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Hands trained for surgery now on machine gun: Kyiv oncologist
The pediatric oncology unit in Kyiv’s National Cancer Institute is empty, with all the children evacuated to safer hospitals in Western Ukraine or further, making it a good place to talk on Zoom.
Against a backdrop of colorful animals painted on the wall, Oleksandr Stakhovskyi, MD, PhD, speaks optimistically about the future of his city, his country, and even his patients, despite acknowledging that his surgical hands are now trained to use a machine gun.
“It’s not as bad as last week,” he laughs, explaining that residents of Kyiv are more relaxed now, despite the air raid sirens, because the city’s anti-missile system has thus far kept them safe.
Even still, missiles have continued hitting civilian residences and Dr. Stakhovskyi, a urologic-oncology surgeon, has evacuated his wife and children out of the country, as have 70% of his colleagues. But for those who stayed in Kyiv, there is a strong resolve.
“People working in IT, in law, in other professions — they just took the guns and stayed in Kyiv,” he said in an interview. “They are just civilians, armed, trying to protect and fortify Kyiv — to make it unbreakable.”
Dr. Stakhovskyi doesn’t have a background in the military, but he now knows how to use a machine gun. “I am a super-specialized oncologist, [but] I realize if I leave right now it will give the Russians momentum to come in. The longer it takes, the weaker the opponent army will become, and we are more and more optimistic,” he said.
In Kyiv, Dr. Stakhovskyi is working half the time at the cancer hospital and the other half at the nearby military hospital, but he said so far war casualties are minimal within the city, and even the flow of patients with cancer has reduced.
“I had my surgeries planned up until the end of March, but when the war started, they were all postponed,” he said. Emergency cancer surgeries have continued, and now there is talk of resuming some others. “We will stratify patients into categories based on need,” he said. “For those patients whose surgery can basically stop the disease and they don’t need neoadjuvant chemo, we’ll probably be doing those.”
Medical oncology clinics have also resumed, said Dr. Stakhovskyi, but the volume of patients is low, because many have left the city. An estimated 3.3 million people have left Ukraine since the Russian invasion on February 24.
Across the country, in Lviv near the Polish border, another surgical oncologist tells a different story. Andriy Hrynkiv, MD, from Lviv Regional Cancer Center, says his hospital has seen a dramatic increase in patients, displaced internally from areas where the medical infrastructure has collapsed.
“Russian forces have destroyed more than 117 hospitals, 43 ambulances have been shot at, 6 doctors have been killed, and 13 wounded,” Dr. Hrynkiv said. In the city of Mariupol, “doctors and patients have been taken hostage,” he said, used by Russian forces as a human shield. In Kharkiv, with approximately 1.5 million residents, the only oncologic hospital has been destroyed.
There is a shortage and instability of medical supplies including all iodine-containing medications that citizens are stocking up on in the face of a potential nuclear attack, he said.
Dr. Hrynkiv was speaking on a webcast organized by the American Society of Clinical Oncology (ASCO) and European Cancer Organisation (ECO).
The two organizations are collaborating with each other and the World Health Organization to create a special network that is aiming to connect professionals, academic and clinical centers, and patient groups.
Additionally, the Ukranian Society of Clinical Oncology (USCO), cofounded by Dr. Stakhovskyi, is trying to keep patients connected with nongovernment organizations.
“These patient organizations moved west when the war started, but they still use us to help them make contact with foreign doctors,” he said. “We have tried to centralize this process but it’s very difficult because patients and organizations are also calling doctors and centers directly looking for treatment options.”
He says USCO is also coordinating the distribution of a donation of immunotherapy pembrolizumab (Keytruda) from pharmaceutical company Merck Sharp & Dohme. “It’s a huge influx of this drug,” he says. “They’ve promised something like 2,000 doses to cover 230 patients for 3 months at least. Usually this is not an easy drug to access for people in Ukraine because it’s really expensive.”
Dr. Stakhovskyi said the optimism he feels is fueled by the support that Ukrainians feel from the rest of the world.
“We see the reaction of our international colleagues. It is so impressive and touching — lots of my ex-professors are texting me and sending me messages from all over the place, from Germany, from Canada, from France, from the United States,” he said. “And if we can be optimistic for ourselves, definitely that translates to our patients.”
A version of this article first appeared on Medscape.com.
The pediatric oncology unit in Kyiv’s National Cancer Institute is empty, with all the children evacuated to safer hospitals in Western Ukraine or further, making it a good place to talk on Zoom.
Against a backdrop of colorful animals painted on the wall, Oleksandr Stakhovskyi, MD, PhD, speaks optimistically about the future of his city, his country, and even his patients, despite acknowledging that his surgical hands are now trained to use a machine gun.
“It’s not as bad as last week,” he laughs, explaining that residents of Kyiv are more relaxed now, despite the air raid sirens, because the city’s anti-missile system has thus far kept them safe.
Even still, missiles have continued hitting civilian residences and Dr. Stakhovskyi, a urologic-oncology surgeon, has evacuated his wife and children out of the country, as have 70% of his colleagues. But for those who stayed in Kyiv, there is a strong resolve.
“People working in IT, in law, in other professions — they just took the guns and stayed in Kyiv,” he said in an interview. “They are just civilians, armed, trying to protect and fortify Kyiv — to make it unbreakable.”
Dr. Stakhovskyi doesn’t have a background in the military, but he now knows how to use a machine gun. “I am a super-specialized oncologist, [but] I realize if I leave right now it will give the Russians momentum to come in. The longer it takes, the weaker the opponent army will become, and we are more and more optimistic,” he said.
In Kyiv, Dr. Stakhovskyi is working half the time at the cancer hospital and the other half at the nearby military hospital, but he said so far war casualties are minimal within the city, and even the flow of patients with cancer has reduced.
“I had my surgeries planned up until the end of March, but when the war started, they were all postponed,” he said. Emergency cancer surgeries have continued, and now there is talk of resuming some others. “We will stratify patients into categories based on need,” he said. “For those patients whose surgery can basically stop the disease and they don’t need neoadjuvant chemo, we’ll probably be doing those.”
Medical oncology clinics have also resumed, said Dr. Stakhovskyi, but the volume of patients is low, because many have left the city. An estimated 3.3 million people have left Ukraine since the Russian invasion on February 24.
Across the country, in Lviv near the Polish border, another surgical oncologist tells a different story. Andriy Hrynkiv, MD, from Lviv Regional Cancer Center, says his hospital has seen a dramatic increase in patients, displaced internally from areas where the medical infrastructure has collapsed.
“Russian forces have destroyed more than 117 hospitals, 43 ambulances have been shot at, 6 doctors have been killed, and 13 wounded,” Dr. Hrynkiv said. In the city of Mariupol, “doctors and patients have been taken hostage,” he said, used by Russian forces as a human shield. In Kharkiv, with approximately 1.5 million residents, the only oncologic hospital has been destroyed.
There is a shortage and instability of medical supplies including all iodine-containing medications that citizens are stocking up on in the face of a potential nuclear attack, he said.
Dr. Hrynkiv was speaking on a webcast organized by the American Society of Clinical Oncology (ASCO) and European Cancer Organisation (ECO).
The two organizations are collaborating with each other and the World Health Organization to create a special network that is aiming to connect professionals, academic and clinical centers, and patient groups.
Additionally, the Ukranian Society of Clinical Oncology (USCO), cofounded by Dr. Stakhovskyi, is trying to keep patients connected with nongovernment organizations.
“These patient organizations moved west when the war started, but they still use us to help them make contact with foreign doctors,” he said. “We have tried to centralize this process but it’s very difficult because patients and organizations are also calling doctors and centers directly looking for treatment options.”
He says USCO is also coordinating the distribution of a donation of immunotherapy pembrolizumab (Keytruda) from pharmaceutical company Merck Sharp & Dohme. “It’s a huge influx of this drug,” he says. “They’ve promised something like 2,000 doses to cover 230 patients for 3 months at least. Usually this is not an easy drug to access for people in Ukraine because it’s really expensive.”
Dr. Stakhovskyi said the optimism he feels is fueled by the support that Ukrainians feel from the rest of the world.
“We see the reaction of our international colleagues. It is so impressive and touching — lots of my ex-professors are texting me and sending me messages from all over the place, from Germany, from Canada, from France, from the United States,” he said. “And if we can be optimistic for ourselves, definitely that translates to our patients.”
A version of this article first appeared on Medscape.com.
The pediatric oncology unit in Kyiv’s National Cancer Institute is empty, with all the children evacuated to safer hospitals in Western Ukraine or further, making it a good place to talk on Zoom.
Against a backdrop of colorful animals painted on the wall, Oleksandr Stakhovskyi, MD, PhD, speaks optimistically about the future of his city, his country, and even his patients, despite acknowledging that his surgical hands are now trained to use a machine gun.
“It’s not as bad as last week,” he laughs, explaining that residents of Kyiv are more relaxed now, despite the air raid sirens, because the city’s anti-missile system has thus far kept them safe.
Even still, missiles have continued hitting civilian residences and Dr. Stakhovskyi, a urologic-oncology surgeon, has evacuated his wife and children out of the country, as have 70% of his colleagues. But for those who stayed in Kyiv, there is a strong resolve.
“People working in IT, in law, in other professions — they just took the guns and stayed in Kyiv,” he said in an interview. “They are just civilians, armed, trying to protect and fortify Kyiv — to make it unbreakable.”
Dr. Stakhovskyi doesn’t have a background in the military, but he now knows how to use a machine gun. “I am a super-specialized oncologist, [but] I realize if I leave right now it will give the Russians momentum to come in. The longer it takes, the weaker the opponent army will become, and we are more and more optimistic,” he said.
In Kyiv, Dr. Stakhovskyi is working half the time at the cancer hospital and the other half at the nearby military hospital, but he said so far war casualties are minimal within the city, and even the flow of patients with cancer has reduced.
“I had my surgeries planned up until the end of March, but when the war started, they were all postponed,” he said. Emergency cancer surgeries have continued, and now there is talk of resuming some others. “We will stratify patients into categories based on need,” he said. “For those patients whose surgery can basically stop the disease and they don’t need neoadjuvant chemo, we’ll probably be doing those.”
Medical oncology clinics have also resumed, said Dr. Stakhovskyi, but the volume of patients is low, because many have left the city. An estimated 3.3 million people have left Ukraine since the Russian invasion on February 24.
Across the country, in Lviv near the Polish border, another surgical oncologist tells a different story. Andriy Hrynkiv, MD, from Lviv Regional Cancer Center, says his hospital has seen a dramatic increase in patients, displaced internally from areas where the medical infrastructure has collapsed.
“Russian forces have destroyed more than 117 hospitals, 43 ambulances have been shot at, 6 doctors have been killed, and 13 wounded,” Dr. Hrynkiv said. In the city of Mariupol, “doctors and patients have been taken hostage,” he said, used by Russian forces as a human shield. In Kharkiv, with approximately 1.5 million residents, the only oncologic hospital has been destroyed.
There is a shortage and instability of medical supplies including all iodine-containing medications that citizens are stocking up on in the face of a potential nuclear attack, he said.
Dr. Hrynkiv was speaking on a webcast organized by the American Society of Clinical Oncology (ASCO) and European Cancer Organisation (ECO).
The two organizations are collaborating with each other and the World Health Organization to create a special network that is aiming to connect professionals, academic and clinical centers, and patient groups.
Additionally, the Ukranian Society of Clinical Oncology (USCO), cofounded by Dr. Stakhovskyi, is trying to keep patients connected with nongovernment organizations.
“These patient organizations moved west when the war started, but they still use us to help them make contact with foreign doctors,” he said. “We have tried to centralize this process but it’s very difficult because patients and organizations are also calling doctors and centers directly looking for treatment options.”
He says USCO is also coordinating the distribution of a donation of immunotherapy pembrolizumab (Keytruda) from pharmaceutical company Merck Sharp & Dohme. “It’s a huge influx of this drug,” he says. “They’ve promised something like 2,000 doses to cover 230 patients for 3 months at least. Usually this is not an easy drug to access for people in Ukraine because it’s really expensive.”
Dr. Stakhovskyi said the optimism he feels is fueled by the support that Ukrainians feel from the rest of the world.
“We see the reaction of our international colleagues. It is so impressive and touching — lots of my ex-professors are texting me and sending me messages from all over the place, from Germany, from Canada, from France, from the United States,” he said. “And if we can be optimistic for ourselves, definitely that translates to our patients.”
A version of this article first appeared on Medscape.com.
Yes, Russian docs should be shut out of medical associations, says ethicist
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the division of medical ethics at the NYU Grossman School of Medicine.
There are many difficult moral issues that are being fueled by the terrible war that Russia is waging against Ukraine. I think there is no way to justify anything that the Russians are doing. Ukraine did not do anything to violate Russian integrity, Russian territorial integrity, or anything by way of being aggressive toward Russia.
Russia decided at some point it wanted the Ukraine back. Putin has a dream, as the long-standing leader of Russia, to restore the Soviet empire, and Ukraine is top of the list of the places that he wants back for a variety of reasons.
We’re not here to debate the merits and demerits of this terrible act of war.
The European Society of Cardiology made a decision very recently to drop, as members, both Russia and Belarus, Russia’s ally in this aggressive war against Ukraine. They basically found it intolerable to have business as usual with these subsidiary cardiology societies as part of the ongoing activities of the European group.
The sole goal of this overarching European group is to reduce the health burden of cardiovascular disease. It doesn’t have political goals. It doesn’t have much to say about anything other than, “Let’s get evidence-based medicine used to try and prevent heart disease or treat heart disease.” So there’s noble intent.
Many of its members asked, “What are we doing in politics? Why are we punishing Russian and Belarussian cardiologists, acting as if somehow they are responsible for what the Russian army is doing or for what Putin has decided to do? Why are we acting against them? They are just trying to fight heart disease. That’s a legitimate goal for any doctor, public health official, or scientist.” They didn’t see, as members, why this exclusion had taken place.
I believe the exclusion is appropriate and some of the membership, obviously, in the European Society of Cardiology, agrees. It’s not because they’re holding doctors or scientists directly accountable for Putin’s war crimes, ethnic cleansing assault, or bombing and shelling of hospitals, maternity hospitals, and civilians.
They understand that these scientists and doctors have little to do with such things, but we are in a new form of warfare, and that warfare is basically economic and sociologic: turning Russia, as an inexcusably aggressive state, into a pariah.
The reason to break the ties is that that is the way to bring pressure upon Putin and his kleptocratic, oligarchic advisers to stop the attack, to try and bring down their economy, to say, “Business is not going to go on as usual. You will be excluded from normal scientific and medical commerce. We’re not going to be holding conferences or exchanging ideas,” and in my view, extending it to say, “We’re not taking your papers, we’re not publishing anything you do. We’re not even having you speak at our meetings until this war, this aggressive invasion, and these war crimes come to a halt.”
There is actually a basis for this action. It isn’t in the organization’s own bylaws, which as I said, are very simple — reduce cardiovascular disease burden — but they are a member of a broader group, the Biomedical Alliance in Europe, which does have a very explicit code of ethics.
I’m going to read you a little bit from that code. It says healthcare organizations should uphold and promote equality, diversity and inclusion, accountability, transparency, and equality. They also say that all members, including the European Society of Cardiology, should be committed both to the Declaration of Helsinki, a fundamental medical ethics document, and the Declaration of Geneva. These rules refer to the highest respect of human beings, responsible resource allocation, and preservation of the environment, among other things.
What the organization is doing is consistent with the code of ethics that the broader organization of all the medical societies of Europe say that these individual groups should be doing. You can’t collaborate with war criminals. You can’t act as if business as usual is going on. That’s not inclusive. That’s not respect for diversity.
I think the Ukrainian medical societies of cardiology and other specialties would find it grimly ironic to say that keeping Russian and Belarus members makes sense, given what’s going on in their country and what is happening to them. They’re under attack. They’re being killed. Their healthcare institutions are being indiscriminately shelled and bombed.
It’s very hard — and I understand that — to say we’re going to punish scientists. We’re going to, perhaps, even cause public health problems in Russia because we’re not going to collaborate right now with doctors and scientists in cardiology or any other medical specialty. I think it’s what has to be done.
We’re in a new era of trying to combat what is basically organized, international ethnic terrorism, complete with war crimes. We fight financially. We fight by isolating. We fight by excluding. It’s painful. It’s difficult. It’s somewhat unfair to individuals.
Only through that kind of pain are we going to get the kind of pressure that will achieve justice. I think that is a goal that we have to commend the European Society of Cardiology for honoring.
Dr. Caplan is director of the division of medical ethics at New York University. He is the author or editor of 35 books and 750 peer-reviewed articles as well as a frequent commentator in the media on bioethical issues. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (an unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the division of medical ethics at the NYU Grossman School of Medicine.
There are many difficult moral issues that are being fueled by the terrible war that Russia is waging against Ukraine. I think there is no way to justify anything that the Russians are doing. Ukraine did not do anything to violate Russian integrity, Russian territorial integrity, or anything by way of being aggressive toward Russia.
Russia decided at some point it wanted the Ukraine back. Putin has a dream, as the long-standing leader of Russia, to restore the Soviet empire, and Ukraine is top of the list of the places that he wants back for a variety of reasons.
We’re not here to debate the merits and demerits of this terrible act of war.
The European Society of Cardiology made a decision very recently to drop, as members, both Russia and Belarus, Russia’s ally in this aggressive war against Ukraine. They basically found it intolerable to have business as usual with these subsidiary cardiology societies as part of the ongoing activities of the European group.
The sole goal of this overarching European group is to reduce the health burden of cardiovascular disease. It doesn’t have political goals. It doesn’t have much to say about anything other than, “Let’s get evidence-based medicine used to try and prevent heart disease or treat heart disease.” So there’s noble intent.
Many of its members asked, “What are we doing in politics? Why are we punishing Russian and Belarussian cardiologists, acting as if somehow they are responsible for what the Russian army is doing or for what Putin has decided to do? Why are we acting against them? They are just trying to fight heart disease. That’s a legitimate goal for any doctor, public health official, or scientist.” They didn’t see, as members, why this exclusion had taken place.
I believe the exclusion is appropriate and some of the membership, obviously, in the European Society of Cardiology, agrees. It’s not because they’re holding doctors or scientists directly accountable for Putin’s war crimes, ethnic cleansing assault, or bombing and shelling of hospitals, maternity hospitals, and civilians.
They understand that these scientists and doctors have little to do with such things, but we are in a new form of warfare, and that warfare is basically economic and sociologic: turning Russia, as an inexcusably aggressive state, into a pariah.
The reason to break the ties is that that is the way to bring pressure upon Putin and his kleptocratic, oligarchic advisers to stop the attack, to try and bring down their economy, to say, “Business is not going to go on as usual. You will be excluded from normal scientific and medical commerce. We’re not going to be holding conferences or exchanging ideas,” and in my view, extending it to say, “We’re not taking your papers, we’re not publishing anything you do. We’re not even having you speak at our meetings until this war, this aggressive invasion, and these war crimes come to a halt.”
There is actually a basis for this action. It isn’t in the organization’s own bylaws, which as I said, are very simple — reduce cardiovascular disease burden — but they are a member of a broader group, the Biomedical Alliance in Europe, which does have a very explicit code of ethics.
I’m going to read you a little bit from that code. It says healthcare organizations should uphold and promote equality, diversity and inclusion, accountability, transparency, and equality. They also say that all members, including the European Society of Cardiology, should be committed both to the Declaration of Helsinki, a fundamental medical ethics document, and the Declaration of Geneva. These rules refer to the highest respect of human beings, responsible resource allocation, and preservation of the environment, among other things.
What the organization is doing is consistent with the code of ethics that the broader organization of all the medical societies of Europe say that these individual groups should be doing. You can’t collaborate with war criminals. You can’t act as if business as usual is going on. That’s not inclusive. That’s not respect for diversity.
I think the Ukrainian medical societies of cardiology and other specialties would find it grimly ironic to say that keeping Russian and Belarus members makes sense, given what’s going on in their country and what is happening to them. They’re under attack. They’re being killed. Their healthcare institutions are being indiscriminately shelled and bombed.
It’s very hard — and I understand that — to say we’re going to punish scientists. We’re going to, perhaps, even cause public health problems in Russia because we’re not going to collaborate right now with doctors and scientists in cardiology or any other medical specialty. I think it’s what has to be done.
We’re in a new era of trying to combat what is basically organized, international ethnic terrorism, complete with war crimes. We fight financially. We fight by isolating. We fight by excluding. It’s painful. It’s difficult. It’s somewhat unfair to individuals.
Only through that kind of pain are we going to get the kind of pressure that will achieve justice. I think that is a goal that we have to commend the European Society of Cardiology for honoring.
Dr. Caplan is director of the division of medical ethics at New York University. He is the author or editor of 35 books and 750 peer-reviewed articles as well as a frequent commentator in the media on bioethical issues. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (an unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the division of medical ethics at the NYU Grossman School of Medicine.
There are many difficult moral issues that are being fueled by the terrible war that Russia is waging against Ukraine. I think there is no way to justify anything that the Russians are doing. Ukraine did not do anything to violate Russian integrity, Russian territorial integrity, or anything by way of being aggressive toward Russia.
Russia decided at some point it wanted the Ukraine back. Putin has a dream, as the long-standing leader of Russia, to restore the Soviet empire, and Ukraine is top of the list of the places that he wants back for a variety of reasons.
We’re not here to debate the merits and demerits of this terrible act of war.
The European Society of Cardiology made a decision very recently to drop, as members, both Russia and Belarus, Russia’s ally in this aggressive war against Ukraine. They basically found it intolerable to have business as usual with these subsidiary cardiology societies as part of the ongoing activities of the European group.
The sole goal of this overarching European group is to reduce the health burden of cardiovascular disease. It doesn’t have political goals. It doesn’t have much to say about anything other than, “Let’s get evidence-based medicine used to try and prevent heart disease or treat heart disease.” So there’s noble intent.
Many of its members asked, “What are we doing in politics? Why are we punishing Russian and Belarussian cardiologists, acting as if somehow they are responsible for what the Russian army is doing or for what Putin has decided to do? Why are we acting against them? They are just trying to fight heart disease. That’s a legitimate goal for any doctor, public health official, or scientist.” They didn’t see, as members, why this exclusion had taken place.
I believe the exclusion is appropriate and some of the membership, obviously, in the European Society of Cardiology, agrees. It’s not because they’re holding doctors or scientists directly accountable for Putin’s war crimes, ethnic cleansing assault, or bombing and shelling of hospitals, maternity hospitals, and civilians.
They understand that these scientists and doctors have little to do with such things, but we are in a new form of warfare, and that warfare is basically economic and sociologic: turning Russia, as an inexcusably aggressive state, into a pariah.
The reason to break the ties is that that is the way to bring pressure upon Putin and his kleptocratic, oligarchic advisers to stop the attack, to try and bring down their economy, to say, “Business is not going to go on as usual. You will be excluded from normal scientific and medical commerce. We’re not going to be holding conferences or exchanging ideas,” and in my view, extending it to say, “We’re not taking your papers, we’re not publishing anything you do. We’re not even having you speak at our meetings until this war, this aggressive invasion, and these war crimes come to a halt.”
There is actually a basis for this action. It isn’t in the organization’s own bylaws, which as I said, are very simple — reduce cardiovascular disease burden — but they are a member of a broader group, the Biomedical Alliance in Europe, which does have a very explicit code of ethics.
I’m going to read you a little bit from that code. It says healthcare organizations should uphold and promote equality, diversity and inclusion, accountability, transparency, and equality. They also say that all members, including the European Society of Cardiology, should be committed both to the Declaration of Helsinki, a fundamental medical ethics document, and the Declaration of Geneva. These rules refer to the highest respect of human beings, responsible resource allocation, and preservation of the environment, among other things.
What the organization is doing is consistent with the code of ethics that the broader organization of all the medical societies of Europe say that these individual groups should be doing. You can’t collaborate with war criminals. You can’t act as if business as usual is going on. That’s not inclusive. That’s not respect for diversity.
I think the Ukrainian medical societies of cardiology and other specialties would find it grimly ironic to say that keeping Russian and Belarus members makes sense, given what’s going on in their country and what is happening to them. They’re under attack. They’re being killed. Their healthcare institutions are being indiscriminately shelled and bombed.
It’s very hard — and I understand that — to say we’re going to punish scientists. We’re going to, perhaps, even cause public health problems in Russia because we’re not going to collaborate right now with doctors and scientists in cardiology or any other medical specialty. I think it’s what has to be done.
We’re in a new era of trying to combat what is basically organized, international ethnic terrorism, complete with war crimes. We fight financially. We fight by isolating. We fight by excluding. It’s painful. It’s difficult. It’s somewhat unfair to individuals.
Only through that kind of pain are we going to get the kind of pressure that will achieve justice. I think that is a goal that we have to commend the European Society of Cardiology for honoring.
Dr. Caplan is director of the division of medical ethics at New York University. He is the author or editor of 35 books and 750 peer-reviewed articles as well as a frequent commentator in the media on bioethical issues. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (an unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.
Lancet Commission reexamines the current approach to death
“The story of dying in the 21st century is a story of paradox.” This is the opening line of a report recently published in the Lancet, in which the Lancet Commission experts tackle what is, for many, a very sensitive topic: the end of life. The recommendations they present aim at “bringing death back into life.”
What makes the story a paradox is that, in end-of-life situations, many people are overtreated, and on the other hand, many people are undertreated.
In short, when all is said and done, “people die bad deaths.” A natural event, a natural part of life, has turned into something that people fear or, in some cases, refuse to even acknowledge or talk about.
This was the motivating factor for the Lancet Commission, a group of experts from various disciplines, to come together to try to better understand this complex concept. , as well as a balance between life and death.
This sensitive topic was explored by Marina Sozzi, PhD. She is the director of the Association for the Support and Assistance of People With Chronic and Oncological Diseases, a nonprofit organization that for more than 30 years has been dedicated to “providing palliative care and supporting individuals with oncological or other chronic and degenerative diseases.”
Call for rebalancing
To give people an idea of a better system in which life and death are in balance, the Lancet Commission experts described a realistic utopia, which they summarized in the following five principles:
- The social determinants of death, dying, and grieving are confronted.
- Dying is understood to be a relational and spiritual process rather than simply a physiological event.
- Networks of care provide support for people who are dying, those caring for them, and those grieving.
- Conversations and stories about everyday death, dying, and grief become common.
- Death is recognized as having value.
Achieving this utopia will not be easy, especially considering the current systems that are in place. “There have been tremendous medical advances over the last hundred years, particularly in increasing life expectancy and curing diseases that were once considered death sentences,” Dr. Sozzi explained. “Indeed, over the course of that time period, medical science acquired an enormous degree of social power, and matters of death – which in previous centuries had been within the purview of religions and houses of worship – were handed over to be handled by doctors and nurses.”
The COVID-19 pandemic has made the medical field’s role in matters of death more prominent: every day, people saw footage of dying people in hospital beds being cared for by health care professionals in masks and gowns. These patients were otherwise alone, their only contact with loved ones being over the phone or online. They died the ultimate medicalized deaths, stripped of almost all opportunities to get emotional support from family and friends.
New perspective needed
The Lancet Commission experts were certain about one point: The need to move away from the reductionist approach to death in order to integrate a more holistic approach, one that takes into account all of the dimensions of death without limiting itself only to the medical aspects.
“Medicine has its own take on the death phenomenon and on disease, which is a reductionist take,” said Dr. Sozzi, noting that, thanks to processes that make it possible to reduce phenomena to the measurable, medicine has managed to make tremendous progress. The same approach has been applied to the view of death, which has by and large become a biologic event.
“The problem is that, in reality, death is a much more complex phenomenon: cultural, social, involving families and society,” she explained. “Not all of these aspects are taken into consideration by medicine, and therefore, our culture has diminished its view of the death phenomenon.” Dr. Sozzi pointed out that, if looked upon more closely, the very question: “What did the person die of?” presupposes, in a certain sense, that it might have been possible to prevent that death – if only medicine had the right technology. So, death comes to be seen as something that could have been avoided.
Power of palliative care
Changing the approach to death requires a profound culture shift and, therefore, a lot of time. The good news is that, although there is still a long way to go, a few steps have been taken in this direction. “Talking about death, and even organizing courses aimed at health care professionals, is definitely easier these days than it was even just 10 years ago,” said Dr. Sozzi, citing, as an example, a project she developed for training nursing home operators in palliative care.
It is in palliative care where the greatest progress has been made in end-of-life matters. “The culture of palliative care allows us to think about death in very different terms and to recognize that moment when we should stop looking at curative care and direct our efforts at ‘comfort care.’ And this care of the dying has to be holistic,” Dr. Sozzi explained. She adds that we are increasingly talking about simultaneous palliative care – care that is not limited to the final days of a person’s life but that rather starts early on, when active treatments are still in place.
Dr. Sozzi mentioned Italy’s Law 38, which took effect in 2010. It regulates access to palliative care and pain management, expanding the right to receive these treatments to patients “in any health care setting, at any stage of life, and for any chronic or progressive condition which has no treatment or has a treatment that is not sufficient to stabilize it.”
A culture shift is also needed in this area; there has already been a movement away from general practitioners to health care professionals who can and must direct a patient to palliative care.
“We need to provide these doctors with more training and make them more aware of what a difference this kind of care can make throughout a patient’s life, not only during the final stages,” said Dr. Sozzi. Concerning training, she mentioned that Italy had recently introduced a specialization in palliative care for medical school graduates. This is another small step and one that adds a sense of dignity to this new approach to life and to death.
The experts’ recommendations
In attempting to find a balance between life and death, we must not look at the period prior to the 1900s as some kind of golden age. Dr. Sozzi explained that back then there was almost none of the medical technology now available to treat people at the end of life. “Palliative care has also set forth original technical aspects for eliminating pain. Without having eliminated a patient’s pain, I can hardly begin a discussion with them about spiritual aspects,” she said, emphasizing the importance of always contextualizing approaches to death.
The Lancet Commission experts assessed the approach to death in many different contexts. They recommended that, to best handle end-of-life matters in all their complexity, one should keep in mind the importance of relationships and networks across society.
They recommended that health care and social care professionals improve their skills and their capacity for taking care of dying patients and their families. When the patient has a life-limiting illness, a caring and compassionate approach should be taken when providing clear information about all interventions involved in palliative care, as well as when having conversations about death.
Governments and policy makers are advised to implement actions to allow all citizens to have the same access to necessary palliative care. In addition, all strategies and reports on social care and well-being more broadly should always include consideration of death, dying, and grieving. It’s an uphill climb, but one that must be made if we’re to build a new culture aimed at bringing death back into life. “As we continue stepping toward this new culture, let us each put a stone in place,” Dr. Sozzi concluded.
A version of this article first appeared on Medscape.com.
“The story of dying in the 21st century is a story of paradox.” This is the opening line of a report recently published in the Lancet, in which the Lancet Commission experts tackle what is, for many, a very sensitive topic: the end of life. The recommendations they present aim at “bringing death back into life.”
What makes the story a paradox is that, in end-of-life situations, many people are overtreated, and on the other hand, many people are undertreated.
In short, when all is said and done, “people die bad deaths.” A natural event, a natural part of life, has turned into something that people fear or, in some cases, refuse to even acknowledge or talk about.
This was the motivating factor for the Lancet Commission, a group of experts from various disciplines, to come together to try to better understand this complex concept. , as well as a balance between life and death.
This sensitive topic was explored by Marina Sozzi, PhD. She is the director of the Association for the Support and Assistance of People With Chronic and Oncological Diseases, a nonprofit organization that for more than 30 years has been dedicated to “providing palliative care and supporting individuals with oncological or other chronic and degenerative diseases.”
Call for rebalancing
To give people an idea of a better system in which life and death are in balance, the Lancet Commission experts described a realistic utopia, which they summarized in the following five principles:
- The social determinants of death, dying, and grieving are confronted.
- Dying is understood to be a relational and spiritual process rather than simply a physiological event.
- Networks of care provide support for people who are dying, those caring for them, and those grieving.
- Conversations and stories about everyday death, dying, and grief become common.
- Death is recognized as having value.
Achieving this utopia will not be easy, especially considering the current systems that are in place. “There have been tremendous medical advances over the last hundred years, particularly in increasing life expectancy and curing diseases that were once considered death sentences,” Dr. Sozzi explained. “Indeed, over the course of that time period, medical science acquired an enormous degree of social power, and matters of death – which in previous centuries had been within the purview of religions and houses of worship – were handed over to be handled by doctors and nurses.”
The COVID-19 pandemic has made the medical field’s role in matters of death more prominent: every day, people saw footage of dying people in hospital beds being cared for by health care professionals in masks and gowns. These patients were otherwise alone, their only contact with loved ones being over the phone or online. They died the ultimate medicalized deaths, stripped of almost all opportunities to get emotional support from family and friends.
New perspective needed
The Lancet Commission experts were certain about one point: The need to move away from the reductionist approach to death in order to integrate a more holistic approach, one that takes into account all of the dimensions of death without limiting itself only to the medical aspects.
“Medicine has its own take on the death phenomenon and on disease, which is a reductionist take,” said Dr. Sozzi, noting that, thanks to processes that make it possible to reduce phenomena to the measurable, medicine has managed to make tremendous progress. The same approach has been applied to the view of death, which has by and large become a biologic event.
“The problem is that, in reality, death is a much more complex phenomenon: cultural, social, involving families and society,” she explained. “Not all of these aspects are taken into consideration by medicine, and therefore, our culture has diminished its view of the death phenomenon.” Dr. Sozzi pointed out that, if looked upon more closely, the very question: “What did the person die of?” presupposes, in a certain sense, that it might have been possible to prevent that death – if only medicine had the right technology. So, death comes to be seen as something that could have been avoided.
Power of palliative care
Changing the approach to death requires a profound culture shift and, therefore, a lot of time. The good news is that, although there is still a long way to go, a few steps have been taken in this direction. “Talking about death, and even organizing courses aimed at health care professionals, is definitely easier these days than it was even just 10 years ago,” said Dr. Sozzi, citing, as an example, a project she developed for training nursing home operators in palliative care.
It is in palliative care where the greatest progress has been made in end-of-life matters. “The culture of palliative care allows us to think about death in very different terms and to recognize that moment when we should stop looking at curative care and direct our efforts at ‘comfort care.’ And this care of the dying has to be holistic,” Dr. Sozzi explained. She adds that we are increasingly talking about simultaneous palliative care – care that is not limited to the final days of a person’s life but that rather starts early on, when active treatments are still in place.
Dr. Sozzi mentioned Italy’s Law 38, which took effect in 2010. It regulates access to palliative care and pain management, expanding the right to receive these treatments to patients “in any health care setting, at any stage of life, and for any chronic or progressive condition which has no treatment or has a treatment that is not sufficient to stabilize it.”
A culture shift is also needed in this area; there has already been a movement away from general practitioners to health care professionals who can and must direct a patient to palliative care.
“We need to provide these doctors with more training and make them more aware of what a difference this kind of care can make throughout a patient’s life, not only during the final stages,” said Dr. Sozzi. Concerning training, she mentioned that Italy had recently introduced a specialization in palliative care for medical school graduates. This is another small step and one that adds a sense of dignity to this new approach to life and to death.
The experts’ recommendations
In attempting to find a balance between life and death, we must not look at the period prior to the 1900s as some kind of golden age. Dr. Sozzi explained that back then there was almost none of the medical technology now available to treat people at the end of life. “Palliative care has also set forth original technical aspects for eliminating pain. Without having eliminated a patient’s pain, I can hardly begin a discussion with them about spiritual aspects,” she said, emphasizing the importance of always contextualizing approaches to death.
The Lancet Commission experts assessed the approach to death in many different contexts. They recommended that, to best handle end-of-life matters in all their complexity, one should keep in mind the importance of relationships and networks across society.
They recommended that health care and social care professionals improve their skills and their capacity for taking care of dying patients and their families. When the patient has a life-limiting illness, a caring and compassionate approach should be taken when providing clear information about all interventions involved in palliative care, as well as when having conversations about death.
Governments and policy makers are advised to implement actions to allow all citizens to have the same access to necessary palliative care. In addition, all strategies and reports on social care and well-being more broadly should always include consideration of death, dying, and grieving. It’s an uphill climb, but one that must be made if we’re to build a new culture aimed at bringing death back into life. “As we continue stepping toward this new culture, let us each put a stone in place,” Dr. Sozzi concluded.
A version of this article first appeared on Medscape.com.
“The story of dying in the 21st century is a story of paradox.” This is the opening line of a report recently published in the Lancet, in which the Lancet Commission experts tackle what is, for many, a very sensitive topic: the end of life. The recommendations they present aim at “bringing death back into life.”
What makes the story a paradox is that, in end-of-life situations, many people are overtreated, and on the other hand, many people are undertreated.
In short, when all is said and done, “people die bad deaths.” A natural event, a natural part of life, has turned into something that people fear or, in some cases, refuse to even acknowledge or talk about.
This was the motivating factor for the Lancet Commission, a group of experts from various disciplines, to come together to try to better understand this complex concept. , as well as a balance between life and death.
This sensitive topic was explored by Marina Sozzi, PhD. She is the director of the Association for the Support and Assistance of People With Chronic and Oncological Diseases, a nonprofit organization that for more than 30 years has been dedicated to “providing palliative care and supporting individuals with oncological or other chronic and degenerative diseases.”
Call for rebalancing
To give people an idea of a better system in which life and death are in balance, the Lancet Commission experts described a realistic utopia, which they summarized in the following five principles:
- The social determinants of death, dying, and grieving are confronted.
- Dying is understood to be a relational and spiritual process rather than simply a physiological event.
- Networks of care provide support for people who are dying, those caring for them, and those grieving.
- Conversations and stories about everyday death, dying, and grief become common.
- Death is recognized as having value.
Achieving this utopia will not be easy, especially considering the current systems that are in place. “There have been tremendous medical advances over the last hundred years, particularly in increasing life expectancy and curing diseases that were once considered death sentences,” Dr. Sozzi explained. “Indeed, over the course of that time period, medical science acquired an enormous degree of social power, and matters of death – which in previous centuries had been within the purview of religions and houses of worship – were handed over to be handled by doctors and nurses.”
The COVID-19 pandemic has made the medical field’s role in matters of death more prominent: every day, people saw footage of dying people in hospital beds being cared for by health care professionals in masks and gowns. These patients were otherwise alone, their only contact with loved ones being over the phone or online. They died the ultimate medicalized deaths, stripped of almost all opportunities to get emotional support from family and friends.
New perspective needed
The Lancet Commission experts were certain about one point: The need to move away from the reductionist approach to death in order to integrate a more holistic approach, one that takes into account all of the dimensions of death without limiting itself only to the medical aspects.
“Medicine has its own take on the death phenomenon and on disease, which is a reductionist take,” said Dr. Sozzi, noting that, thanks to processes that make it possible to reduce phenomena to the measurable, medicine has managed to make tremendous progress. The same approach has been applied to the view of death, which has by and large become a biologic event.
“The problem is that, in reality, death is a much more complex phenomenon: cultural, social, involving families and society,” she explained. “Not all of these aspects are taken into consideration by medicine, and therefore, our culture has diminished its view of the death phenomenon.” Dr. Sozzi pointed out that, if looked upon more closely, the very question: “What did the person die of?” presupposes, in a certain sense, that it might have been possible to prevent that death – if only medicine had the right technology. So, death comes to be seen as something that could have been avoided.
Power of palliative care
Changing the approach to death requires a profound culture shift and, therefore, a lot of time. The good news is that, although there is still a long way to go, a few steps have been taken in this direction. “Talking about death, and even organizing courses aimed at health care professionals, is definitely easier these days than it was even just 10 years ago,” said Dr. Sozzi, citing, as an example, a project she developed for training nursing home operators in palliative care.
It is in palliative care where the greatest progress has been made in end-of-life matters. “The culture of palliative care allows us to think about death in very different terms and to recognize that moment when we should stop looking at curative care and direct our efforts at ‘comfort care.’ And this care of the dying has to be holistic,” Dr. Sozzi explained. She adds that we are increasingly talking about simultaneous palliative care – care that is not limited to the final days of a person’s life but that rather starts early on, when active treatments are still in place.
Dr. Sozzi mentioned Italy’s Law 38, which took effect in 2010. It regulates access to palliative care and pain management, expanding the right to receive these treatments to patients “in any health care setting, at any stage of life, and for any chronic or progressive condition which has no treatment or has a treatment that is not sufficient to stabilize it.”
A culture shift is also needed in this area; there has already been a movement away from general practitioners to health care professionals who can and must direct a patient to palliative care.
“We need to provide these doctors with more training and make them more aware of what a difference this kind of care can make throughout a patient’s life, not only during the final stages,” said Dr. Sozzi. Concerning training, she mentioned that Italy had recently introduced a specialization in palliative care for medical school graduates. This is another small step and one that adds a sense of dignity to this new approach to life and to death.
The experts’ recommendations
In attempting to find a balance between life and death, we must not look at the period prior to the 1900s as some kind of golden age. Dr. Sozzi explained that back then there was almost none of the medical technology now available to treat people at the end of life. “Palliative care has also set forth original technical aspects for eliminating pain. Without having eliminated a patient’s pain, I can hardly begin a discussion with them about spiritual aspects,” she said, emphasizing the importance of always contextualizing approaches to death.
The Lancet Commission experts assessed the approach to death in many different contexts. They recommended that, to best handle end-of-life matters in all their complexity, one should keep in mind the importance of relationships and networks across society.
They recommended that health care and social care professionals improve their skills and their capacity for taking care of dying patients and their families. When the patient has a life-limiting illness, a caring and compassionate approach should be taken when providing clear information about all interventions involved in palliative care, as well as when having conversations about death.
Governments and policy makers are advised to implement actions to allow all citizens to have the same access to necessary palliative care. In addition, all strategies and reports on social care and well-being more broadly should always include consideration of death, dying, and grieving. It’s an uphill climb, but one that must be made if we’re to build a new culture aimed at bringing death back into life. “As we continue stepping toward this new culture, let us each put a stone in place,” Dr. Sozzi concluded.
A version of this article first appeared on Medscape.com.
FROM THE LANCET
‘It’s about transparency’: Indiana law prohibits misleading medical titles
While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.
“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”
such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.
“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
What’s in a title?
The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.
Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.
“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
Medical groups speak out
Several professional medical groups have voiced their opposition to medical title misappropriation.
Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.
The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.
In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.
While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.
A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.
The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”
A version of this article first appeared on Medscape.com.
While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.
“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”
such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.
“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
What’s in a title?
The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.
Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.
“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
Medical groups speak out
Several professional medical groups have voiced their opposition to medical title misappropriation.
Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.
The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.
In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.
While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.
A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.
The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”
A version of this article first appeared on Medscape.com.
While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.
“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”
such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.
“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
What’s in a title?
The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.
Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.
“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
Medical groups speak out
Several professional medical groups have voiced their opposition to medical title misappropriation.
Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.
The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.
In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.
While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.
A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.
The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”
A version of this article first appeared on Medscape.com.
U.S. health officials tracking COVID-19 increase in U.K.
according to NPR.
Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.
“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.
“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.
Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.
“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”
Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.
Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.
“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.
“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”
The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.
The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.
BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.
The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.
The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.
Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.
The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.
“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.
A version of this article first appeared on WebMD.com.
according to NPR.
Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.
“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.
“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.
Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.
“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”
Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.
Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.
“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.
“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”
The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.
The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.
BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.
The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.
The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.
Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.
The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.
“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.
A version of this article first appeared on WebMD.com.
according to NPR.
Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.
“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.
“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.
Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.
“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”
Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.
Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.
“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.
“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”
The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.
The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.
BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.
The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.
The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.
Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.
The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.
“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.
A version of this article first appeared on WebMD.com.
First-line CAR T-cell therapy could help cure some lymphomas
Results of the phase 2 ZUMA-12 trial suggest that axicabtagene ciloleucel (axi-cel), a chimeric antigen receptor (CAR) T-cell therapy approved to treat certain types of lymphoma, also shows promise as a treatment for another group of lymphoma patients – those with high-risk large B-cell lymphoma (LBCL) who failed two rounds of standard chemoimmunotherapy. In fact, a study author said, first-line treatment with this therapy could help usher some patients toward a cure.
The results appeared March 21, 2022, in Nature Medicine.
“The high efficacy with manageable safety profile suggest that further evaluation of axi-cel in first-line setting in patients with high-risk LBCL is warranted in a randomized, phase 3 trial comparing it to standard chemoimmunotherapy,” study lead author Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center, Houston, said in an interview.
According to Dr. Neelapu, “patients with high-risk LBCL include those with high-intermediate or high International Prognostic Index score and those with certain molecular subtypes such as double- or triple-hit lymphoma. These patients have lower response rates and lower progression-free and overall survival with standard chemoimmunotherapy.”
Treatment of these patients can be especially challenging because they are underrepresented in clinical research, hematologist Michael Dickinson, MBBS, of the Peter MacCallum Cancer Center in Melbourne, said in an interview. “They often have disease that requires urgent treatment, so there is no time to recruit them into trials. A feature of ZUMA-12 is that it allowed patients to be recruited after short exposure to chemotherapy, which means that higher-risk patients could successfully be recruited into the trial.”
Axi-cel is already Food and Drug Administration approved for treatment of relapsed or refractory LBCL after 2 or more lines of systemic therapy plus relapsed or refractory follicular lymphoma, also after two or more lines of systemic therapy, Dr. Neelapu said.
For this study, researchers administered the treatment to 40 subjects with high-risk disease from 2019-2020 (median age, 61 years; 68% male; 95% at disease stage III or IV).
The researchers reported that 78% of 37 patients in the primary efficacy analysis reached complete response rate (95% confidence interval, 62-90); the median time to first complete response rate was 30 days (range, 27-207). About 89% of these subjects reached the secondary endpoint of objective response rate (95% CI, 75-97); the median time to first objective response was 29 days (range, 27-207).
At a median follow-up of 15.9 months, 73% were still in objective response.
“This is quite remarkable,” Dr. Neelapu said. “The durability of more than 70% is far higher than what would be expected with standard chemoimmunotherapy in these patients – under 40% durability with standard chemoimmunotherapy. Also, axi-cel induces durable responses in about 40% of patients in second- and third-line setting. However, when used as part of first-line therapy in this study, durable responses were observed in more than 70% of patients, suggesting that the efficacy of axi-cel may be much higher when used in first-line setting.”
Dr. Neelapu added: “Although the follow-up is short, it is highly likely that the majority of the patients with ongoing response beyond 1 year will likely be cured of their lymphoma.”
As for side effects, no treatment-related grade 5 events occurred, but 18 patients (45%) experienced serious adverse events. Grade 3 or higher cytokine release syndrome occurred in three patients (8%) and nine experienced neurologic events (23%).
“The majority of the higher-grade adverse events observed were due to cytopenias, which were expected due to the conditioning therapy,” Dr. Neelapu said. “Such cytopenias would also have been expected if these patients had received standard chemoimmunotherapy.”
Six patients (15%) died, 4 of progressive disease after going forward to other therapies.
As for cost, Dr. Neelapu said it should be similar to that of axi-cel as an FDA-approved third-line therapy. Axi-cel is highly expensive. Research has suggested that CAR T-cell therapy can boost costs beyond standard chemotherapy by $350,000-$490,000 with gains of 2-8 years of life (J Med Econ. Jan-Dec 2021;24[1]:458-68).
The study was funded by Kite. The authors reported various disclosures.
Results of the phase 2 ZUMA-12 trial suggest that axicabtagene ciloleucel (axi-cel), a chimeric antigen receptor (CAR) T-cell therapy approved to treat certain types of lymphoma, also shows promise as a treatment for another group of lymphoma patients – those with high-risk large B-cell lymphoma (LBCL) who failed two rounds of standard chemoimmunotherapy. In fact, a study author said, first-line treatment with this therapy could help usher some patients toward a cure.
The results appeared March 21, 2022, in Nature Medicine.
“The high efficacy with manageable safety profile suggest that further evaluation of axi-cel in first-line setting in patients with high-risk LBCL is warranted in a randomized, phase 3 trial comparing it to standard chemoimmunotherapy,” study lead author Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center, Houston, said in an interview.
According to Dr. Neelapu, “patients with high-risk LBCL include those with high-intermediate or high International Prognostic Index score and those with certain molecular subtypes such as double- or triple-hit lymphoma. These patients have lower response rates and lower progression-free and overall survival with standard chemoimmunotherapy.”
Treatment of these patients can be especially challenging because they are underrepresented in clinical research, hematologist Michael Dickinson, MBBS, of the Peter MacCallum Cancer Center in Melbourne, said in an interview. “They often have disease that requires urgent treatment, so there is no time to recruit them into trials. A feature of ZUMA-12 is that it allowed patients to be recruited after short exposure to chemotherapy, which means that higher-risk patients could successfully be recruited into the trial.”
Axi-cel is already Food and Drug Administration approved for treatment of relapsed or refractory LBCL after 2 or more lines of systemic therapy plus relapsed or refractory follicular lymphoma, also after two or more lines of systemic therapy, Dr. Neelapu said.
For this study, researchers administered the treatment to 40 subjects with high-risk disease from 2019-2020 (median age, 61 years; 68% male; 95% at disease stage III or IV).
The researchers reported that 78% of 37 patients in the primary efficacy analysis reached complete response rate (95% confidence interval, 62-90); the median time to first complete response rate was 30 days (range, 27-207). About 89% of these subjects reached the secondary endpoint of objective response rate (95% CI, 75-97); the median time to first objective response was 29 days (range, 27-207).
At a median follow-up of 15.9 months, 73% were still in objective response.
“This is quite remarkable,” Dr. Neelapu said. “The durability of more than 70% is far higher than what would be expected with standard chemoimmunotherapy in these patients – under 40% durability with standard chemoimmunotherapy. Also, axi-cel induces durable responses in about 40% of patients in second- and third-line setting. However, when used as part of first-line therapy in this study, durable responses were observed in more than 70% of patients, suggesting that the efficacy of axi-cel may be much higher when used in first-line setting.”
Dr. Neelapu added: “Although the follow-up is short, it is highly likely that the majority of the patients with ongoing response beyond 1 year will likely be cured of their lymphoma.”
As for side effects, no treatment-related grade 5 events occurred, but 18 patients (45%) experienced serious adverse events. Grade 3 or higher cytokine release syndrome occurred in three patients (8%) and nine experienced neurologic events (23%).
“The majority of the higher-grade adverse events observed were due to cytopenias, which were expected due to the conditioning therapy,” Dr. Neelapu said. “Such cytopenias would also have been expected if these patients had received standard chemoimmunotherapy.”
Six patients (15%) died, 4 of progressive disease after going forward to other therapies.
As for cost, Dr. Neelapu said it should be similar to that of axi-cel as an FDA-approved third-line therapy. Axi-cel is highly expensive. Research has suggested that CAR T-cell therapy can boost costs beyond standard chemotherapy by $350,000-$490,000 with gains of 2-8 years of life (J Med Econ. Jan-Dec 2021;24[1]:458-68).
The study was funded by Kite. The authors reported various disclosures.
Results of the phase 2 ZUMA-12 trial suggest that axicabtagene ciloleucel (axi-cel), a chimeric antigen receptor (CAR) T-cell therapy approved to treat certain types of lymphoma, also shows promise as a treatment for another group of lymphoma patients – those with high-risk large B-cell lymphoma (LBCL) who failed two rounds of standard chemoimmunotherapy. In fact, a study author said, first-line treatment with this therapy could help usher some patients toward a cure.
The results appeared March 21, 2022, in Nature Medicine.
“The high efficacy with manageable safety profile suggest that further evaluation of axi-cel in first-line setting in patients with high-risk LBCL is warranted in a randomized, phase 3 trial comparing it to standard chemoimmunotherapy,” study lead author Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center, Houston, said in an interview.
According to Dr. Neelapu, “patients with high-risk LBCL include those with high-intermediate or high International Prognostic Index score and those with certain molecular subtypes such as double- or triple-hit lymphoma. These patients have lower response rates and lower progression-free and overall survival with standard chemoimmunotherapy.”
Treatment of these patients can be especially challenging because they are underrepresented in clinical research, hematologist Michael Dickinson, MBBS, of the Peter MacCallum Cancer Center in Melbourne, said in an interview. “They often have disease that requires urgent treatment, so there is no time to recruit them into trials. A feature of ZUMA-12 is that it allowed patients to be recruited after short exposure to chemotherapy, which means that higher-risk patients could successfully be recruited into the trial.”
Axi-cel is already Food and Drug Administration approved for treatment of relapsed or refractory LBCL after 2 or more lines of systemic therapy plus relapsed or refractory follicular lymphoma, also after two or more lines of systemic therapy, Dr. Neelapu said.
For this study, researchers administered the treatment to 40 subjects with high-risk disease from 2019-2020 (median age, 61 years; 68% male; 95% at disease stage III or IV).
The researchers reported that 78% of 37 patients in the primary efficacy analysis reached complete response rate (95% confidence interval, 62-90); the median time to first complete response rate was 30 days (range, 27-207). About 89% of these subjects reached the secondary endpoint of objective response rate (95% CI, 75-97); the median time to first objective response was 29 days (range, 27-207).
At a median follow-up of 15.9 months, 73% were still in objective response.
“This is quite remarkable,” Dr. Neelapu said. “The durability of more than 70% is far higher than what would be expected with standard chemoimmunotherapy in these patients – under 40% durability with standard chemoimmunotherapy. Also, axi-cel induces durable responses in about 40% of patients in second- and third-line setting. However, when used as part of first-line therapy in this study, durable responses were observed in more than 70% of patients, suggesting that the efficacy of axi-cel may be much higher when used in first-line setting.”
Dr. Neelapu added: “Although the follow-up is short, it is highly likely that the majority of the patients with ongoing response beyond 1 year will likely be cured of their lymphoma.”
As for side effects, no treatment-related grade 5 events occurred, but 18 patients (45%) experienced serious adverse events. Grade 3 or higher cytokine release syndrome occurred in three patients (8%) and nine experienced neurologic events (23%).
“The majority of the higher-grade adverse events observed were due to cytopenias, which were expected due to the conditioning therapy,” Dr. Neelapu said. “Such cytopenias would also have been expected if these patients had received standard chemoimmunotherapy.”
Six patients (15%) died, 4 of progressive disease after going forward to other therapies.
As for cost, Dr. Neelapu said it should be similar to that of axi-cel as an FDA-approved third-line therapy. Axi-cel is highly expensive. Research has suggested that CAR T-cell therapy can boost costs beyond standard chemotherapy by $350,000-$490,000 with gains of 2-8 years of life (J Med Econ. Jan-Dec 2021;24[1]:458-68).
The study was funded by Kite. The authors reported various disclosures.
FROM NATURE MEDICINE
Eating olive oil may slow CLL disease progression
Olive oil is a major component of the Mediterranean diet, and olive phenols have been shown to convey antioxidant, anti-inflammatory, anticancer, neuroprotective, and antidiabetic effects by modulating various molecular pathways, Andrea Paola Rojas Gil, PhD, of the University of Peloponnese, Tripoli, Greece, and colleagues wrote.
In most patients, CLL is incurable, but those at the early stages do not need immediate therapy and may benefit from an intervention to prevent disease progression, the authors wrote. Previous research suggested that dietary intervention exerts a salutary effect on early CLL, and in vitro studies suggested that oleocanthal, a component of extra virgin olive oil, induced anticancer activity.
In a study published in Frontiers in Oncology, the researchers enrolled adults with early stage CLL who had not undergone chemotherapy or other treatment. All patients adhered to a Mediterranean-style diet.
After a washout period of 9-12 months, the researchers randomized 22 patients to extra virgin olive oil high in oleocanthal and oleacein (high OC/OL-EVOO). Patients in the intervention group consumed 40 mL/day of high OC/OL-EVOO before meals. Their average age was 71 years; 10 were women and 12 were men.
The primary outcomes included changes in hematological, biochemical, and apoptotic markers. After 6 months, patients in the intervention group showed a statistically significant reduction in white blood cells and lymphocyte count, compared with measurements taken 3 months before the intervention. The WBC decrease was greatest among patients with the highest WBC levels at baseline.
As for biochemical markers, the researchers observed a significant decrease in glucose levels during the intervention, but no significant effects on metabolic indexes or renal function.
After 3 months and also after 6 months of the olive oil intervention, patients showed a significant increase in the apoptotic markers ccK18 and Apo1-Fas (P ≤ .05 for both), as well as an increase in the cell cycle negative regulator p21. The dietary intervention also was associated with significant decreases in expression of the antiapoptotic protein survivin and in cyclin D, a positive cell cycle regulator protein.
Further, patients who had a high ccK18 level at baseline showed a significantly greater increase in ccK18 after the intervention, compared with those with lower ccK18 at baseline (P = .001).
Notably, “a negative correlation of the WBC at the end of the dietary intervention with the fluctuation of the protein expression of the apoptotic marker ccK18 (final – initial) was observed,” the researchers wrote in their discussion.
The study findings were limited by several factors including the small sample size, short intervention time, and pilot design, the researchers said. Other limitations include the possible effect of other unmeasured properties of olive oil.
However, the results reflect previous studies showing the benefits of a Mediterranean-type diet, and they represent the first clinical trial to indicate possible beneficial effects from oleocanthal and oleacein on the progression of CLL. Therefore, the authors concluded, the study is worthy of a large, multicenter trial.
Pilot data merit more research
In an interview, corresponding author Prokopios Magiatis, PhD, noted that CLL is “the most commonly diagnosed adult leukemia in Western countries and is responsible for about one in four cases of all leukemias.” CLL remains incurable in most patients, and ways to delay disease progression are needed.
“Oleocanthal is the active ingredient of early harvest olive oil with proven anticancer activities in vitro and in vivo,” Dr. Magiatis explained. “For this reason, it was a unique challenge to investigate the anticancer activity of this compound for the first time in humans through the dietary consumption of specifically selected olive oil.” He expressed surprise at the beneficial effects of high-oleocanthal olive oil, not only to the white blood cells, but also to glucose levels.
“It seems that oleocanthal can activate mechanisms related to the apoptosis of cancer cells, and also mechanisms related to blood glucose regulation without affecting any normal cells of the body,” he said. “All anticancer drugs usually have severe side effects, however the administration of 25 mg of oleocanthal through the dietary consumption of olive oil did not present any harmful effects for at least 6 months of everyday use.
“The addition of naturally produced high-oleocanthal olive oil in the diet of early-stage CLL patients at a dose of three tablespoons per day [40 mL] is a practice that may lower the cancerous white blood cells of the patients without any risk,” said Dr. Magiatis. “High-oleocanthal early-harvest olive oil has been consumed for centuries, and may be the key of longevity of several Mediterranean populations.
“In our study, the number of the white blood cells returned back to the number it was one year before the initiation of the study; this clearly shows that it could be a significant factor for the delay of the progress of the disease,” he said.
The current trial was a pilot study in one hospital with only 22 patients for 6 months, said Dr. Magiatis. “We are currently preparing the expansion of the study to other hospitals and other countries, and we aim to include at least 100 patients for at least 1 year, to validate the already-obtained beneficial results.”
The clinical trial is supported by the nonprofit organization World Olive Center for Health, he added.
The current study received no outside funding. The researchers had no financial conflicts to disclose.
Olive oil is a major component of the Mediterranean diet, and olive phenols have been shown to convey antioxidant, anti-inflammatory, anticancer, neuroprotective, and antidiabetic effects by modulating various molecular pathways, Andrea Paola Rojas Gil, PhD, of the University of Peloponnese, Tripoli, Greece, and colleagues wrote.
In most patients, CLL is incurable, but those at the early stages do not need immediate therapy and may benefit from an intervention to prevent disease progression, the authors wrote. Previous research suggested that dietary intervention exerts a salutary effect on early CLL, and in vitro studies suggested that oleocanthal, a component of extra virgin olive oil, induced anticancer activity.
In a study published in Frontiers in Oncology, the researchers enrolled adults with early stage CLL who had not undergone chemotherapy or other treatment. All patients adhered to a Mediterranean-style diet.
After a washout period of 9-12 months, the researchers randomized 22 patients to extra virgin olive oil high in oleocanthal and oleacein (high OC/OL-EVOO). Patients in the intervention group consumed 40 mL/day of high OC/OL-EVOO before meals. Their average age was 71 years; 10 were women and 12 were men.
The primary outcomes included changes in hematological, biochemical, and apoptotic markers. After 6 months, patients in the intervention group showed a statistically significant reduction in white blood cells and lymphocyte count, compared with measurements taken 3 months before the intervention. The WBC decrease was greatest among patients with the highest WBC levels at baseline.
As for biochemical markers, the researchers observed a significant decrease in glucose levels during the intervention, but no significant effects on metabolic indexes or renal function.
After 3 months and also after 6 months of the olive oil intervention, patients showed a significant increase in the apoptotic markers ccK18 and Apo1-Fas (P ≤ .05 for both), as well as an increase in the cell cycle negative regulator p21. The dietary intervention also was associated with significant decreases in expression of the antiapoptotic protein survivin and in cyclin D, a positive cell cycle regulator protein.
Further, patients who had a high ccK18 level at baseline showed a significantly greater increase in ccK18 after the intervention, compared with those with lower ccK18 at baseline (P = .001).
Notably, “a negative correlation of the WBC at the end of the dietary intervention with the fluctuation of the protein expression of the apoptotic marker ccK18 (final – initial) was observed,” the researchers wrote in their discussion.
The study findings were limited by several factors including the small sample size, short intervention time, and pilot design, the researchers said. Other limitations include the possible effect of other unmeasured properties of olive oil.
However, the results reflect previous studies showing the benefits of a Mediterranean-type diet, and they represent the first clinical trial to indicate possible beneficial effects from oleocanthal and oleacein on the progression of CLL. Therefore, the authors concluded, the study is worthy of a large, multicenter trial.
Pilot data merit more research
In an interview, corresponding author Prokopios Magiatis, PhD, noted that CLL is “the most commonly diagnosed adult leukemia in Western countries and is responsible for about one in four cases of all leukemias.” CLL remains incurable in most patients, and ways to delay disease progression are needed.
“Oleocanthal is the active ingredient of early harvest olive oil with proven anticancer activities in vitro and in vivo,” Dr. Magiatis explained. “For this reason, it was a unique challenge to investigate the anticancer activity of this compound for the first time in humans through the dietary consumption of specifically selected olive oil.” He expressed surprise at the beneficial effects of high-oleocanthal olive oil, not only to the white blood cells, but also to glucose levels.
“It seems that oleocanthal can activate mechanisms related to the apoptosis of cancer cells, and also mechanisms related to blood glucose regulation without affecting any normal cells of the body,” he said. “All anticancer drugs usually have severe side effects, however the administration of 25 mg of oleocanthal through the dietary consumption of olive oil did not present any harmful effects for at least 6 months of everyday use.
“The addition of naturally produced high-oleocanthal olive oil in the diet of early-stage CLL patients at a dose of three tablespoons per day [40 mL] is a practice that may lower the cancerous white blood cells of the patients without any risk,” said Dr. Magiatis. “High-oleocanthal early-harvest olive oil has been consumed for centuries, and may be the key of longevity of several Mediterranean populations.
“In our study, the number of the white blood cells returned back to the number it was one year before the initiation of the study; this clearly shows that it could be a significant factor for the delay of the progress of the disease,” he said.
The current trial was a pilot study in one hospital with only 22 patients for 6 months, said Dr. Magiatis. “We are currently preparing the expansion of the study to other hospitals and other countries, and we aim to include at least 100 patients for at least 1 year, to validate the already-obtained beneficial results.”
The clinical trial is supported by the nonprofit organization World Olive Center for Health, he added.
The current study received no outside funding. The researchers had no financial conflicts to disclose.
Olive oil is a major component of the Mediterranean diet, and olive phenols have been shown to convey antioxidant, anti-inflammatory, anticancer, neuroprotective, and antidiabetic effects by modulating various molecular pathways, Andrea Paola Rojas Gil, PhD, of the University of Peloponnese, Tripoli, Greece, and colleagues wrote.
In most patients, CLL is incurable, but those at the early stages do not need immediate therapy and may benefit from an intervention to prevent disease progression, the authors wrote. Previous research suggested that dietary intervention exerts a salutary effect on early CLL, and in vitro studies suggested that oleocanthal, a component of extra virgin olive oil, induced anticancer activity.
In a study published in Frontiers in Oncology, the researchers enrolled adults with early stage CLL who had not undergone chemotherapy or other treatment. All patients adhered to a Mediterranean-style diet.
After a washout period of 9-12 months, the researchers randomized 22 patients to extra virgin olive oil high in oleocanthal and oleacein (high OC/OL-EVOO). Patients in the intervention group consumed 40 mL/day of high OC/OL-EVOO before meals. Their average age was 71 years; 10 were women and 12 were men.
The primary outcomes included changes in hematological, biochemical, and apoptotic markers. After 6 months, patients in the intervention group showed a statistically significant reduction in white blood cells and lymphocyte count, compared with measurements taken 3 months before the intervention. The WBC decrease was greatest among patients with the highest WBC levels at baseline.
As for biochemical markers, the researchers observed a significant decrease in glucose levels during the intervention, but no significant effects on metabolic indexes or renal function.
After 3 months and also after 6 months of the olive oil intervention, patients showed a significant increase in the apoptotic markers ccK18 and Apo1-Fas (P ≤ .05 for both), as well as an increase in the cell cycle negative regulator p21. The dietary intervention also was associated with significant decreases in expression of the antiapoptotic protein survivin and in cyclin D, a positive cell cycle regulator protein.
Further, patients who had a high ccK18 level at baseline showed a significantly greater increase in ccK18 after the intervention, compared with those with lower ccK18 at baseline (P = .001).
Notably, “a negative correlation of the WBC at the end of the dietary intervention with the fluctuation of the protein expression of the apoptotic marker ccK18 (final – initial) was observed,” the researchers wrote in their discussion.
The study findings were limited by several factors including the small sample size, short intervention time, and pilot design, the researchers said. Other limitations include the possible effect of other unmeasured properties of olive oil.
However, the results reflect previous studies showing the benefits of a Mediterranean-type diet, and they represent the first clinical trial to indicate possible beneficial effects from oleocanthal and oleacein on the progression of CLL. Therefore, the authors concluded, the study is worthy of a large, multicenter trial.
Pilot data merit more research
In an interview, corresponding author Prokopios Magiatis, PhD, noted that CLL is “the most commonly diagnosed adult leukemia in Western countries and is responsible for about one in four cases of all leukemias.” CLL remains incurable in most patients, and ways to delay disease progression are needed.
“Oleocanthal is the active ingredient of early harvest olive oil with proven anticancer activities in vitro and in vivo,” Dr. Magiatis explained. “For this reason, it was a unique challenge to investigate the anticancer activity of this compound for the first time in humans through the dietary consumption of specifically selected olive oil.” He expressed surprise at the beneficial effects of high-oleocanthal olive oil, not only to the white blood cells, but also to glucose levels.
“It seems that oleocanthal can activate mechanisms related to the apoptosis of cancer cells, and also mechanisms related to blood glucose regulation without affecting any normal cells of the body,” he said. “All anticancer drugs usually have severe side effects, however the administration of 25 mg of oleocanthal through the dietary consumption of olive oil did not present any harmful effects for at least 6 months of everyday use.
“The addition of naturally produced high-oleocanthal olive oil in the diet of early-stage CLL patients at a dose of three tablespoons per day [40 mL] is a practice that may lower the cancerous white blood cells of the patients without any risk,” said Dr. Magiatis. “High-oleocanthal early-harvest olive oil has been consumed for centuries, and may be the key of longevity of several Mediterranean populations.
“In our study, the number of the white blood cells returned back to the number it was one year before the initiation of the study; this clearly shows that it could be a significant factor for the delay of the progress of the disease,” he said.
The current trial was a pilot study in one hospital with only 22 patients for 6 months, said Dr. Magiatis. “We are currently preparing the expansion of the study to other hospitals and other countries, and we aim to include at least 100 patients for at least 1 year, to validate the already-obtained beneficial results.”
The clinical trial is supported by the nonprofit organization World Olive Center for Health, he added.
The current study received no outside funding. The researchers had no financial conflicts to disclose.
FROM FRONTIERS IN ONCOLOGY
Trial gives new guidance for choosing initial PsA treatment
For patients with psoriatic arthritis (PsA) whose condition doesn’t respond adequately to methotrexate, addition of the tumor necrosis factor (TNF) inhibitor adalimumab increased the likelihood of achieving minimum disease activity (MDA), compared with escalation of MTX dose, according to results from a phase 4, open-label study.
The new study is one of only a few to compare treatment protocols in a field that has seen new therapeutic options become available in recent years. That lack of evidence can leave patients and physicians uncertain about the next step if the initial results of treatment are disappointing.
“There are some gaps in our database and our understanding of psoriatic arthritis, compared to rheumatoid arthritis, where we have had many more studies over the years,” Arthur Kavanaugh, MD, told this news organization when asked to comment on the study.
The trial provides one answer, at least. “There was a clear-cut signal that it made more sense to add adalimumab at that early juncture where a person is not quite doing well enough on methotrexate to satisfy our goal of getting the patient to low disease activity. It gives us as clinicians some ammunition to speak to our insurance formulary people on this side of the Atlantic, or [for] people in the U.K. to go to their local regulatory board that approves medicines and be able to show them some actual practically derived evidence about this very common question that comes up in practice,” senior and corresponding author Philip Mease, MD, said in an interview. The study was published online in The Lancet Rheumatology.
“When a clinician and patient are making the decision to move on from methotrexate monotherapy, either because of lack of efficacy or safety issues, tolerability issues, it makes most sense to add on a biologic medication such as a TNF inhibitor at that juncture, rather than intensifying methotrexate therapy,” said Dr. Mease, who is director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and a clinical professor at the University of Washington, both in Seattle.
Physicians may be tempted to bump up the dose for patients who can tolerate MTX and who may be showing some improvement, but the new study should prompt a different strategy if MDA isn’t achieved, according to Oliver FitzGerald, MD, a professor at the Conway Institute for Biomolecular Research at University College Dublin, who was asked to comment on the study. “This study clearly shows that the early addition of adalimumab is the better choice, and it would change practice. That being said, there are clearly some patients who do respond sufficiently to increasing methotrexate, and it would be useful to be able to predict which patients might do that.” He added that the study focused on adalimumab and that the results might not apply to other biologics.
The study should encourage use of a quantitative treat-to-target measure like MDA, which is a composite measure of patient perspectives, Dr. Mease said. The American College of Rheumatology and National Psoriasis Foundation and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis have recommended the use of MDA as a treat-to-target measure for PsA. The ACR and NPF recommend TNF inhibitors as first-line treatment, and GRAPPA includes it as a first-line option, whereas the European Alliance of Associations for Rheumatology recommends MTX only in the first line.
The study also suggests that there is value to using adalimumab on a weekly basis if an every-other-week schedule doesn’t produce the desired results. This strategy hasn’t been examined in PsA or even RA, according to Dr. Kavanaugh, who is a professor of medicine at the University of California, San Diego. “It did look like raising the dose might be an option for patients who are on every other week and are not doing quite as well as we would have hoped.”
The CONTROL study was a phase 4, two-part, open-label study. It included 245 patients in 14 countries who did not have MDA with MTX. In the first part of the study, patients were randomly assigned to receive weekly 15 mg MTX along with 40 mg adalimumab every other week, or escalation of MTX dose to 20-25 mg/week. MTX could be administered orally or intravenously. After 16 weeks (part 1), for patients who achieved MDA, current therapy was maintained or modified; for patients who did not achieve MDA, therapy was escalated over the following 16 weeks by giving adalimumab every week in the combination group or by adding adalimumab every other week in the MTX escalation arm.
Overall, 95% of the MTX plus adalimumab group completed part 1, as did 90% of the MTX escalation group. A total of 41% of the adalimumab group achieved MDA at 16 weeks versus 13% of the MTX group (P < .0001). The result held after accounting for sex and the interaction between sex and treatment (odds ratio, 4.6; 95% confidence interval, 2.4-8.9).
Among patients who achieved MDA at 16 weeks, 80% in the adalimumab group continued to have MDA at 32 weeks even after MTX had been withdrawn. Of those in the MTX escalation group, 67% continued to have MDA at 32 weeks with continued escalation of MTX.
Of the patients in the MTX escalation group who did not respond, 55% reached MDA following introduction of adalimumab every other week. Of those who did not respond to adalimumab, 30% reached MDA after switching to weekly adalimumab doses.
The study was open label, and patients who received adalimumab may have expected some improvement; that could have skewed the findings, Dr. Kavanaugh said. “I think that’s an important consideration as we interpret the data. The people who got the MTX arm probably had less of an expectation that they were going to do much better than those who switched to the adalimumab, as did the doctors taking care of them.”
The CONTROL study was funded by AbbVie. Dr. Mease has received research grants, consulted for, or received speaker honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB. Dr. FitzGerald has received grant support and honoraria from AbbVie. Dr. Kavanaugh has received research support from or consulted for AbbVie, Janssen, Pfizer, Lilly, Novartis, and UCB.
A version of this article first appeared on Medscape.com.
For patients with psoriatic arthritis (PsA) whose condition doesn’t respond adequately to methotrexate, addition of the tumor necrosis factor (TNF) inhibitor adalimumab increased the likelihood of achieving minimum disease activity (MDA), compared with escalation of MTX dose, according to results from a phase 4, open-label study.
The new study is one of only a few to compare treatment protocols in a field that has seen new therapeutic options become available in recent years. That lack of evidence can leave patients and physicians uncertain about the next step if the initial results of treatment are disappointing.
“There are some gaps in our database and our understanding of psoriatic arthritis, compared to rheumatoid arthritis, where we have had many more studies over the years,” Arthur Kavanaugh, MD, told this news organization when asked to comment on the study.
The trial provides one answer, at least. “There was a clear-cut signal that it made more sense to add adalimumab at that early juncture where a person is not quite doing well enough on methotrexate to satisfy our goal of getting the patient to low disease activity. It gives us as clinicians some ammunition to speak to our insurance formulary people on this side of the Atlantic, or [for] people in the U.K. to go to their local regulatory board that approves medicines and be able to show them some actual practically derived evidence about this very common question that comes up in practice,” senior and corresponding author Philip Mease, MD, said in an interview. The study was published online in The Lancet Rheumatology.
“When a clinician and patient are making the decision to move on from methotrexate monotherapy, either because of lack of efficacy or safety issues, tolerability issues, it makes most sense to add on a biologic medication such as a TNF inhibitor at that juncture, rather than intensifying methotrexate therapy,” said Dr. Mease, who is director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and a clinical professor at the University of Washington, both in Seattle.
Physicians may be tempted to bump up the dose for patients who can tolerate MTX and who may be showing some improvement, but the new study should prompt a different strategy if MDA isn’t achieved, according to Oliver FitzGerald, MD, a professor at the Conway Institute for Biomolecular Research at University College Dublin, who was asked to comment on the study. “This study clearly shows that the early addition of adalimumab is the better choice, and it would change practice. That being said, there are clearly some patients who do respond sufficiently to increasing methotrexate, and it would be useful to be able to predict which patients might do that.” He added that the study focused on adalimumab and that the results might not apply to other biologics.
The study should encourage use of a quantitative treat-to-target measure like MDA, which is a composite measure of patient perspectives, Dr. Mease said. The American College of Rheumatology and National Psoriasis Foundation and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis have recommended the use of MDA as a treat-to-target measure for PsA. The ACR and NPF recommend TNF inhibitors as first-line treatment, and GRAPPA includes it as a first-line option, whereas the European Alliance of Associations for Rheumatology recommends MTX only in the first line.
The study also suggests that there is value to using adalimumab on a weekly basis if an every-other-week schedule doesn’t produce the desired results. This strategy hasn’t been examined in PsA or even RA, according to Dr. Kavanaugh, who is a professor of medicine at the University of California, San Diego. “It did look like raising the dose might be an option for patients who are on every other week and are not doing quite as well as we would have hoped.”
The CONTROL study was a phase 4, two-part, open-label study. It included 245 patients in 14 countries who did not have MDA with MTX. In the first part of the study, patients were randomly assigned to receive weekly 15 mg MTX along with 40 mg adalimumab every other week, or escalation of MTX dose to 20-25 mg/week. MTX could be administered orally or intravenously. After 16 weeks (part 1), for patients who achieved MDA, current therapy was maintained or modified; for patients who did not achieve MDA, therapy was escalated over the following 16 weeks by giving adalimumab every week in the combination group or by adding adalimumab every other week in the MTX escalation arm.
Overall, 95% of the MTX plus adalimumab group completed part 1, as did 90% of the MTX escalation group. A total of 41% of the adalimumab group achieved MDA at 16 weeks versus 13% of the MTX group (P < .0001). The result held after accounting for sex and the interaction between sex and treatment (odds ratio, 4.6; 95% confidence interval, 2.4-8.9).
Among patients who achieved MDA at 16 weeks, 80% in the adalimumab group continued to have MDA at 32 weeks even after MTX had been withdrawn. Of those in the MTX escalation group, 67% continued to have MDA at 32 weeks with continued escalation of MTX.
Of the patients in the MTX escalation group who did not respond, 55% reached MDA following introduction of adalimumab every other week. Of those who did not respond to adalimumab, 30% reached MDA after switching to weekly adalimumab doses.
The study was open label, and patients who received adalimumab may have expected some improvement; that could have skewed the findings, Dr. Kavanaugh said. “I think that’s an important consideration as we interpret the data. The people who got the MTX arm probably had less of an expectation that they were going to do much better than those who switched to the adalimumab, as did the doctors taking care of them.”
The CONTROL study was funded by AbbVie. Dr. Mease has received research grants, consulted for, or received speaker honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB. Dr. FitzGerald has received grant support and honoraria from AbbVie. Dr. Kavanaugh has received research support from or consulted for AbbVie, Janssen, Pfizer, Lilly, Novartis, and UCB.
A version of this article first appeared on Medscape.com.
For patients with psoriatic arthritis (PsA) whose condition doesn’t respond adequately to methotrexate, addition of the tumor necrosis factor (TNF) inhibitor adalimumab increased the likelihood of achieving minimum disease activity (MDA), compared with escalation of MTX dose, according to results from a phase 4, open-label study.
The new study is one of only a few to compare treatment protocols in a field that has seen new therapeutic options become available in recent years. That lack of evidence can leave patients and physicians uncertain about the next step if the initial results of treatment are disappointing.
“There are some gaps in our database and our understanding of psoriatic arthritis, compared to rheumatoid arthritis, where we have had many more studies over the years,” Arthur Kavanaugh, MD, told this news organization when asked to comment on the study.
The trial provides one answer, at least. “There was a clear-cut signal that it made more sense to add adalimumab at that early juncture where a person is not quite doing well enough on methotrexate to satisfy our goal of getting the patient to low disease activity. It gives us as clinicians some ammunition to speak to our insurance formulary people on this side of the Atlantic, or [for] people in the U.K. to go to their local regulatory board that approves medicines and be able to show them some actual practically derived evidence about this very common question that comes up in practice,” senior and corresponding author Philip Mease, MD, said in an interview. The study was published online in The Lancet Rheumatology.
“When a clinician and patient are making the decision to move on from methotrexate monotherapy, either because of lack of efficacy or safety issues, tolerability issues, it makes most sense to add on a biologic medication such as a TNF inhibitor at that juncture, rather than intensifying methotrexate therapy,” said Dr. Mease, who is director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and a clinical professor at the University of Washington, both in Seattle.
Physicians may be tempted to bump up the dose for patients who can tolerate MTX and who may be showing some improvement, but the new study should prompt a different strategy if MDA isn’t achieved, according to Oliver FitzGerald, MD, a professor at the Conway Institute for Biomolecular Research at University College Dublin, who was asked to comment on the study. “This study clearly shows that the early addition of adalimumab is the better choice, and it would change practice. That being said, there are clearly some patients who do respond sufficiently to increasing methotrexate, and it would be useful to be able to predict which patients might do that.” He added that the study focused on adalimumab and that the results might not apply to other biologics.
The study should encourage use of a quantitative treat-to-target measure like MDA, which is a composite measure of patient perspectives, Dr. Mease said. The American College of Rheumatology and National Psoriasis Foundation and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis have recommended the use of MDA as a treat-to-target measure for PsA. The ACR and NPF recommend TNF inhibitors as first-line treatment, and GRAPPA includes it as a first-line option, whereas the European Alliance of Associations for Rheumatology recommends MTX only in the first line.
The study also suggests that there is value to using adalimumab on a weekly basis if an every-other-week schedule doesn’t produce the desired results. This strategy hasn’t been examined in PsA or even RA, according to Dr. Kavanaugh, who is a professor of medicine at the University of California, San Diego. “It did look like raising the dose might be an option for patients who are on every other week and are not doing quite as well as we would have hoped.”
The CONTROL study was a phase 4, two-part, open-label study. It included 245 patients in 14 countries who did not have MDA with MTX. In the first part of the study, patients were randomly assigned to receive weekly 15 mg MTX along with 40 mg adalimumab every other week, or escalation of MTX dose to 20-25 mg/week. MTX could be administered orally or intravenously. After 16 weeks (part 1), for patients who achieved MDA, current therapy was maintained or modified; for patients who did not achieve MDA, therapy was escalated over the following 16 weeks by giving adalimumab every week in the combination group or by adding adalimumab every other week in the MTX escalation arm.
Overall, 95% of the MTX plus adalimumab group completed part 1, as did 90% of the MTX escalation group. A total of 41% of the adalimumab group achieved MDA at 16 weeks versus 13% of the MTX group (P < .0001). The result held after accounting for sex and the interaction between sex and treatment (odds ratio, 4.6; 95% confidence interval, 2.4-8.9).
Among patients who achieved MDA at 16 weeks, 80% in the adalimumab group continued to have MDA at 32 weeks even after MTX had been withdrawn. Of those in the MTX escalation group, 67% continued to have MDA at 32 weeks with continued escalation of MTX.
Of the patients in the MTX escalation group who did not respond, 55% reached MDA following introduction of adalimumab every other week. Of those who did not respond to adalimumab, 30% reached MDA after switching to weekly adalimumab doses.
The study was open label, and patients who received adalimumab may have expected some improvement; that could have skewed the findings, Dr. Kavanaugh said. “I think that’s an important consideration as we interpret the data. The people who got the MTX arm probably had less of an expectation that they were going to do much better than those who switched to the adalimumab, as did the doctors taking care of them.”
The CONTROL study was funded by AbbVie. Dr. Mease has received research grants, consulted for, or received speaker honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB. Dr. FitzGerald has received grant support and honoraria from AbbVie. Dr. Kavanaugh has received research support from or consulted for AbbVie, Janssen, Pfizer, Lilly, Novartis, and UCB.
A version of this article first appeared on Medscape.com.
FROM THE LANCET RHEUMATOLOGY
First-year fellows guide to gastroenterology
After the excitement and the well-deserved celebrations of matching in a gastroenterology fellowship program, a whole new set of unanswered questions and worries can start forming in a first-year fellow’s mind. “I made it, but now what? How do I learn a whole new career skill like endoscopy? Is my GI knowledge solid and wide enough to manage patients and answer the medical team consult? How will I keep up with my reading and learning with a busy fellowship schedule? How do I balance growth in clinical knowledge, endoscopy, and research? Can I integrate ‘life’ alongside a busy fellowship?” All of these questions and more can be overwhelming to answer in the beginning. The following guide is designed to help you through this transition and navigate the various aspects of first-year fellowship.
First-year goals
It is important to keep in mind that you have 3 full years to become a well-rounded, highly skilled, and knowledgeable gastroenterologist and endoscopist. So, set realistic goals and expectations for your first year, but be mindful that this year also lays the solid foundations of who you will become as a clinician, educator, or researcher.
One of the main goals of fellowship is to learn and implement evidence-based medicine in the diagnosis and management of GI conditions, as well as to learn endoscopic skills and ethics, all while keeping the patient (as a whole person) at the center of what you do. According to a recently published article by Bollipo and colleagues,1 the overall growth as a gastroenterologist not only depends on acquisition of knowledge but also involves cultivating teamwork, communication, situational awareness, compassion, leadership, and situational awareness. Beyond your medical education, your professional growth is also dependent on intentionally working towards acquiring the following skills:
1. Manage your time efficiently and prioritize your daily tasks
2. Become a consultant: effectively communicate with others, teach, lead, and delegate as appropriate
3. Work as a team with colleagues, faculty, and endoscopy staff
4. Develop critical thinking, give and receive constructive feedback, and understand your skills, limitations, and growth potential
5. Identify mentors and potential niche area
6. Start building your professional network and your reputation
7. Get involved in national GI societies
Consults
Mindset
Shifting gear from residency to fellowship involves a shifting of your clinical mindset too, going from being part of a primary care team responsible for all aspects of a patient’s medical care, to that of a consulting team focused on a patient’s GI condition. It is important to find the right balance of refraining from micromanaging non-GI comorbidities while being fully aware of their impact on your diagnostic and therapeutic approach to the GI condition.
Let’s face it, you will not always get “exciting and interesting GI cases” consults, and on a busy day some consultations might feel unnecessary and frustrating to you. Remember that what seems obvious to you, based on your focused GI knowledge, might not be so simple to the primary team. In addition, every consult is an opportunity to improve your approach to patient care, as well as an opportunity to learn and teach others, from medical students to residents. So, always be professional and respectful when you pick up the phone, and build positive collaborative bridges between you and the medical or surgical consulting teams. Be the GI fellow others are not reluctant to call for help, and better, be the one who communicates GI pearls along the way, inspires others to join the field of gastroenterology, and positively represent the GI division.
Triage
When you answer your consult page, ask the primary team what specific question they have for you and/or what is the main GI complaint or test abnormality the patient has. This will help you assess the urgency and the complexity of the consult, and hence allow you to prioritize each consult (which one you need to see first and give the attending a heads-up), assign (or not) a rotating medical resident or student to the consult, tailor your preliminary recommendations to the primary team, and anticipate the need for a procedure. When you anticipate a procedure, assess its (semi-)urgency to get the process ready for same day or a bedside procedure by getting information on the patient’s vitals, basic labs, significant acute comorbidities, and supportive therapies in place. In other words, by judiciously obtaining key information from the primary team, you can efficiently triage the consults and keep your day organized and manageable (for the most part). Learn to divide and conquer the tasks of the day: split inpatient endoscopy and consults with your cofellows, assign appropriate consults and follow-ups to residents or students rotating on the GI service, and properly communicate with the primary team a plan of care (even a preliminary one) to avoid recurrent pages and interruptions. Some days the number or urgency of the consults and the required multitasking can be overwhelming: stop, breathe, and ask for help from your co-fellows and your attending. Remember, this is a fellowship, not a solo-ship and your program is here to support your work and growth.
Communication
Timely and efficient communication, between you and the different stakeholders, is crucial to provide optimal patient care and minimize the risk of “things falling through the cracks”. Convey to the primary team your recommendations and plan of care clearly, and use direct verbal communication (not just a note in the chart) when managing complex or urgent situations. Obtain information regarding current patient level of care (i.e., ICU), isolation precautions, and cardiac devices (i.e., left ventricular assist device). Keep the dialogue open with your attending about acutely ill patients and potentially urgent procedures. Inform the endoscopy suite early that you are adding a procedure on the same day, and communicate anticipated needs (such as intubation, fluoroscopy room, pediatric scope, stent). Using a “closed-loop” communication structure can ensure that your recommendations are received and implemented appropriately.2
Time management and structure
Having a structured routine to your day, in what seems to be a chaotic process of juggling different duties and being in different locations at once, will ensure that you efficiently complete your tasks in a timely manner. Find what works best for you, taking into account the challenges and resources available to you, such as the number of fellows and other trainees on the GI consult service, the average number of consults per day and their acuity, the availability of inpatient protocols for specific clinical situations (GI bleed, acute severe ulcerative colitis, etc.), and the time and style preferences of the rounding attending. We suggest the following schedule on a consult day: Round early in the morning and leave a note in the chart and/or communicate with the team key information, then review with the rotating trainees the patients they are following and personally reassess some patients as needed. Inform the endoscopy suite of the same day procedures and let your attending know of any issues that require immediate attention. Take your team and head to radiology and review the imaging studies on your patients. Learn and teach key points in diagnosis and therapeutic approach as you move through your day from the inpatient floors to the hallways. Divide consults during the day with your team and agree on a time to touch base. Review your patient list at the end of the day and assess which patients the GI service no longer need to follow and communicate that clearly to the primary team along with the appropriate outpatient GI care follow-up. Let the endoscopy suite know of any procedures you are adding for the next day along with their degree of urgency to allow the charge nurse to prioritize cases. When you leave the hospital, be intentional with your free time: Read about the GI conditions you have encountered, enjoy some fun relaxing time, and rest!
Call
Know your call environment and your emergency cart
Familiarize yourself with the locations where you could potentially perform an emergent case (i.e., the ICU, ED, operating room) and the relevant points of contact (such as the charge nurse, the anesthesia team, the on-call tech team) for overnight or weekend cases. Whether or not you have an endoscopy support team on call, learn to set up the emergency cart, find and check your equipment, and troubleshoot technical issues by soliciting an “in-service” from senior fellows or the endoscopy technical support staff. Before heading to an urgent case, double check that you have your “bleeder” or “food impaction” tools. For food impaction, consider obtaining rat tooth forceps, snares, Roth nets, and an overtube. For bleeding cases, obtain a therapeutic upper endoscope, hemostatic clips, clear caps, injection needles, epinephrine, HemosprayTM, banding kits, and the appropriate electrocautery/thermal set up.
What is an emergency?
Consults that require your immediate attention include food impactions, acute biliary conditions leading to septic shock, and hemodynamically unstable GI bleeds, especially variceal bleeds. Remember that patients who are hemodynamically unstable require adequate resuscitation before proceeding with any endoscopic intervention. Assess the need for intubation, the timing of the procedure, and the most optimal location to perform the procedure, depending on the time and acuity of the patients’ presentation, how they respond to resuscitation measures, and the resources and preferences of your institution.
The overnight ‘nonemergent’ call
Non-emergent consults can be addressed the next day, after reviewing the clinical information provided by the consulting team and the patient’s EMR to ensure no urgent measures are needed. Overnight call may include patient phone calls, from inquiries about colon prep (so familiarize yourself with the different prep instructions and how to troubleshoot prep difficulties) to GI symptoms that you will need to triage to either the ED or to an outpatient follow-up. Document all phone encounters in the EMR and route your note to the appropriate clinician and nurse or administrative assistant for follow-up.
The five E’s of endoscopy
Endoscopy training is a large component of a GI fellowship and can create achievement anxiety in many first-year fellows seeking the cecum! But there is more to endoscopy than technical skills: It is as important to adequately evaluate clinical situations, understand the indications and potential limitations and complications of the procedure, and assess how it will impact the management of the patient. And no, you don’t have to be a video gamer to be a good endoscopist; and yes, you will be able to regularly complete a colonoscopy before the end of your first year!
Evaluation
In order to improve your endoscopic skills, it is important to honestly assess your areas of proficiency and improvement and to welcome real-time constructive feedback from your teaching attending about your endoscopic skills range. Consider meeting regularly with your attending to discuss your short-term and long-term endoscopic goals and how to enhance your skills. This practice demonstrates responsibility, credibility, and accountability amongst your peers as well as a genuine commitment to your growth as an endoscopist.
Efficiency
In addition to focusing on the quality of your endoscopy, learn to be efficient in the pre- and postprocedure time flow. This entails any step from properly explaining the procedure to patients before they come to the endoscopy suite, making sure the needed endoscopy equipment and tools are available in your room, completing your personal setup (i.e., gowning up, setting up your bed/monitor height, testing your endoscope) even before time out, to discharging the patient and communicating key findings and plan of care to the primary team. Depending on the acuity of the procedure and patient’s comorbidities, certain procedures may need to be performed or completed by a more efficient and experienced senior fellow or attending; don’t let this situation trigger passive frustration in you, but rather use it as an active and engaging opportunity to learn.
Expectations
You (and all the other neighborhood kids) didn’t learn to ride a bike without falling, struggling, needing help, and practicing over and over again, and it goes the same when learning to scope as a first-year fellow. Keep this in mind to lessen frustration, set realistic expectations, and be patient with yourself and celebrate all the small victories. Set tangible goals with your attending prior to procedural days/rotations so they can help you hone in and perfect the desired endoscopy skills.
Ergonomics
In a recent study, endoscopy-related injury (ERI) was reported to occur in up to 75% of gastroenterologists.3 While your primary focus might be reaching the cecum, it is as crucial for you to learn how to prevent ERI to ensure your long term health and continued success in procedures.
Excellence over quantity
Your main focus as a trainee is to learn how to provide effective, efficient, and safe care to patients, including in endoscopy. The quality of the endoscopy you perform is much more important than the total number of procedures you do. Thus, it is key to take each procedure as a complete learning opportunity to perform a thorough evaluation, improve your technical skills, interpret the findings, and develop a therapeutic plan.
Work-life balance and burnout
Fellowship is a marathon and not a sprint, so you need to slow down after a busy workday and care for yourself and enjoy time with loved ones. The cognitive, physical, mental, and emotional demands for first-year fellows are arguably the highest during GI training and can lead to burnout. Signs of burnout include emotional exhaustion, loss of empathy, fatigue, depersonalization and detachment, and feelings of personal inadequacy.4 Antiburnout measures include respecting basic healthy life hygiene (eat and sleep well, regular physical activity), having a hobby, practicing meditation, avoiding taking work home, and having a healthy social network.5 Remember that your cofellows whom you share common experiences with are not only your colleagues but can also be your friends and your social support. If you are a parent juggling work and family, remember to ask for help from your peers if you need it and have an open discussion with your attending to find practical solutions to your schedule.
Professional growth in the field of gastroenterology
Becoming a successful gastroenterologist and endoscopist involves going above the “I” and into the inclusive “we.” Building collegial and professional relationships early on with different stakeholders will set you up for success during and beyond your fellowship.
Building relationships
Developing genuine collegial and collaborative relationships with cofellows and faculty will positively impact your wellness during fellowship but also build the foundation of your professional network necessary to your career growth. Be inclusive of your cofellows in your research projects and publications, and support and amplify their work as much as you amplify your own. Your cofellows or attendings are likely to be the ones to help you find the right job, invite you to speak at grand rounds, or sit on a GI committee and promote your postfellowship professional growth.
Mentorship, being an educator and role model
It is important to identify and seek out mentors, within or outside your fellowship program or institution, who can not only guide you in your career choices but also open doors for you and sponsor you to advance your career. On the other hand, you too can be a role model, mentor, and sponsor to medical residents and students interested in the field of GI. Teach others in didactic settings or on the consult service, include trainees in quality improvement projects and publications, and lead by example.
Research
Most academic GI programs have a baseline requirement of research. Choose and devise a project you can realistically complete despite your busy first-year schedule: expand on a residency research project, focus on a specific simple question triggered by a clinical situation you encountered, proceed with a retrospective chart review or quality improvement project, and include other fellows and trainees to divide tasks. Alternatively, devise a specific timeline with a research mentor to complete a larger research project during your three years of fellowship.
Involvement in GI societies/committees
Become a member of one (or all) of the national GI societies that align with your interests. Membership gives you access not only to peer-reviewed scientific articles and guidelines but also to fellow-focused programs, committees’ opportunities, early career research grants, and mentorship.6-10
Summary
The first year of a GI fellowship lays the foundation for your next 3 years: Be mindful of how you can optimize the opportunities at hand to learn, teach, build a solid reputation, and grow your professional network. But also remember you have 3 full years to accomplish all your goals, so be patient, pace yourself, and include others in your journey. Judiciously use the many resources within your program and GI societies to help you achieve your goals, reach out to others to overcome difficulties and barriers, and dedicate time to care for your personal health and growth. This is what a true comprehensive and healthy fellowship is all about!
Dr. Advani is with the division of gastroenterology and hepatology, Stony Brook (N.Y.) University Hospital. Dr. Saeed is with the division of gastroenterology and hepatology, University of Kentucky, Lexington. Dr. Charabaty is with the division of gastroenterology, Johns Hopkins University, Baltimore, and Johns Hopkins–Sibley Memorial Hospital, Washington. Dr. Advani and Dr. Saeed have no conflicts to disclose. Dr. Charabaty disclosed ties to AbbVie, Janssen, Takeda, Pfizer, and Bristol-Myers Squibb and is founder of @MondayNightIBD, and cofounder of Scrubs & Heels.
References
1. Bollipo S. Gastroenterology. 2020 Nov;159(5):1648-52.
2. Adams MA et al. Gastroenterology. 2014 Jan 1;146(1):5-9.
3. Pawa S et al. Am J Gastroenterol. 2021 Mar 1;116(3):530-8.
4. DeCross AJ. Gastroenterology. 2020 Jan 1;158(1):32-5.
5. Burke C et al. Am J Gastroenterol. 2017 Oct 1;112:S593-4.
6. Fellows Resources under Fellows & Early Career. American Gastroenterological Association. https://gastro.org/fellows-and-early-career/training-resources/fellows-resources/.
7. Trainee Courses and Events. American College of Gastroenterology. https://gi.org/trainees/trainee-courses-and-events/.
8. Trainee Resources. American Association for the Study of Liver Diseases. https://www.aasld.org/membership/hepatology-associates/trainee-resources.
9. First Year Fellows Courses under Education. American Society of Gastrointestinal Endoscopy. https://www.asge.org/home/education/advanced-education-training/first-year-fellow-(fyf)-courses.
10. Annual GI Fellow Summer Course Presentations. New York Society for Gastrointestinal Endoscopy. https://www.nysge.org/annual%20gi%20fellows%20summer%20course.
After the excitement and the well-deserved celebrations of matching in a gastroenterology fellowship program, a whole new set of unanswered questions and worries can start forming in a first-year fellow’s mind. “I made it, but now what? How do I learn a whole new career skill like endoscopy? Is my GI knowledge solid and wide enough to manage patients and answer the medical team consult? How will I keep up with my reading and learning with a busy fellowship schedule? How do I balance growth in clinical knowledge, endoscopy, and research? Can I integrate ‘life’ alongside a busy fellowship?” All of these questions and more can be overwhelming to answer in the beginning. The following guide is designed to help you through this transition and navigate the various aspects of first-year fellowship.
First-year goals
It is important to keep in mind that you have 3 full years to become a well-rounded, highly skilled, and knowledgeable gastroenterologist and endoscopist. So, set realistic goals and expectations for your first year, but be mindful that this year also lays the solid foundations of who you will become as a clinician, educator, or researcher.
One of the main goals of fellowship is to learn and implement evidence-based medicine in the diagnosis and management of GI conditions, as well as to learn endoscopic skills and ethics, all while keeping the patient (as a whole person) at the center of what you do. According to a recently published article by Bollipo and colleagues,1 the overall growth as a gastroenterologist not only depends on acquisition of knowledge but also involves cultivating teamwork, communication, situational awareness, compassion, leadership, and situational awareness. Beyond your medical education, your professional growth is also dependent on intentionally working towards acquiring the following skills:
1. Manage your time efficiently and prioritize your daily tasks
2. Become a consultant: effectively communicate with others, teach, lead, and delegate as appropriate
3. Work as a team with colleagues, faculty, and endoscopy staff
4. Develop critical thinking, give and receive constructive feedback, and understand your skills, limitations, and growth potential
5. Identify mentors and potential niche area
6. Start building your professional network and your reputation
7. Get involved in national GI societies
Consults
Mindset
Shifting gear from residency to fellowship involves a shifting of your clinical mindset too, going from being part of a primary care team responsible for all aspects of a patient’s medical care, to that of a consulting team focused on a patient’s GI condition. It is important to find the right balance of refraining from micromanaging non-GI comorbidities while being fully aware of their impact on your diagnostic and therapeutic approach to the GI condition.
Let’s face it, you will not always get “exciting and interesting GI cases” consults, and on a busy day some consultations might feel unnecessary and frustrating to you. Remember that what seems obvious to you, based on your focused GI knowledge, might not be so simple to the primary team. In addition, every consult is an opportunity to improve your approach to patient care, as well as an opportunity to learn and teach others, from medical students to residents. So, always be professional and respectful when you pick up the phone, and build positive collaborative bridges between you and the medical or surgical consulting teams. Be the GI fellow others are not reluctant to call for help, and better, be the one who communicates GI pearls along the way, inspires others to join the field of gastroenterology, and positively represent the GI division.
Triage
When you answer your consult page, ask the primary team what specific question they have for you and/or what is the main GI complaint or test abnormality the patient has. This will help you assess the urgency and the complexity of the consult, and hence allow you to prioritize each consult (which one you need to see first and give the attending a heads-up), assign (or not) a rotating medical resident or student to the consult, tailor your preliminary recommendations to the primary team, and anticipate the need for a procedure. When you anticipate a procedure, assess its (semi-)urgency to get the process ready for same day or a bedside procedure by getting information on the patient’s vitals, basic labs, significant acute comorbidities, and supportive therapies in place. In other words, by judiciously obtaining key information from the primary team, you can efficiently triage the consults and keep your day organized and manageable (for the most part). Learn to divide and conquer the tasks of the day: split inpatient endoscopy and consults with your cofellows, assign appropriate consults and follow-ups to residents or students rotating on the GI service, and properly communicate with the primary team a plan of care (even a preliminary one) to avoid recurrent pages and interruptions. Some days the number or urgency of the consults and the required multitasking can be overwhelming: stop, breathe, and ask for help from your co-fellows and your attending. Remember, this is a fellowship, not a solo-ship and your program is here to support your work and growth.
Communication
Timely and efficient communication, between you and the different stakeholders, is crucial to provide optimal patient care and minimize the risk of “things falling through the cracks”. Convey to the primary team your recommendations and plan of care clearly, and use direct verbal communication (not just a note in the chart) when managing complex or urgent situations. Obtain information regarding current patient level of care (i.e., ICU), isolation precautions, and cardiac devices (i.e., left ventricular assist device). Keep the dialogue open with your attending about acutely ill patients and potentially urgent procedures. Inform the endoscopy suite early that you are adding a procedure on the same day, and communicate anticipated needs (such as intubation, fluoroscopy room, pediatric scope, stent). Using a “closed-loop” communication structure can ensure that your recommendations are received and implemented appropriately.2
Time management and structure
Having a structured routine to your day, in what seems to be a chaotic process of juggling different duties and being in different locations at once, will ensure that you efficiently complete your tasks in a timely manner. Find what works best for you, taking into account the challenges and resources available to you, such as the number of fellows and other trainees on the GI consult service, the average number of consults per day and their acuity, the availability of inpatient protocols for specific clinical situations (GI bleed, acute severe ulcerative colitis, etc.), and the time and style preferences of the rounding attending. We suggest the following schedule on a consult day: Round early in the morning and leave a note in the chart and/or communicate with the team key information, then review with the rotating trainees the patients they are following and personally reassess some patients as needed. Inform the endoscopy suite of the same day procedures and let your attending know of any issues that require immediate attention. Take your team and head to radiology and review the imaging studies on your patients. Learn and teach key points in diagnosis and therapeutic approach as you move through your day from the inpatient floors to the hallways. Divide consults during the day with your team and agree on a time to touch base. Review your patient list at the end of the day and assess which patients the GI service no longer need to follow and communicate that clearly to the primary team along with the appropriate outpatient GI care follow-up. Let the endoscopy suite know of any procedures you are adding for the next day along with their degree of urgency to allow the charge nurse to prioritize cases. When you leave the hospital, be intentional with your free time: Read about the GI conditions you have encountered, enjoy some fun relaxing time, and rest!
Call
Know your call environment and your emergency cart
Familiarize yourself with the locations where you could potentially perform an emergent case (i.e., the ICU, ED, operating room) and the relevant points of contact (such as the charge nurse, the anesthesia team, the on-call tech team) for overnight or weekend cases. Whether or not you have an endoscopy support team on call, learn to set up the emergency cart, find and check your equipment, and troubleshoot technical issues by soliciting an “in-service” from senior fellows or the endoscopy technical support staff. Before heading to an urgent case, double check that you have your “bleeder” or “food impaction” tools. For food impaction, consider obtaining rat tooth forceps, snares, Roth nets, and an overtube. For bleeding cases, obtain a therapeutic upper endoscope, hemostatic clips, clear caps, injection needles, epinephrine, HemosprayTM, banding kits, and the appropriate electrocautery/thermal set up.
What is an emergency?
Consults that require your immediate attention include food impactions, acute biliary conditions leading to septic shock, and hemodynamically unstable GI bleeds, especially variceal bleeds. Remember that patients who are hemodynamically unstable require adequate resuscitation before proceeding with any endoscopic intervention. Assess the need for intubation, the timing of the procedure, and the most optimal location to perform the procedure, depending on the time and acuity of the patients’ presentation, how they respond to resuscitation measures, and the resources and preferences of your institution.
The overnight ‘nonemergent’ call
Non-emergent consults can be addressed the next day, after reviewing the clinical information provided by the consulting team and the patient’s EMR to ensure no urgent measures are needed. Overnight call may include patient phone calls, from inquiries about colon prep (so familiarize yourself with the different prep instructions and how to troubleshoot prep difficulties) to GI symptoms that you will need to triage to either the ED or to an outpatient follow-up. Document all phone encounters in the EMR and route your note to the appropriate clinician and nurse or administrative assistant for follow-up.
The five E’s of endoscopy
Endoscopy training is a large component of a GI fellowship and can create achievement anxiety in many first-year fellows seeking the cecum! But there is more to endoscopy than technical skills: It is as important to adequately evaluate clinical situations, understand the indications and potential limitations and complications of the procedure, and assess how it will impact the management of the patient. And no, you don’t have to be a video gamer to be a good endoscopist; and yes, you will be able to regularly complete a colonoscopy before the end of your first year!
Evaluation
In order to improve your endoscopic skills, it is important to honestly assess your areas of proficiency and improvement and to welcome real-time constructive feedback from your teaching attending about your endoscopic skills range. Consider meeting regularly with your attending to discuss your short-term and long-term endoscopic goals and how to enhance your skills. This practice demonstrates responsibility, credibility, and accountability amongst your peers as well as a genuine commitment to your growth as an endoscopist.
Efficiency
In addition to focusing on the quality of your endoscopy, learn to be efficient in the pre- and postprocedure time flow. This entails any step from properly explaining the procedure to patients before they come to the endoscopy suite, making sure the needed endoscopy equipment and tools are available in your room, completing your personal setup (i.e., gowning up, setting up your bed/monitor height, testing your endoscope) even before time out, to discharging the patient and communicating key findings and plan of care to the primary team. Depending on the acuity of the procedure and patient’s comorbidities, certain procedures may need to be performed or completed by a more efficient and experienced senior fellow or attending; don’t let this situation trigger passive frustration in you, but rather use it as an active and engaging opportunity to learn.
Expectations
You (and all the other neighborhood kids) didn’t learn to ride a bike without falling, struggling, needing help, and practicing over and over again, and it goes the same when learning to scope as a first-year fellow. Keep this in mind to lessen frustration, set realistic expectations, and be patient with yourself and celebrate all the small victories. Set tangible goals with your attending prior to procedural days/rotations so they can help you hone in and perfect the desired endoscopy skills.
Ergonomics
In a recent study, endoscopy-related injury (ERI) was reported to occur in up to 75% of gastroenterologists.3 While your primary focus might be reaching the cecum, it is as crucial for you to learn how to prevent ERI to ensure your long term health and continued success in procedures.
Excellence over quantity
Your main focus as a trainee is to learn how to provide effective, efficient, and safe care to patients, including in endoscopy. The quality of the endoscopy you perform is much more important than the total number of procedures you do. Thus, it is key to take each procedure as a complete learning opportunity to perform a thorough evaluation, improve your technical skills, interpret the findings, and develop a therapeutic plan.
Work-life balance and burnout
Fellowship is a marathon and not a sprint, so you need to slow down after a busy workday and care for yourself and enjoy time with loved ones. The cognitive, physical, mental, and emotional demands for first-year fellows are arguably the highest during GI training and can lead to burnout. Signs of burnout include emotional exhaustion, loss of empathy, fatigue, depersonalization and detachment, and feelings of personal inadequacy.4 Antiburnout measures include respecting basic healthy life hygiene (eat and sleep well, regular physical activity), having a hobby, practicing meditation, avoiding taking work home, and having a healthy social network.5 Remember that your cofellows whom you share common experiences with are not only your colleagues but can also be your friends and your social support. If you are a parent juggling work and family, remember to ask for help from your peers if you need it and have an open discussion with your attending to find practical solutions to your schedule.
Professional growth in the field of gastroenterology
Becoming a successful gastroenterologist and endoscopist involves going above the “I” and into the inclusive “we.” Building collegial and professional relationships early on with different stakeholders will set you up for success during and beyond your fellowship.
Building relationships
Developing genuine collegial and collaborative relationships with cofellows and faculty will positively impact your wellness during fellowship but also build the foundation of your professional network necessary to your career growth. Be inclusive of your cofellows in your research projects and publications, and support and amplify their work as much as you amplify your own. Your cofellows or attendings are likely to be the ones to help you find the right job, invite you to speak at grand rounds, or sit on a GI committee and promote your postfellowship professional growth.
Mentorship, being an educator and role model
It is important to identify and seek out mentors, within or outside your fellowship program or institution, who can not only guide you in your career choices but also open doors for you and sponsor you to advance your career. On the other hand, you too can be a role model, mentor, and sponsor to medical residents and students interested in the field of GI. Teach others in didactic settings or on the consult service, include trainees in quality improvement projects and publications, and lead by example.
Research
Most academic GI programs have a baseline requirement of research. Choose and devise a project you can realistically complete despite your busy first-year schedule: expand on a residency research project, focus on a specific simple question triggered by a clinical situation you encountered, proceed with a retrospective chart review or quality improvement project, and include other fellows and trainees to divide tasks. Alternatively, devise a specific timeline with a research mentor to complete a larger research project during your three years of fellowship.
Involvement in GI societies/committees
Become a member of one (or all) of the national GI societies that align with your interests. Membership gives you access not only to peer-reviewed scientific articles and guidelines but also to fellow-focused programs, committees’ opportunities, early career research grants, and mentorship.6-10
Summary
The first year of a GI fellowship lays the foundation for your next 3 years: Be mindful of how you can optimize the opportunities at hand to learn, teach, build a solid reputation, and grow your professional network. But also remember you have 3 full years to accomplish all your goals, so be patient, pace yourself, and include others in your journey. Judiciously use the many resources within your program and GI societies to help you achieve your goals, reach out to others to overcome difficulties and barriers, and dedicate time to care for your personal health and growth. This is what a true comprehensive and healthy fellowship is all about!
Dr. Advani is with the division of gastroenterology and hepatology, Stony Brook (N.Y.) University Hospital. Dr. Saeed is with the division of gastroenterology and hepatology, University of Kentucky, Lexington. Dr. Charabaty is with the division of gastroenterology, Johns Hopkins University, Baltimore, and Johns Hopkins–Sibley Memorial Hospital, Washington. Dr. Advani and Dr. Saeed have no conflicts to disclose. Dr. Charabaty disclosed ties to AbbVie, Janssen, Takeda, Pfizer, and Bristol-Myers Squibb and is founder of @MondayNightIBD, and cofounder of Scrubs & Heels.
References
1. Bollipo S. Gastroenterology. 2020 Nov;159(5):1648-52.
2. Adams MA et al. Gastroenterology. 2014 Jan 1;146(1):5-9.
3. Pawa S et al. Am J Gastroenterol. 2021 Mar 1;116(3):530-8.
4. DeCross AJ. Gastroenterology. 2020 Jan 1;158(1):32-5.
5. Burke C et al. Am J Gastroenterol. 2017 Oct 1;112:S593-4.
6. Fellows Resources under Fellows & Early Career. American Gastroenterological Association. https://gastro.org/fellows-and-early-career/training-resources/fellows-resources/.
7. Trainee Courses and Events. American College of Gastroenterology. https://gi.org/trainees/trainee-courses-and-events/.
8. Trainee Resources. American Association for the Study of Liver Diseases. https://www.aasld.org/membership/hepatology-associates/trainee-resources.
9. First Year Fellows Courses under Education. American Society of Gastrointestinal Endoscopy. https://www.asge.org/home/education/advanced-education-training/first-year-fellow-(fyf)-courses.
10. Annual GI Fellow Summer Course Presentations. New York Society for Gastrointestinal Endoscopy. https://www.nysge.org/annual%20gi%20fellows%20summer%20course.
After the excitement and the well-deserved celebrations of matching in a gastroenterology fellowship program, a whole new set of unanswered questions and worries can start forming in a first-year fellow’s mind. “I made it, but now what? How do I learn a whole new career skill like endoscopy? Is my GI knowledge solid and wide enough to manage patients and answer the medical team consult? How will I keep up with my reading and learning with a busy fellowship schedule? How do I balance growth in clinical knowledge, endoscopy, and research? Can I integrate ‘life’ alongside a busy fellowship?” All of these questions and more can be overwhelming to answer in the beginning. The following guide is designed to help you through this transition and navigate the various aspects of first-year fellowship.
First-year goals
It is important to keep in mind that you have 3 full years to become a well-rounded, highly skilled, and knowledgeable gastroenterologist and endoscopist. So, set realistic goals and expectations for your first year, but be mindful that this year also lays the solid foundations of who you will become as a clinician, educator, or researcher.
One of the main goals of fellowship is to learn and implement evidence-based medicine in the diagnosis and management of GI conditions, as well as to learn endoscopic skills and ethics, all while keeping the patient (as a whole person) at the center of what you do. According to a recently published article by Bollipo and colleagues,1 the overall growth as a gastroenterologist not only depends on acquisition of knowledge but also involves cultivating teamwork, communication, situational awareness, compassion, leadership, and situational awareness. Beyond your medical education, your professional growth is also dependent on intentionally working towards acquiring the following skills:
1. Manage your time efficiently and prioritize your daily tasks
2. Become a consultant: effectively communicate with others, teach, lead, and delegate as appropriate
3. Work as a team with colleagues, faculty, and endoscopy staff
4. Develop critical thinking, give and receive constructive feedback, and understand your skills, limitations, and growth potential
5. Identify mentors and potential niche area
6. Start building your professional network and your reputation
7. Get involved in national GI societies
Consults
Mindset
Shifting gear from residency to fellowship involves a shifting of your clinical mindset too, going from being part of a primary care team responsible for all aspects of a patient’s medical care, to that of a consulting team focused on a patient’s GI condition. It is important to find the right balance of refraining from micromanaging non-GI comorbidities while being fully aware of their impact on your diagnostic and therapeutic approach to the GI condition.
Let’s face it, you will not always get “exciting and interesting GI cases” consults, and on a busy day some consultations might feel unnecessary and frustrating to you. Remember that what seems obvious to you, based on your focused GI knowledge, might not be so simple to the primary team. In addition, every consult is an opportunity to improve your approach to patient care, as well as an opportunity to learn and teach others, from medical students to residents. So, always be professional and respectful when you pick up the phone, and build positive collaborative bridges between you and the medical or surgical consulting teams. Be the GI fellow others are not reluctant to call for help, and better, be the one who communicates GI pearls along the way, inspires others to join the field of gastroenterology, and positively represent the GI division.
Triage
When you answer your consult page, ask the primary team what specific question they have for you and/or what is the main GI complaint or test abnormality the patient has. This will help you assess the urgency and the complexity of the consult, and hence allow you to prioritize each consult (which one you need to see first and give the attending a heads-up), assign (or not) a rotating medical resident or student to the consult, tailor your preliminary recommendations to the primary team, and anticipate the need for a procedure. When you anticipate a procedure, assess its (semi-)urgency to get the process ready for same day or a bedside procedure by getting information on the patient’s vitals, basic labs, significant acute comorbidities, and supportive therapies in place. In other words, by judiciously obtaining key information from the primary team, you can efficiently triage the consults and keep your day organized and manageable (for the most part). Learn to divide and conquer the tasks of the day: split inpatient endoscopy and consults with your cofellows, assign appropriate consults and follow-ups to residents or students rotating on the GI service, and properly communicate with the primary team a plan of care (even a preliminary one) to avoid recurrent pages and interruptions. Some days the number or urgency of the consults and the required multitasking can be overwhelming: stop, breathe, and ask for help from your co-fellows and your attending. Remember, this is a fellowship, not a solo-ship and your program is here to support your work and growth.
Communication
Timely and efficient communication, between you and the different stakeholders, is crucial to provide optimal patient care and minimize the risk of “things falling through the cracks”. Convey to the primary team your recommendations and plan of care clearly, and use direct verbal communication (not just a note in the chart) when managing complex or urgent situations. Obtain information regarding current patient level of care (i.e., ICU), isolation precautions, and cardiac devices (i.e., left ventricular assist device). Keep the dialogue open with your attending about acutely ill patients and potentially urgent procedures. Inform the endoscopy suite early that you are adding a procedure on the same day, and communicate anticipated needs (such as intubation, fluoroscopy room, pediatric scope, stent). Using a “closed-loop” communication structure can ensure that your recommendations are received and implemented appropriately.2
Time management and structure
Having a structured routine to your day, in what seems to be a chaotic process of juggling different duties and being in different locations at once, will ensure that you efficiently complete your tasks in a timely manner. Find what works best for you, taking into account the challenges and resources available to you, such as the number of fellows and other trainees on the GI consult service, the average number of consults per day and their acuity, the availability of inpatient protocols for specific clinical situations (GI bleed, acute severe ulcerative colitis, etc.), and the time and style preferences of the rounding attending. We suggest the following schedule on a consult day: Round early in the morning and leave a note in the chart and/or communicate with the team key information, then review with the rotating trainees the patients they are following and personally reassess some patients as needed. Inform the endoscopy suite of the same day procedures and let your attending know of any issues that require immediate attention. Take your team and head to radiology and review the imaging studies on your patients. Learn and teach key points in diagnosis and therapeutic approach as you move through your day from the inpatient floors to the hallways. Divide consults during the day with your team and agree on a time to touch base. Review your patient list at the end of the day and assess which patients the GI service no longer need to follow and communicate that clearly to the primary team along with the appropriate outpatient GI care follow-up. Let the endoscopy suite know of any procedures you are adding for the next day along with their degree of urgency to allow the charge nurse to prioritize cases. When you leave the hospital, be intentional with your free time: Read about the GI conditions you have encountered, enjoy some fun relaxing time, and rest!
Call
Know your call environment and your emergency cart
Familiarize yourself with the locations where you could potentially perform an emergent case (i.e., the ICU, ED, operating room) and the relevant points of contact (such as the charge nurse, the anesthesia team, the on-call tech team) for overnight or weekend cases. Whether or not you have an endoscopy support team on call, learn to set up the emergency cart, find and check your equipment, and troubleshoot technical issues by soliciting an “in-service” from senior fellows or the endoscopy technical support staff. Before heading to an urgent case, double check that you have your “bleeder” or “food impaction” tools. For food impaction, consider obtaining rat tooth forceps, snares, Roth nets, and an overtube. For bleeding cases, obtain a therapeutic upper endoscope, hemostatic clips, clear caps, injection needles, epinephrine, HemosprayTM, banding kits, and the appropriate electrocautery/thermal set up.
What is an emergency?
Consults that require your immediate attention include food impactions, acute biliary conditions leading to septic shock, and hemodynamically unstable GI bleeds, especially variceal bleeds. Remember that patients who are hemodynamically unstable require adequate resuscitation before proceeding with any endoscopic intervention. Assess the need for intubation, the timing of the procedure, and the most optimal location to perform the procedure, depending on the time and acuity of the patients’ presentation, how they respond to resuscitation measures, and the resources and preferences of your institution.
The overnight ‘nonemergent’ call
Non-emergent consults can be addressed the next day, after reviewing the clinical information provided by the consulting team and the patient’s EMR to ensure no urgent measures are needed. Overnight call may include patient phone calls, from inquiries about colon prep (so familiarize yourself with the different prep instructions and how to troubleshoot prep difficulties) to GI symptoms that you will need to triage to either the ED or to an outpatient follow-up. Document all phone encounters in the EMR and route your note to the appropriate clinician and nurse or administrative assistant for follow-up.
The five E’s of endoscopy
Endoscopy training is a large component of a GI fellowship and can create achievement anxiety in many first-year fellows seeking the cecum! But there is more to endoscopy than technical skills: It is as important to adequately evaluate clinical situations, understand the indications and potential limitations and complications of the procedure, and assess how it will impact the management of the patient. And no, you don’t have to be a video gamer to be a good endoscopist; and yes, you will be able to regularly complete a colonoscopy before the end of your first year!
Evaluation
In order to improve your endoscopic skills, it is important to honestly assess your areas of proficiency and improvement and to welcome real-time constructive feedback from your teaching attending about your endoscopic skills range. Consider meeting regularly with your attending to discuss your short-term and long-term endoscopic goals and how to enhance your skills. This practice demonstrates responsibility, credibility, and accountability amongst your peers as well as a genuine commitment to your growth as an endoscopist.
Efficiency
In addition to focusing on the quality of your endoscopy, learn to be efficient in the pre- and postprocedure time flow. This entails any step from properly explaining the procedure to patients before they come to the endoscopy suite, making sure the needed endoscopy equipment and tools are available in your room, completing your personal setup (i.e., gowning up, setting up your bed/monitor height, testing your endoscope) even before time out, to discharging the patient and communicating key findings and plan of care to the primary team. Depending on the acuity of the procedure and patient’s comorbidities, certain procedures may need to be performed or completed by a more efficient and experienced senior fellow or attending; don’t let this situation trigger passive frustration in you, but rather use it as an active and engaging opportunity to learn.
Expectations
You (and all the other neighborhood kids) didn’t learn to ride a bike without falling, struggling, needing help, and practicing over and over again, and it goes the same when learning to scope as a first-year fellow. Keep this in mind to lessen frustration, set realistic expectations, and be patient with yourself and celebrate all the small victories. Set tangible goals with your attending prior to procedural days/rotations so they can help you hone in and perfect the desired endoscopy skills.
Ergonomics
In a recent study, endoscopy-related injury (ERI) was reported to occur in up to 75% of gastroenterologists.3 While your primary focus might be reaching the cecum, it is as crucial for you to learn how to prevent ERI to ensure your long term health and continued success in procedures.
Excellence over quantity
Your main focus as a trainee is to learn how to provide effective, efficient, and safe care to patients, including in endoscopy. The quality of the endoscopy you perform is much more important than the total number of procedures you do. Thus, it is key to take each procedure as a complete learning opportunity to perform a thorough evaluation, improve your technical skills, interpret the findings, and develop a therapeutic plan.
Work-life balance and burnout
Fellowship is a marathon and not a sprint, so you need to slow down after a busy workday and care for yourself and enjoy time with loved ones. The cognitive, physical, mental, and emotional demands for first-year fellows are arguably the highest during GI training and can lead to burnout. Signs of burnout include emotional exhaustion, loss of empathy, fatigue, depersonalization and detachment, and feelings of personal inadequacy.4 Antiburnout measures include respecting basic healthy life hygiene (eat and sleep well, regular physical activity), having a hobby, practicing meditation, avoiding taking work home, and having a healthy social network.5 Remember that your cofellows whom you share common experiences with are not only your colleagues but can also be your friends and your social support. If you are a parent juggling work and family, remember to ask for help from your peers if you need it and have an open discussion with your attending to find practical solutions to your schedule.
Professional growth in the field of gastroenterology
Becoming a successful gastroenterologist and endoscopist involves going above the “I” and into the inclusive “we.” Building collegial and professional relationships early on with different stakeholders will set you up for success during and beyond your fellowship.
Building relationships
Developing genuine collegial and collaborative relationships with cofellows and faculty will positively impact your wellness during fellowship but also build the foundation of your professional network necessary to your career growth. Be inclusive of your cofellows in your research projects and publications, and support and amplify their work as much as you amplify your own. Your cofellows or attendings are likely to be the ones to help you find the right job, invite you to speak at grand rounds, or sit on a GI committee and promote your postfellowship professional growth.
Mentorship, being an educator and role model
It is important to identify and seek out mentors, within or outside your fellowship program or institution, who can not only guide you in your career choices but also open doors for you and sponsor you to advance your career. On the other hand, you too can be a role model, mentor, and sponsor to medical residents and students interested in the field of GI. Teach others in didactic settings or on the consult service, include trainees in quality improvement projects and publications, and lead by example.
Research
Most academic GI programs have a baseline requirement of research. Choose and devise a project you can realistically complete despite your busy first-year schedule: expand on a residency research project, focus on a specific simple question triggered by a clinical situation you encountered, proceed with a retrospective chart review or quality improvement project, and include other fellows and trainees to divide tasks. Alternatively, devise a specific timeline with a research mentor to complete a larger research project during your three years of fellowship.
Involvement in GI societies/committees
Become a member of one (or all) of the national GI societies that align with your interests. Membership gives you access not only to peer-reviewed scientific articles and guidelines but also to fellow-focused programs, committees’ opportunities, early career research grants, and mentorship.6-10
Summary
The first year of a GI fellowship lays the foundation for your next 3 years: Be mindful of how you can optimize the opportunities at hand to learn, teach, build a solid reputation, and grow your professional network. But also remember you have 3 full years to accomplish all your goals, so be patient, pace yourself, and include others in your journey. Judiciously use the many resources within your program and GI societies to help you achieve your goals, reach out to others to overcome difficulties and barriers, and dedicate time to care for your personal health and growth. This is what a true comprehensive and healthy fellowship is all about!
Dr. Advani is with the division of gastroenterology and hepatology, Stony Brook (N.Y.) University Hospital. Dr. Saeed is with the division of gastroenterology and hepatology, University of Kentucky, Lexington. Dr. Charabaty is with the division of gastroenterology, Johns Hopkins University, Baltimore, and Johns Hopkins–Sibley Memorial Hospital, Washington. Dr. Advani and Dr. Saeed have no conflicts to disclose. Dr. Charabaty disclosed ties to AbbVie, Janssen, Takeda, Pfizer, and Bristol-Myers Squibb and is founder of @MondayNightIBD, and cofounder of Scrubs & Heels.
References
1. Bollipo S. Gastroenterology. 2020 Nov;159(5):1648-52.
2. Adams MA et al. Gastroenterology. 2014 Jan 1;146(1):5-9.
3. Pawa S et al. Am J Gastroenterol. 2021 Mar 1;116(3):530-8.
4. DeCross AJ. Gastroenterology. 2020 Jan 1;158(1):32-5.
5. Burke C et al. Am J Gastroenterol. 2017 Oct 1;112:S593-4.
6. Fellows Resources under Fellows & Early Career. American Gastroenterological Association. https://gastro.org/fellows-and-early-career/training-resources/fellows-resources/.
7. Trainee Courses and Events. American College of Gastroenterology. https://gi.org/trainees/trainee-courses-and-events/.
8. Trainee Resources. American Association for the Study of Liver Diseases. https://www.aasld.org/membership/hepatology-associates/trainee-resources.
9. First Year Fellows Courses under Education. American Society of Gastrointestinal Endoscopy. https://www.asge.org/home/education/advanced-education-training/first-year-fellow-(fyf)-courses.
10. Annual GI Fellow Summer Course Presentations. New York Society for Gastrointestinal Endoscopy. https://www.nysge.org/annual%20gi%20fellows%20summer%20course.
Step test signals exercise capacity in asthma patients
The incremental step test is a highly reliable measure of exercise capacity in patients with moderate to severe asthma, based on data from 50 individuals.
Asthma patients often limit their physical exercise to avoid respiratory symptoms, which creates a downward spiral of reduced exercise capacity and ability to perform activities of daily living, wrote Renata Cléia Claudino Barbosa of the University of Sao Paulo and colleagues. “However, exercise training has been shown to be an important adjunctive therapy for asthma treatment that improves exercise capacity and health-related quality of life,” they wrote.
Step tests have been identified as a simpler, less costly alternative to cardiopulmonary exercise tests to measure exercise capacity in patients with chronic obstructive pulmonary disease, but their effectiveness for asthma patients has not investigated, the researchers said.
In a study published in Pulmonology, the researchers recruited 50 adults with moderate or severe asthma during routine care at a university hospital. The participants had been clinically stable for at least 6 months, with no hospitalizations, emergency care, or medication changes in the past 30 days. All participants received short-acting and long-acting bronchodilators and inhaled corticosteroids. The patients ranged in age from 18 to 60 years, with body mass index measures from 20 kg/m2 to 40 kg/m2.
Participants were randomized to tests on 2 nonconsecutive days at least 48 hours apart. On the first day, patients completed asthma control questionnaires and lung function tests, then performed either a cardiopulmonary exercise test (CPET) or two incremental step tests (IST-1 and IST-2). On the second day, they performed the other test. Participants were instructed to use bronchodilators 15 minutes before each test.
The step test involved stepping up and down on a 20-cm high wooden bench.
Overall, the peak oxygen uptakes were 27.6 mL/kg per minute for the CPET, 22.3 mL/kg per minute for the first IST, and 23.3 mL/kg per minute for the second IST.
“The IST with better performance regarding the peak VO2 value was called the best IST (b-IST),” and these values were used for validity and interpretability analyses, the researchers wrote.
In a reliability analysis, the intraclass correlation coefficient (ICC) was 0.93, the measurement error was 2.5%, and the construct validity for peak VO2 was significantly more reliable than the CPET (P < 0.001), the researchers said. The ICC for total number of steps was 0.88.
Notably, “the present study also demonstrated that IST is not interchangeable with the CPET since the subjects with moderate to severe asthma did not reach the maximal exercise capacity,” the researchers said. However, “we believe that the IST is superior to walking tests in subjects with asthma because it is an activity that requires greater ventilation in a subject’s daily life,” they said.
The study findings were limited by several factors including the relatively small study population and the small number of male patients, which may limit generalizability to males with asthma or other asthma endotypes, the researchers said. However, the results were strengthened by the randomized design, and support the value of the IST as a cost-effective option for assessing exercise capacity, preferably with two step tests to minimize the learning effect, they said. Additional research is needed to determine whether IST can assess responsiveness to pharmacological and nonpharmalogical treatments in asthma patients, they noted.
The study was supported by the Sao Paulo Research Foundation, Conselho Nacional de Pesquisa, and Coordination of Improvement of Higher Level Personnel--Brazil. The researchers had no financial conflicts to disclose.
The incremental step test is a highly reliable measure of exercise capacity in patients with moderate to severe asthma, based on data from 50 individuals.
Asthma patients often limit their physical exercise to avoid respiratory symptoms, which creates a downward spiral of reduced exercise capacity and ability to perform activities of daily living, wrote Renata Cléia Claudino Barbosa of the University of Sao Paulo and colleagues. “However, exercise training has been shown to be an important adjunctive therapy for asthma treatment that improves exercise capacity and health-related quality of life,” they wrote.
Step tests have been identified as a simpler, less costly alternative to cardiopulmonary exercise tests to measure exercise capacity in patients with chronic obstructive pulmonary disease, but their effectiveness for asthma patients has not investigated, the researchers said.
In a study published in Pulmonology, the researchers recruited 50 adults with moderate or severe asthma during routine care at a university hospital. The participants had been clinically stable for at least 6 months, with no hospitalizations, emergency care, or medication changes in the past 30 days. All participants received short-acting and long-acting bronchodilators and inhaled corticosteroids. The patients ranged in age from 18 to 60 years, with body mass index measures from 20 kg/m2 to 40 kg/m2.
Participants were randomized to tests on 2 nonconsecutive days at least 48 hours apart. On the first day, patients completed asthma control questionnaires and lung function tests, then performed either a cardiopulmonary exercise test (CPET) or two incremental step tests (IST-1 and IST-2). On the second day, they performed the other test. Participants were instructed to use bronchodilators 15 minutes before each test.
The step test involved stepping up and down on a 20-cm high wooden bench.
Overall, the peak oxygen uptakes were 27.6 mL/kg per minute for the CPET, 22.3 mL/kg per minute for the first IST, and 23.3 mL/kg per minute for the second IST.
“The IST with better performance regarding the peak VO2 value was called the best IST (b-IST),” and these values were used for validity and interpretability analyses, the researchers wrote.
In a reliability analysis, the intraclass correlation coefficient (ICC) was 0.93, the measurement error was 2.5%, and the construct validity for peak VO2 was significantly more reliable than the CPET (P < 0.001), the researchers said. The ICC for total number of steps was 0.88.
Notably, “the present study also demonstrated that IST is not interchangeable with the CPET since the subjects with moderate to severe asthma did not reach the maximal exercise capacity,” the researchers said. However, “we believe that the IST is superior to walking tests in subjects with asthma because it is an activity that requires greater ventilation in a subject’s daily life,” they said.
The study findings were limited by several factors including the relatively small study population and the small number of male patients, which may limit generalizability to males with asthma or other asthma endotypes, the researchers said. However, the results were strengthened by the randomized design, and support the value of the IST as a cost-effective option for assessing exercise capacity, preferably with two step tests to minimize the learning effect, they said. Additional research is needed to determine whether IST can assess responsiveness to pharmacological and nonpharmalogical treatments in asthma patients, they noted.
The study was supported by the Sao Paulo Research Foundation, Conselho Nacional de Pesquisa, and Coordination of Improvement of Higher Level Personnel--Brazil. The researchers had no financial conflicts to disclose.
The incremental step test is a highly reliable measure of exercise capacity in patients with moderate to severe asthma, based on data from 50 individuals.
Asthma patients often limit their physical exercise to avoid respiratory symptoms, which creates a downward spiral of reduced exercise capacity and ability to perform activities of daily living, wrote Renata Cléia Claudino Barbosa of the University of Sao Paulo and colleagues. “However, exercise training has been shown to be an important adjunctive therapy for asthma treatment that improves exercise capacity and health-related quality of life,” they wrote.
Step tests have been identified as a simpler, less costly alternative to cardiopulmonary exercise tests to measure exercise capacity in patients with chronic obstructive pulmonary disease, but their effectiveness for asthma patients has not investigated, the researchers said.
In a study published in Pulmonology, the researchers recruited 50 adults with moderate or severe asthma during routine care at a university hospital. The participants had been clinically stable for at least 6 months, with no hospitalizations, emergency care, or medication changes in the past 30 days. All participants received short-acting and long-acting bronchodilators and inhaled corticosteroids. The patients ranged in age from 18 to 60 years, with body mass index measures from 20 kg/m2 to 40 kg/m2.
Participants were randomized to tests on 2 nonconsecutive days at least 48 hours apart. On the first day, patients completed asthma control questionnaires and lung function tests, then performed either a cardiopulmonary exercise test (CPET) or two incremental step tests (IST-1 and IST-2). On the second day, they performed the other test. Participants were instructed to use bronchodilators 15 minutes before each test.
The step test involved stepping up and down on a 20-cm high wooden bench.
Overall, the peak oxygen uptakes were 27.6 mL/kg per minute for the CPET, 22.3 mL/kg per minute for the first IST, and 23.3 mL/kg per minute for the second IST.
“The IST with better performance regarding the peak VO2 value was called the best IST (b-IST),” and these values were used for validity and interpretability analyses, the researchers wrote.
In a reliability analysis, the intraclass correlation coefficient (ICC) was 0.93, the measurement error was 2.5%, and the construct validity for peak VO2 was significantly more reliable than the CPET (P < 0.001), the researchers said. The ICC for total number of steps was 0.88.
Notably, “the present study also demonstrated that IST is not interchangeable with the CPET since the subjects with moderate to severe asthma did not reach the maximal exercise capacity,” the researchers said. However, “we believe that the IST is superior to walking tests in subjects with asthma because it is an activity that requires greater ventilation in a subject’s daily life,” they said.
The study findings were limited by several factors including the relatively small study population and the small number of male patients, which may limit generalizability to males with asthma or other asthma endotypes, the researchers said. However, the results were strengthened by the randomized design, and support the value of the IST as a cost-effective option for assessing exercise capacity, preferably with two step tests to minimize the learning effect, they said. Additional research is needed to determine whether IST can assess responsiveness to pharmacological and nonpharmalogical treatments in asthma patients, they noted.
The study was supported by the Sao Paulo Research Foundation, Conselho Nacional de Pesquisa, and Coordination of Improvement of Higher Level Personnel--Brazil. The researchers had no financial conflicts to disclose.
FROM PULMONOLOGY