There has been substantial PPI contributing to the design, conduct, and interpretation of the CHESS programme. This is reported in detail in our published paper (see Appendix 19).71
Throughout the programme we worked closely with three UK migraine charities and a lay advisory group to help direct the research and ensure that the patient voice had been embedded in our work. We used guidance from the National Institute for Health and Care Research (NIHR) standards for public involvement to help support us in establishing and implementing PPI.72 We started from the premise that PPI representatives were full members of the team and we sought, as far as possible, to reduce power differential.73 We sought to work in an environment of mutual respect and with each team member valuing others’ contributions.
Our lay patient partners were paid for their time and travel; we reimbursed our charity partners for their travel. We summarise the PPI contribution throughout the trial.
Development of research idea
The original research question, ‘Will an education and self-management programme help people living with chronic headache?’, is based on a research recommendation in the 2012 NICE guidelines on the management of headaches.5 Members of the lay guideline development group helped identify the research question.
Grant application
Our co-applicants included representatives of the three leading UK migraine charities. The involvement at this stage was from our charity partners. It did not include direct patient involvement.
Establishing a lay advisory group
We established a lay advisory group, from our larger lay reference group, at the start of the programme. We sought to establish a group of 8–10 people living with chronic headaches. Members needed access to e-mail but not specific skills. Our charity partners approached a diverse group of people with chronic headaches. We also approached people through a University of Warwick PPI initiative. We contacted responders to identify their headache type and basic demographic details. Ten people joined the CHESS lay advisory group. This group then developed their own rules of engagement (see Appendix 19, box 2).71
Trial oversight
We invited representatives of each of the three charities to our monthly trial management groups. The charities found it difficult to commit their staff to meeting times. Our independent PSC had two lay members who contributed to eight meetings over the duration of the programme. One lay representative contributed to our Data Monitoring Committee.
Feasibility study research ethics application
When we sought research ethics approval for the feasibility study our lay advisory group was not established. Our charity partners helped us to find five people who critically reviewed our patient-facing documents.
Headache classification day
Our lay reference group contributed to the classification day, ensuring that the key questions generated were relevant to people with chronic headache and health professionals. Seven lay people attended on the day.
Electronic data collection
The CHESS lay advisory group helped to refine the questions used in the electronic diary and provided feedback on the acceptability, the user experience and the app. A suggestion from our lay advisory group included the addition of a calendar indicating the period of recall.
We provided participants with a summary of their diary data once data collection was complete. The group commented on, and made recommendations to improve, the individual data summary sent to main trial participants at the end of their data collection period.
Intervention design and development
Seven members of Migraine Action took part in an individual, face-to-face interview about their headaches and the treatments they had tried, to inform the intervention development.
Our intervention development day was chaired by one of our professional charity partners and attended by three lay representatives, suggested by our charity partners.
Patient-reported outcome measures
During the feasibility study three members of the lay advisory group helped analyse data from interviews exploring participants’ views on the relevance, clarity, comprehensiveness and acceptability of four PROMs.
Core outcome set for migraine
Three PPI members actively collaborated in all stages of the core outcome set for migraine (COSMIG) project, allowing co-development of a three-stage international Delphi survey, subsequent data interpretation, co-facilitation of the consensus meeting and co-authorship of the subsequent publication.39
Public and media engagement
Following a university press release we were invited onto The Victoria Derbyshire Show (BBC News, London, UK). We were represented by one of our lay members and the chief investigator. Our lay member was able to speak about their experience of chronic headaches and the impact this had on their life. This generated public interest in CHESS.
Post-results patient and public (lay) discussion group
Once the trial outcome was known we sought an additional patient and public perspective on the findings. We ran a 2-hour virtual discussion group with 10 people drawn from the CHESS reference group. The process evaluation team presented an overview of the process evaluation results followed by the trial outcomes. The group were disappointed with the outcome but not completely surprised. Although the CHESS intervention provided useful knowledge and tools, the group thought that developing new skills and behaviours takes time. Participants thought a longer intervention may be needed to reinforce learning and to support behaviour change.
Patient and public involvement learning points
Our thinking on patient involvement has developed substantially since we submitted the first application for funding in June 2012. At that time, we had planned a formal evaluation of PPI in the programme. We were asked to remove this by the funding board at the outline stage. This does mean we have missed the opportunity to do a more in-depth prospective evaluation. Nevertheless, we have identified some key learning points:
- More training in the research process for both our lay and professional PPI partners.
- Lay input, in addition to charity input, into the development of the grant may have provided a different perspective.
- A designated team member to be the PPI contact could have improved engagement.
- Regular correspondence to update the lay advisory group throughout the duration of the programme.