Karen King 

Welcome to the Medical Affairs Professional Society Patient Centricity Focus Area Working Group’s two part podcast series on publication plain language summaries. In this second podcast we will discuss key learnings from a patient perspective in relation to developing publication plain language summaries. I’m Karen King, and I’ll be the moderator for this podcast. I currently serve as a member of the patient centricity focus area working group, and I’m head of medical strategy at CMC affinity, a medical communications agency. I’m also a researcher and published author on publication plain language summaries. Just to say the views expressed in this recording are those of the individuals and do not necessarily reflect the opinions of MAPS, or the companies with which they are affiliated. This presentation is for informational purposes only and is not intended as legal or regulatory advice. So we encourage you to engage in conversations about plain language summaries with other members via the community portal on the MAPS website. Simply log in with the email address and password associated with your MAPS account, and click on the discussion tab. Then scroll down to evidence generation to post a question or review previous postings. The podcast objectives are to explain what publication plain language summaries are and how patients find them useful, and also to share real life patient experience of being involved in reviewing plain language summaries. And key points to consider from a patient’s perspective when developing pls. Please refer to the content hub on the MAPS website for an accompanying elevate article which covers this topic in more detail. I’d like to really thank today’s panelists, Simon Stones, a patient advocate for sharing his expertise with the MAPS membership. Simon, please could you introduce yourself.

Simon Stones 

Thanks for inviting me along, Karen. So I’ve lived with juvenile psoriatic arthritis from the age of three, and Crohn’s disease from the age of 14, alongside another the other conditions. And it’s really been a patient advocate since 2012, when I was invited to sit on a national pediatric rheumatology clinical studies Group here in the UK, as the third person represents it. And since then, I’ve really taken every opportunity to help make a difference advocating locally, nationally and internationally, to patients and families to be valued, respected and involved in their care and research, as well as pushing through increased transparency and communication with patients and families. And using my quote to research belongs to all of us. I’ve been involved in far too many things to mention. But here’s a snapshot and served in over 70 different groups and committees, and co authored over 150 research and advocacy related publications and presentations. And so I’ve seen lots of different experiences over the years. I’m also currently a trustee of a charity called raise which supports young people with invisible illnesses. And I’ve previously served as a trustee at Fibromyalgia action UK. I’m also past president of the European Network Manager associations to and in addition to my advocacy mission, I’ve also undertaken a PhD in Applied Health Research. And in that I’ve developed recommendations to inform and empower young people with arthritis to take control of their health and well being so I’d really got this nice, really associate degree view, patient perspective.

Karen King 

Thank you, Simon. So first of all, we’re going to start with a very quick definition of some of the terms that will be used in the podcasts that are two different types of lease summaries. So this is just to avoid any confusion that are clinical trials, summaries, and also publication plain language summaries or pls. Clinical Trial summaries are no legal requirement and Europe. And they are typically templated summaries hosted on clinical trial databases, summarizing summarizing the results of the trial in plain language for patients, typically for patients that were involved in the trial publication plain language summaries are summaries which are company manuscript publications, which can be in different formats and styles and hosted in different locations including on the journal site. So this also includes summaries in plain language of Congress abstracts often shown on Congress posters. And today we are focusing on our experience with publication plain language summaries are so is really limited guidance on this topic. And we often get lots of questions about this. As well as the fact that it’s really Increasing an interest. So now that we’ve covered that, Simon, I wondered if you could possibly outline your recent experience with helping to develop publication plain language summaries for Congress abstracts.

Simon Stones 

So I’ve been involved with in both manuscripts and abstract plain language summaries for around two years now. And that’s mostly been working in a freelance capacity with one medical communications agency. And they have a pool of patient partners as part of their review process. So we’re made aware in advance that some abstract plain language summaries are on their way on the timeline ahead. And when they arrived with the agency, and they provided to me by email, and I typically have the abstract plain language summary, and the original abstracts in front of me as I review. Now, first and foremost, I think it’s important that I need to make sure that the plain language summary is easy to understand and interpret to patients and non specialists, and so on, make a number of comments and suggested changes to improve the plain language summary. I also advocate against dampening down the signs since I believe this can sometimes lead to inaccuracy in lay terms. So rather, you know, concepts and data need to be explained and illustrated so that patients and other non specialists instantly know what the material is trying to suggest. And once I’ve made all of those suggestions, I send them back off to the team to then incorporate. It’s always really useful to sort of hear back and I say my feedback has or has not been incorporated. And I think after all, we can all learn from each other’s expertise. And extending beyond that role. I’ve also been involved in a couple of pilot studies alongside the agency and the sponsor. So these have been great opportunities for the patient lens to be added to that conversation. And it’s a lens, which has been historically overlooked in medical communications. And we’ve published and discuss the findings of these pilot studies at the conferences over the last few years. And it’s great to see that add into the conversation on the evidence base of the use of abstract plain language summaries,

Karen King 

tests really interesting. Simon, do you think there’s a real genuine interest from patients and meeting the recent research relevant to their condition?

Simon Stones 

I don’t think there’s a genuine interest. I know there is one. And you know, my perspective is that research belongs to all of us. You know, we’re no longer in the era of ivory towers, nor one of them. Who knows, you know, we must also eliminate some of the delusions about patients that we as a group, hiring, educated, are incapable of understanding research or less trusted than those in trained roles. You know, from my perspective, it’s immoral, and quite truthfully unethical. And let me start by saying that, you know, patients aren’t one group, just like researchers, are professionals, you know, patients are dynamic, they’re a group of people with different interests and abilities. You’ll find some people who don’t want to know anything about research, and that’s absolutely fine. And be lost also have some who are interested but don’t know where to begin with finding information out. And you’ll find those, I guess, similar to me in the sense who are interested and actively involved in research, and also using research to shape care of themselves, but also with their communities. And I’m particularly active in the world of Rheumatology. And over the years, you know, I’ve seen a growing number of patients and carers presenting their own research conferences, have been involved in conducting and disseminating research, as well as identify new research outputs to use themselves but also to share with our communities. Fundamentally, you know, patients have the right to access those research findings as soon as they’re available. And they need to be in formats, which are accurate, but most importantly, accessible. Without patients, this industry wouldn’t take this. Therefore, the very least I can we can do is to thank patients taking part in research, involve them in designing and conducting that research purpose will also ensure that they receive the results of the research that they contributed to, and that should be irrelevant to the outcome.

Karen King 

Thanks, Simon, I think that’s really valuable feedback. As a patient yourself, what would you recommend then regarding the best format for a publication plain language summary? And what do you think patients really want to be included in that summary?

Simon Stones 

I think others have already quite clearly shown that, you know, the promise of infographics and I completely agree with that finding, you know, I want to see concise, non technical text with data visualizations to understand those key messages that they’re given piece of research, you know, for people with varying levels of health literacy, and health numeracy. other formats, such as videos can be useful in certain circumstances and certain audiences and I know give the example of children young people and, but the likes of those multimedia videos can be a little problematic when individuals are trying to search them for Because the you know, the less easy to index, for example. And in terms of content, you know, patient, the key points are what does this mean for me? And how does this influence my care or the care of my community? that’s ultimately what people really want to know, supplemented by the research context, for example, disease area or, you know, drug mechanism of action. Other information, such as another study methods are important for the tendency of less interested patients wanting to know what this means to them. But nevertheless, I think it’s important that those points are communicated, so that we can help people to interpret the level of evidence when they’re looking at these plain language summaries.

Karen King 

Thanks, Simon, that’s really interesting. And in terms of working in partnership with patients, the pharmaceutical sponsors, the medical communications agencies, when they’re working in partnership with patients to review the pls, can you sort of maybe talk us through what the most important considerations are during that development process?

Simon Stones 

think you’ve got to remember that patient partners are a part of your team, just like you or do with any of your colleagues. clear and consistent communication is key. So firstly, you know, ensure that all of the practical elements of the partnership are dealt with and facilitated by yourselves. So this includes the likes of contracting, agreed payment rates, confidentiality agreements, amongst other things. You know, it’s very important to touch base with your patient partners, when you have some potential work to review, to see whether they’re able and willing to support you on this occasion. I’m really outlining, you know, when they’re expected to receive the plain language summaries of the review, and when they need to be completed by and I think just this open, transparent way of communicating just enables people to make informed decisions about whether they can support you or not. Now, we all know the unpredictability of timelines within the industry. So it’s important if you can keep this dialogue flowing. And the same also goes once patient partners have provided very important feedback. And I think that includes any follow up comments from the medical writers and editors, for example. Ideally, it would also be useful to provide feedback to patient partners about how their comments and changes are incorporated, or why they weren’t. You know, I strongly believe in mutual learning and, and I’m sure that patient partners agree with me too, on pain and suffering. That’s also why you know, you should also consider appropriate training for patient partners. And approach that topic with them to see if there’s anything that you can do to support them in their role. And, you know, for some, this may be, you know, understanding the business of medical communications a little better. Or it might be something more specific, such as understanding readability scores. Now, the key thing is to use this as an opportunity for you to support your patient partners, in addition to them supporting and educating you and your team on the business about the experience and expertise of patients.

Karen King 

Thank you, Simon. Sounds like communication is really key throughout that whole process. So moving on, in terms of what you recommend in order to help the publication plain language summaries, reach more patients. Any thoughts on that? Simon?

Simon Stones 

Definitely, um, I think, you know, the key thing is developing a good dissemination strategy, which sometimes doesn’t form part of this conversation. So, industry colleagues, particularly those based within Europe, tend to err on the side of caution, and particularly around that fear of blurring the lines between education and promotion. I think when this happens high the no publication plain language summaries are developed, or when they are developed, they’re not utilized as much as they should be. And so I think one of the, one of the most important routes really is to reach that wider group of patients and carers and that can be done by working with patients and care organizations. And when I say that I also include the medical research charities. So engaging in that mutual dialogue about providing accessible research findings to patients and carers is one insurance system way of ensuring patients and carers are able to access and utilize that information.

Karen King 

Thank you, Simon. And lastly, to finish if you had just three top tips for the MAPS community, who might be considering developing publication plain language, somebody that may be just starting out in that process? What What would they be?

Simon Stones 

My first one would be that you need to recognize that this is where the industry is shifting to a place where research is much more transparent, dynamic, inclusive and patient centered. I think Don’t be afraid of communicating with patients. Although it might feel like a big step. If you are new to developing plain language summaries. begin the process as a phased approach and perhaps with a pilot To help you align your team and your organization to see the value with plain language summaries, but rest assured that it’s already happening elsewhere. My second top tip would be to bring plain language summaries into the publication and from the outset, so plan for plain language summaries from the start building in the necessary processes as you go along to ensure it’s timely publication alongside the abstracts and other manuscripts. And finally, I think my last top tip would be to not forget to include the patient and care advice in the process. patients and carers with their expertise and their experiences really adds an invaluable lens and experience to the process. And they’re already involved in writing review and instance check in plain language summaries. So it seems appropriate that they are part of this process rather than being forgotten out of the picture altogether.

Karen King 

Thank you, Simon, that’s really helpful. So it’s clear that more and more patients want information on new clinical research. And they really do value having these summaries that they could clearly clearly understand on the most up to date clinical research relevant to them. So just want to say thank you very much to our speaker Simon stones for sharing his thoughts and all his experience and expertise. This has been the second podcast of two on publication plain language summaries. The first podcast if you haven’t listened to it yet focuses on plain language summaries from the farmer perspective. If you had a MAPS member, thank you for your support of MAPS. And if you’re not yet a MAPS member and would like to access additional resources in this area, please visit the MAPS website to explore joining today Medical Affairs org forward slash membership. And this concludes the podcast. Thank you.