#376 - 💡 Rethinking Phototherapy – Drafting the New AAP Guidelines with Dr. Alex Kemper

Hello friends 👋

In this episode of The Incubator Podcast, Ben and Daphna sit down with Dr. Alex Kemper, Division Chief of Primary Care Pediatrics at Nationwide Children’s Hospital and Editor-in-Chief of Pediatrics. Dr. Kemper served as chair of the American Academy of Pediatrics subcommittee that authored the 2022 revision of the neonatal hyperbilirubinemia guidelines.

Together, they explore the motivations behind revisiting the 2004 guideline, the major changes introduced, and how these revisions are shaping clinical care. Dr. Kemper explains why treatment thresholds for phototherapy were raised, the careful balance between avoiding unnecessary interventions and preventing kernicterus, and the rationale for moving away from the risk stratification nomogram. The discussion highlights phototherapy as an effective but not benign therapy—one that can disrupt bonding, prolong hospitalization, and create family stress when overused.

Listeners will gain insight into the complexities of evidence review, the challenges of consensus-building over eight years of work, and the importance of shared decision-making and reliable follow-up after discharge. This conversation not only demystifies the new guidelines but also reframes the way clinicians think about jaundice management, risk stratification, and the broader impact on families.

Link to episode on youtube: https://youtu.be/Xny3396AvO4

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Short Bio: Alex R. Kemper, M.D., M.P.H., M.S., is the Division Chief of Primary Care Pediatrics at Nationwide Children’s Hospital, Nationwide Foundation Chair in Innovative Pediatric Care, and Professor of Pediatrics at the Ohio State University College of Medicine. He serves as editor-in-chief of Pediatrics, the flagship journal of the American Academy of Pediatrics.  Dr. Kemper completed his pediatric residency training at Duke University followed by combined fellowship training in health services research and medical informatics with residency training in preventive medicine at the University of North Carolina.  His research focuses on preventive services in the primary care practice setting.  Dr. Kemper is a former member of the US Preventive Services Task Force and served as Chair of the Evidence Review Group for the Advisory Committee on Heritable Disorders in Newborns and Children.  Dr. Kemper also served as the Chair of the subcommittee that revised the American Academy of Pediatrics guidelines for the management of neonatal hyperbilirubinemia.

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The article covered on today’s episode of the podcast can be found here 👇

Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation.

Kemper AR, Newman TB, Slaughter JL, Maisels MJ, Watchko JF, Downs SM, Grout RW, Bundy DG, Stark AR, Bogen DL, Holmes AV, Feldman-Winter LB, Bhutani VK, Brown SR, Maradiaga Panayotti GM, Okechukwu K, Rappo PD, Russell TL.Pediatrics. 2022 Sep 1;150(3):e2022058859. doi: 10.1542/peds.2022-058859.PMID: 35927462

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The transcript of today's episode can be found below 👇

Ben Courchia MD (00:00.632)

Hello everybody. Welcome back to the Incubator podcast. We are back today for a special interview. Daphna is in the studio with me. Daphna, good morning. We are joined today by Dr. Alex Kemper. Alex, welcome to the podcast.

Daphna Barbeau (00:06.911)

Good morning, everybody.

Alex Kemper (00:13.603)

Thank you. So excited to be here. And Daphna, Ben, I know we're going to have a great conversation this morning.

Ben Courchia MD (00:19.744)

I think so too. For people who shamefully do not know who you are, you are the division chief of primary care pediatrics at Nationwide Children's Hospital, Nationwide Foundation chair in innovative pediatric care and professor of pediatrics at The Ohio State University College of Medicine. You serve as, I would say, the newly minted editor-in-chief of Pediatrics. Is that correct? Congratulations on that. You completed your pediatric residency at Duke University.

Alex Kemper (00:43.033)

That is 100% correct. Thank you.

Ben Courchia MD (00:49.326)

Followed by a combined fellowship training in health services research and medical informatics with residency training in preventive medicine at the University of North Carolina. Your research focuses on preventive services in the primary care practice setting. You're a former member of the US Preventive Services Task Force and you've served as chair of the evidence review group for the advisory committee on heritable disorders in newborns and children. You also served as the chair of the subcommittee that revised the American Academy of Pediatrics Guidelines for the Management of Neonatal Hyperbilirubinemia, which is one of the reasons why we would like to speak with you today. I guess, my God.

Daphna Barbeau (01:25.291)

So you've been busy.

Ben Courchia MD (01:30.19)

I guess the question that is a good place for us to start, Alex, is hyperbilirubinemia is mentioned in these new 2022 guidelines, right. It remains one of the most common conditions managed in the newborn period. It is something that medical students are trained on. Kernicterus remains rare, but continues to be reported. What is the motivation to go after these 2004 guidelines and come up with a revision? What was the incentive to even begin the project?

Alex Kemper (02:05.327)

Well, I think there's several answers to that question. One is just as policy that the American Academy of Pediatrics has is that it regularly revises all of its guidelines, looking for the best available evidence and making sure that the guidance that it's giving to clinicians is still the right thing to do. And so this was a planned revision, but I think it was also an opportunity to clarify a lot of questions. So there were questions that came up when we began looking at the previous guidelines about things like the role of routine screening of bilirubin before babies get discharged. There were questions around how to best use the risk-based nomogram that was in previous versions. And then there's always been questions about the threshold for phototherapy and exchange transfusion. And so, this revision gave us an opportunity to think more about those kinds of questions. And then as a general pediatrician, one of my goals was to try to simplify the guidelines as best we can. That helps avoid medical error, makes the guidelines easier to follow, makes things more transparent. And as part of the simplification process, I want to make sure that we were being appropriately deferential to the clinicians who are taking care of the babies so that when the evidence wasn't very strong, that we were clear about where options could be made using things like informed decision making between the clinician and the families. So that's sort of the thinking that went into the revision.

Ben Courchia MD (03:52.942)

Yeah, and I think that the new guidelines were welcomed by the community. I think that it's been quite impressive to see how quickly these were implemented by clinicians, both pediatricians and neonatologists. And I believe that one of the most striking changes from the 2004 guideline has been that the thresholds for treatment of hyperbilirubinemia were raised, I would say significantly. And what was striking in the substantiation of that change in the 2022 guidelines was that it seemed that you guys were quoting a lot of evidence that said we've realized that we really don't need to intervene until these levels are quite, quite high. And that even with that, the risks of severe neurological morbidities like kernicterus are, we're still far away from these. And so it was kind of surprising to hear that we had a lot of room to go up on these thresholds that we previously did not realize.

Alex Kemper (04:56.247)

That's exactly right. And figuring out where to put the thresholds really consumed, I would say, like years of conversation. And the reason I say that is we certainly know that there are levels of hazardous hyperbilirubinemia that are associated with developing kernicterus, right? But where exactly is that threshold where the risk-benefit of treatment sort of switches? Where does it really make sense to begin treatment? And when you think about the issues at hand, right, you have babies of varying gestational age, babies with different risk factors for developing hyperbilirubinemia or having what we refer to in the document as hyperbilirubinemia and neurotoxicity risk factors. There are a lot of variables in here. And so, it was really hard to figure out exactly where to draw the line, right? Like ideally you would want to do some sort of risk-based analysis at each threshold, looking at all the variables that we talked about. Well, that's obviously not possible, right? So we had to make informed decisions based on the best available evidence. And I'll tell you that there were some people in the committee who thought that we ought to go higher and...

Ben Courchia MD (06:21.793)

Really?

Alex Kemper (06:23.555)

We were able to look at some data. For example, we had access to data from Kaiser Permanente in Northern California. So we could see and model out what might happen as you change the threshold. So the thresholds went up by one or two milligrams per deciliter, sort of depending upon gestational age and risk factors and those kinds of things. But that's about the order of magnitude of the change. But what I can tell you is that's a substantial drop in the babies that need phototherapy. But there was a lot of discussion and a lot of thought that went into that.

Daphna Barbeau (06:58.303)

Mm-hmm.

Daphna Barbeau (07:06.079)

I love that. I'm actually, I'm tickled to hear that higher thresholds were being considered. Because I think this was a stark change and a little bit of a challenge, you know, for our community, you know, and in our unit. I mean, we changed practice right away, but it was kind of like, "This is a baby I normally would have started phototherapy on and we're not doing it." And so I know you've gotten a lot of feedback. You get a lot of questions and emails. How do you feel like the community has received the new thresholds and have they been able to really introduce it into practice?

Alex Kemper (07:46.605)

You know, I was nervous as the guidelines came out because there were a lot of changes, right? We got rid of the risk-based nomogram, which some people refer to as the Bhutani nomogram. We changed the thresholds. We introduced some new terms. What I can tell you is because we had this, you know, eight-year period in developing the guidelines is that we were able to work with a lot of partners and really understand what it would take to put things into practice. We were also able to work with representatives from a lot of the electronic medical record vendors, right, to help them put in the new thresholds as well after the guidelines came out. And then tied to this whole thing, and I have to give the American Academy of Pediatrics a lot of credit for this, is they put together a quality improvement project that involved lots of different hospitals, multiple hospitals for safe implementation of the guidelines, looking at a lot of the different safety measures. And I can tell you that you asked the question, you know, "What's the experience been like?" And I can tell you that the implementation appears to have been very successful. And so there have been two sort of publications around that. There's one in Pediatrics by Watchko and Stewart, which was the publication that the AAP did. I think it involved, I think it was around 30 hospitals. And they reported the changes during the implementation period. It was very successful. There's been a separate analysis from the Pediatric Health Information System database that looked independently at this issue. Also showing that the guidelines were implemented safely with a reduction in phototherapy treatment along with a significant reduction in hospital transfers due to hyperbilirubinemia. So there's a couple of papers out there on that. A lot of hard work has been put in, not just by the AAP but, you know, all the different community advocates, partners, pediatricians, neonatologists, you name it. So I think the reception has been really good. I've gotten a lot of feedback. You know, everybody complains about the stuff they don't like.

Ben Courchia MD (10:06.53)

Always!

Alex Kemper (10:07.651)

But I haven't gotten very many complaints, right? So that's, I think, a good sign. And the feedback that I have gotten has been very positive, particularly on the routine screening. That's really become the big selling point for a lot of people.

Ben Courchia MD (10:25.772)

That's fantastic. And Alex, I wanted to follow up on the question that you raised about the evidence review, because we were struck when reading through the document, which I think for people who haven't looked at it in addition to the manuscript, there's a really robust technical report that goes through the evidence that was reviewed. And it's in the technical report that we were really able to appreciate how different some of the databases are when it comes to reporting kernicterus, especially in the United States. Right?

Alex Kemper (10:54.829)

Yeah.

Ben Courchia MD (10:55.406)

And you've made the point that kernicterus is rare. You mentioned that earlier. However, I'm curious, what do you guys consider to be significant evidence when you are assessing the rates of kernicterus? Is this case reports? Is this really prospective databases? Because in this day and age, especially in the setting of rare events like you said, it is a bit challenging to prove that the guidelines, changes made in guidelines, may have an effect on the rate of kernicterus because of how rare it is. So I'm curious about that and then about the evidence based on some of the robust databases in the US that don't report much kernicterus at all.

Alex Kemper (11:38.765)

Right. So let's talk first about where a lot of the data came from in terms of trying to understand the rates at which babies develop kernicterus. And the largest database and the most robust one is the National Registry from Denmark. So in Denmark, they have this universal reporting of cases of kernicterus. And their database goes back to, I believe, the early 1990s. And so these are all babies that are born in Denmark and have kernicterus. And the nice thing is that they can track all the babies that were born during that period. They have information on things like the newborn screening, which includes total serum bilirubin. And because their database is big, and they have cases, they can do modeling to look at where risks really seem to start. And this is one of the reasons why I love this kind of research. So because they have this universal database, the Danish study was actually able to do a dose-response analysis. So as the bilirubin level goes up, what happens to the risk for adverse outcomes? And that is a way to look at causality that has its origins dating back to the 1960s with work done around cigarette smoking. So like, are you more likely to get cancer the more you smoke? Right? It's that same construct. So you can use that to try to figure out where does the risk start. And that's one of the things that was very informative for setting the thresholds, is looking at that data in the Danish registry. We had access to the Kaiser Permanente data from Northern California that also helped with our thinking around this. So you might be thinking, "Okay, so we have this great registry in Denmark. Why don't we have a registry in the United States?" There are really two reasons. One is just there's no federal mandate to create a registry, which I think we should have. But the other part of it is actually people think about privacy differently in the United States than they do in Denmark. And so in the past, whenever people have gone out and tried to create voluntary registries, families are often resistant to putting themselves in that kind of a situation. And so we just have not been able to create that registry, which is unfortunate. The other challenge is that defining kernicterus is difficult, right? And so there are different degrees of severity. There's what's referred to as acute bilirubin encephalopathy. And then as that progresses, you can have more severe chronic forms, which would typically be what people think of as sort of chronic kernicterus. And so defining who has it and who doesn't can be very difficult.

Daphna Barbeau (14:39.465)

And that leads me to actually, I wanted to ask you about some other risk factors. So we know that most babies who develop kernicterus, not all of them have hyperbilirubinemia, right? And so can you talk to us a little bit about your thoughts about other risk factors for kernicterus, thinking specifically about hyperbilirubinemia and neurotoxicity risk factors? How did your team go about thinking about babies who are at risk?

Alex Kemper (15:12.439)

So I think this is a really important question that you raise, and it was one of the hardest things for the committee to work through. In this technical report, there's a section that goes through and looks at different risk factors. And so there are some risk factors, for example, things like a history of a sibling with significant hyperbilirubinemia, where there's a lot more data, right? And those are ones where we were able to say pretty confidently, "These are associated with hyperbilirubinemia." But there are other things that are harder to know. And what I can tell you is that one of the lessons that we learned from this is the importance of not just assuming something is a risk factor, but really trying to gather the evidence. And so what I can tell you is we looked, as I said, at things like sibling history, maternal diabetes, East Asian race and ethnicity, breastfeeding of course, those kinds of things. But where the committee really struggled was around this question of, "What are the factors that might make a baby more likely to develop kernicterus at a lower level of serum bilirubin?" And those are what we refer to as hyperbilirubinemia and neurotoxicity risk factors, or HNRFs. And those are things that may affect the way that bilirubin crosses the blood-brain barrier or the susceptibility of the neurons in the brain to being affected by bilirubin. And so examples of that would be things like sepsis, significant clinical instability, and things like that. And for those, the data is much more limited. And so there, we really had to think about what was most likely given the biological mechanisms of how bilirubin gets into the brain, as well as looking at case reports and small case series of babies with kernicterus to try to figure out what seem to be common features. So that's how we came to that. And I will tell you that for babies with those hyperbilirubinemia and neurotoxicity risk factors, we have a much lower threshold for phototherapy because we want to be much more conservative in how we're treating those babies. And so, you know, one of the points of controversy for the committee was things like G6PD deficiency. So should that be a neurotoxicity risk factor? Or is it really just a risk factor for hyperbilirubinemia? And we landed on, it's really a risk factor for developing high bilirubin, but we don't have strong evidence that at the same level it's more likely to cause toxicity. But that was an area where there were some people on the committee who felt strongly one way or the other. And so we had to work through those issues over time.

Ben Courchia MD (18:03.096)

Yeah. And I think that the distinction is really important because at the end of the day, while we're talking about thresholds and we're talking about these hyperbilirubinemia and neurotoxicity risk factors, we're talking about treatment thresholds. But as you mentioned, there's some babies for which, even if they don't meet the threshold, their risk of developing hyperbilirubinemia may be such that you should be monitoring them much more closely. And so...

Alex Kemper (18:17.965)

Exactly.

Ben Courchia MD (18:31.576)

I think one of the most impactful points of the guidelines is this distinction and this understanding that some babies may not need treatment but still need very close follow-up.

Alex Kemper (18:42.497)

That's exactly right. And so one of the changes that was made in the guidelines is we identified these groups of babies who are at higher risk. And the recommendation is that they ought to be seen within 24 hours of discharge. And that's to help make sure that you catch those babies and intervene before they get into trouble. And I think that's a really important change. And the flip side of that is for babies who don't have those risk factors and whose bilirubin was low before they got discharged, you can actually space out that follow-up a little bit more, which I think is actually much more convenient for families. So I think that that's a win-win all around.

Ben Courchia MD (19:26.37)

Yeah. And I think that risk stratification is one of the innovations that really came out in these guidelines. I also, Alex, I wanted to ask you about something that you mentioned which is when you were quoting your thought process and you mentioned the way you guys were thinking about this and you said, "Where does it make sense to treat?" And I was wondering if you could speak to us a little bit about the potential harms of phototherapy. Because I think as we've become, as we're learning, that phototherapy, while relatively safe, it's not completely benign. Can you speak to us a little bit about that and how you guys thought about the potential harms of intervening?

Alex Kemper (20:04.343)

So there's actually a lot of harms associated with phototherapy, right? And so it's not that a baby's going to get hurt by being put under the lights. But the harms are really around separation of the baby from the mom, interference with feeding, interference with bonding. And when you think about, so there's going to be a subset of babies where the bilirubin's going to peak and come down irrespective of treatment. And so you really want to minimize how much you're intervening if the intervention is not necessary. There's also this concept of things like medical trauma that's associated with hospitalization. So I personally have received emails from parents who have shared their experiences with me where they get readmitted to the hospital. The baby's getting treated. And mom is off in a parent room somewhere sleeping, right? And so she's not able to stay with her baby. She's anxious. She is having trouble pumping breast milk. All of those things are very harmful. And so we really took those things into account, which is why we wanted to raise the phototherapy threshold. Because if you can avoid that separation and those consequences for families, that's beneficial.

Daphna Barbeau (21:33.439)

And you mentioned already the universal screening. Can you talk to us a little bit more about that because not every institution was doing universal screening, that bilirubin screen before discharge? What did the data say about universal screening and how did that come to be such an important part of the guidelines?

Alex Kemper (21:57.153)

So when you think about kernicterus and severe hyperbilirubinemia, what you find is that you have babies that look fine when they're getting discharged. But for whatever reason, whether it's feeding issues, whether it's an underlying condition they have, right, their bilirubin shoots up, and they get readmitted with very high bilirubin levels, sometimes requiring exchange transfusion, and sometimes with kernicterus. And so when you think about the interventions you could do to try to prevent that, one intervention is just measuring the bilirubin on everybody before discharge. And there's the hope that by doing that measurement, you can identify who's going to be at risk. And then you couple that with appropriate follow-up, and hopefully you intervene before things get out of control. And so there were two pieces of evidence that were very compelling to me. One is there were regional data from different places where they had looked at the impact of universal screening. And most of these studies all showed benefit. And they usually showed benefit around reduced hospital readmissions and fewer cases with very high bilirubin or what's referred to as hazardous hyperbilirubinemia. So there's that data. And then the second piece of data that was very compelling to me was the implementation study that the AAP did. So as part of the guideline rollout, we had this quality improvement project where different hospitals put in place universal screening. And they looked at what happened. And they found that there was about a 60% decrease in hospital readmissions for hyperbilirubinemia. So, you know, this is not a randomized controlled trial, which would be sort of the gold standard for evidence, but this is about as good as you can get in a real-world implementation study. And the fact that it was consistent with all the other data that had been previously published made it very compelling. So I would say the committee was very convinced that putting in place universal screening would be beneficial.

Ben Courchia MD (24:09.858)

And Alex, I wanted to follow up on an interesting point that was raised by, I believe, Dr. Newman and Dr. Wachko in some of the letters to the editor in response to the guidelines. They raised the point that while the increase in phototherapy threshold was data-driven and was substantiated by the data that you guys reviewed, the concern they raised is that, they said, "It's not clear to us that the discharge timing for these babies was also evidence-based." And they were mentioning, it seems to me, that they were trying to say that if you're raising the threshold, these babies are getting discharged home at risk for reaching these higher levels at home. And they were wondering whether or not the discharge time should be reevaluated in conjunction with these new thresholds. I was curious to hear what you think about their concerns.

Alex Kemper (25:07.109)

So I think it's an outstanding question that they raise. And I think that the way to think about that is through the routine screening. So we looked very carefully at the evidence around timing of discharge, and you can find no good data to suggest that a longer length of stay in the hospital is going to lead to better outcomes. However, that may be because of the increased frequency of follow-up that occurs with early discharge. Right? So there's a practice in place to accommodate for early discharge. And so by putting in place universal screening, you can appropriately risk-stratify babies for follow-up. And based on the evidence that I just described from the implementation project, it appears to be working very well. So I think that that's the way to reconcile those concerns. And I can tell you that, you know, some hospitals have policies where they keep babies longer in the hospital. And if that works for them, that's fine. But I don't think that there's evidence to suggest that that's necessary if you're doing the appropriate screening and follow-up.

Daphna Barbeau (26:29.747)

And that's all, I think, why it's so important to have really good systems in place for follow-up. You mentioned already about, you know, seeing patients back. But, I mean, do you have any other comments about that? I know, specifically for me, sometimes I worry about our Spanish-speaking families and communicating with them. And we know some families may not have access easily to come back, right, in 24 hours even. So do you have any thoughts about barriers to that good follow-up?

Alex Kemper (27:05.687)

I think you're raising a very, very important question around health disparities. And it's also something that I'm very concerned about. So when you think about what we put into the guidelines, there's the expectation that babies are going to get appropriate follow-up. And some of the things that, you know, help facilitate that is having the outreach to families to make sure that they know they're supposed to come back, that they have the resources, the transportation, that everything is in place. And so, you know, when I think about the guidelines, I often talk about the guidelines as one piece of a larger healthcare system that needs to work together. And so, you know, if your health system is not able to provide those supports around things like transportation or language services or whatever it may be, then the guidelines are not going to work as well. And I think that that's a real concern. It's something that...I think all of us need to be working toward addressing those issues. Unfortunately, I don't have a good answer for you on how to fix that other than to acknowledge that it is a problem. And I think that we all need to be advocating for the resources to help support families to make sure that they can get that follow-up care.

Ben Courchia MD (28:33.262)

Yeah, and we've definitely echoed that many times on the show, that even though these guidelines are fantastic, if you do not have the infrastructure to actually execute them properly, then they can be risky. And so I think that it's really important. And I think you've guys acknowledged that, that institutions that do not have the ability to follow up with these patients adequately, they should not be discharging these babies and expecting other people to catch these babies for them. So I think that that's a really important point.

Alex Kemper (29:01.869)

And I would add to that one other thing is that even before this revision, I think there was a sense that there was a lot of variability in how bilirubin was being managed. And I think that that was causing confusion for families and confusion for clinicians. And so one of the goals of these guidelines was to try to standardize care so that there's more consistency, not only within your institution, but across institutions. And I think that that's really important, particularly as you think about babies who might be transferring from one hospital to another.

Ben Courchia MD (29:40.664)

Right. Alex, I wanted to ask you, because we've spent a lot of time talking about the changes in the thresholds and the universal screening. In your mind, do you feel that down the line these thresholds that are now published in the 2022 guidelines could still increase or do you think we've reached sort of a ceiling and we are as high as we can probably safely go?

Alex Kemper (30:06.413)

So that's a fascinating question. Let me tell you a couple of things about that. One of the things that we didn't talk about that's not in the guidelines that has come up that is relevant to this, just want to make sure to put it out there, is that there's also a lot of variability from lab to lab around TSB. So we act like when we get a total serum bilirubin level back that this is like, you know, the exact value and it's being handed down from Mount Sinai, you know, and that this is like God's truth. But there is a huge amount of variability from lab to lab. And so when setting the threshold, you also have to think about that laboratory variation and maybe what you're getting isn't exactly right. And so that was built into things as well. So in the United States, we don't have a kernicterus registry, right? So there's no place where all cases get reported. But I mentioned before the American Academy of Pediatrics did that large quality improvement network. There have been some other secondary analyses that have been done from other data sources like the Pediatric Health Information System, which is a data set put together by the freestanding children's hospitals that have not found an increased risk of hazardous hyperbilirubinemia since the new guidelines have come out. Unfortunately, kernicterus is a rare event, but there's been no signal of increased kernicterus. We have a safe margin in terms of where the phototherapy and exchange transfusion thresholds have been set. I personally, it's always dangerous when you predict the future. It's kind of a fool's errand, but I suspect that the curves will probably stay where they are for those reasons. And, you know, even the small increase, the bump that we put in really had a dramatic effect on the number of babies that are getting phototherapy. I mean, who knows what the future is going to hold, but I suspect that the curves are probably going to stay where they are for the laboratory issues and the overall safety that we talked about.

Daphna Barbeau (39:53.951)

Hmm.

Daphna Barbeau (39:57.397)

Thank you. We've learned a lot about the guidelines, but we also wanted to inquire a little bit more about your expertise on, you know, the production of guidelines. And we've mentioned a few times about specifically how long this guideline took for something that, again, I think the community overall feels pretty comfortable with. And so I wonder, you know, what were really the sticking points, what were the hardest things to navigate, and what are your recommendations for people who are undertaking the work of creating, you know, clinical practice guidelines?

Alex Kemper (40:39.343)

There were a lot of challenges during the, while we were writing it. I think that the biggest issue is the one that we've spent the most time talking about in terms of where do you put the thresholds and how do you balance avoiding unnecessary treatment while not causing risk and the removal of the risk-based nomograms. That all took a lot of time. There was also a lot of discussion around issues like G6PD deficiency and how to consider G6PD deficiency. Trying to think about it. Okay. So, in terms of future recommendations for guidelines in general, I think that it's important to be clear about what you want the outcomes to be at the end. We were lucky in terms of we were very clear that we wanted to simplify things and decrease unnecessary treatment. I think that neonatal hyperbilirubinemia brings up so many issues in terms of having a terrible outcome if you don't treat things appropriately, combined with gaps in the evidence around where things are safe and where they're not safe. So I just think that that's what took most of the time and that members of the committee were very, very thoughtful about how to put things together. I have been involved in putting together a lot of other clinical practice guidelines. And this was really the one that took by far the longest. And yeah, there was this other thing that happened while we were working on it, which you might've read about in the papers, this pandemic, if you could remember that at all. So that certainly didn't help things either, but I thought that it was really important and there were many diverging opinions that we have consensus at the end of the day and I think it led to a better product. So, you know, most clinical guidelines fortunately will not take eight years, but you know, there was a lot of nuance to work through. One of the lessons that I learned in putting this together, which I wish I had thought about earlier on. So when I first began, I thought, "This is going to be easy because the guidelines are working and it's not really going to take very much to clean things up." And then of course, I got into the nuances we've talked about for the last half hour or so. I wish that we had included more parents up front. So as we completed the clinical practice guideline, I did actually reach out to parents and also advocates related to kernicterus to get their feedback. And they were very grateful for us putting in the routine bilirubin screen prior to discharge, because that's something that they had been advocating for for a long time. But it gave me a different perspective on the importance of shared decision making. And it also raised very complicated questions around G6PD deficiency, given that there's no easy way to test for G6PD deficiency when you would really like to know it, which is right there when the baby is in front of you. So the recommendation that I would give myself if I could travel back in time would be to have some of these parents serve on the committee from the start. And I can tell you that I've had lots of conversations with leadership at the AAP, and that's something that they're gonna be routinely doing moving forward. So I think that's great.

Ben Courchia MD (44:51.074)

Yeah, not just for this particular set of guidelines, for an approach. Yeah, yeah. I think that's definitely one of the biggest innovations in our collective opinion about this century of guidelines and approach to neonatal care. Alex, thank you very much. I was going to bring up the issue of having families. And I think it's critical that, as you mentioned, families were involved in the peer review process, but like you said, even involving them from the onset could be even more beneficial. So we really appreciate that perspective. We want to congratulate you again on an amazing paper, eight years worth of work. I mean, I don't think people realize it's more than most of us train for. So...

Alex Kemper (45:39.009)

Yeah, my hair went gray in the process.

Ben Courchia MD (45:44.248)

So that's definitely impressive. And we will link to, again, to the guideline in the episode Show Notes. Thank you again for spending this time with us today. And again, congratulations and best of luck on everything else.

Alex Kemper (45:56.227)

Well, thank you for your kind words, Ben and Daphna. Thank you for inviting me to your forum.

Ben Courchia MD (46:01.198)

Thank you.

Daphna Barbeau (46:01.471)

Our pleasure.