Patient and Public Involvement

Trial History of Patient and Public Involvement within CARE

Between August 2014 and November 2015 most of the co-applicants worked with people with cavernoma, carers, and representatives of the patient support organisation Cavernoma Alliance UK on the Steering Group of the James Lind Alliance Priority Setting Partnership that identified and prioritised the topic of this application as the top priority for further research into cavernoma.

Since November 2015, individuals in the Steering Group of the James Lind Alliance Priority Setting Partnership - including patients and carers - have been involved in reviewing the commissioning brief for this NIHR commissioned call for research.

In May-June 2016, some of the researcher co-applicants worked with Cavernoma Alliance UK to gather the views of patients and carers who are members of the organisation, about research to address this top priority for further research into cavernoma. We consulted 731 Cavernoma Alliance UK members affected by cavernoma or parents/guardians of affected children, by emailing them a link to a web-based survey describing the randomised trials at the core of this proposal. 70% of respondents had not received active treatment for a cavernoma and a minority (28%) of these respondents indicated that they would not participate in the randomised trials proposed.

Between December 2018 and June 2019, we have consulted representatives and members of Cavernoma Alliance UK, including patients with the condition, who have reviewed and shaped the design of the project proposed in this application.

We held a focus group meeting with patients and carers on 6 July 2019: all approved the design of the project and the extent of patient and public involvement. The focus group wanted the trials to be as inclusive of patients as possible. The focus group recognised how the project would benefit from them contributing their 'lived experience' of brain cavernoma. People with cavernoma, carers, and representatives of Cavernoma Alliance UK will also keep an eye on the research by forming an advisory group and meeting regularly to discuss

Current plans of involvement

We expect recruitment to be challenging in the pilot randomised trials, so we hope to maximise recruitment by extensively involving patients, carers, and family members with the collaboration of the patient support organisation that represents them, Cavernoma Alliance UK, and performing a substantial qualitative study of what affects patients’ and carers’ decisions to participate.

We have convened a PPI advisory group identified by Cavernoma Alliance UK, representing the diversity of perspectives of patients and carers. This group has clear terms of reference. Two members of the PPI advisory group represent the views of the group as independent members of the CARE steering committee.

We consulted the PPI advisory group about the design, language and content of the project’s information leaflets (including easy-access and aphasia-friendly versions), videos, informed consent forms, methods of follow-up, importance of particular outcomes, and questionnaire design to make them user-friendly. This group helps to ensure that the methods proposed for the project are accessible and appropriate for potential participants (who may be adults or children, pregnant, from diverse racial/ethnic backgrounds, and who may or may not have mental capacity to make decisions for themselves). Furthermore, this group will have the opportunity to reflect on the evolving findings of the QuinteT qualitative study, and consider potential recommendations about project re-design as part of the QuinteT Recruitment Intervention. The PPI advisory group meets bi-monthly

We will also engage with participants in this project during the two-year period of recruitment and follow-up, so we will seek input from the PPI advisory group on the design, content, and accessibility of progress reports and newsletters for participants.

Project Results

When the results of the project are known, we will ask the PPI advisory group to evaluate them to inform the Steering Committee. We will ask them to interpret the results to help to identify themes that the researchers might miss, to check the validity of our conclusions from a public perspective, and highlight the findings that are most relevant to the public.

We will disseminate our findings not only to participants but also to public audiences with input from, and acknowledgement of, the PPI advisory group. We will offer to present our project and its findings to the annual meetings of Cavernoma Alliance UK and the UK Stroke Assembly, which are national events that give people affected by cavernoma or stroke a voice to talk about the issues that matter to them. We will produce an easy access report of our findings to share with the public and patients, and we will post it in the public domain on websites including those of Cavernoma Alliance UK and the chief investigator’s Research to Understand Stroke due to Haemorrhage (RUSH) programme (www.RUSH.ed.ac.uk). We will keep the public, patients, and carers informed about study progress and results via social media channels (Facebook and Twitter).

Cavernoma Alliance UK

Cavernoma Alliance UK (CAUK) is the biggest cavernoma support organisation in the UK. The charity aims to provice support and information for all those affected by cavernoma - Friends, family, carers and professionals. CAUK provides an extensive support network including: 

• Telephone Support
• Email Support
• Events and Annual Forum
• A cavernoma buddy system
• Professional leactures
• Meet ups
• Therapy
• Webinars
• Support for carers

For more information about Cavernoma Alliance UK please visit the website