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Clinical question: To determine the incidence and consequences of acute kidney injury among children hospitalized with diarrheal illness in the United States.

Background: Diarrheal illness is the fourth leading cause of death for children younger than 5 years and the fifth leading cause of years of life lost globally. In the United States, diarrheal illness remains a leading cause of hospital admission among young children. Complications of severe diarrheal illness include hypovolemic acute kidney injury (AKI). Hospitalized children who develop AKI experience longer hospital stays and higher mortality. Additionally, children who experience AKI are at increased risk for chronic kidney disease (CKD), hypertension, and proteinuria.

Study design: Retrospective cohort study.

Setting: Kids’ Inpatient Database (KID) from 2009 and 2012. The authors used secondary International Classification of Diseases, Ninth Revision (ICD-9) diagnoses of AKI to identify patients.

Synopsis: The authors reviewed all patients with diarrhea and found that the incidence of AKI in children hospitalized was 0.8%. Those with infectious diarrhea had an incidence of 1% and with noninfectious diarrhea had an incidence of 0.6%. There was a higher incidence of dialysis-requiring AKI in patients with infectious diarrhea. The odds of developing AKI increased with older age in both infectious and noninfectious diarrheal illnesses. As compared with noninfectious diarrheal illness, infectious diarrheal illness was associated with higher odds of AKI (odds ratio, 2.1; 95% confidence interval, 1.7-2.7). Irrespective of diarrhea type, hematologic and rheumatologic conditions, solid organ transplant, CKD, and hypertension were associated with higher odds of developing AKI. AKI in infectious diarrheal illness was also associated with other renal or genitourinary abnormalities, whereas AKI in noninfectious diarrheal illness was associated with diabetes, cardiovascular, and neurologic conditions.

Hospitalizations for diarrheal illness complicated by AKI were associated with higher mortality, prolonged LOS, and higher hospital cost with odds of death increased eightfold with AKI, mean hospital stay was prolonged by 3 days, and costs increased by greater than $9,000 per hospital stay. The development of AKI in hospitalized diarrheal illness was associated with an up to 11-fold increase in the odds of in-hospital mortality for infectious (OR, 10.8; 95% CI, 3.4-34.3) and noninfectious diarrheal illness (OR, 7.0; 95% CI, 3.1-15.7).

The strengths of this study include broad representation of hospitals caring for children across the United States. The study was limited by its use of ICD-9 codes which may misidentify AKI. The authors were unable to determine if identifying AKI could improve outcomes for patients with diarrheal illness.

Bottom line: AKI in diarrhea illnesses is relatively rare. Close attention should be given to AKI in patients with certain serious comorbid illnesses.

Article citation: Bradshaw C, Han J, Chertow GM, Long J, Sutherland SM, Anand S. Acute Kidney Injury in Children Hospitalized With Diarrheal Illness in the United States. Hosp Pediatr. 2019 Dec;9(12):933-941.

Dr. Kumar is a pediatric hospitalist at Cleveland Clinic Children’s. She is a clinical assistant professor of pediatrics at Case Western Reserve University, and serves as the pediatrics editor for The Hospitalist.

Clinical question: To determine the incidence and consequences of acute kidney injury among children hospitalized with diarrheal illness in the United States.

Background: Diarrheal illness is the fourth leading cause of death for children younger than 5 years and the fifth leading cause of years of life lost globally. In the United States, diarrheal illness remains a leading cause of hospital admission among young children. Complications of severe diarrheal illness include hypovolemic acute kidney injury (AKI). Hospitalized children who develop AKI experience longer hospital stays and higher mortality. Additionally, children who experience AKI are at increased risk for chronic kidney disease (CKD), hypertension, and proteinuria.

Study design: Retrospective cohort study.

Setting: Kids’ Inpatient Database (KID) from 2009 and 2012. The authors used secondary International Classification of Diseases, Ninth Revision (ICD-9) diagnoses of AKI to identify patients.

Synopsis: The authors reviewed all patients with diarrhea and found that the incidence of AKI in children hospitalized was 0.8%. Those with infectious diarrhea had an incidence of 1% and with noninfectious diarrhea had an incidence of 0.6%. There was a higher incidence of dialysis-requiring AKI in patients with infectious diarrhea. The odds of developing AKI increased with older age in both infectious and noninfectious diarrheal illnesses. As compared with noninfectious diarrheal illness, infectious diarrheal illness was associated with higher odds of AKI (odds ratio, 2.1; 95% confidence interval, 1.7-2.7). Irrespective of diarrhea type, hematologic and rheumatologic conditions, solid organ transplant, CKD, and hypertension were associated with higher odds of developing AKI. AKI in infectious diarrheal illness was also associated with other renal or genitourinary abnormalities, whereas AKI in noninfectious diarrheal illness was associated with diabetes, cardiovascular, and neurologic conditions.

Hospitalizations for diarrheal illness complicated by AKI were associated with higher mortality, prolonged LOS, and higher hospital cost with odds of death increased eightfold with AKI, mean hospital stay was prolonged by 3 days, and costs increased by greater than $9,000 per hospital stay. The development of AKI in hospitalized diarrheal illness was associated with an up to 11-fold increase in the odds of in-hospital mortality for infectious (OR, 10.8; 95% CI, 3.4-34.3) and noninfectious diarrheal illness (OR, 7.0; 95% CI, 3.1-15.7).

The strengths of this study include broad representation of hospitals caring for children across the United States. The study was limited by its use of ICD-9 codes which may misidentify AKI. The authors were unable to determine if identifying AKI could improve outcomes for patients with diarrheal illness.

Bottom line: AKI in diarrhea illnesses is relatively rare. Close attention should be given to AKI in patients with certain serious comorbid illnesses.

Article citation: Bradshaw C, Han J, Chertow GM, Long J, Sutherland SM, Anand S. Acute Kidney Injury in Children Hospitalized With Diarrheal Illness in the United States. Hosp Pediatr. 2019 Dec;9(12):933-941.

Dr. Kumar is a pediatric hospitalist at Cleveland Clinic Children’s. She is a clinical assistant professor of pediatrics at Case Western Reserve University, and serves as the pediatrics editor for The Hospitalist.

Clinical question: To determine the incidence and consequences of acute kidney injury among children hospitalized with diarrheal illness in the United States.

Background: Diarrheal illness is the fourth leading cause of death for children younger than 5 years and the fifth leading cause of years of life lost globally. In the United States, diarrheal illness remains a leading cause of hospital admission among young children. Complications of severe diarrheal illness include hypovolemic acute kidney injury (AKI). Hospitalized children who develop AKI experience longer hospital stays and higher mortality. Additionally, children who experience AKI are at increased risk for chronic kidney disease (CKD), hypertension, and proteinuria.

Study design: Retrospective cohort study.

Setting: Kids’ Inpatient Database (KID) from 2009 and 2012. The authors used secondary International Classification of Diseases, Ninth Revision (ICD-9) diagnoses of AKI to identify patients.

Synopsis: The authors reviewed all patients with diarrhea and found that the incidence of AKI in children hospitalized was 0.8%. Those with infectious diarrhea had an incidence of 1% and with noninfectious diarrhea had an incidence of 0.6%. There was a higher incidence of dialysis-requiring AKI in patients with infectious diarrhea. The odds of developing AKI increased with older age in both infectious and noninfectious diarrheal illnesses. As compared with noninfectious diarrheal illness, infectious diarrheal illness was associated with higher odds of AKI (odds ratio, 2.1; 95% confidence interval, 1.7-2.7). Irrespective of diarrhea type, hematologic and rheumatologic conditions, solid organ transplant, CKD, and hypertension were associated with higher odds of developing AKI. AKI in infectious diarrheal illness was also associated with other renal or genitourinary abnormalities, whereas AKI in noninfectious diarrheal illness was associated with diabetes, cardiovascular, and neurologic conditions.

Hospitalizations for diarrheal illness complicated by AKI were associated with higher mortality, prolonged LOS, and higher hospital cost with odds of death increased eightfold with AKI, mean hospital stay was prolonged by 3 days, and costs increased by greater than $9,000 per hospital stay. The development of AKI in hospitalized diarrheal illness was associated with an up to 11-fold increase in the odds of in-hospital mortality for infectious (OR, 10.8; 95% CI, 3.4-34.3) and noninfectious diarrheal illness (OR, 7.0; 95% CI, 3.1-15.7).

The strengths of this study include broad representation of hospitals caring for children across the United States. The study was limited by its use of ICD-9 codes which may misidentify AKI. The authors were unable to determine if identifying AKI could improve outcomes for patients with diarrheal illness.

Bottom line: AKI in diarrhea illnesses is relatively rare. Close attention should be given to AKI in patients with certain serious comorbid illnesses.

Article citation: Bradshaw C, Han J, Chertow GM, Long J, Sutherland SM, Anand S. Acute Kidney Injury in Children Hospitalized With Diarrheal Illness in the United States. Hosp Pediatr. 2019 Dec;9(12):933-941.

Dr. Kumar is a pediatric hospitalist at Cleveland Clinic Children’s. She is a clinical assistant professor of pediatrics at Case Western Reserve University, and serves as the pediatrics editor for The Hospitalist.

The use of digital tools among physicians has markedly risen since 2016, with telehealth visits and remote patient monitoring making the greatest strides in usage, an American Medical Association report shows.

In 2019, 28% of physicians used televisits/virtual visits, up from 14% in 2016, while remote monitoring and management for improved care rose to 22% in 2019, an increase from 13% in 2016, according to the AMA report, released in February 2020. The report, which surveyed 1,359 doctors, includes responses from 672 primary care physicians and 687 specialists.

Remote monitoring for efficiency, meanwhile, grew to 16% in 2019 from 12% in 2016. Remote monitoring for efficiency pertains to smart versions of common clinical devices such as thermometers, blood pressure cuffs, and scales that automatically enter readings in the record. Remote monitoring for improved care refers to mobile applications and devices used for daily measurement of vital signs such as weight, blood pressure, blood glucose.

Adoption of other digital tools by physicians have also grown, including clinical decision support, which climbed to 37% in 2019 from 28% in 2016 and patient engagement tools, which rose to 33% in 2019, up from 26% in 2016. Clinical decision support tools pertain to modules used in conjunction with the electronic health record (EHR), or mobile applications integrated with an EHR that can signify changes in patient data, such as weight gain/loss, or change in blood chemistry. Patient engagement tools, meanwhile, refer to solutions that promote patient wellness and active patient participation in their care.

Tools that encompass use of point of care/workflow enhancement increased to 47% in 2019, from 42% in 2016. This area includes communication and sharing of electronic clinical data to consult with specialists, make referrals and/or transitions of care. Tools that address consumer access to their clinical data, meanwhile, rose to 58% in 2019 from 53% in 2016, the highest adoption rate among the digital health tool categories.

Overall, more physicians see an advantage to digital health solutions than did 3 years ago. More primary care physicians and specialists in 2019 reported a “definite advantage” to digital tools enhancing care of patients than in 2016. Doctors who see no advantage to such tools are trending downward and are concentrated to those age 50 and older, according to the report.

Solo-practice physicians are slowly increasing their use of digital health tools. In 2016, solo physicians reported using an average of 1.5 digital tools, which in 2019 increased to an average of 2.2 digital tools. Small practices with between one and three doctors used an average of 1.4 tools in 2016, which rose to an average of 2.2 tools in 2019, the report found. PCPs used slightly more digital tools, compared with specialists, in both 2016 and 2019.

Female doctors are slightly ahead of their male counterparts when it comes to digital health tools. In 2019, female physicians used an average of 2.6 digital tools, up from 1.9 in 2016. Male doctors used an average of 2.4 tools in 2019, compared with 1.9 tools in 2016.

For the physicians surveyed, the most important factor associated with usage was that digital tools were covered by malpractice insurance, followed by the importance of data privacy/security ensured by the EHR vendor, and that the tools were well integrated with the EHR. Other important factors included that data security was ensured by the practice or hospital, that doctors were reimbursed for their time spent using digital tools, and that the tools were supported by the EHR vendor.

Regarding the top motivator for doctors to use digital tools, 51% of physicians in 2019 said improved efficiency was “very important,” up from 48% in 2016. Other top motivators included that digital tools increased safety, improved diagnostic ability, and addressed physician burnout.

In 2019, the demonstration of safety and efficacy in peer-reviewed publications as it relates to digital tools also grew in importance. Of the physicians surveyed, 36% reported that safety and efficacy demonstrated in peer-reviewed publications was “very important,” an increase from 32% in 2016. Other “very important” factors for physicians are that digital tools used are proven to be as good/superior to traditional care, that they are intuitive/require no special training, that they align with the standard of care, and that their safety and efficacy is validated by the Food and Drug Administration.

“The rise of the digital-native physician will have a profound impact on health care and patient outcomes, and will place digital health technologies under pressure to perform according to higher expectations,” AMA board chair Jesse M. Ehrenfeld, MD, PhD, said in a statement. “The AMA survey provides deep insight into the emerging requirements that physicians expect from digital technologies and sets an industry guidepost for understanding what a growing number of physicians require to adopt new technology.”

The survey was derived from the same physician panel used in 2016, provided by WebMD. For the 2019 survey, the basic 2016 survey was followed in wording and question order, with a few variations to remove some questions no longer relevant. The 2019 sample used careful quotas to ensure a sample composition similar to that of 2016, according to the report.

[email protected]

SOURCE: AMA Digital Health Research: Physicians’ motivations and requirements for adopting digital health – Adoption and attitudinal shifts from 2016 to 2019. American Medical Association. February 2020.

The use of digital tools among physicians has markedly risen since 2016, with telehealth visits and remote patient monitoring making the greatest strides in usage, an American Medical Association report shows.

In 2019, 28% of physicians used televisits/virtual visits, up from 14% in 2016, while remote monitoring and management for improved care rose to 22% in 2019, an increase from 13% in 2016, according to the AMA report, released in February 2020. The report, which surveyed 1,359 doctors, includes responses from 672 primary care physicians and 687 specialists.

Remote monitoring for efficiency, meanwhile, grew to 16% in 2019 from 12% in 2016. Remote monitoring for efficiency pertains to smart versions of common clinical devices such as thermometers, blood pressure cuffs, and scales that automatically enter readings in the record. Remote monitoring for improved care refers to mobile applications and devices used for daily measurement of vital signs such as weight, blood pressure, blood glucose.

Adoption of other digital tools by physicians have also grown, including clinical decision support, which climbed to 37% in 2019 from 28% in 2016 and patient engagement tools, which rose to 33% in 2019, up from 26% in 2016. Clinical decision support tools pertain to modules used in conjunction with the electronic health record (EHR), or mobile applications integrated with an EHR that can signify changes in patient data, such as weight gain/loss, or change in blood chemistry. Patient engagement tools, meanwhile, refer to solutions that promote patient wellness and active patient participation in their care.

Tools that encompass use of point of care/workflow enhancement increased to 47% in 2019, from 42% in 2016. This area includes communication and sharing of electronic clinical data to consult with specialists, make referrals and/or transitions of care. Tools that address consumer access to their clinical data, meanwhile, rose to 58% in 2019 from 53% in 2016, the highest adoption rate among the digital health tool categories.

Overall, more physicians see an advantage to digital health solutions than did 3 years ago. More primary care physicians and specialists in 2019 reported a “definite advantage” to digital tools enhancing care of patients than in 2016. Doctors who see no advantage to such tools are trending downward and are concentrated to those age 50 and older, according to the report.

Solo-practice physicians are slowly increasing their use of digital health tools. In 2016, solo physicians reported using an average of 1.5 digital tools, which in 2019 increased to an average of 2.2 digital tools. Small practices with between one and three doctors used an average of 1.4 tools in 2016, which rose to an average of 2.2 tools in 2019, the report found. PCPs used slightly more digital tools, compared with specialists, in both 2016 and 2019.

Female doctors are slightly ahead of their male counterparts when it comes to digital health tools. In 2019, female physicians used an average of 2.6 digital tools, up from 1.9 in 2016. Male doctors used an average of 2.4 tools in 2019, compared with 1.9 tools in 2016.

For the physicians surveyed, the most important factor associated with usage was that digital tools were covered by malpractice insurance, followed by the importance of data privacy/security ensured by the EHR vendor, and that the tools were well integrated with the EHR. Other important factors included that data security was ensured by the practice or hospital, that doctors were reimbursed for their time spent using digital tools, and that the tools were supported by the EHR vendor.

Regarding the top motivator for doctors to use digital tools, 51% of physicians in 2019 said improved efficiency was “very important,” up from 48% in 2016. Other top motivators included that digital tools increased safety, improved diagnostic ability, and addressed physician burnout.

In 2019, the demonstration of safety and efficacy in peer-reviewed publications as it relates to digital tools also grew in importance. Of the physicians surveyed, 36% reported that safety and efficacy demonstrated in peer-reviewed publications was “very important,” an increase from 32% in 2016. Other “very important” factors for physicians are that digital tools used are proven to be as good/superior to traditional care, that they are intuitive/require no special training, that they align with the standard of care, and that their safety and efficacy is validated by the Food and Drug Administration.

“The rise of the digital-native physician will have a profound impact on health care and patient outcomes, and will place digital health technologies under pressure to perform according to higher expectations,” AMA board chair Jesse M. Ehrenfeld, MD, PhD, said in a statement. “The AMA survey provides deep insight into the emerging requirements that physicians expect from digital technologies and sets an industry guidepost for understanding what a growing number of physicians require to adopt new technology.”

The survey was derived from the same physician panel used in 2016, provided by WebMD. For the 2019 survey, the basic 2016 survey was followed in wording and question order, with a few variations to remove some questions no longer relevant. The 2019 sample used careful quotas to ensure a sample composition similar to that of 2016, according to the report.

[email protected]

SOURCE: AMA Digital Health Research: Physicians’ motivations and requirements for adopting digital health – Adoption and attitudinal shifts from 2016 to 2019. American Medical Association. February 2020.

The use of digital tools among physicians has markedly risen since 2016, with telehealth visits and remote patient monitoring making the greatest strides in usage, an American Medical Association report shows.

In 2019, 28% of physicians used televisits/virtual visits, up from 14% in 2016, while remote monitoring and management for improved care rose to 22% in 2019, an increase from 13% in 2016, according to the AMA report, released in February 2020. The report, which surveyed 1,359 doctors, includes responses from 672 primary care physicians and 687 specialists.

Remote monitoring for efficiency, meanwhile, grew to 16% in 2019 from 12% in 2016. Remote monitoring for efficiency pertains to smart versions of common clinical devices such as thermometers, blood pressure cuffs, and scales that automatically enter readings in the record. Remote monitoring for improved care refers to mobile applications and devices used for daily measurement of vital signs such as weight, blood pressure, blood glucose.

Adoption of other digital tools by physicians have also grown, including clinical decision support, which climbed to 37% in 2019 from 28% in 2016 and patient engagement tools, which rose to 33% in 2019, up from 26% in 2016. Clinical decision support tools pertain to modules used in conjunction with the electronic health record (EHR), or mobile applications integrated with an EHR that can signify changes in patient data, such as weight gain/loss, or change in blood chemistry. Patient engagement tools, meanwhile, refer to solutions that promote patient wellness and active patient participation in their care.

Tools that encompass use of point of care/workflow enhancement increased to 47% in 2019, from 42% in 2016. This area includes communication and sharing of electronic clinical data to consult with specialists, make referrals and/or transitions of care. Tools that address consumer access to their clinical data, meanwhile, rose to 58% in 2019 from 53% in 2016, the highest adoption rate among the digital health tool categories.

Overall, more physicians see an advantage to digital health solutions than did 3 years ago. More primary care physicians and specialists in 2019 reported a “definite advantage” to digital tools enhancing care of patients than in 2016. Doctors who see no advantage to such tools are trending downward and are concentrated to those age 50 and older, according to the report.

Solo-practice physicians are slowly increasing their use of digital health tools. In 2016, solo physicians reported using an average of 1.5 digital tools, which in 2019 increased to an average of 2.2 digital tools. Small practices with between one and three doctors used an average of 1.4 tools in 2016, which rose to an average of 2.2 tools in 2019, the report found. PCPs used slightly more digital tools, compared with specialists, in both 2016 and 2019.

Female doctors are slightly ahead of their male counterparts when it comes to digital health tools. In 2019, female physicians used an average of 2.6 digital tools, up from 1.9 in 2016. Male doctors used an average of 2.4 tools in 2019, compared with 1.9 tools in 2016.

For the physicians surveyed, the most important factor associated with usage was that digital tools were covered by malpractice insurance, followed by the importance of data privacy/security ensured by the EHR vendor, and that the tools were well integrated with the EHR. Other important factors included that data security was ensured by the practice or hospital, that doctors were reimbursed for their time spent using digital tools, and that the tools were supported by the EHR vendor.

Regarding the top motivator for doctors to use digital tools, 51% of physicians in 2019 said improved efficiency was “very important,” up from 48% in 2016. Other top motivators included that digital tools increased safety, improved diagnostic ability, and addressed physician burnout.

In 2019, the demonstration of safety and efficacy in peer-reviewed publications as it relates to digital tools also grew in importance. Of the physicians surveyed, 36% reported that safety and efficacy demonstrated in peer-reviewed publications was “very important,” an increase from 32% in 2016. Other “very important” factors for physicians are that digital tools used are proven to be as good/superior to traditional care, that they are intuitive/require no special training, that they align with the standard of care, and that their safety and efficacy is validated by the Food and Drug Administration.

“The rise of the digital-native physician will have a profound impact on health care and patient outcomes, and will place digital health technologies under pressure to perform according to higher expectations,” AMA board chair Jesse M. Ehrenfeld, MD, PhD, said in a statement. “The AMA survey provides deep insight into the emerging requirements that physicians expect from digital technologies and sets an industry guidepost for understanding what a growing number of physicians require to adopt new technology.”

The survey was derived from the same physician panel used in 2016, provided by WebMD. For the 2019 survey, the basic 2016 survey was followed in wording and question order, with a few variations to remove some questions no longer relevant. The 2019 sample used careful quotas to ensure a sample composition similar to that of 2016, according to the report.

[email protected]

SOURCE: AMA Digital Health Research: Physicians’ motivations and requirements for adopting digital health – Adoption and attitudinal shifts from 2016 to 2019. American Medical Association. February 2020.

The sodium-glucose transporter 2 (SGLT-2) inhibitor ertugliflozin broke ranks with the other drugs in its class and failed to produce statistically significant drops in the both the combined incidence of cardiovascular (CV) death or heart failure hospitalization, and the rate of adverse renal outcomes, in the mandated CV outcomes trial run for ertugliflozin with more than 8,200 patients with type 2 diabetes and established CV disease.

Merck, one of the companies that markets the drug, announced the topline results in a quarterly financial report released on April 28, 2020.

According to the report, the results from the ertugliflozin cardiovascular outcomes trial “achieved its primary endpoint of noninferiority for major adverse CV events (MACE), compared to placebo in patients with type 2 diabetes mellitus and established atherosclerotic CV disease,” but “the key secondary endpoints of superiority” of ertugliflozin, compared with placebo, “for time to the composite of CV death or hospitalization for heart failure, CV death alone, and the composite of renal death, dialysis/transplant or doubling of serum creatinine from baseline were not met.”

However, the report added that, “while not a prespecified hypothesis for statistical testing, a reduction in hospitalization for heart failure was observed” with ertugliflozin treatment, and the report further said that the drug’s safety profile in the trial “was consistent with that reported in previous studies.” The statement closed by saying that detailed results from the trial are scheduled to be presented on June 16, 2020, at the virtual American Diabetes Association’s 80th Scientific Sessions.

These results came from the VERTIS CV (Evaluation of Ertugliflozin EffIcacy and Safety Cardiovascular Outcomes) trial, which researchers said in 2018 had administered at least one investigational dose to 8,238 randomized patients at centers in any of 34 countries during two enrollment periods in 2013-2015 and 2016-2017 (Am Heart J. 2018 Dec;206:11-23). The tested agent, ertugliflozin (Steglatro) received Food and Drug Administration marketing approval late in 2017 for the indication of improving glycemic control in patients with type 2 diabetes.

The FDA mandated cardiovascular outcomes trials for new glycemic control drugs in guidance the agency issued in 2008 (the FDA released in March 2020 a draft of updated guidance on this topic).

Other FDA-approved agents from the SGLT2 inhibitor class include canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance), and all three showed evidence for a statistically significant effect on reducing the incidence of CV disease death and heart failure hospitalizations, as well as renal complications (Can J Diabetes. 2020 Feb;44[1]:61-7). The evidence showing that several SGLT2 drugs have important and consistent effects on endpoints like CV death, heart failure hospitalizations, and renal complications has helped propel this class of agents to the forefront of glycemic control treatments. More recently, one agent from this group, dapagliflozin, also significantly cut the rate of heart failure worsening or CV disease death in patients with heart failure with reduced ejection fraction but without diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008). Based on this evidence, the FDA is currently considering adding a new indication for dapagliflozin that would also label it for use in patients with heart failure with reduced ejection fraction but without diabetes.

[email protected]

The sodium-glucose transporter 2 (SGLT-2) inhibitor ertugliflozin broke ranks with the other drugs in its class and failed to produce statistically significant drops in the both the combined incidence of cardiovascular (CV) death or heart failure hospitalization, and the rate of adverse renal outcomes, in the mandated CV outcomes trial run for ertugliflozin with more than 8,200 patients with type 2 diabetes and established CV disease.

Merck, one of the companies that markets the drug, announced the topline results in a quarterly financial report released on April 28, 2020.

According to the report, the results from the ertugliflozin cardiovascular outcomes trial “achieved its primary endpoint of noninferiority for major adverse CV events (MACE), compared to placebo in patients with type 2 diabetes mellitus and established atherosclerotic CV disease,” but “the key secondary endpoints of superiority” of ertugliflozin, compared with placebo, “for time to the composite of CV death or hospitalization for heart failure, CV death alone, and the composite of renal death, dialysis/transplant or doubling of serum creatinine from baseline were not met.”

However, the report added that, “while not a prespecified hypothesis for statistical testing, a reduction in hospitalization for heart failure was observed” with ertugliflozin treatment, and the report further said that the drug’s safety profile in the trial “was consistent with that reported in previous studies.” The statement closed by saying that detailed results from the trial are scheduled to be presented on June 16, 2020, at the virtual American Diabetes Association’s 80th Scientific Sessions.

These results came from the VERTIS CV (Evaluation of Ertugliflozin EffIcacy and Safety Cardiovascular Outcomes) trial, which researchers said in 2018 had administered at least one investigational dose to 8,238 randomized patients at centers in any of 34 countries during two enrollment periods in 2013-2015 and 2016-2017 (Am Heart J. 2018 Dec;206:11-23). The tested agent, ertugliflozin (Steglatro) received Food and Drug Administration marketing approval late in 2017 for the indication of improving glycemic control in patients with type 2 diabetes.

The FDA mandated cardiovascular outcomes trials for new glycemic control drugs in guidance the agency issued in 2008 (the FDA released in March 2020 a draft of updated guidance on this topic).

Other FDA-approved agents from the SGLT2 inhibitor class include canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance), and all three showed evidence for a statistically significant effect on reducing the incidence of CV disease death and heart failure hospitalizations, as well as renal complications (Can J Diabetes. 2020 Feb;44[1]:61-7). The evidence showing that several SGLT2 drugs have important and consistent effects on endpoints like CV death, heart failure hospitalizations, and renal complications has helped propel this class of agents to the forefront of glycemic control treatments. More recently, one agent from this group, dapagliflozin, also significantly cut the rate of heart failure worsening or CV disease death in patients with heart failure with reduced ejection fraction but without diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008). Based on this evidence, the FDA is currently considering adding a new indication for dapagliflozin that would also label it for use in patients with heart failure with reduced ejection fraction but without diabetes.

[email protected]

The sodium-glucose transporter 2 (SGLT-2) inhibitor ertugliflozin broke ranks with the other drugs in its class and failed to produce statistically significant drops in the both the combined incidence of cardiovascular (CV) death or heart failure hospitalization, and the rate of adverse renal outcomes, in the mandated CV outcomes trial run for ertugliflozin with more than 8,200 patients with type 2 diabetes and established CV disease.

Merck, one of the companies that markets the drug, announced the topline results in a quarterly financial report released on April 28, 2020.

According to the report, the results from the ertugliflozin cardiovascular outcomes trial “achieved its primary endpoint of noninferiority for major adverse CV events (MACE), compared to placebo in patients with type 2 diabetes mellitus and established atherosclerotic CV disease,” but “the key secondary endpoints of superiority” of ertugliflozin, compared with placebo, “for time to the composite of CV death or hospitalization for heart failure, CV death alone, and the composite of renal death, dialysis/transplant or doubling of serum creatinine from baseline were not met.”

However, the report added that, “while not a prespecified hypothesis for statistical testing, a reduction in hospitalization for heart failure was observed” with ertugliflozin treatment, and the report further said that the drug’s safety profile in the trial “was consistent with that reported in previous studies.” The statement closed by saying that detailed results from the trial are scheduled to be presented on June 16, 2020, at the virtual American Diabetes Association’s 80th Scientific Sessions.

These results came from the VERTIS CV (Evaluation of Ertugliflozin EffIcacy and Safety Cardiovascular Outcomes) trial, which researchers said in 2018 had administered at least one investigational dose to 8,238 randomized patients at centers in any of 34 countries during two enrollment periods in 2013-2015 and 2016-2017 (Am Heart J. 2018 Dec;206:11-23). The tested agent, ertugliflozin (Steglatro) received Food and Drug Administration marketing approval late in 2017 for the indication of improving glycemic control in patients with type 2 diabetes.

The FDA mandated cardiovascular outcomes trials for new glycemic control drugs in guidance the agency issued in 2008 (the FDA released in March 2020 a draft of updated guidance on this topic).

Other FDA-approved agents from the SGLT2 inhibitor class include canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance), and all three showed evidence for a statistically significant effect on reducing the incidence of CV disease death and heart failure hospitalizations, as well as renal complications (Can J Diabetes. 2020 Feb;44[1]:61-7). The evidence showing that several SGLT2 drugs have important and consistent effects on endpoints like CV death, heart failure hospitalizations, and renal complications has helped propel this class of agents to the forefront of glycemic control treatments. More recently, one agent from this group, dapagliflozin, also significantly cut the rate of heart failure worsening or CV disease death in patients with heart failure with reduced ejection fraction but without diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008). Based on this evidence, the FDA is currently considering adding a new indication for dapagliflozin that would also label it for use in patients with heart failure with reduced ejection fraction but without diabetes.

[email protected]

The broad use of telemedicine has been a bright spot in the COVID-19 response, but the pandemic is also creating significant disruption as some physicians are furloughed and others consider practice changes.

verbaska_studio/Getty Images

A recent survey of physicians conducted by Merritt Hawkins and The Physicians Foundation examined how physicians are being affected by and responding to the pandemic. The findings are based on completed surveys from 842 physicians. About one-third of respondents are primary care physicians, while two-thirds are surgical, medical, and diagnostic specialists and subspecialists.

The survey shines a light on the rapid adoption of telemedicine, with 48% of physicians respondents reporting that they are now treating patients through telemedicine.

“I think that is purely explainable on the situation that COVID has led to with the desire to see patients remotely, still take care of them, and the fact that at the federal level this was recognized and doctors are being compensated for seeing patients remotely,” Gary Price, MD, a plastic surgeon and president of The Physicians Foundation, said in an interview.

“The Foundation does a study of the nation’s physicians every other year and in 2018, when we asked the same question, only 18% of physicians were using some form of telemedicine,” he added.

And Dr. Price said he thinks the shift to telemedicine is here to stay.

“I think that will be a lasting effect of the pandemic,” he said. “More physicians and more patients will be using telemedicine approaches, I think, from here on out. We will see a shift that persists. I think that’s a good thing. Physicians like it. Patients like it. It won’t replace all in-person visits, certainly, but there are a number of health care visits that could be taken care of quite well with a virtual visit and it saves the patients travel time, time away from work, and I think it can make the physicians’ practice more efficient as well.”

The key to sustainability, he said, will be that private insurers and the Centers for Medicare & Medicaid Services continue to pay for it.

“I think we will have had a good demonstration, not only that it can work, but that it does work and that it can be accomplished without any diminishment in the quality of care that’s delivered,” he said.

But the recent survey also identified a number of employment issues that have arisen during the COVID-19 pandemic. Overall, 18% of respondents who were treating COVID-19 patients and 30% of those not treating COVID-19 patients reported that they had been furloughed or experienced a pay cut. Among respondents, just 38.5% reported that they are seeing COVID-19 patients.

“It is unprecedented to my knowledge in the physician employment sphere,” Dr. Price said. “That was the most surprising thing to me. I think you might be able to explain that by the increasing number of physicians who are employees now of larger health systems and the fact that a big portion of those health systems too, in normal times, involves care that right now no one is able to get to or even wants to be seen for because of the risk, of course, of COVID-19.”

The survey also revealed that some respondents had or were planning a change in practice because of COVID-19: 14% said they had or would seek a different practice, 6% reported they had or would find a job without patient care, 7% said they had or would close their practice temporarily, 5% reported that they had or would retire, and 4% said they had or would leave private practice and seek employment at a hospital.

“The survey represents how they are feeling at the time and it doesn’t mean they will necessarily do that, but if even a portion of doctors did that all at once, we would really aggravate an access problem and what we know is a worsening physician shortage in the country,” he said. “So we are very concerned about that.”

Dr. Price also predicted there would be increased consolidation within the health care system as more smaller, independent practices feel the financial stress of the pandemic.

“I hope that I am wrong about that,” he said. “I think smaller practices offer a very cost-effective solution for high-quality care, and their competition in the marketplace for health care is a good and healthy thing.”

[email protected]

The broad use of telemedicine has been a bright spot in the COVID-19 response, but the pandemic is also creating significant disruption as some physicians are furloughed and others consider practice changes.

verbaska_studio/Getty Images

A recent survey of physicians conducted by Merritt Hawkins and The Physicians Foundation examined how physicians are being affected by and responding to the pandemic. The findings are based on completed surveys from 842 physicians. About one-third of respondents are primary care physicians, while two-thirds are surgical, medical, and diagnostic specialists and subspecialists.

The survey shines a light on the rapid adoption of telemedicine, with 48% of physicians respondents reporting that they are now treating patients through telemedicine.

“I think that is purely explainable on the situation that COVID has led to with the desire to see patients remotely, still take care of them, and the fact that at the federal level this was recognized and doctors are being compensated for seeing patients remotely,” Gary Price, MD, a plastic surgeon and president of The Physicians Foundation, said in an interview.

“The Foundation does a study of the nation’s physicians every other year and in 2018, when we asked the same question, only 18% of physicians were using some form of telemedicine,” he added.

And Dr. Price said he thinks the shift to telemedicine is here to stay.

“I think that will be a lasting effect of the pandemic,” he said. “More physicians and more patients will be using telemedicine approaches, I think, from here on out. We will see a shift that persists. I think that’s a good thing. Physicians like it. Patients like it. It won’t replace all in-person visits, certainly, but there are a number of health care visits that could be taken care of quite well with a virtual visit and it saves the patients travel time, time away from work, and I think it can make the physicians’ practice more efficient as well.”

The key to sustainability, he said, will be that private insurers and the Centers for Medicare & Medicaid Services continue to pay for it.

“I think we will have had a good demonstration, not only that it can work, but that it does work and that it can be accomplished without any diminishment in the quality of care that’s delivered,” he said.

But the recent survey also identified a number of employment issues that have arisen during the COVID-19 pandemic. Overall, 18% of respondents who were treating COVID-19 patients and 30% of those not treating COVID-19 patients reported that they had been furloughed or experienced a pay cut. Among respondents, just 38.5% reported that they are seeing COVID-19 patients.

“It is unprecedented to my knowledge in the physician employment sphere,” Dr. Price said. “That was the most surprising thing to me. I think you might be able to explain that by the increasing number of physicians who are employees now of larger health systems and the fact that a big portion of those health systems too, in normal times, involves care that right now no one is able to get to or even wants to be seen for because of the risk, of course, of COVID-19.”

The survey also revealed that some respondents had or were planning a change in practice because of COVID-19: 14% said they had or would seek a different practice, 6% reported they had or would find a job without patient care, 7% said they had or would close their practice temporarily, 5% reported that they had or would retire, and 4% said they had or would leave private practice and seek employment at a hospital.

“The survey represents how they are feeling at the time and it doesn’t mean they will necessarily do that, but if even a portion of doctors did that all at once, we would really aggravate an access problem and what we know is a worsening physician shortage in the country,” he said. “So we are very concerned about that.”

Dr. Price also predicted there would be increased consolidation within the health care system as more smaller, independent practices feel the financial stress of the pandemic.

“I hope that I am wrong about that,” he said. “I think smaller practices offer a very cost-effective solution for high-quality care, and their competition in the marketplace for health care is a good and healthy thing.”

[email protected]

The broad use of telemedicine has been a bright spot in the COVID-19 response, but the pandemic is also creating significant disruption as some physicians are furloughed and others consider practice changes.

verbaska_studio/Getty Images

A recent survey of physicians conducted by Merritt Hawkins and The Physicians Foundation examined how physicians are being affected by and responding to the pandemic. The findings are based on completed surveys from 842 physicians. About one-third of respondents are primary care physicians, while two-thirds are surgical, medical, and diagnostic specialists and subspecialists.

The survey shines a light on the rapid adoption of telemedicine, with 48% of physicians respondents reporting that they are now treating patients through telemedicine.

“I think that is purely explainable on the situation that COVID has led to with the desire to see patients remotely, still take care of them, and the fact that at the federal level this was recognized and doctors are being compensated for seeing patients remotely,” Gary Price, MD, a plastic surgeon and president of The Physicians Foundation, said in an interview.

“The Foundation does a study of the nation’s physicians every other year and in 2018, when we asked the same question, only 18% of physicians were using some form of telemedicine,” he added.

And Dr. Price said he thinks the shift to telemedicine is here to stay.

“I think that will be a lasting effect of the pandemic,” he said. “More physicians and more patients will be using telemedicine approaches, I think, from here on out. We will see a shift that persists. I think that’s a good thing. Physicians like it. Patients like it. It won’t replace all in-person visits, certainly, but there are a number of health care visits that could be taken care of quite well with a virtual visit and it saves the patients travel time, time away from work, and I think it can make the physicians’ practice more efficient as well.”

The key to sustainability, he said, will be that private insurers and the Centers for Medicare & Medicaid Services continue to pay for it.

“I think we will have had a good demonstration, not only that it can work, but that it does work and that it can be accomplished without any diminishment in the quality of care that’s delivered,” he said.

But the recent survey also identified a number of employment issues that have arisen during the COVID-19 pandemic. Overall, 18% of respondents who were treating COVID-19 patients and 30% of those not treating COVID-19 patients reported that they had been furloughed or experienced a pay cut. Among respondents, just 38.5% reported that they are seeing COVID-19 patients.

“It is unprecedented to my knowledge in the physician employment sphere,” Dr. Price said. “That was the most surprising thing to me. I think you might be able to explain that by the increasing number of physicians who are employees now of larger health systems and the fact that a big portion of those health systems too, in normal times, involves care that right now no one is able to get to or even wants to be seen for because of the risk, of course, of COVID-19.”

The survey also revealed that some respondents had or were planning a change in practice because of COVID-19: 14% said they had or would seek a different practice, 6% reported they had or would find a job without patient care, 7% said they had or would close their practice temporarily, 5% reported that they had or would retire, and 4% said they had or would leave private practice and seek employment at a hospital.

“The survey represents how they are feeling at the time and it doesn’t mean they will necessarily do that, but if even a portion of doctors did that all at once, we would really aggravate an access problem and what we know is a worsening physician shortage in the country,” he said. “So we are very concerned about that.”

Dr. Price also predicted there would be increased consolidation within the health care system as more smaller, independent practices feel the financial stress of the pandemic.

“I hope that I am wrong about that,” he said. “I think smaller practices offer a very cost-effective solution for high-quality care, and their competition in the marketplace for health care is a good and healthy thing.”

[email protected]

Because of stark racial disparities in COVID-19 infection and mortality, the pandemic is being called a “sentinel” and “bellwether” event that should push the United States to finally come to grips with disparities in health care.

When it comes to COVID-19, the pattern is “irrefutable”: Blacks in the United States are being infected with SARS-CoV-2 and are dying of COVID-19 at higher rates than whites, Clyde W. Yancy, MD, Northwestern University, Chicago, wrote in a viewpoint article published online April 15 in JAMA.

According to one recent survey, he noted, the infection rate is threefold higher and the death rate is sixfold higher in predominantly black counties in the United States relative to predominantly white counties.

A sixfold increase in the rate of death for blacks due to a now ubiquitous virus should be deemed “unconscionable” and a moment of “ethical reckoning,” Dr. Yancy wrote.

“Why is this uniquely important to me? I am an academic cardiologist; I study health care disparities; and I am a black man,” he wrote.

The COVID-19 pandemic may be the “bellwether” event that the United States has needed to fully address disparities in health care, Dr. Yancy said.

“Public health is complicated and social reengineering is complex, but change of this magnitude does not happen without a new resolve,” he concluded. “The U.S. has needed a trigger to fully address health care disparities; COVID-19 may be that bellwether event. Certainly, within the broad and powerful economic and legislative engines of the U.S., there is room to definitively address a scourge even worse than COVID-19: health care disparities. It only takes will. It is time to end the refrain.”

The question is, he asks, will the nation finally “think differently, and, as has been done in response to other major diseases, declare that a civil society will no longer accept disproportionate suffering?”

Keith C. Ferdinand, MD, Tulane University, New Orleans, doesn’t think so.

In a related editorial published online April 17 in the Journal of the American College of Cardiology, he points out that the 1985 Heckler Report, from the Department of Health and Human Services, documented higher racial/ethnic mortality rates and the need to correct them. This was followed in 2002 by a report from the Institute of Medicine called Unequal Treatment that also underscored health disparities.

Despite some progress, the goal of reducing and eventually eliminating racial/ethnic disparities has not been realized, Dr. Ferdinand said. “I think baked into the consciousness of the American psyche is that there are some people who have and some who have not,” he said in an interview.

“To some extent, some societies at some point become immune. We would not like to think that America, with its sense of egalitarianism, would get to that point, but maybe we have,” said Dr. Ferdinand.
 

A ‘sentinel event’

He points out that black people are not genetically or biologically predisposed to COVID-19 but are socially prone to coronavirus exposure and are more likely to have comorbid conditions, such as hypertension, diabetes, obesity, and heart disease, that fuel complications.

The “tragic” higher COVID-19 mortality among African Americans and other racial/ethnic minorities confirms “inadequate” efforts on the part of society to eliminate disparities in cardiovascular disease (CVD) and is a “sentinel event,” Dr. Ferdinand wrote.

A sentinel event, as defined by the Joint Commission, is an unexpected occurrence that leads to death or serious physical or psychological injury or the risk thereof, he explained.

“Conventionally identified sentinel events, such as unintended retention of foreign objects and fall-related events, are used to evaluate quality in hospital care. Similarly, disparate [African American] COVID-19 mortality reflects long-standing, unacceptable U.S. racial/ethnic and socioeconomic CVD inequities and unmasks system failures and unacceptable care to be caught and mitigated,” Dr. Ferdinand concluded.

Dr. Yancy and Dr. Ferdinand have disclosed no relevant financial relationships.

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

Because of stark racial disparities in COVID-19 infection and mortality, the pandemic is being called a “sentinel” and “bellwether” event that should push the United States to finally come to grips with disparities in health care.

When it comes to COVID-19, the pattern is “irrefutable”: Blacks in the United States are being infected with SARS-CoV-2 and are dying of COVID-19 at higher rates than whites, Clyde W. Yancy, MD, Northwestern University, Chicago, wrote in a viewpoint article published online April 15 in JAMA.

According to one recent survey, he noted, the infection rate is threefold higher and the death rate is sixfold higher in predominantly black counties in the United States relative to predominantly white counties.

A sixfold increase in the rate of death for blacks due to a now ubiquitous virus should be deemed “unconscionable” and a moment of “ethical reckoning,” Dr. Yancy wrote.

“Why is this uniquely important to me? I am an academic cardiologist; I study health care disparities; and I am a black man,” he wrote.

The COVID-19 pandemic may be the “bellwether” event that the United States has needed to fully address disparities in health care, Dr. Yancy said.

“Public health is complicated and social reengineering is complex, but change of this magnitude does not happen without a new resolve,” he concluded. “The U.S. has needed a trigger to fully address health care disparities; COVID-19 may be that bellwether event. Certainly, within the broad and powerful economic and legislative engines of the U.S., there is room to definitively address a scourge even worse than COVID-19: health care disparities. It only takes will. It is time to end the refrain.”

The question is, he asks, will the nation finally “think differently, and, as has been done in response to other major diseases, declare that a civil society will no longer accept disproportionate suffering?”

Keith C. Ferdinand, MD, Tulane University, New Orleans, doesn’t think so.

In a related editorial published online April 17 in the Journal of the American College of Cardiology, he points out that the 1985 Heckler Report, from the Department of Health and Human Services, documented higher racial/ethnic mortality rates and the need to correct them. This was followed in 2002 by a report from the Institute of Medicine called Unequal Treatment that also underscored health disparities.

Despite some progress, the goal of reducing and eventually eliminating racial/ethnic disparities has not been realized, Dr. Ferdinand said. “I think baked into the consciousness of the American psyche is that there are some people who have and some who have not,” he said in an interview.

“To some extent, some societies at some point become immune. We would not like to think that America, with its sense of egalitarianism, would get to that point, but maybe we have,” said Dr. Ferdinand.
 

A ‘sentinel event’

He points out that black people are not genetically or biologically predisposed to COVID-19 but are socially prone to coronavirus exposure and are more likely to have comorbid conditions, such as hypertension, diabetes, obesity, and heart disease, that fuel complications.

The “tragic” higher COVID-19 mortality among African Americans and other racial/ethnic minorities confirms “inadequate” efforts on the part of society to eliminate disparities in cardiovascular disease (CVD) and is a “sentinel event,” Dr. Ferdinand wrote.

A sentinel event, as defined by the Joint Commission, is an unexpected occurrence that leads to death or serious physical or psychological injury or the risk thereof, he explained.

“Conventionally identified sentinel events, such as unintended retention of foreign objects and fall-related events, are used to evaluate quality in hospital care. Similarly, disparate [African American] COVID-19 mortality reflects long-standing, unacceptable U.S. racial/ethnic and socioeconomic CVD inequities and unmasks system failures and unacceptable care to be caught and mitigated,” Dr. Ferdinand concluded.

Dr. Yancy and Dr. Ferdinand have disclosed no relevant financial relationships.

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

Because of stark racial disparities in COVID-19 infection and mortality, the pandemic is being called a “sentinel” and “bellwether” event that should push the United States to finally come to grips with disparities in health care.

When it comes to COVID-19, the pattern is “irrefutable”: Blacks in the United States are being infected with SARS-CoV-2 and are dying of COVID-19 at higher rates than whites, Clyde W. Yancy, MD, Northwestern University, Chicago, wrote in a viewpoint article published online April 15 in JAMA.

According to one recent survey, he noted, the infection rate is threefold higher and the death rate is sixfold higher in predominantly black counties in the United States relative to predominantly white counties.

A sixfold increase in the rate of death for blacks due to a now ubiquitous virus should be deemed “unconscionable” and a moment of “ethical reckoning,” Dr. Yancy wrote.

“Why is this uniquely important to me? I am an academic cardiologist; I study health care disparities; and I am a black man,” he wrote.

The COVID-19 pandemic may be the “bellwether” event that the United States has needed to fully address disparities in health care, Dr. Yancy said.

“Public health is complicated and social reengineering is complex, but change of this magnitude does not happen without a new resolve,” he concluded. “The U.S. has needed a trigger to fully address health care disparities; COVID-19 may be that bellwether event. Certainly, within the broad and powerful economic and legislative engines of the U.S., there is room to definitively address a scourge even worse than COVID-19: health care disparities. It only takes will. It is time to end the refrain.”

The question is, he asks, will the nation finally “think differently, and, as has been done in response to other major diseases, declare that a civil society will no longer accept disproportionate suffering?”

Keith C. Ferdinand, MD, Tulane University, New Orleans, doesn’t think so.

In a related editorial published online April 17 in the Journal of the American College of Cardiology, he points out that the 1985 Heckler Report, from the Department of Health and Human Services, documented higher racial/ethnic mortality rates and the need to correct them. This was followed in 2002 by a report from the Institute of Medicine called Unequal Treatment that also underscored health disparities.

Despite some progress, the goal of reducing and eventually eliminating racial/ethnic disparities has not been realized, Dr. Ferdinand said. “I think baked into the consciousness of the American psyche is that there are some people who have and some who have not,” he said in an interview.

“To some extent, some societies at some point become immune. We would not like to think that America, with its sense of egalitarianism, would get to that point, but maybe we have,” said Dr. Ferdinand.
 

A ‘sentinel event’

He points out that black people are not genetically or biologically predisposed to COVID-19 but are socially prone to coronavirus exposure and are more likely to have comorbid conditions, such as hypertension, diabetes, obesity, and heart disease, that fuel complications.

The “tragic” higher COVID-19 mortality among African Americans and other racial/ethnic minorities confirms “inadequate” efforts on the part of society to eliminate disparities in cardiovascular disease (CVD) and is a “sentinel event,” Dr. Ferdinand wrote.

A sentinel event, as defined by the Joint Commission, is an unexpected occurrence that leads to death or serious physical or psychological injury or the risk thereof, he explained.

“Conventionally identified sentinel events, such as unintended retention of foreign objects and fall-related events, are used to evaluate quality in hospital care. Similarly, disparate [African American] COVID-19 mortality reflects long-standing, unacceptable U.S. racial/ethnic and socioeconomic CVD inequities and unmasks system failures and unacceptable care to be caught and mitigated,” Dr. Ferdinand concluded.

Dr. Yancy and Dr. Ferdinand have disclosed no relevant financial relationships.

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

A consensus statement from the American College of Cardiology (ACC), the American College of Emergency Physicians (ACEP), and the Society for Cardiovascular Angiography & Interventions (SCAI) outlines recommendations for a systematic approach for the care of patients with an acute myocardial infarction (AMI) during the COVID-19 pandemic.

The statement was published in the Journal of the American College of Cardiology.

During the COVID-19 pandemic, percutaneous coronary intervention (PCI) remains the standard of care for patients with ST-segment elevation MI (STEMI) at PCI-capable hospitals when it can be provided in a timely fashion in a dedicated cardiac catheterization laboratory with an expert care team wearing personal protection equipment (PPE), the writing group advised.

“A fibrinolysis-based strategy may be entertained at non-PCI capable referral hospitals or in specific situations where primary PCI cannot be executed or is not deemed the best option,” they said.

SCAI President Ehtisham Mahmud, MD, of the University of California, San Diego, and the writing group also said that clinicians should recognize that cardiovascular manifestations of COVID-19 are “complex” in patients presenting with AMI, myocarditis simulating a STEMI, stress cardiomyopathy, nonischemic cardiomyopathy, coronary spasm, or nonspecific myocardial injury.

A “broad differential diagnosis for ST elevations (including COVID-associated myocarditis) should be considered in the ED prior to choosing a reperfusion strategy,” they advised.

In the absence of hemodynamic instability or ongoing ischemic symptoms, non-STEMI patients with known or suspected COVID-19 are best managed with an initial medical stabilization strategy, the group said.

They also said it is “imperative that health care workers use appropriate PPE for all invasive procedures during this pandemic” and that new rapid COVID-19 testing be “expeditiously” disseminated to all hospitals that manage patients with AMI.

Major challenges are that the prevalence of the COVID-19 in the United States remains unknown and there is the risk for asymptomatic spread.

The writing group said it’s “critical” to “inform the public that we can minimize exposure to the coronavirus so they can continue to call the Emergency Medical System (EMS) for acute ischemic heart disease symptoms and therefore get the appropriate level of cardiac care that their presentation warrants.”

This research had no commercial funding. Dr. Mahmud reported receiving clinical trial research support from Corindus, Abbott Vascular, and CSI; consulting with Medtronic; and consulting and equity with Abiomed. A complete list of author disclosures is included with the original article.

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

A consensus statement from the American College of Cardiology (ACC), the American College of Emergency Physicians (ACEP), and the Society for Cardiovascular Angiography & Interventions (SCAI) outlines recommendations for a systematic approach for the care of patients with an acute myocardial infarction (AMI) during the COVID-19 pandemic.

The statement was published in the Journal of the American College of Cardiology.

During the COVID-19 pandemic, percutaneous coronary intervention (PCI) remains the standard of care for patients with ST-segment elevation MI (STEMI) at PCI-capable hospitals when it can be provided in a timely fashion in a dedicated cardiac catheterization laboratory with an expert care team wearing personal protection equipment (PPE), the writing group advised.

“A fibrinolysis-based strategy may be entertained at non-PCI capable referral hospitals or in specific situations where primary PCI cannot be executed or is not deemed the best option,” they said.

SCAI President Ehtisham Mahmud, MD, of the University of California, San Diego, and the writing group also said that clinicians should recognize that cardiovascular manifestations of COVID-19 are “complex” in patients presenting with AMI, myocarditis simulating a STEMI, stress cardiomyopathy, nonischemic cardiomyopathy, coronary spasm, or nonspecific myocardial injury.

A “broad differential diagnosis for ST elevations (including COVID-associated myocarditis) should be considered in the ED prior to choosing a reperfusion strategy,” they advised.

In the absence of hemodynamic instability or ongoing ischemic symptoms, non-STEMI patients with known or suspected COVID-19 are best managed with an initial medical stabilization strategy, the group said.

They also said it is “imperative that health care workers use appropriate PPE for all invasive procedures during this pandemic” and that new rapid COVID-19 testing be “expeditiously” disseminated to all hospitals that manage patients with AMI.

Major challenges are that the prevalence of the COVID-19 in the United States remains unknown and there is the risk for asymptomatic spread.

The writing group said it’s “critical” to “inform the public that we can minimize exposure to the coronavirus so they can continue to call the Emergency Medical System (EMS) for acute ischemic heart disease symptoms and therefore get the appropriate level of cardiac care that their presentation warrants.”

This research had no commercial funding. Dr. Mahmud reported receiving clinical trial research support from Corindus, Abbott Vascular, and CSI; consulting with Medtronic; and consulting and equity with Abiomed. A complete list of author disclosures is included with the original article.

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

A consensus statement from the American College of Cardiology (ACC), the American College of Emergency Physicians (ACEP), and the Society for Cardiovascular Angiography & Interventions (SCAI) outlines recommendations for a systematic approach for the care of patients with an acute myocardial infarction (AMI) during the COVID-19 pandemic.

The statement was published in the Journal of the American College of Cardiology.

During the COVID-19 pandemic, percutaneous coronary intervention (PCI) remains the standard of care for patients with ST-segment elevation MI (STEMI) at PCI-capable hospitals when it can be provided in a timely fashion in a dedicated cardiac catheterization laboratory with an expert care team wearing personal protection equipment (PPE), the writing group advised.

“A fibrinolysis-based strategy may be entertained at non-PCI capable referral hospitals or in specific situations where primary PCI cannot be executed or is not deemed the best option,” they said.

SCAI President Ehtisham Mahmud, MD, of the University of California, San Diego, and the writing group also said that clinicians should recognize that cardiovascular manifestations of COVID-19 are “complex” in patients presenting with AMI, myocarditis simulating a STEMI, stress cardiomyopathy, nonischemic cardiomyopathy, coronary spasm, or nonspecific myocardial injury.

A “broad differential diagnosis for ST elevations (including COVID-associated myocarditis) should be considered in the ED prior to choosing a reperfusion strategy,” they advised.

In the absence of hemodynamic instability or ongoing ischemic symptoms, non-STEMI patients with known or suspected COVID-19 are best managed with an initial medical stabilization strategy, the group said.

They also said it is “imperative that health care workers use appropriate PPE for all invasive procedures during this pandemic” and that new rapid COVID-19 testing be “expeditiously” disseminated to all hospitals that manage patients with AMI.

Major challenges are that the prevalence of the COVID-19 in the United States remains unknown and there is the risk for asymptomatic spread.

The writing group said it’s “critical” to “inform the public that we can minimize exposure to the coronavirus so they can continue to call the Emergency Medical System (EMS) for acute ischemic heart disease symptoms and therefore get the appropriate level of cardiac care that their presentation warrants.”

This research had no commercial funding. Dr. Mahmud reported receiving clinical trial research support from Corindus, Abbott Vascular, and CSI; consulting with Medtronic; and consulting and equity with Abiomed. A complete list of author disclosures is included with the original article.

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

Background: Federal health system programs, including TRICARE for military personnel, spent $259 million in 2013 and $746 million in 2014 for compounded analgesic medications despite a dearth of efficacy data. The purpose of this trial was to evaluate the efficacy and functional impact of this class of medications for chronic localized pain.

The primary outcome was the average pain score at 1 month follow-up, based on self-recorded arithmetic mean pain scores in the preceding week. Secondary outcomes included mean worst pain over the past week, functional improvement (assessed by validated Short-Form 36 Health Survey scores), and satisfaction (measured on a 1 to 5 Likert scale) with the individual treatment regimen.

Patients had small improvements in average pain scores at 1 month in the compounded formulation and placebo subgroups in all pain type categories. No significant differences were noted in the average pain scores compared to baseline, functional improvement or satisfaction in the compounded formulation and placebo groups of the total cohort or in any of the subgroups.

Bottom line: Compounded topical analgesics are costly and ineffective in the treatment of all types of chronic localized pain.

Citation: Brutcher RE et al. Compounded topical pain creams to treat localized chronic pain. Ann Intern Med. 2019;170(5):309-18.

Dr. Lambert is a hospital medicine clinician and addiction medicine specialist in the division of hospital medicine at Massachusetts General Hospital.

Background: Federal health system programs, including TRICARE for military personnel, spent $259 million in 2013 and $746 million in 2014 for compounded analgesic medications despite a dearth of efficacy data. The purpose of this trial was to evaluate the efficacy and functional impact of this class of medications for chronic localized pain.

The primary outcome was the average pain score at 1 month follow-up, based on self-recorded arithmetic mean pain scores in the preceding week. Secondary outcomes included mean worst pain over the past week, functional improvement (assessed by validated Short-Form 36 Health Survey scores), and satisfaction (measured on a 1 to 5 Likert scale) with the individual treatment regimen.

Patients had small improvements in average pain scores at 1 month in the compounded formulation and placebo subgroups in all pain type categories. No significant differences were noted in the average pain scores compared to baseline, functional improvement or satisfaction in the compounded formulation and placebo groups of the total cohort or in any of the subgroups.

Bottom line: Compounded topical analgesics are costly and ineffective in the treatment of all types of chronic localized pain.

Citation: Brutcher RE et al. Compounded topical pain creams to treat localized chronic pain. Ann Intern Med. 2019;170(5):309-18.

Dr. Lambert is a hospital medicine clinician and addiction medicine specialist in the division of hospital medicine at Massachusetts General Hospital.

Background: Federal health system programs, including TRICARE for military personnel, spent $259 million in 2013 and $746 million in 2014 for compounded analgesic medications despite a dearth of efficacy data. The purpose of this trial was to evaluate the efficacy and functional impact of this class of medications for chronic localized pain.

The primary outcome was the average pain score at 1 month follow-up, based on self-recorded arithmetic mean pain scores in the preceding week. Secondary outcomes included mean worst pain over the past week, functional improvement (assessed by validated Short-Form 36 Health Survey scores), and satisfaction (measured on a 1 to 5 Likert scale) with the individual treatment regimen.

Patients had small improvements in average pain scores at 1 month in the compounded formulation and placebo subgroups in all pain type categories. No significant differences were noted in the average pain scores compared to baseline, functional improvement or satisfaction in the compounded formulation and placebo groups of the total cohort or in any of the subgroups.

Bottom line: Compounded topical analgesics are costly and ineffective in the treatment of all types of chronic localized pain.

Citation: Brutcher RE et al. Compounded topical pain creams to treat localized chronic pain. Ann Intern Med. 2019;170(5):309-18.

Dr. Lambert is a hospital medicine clinician and addiction medicine specialist in the division of hospital medicine at Massachusetts General Hospital.

The Centers for Medicare & Medicaid Services will suspend its Medicare advance payment program for clinicians and is reevaluating how much to pay to hospitals going forward through particular COVID-19 relief initiatives. CMS announced the changes on April 26. Physicians and others who use the accelerated and advance Medicare payments program repay these advances, and they are typically given 1 year or less to repay the funding.

CMS said in a news release it will not accept new applications for the advanced Medicare payment, and it will be reevaluating all pending and new applications “in light of historical direct payments made available through the Department of Health & Human Services’ (HHS) Provider Relief Fund.”

The advance Medicare payment program predates COVID-19, although it previously was used on a much smaller scale. In the past 5 years, CMS approved about 100 total requests for advanced Medicare payment, with most being tied to natural disasters such as hurricanes.

CMS said it has approved, since March, more than 21,000 applications for advanced Medicare payment, totaling $59.6 billion, for hospitals and other organizations that bill its Part A program. In addition, CMS approved almost 24,000 applications for its Part B program, advancing $40.4 billion for physicians, other clinicians, and medical equipment suppliers.

CMS noted that Congress also has provided $175 billion in aid for the medical community that clinicians and medical organizations would not need to repay. The Coronavirus Aid, Relief, and Economic Security (CARES) Act enacted in March included $100 billion, and the Paycheck Protection Program and Health Care Enhancement Act, enacted March 24, includes another $75 billion.

A version of this article was originally published on Medscape.com.

The Centers for Medicare & Medicaid Services will suspend its Medicare advance payment program for clinicians and is reevaluating how much to pay to hospitals going forward through particular COVID-19 relief initiatives. CMS announced the changes on April 26. Physicians and others who use the accelerated and advance Medicare payments program repay these advances, and they are typically given 1 year or less to repay the funding.

CMS said in a news release it will not accept new applications for the advanced Medicare payment, and it will be reevaluating all pending and new applications “in light of historical direct payments made available through the Department of Health & Human Services’ (HHS) Provider Relief Fund.”

The advance Medicare payment program predates COVID-19, although it previously was used on a much smaller scale. In the past 5 years, CMS approved about 100 total requests for advanced Medicare payment, with most being tied to natural disasters such as hurricanes.

CMS said it has approved, since March, more than 21,000 applications for advanced Medicare payment, totaling $59.6 billion, for hospitals and other organizations that bill its Part A program. In addition, CMS approved almost 24,000 applications for its Part B program, advancing $40.4 billion for physicians, other clinicians, and medical equipment suppliers.

CMS noted that Congress also has provided $175 billion in aid for the medical community that clinicians and medical organizations would not need to repay. The Coronavirus Aid, Relief, and Economic Security (CARES) Act enacted in March included $100 billion, and the Paycheck Protection Program and Health Care Enhancement Act, enacted March 24, includes another $75 billion.

A version of this article was originally published on Medscape.com.

The Centers for Medicare & Medicaid Services will suspend its Medicare advance payment program for clinicians and is reevaluating how much to pay to hospitals going forward through particular COVID-19 relief initiatives. CMS announced the changes on April 26. Physicians and others who use the accelerated and advance Medicare payments program repay these advances, and they are typically given 1 year or less to repay the funding.

CMS said in a news release it will not accept new applications for the advanced Medicare payment, and it will be reevaluating all pending and new applications “in light of historical direct payments made available through the Department of Health & Human Services’ (HHS) Provider Relief Fund.”

The advance Medicare payment program predates COVID-19, although it previously was used on a much smaller scale. In the past 5 years, CMS approved about 100 total requests for advanced Medicare payment, with most being tied to natural disasters such as hurricanes.

CMS said it has approved, since March, more than 21,000 applications for advanced Medicare payment, totaling $59.6 billion, for hospitals and other organizations that bill its Part A program. In addition, CMS approved almost 24,000 applications for its Part B program, advancing $40.4 billion for physicians, other clinicians, and medical equipment suppliers.

CMS noted that Congress also has provided $175 billion in aid for the medical community that clinicians and medical organizations would not need to repay. The Coronavirus Aid, Relief, and Economic Security (CARES) Act enacted in March included $100 billion, and the Paycheck Protection Program and Health Care Enhancement Act, enacted March 24, includes another $75 billion.

A version of this article was originally published on Medscape.com.

Like you, I’m not sure when this weird Twilight Zone world of coronavirus will end. Even when it does, its effects will be with us for a long time to come.

But in some ways, they may be for the better. Hopefully some of these changes will stick. Like every new situation, I try to take away something of value from it.

As pithy as it sounds, I used to obsess (sort of) over the daily mail delivery. My secretary would check it mid-afternoon, and if it wasn’t there either she or I would run down again before we left. If it still wasn’t there I’d swing by the box when I came in early the next morning. On Saturdays, I’d sometimes drive in just to get the mail.

There certainly are things that come in that are important: payments, bills, medical records, legal cases to review ... but realistically a lot of mail is junk. Office-supply catalogs, CME or pharmaceutical ads, credit card promotions, and so on.

Now? I just don’t care. If I go several days without seeing patients at the office, the mail is at the back of my mind. It’s in a locked box and isn’t going anywhere. Why worry about it? Next time I’m there I can deal with it. It’s not worth thinking about, it’s just the mail. It’s not worth a special trip.

Sleep is another thing. For years my internal alarm has had me up around 4:00 a.m. (I don’t even bother to set one on my phone), and I get up and go in to get started on the day.

Now? I don’t think I’ve ever slept this much. If I have to go to my office, I’m much less rushed. Many days I don’t even have to do that. I walk down to my home office, call up my charts and the day’s video appointment schedule, and we’re off. Granted, once things return to speed, this will probably be back to normal.

My kids are all home from college, so I have the extra time at home to enjoy them and our dogs. My wife, an oncology infusion nurse, doesn’t get home until 6:00 each night, so for now I’ve become a stay-at-home dad. This is actually something I’ve always liked (in high school, I was voted “most likely to to be a house husband”). So I do the laundry and am in charge of dinner each night. I’m enjoying the last, as I get to pick things out, go through recipes, and cook. I won’t say I’m a great cook, but I’m learning and having fun. As strange as it sounds, being a house husband has always been something I wanted to do, so I’m appreciating the opportunity while it lasts.

I think all of us have come to accept this strange pause button that’s been pushed, and I’ll try to learn what I can from it and take that with me as I move forward.

Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.

Like you, I’m not sure when this weird Twilight Zone world of coronavirus will end. Even when it does, its effects will be with us for a long time to come.

But in some ways, they may be for the better. Hopefully some of these changes will stick. Like every new situation, I try to take away something of value from it.

As pithy as it sounds, I used to obsess (sort of) over the daily mail delivery. My secretary would check it mid-afternoon, and if it wasn’t there either she or I would run down again before we left. If it still wasn’t there I’d swing by the box when I came in early the next morning. On Saturdays, I’d sometimes drive in just to get the mail.

There certainly are things that come in that are important: payments, bills, medical records, legal cases to review ... but realistically a lot of mail is junk. Office-supply catalogs, CME or pharmaceutical ads, credit card promotions, and so on.

Now? I just don’t care. If I go several days without seeing patients at the office, the mail is at the back of my mind. It’s in a locked box and isn’t going anywhere. Why worry about it? Next time I’m there I can deal with it. It’s not worth thinking about, it’s just the mail. It’s not worth a special trip.

Sleep is another thing. For years my internal alarm has had me up around 4:00 a.m. (I don’t even bother to set one on my phone), and I get up and go in to get started on the day.

Now? I don’t think I’ve ever slept this much. If I have to go to my office, I’m much less rushed. Many days I don’t even have to do that. I walk down to my home office, call up my charts and the day’s video appointment schedule, and we’re off. Granted, once things return to speed, this will probably be back to normal.

My kids are all home from college, so I have the extra time at home to enjoy them and our dogs. My wife, an oncology infusion nurse, doesn’t get home until 6:00 each night, so for now I’ve become a stay-at-home dad. This is actually something I’ve always liked (in high school, I was voted “most likely to to be a house husband”). So I do the laundry and am in charge of dinner each night. I’m enjoying the last, as I get to pick things out, go through recipes, and cook. I won’t say I’m a great cook, but I’m learning and having fun. As strange as it sounds, being a house husband has always been something I wanted to do, so I’m appreciating the opportunity while it lasts.

I think all of us have come to accept this strange pause button that’s been pushed, and I’ll try to learn what I can from it and take that with me as I move forward.

Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.

Like you, I’m not sure when this weird Twilight Zone world of coronavirus will end. Even when it does, its effects will be with us for a long time to come.

But in some ways, they may be for the better. Hopefully some of these changes will stick. Like every new situation, I try to take away something of value from it.

As pithy as it sounds, I used to obsess (sort of) over the daily mail delivery. My secretary would check it mid-afternoon, and if it wasn’t there either she or I would run down again before we left. If it still wasn’t there I’d swing by the box when I came in early the next morning. On Saturdays, I’d sometimes drive in just to get the mail.

There certainly are things that come in that are important: payments, bills, medical records, legal cases to review ... but realistically a lot of mail is junk. Office-supply catalogs, CME or pharmaceutical ads, credit card promotions, and so on.

Now? I just don’t care. If I go several days without seeing patients at the office, the mail is at the back of my mind. It’s in a locked box and isn’t going anywhere. Why worry about it? Next time I’m there I can deal with it. It’s not worth thinking about, it’s just the mail. It’s not worth a special trip.

Sleep is another thing. For years my internal alarm has had me up around 4:00 a.m. (I don’t even bother to set one on my phone), and I get up and go in to get started on the day.

Now? I don’t think I’ve ever slept this much. If I have to go to my office, I’m much less rushed. Many days I don’t even have to do that. I walk down to my home office, call up my charts and the day’s video appointment schedule, and we’re off. Granted, once things return to speed, this will probably be back to normal.

My kids are all home from college, so I have the extra time at home to enjoy them and our dogs. My wife, an oncology infusion nurse, doesn’t get home until 6:00 each night, so for now I’ve become a stay-at-home dad. This is actually something I’ve always liked (in high school, I was voted “most likely to to be a house husband”). So I do the laundry and am in charge of dinner each night. I’m enjoying the last, as I get to pick things out, go through recipes, and cook. I won’t say I’m a great cook, but I’m learning and having fun. As strange as it sounds, being a house husband has always been something I wanted to do, so I’m appreciating the opportunity while it lasts.

I think all of us have come to accept this strange pause button that’s been pushed, and I’ll try to learn what I can from it and take that with me as I move forward.

Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.

For patients diagnosed with mild acute pancreatitis (AP) in the ED, an observation pathway may significantly reduce hospitalization rate and associated costs without compromising patient safety or quality of care, according to investigators.

Over a 2-year period, the observation pathway at Beth Israel Deaconess Medical Center, Boston, reduced hospitalizations by 31.2%, reported lead author Awais Ahmed, MD, of Harvard Medical School, Boston, and colleagues.

“AP carries a significant burden on the health care system, accounting for the third most common reason for gastrointestinal-related admissions in the United States,” the investigators wrote in the Journal of Clinical Gastroenterology. “As such, streamlining care for AP patients to reduce admissions can reduce the associated financial burden.”

The investigators’ efforts to reduce admissions for patients with AP began in 2016, when they first implemented an observation pathway at Beth Israel. This 6-month pilot study demonstrated proof of concept because it reduced admissions by 22.2% and shortened average length of stay without negatively affecting rates of mortality or readmission.

Based on these encouraging results, the hospital implemented the observation pathway as a standard of care. The present study analyzed 2 years of data from patients diagnosed with AP following the end of the pilot study. The primary outcome was hospitalization rate. Secondary outcomes included health care utilization, 30-day mortality rate, 30-day readmission rate, and median length of stay.

Patients with mild AP entered the observation pathway at the discretion of the supervising clinician, as well as based on absence of exclusion criteria, such as end organ damage, chronic pancreatitis, cholangitis, and other considerations.

Over 2 years, 165 patients were diagnosed with AP in the ED, of whom 118 (71.5%) had mild AP. From this latter group, 54 (45.8%) entered the observation pathway, while 64 (54.2%) were admitted as inpatients, primarily (n = 58) because of exclusion criteria. Within the observation group, 45 out of 54 patients (83.3%) successfully completed the pathway and were discharged. Six of these patients were readmitted within 30 days. Among the 9 patients who did not complete the pathway, 6 failed to meet discharge criteria, resulting in admission, whereas 3 patients left the hospital against medical advice.

Combining data from this 2-year period and the pilot study, the hospitalization rate for mild AP was reduced by 31.2%. In the present study, hospitalization was reduced by 27% for patients with AP of any severity. This figure was steady over a 3-year period, at 25.8%.

Median length of stay for patients with mild AP was significantly shorter in the present study’s observation pathway than in a historical cohort (19.9 vs. 72.0 hours); this remained significant when also including patients from the pilot study (21.2 vs. 72.0 hours). Compared with the historic cohort, patients in the observation had significantly fewer radiographic studies, and more patients were discharged in less than 24 hours. Meanwhile, 30-day readmission and mortality rates remained unchanged.

“In summary, our long-term data of a single center emergency department–based observation management pathway for mild AP demonstrates durability over more than 2 years in maintaining its objective of reducing hospitalization,” the investigators concluded. “This is associated with a [shorter] length of stay, and reduced health care resource utilization, suggesting a possible decrease in financial cost of managing mild AP, without affecting readmission rates or mortality.”

These findings encourage further research, the investigators suggested, while noting that the observation pathway may not be appropriate for all treatment centers.

“The generalizability of the pathway is limited, given its single center location, and tertiary environment,” the investigators wrote. “Smaller hospitals, lacking multidisciplinary support for complications of AP, may find it challenging to implement such a pathway, and thus triage these patients for inpatient admission at their facility or to nearby tertiary centers.”The investigators reported no conflicts of interest.

SOURCE: Ahmed A et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001354.

For patients diagnosed with mild acute pancreatitis (AP) in the ED, an observation pathway may significantly reduce hospitalization rate and associated costs without compromising patient safety or quality of care, according to investigators.

Over a 2-year period, the observation pathway at Beth Israel Deaconess Medical Center, Boston, reduced hospitalizations by 31.2%, reported lead author Awais Ahmed, MD, of Harvard Medical School, Boston, and colleagues.

“AP carries a significant burden on the health care system, accounting for the third most common reason for gastrointestinal-related admissions in the United States,” the investigators wrote in the Journal of Clinical Gastroenterology. “As such, streamlining care for AP patients to reduce admissions can reduce the associated financial burden.”

The investigators’ efforts to reduce admissions for patients with AP began in 2016, when they first implemented an observation pathway at Beth Israel. This 6-month pilot study demonstrated proof of concept because it reduced admissions by 22.2% and shortened average length of stay without negatively affecting rates of mortality or readmission.

Based on these encouraging results, the hospital implemented the observation pathway as a standard of care. The present study analyzed 2 years of data from patients diagnosed with AP following the end of the pilot study. The primary outcome was hospitalization rate. Secondary outcomes included health care utilization, 30-day mortality rate, 30-day readmission rate, and median length of stay.

Patients with mild AP entered the observation pathway at the discretion of the supervising clinician, as well as based on absence of exclusion criteria, such as end organ damage, chronic pancreatitis, cholangitis, and other considerations.

Over 2 years, 165 patients were diagnosed with AP in the ED, of whom 118 (71.5%) had mild AP. From this latter group, 54 (45.8%) entered the observation pathway, while 64 (54.2%) were admitted as inpatients, primarily (n = 58) because of exclusion criteria. Within the observation group, 45 out of 54 patients (83.3%) successfully completed the pathway and were discharged. Six of these patients were readmitted within 30 days. Among the 9 patients who did not complete the pathway, 6 failed to meet discharge criteria, resulting in admission, whereas 3 patients left the hospital against medical advice.

Combining data from this 2-year period and the pilot study, the hospitalization rate for mild AP was reduced by 31.2%. In the present study, hospitalization was reduced by 27% for patients with AP of any severity. This figure was steady over a 3-year period, at 25.8%.

Median length of stay for patients with mild AP was significantly shorter in the present study’s observation pathway than in a historical cohort (19.9 vs. 72.0 hours); this remained significant when also including patients from the pilot study (21.2 vs. 72.0 hours). Compared with the historic cohort, patients in the observation had significantly fewer radiographic studies, and more patients were discharged in less than 24 hours. Meanwhile, 30-day readmission and mortality rates remained unchanged.

“In summary, our long-term data of a single center emergency department–based observation management pathway for mild AP demonstrates durability over more than 2 years in maintaining its objective of reducing hospitalization,” the investigators concluded. “This is associated with a [shorter] length of stay, and reduced health care resource utilization, suggesting a possible decrease in financial cost of managing mild AP, without affecting readmission rates or mortality.”

These findings encourage further research, the investigators suggested, while noting that the observation pathway may not be appropriate for all treatment centers.

“The generalizability of the pathway is limited, given its single center location, and tertiary environment,” the investigators wrote. “Smaller hospitals, lacking multidisciplinary support for complications of AP, may find it challenging to implement such a pathway, and thus triage these patients for inpatient admission at their facility or to nearby tertiary centers.”The investigators reported no conflicts of interest.

SOURCE: Ahmed A et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001354.

For patients diagnosed with mild acute pancreatitis (AP) in the ED, an observation pathway may significantly reduce hospitalization rate and associated costs without compromising patient safety or quality of care, according to investigators.

Over a 2-year period, the observation pathway at Beth Israel Deaconess Medical Center, Boston, reduced hospitalizations by 31.2%, reported lead author Awais Ahmed, MD, of Harvard Medical School, Boston, and colleagues.

“AP carries a significant burden on the health care system, accounting for the third most common reason for gastrointestinal-related admissions in the United States,” the investigators wrote in the Journal of Clinical Gastroenterology. “As such, streamlining care for AP patients to reduce admissions can reduce the associated financial burden.”

The investigators’ efforts to reduce admissions for patients with AP began in 2016, when they first implemented an observation pathway at Beth Israel. This 6-month pilot study demonstrated proof of concept because it reduced admissions by 22.2% and shortened average length of stay without negatively affecting rates of mortality or readmission.

Based on these encouraging results, the hospital implemented the observation pathway as a standard of care. The present study analyzed 2 years of data from patients diagnosed with AP following the end of the pilot study. The primary outcome was hospitalization rate. Secondary outcomes included health care utilization, 30-day mortality rate, 30-day readmission rate, and median length of stay.

Patients with mild AP entered the observation pathway at the discretion of the supervising clinician, as well as based on absence of exclusion criteria, such as end organ damage, chronic pancreatitis, cholangitis, and other considerations.

Over 2 years, 165 patients were diagnosed with AP in the ED, of whom 118 (71.5%) had mild AP. From this latter group, 54 (45.8%) entered the observation pathway, while 64 (54.2%) were admitted as inpatients, primarily (n = 58) because of exclusion criteria. Within the observation group, 45 out of 54 patients (83.3%) successfully completed the pathway and were discharged. Six of these patients were readmitted within 30 days. Among the 9 patients who did not complete the pathway, 6 failed to meet discharge criteria, resulting in admission, whereas 3 patients left the hospital against medical advice.

Combining data from this 2-year period and the pilot study, the hospitalization rate for mild AP was reduced by 31.2%. In the present study, hospitalization was reduced by 27% for patients with AP of any severity. This figure was steady over a 3-year period, at 25.8%.

Median length of stay for patients with mild AP was significantly shorter in the present study’s observation pathway than in a historical cohort (19.9 vs. 72.0 hours); this remained significant when also including patients from the pilot study (21.2 vs. 72.0 hours). Compared with the historic cohort, patients in the observation had significantly fewer radiographic studies, and more patients were discharged in less than 24 hours. Meanwhile, 30-day readmission and mortality rates remained unchanged.

“In summary, our long-term data of a single center emergency department–based observation management pathway for mild AP demonstrates durability over more than 2 years in maintaining its objective of reducing hospitalization,” the investigators concluded. “This is associated with a [shorter] length of stay, and reduced health care resource utilization, suggesting a possible decrease in financial cost of managing mild AP, without affecting readmission rates or mortality.”

These findings encourage further research, the investigators suggested, while noting that the observation pathway may not be appropriate for all treatment centers.

“The generalizability of the pathway is limited, given its single center location, and tertiary environment,” the investigators wrote. “Smaller hospitals, lacking multidisciplinary support for complications of AP, may find it challenging to implement such a pathway, and thus triage these patients for inpatient admission at their facility or to nearby tertiary centers.”The investigators reported no conflicts of interest.

SOURCE: Ahmed A et al. J Clin Gastroenterol. 2020 Apr 14. doi: 10.1097/MCG.0000000000001354.