Episode 58: The Complexity of Breast Density & Breast Cancer Imaging

The Patient from Hell (00:00.462)
Hi everyone, this is Samira Daswani, the host of the podcast, The Patient From Hell. I have with us, I think, a superstar who has been on our podcast before and her episode for you guys listening in and watching this, love! So I'm gonna welcome back Dr. Karen Wernli to our episode. Good to see you, it's been a minute.

Karen Wernli (00:20.208)
Great to see you again.

Karen Wernli (00:25.392)
or like almost half a year or more, right?

The Patient from Hell (00:29.358)
Yes, yes, yes, it's true.

Karen Wernli (00:32.88)
And I think you've had some big life changes recently.

The Patient from Hell (00:36.942)
Mm -hmm. I did get married in December. And it was really nice. I don't think people prepared me for feeling happy. It sounds weird. Like, I think I've just gotten so used to, like, I don't know, preparing for, like, the darker side, you know, cancer diagnosis, all the fun stuff that comes with it, all the wedding planning. Everyone else is like, you're going to be super stressed out. You're going to be like, you know, project managing. All true.

Karen Wernli (00:39.632)
Super exciting.

The Patient from Hell (01:05.262)
But no one prepared me for like the happy barge. And I was like, huh, that's funny. I didn't expect that. So it was really nice. So.

Karen Wernli (01:13.904)
I've been married for almost 24 years at the end of May. I know. I was like just a wee baby when I got married, really. And my mom had died the year before. So it was the first time the whole family was all coming back together. And it was a happy day. It was just a lovely, beautiful, happy day. So I'm so glad to hear that you had a happy day. Or days, maybe.

The Patient from Hell (01:18.83)
What?

The Patient from Hell (01:25.742)
Hello.

The Patient from Hell (01:36.238)
Aww.

The Patient from Hell (01:40.814)
Thank you.

Karen Wernli (01:50.928)
Which maybe is what it should be, right? Because how are you supposed to cram all that happiness in a 24 -hour period plus sleep?

The Patient from Hell (02:00.014)
I think that's a question for you. I had it for 10 days. So it was a little bit longer than 24 hours. No, it was really nice. It was very nice. I think it was the first time, honestly since diagnosis, that I think cancer was mentioned once in the 10 day period.

Karen Wernli (02:08.496)
Yeah, right, right.

The Patient from Hell (02:27.278)
Which is, I mean, we work in oncology, so like that almost never happens anymore. Like, I don't think I go by any single day where the word cancer is not mentioned, right? Like it's mostly every hour, every minute of every day. So to go through a 10 day window where that was not mentioned, it was, a little bit. Yeah. It was liberating. It was like my identity is not tied to it. And I think because I work in it, it,

Karen Wernli (02:38.224)
Mm -hmm.

Karen Wernli (02:47.152)
Liberating?

The Patient from Hell (02:56.782)
It does feel tied to it very often and it wasn't and it was just, it was good.

Karen Wernli (03:05.296)
Really lovely. I'm really glad to hear from you.

The Patient from Hell (03:08.174)
Thank you. Tell me what's happening in your life. Half of your...

Karen Wernli (03:14.576)
Yeah, I thought about this because you sent me an email about it a few days ago. I was like, what has been happening? And then I mentioned it to the art group yesterday. They're like, are you going to talk about us? So here they are again.

The Patient from Hell (03:14.958)
Yeah.

The Patient from Hell (03:19.278)
It's nice to have you.

The Patient from Hell (03:26.958)
There we go, amazing. Let's add that.

Karen Wernli (03:30.192)
Still painting once a week. It's incredible.

The Patient from Hell (03:33.422)
Can we see something? Is that a piece of yours at the back?

Karen Wernli (03:37.36)
No, that's a piece of my children's art.

The Patient from Hell (03:41.23)
Sorry. Ouch.

Karen Wernli (03:44.08)
There's something on my phone.

The Patient from Hell (03:46.094)
All right, we're ready.

Karen Wernli (03:47.632)
Yeah, maybe that's what I could share.

Karen Wernli (03:55.984)
I know just like everybody, right? Like the delay.

We did black and white.

The Patient from Hell (04:01.358)
We'll be back. Done.

The Patient from Hell (04:06.766)
Did you paint it that?

Karen Wernli (04:08.656)
Yeah.

The Patient from Hell (04:09.678)
Whoa!

Karen Wernli (04:12.688)
their colors better.

The Patient from Hell (04:16.686)
That's stunning.

Karen Wernli (04:18.736)
8 hours, 4 sessions x 2 hours, black and white only.

The Patient from Hell (04:28.526)
cool. I don't think I've actually no I have seen that's oil and canvas or acrylic.

Karen Wernli (04:35.536)
Oil on canvas.

The Patient from Hell (04:38.99)
I don't think I have seen a black and white only portrait in oil on canvas. I actually can't think of, I mean, Picasso maybe? But outside of him, I can't, I don't know, I still don't think he was oil on canvas. I think it was a different medium. Like Guernica was mural, is that right?

Karen Wernli (05:05.904)
You know, I don't know.

The Patient from Hell (05:06.158)
Thank you, I love you.

Karen Wernli (05:09.232)
But now I feel like I should tell my art teacher and then we'll discuss it next week.

The Patient from Hell (05:11.694)
Okay, alright, done. You have to tell me what happens in the class. I want to know now.

Karen Wernli (05:19.952)
Yeah, I think what I was thinking about in terms of what's going on in my life is just a lot of transitions. My youngest is going to college.

There's been a lot of illness and death that comes from illness in family members. So just a lot of transition right now.

The Patient from Hell (05:44.526)
Would you mind talking to us about what that feels like?

Karen Wernli (05:53.296)
It's unmooring it, right? It's totally unsettling.

It almost has that feel like when in the pandemic and the early days where people are like, what's going on today? Because you don't, you know, every day is something unexpected.

or can – can be.

The Patient from Hell (06:19.726)
I think it would. Yeah.

Karen Wernli (06:26.448)
Talking to you makes me wonder why we don't talk more often in between the podcasts, right?

The Patient from Hell (06:31.278)
Let's talk more often between the broadcast.

Karen Wernli (06:33.808)
I think we're both too busy.

The Patient from Hell (06:37.006)
Well, we can always make time.

Karen Wernli (06:40.528)
Samira, I don't know if I sent this to you in email, but the best gift of being able to do this podcast is like all of my friends, not in research, not in this academic life, were like, oh my God, I knew you, but I didn't know you. Like all of a sudden you see somebody so familiar because they see me in a personal context.

And then they hear me talking about science where they're like, this was incredible. Like, I learned so much. And I knew you knew things, but I didn't know you knew those things. So that has been such fun feedback to receive. So we'll see what people think of this one.

The Patient from Hell (07:26.03)
Done. I love hearing that. I love hearing that. That was actually, honestly, the intention behind the PCORI grant. That was really the intention. Like when we wrote the grant, one of the things that we spent time writing about was in the world of science, as a patient, you see the clinician, right? You see the oncologist, you see your medical care team, you see the nurses, but we almost never, ever get to see the researchers. You never get that. Right? We don't get that.

Karen Wernli (07:54.096)
You don't, right?

The Patient from Hell (07:55.31)
We don't get to see them. We don't get to see their lives. We don't get to see how they think. We don't get to see how they design science, how they make what they do and their stuff affects us. It's their work that directly impacts the care we get. And we never do. So to hear that makes me so happy. That was exactly the point of the grant. So.

Karen Wernli (08:20.688)
And I should say, not even an audience for which this might be geared for people who maybe are personally experiencing cancer. This was primarily feedback I got from my friends who do not currently have cancer, hope never have cancer, but certainly have experienced it within their lives. Yeah.

The Patient from Hell (08:40.462)
Yeah. Karen, the funny thing about us and I'm learning this and it's all new. We came into it with the intention of supporting people who are going through it right now. And what we're learning is, and it sounds so, I don't know, in some ways really dumb, but what we're learning is everyone is impacted at some point. Every single one of us is.

And it may be happening now, it may have happened in the past and it may happen in the future, either to you or to someone you love. And somehow our hope and intention with the podcast is that it gives you something to anchor on. Right in that moment of transition, because entering into illness and leaving illness are all, including the illness part itself, it can be really, really.

scary.

Karen Wernli (09:39.056)
super scary.

The Patient from Hell (09:41.614)
Hopefully we get to help a little bit.

Karen Wernli (09:48.016)
I'm going to have to interrupt our suite dialog because my battery is low on my ear, which is why I didn't want to use these to begin with. And now we're just going to try a few things to see if it works.

The Patient from Hell (10:01.038)
Yep, I'm marking it.

Karen Wernli (10:20.361)
Can you hear me?

The Patient from Hell (10:21.742)
I can hear you great. Can you hear me? All right. Okay. Perfect. I think we can keep going. Yeah, we should keep going. All right. I'm just going to mark this again. All right. All right, Karen. Let's maybe jump into some of the sciencey stuff. I had a harder paper for you this time. It was hard for me, both from the scientific aspect, but also just from the value of research aspect. So...

Karen Wernli (10:23.753)
Yes.

Karen Wernli (10:40.457)
Okay.

The Patient from Hell (10:52.046)
Maybe we can start with the sciency part and then go into like just broader value of research part. And the sciency part, can we just start with preoperative breast MRI? What in the world is that and why do we need it?

Karen Wernli (11:11.657)
I know you think it's an easy question and it's actually kind of a hard question.

And I think I'm just going to jump to why it's hard. And then we can just roll it back if that's OK.

The Patient from Hell (11:24.398)
Okay, good, totally okay.

Karen Wernli (11:29.609)
The reason why it's a little bit hard is we did this survey of women who were newly diagnosed with breast cancer, maybe had completed most of their treatment. So when we recruited them, they were like six to 18 months from their breast cancer diagnosis. And the question that we asked is what type of imaging did you receive prior

to surgical intervention? Let me just scroll. I actually have the paper up so I could go back to it to remember things I couldn't remember. Yeah, which test did you receive to screen or diagnose your cancer? So that's a tricky question, right? Because when you look at preoperative breast MRI, it's what type of imaging are women self -reporting that they received,

prior to the time in which they had their surgery.

The Patient from Hell (12:22.99)
I see.

Karen Wernli (12:24.649)
And some of them, it's hard for me to know exactly, might have received a breast MRI to screen for breast cancer. And some of them might have received a breast MRI in the diagnostic workup for their cancer. The science itself was compelled based on the diagnostic workup and the use of advanced imaging during that phase. But it could be mixed with, um,

screening breast MRI.

The Patient from Hell (12:56.366)
I see. Maybe we can go to why, why is it an important question to know? Like why study it?

Karen Wernli (13:06.601)
Yeah, um breast MRIs have been increasing, like over the last 20 years.

Karen Wernli (13:15.337)
More women are using it for screening, but also more women are using it for diagnostic purposes. Like 10 years ago, we published this paper that was looking at why women were having breast MRI and sort of the staging and getting prepared for surgery was a high proportion. I don't quite remember, but maybe like 40%. And,

The Patient from Hell (13:39.086)
Well, okay.

Karen Wernli (13:41.481)
It's my understanding that at that time, like 10 years ago, NCCN guidelines were sort of like, you can use this test, but if you're suspecting it's cancer, you should be going to biopsy. You shouldn't be using this test to further define tumors. But I think that some practitioners have really incorporated it in terms of being able to really understand the tumor better. Um, so that the surgery is better. And...

The Patient from Hell (13:56.142)
Ugh.

The Patient from Hell (14:09.678)
Thank you.

Karen Wernli (14:12.841)
Some studies had recently come out and said, you know, that this could delay the time in which women actually start treatment.

Or it could be reassuring to women to know that they've gone through some additional tests to make sure they know sort of where what their tumor structure is like. Maybe that's reassuring. And so we didn't really know. Are these an, you could say additional imaging tests making women nervous or regretful in terms of what's happened in her diagnostic pathway or.

The Patient from Hell (14:35.054)
Hmm.

Karen Wernli (14:50.985)
didn't make no difference or are they happy with it, right? The other reason you can see when you look at the tables, we've stratified it or looked at two separate groups based on breast density. And that's because the grant itself was focused on whether or not there were differences based on breast density, knowing that women who have very dense breasts or heterogeneously dense breasts might be

The Patient from Hell (14:52.59)
Yeah.

Karen Wernli (15:21.513)
more likely to get advanced imaging or more likely to benefit from advanced imaging than maybe women who did not have dense breasts.

The Patient from Hell (15:33.742)
This is where life starts to intersect into our podcast in a really fun way. I'm going to take us on a tangent. I apologize upfront for the tangent.

Karen Wernli (15:38.537)
Okay.

Okay, I'm super excited. Where are we going?

The Patient from Hell (15:44.27)
Breast, dense breasts. So I, sorry, I promise you it's a tangent. Well, maybe it's not that much of a tangent, but it's a tangent to the study anyway. So I have dense breasts. Every time I've done a mammogram, every single time for the last four years, it has been, you have dense breasts. Well, it doesn't say you, but the patient has dense breasts. Additional imaging is required. Great, we know this. It's established.

Karen Wernli (15:49.161)
Okay.

The Patient from Hell (16:14.414)
I switched centers because insurance had to switch long long story had to change centers not because I wanted to insurance shifted I'm in a new system. The new system refuses to give me anything but a mammogram so I am currently smack in the middle of this thing like guys biology dictates, oh and by the way, guidelines dictate I need more than a mammogram

And it is such a fascinating place to be. Very frustrating, I might add. I had a back and forth with the RN and I was like, I copy pasted the link of the guidelines. I highlighted the guideline and I was like, I am pretty certain that I am reading this the right way. And the fact that I have to do that, I think is ridiculous. Sorry. That was my rant. This is why it's a tangent and it's a rant. But it is.

Why is that true? We have the research, we've had it for years, guidance has shifted, and yet we're sitting in this world where it just doesn't make any sense. So, Philip asked a whole question for you. But thank you.

Karen Wernli (17:24.489)
It's tricky.

Right.

And I think that particularly for young women, there's this benefit of additional imaging. We also know that breast density changes as we age and go through menopause. So women who used to have dense breasts might not have dense breasts later. But breast density is an independent risk factor for breast cancer. And it's not only because it can mask breast cancers, it independently of

masking is a risk factor for breast cancer.

Karen Wernli (18:09.033)
Yes. And also...

that inter-radar reliability of breast density can be...

It's not as high as you would think it is.

The Patient from Hell (18:26.157)
Can you say that again? I don't think I caught that. What was the term? The intro?

Karen Wernli (18:29.097)
There are four, well there are four breast density categories, right? Women can have almost entirely fatty breasts. Radiologists get that, great. Women can have very, very dense breasts. Radiologists see that too. But you see a lot of differences between the categories right next to each other, that you could be this category or that category, right, across the spectrum of those four groupings.

The Patient from Hell (18:55.182)
Nice.

Karen Wernli (18:58.729)
And we've defined dense breasts as whether or not you're in the two categories that have dense breasts or the two categories that we define as having non-dense breasts. But there's probably a fair number of women that maybe fall into either of those categories. For example, I did. I had my first mammogram last summer. The first time it didn't say I had dense breasts. Let's call it radiology. Radiologist A.

Second time because I was recalled, I did have dense breasts. So that's what I'm saying.

The Patient from Hell (19:38.19)
I see, I see, I see, I see. Can you help me understand the difference between fatty breasts and dense breasts?

Karen Wernli (19:40.297)
It's messy.

Karen Wernli (19:47.881)
Um.

You know, it's about the architecture structure, the actual structure of the breasts and that the way in which it displays on this x-ray, then is either very dark because it's a fatty breast or has all this tissue infrastructure because it has a dense breast and it seemed to be related to...

The Patient from Hell (20:05.614)
Thank you.

The Patient from Hell (20:11.278)
Oh, interesting.

Karen Wernli (20:19.049)
hormones, but nobody's really sure.

The Patient from Hell (20:22.382)
Hmm. Hmm. Hmm. Okay. That is actually super helpful. I think I learned something completely new today I was not expecting to. That's pretty cool. It's very cool. I didn't know there were four categories of dense press. I didn't realize that that was like a... not a spectrum, but like a spectrum.

Karen Wernli (20:39.369)
You could call it a spectrum because it goes from fatty non -dense breasts to extremely dense dense breasts for four categories. It's not a binary measure and it's not consistent and it changes.

The Patient from Hell (20:45.678)
So, interesting.

The Patient from Hell (20:59.054)
Does it change by time of month?

Karen Wernli (21:04.297)
I don't believe it does. I don't think it does.

The Patient from Hell (21:10.318)
Fascinating. Sorry, we're in a rabbit hole. I was not planning on being in it. But it's fascinating. I actually didn't know that. I didn't realize, I didn't realize that there was a architecture and that it sounds like, and going back to guidelines, it sounds like you need to be on the two plus of like dense, dense breast to qualify again in courts.

Karen Wernli (21:14.825)
home.

The Patient from Hell (21:40.206)
qualify for advanced education.

Karen Wernli (21:43.081)
The radiologist gives a range A, B, C, D score and dense breasts are the C, D category.

The Patient from Hell (21:53.614)
Okay. Okay.

Okay, interesting.

Karen Wernli (22:00.873)
They have terminology that goes with that. The FDA has been in the works for some time in order to have mandatory reporting. As you probably are aware, states, some states have already adopted this, that it will be nationwide as of September of this year that everyone, all women would be notified as to whether or not they have dense breasts.

The Patient from Hell (22:22.51)
Whoa, I did not know there was state reporting on that either. Wow, okay. You know what's gonna happen after this podcast, right? I'm gonna go and pull up my last mammogram report. Look what the test is.

Karen Wernli (22:33.705)
Well for you it probably hasn't changed, right? Like you've had some big life changes but not such big life changes.

The Patient from Hell (22:44.334)
Yeah, I know. I also am not on hormone therapy and I am not at menopause. So it should not have changed dramatically within a year, right? So yeah, I have to look at this now. Now I'm going to go down that rabbit hole before I post post this podcast. It's going to be great. You may get a couple of emails from me. I apologize. Interesting. Okay. All right. So going back to the study, we have dense breasts, the table.

Karen Wernli (23:03.625)
It's okay.

Karen Wernli (23:13.897)
Yes.

The Patient from Hell (23:13.998)
We're doing a retrospective.

I'm going to scroll back up. I'm going to go back to something you said about user, user preference. Wow. My brain patient preference. This is what happens when I work in digital health, not podcast stuff. My head is a user preference. And patient preference side. Um, the question I have for you is very often patients don't know what imaging they got or why they got it.

So how do we value the patient's perspective on what imaging tests they got and whether or not it was helpful or not helpful?

Karen Wernli (23:56.297)
I think that that's a really good question because I think that's accurate, right? You are told...

There's something we see on imaging and we want to do some other tests. And in that moment, you are totally disarmed. So who are you to say, wait a minute, is that the right next test?

Um...

The Patient from Hell (24:25.646)
Yeah.

Karen Wernli (24:26.889)
So it's really about women's perceptions of that process, I think, in a way, and whether or not that process in and of itself was helpful. I think this is actually a good time to go to the table with the primary results.

The Patient from Hell (24:33.262)
Hmm.

see. Yeah.

Karen Wernli (24:49.289)
I'm just going to scroll through it and look at it myself so that I don't get it wrong. So this is what I think is interesting. So we have two outcomes that we were looking at. And the first one was around decision quality. And this is really, it's a standardized measure. It's been used in other studies, other breast cancer studies. So there are other reports of it in different populations. And that's what makes it easier, easier or.

convenient to be able to compare what we see in our study to other populations. And this is really, has been used a lot around shared decision making, like the quality of shared decision making. How well did patients think that their doctors talked to them about

Karen Wernli (25:39.785)
treatment choices or next steps or something. And so our primary results, and we're going to look at the adjusted ones, that's where we take everybody in our groups mathematically in fancy models, take care of factors that might make the groups different to make them more similar so we can compare them. And what we see when we don't worry about breast density yet is that...

Women who did receive a preoperative breast MRI had higher reports of decision quality compared to women who didn't get a breast MRI. And it's, as we say, statistically significantly different.

And we hypothesize that maybe this is happening because if you get this other test, maybe your doctor's just talking to you more a little bit about what's going on with you. And maybe that additional conversation, because maybe you understand something better about it, makes you feel better.

The Patient from Hell (26:50.318)
Can we talk about the measuring tool and the decision quality tool?

Karen Wernli (26:55.017)
a little bit, but maybe not a lot.

The Patient from Hell (26:55.246)
So.

Just a little bit to help explain what that means. What does evaluating decision quality mean? I think where I'm getting a little tripped up is...

The Patient from Hell (27:16.526)
So the perception I got, it's more of like how we measure whether the decision was good retrospectively. I don't know if the question makes any sense. Right? Because decisions are being made now and then there's the like, look back, was that a good decision or not? But not, look back, you just have more data, right? So how do you balance that?

Karen Wernli (27:27.881)
Yeah, yeah.

Karen Wernli (27:46.409)
I think that one of the things you're asking is...

The Patient from Hell (27:46.798)
Thank you.

Karen Wernli (27:52.041)
If we talk to women or had them do a survey the day after they did this, how reliable is this response compared to the response that we're getting today?

The Patient from Hell (28:01.646)
Yes. Yes. Yes. That's the most what we'll say. Yes.

Karen Wernli (28:07.625)
Um...

I don't really know the answer to that.

I know that this measure has been used multiple times and has been validated. And so I think that what that means is that if we give it to people on different days, we consistently get a similar result.

The Patient from Hell (28:32.622)
Got it.

Karen Wernli (28:35.817)
But what I don't really know is whether or not if you actually waited like a year, will you get a different result? And you're right. I think this is important. I think we talked about this before. You know, the women that participate in the survey are not necessarily representative of all the women who have breast cancer in the United States. In fact, these women are highly resourced, highly educated, white women who

are the ones most likely to participate in surveys like this and are the ones for whom we have the most research about outcomes. And their experiences may not reflect all women's experiences. And so I think you also have to take that into consideration when you look at these results. That this might be reflective of a segment

The Patient from Hell (29:26.702)
Mm -hmm.

Karen Wernli (29:32.265)
of the breast cancer population that may not be generalizable to all women with breast cancer.

The Patient from Hell (29:41.742)
That makes a ton of sense to me.

Karen Wernli (29:45.545)
So what's interesting in our results is that when we look at the group of women who have non-dense breasts and we look at the group of women who has dense breasts, the results are a little bit different. They're not statistically significantly different. They're a little bit different. When we look at women who have dense breasts and the difference between those who received a breast MRI and those who didn't,

their responses on decision quality are pretty similar. When we look at women who have non-dense breasts, the women who had a preoperative MRI, their responses, or their reflection on decision quality is a little bit higher than those who didn't get breast MRI.

Karen Wernli (30:36.457)
We did say at the end, so it's a series of questions. I can't remember how many questions are asked. You can imagine it's something like five to ten questions that you summarize and then based on this summary you're able to compare between groups. And so the difference that we're seeing is like a woman answering one more question positively.

And so it's hard to know whether or not these differences, even though they're statistically significantly different in the whole population, are clinically different or meaningfully different.

And their overall values were really similar to what we've seen in other published populations of women who've had breast cancer. So it's likely that preoptive breast hemorrhoea really doesn't do anything in order to alter the pathway.

The Patient from Hell (31:42.734)
If you had to redesign the study today, what would you do differently?

Karen Wernli (31:48.585)
I'd want to know whether or not it was a screening breast MRI or a diagnostic breast MRI.

The Patient from Hell (31:56.014)
Yeah.

Karen Wernli (31:58.505)
I've also done very few surveys and so what I would prefer to do is be able to look at maybe standardly collected patient-reported outcomes that might be in an electronic health record so that you could assess outcomes for all women, maybe even even if it's just in one center, based on utilization.

Because also, as you said, women might not remember whether or not, what kind of imaging they got. I mean, that was also a problem.

The Patient from Hell (32:37.934)
Interesting. Would you still use it, as decision quality as a measure?

Karen Wernli (32:44.265)
Maybe. Maybe.

Karen Wernli (32:49.129)
maybe.

The Patient from Hell (32:53.71)
I'm going to zoom out completely from the PCORI study. I would love to know what you're working on right now.

Karen Wernli (32:56.969)
Okay.

Karen Wernli (33:02.185)
Do you mean that? Like...

The Patient from Hell (33:03.502)
Is she not going to be able to share? Yeah, actually. I am truly serious. Like, what are you working on right now? Like, whatever you can share. I understand that you may not be able to share, but whatever you can share in terms of like, what are you studying today?

Why does it matter today? Because a lot of times you're like...

Karen Wernli (33:20.457)
Yeah, because it's sort of like a left turn into some other things. And so I'm just going to warn you, we're going to take a, yeah.

The Patient from Hell (33:23.662)
That's fine. I think we have established you and I go on tangents, so it's okay.

Karen Wernli (33:29.865)
Okay, I'm leading a pragmatic trial to improve adherence to lung cancer screening using two patient centered interventions.

The Patient from Hell (33:39.727)
Cool, okay. What are the two?

Karen Wernli (33:43.657)
Pragmatic trial means that rather than coming up with some very strict criteria for entry into a randomized trial and then seeing whether or not this intervention that you have produces a signal, we're doing this study only at KPU Washington. Everybody has recently screened for lung cancer screening, so they've chosen to participate in screening.

And we're just trying to deliver some communication tools that would encourage them to screen again on time in one year. One is a video-based intervention that we deliver very soon after they get screened. And the second is a reminder that starts with placing the order that goes to their PCP to sign in order to kick off the scheduling process.

The Patient from Hell (34:22.03)
based intervention that we deliver to these students after they can screen them.

The Patient from Hell (34:33.742)
and

Cool. So one, if I'm hearing this right, one is a video where the burden, I put burden again in quotes, to do the screening and schedule it is on the patient. And the other one is clinician driven almost.

Karen Wernli (34:52.649)
It's multi -level targeted. So as soon as the physician signs the order, we start delivering outreach to patients to encourage them to call and schedule their appointment.

The Patient from Hell (34:53.934)
It's beautiful.

The Patient from Hell (35:07.374)
Very, very cool. Very cool.

Karen Wernli (35:09.193)
It addresses two barriers to screening. Everybody who screens is fiscal through shared decision making with their provider. But I think it's like harms and benefits of screening. It's not like if it and it treats us as if screening is a one and done sort of thing. But it's a program of screening. It's like participating in breast cancer screening or lung cancer screening or colorectal cancer screening, I should say. Yeah.

or nearing the end of accrual into our study, we conservatively estimated that we'd get just over 1600 participants and we've over accrued in a shorter period of time.

The Patient from Hell (35:51.854)
Oh, that's never, that never happened. Very cool.

Karen Wernli (35:54.121)
Never happens because one cancer screening is expanding and some more people are being screened. A protocol paper just came out so I can share that with you later. So that's super cool. I'm also leading a study that's part of a CDC funded network looking at influenza and COVID vaccine effectiveness. So we do recruitment in clinics. I know, I told you.

The Patient from Hell (36:06.83)
That's awesome.

The Patient from Hell (36:21.806)
It's great. Very awesome.

Karen Wernli (36:24.073)
It's so much fun. People say, but that's not what you did. And I was like, yeah, I know, but the skills translate and it's clinical research. So it is what I did. It's just a different topic.

The Patient from Hell (36:40.686)
Lung cancer screening, this is Lodo CD.

Karen Wernli (36:44.329)
Yes, ModoCT.

The Patient from Hell (36:46.446)
and smoking status doesn't matter.

Karen Wernli (36:49.993)
Smoking status does matter. To be eligible for lung cancer screening, you have to have at least a 20-pack year history, so consuming one pack of cigarettes per day for 20 years or longer. And the US Preventive Services Task Force guidelines currently state that you either need to be currently using tobacco or have quit within the last 15 years. And you can see that it can become kind of

problematic. And because of that, the American Cancer Society in the fall recommended that the quit time, time since quit was really irrelevant and recommended that if people meet the PACURA criteria, that they should be eligible for the cancer screening.

The Patient from Hell (37:38.958)
What about asbestos exposure?

Karen Wernli (37:42.793)
They do not account for workplace exposures in the risk assessment.

The Patient from Hell (37:50.862)
interesting.

Karen Wernli (37:52.521)
Yes.

It's been just really interesting work. I get to work with three incredible patient advisor board members who have just been so giving of their time and expertise.

Karen Wernli (38:10.633)
And it's the first study that I'm leading where I like designed interventions. I've worked with other people to implement studies that they've designed, but I really started wanting to understand what the barriers were and then how we could address them using human-centered design principles. And identifying these two areas in terms of education as being a critical one, but also reminding

both the physicians and the patients when they needed to come back. Some people can do it, get it, they get it right away. I say that both from the patient perspective and also from the clinician perspective. Some people need extra help and you're just trying to make it easy for people to do the right thing. You're just trying to make it easy, that's all.

The Patient from Hell (39:04.558)
I love it. Thank you for sharing. That was awesome.

Karen Wernli (39:08.361)
It is not funded by PCORI, but I would be happy to talk to you about these many findings when they're available in a few years.

The Patient from Hell (39:17.838)
Done, happily. Lung cancer is near and dear. I've been doing a lot of lung cancer content generation actually recently because it's one so complicated. The more I learn about it, the more I'm like, whoa, this is just like breast cancer is easy. I don't mean this from a patient perspective, guys. Survival here, it's not easy, but from just like a scientific lens and a clinical lens, my...

Karen Wernli (39:23.465)
Yeah.

The Patient from Hell (39:46.222)
God, lung cancer is complicated. Anyway, so we've been inching our way into it, so.

Karen Wernli (39:54.249)
It's also been underfunded, underappreciated. There's been a lot of stigma in healthcare. Yeah. In that study, because it's a pragmatic trial, people don't consent to enter. So we delivered these low risk communication strategies, and then we're able to measure outcomes from the electronic health record with permission from our human subjects committee.

And then I ask people to participate in a survey where I notify them about the research. And there's differences between who's in the main trial in terms of patient demographics and other factors compared to those who are in the survey.

The Patient from Hell (40:42.19)
Interesting. Huh, interesting.

I have like 18 questions on informed consent, but we will not go there because I'm watching the clock and if we go there, we're going to be talking for another week.

Karen Wernli (40:53.577)
maybe for another another one.

Karen Wernli (40:58.761)
I can send you a paper about that too.

The Patient from Hell (41:01.774)
That would be awesome. We should definitely link to it because consent has gotten so complicated and given all of the noise right now, not noise, I think justifiably, just, justifiably, that's not a word. The news right now on health data, security issues, privacy issues. I think the informed consent conversation is actually a really important one when it comes to research and participation and the use of medical data.

So we should definitely have a conversation on that near and dear to my heart too.

Karen Wernli (41:37.833)
I I I would be happy to because I've become such a big fan of the structure of this trial for interventions that meet the criteria. Low burden, low risk, you know, communication type strategies. This isn't appropriate if you want people to take medications, for example, drugs for the first time. Not appropriate.

The Patient from Hell (41:49.198)
Hmm. Yeah.

The Patient from Hell (42:05.134)
I really like it actually. No, no, I really like it because it sounds like a lot of stuff in the world of like appointment reminders, clinical workflow and as to when you get the like PDF overview of your disease, the reminders for when to ping your doc about it. It sounds like it's, it's in that world and that feels very.

Karen Wernli (42:17.513)
Right.

The Patient from Hell (42:35.662)
Practical, almost like the quality of, what's the word? The, there's a, I read we sometimes have a waiver, right? On quality of equipment. QI, yeah, QI waivers. So it almost sounds like it's in that vein, but not exactly, but the entire study is designed with keeping some amount of that in mind.

Karen Wernli (42:42.793)
TMI like QI.

Karen Wernli (42:54.441)
I think that that's intended to be the point because if you want to make system change, you need to understand how it's going to impact at the system level. Right? How you identify people have to happen at the system level. How you deliver the interventions have to happen at the system level. And so it's less about like, is this intervention working? And more about how do these interventions work when we make this system

change.

The Patient from Hell (43:25.838)
Okay, I learned so much. I always learn so much in our conversations. I'm going to try summarizing because we really did go everywhere today. We went everywhere today. Okay, so summary number one, my favorite, sorry, personal favorite, breast density. There are four types. Who knew? ABCDE, ABCD, that's four. And if...

Karen Wernli (43:37.161)
like all of the things.

The Patient from Hell (43:54.254)
Guidelines do say that if you have high dense breasts, you may be eligible for advanced imaging. The second thing I took away was the use of decision quality as a measure to understand patient perception on the quality of decisions being made. And then we went into study design principles, both retrospective, and then we ended up in pragmatic trial design as an option that is available today

for things that are low risk and really targeted at system improvements. Anything you want to add to that?

Karen Wernli (44:28.041)
Yes.

Karen Wernli (44:32.617)
No, no.

The Patient from Hell (44:36.046)
Karen, this is always, as usual, been such a pleasure. I love connecting with you. The next time we do this, I want to know what your art group thought of a black and white oil and canvas painting. I wonder if there are others out there who do that. Yeah, otherwise you may be the pioneer here. Just saying.

Karen Wernli (44:49.545)
We'll have to research that.

Mmm. Unclear. Unclear.

The Patient from Hell (44:56.782)
That's our hypothesis that we're going to end this podcast with.

Karen Wernli (45:00.009)
Yeah.

The Patient from Hell (45:04.046)
Thank you for being back on this show. I really appreciate it.

Karen Wernli (45:07.433)
Thank you for having me and I can't wait to come back.