To our knowledge this is the largest study of PPI in randomised trials to date. Several of our observations receive support from previous studies and reviews of PPI, although most of this work has not concentrated on PPI in randomised trials. Compared with other forms of health and social care research, randomised trials are highly structured and intensively regulated entities. This limits the relevance of PPI studies conducted outside the context of a randomised trial for understanding how PPI can make a difference within trials. For example, it will usually be harder to change aspects of a randomised trial after it has started than other types of studies.
Our findings are timely given the 2014 announcement71of a strategic review of PPI in research within the
UK and the increased emphasis on stakeholder involvement internationally.
Patient and public involvement in grant applications
The impact of public involvement in the research commissioning programme of the HTA has been previously assessed;72however, this is the first study to look at PPI within a cohort of the research funded
by the HTA and at funding board and referee assessments of PPI plans contained within applications. Our findings point to the difficulties of implementing PPI prior to funding and consequently the difficulties that funding panels and reviewers face in assessing the quality of a trial team’s plans for PPI, beyond identifying potential‘red flags’such as PPI contributors being limited to steering group membership or their involvement being sought only after funding has been awarded.
In England, a PPI bursary scheme has recently been launched by some of the NIHR Research Design Service, but is limited to those in receipt of advice from the Research Design Service although it has been shown to be beneficial.73,74However, the funding available is often small and inaccessible to those working
within the tight timescales of a typical funding call.69Increasing the availability and scale of resource to
provide an infrastructure to support researchers and contributors to initiate PPI at the pre-funding stage would help to facilitate earlier implementation.
Implementation of patient and public involvement: from plans to actions
We found no previous reports on the extent to which documented plans for PPI within trials were subsequently implemented. Nevertheless there have been several accounts of challenges involved in implementing PPI which, while not in a trials context, endorse our findings. For instance, recent reports have referred to tokenism,75,76or highlighted the potential challenges in identifying suitable individuals
long term;16,18,20–22of researchers having little experience of PPI and being uncertain about what to expect;20,22,77and of jargon-related problems.18,55,74INVOLVE suggests that PPI contributors would benefit
from a‘glossary of technical terms’,21again something reflected in the suggestions from contributors
within our study.
Staley5refers to the challenge of ensuring that involvement is meaningful and not simply tokenistic. As
described within this report, a tokenistic or minimalistic approach aimed at meeting funder requirements, rather than meeting goals and objectives set by researchers for PPI, may be a self-fulfilling prophecy.
Pathways to impact
Previous work has pointed to the different types of impact that we identified, both focused24–27,28,44and diffuse.5Previous work has also identified the role of researchers’values,3the quality of the relationship
between researchers and PPI contributors45and the importance of implementing PPI through the‘life
course’of a project5in facilitating the impact of PPI. Our findings concur with the PiiAF,55which was
informed by a large mixed-methods study of the views and experiences of members of the UK health and social care research community. This emphasised the importance of careful planning in implementing PPI and encouraged researchers to be explicit in thinking about how their approach to PPI will lead to the impacts they seek.3,55International guidance has also emphasised the importance of having PPI from an
early stage, and having wider involvement than PPI on a steering committee,78although such guidance has
lacked an evidence base until now. Many countries now encourage or require PPI to be included in research,7–10,78so our findings can be applicable internationally. The opportunity to compare our findings with previous evidence beyond this is limited because, as we note above, few studies have specifically investigated the impact of PPI on trials5and we are not aware of any studies that have examined
influences of PPI across multiple randomised trials. As the first evidence to indicate the ineffectiveness of limiting the involvement of PPI contributors to oversight roles on steering committees, our findings indicate that some recommendations on PPI in TSCs need to be amended to acknowledge the limitations of this type of PPI as the sole means of engagement. This recommendation will be of interest to research funders as well as PPI contributors and researchers. The trials we studied often combined two or more approaches to PPI, and our informants described the importance of having the freedom to tailor PPI to the emergent needs of their trial.
Training
Findings from the EPIC project regarding PPI training needs suggest that, although informants were more receptive to PPI training for researchers, there was considerable reluctance regarding the training of PPI contributors, with a preference for‘informal inductions’. The health service researchers in a previous qualitative interview study varied in how they interpreted PPI policy and in their PPI‘working practices’and referred to how PPI brought a‘fear of the unknown’.76This study also points to a‘know–do’gap, whereby
researchers’talk of the importance and value of PPI in the‘ideal’world stood in contrast to their experiences of‘the reality’of implementing PPI in practice.79
There have been few previous empirical studies of PPI training for either researchers or PPI contributors, although training has generally been recommended for both groups.3,36,37In showing that the appetite for
PPI training is limited, our findings diverge from previous research that indicates more enthusiasm for PPI training among researchers and PPI contributors.3,80–82This may reflect differences in sampling between previous work and ours, and particularly our focus on clinical trials. Previous research has also tended to seek informants’views on training in general, whereas we explored informants’views about training specifically for themselves and for the researchers or PPI contributors with whom they worked. Interestingly, we found informants became more receptive to training when their focus shifted to generalised‘other’researchers or contributors outside their trial.
Informants were particularly concerned that training could hamper contributors’ability to provide a patient perspective. Although it is possible to envisage ways in which training could support rather than detract from this ability, such concerns need to be taken seriously. The pronounced reluctance that we identified
regarding training for PPI contributors, and informants’preferences for‘conversation’over‘training’, align with the emphasis informants gave to establishing good relationships between the PPI contributors and the research team. In a context where good working relationships are prioritised, informants may see conversational approaches to learning as more conductive to successful PPI than the type of practical or technical instruction that is usually associated with training. Indeed, the type of learning needed for PPI may be more wide-ranging and better supported by more discursive types of educational provision such as action learning sets83,84and coaching.85Our study indicated the areas of learning or training need identified by
researchers and PPI contributors (seeTable 24). These are similar to those previously identified,3although
informants in our study tended to speak of training for PPI contributors as comprising‘how to do research’ whereas training for researchers was seen as comprising‘how to do PPI’. Given that some PPI contributors felt they lacked clarity about their roles, training that helps both researchers and PPI contributors to learn how to do PPI would be beneficial. Our informants also described training as something that was delivered separately for PPI contributors and researchers. However, reflecting our informants’emphasis on the need to develop good relationships and mutual understanding of roles, we support previous suggestions that training which allows contributors and researchers to learn from each other in joint sessions would be beneficial.37
Networks
Hanleyet al.49reported on a national questionnaire survey on the role of PPI in designing, conducting and
interpreting randomised controlled trials of clinical trial co-ordinating centres and concluded that PPI was still uncommon. Since the publication of that survey there have been many changes in the clinical research environment, including those brought about by the establishment of the UKCRC in 2004 and the RCTUs in 2007. RCTUs are assessed as having the expertise necessary to ensure high-quality, successful and timely trials, and to meet regulatory and governance requirements. Within the first wave of CTU applications to the UKCRC for registration status, each of the RCTUs agreed to the best-practice principle of‘an organisational commitment to patient/public involvement’.86However, in later registration rounds there
has been no mention of a commitment to PPI. Nonetheless, this project demonstrates a widespread commitment from the CTUs achieving UKCRC registration status. This commitment needs resourcing and may require core funding support to be sustainable. With respect to this, it could therefore be of benefit for future UKCRC registration calls to be explicit about requirements for PPI. This study also identified a need for greater engagement between RCTUs, INVOLVE and funders of research to benefit PPI activity.