The benefits and challenges of PPI in research are increasingly being recognised. The drive to undertake PPI within research is apparent with many funding bodies now requesting that researchers provide evidence of PPI when submitting their proposals including clear plans for PPI activities throughout the proposed research [32–36]. Indeed, one of the strategic goals for the NIHR is that, by 2025, PPI is a ‘required part of high quality research’ .
Research has shown how resources to support public contributors and researchers (INVOLVE resources) are often not used [8, 13]. The developing PPI toolkit described in this paper begins to address this problem.
The developing toolkit
Through mapping out the clinical trial pathway (Phase 1) and exploring resources that might facilitate PPI across this pathway (Phase 2) the CTRC have identified that numerous resources currently exist to support PPI in research or that were suitable for adaptation by the CTRC. We have also identified the need for additional tools that could be developed to address current gaps in the toolkit. These will either be developed locally by the CTRC PPI working group or in collaboration with others involved in PPI in other trials units. The tools within the toolkit will be designed to facilitate meaningful involvement by promoting clear planning of PPI from the outset, by providing tools that encourage a considered approach to involvement activities, and by providing ‘off the shelf’ resources, available online, to support clinical trials, as researchers are sometimes required to develop trials at a fast pace. Phase 2 is ongoing and only preliminary findings have therefore been presented. It is anticipated that by disseminating this work while the toolkit is in development, we will facilitate the engagement of various stakeholders, including public contributors and other clinical trials units in the toolkit’s ongoing development, thereby improving its quality.
Trial teams, including public contributors, will be encouraged to provide evidence of the impact of PPI interventions against planned PPI and examples of any further resources successfully used to undertake and support PPI. It is intended that this collective ownership of the resource will promote enthusiasm for and engagement with PPI. By providing a link in the toolkit to the Guidance for Reporting Involvement of Patients and Public (GRIPP ) checklist on reporting of PPI we aim to support and encourage teams in publishing their PPI activities, including where trials are not funded (there may be useful examples of PPI even where a trial does not get funded). By working with other trials units we may also be able to collectively test out tools to examine to how well they support the meaningful involvement of public contributors in research. We will seek to engage trials teams in this process. This fits with a further strategic PPI goal of the UK NIHR, ensuring “evidence of what works is accessible so that others can put it into practice” .
One of the problems with existing resources not being used is that they are not immediately visible to all researchers and trials teams, often working on many other aspects of the trial. Within our CTRC, members of the PPI working group are working to raise awareness of the developing toolkit and resources within it. An initial training session about the toolkit was hosted at a recent Trial Managers meeting. Ongoing activity by the PPI working group will ensure that the toolkit is regularly promoted as a standing item (with information on updates to the Toolkit) at the Trial Managers meeting. Part of the induction of new trial managers will include information on PPI and the toolkit. Ideally the full trial team should discuss the tool together when planning their research and conducting their trial, but it is recognised that working practices vary. We envisage that statisticians need to be aware of the issues that patients can contribute to. Within the CTRC we expect our senior trials managers to raise awareness of the toolkit with research teams on whichever trial they are working on.
In developing our initial toolkit we recognise that a limitation of our work is that we have not involved patients and the public in its design, but due to restrictions of funding, resource and time the authors decided to develop the initial structure of the toolkit internally. Having this initial structure will enable public contributor engagement with a developing resource, rather than starting with a blank slate. The lead author is also a public contributor in research and clinical trials and this has therefore provided an initial public steer to the work.
There have been calls for greater collaborative working to avoid duplication of work in patient and public involvement. The recent NIHR strategic review of public involvement in research in the UK emphasised “the importance of partnership and collaboration to future success” . The CTRC has worked to develop a network of PPI professionals working in UK CTUs. The CTRC sent an invitation via the UKCRC Registered CTU Network for people with a specific role in PPI in trials units to take part in a teleconference. Twenty-two people from CTUs across the UK expressed an interest including both individuals with a specific PPI role, such as PPI co-ordinators and others, for example, senior trials managers where responsibility for PPI in a CTU was part of their wider role. In April 2015, the CTRC hosted an initial teleconference with this network to explore ways of working in collaboration. A future face to face meeting is planned to further progress collaborative working which may include the development and evaluation of PPI tools, including assessment of the value of elements of the toolkit presented here. We anticipate this group may offer to liaise with their patient panels and public contributors to engage with this process of assessment. We hope that through this consensus process we will optimise the resources made available in the toolkit. This meeting will also offer an opportunity to consider how the success of the toolkit should be measured, since there is little information in the literature of relevance to this issue.
In further developing and reviewing all the tools for the toolkit, and the structure of the toolkit itself, we will involve not only CTRC public contributors and trial teams, but also interested collaborators from the wider UKCRC Registered CTU network and their public contributors, so ensuring that we have the most appropriate and user friendly tools possible and suitable active links to other relevant resources.
Although this toolkit has been designed in the UK, the stages of a clinical trial are similar internationally and therefore many of the resources in this toolkit are relevant to the implementation of PPI in clinical trials in other countries. Indeed, PPI is growing internationally. While the development of this toolkit has not involved a systematic review of resources worldwide, as part of the ongoing development of the toolkit we intend to explore PPI resources internationally. This may include: the Patient Centred Outcomes Research Institute (PCORI, USA); Involving People (Wales); Involving People in Research (Australia); Health Technology Assessment International (HTAI) and the European Patients Academy on Therapeutic Innovation (EUPATI). Where relevant resources are identified from these and other sources we will incorporate links to these.
The toolkit will be further developed and continually informed both by activities that identify gaps or resource needs and by ongoing revision of resources and links based on any newly available research, information or tools to make sure that the toolkit remains current. This work, and the online provision of these resources will be facilitated by CTRC infrastructure funding for the PPI Coordinator post and information systems support. The usefulness of the toolkit and the appropriateness of the resources will be assessed through formal evaluation of public contributor and trial team experience.