Preventing relapse to alcohol in patients with cirrhosis

• This Delphi study will involve collecting feedback from experts, which will be shared and reviewed over a series of stages known as ‘rounds’ until an agreement is made.

• We are planning to recruit about 30 experts from the following groups:
  • Healthcare professionals specialising in liver disease.
  • Healthcare professionals specialising in alcohol misuse.
  • Community based practitioners involved in the care of patients with liver disease and alcohol use disorder. (This includes but is not limited to: GPs, community alcohol services, social services, community nurses.)
  • Commissioners of treatments and interventions for alcohol use disorder.
  • Individuals with alcohol-related cirrhosis.
  • Family members, informal caregivers and friends of patients with alcohol-related cirrhosis.

• You have been invited to consider taking part in this study because we believe you are an expert and a member of one of the above groups.

• Abstinence from alcohol is the most important treatment for patients with alcohol related cirrhosis. During a hospital admission patients have an enforced period of abstinence. This provides an opportunity to establish long term abstinence and provide support to patients to help them prevent relapse.
• In this project, we are seeking to understand the best ways to support patients with alcohol related cirrhosis to avoid relapse to alcohol after an admission to hospital.
• We are conducting a remote, online consensus building exercise with experts and stakeholders to determine priorities for service improvement in this area. To build consensus across a range of stakeholders we are using a technique called Delphi.
• The whole process takes place online and can be done at your own pace at a time convenient to you.
• We would like to invite you to take part in the online remote consensus building process.

• You are invited to participate in an online remote consensus building process. The consensus building process is hosted on a secure online platform known as Thiscovery.
• You will be asked to identify to which group of stakeholders you belong (see above).
• The consensus building process takes place over two rounds using a method called “Delphi”.
• First Round (completed)
  • People were asked to rate recommendations for service improvement in response to the statement: "This recommendation should be prioritised"
  • A nine-point scale was used with responses ranging from "strongly disagree" to “strongly agree".
  • People had the option to provide free text comments.
  • Only recommendations that reached consensus in the first round are being taken forward to a second round.
• Second Round
  • This second round is taking place within 6 weeks of the completion of the first round.
  • You will be asked to rank the recommendations which achieved consensus in round 1.

What is Thiscovery?

• Thiscovery is an online platform that enables the health and care system to improve and innovate through collaboration. Knowledge-led organisations are using Thiscovery to engage with people to understand problems, gather evidence, build shared visions, co-design solutions, and evaluate them.
• Projects held on Thiscovery provide opportunities for the millions of people who use, work in, manage, and study health and care services every day to have meaningful involvement in improving them. It helps organisations deliver actionable results at speed, with rigour, in an engaging and inclusive way with diverse groups of patients and staff.
• Thiscovery is developed by the team at THIS Labs, with roots in THIS Institute – a research centre at the University of Cambridge, made possible by the Health Foundation. THIS Labs is reshaping the way improvement, innovation, and transformation is done in health and care.”

What will you be asked to do on Thiscovery?

• Within Thiscovery you will be asked to complete an initial set of eligibility questions, to read a consent statement and provide consent online. You may request a copy of your completed consent form, provided you have supplied, and consented to sharing your email address with the project team. Once you have given your consent, you will be able to access the survey through the Thiscovery platform.
  

• Work arising from this study will be published under a group authorship model. You will be offered the option to be included that group and therefore recognised in any resulting publications and presentations.
• All participants who complete the survey and the consensus building process will be entered into a draw to win one of two £100 Amazon Vouchers.
• We cannot promise that the study will help you personally. The knowledge we gain from the study should help us improve the treatment offered to patients with alcohol-related liver disease in the future.

• The risks of taking part are minimal. It is possible that the process may bring up topics or memories which may be unpleasant. If you are worried about this, please contact the study team. You are not under any obligation to answer questions which may make you uncomfortable and all questions can be skipped.

• If you change your mind about taking part in the process, you can withdraw at any time without giving a reason. However, it may not be possible to remove data that have already been submitted. To withdraw please email christopher.oldroyd@nhs.net.

How will we use information about you?

• We will need to use information about you for this research project. This information will include:
  • Name
  • Contact e-mail address (if you have provided this)
  • Responses to Delphi process and comments

• This information will initially be stored on Thiscovery before being securely transferred to University of Cambridge password protected drives.
• People will use this information to do the research or to 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 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 reports in a way that no-one can work out that you took part in the study.
• De-identified information about your responses may be made available for other research studies run by CUH and/or the University of Cambridge or other organisations. These organisations may be NHS or other public sector organisations, academic institutions, charities and commercial companies in the UK or abroad. Before your data is shared with other organisations all personal identifiers will be removed. Making information from studies available for further research helps maximise the benefit of conducting studies and allows other researchers to verify results and avoid duplicating research.
• You can find out more about how we use your information:
  • in our leaflet available from https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/gdpr-guidance/templates/template-wording-for-generic-information-document/.
• Alternatively:
  • for Cambridge University Hospitals NHS Foundation Trust, please visit: https://www.cuh.nhs.uk/participant-privacy/.
  • for University of Cambridge, please visit: https://www.information-compliance.admin.cam.ac.uk/data-protection/medical-research-participant-data
  • email The Information Governance team at researchgovernance@medschl.cam.ac.uk
  • ask one of the research team
  • send an email to cuh.gdpr@nhs.net
  • or ring us on 01223 256141.

• You can stop being part of the project at any time, without giving a reason, but we will keep research data that you have already submitted. Please read the earlier section on withdrawing from the project for full details. 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.
• For further information you can review Thiscovery's privacy policy.

• In addition to reports for funders, we hope that the results of the project will be reported in peer-reviewed journals and presented at conferences.
• We can email you about the project’s publications if you wish to be kept informed.
• No personally identifiable information will be included in any reports or other outputs of the survey: any quotations used in reporting will be completely anonymised.

• This project is led by Dr Christopher Oldroyd.
• This project has received ethics approval from West of Scotland Research Ethics Service Ref 24/WS/0112
• This project is organised by The University of Cambridge and Cambridge University Hospitals NHS Foundation Trust.
• Insurance and/or indemnity to meet the potential legal liability of the sponsors for harm to participants arising from the research is provided by the NHS indemnity scheme and by The University of Cambridge Public Liability Insurance Policy.
• This project is funded by The National Institute for Health and Care Research.

• For questions or concerns about anything to do with the project, please email the project team at christopher.oldroyd@nhs.net or help@thiscovery.org. 
• For technical problems or questions about the platform, please contact the Thiscovery team by email at help@thiscovery.org.

• If you have any questions about being in a research study, you can contact the Trust’s Patient Advice Liaison Service (PALS) / Patient Advice and Support Service (PASS) They will tell you about who you can talk to for independent advice. Their contact details are:
  • Email: cuh.pals@nhs.net
  • Phone: 01223 216756
• If you are still not satisfied, you can contact cuh.research@nhs.net
• If you are not happy with their response or believe they are processing your data in a way that is not right or lawful, you can complain to the Information Commissioners Office (ICO) at www.ico.org.uk or telephone 0303 123 1113.

• This project is led by a team of researchers at The University of Cambridge, The University of East Anglia, and Cambridge University Hospitals NHS Foundation Trust. The key members of the research team are:
  • Dr Christopher Oldroyd
  • Dr Michael Allison
  • Prof Graham Martin
  • Prof Caitlin Notley

Version No: V1.2

PIS date: 22/01/2025

IRAS ID/REC Ref No: IRAS 342487