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David Harris - phaware® interview 356

I'm Aware That I'm Rare: the phaware® podcast

Release Date: 12/15/2020

David F. Harris founded Insight & Measurement and provides research, training and speaking to the industry. 

In this episode, he discusses the qualitative and quantitative work that he conducts with PAH patients, so that people who get invited to be part of these types of studies have some understanding of what actually the process is like and what gets done with those results.

My name is David Harris. I run a company called Insight & Measurement, and we do a lot of work in rare diseases and in healthcare. My background has always been in healthcare. I worked in a hospital many years ago and I was director of research methods at the big pharma company called GlaxoSmithKline followed by another company called Merz North America. I've done a lot of work in the area of pulmonary arterial hypertension. I've had the good fortune of being able to work with the people at phaware global association to really help advance the perspective of patients for pharma companies and for device companies.

Today, I want to talk a little bit about the qualitative, and to some extent, the quantitative work that we do with patients, so that people who get invited to be part of these types of studies have some understanding of what actually the process is like and what gets done with those results.

What I like about what I do, and it's probably my favorite part of the work, is when I get to talk to patients, and I also talk with nurses and with doctors too, about their real experience with the disease, with getting diagnosed, with treatments. Very often, companies will contact me because, one, they want to know what is the experience really like and that can range from what was the process like in terms of getting diagnosed to how do you manage your disease to issues around caregivers or care partners. How do you manage your social life, and all of the experiences that people have with the various medicines that get used.

I think when we do this really well, we develop these things called discussion guides. I like to call them with my clients, listening guides, because it gives them an up-close and really personal feeling and view about what it's actually like living with PAH. Sometimes, our studies may have one particular objective, but when we're talking to somebody, they might start talking a lot about cooking and what it's like cooking when you're on a pump and when you're on oxygen. That could take on a whole different discussion which can be enormously useful to the company. But largely these things are around what the overall experience is like and it's helpful to them, because they're spending their careers and lives developing medicines and devices for people with PAH.

We also do a lot of work around designing things. If you think about designing a clinical trial, if you think about the actual details around the design of a device, whether it's a nebulizer or a pump or something like that. We're always much better off when we go out and we talk to people who would use these devices and get as much feedback as possible about how to fix them and how to improve them. I probably don't need to tell you all the different things that might not be right about them. Some of these things have sounds. Some of these things have lights. Some of these things might be too heavy. Some of these things might tip over. Really, the lived experience of what it's like using these various devices or these medicines.

The other category that we work on a lot has to do with, in the industry we call it messaging. So that's really, what do we say and how do we say it? It's a real challenge for people in the healthcare world, because the healthcare world has its own jargon and that sort of thing. My goal, when I talk with patients is to help the company get the messaging and the creative to make as much sense as possible, right? To make it just as clear as possible to a broad spectrum of people. In this case with PAH, but if it were another condition, then that other condition. So, I think in summary, what I would say is the reason why we go out and we want to interview patients and caregivers is to really understand how to adjust things so that they work better.

We also do this work with doctors and nurses too. Very often we need their perspective also. That can often be really, really helpful, particularly around some of the issues that they deal with when they're working with families. So you could imagine the process of talking to a patient about being on a pump. What does that process look like? It's a really tough conversation. A tough process. We need the perspective of patients, as well as the perspectives of the doctors and nurses on how to make that effective, comfortable, and sensitive to all the different emotional issues that are going on with people.

Over the years, and particularly in the past, I don't know, few years the FDA has made it really clear that they want the patient voice included in the development of medicines, devices, and processes for patients. So, when I go out at Insight & Measurement, when I work with phaware and we talk with patients about their experience. First of all, let me say, we follow pretty strict ethical guidelines. We assure you that your identity will be kept confidential. It's completely voluntary. You can just stop at any point, if you wanted to. Usually, these things are done over the phone, so you can do them at the time and place of your choosing so that they're comfortable. We almost always compensate people for their time too. We call that an honoraria or a payment, that sort of thing.

What ends up happening is we develop our discussion guide or our listening guide. We might spend 45 minutes on the phone, it might be an hour, that sort of thing. Sometimes it's survey-based. We'll get the survey information. What we do is we write that study up for the, let's say, pharma company. It could be a device company. I've done work for advocacy groups too. It could be any group that's interested in this and we present that. We present that with our numbers, major themes. I always put together quotes so that they can really read and feel the lived experience of people. In the ideal world, and this is usually the case, what ends up happening is we're going to do the study. We're going to listen to these 20 patients, talk about X, whatever it is. Then they know a lot more about how to further develop that initiative, whether it's a clinical trial or whether it's a device or a medicine, or whether it's materials on how to communicate all that needs to be said about that particular treatment.

Let me talk for a minute also about the timeline for these particular studies and I'll talk about it from, let's say, the patient perspective. Usually, you get recruited for a 45 minute, hour long interview that gets put on the schedule for a time that's convenient for you. If anything comes up, we always reschedule. I always say, "Life comes first," right? So that usually gets done, I don't know, within a couple of weeks of when you first get contacted.

There's another type of study that we do at Insight & Measurement a lot, which are these online studies and we have a platform where people log in. Those will often last a week where you log on for 20 or 30 minutes, once a day for five days. Obviously, if something comes up and you need another week, of course. But those will be online activities where you log in and we use things like, we call them projective techniques, because, well, that's what they are. We might do a task where you write a letter to a hypothetical patient that just got diagnosed with your condition, what advice would you give that person? We might have you select an image from an image bank or upload an image that represents how you felt when you were first diagnosed and describe that. Or represents the role that your condition has played in your life and discuss it.

We also build collages. I hear that they're rewarding for people, like build a collage, select a set of images that represent your relationship with the healthcare community. So people will put the images together and that sort of thing. Those are longer studies. They pay a lot more, but that's another common type of study that we do. Again, we just do this all around what's convenient for you. The timeline for the company is usually a lot longer. So, for example, we might do the exploratory work, the online work where we have the projective techniques, the write a letter, the images, early on, because they're just entering this category. By category, I mean this particular disease state or coming out with a new medicine or device.

A little bit later on when they're developing the messaging around it and we're testing creative and let's just say that's a 45 minute or hour long interview, the company might be six months away from getting approval from the FDA. Their process is a lot longer. I will tell you at the end of my conversations with patients, I almost always ask them, "What inspired you to participate?" What I hear over and over again is, "I just want to help the next patient who has this." A lot of them, it's not about the honoraria, although we usually pay people appropriate amount for their time, but for a lot of them they want to just help the next person who gets diagnosed with what they have.

I have to say, I talk to so many patients with PAH and with other diseases that are either rare or sort of near rare, and it's really moving for me, because I feel like I get to know people pretty well in that process. I think the kind of thing that I think is so helpful to these companies are the big themes about being misunderstood, judged, maybe blamed, minimized, not being seen. There're issues around feeling isolated, hiding the condition for fear of being misunderstood and judged and that sort of thing. There are a lot of issues around how the healthcare community communicates with people with PAH. Underneath a lot of that is just the desire for people with PAH to have hope, right? So when you put that together, particularly with the quotes, the things that people say about their experience around being misunderstood or judged or shamed, and you put that together with the quotes around issues around wanting new medicines and wanting to have hope, it moves people.

We've also done some work with the images where people selected images that represented how PAH has affected their life and what life was like on IV infusion or Sub-Q infusion. We've published work. For even people who have been around the disease and treated it for a decade or more, sometimes it brings tears to their eyes, because they're right up against the truth. The truth really around living with this condition. That's really rewarding to me. I know it's really rewarding to the people that we interview that they really get heard. That's probably the most important thing.

Well, thank you everyone. My name is David Harris and I'm aware that I'm rare.

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