Patient and Public Involvement (PPI) is an essential activity when designing a research study. Gaining insight from patients and the public on particular aspects of study design ensures the appropriate question is being asked, and that the appropriate methods are being employed to answer the question.
In a successful grant application investigating the effectiveness and cost-effectiveness of two methods of post-operative ankle fracture management (plaster versus support boot), PPI activity was commended by the funder who stated: “Committee welcomed this well-written application, which included strong patient and public involvement elements”. The external peer reviews commented that the patient and public involvement was “a real strength area of this project” and that “there appears to be an excellent involvement of patient and public in the design of this research.”
The PPI process
The local Research Design Service PPI Adviser from the Bournemouth University Clinical Research Unit suggested how best to involve service users. A topic guide was drawn-up, and telephone consultations were conducted with 12 service users of a range of ages who experienced an ankle fracture and who had been operated on and had previously taken part in an audit. ‘Lay’ reviews were also obtained.
How the application changed as a result of PPI input
The consultations informed the application as follows:
- Informed sample size calculation by providing information on the most important component of the primary outcome – walking without aids and getting back to work rather than measures of pain, swelling, range of movement, and stiffness etc.
- Refinement of data collection tools – service users reported that the SF-36 was too onerous and therefore the EQ-5D-5L, which is significantly shorter, has been chosen instead.
- Ankle fracture was a life changing experience for a quarter of the patients e.g. cost implications of renting a bungalow; family implications of moving back home with parents for a walk-in shower; employment implications (e.g. retired early); social isolation because of difficulties getting out and about and washing but also positive implications of taking up new hobbies (e.g. guitar). This suggested a range of impacts that were unlikely to be captured by the quantitative data alone. Therefore a qualitative component has been incorporated into the design of the study to explore the experiences of the treatment group.
The view from the Researcher
“This study, unlike other orthopaedic research, focuses largely on subjective rather than objective information. This is a well planned and carefully considered study which has huge practicality simply because of early RDS PPI involvement. Their contribution to the designing and development of this study is invaluable.”
The view from the PPI Adviser
”The PPI for this project was interesting and exciting – not least because of the identification of the most important component of the primary outcome (ie walking unaided and return to work rather than physiological measures such as of pain), but because the service user input anchored the research in the real world. By asking service users about their journeys, it was possible to gain insight into the experience of having a fractured ankle that was more comprehensive than referring to the literature alone. For example, because the impact of sustaining a fractured ankle was profound and diverse for a significant number of patients, it suggested that the data collection tools would need careful consideration to reflect this. It also indicated that qualitative research, specifically interviews, could play a key role in capturing the depth of experiences and provide a more comprehensive picture of the post-operative journey of patients with ankle fractures.”
The view from the Public
The Research Design Service Scientific Committee provided reviews from ‘lay’ members stating that the project was a “sound endeavour,” “taking a holistic approach” and with public involvement being “throughout and very targeted.”