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‘Stunning variation’ in CV test, procedure costs revealed at top U.S. hospitals

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Changed
Wed, 07/27/2022 - 08:37

 

Wide variation in the cost of common cardiovascular (CV) tests and procedures, from stress tests to coronary interventions, was revealed in a cross-sectional analysis based on publicly available data from 20 top-ranked hospitals in the United States.

The analysis also suggested a low level of compliance with the 2021 Hospital Price Transparency Final Rule among the 20 centers.

“The variation we found in payer-negotiated prices for identical cardiovascular tests and procedures was stunning,” Rishi K. Wadhera, MD, MPP, MPhil, Beth Israel Deaconess Medical Center, Boston, told this news organization.

KatarzynaBialasiewicz/Thinkstock


“For example, there was a 10-fold difference in the median price of an echocardiogram, and these differences were even larger for common procedures” such as percutaneous coronary intervention (PCI) and pacemaker implantation, he said. “It’s hard to argue that this variation reflects quality of care, given that we looked at a top group of highly ranked hospitals.”

“Even more striking was how the price of a cardiovascular test within the very same hospital could differ across commercial insurance companies,” he said. “For example, the price of a stress test varied 5-fold in one hospital, and in another hospital, more than 4-fold for a coronary angiogram.”

Dr. Wadhera is senior author on the study published online as a research letter in JAMA Internal Medicine, with lead author Andrew S. Oseran, MD, MBA, also from Beth Israel Deaconess Medical Center.
 

Difficulties with data, interpretation

The researchers looked at payer and self-pay cash prices for noninvasive and invasive CV tests and procedures at the U.S. News & World Report 2021 top 20–ranked U.S. hospitals, based in part on Current Procedural Terminology codes.

Price differences among the hospitals were derived from median negotiated prices for each test and procedure at the centers across all payers. The interquartile ratio (IQR) of prices for each test or procedure across payers was used to evaluate within-hospital price variation.

“Only 80% of the hospitals reported prices for some cardiovascular tests and procedures,” Dr. Wadhera said. “For the most part, even among the hospitals that did report this information, it was extremely challenging to navigate and interpret the data provided.”

Further, the team found that only 7 of the 20 hospitals reported prices for all CV tests and procedures. Centers that did not post prices for some tests or procedures are named in the report’s Figure 1 and Figure 2.

The number of insurance plans listed for each test or procedure ranged from 1 to 432 in the analysis. Median prices ranged from $204 to $2,588 for an echocardiogram, $463 to $3,230 for a stress test, $2,821 to $9,382 for right heart catheterization, $2,868 to $9,203 for a coronary angiogram, $657 to $25,521 for a PCI, and $506 to $20,002 for pacemaker implantation, the report states.

A similar pattern was seen for self-pay cash prices.

Within-hospital variation also ranged broadly. For example, the widest IQR ranges were $3,143-$12,926 for a right heart catheterization, $4,011-$14,486 for a coronary angiogram, $11,325-$23,392 for a PCI, and $8,474-$22,694 for pacemaker implantation.

The report cites a number of limitations to the analysis, among those, the need to rely on the hospitals themselves for data quality and accuracy.
 

‘More needed besides transparency’

“As a means to better understand health care costs, many opined that full price transparency would leverage market dynamics and result in lower costs,” observed Clyde W. Yancy, MD, MSc, professor of medicine and chief of cardiology at Northwestern Medicine, Chicago. The findings “by an expert group of outcomes scientists make clear that more is needed besides price transparency to lower cost,” he said in an interview.

That said, he added, “there are sufficient variations and allowances made for data collection that it is preferable to hold the current findings circumspect at best. Importantly, the voice of the hospitals does not appear.”

Although “price variation among the top 20 hospitals is substantial,” he observed, “without a better assessment of root cause, actual charge capture, prevailing market dynamics – especially nursing and ancillary staff costs – and the general influence of inflation, it is too difficult to emerge with a precise interpretation.”

Across the 20 hospitals, “there are likely to be 20 different business models,” he added, with negotiated prices reflecting “at least regional, if not institutional, variations.”

“These are complex issues. The several-fold price differences in standard procedures are a concern and an area worth further study with the intention of lowering health care costs,” Dr. Yancy said. “But clearly our next efforts should not address lowering prices per se but understanding how prices are set [and] the connection with reimbursement and actual payments.”

Dr. Wadhera discloses receiving personal fees from Abbott and CVS Health unrelated to the current study; disclosures for the other authors are in the report. Dr. Yancy is deputy editor of JAMA Cardiology.

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

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Wide variation in the cost of common cardiovascular (CV) tests and procedures, from stress tests to coronary interventions, was revealed in a cross-sectional analysis based on publicly available data from 20 top-ranked hospitals in the United States.

The analysis also suggested a low level of compliance with the 2021 Hospital Price Transparency Final Rule among the 20 centers.

“The variation we found in payer-negotiated prices for identical cardiovascular tests and procedures was stunning,” Rishi K. Wadhera, MD, MPP, MPhil, Beth Israel Deaconess Medical Center, Boston, told this news organization.

KatarzynaBialasiewicz/Thinkstock


“For example, there was a 10-fold difference in the median price of an echocardiogram, and these differences were even larger for common procedures” such as percutaneous coronary intervention (PCI) and pacemaker implantation, he said. “It’s hard to argue that this variation reflects quality of care, given that we looked at a top group of highly ranked hospitals.”

“Even more striking was how the price of a cardiovascular test within the very same hospital could differ across commercial insurance companies,” he said. “For example, the price of a stress test varied 5-fold in one hospital, and in another hospital, more than 4-fold for a coronary angiogram.”

Dr. Wadhera is senior author on the study published online as a research letter in JAMA Internal Medicine, with lead author Andrew S. Oseran, MD, MBA, also from Beth Israel Deaconess Medical Center.
 

Difficulties with data, interpretation

The researchers looked at payer and self-pay cash prices for noninvasive and invasive CV tests and procedures at the U.S. News & World Report 2021 top 20–ranked U.S. hospitals, based in part on Current Procedural Terminology codes.

Price differences among the hospitals were derived from median negotiated prices for each test and procedure at the centers across all payers. The interquartile ratio (IQR) of prices for each test or procedure across payers was used to evaluate within-hospital price variation.

“Only 80% of the hospitals reported prices for some cardiovascular tests and procedures,” Dr. Wadhera said. “For the most part, even among the hospitals that did report this information, it was extremely challenging to navigate and interpret the data provided.”

Further, the team found that only 7 of the 20 hospitals reported prices for all CV tests and procedures. Centers that did not post prices for some tests or procedures are named in the report’s Figure 1 and Figure 2.

The number of insurance plans listed for each test or procedure ranged from 1 to 432 in the analysis. Median prices ranged from $204 to $2,588 for an echocardiogram, $463 to $3,230 for a stress test, $2,821 to $9,382 for right heart catheterization, $2,868 to $9,203 for a coronary angiogram, $657 to $25,521 for a PCI, and $506 to $20,002 for pacemaker implantation, the report states.

A similar pattern was seen for self-pay cash prices.

Within-hospital variation also ranged broadly. For example, the widest IQR ranges were $3,143-$12,926 for a right heart catheterization, $4,011-$14,486 for a coronary angiogram, $11,325-$23,392 for a PCI, and $8,474-$22,694 for pacemaker implantation.

The report cites a number of limitations to the analysis, among those, the need to rely on the hospitals themselves for data quality and accuracy.
 

‘More needed besides transparency’

“As a means to better understand health care costs, many opined that full price transparency would leverage market dynamics and result in lower costs,” observed Clyde W. Yancy, MD, MSc, professor of medicine and chief of cardiology at Northwestern Medicine, Chicago. The findings “by an expert group of outcomes scientists make clear that more is needed besides price transparency to lower cost,” he said in an interview.

That said, he added, “there are sufficient variations and allowances made for data collection that it is preferable to hold the current findings circumspect at best. Importantly, the voice of the hospitals does not appear.”

Although “price variation among the top 20 hospitals is substantial,” he observed, “without a better assessment of root cause, actual charge capture, prevailing market dynamics – especially nursing and ancillary staff costs – and the general influence of inflation, it is too difficult to emerge with a precise interpretation.”

Across the 20 hospitals, “there are likely to be 20 different business models,” he added, with negotiated prices reflecting “at least regional, if not institutional, variations.”

“These are complex issues. The several-fold price differences in standard procedures are a concern and an area worth further study with the intention of lowering health care costs,” Dr. Yancy said. “But clearly our next efforts should not address lowering prices per se but understanding how prices are set [and] the connection with reimbursement and actual payments.”

Dr. Wadhera discloses receiving personal fees from Abbott and CVS Health unrelated to the current study; disclosures for the other authors are in the report. Dr. Yancy is deputy editor of JAMA Cardiology.

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

 

Wide variation in the cost of common cardiovascular (CV) tests and procedures, from stress tests to coronary interventions, was revealed in a cross-sectional analysis based on publicly available data from 20 top-ranked hospitals in the United States.

The analysis also suggested a low level of compliance with the 2021 Hospital Price Transparency Final Rule among the 20 centers.

“The variation we found in payer-negotiated prices for identical cardiovascular tests and procedures was stunning,” Rishi K. Wadhera, MD, MPP, MPhil, Beth Israel Deaconess Medical Center, Boston, told this news organization.

KatarzynaBialasiewicz/Thinkstock


“For example, there was a 10-fold difference in the median price of an echocardiogram, and these differences were even larger for common procedures” such as percutaneous coronary intervention (PCI) and pacemaker implantation, he said. “It’s hard to argue that this variation reflects quality of care, given that we looked at a top group of highly ranked hospitals.”

“Even more striking was how the price of a cardiovascular test within the very same hospital could differ across commercial insurance companies,” he said. “For example, the price of a stress test varied 5-fold in one hospital, and in another hospital, more than 4-fold for a coronary angiogram.”

Dr. Wadhera is senior author on the study published online as a research letter in JAMA Internal Medicine, with lead author Andrew S. Oseran, MD, MBA, also from Beth Israel Deaconess Medical Center.
 

Difficulties with data, interpretation

The researchers looked at payer and self-pay cash prices for noninvasive and invasive CV tests and procedures at the U.S. News & World Report 2021 top 20–ranked U.S. hospitals, based in part on Current Procedural Terminology codes.

Price differences among the hospitals were derived from median negotiated prices for each test and procedure at the centers across all payers. The interquartile ratio (IQR) of prices for each test or procedure across payers was used to evaluate within-hospital price variation.

“Only 80% of the hospitals reported prices for some cardiovascular tests and procedures,” Dr. Wadhera said. “For the most part, even among the hospitals that did report this information, it was extremely challenging to navigate and interpret the data provided.”

Further, the team found that only 7 of the 20 hospitals reported prices for all CV tests and procedures. Centers that did not post prices for some tests or procedures are named in the report’s Figure 1 and Figure 2.

The number of insurance plans listed for each test or procedure ranged from 1 to 432 in the analysis. Median prices ranged from $204 to $2,588 for an echocardiogram, $463 to $3,230 for a stress test, $2,821 to $9,382 for right heart catheterization, $2,868 to $9,203 for a coronary angiogram, $657 to $25,521 for a PCI, and $506 to $20,002 for pacemaker implantation, the report states.

A similar pattern was seen for self-pay cash prices.

Within-hospital variation also ranged broadly. For example, the widest IQR ranges were $3,143-$12,926 for a right heart catheterization, $4,011-$14,486 for a coronary angiogram, $11,325-$23,392 for a PCI, and $8,474-$22,694 for pacemaker implantation.

The report cites a number of limitations to the analysis, among those, the need to rely on the hospitals themselves for data quality and accuracy.
 

‘More needed besides transparency’

“As a means to better understand health care costs, many opined that full price transparency would leverage market dynamics and result in lower costs,” observed Clyde W. Yancy, MD, MSc, professor of medicine and chief of cardiology at Northwestern Medicine, Chicago. The findings “by an expert group of outcomes scientists make clear that more is needed besides price transparency to lower cost,” he said in an interview.

That said, he added, “there are sufficient variations and allowances made for data collection that it is preferable to hold the current findings circumspect at best. Importantly, the voice of the hospitals does not appear.”

Although “price variation among the top 20 hospitals is substantial,” he observed, “without a better assessment of root cause, actual charge capture, prevailing market dynamics – especially nursing and ancillary staff costs – and the general influence of inflation, it is too difficult to emerge with a precise interpretation.”

Across the 20 hospitals, “there are likely to be 20 different business models,” he added, with negotiated prices reflecting “at least regional, if not institutional, variations.”

“These are complex issues. The several-fold price differences in standard procedures are a concern and an area worth further study with the intention of lowering health care costs,” Dr. Yancy said. “But clearly our next efforts should not address lowering prices per se but understanding how prices are set [and] the connection with reimbursement and actual payments.”

Dr. Wadhera discloses receiving personal fees from Abbott and CVS Health unrelated to the current study; disclosures for the other authors are in the report. Dr. Yancy is deputy editor of JAMA Cardiology.

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

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Study pinpoints best predictor of when reflux symptoms don’t require PPI

Article Type
Changed
Wed, 07/27/2022 - 10:17

Four days is an optimal time for wireless reflux monitoring to determine which patients can stop taking proton pump inhibitors (PPIs) and which ones need long-term antireflux therapy, researchers report.

“This first-of-its kind double-blinded clinical trial demonstrates the comparable, and in some cases better, performance of a simple assessment of daily acid exposure from multiple days of recording compared to other composite or complex assessments,” write Rena Yadlapati, MD, with the Division of Gastroenterology at the University of California, San Diego, and her coauthors.

Their findings were published online in the American Journal of Gastroenterology.

A substantial percentage of patients who have esophageal reflux symptoms do not have gastroesophageal reflux disease (GERD) and can stop taking PPIs.

Wireless reflux monitoring performed while patients are not taking PPIs is the gold standard for determining whether a patient has abnormal acid from GERD, but the optimal daily acid exposure time (AET) and the optimal duration of monitoring have not been well studied.

Aiming to fill this knowledge gap, Dr. Yadlapati and her colleagues conducted a single-arm, double-blinded clinical trial over 4 years at two tertiary care centers. They enrolled adult patients who had demonstrated an inadequate response to more than 8 weeks’ treatment with PPIs.

Study participants were asked to stop taking their PPI for 3 weeks in order for the investigators to determine the rate of relapse after PPI use and establish the study reference standard to discontinue therapy. During the 3-week period, after having stopped taking PPIs for at least a week, patients underwent 96-hour wireless reflux monitoring. They were then told to continue not taking PPIs for an additional 2 weeks. They could use over-the-counter antacids for symptom relief.

The primary outcome was whether PPIs could be successfully discontinued or restarted within 3 weeks. Of the 132 patients, 30% were able to stop taking PPIs.
 

AET less than 4.0% best discontinuation predictor

The team came to two key conclusions.

They found that acid exposure time of less than 4.0% was the best predictor of when stopping PPIs will be effective without worsening symptoms (odds ratio, 2.9; 95% confidence interval, 1.4-6.4). Comparatively, 45% (22 of 49 patients) with total AET of 4.0% or less discontinued taking PPIs, versus 22% (18 of 83 patients) with total AET of more than 4.0%.

Additionally, the investigators concluded that 96 hours of monitoring was better than 48 hours or fewer in predicting whether patients could stop taking PPIs (area under curve [AUC] for 96 hours, 0.63, versus AUC for 48 hours, 0.57).

Dr. Yadlapati told this news organization that the findings should be practice-changing.

“You really need to test for 4 days,” she said. She noted that the battery life of the monitor is 96 hours, and clinicians commonly only test for 2 days.

With only 1-2 days of monitoring, there is too much variability in how much acid is in the esophagus from one day to another. Monitoring over a 4-day period gives a clearer picture of acid exposure burden, she said.

Her advice: “If you have a patient with heartburn or chest pain and you think it might be from reflux, and they’re not responding to a trial of PPI, get the reflux monitoring. Don’t wait.”

After 4 days of monitoring, if exposure to acid is low, “they should really be taken off their PPI therapy,” she said.

They likely have a condition that requires a different therapy, she added.

“It is very consistent with what we have thought to be the case and what some lower-quality studies have shown,” she said. “It just hadn’t been done in a clinical trial with a large patient population and with a full outcome.”
 

 

 

PPI often used inappropriately

Interest is high both in discontinuing PPI in light of widespread and often inappropriate use and in not starting treatment with PPIs for patients who need a different therapy.

As this news organization has reported, some studies have linked long-term PPI use with intestinal infections, pneumonia, stomach cancer, osteoporosis-related bone fractures, chronic kidney disease, vitamin deficiencies, heart attacks, strokes, dementia, and early death.

Avin Aggarwal, MD, a gastroenterologist and medical director of Banner Health’s South Campus endoscopy services and clinical assistant professor at the University of Arizona, Tucson, said in an interview that this study provides the evidence needed to push for practice change.

He said his center has been using 48-hour reflux monitoring. He said that anecdotally, they had gotten better data with 4-day monitoring, but evidence was not directly tied to a measurable outcome such as this study provides.

With 4-day monitoring, “we get way more symptoms on the recorder to actually correlate them with reflux or not,” he said.

He said he will now push for the 96-hour monitoring in his clinic.

He added that part of the problem is in assuming patients have GERD and initiating PPIs in the first place without a specific diagnosis of acid reflux.

Patients, he said, are often aware of the long-term side effects of PPIs and are approaching their physicians to see whether they can discontinue them.

The data from this study, he said, will help guide physicians on when it is appropriate to discontinue treatment.

Dr. Yadlapati is a consultant for Medtronic, Phathom Pharmaceuticals, and StatLinkMD and receives research support from Ironwood Pharmaceuticals. She is on the advisory board with stock options for RJS Mediagnostix. Other study coauthors report ties to Medtronic, Diversatek, Ironwood, Iso-Thrive, Quintiles, Johnson & Johnson, Reckitt, Phathom Pharmaceuticals, Daewood, Takeda, and Crospon. Study coauthor Michael F. Vaezi, MD, PHD, holds a patent on mucosal integrity by Vanderbilt. Dr. Aggarwal reports no relevant financial relationships.

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

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Four days is an optimal time for wireless reflux monitoring to determine which patients can stop taking proton pump inhibitors (PPIs) and which ones need long-term antireflux therapy, researchers report.

“This first-of-its kind double-blinded clinical trial demonstrates the comparable, and in some cases better, performance of a simple assessment of daily acid exposure from multiple days of recording compared to other composite or complex assessments,” write Rena Yadlapati, MD, with the Division of Gastroenterology at the University of California, San Diego, and her coauthors.

Their findings were published online in the American Journal of Gastroenterology.

A substantial percentage of patients who have esophageal reflux symptoms do not have gastroesophageal reflux disease (GERD) and can stop taking PPIs.

Wireless reflux monitoring performed while patients are not taking PPIs is the gold standard for determining whether a patient has abnormal acid from GERD, but the optimal daily acid exposure time (AET) and the optimal duration of monitoring have not been well studied.

Aiming to fill this knowledge gap, Dr. Yadlapati and her colleagues conducted a single-arm, double-blinded clinical trial over 4 years at two tertiary care centers. They enrolled adult patients who had demonstrated an inadequate response to more than 8 weeks’ treatment with PPIs.

Study participants were asked to stop taking their PPI for 3 weeks in order for the investigators to determine the rate of relapse after PPI use and establish the study reference standard to discontinue therapy. During the 3-week period, after having stopped taking PPIs for at least a week, patients underwent 96-hour wireless reflux monitoring. They were then told to continue not taking PPIs for an additional 2 weeks. They could use over-the-counter antacids for symptom relief.

The primary outcome was whether PPIs could be successfully discontinued or restarted within 3 weeks. Of the 132 patients, 30% were able to stop taking PPIs.
 

AET less than 4.0% best discontinuation predictor

The team came to two key conclusions.

They found that acid exposure time of less than 4.0% was the best predictor of when stopping PPIs will be effective without worsening symptoms (odds ratio, 2.9; 95% confidence interval, 1.4-6.4). Comparatively, 45% (22 of 49 patients) with total AET of 4.0% or less discontinued taking PPIs, versus 22% (18 of 83 patients) with total AET of more than 4.0%.

Additionally, the investigators concluded that 96 hours of monitoring was better than 48 hours or fewer in predicting whether patients could stop taking PPIs (area under curve [AUC] for 96 hours, 0.63, versus AUC for 48 hours, 0.57).

Dr. Yadlapati told this news organization that the findings should be practice-changing.

“You really need to test for 4 days,” she said. She noted that the battery life of the monitor is 96 hours, and clinicians commonly only test for 2 days.

With only 1-2 days of monitoring, there is too much variability in how much acid is in the esophagus from one day to another. Monitoring over a 4-day period gives a clearer picture of acid exposure burden, she said.

Her advice: “If you have a patient with heartburn or chest pain and you think it might be from reflux, and they’re not responding to a trial of PPI, get the reflux monitoring. Don’t wait.”

After 4 days of monitoring, if exposure to acid is low, “they should really be taken off their PPI therapy,” she said.

They likely have a condition that requires a different therapy, she added.

“It is very consistent with what we have thought to be the case and what some lower-quality studies have shown,” she said. “It just hadn’t been done in a clinical trial with a large patient population and with a full outcome.”
 

 

 

PPI often used inappropriately

Interest is high both in discontinuing PPI in light of widespread and often inappropriate use and in not starting treatment with PPIs for patients who need a different therapy.

As this news organization has reported, some studies have linked long-term PPI use with intestinal infections, pneumonia, stomach cancer, osteoporosis-related bone fractures, chronic kidney disease, vitamin deficiencies, heart attacks, strokes, dementia, and early death.

Avin Aggarwal, MD, a gastroenterologist and medical director of Banner Health’s South Campus endoscopy services and clinical assistant professor at the University of Arizona, Tucson, said in an interview that this study provides the evidence needed to push for practice change.

He said his center has been using 48-hour reflux monitoring. He said that anecdotally, they had gotten better data with 4-day monitoring, but evidence was not directly tied to a measurable outcome such as this study provides.

With 4-day monitoring, “we get way more symptoms on the recorder to actually correlate them with reflux or not,” he said.

He said he will now push for the 96-hour monitoring in his clinic.

He added that part of the problem is in assuming patients have GERD and initiating PPIs in the first place without a specific diagnosis of acid reflux.

Patients, he said, are often aware of the long-term side effects of PPIs and are approaching their physicians to see whether they can discontinue them.

The data from this study, he said, will help guide physicians on when it is appropriate to discontinue treatment.

Dr. Yadlapati is a consultant for Medtronic, Phathom Pharmaceuticals, and StatLinkMD and receives research support from Ironwood Pharmaceuticals. She is on the advisory board with stock options for RJS Mediagnostix. Other study coauthors report ties to Medtronic, Diversatek, Ironwood, Iso-Thrive, Quintiles, Johnson & Johnson, Reckitt, Phathom Pharmaceuticals, Daewood, Takeda, and Crospon. Study coauthor Michael F. Vaezi, MD, PHD, holds a patent on mucosal integrity by Vanderbilt. Dr. Aggarwal reports no relevant financial relationships.

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

Four days is an optimal time for wireless reflux monitoring to determine which patients can stop taking proton pump inhibitors (PPIs) and which ones need long-term antireflux therapy, researchers report.

“This first-of-its kind double-blinded clinical trial demonstrates the comparable, and in some cases better, performance of a simple assessment of daily acid exposure from multiple days of recording compared to other composite or complex assessments,” write Rena Yadlapati, MD, with the Division of Gastroenterology at the University of California, San Diego, and her coauthors.

Their findings were published online in the American Journal of Gastroenterology.

A substantial percentage of patients who have esophageal reflux symptoms do not have gastroesophageal reflux disease (GERD) and can stop taking PPIs.

Wireless reflux monitoring performed while patients are not taking PPIs is the gold standard for determining whether a patient has abnormal acid from GERD, but the optimal daily acid exposure time (AET) and the optimal duration of monitoring have not been well studied.

Aiming to fill this knowledge gap, Dr. Yadlapati and her colleagues conducted a single-arm, double-blinded clinical trial over 4 years at two tertiary care centers. They enrolled adult patients who had demonstrated an inadequate response to more than 8 weeks’ treatment with PPIs.

Study participants were asked to stop taking their PPI for 3 weeks in order for the investigators to determine the rate of relapse after PPI use and establish the study reference standard to discontinue therapy. During the 3-week period, after having stopped taking PPIs for at least a week, patients underwent 96-hour wireless reflux monitoring. They were then told to continue not taking PPIs for an additional 2 weeks. They could use over-the-counter antacids for symptom relief.

The primary outcome was whether PPIs could be successfully discontinued or restarted within 3 weeks. Of the 132 patients, 30% were able to stop taking PPIs.
 

AET less than 4.0% best discontinuation predictor

The team came to two key conclusions.

They found that acid exposure time of less than 4.0% was the best predictor of when stopping PPIs will be effective without worsening symptoms (odds ratio, 2.9; 95% confidence interval, 1.4-6.4). Comparatively, 45% (22 of 49 patients) with total AET of 4.0% or less discontinued taking PPIs, versus 22% (18 of 83 patients) with total AET of more than 4.0%.

Additionally, the investigators concluded that 96 hours of monitoring was better than 48 hours or fewer in predicting whether patients could stop taking PPIs (area under curve [AUC] for 96 hours, 0.63, versus AUC for 48 hours, 0.57).

Dr. Yadlapati told this news organization that the findings should be practice-changing.

“You really need to test for 4 days,” she said. She noted that the battery life of the monitor is 96 hours, and clinicians commonly only test for 2 days.

With only 1-2 days of monitoring, there is too much variability in how much acid is in the esophagus from one day to another. Monitoring over a 4-day period gives a clearer picture of acid exposure burden, she said.

Her advice: “If you have a patient with heartburn or chest pain and you think it might be from reflux, and they’re not responding to a trial of PPI, get the reflux monitoring. Don’t wait.”

After 4 days of monitoring, if exposure to acid is low, “they should really be taken off their PPI therapy,” she said.

They likely have a condition that requires a different therapy, she added.

“It is very consistent with what we have thought to be the case and what some lower-quality studies have shown,” she said. “It just hadn’t been done in a clinical trial with a large patient population and with a full outcome.”
 

 

 

PPI often used inappropriately

Interest is high both in discontinuing PPI in light of widespread and often inappropriate use and in not starting treatment with PPIs for patients who need a different therapy.

As this news organization has reported, some studies have linked long-term PPI use with intestinal infections, pneumonia, stomach cancer, osteoporosis-related bone fractures, chronic kidney disease, vitamin deficiencies, heart attacks, strokes, dementia, and early death.

Avin Aggarwal, MD, a gastroenterologist and medical director of Banner Health’s South Campus endoscopy services and clinical assistant professor at the University of Arizona, Tucson, said in an interview that this study provides the evidence needed to push for practice change.

He said his center has been using 48-hour reflux monitoring. He said that anecdotally, they had gotten better data with 4-day monitoring, but evidence was not directly tied to a measurable outcome such as this study provides.

With 4-day monitoring, “we get way more symptoms on the recorder to actually correlate them with reflux or not,” he said.

He said he will now push for the 96-hour monitoring in his clinic.

He added that part of the problem is in assuming patients have GERD and initiating PPIs in the first place without a specific diagnosis of acid reflux.

Patients, he said, are often aware of the long-term side effects of PPIs and are approaching their physicians to see whether they can discontinue them.

The data from this study, he said, will help guide physicians on when it is appropriate to discontinue treatment.

Dr. Yadlapati is a consultant for Medtronic, Phathom Pharmaceuticals, and StatLinkMD and receives research support from Ironwood Pharmaceuticals. She is on the advisory board with stock options for RJS Mediagnostix. Other study coauthors report ties to Medtronic, Diversatek, Ironwood, Iso-Thrive, Quintiles, Johnson & Johnson, Reckitt, Phathom Pharmaceuticals, Daewood, Takeda, and Crospon. Study coauthor Michael F. Vaezi, MD, PHD, holds a patent on mucosal integrity by Vanderbilt. Dr. Aggarwal reports no relevant financial relationships.

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

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Cue new mothers: Breastfeed infants – but for how long?

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Tue, 07/26/2022 - 10:31

How long should mothers breastfeed their babies?

The controversial question has cropped up again after the nation’s leading pediatrics group has issued new recommendations calling for women to breastfeed until their children turn 2, and possibly even longer.

The policy statement, Breastfeeding and the Use of Human Milk, was released on June 27 by the American Academy of Pediatrics. It calls out stigma, lack of support, and workplace barriers that make continued breastfeeding difficult for many mothers.

But the new policy statement isn’t going down smoothly with the Fed Is Best Foundation, a nonprofit group hoping to “debunk and sort out for the public” many of the proclamations in the AAP’s policies, said Christie del Castillo-Hegyi, MD, cofounder of the group and emergency physician at CHI St. Vincent, Little Rock, Ark.

The goal of Fed Is Best is to assist families and health care professionals with current research on the safe feeding of infants – whether with breast milk, formula, or a combination.

The AAP’s previous guidelines, issued in 2012, called for infants to be fed breast milk exclusively for their first 6 months. Continued breastfeeding was recommended while introducing complementary foods for a period of 1 year or longer, the policy stated. The updated policy extends the optimum time line for breastfeeding to up to 2 years, citing the health benefits for babies.
 

‘Tone deaf and one-sided’

The AAP policy is “tone deaf and one-sided to the 75% of the U.S. mothers who use formula either by necessity or choice,” Dr. del Castillo-Hegyi told this news organization.

She pointed to a long list of factors that could affect the health outcomes of infants with regard to breastfeeding versus formula-feeding. These include socioeconomic status, baseline maternal health and education, maternal genetics, and the effects of developing feeding complications from exclusive breastfeeding for infants whose mothers can’t produce enough milk. These issues can contribute to negative health outcomes and brain development in infants who go on to be formula fed, she said.

She also objected to the fact that the guidelines make little reference to a mother who needs to supplement breast milk with formula within 4 months – and even before that – to meet her infant’s nutritional requirements.

Mothers need to hear “that making sure their infant is adequately fed is the most important goal of any infant feeding recommendation,” Dr. del Castillo-Hegyi said. She noted that the AAP’s rigid guidelines may be impossible for many mothers to follow.

“The pressure to meet [the AAP’s] exceedingly high expectations is causing harm to mothers and babies,” she said, referring to earlier guidelines that contained similar suggestions.

If a mother’s milk is insufficient, babies are at risk for low growth rates, jaundice, and dehydration. Mothers also can be affected if they’re made to feel shame because they cannot provide adequate amounts of breast milk and must supplement their supply with formula.

The blanket nature of the AAPs recommendations is “irresponsible,” given the fact that only about one in four nursing people can produce sufficient breast milk to feed their baby, Dr. del Castillo-Hegyi said.

“Not only is there harm to the infant, who may suffer from developmental problems as a result of the malnutrition they experience, but it harms the mother who believes in the AAP to provide responsible guidelines that help them ensure the best nutrition to their infants,” she said.

Lori Feldman-Winter, MD, chair of the AAP Section on Breastfeeding, defended the updated guidance.

The policy aims “to clarify the evidence that breastfeeding matters and to use the best evidence to equip pediatricians with the ways they can support the mother’s choice,” Dr. Feldman-Winter said in an interview. “The bottom line is that most women can exclusively breastfeed according to our recommendation, but a growing number of women have conditions that make it difficult, such as obesity. Pediatricians are essential in recognizing suboptimal intake in the breastfed infant, and the policy delineates how to do this.”

Dr. Feldman-Winter added that the criticism of the policy “is not unexpected, given the many barriers in our society for women doing the work of mothering and trying to reach their personal breastfeeding goals. We know over 60% of mothers do not reach their intended goals. These barriers are even more apparent for the populations that are underserved and least likely to breastfeed.”

But Dr. del Castillo-Hegyi pushed back on the AAP’s claim that exclusive breastfeeding of infants up to 6 months of age confers significant benefits beyond combination breastfeeding and formula feeding. The policy “fails to address the fact that many mothers do not have the biological capacity to meet the recommendation and are simply unable to exclusively breastfeed their infants” for that length of time, she said.

While the differences of opinion might leave lactating mothers in limbo, another expert pointed out that “support” of mothers is critical.

Jessica Madden, MD, a pediatrician and lactation consultant in Cleveland, Ohio, said advocates should work to normalize extended breastfeeding in the general public.

“I think everyone should work to advocate together,” Dr. Madden said. “From the professional society standpoint, advocacy for extended breastfeeding should come from the Academy of Breastfeeding Medicine and the AAP’s Section on Breastfeeding Medicine.”

She said more emphasis should be focused on the roles that pediatricians and health care providers play, along with insurers and employers, to ensure that moms are confident and comfortable with whatever breastfeeding journey they take.

The AAP will be revisiting the recommendations again soon, Dr. Feldman-Winter said. The U.S. Preventive Services Task Force has completed a systematic review but has not set a date to release findings, she said.

Among the issues the USPSTF will address are whether interventions that support breastfeeding improve outcomes for children and mothers; how to improve the initiation, duration, intensity, and exclusivity of breastfeeding; and the identification of any potential harms of interventions that support breastfeeding.

“The research plan illustrates that breastfeeding is now an active area for research, and we will continue to update our recommendations according to the best evidence,” Dr. Feldman-Winter said.

Dr. del Castillo-Hegyi, Dr. Feldman-Winter, and Dr. Madden have disclosed no relevant financial relationships.

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

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How long should mothers breastfeed their babies?

The controversial question has cropped up again after the nation’s leading pediatrics group has issued new recommendations calling for women to breastfeed until their children turn 2, and possibly even longer.

The policy statement, Breastfeeding and the Use of Human Milk, was released on June 27 by the American Academy of Pediatrics. It calls out stigma, lack of support, and workplace barriers that make continued breastfeeding difficult for many mothers.

But the new policy statement isn’t going down smoothly with the Fed Is Best Foundation, a nonprofit group hoping to “debunk and sort out for the public” many of the proclamations in the AAP’s policies, said Christie del Castillo-Hegyi, MD, cofounder of the group and emergency physician at CHI St. Vincent, Little Rock, Ark.

The goal of Fed Is Best is to assist families and health care professionals with current research on the safe feeding of infants – whether with breast milk, formula, or a combination.

The AAP’s previous guidelines, issued in 2012, called for infants to be fed breast milk exclusively for their first 6 months. Continued breastfeeding was recommended while introducing complementary foods for a period of 1 year or longer, the policy stated. The updated policy extends the optimum time line for breastfeeding to up to 2 years, citing the health benefits for babies.
 

‘Tone deaf and one-sided’

The AAP policy is “tone deaf and one-sided to the 75% of the U.S. mothers who use formula either by necessity or choice,” Dr. del Castillo-Hegyi told this news organization.

She pointed to a long list of factors that could affect the health outcomes of infants with regard to breastfeeding versus formula-feeding. These include socioeconomic status, baseline maternal health and education, maternal genetics, and the effects of developing feeding complications from exclusive breastfeeding for infants whose mothers can’t produce enough milk. These issues can contribute to negative health outcomes and brain development in infants who go on to be formula fed, she said.

She also objected to the fact that the guidelines make little reference to a mother who needs to supplement breast milk with formula within 4 months – and even before that – to meet her infant’s nutritional requirements.

Mothers need to hear “that making sure their infant is adequately fed is the most important goal of any infant feeding recommendation,” Dr. del Castillo-Hegyi said. She noted that the AAP’s rigid guidelines may be impossible for many mothers to follow.

“The pressure to meet [the AAP’s] exceedingly high expectations is causing harm to mothers and babies,” she said, referring to earlier guidelines that contained similar suggestions.

If a mother’s milk is insufficient, babies are at risk for low growth rates, jaundice, and dehydration. Mothers also can be affected if they’re made to feel shame because they cannot provide adequate amounts of breast milk and must supplement their supply with formula.

The blanket nature of the AAPs recommendations is “irresponsible,” given the fact that only about one in four nursing people can produce sufficient breast milk to feed their baby, Dr. del Castillo-Hegyi said.

“Not only is there harm to the infant, who may suffer from developmental problems as a result of the malnutrition they experience, but it harms the mother who believes in the AAP to provide responsible guidelines that help them ensure the best nutrition to their infants,” she said.

Lori Feldman-Winter, MD, chair of the AAP Section on Breastfeeding, defended the updated guidance.

The policy aims “to clarify the evidence that breastfeeding matters and to use the best evidence to equip pediatricians with the ways they can support the mother’s choice,” Dr. Feldman-Winter said in an interview. “The bottom line is that most women can exclusively breastfeed according to our recommendation, but a growing number of women have conditions that make it difficult, such as obesity. Pediatricians are essential in recognizing suboptimal intake in the breastfed infant, and the policy delineates how to do this.”

Dr. Feldman-Winter added that the criticism of the policy “is not unexpected, given the many barriers in our society for women doing the work of mothering and trying to reach their personal breastfeeding goals. We know over 60% of mothers do not reach their intended goals. These barriers are even more apparent for the populations that are underserved and least likely to breastfeed.”

But Dr. del Castillo-Hegyi pushed back on the AAP’s claim that exclusive breastfeeding of infants up to 6 months of age confers significant benefits beyond combination breastfeeding and formula feeding. The policy “fails to address the fact that many mothers do not have the biological capacity to meet the recommendation and are simply unable to exclusively breastfeed their infants” for that length of time, she said.

While the differences of opinion might leave lactating mothers in limbo, another expert pointed out that “support” of mothers is critical.

Jessica Madden, MD, a pediatrician and lactation consultant in Cleveland, Ohio, said advocates should work to normalize extended breastfeeding in the general public.

“I think everyone should work to advocate together,” Dr. Madden said. “From the professional society standpoint, advocacy for extended breastfeeding should come from the Academy of Breastfeeding Medicine and the AAP’s Section on Breastfeeding Medicine.”

She said more emphasis should be focused on the roles that pediatricians and health care providers play, along with insurers and employers, to ensure that moms are confident and comfortable with whatever breastfeeding journey they take.

The AAP will be revisiting the recommendations again soon, Dr. Feldman-Winter said. The U.S. Preventive Services Task Force has completed a systematic review but has not set a date to release findings, she said.

Among the issues the USPSTF will address are whether interventions that support breastfeeding improve outcomes for children and mothers; how to improve the initiation, duration, intensity, and exclusivity of breastfeeding; and the identification of any potential harms of interventions that support breastfeeding.

“The research plan illustrates that breastfeeding is now an active area for research, and we will continue to update our recommendations according to the best evidence,” Dr. Feldman-Winter said.

Dr. del Castillo-Hegyi, Dr. Feldman-Winter, and Dr. Madden have disclosed no relevant financial relationships.

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

How long should mothers breastfeed their babies?

The controversial question has cropped up again after the nation’s leading pediatrics group has issued new recommendations calling for women to breastfeed until their children turn 2, and possibly even longer.

The policy statement, Breastfeeding and the Use of Human Milk, was released on June 27 by the American Academy of Pediatrics. It calls out stigma, lack of support, and workplace barriers that make continued breastfeeding difficult for many mothers.

But the new policy statement isn’t going down smoothly with the Fed Is Best Foundation, a nonprofit group hoping to “debunk and sort out for the public” many of the proclamations in the AAP’s policies, said Christie del Castillo-Hegyi, MD, cofounder of the group and emergency physician at CHI St. Vincent, Little Rock, Ark.

The goal of Fed Is Best is to assist families and health care professionals with current research on the safe feeding of infants – whether with breast milk, formula, or a combination.

The AAP’s previous guidelines, issued in 2012, called for infants to be fed breast milk exclusively for their first 6 months. Continued breastfeeding was recommended while introducing complementary foods for a period of 1 year or longer, the policy stated. The updated policy extends the optimum time line for breastfeeding to up to 2 years, citing the health benefits for babies.
 

‘Tone deaf and one-sided’

The AAP policy is “tone deaf and one-sided to the 75% of the U.S. mothers who use formula either by necessity or choice,” Dr. del Castillo-Hegyi told this news organization.

She pointed to a long list of factors that could affect the health outcomes of infants with regard to breastfeeding versus formula-feeding. These include socioeconomic status, baseline maternal health and education, maternal genetics, and the effects of developing feeding complications from exclusive breastfeeding for infants whose mothers can’t produce enough milk. These issues can contribute to negative health outcomes and brain development in infants who go on to be formula fed, she said.

She also objected to the fact that the guidelines make little reference to a mother who needs to supplement breast milk with formula within 4 months – and even before that – to meet her infant’s nutritional requirements.

Mothers need to hear “that making sure their infant is adequately fed is the most important goal of any infant feeding recommendation,” Dr. del Castillo-Hegyi said. She noted that the AAP’s rigid guidelines may be impossible for many mothers to follow.

“The pressure to meet [the AAP’s] exceedingly high expectations is causing harm to mothers and babies,” she said, referring to earlier guidelines that contained similar suggestions.

If a mother’s milk is insufficient, babies are at risk for low growth rates, jaundice, and dehydration. Mothers also can be affected if they’re made to feel shame because they cannot provide adequate amounts of breast milk and must supplement their supply with formula.

The blanket nature of the AAPs recommendations is “irresponsible,” given the fact that only about one in four nursing people can produce sufficient breast milk to feed their baby, Dr. del Castillo-Hegyi said.

“Not only is there harm to the infant, who may suffer from developmental problems as a result of the malnutrition they experience, but it harms the mother who believes in the AAP to provide responsible guidelines that help them ensure the best nutrition to their infants,” she said.

Lori Feldman-Winter, MD, chair of the AAP Section on Breastfeeding, defended the updated guidance.

The policy aims “to clarify the evidence that breastfeeding matters and to use the best evidence to equip pediatricians with the ways they can support the mother’s choice,” Dr. Feldman-Winter said in an interview. “The bottom line is that most women can exclusively breastfeed according to our recommendation, but a growing number of women have conditions that make it difficult, such as obesity. Pediatricians are essential in recognizing suboptimal intake in the breastfed infant, and the policy delineates how to do this.”

Dr. Feldman-Winter added that the criticism of the policy “is not unexpected, given the many barriers in our society for women doing the work of mothering and trying to reach their personal breastfeeding goals. We know over 60% of mothers do not reach their intended goals. These barriers are even more apparent for the populations that are underserved and least likely to breastfeed.”

But Dr. del Castillo-Hegyi pushed back on the AAP’s claim that exclusive breastfeeding of infants up to 6 months of age confers significant benefits beyond combination breastfeeding and formula feeding. The policy “fails to address the fact that many mothers do not have the biological capacity to meet the recommendation and are simply unable to exclusively breastfeed their infants” for that length of time, she said.

While the differences of opinion might leave lactating mothers in limbo, another expert pointed out that “support” of mothers is critical.

Jessica Madden, MD, a pediatrician and lactation consultant in Cleveland, Ohio, said advocates should work to normalize extended breastfeeding in the general public.

“I think everyone should work to advocate together,” Dr. Madden said. “From the professional society standpoint, advocacy for extended breastfeeding should come from the Academy of Breastfeeding Medicine and the AAP’s Section on Breastfeeding Medicine.”

She said more emphasis should be focused on the roles that pediatricians and health care providers play, along with insurers and employers, to ensure that moms are confident and comfortable with whatever breastfeeding journey they take.

The AAP will be revisiting the recommendations again soon, Dr. Feldman-Winter said. The U.S. Preventive Services Task Force has completed a systematic review but has not set a date to release findings, she said.

Among the issues the USPSTF will address are whether interventions that support breastfeeding improve outcomes for children and mothers; how to improve the initiation, duration, intensity, and exclusivity of breastfeeding; and the identification of any potential harms of interventions that support breastfeeding.

“The research plan illustrates that breastfeeding is now an active area for research, and we will continue to update our recommendations according to the best evidence,” Dr. Feldman-Winter said.

Dr. del Castillo-Hegyi, Dr. Feldman-Winter, and Dr. Madden have disclosed no relevant financial relationships.

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

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Texas off the table for ob.gyn. board exams

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Tue, 07/26/2022 - 10:32

Ob.gyns. will not have to travel to Texas to take the board certification exam this fall. 

The announcement from the American Board of Obstetrics & Gynecology follows worries from physicians that gathering in large groups for the examination would leave them vulnerable to physical or political retaliation in the wake of the Supreme Court’s decision to overturn Roe v. Wade.

ABOG is headquartered in Dallas; Texas is one of many states with a near-complete ban on abortion.

Though certification is voluntary, many doctors opt to take the 3-hour oral test to enhance their medical expertise beyond what their state requires. 

ABOG held board certification exams online during the pandemic, with plans to return to in-person testing this fall. However, last week, the board said that online testing will continue “due to the increase in COVID-19 cases across the country and concerns regarding the U.S. Supreme Court opinion on Dobbs v. Jackson Women’s Health Organization.”

More than 500 physicians petitioned against having in-person board certification exams last month in a letter addressed to the board.

“The state of Texas has severely restricted access to abortion and has allowed private citizens to take legal action against anyone suspected of assisting or performing terminations,” the letter says. “Due to the ‘aid and abet’ clause included in SB8, we may be targeted for legal or political retribution.”

SB8 is shorthand for the Texas Heartbeat Act, which authorizes anyone in the state of Texas to sue any individual whom they believe to have performed or induced an abortion, as well as people who aid or abet abortions in any way, such as paying for the abortion through their insurance.

Pregnant exam-takers also feared having to seek care for potential complications in Texas.

“We see no justifiable reason to mandate in-person oral board exams in a state that restricts basic healthcare of pregnant people and whose laws encourage vigilante targeting of physicians who perform abortions,” the letter continues.

Alice Abernathy, MD, a national clinician scholar in obstetrics and gynecology at the University of Pennsylvania, Philadelphia, signed the petition and would be required to travel to Texas for her certification exam next year if ABOG’s future exam cycles are held in person.

“My job is straightforward – I take care of patients. I will not expose myself to risk of prosecution for delivering the highest standard of comprehensive reproductive health care to my patients,” Dr. Abernathy told this news organization.

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

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Ob.gyns. will not have to travel to Texas to take the board certification exam this fall. 

The announcement from the American Board of Obstetrics & Gynecology follows worries from physicians that gathering in large groups for the examination would leave them vulnerable to physical or political retaliation in the wake of the Supreme Court’s decision to overturn Roe v. Wade.

ABOG is headquartered in Dallas; Texas is one of many states with a near-complete ban on abortion.

Though certification is voluntary, many doctors opt to take the 3-hour oral test to enhance their medical expertise beyond what their state requires. 

ABOG held board certification exams online during the pandemic, with plans to return to in-person testing this fall. However, last week, the board said that online testing will continue “due to the increase in COVID-19 cases across the country and concerns regarding the U.S. Supreme Court opinion on Dobbs v. Jackson Women’s Health Organization.”

More than 500 physicians petitioned against having in-person board certification exams last month in a letter addressed to the board.

“The state of Texas has severely restricted access to abortion and has allowed private citizens to take legal action against anyone suspected of assisting or performing terminations,” the letter says. “Due to the ‘aid and abet’ clause included in SB8, we may be targeted for legal or political retribution.”

SB8 is shorthand for the Texas Heartbeat Act, which authorizes anyone in the state of Texas to sue any individual whom they believe to have performed or induced an abortion, as well as people who aid or abet abortions in any way, such as paying for the abortion through their insurance.

Pregnant exam-takers also feared having to seek care for potential complications in Texas.

“We see no justifiable reason to mandate in-person oral board exams in a state that restricts basic healthcare of pregnant people and whose laws encourage vigilante targeting of physicians who perform abortions,” the letter continues.

Alice Abernathy, MD, a national clinician scholar in obstetrics and gynecology at the University of Pennsylvania, Philadelphia, signed the petition and would be required to travel to Texas for her certification exam next year if ABOG’s future exam cycles are held in person.

“My job is straightforward – I take care of patients. I will not expose myself to risk of prosecution for delivering the highest standard of comprehensive reproductive health care to my patients,” Dr. Abernathy told this news organization.

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

Ob.gyns. will not have to travel to Texas to take the board certification exam this fall. 

The announcement from the American Board of Obstetrics & Gynecology follows worries from physicians that gathering in large groups for the examination would leave them vulnerable to physical or political retaliation in the wake of the Supreme Court’s decision to overturn Roe v. Wade.

ABOG is headquartered in Dallas; Texas is one of many states with a near-complete ban on abortion.

Though certification is voluntary, many doctors opt to take the 3-hour oral test to enhance their medical expertise beyond what their state requires. 

ABOG held board certification exams online during the pandemic, with plans to return to in-person testing this fall. However, last week, the board said that online testing will continue “due to the increase in COVID-19 cases across the country and concerns regarding the U.S. Supreme Court opinion on Dobbs v. Jackson Women’s Health Organization.”

More than 500 physicians petitioned against having in-person board certification exams last month in a letter addressed to the board.

“The state of Texas has severely restricted access to abortion and has allowed private citizens to take legal action against anyone suspected of assisting or performing terminations,” the letter says. “Due to the ‘aid and abet’ clause included in SB8, we may be targeted for legal or political retribution.”

SB8 is shorthand for the Texas Heartbeat Act, which authorizes anyone in the state of Texas to sue any individual whom they believe to have performed or induced an abortion, as well as people who aid or abet abortions in any way, such as paying for the abortion through their insurance.

Pregnant exam-takers also feared having to seek care for potential complications in Texas.

“We see no justifiable reason to mandate in-person oral board exams in a state that restricts basic healthcare of pregnant people and whose laws encourage vigilante targeting of physicians who perform abortions,” the letter continues.

Alice Abernathy, MD, a national clinician scholar in obstetrics and gynecology at the University of Pennsylvania, Philadelphia, signed the petition and would be required to travel to Texas for her certification exam next year if ABOG’s future exam cycles are held in person.

“My job is straightforward – I take care of patients. I will not expose myself to risk of prosecution for delivering the highest standard of comprehensive reproductive health care to my patients,” Dr. Abernathy told this news organization.

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

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Heart health poor for many U.S. children

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Tue, 07/26/2022 - 12:08

U.S. children appear to be failing an important test – of their hearts, not minds.

New research from the Ann & Robert H. Lurie Children’s Hospital of Chicago shows that heart health is a concern for many long before adulthood because fewer than one-third of children aged 2-19 years scored highly on the American Heart Association’s checklist for ideal cardiovascular fitness.

“This study gives us a new baseline for children’s heart health in the United States,” said Amanda Perak, MD, pediatric cardiologist at Ann & Robert H. Lurie Children’s Hospital of Chicago and a coauthor of the study.

Dr. Perak and colleagues published their findings in the journal Circulation.

The researchers identified 9888 children who completed the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey between 2013 and 2018. They analyzed the available data using the AHA’s Life’s Essential 8 – a 100-point assessment of eight predictors for measuring heart health, including sleep, nicotine exposure, and blood glucose.

Data for only three metrics were available for all children in the study: diet, physical activity, and body mass index. As children aged, more metrics were averaged to obtain the overall cardiovascular health score. For instance, cholesterol/lipid levels become available at age 6 years, and blood pressure can be measured starting at age 8 years.

Only 2.2% of children in the study had optimal heart health, according to the Life’s Essential 8 scoring system, which spans poor (0-49), moderate (50-79), and high (80-100). Fewer than one in three (29.1%) overall had high scores, and scores worsened with age.

In the 2- to 5-year age group, over half (56.5%) of the children had good heart health. However, only one-third (33.5%) of 6- to 11-year-olds scored highly. Meanwhile, only 14% of adolescents had good heart scores, Dr. Perak’s group found.

Heart health scores based on diet were lowest for every age group. In the youngest age group, the average cardiovascular health (CVH) score was about 61. In the 12- to 19-year age group, however, the average CVH score decreased to 28.5, the lowest measured score for any group in the study.

With such worrisome diet scores for the 12- to 19-year-old group, public health policies need to focus on changes, like removing sugar-sweetened beverage options from schools, according to Joseph Mahgerefteh, MD, director of preventive cardiology at the Mount Sinai Kravis Children’s Heart Center, New York. He added that parents and their children also have a role to play.

“Some of our teenagers forget they can drink water when they are thirsty, and it is not necessary to drink sugar-sweetened beverages for thirst,” Dr. Mahgerefteh, who was not involved in the study, said in an interview. “Fresh vegetable intake is so low to a degree that some of our patients refuse to have any type of vegetable in their diet.”

“As a physician community caring for these patients, we need to be much more aggressive with our counseling and referral of these patients,” added Barry Love, MD, director of the congenital cardiac catheterization program at the Mount Sinai Kravis Children’s Heart Center. “These youngsters will inevitably encounter the effect of these conditions – coronary artery disease and stroke – at a much earlier adult age.”

Dr. Perak, Dr. Mahgerefteh, and Dr. Love reported no relevant financial conflicts of interest.

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

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U.S. children appear to be failing an important test – of their hearts, not minds.

New research from the Ann & Robert H. Lurie Children’s Hospital of Chicago shows that heart health is a concern for many long before adulthood because fewer than one-third of children aged 2-19 years scored highly on the American Heart Association’s checklist for ideal cardiovascular fitness.

“This study gives us a new baseline for children’s heart health in the United States,” said Amanda Perak, MD, pediatric cardiologist at Ann & Robert H. Lurie Children’s Hospital of Chicago and a coauthor of the study.

Dr. Perak and colleagues published their findings in the journal Circulation.

The researchers identified 9888 children who completed the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey between 2013 and 2018. They analyzed the available data using the AHA’s Life’s Essential 8 – a 100-point assessment of eight predictors for measuring heart health, including sleep, nicotine exposure, and blood glucose.

Data for only three metrics were available for all children in the study: diet, physical activity, and body mass index. As children aged, more metrics were averaged to obtain the overall cardiovascular health score. For instance, cholesterol/lipid levels become available at age 6 years, and blood pressure can be measured starting at age 8 years.

Only 2.2% of children in the study had optimal heart health, according to the Life’s Essential 8 scoring system, which spans poor (0-49), moderate (50-79), and high (80-100). Fewer than one in three (29.1%) overall had high scores, and scores worsened with age.

In the 2- to 5-year age group, over half (56.5%) of the children had good heart health. However, only one-third (33.5%) of 6- to 11-year-olds scored highly. Meanwhile, only 14% of adolescents had good heart scores, Dr. Perak’s group found.

Heart health scores based on diet were lowest for every age group. In the youngest age group, the average cardiovascular health (CVH) score was about 61. In the 12- to 19-year age group, however, the average CVH score decreased to 28.5, the lowest measured score for any group in the study.

With such worrisome diet scores for the 12- to 19-year-old group, public health policies need to focus on changes, like removing sugar-sweetened beverage options from schools, according to Joseph Mahgerefteh, MD, director of preventive cardiology at the Mount Sinai Kravis Children’s Heart Center, New York. He added that parents and their children also have a role to play.

“Some of our teenagers forget they can drink water when they are thirsty, and it is not necessary to drink sugar-sweetened beverages for thirst,” Dr. Mahgerefteh, who was not involved in the study, said in an interview. “Fresh vegetable intake is so low to a degree that some of our patients refuse to have any type of vegetable in their diet.”

“As a physician community caring for these patients, we need to be much more aggressive with our counseling and referral of these patients,” added Barry Love, MD, director of the congenital cardiac catheterization program at the Mount Sinai Kravis Children’s Heart Center. “These youngsters will inevitably encounter the effect of these conditions – coronary artery disease and stroke – at a much earlier adult age.”

Dr. Perak, Dr. Mahgerefteh, and Dr. Love reported no relevant financial conflicts of interest.

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

U.S. children appear to be failing an important test – of their hearts, not minds.

New research from the Ann & Robert H. Lurie Children’s Hospital of Chicago shows that heart health is a concern for many long before adulthood because fewer than one-third of children aged 2-19 years scored highly on the American Heart Association’s checklist for ideal cardiovascular fitness.

“This study gives us a new baseline for children’s heart health in the United States,” said Amanda Perak, MD, pediatric cardiologist at Ann & Robert H. Lurie Children’s Hospital of Chicago and a coauthor of the study.

Dr. Perak and colleagues published their findings in the journal Circulation.

The researchers identified 9888 children who completed the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey between 2013 and 2018. They analyzed the available data using the AHA’s Life’s Essential 8 – a 100-point assessment of eight predictors for measuring heart health, including sleep, nicotine exposure, and blood glucose.

Data for only three metrics were available for all children in the study: diet, physical activity, and body mass index. As children aged, more metrics were averaged to obtain the overall cardiovascular health score. For instance, cholesterol/lipid levels become available at age 6 years, and blood pressure can be measured starting at age 8 years.

Only 2.2% of children in the study had optimal heart health, according to the Life’s Essential 8 scoring system, which spans poor (0-49), moderate (50-79), and high (80-100). Fewer than one in three (29.1%) overall had high scores, and scores worsened with age.

In the 2- to 5-year age group, over half (56.5%) of the children had good heart health. However, only one-third (33.5%) of 6- to 11-year-olds scored highly. Meanwhile, only 14% of adolescents had good heart scores, Dr. Perak’s group found.

Heart health scores based on diet were lowest for every age group. In the youngest age group, the average cardiovascular health (CVH) score was about 61. In the 12- to 19-year age group, however, the average CVH score decreased to 28.5, the lowest measured score for any group in the study.

With such worrisome diet scores for the 12- to 19-year-old group, public health policies need to focus on changes, like removing sugar-sweetened beverage options from schools, according to Joseph Mahgerefteh, MD, director of preventive cardiology at the Mount Sinai Kravis Children’s Heart Center, New York. He added that parents and their children also have a role to play.

“Some of our teenagers forget they can drink water when they are thirsty, and it is not necessary to drink sugar-sweetened beverages for thirst,” Dr. Mahgerefteh, who was not involved in the study, said in an interview. “Fresh vegetable intake is so low to a degree that some of our patients refuse to have any type of vegetable in their diet.”

“As a physician community caring for these patients, we need to be much more aggressive with our counseling and referral of these patients,” added Barry Love, MD, director of the congenital cardiac catheterization program at the Mount Sinai Kravis Children’s Heart Center. “These youngsters will inevitably encounter the effect of these conditions – coronary artery disease and stroke – at a much earlier adult age.”

Dr. Perak, Dr. Mahgerefteh, and Dr. Love reported no relevant financial conflicts of interest.

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

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Clinical characteristics of recurrent RIME elucidated in chart review

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Onset of recurrent reactive infectious mucocutaneous eruption (RIME) was most common among males between the ages of 11 and 12 years, which is younger than previously described, in a single-center retrospective study. In addition, 71% of patients with recurrent disease experienced 1-2 recurrences – episodes that were generally milder and occurred at variable intervals.

Those are among key findings from the study of 50 patients with RIME, presented by Catherina X. Pan at the annual meeting of the Society for Pediatric Dermatology.

Catherina X. Pan

Reactive infectious mucocutaneous eruption (RIME) is a novel term encompassing an array of rare, parainfectious mucositis diseases, noted Ms. Pan, a fourth-year medical student at Harvard Medical School, Boston. Previously known as Mycoplasma pneumoniae-induced rash and mucositis (MIRM), common clinical characteristics of RIME include less than 10% body surface area involvement of polymorphic skin lesions (vesiculobullous or targetoid macules/papules); erosive oral, genital, and/or ocular mucositis involving more than two sites, and evidence of prior infection including but not limited to upper respiratory infection, fever, and cough.

In addition to M. pneumoniae, other pathogens have been implicated, she said. “While the underlying etiology of the disease is not entirely clear, it’s become increasingly known that RIME tends to recur in a subset of patients.”

A cohort study of 13 patients with RIME found that Black race, male sex, and older age were predominant among the five patients who developed recurrent disease.

The estimated recurrence rate is between 8% and 38%, but the clinical characteristics of patients who develop recurrent RIME tend to be poorly understood, Ms. Pan said.

Along with her mentor, Sadaf Hussain, MD, of the department of dermatology at Boston Children’s Hospital, Ms. Pan conducted a retrospective chart review to characterize the clinical history and course of disease in patients diagnosed with recurrent RIME. They extracted data between January of 2000 and March of 2022 using ICD-10 codes used by board-certified dermatologists at Boston Children’s Hospital, as well as a text search for RIME or MIRM in the dermatology notes. Patients were included if they had a RIME/MIRM diagnosis by a board-certified dermatologist and/or infection on PCR/serology and mucositis involvement with limited skin involvement.

The study population included 50 patients: 24 with recurrent RIME and 26 with isolated RIME. The majority (66%) were male, and the mean age of RIME onset was between 11 and 12 years old, which is up to two years younger than previously reported in the case series of 13 patients. Most of the study participants (79%) were White, but there were no significant differences in patients who had recurrent RIME and those who had isolated RIME in terms of age, sex, or race.
 

Isolated vs. recurrent RIME

However, compared with patients who had isolated RIME, a greater proportion of those with recurrent RIME had a history of atopic disease (46% vs. 23%, respectively; P = .136), as well as a history of tonsillectomy and adenoidectomy (25% vs. 4%; P = .045). “This has not been previously observed, but it may generate a hypothesis that patients with a history of frequent infection as well as amplified immune responses may be associated with disease recurrence,” Ms. Pan said.

The average number of episodes among patients with recurrent RIME was 3.5 and the interval between episodes was variable, at a mean of 10.2 months. Ms. Pan reported that 71% of recurrent RIME patients experienced 1-2 episodes, although one patient experienced 9 episodes.

Clinically, episodes among all patients with RIME were characterized by infectious prodromal symptoms (69%), oral lesions (95%), ocular lesions (60%), genital lesions (41%) and cutaneous lesions (40%). However, RIME recurrences were less severe and more atypical, with 49% involving only one mucosal surface and 29% involving two mucosal surfaces. Also, except for oral lesions, rates of infectious prodromal symptoms and other lesions significantly decreased among recurrences compared with initial RIME.

“Notably, we found that M. pneumoniae was the most common known cause of RIME, particularly among the initial episodes,” Ms. Pan said. “However, 61% of recurrent RIME episodes did not have a known cause in terms of infectious etiology. And, concordant with prior studies, we also found decreased severity [of RIME recurrences] as indicated by decreased rates of emergency department presentation, hospitalization, and duration of hospitalization.”

In other findings, psychiatric complications such as anxiety and depression followed the onset of RIME in 33% of those with recurrent disease and 22% of those with isolated disease. In addition, the three most common treatments among all 50 patients were systemic steroids, topical steroids, and M. pneumoniae-specific antibiotics.



“While RIME is considered as typically milder than Stevens-Johnson syndrome and toxic epidermal necrolysis with low mortality rates, it can lead to severe complications including conjunctival shrinkage, corneal ulceration and scarring, blindness, and oral, ocular, urogenital synechiae,” Ms. Pan noted. “Increased use of corticosteroids and steroid-sparing agents such as IVIG have also been observed. Multidisciplinary care with ophthalmology, urology, and mental health services is critical.”

She acknowledged certain limitations of the study, including its retrospective, single-center design, and the possibility that milder cases may have been excluded due to a lack of accurate diagnosis or referral.

Carrie C. Coughlin, MD, who was asked to comment on the study results, pointed out that nearly half (24) of patients in the cohort experienced recurrent RIME. “This is a high proportion, suggesting counseling about the possibility of recurrence is more important than previously thought,” said Dr. Coughlin, director of the section of pediatric dermatology Washington University/St. Louis Children’s Hospital.

“Fortunately, recurrent cases tended to be less severe. However, many patients had more than one recurrence, making this challenging for affected patients.”

The researchers reported having no financial disclosures. Dr. Coughlin is on the board of the Pediatric Dermatology Research Alliance (PeDRA) and the International Immunosuppression and Transplant Skin Cancer Collaborative.

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Onset of recurrent reactive infectious mucocutaneous eruption (RIME) was most common among males between the ages of 11 and 12 years, which is younger than previously described, in a single-center retrospective study. In addition, 71% of patients with recurrent disease experienced 1-2 recurrences – episodes that were generally milder and occurred at variable intervals.

Those are among key findings from the study of 50 patients with RIME, presented by Catherina X. Pan at the annual meeting of the Society for Pediatric Dermatology.

Catherina X. Pan

Reactive infectious mucocutaneous eruption (RIME) is a novel term encompassing an array of rare, parainfectious mucositis diseases, noted Ms. Pan, a fourth-year medical student at Harvard Medical School, Boston. Previously known as Mycoplasma pneumoniae-induced rash and mucositis (MIRM), common clinical characteristics of RIME include less than 10% body surface area involvement of polymorphic skin lesions (vesiculobullous or targetoid macules/papules); erosive oral, genital, and/or ocular mucositis involving more than two sites, and evidence of prior infection including but not limited to upper respiratory infection, fever, and cough.

In addition to M. pneumoniae, other pathogens have been implicated, she said. “While the underlying etiology of the disease is not entirely clear, it’s become increasingly known that RIME tends to recur in a subset of patients.”

A cohort study of 13 patients with RIME found that Black race, male sex, and older age were predominant among the five patients who developed recurrent disease.

The estimated recurrence rate is between 8% and 38%, but the clinical characteristics of patients who develop recurrent RIME tend to be poorly understood, Ms. Pan said.

Along with her mentor, Sadaf Hussain, MD, of the department of dermatology at Boston Children’s Hospital, Ms. Pan conducted a retrospective chart review to characterize the clinical history and course of disease in patients diagnosed with recurrent RIME. They extracted data between January of 2000 and March of 2022 using ICD-10 codes used by board-certified dermatologists at Boston Children’s Hospital, as well as a text search for RIME or MIRM in the dermatology notes. Patients were included if they had a RIME/MIRM diagnosis by a board-certified dermatologist and/or infection on PCR/serology and mucositis involvement with limited skin involvement.

The study population included 50 patients: 24 with recurrent RIME and 26 with isolated RIME. The majority (66%) were male, and the mean age of RIME onset was between 11 and 12 years old, which is up to two years younger than previously reported in the case series of 13 patients. Most of the study participants (79%) were White, but there were no significant differences in patients who had recurrent RIME and those who had isolated RIME in terms of age, sex, or race.
 

Isolated vs. recurrent RIME

However, compared with patients who had isolated RIME, a greater proportion of those with recurrent RIME had a history of atopic disease (46% vs. 23%, respectively; P = .136), as well as a history of tonsillectomy and adenoidectomy (25% vs. 4%; P = .045). “This has not been previously observed, but it may generate a hypothesis that patients with a history of frequent infection as well as amplified immune responses may be associated with disease recurrence,” Ms. Pan said.

The average number of episodes among patients with recurrent RIME was 3.5 and the interval between episodes was variable, at a mean of 10.2 months. Ms. Pan reported that 71% of recurrent RIME patients experienced 1-2 episodes, although one patient experienced 9 episodes.

Clinically, episodes among all patients with RIME were characterized by infectious prodromal symptoms (69%), oral lesions (95%), ocular lesions (60%), genital lesions (41%) and cutaneous lesions (40%). However, RIME recurrences were less severe and more atypical, with 49% involving only one mucosal surface and 29% involving two mucosal surfaces. Also, except for oral lesions, rates of infectious prodromal symptoms and other lesions significantly decreased among recurrences compared with initial RIME.

“Notably, we found that M. pneumoniae was the most common known cause of RIME, particularly among the initial episodes,” Ms. Pan said. “However, 61% of recurrent RIME episodes did not have a known cause in terms of infectious etiology. And, concordant with prior studies, we also found decreased severity [of RIME recurrences] as indicated by decreased rates of emergency department presentation, hospitalization, and duration of hospitalization.”

In other findings, psychiatric complications such as anxiety and depression followed the onset of RIME in 33% of those with recurrent disease and 22% of those with isolated disease. In addition, the three most common treatments among all 50 patients were systemic steroids, topical steroids, and M. pneumoniae-specific antibiotics.



“While RIME is considered as typically milder than Stevens-Johnson syndrome and toxic epidermal necrolysis with low mortality rates, it can lead to severe complications including conjunctival shrinkage, corneal ulceration and scarring, blindness, and oral, ocular, urogenital synechiae,” Ms. Pan noted. “Increased use of corticosteroids and steroid-sparing agents such as IVIG have also been observed. Multidisciplinary care with ophthalmology, urology, and mental health services is critical.”

She acknowledged certain limitations of the study, including its retrospective, single-center design, and the possibility that milder cases may have been excluded due to a lack of accurate diagnosis or referral.

Carrie C. Coughlin, MD, who was asked to comment on the study results, pointed out that nearly half (24) of patients in the cohort experienced recurrent RIME. “This is a high proportion, suggesting counseling about the possibility of recurrence is more important than previously thought,” said Dr. Coughlin, director of the section of pediatric dermatology Washington University/St. Louis Children’s Hospital.

“Fortunately, recurrent cases tended to be less severe. However, many patients had more than one recurrence, making this challenging for affected patients.”

The researchers reported having no financial disclosures. Dr. Coughlin is on the board of the Pediatric Dermatology Research Alliance (PeDRA) and the International Immunosuppression and Transplant Skin Cancer Collaborative.

Onset of recurrent reactive infectious mucocutaneous eruption (RIME) was most common among males between the ages of 11 and 12 years, which is younger than previously described, in a single-center retrospective study. In addition, 71% of patients with recurrent disease experienced 1-2 recurrences – episodes that were generally milder and occurred at variable intervals.

Those are among key findings from the study of 50 patients with RIME, presented by Catherina X. Pan at the annual meeting of the Society for Pediatric Dermatology.

Catherina X. Pan

Reactive infectious mucocutaneous eruption (RIME) is a novel term encompassing an array of rare, parainfectious mucositis diseases, noted Ms. Pan, a fourth-year medical student at Harvard Medical School, Boston. Previously known as Mycoplasma pneumoniae-induced rash and mucositis (MIRM), common clinical characteristics of RIME include less than 10% body surface area involvement of polymorphic skin lesions (vesiculobullous or targetoid macules/papules); erosive oral, genital, and/or ocular mucositis involving more than two sites, and evidence of prior infection including but not limited to upper respiratory infection, fever, and cough.

In addition to M. pneumoniae, other pathogens have been implicated, she said. “While the underlying etiology of the disease is not entirely clear, it’s become increasingly known that RIME tends to recur in a subset of patients.”

A cohort study of 13 patients with RIME found that Black race, male sex, and older age were predominant among the five patients who developed recurrent disease.

The estimated recurrence rate is between 8% and 38%, but the clinical characteristics of patients who develop recurrent RIME tend to be poorly understood, Ms. Pan said.

Along with her mentor, Sadaf Hussain, MD, of the department of dermatology at Boston Children’s Hospital, Ms. Pan conducted a retrospective chart review to characterize the clinical history and course of disease in patients diagnosed with recurrent RIME. They extracted data between January of 2000 and March of 2022 using ICD-10 codes used by board-certified dermatologists at Boston Children’s Hospital, as well as a text search for RIME or MIRM in the dermatology notes. Patients were included if they had a RIME/MIRM diagnosis by a board-certified dermatologist and/or infection on PCR/serology and mucositis involvement with limited skin involvement.

The study population included 50 patients: 24 with recurrent RIME and 26 with isolated RIME. The majority (66%) were male, and the mean age of RIME onset was between 11 and 12 years old, which is up to two years younger than previously reported in the case series of 13 patients. Most of the study participants (79%) were White, but there were no significant differences in patients who had recurrent RIME and those who had isolated RIME in terms of age, sex, or race.
 

Isolated vs. recurrent RIME

However, compared with patients who had isolated RIME, a greater proportion of those with recurrent RIME had a history of atopic disease (46% vs. 23%, respectively; P = .136), as well as a history of tonsillectomy and adenoidectomy (25% vs. 4%; P = .045). “This has not been previously observed, but it may generate a hypothesis that patients with a history of frequent infection as well as amplified immune responses may be associated with disease recurrence,” Ms. Pan said.

The average number of episodes among patients with recurrent RIME was 3.5 and the interval between episodes was variable, at a mean of 10.2 months. Ms. Pan reported that 71% of recurrent RIME patients experienced 1-2 episodes, although one patient experienced 9 episodes.

Clinically, episodes among all patients with RIME were characterized by infectious prodromal symptoms (69%), oral lesions (95%), ocular lesions (60%), genital lesions (41%) and cutaneous lesions (40%). However, RIME recurrences were less severe and more atypical, with 49% involving only one mucosal surface and 29% involving two mucosal surfaces. Also, except for oral lesions, rates of infectious prodromal symptoms and other lesions significantly decreased among recurrences compared with initial RIME.

“Notably, we found that M. pneumoniae was the most common known cause of RIME, particularly among the initial episodes,” Ms. Pan said. “However, 61% of recurrent RIME episodes did not have a known cause in terms of infectious etiology. And, concordant with prior studies, we also found decreased severity [of RIME recurrences] as indicated by decreased rates of emergency department presentation, hospitalization, and duration of hospitalization.”

In other findings, psychiatric complications such as anxiety and depression followed the onset of RIME in 33% of those with recurrent disease and 22% of those with isolated disease. In addition, the three most common treatments among all 50 patients were systemic steroids, topical steroids, and M. pneumoniae-specific antibiotics.



“While RIME is considered as typically milder than Stevens-Johnson syndrome and toxic epidermal necrolysis with low mortality rates, it can lead to severe complications including conjunctival shrinkage, corneal ulceration and scarring, blindness, and oral, ocular, urogenital synechiae,” Ms. Pan noted. “Increased use of corticosteroids and steroid-sparing agents such as IVIG have also been observed. Multidisciplinary care with ophthalmology, urology, and mental health services is critical.”

She acknowledged certain limitations of the study, including its retrospective, single-center design, and the possibility that milder cases may have been excluded due to a lack of accurate diagnosis or referral.

Carrie C. Coughlin, MD, who was asked to comment on the study results, pointed out that nearly half (24) of patients in the cohort experienced recurrent RIME. “This is a high proportion, suggesting counseling about the possibility of recurrence is more important than previously thought,” said Dr. Coughlin, director of the section of pediatric dermatology Washington University/St. Louis Children’s Hospital.

“Fortunately, recurrent cases tended to be less severe. However, many patients had more than one recurrence, making this challenging for affected patients.”

The researchers reported having no financial disclosures. Dr. Coughlin is on the board of the Pediatric Dermatology Research Alliance (PeDRA) and the International Immunosuppression and Transplant Skin Cancer Collaborative.

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Barrett’s esophagus: AGA screening update ‘goes above and beyond’

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Wed, 09/07/2022 - 14:04

A new clinical practice update from the American Gastroenterological Association offers practical advice around surveillance and use of new screening technologies for Barrett’s esophagus.

The AGA clinical practice update, published in Clinical Gastroenterology and Hepatology comes from the AGA’s Center for GI Innovation and Technology. It offers 15 best practice advice statements based on expert review of existing literature combined with discussion and expert opinion. The aim is “to provide an update on advances and innovation” but not to replace current guidelines.

“Guidelines operate on rigorous methodology which requires the use of [Grading of Recommendations, Assessment, Development and Evaluation] methodology and a higher level of evidence. In gastroenterology especially, innovation is moving quickly and there’s no way for patients to reap their benefits if clinical practice was dictated by guidelines alone. That said, we do need documents that support and drive innovation in clinical practice,” corresponding author Srinadh Komanduri, MD, professor of medicine and surgery in the division of gastroenterology and hepatology at Northwestern University, Chicago, told this news publication.

Asked to comment, Vivek Kaul, MD, the Segal-Watson Professor of Medicine in the Center for Advanced Therapeutic Endoscopy in the division of gastroenterology and hepatology at the University of Rochester (N.Y.) Medical Center, said that the document is “an important attempt to not only present the available scientific literature in a very concise and understandable manner, but it goes above and beyond that in terms of diving into some novel paradigms and technologies and procedures that are either emerging or will be emerging in the near future.”
 

Improving detection by dropping GERD requirement

The first of the 15 statements may also be the most paradigm shifting: The panel suggests screening via standard upper endoscopy of people with at least three risk factors for Barrett’s esophagus and esophageal adenocarcinoma, including those who are male, are non-Hispanic White, are aged above 50 years, and have a history of smoking, chronic gastroesophageal reflux disease (GERD), obesity, or a family history of Barrett’s esophagus or esophageal adenocarcinoma.

This represents a departure from all current guidelines, which stipulate GERD as a necessary prerequisite for screening. But the reason is simple, according to the authors: A majority of patients diagnosed with esophageal cancer never experience classic GERD symptoms.

“There is growing evidence in high-level publications over the last couple of years that reflux is not the ideal predictor, based on odds, for development of Barrett’s esophagus. So the consensus among the experts was that we need to remove GERD as an absolute prerequisite or we’re never going to make progress. In order to make an impact on the rise of esophageal adenocarcinoma we have to increase the denominator of patients we are seeing,” Dr. Komanduri explained.

While it might be difficult to screen every White male over 50 years of age, the data do suggest screening those who also have obesity and/or are current smokers. “That’s a perfect subset you might want to start with. There are permutations that have greater value that don’t occupy unnecessary resource utilization. Most critical are the family history of esophageal cancer or Barrett’s esophagus,” he noted.

Dr. Kaul said that a one-time Barrett’s esophagus screening of all White males over 50 years old “is not unreasonable, especially given the rising rates of esophageal cancer.”

However, he also noted, “The feasibility, preferred screening modality, incremental costs, and yield of this new strategy will need to be studied further. Access to GI endoscopy in the postpandemic world is already a concern and will need to be factored into execution of this [advice statement] and will likely impact adoption in some way.”

For his part, Dr. Komanduri said that more investigation will be needed to validate which patients most benefit from screening and that the AGA is planning educational programs for clinicians about interpreting this new paradigm.
 

 

 

New technology could make screening easier and cheaper

The availability of nonendoscopic cell collection devices, including the swallowable Cytosponge (Medtronic), EsoCheck (Lucid), and EsoCap (Capnostics) could help make screening for Barrett’s esophagus easier and more cost effective. They are designed for in-office use and don’t require sedation. Each one is currently in various stages of development and clinical trials. As of now they’re approved in the United States only for cell collection but not for Barrett’s esophagus screening, but their use is endorsed by some guidelines. The Cytosponge in particular is widely available and has been used extensively in the United Kingdom.

Dr. Kaul commented, “While there is a need for nonendoscopic screening devices, the ideal patient population and practice setting for administration of these devices has not been clearly defined. Also, who will be delivering these tests: Primary care or gastroenterology providers? These devices ... represent a major step forward and a novel paradigm for Barrett’s esophagus screening, and the only platform that non-GI providers could use.”
 

Virtual chromoendoscopy: A must have in 2022

A third best practice advice statement shouldn’t be controversial because it’s in other guidelines already, but data show clinicians aren’t always doing it: Performing screening and surveillance endoscopic examinations using virtual chromoendoscopy in addition to high-definition white light endoscopy, with adequate time spent inspecting the Barrett’s segment. The majority of data supporting this is for narrow-band imaging only.

“The blue light lets you pick up early mucosal and vascular changes which might represent dysplastic lesions. It’s not a question of should. It’s a medicolegal slam dunk; you must do it. It’s been a guideline recommendation in the last few years, and it’s just a switch on the scope. It doesn’t require separate equipment, yet people are often still skipping it,” Dr. Komanduri said.

Indeed, Dr. Kaul concurred, “The importance of a high quality, meticulous endoscopic examination for screening and surveillance in Barrett’s esophagus cannot be overemphasized.”
 

‘Finally pushing the needle in the right direction’

The overall goals, Dr. Komanduri said, are “increasing the denominator, using less invasive screening, but finding more patients. If we find more patients we’ll need to stratify their risk. We hope that all these things eventually tie together in a nice story, all with the aim of preventing an invasive cancer that can’t be treated.”

He believes the new update “is a pivotal document in this field that’s going to be a paradigm changer. A lot of aspects need further validation. It’s by no means the end. But I think we’re finally pushing the needle in the right direction as things move forward with innovation.”

Dr. Kaul agrees. “It’s highlighting the principles that may become established paradigms in the future.”

Dr. Komanduri and the other authors of the update reported relationships, including consulting and research support, with companies like Boston Scientific, Medtronic, Virgo Video Solutions, and Castle Biosciences. Dr. Kaul serves as a consultant and advisory board member for CDx Diagnostics, an advisory board member for Castle Biosciences, and an investigator for Lucid Diagnostics.

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A new clinical practice update from the American Gastroenterological Association offers practical advice around surveillance and use of new screening technologies for Barrett’s esophagus.

The AGA clinical practice update, published in Clinical Gastroenterology and Hepatology comes from the AGA’s Center for GI Innovation and Technology. It offers 15 best practice advice statements based on expert review of existing literature combined with discussion and expert opinion. The aim is “to provide an update on advances and innovation” but not to replace current guidelines.

“Guidelines operate on rigorous methodology which requires the use of [Grading of Recommendations, Assessment, Development and Evaluation] methodology and a higher level of evidence. In gastroenterology especially, innovation is moving quickly and there’s no way for patients to reap their benefits if clinical practice was dictated by guidelines alone. That said, we do need documents that support and drive innovation in clinical practice,” corresponding author Srinadh Komanduri, MD, professor of medicine and surgery in the division of gastroenterology and hepatology at Northwestern University, Chicago, told this news publication.

Asked to comment, Vivek Kaul, MD, the Segal-Watson Professor of Medicine in the Center for Advanced Therapeutic Endoscopy in the division of gastroenterology and hepatology at the University of Rochester (N.Y.) Medical Center, said that the document is “an important attempt to not only present the available scientific literature in a very concise and understandable manner, but it goes above and beyond that in terms of diving into some novel paradigms and technologies and procedures that are either emerging or will be emerging in the near future.”
 

Improving detection by dropping GERD requirement

The first of the 15 statements may also be the most paradigm shifting: The panel suggests screening via standard upper endoscopy of people with at least three risk factors for Barrett’s esophagus and esophageal adenocarcinoma, including those who are male, are non-Hispanic White, are aged above 50 years, and have a history of smoking, chronic gastroesophageal reflux disease (GERD), obesity, or a family history of Barrett’s esophagus or esophageal adenocarcinoma.

This represents a departure from all current guidelines, which stipulate GERD as a necessary prerequisite for screening. But the reason is simple, according to the authors: A majority of patients diagnosed with esophageal cancer never experience classic GERD symptoms.

“There is growing evidence in high-level publications over the last couple of years that reflux is not the ideal predictor, based on odds, for development of Barrett’s esophagus. So the consensus among the experts was that we need to remove GERD as an absolute prerequisite or we’re never going to make progress. In order to make an impact on the rise of esophageal adenocarcinoma we have to increase the denominator of patients we are seeing,” Dr. Komanduri explained.

While it might be difficult to screen every White male over 50 years of age, the data do suggest screening those who also have obesity and/or are current smokers. “That’s a perfect subset you might want to start with. There are permutations that have greater value that don’t occupy unnecessary resource utilization. Most critical are the family history of esophageal cancer or Barrett’s esophagus,” he noted.

Dr. Kaul said that a one-time Barrett’s esophagus screening of all White males over 50 years old “is not unreasonable, especially given the rising rates of esophageal cancer.”

However, he also noted, “The feasibility, preferred screening modality, incremental costs, and yield of this new strategy will need to be studied further. Access to GI endoscopy in the postpandemic world is already a concern and will need to be factored into execution of this [advice statement] and will likely impact adoption in some way.”

For his part, Dr. Komanduri said that more investigation will be needed to validate which patients most benefit from screening and that the AGA is planning educational programs for clinicians about interpreting this new paradigm.
 

 

 

New technology could make screening easier and cheaper

The availability of nonendoscopic cell collection devices, including the swallowable Cytosponge (Medtronic), EsoCheck (Lucid), and EsoCap (Capnostics) could help make screening for Barrett’s esophagus easier and more cost effective. They are designed for in-office use and don’t require sedation. Each one is currently in various stages of development and clinical trials. As of now they’re approved in the United States only for cell collection but not for Barrett’s esophagus screening, but their use is endorsed by some guidelines. The Cytosponge in particular is widely available and has been used extensively in the United Kingdom.

Dr. Kaul commented, “While there is a need for nonendoscopic screening devices, the ideal patient population and practice setting for administration of these devices has not been clearly defined. Also, who will be delivering these tests: Primary care or gastroenterology providers? These devices ... represent a major step forward and a novel paradigm for Barrett’s esophagus screening, and the only platform that non-GI providers could use.”
 

Virtual chromoendoscopy: A must have in 2022

A third best practice advice statement shouldn’t be controversial because it’s in other guidelines already, but data show clinicians aren’t always doing it: Performing screening and surveillance endoscopic examinations using virtual chromoendoscopy in addition to high-definition white light endoscopy, with adequate time spent inspecting the Barrett’s segment. The majority of data supporting this is for narrow-band imaging only.

“The blue light lets you pick up early mucosal and vascular changes which might represent dysplastic lesions. It’s not a question of should. It’s a medicolegal slam dunk; you must do it. It’s been a guideline recommendation in the last few years, and it’s just a switch on the scope. It doesn’t require separate equipment, yet people are often still skipping it,” Dr. Komanduri said.

Indeed, Dr. Kaul concurred, “The importance of a high quality, meticulous endoscopic examination for screening and surveillance in Barrett’s esophagus cannot be overemphasized.”
 

‘Finally pushing the needle in the right direction’

The overall goals, Dr. Komanduri said, are “increasing the denominator, using less invasive screening, but finding more patients. If we find more patients we’ll need to stratify their risk. We hope that all these things eventually tie together in a nice story, all with the aim of preventing an invasive cancer that can’t be treated.”

He believes the new update “is a pivotal document in this field that’s going to be a paradigm changer. A lot of aspects need further validation. It’s by no means the end. But I think we’re finally pushing the needle in the right direction as things move forward with innovation.”

Dr. Kaul agrees. “It’s highlighting the principles that may become established paradigms in the future.”

Dr. Komanduri and the other authors of the update reported relationships, including consulting and research support, with companies like Boston Scientific, Medtronic, Virgo Video Solutions, and Castle Biosciences. Dr. Kaul serves as a consultant and advisory board member for CDx Diagnostics, an advisory board member for Castle Biosciences, and an investigator for Lucid Diagnostics.

A new clinical practice update from the American Gastroenterological Association offers practical advice around surveillance and use of new screening technologies for Barrett’s esophagus.

The AGA clinical practice update, published in Clinical Gastroenterology and Hepatology comes from the AGA’s Center for GI Innovation and Technology. It offers 15 best practice advice statements based on expert review of existing literature combined with discussion and expert opinion. The aim is “to provide an update on advances and innovation” but not to replace current guidelines.

“Guidelines operate on rigorous methodology which requires the use of [Grading of Recommendations, Assessment, Development and Evaluation] methodology and a higher level of evidence. In gastroenterology especially, innovation is moving quickly and there’s no way for patients to reap their benefits if clinical practice was dictated by guidelines alone. That said, we do need documents that support and drive innovation in clinical practice,” corresponding author Srinadh Komanduri, MD, professor of medicine and surgery in the division of gastroenterology and hepatology at Northwestern University, Chicago, told this news publication.

Asked to comment, Vivek Kaul, MD, the Segal-Watson Professor of Medicine in the Center for Advanced Therapeutic Endoscopy in the division of gastroenterology and hepatology at the University of Rochester (N.Y.) Medical Center, said that the document is “an important attempt to not only present the available scientific literature in a very concise and understandable manner, but it goes above and beyond that in terms of diving into some novel paradigms and technologies and procedures that are either emerging or will be emerging in the near future.”
 

Improving detection by dropping GERD requirement

The first of the 15 statements may also be the most paradigm shifting: The panel suggests screening via standard upper endoscopy of people with at least three risk factors for Barrett’s esophagus and esophageal adenocarcinoma, including those who are male, are non-Hispanic White, are aged above 50 years, and have a history of smoking, chronic gastroesophageal reflux disease (GERD), obesity, or a family history of Barrett’s esophagus or esophageal adenocarcinoma.

This represents a departure from all current guidelines, which stipulate GERD as a necessary prerequisite for screening. But the reason is simple, according to the authors: A majority of patients diagnosed with esophageal cancer never experience classic GERD symptoms.

“There is growing evidence in high-level publications over the last couple of years that reflux is not the ideal predictor, based on odds, for development of Barrett’s esophagus. So the consensus among the experts was that we need to remove GERD as an absolute prerequisite or we’re never going to make progress. In order to make an impact on the rise of esophageal adenocarcinoma we have to increase the denominator of patients we are seeing,” Dr. Komanduri explained.

While it might be difficult to screen every White male over 50 years of age, the data do suggest screening those who also have obesity and/or are current smokers. “That’s a perfect subset you might want to start with. There are permutations that have greater value that don’t occupy unnecessary resource utilization. Most critical are the family history of esophageal cancer or Barrett’s esophagus,” he noted.

Dr. Kaul said that a one-time Barrett’s esophagus screening of all White males over 50 years old “is not unreasonable, especially given the rising rates of esophageal cancer.”

However, he also noted, “The feasibility, preferred screening modality, incremental costs, and yield of this new strategy will need to be studied further. Access to GI endoscopy in the postpandemic world is already a concern and will need to be factored into execution of this [advice statement] and will likely impact adoption in some way.”

For his part, Dr. Komanduri said that more investigation will be needed to validate which patients most benefit from screening and that the AGA is planning educational programs for clinicians about interpreting this new paradigm.
 

 

 

New technology could make screening easier and cheaper

The availability of nonendoscopic cell collection devices, including the swallowable Cytosponge (Medtronic), EsoCheck (Lucid), and EsoCap (Capnostics) could help make screening for Barrett’s esophagus easier and more cost effective. They are designed for in-office use and don’t require sedation. Each one is currently in various stages of development and clinical trials. As of now they’re approved in the United States only for cell collection but not for Barrett’s esophagus screening, but their use is endorsed by some guidelines. The Cytosponge in particular is widely available and has been used extensively in the United Kingdom.

Dr. Kaul commented, “While there is a need for nonendoscopic screening devices, the ideal patient population and practice setting for administration of these devices has not been clearly defined. Also, who will be delivering these tests: Primary care or gastroenterology providers? These devices ... represent a major step forward and a novel paradigm for Barrett’s esophagus screening, and the only platform that non-GI providers could use.”
 

Virtual chromoendoscopy: A must have in 2022

A third best practice advice statement shouldn’t be controversial because it’s in other guidelines already, but data show clinicians aren’t always doing it: Performing screening and surveillance endoscopic examinations using virtual chromoendoscopy in addition to high-definition white light endoscopy, with adequate time spent inspecting the Barrett’s segment. The majority of data supporting this is for narrow-band imaging only.

“The blue light lets you pick up early mucosal and vascular changes which might represent dysplastic lesions. It’s not a question of should. It’s a medicolegal slam dunk; you must do it. It’s been a guideline recommendation in the last few years, and it’s just a switch on the scope. It doesn’t require separate equipment, yet people are often still skipping it,” Dr. Komanduri said.

Indeed, Dr. Kaul concurred, “The importance of a high quality, meticulous endoscopic examination for screening and surveillance in Barrett’s esophagus cannot be overemphasized.”
 

‘Finally pushing the needle in the right direction’

The overall goals, Dr. Komanduri said, are “increasing the denominator, using less invasive screening, but finding more patients. If we find more patients we’ll need to stratify their risk. We hope that all these things eventually tie together in a nice story, all with the aim of preventing an invasive cancer that can’t be treated.”

He believes the new update “is a pivotal document in this field that’s going to be a paradigm changer. A lot of aspects need further validation. It’s by no means the end. But I think we’re finally pushing the needle in the right direction as things move forward with innovation.”

Dr. Kaul agrees. “It’s highlighting the principles that may become established paradigms in the future.”

Dr. Komanduri and the other authors of the update reported relationships, including consulting and research support, with companies like Boston Scientific, Medtronic, Virgo Video Solutions, and Castle Biosciences. Dr. Kaul serves as a consultant and advisory board member for CDx Diagnostics, an advisory board member for Castle Biosciences, and an investigator for Lucid Diagnostics.

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Rosuvastatin again linked with risks to kidneys

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Tue, 07/26/2022 - 10:40

Rosuvastatin for cholesterol lowering was associated with slightly greater risks for kidney harm than atorvastatin, risks that were greater at higher-dose levels, in a large retrospective cohort study.

The most potent statin on the market, rosuvastatin has been linked with excess risk for kidney damage compared with atorvastatin in case reports and small trials, but there has been little surveillance of the issue following its approval in 2003.

The current analysis “is one of the first and largest real-world studies” examining rosuvastatin versus atorvastatin for risk for hematuria, proteinuria, and kidney failure with replacement therapy – dialysis or transplantation – across a range of estimated glomerular filtration rates (eGFR) in a heterogeneous population, the researchers write.

“Our findings suggest the need for greater care in prescribing and monitoring of rosuvastatin, particularly in patients who are receiving high doses” or have severe chronic kidney disease (CKD), they concluded in their report published online in the Journal of the American Society of Nephrology.

The analysis included close to 1 million patients in the United States who were newly prescribed rosuvastatin or atorvastatin from 2011 through 2019; they were followed a median of 3.1 years. Among the findings:

  • Users of rosuvastatin had an 8% higher risk for hematuria, a 17% higher risk for proteinuria, and a 15% higher risk for kidney failure with replacement therapy, compared with those on atorvastatin
  • The two groups avoided MI and stroke to similar extents
  • About 44% of patients with severe CKD G4+ (eGFR < 30 mL/min per 1.73 m2) were prescribed a higher rosuvastatin dosage than the maximum 10 mg/day recommended for such patients by the Food and Drug Administration.

From this study, “we do not know why the adherence of FDA dosing recommendation for rosuvastatin in patients with severe CKD is low,” lead author Jung-Im Shin, MD, PhD, said in an interview.

“It is likely that not many clinicians are aware of rosuvastatin’s dosing recommendations [in severe CKD], or potential risks of hematuria or proteinuria,” speculated Dr. Shin, assistant professor at Johns Hopkins University, Baltimore.

“High-dose rosuvastatin [and its cardiovascular benefits] may not merit the risk, even if small, particularly in low eGFR,” she said. “Our study provides the opportunity to increase awareness of this clinical issue.”

“Future studies are warranted to shed light on the discrepancy between real-world practice and FDA dosing recommendations for high-dose rosuvastatin,” the researchers noted.

‘Greater awareness and education are key’

Invited to comment, Swapnil Hiremath, MD, a nephrologist at the Ottawa Hospital Research Institute, noted that the higher risk for nephrotoxicity with high-dose rosuvastatin versus high-dose atorvastatin was shown in the PLANET 1 trial published in 2015 and in, for example, a case report published in 2016 – which the researchers also mention.

“I was personally surprised” at the high proportion of patients with severe CKD who received higher than recommended doses of rosuvastatin, said Dr. Hiremath, who is also an associate professor at the University of Ottawa and a Freely Filtered podcaster, and not associated with the current study.

“We do see this occasionally,” he continued, “but either because someone is targeting LDL [cholesterol] and hasn’t noted the GFR, or possibly the patient was started on a high dose a long time ago and the kidney function has declined, and no one has noted the high dose.”

“Greater awareness and education are key,” observed Dr. Hiremath. “My personal bias is to have renal pharmacists involved in multidisciplinary clinics when GFR [is] less than 30 or so,” he said. “There are so many other tricky medicine/interaction issues” in patients with kidney disease.

Nevertheless, “I would be careful in drawing too many conclusions from an observational study,” Dr. Hiremath added. “There’s always the threat of residual confounding and selection bias,” which the researchers acknowledge, “and especially competing risks.”

For example, “if there is less cardiovascular death with rosuvastatin, then more people will remain alive to develop kidney failure.”
 

 

 

Dosing in practice unclear

Atorvastatin at 40-mg and 80-mg dosages and rosuvastatin at 20 mg and 40 mg are the only two statins considered high-intensity, the researchers noted.

Development of an 80-mg dosage for rosuvastatin was dropped because of hematuria and proteinuria safety signals highlighted at the time of rosuvastatin’s FDA approval.

However, there has been little postmarketing surveillance to assess real-world risk from high-intensity rosuvastatin, and it remains unclear whether and to what extent clinical practice adheres to the starting dosage recommended by the FDA in severe CKD, 5 mg/day with a maximum of 10 mg/day, the report noted.

The researchers analyzed deidentified electronic health record data from 40 health care organizations in the United States from the OptumLabs Data Warehouse database. They entered 152,101 new rosuvastatin users and 795,799 new atorvastatin users, and excluded patients with a history of rhabdomyolysis.

Patients in the two groups were similar with respect to CKD prevalence, cardiovascular risk factors, and demographics. Their age averaged 60 years, 48% were women, and 82% were White.

Hematuria was defined as dipstick hematuria > + or the presence of more than 3 red blood cells per high-power field in urine microscopy, at least twice. Proteinuria was defined as dipstick proteinuria > ++ or urine albumin-to-creatinine ratio greater than 300 mg/g at least twice.

Overall, 2.9% of patients had hematuria (3.4% of the rosuvastatin group and 2.8% of those taking atorvastatin) and 1% of patients had proteinuria (1.2% and 0.9%, respectively).

After balancing baseline characteristics in both groups using inverse probability of treatment weighting, rosuvastatin treatment, compared with atorvastatin, was associated with significantly greater risks for hematuria (hazard ratio, 1.08), proteinuria (HR, 1.17), and kidney failure requiring replacement therapy (HR, 1.15).  

Patients with eGFR less than 30 mL/min per 1.73 m2 had an approximately twofold higher risk for hematuria and ninefold higher risk for proteinuria during the follow-up compared with patients with eGFR of at least 60 mL/min per 1.73 m2.

Patients with eGFR less than 30 mL/min per 1.73 m2 were commonly prescribed high-dose rosuvastatin (29.9% received the 20-mg dose and 14% the 40-mg dose), contrary to the labeling recommendation.

Dr. Shin reported receiving research Funding from the National Institutes of Health and Merck; disclosures for the other authors are in the report. Dr. Hiremath reported having no relevant financial relationships.

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

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Rosuvastatin for cholesterol lowering was associated with slightly greater risks for kidney harm than atorvastatin, risks that were greater at higher-dose levels, in a large retrospective cohort study.

The most potent statin on the market, rosuvastatin has been linked with excess risk for kidney damage compared with atorvastatin in case reports and small trials, but there has been little surveillance of the issue following its approval in 2003.

The current analysis “is one of the first and largest real-world studies” examining rosuvastatin versus atorvastatin for risk for hematuria, proteinuria, and kidney failure with replacement therapy – dialysis or transplantation – across a range of estimated glomerular filtration rates (eGFR) in a heterogeneous population, the researchers write.

“Our findings suggest the need for greater care in prescribing and monitoring of rosuvastatin, particularly in patients who are receiving high doses” or have severe chronic kidney disease (CKD), they concluded in their report published online in the Journal of the American Society of Nephrology.

The analysis included close to 1 million patients in the United States who were newly prescribed rosuvastatin or atorvastatin from 2011 through 2019; they were followed a median of 3.1 years. Among the findings:

  • Users of rosuvastatin had an 8% higher risk for hematuria, a 17% higher risk for proteinuria, and a 15% higher risk for kidney failure with replacement therapy, compared with those on atorvastatin
  • The two groups avoided MI and stroke to similar extents
  • About 44% of patients with severe CKD G4+ (eGFR < 30 mL/min per 1.73 m2) were prescribed a higher rosuvastatin dosage than the maximum 10 mg/day recommended for such patients by the Food and Drug Administration.

From this study, “we do not know why the adherence of FDA dosing recommendation for rosuvastatin in patients with severe CKD is low,” lead author Jung-Im Shin, MD, PhD, said in an interview.

“It is likely that not many clinicians are aware of rosuvastatin’s dosing recommendations [in severe CKD], or potential risks of hematuria or proteinuria,” speculated Dr. Shin, assistant professor at Johns Hopkins University, Baltimore.

“High-dose rosuvastatin [and its cardiovascular benefits] may not merit the risk, even if small, particularly in low eGFR,” she said. “Our study provides the opportunity to increase awareness of this clinical issue.”

“Future studies are warranted to shed light on the discrepancy between real-world practice and FDA dosing recommendations for high-dose rosuvastatin,” the researchers noted.

‘Greater awareness and education are key’

Invited to comment, Swapnil Hiremath, MD, a nephrologist at the Ottawa Hospital Research Institute, noted that the higher risk for nephrotoxicity with high-dose rosuvastatin versus high-dose atorvastatin was shown in the PLANET 1 trial published in 2015 and in, for example, a case report published in 2016 – which the researchers also mention.

“I was personally surprised” at the high proportion of patients with severe CKD who received higher than recommended doses of rosuvastatin, said Dr. Hiremath, who is also an associate professor at the University of Ottawa and a Freely Filtered podcaster, and not associated with the current study.

“We do see this occasionally,” he continued, “but either because someone is targeting LDL [cholesterol] and hasn’t noted the GFR, or possibly the patient was started on a high dose a long time ago and the kidney function has declined, and no one has noted the high dose.”

“Greater awareness and education are key,” observed Dr. Hiremath. “My personal bias is to have renal pharmacists involved in multidisciplinary clinics when GFR [is] less than 30 or so,” he said. “There are so many other tricky medicine/interaction issues” in patients with kidney disease.

Nevertheless, “I would be careful in drawing too many conclusions from an observational study,” Dr. Hiremath added. “There’s always the threat of residual confounding and selection bias,” which the researchers acknowledge, “and especially competing risks.”

For example, “if there is less cardiovascular death with rosuvastatin, then more people will remain alive to develop kidney failure.”
 

 

 

Dosing in practice unclear

Atorvastatin at 40-mg and 80-mg dosages and rosuvastatin at 20 mg and 40 mg are the only two statins considered high-intensity, the researchers noted.

Development of an 80-mg dosage for rosuvastatin was dropped because of hematuria and proteinuria safety signals highlighted at the time of rosuvastatin’s FDA approval.

However, there has been little postmarketing surveillance to assess real-world risk from high-intensity rosuvastatin, and it remains unclear whether and to what extent clinical practice adheres to the starting dosage recommended by the FDA in severe CKD, 5 mg/day with a maximum of 10 mg/day, the report noted.

The researchers analyzed deidentified electronic health record data from 40 health care organizations in the United States from the OptumLabs Data Warehouse database. They entered 152,101 new rosuvastatin users and 795,799 new atorvastatin users, and excluded patients with a history of rhabdomyolysis.

Patients in the two groups were similar with respect to CKD prevalence, cardiovascular risk factors, and demographics. Their age averaged 60 years, 48% were women, and 82% were White.

Hematuria was defined as dipstick hematuria > + or the presence of more than 3 red blood cells per high-power field in urine microscopy, at least twice. Proteinuria was defined as dipstick proteinuria > ++ or urine albumin-to-creatinine ratio greater than 300 mg/g at least twice.

Overall, 2.9% of patients had hematuria (3.4% of the rosuvastatin group and 2.8% of those taking atorvastatin) and 1% of patients had proteinuria (1.2% and 0.9%, respectively).

After balancing baseline characteristics in both groups using inverse probability of treatment weighting, rosuvastatin treatment, compared with atorvastatin, was associated with significantly greater risks for hematuria (hazard ratio, 1.08), proteinuria (HR, 1.17), and kidney failure requiring replacement therapy (HR, 1.15).  

Patients with eGFR less than 30 mL/min per 1.73 m2 had an approximately twofold higher risk for hematuria and ninefold higher risk for proteinuria during the follow-up compared with patients with eGFR of at least 60 mL/min per 1.73 m2.

Patients with eGFR less than 30 mL/min per 1.73 m2 were commonly prescribed high-dose rosuvastatin (29.9% received the 20-mg dose and 14% the 40-mg dose), contrary to the labeling recommendation.

Dr. Shin reported receiving research Funding from the National Institutes of Health and Merck; disclosures for the other authors are in the report. Dr. Hiremath reported having no relevant financial relationships.

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

Rosuvastatin for cholesterol lowering was associated with slightly greater risks for kidney harm than atorvastatin, risks that were greater at higher-dose levels, in a large retrospective cohort study.

The most potent statin on the market, rosuvastatin has been linked with excess risk for kidney damage compared with atorvastatin in case reports and small trials, but there has been little surveillance of the issue following its approval in 2003.

The current analysis “is one of the first and largest real-world studies” examining rosuvastatin versus atorvastatin for risk for hematuria, proteinuria, and kidney failure with replacement therapy – dialysis or transplantation – across a range of estimated glomerular filtration rates (eGFR) in a heterogeneous population, the researchers write.

“Our findings suggest the need for greater care in prescribing and monitoring of rosuvastatin, particularly in patients who are receiving high doses” or have severe chronic kidney disease (CKD), they concluded in their report published online in the Journal of the American Society of Nephrology.

The analysis included close to 1 million patients in the United States who were newly prescribed rosuvastatin or atorvastatin from 2011 through 2019; they were followed a median of 3.1 years. Among the findings:

  • Users of rosuvastatin had an 8% higher risk for hematuria, a 17% higher risk for proteinuria, and a 15% higher risk for kidney failure with replacement therapy, compared with those on atorvastatin
  • The two groups avoided MI and stroke to similar extents
  • About 44% of patients with severe CKD G4+ (eGFR < 30 mL/min per 1.73 m2) were prescribed a higher rosuvastatin dosage than the maximum 10 mg/day recommended for such patients by the Food and Drug Administration.

From this study, “we do not know why the adherence of FDA dosing recommendation for rosuvastatin in patients with severe CKD is low,” lead author Jung-Im Shin, MD, PhD, said in an interview.

“It is likely that not many clinicians are aware of rosuvastatin’s dosing recommendations [in severe CKD], or potential risks of hematuria or proteinuria,” speculated Dr. Shin, assistant professor at Johns Hopkins University, Baltimore.

“High-dose rosuvastatin [and its cardiovascular benefits] may not merit the risk, even if small, particularly in low eGFR,” she said. “Our study provides the opportunity to increase awareness of this clinical issue.”

“Future studies are warranted to shed light on the discrepancy between real-world practice and FDA dosing recommendations for high-dose rosuvastatin,” the researchers noted.

‘Greater awareness and education are key’

Invited to comment, Swapnil Hiremath, MD, a nephrologist at the Ottawa Hospital Research Institute, noted that the higher risk for nephrotoxicity with high-dose rosuvastatin versus high-dose atorvastatin was shown in the PLANET 1 trial published in 2015 and in, for example, a case report published in 2016 – which the researchers also mention.

“I was personally surprised” at the high proportion of patients with severe CKD who received higher than recommended doses of rosuvastatin, said Dr. Hiremath, who is also an associate professor at the University of Ottawa and a Freely Filtered podcaster, and not associated with the current study.

“We do see this occasionally,” he continued, “but either because someone is targeting LDL [cholesterol] and hasn’t noted the GFR, or possibly the patient was started on a high dose a long time ago and the kidney function has declined, and no one has noted the high dose.”

“Greater awareness and education are key,” observed Dr. Hiremath. “My personal bias is to have renal pharmacists involved in multidisciplinary clinics when GFR [is] less than 30 or so,” he said. “There are so many other tricky medicine/interaction issues” in patients with kidney disease.

Nevertheless, “I would be careful in drawing too many conclusions from an observational study,” Dr. Hiremath added. “There’s always the threat of residual confounding and selection bias,” which the researchers acknowledge, “and especially competing risks.”

For example, “if there is less cardiovascular death with rosuvastatin, then more people will remain alive to develop kidney failure.”
 

 

 

Dosing in practice unclear

Atorvastatin at 40-mg and 80-mg dosages and rosuvastatin at 20 mg and 40 mg are the only two statins considered high-intensity, the researchers noted.

Development of an 80-mg dosage for rosuvastatin was dropped because of hematuria and proteinuria safety signals highlighted at the time of rosuvastatin’s FDA approval.

However, there has been little postmarketing surveillance to assess real-world risk from high-intensity rosuvastatin, and it remains unclear whether and to what extent clinical practice adheres to the starting dosage recommended by the FDA in severe CKD, 5 mg/day with a maximum of 10 mg/day, the report noted.

The researchers analyzed deidentified electronic health record data from 40 health care organizations in the United States from the OptumLabs Data Warehouse database. They entered 152,101 new rosuvastatin users and 795,799 new atorvastatin users, and excluded patients with a history of rhabdomyolysis.

Patients in the two groups were similar with respect to CKD prevalence, cardiovascular risk factors, and demographics. Their age averaged 60 years, 48% were women, and 82% were White.

Hematuria was defined as dipstick hematuria > + or the presence of more than 3 red blood cells per high-power field in urine microscopy, at least twice. Proteinuria was defined as dipstick proteinuria > ++ or urine albumin-to-creatinine ratio greater than 300 mg/g at least twice.

Overall, 2.9% of patients had hematuria (3.4% of the rosuvastatin group and 2.8% of those taking atorvastatin) and 1% of patients had proteinuria (1.2% and 0.9%, respectively).

After balancing baseline characteristics in both groups using inverse probability of treatment weighting, rosuvastatin treatment, compared with atorvastatin, was associated with significantly greater risks for hematuria (hazard ratio, 1.08), proteinuria (HR, 1.17), and kidney failure requiring replacement therapy (HR, 1.15).  

Patients with eGFR less than 30 mL/min per 1.73 m2 had an approximately twofold higher risk for hematuria and ninefold higher risk for proteinuria during the follow-up compared with patients with eGFR of at least 60 mL/min per 1.73 m2.

Patients with eGFR less than 30 mL/min per 1.73 m2 were commonly prescribed high-dose rosuvastatin (29.9% received the 20-mg dose and 14% the 40-mg dose), contrary to the labeling recommendation.

Dr. Shin reported receiving research Funding from the National Institutes of Health and Merck; disclosures for the other authors are in the report. Dr. Hiremath reported having no relevant financial relationships.

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

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FDA clears endoscopic devices for sleeve gastroplasty, bariatric revision

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Tue, 07/26/2022 - 10:42

The Food and Drug Administration has cleared for marketing the first devices indicated for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision, according to the manufacturer.

The Apollo ESG, Apollo ESG Sx, Apollo Revise, and Apollo Revise Sx systems made by Apollo Endosurgery were reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

“The Apollo ESG and Apollo Revise systems offer a compelling mix of effectiveness, safety, durability, and convenience for treatment of patients with obesity,” Chas McKhann, president and CEO of the company, said in a news release.

“The authorization of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic,” Mr. McKhann added.

The Apollo ESG and Apollo ESG Sx systems are intended for use by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity who have failed to lose weight or maintain weight loss through more conservative measures, the company says.

The Apollo Revise and Apollo Revise Sx systems allow gastroenterologists or surgeons to perform transoral outlet reduction (TORe) as a revision to a previous bariatric procedure.

Studies have shown that 10 years after bariatric surgery, patients have regained an average of 20%-30% of weight they initially lost. Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.

TORe is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.

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

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The Food and Drug Administration has cleared for marketing the first devices indicated for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision, according to the manufacturer.

The Apollo ESG, Apollo ESG Sx, Apollo Revise, and Apollo Revise Sx systems made by Apollo Endosurgery were reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

“The Apollo ESG and Apollo Revise systems offer a compelling mix of effectiveness, safety, durability, and convenience for treatment of patients with obesity,” Chas McKhann, president and CEO of the company, said in a news release.

“The authorization of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic,” Mr. McKhann added.

The Apollo ESG and Apollo ESG Sx systems are intended for use by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity who have failed to lose weight or maintain weight loss through more conservative measures, the company says.

The Apollo Revise and Apollo Revise Sx systems allow gastroenterologists or surgeons to perform transoral outlet reduction (TORe) as a revision to a previous bariatric procedure.

Studies have shown that 10 years after bariatric surgery, patients have regained an average of 20%-30% of weight they initially lost. Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.

TORe is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.

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

The Food and Drug Administration has cleared for marketing the first devices indicated for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision, according to the manufacturer.

The Apollo ESG, Apollo ESG Sx, Apollo Revise, and Apollo Revise Sx systems made by Apollo Endosurgery were reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

“The Apollo ESG and Apollo Revise systems offer a compelling mix of effectiveness, safety, durability, and convenience for treatment of patients with obesity,” Chas McKhann, president and CEO of the company, said in a news release.

“The authorization of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic,” Mr. McKhann added.

The Apollo ESG and Apollo ESG Sx systems are intended for use by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity who have failed to lose weight or maintain weight loss through more conservative measures, the company says.

The Apollo Revise and Apollo Revise Sx systems allow gastroenterologists or surgeons to perform transoral outlet reduction (TORe) as a revision to a previous bariatric procedure.

Studies have shown that 10 years after bariatric surgery, patients have regained an average of 20%-30% of weight they initially lost. Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.

TORe is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.

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

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Does your patient have long COVID? Some clues on what to look for

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Fri, 07/22/2022 - 14:17

New Yorker Lyss Stern came down with COVID-19 at the beginning of the pandemic, in March 2020. She ran a 103° F fever for 5 days straight and was bedridden for several weeks. Yet symptoms such as a persistent headache and tinnitus, or ringing in her ears, lingered.

“Four months later, I still couldn’t walk four blocks without becoming winded,” says Ms. Stern, 48. Five months after her diagnosis, her doctors finally gave a name to her condition: long COVID.

Long COVID is known by many different names: long-haul COVID, postacute COVID-19, or even chronic COVID. It’s a general term used to describe the range of ongoing health problems people can have after their infection.

The most recent data from the Centers for Disease Control and Prevention has found that one in 13 adults in the United States – 7.5% – have symptoms that last at least 3 months after they first came down with the virus. Another earlier report found that one in five COVID-19 survivors between the ages of 18 and 64, and one in four survivors aged at least 65, have a health condition that may be related to their previous bout with the virus.

Unfortunately, there’s no easy way to screen for long COVID.

“There’s no definite laboratory test to give us a diagnosis,” says Daniel Sterman, MD, director of the division of pulmonary, critical care and sleep medicine at NYU Langone Health in New York. “We’re also still working on a definition, since there’s a whole slew of symptoms associated with the condition.”

It’s a challenge that Ms. Stern is personally acquainted with after she bounced from doctor to doctor for several months before she found her way to the Center for Post-COVID Care at Mount Sinai Hospital in New York. “It was a relief to have an official diagnosis, even if it didn’t bring immediate answers,” she says.
 

What to look for

Many people who become infected with COVID-19 get symptoms that linger for 2-3 weeks after their infection has cleared, says Brittany Baloun, a certified nurse practitioner at the Cleveland Clinic. “It’s not unusual to feel some residual shortness of breath or heart palpitations, especially if you are exerting yourself,” she says. “The acute phase of COVID itself can last for up to 14 days. But if it’s been 30 days since you came down with the virus, and your symptoms are still there and not improving, it indicates some level of long COVID.”

More than 200 symptoms can be linked to long COVID. But perhaps the one that stands out the most is constant fatigue that interferes with daily life.

“We often hear that these patients can’t fold the laundry or take a short walk with their dog without feeling exhausted,” Ms. Baloun says.

This exhaustion may get worse after patients exercise or do something mentally taxing, a condition known as postexertional malaise.

“It can be crushing fatigue; I may clean my room for an hour and talk to a friend, and the next day feel like I can’t get out of bed,” says Allison Guy, 36, who was diagnosed with COVID in February 2021. She’s now a long-COVID advocate in Washington.

Other symptoms can be divided into different categories, which include cardiac/lung symptoms such as shortness of breath, coughing, chest pain, and heart palpitations, as well as neurologic symptoms.

One of the most common neurologic symptoms is brain fog, says Andrew Schamess, MD, a professor of internal medicine at Ohio State University Wexner Medical Center, Columbus, who runs its post-COVID recovery program. “Patients describe feeling ‘fuzzy’ or ‘spacey,’ and often report that they are forgetful or have memory problems,” he says. Others include:

  • Headache.
  • Sleep problems. One 2022 study from the Cleveland Clinic found that more than 40% of patients with long COVID reported sleep disturbances.
  • Dizziness when standing.
  • Pins-and-needles feelings.
  • Changes in smell or taste.
  • Depression or anxiety.

You could also have digestive symptoms such as diarrhea or stomach pain. Other symptoms include joint or muscle pain, rashes, or changes in menstrual cycles.
 

Risk of having other health conditions

People who have had COVID-19, particularly a severe case, may be more at risk of getting other health conditions, such as:

  • Type 2 diabetes.
  • Kidney failure.
  • Pulmonary embolism, or a blood clot in the lung.
  • Myocarditis, an inflamed heart.

While it’s hard to say precisely whether these conditions were caused by COVID, they are most likely linked to it, says Dr. Schamess. A March 2022 study published in The Lancet Diabetes & Endocrinology, for example, found that people who had recovered from COVID-19 had a 40% higher risk of being diagnosed with type 2 diabetes over the next year.

“We don’t know for sure that infection with COVID-19 triggered someone’s diabetes – it may have been that they already had risk factors and the virus pushed them over the edge,” he says.

COVID-19 itself may also worsen conditions you already have, such as asthma, sleep apnea, or fibromyalgia. “We see patients with previously mild asthma who come in constantly coughing and wheezing, for example,” says Dr. Schamess. “They usually respond well once we start aggressive treatment.” That might include a continuous positive airway pressure, or CPAP, setup to help treat sleep apnea, or gabapentin to treat fibromyalgia symptoms.
 

Is it long COVID or something else?

Long COVID can cause a long list of symptoms, and they can easily mean other ailments. That’s one reason why, if your symptoms last for more than a month, it’s important to see a doctor, Ms. Baloun says. They can run a wide variety of tests to check for other conditions, such as a thyroid disorder or vitamin deficiency, that could be confused with long COVID.

They should also run blood tests such as D-dimer. This helps rule out a pulmonary embolism, which can be a complication of COVID-19 and also causes symptoms that may mimic long COVID, such as breathlessness and anxiety. They will also run tests to look for inflammation, Ms. Baloun says.

“These tests can’t provide definitive answers, but they can help provide clues as to what’s causing symptoms and whether they are related to long COVID,” she says.

What’s just as important, says Dr. Schamess, is a careful medical history. This can help pinpoint exactly when symptoms started, when they worsened, and whether anything else could have triggered them.

“I saw a patient recently who presented with symptoms of brain fog, memory loss, fatigue, headache, and sleep disturbance 5 months after she had COVID-19,” says Dr. Schamess. “After we talked, we realized that her symptoms were due to a fainting spell a couple of months earlier where she whacked her head very hard. She didn’t have long COVID – she had a concussion. But I wouldn’t have picked that up if I had just run a whole battery of tests.”

Ms. Stern agrees. “If you have long COVID, you may come across doctors who dismiss your symptoms, especially if your workups don’t show an obvious problem,” she says. “But you know your body. If it still seems like something is wrong, then you need to continue to push until you find answers.”

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

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New Yorker Lyss Stern came down with COVID-19 at the beginning of the pandemic, in March 2020. She ran a 103° F fever for 5 days straight and was bedridden for several weeks. Yet symptoms such as a persistent headache and tinnitus, or ringing in her ears, lingered.

“Four months later, I still couldn’t walk four blocks without becoming winded,” says Ms. Stern, 48. Five months after her diagnosis, her doctors finally gave a name to her condition: long COVID.

Long COVID is known by many different names: long-haul COVID, postacute COVID-19, or even chronic COVID. It’s a general term used to describe the range of ongoing health problems people can have after their infection.

The most recent data from the Centers for Disease Control and Prevention has found that one in 13 adults in the United States – 7.5% – have symptoms that last at least 3 months after they first came down with the virus. Another earlier report found that one in five COVID-19 survivors between the ages of 18 and 64, and one in four survivors aged at least 65, have a health condition that may be related to their previous bout with the virus.

Unfortunately, there’s no easy way to screen for long COVID.

“There’s no definite laboratory test to give us a diagnosis,” says Daniel Sterman, MD, director of the division of pulmonary, critical care and sleep medicine at NYU Langone Health in New York. “We’re also still working on a definition, since there’s a whole slew of symptoms associated with the condition.”

It’s a challenge that Ms. Stern is personally acquainted with after she bounced from doctor to doctor for several months before she found her way to the Center for Post-COVID Care at Mount Sinai Hospital in New York. “It was a relief to have an official diagnosis, even if it didn’t bring immediate answers,” she says.
 

What to look for

Many people who become infected with COVID-19 get symptoms that linger for 2-3 weeks after their infection has cleared, says Brittany Baloun, a certified nurse practitioner at the Cleveland Clinic. “It’s not unusual to feel some residual shortness of breath or heart palpitations, especially if you are exerting yourself,” she says. “The acute phase of COVID itself can last for up to 14 days. But if it’s been 30 days since you came down with the virus, and your symptoms are still there and not improving, it indicates some level of long COVID.”

More than 200 symptoms can be linked to long COVID. But perhaps the one that stands out the most is constant fatigue that interferes with daily life.

“We often hear that these patients can’t fold the laundry or take a short walk with their dog without feeling exhausted,” Ms. Baloun says.

This exhaustion may get worse after patients exercise or do something mentally taxing, a condition known as postexertional malaise.

“It can be crushing fatigue; I may clean my room for an hour and talk to a friend, and the next day feel like I can’t get out of bed,” says Allison Guy, 36, who was diagnosed with COVID in February 2021. She’s now a long-COVID advocate in Washington.

Other symptoms can be divided into different categories, which include cardiac/lung symptoms such as shortness of breath, coughing, chest pain, and heart palpitations, as well as neurologic symptoms.

One of the most common neurologic symptoms is brain fog, says Andrew Schamess, MD, a professor of internal medicine at Ohio State University Wexner Medical Center, Columbus, who runs its post-COVID recovery program. “Patients describe feeling ‘fuzzy’ or ‘spacey,’ and often report that they are forgetful or have memory problems,” he says. Others include:

  • Headache.
  • Sleep problems. One 2022 study from the Cleveland Clinic found that more than 40% of patients with long COVID reported sleep disturbances.
  • Dizziness when standing.
  • Pins-and-needles feelings.
  • Changes in smell or taste.
  • Depression or anxiety.

You could also have digestive symptoms such as diarrhea or stomach pain. Other symptoms include joint or muscle pain, rashes, or changes in menstrual cycles.
 

Risk of having other health conditions

People who have had COVID-19, particularly a severe case, may be more at risk of getting other health conditions, such as:

  • Type 2 diabetes.
  • Kidney failure.
  • Pulmonary embolism, or a blood clot in the lung.
  • Myocarditis, an inflamed heart.

While it’s hard to say precisely whether these conditions were caused by COVID, they are most likely linked to it, says Dr. Schamess. A March 2022 study published in The Lancet Diabetes & Endocrinology, for example, found that people who had recovered from COVID-19 had a 40% higher risk of being diagnosed with type 2 diabetes over the next year.

“We don’t know for sure that infection with COVID-19 triggered someone’s diabetes – it may have been that they already had risk factors and the virus pushed them over the edge,” he says.

COVID-19 itself may also worsen conditions you already have, such as asthma, sleep apnea, or fibromyalgia. “We see patients with previously mild asthma who come in constantly coughing and wheezing, for example,” says Dr. Schamess. “They usually respond well once we start aggressive treatment.” That might include a continuous positive airway pressure, or CPAP, setup to help treat sleep apnea, or gabapentin to treat fibromyalgia symptoms.
 

Is it long COVID or something else?

Long COVID can cause a long list of symptoms, and they can easily mean other ailments. That’s one reason why, if your symptoms last for more than a month, it’s important to see a doctor, Ms. Baloun says. They can run a wide variety of tests to check for other conditions, such as a thyroid disorder or vitamin deficiency, that could be confused with long COVID.

They should also run blood tests such as D-dimer. This helps rule out a pulmonary embolism, which can be a complication of COVID-19 and also causes symptoms that may mimic long COVID, such as breathlessness and anxiety. They will also run tests to look for inflammation, Ms. Baloun says.

“These tests can’t provide definitive answers, but they can help provide clues as to what’s causing symptoms and whether they are related to long COVID,” she says.

What’s just as important, says Dr. Schamess, is a careful medical history. This can help pinpoint exactly when symptoms started, when they worsened, and whether anything else could have triggered them.

“I saw a patient recently who presented with symptoms of brain fog, memory loss, fatigue, headache, and sleep disturbance 5 months after she had COVID-19,” says Dr. Schamess. “After we talked, we realized that her symptoms were due to a fainting spell a couple of months earlier where she whacked her head very hard. She didn’t have long COVID – she had a concussion. But I wouldn’t have picked that up if I had just run a whole battery of tests.”

Ms. Stern agrees. “If you have long COVID, you may come across doctors who dismiss your symptoms, especially if your workups don’t show an obvious problem,” she says. “But you know your body. If it still seems like something is wrong, then you need to continue to push until you find answers.”

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

New Yorker Lyss Stern came down with COVID-19 at the beginning of the pandemic, in March 2020. She ran a 103° F fever for 5 days straight and was bedridden for several weeks. Yet symptoms such as a persistent headache and tinnitus, or ringing in her ears, lingered.

“Four months later, I still couldn’t walk four blocks without becoming winded,” says Ms. Stern, 48. Five months after her diagnosis, her doctors finally gave a name to her condition: long COVID.

Long COVID is known by many different names: long-haul COVID, postacute COVID-19, or even chronic COVID. It’s a general term used to describe the range of ongoing health problems people can have after their infection.

The most recent data from the Centers for Disease Control and Prevention has found that one in 13 adults in the United States – 7.5% – have symptoms that last at least 3 months after they first came down with the virus. Another earlier report found that one in five COVID-19 survivors between the ages of 18 and 64, and one in four survivors aged at least 65, have a health condition that may be related to their previous bout with the virus.

Unfortunately, there’s no easy way to screen for long COVID.

“There’s no definite laboratory test to give us a diagnosis,” says Daniel Sterman, MD, director of the division of pulmonary, critical care and sleep medicine at NYU Langone Health in New York. “We’re also still working on a definition, since there’s a whole slew of symptoms associated with the condition.”

It’s a challenge that Ms. Stern is personally acquainted with after she bounced from doctor to doctor for several months before she found her way to the Center for Post-COVID Care at Mount Sinai Hospital in New York. “It was a relief to have an official diagnosis, even if it didn’t bring immediate answers,” she says.
 

What to look for

Many people who become infected with COVID-19 get symptoms that linger for 2-3 weeks after their infection has cleared, says Brittany Baloun, a certified nurse practitioner at the Cleveland Clinic. “It’s not unusual to feel some residual shortness of breath or heart palpitations, especially if you are exerting yourself,” she says. “The acute phase of COVID itself can last for up to 14 days. But if it’s been 30 days since you came down with the virus, and your symptoms are still there and not improving, it indicates some level of long COVID.”

More than 200 symptoms can be linked to long COVID. But perhaps the one that stands out the most is constant fatigue that interferes with daily life.

“We often hear that these patients can’t fold the laundry or take a short walk with their dog without feeling exhausted,” Ms. Baloun says.

This exhaustion may get worse after patients exercise or do something mentally taxing, a condition known as postexertional malaise.

“It can be crushing fatigue; I may clean my room for an hour and talk to a friend, and the next day feel like I can’t get out of bed,” says Allison Guy, 36, who was diagnosed with COVID in February 2021. She’s now a long-COVID advocate in Washington.

Other symptoms can be divided into different categories, which include cardiac/lung symptoms such as shortness of breath, coughing, chest pain, and heart palpitations, as well as neurologic symptoms.

One of the most common neurologic symptoms is brain fog, says Andrew Schamess, MD, a professor of internal medicine at Ohio State University Wexner Medical Center, Columbus, who runs its post-COVID recovery program. “Patients describe feeling ‘fuzzy’ or ‘spacey,’ and often report that they are forgetful or have memory problems,” he says. Others include:

  • Headache.
  • Sleep problems. One 2022 study from the Cleveland Clinic found that more than 40% of patients with long COVID reported sleep disturbances.
  • Dizziness when standing.
  • Pins-and-needles feelings.
  • Changes in smell or taste.
  • Depression or anxiety.

You could also have digestive symptoms such as diarrhea or stomach pain. Other symptoms include joint or muscle pain, rashes, or changes in menstrual cycles.
 

Risk of having other health conditions

People who have had COVID-19, particularly a severe case, may be more at risk of getting other health conditions, such as:

  • Type 2 diabetes.
  • Kidney failure.
  • Pulmonary embolism, or a blood clot in the lung.
  • Myocarditis, an inflamed heart.

While it’s hard to say precisely whether these conditions were caused by COVID, they are most likely linked to it, says Dr. Schamess. A March 2022 study published in The Lancet Diabetes & Endocrinology, for example, found that people who had recovered from COVID-19 had a 40% higher risk of being diagnosed with type 2 diabetes over the next year.

“We don’t know for sure that infection with COVID-19 triggered someone’s diabetes – it may have been that they already had risk factors and the virus pushed them over the edge,” he says.

COVID-19 itself may also worsen conditions you already have, such as asthma, sleep apnea, or fibromyalgia. “We see patients with previously mild asthma who come in constantly coughing and wheezing, for example,” says Dr. Schamess. “They usually respond well once we start aggressive treatment.” That might include a continuous positive airway pressure, or CPAP, setup to help treat sleep apnea, or gabapentin to treat fibromyalgia symptoms.
 

Is it long COVID or something else?

Long COVID can cause a long list of symptoms, and they can easily mean other ailments. That’s one reason why, if your symptoms last for more than a month, it’s important to see a doctor, Ms. Baloun says. They can run a wide variety of tests to check for other conditions, such as a thyroid disorder or vitamin deficiency, that could be confused with long COVID.

They should also run blood tests such as D-dimer. This helps rule out a pulmonary embolism, which can be a complication of COVID-19 and also causes symptoms that may mimic long COVID, such as breathlessness and anxiety. They will also run tests to look for inflammation, Ms. Baloun says.

“These tests can’t provide definitive answers, but they can help provide clues as to what’s causing symptoms and whether they are related to long COVID,” she says.

What’s just as important, says Dr. Schamess, is a careful medical history. This can help pinpoint exactly when symptoms started, when they worsened, and whether anything else could have triggered them.

“I saw a patient recently who presented with symptoms of brain fog, memory loss, fatigue, headache, and sleep disturbance 5 months after she had COVID-19,” says Dr. Schamess. “After we talked, we realized that her symptoms were due to a fainting spell a couple of months earlier where she whacked her head very hard. She didn’t have long COVID – she had a concussion. But I wouldn’t have picked that up if I had just run a whole battery of tests.”

Ms. Stern agrees. “If you have long COVID, you may come across doctors who dismiss your symptoms, especially if your workups don’t show an obvious problem,” she says. “But you know your body. If it still seems like something is wrong, then you need to continue to push until you find answers.”

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

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