Service complaints mechanisms are available to you and are not compromised in any way because you have taken part in a research study. Should you have any cause for concern or wish to complain please contact Esther Hobson, the Principal Investigator at Sheffield Teaching Hospitals on the contact details below or contact the Patient Services Team (PST): Telephone; 1004 271 2400, Email; sth.pals@nhs.net or in person in the Patient Partnership Department on B Floor, Royal Hallamshire Hospital or Huntsman main entrance on C Floor at the Northern General Hospital.
If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).
The STH Data Protection Officer can be contacted at sth.infogov@nhs.net.
Who is funding the research?
This research is funded by the National Institute for Health Research (NIHR).
Has the research been approved by an ethics committee?
The study has been reviewed by the Harrow research ethics committee. The reference number for the study is: IRAS 331082.
What do I need to do now?
If you are happy to participate in the stakeholder group, please contact us on the contact details below.
If you have any questions about the research, please contact:
Chief Investigator: Charlotte Massey
Department of Neuroscience
Sheffield Institute for Translational Neuroscience (SITraN)
University of Sheffield
385a Glossop Road
Sheffield
S10 2HQ
Email: charlotte.massey3@nhs.net
Phone: 0114 222 2230
Principal Investigator: Dr Esther Hobson
Department of Neuroscience
Sheffield Institute for Translational Neuroscience (SITraN)
University of Sheffield
385a Glossop Road
Sheffield
S10 2HQ
Email: e.hobson@sheffield.ac.uk
Phone: 0114 222 2230
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