The benefits of continuing patient and public involvement as part of a randomised controlled trial during the Covid-19 global pandemic

PPI in MICE

PPI plays a substantial role in the MICE study, and has done for over three years. Coordinators set up and facilitated an active PPI group to help advise the trial from its inception, in accordance with guidelines set out in the King’s Fund paper Making Shared Decision-Making a Reality (Coulter and Collins, 2011). The group consists of parents and children and young people with epilepsy (with an age range of 6–15 years), all of whom have been involved from the start. Initially, PPI groups were conducted face-to-face at the UCL Institute of Child Health (University College London, UK) on a quarterly basis, and groups were facilitated by members of the research team and an appointed PPI lead. The group was separated into parents, and children and young people, to allow for open, honest conversations in a safe space. All PPI members have advised on several aspects of the research study, from creating appropriate epilepsy-specific materials to be used in the therapy manual (including a set of ‘frequently asked questions’ for families about the relationship between epilepsy and mental health), to informing on the types of questions parents should be asked during qualitative interviews.

Impact of Covid-19

The impact of Covid-19 on epilepsy care management has further reinforced the importance of integrating the physical and mental health needs of young people with epilepsy. The mental health of those with pre-existing health conditions has been reported to remain significantly worse than those without pre-existing health conditions (Pan et al., 2021), emphasising the importance of continued care. Reilly et al. (2021) conducted an online survey in June 2020 to gather young people’s and carers’ perceptions of the impact of Covid-19 on their epilepsy. Findings indicate that young people reported an increase in seizure frequency, and a deterioration in mood and sleep; moreover, caregivers reported an increase in stress and anxiety.

Research into the impact of Covid-19 has also highlighted the importance of continued PPI. O’Conner et al. (2020) lay out the research priorities for those in psychological science, as informed by an expert panel at the British Psychological Society. Researchers emphasise the importance of engaging with stakeholders and those with lived experience during this time of national crisis (O’Conner et al., 2020). PPI is needed to ensure that researchers are investigating topics that are relevant, current and important to the patient groups themselves, during a time of global crisis (Holmes et al., 2020).

Findings from a large systematic review indicate that the voices of those with lived experience have continued to be overlooked during the Covid-19 pandemic (Ocloo et al., 2021). In particular, there has been little focus on the effectiveness of PPI facilitated remotely during this time. Prior to the pandemic, there have been some promising findings into the feasibility, acceptability and functionality of PPI via an online forum for carers of people in palliative care (Brighton et al., 2018). Qualitative findings indicated that participants found the online PPI platform supportive and helpful, but equally felt that it was too researcher-led (Brighton et al., 2018). Their findings suggest that technology should not be considered a barrier, but that members should instead be supported to overcome any technological difficulties. Findings also suggested that being involved in online PPI provided a sense of control and empowerment in what is otherwise an unpredictable life due to caring responsibilities or disease progression. Both Brighton et al.’s (2018) and Daveson et al.’s (2015) research emphasised the importance of utilising a flexible approach to PPI implementation and facilitation, ensuring to meet the needs of its PPI members, and that a combination of face-to-face and remote methods provide more accessibility for its members. Communication between PPI members and researchers in online settings is critical to empowerment and facilitation of collaborative relationships.

The Covid-19 pandemic has inspired discussions about the many benefits of keeping services online after restrictions are lifted, for example, increased accessibility and decreased costs and travel. In this article, we aim to consider: (1) how the PPI Research Advisory Group (RAG) supported the research, during the course of the pandemic, using a ‘you said, we did’ approach; and (2) the benefits and disadvantages of remotely delivered PPI, through a survey of the MICE PPI RAG members regarding their views.

Group set-up

Our pre-existing PPI group advise the MICE randomised controlled trial running at Great Ormond Street Hospital for Children in London and the UCL Institute of Child Health. Originally, the PPI groups were conducted face-to-face, as well as over a group WhatsApp, with communication between group members through email and messaging, as the researchers strived for meaningful group collaboration. Consultation workshops run with patients in other research indicate that face-to-face meetings combined with between-group contact via social media platforms and online forums are the optimal way to avoid contributions feeling tokenistic (Daveson et al., 2015). The MICE study researchers wanted to learn from PPI members, and therefore every effort was made to reduce hierarchal structures and traditional decision-making power imbalances. There was sufficient feedback to ensure that members understood the value of their contributions as a result of implementation, which are key aspects for successful PPI (NIHR, 2017; NICE, 2013).

The PPI meetings continued throughout the Covid-19 restrictions, on a quarterly basis. Groups were conducted via the online platform Zoom, and were facilitated by two researchers, as well as our MICE PPI lead, with the group mostly consisting of parents. Having given consent, all contributions from PPI members were audio-recorded and transcribed, from which actions were derived and addressed by the researchers before the following PPI group. We utilised a ‘You Said, We Did’ approach, a methodology commonly used by NHS clinical commissioning groups when engaging with the public and patients, to ensure that the recommendations given to us by the PPI members were documented and acted upon.

Ethical approval

Ethical approval for the MICE study was obtained from South Central – Oxford A Research Ethics Committee (reference: 18/SC/0250). This involvement project fulfils one of the four aims of the MICE trial’s PPI, as quoted in the Integrated Research Application System (IRAS) form to create a ‘meaningful experience for the members of the RAG’. The present article reports on engagement activities related to the MICE study.

Survey development and procedure

To address the second aim, we surveyed the MICE PPI RAG members regarding their views on remotely delivered PPI to make sure that future meetings met their needs, and that everyone felt able to contribute fully. The survey used both closed and open-ended questions to give the members adequate space to have their opinions heard. The survey was hosted on Qualtrics Q Lite, an online platform, and was anonymously completed. Electronic results were anonymised by replacing participant names and other identifiable information with assigned numbers. The survey included demographic questions, nine of which focused on the issue of research. Participants responded using the following five-point Likert scale: strongly agree, agree, neutral, disagree and strongly disagree. All nine questions had a free-text option for qualitative analysis. Survey questions were designed to explore respondents’ opinions and attitudes towards remote public engagement, and were created in collaboration with one of the PPI group members. Items on the survey encompassed a range of factors that may constrain or facilitate remote participation, inspired by previous literature highlighting the common benefits and challenges of remotely facilitated therapy (Batchelor et al., 2020). Items were balanced, with some of the questions on the survey being statements in favour of remote PPI (for example, ‘The group running remotely was helpful in other ways, e.g. peer support’) and others highlighting the challenges (for example, ‘I find it harder to express my views in the remote PPI group, compared with in person’).

Participants were approached in December 2020 during the PPI group, around the time of the second wave of Covid-19 in the United Kingdom and during the second national lockdown, when many social restrictions were implemented across the country, such as closing restaurants, religious public spaces and museums (GOV.UK, 2020). Medical appointments that could be conducted over the phone or online were encouraged to be carried out in this way, for example, appointments with a GP. All the PPI members attending the PPI group were invited to participate, and all completed the survey (n = 9, including three couples). Eight of the participants were female and one participant was male. Participants ranged from 25 years and under to 65 years and over; the modal age category of the group was 35–44 years old. Eight participants identified their ethnicity as ‘White’, and one participant identified as ‘Other’ ethnicity.

Descriptive statistical methods in SPSS were used to analyse the quantitative data. The free-text answers were reviewed qualitatively, and authors identified key topics and ideas in the quantitative results. Results were discussed with the PPI RAG facilitator.

Participant recruitment

The researchers’ usual approach of attending epilepsy clinics and meeting families in the waiting room came to a halt due to the national lockdown resulting in cancellations of all face-to-face clinics. Consequently, the team received fewer referrals than the proposed recruitment figures agreed upon with the NIHR. PPI members provided valuable advice on recruitment of families pre-pandemic, and the researchers hoped that they could provide additional insight into how best to recruit families. PPI members explained that they regularly receive letters in the post from epilepsy specialists (for example, epilepsy nurses) containing information about clinics or appointments. Our families stated that they would trust fliers advertising research opportunities sent enclosed with these letters, as they would expect advertisements sent via this method to be reputable research opportunities. In contrast, they explained that they would be unlikely to consent to take part in research advertised on social media, due to a lack of trust. Following the advice of our PPI group members, the MICE research team created a self-referral recruitment poster to distribute widely across the NHS sites involved in the trial. This yielded nine self-referrals and six recruited families in the early phase of the pandemic.

Therapy

One PPI member described the PPI group as being ‘canaries in the mine’ – they could give early warning of the daily challenges of families with children with epilepsy during the pandemic. All PPI members considered it vitally important that the research continued, not least because they felt abandoned by many other services, which were reducing appointment frequencies and postponing operations. However, they also reported that finding a weekly hour-long uninterrupted slot for therapy when home-schooling and working from home could be difficult, if not impossible, for many families in the research. We therefore allowed for greater flexibility in the research protocol than had previously been the case, including more leeway with session timings, having sessions over the phone or email rather than Zoom, if required, and having shorter sessions and/or a longer interval between sessions. We recorded such differences in delivery as deviations from the protocol to ensure that the effect of this could be examined at the end of the study. A positive result was that only one participant withdrew from the research during the course of the pandemic.

Follow-up

The research team contacted parents of the children and young people participating in the study, at 6 months and 12 months after randomisation to complete standardised questionnaires (some on the telephone and some online) to assess the efficacy of the MATCH-ADTC intervention. Scores to questionnaires were then reported in a letter which was sent to all professionals involved in the child’s care (for example, GP, neurologist, paediatrician). PPI group members provided advice on how best to contact families regarding their follow-up assessment, including how to describe this phase of the study from the outset, with a strong emphasis on the importance of their contributions, through to their 6- and 12-month time points. The researchers also sought advice regarding how to make the follow-up letters meaningful for families, with a particular focus on the scores to questionnaires. PPI members provided valuable advice, including providing families with a glossary of terms at the beginning of the study, as well as brief summaries of each questionnaire that parents completed.

Maintaining meaningful PPI involvement

PPI contributions were necessary to ensure that the research continued to meet the needs of the families it was designed to support. However, running PPI groups remotely came with its own challenges. First, the difficulties with recruiting led to a one-year extension of the study time frame. We were therefore in a different study phase than originally planned, with a recruitment period longer by a year. We wanted to ensure that PPI contributions remained meaningful and not tokenistic during this extended recruitment period. The group chose to make audio recordings that could be used for teaching, training and dissemination, specifically on the following topics: Why is PPI important?; Why is researching mental health interventions for children and young people with epilepsy important?; and What makes meaningful PPI? These recordings will be used in presentations going forward through the study, and will therefore enable dissemination throughout the study period and not only at the end, in line with NIHR guidance (Hayes et al., 2012). Meaningful involvement of children and young people was particularly challenging; many of the children and young people in our PPI RAG had intellectual and/or neurodevelopmental disabilities, and they had previously been seated in a separate room from their parents in RAG meetings to ensure confidentiality. Finding a space separate from their parents at home caused logistical difficulties. In addition, it was more difficult for some of the younger RAG members to concentrate for extended periods of time on a screen. As such, it seemed inappropriate to include the younger members of the RAG group in the survey about online involvement groups. Instead, it was decided that audio recordings for the videos be completed in the PPI members’ own homes, in their own time, alleviating the pressures during the session. This was particularly beneficial for our younger RAG members, who were then able to participate and contribute to the videos.

Remote PPI group meetings are preferable to no PPI group meetings

As shown in Table 1, all respondents liked the fact that the PPI group continued to run remotely. There was general acknowledgement that, while participants valued face-to-face meetings, having remote PPI meetings was preferable to having none at all:

Although I miss face-to-face groups, I feel relieved that the group carried on during lockdown. (P7)

Continuing the group remotely was important for the continuity of [the] project. (P8)

As demonstrated in Table 1, most participants would recommend remote PPI groups for other clinical trials. Participants suggested that remotely delivered PPI is a good compromise within the context of a global pandemic, with some participants suggesting that a mixed approach (of some remote and some face-to-face meetings) be taken after the pandemic:

Given that it will be a while before we return to ‘normal’ it’s a good option. Or, maybe use a mixture of both when we can. (P6)

Yes, but only in the context of Covid-19. (P7)

This would depend on the group make-up. Certainly a mixture of face-to-face with online could have further benefits than solely one or other. (P9)

Overall preference for face-to-face PPI groups

Overall, despite agreeing that remote groups are preferable to not having PPI group meetings at all, most respondents preferred face-to-face groups to remote ones (Table 1). There was a general feeling in participants’ answers that remotely facilitated PPI lacked a ‘dimension’ that face-to-face PPI groups had:

I would still rather meet in person as even well-facilitated online meetings lack warmth and feel a little two-dimensional. (P2)

It’s always nice to see people! (P8)

What participants liked about remote PPI

All participants except one felt that the group running remotely was helpful in other ways, such as for peer support. There was general acknowledgement in the free-text answers that the PPI members have always valued being part of the group for the opportunities to receive support from other families who have had similar experiences:

… the group has always provided this but for participants who have been shielding or who have little to no familial support, it has become even more important. (P2)

… it’s always great to catch up with those who have understanding of how you feel. (P8)

Almost half of the PPI members found attending the PPI group remotely more convenient than attending face-to-face meetings, with five participants reportedly feeling ‘neutral’ about this (Table 1). A few respondents elaborated on this in the survey, by explaining that they found not needing to travel to Great Ormond Street Hospital convenient. Participants mostly disagreed that the PPI group running remotely made other things more difficult to balance, although a small group of PPI members did agree with this statement (Table 1). Technical difficulties were not felt to be a barrier to remote PPI by most participants.

What PPI members found challenging about remote PPI groups, compared with face-to-face group involvement

As seen in Table 1, the majority of participants felt that their views were listened to during the remote PPI groups. Group members thought that an online teleconferencing platform may make it more challenging for more reserved members of the group to make contributions:

I worry for other participants, as face-to-face I can read non-verbal cues if someone is dominating or someone wants to contribute but can’t find a gap. (P2)

… meeting over Zoom tends to discourage the less forthcoming therefore stronger characters could dominate discussions. (P9)

Conversely, one member reported that:

… all participants are respectful and interested in others views and comments. (P8)

Opinions were mixed about whether participants found it harder to express their views remotely, compared with face-to-face. PPI members indicated that it may be more difficult to express opinions during remote PPI, because of the inability to use social cues and body language to indicate when you or someone else would like to speak:

It’s easier to find a gap to talk when face-to-face. Remote is harder because you lose the ability to see the room of people and pick up on subtle body language and facial expressions. (P7)

I personally don’t but it can be difficult moving people along and trying to ensure an equal ‘floor space’ to those who may be more introverted members. … In face-to-face meetings, I can spot someone with their hand up or taking a breath to speak … this is almost impossible to do online. (P2)