Stage three take part
Thank you for your interest in the Delphi study. We are currently closed to recruitment and busy analyzing our data.
Delphi Participant Information Sheet
Person-centred outcome measures in End-of-life cAre in Critical carE
(PEACE-COS)
Invitation
We would like to invite you to take part in stage three of the PEACE-COS research study.
Before you decide whether or not to participate it is important that you understand why the research is being done, what it will involve for you and how we will use the information we collect from you.
Please take time to read the following information carefully. You may discuss it with others if you wish.
Please ask us if there is anything that is not clear, you would like more information or the information in an alternative format. A member of our research team will go through the information sheet with you and answer any questions you have. Thank you for taking the time to read this information and considering taking part in the PEACE-COS study.
Why is this study needed?
Currently, researchers use a range of different measures (‘outcomes’) to evaluate end-of-life care in critical care. For example, some research may look at how long patients stayed in critical care while others look at what treatment a patient received. This means when the two studies are finished, we cannot compare or combine their results because they have used different outcomes.
When researchers design end-of-life care research studies, they need to measure important and relevant outcomes to those affected. To decide which outcomes are important, researchers need to get everyone’s opinion and try to reach an agreement, or ‘consensus’, on the most important outcomes. To do this, researchers carry out a ‘consensus exercise’ by using something called a ‘Delphi’ study.
From looking at research papers and interviewing people involved in end-of-life care, we have developed a long list of possible outcomes that we would like you to rate in order of importance through a series of online questionnaires. No-one in the group can see another individual’s scores.
At the end of the questionnaires, we will invite some of the people who have taken part to discuss the results and the research team will produce a report on what people have agreed as the most important outcomes. These will be called a ‘core outcome set’ and will be the main outcomes for all future studies to measure in end-of-life care studies in critical care.
Why have I been invited?
You have been invited to participate in this study because we think it is important to include the opinions of:
- family members and friends of patients who received end-of-life care in critical care
- health professionals providing end-of-life care
- researchers
- critical care survivors who were given a limited chance of survival whilst in critical care
Do I have to take part?
No. It is up to you to decide whether or not to take part. This information sheet will describe the research study and help you decide. You can also discuss taking part with your friends and family.
If you decide to take part, you are still free to withdraw at any time and without giving a reason. You can do this by exiting the questionnaire or consensus meeting.
What will happen if I take part in the study?
You will need to confirm that you have read the participant information sheet and that you meet the study criteria by completing an online form.
On the same form, you will be asked to consent to participating in two questionnaires and to keep the questionnaire results confidential. You will be invited to answer mandatory demographic, accessibility and contact questions (age, ethnicity, gender, profession, experience and email address).
You will be asked to consent to receive an invitation to be part of a MS Teams video-conference consensus meeting. Consenting to be approached for the consensus meeting does not mean that you are obliged to take part nor that you will be approached to do so. Not everyone who consents to take part will be invited to attend as we need to ensure we include a diverse range of participants and places are limited.
We will contact you via the email address you provided with a link to start the first questionnaire.
The questionnaire involves reviewing lists of outcomes and rating their importance. Instructions will be provided. You have up to three weeks to complete the questionnaire.
The research team will use your feedback and other experts’ feedback to revise the outcome list.
You will be sent a link to a revised questionnaire, together with a summary of the results from the previous questionnaire, and asked to rate each outcome. Each questionnaire should take no more than 30 minutes to complete and will be sent out approximately four weeks apart. Submitting your completed questionnaire indicates your ongoing consent to take part.
If you are not selected to participate in the consensus meeting your involvement in the study will finish following the submission of the second questionnaire. We will write up the results and may use anonymised direct quotes (where your identify is not disclosed) in publications.
Consensus Meeting (additional optional component by invitation only)
You will receive an email inviting you to take part in an online consensus meeting. Participants will be selected to represent the different organisations and perspectives.
You will need to confirm that you have read the information sheet by completing an online form.
On the same form, you will be asked to consent to participating in the online video conference consensus meeting. You will be invited to answer six mandatory demographic, accessibility and contact questions (age, ethnicity, gender, profession, experience and email address).
We will contact you via the email address you provide to let you know the date and time of the consensus group meeting together with the information you will need to join. The meeting will take place using MS Teams.
When you join, you will be entered into a virtual waiting room until everyone has joined. There will be a maximum of 40 people. We will guide you through the end-of-life outcomes we want to explore. There are no right or wrong answers we are simply interested in your opinions.
The consensus group meeting will last a maximum of three hours with breaks. We will take notes and make an audiovisual recording. The meeting will be written up (professionally transcribed or transcribed by the research team). All transcripts will be pseudonymised (real names replaced) and the recording deleted.
Your involvement in the study will finish following the consensus group meeting. We will write up the results and may use anonymised direct quotes in publications.
Possible benefits
Participating in this study may not help you directly but will allow us to develop a clearer understanding about what end-of-life outcomes truly matter to patients and their families, which will improve future research together with patient and family care.
Possible disadvantages
We understand that thinking about and talking about end-of-life care and the death is likely to be emotional or stressful experience for you. It can make you feel upset, angry, sad and cry. These powerful feeling can occur before, during or after the interview.
Each outcome description has been written sensitively by a researcher with appropriate training. If you do feel upset or distressed at any point, you can pause, take a break or stop altogether, depending on your wishes.
A list of bereavement support services is also available on the study website.
What if there is a problem?
If you have any concerns about any aspect of the study then you can speak with the researchers in the first instance who will do their best to answer your questions or concerns.
If you have any complaints or concerns about any aspect of the way you have been approached or treated during this study, you can also write to the University’s Secretary and Registrar at the following address:
Sharon Harrison-Barker Secretary and Registrar, University of Hertfordshire, College Lane, Hatfield, Hertfordshire, AL10 9AB.
How we use your data
In this research study we will use information from you. We will only use information that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study. Everyone involved in this study will keep your data safe and secure. We will follow all privacy rules.
At the end of the study we will save some of the data in case we need to check it and for future research. We will make sure no-one can work out who you are from the reports we write.
We will need to use information from you for this research project. This information will include your name and contact details. People use this information to do the research or check your records 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 name or contact details. Your data will have a code number instead. We will keep all your information about you safe and secure.
Once we have finished the study, we will keep some of the data so we can check the results. We will write our report in a way that no-one can work out that you took part in the study.
What are my choices in how my information is used?
You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
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.
If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study in the secure University data systems. Your data will be anonymous, meaning you will not be identified.
More information
You can find out more about how we use your information
- at www.hra.nhs.uk/information-about-patients
- by asking a member of the research team
- by sending an email to dataprotection@herts.ac.uk
Organisation and funding
The research is being organised and run by the University of Hertfordshire. The study is led by Sally Humphreys, a PhD research student at the University of Hertfordshire and NHS critical care research nurse. She is supervised by Professor Natalie Pattison and Dr Rosemary Godbold at the University of Hertfordshire and Dr Nazir Lone at the University of Edinburgh, all of whom have extensive experience in conducting research.
The day-to-day conduct of the study will be managed by Sally Humphreys and the study will contribute towards Sally’s PhD thesis.
Expenses and payments
None of the study team are paid for you participating in this study. You will not be paid for participating in this study. Participation is entirely voluntary.
Who has reviewed the study?
To protect your interests this study has been looked at by an independent group of people, called a Research Ethics Committee (REC). All the study information has been reviewed and given a favourable opinion by North East – Tyne & Wear South REC and the Health Research Authority (HRA). It has also been reviewed by the University of Hertfordshire Health, Science, Engineering and Technology Ethics Committee with Delegated Authority.
Study results
The results of the study will be written up and published in a professional journal and will form part of Sally Humphreys’ PhD thesis. The results will also be presented at conferences. The data will be anonymous, meaning none of the people involved in the study will be identified in any report or publication.
A summary of the Delphi results will be provided to all participants via email.
Our contacts
You are encouraged to ask any questions you wish, before during or after the study. If you have any questions or require further information about the study please contact one of the following people:
Lead Researcher
Primary Supervisor
Independent Contact
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01707 289375
Participant Information Sheet Version 1.0 30/08/2024/
PEACE-COS 