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Rachel shares many of the advantages and pitfalls of patient and public involvement (PPI) in healthcare, with illuminating examples and their potential impact. We think there are clear parallels to be drawn between PPI and coproduction approaches in usability research.

Patient and Public Involvement in research: no decision about me, without me

By Dr Rachel Dewar-Haggart (27/07/2022)

Before you read on, I want to reassure you that any reference to PPI is not about ‘that’ PPI. No dodgy sales calls here! In health research, it stands for Patient and Public Involvement.

When we conduct trials and studies in health, we want to make sure it’s done with or by members of the public, rather than to, about, or for them. Health is universal – and so is access to healthcare in the UK. Therefore, it makes complete sense to carry out research with involvement and contribution from people that will be using these services.

Being a PPI contributor is different to being a participant in research. If you’re a participant, you’re the to, about, or for bit of the statement above. If you’re a PPI contributor in research, you’re part of the bigger team – you’re the with or by. You’re there from the very beginning of the research cycle, helping to inform and make crucial decisions about how the research is run, alongside a team of academic researchers.

I wanted to share some examples where PPI contribution has been beneficial in some research I’ve worked on. To give a bit of context, over the last 8 years I’ve been working on a programme of research investigating the best way to assess and monitor people going to their GP with new episodes of depression. My PhD looked at peoples’ beliefs about long-term antidepressant use; and I’ve just started working on a study that aims to improve GPs’ communication skills when seeing people with pain. All these studies have had a PPI contributor. They’ve contributed towards study development and grant applications, the preparation of study materials, recruitment of participants, some data analysis, and telling people about our findings. Some of their input may appear small in the grand scheme of things, but these changes make all the difference as to whether someone can take part in research or not.

Preparing study materials

We are required by ethics committees to put together information sheets for potential participants. We need to tell them what the study’s about, what they need to do, and any risks of taking part. We also need to include a TON of information about confidentiality, data protection, and governance. The problem is that this information isn’t always easy to understand. I’ve found that people treat the data protection and governance bits like the Terms & Conditions on social media websites. They trust that because it’s there, it’s fair. They don’t want to read every single detail.

People are usually invited to take part in our research by their GP surgery. They’re given a Participant Information Leaflet (PIL), and if they’re interested, they contact the research team. When I speak to potential participants for the first time, part of my patter is to ask them if they have had a chance to read through the information leaflet, and whether they have any questions. This is usually met with a pause, an ‘um’ and ‘ah’…and then something along the lines of ‘I remember seeing something, but I haven’t read it/don’t remember what it said/don’t understand it.’

This is a common problem in depression research. People with a new episode of depression can find it difficult to even get out of bed in the morning, let alone remember receiving a PIL out of the blue inviting them to take part in research, and whole load of information about confidentiality and data storage. The PIL is one of our most powerful recruitment tools, so getting the tone right is important. Too little information, and people could question the credibility of the research. Too complex, and people could quickly get frustrated, confused, and give up before they’ve even started.

I struggle to write PILs that are of a suitable reading age. When you’re very familiar with research processes it’s easy to assume that everyone else is too. So, I’ll ask a PPI contributor to read the information leaflet I’ve drafted and get them to tell me, in their own words, what they think the study is about, and what they’d need to do. This throws up some extremely mixed (and sometimes entertaining) responses. It’s a way to see what information is relevant. People are not so fussed about whether it’s a double-blind-placebo-randomised-controlled-trial. They want to have a simple explanation of what the study is about, what they would need to do, how much time and effort their involvement would require, and whether there are any risks. PPI contributors can help to shape a lay perspective on the information and get the tone right.

As well as the use of language, PPI contributors have also made suggestions around how information is delivered. A PIL with 3-4 A4 pages of nothing but tiny black text is potentially boring or inaccessible. Simple changes such as turning it into an A5 booklet, with coloured headings, wider line spacing, and diagrams illustrating the research process can make a world of difference. It ensures the delivery of information is more accessible to a wider population, including people with lower literacy levels, or non-native English speakers. To reach a wider geographical group, there’s been a shift to using online surveys. All well and good, but there’s a need to ensure that online surveys are as accessible to as many as people as possible. Thanks to the PPI contributor on the communication trial, I’ve learned about ‘Web Content Accessibility Guidelines’ (WCAG). I had no idea that the shade of blue our trial was using for various titles and images was too light and potentially hard to read for some people. After she’d read through the first draft of our PIL, she said she wasn’t bothered about the 2 sides worth of data protection policy and governance, describing it as ‘tedious overkill’. Together, we’ve worked through solutions to include all the relevant sections (i.e. what a person will be asked to do if they take part) on the first page of the survey, then to have each of the ‘tedious overkill’ click to expand buttons. All the information is still there if people want it, but it makes the whole process a lot less overwhelming and accessible.

Questionnaires are a common way of collecting data in health research, but there are still barriers we must consider when using them. One key issue is around individuals’ literacy levels to be able to complete them. When I’ve made initial contact with people who want to take part in research, some have been extremely apologetic when they tell me that they struggle to read or write, making it difficult for them to complete questionnaires. They worry that they are wasting my time as they want to (but can’t) take part.

This has made me wonder how many people have just ignored invitations to take part in studies, because they feel they can’t. This shouldn’t have to be the case. Limited literacy levels or any other disabilities that make it difficult to read or write should not be an exclusion criterion. Instead, researchers should take as pragmatic an approach as possible to make research accessible to all.

We’ve done the best we can to tackle barriers around reading and writing in research, with input from PPI contributors. It’s not a perfect solution, but at the top of our PILs, we state (in larger font and at an appropriate reading level) that people should contact the research team or ask a family member or friend if they need help with reading or writing. A simple yet extremely effective change (just don’t do like I did for the first draft and place this statement about halfway down the leaflet! It kind of defeats the point…).

Another solution is that it’s more than feasible for researchers to read out questions and write responses for the participant. We’ve also included visual questions – rather than having to read a whole bunch of statements about how you’re feeling and then choosing the one that best applies to you, why not point on a scale from 0-10 or a picture of a smiling or sad face about how you’re feeling? However, there are still barriers with visual cues. For example, we had a ‘traffic light’ system to show someone the severity of their depression symptoms. Green for the mildest of symptoms, through to yellow, then orange, then red for the most severe symptoms. It sounds like a great visual cue for someone to gauge on a scale where their depression symptoms were. Until a PPI contributor suggested that this may be difficult for someone with colour blindness to interpret. Including the name of the colour in the traffic light was an acceptable and very simple change.

Where do we go from here?

The examples above are a tiny snapshot of how including members of the public in research processes can help to open up studies to a wider population, by making really simple (and sometimes obvious) changes. However, while PPI in health research has improved over the years, it’s still got some way to go.

When coming up with a research idea, it’s very easy to fall into the trap of only thinking in black and white: the study design and anticipated outcome. This is where bad grant applications fall at the first hurdle. Applicants will ignore the importance of PPI from the inception of the research idea. They’ll get to the part of the form where they need to discuss how PPI will be used in their research, and the generic response will be given – there’ll be a contributor, they’ll read a couple of documents, get invited to meetings, and be acknowledged in any publications. This shows that PPI has been thought about in the context of the ‘tick box exercise’, rather than really considering the exact mechanisms of how and why PPI should (and will) be integrated into the research process.

A trend I’ve encountered (particularly with depression research) is that much of the data we collect are from a particular demographic – people who are from a relatively comfortable socioeconomic part of society, and of White ethnic origin. The same goes for PPI contributors. While anyone can (and should) be a PPI contributor, finding people from under-served groups willing to get involved is a challenge. The NIHR (the NHS research group) have been running the INCLUDE project, which aims to improve inclusion of under-served groups in clinical research. Their definition of ‘under-served’ include groups of people who have lower rates of inclusion in research relative to their population size, people with higher healthcare needs or healthcare burden, or people who aren’t responding to or engaging with particular aspects of healthcare. If these under-served groups are not engaging in research, then the research will continue to fail to address barriers to equality in healthcare.

Researchers are given pots of public money to try to find the best solutions for improving healthcare, so we should listen to the people that will be using these services. There is no point in doing health research if services are not fit for purpose for those who are going to use it. Encouraging people from under-served groups to act as PPI contributors should be the stepping stone to ensuring that research is relevant and inclusive for everyone. The next step is to continue discussions around creating a research environment that is inclusive and accessible. Essentially, we need to stick to the principle that no decision about me, should be made without me.