Time constraint has been cited as a barrier to PPI in research during the pandemic (12). The experience described in this paper demonstrates that valuable PPI for clinical trials can be conducted in a time-efficient manner within the pressured environment of a pandemic. The adaptations to the trial protocol which were made as a consequence of the PPI work were vital for improving the acceptability of the study to potential participants and which may in turn help to support recruitment and retention into the trial. Key to this process was involving PPI contributors at a very early stage which maximised the opportunity to shape and influence the trial. This also limited potential delays which could occur if changes to the protocol had to be made at a later stage. The approach to PPI employed in this paper can be applied to COVID-19 research conducted in other countries as well as for future epidemics.
The time required to identify appropriate public contributors to involve in the research process at short notice can also be a barrier to PPI. In recognition of this issue, the Health Research Authority has launched a public involvement service for COVID-19 research studies applying for fast-track ethics review(13). The service provides guidance to researchers on who they should involve, what type of involvement they should seek, and then matches research teams with coordinators of relevant public involvement groups across the country.
We were fortunate to already have access to an active PPI panel as well as individual public contributors. The members of our Panel have varying levels of experience with PPI in clinical trials. Some PPI roles are better suited to contributors with previous experience in trials. However, providing feedback on early stage trial development relies heavily on experiential knowledge and we found that a lack of PPI trials experience was not a barrier to contributing to discussions.
In addition, this contribution is enhanced through the development of good working relationships both between the facilitators and PPI members, and between the members themselves which provides the optimal environment for rapid consultation work.
Building strong relationships with public contributors is particularly important during the crisis as it is an anxious and stressful time for all and especially for those groups with underlying health conditions. The majority of members of our Panel have significant health issues and, against the background of the pandemic, the PPI process may be particularly anxiety-provoking for some contributors. Conducting PPI during this time offers opportunities to understand that anxiety, but also requires a mindful, respectful, and emotionally sensitive approach in order to avoid any exacerbation of concerns.
The Evidence Base for Public Involvement in Clinical Trials (EPIC) study explores the different models of PPI that can be applied to a trial(14). The report concludes that responsive and managerial roles for PPI contributors are likely to bring greater benefit to the trial than PPI contributors in oversight positions such as Trial Steering Committees. An experienced PPI contributor appointed to the TMG could also be particularly helpful in advising the TMG on using the feedback from the Panel in adapting the trial protocol.
The Evidence Base for Public Involvement in Clinical Trials (EPIC) study explores the different models of PPI that can be applied to a trial(14). The report concludes that responsive and managerial roles for PPI contributors such as membership of Trial Management Groups(TMGs) are likely to bring greater benefit to the trial than PPI contributors in oversight positions such as Trial Steering Committees. At the time of working on RAPID-19, the CTU did not appoint PPI representatives to TMGs.
On reflection, we recognise that the study would have benefitted from having a PPI representative on the TMG to ensure continual PPI input throughout the development of the trial. Furthermore, the TMG PPI representative could advise the TMG on using the feedback from the Panel in adapting the trial protocol. As a result, the CTU is now looking to expand the models of PPI that we employ and are planning to appoint PPI representatives to sit on the TMG for future trials.
The feedback from the Panel could also be supplemented with a rapid review of existing studies and trials that explore relevant patient acceptability themes applicable to the trial. Additionally, there is now a wealth of on-the-ground experience emerging from COVID-19 clinical trials. New trials would benefit from incumbent research teams sharing examples of good practice in PPI, and how they have overcome challenges to build knowledge and contribute to the evidence-base in this field.
Researchers have been sharing their experiences and best practice for online and remote co-production and patient involvement as well as the pros and cons of the different virtual platforms available(15)(16). We held our meeting by teleconference which unlike with videoconferencing, does not give you the benefit of non-verbal cues and it can be challenging to ensure that everyone in the group has an opportunity to speak. We followed up the meeting with an email to all attendees asking them to phone the facilitator or to send any further comments by email to ensure that we were able to benefit from the contribution of all attendees.
While there are inherent challenges with working virtually, it does offer some opportunities. Even at the best of times, there are a number of difficulties with organising face-to-face meetings at short notice. This includes the availability of some members especially those with caring responsibilities, the cost of travel and the fact that our Panel is geographically dispersed across England. Virtual meetings can offer important solutions to these practical difficulties. In addition, new ways of working may help to broaden the representation of patients and public involved in research and address the lack of diversity of PPI contributors which has long been recognised as a weakness of the PPI system(17).
PPI in research plays an important role in building public trust in scientific evidence(18). A survey conducted by the Academy of Medical Sciences found that only a third of the public trust evidence generated through medical research(18). Crises create a climate of fear and panic, where misinformation and distrust can easily proliferate. Recent scandals during the pandemic, including the well-publicised retraction of the Lancet journal article on hydroxychloroquine(19) may further erode trust in science. Lack of trust may not only compromise recruitment into critical clinical trials, but can also undermine the translation of that evidence into clinical practice. Funders, Sponsors and Research Ethics Committees must uphold PPI standards for COVID-19 research including those for studies eligible for fast-track review.
This paper describes the lessons learnt for conducting rapid PPI consultation from the perspective of the research team. However, the PPI Panel have contributed to the manuscript and are named as an author on the paper. The findings presented in this paper could be strengthened by using qualitative research to actively explore with the PPI contributors, their experience of rapid PPI, the perceived impact of their involvement and to consider how they feel the process could be improved.