Introduction
Methods
Sampling
Data collection
Questioning for trialists/funder representatives/sponsor representatives | |
Views of PPI and actual impact on trial conduct decisions | |
Role of PPI on the TMG/TSC | |
Background of public members on the TMG/TSC | |
Reasons for selecting public members to be part of the TMG/TSC | |
Views on which committee (TMG/TSC) public members are best placed to contribute | |
Questioning for public contributors | |
Experience in trial oversight committees | |
Their understanding of their role in the committee | |
Examples of how they perceived they had influenced trial conduct | |
How they felt during oversight meetings |
Data analysis
Methods used for PPI within the study
Results
PPI representation in eight trials facing challenges
Trial number | Clinical area/population | Meetings observed | Public contributors at meeting | Discussion of PPI if no contributors at meeting observed | PPI in the trial reported by interviewees, if not observed | |||
---|---|---|---|---|---|---|---|---|
TSC | TMG | TSC | TMG | TSC | TMG | |||
1 | Oncology | ✓ | ✓ | 0 | 0 | x | x | On TMG, although not at meeting observed |
2 | Oncology | ✓ | x | 0 | – | x | – | On TMG. |
3 | Arthritis | ✓ | ✓ | 0 | 0 | x | ✓ | Previous involvement of a public member, trying to recruit a new member |
4 | Frailty | ✓ | ✓ | 0 | 0 | x | ✓ | Confusion as to whether certain trial interactions with patients counted as PPI. Patient charity representative invited to TSC meetings with poor attendance. |
5 | Oncology | ✓ | ✓ | 0 | 2 | x | n/a | |
6 | Urology | ✓ | x | 1 | – | n/a | – | |
7 | Psychology | ✓ | ✓ | 1 | 1* | n/a | n/a | |
8 | Oncology | ✓ | ✓ | 1* | 1* | n/a | n/a |
Participant ID | Role | Trial(s) involved in (subject area), where applicable |
---|---|---|
01 | TSC Chair | 1, 2 (oncology) |
02* | Project lead | 1, 5 (oncology) |
03 | TSC coordinator #1 | 1, 2 (oncology) |
04 | TSC coordinator #2 | 1, 2 (oncology) |
05* | Sponsor representative | 1, 2 (oncology) |
06* | Sponsor representative | 1, 2 (oncology) |
07* | Trial manager | 1 (oncology) |
08* | CI | 2 (oncology) |
09* | Trial manager | 2 (oncology) |
10* | Trial manager | 3 (arthritis) |
11* | Statistician | 3 (arthritis) |
12* | Trial manager | 3 (arthritis) |
13 | Statistician | 3 (arthritis) |
14 | CI | 3 (arthritis) |
15 | TSC Chair | 3 (arthritis) |
16* | Trial manager | 4 (frailty) |
17 | TSC Chair | 4 (frailty) |
18 | CI | 4 (frailty) |
19 | TMG Chair | 4 (frailty) |
20* | TMG member | 4 (frailty) |
21* | Trial manager | 5 (oncology) |
22 | Statistician | 5 (oncology) |
23* | CI | 5 (oncology) |
24* | Independent TSC member | 5 (oncology) |
25 | Independent TSC member | 5 (oncology) |
26* | Trial manager | 6 (urology) |
27* | Trial manager | 6 (urology) |
28* | Statistician | 6 (urology) |
29* | CI | 6 (urology) |
30* | TSC Chair | 6 (urology) |
31* | Independent TSC member | 6 (urology) |
32* | TMG member | 6 (urology) |
33* | Trial manager | 7 (psychology) |
34* | CI | 7 (psychology) |
35* | Public contributor | 7 (psychology) |
36* | TSC Chair | 7 (psychology) |
37* | Statistician | 7 (psychology) |
38* | TSC Member | 7 (psychology) |
39 | CTU Director | 7 (psychology) |
40* | Trial manager | 7 (psychology) |
41* | Trial manager | 8 (oncology) |
42* | Chair | 8 (oncology) |
43a* | Public contributor | 8 (oncology) |
43b* | Public contributor | 8 (oncology) |
44 | Statistician | 8 (oncology) |
45* | Sponsor representative | 8 (oncology) |
46* | CI of other trial/member of TSCs | n/a |
47* | Funder representative | n/a |
48 | Sponsor representative | n/a |
49* | Funder representative | n/a |
50* | Statistician | n/a |
51* | Funder representative | n/a |
The role of PPI in trial oversight
Patient voice and advocacy
…the reason why they [public contributor] were invited was so we got their views on how a patient would feel … [what they] might be going through, why patients might not want to participate in trials, and how … they think a [specialist clinician] should be approaching patients and sensitive issues. [07, Trial manager, trial 1]
My actual role, as I see it, is to represent the patients … to make sure their interests are dealt with correctly, that they are not just used as pawns in the research … as a piece of research data. At the end of it, it is a patient...a person that they are talking about, not just a source of data they can stick a tack on or switch on. [35, public contributor, trial 7]
The idea of patient involvement in this [trial] seems to stem from the fact that they thought that maybe the doctors … would have their own ideals on what should be examined, which may not necessarily be that which benefits the patient the most. I don’t think the patient representatives are in a terribly strong position to be able to judge what does benefit the patients most in practical terms … the patients simply don’t know enough … understanding all the mechanism, it’s a very highly complex thing [43b, public contributor, trial 8]
Extent of PPI role
Trial manager, trial 8 TSC: …the trial is very dependent on questionnaires and quality of life outcomes. With it being one of our primary outcomes, it’s really important that we get the questionnaires back, and so if we can make that clearer to patients up front, so that they know that the trial involves a lot of questionnaires, then –
Public contributor, trial 8 TSC: Although you need not to put too much stress on it…. it’s a balance…I think you need to make them feel that any answer is useful rather than just abandoning the whole thing, yes.
Public contributor, trial 5 TMG: Can I just go back on what you said, it would be introduced through all arms of the trial?
CI, trial 5 TMG: Sorry that was me not speaking clearly…I didn’t mean all arms, I meant all stages.
…I did help to influence the decision, because my actual inputs were taken in and were used, along with everybody else’s. If you like, I completed the equation. [35, public contributor, trial 7]
…I don’t think they [public contributor] necessarily were involved in making the decision…I think they ratified our decisions rather than helped us make them, if that makes sense? [36, TSC chair, trial 7]
Barriers and facilitators to meaningful PPI in trial oversight
Confusion about definition and roles of PPI
I think it’s perhaps recognising that tension between something that is very overtly and officially PPI…having lay members in your Trial Steering Committee or, “We had engagement with them when we were putting in the bid … and we did get people to look at the participant information sheets.”…but whether we were counting things, or whether we were saying it was the qualitative research element in the intervention development is a bit grey. [19, TMG Chair, trial 4 - TMG meeting]
I agree it’s important, but the way it’s done at the moment, I think it’s hit and miss and often it’s tokenism, which is the worst of all worlds...I just wish it wasn’t like the Emperor’s new clothes, that people would have the courage to say “We don't think we need PPI at the moment, but when we do, we’ll get someone”…everybody at the moment thinks it’s fashionable, it’s what happens…I think there’s a great resource out there to get used, but I’m not sure of the optimal way of doing it [28, Statistician, trial 6]
Appreciated qualities of public contributors
…you need to find the right person because you don’t want it to just be tokenism… [31, Independent TSC member, trial 6]
…the issue I think we have with PPI is finding knowledgeable people who have an interest and understanding of research…sometimes it’s more of a hindrance because people don’t understand the need for research or the research processes [26, Trial manager, trial 6]
We had one example where…the patient representative was from the [national organisation]. They have very definite opinions and beliefs about [topic], and basically this representative just didn’t believe the trial was necessary…So that was a bad experience. Where I don’t think that person was in any way, shape or form, protecting the safety of the participants…Nor was it protecting the integrity of the trial. [37, Statistician, trial 7]
Interviewer: How do you know she’s a good patient advocate?
[42, Chair, trial 8]: firstly…a breadth of knowledge which comes across in the way she responds to comments and questions – sound stuff…she’s sympathetic, empathetic and…very well focused…Also…she has cared for somebody who had [clinical condition], so there’s an inside knowledge, a personal aspect to her as well which she doesn’t let come through at the meetings. There’s no personal agenda.
The lay reps come on board early. They are enthusiastic. They then do not come to any more meetings…I think that is an incredible shame, if they just decide that it is not for them anymore, or they are too busy, or if they are a lay rep because they have got a condition, and they get ill. So I think, to me, choosing the lay representatives is the biggest challenge. [38, TSC member, trial 7]
Routes to invite public contributors
Interviewer: …and you have two because...?
02, Project lead, trials 1,5: Because of continuity, partly people can’t always turn up to meetings, partly because when you’ve got a lot of high powered people around a table it can be difficult for people to make their voices and opinions heard and…two people there can in fact really help, partly through if they do have a spell of ill health they don’t feel obliged to make an effort to engage when they don’t feel up to it…
…she transferred from the iDMC…We had the patient representative, she had to stand down, and then when the decision was taken, that the DMC could stand down, she was a kind of gift-wrapped transfer. [37, Statistician, trial 7]
He [public contributor] was given to me by somebody else. I said can you find me a lay person from your pool of PPI people...it's another university where they've got a very active and developed PPI network…and they're [public contributor] currently unwell actually. So that's a problem. [46, CI of other trials/TSCs member]
It’s actually quite hard to find them [public contributors] and if you advertise you tend to get people with an agenda. They get involved because it's something they want to have a go about…They're not always there for good purposes... [29, CI, trial 6]
…we asked for the help of the [research network]…and they went through the involvement centre to get expressions of interest from people who had…done some involvement work previously…[public contributor]’s good…been helpful. [33, Trial manager, trial 7]
Involving PPI at optimal level of oversight and trial stage
I think probably TMG…the best place to get input from them because that's really where we make decisions about changes to questionnaires and things like that... [29, CI, trial 6]
…we decided the TSC…wasn’t quite the right place to put patient representatives…it could cause problems for them, the trial, the patients we have are…very often advocates for (the) treatment of the research - we thought…the discussions that they have with patients and doctors, they could find themselves in a more difficult position by having been exposed to certain data and conversations and so we thought the TMG is probably the right place... [02, Project lead, trials 1,5]
…because we look at people who are pretty old and frail, it’s actually quite hard to do that…in the TMG because that’s a group where you’re asking quite a lot of people to come along to a monthly meeting to read stuff, to really get very immersed in the whole thing and to potentially have to do stuff as well… [31, Independent TSC member, trial 6]
Interviewer: …as I was listening to you, I just thought, “Well, gosh, isn’t that…PPI involvement?”
20, TMG member, trial 4: I don’t know. It’s a horrible boundary, isn’t it?...I’m in charge of PPI. So, we’ve got this PPI group and we meet in between TMGs and they’ve been doing loads of work on all the documentation and they’re going to do training, when we get our new Research Associate…It just feels like that’s the PPI.
I don’t mind where they are really as long as they have some role, preferably at the time when the trial is being designed because I think it’s really important they have their input into the feasibility... [51, Funder representative]
The formality of oversight meetings and technical language
…the patient representative had some issues with maintaining her attendance at the meetings...I suspect that the strangeness of…being on a TSC, because it is a fairly unusual activity. I think we tend to forget that, as experienced researchers. But it’s got a lot of rules, it’s quite formal; it’s designed for academics really, to give their opinions. I think she found the whole process bewildering. [37, Statistician, trial 7]
It’s okay for me now, but I didn’t actually ask them when I first started because I was a little shy…but that became embarrassing, because they’d been talking about it so long, I didn’t like to say, “Just a minute, what does that mean?” [43b, public contributor, trial 8]
I think the issues that come up from an iDMC need to be very, very clearly laid out in advance by the relevant statisticians and framed in the way that a savvy clinician or lay member… - and I think lay people probably should be involved - the statistician needs to set up the presentation in such a way that it doesn’t take statistical skills to follow. [06, Sponsor representative, trials 1&2]
Support and/or mentorship from the trial team
...we make sure that any patient representative has adequate training at the beginning before joining so we have training teleconferences and just taking them through the protocol and what it means and the organisation of the TMG… [21, Trial manager, trial 5]
I read it [notes of meetings] as well. If I can’t understand it, I email [trial manager] and say, “Look, I can’t understand this. What is it we are trying to say here? What is trying to be said?” [35, public contributor, trial 7]
21, Trial manager, trial 5 TMG: [public contributor 1] and [public contributor 2] I am conscious that was a quite full of items agenda. I would like to follow this up with you, tomorrow or in the next couple of days, in a separate teleconference or in e-mail, so that everything is clear to both of you. Particularly [public contributor 1] as you just joined the TMG.
Public member, trial 5 TMG: Yes, sounds fine.
…we’ve actually as a CTU changed our approach…we’ve now got somebody to…act as PPI support…who is employed by the CTU…they [public contributors] have somebody that they can go to, to ask questions… [12, Trial manager, trial 3]
…I think you need to either select people who are confident about speaking in those kind of circumstances or you need to have a TSC chair who will drag views out of them to specifically ask them what they think and for their contribution…really the TSC chair needs to be specifically reminded that they have to involve the public members. [50, Statistician]
I felt…the meeting was a bit…lop-sided. We went through the last agenda items as if they weren’t there, including the patient representative’s report… [Chair] didn’t even mention it...But, the time was pressing and…[Chair] didn’t quite keep to time. But, that’s been a general feature of those TMGs…sometimes, it’s gone on for much longer than two hours. [43b, public contributor, trial 8]
Influence of PPI on study results
Discussion
Steps to maximise the benefit of PPI | Facilitated by: |
---|---|
Agree PPI needs of trial with research team (early trial design stage)* • Define clear role/s and/or goals for PPI • Define trial stages that PPI needed – including trial design stage • Define demographic characteristics, skills and experience desired from public contributors • Identify optimal format for PPI (e.g. attendance at trial oversight committee(s), and/or separate PPI meetings, email/telephone) – negotiate this with public contributors recruited • Ensure PPI is costed properly to re-imburse for public contributors’ time and expenses, including carer support if appropriate • Ensure PPI plan is fully justified in both funding applications and trial protocols | • Training for research team on the role PPI can play in trials and how to maximise meaningful input. Include opportunities for discussion. • Accessing useful PPI planning resources (e.g. PPI Toolkit for clinical trials [16]), and the NIHR INVOLVE public involvement cost calculator (https://www.invo.org.uk/resource-centre/payment-and-recognition-for-public-involvement/involvement-cost-calculator/) • Consulting with existing patient or public panels may be useful at this early stage to help define PPI needs • Consider inviting public contributors to be co-applicants on grant applications |
Recruit diverse public contributors • Consider effective routes to invite public contributors (e.g. local groups, national organisations, existing PPI groups, advertising) to allow for diversity • Recruit more than one public contributor, focusing on diversity of characteristics, skills and experience (e.g. some with research/committee experience and some without) | • Drawing on insight of colleagues with previous experience of identifying and working with public contributors from target population, and existing relevant patient or public panels. |
Engage public contributors in trial oversight • Provide an induction to the trial for public contributors including oversight processes • Ensure meeting Chairs have skills to engage public contributors • Provide on-going mentoring/support to public contributors in between oversight meetings, e.g. regular meetings/phone calls to foster relationship, answer queries, and provide training as deemed appropriate • Accommodate needs of the patient group to facilitate PPI attendance at meetings (e.g. shorter meetings/attendance for part of the meeting, care needs or caring responsibilities) • Adapt format of PPI to the emerging needs of the trial and public contributors | • Accessing PPI training/support for trial team including meeting Chairs (e.g. UKCRC/NCRI PPI in research groups - Guidance for Chairs [41]) • Identifying appropriate research team member to provide on-going support to public contributors, and allowing protected time for this within their role • Drawing on relevant resources provided in the PPI Toolkit for clinical trials [16] to familiarise public contributors with their role in the trial oversight committee, academic terminology and environment • Considering both academic and public contributors’ commitments |