PPI plans: from intentions to actions

As illustrated in figure 1, 28 trials were eligible for inclusion in the current analysis. We conducted interviews with the CI and a PPI contributor in 9 of the 28 trials, with the CI only in 12 trials and a PPI contributor only in 7 trials. One PPI contributor was involved in two of the trials in this sample, while a further two trials had two PPI contributor interviews. We also conducted interviews with 10 TMs and consulted 1 of these transcripts where there was ambiguity in CI/PPI accounts regarding whether all plans for PPI had been implemented. Interviews lasted 45 min on average. Where multiple sources of interview data were available, for example, from a CI and a PPI contributor, there were no major discrepancies between accounts.

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Figure 1

EPIC trials eligible for analysis comparing PPI plans and implementation. *There were 17 contributor interviews for 17 trials, although 1 PPI contributor was in 2 trials while a further 2 trials had 2 PPI contributor interviews. CI, chief investigator; PPI, patient and public involvement; EPIC, Evidence base for Patient and public Involvement in Clinical trials.

As shown in table 1, all but 3 of the 28 trials had documented plans for PPI in their grant application or protocol or both. These documents varied greatly regarding the extensiveness of PPI activity planned and precision with which plans were described, from vague references to activities that hinted at PPI, “We will make use of two primary care research networks and an [intervention-specific] research network” (trial 115), to statements that were quite precise, “The [Society] confirmed their willingness to represent their members through steering committee membership […] and to help in the construction of the MREC application and patient information leaflets” (trial 102). On the basis of informants’ interview accounts, all trials subsequently incorporated some form of PPI and it was clear from the interviews that documented plans were fully implemented in most (20/25) instances regardless of whether the plans were vague or precise, minimal or extensive. The three trials without documented plans did proceed to include some PPI activity, perhaps prompted, to an extent, by comments from peer reviewers who had remarked on the lack of PPI plans in each case. This is particularly likely in trial 2. Here, the grant application referred to prefunding PPI and when interviewed the CI spoke of initial ‘tokenism’ and ‘ignorance’ about how PPI should work. A further three trials expanded on documented plans, giving a total of six trials which had seen addition or expansion of plans for PPI.

Despite informants indicating that most of the documented plans for PPI had been implemented, some revealed no personal expectations for PPI and spoke of using it as a means of ‘ticking the right boxes’. This raises questions about the motivations behind the PPI plans in some grant applications. As noted, we had previously identified three types of PPI roles within our cohort of RCTs: oversight, managerial and responsive,22 and many trials built into their plans a combination of these roles. On the basis of informants’ accounts it appeared that six trials largely confined PPI to an oversight mode of involvement, although some had hinted at other modes in their applications. We begin by examining what happened in these trials.

Oversight mode trials (n=6)

Oversight mode trials were those which confined PPI input to membership of TSCs. On the basis of informant interview accounts, there were six trials that constrained PPI to this mode of involvement, although three of these had hinted at other modes in their applications. A further application had been too vague to discern the mode of planned PPI, and another had no documented plans for PPI (table 1).

On the basis of informants’ accounts, all trials which had documented plans for PPI membership on their TSC had implemented this aspect of the plans. Researcher interviews were available for four of these six oversight trials and of the four, only one researcher divulged any personal expectations for PPI in the trial. Moreover, informants’ accounts raise concerns about the motivations for including PPI in their applications and the danger of assuming that contributors know what is expected of them. For example, trial 36 had named a ‘patient representative’ as a member of the TSC at the application stage then subsequently, in direct response to peer reviewer comments, the team had indicated that they would consider increasing the number of ‘patient representatives’ on the TSC from one to two, in order to provide ‘mutual support’. The team proceeded to include two PPI contributors on the TSC, thereby achieving their documented plans. Despite having prior experience of PPI, however, the researcher divulged no personal expectations for PPI within this particular trial and referred to PPI as a ‘tick box’ exercise: It was a requirement of...that we had representation on our steering committee and therefore I went through that […] We can say [the PPI contributors] are there and therefore it's, if you like, ticking a political box. (CI 36)

The documentation for trial 2 included no plans for PPI during the trial but did state that there had been ‘several stages of user involvement’ prior to the grant application, “to confirm that the research question is pertinent to both the needs of the NHS and the NIHR programme of research development.” Two grant reviewers commented on the lack of ‘service user representation’ on the team and suggested membership ‘on the research team or steering group’. The TSC did include PPI membership but during the interview the researcher spoke of his initial ‘tokenism’ and ‘ignorance’ about how PPI ‘should and could work’. When asked about the expectations of their role, the PPI contributors in two other oversight trials (115 and 96) implied similar uncertainties when they spoke of not knowing what was expected of them and of feeling ‘bewildered’ in meetings: I can't understand why they use me… they seem to find me useful but I just sit there bewildered. I'm there as a sort of grey background while the others do all the sparky stuff. (PPI 115)

In the next section we describe planned and implemented PPI in 14 trials which incorporated a managerial role of PPI. Unlike the six trials with a mainly oversight mode, many of the managerial mode trials had utilised more than one form of PPI.

Beyond oversight, into managerial mode (n=14)

Most of these 14 trials had indicated some type of managerial involvement in the documented plans, usually to include PPI contributors as co-investigators (table 1). Two trials (4 and 27) did not have PPI contributors as co-investigators but planned to include PPI contributors on the trial management group, and interviews with informants indicated that this had been implemented. It was unclear in one ongoing trial whether there was a PPI co-investigator, but documented plans stated that a named PPI collaborator would be “directly involved in decision making of trial processes and then relay back information to user groups”; according to the PPI contributor interview these plans were being implemented (trial 18). Trial 10 had no documented plans for PPI but the interview with the CI indicated that there was a PPI co-investigator (trial 10).

Informants’ accounts indicated that all trials which had planned a managerial mode of PPI did implement it (table 1). This included trial 21, which had a PPI co-applicant and documented plans to involve user groups in developing information leaflets, consent forms, letters and in questionnaire design. There was a budget for PPI travel and expenses which is perhaps indicative of careful planning. The documented plans stated that “user and consumer groups were very keen that a user was a collaborator on the grant application.” The applicants also planned and included oversight PPI (TSC membership) and expanded beyond their plans to include contributors in recruitment, in the analysis and interpretation of results, and in dissemination. Although we could not pinpoint from the informant interviews exactly what prompted these additional PPI activities, the PPI contributor who we interviewed described his extensive previous experience in similar roles and noted that his role in this particular trial had ‘evolved’. He also explained that “I'm there because I want to change things” (PPI 21) and this proactive approach may have contributed to the expansion of PPI in this particular trial. Correspondingly, the CI spoke of wanting the PPI contributors to “feel welcomed and valued as part of the group,” and had personal expectations for PPI that included PPI contributors helping with ‘running the study’, ‘disseminating the results’ and that ‘they would stay involved’ and ‘feel able to speak out and have their own opinion’: We wanted them to offer to do things that they felt they could do and feel happy to say if they didn't feel they could do certain things that might come their way. (CI 21)

There were several examples akin to this among trials incorporating a managerial mode of PPI, in which CIs reported having personal expectations for PPI or in which PPI contributors appeared to be an integral member of the research team. However, one of the two exceptions was trial 14, in which documented plans had been to involve a PPI co-applicant “with an academic interest in representing patients’ perspectives in the design and conduct of health care research,” adding that this individual would advise on “the development of processes and materials which take into account patient concerns.” Responses to the CI survey described the PPI contributor as ‘a serial patient representative’. When interviewed, the CI divulged no personal expectations regarding PPI contribution, describing it as a ‘tick box exercise’: The funders were insistent on having patient representation and wanted to know what that representation was on your grant submission. (CI 14)

In summary, most trials which planned a managerial mode of PPI implemented it. However, as trial 14 shows, simply having a PPI co-investigator is not necessarily a guarantee of meaningful contribution if researchers have no expectations for PPI or if contributors are unable to provide the input that a particular trial requires, for example because they are selected out of convenience rather than to match trial needs. In the next section we focus on the less formal, responsive, form of PPI in which researchers ‘reach out’ for specific PPI input as and when needed.

‘Reaching out’—responsive roles (n=14)

Fourteen trials embraced some form of responsive involvement, although trial documents for two (10 and 79) had not indicated any plans for PPI (table 1). The remaining 12 had stated in their documented plans that they would, or already did, engage with PPI groups or panels rather than just with the one or two individuals that was typical of oversight and managerial PPI. Data from application forms, project descriptions and informant interviews showed that this responsive activity sometimes entailed seeking advice from PPI groups prior to the application for funding. Informants noted that many trialists continued to seek advice from such groups during the trial regarding specific issues. Other trials began a responsive approach once the trial had begun, often as and when particular problems arose. Most trials implemented all aspects of their documented plans but in one case (trial 76) it was unclear from the CI interview whether specific plans to seek advice of a new advisory group before recruitment were implemented.

Trial 20 used responsive alongside managerial PPI, including having a PPI co-applicant. The trial had ended at the time of the interviews, and the researcher stressed that the responsive PPI had been ‘crucial’ when faced with specific problems. The CI explained that one PPI contributor would attend research team meetings: but I then reached out to other people in addition when we needed more help […] I think what was crucial was being able to get input, not in terms of regular intervals but […] when you've got a problem. (CI 20)

Further illustrating the flexibility that responsive PPI allows, in her interview one of the PPI contributors on the same trial (who on this particular trial had a managerial role), advised researchers to ‘have some understanding’ of the needs of PPI contributors. She then went on to refer to another contributor on the same trial who did not attend project meetings but who operated in a more responsive mode outside of meetings. It appeared this arrangement had evolved to accommodate the needs of the latter contributor, who, it seemed, found meetings difficult. She didn't really know what to do, so I think it was much more a one-to-one conversation which is what she was happy with rather than sitting in a committee. (PPI 20)

Documented plans for trial 7 involved a combination of oversight, managerial and responsive modes. This trial was collecting outcome data at the time of the researcher interview, and PPI plans were being implemented including consultation with a panel of service users who advised on issues such as how to increase participant response rates to the outcome questionnaire, and on the promotional material that accompanied it. When interviewed, the researcher spoke of her personal expectations that PPI would help to maximise recruitment, ensure the right outcomes were measured, and help in interpreting the findings. There was no PPI contributor interview but the researcher also spoke of having to tailor ‘different ways of involving people’ in PPI depending on the ‘population of interest’: It might be children, people from disadvantaged groups or older people [...] so you probably have to find other tailored ways of including people to make it effective. So it's not a one size fits all. (CI 7)

The majority of those researchers interviewed who described such ‘as and when’ contributions (10/12) spoke of expectations for PPI, and tended to view responsive modes as constructive. Only in one case (trial 101) did the researcher allude to the PPI within their trial as a ‘tick box’ exercise.

Three trials undertook additional responsive PPI activity that had not been specified in their documented plans. Trials 21 and 102 expanded on their plans by involving PPI contributors in a broader range of activities than initially indicated, namely advising on recruitment and interpretation and dissemination of study findings. As with trial 21 (described in the Managerial Mode section above), we could not determine from the CI interview why plans for Trial 102 had been expanded, and there was no PPI contributor interview for trial 102 to help illuminate this issue. The PPI contributor for the third trial (trial 91) mentioned that she sought the views of ‘women's groups’. This was additional to the documented plans for her to be involved in ‘protocol design of the study’. As with Trial 21, this PPI contributor had previous PPI experience and appeared to be a particularly active member of the research team, and with considerable knowledge of the relevant health condition.

In summary, most applicants implemented their documented plans for PPI regardless of the mode of planned involvement. In five cases we were unable to discern whether or not PPI plans were fully implemented, although some PPI was achieved in these trials. Regardless of whether PPI was implemented as planned or evolved, most trial teams faced challenges and learnt lessons about implementing PPI as they went along. We now turn to their accounts of this learning and then use these to derive practical advice for planning and implementing PPI.

Researchers on the challenges of PPI and lessons learnt

Most CIs spoke of the challenges they encountered in implementing PPI (table 2) and things they would do differently as a result. The involvement of trial investigators’ own patients as contributors was perceived to lead to a ‘conflict’ (CI 20) between an investigator's research and clinical roles. This brought a risk that research would “cross over into clinical care” (CI 6), and that such contributors would be ‘out of their depth’ (CI 20) and find it difficult to “say something which might imply a criticism of their clinician” (CI 20). CIs talked about the problems of failing to engage PPI contributors fully or early enough to inform changes in study design, and ‘under-utilising’ (CI 101) PPI contributors by not involving them in the planning stages, thereby making PPI less thorough or, as one informant noted, less ‘robust’ (CI 101). They reflected on the potential detrimental consequences of such failings on the relationship between researcher and PPI contributors, for example being less likely to “form a bond and get loyalty” (CI 14). Finding and engaging the right people with an interest in and understanding of the research, and with the necessary confidence, commitment and impartiality was another major stumbling block: You hear that some consumers get involved […] because they have a particular point of view or axe to grind […] in those circumstances it could be very detrimental to a trial, to be driven by somebody who has had a bad experience […] and those are the ones you don’t want on your team. (CI 5) You've got trialists in the [meeting] who are trained to run clinical trials. And then you've got one lay representative who may be slightly intimidated by everyone else, who'll not be able to truly give their views, may be slightly overawed. (CI 14)

Researchers also pointed to the practical difficulties that contributors experienced in attending meetings due to geographical distance or time constraints (table 2). They emphasised how teleconferences could be less conducive to forming a relationship with PPI contributors than face-to-face meetings. They also reported problems relating to communication and mutual comprehension between themselves and PPI contributors. Some described PPI contributors as struggling to understand the nature of research, or the distinction between research and clinical practice, and one CI referred to his own ‘naivety’ (CI 55) in underestimating how much training PPI contributors might need. CIs described difficulties getting other staff such as TMs to understand or prioritise PPI. This included one CI who noted that some investigators are unable to ‘cope’ with having a “working relationship with service users” and “can't let go of the fact that [they] are people they study”: It's a mindset […] an attitude where you have an equal partnership. You're working together not studying these people. You're asking for their expertise and I've found that some people who've worked with me, that comes easily and some people absolutely never get it. (CI 20)

CIs remarked that they were unclear about what to expect in relation to PPI and worried about taking up the contributor’s time. External forces also played a part in some cases: for example, one CI described PPI contributors being ‘poached’ by other studies, a ‘fight’ with the university regarding paying a PPI contributor for his time, and disagreement with funders when a contributor wanted to add to the patient information sheet that he was a PPI contributor on the project (CI 21).

CIs spoke of how they had learnt as the trial went along, revealing that their ‘practice had evolved’ (CI 14) and their skills had “changed beyond recognition […] now we're much better equipped […] but at the time when [trial] started we had very little idea at all about what PPI involved or how it would help or how it would work” (CI 2).

In light of these challenges, CIs spoke of how in future they would involve more than one PPI contributor, in particular by using focus groups or panels of contributors rather than individual contributors, enlist the help of relevant charities, and conduct surveys or use social media when there was a ‘burning question’ (CI 55). Use of responsive PPI rather than individual contributors was described as ‘gold standard’ PPI (CI 14), as this avoided “the danger of having a single opinion” (CI 76), provided structure for all parties, and helped to enhance the confidence of individual contributors. I would certainly have more involvement and some kind of framework around it […] a small user group and set boundaries […] try to agree how often we should meet and what peoples’ roles and responsibilities are […] and provided more structure […] to make them feel that their views are important, and their involvement is very important, I think that would go a long way to easing the process. (CI 41)

Many CIs indicated that they would extend PPI in future by asking contributors to lead in the dissemination of findings to relevant groups, help in the development of research questions, study design, and involve PPI contributors as co-investigators. CIs placed particular emphasis on how ‘crucial’ it was to have ‘early input’ (CI 14): The most useful things are […] the design stage […] RCTs you've got to plan ahead [...] after the development phase you shouldn't really be changing anything […] it is during that development phase when decisions are being made. (CI 115) Early engagement and appreciation that their input into the question is really important […] with retrospect and for the future studies […] more involvement at the front end, less in the middle and more at the end. (CI 2)

Finally, CIs reflected on the importance of ‘thinking through’ plans and being clear about whether, what and why PPI is needed for individual trials: Be clear about the link between particular methods [of PPI] and particular benefits and challenges […] it's not all the same, there are so many ways of doing it but you have to have good reasons for choosing how to do it. (CI 20) “I don't think it should be automatic that there must be PPI involvement in every study, and different types of involvement are necessary for different parts of study. Having a core group is not necessarily the right thing because at different points there are different types of people and types of involvement that would be useful. (CI 10)

Contributors on the challenges of PPI and suggestions for improvement

Most PPI contributors mentioned challenges or difficulties linked to their involvement in the trial which may inform future research teams in planning and implementing PPI. Some of the contributors’ challenges paralleled CIs’ accounts while others were unique to the contributors (table 2). While researchers referred to problems they had experienced in their communication with contributors, a prominent issue exclusively mentioned by contributors related to the problems they experienced with ‘jargon’ and the technical language that was used in trials such as statistical or medical terminology and acronyms. Several contributors suggested remedies such as supplying a list of acronyms or a booklet of research terms, or simply that “if they're going to use jargon, explain it” (PPI 64). A further idea was that the person chairing meetings could try to ensure that discussion about statistical issues or other areas of technical expertise were translated and summarised adequately. Contributors talked about difficulties in interacting with researchers, including not always feeling listened to by everyone. One contributor who had been invited by her consultant and had previous experience of PPI implied that ‘some doctors’ were unwilling to understand the perspectives of patients (PPI2 27). Another felt that female researchers were more understanding than males regarding problems with travelling or feelings of insecurity, while a further contributor alluded to how in meetings the team sometimes talked about patient experiences in a ‘dispassionate’ way, and although this was not a problem for the individual contributor she felt it might be for others (PPI1 27).

Some of the challenges that contributors described echoed those that the CIs has raised. These included lack of clarity about roles, and the difficulties contributors experienced in attending meetings, for instance because of a health condition. Such practical difficulties could give rise to additional complexities. For one contributor, infrequent meetings meant “not much to build a relationship on” and while academics worked closely together, she had to “work quite hard to keep up” (PPI 16). Contributors also talked about wanting to be more involved in between annual meetings, in ‘shaping the bid’ (PPI 20) so that it was less focused on the primary clinical outcome, in seeing the intervention itself, and to have initial briefing meetings at the outset of their involvement. Finally, one contributor described it as a ‘downfall’ that he was not receiving feedback or ‘thank yous’ and commented on how important it was to make PPI contributors ‘feel valued’ (PPI 34).