Do you P.U.I.?

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Changed
Tue, 08/29/2023 - 12:44

In case you are looking for a place to park your discretionary funds, I have recently learned that nonalcoholic beer is the fastest-growing segment of the beer industry. It is just barely outperforming the strong beer market while the standard beer market is flat. The reasons behind this surge in popularity are unclear. While the general population doesn’t seem to grasp the importance of diet and exercise, there seem to be enough folks who are health conscious to support a demand.

Possibly more important has been the emergence of a couple of small breweries that have been able to produce a nonalcoholic product that actually tastes as good as regular beer, and in some cases even better than the real stuff. In Europe, nonalcoholic beer has become popular as a rehydration drink among athletes. We recently found it everywhere we looked while bicycling in France. The large breweries have taken notice and it is hard to find a restaurant here in Maine that doesn’t offer nonalcoholic beer on its menu.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

My history with beer goes back to preadolescence, when my father offered me a sip of his beer. I was never sure of his motive but that taste did not immediately whet my appetite for more. However, when I was in high school, New York State’s drinking age was 18 and beer just became part of growing up.

When I went into practice, my routine of having a can or bottle of beer with dinner presented a problem. When I was on call the odds of having to leave the house and see a patient or two was substantial. Back at the beginning I was never much concerned about having alcohol circulating through my brain but I didn’t want to be exhaling its vapors as I interacted with the parents and nurses. As I got older I became more aware that when I was tired, which was always the case at the end of a long office day, even just a glass of beer might impair my decision making. As a result, I drank only nonalcoholic beer when I was on call. Were I still practicing today this wouldn’t have represented a sacrifice on my part. However, until 5 years ago the nonalcoholic beer was not even a close approximation of the alcohol-containing product.

So this brings me to my question. Do you share any of my concerns about practicing under the influence of alcohol (P.U.I.)? And, if you have any concerns, how do you deal with them?

Do you make a distinction between physical and mental impairment? Would you have a drink if you were only fielding phone calls? Would your decision change if you knew you might be called in to perform surgery or start an intravenous on a premie?

Does the prospect of meeting face to face with your patient/parents change your decision? Is practicing telemedicine under the influence any less concerning to you than seeing patients in your office or the emergency room?

Can you imagine any extenuating circumstances? For example, let’s say you are the only pediatric ENT in your county. While you have office hours 4½ days per week, in effect you are on call 24/7 for emergencies. If you made a decision to never practice under the influence, does that mean you will never drink alcohol?

Am I making too big of a thing out of a can of beer or a glass of wine? We have certainly read concerns about patient safety when cared for by house officers working on schedules that leave them practicing while sleep deprived (P.W.S.D.) You don’t hear anything about physicians’ P.U.I. Is it a real problem? Certainly, with marijuana becoming legal in more states alcohol may not be the only influencer to consider.

In the bigger picture I suspect that P.W.S.D. is the bigger problem both for house officers and practicing physicians but it is time we swept away the cloud of silence around P.U.I and had a frank discussion about both among ourselves.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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In case you are looking for a place to park your discretionary funds, I have recently learned that nonalcoholic beer is the fastest-growing segment of the beer industry. It is just barely outperforming the strong beer market while the standard beer market is flat. The reasons behind this surge in popularity are unclear. While the general population doesn’t seem to grasp the importance of diet and exercise, there seem to be enough folks who are health conscious to support a demand.

Possibly more important has been the emergence of a couple of small breweries that have been able to produce a nonalcoholic product that actually tastes as good as regular beer, and in some cases even better than the real stuff. In Europe, nonalcoholic beer has become popular as a rehydration drink among athletes. We recently found it everywhere we looked while bicycling in France. The large breweries have taken notice and it is hard to find a restaurant here in Maine that doesn’t offer nonalcoholic beer on its menu.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

My history with beer goes back to preadolescence, when my father offered me a sip of his beer. I was never sure of his motive but that taste did not immediately whet my appetite for more. However, when I was in high school, New York State’s drinking age was 18 and beer just became part of growing up.

When I went into practice, my routine of having a can or bottle of beer with dinner presented a problem. When I was on call the odds of having to leave the house and see a patient or two was substantial. Back at the beginning I was never much concerned about having alcohol circulating through my brain but I didn’t want to be exhaling its vapors as I interacted with the parents and nurses. As I got older I became more aware that when I was tired, which was always the case at the end of a long office day, even just a glass of beer might impair my decision making. As a result, I drank only nonalcoholic beer when I was on call. Were I still practicing today this wouldn’t have represented a sacrifice on my part. However, until 5 years ago the nonalcoholic beer was not even a close approximation of the alcohol-containing product.

So this brings me to my question. Do you share any of my concerns about practicing under the influence of alcohol (P.U.I.)? And, if you have any concerns, how do you deal with them?

Do you make a distinction between physical and mental impairment? Would you have a drink if you were only fielding phone calls? Would your decision change if you knew you might be called in to perform surgery or start an intravenous on a premie?

Does the prospect of meeting face to face with your patient/parents change your decision? Is practicing telemedicine under the influence any less concerning to you than seeing patients in your office or the emergency room?

Can you imagine any extenuating circumstances? For example, let’s say you are the only pediatric ENT in your county. While you have office hours 4½ days per week, in effect you are on call 24/7 for emergencies. If you made a decision to never practice under the influence, does that mean you will never drink alcohol?

Am I making too big of a thing out of a can of beer or a glass of wine? We have certainly read concerns about patient safety when cared for by house officers working on schedules that leave them practicing while sleep deprived (P.W.S.D.) You don’t hear anything about physicians’ P.U.I. Is it a real problem? Certainly, with marijuana becoming legal in more states alcohol may not be the only influencer to consider.

In the bigger picture I suspect that P.W.S.D. is the bigger problem both for house officers and practicing physicians but it is time we swept away the cloud of silence around P.U.I and had a frank discussion about both among ourselves.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

In case you are looking for a place to park your discretionary funds, I have recently learned that nonalcoholic beer is the fastest-growing segment of the beer industry. It is just barely outperforming the strong beer market while the standard beer market is flat. The reasons behind this surge in popularity are unclear. While the general population doesn’t seem to grasp the importance of diet and exercise, there seem to be enough folks who are health conscious to support a demand.

Possibly more important has been the emergence of a couple of small breweries that have been able to produce a nonalcoholic product that actually tastes as good as regular beer, and in some cases even better than the real stuff. In Europe, nonalcoholic beer has become popular as a rehydration drink among athletes. We recently found it everywhere we looked while bicycling in France. The large breweries have taken notice and it is hard to find a restaurant here in Maine that doesn’t offer nonalcoholic beer on its menu.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

My history with beer goes back to preadolescence, when my father offered me a sip of his beer. I was never sure of his motive but that taste did not immediately whet my appetite for more. However, when I was in high school, New York State’s drinking age was 18 and beer just became part of growing up.

When I went into practice, my routine of having a can or bottle of beer with dinner presented a problem. When I was on call the odds of having to leave the house and see a patient or two was substantial. Back at the beginning I was never much concerned about having alcohol circulating through my brain but I didn’t want to be exhaling its vapors as I interacted with the parents and nurses. As I got older I became more aware that when I was tired, which was always the case at the end of a long office day, even just a glass of beer might impair my decision making. As a result, I drank only nonalcoholic beer when I was on call. Were I still practicing today this wouldn’t have represented a sacrifice on my part. However, until 5 years ago the nonalcoholic beer was not even a close approximation of the alcohol-containing product.

So this brings me to my question. Do you share any of my concerns about practicing under the influence of alcohol (P.U.I.)? And, if you have any concerns, how do you deal with them?

Do you make a distinction between physical and mental impairment? Would you have a drink if you were only fielding phone calls? Would your decision change if you knew you might be called in to perform surgery or start an intravenous on a premie?

Does the prospect of meeting face to face with your patient/parents change your decision? Is practicing telemedicine under the influence any less concerning to you than seeing patients in your office or the emergency room?

Can you imagine any extenuating circumstances? For example, let’s say you are the only pediatric ENT in your county. While you have office hours 4½ days per week, in effect you are on call 24/7 for emergencies. If you made a decision to never practice under the influence, does that mean you will never drink alcohol?

Am I making too big of a thing out of a can of beer or a glass of wine? We have certainly read concerns about patient safety when cared for by house officers working on schedules that leave them practicing while sleep deprived (P.W.S.D.) You don’t hear anything about physicians’ P.U.I. Is it a real problem? Certainly, with marijuana becoming legal in more states alcohol may not be the only influencer to consider.

In the bigger picture I suspect that P.W.S.D. is the bigger problem both for house officers and practicing physicians but it is time we swept away the cloud of silence around P.U.I and had a frank discussion about both among ourselves.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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Despite recent uptick in cases, leprosy is very rare, expert says

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Mon, 08/14/2023 - 14:58

Despite the recent uptick in leprosy cases in Central Florida, the disease is very rare, and casual contact with an infected person is likely to not result in transmission, according to Jose A. Lucar, MD.

“Contrary to historical beliefs, leprosy is not highly contagious,” Dr. Lucar, an infectious disease physician and associate professor of medicine at George Washington University, Washington, said in an interview. “For reasons that have to do with the makeup of genes that affect their immune system, most people are not susceptible to acquire leprosy. It’s really a small percentage of the population. It does require prolonged contact with someone with untreated leprosy – over several months – to acquire an infection. So, the risk from any type of casual contact is low.”

Dr. Lucar
Dr. Jose A. Lucar

According to a research letter published in the CDC’s Emerging Infectious Diseases, the number of reported leprosy cases has more than doubled in the past decade. Of the 159 new cases reported nationwide in 2020, Florida accounted for about one-fifth of cases, with most limited to the central part of the state. “In the U.S., there have been 150-250 cases reported each year over the past several years,” said Dr. Lucar, who was not affiliated with the research letter. “What seems to have changed is that since 2015, there has been a rise in cases in people who are U.S.-born “In the U.S., there have been 150-250 cases reported each year over the past several years,” said Dr. Lucar, who was not affiliated with the research letter. “What seems to have changed is that since 2015, there has been a rise in cases in people who are U.S.-born," and currently, about one-third of leprosy cases are in individuals born in the United States, he noted.

The research letter described a case of leprosy in a 54-year-old man who worked in landscaping, who sought treatment at a dermatology clinic in Central Florida in 2022 for a painful and progressive erythematous rash. The lesions began on his distal extensor extremities and progressed to involve his trunk and face. According to the report, the man denied any domestic or foreign travel, exposure to armadillos (a known source of transmission), prolonged contact with immigrants from leprosy-endemic countries, or connections with someone known to have leprosy. The authors concluded that the case “adds to the growing body of literature suggesting that central Florida represents an endemic location for leprosy. Travel to this area, even in the absence of other risk factors, should prompt consideration of leprosy in the appropriate clinical context.”



Dr. Lucar said that the mechanism of leprosy transmission is not fully understood, but armadillos, which typically traverse the southern United States, are naturally infected with the bacteria that causes leprosy. “It’s possible that they can spread it to people,” he said. “People who have occupations or hobbies that put them in potential contact with wildlife should avoid any close contact with armadillos. There’s also a discussion of whether [the spike in leprosy cases] may have to do with climate change. That is not yet confirmed. It’s not entirely clear why there’s been a recent rise. It remains an area of investigation.”

Meanwhile, clinicians should keep a high level of suspicion in patients who present with skin lesions compatible with leprosy. “These are typically discolored or numb patches on the skin,” Dr. Lucar said. “This can range from a single or a few lesions to very extensive involvement of the skin. The diminished sensation or loss of sensation within those skin patches is an important sign. There’s a loss of skin color but sometimes they can be reddish.” He emphasized that leprosy “does not spread easily from person to person; casual contact will not spread leprosy. It’s important for the public to understand that.”

Dr. Lucar reported no disclosures.

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Despite the recent uptick in leprosy cases in Central Florida, the disease is very rare, and casual contact with an infected person is likely to not result in transmission, according to Jose A. Lucar, MD.

“Contrary to historical beliefs, leprosy is not highly contagious,” Dr. Lucar, an infectious disease physician and associate professor of medicine at George Washington University, Washington, said in an interview. “For reasons that have to do with the makeup of genes that affect their immune system, most people are not susceptible to acquire leprosy. It’s really a small percentage of the population. It does require prolonged contact with someone with untreated leprosy – over several months – to acquire an infection. So, the risk from any type of casual contact is low.”

Dr. Lucar
Dr. Jose A. Lucar

According to a research letter published in the CDC’s Emerging Infectious Diseases, the number of reported leprosy cases has more than doubled in the past decade. Of the 159 new cases reported nationwide in 2020, Florida accounted for about one-fifth of cases, with most limited to the central part of the state. “In the U.S., there have been 150-250 cases reported each year over the past several years,” said Dr. Lucar, who was not affiliated with the research letter. “What seems to have changed is that since 2015, there has been a rise in cases in people who are U.S.-born “In the U.S., there have been 150-250 cases reported each year over the past several years,” said Dr. Lucar, who was not affiliated with the research letter. “What seems to have changed is that since 2015, there has been a rise in cases in people who are U.S.-born," and currently, about one-third of leprosy cases are in individuals born in the United States, he noted.

The research letter described a case of leprosy in a 54-year-old man who worked in landscaping, who sought treatment at a dermatology clinic in Central Florida in 2022 for a painful and progressive erythematous rash. The lesions began on his distal extensor extremities and progressed to involve his trunk and face. According to the report, the man denied any domestic or foreign travel, exposure to armadillos (a known source of transmission), prolonged contact with immigrants from leprosy-endemic countries, or connections with someone known to have leprosy. The authors concluded that the case “adds to the growing body of literature suggesting that central Florida represents an endemic location for leprosy. Travel to this area, even in the absence of other risk factors, should prompt consideration of leprosy in the appropriate clinical context.”



Dr. Lucar said that the mechanism of leprosy transmission is not fully understood, but armadillos, which typically traverse the southern United States, are naturally infected with the bacteria that causes leprosy. “It’s possible that they can spread it to people,” he said. “People who have occupations or hobbies that put them in potential contact with wildlife should avoid any close contact with armadillos. There’s also a discussion of whether [the spike in leprosy cases] may have to do with climate change. That is not yet confirmed. It’s not entirely clear why there’s been a recent rise. It remains an area of investigation.”

Meanwhile, clinicians should keep a high level of suspicion in patients who present with skin lesions compatible with leprosy. “These are typically discolored or numb patches on the skin,” Dr. Lucar said. “This can range from a single or a few lesions to very extensive involvement of the skin. The diminished sensation or loss of sensation within those skin patches is an important sign. There’s a loss of skin color but sometimes they can be reddish.” He emphasized that leprosy “does not spread easily from person to person; casual contact will not spread leprosy. It’s important for the public to understand that.”

Dr. Lucar reported no disclosures.

Despite the recent uptick in leprosy cases in Central Florida, the disease is very rare, and casual contact with an infected person is likely to not result in transmission, according to Jose A. Lucar, MD.

“Contrary to historical beliefs, leprosy is not highly contagious,” Dr. Lucar, an infectious disease physician and associate professor of medicine at George Washington University, Washington, said in an interview. “For reasons that have to do with the makeup of genes that affect their immune system, most people are not susceptible to acquire leprosy. It’s really a small percentage of the population. It does require prolonged contact with someone with untreated leprosy – over several months – to acquire an infection. So, the risk from any type of casual contact is low.”

Dr. Lucar
Dr. Jose A. Lucar

According to a research letter published in the CDC’s Emerging Infectious Diseases, the number of reported leprosy cases has more than doubled in the past decade. Of the 159 new cases reported nationwide in 2020, Florida accounted for about one-fifth of cases, with most limited to the central part of the state. “In the U.S., there have been 150-250 cases reported each year over the past several years,” said Dr. Lucar, who was not affiliated with the research letter. “What seems to have changed is that since 2015, there has been a rise in cases in people who are U.S.-born “In the U.S., there have been 150-250 cases reported each year over the past several years,” said Dr. Lucar, who was not affiliated with the research letter. “What seems to have changed is that since 2015, there has been a rise in cases in people who are U.S.-born," and currently, about one-third of leprosy cases are in individuals born in the United States, he noted.

The research letter described a case of leprosy in a 54-year-old man who worked in landscaping, who sought treatment at a dermatology clinic in Central Florida in 2022 for a painful and progressive erythematous rash. The lesions began on his distal extensor extremities and progressed to involve his trunk and face. According to the report, the man denied any domestic or foreign travel, exposure to armadillos (a known source of transmission), prolonged contact with immigrants from leprosy-endemic countries, or connections with someone known to have leprosy. The authors concluded that the case “adds to the growing body of literature suggesting that central Florida represents an endemic location for leprosy. Travel to this area, even in the absence of other risk factors, should prompt consideration of leprosy in the appropriate clinical context.”



Dr. Lucar said that the mechanism of leprosy transmission is not fully understood, but armadillos, which typically traverse the southern United States, are naturally infected with the bacteria that causes leprosy. “It’s possible that they can spread it to people,” he said. “People who have occupations or hobbies that put them in potential contact with wildlife should avoid any close contact with armadillos. There’s also a discussion of whether [the spike in leprosy cases] may have to do with climate change. That is not yet confirmed. It’s not entirely clear why there’s been a recent rise. It remains an area of investigation.”

Meanwhile, clinicians should keep a high level of suspicion in patients who present with skin lesions compatible with leprosy. “These are typically discolored or numb patches on the skin,” Dr. Lucar said. “This can range from a single or a few lesions to very extensive involvement of the skin. The diminished sensation or loss of sensation within those skin patches is an important sign. There’s a loss of skin color but sometimes they can be reddish.” He emphasized that leprosy “does not spread easily from person to person; casual contact will not spread leprosy. It’s important for the public to understand that.”

Dr. Lucar reported no disclosures.

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Crossed wires: Ischemia testing and monomorphic VT storm

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Mon, 08/14/2023 - 12:48

Patients with a severe form of ventricular arrhythmia who may be referred for catheter ablation are often first tested for coronary artery disease (CAD) or ischemia. But such testing seldom makes a difference to downstream management or outcomes, researchers conclude based on registry data.

The findings, they say, question such routine CAD/ischemia testing in patients like those studied, who had episodes of monomorphic ventricular tachycardia (VT) storm but not an acute coronary syndrome (ACS) and ultimately went to ablation.

Of 97 such patients, about 44% underwent CAD/ischemia testing by invasive angiography, myocardial functional imaging, or both. But the tests didn’t predict important ablation outcomes, including pre- or postablation VT inducibility. Nor did they significantly affect the likelihood or outcomes of preablation revascularization or 2-year survival.

The findings “argue against performing routine evaluations to rule out coronary [disease] or myocardial ischemia as culprits in monomorphic VT storm” in patients without evidence of ACS, write Feras Alkhalaileh, MD, Heart and Vascular Institute, Cleveland Clinic, and colleagues in their report published in JACC: Clinical Electrophysiology.

They suggest it’s “reasonable” not to perform tests for CAD or ischemia in such patients, senior author Ayman A. Hussein, MD, from the same center, said in an interview. Although such tests may be considered “case by case,” performed routinely they “aren’t going to add much to patient care, and as a matter of fact, may delay proper care and expose them to risks,” Dr. Hussein said.

It’s “reasonable” to test for CAD or ischemia in patients with polymorphic VT storm, which is likely ischemia-driven, he observed. In contrast, monomorphic VT storm is likely caused by myocardial scar, which revascularization cannot treat. “Because there’s scar substrate, we find that ischemic evaluations are technically without much yield.”

These issues are “not very controversial” among cardiac electrophysiologists, Dr. Hussein said, but it remains “common practice” for other specialists to order angiography or ischemia testing for patients with monomorphic VT storm, typically in the cardiac care unit (CCU), before considering ablation.

“Sometimes, as electrophysiologists, we don’t get to see them before an ischemic evaluation has already been done,” he added.

It’s “very hard to convince interventional cardiologists, CCU intensivists, or general cardiologists” that a VT may not be caused by ischemia, said electrophysiologist Roderick Tung, MD, University of Arizona College of Medicine, Phoenix, who was not involved in the current study.

In patients with monomorphic VT storm, “by the time we’re consulted, they’ve already had a cath. And it’s probably just not necessary,” Dr. Tung said. “That’s why this is such a great paper, because it has an immediate message [for nonelectrophysiologist clinicians and] the potential to change clinical practice.”

The study included 97 patients with monomorphic VT storm from a prospective VT-ablation registry covering about 7 years at a major referral center. Their mean age was 64 years, and 88% were men. Two-thirds were known to have ischemic cardiomyopathy and were in NYHA functional class II.

As reported, 10% of the cohort underwent coronary angiography after presentation with monomorphic VT storm, 26% had CT or PET myocardial functional imaging, and 9% had both tests.

Only four patients ultimately underwent coronary revascularization; no acute coronary occlusions were involved. Monomorphic VT recurred in all four cases, the report notes.

The 43 and 54 patients who did or did not get the CAD/ischemia tests, respectively, showed no significant procedural differences in extent of scar modification, prevalence of clinical or hemodynamically stable VT, or use of mechanical circulatory support; or in postablation, VT inducibility or overall mortality during follow-up averaging 24.3 months.

To address possible concerns about selection bias in the main cohort, all of whom underwent ablation, a secondary analysis was conducted with 91 patients with known asymptomatic coronary disease and monomorphic VT storm who were selected from the registry without regard to whether they underwent catheter ablation.

Of that cohort, 21 went to invasive angiography and 25 underwent stress testing; six of the latter went on to coronary angiography, the report states. Monomorphic VT later recurred in four of the five patients, who then underwent coronary revascularization.

Such patients with known coronary disease, Dr. Hussein said, are those “possibly more likely to get an ischemic evaluation.” And yet, “regardless of whether they had ablation, the yield of ischemic evaluations in these patients was low.”

By far most of the CAD/ischemia tests in the study’s primary cohort were performed using noninvasive imaging, notes an editorial accompanying the new report. “This raises the possibility of false negatives with very proximal and multivessel CAD, and with balanced ischemia,” write Saurabh Kumar, BSc (Med)/MBBS, PhD, and Ashwin Bhaskaran, MBBS, MSc, University of Sydney.

Ideally, the issues addressed by the study should be tested in large randomized, controlled trials, they state. “Achieving sufficient recruitment to address this clinical question may be difficult, leaving clinicians with the challenge of applying observational data to their patients.”

A version of this article appeared on Medscape.com.

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Patients with a severe form of ventricular arrhythmia who may be referred for catheter ablation are often first tested for coronary artery disease (CAD) or ischemia. But such testing seldom makes a difference to downstream management or outcomes, researchers conclude based on registry data.

The findings, they say, question such routine CAD/ischemia testing in patients like those studied, who had episodes of monomorphic ventricular tachycardia (VT) storm but not an acute coronary syndrome (ACS) and ultimately went to ablation.

Of 97 such patients, about 44% underwent CAD/ischemia testing by invasive angiography, myocardial functional imaging, or both. But the tests didn’t predict important ablation outcomes, including pre- or postablation VT inducibility. Nor did they significantly affect the likelihood or outcomes of preablation revascularization or 2-year survival.

The findings “argue against performing routine evaluations to rule out coronary [disease] or myocardial ischemia as culprits in monomorphic VT storm” in patients without evidence of ACS, write Feras Alkhalaileh, MD, Heart and Vascular Institute, Cleveland Clinic, and colleagues in their report published in JACC: Clinical Electrophysiology.

They suggest it’s “reasonable” not to perform tests for CAD or ischemia in such patients, senior author Ayman A. Hussein, MD, from the same center, said in an interview. Although such tests may be considered “case by case,” performed routinely they “aren’t going to add much to patient care, and as a matter of fact, may delay proper care and expose them to risks,” Dr. Hussein said.

It’s “reasonable” to test for CAD or ischemia in patients with polymorphic VT storm, which is likely ischemia-driven, he observed. In contrast, monomorphic VT storm is likely caused by myocardial scar, which revascularization cannot treat. “Because there’s scar substrate, we find that ischemic evaluations are technically without much yield.”

These issues are “not very controversial” among cardiac electrophysiologists, Dr. Hussein said, but it remains “common practice” for other specialists to order angiography or ischemia testing for patients with monomorphic VT storm, typically in the cardiac care unit (CCU), before considering ablation.

“Sometimes, as electrophysiologists, we don’t get to see them before an ischemic evaluation has already been done,” he added.

It’s “very hard to convince interventional cardiologists, CCU intensivists, or general cardiologists” that a VT may not be caused by ischemia, said electrophysiologist Roderick Tung, MD, University of Arizona College of Medicine, Phoenix, who was not involved in the current study.

In patients with monomorphic VT storm, “by the time we’re consulted, they’ve already had a cath. And it’s probably just not necessary,” Dr. Tung said. “That’s why this is such a great paper, because it has an immediate message [for nonelectrophysiologist clinicians and] the potential to change clinical practice.”

The study included 97 patients with monomorphic VT storm from a prospective VT-ablation registry covering about 7 years at a major referral center. Their mean age was 64 years, and 88% were men. Two-thirds were known to have ischemic cardiomyopathy and were in NYHA functional class II.

As reported, 10% of the cohort underwent coronary angiography after presentation with monomorphic VT storm, 26% had CT or PET myocardial functional imaging, and 9% had both tests.

Only four patients ultimately underwent coronary revascularization; no acute coronary occlusions were involved. Monomorphic VT recurred in all four cases, the report notes.

The 43 and 54 patients who did or did not get the CAD/ischemia tests, respectively, showed no significant procedural differences in extent of scar modification, prevalence of clinical or hemodynamically stable VT, or use of mechanical circulatory support; or in postablation, VT inducibility or overall mortality during follow-up averaging 24.3 months.

To address possible concerns about selection bias in the main cohort, all of whom underwent ablation, a secondary analysis was conducted with 91 patients with known asymptomatic coronary disease and monomorphic VT storm who were selected from the registry without regard to whether they underwent catheter ablation.

Of that cohort, 21 went to invasive angiography and 25 underwent stress testing; six of the latter went on to coronary angiography, the report states. Monomorphic VT later recurred in four of the five patients, who then underwent coronary revascularization.

Such patients with known coronary disease, Dr. Hussein said, are those “possibly more likely to get an ischemic evaluation.” And yet, “regardless of whether they had ablation, the yield of ischemic evaluations in these patients was low.”

By far most of the CAD/ischemia tests in the study’s primary cohort were performed using noninvasive imaging, notes an editorial accompanying the new report. “This raises the possibility of false negatives with very proximal and multivessel CAD, and with balanced ischemia,” write Saurabh Kumar, BSc (Med)/MBBS, PhD, and Ashwin Bhaskaran, MBBS, MSc, University of Sydney.

Ideally, the issues addressed by the study should be tested in large randomized, controlled trials, they state. “Achieving sufficient recruitment to address this clinical question may be difficult, leaving clinicians with the challenge of applying observational data to their patients.”

A version of this article appeared on Medscape.com.

Patients with a severe form of ventricular arrhythmia who may be referred for catheter ablation are often first tested for coronary artery disease (CAD) or ischemia. But such testing seldom makes a difference to downstream management or outcomes, researchers conclude based on registry data.

The findings, they say, question such routine CAD/ischemia testing in patients like those studied, who had episodes of monomorphic ventricular tachycardia (VT) storm but not an acute coronary syndrome (ACS) and ultimately went to ablation.

Of 97 such patients, about 44% underwent CAD/ischemia testing by invasive angiography, myocardial functional imaging, or both. But the tests didn’t predict important ablation outcomes, including pre- or postablation VT inducibility. Nor did they significantly affect the likelihood or outcomes of preablation revascularization or 2-year survival.

The findings “argue against performing routine evaluations to rule out coronary [disease] or myocardial ischemia as culprits in monomorphic VT storm” in patients without evidence of ACS, write Feras Alkhalaileh, MD, Heart and Vascular Institute, Cleveland Clinic, and colleagues in their report published in JACC: Clinical Electrophysiology.

They suggest it’s “reasonable” not to perform tests for CAD or ischemia in such patients, senior author Ayman A. Hussein, MD, from the same center, said in an interview. Although such tests may be considered “case by case,” performed routinely they “aren’t going to add much to patient care, and as a matter of fact, may delay proper care and expose them to risks,” Dr. Hussein said.

It’s “reasonable” to test for CAD or ischemia in patients with polymorphic VT storm, which is likely ischemia-driven, he observed. In contrast, monomorphic VT storm is likely caused by myocardial scar, which revascularization cannot treat. “Because there’s scar substrate, we find that ischemic evaluations are technically without much yield.”

These issues are “not very controversial” among cardiac electrophysiologists, Dr. Hussein said, but it remains “common practice” for other specialists to order angiography or ischemia testing for patients with monomorphic VT storm, typically in the cardiac care unit (CCU), before considering ablation.

“Sometimes, as electrophysiologists, we don’t get to see them before an ischemic evaluation has already been done,” he added.

It’s “very hard to convince interventional cardiologists, CCU intensivists, or general cardiologists” that a VT may not be caused by ischemia, said electrophysiologist Roderick Tung, MD, University of Arizona College of Medicine, Phoenix, who was not involved in the current study.

In patients with monomorphic VT storm, “by the time we’re consulted, they’ve already had a cath. And it’s probably just not necessary,” Dr. Tung said. “That’s why this is such a great paper, because it has an immediate message [for nonelectrophysiologist clinicians and] the potential to change clinical practice.”

The study included 97 patients with monomorphic VT storm from a prospective VT-ablation registry covering about 7 years at a major referral center. Their mean age was 64 years, and 88% were men. Two-thirds were known to have ischemic cardiomyopathy and were in NYHA functional class II.

As reported, 10% of the cohort underwent coronary angiography after presentation with monomorphic VT storm, 26% had CT or PET myocardial functional imaging, and 9% had both tests.

Only four patients ultimately underwent coronary revascularization; no acute coronary occlusions were involved. Monomorphic VT recurred in all four cases, the report notes.

The 43 and 54 patients who did or did not get the CAD/ischemia tests, respectively, showed no significant procedural differences in extent of scar modification, prevalence of clinical or hemodynamically stable VT, or use of mechanical circulatory support; or in postablation, VT inducibility or overall mortality during follow-up averaging 24.3 months.

To address possible concerns about selection bias in the main cohort, all of whom underwent ablation, a secondary analysis was conducted with 91 patients with known asymptomatic coronary disease and monomorphic VT storm who were selected from the registry without regard to whether they underwent catheter ablation.

Of that cohort, 21 went to invasive angiography and 25 underwent stress testing; six of the latter went on to coronary angiography, the report states. Monomorphic VT later recurred in four of the five patients, who then underwent coronary revascularization.

Such patients with known coronary disease, Dr. Hussein said, are those “possibly more likely to get an ischemic evaluation.” And yet, “regardless of whether they had ablation, the yield of ischemic evaluations in these patients was low.”

By far most of the CAD/ischemia tests in the study’s primary cohort were performed using noninvasive imaging, notes an editorial accompanying the new report. “This raises the possibility of false negatives with very proximal and multivessel CAD, and with balanced ischemia,” write Saurabh Kumar, BSc (Med)/MBBS, PhD, and Ashwin Bhaskaran, MBBS, MSc, University of Sydney.

Ideally, the issues addressed by the study should be tested in large randomized, controlled trials, they state. “Achieving sufficient recruitment to address this clinical question may be difficult, leaving clinicians with the challenge of applying observational data to their patients.”

A version of this article appeared on Medscape.com.

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Controversial issue of maintenance therapy for bipolar depression still unresolved

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Mon, 08/14/2023 - 12:44

The first randomized controlled trial testing the safety and efficacy of long-term antidepressant maintenance therapy after remission of a depressive episode in adults with bipolar I disorder has yielded mixed results.

Continuing antidepressant therapy for 52 weeks, as opposed to stopping it at 8 weeks, was not more beneficial with regard to the primary outcome of occurrence of any mood episode.

However, a prespecified sensitivity analysis of the primary outcome and of the secondary analyses suggests that continuing antidepressant therapy for 52 weeks may prolong the time to a depressive relapse.

“Because the primary outcome is negative and the prespecified sensitivity analysis is positive and the secondary outcomes are positive, some clinicians will pick the position that they work and some that they don’t work,” lead investigator Lakshmi Yatham, MBBS, with University of British Columbia, Vancouver, told this news organization.

University of British Columbia
Dr. Lakshmi Yatham


The study was published online  in the New England Journal of Medicine.
 

Controversial issue

Adjunctive antidepressant therapy – alongside mood stabilizers and/or second-generation antipsychotic medications – are often used to treat acute depressive episodes in patients with bipolar I disorder.

Currently, the Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) advise discontinuing antidepressant treatment 8 weeks after remission of depression.

Yet, the duration of antidepressant therapy for bipolar depression is “highly controversial,” due to a lack of evidence and concerns that antidepressants may induce mania, mixed states, or rapid cycling between mania and depression, Dr. Yatham said.

Dr. Yatham and colleagues assessed the safety and efficacy of continuing adjunctive antidepressant treatment (escitalopram or bupropion XL) for 52 weeks after remission, compared with discontinuing antidepressant therapy at 8 weeks after remission.

The final analysis included 177 patients (mean age 41 years, 48% men) with bipolar I disorder who had remission of depression; 90 patients continued treatment with an antidepressant for 52 weeks and 87 were switched to placebo at 8 weeks. All were taking a mood stabilizer or a second-generation antipsychotic or both.

The primary outcome, assessed in a time-to-event analysis, was any mood episode, as defined by scores on scales measuring symptoms of hypomania or mania, depression, suicidality, and mood-episode severity; additional treatment or hospitalization for mood symptoms; or attempted or completed suicide.

At 52 weeks, 28 patients (31%) in the 52-week group had experienced any mood episode (primary outcome), compared with 40 patients (46%) in the 8-week group.

The primary outcome did not reach statistical significance (hazard ratio, 0.68; 95% confidence interval, 0.43-1.10; P = .12).

The researchers note that the decision by the study team to include relapses that occurred during the first 6 weeks of the study may have affected the primary outcome.

“During the first 6 weeks, both groups were getting the same treatment, and we thought there shouldn’t be any difference in relapse, but sadly, there were more relapses in the 52-week group even though the treatments were identical,” Dr. Yatham said.

However, in a sensitivity analysis of the primary outcome after week 6, when treatment between the two groups differed, patients continuing antidepressant treatment were 40% less likely to experience a relapse of any mood event (HR, 0.60) and 59% less likely to experience a depressive episode (HR, 0.41) relative to the placebo group.

“From the point where the two groups began receiving different treatments, we see a significant benefit for patients who continued treatment with antidepressants,” Dr. Yatham said in a news release.

“Treating depression in bipolar disorder is challenging. Reducing the risk of relapse is important because it can provide patients with a great deal of stability that ultimately lets them get back to the activities they enjoy and can greatly improve their quality of life,” he added.

Although fewer patients in the 52-week group than 8-week group had a depressive episode within 52 weeks (17% vs. 40%; HR, 0.43), more had a manic or hypomanic event (12% vs. 6%; HR, 2.28).

The estimated probability of remaining free of a depressive episode at 52 weeks was 72% in the 52-week group versus 53% in the 8-week group. The estimated probability of remaining free of a manic episode at 52 weeks was 81% and 92%, respectively.

The incidence of adverse events was similar in the two groups, with a low rate of discontinuation due to adverse events and no serious adverse events. Clinically significant weight gain (≥ 7% increase in body weight) was observed in 14% of patients in the 52-week group and 7% of patients in the 8-week group.

Limitations of the trial include the fact that it was stopped early, before the planned sample size was reached, owing to slow recruitment and funding issues.

Other limitations include a lack of ethnic diversity (only 12% were White and < 1% Black) and overrepresentation of patients from India, which may limit generalizability. 

In addition, the findings may not be applicable to treatment with antidepressants other than escitalopram and buproprion XL. Finally, the study population was also enriched for patients who responded to these antidepressants.
 

 

 

Need for an individualized approach

Commenting on the study, Roger McIntyre, MD, professor of psychiatry in pharmacology, University of Toronto, noted the study was not easy to conduct, and the investigators should be credited for conducting a maintenance study in bipolar depression.

Dr. Roger S. McIntyre

“Although the study reports, as it should, that there is no evidence of maintenance effect, the secondary analysis, which was not adjusted for multiplicity, does suggest that there is a benefit,” said Dr. McIntyre, who was not associated with this research.

“However, the authors are also correct in stating that one cannot draw a conclusion because it was not the primary question and was not adjusted for multiplicity,” he added.

“If anything,” said Dr. McIntyre, “what these results do support is the notion that antidepressants are unlikely to destabilize all patients. Instead, the risk of destabilization seems to be largely limited to some persons, and there is a suggestion, based on the secondary outcome of this study, that maintenance antidepressant benefits can be seen in some people. But again that’s a testable hypothesis.”

Also weighing in on the research, Madhukar H. Trivedi, MD, professor of psychiatry and director, Center for Depression Research and Clinical Care, University of Texas Southwestern Medical Center, Dallas, said the study is “interesting,” adding that it was “unfortunate that the researchers had to curtail recruitment and reduce the size of the trial.”

University of Texas Southwestern Medical Center
Dr. Madhukar H. Trivedi


“But the main finding is indeed that there was no significant advantage with 52 [weeks] continuation, except maybe increasing time to relapse. There are indeed a number of interesting findings in the secondary analyses, but sample size may have limited certainty,” Dr. Trivedi said.

“It seems that the results would not suggest a change in the current guidelines, and yet, we have to also mention that, for now, one has to make individual decisions and maybe recommend a more definitive complete trial,” added Dr. Trivedi, who was not involved in the study.

The study was supported by the Canadian Institutes of Health Research. Bausch Health (formerly Valeant), Lundbeck, and Lupin provided trial medications but were not involved in the design or conduct of the trial, data collection or analyses, writing of the manuscript, or decision to submit the manuscript for publication. Disclosures for authors are available at the conclusion of the original article.

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

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The first randomized controlled trial testing the safety and efficacy of long-term antidepressant maintenance therapy after remission of a depressive episode in adults with bipolar I disorder has yielded mixed results.

Continuing antidepressant therapy for 52 weeks, as opposed to stopping it at 8 weeks, was not more beneficial with regard to the primary outcome of occurrence of any mood episode.

However, a prespecified sensitivity analysis of the primary outcome and of the secondary analyses suggests that continuing antidepressant therapy for 52 weeks may prolong the time to a depressive relapse.

“Because the primary outcome is negative and the prespecified sensitivity analysis is positive and the secondary outcomes are positive, some clinicians will pick the position that they work and some that they don’t work,” lead investigator Lakshmi Yatham, MBBS, with University of British Columbia, Vancouver, told this news organization.

University of British Columbia
Dr. Lakshmi Yatham


The study was published online  in the New England Journal of Medicine.
 

Controversial issue

Adjunctive antidepressant therapy – alongside mood stabilizers and/or second-generation antipsychotic medications – are often used to treat acute depressive episodes in patients with bipolar I disorder.

Currently, the Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) advise discontinuing antidepressant treatment 8 weeks after remission of depression.

Yet, the duration of antidepressant therapy for bipolar depression is “highly controversial,” due to a lack of evidence and concerns that antidepressants may induce mania, mixed states, or rapid cycling between mania and depression, Dr. Yatham said.

Dr. Yatham and colleagues assessed the safety and efficacy of continuing adjunctive antidepressant treatment (escitalopram or bupropion XL) for 52 weeks after remission, compared with discontinuing antidepressant therapy at 8 weeks after remission.

The final analysis included 177 patients (mean age 41 years, 48% men) with bipolar I disorder who had remission of depression; 90 patients continued treatment with an antidepressant for 52 weeks and 87 were switched to placebo at 8 weeks. All were taking a mood stabilizer or a second-generation antipsychotic or both.

The primary outcome, assessed in a time-to-event analysis, was any mood episode, as defined by scores on scales measuring symptoms of hypomania or mania, depression, suicidality, and mood-episode severity; additional treatment or hospitalization for mood symptoms; or attempted or completed suicide.

At 52 weeks, 28 patients (31%) in the 52-week group had experienced any mood episode (primary outcome), compared with 40 patients (46%) in the 8-week group.

The primary outcome did not reach statistical significance (hazard ratio, 0.68; 95% confidence interval, 0.43-1.10; P = .12).

The researchers note that the decision by the study team to include relapses that occurred during the first 6 weeks of the study may have affected the primary outcome.

“During the first 6 weeks, both groups were getting the same treatment, and we thought there shouldn’t be any difference in relapse, but sadly, there were more relapses in the 52-week group even though the treatments were identical,” Dr. Yatham said.

However, in a sensitivity analysis of the primary outcome after week 6, when treatment between the two groups differed, patients continuing antidepressant treatment were 40% less likely to experience a relapse of any mood event (HR, 0.60) and 59% less likely to experience a depressive episode (HR, 0.41) relative to the placebo group.

“From the point where the two groups began receiving different treatments, we see a significant benefit for patients who continued treatment with antidepressants,” Dr. Yatham said in a news release.

“Treating depression in bipolar disorder is challenging. Reducing the risk of relapse is important because it can provide patients with a great deal of stability that ultimately lets them get back to the activities they enjoy and can greatly improve their quality of life,” he added.

Although fewer patients in the 52-week group than 8-week group had a depressive episode within 52 weeks (17% vs. 40%; HR, 0.43), more had a manic or hypomanic event (12% vs. 6%; HR, 2.28).

The estimated probability of remaining free of a depressive episode at 52 weeks was 72% in the 52-week group versus 53% in the 8-week group. The estimated probability of remaining free of a manic episode at 52 weeks was 81% and 92%, respectively.

The incidence of adverse events was similar in the two groups, with a low rate of discontinuation due to adverse events and no serious adverse events. Clinically significant weight gain (≥ 7% increase in body weight) was observed in 14% of patients in the 52-week group and 7% of patients in the 8-week group.

Limitations of the trial include the fact that it was stopped early, before the planned sample size was reached, owing to slow recruitment and funding issues.

Other limitations include a lack of ethnic diversity (only 12% were White and < 1% Black) and overrepresentation of patients from India, which may limit generalizability. 

In addition, the findings may not be applicable to treatment with antidepressants other than escitalopram and buproprion XL. Finally, the study population was also enriched for patients who responded to these antidepressants.
 

 

 

Need for an individualized approach

Commenting on the study, Roger McIntyre, MD, professor of psychiatry in pharmacology, University of Toronto, noted the study was not easy to conduct, and the investigators should be credited for conducting a maintenance study in bipolar depression.

Dr. Roger S. McIntyre

“Although the study reports, as it should, that there is no evidence of maintenance effect, the secondary analysis, which was not adjusted for multiplicity, does suggest that there is a benefit,” said Dr. McIntyre, who was not associated with this research.

“However, the authors are also correct in stating that one cannot draw a conclusion because it was not the primary question and was not adjusted for multiplicity,” he added.

“If anything,” said Dr. McIntyre, “what these results do support is the notion that antidepressants are unlikely to destabilize all patients. Instead, the risk of destabilization seems to be largely limited to some persons, and there is a suggestion, based on the secondary outcome of this study, that maintenance antidepressant benefits can be seen in some people. But again that’s a testable hypothesis.”

Also weighing in on the research, Madhukar H. Trivedi, MD, professor of psychiatry and director, Center for Depression Research and Clinical Care, University of Texas Southwestern Medical Center, Dallas, said the study is “interesting,” adding that it was “unfortunate that the researchers had to curtail recruitment and reduce the size of the trial.”

University of Texas Southwestern Medical Center
Dr. Madhukar H. Trivedi


“But the main finding is indeed that there was no significant advantage with 52 [weeks] continuation, except maybe increasing time to relapse. There are indeed a number of interesting findings in the secondary analyses, but sample size may have limited certainty,” Dr. Trivedi said.

“It seems that the results would not suggest a change in the current guidelines, and yet, we have to also mention that, for now, one has to make individual decisions and maybe recommend a more definitive complete trial,” added Dr. Trivedi, who was not involved in the study.

The study was supported by the Canadian Institutes of Health Research. Bausch Health (formerly Valeant), Lundbeck, and Lupin provided trial medications but were not involved in the design or conduct of the trial, data collection or analyses, writing of the manuscript, or decision to submit the manuscript for publication. Disclosures for authors are available at the conclusion of the original article.

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

The first randomized controlled trial testing the safety and efficacy of long-term antidepressant maintenance therapy after remission of a depressive episode in adults with bipolar I disorder has yielded mixed results.

Continuing antidepressant therapy for 52 weeks, as opposed to stopping it at 8 weeks, was not more beneficial with regard to the primary outcome of occurrence of any mood episode.

However, a prespecified sensitivity analysis of the primary outcome and of the secondary analyses suggests that continuing antidepressant therapy for 52 weeks may prolong the time to a depressive relapse.

“Because the primary outcome is negative and the prespecified sensitivity analysis is positive and the secondary outcomes are positive, some clinicians will pick the position that they work and some that they don’t work,” lead investigator Lakshmi Yatham, MBBS, with University of British Columbia, Vancouver, told this news organization.

University of British Columbia
Dr. Lakshmi Yatham


The study was published online  in the New England Journal of Medicine.
 

Controversial issue

Adjunctive antidepressant therapy – alongside mood stabilizers and/or second-generation antipsychotic medications – are often used to treat acute depressive episodes in patients with bipolar I disorder.

Currently, the Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) advise discontinuing antidepressant treatment 8 weeks after remission of depression.

Yet, the duration of antidepressant therapy for bipolar depression is “highly controversial,” due to a lack of evidence and concerns that antidepressants may induce mania, mixed states, or rapid cycling between mania and depression, Dr. Yatham said.

Dr. Yatham and colleagues assessed the safety and efficacy of continuing adjunctive antidepressant treatment (escitalopram or bupropion XL) for 52 weeks after remission, compared with discontinuing antidepressant therapy at 8 weeks after remission.

The final analysis included 177 patients (mean age 41 years, 48% men) with bipolar I disorder who had remission of depression; 90 patients continued treatment with an antidepressant for 52 weeks and 87 were switched to placebo at 8 weeks. All were taking a mood stabilizer or a second-generation antipsychotic or both.

The primary outcome, assessed in a time-to-event analysis, was any mood episode, as defined by scores on scales measuring symptoms of hypomania or mania, depression, suicidality, and mood-episode severity; additional treatment or hospitalization for mood symptoms; or attempted or completed suicide.

At 52 weeks, 28 patients (31%) in the 52-week group had experienced any mood episode (primary outcome), compared with 40 patients (46%) in the 8-week group.

The primary outcome did not reach statistical significance (hazard ratio, 0.68; 95% confidence interval, 0.43-1.10; P = .12).

The researchers note that the decision by the study team to include relapses that occurred during the first 6 weeks of the study may have affected the primary outcome.

“During the first 6 weeks, both groups were getting the same treatment, and we thought there shouldn’t be any difference in relapse, but sadly, there were more relapses in the 52-week group even though the treatments were identical,” Dr. Yatham said.

However, in a sensitivity analysis of the primary outcome after week 6, when treatment between the two groups differed, patients continuing antidepressant treatment were 40% less likely to experience a relapse of any mood event (HR, 0.60) and 59% less likely to experience a depressive episode (HR, 0.41) relative to the placebo group.

“From the point where the two groups began receiving different treatments, we see a significant benefit for patients who continued treatment with antidepressants,” Dr. Yatham said in a news release.

“Treating depression in bipolar disorder is challenging. Reducing the risk of relapse is important because it can provide patients with a great deal of stability that ultimately lets them get back to the activities they enjoy and can greatly improve their quality of life,” he added.

Although fewer patients in the 52-week group than 8-week group had a depressive episode within 52 weeks (17% vs. 40%; HR, 0.43), more had a manic or hypomanic event (12% vs. 6%; HR, 2.28).

The estimated probability of remaining free of a depressive episode at 52 weeks was 72% in the 52-week group versus 53% in the 8-week group. The estimated probability of remaining free of a manic episode at 52 weeks was 81% and 92%, respectively.

The incidence of adverse events was similar in the two groups, with a low rate of discontinuation due to adverse events and no serious adverse events. Clinically significant weight gain (≥ 7% increase in body weight) was observed in 14% of patients in the 52-week group and 7% of patients in the 8-week group.

Limitations of the trial include the fact that it was stopped early, before the planned sample size was reached, owing to slow recruitment and funding issues.

Other limitations include a lack of ethnic diversity (only 12% were White and < 1% Black) and overrepresentation of patients from India, which may limit generalizability. 

In addition, the findings may not be applicable to treatment with antidepressants other than escitalopram and buproprion XL. Finally, the study population was also enriched for patients who responded to these antidepressants.
 

 

 

Need for an individualized approach

Commenting on the study, Roger McIntyre, MD, professor of psychiatry in pharmacology, University of Toronto, noted the study was not easy to conduct, and the investigators should be credited for conducting a maintenance study in bipolar depression.

Dr. Roger S. McIntyre

“Although the study reports, as it should, that there is no evidence of maintenance effect, the secondary analysis, which was not adjusted for multiplicity, does suggest that there is a benefit,” said Dr. McIntyre, who was not associated with this research.

“However, the authors are also correct in stating that one cannot draw a conclusion because it was not the primary question and was not adjusted for multiplicity,” he added.

“If anything,” said Dr. McIntyre, “what these results do support is the notion that antidepressants are unlikely to destabilize all patients. Instead, the risk of destabilization seems to be largely limited to some persons, and there is a suggestion, based on the secondary outcome of this study, that maintenance antidepressant benefits can be seen in some people. But again that’s a testable hypothesis.”

Also weighing in on the research, Madhukar H. Trivedi, MD, professor of psychiatry and director, Center for Depression Research and Clinical Care, University of Texas Southwestern Medical Center, Dallas, said the study is “interesting,” adding that it was “unfortunate that the researchers had to curtail recruitment and reduce the size of the trial.”

University of Texas Southwestern Medical Center
Dr. Madhukar H. Trivedi


“But the main finding is indeed that there was no significant advantage with 52 [weeks] continuation, except maybe increasing time to relapse. There are indeed a number of interesting findings in the secondary analyses, but sample size may have limited certainty,” Dr. Trivedi said.

“It seems that the results would not suggest a change in the current guidelines, and yet, we have to also mention that, for now, one has to make individual decisions and maybe recommend a more definitive complete trial,” added Dr. Trivedi, who was not involved in the study.

The study was supported by the Canadian Institutes of Health Research. Bausch Health (formerly Valeant), Lundbeck, and Lupin provided trial medications but were not involved in the design or conduct of the trial, data collection or analyses, writing of the manuscript, or decision to submit the manuscript for publication. Disclosures for authors are available at the conclusion of the original article.

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

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Study documents obesity-related defecation disorders

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Mon, 10/02/2023 - 10:27

A new study suggests that being obese is significantly associated with fecal incontinence, fecal urgency, and vaginal digitation, as well as clinically significant rectocele and increased anal resting and rectal pressures.

The study, which was published in the American Journal of Gastroenterology and led by Pam Chaichanavichkij, MBChB, MRCS, of Queen Mary University, London, included 1,155 patients (84% female, median age 52) who were obese (31.7%), overweight (34.8%), or of normal weight 33.5%).

“These results support the notion that rectal evacuation disorder/incomplete evacuation may be an important underlying mechanism for fecal incontinence in obese patients,” the authors wrote.

Obese patients had higher odds of fecal incontinence to liquid stools (69.9 vs. 47.8%; odds ratio, 1.96 [confidence interval, 1.43-2.70]), use of containment products (54.6% vs. 32.6%; OR, 1.81 [CI, 1.31-2.51]), fecal urgency (74.6% vs. 60.7%; OR, 1.54 [CI, 1.11-2.14]), urge fecal incontinence (63.4% vs. 47.3%, OR, 1.68 [CI, 1.23-2.29]), and vaginal digitation (18.0% vs. 9.7%; OR, 2.18 [CI, 1.26-3.86]).

Obese patients were also more likely to have functional constipation (50.3%), compared with overweight (44.8%) and normal weight patients (41.1%).

There was a positive linear association between body mass index (BMI) and anal resting pressure (beta 0.45; R2, 0.25, P = 0.0003), though the odds of anal hypertension were not significantly higher after Benjamini-Hochberg correction. Obese patients more often had a large clinically significant rectocele (34.4% vs. 20.6%; OR, 2.62 [CI, 1.51-4.55]), compared with normal BMI patients.

The data showed higher rates of gynecological surgery, cholecystectomy, diabetes, and self-reported use of opioids, antidepressants, and anticholinergic medications in the obese group, compared with the others.

In morphological differences measured by x-ray defecography, obese patients had more than two-fold higher odds of having a rectocele and even greater odds of the rectocele being large and clinically significant. Anal and rectal resting pressures were linearly related to increasing BMI, the authors report.

Because most patients in the study were female, the findings may not be generalizable to the general population or male patients. Also, diet and exercise, two factors that may affect defecation disorders, were not accounted for in this study.

Dr. Chaichanavichkij reported no disclosures. Two other authors reported financial relationships with Medtronic Inc. and MMS/Laborie.

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A new study suggests that being obese is significantly associated with fecal incontinence, fecal urgency, and vaginal digitation, as well as clinically significant rectocele and increased anal resting and rectal pressures.

The study, which was published in the American Journal of Gastroenterology and led by Pam Chaichanavichkij, MBChB, MRCS, of Queen Mary University, London, included 1,155 patients (84% female, median age 52) who were obese (31.7%), overweight (34.8%), or of normal weight 33.5%).

“These results support the notion that rectal evacuation disorder/incomplete evacuation may be an important underlying mechanism for fecal incontinence in obese patients,” the authors wrote.

Obese patients had higher odds of fecal incontinence to liquid stools (69.9 vs. 47.8%; odds ratio, 1.96 [confidence interval, 1.43-2.70]), use of containment products (54.6% vs. 32.6%; OR, 1.81 [CI, 1.31-2.51]), fecal urgency (74.6% vs. 60.7%; OR, 1.54 [CI, 1.11-2.14]), urge fecal incontinence (63.4% vs. 47.3%, OR, 1.68 [CI, 1.23-2.29]), and vaginal digitation (18.0% vs. 9.7%; OR, 2.18 [CI, 1.26-3.86]).

Obese patients were also more likely to have functional constipation (50.3%), compared with overweight (44.8%) and normal weight patients (41.1%).

There was a positive linear association between body mass index (BMI) and anal resting pressure (beta 0.45; R2, 0.25, P = 0.0003), though the odds of anal hypertension were not significantly higher after Benjamini-Hochberg correction. Obese patients more often had a large clinically significant rectocele (34.4% vs. 20.6%; OR, 2.62 [CI, 1.51-4.55]), compared with normal BMI patients.

The data showed higher rates of gynecological surgery, cholecystectomy, diabetes, and self-reported use of opioids, antidepressants, and anticholinergic medications in the obese group, compared with the others.

In morphological differences measured by x-ray defecography, obese patients had more than two-fold higher odds of having a rectocele and even greater odds of the rectocele being large and clinically significant. Anal and rectal resting pressures were linearly related to increasing BMI, the authors report.

Because most patients in the study were female, the findings may not be generalizable to the general population or male patients. Also, diet and exercise, two factors that may affect defecation disorders, were not accounted for in this study.

Dr. Chaichanavichkij reported no disclosures. Two other authors reported financial relationships with Medtronic Inc. and MMS/Laborie.

A new study suggests that being obese is significantly associated with fecal incontinence, fecal urgency, and vaginal digitation, as well as clinically significant rectocele and increased anal resting and rectal pressures.

The study, which was published in the American Journal of Gastroenterology and led by Pam Chaichanavichkij, MBChB, MRCS, of Queen Mary University, London, included 1,155 patients (84% female, median age 52) who were obese (31.7%), overweight (34.8%), or of normal weight 33.5%).

“These results support the notion that rectal evacuation disorder/incomplete evacuation may be an important underlying mechanism for fecal incontinence in obese patients,” the authors wrote.

Obese patients had higher odds of fecal incontinence to liquid stools (69.9 vs. 47.8%; odds ratio, 1.96 [confidence interval, 1.43-2.70]), use of containment products (54.6% vs. 32.6%; OR, 1.81 [CI, 1.31-2.51]), fecal urgency (74.6% vs. 60.7%; OR, 1.54 [CI, 1.11-2.14]), urge fecal incontinence (63.4% vs. 47.3%, OR, 1.68 [CI, 1.23-2.29]), and vaginal digitation (18.0% vs. 9.7%; OR, 2.18 [CI, 1.26-3.86]).

Obese patients were also more likely to have functional constipation (50.3%), compared with overweight (44.8%) and normal weight patients (41.1%).

There was a positive linear association between body mass index (BMI) and anal resting pressure (beta 0.45; R2, 0.25, P = 0.0003), though the odds of anal hypertension were not significantly higher after Benjamini-Hochberg correction. Obese patients more often had a large clinically significant rectocele (34.4% vs. 20.6%; OR, 2.62 [CI, 1.51-4.55]), compared with normal BMI patients.

The data showed higher rates of gynecological surgery, cholecystectomy, diabetes, and self-reported use of opioids, antidepressants, and anticholinergic medications in the obese group, compared with the others.

In morphological differences measured by x-ray defecography, obese patients had more than two-fold higher odds of having a rectocele and even greater odds of the rectocele being large and clinically significant. Anal and rectal resting pressures were linearly related to increasing BMI, the authors report.

Because most patients in the study were female, the findings may not be generalizable to the general population or male patients. Also, diet and exercise, two factors that may affect defecation disorders, were not accounted for in this study.

Dr. Chaichanavichkij reported no disclosures. Two other authors reported financial relationships with Medtronic Inc. and MMS/Laborie.

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FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY

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What did you learn in med school that you disagree with now?

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Medical education has changed drastically over the years. As theories and practices continue to change, what was once standard 10 or 20 years ago has been replaced with newer ideologies, processes, or technology. It seems likely, then, that you may disagree with some of the things that you learned as medical school has evolved.

This news organization asked physicians what they learned in med school that they now contest. Many of their answers include newer philosophies and practice methods.
 

Treat appropriately for pain

Jacqui O’Kane, DO, a 2013 med school graduate, was taught to avoid prescribing controlled medications whenever possible.

“Initially this attitude made sense to me,” says Dr. O’Kane, “but as I became an experienced physician – and patient – I saw the harm that such an attitude could cause. Patients on controlled medication long-term were often viewed as drug-seekers and treated as such, even if their regimen was largely regarded as appropriate. Likewise, those who could benefit from short-term controlled prescriptions were sometimes denied them because of their clinician’s fear.”

Today, Dr. O’Kane believes controlled medications should seldom be the first option for patients suffering pain, anxiety, or insomnia. But, she says, “they should remain on the table and without judgment for those who fail first-line treatment or for whom alternatives are contraindicated.”

Amy Baxter, MD, believes that the amount of time spent on pain education in school needs to change.

“Doctors in the U.S. get only 12 hours of pain education, and most of it is on pharmacology,” says Dr. Baxter, who graduated from med school in 1995. “In addition to incorrect information on home opioids and addiction, I was left with the impression that medication could treat chronic pain. I now have a completely different understanding of pain as a whole-brain warning system. The goal shouldn’t be pain-free, just more comfortable.”
 

Practice lifestyle and preventive medicine

Dolapo Babalola, MD, went to medical school eager to learn how to care for the human body and her family members’ illnesses, such as the debilitating effects of arthritic pain and other chronic diseases.

“I was taught the pathology behind arthritic pain, symptoms, signs, and treatment – that it has a genetic component and is inevitable to avoid – but nothing about how to prevent it,” says Dr. Babalola, a 2000 graduate.

Twenty years later, she discovered lifestyle medicine when she began to experience knee pain.

“I was introduced to the power of health restoration by discovering the root cause of diseases such as inflammation, hormonal imbalance, and insulin resistance due to poor lifestyle choices such as diet, inactivity, stress, inadequate sleep, and substance abuse,” she says.

Adebisi Alli, DO, who graduated in 2011, remembers being taught to treat type 2 diabetes by delaying progression rather than aiming for remission. But today, “lifestyle-led, team-based approaches are steadily becoming a first prescription across medical training with the goal to put diabetes in remission,” she says.
 

Patient care is at the core of medicine

Tracey O’Connell, MD, recalls her radiology residency in the early to mid-90s, when radiologists were integral to the health care team.

“We interacted with referrers and followed the course of patients’ diseases,” says Dr. O’Connell. “We knew patient histories, their stories. We were connected to other humans, doctors, nurses, teams, and the patients themselves.”

But with the advent of picture archiving and communication systems, high-speed CT and MRI, digital radiography, and voice recognition, the practice of radiology has changed dramatically.

“There’s no time to review or discuss cases anymore,” she says. “Reports went from eloquent and articulate documents with lists of differential diagnoses to short checklists and templates. The whole field of patient care has become dehumanizing, exactly the opposite of what humans need.”

Mache Seibel, MD, who graduated almost 50 years ago, agrees that patient care has lost its focus, to the detriment of patients.

“What I learned in medical school that is forgotten today is how to listen to patients, take a history, and do an examination using my hands and a stethoscope,” says Dr. Seibel. “Today with technology and time constraints, the focus is too much on the symptom without context, ordering a test, and getting the EMR boxes filled out.”
 

Physician, heal thyself

Priya Radhakrishnan, MD, remembers learning that a physician’s well-being was their responsibility. “We now know that well-being is the health system’s responsibility and that we need to diagnose ourselves and support each other, especially our trainees,” says Dr. Radhakrishna. She graduated in 1992. “Destigmatizing mental health is essential to well-being.”

Rachel Miller, MD, a 2009 med school graduate was taught that learning about health care systems and policy wasn’t necessary. Dr. Miller says they learned that policy knowledge would come in time. “I currently disagree. It is vital to understand aspects of health care systems and policy. Not knowing these things has partly contributed to the pervasiveness of burnout among physicians and other health care providers.”
 

Practice with gender at the forefront

Janice L. Werbinski, MD, an ob.gyn., and Elizabeth Anne Comen, MD, a breast cancer oncologist, remember when nearly all medical research was performed on the 140-lb White man. Doctors learned to treat patients through that male lens.

“The majority of the anatomy we saw in medical school was on a male figure,” says Dr. Comen, author of “All in Her Head,” a HarperCollins book slated to be released in February 2024. She graduated from med school in 2004. “The only time we saw anatomy for females was in the female reproductive system. That’s changing for the better.”

Dr. Werbinski chose a residency in obstetrics and gynecology in 1975 because she thought it was the only way she could serve female patients.

“I really thought that was the place for women’s health,” says Dr. Werbinski, cochair of the American Medical Women’s Association Sex & Gender Health Coalition.

“I am happy to say that significant awareness has grown since I graduated from medical school. I hope that when this question is asked of current medical students, they will be able to say that they know to practice with a sex- and gender-focused lens.”
 

 

 

Talk about racial disparities

John McHugh, MD, an ob.gyn., recalls learning little about the social determinants of health when he attended med school more than 30 years ago.

“We saw disparities in outcomes based on race and class but assumed that we would overcome them when we were in practice,” says Dr. McHugh, an AMWA Action Coalition for Equity member. “We didn’t understand the root causes of disparities and had never heard of concepts like epigenetics or weathering. I’m hopeful current research will help our understanding and today’s medical students will serve a safer, healthier, and more equitable world.”

Curtiland Deville, MD, an associate professor of radiation oncology, recalls having few conversations around race; racial disparities; and diversity, equity, and inclusion.

“When I went to medical school, it often felt like you weren’t supposed to talk about the differences in race,” says Dr. Deville, who graduated in 2005. But today, in the post-2020 era between COVID, during which health disparities got highlighted, and calls for racial justice taking center stage, Dr. Deville says many of the things they didn’t talk about have come to the forefront in our medical institutions.
 

Information at your fingertips

For Paru David, MD, a 1996 graduate, the most significant change is the amount of health and medical information available today. “Before, the information that was taught in medical school was obtained through textbooks or within journal articles,” says Dr. David.

“Now, we have databases of information. The key to success is being able to navigate the information available to us, digest it with a keen eye, and then apply it to patient care in a timely manner.”

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

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Medical education has changed drastically over the years. As theories and practices continue to change, what was once standard 10 or 20 years ago has been replaced with newer ideologies, processes, or technology. It seems likely, then, that you may disagree with some of the things that you learned as medical school has evolved.

This news organization asked physicians what they learned in med school that they now contest. Many of their answers include newer philosophies and practice methods.
 

Treat appropriately for pain

Jacqui O’Kane, DO, a 2013 med school graduate, was taught to avoid prescribing controlled medications whenever possible.

“Initially this attitude made sense to me,” says Dr. O’Kane, “but as I became an experienced physician – and patient – I saw the harm that such an attitude could cause. Patients on controlled medication long-term were often viewed as drug-seekers and treated as such, even if their regimen was largely regarded as appropriate. Likewise, those who could benefit from short-term controlled prescriptions were sometimes denied them because of their clinician’s fear.”

Today, Dr. O’Kane believes controlled medications should seldom be the first option for patients suffering pain, anxiety, or insomnia. But, she says, “they should remain on the table and without judgment for those who fail first-line treatment or for whom alternatives are contraindicated.”

Amy Baxter, MD, believes that the amount of time spent on pain education in school needs to change.

“Doctors in the U.S. get only 12 hours of pain education, and most of it is on pharmacology,” says Dr. Baxter, who graduated from med school in 1995. “In addition to incorrect information on home opioids and addiction, I was left with the impression that medication could treat chronic pain. I now have a completely different understanding of pain as a whole-brain warning system. The goal shouldn’t be pain-free, just more comfortable.”
 

Practice lifestyle and preventive medicine

Dolapo Babalola, MD, went to medical school eager to learn how to care for the human body and her family members’ illnesses, such as the debilitating effects of arthritic pain and other chronic diseases.

“I was taught the pathology behind arthritic pain, symptoms, signs, and treatment – that it has a genetic component and is inevitable to avoid – but nothing about how to prevent it,” says Dr. Babalola, a 2000 graduate.

Twenty years later, she discovered lifestyle medicine when she began to experience knee pain.

“I was introduced to the power of health restoration by discovering the root cause of diseases such as inflammation, hormonal imbalance, and insulin resistance due to poor lifestyle choices such as diet, inactivity, stress, inadequate sleep, and substance abuse,” she says.

Adebisi Alli, DO, who graduated in 2011, remembers being taught to treat type 2 diabetes by delaying progression rather than aiming for remission. But today, “lifestyle-led, team-based approaches are steadily becoming a first prescription across medical training with the goal to put diabetes in remission,” she says.
 

Patient care is at the core of medicine

Tracey O’Connell, MD, recalls her radiology residency in the early to mid-90s, when radiologists were integral to the health care team.

“We interacted with referrers and followed the course of patients’ diseases,” says Dr. O’Connell. “We knew patient histories, their stories. We were connected to other humans, doctors, nurses, teams, and the patients themselves.”

But with the advent of picture archiving and communication systems, high-speed CT and MRI, digital radiography, and voice recognition, the practice of radiology has changed dramatically.

“There’s no time to review or discuss cases anymore,” she says. “Reports went from eloquent and articulate documents with lists of differential diagnoses to short checklists and templates. The whole field of patient care has become dehumanizing, exactly the opposite of what humans need.”

Mache Seibel, MD, who graduated almost 50 years ago, agrees that patient care has lost its focus, to the detriment of patients.

“What I learned in medical school that is forgotten today is how to listen to patients, take a history, and do an examination using my hands and a stethoscope,” says Dr. Seibel. “Today with technology and time constraints, the focus is too much on the symptom without context, ordering a test, and getting the EMR boxes filled out.”
 

Physician, heal thyself

Priya Radhakrishnan, MD, remembers learning that a physician’s well-being was their responsibility. “We now know that well-being is the health system’s responsibility and that we need to diagnose ourselves and support each other, especially our trainees,” says Dr. Radhakrishna. She graduated in 1992. “Destigmatizing mental health is essential to well-being.”

Rachel Miller, MD, a 2009 med school graduate was taught that learning about health care systems and policy wasn’t necessary. Dr. Miller says they learned that policy knowledge would come in time. “I currently disagree. It is vital to understand aspects of health care systems and policy. Not knowing these things has partly contributed to the pervasiveness of burnout among physicians and other health care providers.”
 

Practice with gender at the forefront

Janice L. Werbinski, MD, an ob.gyn., and Elizabeth Anne Comen, MD, a breast cancer oncologist, remember when nearly all medical research was performed on the 140-lb White man. Doctors learned to treat patients through that male lens.

“The majority of the anatomy we saw in medical school was on a male figure,” says Dr. Comen, author of “All in Her Head,” a HarperCollins book slated to be released in February 2024. She graduated from med school in 2004. “The only time we saw anatomy for females was in the female reproductive system. That’s changing for the better.”

Dr. Werbinski chose a residency in obstetrics and gynecology in 1975 because she thought it was the only way she could serve female patients.

“I really thought that was the place for women’s health,” says Dr. Werbinski, cochair of the American Medical Women’s Association Sex & Gender Health Coalition.

“I am happy to say that significant awareness has grown since I graduated from medical school. I hope that when this question is asked of current medical students, they will be able to say that they know to practice with a sex- and gender-focused lens.”
 

 

 

Talk about racial disparities

John McHugh, MD, an ob.gyn., recalls learning little about the social determinants of health when he attended med school more than 30 years ago.

“We saw disparities in outcomes based on race and class but assumed that we would overcome them when we were in practice,” says Dr. McHugh, an AMWA Action Coalition for Equity member. “We didn’t understand the root causes of disparities and had never heard of concepts like epigenetics or weathering. I’m hopeful current research will help our understanding and today’s medical students will serve a safer, healthier, and more equitable world.”

Curtiland Deville, MD, an associate professor of radiation oncology, recalls having few conversations around race; racial disparities; and diversity, equity, and inclusion.

“When I went to medical school, it often felt like you weren’t supposed to talk about the differences in race,” says Dr. Deville, who graduated in 2005. But today, in the post-2020 era between COVID, during which health disparities got highlighted, and calls for racial justice taking center stage, Dr. Deville says many of the things they didn’t talk about have come to the forefront in our medical institutions.
 

Information at your fingertips

For Paru David, MD, a 1996 graduate, the most significant change is the amount of health and medical information available today. “Before, the information that was taught in medical school was obtained through textbooks or within journal articles,” says Dr. David.

“Now, we have databases of information. The key to success is being able to navigate the information available to us, digest it with a keen eye, and then apply it to patient care in a timely manner.”

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

Medical education has changed drastically over the years. As theories and practices continue to change, what was once standard 10 or 20 years ago has been replaced with newer ideologies, processes, or technology. It seems likely, then, that you may disagree with some of the things that you learned as medical school has evolved.

This news organization asked physicians what they learned in med school that they now contest. Many of their answers include newer philosophies and practice methods.
 

Treat appropriately for pain

Jacqui O’Kane, DO, a 2013 med school graduate, was taught to avoid prescribing controlled medications whenever possible.

“Initially this attitude made sense to me,” says Dr. O’Kane, “but as I became an experienced physician – and patient – I saw the harm that such an attitude could cause. Patients on controlled medication long-term were often viewed as drug-seekers and treated as such, even if their regimen was largely regarded as appropriate. Likewise, those who could benefit from short-term controlled prescriptions were sometimes denied them because of their clinician’s fear.”

Today, Dr. O’Kane believes controlled medications should seldom be the first option for patients suffering pain, anxiety, or insomnia. But, she says, “they should remain on the table and without judgment for those who fail first-line treatment or for whom alternatives are contraindicated.”

Amy Baxter, MD, believes that the amount of time spent on pain education in school needs to change.

“Doctors in the U.S. get only 12 hours of pain education, and most of it is on pharmacology,” says Dr. Baxter, who graduated from med school in 1995. “In addition to incorrect information on home opioids and addiction, I was left with the impression that medication could treat chronic pain. I now have a completely different understanding of pain as a whole-brain warning system. The goal shouldn’t be pain-free, just more comfortable.”
 

Practice lifestyle and preventive medicine

Dolapo Babalola, MD, went to medical school eager to learn how to care for the human body and her family members’ illnesses, such as the debilitating effects of arthritic pain and other chronic diseases.

“I was taught the pathology behind arthritic pain, symptoms, signs, and treatment – that it has a genetic component and is inevitable to avoid – but nothing about how to prevent it,” says Dr. Babalola, a 2000 graduate.

Twenty years later, she discovered lifestyle medicine when she began to experience knee pain.

“I was introduced to the power of health restoration by discovering the root cause of diseases such as inflammation, hormonal imbalance, and insulin resistance due to poor lifestyle choices such as diet, inactivity, stress, inadequate sleep, and substance abuse,” she says.

Adebisi Alli, DO, who graduated in 2011, remembers being taught to treat type 2 diabetes by delaying progression rather than aiming for remission. But today, “lifestyle-led, team-based approaches are steadily becoming a first prescription across medical training with the goal to put diabetes in remission,” she says.
 

Patient care is at the core of medicine

Tracey O’Connell, MD, recalls her radiology residency in the early to mid-90s, when radiologists were integral to the health care team.

“We interacted with referrers and followed the course of patients’ diseases,” says Dr. O’Connell. “We knew patient histories, their stories. We were connected to other humans, doctors, nurses, teams, and the patients themselves.”

But with the advent of picture archiving and communication systems, high-speed CT and MRI, digital radiography, and voice recognition, the practice of radiology has changed dramatically.

“There’s no time to review or discuss cases anymore,” she says. “Reports went from eloquent and articulate documents with lists of differential diagnoses to short checklists and templates. The whole field of patient care has become dehumanizing, exactly the opposite of what humans need.”

Mache Seibel, MD, who graduated almost 50 years ago, agrees that patient care has lost its focus, to the detriment of patients.

“What I learned in medical school that is forgotten today is how to listen to patients, take a history, and do an examination using my hands and a stethoscope,” says Dr. Seibel. “Today with technology and time constraints, the focus is too much on the symptom without context, ordering a test, and getting the EMR boxes filled out.”
 

Physician, heal thyself

Priya Radhakrishnan, MD, remembers learning that a physician’s well-being was their responsibility. “We now know that well-being is the health system’s responsibility and that we need to diagnose ourselves and support each other, especially our trainees,” says Dr. Radhakrishna. She graduated in 1992. “Destigmatizing mental health is essential to well-being.”

Rachel Miller, MD, a 2009 med school graduate was taught that learning about health care systems and policy wasn’t necessary. Dr. Miller says they learned that policy knowledge would come in time. “I currently disagree. It is vital to understand aspects of health care systems and policy. Not knowing these things has partly contributed to the pervasiveness of burnout among physicians and other health care providers.”
 

Practice with gender at the forefront

Janice L. Werbinski, MD, an ob.gyn., and Elizabeth Anne Comen, MD, a breast cancer oncologist, remember when nearly all medical research was performed on the 140-lb White man. Doctors learned to treat patients through that male lens.

“The majority of the anatomy we saw in medical school was on a male figure,” says Dr. Comen, author of “All in Her Head,” a HarperCollins book slated to be released in February 2024. She graduated from med school in 2004. “The only time we saw anatomy for females was in the female reproductive system. That’s changing for the better.”

Dr. Werbinski chose a residency in obstetrics and gynecology in 1975 because she thought it was the only way she could serve female patients.

“I really thought that was the place for women’s health,” says Dr. Werbinski, cochair of the American Medical Women’s Association Sex & Gender Health Coalition.

“I am happy to say that significant awareness has grown since I graduated from medical school. I hope that when this question is asked of current medical students, they will be able to say that they know to practice with a sex- and gender-focused lens.”
 

 

 

Talk about racial disparities

John McHugh, MD, an ob.gyn., recalls learning little about the social determinants of health when he attended med school more than 30 years ago.

“We saw disparities in outcomes based on race and class but assumed that we would overcome them when we were in practice,” says Dr. McHugh, an AMWA Action Coalition for Equity member. “We didn’t understand the root causes of disparities and had never heard of concepts like epigenetics or weathering. I’m hopeful current research will help our understanding and today’s medical students will serve a safer, healthier, and more equitable world.”

Curtiland Deville, MD, an associate professor of radiation oncology, recalls having few conversations around race; racial disparities; and diversity, equity, and inclusion.

“When I went to medical school, it often felt like you weren’t supposed to talk about the differences in race,” says Dr. Deville, who graduated in 2005. But today, in the post-2020 era between COVID, during which health disparities got highlighted, and calls for racial justice taking center stage, Dr. Deville says many of the things they didn’t talk about have come to the forefront in our medical institutions.
 

Information at your fingertips

For Paru David, MD, a 1996 graduate, the most significant change is the amount of health and medical information available today. “Before, the information that was taught in medical school was obtained through textbooks or within journal articles,” says Dr. David.

“Now, we have databases of information. The key to success is being able to navigate the information available to us, digest it with a keen eye, and then apply it to patient care in a timely manner.”

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

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Noteworthy advances in treatment and management of IBD

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– At this year’s AGA Postgraduate Course in May at the annual Digestive Disease Week®(DDW), we reviewed the latest updates in inflammatory bowel disease (IBD).

Although it had been thought that incidence rates of IBD were plateauing in high-incidence areas, a Danish study found a steady increase in incidence of Crohn’s disease and ulcerative colitis (UC).1 The highest increase in rates occurred in children and young adults, which will have repercussions as people get older and contribute to higher compounding prevalence. We need to get better at dealing with other health conditions as patients get older. A very large prospective Spanish study found that 42% of IBD patients scanned consecutively had MAFLD (metabolic-associated fatty liver disease) – even if they didn’t have high BMI and type 2 diabetes, suggesting that systemic inflammation in IBD contributes to the development of metabolic liver disease.2

University of Miami
Dr. Maria T. Abreu

The AGA has recently published guidelines for using biomarkers in the management of UC. Patients with very low fecal calprotectin (FCP) are unlikely to have active disease whereas FCP over 150 with significant symptoms may warrant empiric changes in treatment.3

Intestinal ultrasound is gaining wider acceptance as a noninvasive way to monitor IBD.4 In a UC study, improvement in bowel wall thickness following tofacitinib treatment correlated well with endoscopic activity.5

Brigham and Women&#039;s Hospital
Dr. Jessica R. Allegretti

The majority of the presentation focused on the explosion of Food and Drug Administration–-approved medications for IBD in recent years. S1P receptor agonists, such as ozanimod and etrasimod, may work by trapping specific T-cell subsets in peripheral lymph nodes, preventing migration to intestinal tissues. Ozanimod is approved for UC. Etrasimod showed efficacy in UC with clinical remission rates of about 27% at week 12 and 32% at week 52.6,7

There has been a lot of excitement about JAK inhibitors for IBD. Upadacitinib has recently been approved for both UC and Crohn’s disease. Response rates of 73% and remission rates of 26% were seen in UC patients who had been largely biologic exposed.8 Similar results were seen in a biologic-exposed Crohn’s disease population treated with upadacitinib including in endoscopy.9 Upadacitinib was effective in maintaining remission at both 15-mg and 30-mg doses; but the higher dose had a greater effect on endoscopic endpoints.10

Dr. Loftus
Dr. Edward V. Loftus Jr.

For Crohn’s disease, we now have risankizumab, an anti-p19/IL-23 inhibitor. Risankizumab was efficacious at inducing and maintain remission in the pivotal phase 3 studies, even with 75% of patients being biologic exposed. These studies used combined endpoints of clinical remission as well as endoscopic response.11 Guselkumab (anti-p19/IL-23) is also being studied for Crohn’s disease and early trials has appears to be efficacious.12

A head-to-head study of naive CD patients treated with ustekinumab or adalimumab (SEAVUE) showed comparable rates of clinical remission. At 52 weeks, the rates of clinical remission were quite high: >60% and endoscopic remission >30% with either therapy.13

Dr. Ryan C. Ungaro

We now have phase 3 data showing that a biologic is efficacious in patients with chronic pouchitis. The EARNEST trial demonstrated that vedolizumab has efficacy in treating pouchitis with improved clinical symptoms and endoscopy.14 Future treatment strategies may involve combinations of biologic therapies. The VEGA study showed that combining an anti-TNF, golimumab, with an anti-IL23, guselkumab, was superior than either alone with respect to clinical remission and endoscopic improvement in UC.15 We will see more studies combining therapies with diverse mechanisms of action.

In summary, there have been many noteworthy advances in treatment and management of IBD in the past year.

DDW is sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and The Society for Surgery of the Alimentary Tract (SSAT).

Dr. Abreu is director of the Crohn’s and Colitis Center and professor of medicine, microbiology, and immunology at the University of Miami. She is president-elect of AGA. Dr. Allegretti is director of the Crohn’s and Colitis Center and director of the fecal microbiota transplant program at Brigham and Women’s Hospital, Boston. She is associate professor of medicine at Harvard Medical School, Boston. Dr. Loftus is the Maxine and Jack Zarrow Family Professor of Gastroenterology, codirector of the advanced IBD fellowship in the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn. Dr. Ungaro is associate professor of medicine at the Icahn School of Medicine at Mount Sinai, New York.

References

1. Agrawal M et al. Gastroenterology. 2022;163(6):1547-54.e5.

2. Rodriguez-Duque JC et al. Clin Gastroenterol Hepatol. 2023;21(2):406-14.e7.

3. Singh S, et al. Gastroenterology. 2023;164(3):344-72.

4. de Voogd F et al. Gastroenterology. 2022;163(6):1569-81.

5. Sandborn WJ et al. N Engl J Med. 2017;376(18):1723-36.

6. Sandborn WJ et al. N Engl J Med. 2021;385(14):1280-91.

7. Sandborn WJ et al. Lancet. 2023 Mar 25;401(10381):1000]. Lancet. 2023;401(10383):1159-71.

8. Danese S et al. Lancet. 2022 Sep 24;400(10357):996]. Lancet. 2022;399(10341):2113-28.

9. Loftus EV Jr et al. N Engl J Med. 2023 May 25;388(21):1966-80.

10. Panes J et al. Am J Gastroenterol 2022;117(S10). Abstract S37.

11. D’Haens G, et al. Lancet. 2022;399(10340):2015-30

12. Sandborn WJ et al. Gastroenterology. 2022;162(6):1650-64.e8.

13. Sands BE, et al. Lancet. 2022;399(10342):2200-11.

14. Travis S et al. N Engl J Med. 2023;388(13):1191-1200.

15. Feagan BG et al. Lancet Gastroenterol Hepatol. 2023;8(4):307-20.

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– At this year’s AGA Postgraduate Course in May at the annual Digestive Disease Week®(DDW), we reviewed the latest updates in inflammatory bowel disease (IBD).

Although it had been thought that incidence rates of IBD were plateauing in high-incidence areas, a Danish study found a steady increase in incidence of Crohn’s disease and ulcerative colitis (UC).1 The highest increase in rates occurred in children and young adults, which will have repercussions as people get older and contribute to higher compounding prevalence. We need to get better at dealing with other health conditions as patients get older. A very large prospective Spanish study found that 42% of IBD patients scanned consecutively had MAFLD (metabolic-associated fatty liver disease) – even if they didn’t have high BMI and type 2 diabetes, suggesting that systemic inflammation in IBD contributes to the development of metabolic liver disease.2

University of Miami
Dr. Maria T. Abreu

The AGA has recently published guidelines for using biomarkers in the management of UC. Patients with very low fecal calprotectin (FCP) are unlikely to have active disease whereas FCP over 150 with significant symptoms may warrant empiric changes in treatment.3

Intestinal ultrasound is gaining wider acceptance as a noninvasive way to monitor IBD.4 In a UC study, improvement in bowel wall thickness following tofacitinib treatment correlated well with endoscopic activity.5

Brigham and Women&#039;s Hospital
Dr. Jessica R. Allegretti

The majority of the presentation focused on the explosion of Food and Drug Administration–-approved medications for IBD in recent years. S1P receptor agonists, such as ozanimod and etrasimod, may work by trapping specific T-cell subsets in peripheral lymph nodes, preventing migration to intestinal tissues. Ozanimod is approved for UC. Etrasimod showed efficacy in UC with clinical remission rates of about 27% at week 12 and 32% at week 52.6,7

There has been a lot of excitement about JAK inhibitors for IBD. Upadacitinib has recently been approved for both UC and Crohn’s disease. Response rates of 73% and remission rates of 26% were seen in UC patients who had been largely biologic exposed.8 Similar results were seen in a biologic-exposed Crohn’s disease population treated with upadacitinib including in endoscopy.9 Upadacitinib was effective in maintaining remission at both 15-mg and 30-mg doses; but the higher dose had a greater effect on endoscopic endpoints.10

Dr. Loftus
Dr. Edward V. Loftus Jr.

For Crohn’s disease, we now have risankizumab, an anti-p19/IL-23 inhibitor. Risankizumab was efficacious at inducing and maintain remission in the pivotal phase 3 studies, even with 75% of patients being biologic exposed. These studies used combined endpoints of clinical remission as well as endoscopic response.11 Guselkumab (anti-p19/IL-23) is also being studied for Crohn’s disease and early trials has appears to be efficacious.12

A head-to-head study of naive CD patients treated with ustekinumab or adalimumab (SEAVUE) showed comparable rates of clinical remission. At 52 weeks, the rates of clinical remission were quite high: >60% and endoscopic remission >30% with either therapy.13

Dr. Ryan C. Ungaro

We now have phase 3 data showing that a biologic is efficacious in patients with chronic pouchitis. The EARNEST trial demonstrated that vedolizumab has efficacy in treating pouchitis with improved clinical symptoms and endoscopy.14 Future treatment strategies may involve combinations of biologic therapies. The VEGA study showed that combining an anti-TNF, golimumab, with an anti-IL23, guselkumab, was superior than either alone with respect to clinical remission and endoscopic improvement in UC.15 We will see more studies combining therapies with diverse mechanisms of action.

In summary, there have been many noteworthy advances in treatment and management of IBD in the past year.

DDW is sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and The Society for Surgery of the Alimentary Tract (SSAT).

Dr. Abreu is director of the Crohn’s and Colitis Center and professor of medicine, microbiology, and immunology at the University of Miami. She is president-elect of AGA. Dr. Allegretti is director of the Crohn’s and Colitis Center and director of the fecal microbiota transplant program at Brigham and Women’s Hospital, Boston. She is associate professor of medicine at Harvard Medical School, Boston. Dr. Loftus is the Maxine and Jack Zarrow Family Professor of Gastroenterology, codirector of the advanced IBD fellowship in the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn. Dr. Ungaro is associate professor of medicine at the Icahn School of Medicine at Mount Sinai, New York.

References

1. Agrawal M et al. Gastroenterology. 2022;163(6):1547-54.e5.

2. Rodriguez-Duque JC et al. Clin Gastroenterol Hepatol. 2023;21(2):406-14.e7.

3. Singh S, et al. Gastroenterology. 2023;164(3):344-72.

4. de Voogd F et al. Gastroenterology. 2022;163(6):1569-81.

5. Sandborn WJ et al. N Engl J Med. 2017;376(18):1723-36.

6. Sandborn WJ et al. N Engl J Med. 2021;385(14):1280-91.

7. Sandborn WJ et al. Lancet. 2023 Mar 25;401(10381):1000]. Lancet. 2023;401(10383):1159-71.

8. Danese S et al. Lancet. 2022 Sep 24;400(10357):996]. Lancet. 2022;399(10341):2113-28.

9. Loftus EV Jr et al. N Engl J Med. 2023 May 25;388(21):1966-80.

10. Panes J et al. Am J Gastroenterol 2022;117(S10). Abstract S37.

11. D’Haens G, et al. Lancet. 2022;399(10340):2015-30

12. Sandborn WJ et al. Gastroenterology. 2022;162(6):1650-64.e8.

13. Sands BE, et al. Lancet. 2022;399(10342):2200-11.

14. Travis S et al. N Engl J Med. 2023;388(13):1191-1200.

15. Feagan BG et al. Lancet Gastroenterol Hepatol. 2023;8(4):307-20.

– At this year’s AGA Postgraduate Course in May at the annual Digestive Disease Week®(DDW), we reviewed the latest updates in inflammatory bowel disease (IBD).

Although it had been thought that incidence rates of IBD were plateauing in high-incidence areas, a Danish study found a steady increase in incidence of Crohn’s disease and ulcerative colitis (UC).1 The highest increase in rates occurred in children and young adults, which will have repercussions as people get older and contribute to higher compounding prevalence. We need to get better at dealing with other health conditions as patients get older. A very large prospective Spanish study found that 42% of IBD patients scanned consecutively had MAFLD (metabolic-associated fatty liver disease) – even if they didn’t have high BMI and type 2 diabetes, suggesting that systemic inflammation in IBD contributes to the development of metabolic liver disease.2

University of Miami
Dr. Maria T. Abreu

The AGA has recently published guidelines for using biomarkers in the management of UC. Patients with very low fecal calprotectin (FCP) are unlikely to have active disease whereas FCP over 150 with significant symptoms may warrant empiric changes in treatment.3

Intestinal ultrasound is gaining wider acceptance as a noninvasive way to monitor IBD.4 In a UC study, improvement in bowel wall thickness following tofacitinib treatment correlated well with endoscopic activity.5

Brigham and Women&#039;s Hospital
Dr. Jessica R. Allegretti

The majority of the presentation focused on the explosion of Food and Drug Administration–-approved medications for IBD in recent years. S1P receptor agonists, such as ozanimod and etrasimod, may work by trapping specific T-cell subsets in peripheral lymph nodes, preventing migration to intestinal tissues. Ozanimod is approved for UC. Etrasimod showed efficacy in UC with clinical remission rates of about 27% at week 12 and 32% at week 52.6,7

There has been a lot of excitement about JAK inhibitors for IBD. Upadacitinib has recently been approved for both UC and Crohn’s disease. Response rates of 73% and remission rates of 26% were seen in UC patients who had been largely biologic exposed.8 Similar results were seen in a biologic-exposed Crohn’s disease population treated with upadacitinib including in endoscopy.9 Upadacitinib was effective in maintaining remission at both 15-mg and 30-mg doses; but the higher dose had a greater effect on endoscopic endpoints.10

Dr. Loftus
Dr. Edward V. Loftus Jr.

For Crohn’s disease, we now have risankizumab, an anti-p19/IL-23 inhibitor. Risankizumab was efficacious at inducing and maintain remission in the pivotal phase 3 studies, even with 75% of patients being biologic exposed. These studies used combined endpoints of clinical remission as well as endoscopic response.11 Guselkumab (anti-p19/IL-23) is also being studied for Crohn’s disease and early trials has appears to be efficacious.12

A head-to-head study of naive CD patients treated with ustekinumab or adalimumab (SEAVUE) showed comparable rates of clinical remission. At 52 weeks, the rates of clinical remission were quite high: >60% and endoscopic remission >30% with either therapy.13

Dr. Ryan C. Ungaro

We now have phase 3 data showing that a biologic is efficacious in patients with chronic pouchitis. The EARNEST trial demonstrated that vedolizumab has efficacy in treating pouchitis with improved clinical symptoms and endoscopy.14 Future treatment strategies may involve combinations of biologic therapies. The VEGA study showed that combining an anti-TNF, golimumab, with an anti-IL23, guselkumab, was superior than either alone with respect to clinical remission and endoscopic improvement in UC.15 We will see more studies combining therapies with diverse mechanisms of action.

In summary, there have been many noteworthy advances in treatment and management of IBD in the past year.

DDW is sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and The Society for Surgery of the Alimentary Tract (SSAT).

Dr. Abreu is director of the Crohn’s and Colitis Center and professor of medicine, microbiology, and immunology at the University of Miami. She is president-elect of AGA. Dr. Allegretti is director of the Crohn’s and Colitis Center and director of the fecal microbiota transplant program at Brigham and Women’s Hospital, Boston. She is associate professor of medicine at Harvard Medical School, Boston. Dr. Loftus is the Maxine and Jack Zarrow Family Professor of Gastroenterology, codirector of the advanced IBD fellowship in the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn. Dr. Ungaro is associate professor of medicine at the Icahn School of Medicine at Mount Sinai, New York.

References

1. Agrawal M et al. Gastroenterology. 2022;163(6):1547-54.e5.

2. Rodriguez-Duque JC et al. Clin Gastroenterol Hepatol. 2023;21(2):406-14.e7.

3. Singh S, et al. Gastroenterology. 2023;164(3):344-72.

4. de Voogd F et al. Gastroenterology. 2022;163(6):1569-81.

5. Sandborn WJ et al. N Engl J Med. 2017;376(18):1723-36.

6. Sandborn WJ et al. N Engl J Med. 2021;385(14):1280-91.

7. Sandborn WJ et al. Lancet. 2023 Mar 25;401(10381):1000]. Lancet. 2023;401(10383):1159-71.

8. Danese S et al. Lancet. 2022 Sep 24;400(10357):996]. Lancet. 2022;399(10341):2113-28.

9. Loftus EV Jr et al. N Engl J Med. 2023 May 25;388(21):1966-80.

10. Panes J et al. Am J Gastroenterol 2022;117(S10). Abstract S37.

11. D’Haens G, et al. Lancet. 2022;399(10340):2015-30

12. Sandborn WJ et al. Gastroenterology. 2022;162(6):1650-64.e8.

13. Sands BE, et al. Lancet. 2022;399(10342):2200-11.

14. Travis S et al. N Engl J Med. 2023;388(13):1191-1200.

15. Feagan BG et al. Lancet Gastroenterol Hepatol. 2023;8(4):307-20.

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Managing intrahepatic cholestasis of pregnancy

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CASE Pregnant woman with intense itching

A 28-year-old woman (G1P0) is seen for a routine prenatal visit at 32 3/7 weeks’ gestation. She reports having generalized intense itching, including on her palms and soles, that is most intense at night and has been present for approximately 1 week. Her pregnancy is otherwise uncomplicated to date. Physical exam is within normal limits, with no evidence of a skin rash. Cholestasis of pregnancy is suspected, and laboratory tests are ordered, including bile acids and liver transaminases. Test results show that her aspartate transaminase (AST) and alanine transaminase (ALT) levels are mildly elevated at 55 IU/L and 41 IU/L, respectively, and several days later her bile acid level result is 21 µmol/L.

How should this patient be managed?

Intrahepatic cholestasis of pregnancy (ICP) affects 0.5% to 0.7% of pregnant individuals and results in maternal pruritus and elevated serum bile acid levels.1-3 Pruritus in ICP typically is generalized, including occurrence on the palms of the hands and soles of the feet, and it often is reported to be worse at night.4 Up to 25% of pregnant women will develop pruritus during pregnancy but the majority will not have ICP.2,5 Patients with ICP have no associated rash, but clinicians may note excoriations on exam. ICP typically presents in the third trimester of pregnancy but has been reported to occur earlier in gestation.6

Making a diagnosis of ICP

The presence of maternal pruritus in the absence of a skin condition along with elevated levels of serum bile acids are required for the diagnosis of ICP.7 Thus, a thorough history and physical exam is recommended to rule out another skin condition that could potentially explain the patient’s pruritus.

Some controversy exists regarding the bile acid level cutoff that should be used to make a diagnosis of ICP.8 It has been noted that nonfasting serum bile acid levels in pregnancy are considerably higher than those in in the nonpregnant state, and an upper limit of 18 µmol/L has been proposed as a cutoff in pregnancy.9 However, nonfasting total serum bile acids also have been shown to vary considerably by race, with levels 25.8% higher in Black women compared with those in White women and 24.3% higher in Black women compared with those in south Asian women.9 This raises the question of whether we should be using race-specific bile acid values to make a diagnosis of ICP.

Bile acid levels also vary based on whether a patient is in a fasting or postprandial state.10 Despite this variation, most guidelines do not recommend testing fasting bile acid levels as the postprandial state effect overall is small.7,9,11 The Society for Maternal-Fetal Medicine (SMFM) recommends that if a pregnancy-specific bile acid range is available from the laboratory, then the upper limit of normal for pregnancy should be used when making a diagnosis of ICP.7 The SMFM guidelines also acknowledge, however, that pregnancy-specific values rarely are available, and in this case, levels above the upper limit of normal—often 10 µmol/L should be considered diagnostic for ICP until further evidence regarding optimal bile acid cutoff levels in pregnancy becomes available.7

For patients with suspected ICP, liver transaminase levels should be measured in addition to nonfasting serum bile acid levels.7 A thorough history should include assessment for additional symptoms of liver disease, such as changes in weight, appetite, jaundice, excessive fatigue, malaise, and abdominal pain.7 Elevated transaminases levels may be associated with ICP, but they are not necessary for diagnosis. In the absence of additional clinical symptoms that suggest underlying liver disease or severe early onset ICP, additional evaluation beyond nonfasting serum bile acids and liver transaminase levels, such as liver ultrasonography or evaluation for viral or autoimmune hepatitis, is not recommended.7 Obstetric care clinicians should be aware that there is an increased incidence of preeclampsia among patients with ICP, although no specific guidance regarding further recommendations for screening is provided.7

PHOTO: CHAJAMP/SHUTTERSTOCK

Continue to: Risks associated with ICP...

 

 

Risks associated with ICP

For both patients and clinicians, the greatest concern among patients with ICP is the increased risk of stillbirth. Stillbirth risk in ICP appears to be related to serum bile acid levels and has been reported to be highest in patients with bile acid levels greater than 100 µmol/L. A systematic review and meta-analysis of ICP studies demonstrated no increased risk of stillbirth among patients with bile acid levels less than 100 µmol/L.12 These results, however, must be interpreted with extreme caution as the majority of studies included patients with ICP who were actively managed with attempts to mitigate the risk of stillbirth.7

In the absence of additional pregnancy risk factors, the risk of stillbirth among patients with ICP and serum bile acid levels between 19 and 39 µmol/L does not appear to be elevated above their baseline risk.11 The same is true for pregnant individuals with ICP and no additional pregnancy risk factors with serum bile acid levels between 40 and 99 µmol/L until approximately 38 weeks’ gestation, when the risk of stillbirth is elevated.11 The risk of stillbirth is elevated in ICP with peak bile acid levels greater than 100 µmol/L, with an absolute risk of 3.44%.11

Management of patients with ICP

Laboratory evaluation

There is no consensus on the need for repeat testing of bile acid levels in patients with ICP. SMFM advises that follow-up testing of bile acid levels may help to guide delivery timing, especially in cases of severe ICP, but the society recommends against serial testing.7 By contrast, the Royal College of Obstetricians and Gynaecologists (RCOG) provides a detailed algorithm regarding time intervals between serum bile acid level testing to guide delivery timing.11 The TABLE lists the strategy for reassessment of serum bile acid levels in ICP as recommended by the RCOG.11

In the United States, bile acid testing traditionally takes several days as the testing is commonly performed at reference laboratories. We therefore suggest that clinicians consider repeating bile acid level testing in situations in which the timing of delivery may be altered if further elevations of bile acid levels were noted. This is particularly relevant for patients diagnosed with ICP early in the third trimester when repeat bile acid levels would still allow for an adjustment in delivery timing.

Antepartum fetal surveillance

Unfortunately, antepartum fetal testing for pregnant patients with ICP does not appear to reliably predict or prevent stillbirth as several studies have reported stillbirths within days of normal fetal testing.13-16 It is therefore important to counsel pregnant patients regarding monitoring of fetal movements and advise them to present for evaluation if concerns arise.

Currently, SMFM recommends that patients with ICP should begin antenatal fetal surveillance at a gestational age when abnormal fetal testing would result in delivery.7 Patients should be counseled, however, regarding the unpredictability of stillbirth with ICP in the setting of a low absolute risk of such.

Medications

While SMFM recommends a starting dose of ursodeoxycholic acid 10 to 15 mg/kg per day divided into 2 or 3 daily doses as first-line therapy for the treatment of maternal symptoms of ICP, it is important to acknowledge that the goal of treatment is to alleviate maternal symptoms as there is no evidence that ursodeoxycholic acid improves either maternal serum bile acid levels or perinatal outcomes.7,17,18 Since publication of the guidelines, ursodeoxycholic acid’s lack of benefit has been further confirmed in a meta-analysis, and thus discontinuation is not unreasonable in the absence of any improvement in maternal symptoms.18

Timing of delivery

The optimal management of ICP remains unknown. SMFM recommends delivery based on peak serum bile acid levels. Delivery is recommended at 36 weeks’ gestation with ICP and total bile acid levels greater than 100 µmol/L as these patients have the greatest risk of stillbirth.7 For patients with ICP and bile acid levels less than 100 µmol/L, delivery is recommended between 36 0/7 and 39 0/7 weeks’ gestation.7 This is a wide gestational age window for clinicians to consider timing of delivery, and certainly the risks of stillbirth should be carefully balanced with the morbidity associated with a preterm or early term delivery.

For patients with ICP who have bile acid levels greater than 40 µmol/L, it is reasonable to consider delivery earlier in the gestational age window, given an evidence of increased risk of stillbirth after 38 weeks.7,12 For patients with ICP who have bile acid levels less than 40 µmol/L, delivery closer to 39 weeks’ gestation is recommended, as the risk of stillbirth does not appear to be increased above the baseline risk.7,12 Clinicians should be aware that the presence of concomitant morbidities, such as preeclampsia and gestational diabetes, are associated with an increased risk of stillbirth and should be considered for delivery planning.19

Postpartum follow-up

Routine laboratory evaluation following delivery is not recommended.7 However, in the presence of persistent pruritus or other signs and symptoms of hepatobiliary disease, liver function tests should be repeated with referral to hepatology if results are persistently abnormal 4 to 6 weeks postpartum.7

CASE Patient follow-up and outcomes

The patient was counseled regarding the diagnosis of ICP. Following shared decision making, the patient opted to undergo twice weekly nonstress tests but was aware to carefully monitor fetal movements due to the unpredictability of stillbirth in ICP. The patient also opted to trial ursodeoxycholic acid for relief of maternal symptoms. Two weeks after her initial diagnosis, repeat total bile acid levels were stable at 22 µmol/L. Therefore, following extensive counseling, the patient opted to undergo induction of labor at 38 weeks’ gestation, with a normal outcome for mother and neonate. ●

References
  1. Abedin P, Weaver JB, Egginton E. Intrahepatic cholestasis of pregnancy: prevalence and ethnic distribution. Ethn Health. 1999;4:35-37.
  2.  Kenyon AP, Tribe RM, Nelson-Piercy C, et al. Pruritus in pregnancy: a study of anatomical distribution and prevalence in relation to the development of obstetric cholestasis. Obstet Med. 2010;3:25-29.
  3. Wikstrom Shemer E, Marschall HU, Ludvigsson JF, et al. Intrahepatic cholestasis of pregnancy and associated adverse pregnancy and fetal outcomes: a 12-year population-based cohort study. BJOG. 2013;120:717-723.
  4.  Ambros-Rudolph CM, Glatz M, Trauner M, et al. The importance of serum bile acid level analysis and treatment with ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a case series from central Europe. Arch Dermatol. 2007;143:757-762.
  5.  Szczech J, Wiatrowski A, Hirnle L, et al. Prevalence and relevance of pruritus in pregnancy. Biomed Res Int. 2017;2017:4238139.
  6.  Geenes V, Williamson C. Intrahepatic cholestasis of pregnancy. World J Gastroenterol. 2009;15:2049-2066.
  7.  Society for Maternal-Fetal Medicine; Lee RH, Greenberg M, Metz TD, et al. Society for Maternal-Fetal Medicine Consult Series #53: intrahepatic cholestasis of pregnancy: replaces Consult #13, April 2011. Am J Obstet Gynecol. 2021;224:B2-B9.
  8. Horgan R, Bitas C, Abuhamad A. Intrahepatic cholestasis of pregnancy: a comparison of Society for Maternal-Fetal Medicine and the Royal College of Obstetricians and Gynaecologists’ guidelines. Am J Obstet Gynecol MFM. 2023;5:100838.
  9. Mitchell AL, Ovadia C, Syngelaki A, et al. Re-evaluating diagnostic thresholds for intrahepatic cholestasis of pregnancy: case-control and cohort study. BJOG. 2021;128:1635-1644.
  10. Adams A, Jacobs K, Vogel RI, et al. Bile acid determination after standardized glucose load in pregnant women. AJP Rep. 2015;5:e168-e171.
  11. Girling J, Knight CL, Chappell L; Royal College of Obstetricians and Gynaecologists. Intrahepatic cholestasis of pregnancy: Green-top guideline no. 43, June 2022. BJOG. 2022;129:e95-e114.
  12.  Ovadia C, Seed PT, Sklavounos A, et al. Association of adverse perinatal outcomes of intrahepatic cholestasis of pregnancy with biochemical markers: results of aggregate and individual patient data meta-analyses. Lancet. 2019;393:899-909.
  13.  Alsulyman OM, Ouzounian JG, Ames-Castro M, et al. Intrahepatic cholestasis of pregnancy: perinatal outcome associated with expectant management. Am J Obstet Gynecol. 1996;175:957-960.
  14. Herrera CA, Manuck TA, Stoddard GJ, et al. Perinatal outcomes associated with intrahepatic cholestasis of pregnancy. J Matern Fetal Neonatal Med. 2018;31:1913-1920.
  15. Lee RH, Incerpi MH, Miller DA, et al. Sudden fetal death in intrahepatic cholestasis of pregnancy. Obstet Gynecol. 2009;113:528-531.
  16.  Sentilhes L, Verspyck E, Pia P, et al. Fetal death in a patient with intrahepatic cholestasis of pregnancy. Obstet Gynecol. 2006;107:458-460.
  17.  Chappell LC, Bell JL, Smith A, et al; PITCHES Study Group. Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial. Lancet. 2019;394:849-860.
  18.  Ovadia C, Sajous J, Seed PT, et al. Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a systematic review and individual participant data meta-analysis. Lancet Gastroenterol Hepatol. 2021;6:547-558.
  19.  Geenes V, Chappell LC, Seed PT, et al. Association of severe intrahepatic cholestasis of pregnancy with adverse pregnancy outcomes: a prospective population-based case-control study. Hepatology. 2014;59:1482-1491.
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Dr. Abuhamad is President, Provost and Dean, Eastern Virginia Medical School, Norfolk.

 

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The authors report no financial relationships relevant to  this article.

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Dr. Abuhamad is President, Provost and Dean, Eastern Virginia Medical School, Norfolk.

 

The authors report no financial relationships relevant to  this article.

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CASE Pregnant woman with intense itching

A 28-year-old woman (G1P0) is seen for a routine prenatal visit at 32 3/7 weeks’ gestation. She reports having generalized intense itching, including on her palms and soles, that is most intense at night and has been present for approximately 1 week. Her pregnancy is otherwise uncomplicated to date. Physical exam is within normal limits, with no evidence of a skin rash. Cholestasis of pregnancy is suspected, and laboratory tests are ordered, including bile acids and liver transaminases. Test results show that her aspartate transaminase (AST) and alanine transaminase (ALT) levels are mildly elevated at 55 IU/L and 41 IU/L, respectively, and several days later her bile acid level result is 21 µmol/L.

How should this patient be managed?

Intrahepatic cholestasis of pregnancy (ICP) affects 0.5% to 0.7% of pregnant individuals and results in maternal pruritus and elevated serum bile acid levels.1-3 Pruritus in ICP typically is generalized, including occurrence on the palms of the hands and soles of the feet, and it often is reported to be worse at night.4 Up to 25% of pregnant women will develop pruritus during pregnancy but the majority will not have ICP.2,5 Patients with ICP have no associated rash, but clinicians may note excoriations on exam. ICP typically presents in the third trimester of pregnancy but has been reported to occur earlier in gestation.6

Making a diagnosis of ICP

The presence of maternal pruritus in the absence of a skin condition along with elevated levels of serum bile acids are required for the diagnosis of ICP.7 Thus, a thorough history and physical exam is recommended to rule out another skin condition that could potentially explain the patient’s pruritus.

Some controversy exists regarding the bile acid level cutoff that should be used to make a diagnosis of ICP.8 It has been noted that nonfasting serum bile acid levels in pregnancy are considerably higher than those in in the nonpregnant state, and an upper limit of 18 µmol/L has been proposed as a cutoff in pregnancy.9 However, nonfasting total serum bile acids also have been shown to vary considerably by race, with levels 25.8% higher in Black women compared with those in White women and 24.3% higher in Black women compared with those in south Asian women.9 This raises the question of whether we should be using race-specific bile acid values to make a diagnosis of ICP.

Bile acid levels also vary based on whether a patient is in a fasting or postprandial state.10 Despite this variation, most guidelines do not recommend testing fasting bile acid levels as the postprandial state effect overall is small.7,9,11 The Society for Maternal-Fetal Medicine (SMFM) recommends that if a pregnancy-specific bile acid range is available from the laboratory, then the upper limit of normal for pregnancy should be used when making a diagnosis of ICP.7 The SMFM guidelines also acknowledge, however, that pregnancy-specific values rarely are available, and in this case, levels above the upper limit of normal—often 10 µmol/L should be considered diagnostic for ICP until further evidence regarding optimal bile acid cutoff levels in pregnancy becomes available.7

For patients with suspected ICP, liver transaminase levels should be measured in addition to nonfasting serum bile acid levels.7 A thorough history should include assessment for additional symptoms of liver disease, such as changes in weight, appetite, jaundice, excessive fatigue, malaise, and abdominal pain.7 Elevated transaminases levels may be associated with ICP, but they are not necessary for diagnosis. In the absence of additional clinical symptoms that suggest underlying liver disease or severe early onset ICP, additional evaluation beyond nonfasting serum bile acids and liver transaminase levels, such as liver ultrasonography or evaluation for viral or autoimmune hepatitis, is not recommended.7 Obstetric care clinicians should be aware that there is an increased incidence of preeclampsia among patients with ICP, although no specific guidance regarding further recommendations for screening is provided.7

PHOTO: CHAJAMP/SHUTTERSTOCK

Continue to: Risks associated with ICP...

 

 

Risks associated with ICP

For both patients and clinicians, the greatest concern among patients with ICP is the increased risk of stillbirth. Stillbirth risk in ICP appears to be related to serum bile acid levels and has been reported to be highest in patients with bile acid levels greater than 100 µmol/L. A systematic review and meta-analysis of ICP studies demonstrated no increased risk of stillbirth among patients with bile acid levels less than 100 µmol/L.12 These results, however, must be interpreted with extreme caution as the majority of studies included patients with ICP who were actively managed with attempts to mitigate the risk of stillbirth.7

In the absence of additional pregnancy risk factors, the risk of stillbirth among patients with ICP and serum bile acid levels between 19 and 39 µmol/L does not appear to be elevated above their baseline risk.11 The same is true for pregnant individuals with ICP and no additional pregnancy risk factors with serum bile acid levels between 40 and 99 µmol/L until approximately 38 weeks’ gestation, when the risk of stillbirth is elevated.11 The risk of stillbirth is elevated in ICP with peak bile acid levels greater than 100 µmol/L, with an absolute risk of 3.44%.11

Management of patients with ICP

Laboratory evaluation

There is no consensus on the need for repeat testing of bile acid levels in patients with ICP. SMFM advises that follow-up testing of bile acid levels may help to guide delivery timing, especially in cases of severe ICP, but the society recommends against serial testing.7 By contrast, the Royal College of Obstetricians and Gynaecologists (RCOG) provides a detailed algorithm regarding time intervals between serum bile acid level testing to guide delivery timing.11 The TABLE lists the strategy for reassessment of serum bile acid levels in ICP as recommended by the RCOG.11

In the United States, bile acid testing traditionally takes several days as the testing is commonly performed at reference laboratories. We therefore suggest that clinicians consider repeating bile acid level testing in situations in which the timing of delivery may be altered if further elevations of bile acid levels were noted. This is particularly relevant for patients diagnosed with ICP early in the third trimester when repeat bile acid levels would still allow for an adjustment in delivery timing.

Antepartum fetal surveillance

Unfortunately, antepartum fetal testing for pregnant patients with ICP does not appear to reliably predict or prevent stillbirth as several studies have reported stillbirths within days of normal fetal testing.13-16 It is therefore important to counsel pregnant patients regarding monitoring of fetal movements and advise them to present for evaluation if concerns arise.

Currently, SMFM recommends that patients with ICP should begin antenatal fetal surveillance at a gestational age when abnormal fetal testing would result in delivery.7 Patients should be counseled, however, regarding the unpredictability of stillbirth with ICP in the setting of a low absolute risk of such.

Medications

While SMFM recommends a starting dose of ursodeoxycholic acid 10 to 15 mg/kg per day divided into 2 or 3 daily doses as first-line therapy for the treatment of maternal symptoms of ICP, it is important to acknowledge that the goal of treatment is to alleviate maternal symptoms as there is no evidence that ursodeoxycholic acid improves either maternal serum bile acid levels or perinatal outcomes.7,17,18 Since publication of the guidelines, ursodeoxycholic acid’s lack of benefit has been further confirmed in a meta-analysis, and thus discontinuation is not unreasonable in the absence of any improvement in maternal symptoms.18

Timing of delivery

The optimal management of ICP remains unknown. SMFM recommends delivery based on peak serum bile acid levels. Delivery is recommended at 36 weeks’ gestation with ICP and total bile acid levels greater than 100 µmol/L as these patients have the greatest risk of stillbirth.7 For patients with ICP and bile acid levels less than 100 µmol/L, delivery is recommended between 36 0/7 and 39 0/7 weeks’ gestation.7 This is a wide gestational age window for clinicians to consider timing of delivery, and certainly the risks of stillbirth should be carefully balanced with the morbidity associated with a preterm or early term delivery.

For patients with ICP who have bile acid levels greater than 40 µmol/L, it is reasonable to consider delivery earlier in the gestational age window, given an evidence of increased risk of stillbirth after 38 weeks.7,12 For patients with ICP who have bile acid levels less than 40 µmol/L, delivery closer to 39 weeks’ gestation is recommended, as the risk of stillbirth does not appear to be increased above the baseline risk.7,12 Clinicians should be aware that the presence of concomitant morbidities, such as preeclampsia and gestational diabetes, are associated with an increased risk of stillbirth and should be considered for delivery planning.19

Postpartum follow-up

Routine laboratory evaluation following delivery is not recommended.7 However, in the presence of persistent pruritus or other signs and symptoms of hepatobiliary disease, liver function tests should be repeated with referral to hepatology if results are persistently abnormal 4 to 6 weeks postpartum.7

CASE Patient follow-up and outcomes

The patient was counseled regarding the diagnosis of ICP. Following shared decision making, the patient opted to undergo twice weekly nonstress tests but was aware to carefully monitor fetal movements due to the unpredictability of stillbirth in ICP. The patient also opted to trial ursodeoxycholic acid for relief of maternal symptoms. Two weeks after her initial diagnosis, repeat total bile acid levels were stable at 22 µmol/L. Therefore, following extensive counseling, the patient opted to undergo induction of labor at 38 weeks’ gestation, with a normal outcome for mother and neonate. ●

 

 

CASE Pregnant woman with intense itching

A 28-year-old woman (G1P0) is seen for a routine prenatal visit at 32 3/7 weeks’ gestation. She reports having generalized intense itching, including on her palms and soles, that is most intense at night and has been present for approximately 1 week. Her pregnancy is otherwise uncomplicated to date. Physical exam is within normal limits, with no evidence of a skin rash. Cholestasis of pregnancy is suspected, and laboratory tests are ordered, including bile acids and liver transaminases. Test results show that her aspartate transaminase (AST) and alanine transaminase (ALT) levels are mildly elevated at 55 IU/L and 41 IU/L, respectively, and several days later her bile acid level result is 21 µmol/L.

How should this patient be managed?

Intrahepatic cholestasis of pregnancy (ICP) affects 0.5% to 0.7% of pregnant individuals and results in maternal pruritus and elevated serum bile acid levels.1-3 Pruritus in ICP typically is generalized, including occurrence on the palms of the hands and soles of the feet, and it often is reported to be worse at night.4 Up to 25% of pregnant women will develop pruritus during pregnancy but the majority will not have ICP.2,5 Patients with ICP have no associated rash, but clinicians may note excoriations on exam. ICP typically presents in the third trimester of pregnancy but has been reported to occur earlier in gestation.6

Making a diagnosis of ICP

The presence of maternal pruritus in the absence of a skin condition along with elevated levels of serum bile acids are required for the diagnosis of ICP.7 Thus, a thorough history and physical exam is recommended to rule out another skin condition that could potentially explain the patient’s pruritus.

Some controversy exists regarding the bile acid level cutoff that should be used to make a diagnosis of ICP.8 It has been noted that nonfasting serum bile acid levels in pregnancy are considerably higher than those in in the nonpregnant state, and an upper limit of 18 µmol/L has been proposed as a cutoff in pregnancy.9 However, nonfasting total serum bile acids also have been shown to vary considerably by race, with levels 25.8% higher in Black women compared with those in White women and 24.3% higher in Black women compared with those in south Asian women.9 This raises the question of whether we should be using race-specific bile acid values to make a diagnosis of ICP.

Bile acid levels also vary based on whether a patient is in a fasting or postprandial state.10 Despite this variation, most guidelines do not recommend testing fasting bile acid levels as the postprandial state effect overall is small.7,9,11 The Society for Maternal-Fetal Medicine (SMFM) recommends that if a pregnancy-specific bile acid range is available from the laboratory, then the upper limit of normal for pregnancy should be used when making a diagnosis of ICP.7 The SMFM guidelines also acknowledge, however, that pregnancy-specific values rarely are available, and in this case, levels above the upper limit of normal—often 10 µmol/L should be considered diagnostic for ICP until further evidence regarding optimal bile acid cutoff levels in pregnancy becomes available.7

For patients with suspected ICP, liver transaminase levels should be measured in addition to nonfasting serum bile acid levels.7 A thorough history should include assessment for additional symptoms of liver disease, such as changes in weight, appetite, jaundice, excessive fatigue, malaise, and abdominal pain.7 Elevated transaminases levels may be associated with ICP, but they are not necessary for diagnosis. In the absence of additional clinical symptoms that suggest underlying liver disease or severe early onset ICP, additional evaluation beyond nonfasting serum bile acids and liver transaminase levels, such as liver ultrasonography or evaluation for viral or autoimmune hepatitis, is not recommended.7 Obstetric care clinicians should be aware that there is an increased incidence of preeclampsia among patients with ICP, although no specific guidance regarding further recommendations for screening is provided.7

PHOTO: CHAJAMP/SHUTTERSTOCK

Continue to: Risks associated with ICP...

 

 

Risks associated with ICP

For both patients and clinicians, the greatest concern among patients with ICP is the increased risk of stillbirth. Stillbirth risk in ICP appears to be related to serum bile acid levels and has been reported to be highest in patients with bile acid levels greater than 100 µmol/L. A systematic review and meta-analysis of ICP studies demonstrated no increased risk of stillbirth among patients with bile acid levels less than 100 µmol/L.12 These results, however, must be interpreted with extreme caution as the majority of studies included patients with ICP who were actively managed with attempts to mitigate the risk of stillbirth.7

In the absence of additional pregnancy risk factors, the risk of stillbirth among patients with ICP and serum bile acid levels between 19 and 39 µmol/L does not appear to be elevated above their baseline risk.11 The same is true for pregnant individuals with ICP and no additional pregnancy risk factors with serum bile acid levels between 40 and 99 µmol/L until approximately 38 weeks’ gestation, when the risk of stillbirth is elevated.11 The risk of stillbirth is elevated in ICP with peak bile acid levels greater than 100 µmol/L, with an absolute risk of 3.44%.11

Management of patients with ICP

Laboratory evaluation

There is no consensus on the need for repeat testing of bile acid levels in patients with ICP. SMFM advises that follow-up testing of bile acid levels may help to guide delivery timing, especially in cases of severe ICP, but the society recommends against serial testing.7 By contrast, the Royal College of Obstetricians and Gynaecologists (RCOG) provides a detailed algorithm regarding time intervals between serum bile acid level testing to guide delivery timing.11 The TABLE lists the strategy for reassessment of serum bile acid levels in ICP as recommended by the RCOG.11

In the United States, bile acid testing traditionally takes several days as the testing is commonly performed at reference laboratories. We therefore suggest that clinicians consider repeating bile acid level testing in situations in which the timing of delivery may be altered if further elevations of bile acid levels were noted. This is particularly relevant for patients diagnosed with ICP early in the third trimester when repeat bile acid levels would still allow for an adjustment in delivery timing.

Antepartum fetal surveillance

Unfortunately, antepartum fetal testing for pregnant patients with ICP does not appear to reliably predict or prevent stillbirth as several studies have reported stillbirths within days of normal fetal testing.13-16 It is therefore important to counsel pregnant patients regarding monitoring of fetal movements and advise them to present for evaluation if concerns arise.

Currently, SMFM recommends that patients with ICP should begin antenatal fetal surveillance at a gestational age when abnormal fetal testing would result in delivery.7 Patients should be counseled, however, regarding the unpredictability of stillbirth with ICP in the setting of a low absolute risk of such.

Medications

While SMFM recommends a starting dose of ursodeoxycholic acid 10 to 15 mg/kg per day divided into 2 or 3 daily doses as first-line therapy for the treatment of maternal symptoms of ICP, it is important to acknowledge that the goal of treatment is to alleviate maternal symptoms as there is no evidence that ursodeoxycholic acid improves either maternal serum bile acid levels or perinatal outcomes.7,17,18 Since publication of the guidelines, ursodeoxycholic acid’s lack of benefit has been further confirmed in a meta-analysis, and thus discontinuation is not unreasonable in the absence of any improvement in maternal symptoms.18

Timing of delivery

The optimal management of ICP remains unknown. SMFM recommends delivery based on peak serum bile acid levels. Delivery is recommended at 36 weeks’ gestation with ICP and total bile acid levels greater than 100 µmol/L as these patients have the greatest risk of stillbirth.7 For patients with ICP and bile acid levels less than 100 µmol/L, delivery is recommended between 36 0/7 and 39 0/7 weeks’ gestation.7 This is a wide gestational age window for clinicians to consider timing of delivery, and certainly the risks of stillbirth should be carefully balanced with the morbidity associated with a preterm or early term delivery.

For patients with ICP who have bile acid levels greater than 40 µmol/L, it is reasonable to consider delivery earlier in the gestational age window, given an evidence of increased risk of stillbirth after 38 weeks.7,12 For patients with ICP who have bile acid levels less than 40 µmol/L, delivery closer to 39 weeks’ gestation is recommended, as the risk of stillbirth does not appear to be increased above the baseline risk.7,12 Clinicians should be aware that the presence of concomitant morbidities, such as preeclampsia and gestational diabetes, are associated with an increased risk of stillbirth and should be considered for delivery planning.19

Postpartum follow-up

Routine laboratory evaluation following delivery is not recommended.7 However, in the presence of persistent pruritus or other signs and symptoms of hepatobiliary disease, liver function tests should be repeated with referral to hepatology if results are persistently abnormal 4 to 6 weeks postpartum.7

CASE Patient follow-up and outcomes

The patient was counseled regarding the diagnosis of ICP. Following shared decision making, the patient opted to undergo twice weekly nonstress tests but was aware to carefully monitor fetal movements due to the unpredictability of stillbirth in ICP. The patient also opted to trial ursodeoxycholic acid for relief of maternal symptoms. Two weeks after her initial diagnosis, repeat total bile acid levels were stable at 22 µmol/L. Therefore, following extensive counseling, the patient opted to undergo induction of labor at 38 weeks’ gestation, with a normal outcome for mother and neonate. ●

References
  1. Abedin P, Weaver JB, Egginton E. Intrahepatic cholestasis of pregnancy: prevalence and ethnic distribution. Ethn Health. 1999;4:35-37.
  2.  Kenyon AP, Tribe RM, Nelson-Piercy C, et al. Pruritus in pregnancy: a study of anatomical distribution and prevalence in relation to the development of obstetric cholestasis. Obstet Med. 2010;3:25-29.
  3. Wikstrom Shemer E, Marschall HU, Ludvigsson JF, et al. Intrahepatic cholestasis of pregnancy and associated adverse pregnancy and fetal outcomes: a 12-year population-based cohort study. BJOG. 2013;120:717-723.
  4.  Ambros-Rudolph CM, Glatz M, Trauner M, et al. The importance of serum bile acid level analysis and treatment with ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a case series from central Europe. Arch Dermatol. 2007;143:757-762.
  5.  Szczech J, Wiatrowski A, Hirnle L, et al. Prevalence and relevance of pruritus in pregnancy. Biomed Res Int. 2017;2017:4238139.
  6.  Geenes V, Williamson C. Intrahepatic cholestasis of pregnancy. World J Gastroenterol. 2009;15:2049-2066.
  7.  Society for Maternal-Fetal Medicine; Lee RH, Greenberg M, Metz TD, et al. Society for Maternal-Fetal Medicine Consult Series #53: intrahepatic cholestasis of pregnancy: replaces Consult #13, April 2011. Am J Obstet Gynecol. 2021;224:B2-B9.
  8. Horgan R, Bitas C, Abuhamad A. Intrahepatic cholestasis of pregnancy: a comparison of Society for Maternal-Fetal Medicine and the Royal College of Obstetricians and Gynaecologists’ guidelines. Am J Obstet Gynecol MFM. 2023;5:100838.
  9. Mitchell AL, Ovadia C, Syngelaki A, et al. Re-evaluating diagnostic thresholds for intrahepatic cholestasis of pregnancy: case-control and cohort study. BJOG. 2021;128:1635-1644.
  10. Adams A, Jacobs K, Vogel RI, et al. Bile acid determination after standardized glucose load in pregnant women. AJP Rep. 2015;5:e168-e171.
  11. Girling J, Knight CL, Chappell L; Royal College of Obstetricians and Gynaecologists. Intrahepatic cholestasis of pregnancy: Green-top guideline no. 43, June 2022. BJOG. 2022;129:e95-e114.
  12.  Ovadia C, Seed PT, Sklavounos A, et al. Association of adverse perinatal outcomes of intrahepatic cholestasis of pregnancy with biochemical markers: results of aggregate and individual patient data meta-analyses. Lancet. 2019;393:899-909.
  13.  Alsulyman OM, Ouzounian JG, Ames-Castro M, et al. Intrahepatic cholestasis of pregnancy: perinatal outcome associated with expectant management. Am J Obstet Gynecol. 1996;175:957-960.
  14. Herrera CA, Manuck TA, Stoddard GJ, et al. Perinatal outcomes associated with intrahepatic cholestasis of pregnancy. J Matern Fetal Neonatal Med. 2018;31:1913-1920.
  15. Lee RH, Incerpi MH, Miller DA, et al. Sudden fetal death in intrahepatic cholestasis of pregnancy. Obstet Gynecol. 2009;113:528-531.
  16.  Sentilhes L, Verspyck E, Pia P, et al. Fetal death in a patient with intrahepatic cholestasis of pregnancy. Obstet Gynecol. 2006;107:458-460.
  17.  Chappell LC, Bell JL, Smith A, et al; PITCHES Study Group. Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial. Lancet. 2019;394:849-860.
  18.  Ovadia C, Sajous J, Seed PT, et al. Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a systematic review and individual participant data meta-analysis. Lancet Gastroenterol Hepatol. 2021;6:547-558.
  19.  Geenes V, Chappell LC, Seed PT, et al. Association of severe intrahepatic cholestasis of pregnancy with adverse pregnancy outcomes: a prospective population-based case-control study. Hepatology. 2014;59:1482-1491.
References
  1. Abedin P, Weaver JB, Egginton E. Intrahepatic cholestasis of pregnancy: prevalence and ethnic distribution. Ethn Health. 1999;4:35-37.
  2.  Kenyon AP, Tribe RM, Nelson-Piercy C, et al. Pruritus in pregnancy: a study of anatomical distribution and prevalence in relation to the development of obstetric cholestasis. Obstet Med. 2010;3:25-29.
  3. Wikstrom Shemer E, Marschall HU, Ludvigsson JF, et al. Intrahepatic cholestasis of pregnancy and associated adverse pregnancy and fetal outcomes: a 12-year population-based cohort study. BJOG. 2013;120:717-723.
  4.  Ambros-Rudolph CM, Glatz M, Trauner M, et al. The importance of serum bile acid level analysis and treatment with ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a case series from central Europe. Arch Dermatol. 2007;143:757-762.
  5.  Szczech J, Wiatrowski A, Hirnle L, et al. Prevalence and relevance of pruritus in pregnancy. Biomed Res Int. 2017;2017:4238139.
  6.  Geenes V, Williamson C. Intrahepatic cholestasis of pregnancy. World J Gastroenterol. 2009;15:2049-2066.
  7.  Society for Maternal-Fetal Medicine; Lee RH, Greenberg M, Metz TD, et al. Society for Maternal-Fetal Medicine Consult Series #53: intrahepatic cholestasis of pregnancy: replaces Consult #13, April 2011. Am J Obstet Gynecol. 2021;224:B2-B9.
  8. Horgan R, Bitas C, Abuhamad A. Intrahepatic cholestasis of pregnancy: a comparison of Society for Maternal-Fetal Medicine and the Royal College of Obstetricians and Gynaecologists’ guidelines. Am J Obstet Gynecol MFM. 2023;5:100838.
  9. Mitchell AL, Ovadia C, Syngelaki A, et al. Re-evaluating diagnostic thresholds for intrahepatic cholestasis of pregnancy: case-control and cohort study. BJOG. 2021;128:1635-1644.
  10. Adams A, Jacobs K, Vogel RI, et al. Bile acid determination after standardized glucose load in pregnant women. AJP Rep. 2015;5:e168-e171.
  11. Girling J, Knight CL, Chappell L; Royal College of Obstetricians and Gynaecologists. Intrahepatic cholestasis of pregnancy: Green-top guideline no. 43, June 2022. BJOG. 2022;129:e95-e114.
  12.  Ovadia C, Seed PT, Sklavounos A, et al. Association of adverse perinatal outcomes of intrahepatic cholestasis of pregnancy with biochemical markers: results of aggregate and individual patient data meta-analyses. Lancet. 2019;393:899-909.
  13.  Alsulyman OM, Ouzounian JG, Ames-Castro M, et al. Intrahepatic cholestasis of pregnancy: perinatal outcome associated with expectant management. Am J Obstet Gynecol. 1996;175:957-960.
  14. Herrera CA, Manuck TA, Stoddard GJ, et al. Perinatal outcomes associated with intrahepatic cholestasis of pregnancy. J Matern Fetal Neonatal Med. 2018;31:1913-1920.
  15. Lee RH, Incerpi MH, Miller DA, et al. Sudden fetal death in intrahepatic cholestasis of pregnancy. Obstet Gynecol. 2009;113:528-531.
  16.  Sentilhes L, Verspyck E, Pia P, et al. Fetal death in a patient with intrahepatic cholestasis of pregnancy. Obstet Gynecol. 2006;107:458-460.
  17.  Chappell LC, Bell JL, Smith A, et al; PITCHES Study Group. Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial. Lancet. 2019;394:849-860.
  18.  Ovadia C, Sajous J, Seed PT, et al. Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a systematic review and individual participant data meta-analysis. Lancet Gastroenterol Hepatol. 2021;6:547-558.
  19.  Geenes V, Chappell LC, Seed PT, et al. Association of severe intrahepatic cholestasis of pregnancy with adverse pregnancy outcomes: a prospective population-based case-control study. Hepatology. 2014;59:1482-1491.
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Research supports CRC screening at age 45

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Changed
Mon, 08/14/2023 - 14:36

In the wake of newly issued guidance by the American College of Physicians, the American Gastroenterological Association is advising clinicians to follow the 2021 colorectal cancer (CRC) screening recommendations from the U.S. Multi-Society Task Force on Colorectal Cancer (MSTF) which recommend that average risk individuals be screened beginning at age 45.

The ACP, in a new guidance, says that “clinicians should consider not screening asymptomatic average-risk adults between the ages of 45 to 49 years. Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”

The guidance is at odds with the recommendations from the task force, which represents the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy. The consensus was that people ages 45 and up should receive CRC screening.

“We’re disappointed that the ACP has suggested to not screen average-risk individuals between the ages of 45 to 49,” said Swati Patel, MD, MS, a member of the USMSTF, the lead author on the recent USMSTF guidance, and associate professor of medicine-gastroenterology at the University of Colorado at Denver, Aurora. “This guidance essentially contradicts these other organizations, and I think from the patient perspective, likely raises a lot of confusion.”

Barbara Jung, MD, AGAF, president of the AGA said in a written statement: “Studies show that colorectal cancer is increasing in younger patients and we have data backing screening for average-risk patients at 45. Bottomline: it saves lives. To release contradictory guidance is reckless.”

Timothy Wilt, MD, MPH, professor of medicine at the University of Minnesota, Minneapolis, and past chair of the guidelines committee at the ACP, said that a key consideration for the ACP was what they considered an “incredibly small” increase in CRC incidence in people under 50 from 2000 to 2019 – from 6.0 per 100,000 to 8.7 per 100,000.

“If I would tell my patients, your chance of colorectal cancer is 6 per 100,000 and now it’s really 9 per 100,000, they would say, ‘No thanks,’ ” he said. “I have trouble getting my patients to take a statin for heart disease when their risk of heart disease in the future is 25%.”

Dr. Patel said that these incidence numbers don’t capture the magnitude of the CRC health burden, because screening historically hadn’t been performed on those under 50. A 2020 study that broke incidence down in single-year increments found a 46% jump from age 49 to age 50, she noted.

“We only diagnose a cancer once we check for it,” she said. The dramatic jump in CRC incidence at age 50 isn’t a sign of new cancer, she said. Rather, these cancers have “been there for years and are cancers that would have been detected between 45 and 49. We just didn’t know about them because patients didn’t get the colonoscopy.”

Data show that 16% of all rectal cancer now occur in patients under 50, she said.

“That is a substantial proportion of all rectal cancers,” she said. “If these trends continue without us doing something about it, that suggests that colon cancer and rectal cancer will be the leading cause of cancer-related death in individuals under the age of 50 by 2030. That’s not that far away.”

Moreover, she said, when the ACP says in its guidance that “the small estimated benefits and harms roughly balance each other out,” it overestimates the risk of CRC screening. The first step, which includes noninvasive options such as a stool-based screen, is no-risk and needs to be followed by a colonoscopy only in a small percentage of cases, she noted. And in recent randomized controlled trials, out of more than 28,000 colonoscopies, there were two perforations, 30 bleeding events, and no deaths.

“I think the ACP statement very much overinflates the risks of screening,” she said.

Dr. Wilt suggested that guidance that flatly recommends that screening should start at age 45 is an overly blunt strategy, not accounting for lower CRC rates among women and varying risk for different races and ethnicities – information that patients should be given in order to make decisions.

“What I would say is, talk to your physicians, ask about the information, make a clinical decision that’s right for you. ... It’s your health,” he said. “We believe our guidance statements are incredibly patient-centered.”

Dr. Patel said that such an approach is not necessarily what patients look for from their physicians.

“I think in theory it’s great to have quote-unquote shared decision-making, and empower the patient to make a decision,” she said. “But generally speaking, patients seek our advice and seek our expertise to synthesize all of this complex data, to provide a recommendation that is driven by those data points.”

The ACP guidance also suggests that “opportunity costs and resources need to be weighed” and that expanding the screening population will take resources away from other medical services.

“We are the front-line docs who have to engage in these conversations,” Dr. Wilt said. “We value our GI and specialty consultants (but) they are not the ones who are there at the front line having to have these discussions.”

Dr. Patel agreed that, with expanded screening, primary care physicians need more support and that “we have a long way to go in providing those support resources.” But she added, “my perspective is that we have to look agnostically at the data.” The data the AGA cites, she added, are peer-reviewed, epidemiological data, not society-generated data.

“I don’t agree with the approach of, even though it’s an additional burden, because we don’t have the resources and time now, to just not proceed,” she said.

“I think our hope would be that practicing physicians – either within the ACP or outside – just have a clear message to patients, that colon cancer is a big deal, it’s increasing in young patients, starting at age 45 you should be screened, and you should use the test that you’re most likely to get done.”
 

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In the wake of newly issued guidance by the American College of Physicians, the American Gastroenterological Association is advising clinicians to follow the 2021 colorectal cancer (CRC) screening recommendations from the U.S. Multi-Society Task Force on Colorectal Cancer (MSTF) which recommend that average risk individuals be screened beginning at age 45.

The ACP, in a new guidance, says that “clinicians should consider not screening asymptomatic average-risk adults between the ages of 45 to 49 years. Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”

The guidance is at odds with the recommendations from the task force, which represents the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy. The consensus was that people ages 45 and up should receive CRC screening.

“We’re disappointed that the ACP has suggested to not screen average-risk individuals between the ages of 45 to 49,” said Swati Patel, MD, MS, a member of the USMSTF, the lead author on the recent USMSTF guidance, and associate professor of medicine-gastroenterology at the University of Colorado at Denver, Aurora. “This guidance essentially contradicts these other organizations, and I think from the patient perspective, likely raises a lot of confusion.”

Barbara Jung, MD, AGAF, president of the AGA said in a written statement: “Studies show that colorectal cancer is increasing in younger patients and we have data backing screening for average-risk patients at 45. Bottomline: it saves lives. To release contradictory guidance is reckless.”

Timothy Wilt, MD, MPH, professor of medicine at the University of Minnesota, Minneapolis, and past chair of the guidelines committee at the ACP, said that a key consideration for the ACP was what they considered an “incredibly small” increase in CRC incidence in people under 50 from 2000 to 2019 – from 6.0 per 100,000 to 8.7 per 100,000.

“If I would tell my patients, your chance of colorectal cancer is 6 per 100,000 and now it’s really 9 per 100,000, they would say, ‘No thanks,’ ” he said. “I have trouble getting my patients to take a statin for heart disease when their risk of heart disease in the future is 25%.”

Dr. Patel said that these incidence numbers don’t capture the magnitude of the CRC health burden, because screening historically hadn’t been performed on those under 50. A 2020 study that broke incidence down in single-year increments found a 46% jump from age 49 to age 50, she noted.

“We only diagnose a cancer once we check for it,” she said. The dramatic jump in CRC incidence at age 50 isn’t a sign of new cancer, she said. Rather, these cancers have “been there for years and are cancers that would have been detected between 45 and 49. We just didn’t know about them because patients didn’t get the colonoscopy.”

Data show that 16% of all rectal cancer now occur in patients under 50, she said.

“That is a substantial proportion of all rectal cancers,” she said. “If these trends continue without us doing something about it, that suggests that colon cancer and rectal cancer will be the leading cause of cancer-related death in individuals under the age of 50 by 2030. That’s not that far away.”

Moreover, she said, when the ACP says in its guidance that “the small estimated benefits and harms roughly balance each other out,” it overestimates the risk of CRC screening. The first step, which includes noninvasive options such as a stool-based screen, is no-risk and needs to be followed by a colonoscopy only in a small percentage of cases, she noted. And in recent randomized controlled trials, out of more than 28,000 colonoscopies, there were two perforations, 30 bleeding events, and no deaths.

“I think the ACP statement very much overinflates the risks of screening,” she said.

Dr. Wilt suggested that guidance that flatly recommends that screening should start at age 45 is an overly blunt strategy, not accounting for lower CRC rates among women and varying risk for different races and ethnicities – information that patients should be given in order to make decisions.

“What I would say is, talk to your physicians, ask about the information, make a clinical decision that’s right for you. ... It’s your health,” he said. “We believe our guidance statements are incredibly patient-centered.”

Dr. Patel said that such an approach is not necessarily what patients look for from their physicians.

“I think in theory it’s great to have quote-unquote shared decision-making, and empower the patient to make a decision,” she said. “But generally speaking, patients seek our advice and seek our expertise to synthesize all of this complex data, to provide a recommendation that is driven by those data points.”

The ACP guidance also suggests that “opportunity costs and resources need to be weighed” and that expanding the screening population will take resources away from other medical services.

“We are the front-line docs who have to engage in these conversations,” Dr. Wilt said. “We value our GI and specialty consultants (but) they are not the ones who are there at the front line having to have these discussions.”

Dr. Patel agreed that, with expanded screening, primary care physicians need more support and that “we have a long way to go in providing those support resources.” But she added, “my perspective is that we have to look agnostically at the data.” The data the AGA cites, she added, are peer-reviewed, epidemiological data, not society-generated data.

“I don’t agree with the approach of, even though it’s an additional burden, because we don’t have the resources and time now, to just not proceed,” she said.

“I think our hope would be that practicing physicians – either within the ACP or outside – just have a clear message to patients, that colon cancer is a big deal, it’s increasing in young patients, starting at age 45 you should be screened, and you should use the test that you’re most likely to get done.”
 

In the wake of newly issued guidance by the American College of Physicians, the American Gastroenterological Association is advising clinicians to follow the 2021 colorectal cancer (CRC) screening recommendations from the U.S. Multi-Society Task Force on Colorectal Cancer (MSTF) which recommend that average risk individuals be screened beginning at age 45.

The ACP, in a new guidance, says that “clinicians should consider not screening asymptomatic average-risk adults between the ages of 45 to 49 years. Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”

The guidance is at odds with the recommendations from the task force, which represents the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy. The consensus was that people ages 45 and up should receive CRC screening.

“We’re disappointed that the ACP has suggested to not screen average-risk individuals between the ages of 45 to 49,” said Swati Patel, MD, MS, a member of the USMSTF, the lead author on the recent USMSTF guidance, and associate professor of medicine-gastroenterology at the University of Colorado at Denver, Aurora. “This guidance essentially contradicts these other organizations, and I think from the patient perspective, likely raises a lot of confusion.”

Barbara Jung, MD, AGAF, president of the AGA said in a written statement: “Studies show that colorectal cancer is increasing in younger patients and we have data backing screening for average-risk patients at 45. Bottomline: it saves lives. To release contradictory guidance is reckless.”

Timothy Wilt, MD, MPH, professor of medicine at the University of Minnesota, Minneapolis, and past chair of the guidelines committee at the ACP, said that a key consideration for the ACP was what they considered an “incredibly small” increase in CRC incidence in people under 50 from 2000 to 2019 – from 6.0 per 100,000 to 8.7 per 100,000.

“If I would tell my patients, your chance of colorectal cancer is 6 per 100,000 and now it’s really 9 per 100,000, they would say, ‘No thanks,’ ” he said. “I have trouble getting my patients to take a statin for heart disease when their risk of heart disease in the future is 25%.”

Dr. Patel said that these incidence numbers don’t capture the magnitude of the CRC health burden, because screening historically hadn’t been performed on those under 50. A 2020 study that broke incidence down in single-year increments found a 46% jump from age 49 to age 50, she noted.

“We only diagnose a cancer once we check for it,” she said. The dramatic jump in CRC incidence at age 50 isn’t a sign of new cancer, she said. Rather, these cancers have “been there for years and are cancers that would have been detected between 45 and 49. We just didn’t know about them because patients didn’t get the colonoscopy.”

Data show that 16% of all rectal cancer now occur in patients under 50, she said.

“That is a substantial proportion of all rectal cancers,” she said. “If these trends continue without us doing something about it, that suggests that colon cancer and rectal cancer will be the leading cause of cancer-related death in individuals under the age of 50 by 2030. That’s not that far away.”

Moreover, she said, when the ACP says in its guidance that “the small estimated benefits and harms roughly balance each other out,” it overestimates the risk of CRC screening. The first step, which includes noninvasive options such as a stool-based screen, is no-risk and needs to be followed by a colonoscopy only in a small percentage of cases, she noted. And in recent randomized controlled trials, out of more than 28,000 colonoscopies, there were two perforations, 30 bleeding events, and no deaths.

“I think the ACP statement very much overinflates the risks of screening,” she said.

Dr. Wilt suggested that guidance that flatly recommends that screening should start at age 45 is an overly blunt strategy, not accounting for lower CRC rates among women and varying risk for different races and ethnicities – information that patients should be given in order to make decisions.

“What I would say is, talk to your physicians, ask about the information, make a clinical decision that’s right for you. ... It’s your health,” he said. “We believe our guidance statements are incredibly patient-centered.”

Dr. Patel said that such an approach is not necessarily what patients look for from their physicians.

“I think in theory it’s great to have quote-unquote shared decision-making, and empower the patient to make a decision,” she said. “But generally speaking, patients seek our advice and seek our expertise to synthesize all of this complex data, to provide a recommendation that is driven by those data points.”

The ACP guidance also suggests that “opportunity costs and resources need to be weighed” and that expanding the screening population will take resources away from other medical services.

“We are the front-line docs who have to engage in these conversations,” Dr. Wilt said. “We value our GI and specialty consultants (but) they are not the ones who are there at the front line having to have these discussions.”

Dr. Patel agreed that, with expanded screening, primary care physicians need more support and that “we have a long way to go in providing those support resources.” But she added, “my perspective is that we have to look agnostically at the data.” The data the AGA cites, she added, are peer-reviewed, epidemiological data, not society-generated data.

“I don’t agree with the approach of, even though it’s an additional burden, because we don’t have the resources and time now, to just not proceed,” she said.

“I think our hope would be that practicing physicians – either within the ACP or outside – just have a clear message to patients, that colon cancer is a big deal, it’s increasing in young patients, starting at age 45 you should be screened, and you should use the test that you’re most likely to get done.”
 

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Simpler method of adenoma detection rate might be possible, study suggests

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Mon, 08/14/2023 - 10:44

Using the adenoma detection rate (ADR) for all colonoscopies could be just as good as using the more traditional ADR approach of using only colonoscopies that are performed for screening purposes, a new paper suggests.

The findings, published earlier this year in Gastroenterology, point to a potentially simpler approach to the ADR, an established colonoscopy quality metric that measures the percentage of colonoscopies in which at least one adenoma was found, the researchers said, because of the complexities posed by separating out screening colonoscopies from those for other indications.

“Methods for ascertaining colonoscopy indication include manual review, electronic medical record queries, and text string searches of colonoscopy reports, which are resource-intensive and subject to misclassification,” said the researchers, led by Douglas Corley, MD, PhD, MPH, and Christopher Jensen, PhD, researchers at Kaiser Permanente Northern California. “These barriers have impeded the universal adoption of screening ADR reporting and suggest the need for a simpler, valid alternative to screening ADR.”

The analysis included Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and the University of Texas Southwestern’s Parkland Memorial Hospital – large, demographically diverse, community-based health systems with 45 endoscopy centers and covering about 3% of the U.S. population. The data that were assessed covered 487 endoscopists who performed 1,046,916 cancer-negative colonoscopies from January 2011 to June 2019.

The median overall ADR was 36.3%; the median screening, ADR 29.7%; the diagnostic ADR, 37.1%; and the surveillance ADR, 48.6%.

No matter the colonoscopy indication, the researchers found, ADRs were similarly inversely related to the risk of post-colonoscopy colorectal cancer (PCCRC) rate. For patients of physicians with ADRs of 45% or more, using the group with a less than 25% ADR as the reference group, the risk hazard ratio for the overall ADRs was 0.44, and for the screening ADRs, it was 0.43.

Researchers also found that the quartile of overall ADR had a similar overall predictive ability for PCCRC to the quartile of screening ADR – both with a C-statistic of 0.71.

The overall ADR did just about as well as the screening ADR in identifying physician performance quartile groupings – especially in the case of the lowest quartile. Among the 293 endoscopists who performed colonoscopies in 2017-2018, for instance, 62 of the 73 providers who were in the lowest quartile for screening ADR were also in the lowest quartile for the overall ADR, the researchers found. And there were no providers who differed by more than one quartile.

When considering all quartiles, 69.6% of endoscopists had identical quartile rankings for overall ADR and screening ADR, 29.4% differed by one quartile, and only 1% differed by two quartiles.

The inclination to use screening colonoscopies to compute ADR metrics was intended to promote uniformity in the field, but this might not be the best practice, the researchers suggest.

“Given the large differences in screening ADRs between settings and the potential for indication misclassification, it is not clear that restricting ADR calculations to screening colonoscopies allows for a more ‘apples-to-apples’ comparison across settings than methods that include all colonoscopies,” they said. “The current study found that overall ADR as a quality metric performed similarly to screening ADR for predicting PCCRC and identifying the same providers in the lowest quartile. In addition, it is simpler to calculate, not susceptible to indication misclassification or potential provider-related biases, and more precise because it includes many more colonoscopies.”

In an editorial that was published in Gastroenterology, Jill Tinmouth, MD, PhD, University of Toronto, and Catherine Dubé, MD, University of Ottawa, noted that measuring ADR is valuable only if it improves the quality of colonoscopies.

“Ultimately, this new approach to measuring ADR and identifying underperformance is only valuable if it leads to improvement in colonoscopy quality. The approach proposed by Corley et al. should make it easier for facilities, screening programs, and jurisdictions to measure ADR, and this is an important first step. However, to move the dial on quality, reporting ADR needs to be accompanied by physician uptake of strategies to improve their colonoscopy performance, that is, split-dose bowel preparation, proper insertion and withdrawal techniques ([e.g.], careful cleaning and inspection and turning the patient, when possible), and improved polypectomy skills,” they wrote.

The authors disclosed no conflicts of interest.

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Using the adenoma detection rate (ADR) for all colonoscopies could be just as good as using the more traditional ADR approach of using only colonoscopies that are performed for screening purposes, a new paper suggests.

The findings, published earlier this year in Gastroenterology, point to a potentially simpler approach to the ADR, an established colonoscopy quality metric that measures the percentage of colonoscopies in which at least one adenoma was found, the researchers said, because of the complexities posed by separating out screening colonoscopies from those for other indications.

“Methods for ascertaining colonoscopy indication include manual review, electronic medical record queries, and text string searches of colonoscopy reports, which are resource-intensive and subject to misclassification,” said the researchers, led by Douglas Corley, MD, PhD, MPH, and Christopher Jensen, PhD, researchers at Kaiser Permanente Northern California. “These barriers have impeded the universal adoption of screening ADR reporting and suggest the need for a simpler, valid alternative to screening ADR.”

The analysis included Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and the University of Texas Southwestern’s Parkland Memorial Hospital – large, demographically diverse, community-based health systems with 45 endoscopy centers and covering about 3% of the U.S. population. The data that were assessed covered 487 endoscopists who performed 1,046,916 cancer-negative colonoscopies from January 2011 to June 2019.

The median overall ADR was 36.3%; the median screening, ADR 29.7%; the diagnostic ADR, 37.1%; and the surveillance ADR, 48.6%.

No matter the colonoscopy indication, the researchers found, ADRs were similarly inversely related to the risk of post-colonoscopy colorectal cancer (PCCRC) rate. For patients of physicians with ADRs of 45% or more, using the group with a less than 25% ADR as the reference group, the risk hazard ratio for the overall ADRs was 0.44, and for the screening ADRs, it was 0.43.

Researchers also found that the quartile of overall ADR had a similar overall predictive ability for PCCRC to the quartile of screening ADR – both with a C-statistic of 0.71.

The overall ADR did just about as well as the screening ADR in identifying physician performance quartile groupings – especially in the case of the lowest quartile. Among the 293 endoscopists who performed colonoscopies in 2017-2018, for instance, 62 of the 73 providers who were in the lowest quartile for screening ADR were also in the lowest quartile for the overall ADR, the researchers found. And there were no providers who differed by more than one quartile.

When considering all quartiles, 69.6% of endoscopists had identical quartile rankings for overall ADR and screening ADR, 29.4% differed by one quartile, and only 1% differed by two quartiles.

The inclination to use screening colonoscopies to compute ADR metrics was intended to promote uniformity in the field, but this might not be the best practice, the researchers suggest.

“Given the large differences in screening ADRs between settings and the potential for indication misclassification, it is not clear that restricting ADR calculations to screening colonoscopies allows for a more ‘apples-to-apples’ comparison across settings than methods that include all colonoscopies,” they said. “The current study found that overall ADR as a quality metric performed similarly to screening ADR for predicting PCCRC and identifying the same providers in the lowest quartile. In addition, it is simpler to calculate, not susceptible to indication misclassification or potential provider-related biases, and more precise because it includes many more colonoscopies.”

In an editorial that was published in Gastroenterology, Jill Tinmouth, MD, PhD, University of Toronto, and Catherine Dubé, MD, University of Ottawa, noted that measuring ADR is valuable only if it improves the quality of colonoscopies.

“Ultimately, this new approach to measuring ADR and identifying underperformance is only valuable if it leads to improvement in colonoscopy quality. The approach proposed by Corley et al. should make it easier for facilities, screening programs, and jurisdictions to measure ADR, and this is an important first step. However, to move the dial on quality, reporting ADR needs to be accompanied by physician uptake of strategies to improve their colonoscopy performance, that is, split-dose bowel preparation, proper insertion and withdrawal techniques ([e.g.], careful cleaning and inspection and turning the patient, when possible), and improved polypectomy skills,” they wrote.

The authors disclosed no conflicts of interest.

Using the adenoma detection rate (ADR) for all colonoscopies could be just as good as using the more traditional ADR approach of using only colonoscopies that are performed for screening purposes, a new paper suggests.

The findings, published earlier this year in Gastroenterology, point to a potentially simpler approach to the ADR, an established colonoscopy quality metric that measures the percentage of colonoscopies in which at least one adenoma was found, the researchers said, because of the complexities posed by separating out screening colonoscopies from those for other indications.

“Methods for ascertaining colonoscopy indication include manual review, electronic medical record queries, and text string searches of colonoscopy reports, which are resource-intensive and subject to misclassification,” said the researchers, led by Douglas Corley, MD, PhD, MPH, and Christopher Jensen, PhD, researchers at Kaiser Permanente Northern California. “These barriers have impeded the universal adoption of screening ADR reporting and suggest the need for a simpler, valid alternative to screening ADR.”

The analysis included Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and the University of Texas Southwestern’s Parkland Memorial Hospital – large, demographically diverse, community-based health systems with 45 endoscopy centers and covering about 3% of the U.S. population. The data that were assessed covered 487 endoscopists who performed 1,046,916 cancer-negative colonoscopies from January 2011 to June 2019.

The median overall ADR was 36.3%; the median screening, ADR 29.7%; the diagnostic ADR, 37.1%; and the surveillance ADR, 48.6%.

No matter the colonoscopy indication, the researchers found, ADRs were similarly inversely related to the risk of post-colonoscopy colorectal cancer (PCCRC) rate. For patients of physicians with ADRs of 45% or more, using the group with a less than 25% ADR as the reference group, the risk hazard ratio for the overall ADRs was 0.44, and for the screening ADRs, it was 0.43.

Researchers also found that the quartile of overall ADR had a similar overall predictive ability for PCCRC to the quartile of screening ADR – both with a C-statistic of 0.71.

The overall ADR did just about as well as the screening ADR in identifying physician performance quartile groupings – especially in the case of the lowest quartile. Among the 293 endoscopists who performed colonoscopies in 2017-2018, for instance, 62 of the 73 providers who were in the lowest quartile for screening ADR were also in the lowest quartile for the overall ADR, the researchers found. And there were no providers who differed by more than one quartile.

When considering all quartiles, 69.6% of endoscopists had identical quartile rankings for overall ADR and screening ADR, 29.4% differed by one quartile, and only 1% differed by two quartiles.

The inclination to use screening colonoscopies to compute ADR metrics was intended to promote uniformity in the field, but this might not be the best practice, the researchers suggest.

“Given the large differences in screening ADRs between settings and the potential for indication misclassification, it is not clear that restricting ADR calculations to screening colonoscopies allows for a more ‘apples-to-apples’ comparison across settings than methods that include all colonoscopies,” they said. “The current study found that overall ADR as a quality metric performed similarly to screening ADR for predicting PCCRC and identifying the same providers in the lowest quartile. In addition, it is simpler to calculate, not susceptible to indication misclassification or potential provider-related biases, and more precise because it includes many more colonoscopies.”

In an editorial that was published in Gastroenterology, Jill Tinmouth, MD, PhD, University of Toronto, and Catherine Dubé, MD, University of Ottawa, noted that measuring ADR is valuable only if it improves the quality of colonoscopies.

“Ultimately, this new approach to measuring ADR and identifying underperformance is only valuable if it leads to improvement in colonoscopy quality. The approach proposed by Corley et al. should make it easier for facilities, screening programs, and jurisdictions to measure ADR, and this is an important first step. However, to move the dial on quality, reporting ADR needs to be accompanied by physician uptake of strategies to improve their colonoscopy performance, that is, split-dose bowel preparation, proper insertion and withdrawal techniques ([e.g.], careful cleaning and inspection and turning the patient, when possible), and improved polypectomy skills,” they wrote.

The authors disclosed no conflicts of interest.

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