HLOL Podcast Transcripts

Health Literacy

Patient Authors of Research Studies (HLOL #211)

Helen Osborne: Welcome to Health Literacy Out Loud. I’m Helen Osborne, President of Health Literacy Consulting, founder of Health Literacy Month and author of the book Health Literacy from A to Z: Practical Ways to Communicate Your Health Message. I also produce and host this podcast series, Health Literacy Out Loud.

Today, I’m talking with two guests. Professor Karen Woolley has conducted and published more than 100 research studies on patient involvement and ethical practices in medical communications.

She brings to this work extensive experience as a university professor, journal editor and senior leader at an international pharmaceutical company.

Karen and patients co-created the world’s first “Plain Language Summaries of Publications Toolkit.” Together, they also co-authored the first-ever systematic review of the benefits and risks of patient involvement in publications.

Karen speaks with us today from her home in Australia.

My other guest is Thomas Gegeny, who brings more than two decades of experience in medical writing, editing and publishing. He is very active in the American Medical Writers Association, or AMWA, having served as its president and been involved in many of AMWA’s professional development activities. This includes helping to establish the first-ever certification program for professional medical writers.

Tom has worked as a writer, editor and director of several large-scale health initiatives. He now is at Envision Pharma Group where he met and worked with Karen Woolley.

Tom is based in the US.

Like Tom, I’m a member of AMWA, and I recently read an article in AWMA’s Journal that Tom and Karen co-authored. The title was “Medical Communicators, Meet Your New Authors — Patients!” I was immediately intrigued and, of course, read the whole thing and highlighted all over the place.

I’m delighted that Karen and Tom agreed to talk with all of us about the benefit and what it’s all about to have patients as co-authors.

Welcome to you both.

Karen Woolley: Thank you, Helen. I think we’re both excited to be part of your podcast. Thank you very much.

Thomas Gegeny: Absolutely. Thank you very much.

Helen Osborne: That’s great. We’re an eclectic group. We’re from all over the world at this point. We have similarities and differences, but what we’re all intrigued with, and I want to keep learning from both of you, is about patient authors. You use that term a lot. Tell us all what you mean by the term “patient authors.”

Karen Woolley: Tom, please complement what I say. But it is broadly a person with lived experience of a disease or condition who meets the criteria for authorship. This basically means that they help prepare and take responsibility for a publication in a medical journal.

Helen, this isn’t some abstract concept. I think what’s really important for your listeners to realize is that patient authors exist. They are authoring publications right now. Even though it might be new for many of us, it’s actually happening right now.

Helen Osborne: I just want to ask you about that, Karen. Is it happening in other parts of the world? Until I read this article that you wrote along with a patient author in the AMWA Journal, I had never heard that term or really thought much about that concept of patient authors. This might be familiar to you, but it was new to me.

Karen Woolley: We’ve worked with patient authors in the US, Europe, Japan and Australia. I think it’s an innovation in publication practices, so none of us should feel baffled that we haven’t heard about patient authorship.

But I’ll tell you, in 30 years of medical communications, I’ve never seen something accelerate so quickly. It’s a real privilege to be in this profession at this time.

I think largely this acceleration is being driven, number one, by patients who cannot see why they can’t contribute to publications, and secondly by their champions, their supporters.

I think Tom and I fell into that category pretty quickly, and that has led to us and other members of our Envision the Patient team doing the research with patients to help with any innovation. What’s the right way? How do we go about this? I’m sure your listeners have many questions.

Helen Osborne: I do. I’m going to speak for the listeners. I’m the questioning voice representing listeners, if I may be so bold. I feel that that’s what these podcasts are actually all about. If I’m curious, I’m figuring other people are curious, too.

Karen, you’ve been involved with this for a while at a senior level at an international pharmaceutical company. Tom, from your perspective as a medical writer and editor, and you now work at that company, how did you get on board with this?

Thomas Gegeny: For a number of reasons. One is that my background is in advocacy. Before I joined Envision as a communications agency employee, I was working at a small, but with national participation, advocacy organization in HIV/AIDS in Houston, Texas.

With doing that work, with working as an advocate, working in the research and treatment development space, as a stakeholder, as a patient representative, it was very clear to me that there was a number of opportunities for patients and advocates to participate in the medicine development spectrum, all the different stages, from early to late stage and post-approval.

Most of the time, that was on committees and advisory boards, but there were opportunities to provide insights in publications.

To Karen’s point, while this is all very new and being talked about quite a bit, it was just not even on the radar 20 or 30 years ago. While it was happening, and may have happened sporadically, there was no way to identify that patient voice or to readily see, “This publication has an author who’s either a patient or an advocate with deep experience with the disease.”

Now I think there’s a realization that not only can patients and advocates be of value at various stages for advisory and perspective, but also in another stage of the medicine development lifecycle, which is publication of research and providing that context and perspective in which to share lived experience, as Karen mentioned, with the disease.

Helen Osborne: I can share that my enthusiasm about this comes from health literacy. I’m not involved in the research or the publication and peer-reviewed journals very much. But it comes from health literacy, which is about communicating in ways that patients and the public can understand. It’s actually broader than just the word patients. It can be caregivers or any recipient of messages.

It’s really that lived experience that we can’t do it just about people or to people. We need to do it with them.

I am championing you. I am a huge advocate, as probably most of our listeners are, of plain language and the growing movement of plain language abstracts and summaries. But now I’m learning more about doing this in peer-reviewed scientific journals.

We’re all on board, but I think our listeners and I are eager to know what we can do. This is where we’re at. It’s here. It’s now. Being aware of it is Step 1.

Our Health Literacy Out Loud listeners come from a variety of backgrounds. We might be clinicians, public health, librarians or teachers. We all want to communicate better today than we did yesterday. What have you learned that we can all take from this about this experience of patient authors?

Karen Woolley: One of the things that I think I learned very quickly was listening to patients. Of course, that sounds like a bit of a cliché, but I can share a quick story with you.

Helen Osborne: Sure. Please do.

Karen Woolley: Working with non-patient authors and patient authors, we will have what’s called, understandably, an authorship meeting. My role in those meetings, I might be facilitating the meeting, but I’m certainly taking notes for when key points are brought out by the authors that we really have to ensure are prioritized in the publication.

After 30 years, you can imagine that you get fairly used to these authorship meetings, and your note-taking might not be as prolific as it was when you first started out. The concepts are similar. One word and you can capture that.

What happened when patient authors started joining these authorship meetings was they were bringing such important and fresh, new perspectives that the other authors weren’t that I started to run out of space. I’m writing furiously. The number of exclamation marks went up exponentially.

I realized that this contribution, this voice, this perspective, as Tom was saying, just hadn’t been in the authorship meeting. We’d had surrogates for the patient voice. Why have surrogates? Why not bring the patients into the authorship room?

I really just understood that patients can make the publication more relevant and understandable, and they can help us make it more accessible. Three key benefits that I saw very quickly simply by listening to patients.

Helen Osborne: Karen, I’m listening to you. We’ve not met in person and we’re certainly not doing this podcast in person. But I hear an excitement and enthusiasm from you.

For someone who has been doing this work for decades, I hear that excitement that happened as you were developing articles now with patients.

I think we all need that. We get in a rut with what we’re doing. We just do it because it’s the way we’ve always been doing it. You talked about the power of listening. That’s so powerful. But also reminding us why we do this work.

Karen Woolley: Exactly.

Helen Osborne: What about some tips or lessons learned for those who, like me, just want to do a better job today than yesterday?

Thomas Gegeny: I’ll jump in here, Helen. One of the things I think I’ve been seeing and what listeners can do is to be prepared for people to not understand. I think that’s important. When you say “patient author,” just as we’re exploring today on the podcast, not everybody gets that.

I think by being a medical communicator or being someone who works in this space and works with a variety of audiences and stakeholders, the better perspective is one that is representative of all the different groups involved.

Whether it’s mostly physicians who did the research or it’s the perspective of patients who have the disease that’s being researched on, all of those perspectives are valid and helpful.

When you can allow for the patient voice to come through in a publication, you get that understanding coming through.

One of the things you can do is be proactive in communicating that there’s a patient author and what that brings to the publication.

I remember a few months ago having a discussion about a publication that had a patient author. Peer reviewers from the journal came back and said, “We don’t understand why you’re devoting a good part of this paper to a side effect.”

A side effect of the drug was alopecia, hair loss. Yes, while it wasn’t a high frequency or incidence of this side effect, the authors were very particular about devoting some time to talk about it because it’s of very great concern to patients.

I think back on that publication and think, “What if you had maybe introduced some of those perspectives into even the cover letter upon submission so that it was communicated at the front that we are very proud to include a patient author? This is what the author, who meets all the authorship criteria, has helped bring to the publication in terms of perspective and patient views.”

I think it’s communicating that proactively and making it clear what the contributions are and the value, and then helping to educate in that way.

Helen Osborne: Tom, you used the term “be prepared to not understand.” At your high-level meetings, for both of you, is there pushback from professionals, like, “Why do we need to do that?” or, “This was perfectly good. Why are you making this process more cumbersome right now to get to publication?”

Karen Woolley: Helen, very early on when we started working with patient advocates and really looking at, “How do we bring patients as partners into the publication space?” sometimes people would just be silent on the issue and you would think, “Oh, they don’t agree with patient authorship.”

But we did some research at Envision which showed that actually the number one reason that patients weren’t being considered as authors was because it hadn’t even been considered. Patients just weren’t even seen. Talk about being seen but not heard. They weren’t seen and they weren’t heard.

People listening to this podcast, if people can just say, “Hey, do you think we should ask a patient about this?” that’s something very practical.

I think in your book, Helen, when you talk about health literacy, you talk about this shared responsibility. We can’t put the onus on the patient author to be everything from the beginning.

As Tom said, there’s education that is required. Anybody working in that medical communications/health literacy space, you know it’s a shared responsibility.

One of the tips that I would have if people do get involved with a patient author, one of the first things, is to appoint a go-to person, a contact person for that patient author. There’s just a friendly, respectful dialogue that can happen between that patient author and a publication expert.

This would be somebody like an AMWA member, ISMPP member or somebody who has publication expertise. People talk about dumb questions. There are no dumb questions.

Helen Osborne: But you really mean it. If you’re with a group of Ph.D.s and M.D.s and everybody else who has all these lofty titles, and you’re coming in with, “I’m worried about getting alopecia,” it feels like an inequity right there. It sounds like you have to do ways to welcome the patient author.

Karen Woolley: Exactly.

Helen Osborne: I know that you’re preparing the patient author and when you go about choosing it, but you’re also doing work on the staff side, too.

I want to take a little bit of a step aside. The world both of you live in is peer-reviewed, research publications. Are these lessons learned, do you think, equally applicable to perhaps the booklets, leaflets and handouts that many of us do every day?

Karen Woolley: Yes, I would.

Thomas Gegeny: Yes.

Karen Woolley: One of the things that our systematic review that we did, Helen, with patient authors . . . We made 21 recommendations that your listeners can go through, and we broke them up into what you should do before, during and after a publication project.

But you could use those same principles for any type of health literacy project. What’s interesting is that the bulk of the recommendations are what you do before a project starts.

For example, patient education leaflets. Patients were often involved in testing the leaflet at the end. Bringing patients in much earlier upstream of the project, I think, will maximize the benefits and minimize the risks.

Tom, would you like to add anything?

Thomas Gegeny: You’re saying exactly what I was thinking, Karen. Patient involvement in publications and in this process of medicine development at any stage really relies on a multitude of modalities. It’s not just saying, “We need a patient who’s an author.”

A leaflet or something like that, traditionally you would want to test it on target audiences or you would want to have readers give feedback and help review what’s understandable or what could be improved.

Having that level of participation through advisors, reviewers or, in the case of certain publications, authors, all of that makes a difference. There are many different opportunities and avenues in which to have that partnership and collaboration.

Helen Osborne: Thank you. On your Health Literacy Out Loud web page, we will have a number of references, because there’s a growing body of information for all our listeners who just are hungry, like, “Tell me more. I want to do this.” That’s where I come at on this, too.

We’ll have those links. One will be the AMWA article we will mention. But there’s a lot that’s also available on open access.

One of the articles that I really recommend has a long title, but it gets to a point that I think is important. That is this isn’t just a whim or a feel-good initiative. These are evidence-based.

You have an article called “Patient involvement in preparing health research peer-reviewed publications or results summaries: a systematic review and evidence-based recommendations.”

In that article are the 21 tips specifically that you’re talking about, the evidence-based best practice recommendations for involving patients as authors. You look at what to do before, during and after.

We don’t have time to go into those, but boy do I recommend to listeners to take a look at that. This is a movement. Let’s all be part of it. This is certainly health literacy in action.

In the interest of time, I’m just going to ask you to put on your future-looking hat. Farther down the road, what do you see as the state of publications and patient involvement in publications a few years from now?

Karen Woolley: What an opportunity to dream and to hope.

Helen Osborne: Dream and hope. Do it.

Karen Woolley: I think one dream that was a dream only a year ago and is now a reality, but something your listeners will see more of, is patients being involved in planning the publication. This is where they become members of a publication steering committee.

A world first is happening. UCB Pharma has been driving that with our team at Envision and patient partners. It has never been done before. It’s fantastic. I think you’ll see that taken up.

This is where patients decide what publications are legitimately needed, what the hot topics are, who should be authors, which journals they should be published in and which conferences they should be attending. It’s all of that planning upfront and upstream.

Then I think the other thing is that you will see more patient authorship because patients will be leading more research. Funders around the world and patients around the world are saying, “We want this topic researched. We will obtain funds and do this study. There are supporters and champions of that.”

Two things: patient publication steering committees and patients leading research teams to generate the evidence that matters most to patient care.

Helen Osborne: I love your dreams. Thanks for having them and saying them out loud on Health Literacy Out Loud.

How about you, Tom?

Thomas Gegeny: I think about the future being a little bit of a continuation from the past. At the time when I was working in the advocacy world, there were some areas, like cancer and HIV, that had very active advocacy groups, but there was so much more still to learn. I think there was a trail being blazed there and a model that other disease areas and other groups have looked at and grown and adapted to themselves.

Now there are so many great patient advocacy groups out there that are just not service organizations but that are actually involved at the forefront funding the research and driving the research.

What I see in the future is helping to contribute to the research, to Karen’s point, and sharing in the communication, authorship and recognition of that research.

That’s what I see as a true partnership. It’s the many stakeholders coming together and maybe some fruition to what has been a growing trend of involvement and engagement throughout the process of advisory boards and various activities that help to contribute to the product development lifecycle.

I do think that advocacy groups are going to be a great place to go to if someone doesn’t know where to turn. How do we get involved with patients? Where do we go? Community-based nonprofit advocacy organizations will be a great resource.

I think what seems so foreign and so unusual will not be for long. People will know how to tap in to the great resources and perspectives that patients and advocates can provide.

Helen Osborne: Thank you both. Listening to this, I’m more enthused than I was even before. This truly is health literacy in action. I thank you both individually and collectively for what you are doing to bring in the patient’s voice and for sharing it with us on Health Literacy Out Loud.

Thomas Gegeny: Thank you.

Karen Woolley: Thanks so much, Helen. It’s really on behalf of a larger team behind Tom and me. But thank you very much for giving us the privilege to participate in this podcast.

Thomas Gegeny: Absolutely.

Helen Osborne: As we just heard from Karen Woolley and Tom Gegeny, it is so important to include the patient voice in all we do. But doing so isn’t always easy.

For help clearly communicating your health message, take a look at my book Health Literacy from A to Z. You might be especially interested in Chapter 40 called “X-tras,” which is about innovative thinking and new ideas, which, to me, patient authors are part of that.

Feel free to also explore my website, www.HealthLiteracy.com, or contact me directly at helen@healthliteracy.com.

New Health Literacy Out Loud interviews come out every few weeks. Get them all for free by subscribing at www.HealthLiteracyOutLoud.com, or wherever you get your podcasts.

Please help spread the word about Health Literacy Out Loud. Together, let’s tell the whole world why health literacy matters.

Until next time, I’m Helen Osborne.

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