This week’s blog comes to you from Joanna Crocker, Patient Involvement Impact Assessment Fellow with the NIHR Oxford Biomedical Research Centre
What difference does patient and public involvement (PPI) make? This is one of the most complex and fascinating topics I have ever had the pleasure to work on, as well as one of the most challenging and controversial. There are mounting calls for evidence to demonstrate the value (or otherwise) of PPI, to justify the extra time and money required to involve patients and members of the public in research. Even if we believe that PPI is the ‘right’ thing to do on moral grounds, how should the limited time and budget for PPI be best spent to ensure the most benefit for patients and the least possible harm? Who should be involved, when and how? We need better evidence of the impact of PPI, in its many different guises, to be able to answer these questions. And it’s not just researchers who think so; many PPI contributors interviewed for our recent HealthTalk project agreed. As one carer put it, ‘This is a big investment that we’re making, and so we ought to be contributing something. It’s not just about having quite a nice time’!
The PIRRIST study will take a common problem in clinical trials – poor recruitment and retention of participants – and see whether these can be measurably improved by PPI. But not just any PPI… If we invite Mrs B., a breast cancer survivor, to join an advisory panel for a breast cancer clinical trial, would we expect her involvement to improve recruitment to the trial? Her impact will depend on many things, including her unique skills, experience, personality, links to wider networks of patients, and the behaviour of the rest of the panel and research team, such as: how much of a voice they give her (how much they listen), how early they involve her, what they ask her to do. If the research team involves Mrs B. after all the decisions about the clinical trial and recruitment have been made, or do not seriously consider what she has to say, how could we expect her involvement to influence recruitment? We might conclude that PPI has no impact on recruitment, when in fact it might, if done differently.
So, PIRRIST will develop a PPI intervention designed to enhance recruitment and retention in surgical trials. Recruitment and retention are attractive targets, since they are often problematic and this can lead to complete failure of clinical trials (meaning lots of wasted time and money, and no benefit for patients). PIRRIST is part of the Trial Forge initiative to improve the efficiency of clinical trials, and focuses on surgical trials where recruitment and retention can be particularly difficult.
Our intervention will be developed using the best available evidence and knowledge so that it has genuine potential to improve recruitment and retention. Some of this evidence already exists, and some of it will be collected by us through surveys, focus groups and a workshop with ‘key players’ over the next 12 months. Those key players are people who ‘do’ PPI and who recruit and retain participants in surgical trials – involved patients and members of the public, surgical trial investigators and administrators, research nurses and PPI co-ordinators. The workshop at the end of the process will result in one PPI intervention that all agree is most promising.
We hope to then test this intervention experimentally, by comparing the recruitment and retention of surgical trial participants with and without the intervention, to see whether the intervention makes a measurable difference. A key part of our study will also investigate how different situations and practices influence the way the intervention works and how much difference it makes, as well as other impacts it may have, positive or negative, beyond recruitment and retention. Some people argue that PPI is so complex and context-dependent that it should not be subjected to experimental testing. And such experiments are few and far between. But for now I believe this type of evaluation can play an important role in assessing the impact of PPI, alongside other methods. Without it, we simply can’t say attribute recruitment successes to PPI. We can’t say that PPI ‘works’ in this sense, let alone ‘when’ and ‘how’.
Perhaps this desire to apply an experimental approach to PPI stems from my original training in biomedical science, which I will probably never shake off (and secretly don’t want to). And perhaps I will be persuaded to change my mind in time. But it is certainly very exciting to be having a go, and I can’t wait to reveal what our intervention will be and share our findings with you… Watch this space!
Joanna Crocker is a postdoctoral Research Fellow funded by the NIHR Oxford Biomedical Research Centre. She is very grateful to a fantastically supportive and inspiring team of academic and lay colleagues and advisors, and for additional support from the MRC Network of Hubs for Trials Methodology Research.