Siloed, adj.:

Kept in isolation in a way that hinders communication and cooperation . . .

—Merriam-Webster’s Dictionary

Humans naturally separate into groups, and the medical field is no exception. Being a member of a likeminded group, such as one’s specialty, can improve self-esteem and provide social organization: it feels good to identify with people we admire. Through culture, these specialty-based groups implicitly and explicitly guide and encourage positive attributes or behaviors like a hospitalist’s thoroughness or an emergency medicine physician’s steady management of unstable patients. Our specialties also provide support and understanding in challenging times. 

Despite these positive aspects, such divisions can negatively affect interprofessional relationships when our specialties become siloed. A potential side-effect of building up ourselves and our own groups is that we can implicitly put others down. For example, a hospitalist who spends extra time on the phone regularly updating each patient’s family will appropriately take pride in their practice, but over time this can also lead to an unreasonable assumption that physicians in other departments with different routines are not as committed to outstanding communication.

These rigid separations facilitate the fundamental attribution error, the tendency to ascribe a problem or disagreement to a colleague’s substandard character or ability. Imagine that the aforementioned hospitalist’s phone call delays a response to an admission page from the emergency room. The emergency medicine physician, who is waiting to sign out the admission while simultaneously managing many sick and complex patients, could assume the hospitalist is being disrespectful, rather than also working hard to provide the best care. Our siloed specialty identities can lead us to imagine the worst in each other and exacerbate intergroup conflict.¹

Silos in medicine also adversely affect patients. Poor communication and lack of information-sharing across disciplines can lead to medical error² and stifle dissemination of safer practices.³ Further, the unintentional disparaging of other medical specialties undermines the confidence our patients have in all of us; a patient within earshot of the hospitalist expressing annoyance at the “impatient” emergency medicine physician who “won’t stop paging,” or the emergency medicine physician complaining about the hospitalist who “refuses to call back,” will lose trust in each of their providers. 

We suggest three steps to reduce the negative impact of specialty silos in medicine: 

1. Get to know each other personally. Friendly conversation during work hours and social interaction outside the hospital can inoculate against interspecialty conflict by putting a human face on our colleagues. The resultant relationships make it easier to work together and see things from another’s perspective. 
2. Emphasize our shared affiliations.⁴ The greater the salience of a mutual identity as “healthcare providers,” the more likely we are to recognize each other’s unique contributions and question the stereotypes we imagine about one another. 
3. Consider projects across specialties. Interdepartmental data-sharing and joint meetings, including educational conferences, can facilitate situational awareness, synergy, and efficient problem-solving. 

Our medical specialties will continue to group together. While these groups can be a source of strength and meaning, silos can interfere with professional alliances and effective patient care. Mitigating the harmful effects of silos can benefit all of us and our patients.

Authors’ note: This article was previously published using the term “tribalism,” which we have since learned is derogatory to Indigenous Americans and others. We apologize for any harm. We have retracted and republished the article without this language. We appreciate readers teaching us how to choose better words so all people feel respected and valued.

Siloed, adj.:

Kept in isolation in a way that hinders communication and cooperation . . .

—Merriam-Webster’s Dictionary

Humans naturally separate into groups, and the medical field is no exception. Being a member of a likeminded group, such as one’s specialty, can improve self-esteem and provide social organization: it feels good to identify with people we admire. Through culture, these specialty-based groups implicitly and explicitly guide and encourage positive attributes or behaviors like a hospitalist’s thoroughness or an emergency medicine physician’s steady management of unstable patients. Our specialties also provide support and understanding in challenging times. 

Despite these positive aspects, such divisions can negatively affect interprofessional relationships when our specialties become siloed. A potential side-effect of building up ourselves and our own groups is that we can implicitly put others down. For example, a hospitalist who spends extra time on the phone regularly updating each patient’s family will appropriately take pride in their practice, but over time this can also lead to an unreasonable assumption that physicians in other departments with different routines are not as committed to outstanding communication.

These rigid separations facilitate the fundamental attribution error, the tendency to ascribe a problem or disagreement to a colleague’s substandard character or ability. Imagine that the aforementioned hospitalist’s phone call delays a response to an admission page from the emergency room. The emergency medicine physician, who is waiting to sign out the admission while simultaneously managing many sick and complex patients, could assume the hospitalist is being disrespectful, rather than also working hard to provide the best care. Our siloed specialty identities can lead us to imagine the worst in each other and exacerbate intergroup conflict.¹

Silos in medicine also adversely affect patients. Poor communication and lack of information-sharing across disciplines can lead to medical error² and stifle dissemination of safer practices.³ Further, the unintentional disparaging of other medical specialties undermines the confidence our patients have in all of us; a patient within earshot of the hospitalist expressing annoyance at the “impatient” emergency medicine physician who “won’t stop paging,” or the emergency medicine physician complaining about the hospitalist who “refuses to call back,” will lose trust in each of their providers. 

We suggest three steps to reduce the negative impact of specialty silos in medicine: 

1. Get to know each other personally. Friendly conversation during work hours and social interaction outside the hospital can inoculate against interspecialty conflict by putting a human face on our colleagues. The resultant relationships make it easier to work together and see things from another’s perspective. 
2. Emphasize our shared affiliations.⁴ The greater the salience of a mutual identity as “healthcare providers,” the more likely we are to recognize each other’s unique contributions and question the stereotypes we imagine about one another. 
3. Consider projects across specialties. Interdepartmental data-sharing and joint meetings, including educational conferences, can facilitate situational awareness, synergy, and efficient problem-solving. 

Our medical specialties will continue to group together. While these groups can be a source of strength and meaning, silos can interfere with professional alliances and effective patient care. Mitigating the harmful effects of silos can benefit all of us and our patients.

Authors’ note: This article was previously published using the term “tribalism,” which we have since learned is derogatory to Indigenous Americans and others. We apologize for any harm. We have retracted and republished the article without this language. We appreciate readers teaching us how to choose better words so all people feel respected and valued.

Siloed, adj.:

Kept in isolation in a way that hinders communication and cooperation . . .

—Merriam-Webster’s Dictionary

Humans naturally separate into groups, and the medical field is no exception. Being a member of a likeminded group, such as one’s specialty, can improve self-esteem and provide social organization: it feels good to identify with people we admire. Through culture, these specialty-based groups implicitly and explicitly guide and encourage positive attributes or behaviors like a hospitalist’s thoroughness or an emergency medicine physician’s steady management of unstable patients. Our specialties also provide support and understanding in challenging times. 

Despite these positive aspects, such divisions can negatively affect interprofessional relationships when our specialties become siloed. A potential side-effect of building up ourselves and our own groups is that we can implicitly put others down. For example, a hospitalist who spends extra time on the phone regularly updating each patient’s family will appropriately take pride in their practice, but over time this can also lead to an unreasonable assumption that physicians in other departments with different routines are not as committed to outstanding communication.

These rigid separations facilitate the fundamental attribution error, the tendency to ascribe a problem or disagreement to a colleague’s substandard character or ability. Imagine that the aforementioned hospitalist’s phone call delays a response to an admission page from the emergency room. The emergency medicine physician, who is waiting to sign out the admission while simultaneously managing many sick and complex patients, could assume the hospitalist is being disrespectful, rather than also working hard to provide the best care. Our siloed specialty identities can lead us to imagine the worst in each other and exacerbate intergroup conflict.¹

Silos in medicine also adversely affect patients. Poor communication and lack of information-sharing across disciplines can lead to medical error² and stifle dissemination of safer practices.³ Further, the unintentional disparaging of other medical specialties undermines the confidence our patients have in all of us; a patient within earshot of the hospitalist expressing annoyance at the “impatient” emergency medicine physician who “won’t stop paging,” or the emergency medicine physician complaining about the hospitalist who “refuses to call back,” will lose trust in each of their providers. 

We suggest three steps to reduce the negative impact of specialty silos in medicine: 

1. Get to know each other personally. Friendly conversation during work hours and social interaction outside the hospital can inoculate against interspecialty conflict by putting a human face on our colleagues. The resultant relationships make it easier to work together and see things from another’s perspective. 
2. Emphasize our shared affiliations.⁴ The greater the salience of a mutual identity as “healthcare providers,” the more likely we are to recognize each other’s unique contributions and question the stereotypes we imagine about one another. 
3. Consider projects across specialties. Interdepartmental data-sharing and joint meetings, including educational conferences, can facilitate situational awareness, synergy, and efficient problem-solving. 

Our medical specialties will continue to group together. While these groups can be a source of strength and meaning, silos can interfere with professional alliances and effective patient care. Mitigating the harmful effects of silos can benefit all of us and our patients.

Authors’ note: This article was previously published using the term “tribalism,” which we have since learned is derogatory to Indigenous Americans and others. We apologize for any harm. We have retracted and republished the article without this language. We appreciate readers teaching us how to choose better words so all people feel respected and valued.

Converge 2021 session

High Value Care in Pediatrics – Things We Do for No Reason

Presenter

Ricardo Quinonez, MD, FAAP, FHM

Session summary

Dr. Ricardo Quinonez, associate professor of pediatrics at Baylor College of Medicine and chief of pediatric hospital medicine at Texas Children’s Hospital, both in Houston, presented key topics in pediatric hospital medicine with low-value care management practices which are not supported by recent literature. This session was a continuation of the popular lecture series first presented at the Society of Hospital Medicine annual conference and the “Choosing Wisely: Things We Do for No Reason” article series in the Journal of Hospital Medicine.

Dr. Quinonez began by discussing high flow nasal cannula (HFNC) in bronchiolitis. At first, early observational studies showed a decrease in intubation rate for children placed on HFNC, which resulted in its high utilization. Randomized, controlled trials (RCTs) later showed that early initiation of HFNC did not affect rates of transfer to the ICU, duration of oxygen need, or length of stay.

He then discussed the treatment of symptomatic spontaneous pneumothorax in children, which is often managed by hospital admission, needle aspiration and chest tube placement, and serial chest x-rays. Instead, recent literature supports an ambulatory approach by placing a device with an 8 French catheter with one way Heimlich valve. After placement, a chest x-ray is performed and if the pneumothorax is stable, the patient is discharged with plans for serial chest x-rays as an outpatient. The device is removed after re-expansion of the lung.

Dr. Quinonez then discussed the frequent pediatric complaint of constipation. He stated that abdominal x-rays for evaluation of “stool burden” are not reliable, and x-rays are recommended against in both U.S. and British guidelines. Furthermore, a high-fiber diet is often recommended as a treatment for constipation. However, after review of recent RCTs and cohort studies, no relationship between a low-fiber diet and constipation was seen. Instead, genetics likely plays a large part in causing constipation.

Lastly, Dr. Quinonez discussed electrolyte testing in children with acute gastroenteritis. Electrolyte testing is commonly performed, yet testing patterns vary greatly across children’s hospitals. One quality improvement project found that after decreasing electrolyte testing by more than a third during hospitalizations, no change in readmission rate or renal replacement therapy was reported.
 

Key takeaways

• Early use of high flow nasal cannula in bronchiolitis does not affect rates of transfer to the ICU or length of stay.
• Abdominal x-rays to assess for constipation are not recommended and are not reliable in measuring stool burden.
• A low-fiber diet does not cause constipation.
• Quality improvement projects can help physicians “choose wisely” and decrease things we do for no reason.

Dr. Tantoco is an academic med-peds hospitalist at Northwestern Memorial Hospital and Ann & Robert H. Lurie Children’s Hospital of Chicago. She is an instructor of medicine (hospital medicine) and pediatrics at Northwestern University, Chicago.

Converge 2021 session

High Value Care in Pediatrics – Things We Do for No Reason

Presenter

Ricardo Quinonez, MD, FAAP, FHM

Session summary

Dr. Ricardo Quinonez, associate professor of pediatrics at Baylor College of Medicine and chief of pediatric hospital medicine at Texas Children’s Hospital, both in Houston, presented key topics in pediatric hospital medicine with low-value care management practices which are not supported by recent literature. This session was a continuation of the popular lecture series first presented at the Society of Hospital Medicine annual conference and the “Choosing Wisely: Things We Do for No Reason” article series in the Journal of Hospital Medicine.

Dr. Quinonez began by discussing high flow nasal cannula (HFNC) in bronchiolitis. At first, early observational studies showed a decrease in intubation rate for children placed on HFNC, which resulted in its high utilization. Randomized, controlled trials (RCTs) later showed that early initiation of HFNC did not affect rates of transfer to the ICU, duration of oxygen need, or length of stay.

He then discussed the treatment of symptomatic spontaneous pneumothorax in children, which is often managed by hospital admission, needle aspiration and chest tube placement, and serial chest x-rays. Instead, recent literature supports an ambulatory approach by placing a device with an 8 French catheter with one way Heimlich valve. After placement, a chest x-ray is performed and if the pneumothorax is stable, the patient is discharged with plans for serial chest x-rays as an outpatient. The device is removed after re-expansion of the lung.

Dr. Quinonez then discussed the frequent pediatric complaint of constipation. He stated that abdominal x-rays for evaluation of “stool burden” are not reliable, and x-rays are recommended against in both U.S. and British guidelines. Furthermore, a high-fiber diet is often recommended as a treatment for constipation. However, after review of recent RCTs and cohort studies, no relationship between a low-fiber diet and constipation was seen. Instead, genetics likely plays a large part in causing constipation.

Lastly, Dr. Quinonez discussed electrolyte testing in children with acute gastroenteritis. Electrolyte testing is commonly performed, yet testing patterns vary greatly across children’s hospitals. One quality improvement project found that after decreasing electrolyte testing by more than a third during hospitalizations, no change in readmission rate or renal replacement therapy was reported.
 

Key takeaways

• Early use of high flow nasal cannula in bronchiolitis does not affect rates of transfer to the ICU or length of stay.
• Abdominal x-rays to assess for constipation are not recommended and are not reliable in measuring stool burden.
• A low-fiber diet does not cause constipation.
• Quality improvement projects can help physicians “choose wisely” and decrease things we do for no reason.

Dr. Tantoco is an academic med-peds hospitalist at Northwestern Memorial Hospital and Ann & Robert H. Lurie Children’s Hospital of Chicago. She is an instructor of medicine (hospital medicine) and pediatrics at Northwestern University, Chicago.

Converge 2021 session

High Value Care in Pediatrics – Things We Do for No Reason

Presenter

Ricardo Quinonez, MD, FAAP, FHM

Session summary

Dr. Ricardo Quinonez, associate professor of pediatrics at Baylor College of Medicine and chief of pediatric hospital medicine at Texas Children’s Hospital, both in Houston, presented key topics in pediatric hospital medicine with low-value care management practices which are not supported by recent literature. This session was a continuation of the popular lecture series first presented at the Society of Hospital Medicine annual conference and the “Choosing Wisely: Things We Do for No Reason” article series in the Journal of Hospital Medicine.

Dr. Quinonez began by discussing high flow nasal cannula (HFNC) in bronchiolitis. At first, early observational studies showed a decrease in intubation rate for children placed on HFNC, which resulted in its high utilization. Randomized, controlled trials (RCTs) later showed that early initiation of HFNC did not affect rates of transfer to the ICU, duration of oxygen need, or length of stay.

He then discussed the treatment of symptomatic spontaneous pneumothorax in children, which is often managed by hospital admission, needle aspiration and chest tube placement, and serial chest x-rays. Instead, recent literature supports an ambulatory approach by placing a device with an 8 French catheter with one way Heimlich valve. After placement, a chest x-ray is performed and if the pneumothorax is stable, the patient is discharged with plans for serial chest x-rays as an outpatient. The device is removed after re-expansion of the lung.

Dr. Quinonez then discussed the frequent pediatric complaint of constipation. He stated that abdominal x-rays for evaluation of “stool burden” are not reliable, and x-rays are recommended against in both U.S. and British guidelines. Furthermore, a high-fiber diet is often recommended as a treatment for constipation. However, after review of recent RCTs and cohort studies, no relationship between a low-fiber diet and constipation was seen. Instead, genetics likely plays a large part in causing constipation.

Lastly, Dr. Quinonez discussed electrolyte testing in children with acute gastroenteritis. Electrolyte testing is commonly performed, yet testing patterns vary greatly across children’s hospitals. One quality improvement project found that after decreasing electrolyte testing by more than a third during hospitalizations, no change in readmission rate or renal replacement therapy was reported.
 

Key takeaways

• Early use of high flow nasal cannula in bronchiolitis does not affect rates of transfer to the ICU or length of stay.
• Abdominal x-rays to assess for constipation are not recommended and are not reliable in measuring stool burden.
• A low-fiber diet does not cause constipation.
• Quality improvement projects can help physicians “choose wisely” and decrease things we do for no reason.

Dr. Tantoco is an academic med-peds hospitalist at Northwestern Memorial Hospital and Ann & Robert H. Lurie Children’s Hospital of Chicago. She is an instructor of medicine (hospital medicine) and pediatrics at Northwestern University, Chicago.

A cohort analysis using advanced strategies to minimize the impact of confounders has concluded that the current Food and Drug Administration warning about paclitaxel-coated devices used for femoropopliteal endovascular treatment should be lifted, according to investigators of a study called SAFE-PAD.

In early 2019, an FDA letter to clinicians warned that endovascular stents and balloons coated with paclitaxel might increase mortality, recounted the principal investigator of SAFE-PAD, Eric A. Secemsky, MD, director of vascular intervention, Beth Israel Deaconess Hospital, Boston.

An FDA advisory committee that was subsequently convened in 2019 did not elect to remove these devices from the market, but it did call for restrictions and for the collection of more safety data. In the absence of a clear mechanism of risk, and in the context of perceived problems with data suggesting harm, Dr. Secemsky said that there was interest in a conclusive answer.

The problem was that a randomized controlled trial, even if funding were available, was considered impractical, he noted in presenting SAFE-PAD at the annual scientific sessions of the American College of Cardiology.

In the initial meta-analysis that suggested an increased mortality risk, no risk was seen in the first year after exposure, and it climbed to only 3.5% after 2 years. As a result, the definitive 2-year study with sufficient power to produce conclusive results was an estimated 40,000 patients. Even if extended to 5 years, 20,000 patients would be needed, according to Dr. Secemsky.
 

SAFE-PAD born of collaboration

An alternative solution was required, which is why “we became engaged with the FDA to design a real-world study for use in making a regulatory decision,” Dr. Secemsky said.

SAFE-PAD, designed with feedback from the FDA, employed sophisticated methodologies to account for known and unknown confounding in the Medicare cohort data used for this study.

Of 168,553 Medicare fee-for-service patients undergoing femoropopliteal artery revascularization with a stent, a balloon, or both at 2,978 institutions, 70,584 (42%) were treated with a paclitaxel drug-coated device (DCD) and the remainder were managed with a non–drug-coated device (NDCD).

The groups were compared with a primary outcome of all-cause mortality in a design to evaluate DCD for noninferiority. Several secondary outcomes, such as repeated lower extremity revascularization, were also evaluated.

To create balanced groups, inverse probability of treatment weighting (IPTW) blinded to outcome was the primary analytic strategy. In addition, several sensitivity analyses were applied, including a technique that tests for the impact of a hypothetical variable that allows adjustment for an unknown confounder.

After a median follow-up of 2.7 years (longest more than 5 years), the cumulative mortality after weighting was 53.8% in the DCD group and 55.1% in the NDCD group. The 5% advantage for the DCD group (hazard ratio, 0.95; 95% confidence interval, 0.94-0.97) ensured noninferiority (P < .001).

On unweighted analysis, the mortality difference favoring DCD was even greater (HR, 0.85; 95% CI, 0.82–0.85).

None of the sensitivity analyses – including a multivariable Cox regression analysis, an instrumental variable analysis, and a falsification endpoints analysis that employed myocardial infarction, pneumonia, and heart failure – altered the conclusion. The hypothetical variable analysis produced the same result.

“A missing confounder would need to be more prevalent and more strongly associated to outcome than any measured variable in this analysis,” reported Dr. Secemsky, indicating that this ruled out essentially any probability of this occurring.

A subgroup analysis told the same story. By hazard ratio for the outcome of mortality, DCD was consistently favored over NDCD for groups characterized by low risk (HR, 0.98), stent implantation (HR, 0.97), receipt of balloon angioplasty alone (HR, 0.94), having critical limb ischemia (HR, 0.95) or no critical limb ischemia (HR, 0.97), and being managed inpatient (HR, 0.97) or outpatient (HR, 0.95).

The results of SAFE-PAD were simultaneously published with Dr. Secemsky’s ACC presentation.
 

Value of revascularization questioned

In an accompanying editorial, the coauthors Rita F. Redberg, MD, of the University of California, San Francisco, and Mary M. McDermott, MD, of Northwestern University, Chicago, reiterated the findings and the conclusions, but used the forum to draw attention to the low survival rates.

“Thus, while this well-done observational study provides new information,” they wrote, “a major conclusion should be that mortality is high among Medicare beneficiaries undergoing revascularization [for peripheral artery disease] with any devices.”
 

‘Very impressive’ methods

Marc P. Bonaca, MD, director of vascular research, University of Colorado at Denver, Aurora, called the methods to ensure the validity of the conclusions of this study “very impressive.” In situations where prospective randomized trials are impractical, he suggested that this type of approach might answer an unmet need.

“We have always desired the ability to look at these large datasets with a lot of power to answer important questions,” he said. While “the issue has always been residual confounding,” he expressed interest in further verifications that this type of methodology can serve as a template for data analysis to guide other regulatory decisions.

Dr. Secemsky reports financial relationships with Abbott, Bayer, Boston Scientific, Cook, CSI, Inari, Janssen, Medtronic, and Phillips. Dr. Redford reports no potential conflicts of interest. Dr. McDermott reports a financial relationship with Regeneron. Dr. Bonaca reports financial relationships with Amgen, AstraZeneca, Bayer, Janssen Merck, Novo Nordisk, Pfizer, and Sanofi.

A cohort analysis using advanced strategies to minimize the impact of confounders has concluded that the current Food and Drug Administration warning about paclitaxel-coated devices used for femoropopliteal endovascular treatment should be lifted, according to investigators of a study called SAFE-PAD.

In early 2019, an FDA letter to clinicians warned that endovascular stents and balloons coated with paclitaxel might increase mortality, recounted the principal investigator of SAFE-PAD, Eric A. Secemsky, MD, director of vascular intervention, Beth Israel Deaconess Hospital, Boston.

An FDA advisory committee that was subsequently convened in 2019 did not elect to remove these devices from the market, but it did call for restrictions and for the collection of more safety data. In the absence of a clear mechanism of risk, and in the context of perceived problems with data suggesting harm, Dr. Secemsky said that there was interest in a conclusive answer.

The problem was that a randomized controlled trial, even if funding were available, was considered impractical, he noted in presenting SAFE-PAD at the annual scientific sessions of the American College of Cardiology.

In the initial meta-analysis that suggested an increased mortality risk, no risk was seen in the first year after exposure, and it climbed to only 3.5% after 2 years. As a result, the definitive 2-year study with sufficient power to produce conclusive results was an estimated 40,000 patients. Even if extended to 5 years, 20,000 patients would be needed, according to Dr. Secemsky.
 

SAFE-PAD born of collaboration

An alternative solution was required, which is why “we became engaged with the FDA to design a real-world study for use in making a regulatory decision,” Dr. Secemsky said.

SAFE-PAD, designed with feedback from the FDA, employed sophisticated methodologies to account for known and unknown confounding in the Medicare cohort data used for this study.

Of 168,553 Medicare fee-for-service patients undergoing femoropopliteal artery revascularization with a stent, a balloon, or both at 2,978 institutions, 70,584 (42%) were treated with a paclitaxel drug-coated device (DCD) and the remainder were managed with a non–drug-coated device (NDCD).

The groups were compared with a primary outcome of all-cause mortality in a design to evaluate DCD for noninferiority. Several secondary outcomes, such as repeated lower extremity revascularization, were also evaluated.

To create balanced groups, inverse probability of treatment weighting (IPTW) blinded to outcome was the primary analytic strategy. In addition, several sensitivity analyses were applied, including a technique that tests for the impact of a hypothetical variable that allows adjustment for an unknown confounder.

After a median follow-up of 2.7 years (longest more than 5 years), the cumulative mortality after weighting was 53.8% in the DCD group and 55.1% in the NDCD group. The 5% advantage for the DCD group (hazard ratio, 0.95; 95% confidence interval, 0.94-0.97) ensured noninferiority (P < .001).

On unweighted analysis, the mortality difference favoring DCD was even greater (HR, 0.85; 95% CI, 0.82–0.85).

None of the sensitivity analyses – including a multivariable Cox regression analysis, an instrumental variable analysis, and a falsification endpoints analysis that employed myocardial infarction, pneumonia, and heart failure – altered the conclusion. The hypothetical variable analysis produced the same result.

“A missing confounder would need to be more prevalent and more strongly associated to outcome than any measured variable in this analysis,” reported Dr. Secemsky, indicating that this ruled out essentially any probability of this occurring.

A subgroup analysis told the same story. By hazard ratio for the outcome of mortality, DCD was consistently favored over NDCD for groups characterized by low risk (HR, 0.98), stent implantation (HR, 0.97), receipt of balloon angioplasty alone (HR, 0.94), having critical limb ischemia (HR, 0.95) or no critical limb ischemia (HR, 0.97), and being managed inpatient (HR, 0.97) or outpatient (HR, 0.95).

The results of SAFE-PAD were simultaneously published with Dr. Secemsky’s ACC presentation.
 

Value of revascularization questioned

In an accompanying editorial, the coauthors Rita F. Redberg, MD, of the University of California, San Francisco, and Mary M. McDermott, MD, of Northwestern University, Chicago, reiterated the findings and the conclusions, but used the forum to draw attention to the low survival rates.

“Thus, while this well-done observational study provides new information,” they wrote, “a major conclusion should be that mortality is high among Medicare beneficiaries undergoing revascularization [for peripheral artery disease] with any devices.”
 

‘Very impressive’ methods

Marc P. Bonaca, MD, director of vascular research, University of Colorado at Denver, Aurora, called the methods to ensure the validity of the conclusions of this study “very impressive.” In situations where prospective randomized trials are impractical, he suggested that this type of approach might answer an unmet need.

“We have always desired the ability to look at these large datasets with a lot of power to answer important questions,” he said. While “the issue has always been residual confounding,” he expressed interest in further verifications that this type of methodology can serve as a template for data analysis to guide other regulatory decisions.

Dr. Secemsky reports financial relationships with Abbott, Bayer, Boston Scientific, Cook, CSI, Inari, Janssen, Medtronic, and Phillips. Dr. Redford reports no potential conflicts of interest. Dr. McDermott reports a financial relationship with Regeneron. Dr. Bonaca reports financial relationships with Amgen, AstraZeneca, Bayer, Janssen Merck, Novo Nordisk, Pfizer, and Sanofi.

A cohort analysis using advanced strategies to minimize the impact of confounders has concluded that the current Food and Drug Administration warning about paclitaxel-coated devices used for femoropopliteal endovascular treatment should be lifted, according to investigators of a study called SAFE-PAD.

In early 2019, an FDA letter to clinicians warned that endovascular stents and balloons coated with paclitaxel might increase mortality, recounted the principal investigator of SAFE-PAD, Eric A. Secemsky, MD, director of vascular intervention, Beth Israel Deaconess Hospital, Boston.

An FDA advisory committee that was subsequently convened in 2019 did not elect to remove these devices from the market, but it did call for restrictions and for the collection of more safety data. In the absence of a clear mechanism of risk, and in the context of perceived problems with data suggesting harm, Dr. Secemsky said that there was interest in a conclusive answer.

The problem was that a randomized controlled trial, even if funding were available, was considered impractical, he noted in presenting SAFE-PAD at the annual scientific sessions of the American College of Cardiology.

In the initial meta-analysis that suggested an increased mortality risk, no risk was seen in the first year after exposure, and it climbed to only 3.5% after 2 years. As a result, the definitive 2-year study with sufficient power to produce conclusive results was an estimated 40,000 patients. Even if extended to 5 years, 20,000 patients would be needed, according to Dr. Secemsky.
 

SAFE-PAD born of collaboration

An alternative solution was required, which is why “we became engaged with the FDA to design a real-world study for use in making a regulatory decision,” Dr. Secemsky said.

SAFE-PAD, designed with feedback from the FDA, employed sophisticated methodologies to account for known and unknown confounding in the Medicare cohort data used for this study.

Of 168,553 Medicare fee-for-service patients undergoing femoropopliteal artery revascularization with a stent, a balloon, or both at 2,978 institutions, 70,584 (42%) were treated with a paclitaxel drug-coated device (DCD) and the remainder were managed with a non–drug-coated device (NDCD).

The groups were compared with a primary outcome of all-cause mortality in a design to evaluate DCD for noninferiority. Several secondary outcomes, such as repeated lower extremity revascularization, were also evaluated.

To create balanced groups, inverse probability of treatment weighting (IPTW) blinded to outcome was the primary analytic strategy. In addition, several sensitivity analyses were applied, including a technique that tests for the impact of a hypothetical variable that allows adjustment for an unknown confounder.

After a median follow-up of 2.7 years (longest more than 5 years), the cumulative mortality after weighting was 53.8% in the DCD group and 55.1% in the NDCD group. The 5% advantage for the DCD group (hazard ratio, 0.95; 95% confidence interval, 0.94-0.97) ensured noninferiority (P < .001).

On unweighted analysis, the mortality difference favoring DCD was even greater (HR, 0.85; 95% CI, 0.82–0.85).

None of the sensitivity analyses – including a multivariable Cox regression analysis, an instrumental variable analysis, and a falsification endpoints analysis that employed myocardial infarction, pneumonia, and heart failure – altered the conclusion. The hypothetical variable analysis produced the same result.

“A missing confounder would need to be more prevalent and more strongly associated to outcome than any measured variable in this analysis,” reported Dr. Secemsky, indicating that this ruled out essentially any probability of this occurring.

A subgroup analysis told the same story. By hazard ratio for the outcome of mortality, DCD was consistently favored over NDCD for groups characterized by low risk (HR, 0.98), stent implantation (HR, 0.97), receipt of balloon angioplasty alone (HR, 0.94), having critical limb ischemia (HR, 0.95) or no critical limb ischemia (HR, 0.97), and being managed inpatient (HR, 0.97) or outpatient (HR, 0.95).

The results of SAFE-PAD were simultaneously published with Dr. Secemsky’s ACC presentation.
 

Value of revascularization questioned

In an accompanying editorial, the coauthors Rita F. Redberg, MD, of the University of California, San Francisco, and Mary M. McDermott, MD, of Northwestern University, Chicago, reiterated the findings and the conclusions, but used the forum to draw attention to the low survival rates.

“Thus, while this well-done observational study provides new information,” they wrote, “a major conclusion should be that mortality is high among Medicare beneficiaries undergoing revascularization [for peripheral artery disease] with any devices.”
 

‘Very impressive’ methods

Marc P. Bonaca, MD, director of vascular research, University of Colorado at Denver, Aurora, called the methods to ensure the validity of the conclusions of this study “very impressive.” In situations where prospective randomized trials are impractical, he suggested that this type of approach might answer an unmet need.

“We have always desired the ability to look at these large datasets with a lot of power to answer important questions,” he said. While “the issue has always been residual confounding,” he expressed interest in further verifications that this type of methodology can serve as a template for data analysis to guide other regulatory decisions.

Dr. Secemsky reports financial relationships with Abbott, Bayer, Boston Scientific, Cook, CSI, Inari, Janssen, Medtronic, and Phillips. Dr. Redford reports no potential conflicts of interest. Dr. McDermott reports a financial relationship with Regeneron. Dr. Bonaca reports financial relationships with Amgen, AstraZeneca, Bayer, Janssen Merck, Novo Nordisk, Pfizer, and Sanofi.

Family physicians again ranked near the bottom in average earnings, but pay increased slightly this year, to $236,000, up from $234,000 last year, even as many practices saw a decrease in hours and patient visits during the pandemic.

Only pediatricians earned less ($221,000) according to the Medscape Family Physician Compensation Report 2021. Plastic surgeons topped this year’s list, at $526,000, followed by orthopedists, at $511,000, and cardiologists, at $459,000.

Family physicians ranked in the middle of specialties in terms of the percentages of physicians who thought they were fairly compensated: 57% of family physicians said they were fairly paid, and 79% of oncologists said they were. Only 44% of infectious disease physicians said they were fairly compensated.

Survey answers indicate, though, that pay isn’t driving family physicians’ satisfaction.

Only 10% of family physicians in the survey said that “making good money at a job I like” was the most rewarding aspect of the job. The top two answers by far were “gratitude/relationships with patients” (chosen by 34%) and “knowing I’m making the world a better place” (27%). Respondents could choose more than one answer.

Despite the small uptick in earnings overall in the specialty, more than one-third of family physicians (36%) reported a decline in compensation in this year’s survey, which included 18,000 responses from physicians in 29 specialties.

Male family physicians continue to be paid much more than their female colleagues, this year 29% more, widening the gap from 26% last year. Overall, men in primary care earned 27% more than their female colleagues, and male specialists earned 33% more.

As for decline in patients seen in some specialties, family physicians are holding their own.

Whereas pediatricians have seen a drop of 18% in patient visits, family physicians saw a decline of just 5%, from an average of 81 to 77 patients per week.
 

Most expect return to normal pay within 3 years

Most family physicians (83%) who incurred financial losses this year said they expect that income will return to normal within 3 years. More than one-third of that group (38%) said they expect compensation to get back to normal in the next year.

Almost all of the family physicians who lost income (91%) pointed the finger at COVID-19. Respondents could choose more than one answer, and 18% said other factors were also to blame.

Family physicians averaged $27,000 in incentive bonuses, higher than those in internal medicine, pediatrics, and psychiatry. Orthopedists had by far the highest bonuses, at $116,000.

For family physicians who received a bonus this year, the amount equaled about 12% of their salary, up from 10% last year. Bonuses are usually based on productivity but can also be tied to patient satisfaction, clinical processes, and other factors.

The number of family physicians who achieved more than three-quarters of their potential annual bonus rose to 61% this year, up from 55%.
 

17 hours a week on administrative tasks

The survey also ranked specialties by the amount of time physicians spent on paperwork and administrative tasks, including participation in professional organizations and clinical reading.

Family physicians fell squarely in the middle, with 17 hours per week spent on such tasks. Infectious disease physicians spent the most time, at 24.2 hours a week, and anesthesiologists spent the least, at 10.1.

Work hours declined for many physicians during the pandemic, and some were furloughed.

But, like most physicians, family physicians are once more working normal hours. They average 49 hours per week, which is slightly more than before the pandemic.

Specialists whose weekly hours are above normal are infectious disease physicians, intensivists, and public health and preventive medicine physicians; all are working 6 to 7 hours a week more than usual, according to the survey responses.

Responses also turned up some uncertainty on the future makeup of patient panels.

Most family physicians (69%) said they would continue to take new and current Medicare/Medicaid patients.

However, close to one-third of family physicians said they would stop treating at least some patients they already have and will not take new ones or haven’t decided yet.

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

Family physicians again ranked near the bottom in average earnings, but pay increased slightly this year, to $236,000, up from $234,000 last year, even as many practices saw a decrease in hours and patient visits during the pandemic.

Only pediatricians earned less ($221,000) according to the Medscape Family Physician Compensation Report 2021. Plastic surgeons topped this year’s list, at $526,000, followed by orthopedists, at $511,000, and cardiologists, at $459,000.

Family physicians ranked in the middle of specialties in terms of the percentages of physicians who thought they were fairly compensated: 57% of family physicians said they were fairly paid, and 79% of oncologists said they were. Only 44% of infectious disease physicians said they were fairly compensated.

Survey answers indicate, though, that pay isn’t driving family physicians’ satisfaction.

Only 10% of family physicians in the survey said that “making good money at a job I like” was the most rewarding aspect of the job. The top two answers by far were “gratitude/relationships with patients” (chosen by 34%) and “knowing I’m making the world a better place” (27%). Respondents could choose more than one answer.

Despite the small uptick in earnings overall in the specialty, more than one-third of family physicians (36%) reported a decline in compensation in this year’s survey, which included 18,000 responses from physicians in 29 specialties.

Male family physicians continue to be paid much more than their female colleagues, this year 29% more, widening the gap from 26% last year. Overall, men in primary care earned 27% more than their female colleagues, and male specialists earned 33% more.

As for decline in patients seen in some specialties, family physicians are holding their own.

Whereas pediatricians have seen a drop of 18% in patient visits, family physicians saw a decline of just 5%, from an average of 81 to 77 patients per week.
 

Most expect return to normal pay within 3 years

Most family physicians (83%) who incurred financial losses this year said they expect that income will return to normal within 3 years. More than one-third of that group (38%) said they expect compensation to get back to normal in the next year.

Almost all of the family physicians who lost income (91%) pointed the finger at COVID-19. Respondents could choose more than one answer, and 18% said other factors were also to blame.

Family physicians averaged $27,000 in incentive bonuses, higher than those in internal medicine, pediatrics, and psychiatry. Orthopedists had by far the highest bonuses, at $116,000.

For family physicians who received a bonus this year, the amount equaled about 12% of their salary, up from 10% last year. Bonuses are usually based on productivity but can also be tied to patient satisfaction, clinical processes, and other factors.

The number of family physicians who achieved more than three-quarters of their potential annual bonus rose to 61% this year, up from 55%.
 

17 hours a week on administrative tasks

The survey also ranked specialties by the amount of time physicians spent on paperwork and administrative tasks, including participation in professional organizations and clinical reading.

Family physicians fell squarely in the middle, with 17 hours per week spent on such tasks. Infectious disease physicians spent the most time, at 24.2 hours a week, and anesthesiologists spent the least, at 10.1.

Work hours declined for many physicians during the pandemic, and some were furloughed.

But, like most physicians, family physicians are once more working normal hours. They average 49 hours per week, which is slightly more than before the pandemic.

Specialists whose weekly hours are above normal are infectious disease physicians, intensivists, and public health and preventive medicine physicians; all are working 6 to 7 hours a week more than usual, according to the survey responses.

Responses also turned up some uncertainty on the future makeup of patient panels.

Most family physicians (69%) said they would continue to take new and current Medicare/Medicaid patients.

However, close to one-third of family physicians said they would stop treating at least some patients they already have and will not take new ones or haven’t decided yet.

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

Family physicians again ranked near the bottom in average earnings, but pay increased slightly this year, to $236,000, up from $234,000 last year, even as many practices saw a decrease in hours and patient visits during the pandemic.

Only pediatricians earned less ($221,000) according to the Medscape Family Physician Compensation Report 2021. Plastic surgeons topped this year’s list, at $526,000, followed by orthopedists, at $511,000, and cardiologists, at $459,000.

Family physicians ranked in the middle of specialties in terms of the percentages of physicians who thought they were fairly compensated: 57% of family physicians said they were fairly paid, and 79% of oncologists said they were. Only 44% of infectious disease physicians said they were fairly compensated.

Survey answers indicate, though, that pay isn’t driving family physicians’ satisfaction.

Only 10% of family physicians in the survey said that “making good money at a job I like” was the most rewarding aspect of the job. The top two answers by far were “gratitude/relationships with patients” (chosen by 34%) and “knowing I’m making the world a better place” (27%). Respondents could choose more than one answer.

Despite the small uptick in earnings overall in the specialty, more than one-third of family physicians (36%) reported a decline in compensation in this year’s survey, which included 18,000 responses from physicians in 29 specialties.

Male family physicians continue to be paid much more than their female colleagues, this year 29% more, widening the gap from 26% last year. Overall, men in primary care earned 27% more than their female colleagues, and male specialists earned 33% more.

As for decline in patients seen in some specialties, family physicians are holding their own.

Whereas pediatricians have seen a drop of 18% in patient visits, family physicians saw a decline of just 5%, from an average of 81 to 77 patients per week.
 

Most expect return to normal pay within 3 years

Most family physicians (83%) who incurred financial losses this year said they expect that income will return to normal within 3 years. More than one-third of that group (38%) said they expect compensation to get back to normal in the next year.

Almost all of the family physicians who lost income (91%) pointed the finger at COVID-19. Respondents could choose more than one answer, and 18% said other factors were also to blame.

Family physicians averaged $27,000 in incentive bonuses, higher than those in internal medicine, pediatrics, and psychiatry. Orthopedists had by far the highest bonuses, at $116,000.

For family physicians who received a bonus this year, the amount equaled about 12% of their salary, up from 10% last year. Bonuses are usually based on productivity but can also be tied to patient satisfaction, clinical processes, and other factors.

The number of family physicians who achieved more than three-quarters of their potential annual bonus rose to 61% this year, up from 55%.
 

17 hours a week on administrative tasks

The survey also ranked specialties by the amount of time physicians spent on paperwork and administrative tasks, including participation in professional organizations and clinical reading.

Family physicians fell squarely in the middle, with 17 hours per week spent on such tasks. Infectious disease physicians spent the most time, at 24.2 hours a week, and anesthesiologists spent the least, at 10.1.

Work hours declined for many physicians during the pandemic, and some were furloughed.

But, like most physicians, family physicians are once more working normal hours. They average 49 hours per week, which is slightly more than before the pandemic.

Specialists whose weekly hours are above normal are infectious disease physicians, intensivists, and public health and preventive medicine physicians; all are working 6 to 7 hours a week more than usual, according to the survey responses.

Responses also turned up some uncertainty on the future makeup of patient panels.

Most family physicians (69%) said they would continue to take new and current Medicare/Medicaid patients.

However, close to one-third of family physicians said they would stop treating at least some patients they already have and will not take new ones or haven’t decided yet.

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

Although 45% of ob.gyns. reported some decline in compensation during the pandemic, they earned more income in 2020 than they did in 2019, according to the 2021 Medscape Ob/Gyn Compensation Report.

The report, which surveyed nearly 18,000 physicians in more than 29 specialties, found that ob.gyns.’ income level was $312,000 in 2020, compared with $308,000 in 2019.

Despite the $4,000 increase, they still ranked near the bottom half in comparison with all other specialties. The lowest-paid specialties were public health & preventive medicine ($237,000), family medicine ($236,000), and pediatrics ($221,000), and the top earning specialties were plastic surgery ($526,000), orthopedics ($511,000), and cardiology ($459,000).
 

Optimistic about financial bounce back

Most ob.gyns. who experienced income loss cited job loss, reduction in hours, and lower patient volume because of the COVID-19 pandemic as reasons for their wage decline.

The specialty’s average incentive bonus, which is usually based on productivity and can be tied to patient satisfaction and clinical processes, was $48,000, and accounted for about 14% of total salary.

Of the ob.gyns. who reported financial losses during the pandemic, 41% expect their income to return to normal this year. However, 45% believe it will take 2-3 years to bounce back from the pandemic’s financial effect. About 11% believe they will never return to their pre–COVID-19 income.
 

Working similar hours, seeing fewer patients

The survey also found that ob.gyns. are back to working about the same number of hours they did prepandemic. Ob.gyns. currently work on average 54 hours per week, compared with the 56 hours per week they worked before the pandemic. However, they are only seeing 76 patients per week, compared with 81 patients per week before the pandemic.

Ob.gyns. reported spending 15.1 hours per week on medical-related work outside of patient visits, including paperwork, EHR documentation, administrative and managerial work, and clinical reading. The time required was slightly longer than last year (14.3 hours per week).

Similar to last year’s report, 55% of ob.gyns. said they are fairly compensated. Around 34% of them said the most rewarding part of their job is the relationships they have with their patients, followed by helping others (23%), and being good at what they do (22%). Only 11% said money was the most rewarding part of their job.
 

Challenges

The pandemic has brought many challenges for physicians, including financial difficulties and the potential to be exposed to SARS-CoV-2. However, when asked about the most challenging part of their job, only 4% of ob.gyns. said the danger or risk associated with treating patients with COVID-19 was the most challenging aspect of their job. By contrast, 21% of ob.gyns. said working long hours and having so many rules and regulations bog down their daily work.

Despite the pandemic-related challenges, 74% of ob.gyns. said they would choose medicine again and work in the same specialty.

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

Although 45% of ob.gyns. reported some decline in compensation during the pandemic, they earned more income in 2020 than they did in 2019, according to the 2021 Medscape Ob/Gyn Compensation Report.

The report, which surveyed nearly 18,000 physicians in more than 29 specialties, found that ob.gyns.’ income level was $312,000 in 2020, compared with $308,000 in 2019.

Despite the $4,000 increase, they still ranked near the bottom half in comparison with all other specialties. The lowest-paid specialties were public health & preventive medicine ($237,000), family medicine ($236,000), and pediatrics ($221,000), and the top earning specialties were plastic surgery ($526,000), orthopedics ($511,000), and cardiology ($459,000).
 

Optimistic about financial bounce back

Most ob.gyns. who experienced income loss cited job loss, reduction in hours, and lower patient volume because of the COVID-19 pandemic as reasons for their wage decline.

The specialty’s average incentive bonus, which is usually based on productivity and can be tied to patient satisfaction and clinical processes, was $48,000, and accounted for about 14% of total salary.

Of the ob.gyns. who reported financial losses during the pandemic, 41% expect their income to return to normal this year. However, 45% believe it will take 2-3 years to bounce back from the pandemic’s financial effect. About 11% believe they will never return to their pre–COVID-19 income.
 

Working similar hours, seeing fewer patients

The survey also found that ob.gyns. are back to working about the same number of hours they did prepandemic. Ob.gyns. currently work on average 54 hours per week, compared with the 56 hours per week they worked before the pandemic. However, they are only seeing 76 patients per week, compared with 81 patients per week before the pandemic.

Ob.gyns. reported spending 15.1 hours per week on medical-related work outside of patient visits, including paperwork, EHR documentation, administrative and managerial work, and clinical reading. The time required was slightly longer than last year (14.3 hours per week).

Similar to last year’s report, 55% of ob.gyns. said they are fairly compensated. Around 34% of them said the most rewarding part of their job is the relationships they have with their patients, followed by helping others (23%), and being good at what they do (22%). Only 11% said money was the most rewarding part of their job.
 

Challenges

The pandemic has brought many challenges for physicians, including financial difficulties and the potential to be exposed to SARS-CoV-2. However, when asked about the most challenging part of their job, only 4% of ob.gyns. said the danger or risk associated with treating patients with COVID-19 was the most challenging aspect of their job. By contrast, 21% of ob.gyns. said working long hours and having so many rules and regulations bog down their daily work.

Despite the pandemic-related challenges, 74% of ob.gyns. said they would choose medicine again and work in the same specialty.

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

Although 45% of ob.gyns. reported some decline in compensation during the pandemic, they earned more income in 2020 than they did in 2019, according to the 2021 Medscape Ob/Gyn Compensation Report.

The report, which surveyed nearly 18,000 physicians in more than 29 specialties, found that ob.gyns.’ income level was $312,000 in 2020, compared with $308,000 in 2019.

Despite the $4,000 increase, they still ranked near the bottom half in comparison with all other specialties. The lowest-paid specialties were public health & preventive medicine ($237,000), family medicine ($236,000), and pediatrics ($221,000), and the top earning specialties were plastic surgery ($526,000), orthopedics ($511,000), and cardiology ($459,000).
 

Optimistic about financial bounce back

Most ob.gyns. who experienced income loss cited job loss, reduction in hours, and lower patient volume because of the COVID-19 pandemic as reasons for their wage decline.

The specialty’s average incentive bonus, which is usually based on productivity and can be tied to patient satisfaction and clinical processes, was $48,000, and accounted for about 14% of total salary.

Of the ob.gyns. who reported financial losses during the pandemic, 41% expect their income to return to normal this year. However, 45% believe it will take 2-3 years to bounce back from the pandemic’s financial effect. About 11% believe they will never return to their pre–COVID-19 income.
 

Working similar hours, seeing fewer patients

The survey also found that ob.gyns. are back to working about the same number of hours they did prepandemic. Ob.gyns. currently work on average 54 hours per week, compared with the 56 hours per week they worked before the pandemic. However, they are only seeing 76 patients per week, compared with 81 patients per week before the pandemic.

Ob.gyns. reported spending 15.1 hours per week on medical-related work outside of patient visits, including paperwork, EHR documentation, administrative and managerial work, and clinical reading. The time required was slightly longer than last year (14.3 hours per week).

Similar to last year’s report, 55% of ob.gyns. said they are fairly compensated. Around 34% of them said the most rewarding part of their job is the relationships they have with their patients, followed by helping others (23%), and being good at what they do (22%). Only 11% said money was the most rewarding part of their job.
 

Challenges

The pandemic has brought many challenges for physicians, including financial difficulties and the potential to be exposed to SARS-CoV-2. However, when asked about the most challenging part of their job, only 4% of ob.gyns. said the danger or risk associated with treating patients with COVID-19 was the most challenging aspect of their job. By contrast, 21% of ob.gyns. said working long hours and having so many rules and regulations bog down their daily work.

Despite the pandemic-related challenges, 74% of ob.gyns. said they would choose medicine again and work in the same specialty.

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

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. The following is a preview of a recent popular clinical discussion.  

In the post “Cessation of surveillance colonoscopy,” Gyanprakash A. Ketwaroo, MD, asked the following:Wanted to get your thoughts on how you approach stopping surveillance colonoscopy for older adults. Do you use decision support tools, assessing life-expectancy, prior polyp history, etc? Or is it more practical to defer to PCP for goals of care discussion prior to surveillance colonoscopy at certain age (eg 75 or 80)?See how AGA members responded and join the discussion: https://community.gastro.org/posts/24089.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. The following is a preview of a recent popular clinical discussion.  

In the post “Cessation of surveillance colonoscopy,” Gyanprakash A. Ketwaroo, MD, asked the following:Wanted to get your thoughts on how you approach stopping surveillance colonoscopy for older adults. Do you use decision support tools, assessing life-expectancy, prior polyp history, etc? Or is it more practical to defer to PCP for goals of care discussion prior to surveillance colonoscopy at certain age (eg 75 or 80)?See how AGA members responded and join the discussion: https://community.gastro.org/posts/24089.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. The following is a preview of a recent popular clinical discussion.  

In the post “Cessation of surveillance colonoscopy,” Gyanprakash A. Ketwaroo, MD, asked the following:Wanted to get your thoughts on how you approach stopping surveillance colonoscopy for older adults. Do you use decision support tools, assessing life-expectancy, prior polyp history, etc? Or is it more practical to defer to PCP for goals of care discussion prior to surveillance colonoscopy at certain age (eg 75 or 80)?See how AGA members responded and join the discussion: https://community.gastro.org/posts/24089.

Two widely used rotavirus vaccines performed comparably in a meta-analysis, reducing risk of rotavirus gastroenteritis (RVGE) by more than 60% in young children. While the findings evidence a high protection level and low-risk safety profile, investigators of the study called for additional head-to-head comparisons to assess risks and benefits.

RVGE, which accounts for 28.8% of all deaths from diarrhea worldwide, is the leading cause of diarrhea in children under age 5. More than 100 countries include rotavirus vaccines in their immunization programs. Among six types of vaccines currently in use, two live-attenuated oral vaccines: the two-dose monovalent Rotarix (RV1) and three-dose pentavalent RotaTeq (RV5]) are in use worldwide.

Not much is known about their interchangeability, although a previous meta-analysis reported similarities in effectiveness of Rotarix (83%), RotaTeq (85%), and Rotarix and RotaTeq mixed series (86%) in low-mortality countries. RVGE morbidity and mortality have declined since the introduction of these vaccines, but concerns persist about their safety, Zi-Wei Sun, MSc, of Nanjing (China) Medical University and colleagues wrote in JAMA Pediatrics.

Their systematic review and meta-analysis of randomized clinical trials, case-control, and cohort studies compared benefit, risk, and immunogenicity of these vaccines and their effectiveness in reducing RVGE. Combing through databases Embase, PubMed, the Cochrane Library, and Web of Science using search terms “rotavirus” and “vaccine,” they chose 121 randomized clinical trials and cohort and case-control studies that included more than 100 children younger than 5 years. Thirty-eight of the randomized clinical trials had related data that examined the vaccines’ protection against RVGE hospitalization, study coauthor Hemant Goyal, MD, FACP, explained in an interview.

All of the studies reported on the safety and effectiveness or immunogenicity of rotavirus vaccines. The investigators used a random-effects model to calculate relative risks, odds ratios, risk differences, and 95% confidence intervals. They also stratified studies by economic development of countries, given that vaccine efficacy is often higher in middle- and high-income countries, compared with low-income countries. An adjusted indirect treatment comparison evaluated differences in vaccine protection among different subgroups, adopting P < .05 as the level of statistical significance.

Primary outcomes included RVGE, severe RVGE, and RVGE hospitalization and safety-associated outcomes such as serious adverse events, intussusception, and mortality.

Rotarix and RotaTeq reduced RVGE in children younger than 5 years by 68.4% and 63.6%, respectively. Dr. Goyal and colleagues confirmed these results in case-control studies (65.3% and 72.8%, respectively). Both vaccines significantly reduced RVGE and RVGE hospitalization risk and demonstrated higher protection against severe RVGE. In adjusted indirect comparisons, the two vaccines showed no significant differences in protection. They also found a positive correlation between immunogenicity and vaccine protection.

“RotaTeq seems to show lower protection in low-income countries, compared with Rotarix, but these estimates should be interpreted with caution as there was only one study for low-income countries and indirect comparison," said Dr. Goyal, a second-year gastroenterology fellow at the Wright Center for Graduate Medical Education, Scranton, Penn.

None of the vaccines demonstrated risk of serious adverse events. However, an Australian study in 2013 did report a small increased risk of intussusception after RV1 and RV5 vaccination. “Therefore, continuous surveillance of the benefits and adverse effects of rotavirus vaccines is required after vaccination,” the investigators noted.

Analyzing newer, less widely distributed vaccines, Rotavac, Rotasiil, and Lanzhou lamb rotavirus vaccine also showed moderate effectiveness in reducing RVGE risk.
 

Immunity wanes over time

Protection against rotavirus diseases seems to wane over time after vaccination. “Although our results indicated that rotavirus vaccines can provide substantial protection against RVGE during the first 2 years of life, more studies following up the vaccine efficacy for more than 2 years are required,” the investigators recommended.

Declining vaccine-induced antibodies, RVGE-acquired protection from the vaccine’s indirect effects, or exposure to unvaccinated populations may explain gradual loss of immunity.

Monitoring of rotavirus strains following vaccination should take place “to avoid population-based selection of so-called escape strains, especially fully heterotypic strains and new strains, because of the long-term pressure of vaccine immunity,” they recommended.

The findings emphasize the importance of introducing vaccines worldwide to reduce infection, summarized Dr. Goyal and colleagues. Given how challenging it is to treat the wide varieties of rotavirus, “It encouraging that RV1 and RV5 work well against heterotypic strains,” they added. Similar performance between Rotarix and RotaTeq also makes it easier for clinicians to choose a vaccine.

Increasing the availability and efficacy of these vaccines in low-income countries with high mortality rates is a high priority,

David I. Bernstein, MD, MA, wrote in a related editorial: “A clear gradient in vaccine protections was noted by country income level in the analysis presented, and much effort has been spent to understand this discrepancy.”

Overall, the study confirmed the efficacy of these two vaccines and their equivalence, noted Dr. Bernstein.

The study’s literature search process had some limitations. “Especially in stratified analyses, sparse data in some subgroups limit generalizability. ... The most accurate method, head-to-head comparisons, to evaluate the comparative efficacy of different vaccines is required in further studies,” the study investigators wrote.

Such studies would directly compare Rotarix and RotaTeq from multiple perspectives: efficacy, cost-effectiveness, strain-specific protection, the duration of protection, safety, and immunogenicity, said Dr. Goyal.

*This story was updated on May 24, 2021.

Two widely used rotavirus vaccines performed comparably in a meta-analysis, reducing risk of rotavirus gastroenteritis (RVGE) by more than 60% in young children. While the findings evidence a high protection level and low-risk safety profile, investigators of the study called for additional head-to-head comparisons to assess risks and benefits.

RVGE, which accounts for 28.8% of all deaths from diarrhea worldwide, is the leading cause of diarrhea in children under age 5. More than 100 countries include rotavirus vaccines in their immunization programs. Among six types of vaccines currently in use, two live-attenuated oral vaccines: the two-dose monovalent Rotarix (RV1) and three-dose pentavalent RotaTeq (RV5]) are in use worldwide.

Not much is known about their interchangeability, although a previous meta-analysis reported similarities in effectiveness of Rotarix (83%), RotaTeq (85%), and Rotarix and RotaTeq mixed series (86%) in low-mortality countries. RVGE morbidity and mortality have declined since the introduction of these vaccines, but concerns persist about their safety, Zi-Wei Sun, MSc, of Nanjing (China) Medical University and colleagues wrote in JAMA Pediatrics.

Their systematic review and meta-analysis of randomized clinical trials, case-control, and cohort studies compared benefit, risk, and immunogenicity of these vaccines and their effectiveness in reducing RVGE. Combing through databases Embase, PubMed, the Cochrane Library, and Web of Science using search terms “rotavirus” and “vaccine,” they chose 121 randomized clinical trials and cohort and case-control studies that included more than 100 children younger than 5 years. Thirty-eight of the randomized clinical trials had related data that examined the vaccines’ protection against RVGE hospitalization, study coauthor Hemant Goyal, MD, FACP, explained in an interview.

All of the studies reported on the safety and effectiveness or immunogenicity of rotavirus vaccines. The investigators used a random-effects model to calculate relative risks, odds ratios, risk differences, and 95% confidence intervals. They also stratified studies by economic development of countries, given that vaccine efficacy is often higher in middle- and high-income countries, compared with low-income countries. An adjusted indirect treatment comparison evaluated differences in vaccine protection among different subgroups, adopting P < .05 as the level of statistical significance.

Primary outcomes included RVGE, severe RVGE, and RVGE hospitalization and safety-associated outcomes such as serious adverse events, intussusception, and mortality.

Rotarix and RotaTeq reduced RVGE in children younger than 5 years by 68.4% and 63.6%, respectively. Dr. Goyal and colleagues confirmed these results in case-control studies (65.3% and 72.8%, respectively). Both vaccines significantly reduced RVGE and RVGE hospitalization risk and demonstrated higher protection against severe RVGE. In adjusted indirect comparisons, the two vaccines showed no significant differences in protection. They also found a positive correlation between immunogenicity and vaccine protection.

“RotaTeq seems to show lower protection in low-income countries, compared with Rotarix, but these estimates should be interpreted with caution as there was only one study for low-income countries and indirect comparison," said Dr. Goyal, a second-year gastroenterology fellow at the Wright Center for Graduate Medical Education, Scranton, Penn.

None of the vaccines demonstrated risk of serious adverse events. However, an Australian study in 2013 did report a small increased risk of intussusception after RV1 and RV5 vaccination. “Therefore, continuous surveillance of the benefits and adverse effects of rotavirus vaccines is required after vaccination,” the investigators noted.

Analyzing newer, less widely distributed vaccines, Rotavac, Rotasiil, and Lanzhou lamb rotavirus vaccine also showed moderate effectiveness in reducing RVGE risk.
 

Immunity wanes over time

Protection against rotavirus diseases seems to wane over time after vaccination. “Although our results indicated that rotavirus vaccines can provide substantial protection against RVGE during the first 2 years of life, more studies following up the vaccine efficacy for more than 2 years are required,” the investigators recommended.

Declining vaccine-induced antibodies, RVGE-acquired protection from the vaccine’s indirect effects, or exposure to unvaccinated populations may explain gradual loss of immunity.

Monitoring of rotavirus strains following vaccination should take place “to avoid population-based selection of so-called escape strains, especially fully heterotypic strains and new strains, because of the long-term pressure of vaccine immunity,” they recommended.

The findings emphasize the importance of introducing vaccines worldwide to reduce infection, summarized Dr. Goyal and colleagues. Given how challenging it is to treat the wide varieties of rotavirus, “It encouraging that RV1 and RV5 work well against heterotypic strains,” they added. Similar performance between Rotarix and RotaTeq also makes it easier for clinicians to choose a vaccine.

Increasing the availability and efficacy of these vaccines in low-income countries with high mortality rates is a high priority,

David I. Bernstein, MD, MA, wrote in a related editorial: “A clear gradient in vaccine protections was noted by country income level in the analysis presented, and much effort has been spent to understand this discrepancy.”

Overall, the study confirmed the efficacy of these two vaccines and their equivalence, noted Dr. Bernstein.

The study’s literature search process had some limitations. “Especially in stratified analyses, sparse data in some subgroups limit generalizability. ... The most accurate method, head-to-head comparisons, to evaluate the comparative efficacy of different vaccines is required in further studies,” the study investigators wrote.

Such studies would directly compare Rotarix and RotaTeq from multiple perspectives: efficacy, cost-effectiveness, strain-specific protection, the duration of protection, safety, and immunogenicity, said Dr. Goyal.

*This story was updated on May 24, 2021.

Two widely used rotavirus vaccines performed comparably in a meta-analysis, reducing risk of rotavirus gastroenteritis (RVGE) by more than 60% in young children. While the findings evidence a high protection level and low-risk safety profile, investigators of the study called for additional head-to-head comparisons to assess risks and benefits.

RVGE, which accounts for 28.8% of all deaths from diarrhea worldwide, is the leading cause of diarrhea in children under age 5. More than 100 countries include rotavirus vaccines in their immunization programs. Among six types of vaccines currently in use, two live-attenuated oral vaccines: the two-dose monovalent Rotarix (RV1) and three-dose pentavalent RotaTeq (RV5]) are in use worldwide.

Not much is known about their interchangeability, although a previous meta-analysis reported similarities in effectiveness of Rotarix (83%), RotaTeq (85%), and Rotarix and RotaTeq mixed series (86%) in low-mortality countries. RVGE morbidity and mortality have declined since the introduction of these vaccines, but concerns persist about their safety, Zi-Wei Sun, MSc, of Nanjing (China) Medical University and colleagues wrote in JAMA Pediatrics.

Their systematic review and meta-analysis of randomized clinical trials, case-control, and cohort studies compared benefit, risk, and immunogenicity of these vaccines and their effectiveness in reducing RVGE. Combing through databases Embase, PubMed, the Cochrane Library, and Web of Science using search terms “rotavirus” and “vaccine,” they chose 121 randomized clinical trials and cohort and case-control studies that included more than 100 children younger than 5 years. Thirty-eight of the randomized clinical trials had related data that examined the vaccines’ protection against RVGE hospitalization, study coauthor Hemant Goyal, MD, FACP, explained in an interview.

All of the studies reported on the safety and effectiveness or immunogenicity of rotavirus vaccines. The investigators used a random-effects model to calculate relative risks, odds ratios, risk differences, and 95% confidence intervals. They also stratified studies by economic development of countries, given that vaccine efficacy is often higher in middle- and high-income countries, compared with low-income countries. An adjusted indirect treatment comparison evaluated differences in vaccine protection among different subgroups, adopting P < .05 as the level of statistical significance.

Primary outcomes included RVGE, severe RVGE, and RVGE hospitalization and safety-associated outcomes such as serious adverse events, intussusception, and mortality.

Rotarix and RotaTeq reduced RVGE in children younger than 5 years by 68.4% and 63.6%, respectively. Dr. Goyal and colleagues confirmed these results in case-control studies (65.3% and 72.8%, respectively). Both vaccines significantly reduced RVGE and RVGE hospitalization risk and demonstrated higher protection against severe RVGE. In adjusted indirect comparisons, the two vaccines showed no significant differences in protection. They also found a positive correlation between immunogenicity and vaccine protection.

“RotaTeq seems to show lower protection in low-income countries, compared with Rotarix, but these estimates should be interpreted with caution as there was only one study for low-income countries and indirect comparison," said Dr. Goyal, a second-year gastroenterology fellow at the Wright Center for Graduate Medical Education, Scranton, Penn.

None of the vaccines demonstrated risk of serious adverse events. However, an Australian study in 2013 did report a small increased risk of intussusception after RV1 and RV5 vaccination. “Therefore, continuous surveillance of the benefits and adverse effects of rotavirus vaccines is required after vaccination,” the investigators noted.

Analyzing newer, less widely distributed vaccines, Rotavac, Rotasiil, and Lanzhou lamb rotavirus vaccine also showed moderate effectiveness in reducing RVGE risk.
 

Immunity wanes over time

Protection against rotavirus diseases seems to wane over time after vaccination. “Although our results indicated that rotavirus vaccines can provide substantial protection against RVGE during the first 2 years of life, more studies following up the vaccine efficacy for more than 2 years are required,” the investigators recommended.

Declining vaccine-induced antibodies, RVGE-acquired protection from the vaccine’s indirect effects, or exposure to unvaccinated populations may explain gradual loss of immunity.

Monitoring of rotavirus strains following vaccination should take place “to avoid population-based selection of so-called escape strains, especially fully heterotypic strains and new strains, because of the long-term pressure of vaccine immunity,” they recommended.

The findings emphasize the importance of introducing vaccines worldwide to reduce infection, summarized Dr. Goyal and colleagues. Given how challenging it is to treat the wide varieties of rotavirus, “It encouraging that RV1 and RV5 work well against heterotypic strains,” they added. Similar performance between Rotarix and RotaTeq also makes it easier for clinicians to choose a vaccine.

Increasing the availability and efficacy of these vaccines in low-income countries with high mortality rates is a high priority,

David I. Bernstein, MD, MA, wrote in a related editorial: “A clear gradient in vaccine protections was noted by country income level in the analysis presented, and much effort has been spent to understand this discrepancy.”

Overall, the study confirmed the efficacy of these two vaccines and their equivalence, noted Dr. Bernstein.

The study’s literature search process had some limitations. “Especially in stratified analyses, sparse data in some subgroups limit generalizability. ... The most accurate method, head-to-head comparisons, to evaluate the comparative efficacy of different vaccines is required in further studies,” the study investigators wrote.

Such studies would directly compare Rotarix and RotaTeq from multiple perspectives: efficacy, cost-effectiveness, strain-specific protection, the duration of protection, safety, and immunogenicity, said Dr. Goyal.

*This story was updated on May 24, 2021.

Length of hospital stay and the need for intensive care for pediatric COVID-19 patients with multisystem inflammatory syndrome in children was not significantly different for those who presented first as outpatients or emergency patients, based on data from 34 children.

Multisystem inflammatory syndrome in children (MIS-C) can be challenging to diagnose, as the key characteristics of fever, elevated inflammatory markers, and involvement of at least two organ systems often overlap with other illnesses, said Erin B. Treemarcki, DO, of the University of Utah, Salt Lake City, and colleagues.

“Primary care and urgent care providers are often the first point of health care for children with symptoms of MIS-C,” the researchers wrote. In a study (Poster 142) presented at the annual meeting of the Pediatric Academic Societies, held virtually, the researchers conducted a retrospective review of 34 patients younger than 21 years who were hospitalized with MIS-C at a single center between April 2020 and December 2020. The average age of the patients was 7.9 years, 68% were male, 82% were White, and 53% first presented to an outpatient clinic.

Sixteen patients presented to an emergency department and 18 presented to an ambulatory setting. The length of hospitalization ranged from 3 to 16 days with a median of 6 days, and the PICU stay ranged from 1 to 10 days with a median of 2 days.

Overall, the length of hospital stay and rate of PICU admission were not significantly different between the emergency presentation and outpatient presentation groups. Twenty-four patients entered the PICU, 13 at admission and 11 as transfers. However, the median number of days of symptoms prior to admission was significantly higher for outpatient cases (6 days vs. 4 days, P = .03).

One patient was readmitted to the hospital within 30 days for aseptic meningitis, and none of the patients died.

Initial symptoms were not significantly different for outpatient vs. emergency department patients. The most common initial manifestations of MIS-C included fever (100%), gastrointestinal symptoms (85%), and mucocutaneous symptoms (88%). Mucocutaneous symptoms included rash, oral mucosal changes, conjunctivitis, and hand/foot edema. In addition, 65% of the patients met at least 3 criteria for Kawasaki disease, the researchers noted.

The most common elevated labs at presentation regardless of setting were D-dimer (100%), C-reactive protein (97%), ferritin (97%), procalcitonin (97%), and serum IL-6 (94%).

The study findings were limited by the small sample size and focus on data from a single center. However, the results emphasize the varied presentations of MIS-C and the importance that both primary care and urgent care providers know the signs, as they are often the first point of health care for children with MIS-C, the researchers noted.
 

Keep looking for factors that put children at risk

“MIS-C is probably the most serious complication of COVID in children, so we as pediatricians on the front line need to know what it looks like,” Karalyn Kinsella, MD, a pediatrician in Cheshire, Conn., said in an interview.

Dr. Kinsella said she was surprised by the study finding that children’s length of hospital stay was not affected by presentation setting.

“I would have thought the kids presenting in an outpatient setting would take longer to diagnose, and therefore have a longer hospital stay,” she noted. Instead, the take-home message is that whether the MIS-C diagnosis occurs in the outpatient or emergency setting, the length of stay is the same, and that the most common symptoms are fever, gastrointestinal, mucocutaneous, and cardiac symptoms regardless of initial presentation setting, she said.

More research is needed, and future studies should examine “any potential underlying factors making these particular kids susceptible to MIS-C,” Dr. Kinsella added.

The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts, but serves on the Pediatric News Editorial Advisory Board.

Length of hospital stay and the need for intensive care for pediatric COVID-19 patients with multisystem inflammatory syndrome in children was not significantly different for those who presented first as outpatients or emergency patients, based on data from 34 children.

Multisystem inflammatory syndrome in children (MIS-C) can be challenging to diagnose, as the key characteristics of fever, elevated inflammatory markers, and involvement of at least two organ systems often overlap with other illnesses, said Erin B. Treemarcki, DO, of the University of Utah, Salt Lake City, and colleagues.

“Primary care and urgent care providers are often the first point of health care for children with symptoms of MIS-C,” the researchers wrote. In a study (Poster 142) presented at the annual meeting of the Pediatric Academic Societies, held virtually, the researchers conducted a retrospective review of 34 patients younger than 21 years who were hospitalized with MIS-C at a single center between April 2020 and December 2020. The average age of the patients was 7.9 years, 68% were male, 82% were White, and 53% first presented to an outpatient clinic.

Sixteen patients presented to an emergency department and 18 presented to an ambulatory setting. The length of hospitalization ranged from 3 to 16 days with a median of 6 days, and the PICU stay ranged from 1 to 10 days with a median of 2 days.

Overall, the length of hospital stay and rate of PICU admission were not significantly different between the emergency presentation and outpatient presentation groups. Twenty-four patients entered the PICU, 13 at admission and 11 as transfers. However, the median number of days of symptoms prior to admission was significantly higher for outpatient cases (6 days vs. 4 days, P = .03).

One patient was readmitted to the hospital within 30 days for aseptic meningitis, and none of the patients died.

Initial symptoms were not significantly different for outpatient vs. emergency department patients. The most common initial manifestations of MIS-C included fever (100%), gastrointestinal symptoms (85%), and mucocutaneous symptoms (88%). Mucocutaneous symptoms included rash, oral mucosal changes, conjunctivitis, and hand/foot edema. In addition, 65% of the patients met at least 3 criteria for Kawasaki disease, the researchers noted.

The most common elevated labs at presentation regardless of setting were D-dimer (100%), C-reactive protein (97%), ferritin (97%), procalcitonin (97%), and serum IL-6 (94%).

The study findings were limited by the small sample size and focus on data from a single center. However, the results emphasize the varied presentations of MIS-C and the importance that both primary care and urgent care providers know the signs, as they are often the first point of health care for children with MIS-C, the researchers noted.
 

Keep looking for factors that put children at risk

“MIS-C is probably the most serious complication of COVID in children, so we as pediatricians on the front line need to know what it looks like,” Karalyn Kinsella, MD, a pediatrician in Cheshire, Conn., said in an interview.

Dr. Kinsella said she was surprised by the study finding that children’s length of hospital stay was not affected by presentation setting.

“I would have thought the kids presenting in an outpatient setting would take longer to diagnose, and therefore have a longer hospital stay,” she noted. Instead, the take-home message is that whether the MIS-C diagnosis occurs in the outpatient or emergency setting, the length of stay is the same, and that the most common symptoms are fever, gastrointestinal, mucocutaneous, and cardiac symptoms regardless of initial presentation setting, she said.

More research is needed, and future studies should examine “any potential underlying factors making these particular kids susceptible to MIS-C,” Dr. Kinsella added.

The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts, but serves on the Pediatric News Editorial Advisory Board.

Length of hospital stay and the need for intensive care for pediatric COVID-19 patients with multisystem inflammatory syndrome in children was not significantly different for those who presented first as outpatients or emergency patients, based on data from 34 children.

Multisystem inflammatory syndrome in children (MIS-C) can be challenging to diagnose, as the key characteristics of fever, elevated inflammatory markers, and involvement of at least two organ systems often overlap with other illnesses, said Erin B. Treemarcki, DO, of the University of Utah, Salt Lake City, and colleagues.

“Primary care and urgent care providers are often the first point of health care for children with symptoms of MIS-C,” the researchers wrote. In a study (Poster 142) presented at the annual meeting of the Pediatric Academic Societies, held virtually, the researchers conducted a retrospective review of 34 patients younger than 21 years who were hospitalized with MIS-C at a single center between April 2020 and December 2020. The average age of the patients was 7.9 years, 68% were male, 82% were White, and 53% first presented to an outpatient clinic.

Sixteen patients presented to an emergency department and 18 presented to an ambulatory setting. The length of hospitalization ranged from 3 to 16 days with a median of 6 days, and the PICU stay ranged from 1 to 10 days with a median of 2 days.

Overall, the length of hospital stay and rate of PICU admission were not significantly different between the emergency presentation and outpatient presentation groups. Twenty-four patients entered the PICU, 13 at admission and 11 as transfers. However, the median number of days of symptoms prior to admission was significantly higher for outpatient cases (6 days vs. 4 days, P = .03).

One patient was readmitted to the hospital within 30 days for aseptic meningitis, and none of the patients died.

Initial symptoms were not significantly different for outpatient vs. emergency department patients. The most common initial manifestations of MIS-C included fever (100%), gastrointestinal symptoms (85%), and mucocutaneous symptoms (88%). Mucocutaneous symptoms included rash, oral mucosal changes, conjunctivitis, and hand/foot edema. In addition, 65% of the patients met at least 3 criteria for Kawasaki disease, the researchers noted.

The most common elevated labs at presentation regardless of setting were D-dimer (100%), C-reactive protein (97%), ferritin (97%), procalcitonin (97%), and serum IL-6 (94%).

The study findings were limited by the small sample size and focus on data from a single center. However, the results emphasize the varied presentations of MIS-C and the importance that both primary care and urgent care providers know the signs, as they are often the first point of health care for children with MIS-C, the researchers noted.
 

Keep looking for factors that put children at risk

“MIS-C is probably the most serious complication of COVID in children, so we as pediatricians on the front line need to know what it looks like,” Karalyn Kinsella, MD, a pediatrician in Cheshire, Conn., said in an interview.

Dr. Kinsella said she was surprised by the study finding that children’s length of hospital stay was not affected by presentation setting.

“I would have thought the kids presenting in an outpatient setting would take longer to diagnose, and therefore have a longer hospital stay,” she noted. Instead, the take-home message is that whether the MIS-C diagnosis occurs in the outpatient or emergency setting, the length of stay is the same, and that the most common symptoms are fever, gastrointestinal, mucocutaneous, and cardiac symptoms regardless of initial presentation setting, she said.

More research is needed, and future studies should examine “any potential underlying factors making these particular kids susceptible to MIS-C,” Dr. Kinsella added.

The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts, but serves on the Pediatric News Editorial Advisory Board.

Incomplete resection and very early epilepsy onset were among the chief predictors of late seizure relapse following epilepsy surgery, according to a new study on the factors most associated with seizure recurrence in drug-resistant epilepsy.

“As our study analyzed late seizure relapse, our results are not applicable for short‐term seizure control. Vice versa, results for short‐term outcomes should not be transferred to long‐term outcomes,” Stephan Petrik of the Epilepsy Center at the University of Freiburg (Germany) and colleagues wrote. The study was published in the May 2021 issue of Epilepsia.

To assess the variables that increase risk of late seizure recurrence following surgery, the researchers retrospectively studied the medical records of patients who underwent resective epilepsy surgery at the University Hospital Freiburg (Germany) between 1999 and 2015. Of the 1,278 initial patients, a group of 99 participants (7.7%) with seizure relapses after at least 2 years of complete seizure freedom were matched with controls experiencing long-term seizure freedom. The two groups had similar mean durations of epilepsy from onset to surgery: 13.9 years in the relapse group and 13.0 years in the control group.

The mean follow-up was 9.7 years (standard deviation, 4.0; range, 2.9-18.5) in the relapse group and 8.2 years (SD, 3.5; range, 2.2-18.3) in the control group. The mean time to late seizure recurrence was 56.6 months, and two-thirds of patients relapsed in the 5 years after surgery. Twenty of the relapse patients only experienced a single seizure, and 41% of the patients who reported more than one seizure had a frequency of less than one per month.

The type of resection had no discernible impact on outcomes, although anterior temporal lobe resection did trend toward being associated with recurrence (odds ratio, 2.7; 95% confidence interval, 0.93-8.89; P = .06). Incomplete resection was significantly associated with late relapse but did not seem to affect timing: the mean duration of seizure freedom was 56.5 months with complete resection and 58.5 months with incomplete resection (P = .62). Additional preoperative PET scans were performed on 45% of patients in the relapse group, compared with 29% in the control group.

After multivariate analysis, predictors for late relapse included incomplete resection (OR, 3.81; 95% CI, 1.79-8.53; P < .001); the existence of additional, potentially epileptogenic lesions in the contralateral hemisphere on presurgical MRI (OR, 3.36; 95% CI, 1.18-10.62; P = .03); epilepsy onset during the first year of life (OR, 4.24; 95% CI, 1.4-15.89; P = .02); and preoperative PET scans being performed (OR, 2.47; 95% CI, 1.25-4.97; P = .01). Though use of preoperative and postoperative antiepileptic drugs (AEDs) was higher in the relapse group, along with complete withdrawal being more common in the control group (68%, compared with 51%), neither was deemed significant in multivariate analysis.
 

What to do about seizure relapse risk factors

“This is one of the best analyses of the factors that contribute to late seizure relapse,” Gregory K. Bergey, MD, director of the Johns Hopkins Epilepsy Center in Baltimore, said in an interview. “Am I surprised by their results? Not necessarily.”

What did jump out, he said, was AED use not being a predictor of recurrence, as well as all the patients with late relapse having lesional epilepsy. “As they point out, you can have relapse with nonlesional epilepsy, but very often it happens in the first year or 2. If someone is 2 years out and doesn’t have a lesion, they’re probably more likely to remain seizure free.”

Despite the researchers’ comprehensive review of risk factors, the question remains: What to do with this information?

“They’ve done a very good job of identifying that 7.7% of 1,200 who are at risk of a late relapse,” he said. “Now, take those patients with high-risk factors and launch a trial where you keep medicines the same or do something that would alter that outcome.”

“The problem is,” he added, “that’s a 10-year study. It’s easy for me to sit here and call for one of those. But still, as valuable as this was, it’s a retrospective study. Now you have to say, what are the implications of this? What can we do in the prospective fashion?”

The authors acknowledged their study’s other limitations, including a lack of information on the reasons for an incomplete resection, a notable decrease in follow-up visits more than 5 years after surgery, and potential selection bias. They added, however, that “matching by age at surgery, gender, and time to relapse/last follow‐up” should have helped reduce any significant bias.

No potential conflicts of interest were disclosed.

Incomplete resection and very early epilepsy onset were among the chief predictors of late seizure relapse following epilepsy surgery, according to a new study on the factors most associated with seizure recurrence in drug-resistant epilepsy.

“As our study analyzed late seizure relapse, our results are not applicable for short‐term seizure control. Vice versa, results for short‐term outcomes should not be transferred to long‐term outcomes,” Stephan Petrik of the Epilepsy Center at the University of Freiburg (Germany) and colleagues wrote. The study was published in the May 2021 issue of Epilepsia.

To assess the variables that increase risk of late seizure recurrence following surgery, the researchers retrospectively studied the medical records of patients who underwent resective epilepsy surgery at the University Hospital Freiburg (Germany) between 1999 and 2015. Of the 1,278 initial patients, a group of 99 participants (7.7%) with seizure relapses after at least 2 years of complete seizure freedom were matched with controls experiencing long-term seizure freedom. The two groups had similar mean durations of epilepsy from onset to surgery: 13.9 years in the relapse group and 13.0 years in the control group.

The mean follow-up was 9.7 years (standard deviation, 4.0; range, 2.9-18.5) in the relapse group and 8.2 years (SD, 3.5; range, 2.2-18.3) in the control group. The mean time to late seizure recurrence was 56.6 months, and two-thirds of patients relapsed in the 5 years after surgery. Twenty of the relapse patients only experienced a single seizure, and 41% of the patients who reported more than one seizure had a frequency of less than one per month.

The type of resection had no discernible impact on outcomes, although anterior temporal lobe resection did trend toward being associated with recurrence (odds ratio, 2.7; 95% confidence interval, 0.93-8.89; P = .06). Incomplete resection was significantly associated with late relapse but did not seem to affect timing: the mean duration of seizure freedom was 56.5 months with complete resection and 58.5 months with incomplete resection (P = .62). Additional preoperative PET scans were performed on 45% of patients in the relapse group, compared with 29% in the control group.

After multivariate analysis, predictors for late relapse included incomplete resection (OR, 3.81; 95% CI, 1.79-8.53; P < .001); the existence of additional, potentially epileptogenic lesions in the contralateral hemisphere on presurgical MRI (OR, 3.36; 95% CI, 1.18-10.62; P = .03); epilepsy onset during the first year of life (OR, 4.24; 95% CI, 1.4-15.89; P = .02); and preoperative PET scans being performed (OR, 2.47; 95% CI, 1.25-4.97; P = .01). Though use of preoperative and postoperative antiepileptic drugs (AEDs) was higher in the relapse group, along with complete withdrawal being more common in the control group (68%, compared with 51%), neither was deemed significant in multivariate analysis.
 

What to do about seizure relapse risk factors

“This is one of the best analyses of the factors that contribute to late seizure relapse,” Gregory K. Bergey, MD, director of the Johns Hopkins Epilepsy Center in Baltimore, said in an interview. “Am I surprised by their results? Not necessarily.”

What did jump out, he said, was AED use not being a predictor of recurrence, as well as all the patients with late relapse having lesional epilepsy. “As they point out, you can have relapse with nonlesional epilepsy, but very often it happens in the first year or 2. If someone is 2 years out and doesn’t have a lesion, they’re probably more likely to remain seizure free.”

Despite the researchers’ comprehensive review of risk factors, the question remains: What to do with this information?

“They’ve done a very good job of identifying that 7.7% of 1,200 who are at risk of a late relapse,” he said. “Now, take those patients with high-risk factors and launch a trial where you keep medicines the same or do something that would alter that outcome.”

“The problem is,” he added, “that’s a 10-year study. It’s easy for me to sit here and call for one of those. But still, as valuable as this was, it’s a retrospective study. Now you have to say, what are the implications of this? What can we do in the prospective fashion?”

The authors acknowledged their study’s other limitations, including a lack of information on the reasons for an incomplete resection, a notable decrease in follow-up visits more than 5 years after surgery, and potential selection bias. They added, however, that “matching by age at surgery, gender, and time to relapse/last follow‐up” should have helped reduce any significant bias.

No potential conflicts of interest were disclosed.

Incomplete resection and very early epilepsy onset were among the chief predictors of late seizure relapse following epilepsy surgery, according to a new study on the factors most associated with seizure recurrence in drug-resistant epilepsy.

“As our study analyzed late seizure relapse, our results are not applicable for short‐term seizure control. Vice versa, results for short‐term outcomes should not be transferred to long‐term outcomes,” Stephan Petrik of the Epilepsy Center at the University of Freiburg (Germany) and colleagues wrote. The study was published in the May 2021 issue of Epilepsia.

To assess the variables that increase risk of late seizure recurrence following surgery, the researchers retrospectively studied the medical records of patients who underwent resective epilepsy surgery at the University Hospital Freiburg (Germany) between 1999 and 2015. Of the 1,278 initial patients, a group of 99 participants (7.7%) with seizure relapses after at least 2 years of complete seizure freedom were matched with controls experiencing long-term seizure freedom. The two groups had similar mean durations of epilepsy from onset to surgery: 13.9 years in the relapse group and 13.0 years in the control group.

The mean follow-up was 9.7 years (standard deviation, 4.0; range, 2.9-18.5) in the relapse group and 8.2 years (SD, 3.5; range, 2.2-18.3) in the control group. The mean time to late seizure recurrence was 56.6 months, and two-thirds of patients relapsed in the 5 years after surgery. Twenty of the relapse patients only experienced a single seizure, and 41% of the patients who reported more than one seizure had a frequency of less than one per month.

The type of resection had no discernible impact on outcomes, although anterior temporal lobe resection did trend toward being associated with recurrence (odds ratio, 2.7; 95% confidence interval, 0.93-8.89; P = .06). Incomplete resection was significantly associated with late relapse but did not seem to affect timing: the mean duration of seizure freedom was 56.5 months with complete resection and 58.5 months with incomplete resection (P = .62). Additional preoperative PET scans were performed on 45% of patients in the relapse group, compared with 29% in the control group.

After multivariate analysis, predictors for late relapse included incomplete resection (OR, 3.81; 95% CI, 1.79-8.53; P < .001); the existence of additional, potentially epileptogenic lesions in the contralateral hemisphere on presurgical MRI (OR, 3.36; 95% CI, 1.18-10.62; P = .03); epilepsy onset during the first year of life (OR, 4.24; 95% CI, 1.4-15.89; P = .02); and preoperative PET scans being performed (OR, 2.47; 95% CI, 1.25-4.97; P = .01). Though use of preoperative and postoperative antiepileptic drugs (AEDs) was higher in the relapse group, along with complete withdrawal being more common in the control group (68%, compared with 51%), neither was deemed significant in multivariate analysis.
 

What to do about seizure relapse risk factors

“This is one of the best analyses of the factors that contribute to late seizure relapse,” Gregory K. Bergey, MD, director of the Johns Hopkins Epilepsy Center in Baltimore, said in an interview. “Am I surprised by their results? Not necessarily.”

What did jump out, he said, was AED use not being a predictor of recurrence, as well as all the patients with late relapse having lesional epilepsy. “As they point out, you can have relapse with nonlesional epilepsy, but very often it happens in the first year or 2. If someone is 2 years out and doesn’t have a lesion, they’re probably more likely to remain seizure free.”

Despite the researchers’ comprehensive review of risk factors, the question remains: What to do with this information?

“They’ve done a very good job of identifying that 7.7% of 1,200 who are at risk of a late relapse,” he said. “Now, take those patients with high-risk factors and launch a trial where you keep medicines the same or do something that would alter that outcome.”

“The problem is,” he added, “that’s a 10-year study. It’s easy for me to sit here and call for one of those. But still, as valuable as this was, it’s a retrospective study. Now you have to say, what are the implications of this? What can we do in the prospective fashion?”

The authors acknowledged their study’s other limitations, including a lack of information on the reasons for an incomplete resection, a notable decrease in follow-up visits more than 5 years after surgery, and potential selection bias. They added, however, that “matching by age at surgery, gender, and time to relapse/last follow‐up” should have helped reduce any significant bias.

No potential conflicts of interest were disclosed.