Clinical Neurology News

“How did we miss out on that?” “What?” my physician friend replied as we stood in line at the coffee cart. “Root cause. I mean, we invented this idea and now all these naturopaths and functional medicine quacks are gettin’ rich off it.” “Take it easy,” he says. “Just order a coffee.”

It’s hard not to be indignant. I had a morning clinic with three patients insisting I find the “root cause” of their problem. Now, if one had flagellate dermatitis after eating Asian mushroom soup, I’d have said “Root cause? Shiitake mushrooms!” and walked out like Costanza in Seinfeld, “All right, that’s it for me! Be good everybody!”

Alas no. They had perioral dermatitis, alopecia areata, eczema – no satisfying “roots” for walk-off answers.

There is a universal desire to find the proximal cause for problems. Patients often want to know it so that we address the root of their trouble and not just cut off the branches. This is deeply gratifying for those who want not only to know why, but also to have agency in how to control their disease. For example, if they believe the root cause of perioral dermatitis was excess yeast, then eating a “candida diet’’ should do the trick! Food sensitivities, hormones, and heavy metals round out the top suspects that root cause patients want to talk about.

Of course, patients have been asking about this for a long time, but lately, the root cause visit seems to be on trend. Check out any hip primary care start-up such as One Medical or any hot direct-to-consumer virtual offering such as ParsleyHealth and you will see root-cause everywhere. Our patients are expecting us to address it, or it seems they will find someone cooler who will.

Yet, it wasn’t the slick marketing team at ParsleyHeath who invented the “root cause doctor visit.” We did. It’s an idea that started with our Greek physician ancestors. Breaking from the diviners and priests, we were the first “naturalists” positing that there was a natural, not a divine cause for illness. The cardinal concept in the Hippocratic Corpus was that health was an equilibrium and illness an imbalance. They didn’t have dehydroepiandrosterone tests or mercury levels, but did have bodily fluids. Yellow bile, black bile, blood, and phlegm, were the root of all root causes. A physician simply had to identify which was in excess or deficient and fix that to cure the disease. Interestingly, the word “diagnosis” appears only once in the Corpus. The word “Diagignoskein” appears occasionally but this describes studying thoroughly, not naming a diagnosis as we understand it.

Advances in chemistry in the 17th century meant physicians could add new theories, and new root causes. Now alkaline or other chemical elixirs were added to cure at the source. Since there was no verifiable evidence to prove causes, theories were adopted to provide some rational direction to treatment. In the 18th century, physicians such as Dr. Benjamin Rush, one of the original faculty at the University of Pennsylvania school of medicine, taught that spasms of the arteries were the root cause of illnesses. “Heroic” treatments such as extreme bloodletting were the cure. (Note, those patients who survived us kept coming back to us for more).

Scientific knowledge and diagnostic technologies led to more and more complex and abstruse causes. Yet, as we became more precise and effective, our explanations became less satisfying to our patients. I can diagnose and readily treat perioral dermatitis, yet I’m hard pressed to give an answer to its root cause. “Root cause? Yes. Just apply this pimecrolimus cream for a couple of weeks and it’ll be better! All right, that’s it for me! Be good everybody!”

You’ll have to do better, George.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com

“How did we miss out on that?” “What?” my physician friend replied as we stood in line at the coffee cart. “Root cause. I mean, we invented this idea and now all these naturopaths and functional medicine quacks are gettin’ rich off it.” “Take it easy,” he says. “Just order a coffee.”

It’s hard not to be indignant. I had a morning clinic with three patients insisting I find the “root cause” of their problem. Now, if one had flagellate dermatitis after eating Asian mushroom soup, I’d have said “Root cause? Shiitake mushrooms!” and walked out like Costanza in Seinfeld, “All right, that’s it for me! Be good everybody!”

Alas no. They had perioral dermatitis, alopecia areata, eczema – no satisfying “roots” for walk-off answers.

There is a universal desire to find the proximal cause for problems. Patients often want to know it so that we address the root of their trouble and not just cut off the branches. This is deeply gratifying for those who want not only to know why, but also to have agency in how to control their disease. For example, if they believe the root cause of perioral dermatitis was excess yeast, then eating a “candida diet’’ should do the trick! Food sensitivities, hormones, and heavy metals round out the top suspects that root cause patients want to talk about.

Of course, patients have been asking about this for a long time, but lately, the root cause visit seems to be on trend. Check out any hip primary care start-up such as One Medical or any hot direct-to-consumer virtual offering such as ParsleyHealth and you will see root-cause everywhere. Our patients are expecting us to address it, or it seems they will find someone cooler who will.

Yet, it wasn’t the slick marketing team at ParsleyHeath who invented the “root cause doctor visit.” We did. It’s an idea that started with our Greek physician ancestors. Breaking from the diviners and priests, we were the first “naturalists” positing that there was a natural, not a divine cause for illness. The cardinal concept in the Hippocratic Corpus was that health was an equilibrium and illness an imbalance. They didn’t have dehydroepiandrosterone tests or mercury levels, but did have bodily fluids. Yellow bile, black bile, blood, and phlegm, were the root of all root causes. A physician simply had to identify which was in excess or deficient and fix that to cure the disease. Interestingly, the word “diagnosis” appears only once in the Corpus. The word “Diagignoskein” appears occasionally but this describes studying thoroughly, not naming a diagnosis as we understand it.

Advances in chemistry in the 17th century meant physicians could add new theories, and new root causes. Now alkaline or other chemical elixirs were added to cure at the source. Since there was no verifiable evidence to prove causes, theories were adopted to provide some rational direction to treatment. In the 18th century, physicians such as Dr. Benjamin Rush, one of the original faculty at the University of Pennsylvania school of medicine, taught that spasms of the arteries were the root cause of illnesses. “Heroic” treatments such as extreme bloodletting were the cure. (Note, those patients who survived us kept coming back to us for more).

Scientific knowledge and diagnostic technologies led to more and more complex and abstruse causes. Yet, as we became more precise and effective, our explanations became less satisfying to our patients. I can diagnose and readily treat perioral dermatitis, yet I’m hard pressed to give an answer to its root cause. “Root cause? Yes. Just apply this pimecrolimus cream for a couple of weeks and it’ll be better! All right, that’s it for me! Be good everybody!”

You’ll have to do better, George.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com

“How did we miss out on that?” “What?” my physician friend replied as we stood in line at the coffee cart. “Root cause. I mean, we invented this idea and now all these naturopaths and functional medicine quacks are gettin’ rich off it.” “Take it easy,” he says. “Just order a coffee.”

It’s hard not to be indignant. I had a morning clinic with three patients insisting I find the “root cause” of their problem. Now, if one had flagellate dermatitis after eating Asian mushroom soup, I’d have said “Root cause? Shiitake mushrooms!” and walked out like Costanza in Seinfeld, “All right, that’s it for me! Be good everybody!”

Alas no. They had perioral dermatitis, alopecia areata, eczema – no satisfying “roots” for walk-off answers.

There is a universal desire to find the proximal cause for problems. Patients often want to know it so that we address the root of their trouble and not just cut off the branches. This is deeply gratifying for those who want not only to know why, but also to have agency in how to control their disease. For example, if they believe the root cause of perioral dermatitis was excess yeast, then eating a “candida diet’’ should do the trick! Food sensitivities, hormones, and heavy metals round out the top suspects that root cause patients want to talk about.

Of course, patients have been asking about this for a long time, but lately, the root cause visit seems to be on trend. Check out any hip primary care start-up such as One Medical or any hot direct-to-consumer virtual offering such as ParsleyHealth and you will see root-cause everywhere. Our patients are expecting us to address it, or it seems they will find someone cooler who will.

Yet, it wasn’t the slick marketing team at ParsleyHeath who invented the “root cause doctor visit.” We did. It’s an idea that started with our Greek physician ancestors. Breaking from the diviners and priests, we were the first “naturalists” positing that there was a natural, not a divine cause for illness. The cardinal concept in the Hippocratic Corpus was that health was an equilibrium and illness an imbalance. They didn’t have dehydroepiandrosterone tests or mercury levels, but did have bodily fluids. Yellow bile, black bile, blood, and phlegm, were the root of all root causes. A physician simply had to identify which was in excess or deficient and fix that to cure the disease. Interestingly, the word “diagnosis” appears only once in the Corpus. The word “Diagignoskein” appears occasionally but this describes studying thoroughly, not naming a diagnosis as we understand it.

Advances in chemistry in the 17th century meant physicians could add new theories, and new root causes. Now alkaline or other chemical elixirs were added to cure at the source. Since there was no verifiable evidence to prove causes, theories were adopted to provide some rational direction to treatment. In the 18th century, physicians such as Dr. Benjamin Rush, one of the original faculty at the University of Pennsylvania school of medicine, taught that spasms of the arteries were the root cause of illnesses. “Heroic” treatments such as extreme bloodletting were the cure. (Note, those patients who survived us kept coming back to us for more).

Scientific knowledge and diagnostic technologies led to more and more complex and abstruse causes. Yet, as we became more precise and effective, our explanations became less satisfying to our patients. I can diagnose and readily treat perioral dermatitis, yet I’m hard pressed to give an answer to its root cause. “Root cause? Yes. Just apply this pimecrolimus cream for a couple of weeks and it’ll be better! All right, that’s it for me! Be good everybody!”

You’ll have to do better, George.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com

Blogging is a great way to capture the attention of new patients and anyone interested in the diagnoses and procedures you specialize in. Health information is one of the most popular topics people search for online. Starting a physician blog can provide your practice with promotional and marketing benefits that you may have a difficult time finding elsewhere. A blog can be an effective way to drive traffic to your website, establish yourself as an authority or expert in a particular area, and stay on the radar with your patients. However, there are a few things you should think about before you start.

Start by determining what you want to accomplish. Do you want to reach quantitative milestones, like a certain number of followers, or are you looking to increase your website traffic from potential patients? One goal will probably be to augment the health knowledge of your patients. Decide early on what your benchmarks will be and how you will track them.

Next, determine who your potential readers are. Initially, most will probably be local (your existing patient base and their family and friends), but your audience may expand geographically as your blog gains in popularity.

By now, you probably realize that blogging will require a significant commitment, over and above the time needed to write the content. Decide whether you have the time and energy to take this on yourself, or whether help will be needed. Ideally, you should have one person in charge of all your social media efforts, so that everything is consistent and has the same voice. That person can be in-house, or you can outsource to any of the many companies that administer blogs and other media functions. (As always, I have no financial interest in any company or service mentioned in this column.)

The advantage of hiring an outside administrator is that a professionally designed blog will be far more attractive and polished than anything you could build yourself. Furthermore, an experienced designer will employ “search engine optimization” (SEO), meaning that content will be created using key words and phrases that will make it readily visible to search engine users.

You can leave design and SEO to the pros, but don’t delegate the content itself; as captain of the ship you are responsible for all the facts and opinions on your blog. You may not be up to writing everything yourself, but anything you don’t write personally needs to be scrutinized by you personally to make sure that it is factually accurate and reflects your personal view. And remember that, once it’s online, it’s online forever; consider the ramifications of anything you post on any site – yours or others – before hitting the “send” button. “The most damaging item about you,” one consultant told me, “could well be something you post yourself.” Just ask any of several prominent politicians who have famously sabotaged their own careers online.

That said, don’t be shy about creating content. Patients appreciate factual information, but they value your opinions too. Give people content that will be of interest or benefit to them. This can include health-related tips, reminders, suggestions, whatever. If they are interested in it, they will keep reading and may even share it with others. You should also write about subjects – medical and otherwise – that interest you personally. If you have expertise in a particular field, be sure to write about that.

Your practice is a local business, so localize your blog to attract people from your area. Be sure to include local city keywords in your writing. You may also want to post about local events in which your practice is involved.

Try to avoid political diatribes. While most physicians have strong political opinions, and some are not shy about expressing them, there are many venues that are more appropriate for those discussions than medical blogs. Also avoid outright sales pitches. It’s fine to describe procedures that you offer, but aggressive solicitation will only turn readers off.

Keep any medical advice in general terms; don’t use any specific examples that might make a patient identifiable and generate a HIPAA violation.

If you are having trouble growing your readership, use your practice’s Facebook page to push blog updates into patients’ feeds. Additionally, track Twitter hashtags that are relevant to your practice, and use them to find existing online communities with an interest in your blog’s topics. 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

*This article was updated 10/17/2022.

Blogging is a great way to capture the attention of new patients and anyone interested in the diagnoses and procedures you specialize in. Health information is one of the most popular topics people search for online. Starting a physician blog can provide your practice with promotional and marketing benefits that you may have a difficult time finding elsewhere. A blog can be an effective way to drive traffic to your website, establish yourself as an authority or expert in a particular area, and stay on the radar with your patients. However, there are a few things you should think about before you start.

Start by determining what you want to accomplish. Do you want to reach quantitative milestones, like a certain number of followers, or are you looking to increase your website traffic from potential patients? One goal will probably be to augment the health knowledge of your patients. Decide early on what your benchmarks will be and how you will track them.

Next, determine who your potential readers are. Initially, most will probably be local (your existing patient base and their family and friends), but your audience may expand geographically as your blog gains in popularity.

By now, you probably realize that blogging will require a significant commitment, over and above the time needed to write the content. Decide whether you have the time and energy to take this on yourself, or whether help will be needed. Ideally, you should have one person in charge of all your social media efforts, so that everything is consistent and has the same voice. That person can be in-house, or you can outsource to any of the many companies that administer blogs and other media functions. (As always, I have no financial interest in any company or service mentioned in this column.)

The advantage of hiring an outside administrator is that a professionally designed blog will be far more attractive and polished than anything you could build yourself. Furthermore, an experienced designer will employ “search engine optimization” (SEO), meaning that content will be created using key words and phrases that will make it readily visible to search engine users.

You can leave design and SEO to the pros, but don’t delegate the content itself; as captain of the ship you are responsible for all the facts and opinions on your blog. You may not be up to writing everything yourself, but anything you don’t write personally needs to be scrutinized by you personally to make sure that it is factually accurate and reflects your personal view. And remember that, once it’s online, it’s online forever; consider the ramifications of anything you post on any site – yours or others – before hitting the “send” button. “The most damaging item about you,” one consultant told me, “could well be something you post yourself.” Just ask any of several prominent politicians who have famously sabotaged their own careers online.

That said, don’t be shy about creating content. Patients appreciate factual information, but they value your opinions too. Give people content that will be of interest or benefit to them. This can include health-related tips, reminders, suggestions, whatever. If they are interested in it, they will keep reading and may even share it with others. You should also write about subjects – medical and otherwise – that interest you personally. If you have expertise in a particular field, be sure to write about that.

Your practice is a local business, so localize your blog to attract people from your area. Be sure to include local city keywords in your writing. You may also want to post about local events in which your practice is involved.

Try to avoid political diatribes. While most physicians have strong political opinions, and some are not shy about expressing them, there are many venues that are more appropriate for those discussions than medical blogs. Also avoid outright sales pitches. It’s fine to describe procedures that you offer, but aggressive solicitation will only turn readers off.

Keep any medical advice in general terms; don’t use any specific examples that might make a patient identifiable and generate a HIPAA violation.

If you are having trouble growing your readership, use your practice’s Facebook page to push blog updates into patients’ feeds. Additionally, track Twitter hashtags that are relevant to your practice, and use them to find existing online communities with an interest in your blog’s topics. 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

*This article was updated 10/17/2022.

Blogging is a great way to capture the attention of new patients and anyone interested in the diagnoses and procedures you specialize in. Health information is one of the most popular topics people search for online. Starting a physician blog can provide your practice with promotional and marketing benefits that you may have a difficult time finding elsewhere. A blog can be an effective way to drive traffic to your website, establish yourself as an authority or expert in a particular area, and stay on the radar with your patients. However, there are a few things you should think about before you start.

Start by determining what you want to accomplish. Do you want to reach quantitative milestones, like a certain number of followers, or are you looking to increase your website traffic from potential patients? One goal will probably be to augment the health knowledge of your patients. Decide early on what your benchmarks will be and how you will track them.

Next, determine who your potential readers are. Initially, most will probably be local (your existing patient base and their family and friends), but your audience may expand geographically as your blog gains in popularity.

By now, you probably realize that blogging will require a significant commitment, over and above the time needed to write the content. Decide whether you have the time and energy to take this on yourself, or whether help will be needed. Ideally, you should have one person in charge of all your social media efforts, so that everything is consistent and has the same voice. That person can be in-house, or you can outsource to any of the many companies that administer blogs and other media functions. (As always, I have no financial interest in any company or service mentioned in this column.)

The advantage of hiring an outside administrator is that a professionally designed blog will be far more attractive and polished than anything you could build yourself. Furthermore, an experienced designer will employ “search engine optimization” (SEO), meaning that content will be created using key words and phrases that will make it readily visible to search engine users.

You can leave design and SEO to the pros, but don’t delegate the content itself; as captain of the ship you are responsible for all the facts and opinions on your blog. You may not be up to writing everything yourself, but anything you don’t write personally needs to be scrutinized by you personally to make sure that it is factually accurate and reflects your personal view. And remember that, once it’s online, it’s online forever; consider the ramifications of anything you post on any site – yours or others – before hitting the “send” button. “The most damaging item about you,” one consultant told me, “could well be something you post yourself.” Just ask any of several prominent politicians who have famously sabotaged their own careers online.

That said, don’t be shy about creating content. Patients appreciate factual information, but they value your opinions too. Give people content that will be of interest or benefit to them. This can include health-related tips, reminders, suggestions, whatever. If they are interested in it, they will keep reading and may even share it with others. You should also write about subjects – medical and otherwise – that interest you personally. If you have expertise in a particular field, be sure to write about that.

Your practice is a local business, so localize your blog to attract people from your area. Be sure to include local city keywords in your writing. You may also want to post about local events in which your practice is involved.

Try to avoid political diatribes. While most physicians have strong political opinions, and some are not shy about expressing them, there are many venues that are more appropriate for those discussions than medical blogs. Also avoid outright sales pitches. It’s fine to describe procedures that you offer, but aggressive solicitation will only turn readers off.

Keep any medical advice in general terms; don’t use any specific examples that might make a patient identifiable and generate a HIPAA violation.

If you are having trouble growing your readership, use your practice’s Facebook page to push blog updates into patients’ feeds. Additionally, track Twitter hashtags that are relevant to your practice, and use them to find existing online communities with an interest in your blog’s topics. 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

*This article was updated 10/17/2022.

This article was originally published Oct. 8 on Medscape Editor-In-Chief Eric Topol’s “Ground Truths” column on Substack. 

A recent piece in The Economist about masks, and how at least half of the people in Japan are planning to continue to use masks indefinitely (where there was never a mandate), prompts a deeper look into what has been the secret of Japan’s extraordinary success in the pandemic. Over time it has the least cumulative deaths per capita of any major country in the world. That’s without a zero-Covid policy or any national lockdowns, which is why I have not included China as a comparator.

Before we get into that data, let’s take a look at the age pyramids for Japan and the United States. The No. 1 risk factor for death from COVID-19 is advanced age, and you can see that in Japan about 25% of the population is age 65 and older, whereas in the United States that proportion is substantially reduced at 15%. Sure there are differences in comorbidities such as obesity and diabetes, but there is also the trade-off of a much higher population density in Japan.

Besides masks, which were distributed early on by the government to the population in Japan, there was the “Avoid the 3Cs” cluster-busting strategy, widely disseminated in the spring of 2020, leveraging Pareto’s 80-20 principle, long before there were any vaccines available. For a good portion of the pandemic, the Ministry of Foreign Affairs of Japan maintained a strict policy for border control, which while hard to quantify, may certainly have contributed to its success.

Besides these factors, once vaccines became available, Japan got the population with the primary series to 83% rapidly, even after getting a late start by many months compared with the United States, which has peaked at 68%. That’s a big gap.

But that gap got much worse when it came to boosters. Ninety-five percent of Japanese eligible compared with 40.8% of Americans have had a booster shot. Of note, that 95% in Japan pertains to the whole population. In the United States the percentage of people age 65 and older who have had two boosters is currently only 42%. I’ve previously reviewed the important lifesaving impact of two boosters among people age 65 and older from five independent studies during Omicron waves throughout the world.

Now let’s turn to cumulative fatalities in the two countries. There’s a huge, nearly ninefold difference, per capita. Using today’s Covid-19 Dashboard, there are cumulatively 45,533 deaths in Japan and 1,062,560 American deaths. That translates to 1 in 2,758 people in Japan compared with 1 in 315 Americans dying of COVID.

And if we look at excess mortality instead of confirmed COVID deaths, that enormous gap doesn’t change.

Obviously it would be good to have data for other COVID outcomes, such as hospitalizations, ICUs, and Long COVID, but they are not accessible.

Comparing Japan, the country that has fared the best, with the United States, one of the worst pandemic outcome results, leaves us with a sense that Prof Ian MacKay’s “Swiss cheese model” is the best explanation. It’s not just one thing. Masks, consistent evidence-based communication (3Cs) with attention to ventilation and air quality, and the outstanding uptake of vaccines and boosters all contributed to Japan’s success.

There is another factor to add to that model – Paxlovid. Its benefit of reducing hospitalizations and deaths for people over age 65 is unquestionable.

That’s why I had previously modified the Swiss cheese model to add Paxlovid.

But in the United States, where 15% of the population is 65 and older, they account for over 75% of the daily death toll, still in the range of 400 per day. Here, with a very high proportion of people age 65 and older left vulnerable without boosters, or primary vaccines, Paxlovid is only being given to less than 25% of the eligible (age 50+), and less people age 80 and older are getting Paxlovid than those age 45. The reasons that doctors are not prescribing it – worried about interactions for a 5-day course and rebound – are not substantiated.

Bottom line: In the United States we are not protecting our population anywhere near as well as Japan, as grossly evident by the fatalities among people at the highest risk. There needs to be far better uptake of boosters and use of Paxlovid in the age 65+ group, but the need for amped up protection is not at all restricted to this age subgroup. Across all age groups age 18 and over there is an 81% reduction of hospitalizations with two boosters with the most updated CDC data available, through the Omicron BA.5 wave.

No less the previous data through May 2022 showing protection from death across all ages with two boosters

And please don’t forget that around the world, over 20 million lives were saved, just in 2021, the first year of vaccines.

We can learn so much from a model country like Japan. Yes, we need nasal and variant-proof vaccines to effectively deal with the new variants that are already getting legs in places like XBB in Singapore and ones not on the radar yet. But right now we’ve got to do far better for people getting boosters and, when a person age 65 or older gets COVID, Paxlovid. Take a look at the Chris Hayes video segment when he pleaded for Americans to get a booster shot. Every day that vaccine waning of the U.S. population exceeds the small percentage of people who get a booster, our vulnerability increases. If we don’t get that on track, it’s likely going to be a rough winter ahead.

Dr. Topol is director of the Scripps Translational Science Institute in La Jolla, Calif. He has received research grants from the National Institutes of Health and reported conflicts of interest involving Dexcom, Illumina, Molecular Stethoscope, Quest Diagnostics, and Blue Cross Blue Shield Association. A version of this article appeared on Medscape.com.

This article was originally published Oct. 8 on Medscape Editor-In-Chief Eric Topol’s “Ground Truths” column on Substack. 

A recent piece in The Economist about masks, and how at least half of the people in Japan are planning to continue to use masks indefinitely (where there was never a mandate), prompts a deeper look into what has been the secret of Japan’s extraordinary success in the pandemic. Over time it has the least cumulative deaths per capita of any major country in the world. That’s without a zero-Covid policy or any national lockdowns, which is why I have not included China as a comparator.

Before we get into that data, let’s take a look at the age pyramids for Japan and the United States. The No. 1 risk factor for death from COVID-19 is advanced age, and you can see that in Japan about 25% of the population is age 65 and older, whereas in the United States that proportion is substantially reduced at 15%. Sure there are differences in comorbidities such as obesity and diabetes, but there is also the trade-off of a much higher population density in Japan.

Besides masks, which were distributed early on by the government to the population in Japan, there was the “Avoid the 3Cs” cluster-busting strategy, widely disseminated in the spring of 2020, leveraging Pareto’s 80-20 principle, long before there were any vaccines available. For a good portion of the pandemic, the Ministry of Foreign Affairs of Japan maintained a strict policy for border control, which while hard to quantify, may certainly have contributed to its success.

Besides these factors, once vaccines became available, Japan got the population with the primary series to 83% rapidly, even after getting a late start by many months compared with the United States, which has peaked at 68%. That’s a big gap.

But that gap got much worse when it came to boosters. Ninety-five percent of Japanese eligible compared with 40.8% of Americans have had a booster shot. Of note, that 95% in Japan pertains to the whole population. In the United States the percentage of people age 65 and older who have had two boosters is currently only 42%. I’ve previously reviewed the important lifesaving impact of two boosters among people age 65 and older from five independent studies during Omicron waves throughout the world.

Now let’s turn to cumulative fatalities in the two countries. There’s a huge, nearly ninefold difference, per capita. Using today’s Covid-19 Dashboard, there are cumulatively 45,533 deaths in Japan and 1,062,560 American deaths. That translates to 1 in 2,758 people in Japan compared with 1 in 315 Americans dying of COVID.

And if we look at excess mortality instead of confirmed COVID deaths, that enormous gap doesn’t change.

Obviously it would be good to have data for other COVID outcomes, such as hospitalizations, ICUs, and Long COVID, but they are not accessible.

Comparing Japan, the country that has fared the best, with the United States, one of the worst pandemic outcome results, leaves us with a sense that Prof Ian MacKay’s “Swiss cheese model” is the best explanation. It’s not just one thing. Masks, consistent evidence-based communication (3Cs) with attention to ventilation and air quality, and the outstanding uptake of vaccines and boosters all contributed to Japan’s success.

There is another factor to add to that model – Paxlovid. Its benefit of reducing hospitalizations and deaths for people over age 65 is unquestionable.

That’s why I had previously modified the Swiss cheese model to add Paxlovid.

But in the United States, where 15% of the population is 65 and older, they account for over 75% of the daily death toll, still in the range of 400 per day. Here, with a very high proportion of people age 65 and older left vulnerable without boosters, or primary vaccines, Paxlovid is only being given to less than 25% of the eligible (age 50+), and less people age 80 and older are getting Paxlovid than those age 45. The reasons that doctors are not prescribing it – worried about interactions for a 5-day course and rebound – are not substantiated.

Bottom line: In the United States we are not protecting our population anywhere near as well as Japan, as grossly evident by the fatalities among people at the highest risk. There needs to be far better uptake of boosters and use of Paxlovid in the age 65+ group, but the need for amped up protection is not at all restricted to this age subgroup. Across all age groups age 18 and over there is an 81% reduction of hospitalizations with two boosters with the most updated CDC data available, through the Omicron BA.5 wave.

No less the previous data through May 2022 showing protection from death across all ages with two boosters

And please don’t forget that around the world, over 20 million lives were saved, just in 2021, the first year of vaccines.

We can learn so much from a model country like Japan. Yes, we need nasal and variant-proof vaccines to effectively deal with the new variants that are already getting legs in places like XBB in Singapore and ones not on the radar yet. But right now we’ve got to do far better for people getting boosters and, when a person age 65 or older gets COVID, Paxlovid. Take a look at the Chris Hayes video segment when he pleaded for Americans to get a booster shot. Every day that vaccine waning of the U.S. population exceeds the small percentage of people who get a booster, our vulnerability increases. If we don’t get that on track, it’s likely going to be a rough winter ahead.

Dr. Topol is director of the Scripps Translational Science Institute in La Jolla, Calif. He has received research grants from the National Institutes of Health and reported conflicts of interest involving Dexcom, Illumina, Molecular Stethoscope, Quest Diagnostics, and Blue Cross Blue Shield Association. A version of this article appeared on Medscape.com.

This article was originally published Oct. 8 on Medscape Editor-In-Chief Eric Topol’s “Ground Truths” column on Substack. 

A recent piece in The Economist about masks, and how at least half of the people in Japan are planning to continue to use masks indefinitely (where there was never a mandate), prompts a deeper look into what has been the secret of Japan’s extraordinary success in the pandemic. Over time it has the least cumulative deaths per capita of any major country in the world. That’s without a zero-Covid policy or any national lockdowns, which is why I have not included China as a comparator.

Before we get into that data, let’s take a look at the age pyramids for Japan and the United States. The No. 1 risk factor for death from COVID-19 is advanced age, and you can see that in Japan about 25% of the population is age 65 and older, whereas in the United States that proportion is substantially reduced at 15%. Sure there are differences in comorbidities such as obesity and diabetes, but there is also the trade-off of a much higher population density in Japan.

Besides masks, which were distributed early on by the government to the population in Japan, there was the “Avoid the 3Cs” cluster-busting strategy, widely disseminated in the spring of 2020, leveraging Pareto’s 80-20 principle, long before there were any vaccines available. For a good portion of the pandemic, the Ministry of Foreign Affairs of Japan maintained a strict policy for border control, which while hard to quantify, may certainly have contributed to its success.

Besides these factors, once vaccines became available, Japan got the population with the primary series to 83% rapidly, even after getting a late start by many months compared with the United States, which has peaked at 68%. That’s a big gap.

But that gap got much worse when it came to boosters. Ninety-five percent of Japanese eligible compared with 40.8% of Americans have had a booster shot. Of note, that 95% in Japan pertains to the whole population. In the United States the percentage of people age 65 and older who have had two boosters is currently only 42%. I’ve previously reviewed the important lifesaving impact of two boosters among people age 65 and older from five independent studies during Omicron waves throughout the world.

Now let’s turn to cumulative fatalities in the two countries. There’s a huge, nearly ninefold difference, per capita. Using today’s Covid-19 Dashboard, there are cumulatively 45,533 deaths in Japan and 1,062,560 American deaths. That translates to 1 in 2,758 people in Japan compared with 1 in 315 Americans dying of COVID.

And if we look at excess mortality instead of confirmed COVID deaths, that enormous gap doesn’t change.

Obviously it would be good to have data for other COVID outcomes, such as hospitalizations, ICUs, and Long COVID, but they are not accessible.

Comparing Japan, the country that has fared the best, with the United States, one of the worst pandemic outcome results, leaves us with a sense that Prof Ian MacKay’s “Swiss cheese model” is the best explanation. It’s not just one thing. Masks, consistent evidence-based communication (3Cs) with attention to ventilation and air quality, and the outstanding uptake of vaccines and boosters all contributed to Japan’s success.

There is another factor to add to that model – Paxlovid. Its benefit of reducing hospitalizations and deaths for people over age 65 is unquestionable.

That’s why I had previously modified the Swiss cheese model to add Paxlovid.

But in the United States, where 15% of the population is 65 and older, they account for over 75% of the daily death toll, still in the range of 400 per day. Here, with a very high proportion of people age 65 and older left vulnerable without boosters, or primary vaccines, Paxlovid is only being given to less than 25% of the eligible (age 50+), and less people age 80 and older are getting Paxlovid than those age 45. The reasons that doctors are not prescribing it – worried about interactions for a 5-day course and rebound – are not substantiated.

Bottom line: In the United States we are not protecting our population anywhere near as well as Japan, as grossly evident by the fatalities among people at the highest risk. There needs to be far better uptake of boosters and use of Paxlovid in the age 65+ group, but the need for amped up protection is not at all restricted to this age subgroup. Across all age groups age 18 and over there is an 81% reduction of hospitalizations with two boosters with the most updated CDC data available, through the Omicron BA.5 wave.

No less the previous data through May 2022 showing protection from death across all ages with two boosters

And please don’t forget that around the world, over 20 million lives were saved, just in 2021, the first year of vaccines.

We can learn so much from a model country like Japan. Yes, we need nasal and variant-proof vaccines to effectively deal with the new variants that are already getting legs in places like XBB in Singapore and ones not on the radar yet. But right now we’ve got to do far better for people getting boosters and, when a person age 65 or older gets COVID, Paxlovid. Take a look at the Chris Hayes video segment when he pleaded for Americans to get a booster shot. Every day that vaccine waning of the U.S. population exceeds the small percentage of people who get a booster, our vulnerability increases. If we don’t get that on track, it’s likely going to be a rough winter ahead.

Dr. Topol is director of the Scripps Translational Science Institute in La Jolla, Calif. He has received research grants from the National Institutes of Health and reported conflicts of interest involving Dexcom, Illumina, Molecular Stethoscope, Quest Diagnostics, and Blue Cross Blue Shield Association. A version of this article appeared on Medscape.com.

Queen Elizabeth is everywhere. She was even on the last slide of a presentation on COVID, monkeypox, and influenza vaccines given by our physician in charge of quality. This was odd. The presenter wasn’t English. The Queen had nothing to do with vaccines. Nor apparently would she have said even if she did have an opinion about them. But there we were, an audience of physicians and staff pausing for a moment of remembrance of her.

I’m not a Monarchist – except perhaps for the Kennedys. I grew up in New England. I don’t have an opinion on whether or not the British Crown should endure. But I do marvel at the astounding effect Queen Elizabeth’s passing had on so many around the world. Her personal qualities, particularly her steadiness and humane sympathy, might explain why so many are sad hearing the news. But also I think there was something in her role that we all wished for: Not the owning of palaces and sceptres, but rather, the respect that was given to her.

She was a stateswoman of “unmatched dignity,” the White House wrote. That was true, but it seems being the Queen might have been the last job on earth where such dignity is still possible. Certainly in politics, education, and even health care, there doesn’t seem to be much left lately.

The same day of that presentation I walked into the room of a patient 22 minutes late, she held her arm forth tapping her watch to indicate the time and my tardiness. Unnecessary, if not impertinent. Covering for one of my female physician colleagues, I read an email from a patient which began, “Dear Julie, With all due respect …” Another patient submitted a photo for us to review that was clearly taken from her car while waiting at a stop light. Hardly the consideration a clinical encounter should be given.

Much has been lost for patients. too. There are patients trying to make appointments lately who are told: “There are none. Call back later.” Gone it seems are the days of a two-part office visit, the first part fully clothed in the physician’s office, then the exam. There is no dignified way to remove exam paper stuck to your backside before introducing yourself to the doctor. Maybe that last slide of Her Majesty was in fact for us to have a moment of silence for what we’ve all lost.

Walter Bagehot (pronounce it “Baj-et” if you tell this story to your Harlan wine friends) was a political writer and editor of The Economist in the 1860s. He famously said that the secret to the English government was having two kinds of institutions, the dignified and the efficient. The efficient, Parliament, was responsible for all the work. The dignified, the Crown, gives significance and holds everyone’s respect. If medicine ever once was both dignified and efficient, we aren’t lately. We push to reduce backlogs, offer same-time virtual care, work to reduce costs. We’ve driven medicine to the efficient and left little of the dignity it seems.

The Queen will be remembered for her lifelong dedication to the laborious service of others. Even though each of us in medicine pledges the same, we also mourn this week the loss of dignity that once came with it.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

Queen Elizabeth is everywhere. She was even on the last slide of a presentation on COVID, monkeypox, and influenza vaccines given by our physician in charge of quality. This was odd. The presenter wasn’t English. The Queen had nothing to do with vaccines. Nor apparently would she have said even if she did have an opinion about them. But there we were, an audience of physicians and staff pausing for a moment of remembrance of her.

I’m not a Monarchist – except perhaps for the Kennedys. I grew up in New England. I don’t have an opinion on whether or not the British Crown should endure. But I do marvel at the astounding effect Queen Elizabeth’s passing had on so many around the world. Her personal qualities, particularly her steadiness and humane sympathy, might explain why so many are sad hearing the news. But also I think there was something in her role that we all wished for: Not the owning of palaces and sceptres, but rather, the respect that was given to her.

She was a stateswoman of “unmatched dignity,” the White House wrote. That was true, but it seems being the Queen might have been the last job on earth where such dignity is still possible. Certainly in politics, education, and even health care, there doesn’t seem to be much left lately.

The same day of that presentation I walked into the room of a patient 22 minutes late, she held her arm forth tapping her watch to indicate the time and my tardiness. Unnecessary, if not impertinent. Covering for one of my female physician colleagues, I read an email from a patient which began, “Dear Julie, With all due respect …” Another patient submitted a photo for us to review that was clearly taken from her car while waiting at a stop light. Hardly the consideration a clinical encounter should be given.

Much has been lost for patients. too. There are patients trying to make appointments lately who are told: “There are none. Call back later.” Gone it seems are the days of a two-part office visit, the first part fully clothed in the physician’s office, then the exam. There is no dignified way to remove exam paper stuck to your backside before introducing yourself to the doctor. Maybe that last slide of Her Majesty was in fact for us to have a moment of silence for what we’ve all lost.

Walter Bagehot (pronounce it “Baj-et” if you tell this story to your Harlan wine friends) was a political writer and editor of The Economist in the 1860s. He famously said that the secret to the English government was having two kinds of institutions, the dignified and the efficient. The efficient, Parliament, was responsible for all the work. The dignified, the Crown, gives significance and holds everyone’s respect. If medicine ever once was both dignified and efficient, we aren’t lately. We push to reduce backlogs, offer same-time virtual care, work to reduce costs. We’ve driven medicine to the efficient and left little of the dignity it seems.

The Queen will be remembered for her lifelong dedication to the laborious service of others. Even though each of us in medicine pledges the same, we also mourn this week the loss of dignity that once came with it.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

Queen Elizabeth is everywhere. She was even on the last slide of a presentation on COVID, monkeypox, and influenza vaccines given by our physician in charge of quality. This was odd. The presenter wasn’t English. The Queen had nothing to do with vaccines. Nor apparently would she have said even if she did have an opinion about them. But there we were, an audience of physicians and staff pausing for a moment of remembrance of her.

I’m not a Monarchist – except perhaps for the Kennedys. I grew up in New England. I don’t have an opinion on whether or not the British Crown should endure. But I do marvel at the astounding effect Queen Elizabeth’s passing had on so many around the world. Her personal qualities, particularly her steadiness and humane sympathy, might explain why so many are sad hearing the news. But also I think there was something in her role that we all wished for: Not the owning of palaces and sceptres, but rather, the respect that was given to her.

She was a stateswoman of “unmatched dignity,” the White House wrote. That was true, but it seems being the Queen might have been the last job on earth where such dignity is still possible. Certainly in politics, education, and even health care, there doesn’t seem to be much left lately.

The same day of that presentation I walked into the room of a patient 22 minutes late, she held her arm forth tapping her watch to indicate the time and my tardiness. Unnecessary, if not impertinent. Covering for one of my female physician colleagues, I read an email from a patient which began, “Dear Julie, With all due respect …” Another patient submitted a photo for us to review that was clearly taken from her car while waiting at a stop light. Hardly the consideration a clinical encounter should be given.

Much has been lost for patients. too. There are patients trying to make appointments lately who are told: “There are none. Call back later.” Gone it seems are the days of a two-part office visit, the first part fully clothed in the physician’s office, then the exam. There is no dignified way to remove exam paper stuck to your backside before introducing yourself to the doctor. Maybe that last slide of Her Majesty was in fact for us to have a moment of silence for what we’ve all lost.

Walter Bagehot (pronounce it “Baj-et” if you tell this story to your Harlan wine friends) was a political writer and editor of The Economist in the 1860s. He famously said that the secret to the English government was having two kinds of institutions, the dignified and the efficient. The efficient, Parliament, was responsible for all the work. The dignified, the Crown, gives significance and holds everyone’s respect. If medicine ever once was both dignified and efficient, we aren’t lately. We push to reduce backlogs, offer same-time virtual care, work to reduce costs. We’ve driven medicine to the efficient and left little of the dignity it seems.

The Queen will be remembered for her lifelong dedication to the laborious service of others. Even though each of us in medicine pledges the same, we also mourn this week the loss of dignity that once came with it.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

I wrote my first column on electronic health records in the mid-1990s. At the time, it seemed like an idea whose time had come. After all, in an era when just about every essential process in medicine had already been computerized, we physicians continued to process clinical data – our key asset – with pen and paper. Most of us were reluctant to make the switch, and for good reason: choosing the right EHR system was difficult at best, and once the choice was made, conversion was a nightmare. Plus, there was no clear incentive to do it.

Then, the government stepped in. Shortly after his inauguration in 2000, President George W. Bush outlined a plan to ensure that most Americans had electronic health records within 10 years. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” The goal was to eliminate missing charts, duplication of lab testing, ineffective documentation, and inordinate amounts of time spent on paperwork, not to mention illegible handwriting, poor coordination of care between physicians, and many other problems. Studies were quoted, suggesting that EHR shortened inpatient stays, decreased risk of adverse drug interactions, improved the consistency and content of records, and improved continuity of care and follow-up.

The EHR Incentive Program (later renamed the Promoting Interoperability Program) was introduced to encourage physicians and hospitals “to adopt, implement, upgrade, and demonstrate meaningful use of certified electronic health record technology.”

Nearly a quarter-century later, implementation is well behind schedule. According to a 2019 federal study, while nearly all hospitals (96%) have adopted a certified EHR, only 72% of office-based physicians have done so.

There are multiple reasons for this. For one thing, EHR is still by and large slower than pen and paper, because direct data entry is still primarily done by keyboard. Voice recognition, hand-held and wireless devices have been developed, but most work only on specialized tasks. Even the best systems take more clinician time per encounter than the manual processes they replace.

Physicians have been slow to warm to a system that slows them down and forces them to change the way they think and work. In addition, paper systems never crash; the prospect of a server malfunction or Internet failure bringing an entire clinic to a grinding halt is not particularly inviting.

The special needs of dermatology – high patient volumes, multiple diagnoses and prescriptions per patient, the wide variety of procedures we perform, and digital image storage – present further hurdles.

Nevertheless, the march toward electronic record keeping continues, and I continue to receive many questions about choosing a good EHR system. As always, I cannot recommend any specific products since every office has unique needs and requirements.

The key phrase to keep in mind is caveat emptor. Several regulatory bodies exist to test vendor claims and certify system behaviors, but different agencies use different criteria that may or may not be relevant to your requirements. Vaporware is still as common as real software; beware the “feature in the next release” that might never appear, particularly if you need it right now.

Avoid the temptation to buy a flashy new system and then try to adapt it to your office; figure out your needs first, then find a system that meets them.

Unfortunately, there is no easy way around doing the work of comparing one system with another. The most important information a vendor can give you is the names and addresses of two or more offices where you can go watch their system in action. Site visits are time-consuming, but they are only way to pick the best EHR the first time around.

Don’t be the first office using a new system. Let the vendor work out the bugs somewhere else.

Above all, if you have disorganized paper records, don’t count on EHR to automatically solve your problems. Well-designed paper systems usually lend themselves to effective automation, but automating a poorly designed system just increases the chaos. If your paper system is in disarray, solve that problem before considering EHR.

With all of its problems and hurdles, EHRs will inevitably be a part of most of our lives. And for those who take the time to do it right, it will ultimately be an improvement.

Think of information technologies as power tools: They can help you to do things better, but they can also amplify your errors. So choose carefully.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

I wrote my first column on electronic health records in the mid-1990s. At the time, it seemed like an idea whose time had come. After all, in an era when just about every essential process in medicine had already been computerized, we physicians continued to process clinical data – our key asset – with pen and paper. Most of us were reluctant to make the switch, and for good reason: choosing the right EHR system was difficult at best, and once the choice was made, conversion was a nightmare. Plus, there was no clear incentive to do it.

Then, the government stepped in. Shortly after his inauguration in 2000, President George W. Bush outlined a plan to ensure that most Americans had electronic health records within 10 years. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” The goal was to eliminate missing charts, duplication of lab testing, ineffective documentation, and inordinate amounts of time spent on paperwork, not to mention illegible handwriting, poor coordination of care between physicians, and many other problems. Studies were quoted, suggesting that EHR shortened inpatient stays, decreased risk of adverse drug interactions, improved the consistency and content of records, and improved continuity of care and follow-up.

The EHR Incentive Program (later renamed the Promoting Interoperability Program) was introduced to encourage physicians and hospitals “to adopt, implement, upgrade, and demonstrate meaningful use of certified electronic health record technology.”

Nearly a quarter-century later, implementation is well behind schedule. According to a 2019 federal study, while nearly all hospitals (96%) have adopted a certified EHR, only 72% of office-based physicians have done so.

There are multiple reasons for this. For one thing, EHR is still by and large slower than pen and paper, because direct data entry is still primarily done by keyboard. Voice recognition, hand-held and wireless devices have been developed, but most work only on specialized tasks. Even the best systems take more clinician time per encounter than the manual processes they replace.

Physicians have been slow to warm to a system that slows them down and forces them to change the way they think and work. In addition, paper systems never crash; the prospect of a server malfunction or Internet failure bringing an entire clinic to a grinding halt is not particularly inviting.

The special needs of dermatology – high patient volumes, multiple diagnoses and prescriptions per patient, the wide variety of procedures we perform, and digital image storage – present further hurdles.

Nevertheless, the march toward electronic record keeping continues, and I continue to receive many questions about choosing a good EHR system. As always, I cannot recommend any specific products since every office has unique needs and requirements.

The key phrase to keep in mind is caveat emptor. Several regulatory bodies exist to test vendor claims and certify system behaviors, but different agencies use different criteria that may or may not be relevant to your requirements. Vaporware is still as common as real software; beware the “feature in the next release” that might never appear, particularly if you need it right now.

Avoid the temptation to buy a flashy new system and then try to adapt it to your office; figure out your needs first, then find a system that meets them.

Unfortunately, there is no easy way around doing the work of comparing one system with another. The most important information a vendor can give you is the names and addresses of two or more offices where you can go watch their system in action. Site visits are time-consuming, but they are only way to pick the best EHR the first time around.

Don’t be the first office using a new system. Let the vendor work out the bugs somewhere else.

Above all, if you have disorganized paper records, don’t count on EHR to automatically solve your problems. Well-designed paper systems usually lend themselves to effective automation, but automating a poorly designed system just increases the chaos. If your paper system is in disarray, solve that problem before considering EHR.

With all of its problems and hurdles, EHRs will inevitably be a part of most of our lives. And for those who take the time to do it right, it will ultimately be an improvement.

Think of information technologies as power tools: They can help you to do things better, but they can also amplify your errors. So choose carefully.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

I wrote my first column on electronic health records in the mid-1990s. At the time, it seemed like an idea whose time had come. After all, in an era when just about every essential process in medicine had already been computerized, we physicians continued to process clinical data – our key asset – with pen and paper. Most of us were reluctant to make the switch, and for good reason: choosing the right EHR system was difficult at best, and once the choice was made, conversion was a nightmare. Plus, there was no clear incentive to do it.

Then, the government stepped in. Shortly after his inauguration in 2000, President George W. Bush outlined a plan to ensure that most Americans had electronic health records within 10 years. “By computerizing health records,” the president said, “we can avoid dangerous medical mistakes, reduce costs, and improve care.” The goal was to eliminate missing charts, duplication of lab testing, ineffective documentation, and inordinate amounts of time spent on paperwork, not to mention illegible handwriting, poor coordination of care between physicians, and many other problems. Studies were quoted, suggesting that EHR shortened inpatient stays, decreased risk of adverse drug interactions, improved the consistency and content of records, and improved continuity of care and follow-up.

The EHR Incentive Program (later renamed the Promoting Interoperability Program) was introduced to encourage physicians and hospitals “to adopt, implement, upgrade, and demonstrate meaningful use of certified electronic health record technology.”

Nearly a quarter-century later, implementation is well behind schedule. According to a 2019 federal study, while nearly all hospitals (96%) have adopted a certified EHR, only 72% of office-based physicians have done so.

There are multiple reasons for this. For one thing, EHR is still by and large slower than pen and paper, because direct data entry is still primarily done by keyboard. Voice recognition, hand-held and wireless devices have been developed, but most work only on specialized tasks. Even the best systems take more clinician time per encounter than the manual processes they replace.

Physicians have been slow to warm to a system that slows them down and forces them to change the way they think and work. In addition, paper systems never crash; the prospect of a server malfunction or Internet failure bringing an entire clinic to a grinding halt is not particularly inviting.

The special needs of dermatology – high patient volumes, multiple diagnoses and prescriptions per patient, the wide variety of procedures we perform, and digital image storage – present further hurdles.

Nevertheless, the march toward electronic record keeping continues, and I continue to receive many questions about choosing a good EHR system. As always, I cannot recommend any specific products since every office has unique needs and requirements.

The key phrase to keep in mind is caveat emptor. Several regulatory bodies exist to test vendor claims and certify system behaviors, but different agencies use different criteria that may or may not be relevant to your requirements. Vaporware is still as common as real software; beware the “feature in the next release” that might never appear, particularly if you need it right now.

Avoid the temptation to buy a flashy new system and then try to adapt it to your office; figure out your needs first, then find a system that meets them.

Unfortunately, there is no easy way around doing the work of comparing one system with another. The most important information a vendor can give you is the names and addresses of two or more offices where you can go watch their system in action. Site visits are time-consuming, but they are only way to pick the best EHR the first time around.

Don’t be the first office using a new system. Let the vendor work out the bugs somewhere else.

Above all, if you have disorganized paper records, don’t count on EHR to automatically solve your problems. Well-designed paper systems usually lend themselves to effective automation, but automating a poorly designed system just increases the chaos. If your paper system is in disarray, solve that problem before considering EHR.

With all of its problems and hurdles, EHRs will inevitably be a part of most of our lives. And for those who take the time to do it right, it will ultimately be an improvement.

Think of information technologies as power tools: They can help you to do things better, but they can also amplify your errors. So choose carefully.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

PORTLAND, ORE. – Some pernio-like/chilblains-like lesions on the toes – which became widely known as “COVID toes” – and other acral sites that have occurred during the COVID-19 pandemic are related to COVID-19 infection, while others are not, according to Lindy P. Fox, MD, professor of dermatology and director of the hospital consultation service at the University of California, San Francisco.

“We’re learning a lot about pernio because of COVID,” Dr. Fox, a member of the American Academy of Dermatology’s Ad Hoc Task Force on COVID-19, said at the annual meeting of the Pacific Dermatologic Association. “Patients with pernio tend to either have bright red or purple individual lesions or an erythromelalgia-like presentation, often waking up in the middle of the night saying ‘my feet hurt. I can’t put sheets over my feet.’ In my experience, the patients with an erythromelalgia-like presentation tend to be a lot harder to treat.”

courtesy UCSF

Establishing terminology to describe pernio-like lesions was a challenge in the early stages of the COVID-19 pandemic, Dr. Fox added, with clinicians using terms like erythema multiforme-like, coxsackie-like, or even necrotic to describe the lesions. “I don’t think pernio is truly necrotic; I think it’s really inflammatory and purpuric,” she said.

Early in the pandemic, studies suggesting a link with these cases and COVID-19 infection include a case series of 318 patients with pernio-like skin lesions who had confirmed or suspected COVID-19. Most of these patients were generally young and healthy and most had relatively mild COVID-19; 7% were laboratory-confirmed COVID-19 positive, and 6% were close contacts of patients with confirmed COVID-19. Pernio-like lesions were the only symptoms in 55% of the patients.

In another study, researchers in France evaluated the clinical, laboratory, and pathologic characteristics of 40 patients who developed chilblain-like lesions (mostly involving the toes) during the COVID-19 pandemic and were seen as outpatients in April 2020 . All were polymerase chain reaction (PCR) negative, 30% were SARS-CoV-2 serology positive, and 60% had elevated D-dimers. Histology obtained from 19 of the patients revealed lymphocytic inflammation and vascular damage, and 8 had IgA positivity.

In a retrospective analysis of seven pediatric chilblains cases during the pandemic, researchers examined the skin biopsies to evaluate histopathological features and explored the presence of SARS-CoV-2 in the tissue. All patients were PCR negative. The authors observed cytoplasmic granular positivity for SARS-CoV-2 spike protein in endothelial cells, a feature that they said showed coronavirus-like particles, consistent with SARS-CoV-2.

Not all studies in the medical literature have demonstrated an association between pernio-like/chilblains-like lesions and COVID-19, though. An analysis of 23 patients, with skin eruptions considered associated with SARS-CoV-2 infections (including 21 cases of chilblains) during the first wave of the pandemic found that the antibody and T-cell response in patients with pandemic chilblains was the same as in negative controls.

“What’s remarkably interesting about this study is that they did autopsies of samples from patients who had died prepandemic, so there was no such thing as COVID-19,” said Dr. Fox, who was not involved with the study. “They stained for viral particles in those patients, and they were positive in a subset of patients. This makes me wonder about what the significance of that staining positivity is.”

Yet another group of investigators looked at what was happening with pernio during the waves of COVID in a study of chilblains cases in children in Spain, and found a stronger association between lockdown and cold temperature, which argues against a direct association between pernio and COVID infection.

In Dr. Fox’s experience, COVID toes can recur, especially upon exposure to cold. “What taught me this in real life is a patient who I saw remotely by video,” she recalled. “It was early on in the pandemic. I could not prove he had COVID no matter how hard I tried, but I do think he had COVID toes at that time.” When he later was confirmed to have COVID, “he got pernio in the same exact location as his original suspected COVID toes.”

According to an analysis of long COVID in the skin, based on cases reported to the American Academy of Dermatology–International League of Dermatological Societies registry from April 8 to Oct. 8, 2020, pernio-like lesions lasted a median of 12 days in patients with lab-confirmed COVID-19 and a median of 15 days in those with suspected COVID-19. But almost 7% of the 103 pernio cases were long-haulers, defined as those with dermatologic signs of COVID that lasted beyond 60 days.

“There are some patients who are resistant to treatment,” Dr. Fox said. “In addition, recurrent lesions make me think that maybe all pernio is triggered by some viral cause. This causes an immunologic phenomenon that’s responding to a viral trigger you’re trying to deal with. That may be the better way to think about COVID toes.”

Different variants of COVID also appear to be changing the characteristics of dermatologic manifestations associated with infection. Results from a large retrospective analysis of nearly 350,000 users of a COVID study App in the United Kingdom found that skin lesions were more predictive of a positive test in the Delta wave, compared with the Omicron wave, while pernio-like lesions were predictive of infection in the Delta wave but not in the Omicron wave.

“And, whether you were vaccinated or unvaccinated really did not influence whether or not you were going to have a skin rash as a presenting sign of COVID, except for the burning rash, which was less in vaccinated patients,” said Dr. Fox, who was not involved with the study.

Dr. Fox reported having no relevant disclosures.

PORTLAND, ORE. – Some pernio-like/chilblains-like lesions on the toes – which became widely known as “COVID toes” – and other acral sites that have occurred during the COVID-19 pandemic are related to COVID-19 infection, while others are not, according to Lindy P. Fox, MD, professor of dermatology and director of the hospital consultation service at the University of California, San Francisco.

“We’re learning a lot about pernio because of COVID,” Dr. Fox, a member of the American Academy of Dermatology’s Ad Hoc Task Force on COVID-19, said at the annual meeting of the Pacific Dermatologic Association. “Patients with pernio tend to either have bright red or purple individual lesions or an erythromelalgia-like presentation, often waking up in the middle of the night saying ‘my feet hurt. I can’t put sheets over my feet.’ In my experience, the patients with an erythromelalgia-like presentation tend to be a lot harder to treat.”

courtesy UCSF

Establishing terminology to describe pernio-like lesions was a challenge in the early stages of the COVID-19 pandemic, Dr. Fox added, with clinicians using terms like erythema multiforme-like, coxsackie-like, or even necrotic to describe the lesions. “I don’t think pernio is truly necrotic; I think it’s really inflammatory and purpuric,” she said.

Early in the pandemic, studies suggesting a link with these cases and COVID-19 infection include a case series of 318 patients with pernio-like skin lesions who had confirmed or suspected COVID-19. Most of these patients were generally young and healthy and most had relatively mild COVID-19; 7% were laboratory-confirmed COVID-19 positive, and 6% were close contacts of patients with confirmed COVID-19. Pernio-like lesions were the only symptoms in 55% of the patients.

In another study, researchers in France evaluated the clinical, laboratory, and pathologic characteristics of 40 patients who developed chilblain-like lesions (mostly involving the toes) during the COVID-19 pandemic and were seen as outpatients in April 2020 . All were polymerase chain reaction (PCR) negative, 30% were SARS-CoV-2 serology positive, and 60% had elevated D-dimers. Histology obtained from 19 of the patients revealed lymphocytic inflammation and vascular damage, and 8 had IgA positivity.

In a retrospective analysis of seven pediatric chilblains cases during the pandemic, researchers examined the skin biopsies to evaluate histopathological features and explored the presence of SARS-CoV-2 in the tissue. All patients were PCR negative. The authors observed cytoplasmic granular positivity for SARS-CoV-2 spike protein in endothelial cells, a feature that they said showed coronavirus-like particles, consistent with SARS-CoV-2.

Not all studies in the medical literature have demonstrated an association between pernio-like/chilblains-like lesions and COVID-19, though. An analysis of 23 patients, with skin eruptions considered associated with SARS-CoV-2 infections (including 21 cases of chilblains) during the first wave of the pandemic found that the antibody and T-cell response in patients with pandemic chilblains was the same as in negative controls.

“What’s remarkably interesting about this study is that they did autopsies of samples from patients who had died prepandemic, so there was no such thing as COVID-19,” said Dr. Fox, who was not involved with the study. “They stained for viral particles in those patients, and they were positive in a subset of patients. This makes me wonder about what the significance of that staining positivity is.”

Yet another group of investigators looked at what was happening with pernio during the waves of COVID in a study of chilblains cases in children in Spain, and found a stronger association between lockdown and cold temperature, which argues against a direct association between pernio and COVID infection.

In Dr. Fox’s experience, COVID toes can recur, especially upon exposure to cold. “What taught me this in real life is a patient who I saw remotely by video,” she recalled. “It was early on in the pandemic. I could not prove he had COVID no matter how hard I tried, but I do think he had COVID toes at that time.” When he later was confirmed to have COVID, “he got pernio in the same exact location as his original suspected COVID toes.”

According to an analysis of long COVID in the skin, based on cases reported to the American Academy of Dermatology–International League of Dermatological Societies registry from April 8 to Oct. 8, 2020, pernio-like lesions lasted a median of 12 days in patients with lab-confirmed COVID-19 and a median of 15 days in those with suspected COVID-19. But almost 7% of the 103 pernio cases were long-haulers, defined as those with dermatologic signs of COVID that lasted beyond 60 days.

“There are some patients who are resistant to treatment,” Dr. Fox said. “In addition, recurrent lesions make me think that maybe all pernio is triggered by some viral cause. This causes an immunologic phenomenon that’s responding to a viral trigger you’re trying to deal with. That may be the better way to think about COVID toes.”

Different variants of COVID also appear to be changing the characteristics of dermatologic manifestations associated with infection. Results from a large retrospective analysis of nearly 350,000 users of a COVID study App in the United Kingdom found that skin lesions were more predictive of a positive test in the Delta wave, compared with the Omicron wave, while pernio-like lesions were predictive of infection in the Delta wave but not in the Omicron wave.

“And, whether you were vaccinated or unvaccinated really did not influence whether or not you were going to have a skin rash as a presenting sign of COVID, except for the burning rash, which was less in vaccinated patients,” said Dr. Fox, who was not involved with the study.

Dr. Fox reported having no relevant disclosures.

PORTLAND, ORE. – Some pernio-like/chilblains-like lesions on the toes – which became widely known as “COVID toes” – and other acral sites that have occurred during the COVID-19 pandemic are related to COVID-19 infection, while others are not, according to Lindy P. Fox, MD, professor of dermatology and director of the hospital consultation service at the University of California, San Francisco.

“We’re learning a lot about pernio because of COVID,” Dr. Fox, a member of the American Academy of Dermatology’s Ad Hoc Task Force on COVID-19, said at the annual meeting of the Pacific Dermatologic Association. “Patients with pernio tend to either have bright red or purple individual lesions or an erythromelalgia-like presentation, often waking up in the middle of the night saying ‘my feet hurt. I can’t put sheets over my feet.’ In my experience, the patients with an erythromelalgia-like presentation tend to be a lot harder to treat.”

courtesy UCSF

Establishing terminology to describe pernio-like lesions was a challenge in the early stages of the COVID-19 pandemic, Dr. Fox added, with clinicians using terms like erythema multiforme-like, coxsackie-like, or even necrotic to describe the lesions. “I don’t think pernio is truly necrotic; I think it’s really inflammatory and purpuric,” she said.

Early in the pandemic, studies suggesting a link with these cases and COVID-19 infection include a case series of 318 patients with pernio-like skin lesions who had confirmed or suspected COVID-19. Most of these patients were generally young and healthy and most had relatively mild COVID-19; 7% were laboratory-confirmed COVID-19 positive, and 6% were close contacts of patients with confirmed COVID-19. Pernio-like lesions were the only symptoms in 55% of the patients.

In another study, researchers in France evaluated the clinical, laboratory, and pathologic characteristics of 40 patients who developed chilblain-like lesions (mostly involving the toes) during the COVID-19 pandemic and were seen as outpatients in April 2020 . All were polymerase chain reaction (PCR) negative, 30% were SARS-CoV-2 serology positive, and 60% had elevated D-dimers. Histology obtained from 19 of the patients revealed lymphocytic inflammation and vascular damage, and 8 had IgA positivity.

In a retrospective analysis of seven pediatric chilblains cases during the pandemic, researchers examined the skin biopsies to evaluate histopathological features and explored the presence of SARS-CoV-2 in the tissue. All patients were PCR negative. The authors observed cytoplasmic granular positivity for SARS-CoV-2 spike protein in endothelial cells, a feature that they said showed coronavirus-like particles, consistent with SARS-CoV-2.

Not all studies in the medical literature have demonstrated an association between pernio-like/chilblains-like lesions and COVID-19, though. An analysis of 23 patients, with skin eruptions considered associated with SARS-CoV-2 infections (including 21 cases of chilblains) during the first wave of the pandemic found that the antibody and T-cell response in patients with pandemic chilblains was the same as in negative controls.

“What’s remarkably interesting about this study is that they did autopsies of samples from patients who had died prepandemic, so there was no such thing as COVID-19,” said Dr. Fox, who was not involved with the study. “They stained for viral particles in those patients, and they were positive in a subset of patients. This makes me wonder about what the significance of that staining positivity is.”

Yet another group of investigators looked at what was happening with pernio during the waves of COVID in a study of chilblains cases in children in Spain, and found a stronger association between lockdown and cold temperature, which argues against a direct association between pernio and COVID infection.

In Dr. Fox’s experience, COVID toes can recur, especially upon exposure to cold. “What taught me this in real life is a patient who I saw remotely by video,” she recalled. “It was early on in the pandemic. I could not prove he had COVID no matter how hard I tried, but I do think he had COVID toes at that time.” When he later was confirmed to have COVID, “he got pernio in the same exact location as his original suspected COVID toes.”

According to an analysis of long COVID in the skin, based on cases reported to the American Academy of Dermatology–International League of Dermatological Societies registry from April 8 to Oct. 8, 2020, pernio-like lesions lasted a median of 12 days in patients with lab-confirmed COVID-19 and a median of 15 days in those with suspected COVID-19. But almost 7% of the 103 pernio cases were long-haulers, defined as those with dermatologic signs of COVID that lasted beyond 60 days.

“There are some patients who are resistant to treatment,” Dr. Fox said. “In addition, recurrent lesions make me think that maybe all pernio is triggered by some viral cause. This causes an immunologic phenomenon that’s responding to a viral trigger you’re trying to deal with. That may be the better way to think about COVID toes.”

Different variants of COVID also appear to be changing the characteristics of dermatologic manifestations associated with infection. Results from a large retrospective analysis of nearly 350,000 users of a COVID study App in the United Kingdom found that skin lesions were more predictive of a positive test in the Delta wave, compared with the Omicron wave, while pernio-like lesions were predictive of infection in the Delta wave but not in the Omicron wave.

“And, whether you were vaccinated or unvaccinated really did not influence whether or not you were going to have a skin rash as a presenting sign of COVID, except for the burning rash, which was less in vaccinated patients,” said Dr. Fox, who was not involved with the study.

Dr. Fox reported having no relevant disclosures.

MILAN – The therapeutic value of inhibiting the activity of IgE in patients with chronic spontaneous urticaria (CSU) was reinforced by two large phase 3 trials with ligelizumab, a drug characterized as a new generation anti-IgE monoclonal antibody.

Both doses of ligelizumab evaluated met the primary endpoint of superiority to placebo for a complete response at 16 weeks of therapy, reported Marcus Maurer, MD, director of the Urticaria Center for Reference and Excellence at the Charité Hospital, Berlin.

The data from the two identically designed trials, PEARL 1 and PEARL 2, were presented at the annual congress of the European Academy of Dermatology and Venereology. The two ligelizumab experimental arms (72 mg or 120 mg administered subcutaneously every 4 weeks) and the active comparative arm of omalizumab (300 mg administered subcutaneously every 4 weeks) demonstrated similar efficacy, all three of which were highly superior to placebo.

The data show that “another anti-IgE therapy – ligelizumab – is effective in CSU,” Dr. Maurer said.

“While the benefit was not different from omalizumab, ligelizumab showed remarkable results in disease activity and by demonstrating just how many patients achieved what we want them to achieve, which is to have no more signs and symptoms,” he added.
 

Majority of participants with severe urticaria

All of the patients entered into the two trials had severe (about 65%) or moderate (about 35%) symptoms at baseline. The results of the two trials were almost identical. In the randomization arms, a weekly Urticaria Activity Score (UAS7) of 0, which was the primary endpoint, was achieved at week 16 by 31.0% of those receiving 72-mg ligelizumab, 38.3% of those receiving 120-mg ligelizumab, and 34.1% of those receiving omalizumab (Xolair). The placebo response was 5.7%.

The UAS7 score is drawn from two components, wheals and itch. The range is 0 (no symptoms) to 42 (most severe). At baseline, the average patients’ scores were about 30, which correlates with a substantial symptom burden, according to Dr. Maurer.

The mean reduction in the UAS7 score in PEARL 2, which differed from PEARL 1 by no more than 0.4 points for any treatment group, was 19.2 points in the 72-mg ligelizumab group, 19.3 points in the 120-mg ligelizumab group, 19.6 points in the omalizumab group, and 9.2 points in the placebo group. There were no significant differences between any active treatment arm.

Complete symptom relief, meaning a UAS7 score of 0, was selected as the primary endpoint, because Dr. Maurer said that this is the goal of treatment. Although he admitted that a UAS7 score of 0 is analogous to a PASI score in psoriasis of 100 (complete clearing), he said, “Chronic urticaria is a debilitating disease, and we want to eliminate the symptoms. Gone is gone.”

Combined, the two phase 3 trials represent “the biggest chronic urticaria program ever,” according to Dr. Maurer. The 1,034 patients enrolled in PEARL 1 and the 1,023 enrolled in PEARL 2 were randomized in a 3:3:3:1 ratio with placebo representing the smaller group.

The planned follow-up is 52 weeks, but the placebo group will be switched to 120 mg ligelizumab every 4 weeks at the end of 24 weeks. The switch is required because “you cannot maintain patients with this disease on placebo over a long period,” Dr. Maurer said.
 

Ligelizumab associated with low discontinuation rate

Adverse events overall and stratified by severity have been similar across treatment arms, including placebo. The possible exception was a lower rate of moderate events (16.5%) in the placebo arm relative to the 72-mg ligelizumab arm (19.8%), the 120-mg ligelizumab arm (21.6%), and the omalizumab arm (22.3%). Discontinuations because of an adverse event were under 4% in every treatment arm.

Although Dr. Maurer did not present outcomes at 52 weeks, he did note that “only 15% of those who enrolled in these trials have discontinued treatment.” He considered this remarkable in that the study was conducted in the midst of the COVID-19 pandemic, and it appears that at least some of those left the trial did so because of concern for clinic visits.

Despite the similar benefit provided by ligelizumab and omalizumab, Dr. Maurer said that subgroup analyses will be coming. The possibility that some patients benefit more from one than the another cannot yet be ruled out. There are also, as of yet, no data to determine whether at least some patients respond to one after an inadequate response to the other.

Still, given the efficacy and the safety of ligelizumab, Dr. Maurer indicated that the drug is likely to find a role in routine management of CSU if approved.

“We only have two options for chronic spontaneous urticaria. There are antihistamines, which do not usually work, and omalizumab,” he said. “It is very important we develop more treatment options.”

Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, agreed.

“More therapeutic options, especially for disease states that have a small armament – even if equivalent in efficacy to established therapies – is always a win for patients as it almost always increases access to treatment,” Dr. Friedman said in an interview.

“Furthermore, the heterogeneous nature of inflammatory skin diseases is often not captured in even phase 3 studies. Therefore, having additional options could offer relief where previous therapies have failed,” he added.

Dr. Maurer reports financial relationships with more than 10 pharmaceutical companies, including Novartis, which is developing ligelizumab. Dr. Friedman has a financial relationship with more than 20 pharmaceutical companies but has no current financial association with Novartis and was not involved in the PEARL 1 and 2 trials.

MILAN – The therapeutic value of inhibiting the activity of IgE in patients with chronic spontaneous urticaria (CSU) was reinforced by two large phase 3 trials with ligelizumab, a drug characterized as a new generation anti-IgE monoclonal antibody.

Both doses of ligelizumab evaluated met the primary endpoint of superiority to placebo for a complete response at 16 weeks of therapy, reported Marcus Maurer, MD, director of the Urticaria Center for Reference and Excellence at the Charité Hospital, Berlin.

The data from the two identically designed trials, PEARL 1 and PEARL 2, were presented at the annual congress of the European Academy of Dermatology and Venereology. The two ligelizumab experimental arms (72 mg or 120 mg administered subcutaneously every 4 weeks) and the active comparative arm of omalizumab (300 mg administered subcutaneously every 4 weeks) demonstrated similar efficacy, all three of which were highly superior to placebo.

The data show that “another anti-IgE therapy – ligelizumab – is effective in CSU,” Dr. Maurer said.

“While the benefit was not different from omalizumab, ligelizumab showed remarkable results in disease activity and by demonstrating just how many patients achieved what we want them to achieve, which is to have no more signs and symptoms,” he added.
 

Majority of participants with severe urticaria

All of the patients entered into the two trials had severe (about 65%) or moderate (about 35%) symptoms at baseline. The results of the two trials were almost identical. In the randomization arms, a weekly Urticaria Activity Score (UAS7) of 0, which was the primary endpoint, was achieved at week 16 by 31.0% of those receiving 72-mg ligelizumab, 38.3% of those receiving 120-mg ligelizumab, and 34.1% of those receiving omalizumab (Xolair). The placebo response was 5.7%.

The UAS7 score is drawn from two components, wheals and itch. The range is 0 (no symptoms) to 42 (most severe). At baseline, the average patients’ scores were about 30, which correlates with a substantial symptom burden, according to Dr. Maurer.

The mean reduction in the UAS7 score in PEARL 2, which differed from PEARL 1 by no more than 0.4 points for any treatment group, was 19.2 points in the 72-mg ligelizumab group, 19.3 points in the 120-mg ligelizumab group, 19.6 points in the omalizumab group, and 9.2 points in the placebo group. There were no significant differences between any active treatment arm.

Complete symptom relief, meaning a UAS7 score of 0, was selected as the primary endpoint, because Dr. Maurer said that this is the goal of treatment. Although he admitted that a UAS7 score of 0 is analogous to a PASI score in psoriasis of 100 (complete clearing), he said, “Chronic urticaria is a debilitating disease, and we want to eliminate the symptoms. Gone is gone.”

Combined, the two phase 3 trials represent “the biggest chronic urticaria program ever,” according to Dr. Maurer. The 1,034 patients enrolled in PEARL 1 and the 1,023 enrolled in PEARL 2 were randomized in a 3:3:3:1 ratio with placebo representing the smaller group.

The planned follow-up is 52 weeks, but the placebo group will be switched to 120 mg ligelizumab every 4 weeks at the end of 24 weeks. The switch is required because “you cannot maintain patients with this disease on placebo over a long period,” Dr. Maurer said.
 

Ligelizumab associated with low discontinuation rate

Adverse events overall and stratified by severity have been similar across treatment arms, including placebo. The possible exception was a lower rate of moderate events (16.5%) in the placebo arm relative to the 72-mg ligelizumab arm (19.8%), the 120-mg ligelizumab arm (21.6%), and the omalizumab arm (22.3%). Discontinuations because of an adverse event were under 4% in every treatment arm.

Although Dr. Maurer did not present outcomes at 52 weeks, he did note that “only 15% of those who enrolled in these trials have discontinued treatment.” He considered this remarkable in that the study was conducted in the midst of the COVID-19 pandemic, and it appears that at least some of those left the trial did so because of concern for clinic visits.

Despite the similar benefit provided by ligelizumab and omalizumab, Dr. Maurer said that subgroup analyses will be coming. The possibility that some patients benefit more from one than the another cannot yet be ruled out. There are also, as of yet, no data to determine whether at least some patients respond to one after an inadequate response to the other.

Still, given the efficacy and the safety of ligelizumab, Dr. Maurer indicated that the drug is likely to find a role in routine management of CSU if approved.

“We only have two options for chronic spontaneous urticaria. There are antihistamines, which do not usually work, and omalizumab,” he said. “It is very important we develop more treatment options.”

Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, agreed.

“More therapeutic options, especially for disease states that have a small armament – even if equivalent in efficacy to established therapies – is always a win for patients as it almost always increases access to treatment,” Dr. Friedman said in an interview.

“Furthermore, the heterogeneous nature of inflammatory skin diseases is often not captured in even phase 3 studies. Therefore, having additional options could offer relief where previous therapies have failed,” he added.

Dr. Maurer reports financial relationships with more than 10 pharmaceutical companies, including Novartis, which is developing ligelizumab. Dr. Friedman has a financial relationship with more than 20 pharmaceutical companies but has no current financial association with Novartis and was not involved in the PEARL 1 and 2 trials.

MILAN – The therapeutic value of inhibiting the activity of IgE in patients with chronic spontaneous urticaria (CSU) was reinforced by two large phase 3 trials with ligelizumab, a drug characterized as a new generation anti-IgE monoclonal antibody.

Both doses of ligelizumab evaluated met the primary endpoint of superiority to placebo for a complete response at 16 weeks of therapy, reported Marcus Maurer, MD, director of the Urticaria Center for Reference and Excellence at the Charité Hospital, Berlin.

The data from the two identically designed trials, PEARL 1 and PEARL 2, were presented at the annual congress of the European Academy of Dermatology and Venereology. The two ligelizumab experimental arms (72 mg or 120 mg administered subcutaneously every 4 weeks) and the active comparative arm of omalizumab (300 mg administered subcutaneously every 4 weeks) demonstrated similar efficacy, all three of which were highly superior to placebo.

The data show that “another anti-IgE therapy – ligelizumab – is effective in CSU,” Dr. Maurer said.

“While the benefit was not different from omalizumab, ligelizumab showed remarkable results in disease activity and by demonstrating just how many patients achieved what we want them to achieve, which is to have no more signs and symptoms,” he added.
 

Majority of participants with severe urticaria

All of the patients entered into the two trials had severe (about 65%) or moderate (about 35%) symptoms at baseline. The results of the two trials were almost identical. In the randomization arms, a weekly Urticaria Activity Score (UAS7) of 0, which was the primary endpoint, was achieved at week 16 by 31.0% of those receiving 72-mg ligelizumab, 38.3% of those receiving 120-mg ligelizumab, and 34.1% of those receiving omalizumab (Xolair). The placebo response was 5.7%.

The UAS7 score is drawn from two components, wheals and itch. The range is 0 (no symptoms) to 42 (most severe). At baseline, the average patients’ scores were about 30, which correlates with a substantial symptom burden, according to Dr. Maurer.

The mean reduction in the UAS7 score in PEARL 2, which differed from PEARL 1 by no more than 0.4 points for any treatment group, was 19.2 points in the 72-mg ligelizumab group, 19.3 points in the 120-mg ligelizumab group, 19.6 points in the omalizumab group, and 9.2 points in the placebo group. There were no significant differences between any active treatment arm.

Complete symptom relief, meaning a UAS7 score of 0, was selected as the primary endpoint, because Dr. Maurer said that this is the goal of treatment. Although he admitted that a UAS7 score of 0 is analogous to a PASI score in psoriasis of 100 (complete clearing), he said, “Chronic urticaria is a debilitating disease, and we want to eliminate the symptoms. Gone is gone.”

Combined, the two phase 3 trials represent “the biggest chronic urticaria program ever,” according to Dr. Maurer. The 1,034 patients enrolled in PEARL 1 and the 1,023 enrolled in PEARL 2 were randomized in a 3:3:3:1 ratio with placebo representing the smaller group.

The planned follow-up is 52 weeks, but the placebo group will be switched to 120 mg ligelizumab every 4 weeks at the end of 24 weeks. The switch is required because “you cannot maintain patients with this disease on placebo over a long period,” Dr. Maurer said.
 

Ligelizumab associated with low discontinuation rate

Adverse events overall and stratified by severity have been similar across treatment arms, including placebo. The possible exception was a lower rate of moderate events (16.5%) in the placebo arm relative to the 72-mg ligelizumab arm (19.8%), the 120-mg ligelizumab arm (21.6%), and the omalizumab arm (22.3%). Discontinuations because of an adverse event were under 4% in every treatment arm.

Although Dr. Maurer did not present outcomes at 52 weeks, he did note that “only 15% of those who enrolled in these trials have discontinued treatment.” He considered this remarkable in that the study was conducted in the midst of the COVID-19 pandemic, and it appears that at least some of those left the trial did so because of concern for clinic visits.

Despite the similar benefit provided by ligelizumab and omalizumab, Dr. Maurer said that subgroup analyses will be coming. The possibility that some patients benefit more from one than the another cannot yet be ruled out. There are also, as of yet, no data to determine whether at least some patients respond to one after an inadequate response to the other.

Still, given the efficacy and the safety of ligelizumab, Dr. Maurer indicated that the drug is likely to find a role in routine management of CSU if approved.

“We only have two options for chronic spontaneous urticaria. There are antihistamines, which do not usually work, and omalizumab,” he said. “It is very important we develop more treatment options.”

Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, agreed.

“More therapeutic options, especially for disease states that have a small armament – even if equivalent in efficacy to established therapies – is always a win for patients as it almost always increases access to treatment,” Dr. Friedman said in an interview.

“Furthermore, the heterogeneous nature of inflammatory skin diseases is often not captured in even phase 3 studies. Therefore, having additional options could offer relief where previous therapies have failed,” he added.

Dr. Maurer reports financial relationships with more than 10 pharmaceutical companies, including Novartis, which is developing ligelizumab. Dr. Friedman has a financial relationship with more than 20 pharmaceutical companies but has no current financial association with Novartis and was not involved in the PEARL 1 and 2 trials.

A recent uptick in severe respiratory illness in children may be tied to a strain of enterovirus that can cause a rare polio-like condition, according to a Health Network Alert advisory by the Centers for Disease Control and Prevention.

In August, health care providers and hospitals notified the CDC of an increase in severe respiratory illness in children who also tested positive for rhinovirus (RV) or enterovirus (EV). Additional testing revealed that some children were positive for EV-D68, which primarily causes acute respiratory illness. However, the virus has been associated with acute flaccid myelitis (AFM), a rare neurologic condition involving muscle weakness.

Also, in July and August 2022, surveillance networks reported an increase in EV-D68 activity compared with the same months in 2019, 2020, and 2021, the agency said in the alert. As of Aug. 30, the CDC has not received any reports of AFM beginning this year; however, spikes in EV-D68 typically come before cases of AFM, they said.

“Something we are always on the lookout for in the late summer and fall is AFM cases,” said Rick Malley, MD, of the division of infectious disease at Boston Children’s Hospital, in an interview with this news organization. “Unfortunately, we kind of expect them during enterovirus season,” he said. That season is thought to peak in the late summer and early fall.

Since the CDC began tracking AFM in August 2014, there have been 692 confirmed cases in the United States. AFM cases spiked in 2014, 2016, and 2018, mostly in young children. In 2021, there were 28 confirmed cases across 15 states. The CDC did not specify the age of those cases, but in 2018 – when EV-D68 most recently circulated at high levels – the median age of children who visited the emergency department or were hospitalized for EV-D68–associated respiratory illness was 3 years.

“[AFM] can be very severe and it can be very scary for the parents of children who have it,” Dr. Malley said, “but given the prevalence of enteroviruses in the community, you have to conclude it’s a relatively rare event in susceptible individuals. Why some get it and others don’t is unfortunately unclear at this moment.”

The CDC recommends that providers consider EV-D68 as a possible cause for acute, severe respiratory illness in children. If the cause of a respiratory illness in a severely ill patient is not clear, health professionals should test for RVs and EVs, if this is not already part of a typical diagnostic workflow, the agency said. Currently, there are no vaccines or specific treatments for RV or EV, and the CDC recommends supportive clinical management.

The advisory also urged providers to “strongly consider AFM in patients with acute flaccid limb weakness, especially after respiratory illness or fever, and between the months of August and November 2022.”

For any patient presenting with possible AFM, clinicians should collect samples from multiple sources, including cerebrospinal fluid, serum, stool, and a nasopharyngeal or oropharyngeal swab. Samples should be taken “as early as possible and preferably on the day of onset of limb weakness,” the alert said. There is currently no specific medicine for AFM, the agency said, though recommended interventions may vary for each patient.

A version of this article first appeared on Medscape.com.

A recent uptick in severe respiratory illness in children may be tied to a strain of enterovirus that can cause a rare polio-like condition, according to a Health Network Alert advisory by the Centers for Disease Control and Prevention.

In August, health care providers and hospitals notified the CDC of an increase in severe respiratory illness in children who also tested positive for rhinovirus (RV) or enterovirus (EV). Additional testing revealed that some children were positive for EV-D68, which primarily causes acute respiratory illness. However, the virus has been associated with acute flaccid myelitis (AFM), a rare neurologic condition involving muscle weakness.

Also, in July and August 2022, surveillance networks reported an increase in EV-D68 activity compared with the same months in 2019, 2020, and 2021, the agency said in the alert. As of Aug. 30, the CDC has not received any reports of AFM beginning this year; however, spikes in EV-D68 typically come before cases of AFM, they said.

“Something we are always on the lookout for in the late summer and fall is AFM cases,” said Rick Malley, MD, of the division of infectious disease at Boston Children’s Hospital, in an interview with this news organization. “Unfortunately, we kind of expect them during enterovirus season,” he said. That season is thought to peak in the late summer and early fall.

Since the CDC began tracking AFM in August 2014, there have been 692 confirmed cases in the United States. AFM cases spiked in 2014, 2016, and 2018, mostly in young children. In 2021, there were 28 confirmed cases across 15 states. The CDC did not specify the age of those cases, but in 2018 – when EV-D68 most recently circulated at high levels – the median age of children who visited the emergency department or were hospitalized for EV-D68–associated respiratory illness was 3 years.

“[AFM] can be very severe and it can be very scary for the parents of children who have it,” Dr. Malley said, “but given the prevalence of enteroviruses in the community, you have to conclude it’s a relatively rare event in susceptible individuals. Why some get it and others don’t is unfortunately unclear at this moment.”

The CDC recommends that providers consider EV-D68 as a possible cause for acute, severe respiratory illness in children. If the cause of a respiratory illness in a severely ill patient is not clear, health professionals should test for RVs and EVs, if this is not already part of a typical diagnostic workflow, the agency said. Currently, there are no vaccines or specific treatments for RV or EV, and the CDC recommends supportive clinical management.

The advisory also urged providers to “strongly consider AFM in patients with acute flaccid limb weakness, especially after respiratory illness or fever, and between the months of August and November 2022.”

For any patient presenting with possible AFM, clinicians should collect samples from multiple sources, including cerebrospinal fluid, serum, stool, and a nasopharyngeal or oropharyngeal swab. Samples should be taken “as early as possible and preferably on the day of onset of limb weakness,” the alert said. There is currently no specific medicine for AFM, the agency said, though recommended interventions may vary for each patient.

A version of this article first appeared on Medscape.com.

A recent uptick in severe respiratory illness in children may be tied to a strain of enterovirus that can cause a rare polio-like condition, according to a Health Network Alert advisory by the Centers for Disease Control and Prevention.

In August, health care providers and hospitals notified the CDC of an increase in severe respiratory illness in children who also tested positive for rhinovirus (RV) or enterovirus (EV). Additional testing revealed that some children were positive for EV-D68, which primarily causes acute respiratory illness. However, the virus has been associated with acute flaccid myelitis (AFM), a rare neurologic condition involving muscle weakness.

Also, in July and August 2022, surveillance networks reported an increase in EV-D68 activity compared with the same months in 2019, 2020, and 2021, the agency said in the alert. As of Aug. 30, the CDC has not received any reports of AFM beginning this year; however, spikes in EV-D68 typically come before cases of AFM, they said.

“Something we are always on the lookout for in the late summer and fall is AFM cases,” said Rick Malley, MD, of the division of infectious disease at Boston Children’s Hospital, in an interview with this news organization. “Unfortunately, we kind of expect them during enterovirus season,” he said. That season is thought to peak in the late summer and early fall.

Since the CDC began tracking AFM in August 2014, there have been 692 confirmed cases in the United States. AFM cases spiked in 2014, 2016, and 2018, mostly in young children. In 2021, there were 28 confirmed cases across 15 states. The CDC did not specify the age of those cases, but in 2018 – when EV-D68 most recently circulated at high levels – the median age of children who visited the emergency department or were hospitalized for EV-D68–associated respiratory illness was 3 years.

“[AFM] can be very severe and it can be very scary for the parents of children who have it,” Dr. Malley said, “but given the prevalence of enteroviruses in the community, you have to conclude it’s a relatively rare event in susceptible individuals. Why some get it and others don’t is unfortunately unclear at this moment.”

The CDC recommends that providers consider EV-D68 as a possible cause for acute, severe respiratory illness in children. If the cause of a respiratory illness in a severely ill patient is not clear, health professionals should test for RVs and EVs, if this is not already part of a typical diagnostic workflow, the agency said. Currently, there are no vaccines or specific treatments for RV or EV, and the CDC recommends supportive clinical management.

The advisory also urged providers to “strongly consider AFM in patients with acute flaccid limb weakness, especially after respiratory illness or fever, and between the months of August and November 2022.”

For any patient presenting with possible AFM, clinicians should collect samples from multiple sources, including cerebrospinal fluid, serum, stool, and a nasopharyngeal or oropharyngeal swab. Samples should be taken “as early as possible and preferably on the day of onset of limb weakness,” the alert said. There is currently no specific medicine for AFM, the agency said, though recommended interventions may vary for each patient.

A version of this article first appeared on Medscape.com.

You can observe a lot by watching. – Yogi Berra

He was a fit man in his 40s. Thick legs. Maybe he was a long-distance walker? The bones of his right arm were more developed than his left – a right-handed thrower. His lower left fibula was fractured from a severely rolled ankle. He carried a walking stick that was glossy in the middle from where he gripped it with his left hand, dragging his bad left foot along. Dental cavities tell the story of his diet: honey, carobs, dates. Carbon 14 dating confirms that he lived during the Chalcolithic period, approximately 6,000 years ago. He was likely a shepherd in the Judean Desert.

Isn’t it amazing how much we can know about another human even across such an enormous chasm of time? If you’d asked me when I was 11 what I wanted to be, I’d have said archaeologist. How cool to study artifacts and recreate stories from eons ago! I sometimes still get to be that kid in my office. Noticing people, their scars, their flaws, knowing there is a story behind each one.

A 64-year-old woman with a 4-cm red, brown shiny plaque on her right calf. She burned it on her boyfriend’s Harley Davidson nearly 40 years ago. She wonders where he is now.

A 58-year-old man with a 3-inch scar on his right wrist. He fell off his 6-year-old’s skimboard. ORIF.

A 40-year-old woman with bilateral mastectomy scars.

A 66-year-old with a lichenified nodule on his left forearm. When I shaved it off, a quarter inch spicule of glass came out. It was from a car accident in his first car, a Chevy Impala. He saved the piece of glass as a souvenir.

A fit 50-year-old with extensive scars on his feet and ankles. “Yeah, I went ‘whistling-in’ on a training jump,” he said. He was a retired Navy Seal and raconteur with quite a tale about the day his parachute malfunctioned. Some well placed live oak trees is why he’s around for his skin screening.

A classic, rope-like open-heart scar on the chest of a thin, young, healthy, flaxen-haired woman. Dissected aorta.

A 30-something woman dressed in a pants suit with razor-thin parallel scars on her volar forearms and proximal thighs. She asks if any laser could remove them.

A rotund, hard-living, bearded man with chest and upper-arm tattoos of flames and nudie girls now mixed with the striking face of an old woman and three little kids: His mom and grandkids. He shows me where the fourth grandkid will go and gives me a bear hug to thank me for the care when he leaves.

Attending to these details shifts us from autopilot to present. It keeps us involved, holding our attention even if it’s the 20th skin screening or diabetic foot exam of the day. And what a gift to share in the intimate details of another’s life.

Like examining the minute details of an ancient bone, dig for the history with curiosity, pity, humility. The perfect moment for asking might be when you stand with your #15 blade ready to introduce a new scar and become part of this human’s story forever.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

You can observe a lot by watching. – Yogi Berra

He was a fit man in his 40s. Thick legs. Maybe he was a long-distance walker? The bones of his right arm were more developed than his left – a right-handed thrower. His lower left fibula was fractured from a severely rolled ankle. He carried a walking stick that was glossy in the middle from where he gripped it with his left hand, dragging his bad left foot along. Dental cavities tell the story of his diet: honey, carobs, dates. Carbon 14 dating confirms that he lived during the Chalcolithic period, approximately 6,000 years ago. He was likely a shepherd in the Judean Desert.

Isn’t it amazing how much we can know about another human even across such an enormous chasm of time? If you’d asked me when I was 11 what I wanted to be, I’d have said archaeologist. How cool to study artifacts and recreate stories from eons ago! I sometimes still get to be that kid in my office. Noticing people, their scars, their flaws, knowing there is a story behind each one.

A 64-year-old woman with a 4-cm red, brown shiny plaque on her right calf. She burned it on her boyfriend’s Harley Davidson nearly 40 years ago. She wonders where he is now.

A 58-year-old man with a 3-inch scar on his right wrist. He fell off his 6-year-old’s skimboard. ORIF.

A 40-year-old woman with bilateral mastectomy scars.

A 66-year-old with a lichenified nodule on his left forearm. When I shaved it off, a quarter inch spicule of glass came out. It was from a car accident in his first car, a Chevy Impala. He saved the piece of glass as a souvenir.

A fit 50-year-old with extensive scars on his feet and ankles. “Yeah, I went ‘whistling-in’ on a training jump,” he said. He was a retired Navy Seal and raconteur with quite a tale about the day his parachute malfunctioned. Some well placed live oak trees is why he’s around for his skin screening.

A classic, rope-like open-heart scar on the chest of a thin, young, healthy, flaxen-haired woman. Dissected aorta.

A 30-something woman dressed in a pants suit with razor-thin parallel scars on her volar forearms and proximal thighs. She asks if any laser could remove them.

A rotund, hard-living, bearded man with chest and upper-arm tattoos of flames and nudie girls now mixed with the striking face of an old woman and three little kids: His mom and grandkids. He shows me where the fourth grandkid will go and gives me a bear hug to thank me for the care when he leaves.

Attending to these details shifts us from autopilot to present. It keeps us involved, holding our attention even if it’s the 20th skin screening or diabetic foot exam of the day. And what a gift to share in the intimate details of another’s life.

Like examining the minute details of an ancient bone, dig for the history with curiosity, pity, humility. The perfect moment for asking might be when you stand with your #15 blade ready to introduce a new scar and become part of this human’s story forever.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

You can observe a lot by watching. – Yogi Berra

He was a fit man in his 40s. Thick legs. Maybe he was a long-distance walker? The bones of his right arm were more developed than his left – a right-handed thrower. His lower left fibula was fractured from a severely rolled ankle. He carried a walking stick that was glossy in the middle from where he gripped it with his left hand, dragging his bad left foot along. Dental cavities tell the story of his diet: honey, carobs, dates. Carbon 14 dating confirms that he lived during the Chalcolithic period, approximately 6,000 years ago. He was likely a shepherd in the Judean Desert.

Isn’t it amazing how much we can know about another human even across such an enormous chasm of time? If you’d asked me when I was 11 what I wanted to be, I’d have said archaeologist. How cool to study artifacts and recreate stories from eons ago! I sometimes still get to be that kid in my office. Noticing people, their scars, their flaws, knowing there is a story behind each one.

A 64-year-old woman with a 4-cm red, brown shiny plaque on her right calf. She burned it on her boyfriend’s Harley Davidson nearly 40 years ago. She wonders where he is now.

A 58-year-old man with a 3-inch scar on his right wrist. He fell off his 6-year-old’s skimboard. ORIF.

A 40-year-old woman with bilateral mastectomy scars.

A 66-year-old with a lichenified nodule on his left forearm. When I shaved it off, a quarter inch spicule of glass came out. It was from a car accident in his first car, a Chevy Impala. He saved the piece of glass as a souvenir.

A fit 50-year-old with extensive scars on his feet and ankles. “Yeah, I went ‘whistling-in’ on a training jump,” he said. He was a retired Navy Seal and raconteur with quite a tale about the day his parachute malfunctioned. Some well placed live oak trees is why he’s around for his skin screening.

A classic, rope-like open-heart scar on the chest of a thin, young, healthy, flaxen-haired woman. Dissected aorta.

A 30-something woman dressed in a pants suit with razor-thin parallel scars on her volar forearms and proximal thighs. She asks if any laser could remove them.

A rotund, hard-living, bearded man with chest and upper-arm tattoos of flames and nudie girls now mixed with the striking face of an old woman and three little kids: His mom and grandkids. He shows me where the fourth grandkid will go and gives me a bear hug to thank me for the care when he leaves.

Attending to these details shifts us from autopilot to present. It keeps us involved, holding our attention even if it’s the 20th skin screening or diabetic foot exam of the day. And what a gift to share in the intimate details of another’s life.

Like examining the minute details of an ancient bone, dig for the history with curiosity, pity, humility. The perfect moment for asking might be when you stand with your #15 blade ready to introduce a new scar and become part of this human’s story forever.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

The PREDICT score does not seem to be particularly accurate when it comes to estimating overall survival (OS) in patients with HER2-positive early breast cancer who are treated with modern chemotherapy and anti-HER2 targeted therapies. This is the conclusion of an international study published in the journal npj Breast Cancer. The work was supervised by Matteo Lambertini, MD, PhD, an oncologist at the IRCCS San Martino Polyclinic Hospital in Genoa, Italy.

As the authors explain, “PREDICT is a publicly available online tool that helps to predict the individual prognosis of patients with early breast cancer and to show the impact of adjuvant treatments administered after breast cancer surgery.” The tool uses traditional clinical-pathological factors. The authors also point out that the original version of this tool was validated in several datasets of patients with breast cancer. In 2011, it was updated to include HER2 status.

The investigators noted that, although the use of PREDICT is recommended to aid decision-making in the adjuvant setting, its prognostic role in patients with HER2-positive early breast cancer who are treated with modern chemotherapy and anti-HER2 therapies – even trastuzumab-based ones – remains unclear.

Therefore, they decided to analyze PREDICT’s prognostic performance using data extracted from the ALTTO trial, the largest adjuvant study ever conducted in the field of HER2-positive early breast cancer. That trial “represented a unique opportunity to investigate the reliability and prognostic performance of PREDICT in women with HER2-positive disease,” according to the investigators. They went on to specify that ALTTO evaluated adjuvant lapatinib plus trastuzumab vs. trastuzumab alone in 8,381 patients – 2,794 of whom were included in their own analysis.

What the analysis found was that, overall, PREDICT underestimated 5-year OS by 6.7%. The observed 5-year OS was 94.7%, and the predicted 5-year OS was 88.0%.

“The underestimation was consistent across all subgroups, including those according to the type of anti-HER2 therapy. The highest absolute differences were observed for patients with hormone receptor–negative disease, nodal involvement, and large tumor size (13.0%, 15.8%, and 15.3%, respectively),” they wrote. Furthermore, they reported that “the suboptimal performance of this prognostic tool was observed irrespective of type of anti-HER2 treatment, type of chemotherapy regimen, age of the patients at the time of diagnosis, central hormone receptor status, pathological nodal status, and pathological tumor size.”

To potentially explain the reasons for the underestimation of patients’ OS, the authors questioned whether the population used to validate PREDICT accurately mirrored the real-world population of patients with HER2-positive disease treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies. “Moreover, the current standard of care for early breast cancer is even superior to the treatment received by many patients in the ALTTO study. … As such, the discordance between OS estimated by PREDICT and the current real-world OS is expected to be even higher. Therefore,” the researchers concluded, “our results suggest that the current version of PREDICT should be used with caution for prognostication in HER2-positive early breast cancer patients treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies.”

A version of this article first appeared on Medscape.com. This article was translated from Univadis Italy.

The PREDICT score does not seem to be particularly accurate when it comes to estimating overall survival (OS) in patients with HER2-positive early breast cancer who are treated with modern chemotherapy and anti-HER2 targeted therapies. This is the conclusion of an international study published in the journal npj Breast Cancer. The work was supervised by Matteo Lambertini, MD, PhD, an oncologist at the IRCCS San Martino Polyclinic Hospital in Genoa, Italy.

As the authors explain, “PREDICT is a publicly available online tool that helps to predict the individual prognosis of patients with early breast cancer and to show the impact of adjuvant treatments administered after breast cancer surgery.” The tool uses traditional clinical-pathological factors. The authors also point out that the original version of this tool was validated in several datasets of patients with breast cancer. In 2011, it was updated to include HER2 status.

The investigators noted that, although the use of PREDICT is recommended to aid decision-making in the adjuvant setting, its prognostic role in patients with HER2-positive early breast cancer who are treated with modern chemotherapy and anti-HER2 therapies – even trastuzumab-based ones – remains unclear.

Therefore, they decided to analyze PREDICT’s prognostic performance using data extracted from the ALTTO trial, the largest adjuvant study ever conducted in the field of HER2-positive early breast cancer. That trial “represented a unique opportunity to investigate the reliability and prognostic performance of PREDICT in women with HER2-positive disease,” according to the investigators. They went on to specify that ALTTO evaluated adjuvant lapatinib plus trastuzumab vs. trastuzumab alone in 8,381 patients – 2,794 of whom were included in their own analysis.

What the analysis found was that, overall, PREDICT underestimated 5-year OS by 6.7%. The observed 5-year OS was 94.7%, and the predicted 5-year OS was 88.0%.

“The underestimation was consistent across all subgroups, including those according to the type of anti-HER2 therapy. The highest absolute differences were observed for patients with hormone receptor–negative disease, nodal involvement, and large tumor size (13.0%, 15.8%, and 15.3%, respectively),” they wrote. Furthermore, they reported that “the suboptimal performance of this prognostic tool was observed irrespective of type of anti-HER2 treatment, type of chemotherapy regimen, age of the patients at the time of diagnosis, central hormone receptor status, pathological nodal status, and pathological tumor size.”

To potentially explain the reasons for the underestimation of patients’ OS, the authors questioned whether the population used to validate PREDICT accurately mirrored the real-world population of patients with HER2-positive disease treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies. “Moreover, the current standard of care for early breast cancer is even superior to the treatment received by many patients in the ALTTO study. … As such, the discordance between OS estimated by PREDICT and the current real-world OS is expected to be even higher. Therefore,” the researchers concluded, “our results suggest that the current version of PREDICT should be used with caution for prognostication in HER2-positive early breast cancer patients treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies.”

A version of this article first appeared on Medscape.com. This article was translated from Univadis Italy.

The PREDICT score does not seem to be particularly accurate when it comes to estimating overall survival (OS) in patients with HER2-positive early breast cancer who are treated with modern chemotherapy and anti-HER2 targeted therapies. This is the conclusion of an international study published in the journal npj Breast Cancer. The work was supervised by Matteo Lambertini, MD, PhD, an oncologist at the IRCCS San Martino Polyclinic Hospital in Genoa, Italy.

As the authors explain, “PREDICT is a publicly available online tool that helps to predict the individual prognosis of patients with early breast cancer and to show the impact of adjuvant treatments administered after breast cancer surgery.” The tool uses traditional clinical-pathological factors. The authors also point out that the original version of this tool was validated in several datasets of patients with breast cancer. In 2011, it was updated to include HER2 status.

The investigators noted that, although the use of PREDICT is recommended to aid decision-making in the adjuvant setting, its prognostic role in patients with HER2-positive early breast cancer who are treated with modern chemotherapy and anti-HER2 therapies – even trastuzumab-based ones – remains unclear.

Therefore, they decided to analyze PREDICT’s prognostic performance using data extracted from the ALTTO trial, the largest adjuvant study ever conducted in the field of HER2-positive early breast cancer. That trial “represented a unique opportunity to investigate the reliability and prognostic performance of PREDICT in women with HER2-positive disease,” according to the investigators. They went on to specify that ALTTO evaluated adjuvant lapatinib plus trastuzumab vs. trastuzumab alone in 8,381 patients – 2,794 of whom were included in their own analysis.

What the analysis found was that, overall, PREDICT underestimated 5-year OS by 6.7%. The observed 5-year OS was 94.7%, and the predicted 5-year OS was 88.0%.

“The underestimation was consistent across all subgroups, including those according to the type of anti-HER2 therapy. The highest absolute differences were observed for patients with hormone receptor–negative disease, nodal involvement, and large tumor size (13.0%, 15.8%, and 15.3%, respectively),” they wrote. Furthermore, they reported that “the suboptimal performance of this prognostic tool was observed irrespective of type of anti-HER2 treatment, type of chemotherapy regimen, age of the patients at the time of diagnosis, central hormone receptor status, pathological nodal status, and pathological tumor size.”

To potentially explain the reasons for the underestimation of patients’ OS, the authors questioned whether the population used to validate PREDICT accurately mirrored the real-world population of patients with HER2-positive disease treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies. “Moreover, the current standard of care for early breast cancer is even superior to the treatment received by many patients in the ALTTO study. … As such, the discordance between OS estimated by PREDICT and the current real-world OS is expected to be even higher. Therefore,” the researchers concluded, “our results suggest that the current version of PREDICT should be used with caution for prognostication in HER2-positive early breast cancer patients treated in the modern era with effective chemotherapy and anti-HER2 targeted therapies.”

A version of this article first appeared on Medscape.com. This article was translated from Univadis Italy.