Spotlight on Research for Health: Incorporating lived experience

How can clinical research better involve and recognise those with lived experience? Ensuring diverse representation and removing barriers to trial participation is essential for equitable health research, but key voices are being missed. Senior editor at The Lancet Callam Davidson is joined by trialist Otavio Berwanger and consumer adviser Vicki Grey to discuss the benefits and challenges of patient and public involvement, in the first of a series of podcasts spotlighting research for health.

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Transcript

This transcript was automatically generated using speech recognition technology and may differ from the original audio. In citing or otherwise referring to the contents of this podcast, please ensure that you are quoting the recorded audio rather than this transcript.

Callam: Hello and welcome to another episode of the Lancet Voice Podcast. I'm Callam Davidson, a senior editor at the Lancet, and this week I'll be presenting the first episode in a series of podcasts focusing on research for health. This series 200th Anniversary Spotlight Initiative. Through which we hope to shine a light on what we believe to be the most critical issues impacting health globally.

Today's podcast will be focusing on clinical trial participants, specifically the ways in which those with lived experience of a health condition can both contribute to and shape the clinical research process beyond just taking part in a study. Commonly referred to in the UK as patient and public involvement, the process is based on the principle that the best clinical research should be something that's conducted with people with relevant lived experience, as opposed to being something that's done to them.

People with lived experience is commonly interpreted to refer to patients, And though that is often the case, it's important to note this can extend to others, for example, carers. Joining me today, I have two fantastic guests, Ottavio Berwanger and Vicky Gray, who both bring their own unique perspectives on this fascinating topic.

Now, as I've been talking for a while, I'm going to hand over to our guests to let them introduce themselves. So, Ottavio, if you would like to go first. 

Otavio: Yes, thank you very much, Callum. It's a pleasure to be here to be with you and Vicky to discuss such a fascinating topic. I'm Ottavio Berwanger. I'm the Executive Director for the Georgie Stood for Global Health UK and chairing clinical trials at Imperial College London.

Callam: Thank you very much, Ottavio. And Vicky, if you could now introduce yourself. 

Vicki: Yes, for certain. Thank you, Callum. My name is Vicky Gray. I am a kidney and pancreas transplant recipient. I was fortunate enough to receive a kidney and pancreas transplant three years ago. Prior to that, I was insulin dependent diabetic for 42 years and had chronic kidney disease for 20 of those years.

Callam: Thank you very much and a warm welcome to both of you. So, uh, to kick off with the questions, I have to confess, in researching this podcast, I realized just how little I actually knew about the sort of patient and public involvement process. So, maybe to begin with, uh, Octavio, could you let us know some of the different ways that trialists are able to involve those with lived experience in the research process?

Otavio: Yes, sure. So, I think patients or participants need to be involved throughout the trial cycles and, and that, and that includes helping us to come up with relevant research questions. So defining the research question is a way. I think number two, in terms of designing the trial, making sure that the protocol and all aspects related to the protocol meet the patient needs.

I think that that's very important. Once the protocol is approved, Uh, I also think that participants need to be involved in terms of the trial conduct. So, everything related to the trial conduct and some participants, I think, can also become part of the team, part of the trial team and join regular meetings, join investigator meetings, uh.

You maybe also help in terms of recruitment, to reach out to other patients. Finally, I think in terms of results interpretation and dissemination, that's also another part where patients can make a huge difference. So, in other words, Patient needs to be engaged early and need to be engaged throughout the trial cycle or process.

Callam: Excellent, that's a great summary. So Vicky, as someone who's had experience from the other side of the coin, so to speak, maybe you could let us know a little bit about Your understanding of the process and your your experiences. And also I could just double check at this point. So in in Australia, where you're based, it's a consumer advisor or consumer partner is sort of the same.

The same term refers to the public and patient involvement process. Have I got that right? 

Vicki: You absolutely have. It's exactly the same. And I think that, um, certainly what, um, Um, what Octavio says is extremely interesting to me. One of the things I didn't say in my introduction is that, uh, when I'm not being a patient, um, I'm also a lawyer.

Um, I am a financial services lawyer. So one of the things that I think is really important that if I may say, medical people don't necessarily understand is how to communicate with patients and how to, Get the message across to patients. So, in a lot of the work that I do, um, with the George Institute and with other clinical trials, where I have, um, actually, um, participated as a named investigator on several of those trials.

Um, what Octavio says is 100 percent right. I love being involved in the start when we're actually designing the trial, when we're talking about what is good for these patients? What is annoying for patients? What is a good outcome for patients? It's not always a great outcome to say, Oh, look, their scores on this medical test are now closer to normal than they were before.

If the entire process for the patient means that their quality of life or what they want to do with their life is completely and utterly destroyed in the process. So I think that, um, one of the things that patients. And consumers bring to that. And I think that carers, as you said before, Callum, are really important to this as well because carers have to put up with people when they're not feeling their best and when they're, you know, think that the world's against them because they're the ones that have got kidney disease.

Um, they're also really important to bringing to how the trial is actually designed. What people are going to have to do, what is important to one person versus what is important to another person. The thing that I then get very involved in which, and which I am passionate about is the dissemination of what the trial is about to other participants or to participants that are willing to put their hand up and say, yes, I'm going to participate in this trial for two years or however long it's going to go on for.

One of the things that I've done in a number of the trials I've worked with is. Sort of gone, I know that there's this 15 page consent form, and that's lovely. You've got everything that a lawyer is going to want you to put in that. However, does your 60 year old kidney pancreas diseased person who wants to participate in your trial, really going to read that?

And are they really going to understand that? And I think that consumers bring a really good Um, Outlook on that side of it for the medical profession, and that's one of the things I focus on a lot in the work that I do with the trials that I'm involved in. Um, We can come back to that perhaps, rather than me talking incessantly, but I'll just finalize, finally say the other thing that I think is really good that consumers bring, or perhaps not necessarily consumers, but perhaps non medical people bring.

Is an analysis from a qualitative perspective of the data rather than a quantitative perspective. 

Callam: That's a fantastic insight. Yeah, you've covered a huge amount of ground there. And yes, I've definitely got plenty of questions that will hopefully touch on some of those things in more detail. Um, So that's great.

Yeah, really interesting to hear from, from two sides of the, the same coin. Um, and interesting how you both obviously have, uh, the same sorts of understanding of parts of the process, but you've also clearly kind of taken an appreciation for, for different things that it brings. So it leads quite neatly onto my next question.

What, what do you feel are the main, the main benefits of this entire process? What, what do you think are the main things that both the medical community and the non medical community stand to gain? On the kind of flip side of that, maybe, what are the main challenges, um, involved in the process? Because I imagine, although you two have both made it sound like a really smooth, simple process in your descriptions there, there must be difficulties, uh, in making sure you do this quite complicated, um, kind of procedure correctly.

So maybe this time, uh, well, to give Vickie a break, we'll, we'll ask Octavio again if he could comment on that. 

Otavio: Thank you. Thank you, Callum. And, and Vicky, just to reinforce, I fully agree with, with your points. You're absolutely right. And I'm sure we'll, we'll come back to some of them in, in more detail. But in terms, in terms of the benefits, I see several benefits.

I think, I think number one, if we involve patients or participants early on, and once again, throughout the trial processes, uh, I think we'll have trials which are more relevant to them. Because in the end, they're the most important stakeholder. We want to make sure that we're addressing their needs, not our needs as scientists or publishers or regulators.

So, so that's, that's probably the most important benefit. But, but I think there are other secondary benefits as well. Number one, I think faster recruitment. Because I think if we involve patients in, in designing recruitment strategies, recruitment will go faster. There are some examples of that currently.

Thank you. I think better patient retention, so patient, I mean, especially when we do preventive trials like Vic, you mentioned some chronic kidney disease trials and diabetes trials or trials and cardiovascular medicine types of trials, for example, that we do at the Georgia and Imperial College. I mean, sometimes these trials can last for five years, six years, seven years.

So, it's a commitment of, of, of your life, of your relatives to, to join such an effort. So I think if you have other participants design the procedures, definitely retention will be better. I think also it has to do with efficiency because you avoid wasting and you avoid research waste and things that are not relevant to patients.

So. I think avoiding waste. And finally, I think when you select outcomes which are more relevant to patients based on their advice, the dissemination of results I think will be clearer and probably implementation of findings and patient adherence post trial will also be improved. So I think there are several benefits, uh, that we gain from patient involvement.

I'm not sure if Vicky agrees, but. But that's my view of that. 

Vicki: I definitely agree. I, I don't think I could really add anything there, Octavio, other than, which I'm sure will go on to Callum, is how you actually do involve patient involvement. Because you obviously get someone like me who has a very different experience to perhaps the laboratory.

Some people say the normal consumer, and I think that you can't have 55 consumers as part of your investigators on a trial because you're just never going to get anything done. So I think that's probably where it might be interesting to, to explore. I know what I think about that, but interesting to explore what, what, um, what you would think about that or to Octavia, because I think I couldn't agree, couldn't disagree with anything else that, 100 percent wrong.

Callam: Possibly, um, a good thing to ask them would be, um, how did you first get involved in, in this, uh, consumer advice process then, Vicky? What was it that, um, motivated you to get involved? Were you approached or did you approach the George Institute about getting involved? 

Vicki: Um, I was approached, but it was very clear to me that, um, you know, kidney and pancreas transplants are quite rare.

Um, there's not that many people in the world that have them. And certainly in Australia, we have two hospitals that perform, um, the, the dual combined kidney and pancreas transplant. So I made it my business to make sure everyone at Westmead Hospital was aware of the fact that I was willing to do whatever it was.

Um, to try and give back to something which I thought was incredibly fortunate for me to have been part of and to have received. They, they did do some work and I did do some work, um, with Transplant Australia and various other. Entities in Australia, but it was actually my, um, nephrologist that asked me about working with the George Institute.

He is an associate professor at Sydney University, part of the George Institute in Australia. And he asked me to join what they were putting together, which was a consumer kidney panel. And it was basically, um, really something that sat off to the side and, um, just reviewed a number of largely grant applications.

With, um, the eyes of the consumer on it to provide feedback on what could be improved, what might not work, what might their reaction be. So I of course said absolutely, very happy, sign me up, um, and from there I have been part of that, um, kidney panel now since I think, uh, November 2020 when it was first established.

And as part of that, a number of the. Um, researchers that have come and presented their potential grant applications to the panel have asked me to actually act as a, um, as a, you know, associate, um, investigator on those, um, applications. Those grant applications and then those grant applications that have been successful, those actual trials.

Callam: So it sounds like you took quite a sort of proactive stance in, in, yeah, making people aware you were happy to do that, that sort of, um, yeah, contributing to the process. And Octavia, has that been your experience? Is that, um, when your teams are looking for people to be involved, do you look for people like Fiji who have already kind of made it known they'd help?

Or do you have to do some outreach as well to try and, there must be other people in the community who would want to help, but maybe, you know, Haven't, haven't made, um, made, made the trial team so aware of that. 

Otavio: Well, yeah, that, that's exactly right. So currently all the trials we are designing, we want to have patient involvement early on.

Uh, I think, uh, but, but coming back a bit to your question, because I think it's related to this topic, I think one of the challenges is it's a cultural shift is, is related to a cultural shift because still. Uh, investigators and regulators and research ethics boards and journals, should I say, they're not used to have patients or participants as, as, as part of the trial team.

So usually, you know, the standard operating procedures, the trial documents, The trial protocol, and I think you would agree me again, uh, the trial meetings are usually written in very technical language, so with complex statistical terminology or medical terminology. And, um, and this sometimes prevents patients from engaging in more fruitful discussion.

So I think culturally, the procedures and the mindset of, you know, trialists and once again, regulators. But also conferences where the publishers are not connected with patient engagement. So we need to change that. So I think, as you mentioned, that's not a simple process. Of course, we're discussing the benefits, but it's obviously not simple.

So I think this is a work in progress, there is a learning curve, we're trying to learn from it, But we're definitely trying to engage participants early on. So, I guess another challenge, and I think we'll discuss. More of this relates to diversity because we do run global trials. So currently, for example, the George and Imperial College, uh, both run trial in 55 countries on average.

So, so these are very big, large scale trials and, and of course, regions are culturally different. And sometimes we may have like a Asian consumer like Vicky in Australia or someone here in the UK, but then we want to run a trial in Latin America, in South Asia, in North America. So, uh, And in the Middle East and culturally.

So in term there's maybe some barriers. Cultural barriers, language barriers. So, uh, I, I think we struggle a bit to find patient representatives from different regions and from different cultures. And this is important because of trial diversity. I think we'll discuss more about it. And also due to the fact that currently 80% of the burden.

of chronic disease occur in low and middle income countries. So we need representatives from those regions more than from high income countries. But anyway, uh, but in summary, uh, now it's the standard, is the standard process for us to have patients engaged early on as part of the trials during comedy in the trial team.

That's an objective answer to your question. 

Vicki: I was just going to comment on what Octavio said. I think the other thing Octavio is that even within the You know, the higher, um, socioeconomic type, um, countries, what you find is that the people that have the most burden of chronic illnesses are the people that are in the lower end of that country, even so, if you take Australia.

It's quite interesting because the people that we would be designing the consent forms for aren't people like myself who have law degrees and, you know, several degrees and all the rest of it. We're actually trying to write those consent forms and the information brochures for people that are not really wanting to read long slabs of written language.

And. If I can comment on some of the work that I've been involved in at the George Institute in, in Sydney, in this kidney consumer panel that we refer to, it's been fascinating for me as a consumer to watch, as I can only imagine how interesting it's been for the research team, because some of the things that the other consumers on this panel have picked up make me think, wow, okay, I would never have thought of that.

Um, for example, they really like. An infographic and there was a stage there at one stage where a full researcher would come in and say, we're running this trial, how do we make it clear to our potential patients and, and, and someone would say, Oh, you need an infographic. And it's like, well, some trials look really good with infographics, but yeah, when you got a picture of a kidney here and a picture of a thick kidney there, it's not really a really good infographic.

Um, so I think that it's really interesting to work out. That you need just not a patient or a consumer representative, you need someone that can actually get the experience as, um, Octavia said before, from other consumers and bring it back, um, to, to the trial team. 

Callam: Yes, sort of, um, an ambassador for, for their community, so to speak, kind of a representative who can capture a lot of opinion and, and bring it to the team, yeah.

No, that's that's fascinating. Um, there's so many things you've you've mentioned. It's hard to know which uh, Which sort of avenue to go down but yeah on the topic of um, a culture shift I found that really interesting at avio. There's there's definitely a feeling that yeah across the kind of research spectrum.

Um, Journals included, uh, there is this kind of desire to, to make sure we are hearing from people with lived experience. So I, there's a few initiatives here at the Lancet. We've got, uh, the Lancet psychiatry has been, um, a real push, uh, for several years now to involve, yeah, people with lived experience or carers in the peer review process.

And I know a few other journals are bringing in similar sorts of things. I know at the Lancet, um, child and adolescent health, they've got a youth advisory panel, um, who again, they'll, they'll sort of approach regarding it. Um, various aspects of the kind of publication process. So, so yeah, there is a shift, but it's, um, there's a lot of work still to be done.

Um, no doubt. So, um, I think we, we've touched on the issue of, of diversity and recruitment. And I do want to come back to that, but before we move too far from actual ways that clinical trials can be designed, um, to ensure maximum benefit, you both referred to patient reported outcomes in your answers. And Vicky, you also said something interesting about qualitative research.

So. Maybe, um, if we could ask Octavio first, what sorts of considerations and features can be included in a trial to, to ensure, you know, you're going to get the most for both the people with lived experience and the, the medical community? 

Otavio: Once again, coming back to what I first mentioned in terms of involving patients throughout the trial cycle, I think, uh, I'm a, well, first of all, I think I'm a big fan of large, simple, pragmatic trials.

I think they're still the best. So Sometimes, I think engaging patients in designing the eligibility criteria, it's key, right? Because sometimes we create complexities in terms of screening processes which are really uncomfortable and we sometimes copy and paste exclusion criteria from other trials. So I'll give you a simple example, like how about pregnant and breastfeeding women?

And maybe we're excluding them from some trials that We shouldn't exclude them, like they were excluded initially from COVID 19 vaccine trials. I understand, I understand it's, it's the common sense. I understand the issue of maximizing benefits and harms and that's like the default. But wait a minute, is there really a clear medical reason for this?

So, so I think patients with multiple, uh, patients with comorbidities, patients with multiple conditions, and so patients with mental health issues are usually excluded from trials. And the question is why? Why is that? Oh, because they won't be able to comply with the trial procedure. So wait, wait a minute, maybe the trial procedures needs to be adapted to them.

Um, so, so I think, I think the issue is. So, traditional trials usually require patients or participants to adapt to the trial procedures. And that's wrong. Because what needs to happen is the trial procedures need to adapt to the patient needs. So, so, so that's, that's an important also go through shift. So, once again, the most important stakeholder.

Should be the patient or the participant. It's not a principal investigator or the steering committee or the regulator or the invest, or the other investigators. It's the patient or the participant. So that's the most important stakeholder. So everything adapts to him or to her. Um, so I think in terms of the inclusion criteria, I think Vicky mentioned about, Recruitment engaging other participants and telling them, look, I'm participating in this trial.

It's, it's really, it's not only comfortable, but it's fun. It's safe. It's something I've been taking, my needs are being taken care of and things like that. I think, I think that's important. I think, uh, also Vicky mentioned something which is really, really important is that consent forms. They're usually very long, and they're not informing patients.

You already told me right, you're a lawyer, so you know, sometimes things are written just to protect the sponsor or the institution. Yeah, but, but are we, are we protecting the patients? That's, that's the question. And number two, are we informing the patients? So, so I think we need to transform the way we deliver the, we build, design, and deliver the consent forms.

And there, there's tons of options now with e consent, gamification, infographs, and, and, and other, and other features. I think you also mentioned, Vicky, Uh, the outcomes. Sometimes we create this fancy ordinal scales or complex, you know, mirrors. So sometimes our statisticians love to transform the way we analyze trials and we create this beautiful adaptive trial designs with complex outcomes, which are great from a scientific point of view.

But, but then what do you, what do you want to explain the results to a patient and say, well, wait a minute. What that means, so, so what I'm gaining from, from this, so making sure that the outcomes are important to patients, are clear, uh, obviously we're interested in reducing mortality and incidence of disease, but sometimes symptoms are very important, quality of life, comfort, so we, we need to take those into, into account.

And finally, Callum, I think another big transformation that is happening, it's about convenience and comfort. If you think about banks and travel agencies, so everything that we need now is our smartphone. So, so, so you don't need to go to a branch to talk to your manager to do simple financial operations.

We also, which also has sensitive information. You can book your holidays with your family just using your laptop or your phone. So why don't we do the same with trials? And this is called, book Decentralized trial. So instead of requiring patients to come to an academic center and to spend a whole day with lots of complex screening tests, maybe we can bring the trial to the patient's home.

So, so there's a lot of development in this area. But maybe I'll stop here because I also would like to hear. Vicky's thoughts on, on all these issues, but, but yes, I mean, there are several ways in which we can involve participants and transform the way we deliver trials. 

Vicki: Now, I was just going to say that I think that what is really difficult, one of the things that you said, Octavio, which I think is fascinating, is the fact that you want to put the patient at the center of the most important person in, in, in the entire, um, trial and as the main stakeholder.

Yeah. I think that is incredibly challenging because I think every single patient has different expectation and a different level of what is important to them. And I think that in order to get to the place where we can actually say we are making patients at the center of our trial, we're going to need a lot of experience and research and trial and error as to really at the end of the day, um, you can't please all the people all the time.

So, how is it that we create something which is, um, going to suit the vast majority of people, um, rather than think that at any time, we're always going to make the best outcome for the patient and make that person the stakeholder at the center. For example, there was a fascinating trial which I've been working on, um, and which I'm a big, big, big supporter of.

I think it's got a lot of validity involved in it. Um, and one of the, um, ways that the outcomes were measured. Was that, um, it would be an improvement if there was a reduction in the number of days in hospital over a period of 12 months. As a result, it was testing the difference between PD, um, sorry, peritoneal dialysis and hemodialysis.

See, I'm as good at using medical terms as the doctors are too, Octavia. Um, and the interesting thing was that it was considered to be a good outcome if a patient, um, Spent less days in hospital and that makes perfect sense to me. It makes perfect sense to everyone. But when I was certainly, um, at a hospital setting every day, following a transplant, having, following various checkups, um, my father had to drive me there and he sat in the waiting room with all of the people that were having hemodialysis.

I can promise you, according to my dad, telling them not to come to the hospital on a particular day was the worst thing for them because that was their social network. That was where they went to catch up with people. So we need to be very careful about making assumptions about what we would consider to be the best thing.

And I can tell you for me, not going to hospital every day, a hundred percent, sign me up, that sounds great. But maybe for other people, that's not the actual, the most desirable outcome. So that's a very big challenge. When we look at how do I design a trial and a method of making this research work with the consumer and the patient at the center.

Yeah. 

Callam: There's so many different voices that need to be heard. It's clearly, yeah, the more, the more kind of people you can hear from, um, and can inform the trial process, the more everyone stands to kind of learn and the most you stand to get out of the trial. So again, leads very neatly onto what was going to be my next question, which is as with any aspect of health, um, ensuring diverse representation, Minimizing barriers to trial participation.

Hearing as many voices as possible is essential for equitable health research, um, and maximizing benefits for every, every stakeholder. So we've already touched on this a little bit. Um, Vicky, you raised a really interesting point that there's both considerations between different kind of World Bank income, um, classifications in countries, but also within countries.

We, we obviously have. Uh, a huge breadth of kind of socioeconomic circumstance, and it's often those who would stand to benefit the most whose voices are heard the least. So yeah, maybe, um, pass back to Ottavio. What do you think is, you know, what are the biggest challenges in this regards? Which voices do you think are being missed and what can we do to, to improve the situation?

Otavio: Yeah. So I'd like to go back to, to the issue of diversity, um, and once again, currently the 80 percent of the burden of non communicable diseases and diseases. Like cardiovascular diseases, diabetes, most types of cancer. are occurring in low and middle income countries. So if, if, if we don't include low and middle income countries, I think we're missing a big part of the problem.

And, and I, I also do agree with Vicky. Yeah, yeah, absolutely. You're absolutely right. Even in high income countries, there are underprivileged population, which are being excluded from trials and which are suffering the greatest burden of disease. No, no, no question. Um, well, so, so, The other problem is, uh, I think it's a matter of sex and gender equity.

For example, currently, 77 percent of trial participants are Caucasian male, and that, of course, we want Caucasian male in the trials, we, we need that, but that doesn't represent the epidemiology of most diseases, so, so we need representation. So, women are being excluded from trials without any clear medical justification.

Um, we, we have a project in, in the George Institute and Imperial College called the Message Project, funded by the Wellcome Trust, which is exactly about sex and gender equity. And that also applies to gender as well. There's a lot of exclusions which are not justified from a medical perspective. So, I think we, we need to transform this and we need to put, action into place to make sure that's not the case.

Um, then I think exclusion of, uh, patients from lower middle income countries, it's, it's a problem and not involving them in, also in trial design. And, and sometimes the justification is, well, this grant is not applicable outside of a high income country, or sometimes sponsors think that, There's not enough infrastructure in low income countries to conduct a trial.

But I think it's a matter of building capacity, creating capacity, and part of this capacity building involves engagement of patients locally. I know, Vicky, it's, and I fully agree with your previous comment, it is, it is very tricky to put patients at the center of clinical trials. But, but I mean, it's a work in progress, once again, it's a learning curve, and, and, and we need to try to do that.

I think it's the same when, is when we started doing trials, like when Bradford Hill did the first trial in 1948, tuberculosis, try the first really randomized trial. I mean, there was a lot of things that, a lot of advances, lots of things were new and then the methodology evolved, the procedures evolved, the way we interpret the trials evolved.

It's the same. I mean, it's a matter of starting. There is a trial and error. We won't get it, everything right. at the first attempt, but once again, we need to try more and more and more to modify it. But, but, but, Callan, to your point, I think the voice of low and medium income countries and patients from low and medium income countries are not being heard.

I think that's, that's the most important gap and also the sex and gender gap. It's a Very, very important clinical trials and we need to address that. 

Callam: And Vicky, from your experience, um, what would you add to that? You've already alluded to a couple of, um, interesting things that hadn't occurred to me around, uh, all the stuff around the informed consent process you were talking about and, and yeah, the various challenges in, in reaching, um, communities across Australia.

So yeah, anything you can add to Octavio's great answer there. 

Vicki: Um, I think that one of the things that's really interesting to reflect on is we talk about. The participation of people that are involved in a trial, which is not the same as the participation of a consumer representative or representatives in the actual design of the trial and the ongoing monitoring and analysis of the trial.

And as I said previously, there is really absolutely no way 55 consumers all coming from diverse backgrounds, participating in the design and implementation and ending the actual trial. Um, apart from anything else, with all due respect, I think that many patients are going to feel absolutely out of their depth in such an environment, because as Octavio said, there's a lot of medical jargon being thrown around, and they, they really just not there, don't feel that they belong.

But I think that what you can do is if you've got, um, maybe one or two people who are, let's face it, probably going to be from a more educated end of the, of the spectrum, but they can perhaps be involved in chairing committees which involve potential participants in a trial, because sometimes participants like hearing people that can stand up and say, well, I'm a kidney and pancreas transplant recipient, or I've also got kidney disease, or I've got whatever it is.

Um, and they almost believe that person more than they believe a very highly educated doctor. So, um, I think that they get plenty of the highly educated doctor from their own specialists and from the, the trial. Um, outcomes that are communicated to them, but I think that may be the way that we can really make sure we reach the participants in a trial to get down to that level that Octavia is talking about and involving the people in the community that need it most and who we need to hear the most.

It's just simply not possible in my view to put them on the trial steering committee. But it is possible to use them well in that trial steering committee to reach people in the participation group that you might not otherwise be able to reach. 

Otavio: Can I add something to that Callum? And I think it, you're absolutely right Vicky, but I think that's not different somewhat from what we do in a trial.

So for example, when you have 30 countries in a trial, of course you don't have a steering committee with 500 people. But, but what you do is you have an executive or, and maybe a steering committee. You know, coming forward with the general idea, with the protocol, with the procedures. Then you do investigators meetings in different countries, sometimes bringing all of them together.

Sometimes you do a regional investigator meeting. Uh, sometimes when you, when you have sites who struggle with the trial protocol, you, you have to meet them on a one on one basis and, and discuss specific issues. So I think we should do exactly the same. I mean, some participants or patients will be part of the steering committee and will help designing the study.

And maybe we can have, they can have meetings with participants from other regions and hear their needs and bring back to the Syringe Committee. So it's not different to what we do with the investigators from multiple countries in, in global trials. But yes, uh, in, but, but in terms of the terminology, I think, I think it's a matter of, you know, adjusting it, uh, and, and once again, it will require a code for shift.

We know that code for shifts are not, and behavioral change are not, uh, are things that are difficult to achieve, but, but we need to try a bit harder, I suppose, and, and, and we really need to, to, to force it. I, I guess, 

Vicki: I, I think that that's an interesting comment. I think that, um, the medical profession needs not to underestimate the consumers.

As a person that had diabetes for 42 years, I guarantee that unless your area is endocrinology, I can outtalk medical science with you any day of the week. And most of the participants that I know can do that as well, because you live with it all day, every day, 42 years of my life. I can tell you that I know all of the medical terms.

I know exactly what tests do what. I know exactly what ranges what tests should be in. Now, if you want to talk to me about cancer, I've got absolutely no idea. But I can talk to you about this because that's what I know, and the person that's going to be representing the consumers on a particular trial is going to know probably more than, um, that perhaps the trialists give that person credit for.

Having said that, when you go to the next level, and we're down talking to the participants that are actually in the trial, And the consumers that are turning up and being part of this study group, that is where the consent comes in. And that is where you can't start talking jargon and you can't start talking all of the medical terms in the names of drugs.

They don't actually care. Quite frankly, you know, the, the generic brand name or whatever it is. is going to do for them. They don't actually know what the active ingredient is. And one of the things that I read when I read the consent forms and the information brochures and sort of like put huge crosses through them, um, is because realistically at that next level down, those people don't really care about it.

They want to know, you know, this drug is used for this and it's used for that. And we're trying it to see if it works for this, something else, or whatever it might be. And I think that's the level that, that we really need to make that adjustment at. And, um, we don't need 15 pages. 

Callam: So we've heard a lot about your, your experiences of, of trial involvements, both from the trialist and the, the consumer advisor sides.

Um, are there any aspects of the research process that you feel don't currently have enough kind of participant involvement, um, so to speak? So I know we've touched on a few things like dissemination of trial findings. We've got post trial care. Obviously, yeah, many, many areas where people could feed into the, the research process.

From both of you, like, where do you feel we're possibly missing a trick and we need, need further development of the process? Um, again, I'll pass back to Octavio just to give people's voices a break. 

Otavio: I think dissemination of trial findings and publication of trial results or presentation for our results.

It's, it's an important area, uh, of course, and, and, you know, it is better than us that we, we, we submit, let's say a. Manuscript to the Lancer or to the England Journal, JAMA, BMJ, or whatever journal, we stick to the consort statement and you, you want to make the trial results transparent. We follow the statistical analysis plan and everything and everything else.

It's and of course, even sometimes physicians were not trialists. They have a hard time understanding the results and the complex graphs, et cetera. Of course, The journal editors and reviewers understand that the audit trialists understand that but then even Colleagues cannot understand it and and and sometimes of course or most of the times you know the patient's voice I I know that we have now some patient summaries or summary or Patients summaries in late terms and things like that.

But I think we should do more. And why not, you know, have something similar to the consult statement, for example, where we have some standards of, some reporting standards for patient summaries with the key terms and the correct way of presenting it and maybe even patients as alters or patients as part of the peer review process.

I don't know if there's anything going on in this respect, Callum, at the Lancet or other journals. But maybe, but I think dissemination results is very important because if patients don't believe in the results or if they don't understand the results, The reality is that the trial findings won't get implemented and, and, and if the trial findings are not implemented, I mean, it's just a beautiful academic exercise to have a nice paper, a nice result, but if they're not implemented, so we're failing enormously.

So I think there's a lot of potential to transform also the way we disseminate results, uh, involving patients in the process. 

Callam: Vicky, do you have anything you would add to that? 

Vicki: Only that the comment that I get every time I talk to a kidney consumer body, the only question they ask is, will we find out the results?

So it is absolutely a burning question for patients that have been involved in trials and they don't seem to feel at the moment like they are getting that feedback. So what Octavio said is fantastic. And I think the other thing he touched on, which I think is really important just to really bring out, is the fact that the people that are experts in this particular field of medicine.

Um, or research are going to be able to understand the journal and article that's written in the Lancet and that won't be a problem. But if we take it down to, you know, the GPs, for example. Um, they may not read the Lancet, they probably should, but they probably don't, and they may not, as Octavia said, be able to understand exactly what the benefits are for their patients from the, the, you know, the very, very important articles that are, that are published.

So being able, as Octavia said, I've got about five examples that I could think of off the top of my head where that really would make a huge difference. 

Callam: Yes, I completely agree with you both. Um, obviously, as an editor of a general medical journal, I spent a lot of my time reading very complicated science from across a huge spectrum of different, um, disciplines.

And, uh, yeah, yeah, definitely, um, it's important to think about both people who are going to benefit from the research but also researchers themselves. Obviously, um, everyone benefits from, from thinking about the ways we can kind of get across the message as clearly as possible. Um, yeah, definitely. And yes, to, to mention, uh, you, you alluded to journals, obviously at the Lancet, I can speak for the Lancet, but, um, we do have projects that are trying to move in that direction, peer review process, as you said, uh, Atavio, we've got the Lancet psychiatry already have something in place, um, whereby, yeah, um, people with lived experience are involved in the process, and I'm sure there'll be a lot of people at the Lancet very, very interested to listen to this podcast, because I think, uh, there's been some great ideas floated.

So we're, um, approaching sort of the end of the time we have available. Um, I wanted to finish with a sort of broader question around research participants and whether you feel that participants receive adequate recognition for their part in advancing knowledge and understanding about health. Now, obviously, it's quite a sort of vague term, um, adequate recognition.

I'm, I'm aware not everyone would get involved in the process because they wanted to be publicly recognized. But obviously, just listening to you both talk today, it's obvious that people who have lived the experience feeding into this process add so much value. So I just wondered, I think it would be good to start with Vicky for this question.

Do you feel that, yeah, research participants receive adequate recognition for this work? 

Vicki: My observation and the feedback that I've been given by the people that I know that have been involved in trials, um, don't feel that they're at all recognized. I think that even the consumer panels, which are Um, providing feedback to the various, um, opportunities of, um, trials, you know, I feel some of the people in my committee and my panel don't feel that they're being listened to.

I think it very much depends on the individual researcher. There's a couple at, um, the George in Sydney that I must say are brilliant at it. Absolutely brilliant. Well, if they'll come to, say, the, the George Institute Consumer Panel, uh, for kidney disease, they'll present an idea for a trial, they'll get some feedback, they'll go away, and six months later, they'll come back and they'll go, well, this is what we've done to implement what you came up with.

Does that work better now? Absolutely magic for that, for that committee. They feel like their input was listened to and valued, and it made a huge difference a number of times. And I think the outcome was fantastic. Great. Um, because if you have a second go at it, you can go, Oh, actually, no, that wasn't exactly what I had in mind or whatever.

So I think that's absolutely brilliant. Um, so that side of things, definitely recognition and appreciation really important, but then there needs to be recognition as well of the people that have actually participated in the trial much more as well. 

Otavio: First of all, I fully agree with Vicky again. Exactly on the same page on everything.

We discuss it today. But I think the objective answer to your question is no. I, I, I don't think participants are getting the adequate recognition and, and we need to transform this. So I think for, once again, for patients or participants who part of the string committee or the trial team, I think why not think about eldership and, and.

You know, other types of public recognition, I think that's, that's important. Um, I think in terms of participants who are in the trial, obviously, but not part of the string commuter of the trial team, I think probably, Vicky, please correct me if I'm wrong, but, uh, as you mentioned, they, they don't have access to the trial results of what happened to Ben and, and we need to be transparent with them in terms of what we're finding, what are the implications of the trial results And I think providing feedback to them, probably, once again, correct me if I'm wrong, Vicky, but probably will be the most important recognition.

I mean, it's about transparency, about communication, about, you know, making sure they understand their contribution and yeah, but, but, but definitely I think we're failing. I think in terms of patient recognition, there's lots of work to be done, Calum. 

Callam: Thank you ever so much to both of my guests today, Octavio Berwang and Vicky Gray.

I've learned a huge amount from speaking to you and I'm sure our listeners will have done as well. So I hope you've enjoyed today's podcast. If you did, I highly recommend subscribing to the Lancet Voice podcast to ensure you don't miss any future episodes of our exciting 200th year spotlight series.

Thank you very much for listening.