We have reported on the successful, multi-factorial aspects of PI in a national multi-centre clinical research study, focusing on the impact the public contributions made to the design, conduct, and reporting of the study. We have demonstrated that the PI work in the research study can be considered in terms of the UK Standards, which were introduced during the course of the study. It is hoped that this paper adds to the increasing body of literature highlighting examples of good practice demonstrating the value of PI in clinical research.
In achieving the aims of this paper, we have used the UK Standards for public involvement in research, through a purpose designed review tool to ensure adequate coverage of key detail of the research process.
There are several issues to be considered:
Utility of UK standards useful in evaluating the use of PI in the HIDDen research
The UK Standards provide thorough and useful guidelines of how research should be structured around PI. In terms of evaluating a research study that had started before the UK Standards were finalised, retrospective recall may however lack detail about all the valuable co-construction that occurred.
There is some potential overlap in the UK Standards since PI activity may ‘fit’ into two or more of the standards. This makes it difficult to use them in a review of a completed complex piece of research. It is however possible to recognise possible areas where the standards were not met. For instance, whilst it is straightforward to note the involvement of PC1 to the research question, project management groups and organograms: there is no evidence to suggest any involvement in the study design. Thus, standards one (opportunities) and six (governance) suggest this might be a possible area for improvement.
It was not possible to evaluate all standards within a finite period of time. Even when the research has been completed some actions were ongoing. For instance, standard five (impact) is a rich and evolving tapestry of PI actions that are still being implemented.
It was straightforward to document examples of working together (standard two) and the mutual respect and team ethos came across clearly. The standards will undoubtedly enhance this in future pieces of research.
There were many instances of support and learning (standard three). Unpicking the range offered could perhaps be helped if the standards highlighted that there is a spectrum to be considered here; from simple training (documented) to capture of PI input for joint authorship of conference papers and posters. Perhaps one of the best documented examples of the UK Standards in this research is in the abundant evidence of good communication (standard four).
Contribution to the Research Ethics Committee (REC) paperwork and attendance in REC meetings is a growing area of PI involvement in a number of research projects. Whilst help with ethics paperwork was documented, attendance at the REC meeting was not.
The UK Standards thus provide a basis from which further action might evolve. Given that the HIDDen study was ongoing during the release of the UK Standards the PI was commendable. Consideration of the UK Standards in research is increasing as researchers see potential benefits that can accrue though using them as a guide in future projects.
How does PI in the HIDDen project fits into the wider picture of PI in research?
A recent systematic review by Greenhalgh and colleagues identified 65 frameworks for supporting patient and public involvement in research . They proposed five categories of framework or types of PI focus:
Power-focused; designed to surface, explore and overcome researcher-lay power imbalances. Their theory underpins many of the other frameworks.
Priority-setting focus: designed to involve patients and lay people in setting research priorities e.g. James Lind Alliance
Study-focused: principles and methods for involving patients and lay people in conducting research, building a culture of involvement at all stages of the research cycle. Thereby improving the quality and efficiency of research and maximizing its societal impact e.g. UK Standards for Public Involvement in research and the earlier NIHR Research Handbook 2014 which illustrates PI in terms of the research cycle. This is the basis of this paper
Report-focused: designed to guide writing up and critical appraisal of research reports; a checklist for critically appraising a published study for the quality and comprehensiveness of patient and lay involvement.
Partnership-focused: designed to assure transparency and public accountability in researcher-lay collaborations. e.g. the INVOLVE values and principles. This sets out the principles of 1. Respect 2. Support 3. Transparency 4. Responsiveness 5. Fairness of opportunity 6. Accountability. They are to a large extent included in the UK Standards where INVOLVE had a key role and have thus already been considered
They suggested the breadth of “off-the-shelf” published frameworks have limited transferability and that stakeholders consider co-designing their own frameworks based on a menu of evidence-based resources . They concluded that “a single one size-fits-all framework may be less useful than a range of resources that can be adapted and combined in a locally generated co-design activity”. In this paper, three of the listed frameworks (study, report and partnership focussed) have been incorporated to create a fitting basis for exploration. As suggested, these frameworks might be used selectively by stakeholders to co-design their own frameworks. For this review the study-focused framework allowed consideration of:
The research context and nature of the proposed study
The planning for involvement including the resources needed alongside the UK Standards for PI
How the research went beyond tokenism – ensuring that PI is more than “ticking a box”
Inclusivity and human aspects such as building relationships, clarifying roles, communicating clearly, establishing trust and sharing information
The development and nurturing of an ongoing relationship with lay partners
We have reported the impact of PI in a major multi-site research study using the frameworks of the UK Standards for PI. The HIDDen study successfully used aspects of all UK Standards as a benchmark. This is a useful case study to further inform clinical researchers wanting to work effectively with public contributors. The UK Standards highlight partnerships-focused values and principles and a consideration of respect, support, transparency, responsiveness and accountability when working with public contributors.
Limitations to the project and lessons learned
This was the first time the UK Standards have been used to evaluate PI in a multi-national clinical study and from the start, it was always expected to be an iterative processes. Limitations to the project were inevitable and should be viewed within the wider context of what the project has achieved.
Firstly, the decision to evaluate HIDDen PI against the UK standards was a bold one since they were still in development and undergoing modifications. Such an example was the use of indicators, which were removed from the final draft of the standards but present at the time we undertook our evaluation. Has been evaluated, Secondly, the review was retrospective and some detail was inevitably lost since it relied on recall and some meeting documentation was unavailable as mentioned. Future studies within our group shall look to evaluate PI prospectively. Finally, it should be acknowledged that the evaluation reflects many interpretations and judgements on the part of the first author which risks bias. Every effort was made to limit this through he review of data by members of the trial management group in order to bring other perspectives to the interpretation of the data.
In considering lessons learned, the most significant is the importance of ensuring the UK Standards are used at the outset of the research project. Ideally this should be at stage of developing the research question. This would ensure full value for PI involvement. In the context of HIDDen study specifically, the evaluation concluded that PI did not meet the standards with respect to GOVERNANCE. In future studies we would aim to improve PI opportunities in research management, regulation and leadership.