Journal of Clinical Outcomes Management

Third-party vendor physicians appear to be more much more likely than their system-employed counterparts to prescribe antibiotics during acute care telehealth visits for acute respiratory infection (ARI), according to a study in the Journal of Telemedicine and Telecare.

As health systems expand their direct-to-consumer (DTC) virtual care, the quality of that care seems to vary, write the authors. Patients with ARI symptoms make up about one-third of virtual visits. Prescribing practice is a commonly cited measure of care quality for ARI, which is usually viral and rarely benefits from antibiotics.

“When providing care through telehealth, hospital-affiliated emergency physicians practiced better antibiotic stewardship than vendor-supplied, non–hospital-affiliated physicians,” lead study author Kathleen Li, MD, MS, a clinical lecturer in the department of emergency medicine at the University of Michigan, Ann Arbor, told this news organization.

“We had a sense that a difference existed, but the magnitude of the difference was larger than expected,” she said.

Dr. Li and her colleagues retrospectively analyzed on-demand telehealth visits available to health system employees and dependents of a large urban academic health system from March 2018, when the service began, through July 2019.

All 16 affiliated physicians providing ARI care were board-certified in emergency medicine, compared with 2 (8%) of the 25 unaffiliated (vendor-employed) physicians. Most unaffiliated physicians were known to be board-certified in family medicine, internal medicine, or pediatrics.

Unaffiliated physicians were not given access to the health system’s electronic medical record. Instead, all their patient histories, exams, assessments, plans, impressions, and discharge instructions were scanned into the electronic medical record system by other staff the next day.
 

Unaffiliated doctors were more than twice as likely to prescribe antibiotics

The researchers extracted data on all 257 virtual ARI visits from the electronic health record system, including prescriptions and medication therapeutic class. They performed multivariable logistic regression, adjusting for patient age and time of visit (weekday vs. weekend; day vs. overnight).

Antibiotic prescription rates were similar between weekday and weekend visits, and between day and night visits. Regardless of provider status, older patients were more likely to be prescribed antibiotics (P = .01). 

Overall, affiliated physicians prescribed antibiotics during 18% of visits, whereas vendor physicians prescribed antibiotics during 37% of visits. After adjustments, the odds were 2.3 times higher that a patient in a telehealth visit with a vendor provider would be prescribed antibiotics (95% confidence interval, 1.1-4.5).

The predicted antibiotic prescribing rate for ARI was 19% (95% confidence interval, 13%-25%) for affiliated providers vs. 35% (95% CI, 22%-47%) for unaffiliated providers, an average marginal effect of 15% (95% CI, 2%-29%). The difference was even greater (average marginal effect 20%, 95% CI, 4%-35%) when children and patients over 65 were excluded.
 

Consistent, high-quality care and antibiotic stewardship are needed in all settings

Three experts who were not involved in the study commented on the study.

Joshua W. Elder, MD, MPH, MHS, medical director of Telehealth Express Care (direct-to-consumer telemedicine) at UC Davis Health in Sacramento, Calif., said, “An important unanswered question is how factors such as communication (policy and procedures, practice guidelines), connection (electronic health records), and reimbursement and incentives that health system and vendor-based providers received impacted this outcome.

“As the volume of virtual practices grows, most health systems will need to create a hybrid between health-system-employed and vendor-and/or-payer-supplied physicians,” he added. “Finding ways to create similar quality and outcomes will be essential in the evolving digital health infrastructure being developed.”

Charles Teixeira, DO, an infectious disease specialist at the Medical University of South Carolina in Charleston, said that this study highlighted the need to consistently provide high-quality, evidence-based care regardless of the encounter setting.

“It was important to compare the prescribing practices for commonly used medications, especially those as important as antibiotics,” he added. “Overprescribing antibiotics can have a progressive, long-term effect on a community and increase the risk for patients to develop multidrug-resistant bacteria.”

Jeffrey A. Linder, MD, MPH, the chief of general internal medicine and geriatrics in the department of medicine at Northwestern University in Chicago, commended the authors for investigating the quality of telehealth.

“The major limitation,” he found, “is that the investigators lumped all ARI visits – including those that are potentially antibiotic appropriate (e.g., otitis media, pharyngitis, sinusitis), those that are non–antibiotic appropriate (e.g., bronchitis, influenza, laryngitis, URI, viral syndrome), and those that are nonspecific symptoms (e.g., cough, congestion, fever, sore throat) – into the same category.”

No clinical information was collected or presented that would enable the reader to tell if these two groups of physicians were evaluating different patient populations or even if they just diagnosed patients differently,” he added.

“Our study did not delve into why we saw the difference,” Dr. Li explained. “Exploring potential reasons further will have important implications for how to optimally deliver care via telehealth.”

All authors and independent experts have disclosed no relevant financial relationships. The study received no financial support.

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

Third-party vendor physicians appear to be more much more likely than their system-employed counterparts to prescribe antibiotics during acute care telehealth visits for acute respiratory infection (ARI), according to a study in the Journal of Telemedicine and Telecare.

As health systems expand their direct-to-consumer (DTC) virtual care, the quality of that care seems to vary, write the authors. Patients with ARI symptoms make up about one-third of virtual visits. Prescribing practice is a commonly cited measure of care quality for ARI, which is usually viral and rarely benefits from antibiotics.

“When providing care through telehealth, hospital-affiliated emergency physicians practiced better antibiotic stewardship than vendor-supplied, non–hospital-affiliated physicians,” lead study author Kathleen Li, MD, MS, a clinical lecturer in the department of emergency medicine at the University of Michigan, Ann Arbor, told this news organization.

“We had a sense that a difference existed, but the magnitude of the difference was larger than expected,” she said.

Dr. Li and her colleagues retrospectively analyzed on-demand telehealth visits available to health system employees and dependents of a large urban academic health system from March 2018, when the service began, through July 2019.

All 16 affiliated physicians providing ARI care were board-certified in emergency medicine, compared with 2 (8%) of the 25 unaffiliated (vendor-employed) physicians. Most unaffiliated physicians were known to be board-certified in family medicine, internal medicine, or pediatrics.

Unaffiliated physicians were not given access to the health system’s electronic medical record. Instead, all their patient histories, exams, assessments, plans, impressions, and discharge instructions were scanned into the electronic medical record system by other staff the next day.
 

Unaffiliated doctors were more than twice as likely to prescribe antibiotics

The researchers extracted data on all 257 virtual ARI visits from the electronic health record system, including prescriptions and medication therapeutic class. They performed multivariable logistic regression, adjusting for patient age and time of visit (weekday vs. weekend; day vs. overnight).

Antibiotic prescription rates were similar between weekday and weekend visits, and between day and night visits. Regardless of provider status, older patients were more likely to be prescribed antibiotics (P = .01). 

Overall, affiliated physicians prescribed antibiotics during 18% of visits, whereas vendor physicians prescribed antibiotics during 37% of visits. After adjustments, the odds were 2.3 times higher that a patient in a telehealth visit with a vendor provider would be prescribed antibiotics (95% confidence interval, 1.1-4.5).

The predicted antibiotic prescribing rate for ARI was 19% (95% confidence interval, 13%-25%) for affiliated providers vs. 35% (95% CI, 22%-47%) for unaffiliated providers, an average marginal effect of 15% (95% CI, 2%-29%). The difference was even greater (average marginal effect 20%, 95% CI, 4%-35%) when children and patients over 65 were excluded.
 

Consistent, high-quality care and antibiotic stewardship are needed in all settings

Three experts who were not involved in the study commented on the study.

Joshua W. Elder, MD, MPH, MHS, medical director of Telehealth Express Care (direct-to-consumer telemedicine) at UC Davis Health in Sacramento, Calif., said, “An important unanswered question is how factors such as communication (policy and procedures, practice guidelines), connection (electronic health records), and reimbursement and incentives that health system and vendor-based providers received impacted this outcome.

“As the volume of virtual practices grows, most health systems will need to create a hybrid between health-system-employed and vendor-and/or-payer-supplied physicians,” he added. “Finding ways to create similar quality and outcomes will be essential in the evolving digital health infrastructure being developed.”

Charles Teixeira, DO, an infectious disease specialist at the Medical University of South Carolina in Charleston, said that this study highlighted the need to consistently provide high-quality, evidence-based care regardless of the encounter setting.

“It was important to compare the prescribing practices for commonly used medications, especially those as important as antibiotics,” he added. “Overprescribing antibiotics can have a progressive, long-term effect on a community and increase the risk for patients to develop multidrug-resistant bacteria.”

Jeffrey A. Linder, MD, MPH, the chief of general internal medicine and geriatrics in the department of medicine at Northwestern University in Chicago, commended the authors for investigating the quality of telehealth.

“The major limitation,” he found, “is that the investigators lumped all ARI visits – including those that are potentially antibiotic appropriate (e.g., otitis media, pharyngitis, sinusitis), those that are non–antibiotic appropriate (e.g., bronchitis, influenza, laryngitis, URI, viral syndrome), and those that are nonspecific symptoms (e.g., cough, congestion, fever, sore throat) – into the same category.”

No clinical information was collected or presented that would enable the reader to tell if these two groups of physicians were evaluating different patient populations or even if they just diagnosed patients differently,” he added.

“Our study did not delve into why we saw the difference,” Dr. Li explained. “Exploring potential reasons further will have important implications for how to optimally deliver care via telehealth.”

All authors and independent experts have disclosed no relevant financial relationships. The study received no financial support.

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

Third-party vendor physicians appear to be more much more likely than their system-employed counterparts to prescribe antibiotics during acute care telehealth visits for acute respiratory infection (ARI), according to a study in the Journal of Telemedicine and Telecare.

As health systems expand their direct-to-consumer (DTC) virtual care, the quality of that care seems to vary, write the authors. Patients with ARI symptoms make up about one-third of virtual visits. Prescribing practice is a commonly cited measure of care quality for ARI, which is usually viral and rarely benefits from antibiotics.

“When providing care through telehealth, hospital-affiliated emergency physicians practiced better antibiotic stewardship than vendor-supplied, non–hospital-affiliated physicians,” lead study author Kathleen Li, MD, MS, a clinical lecturer in the department of emergency medicine at the University of Michigan, Ann Arbor, told this news organization.

“We had a sense that a difference existed, but the magnitude of the difference was larger than expected,” she said.

Dr. Li and her colleagues retrospectively analyzed on-demand telehealth visits available to health system employees and dependents of a large urban academic health system from March 2018, when the service began, through July 2019.

All 16 affiliated physicians providing ARI care were board-certified in emergency medicine, compared with 2 (8%) of the 25 unaffiliated (vendor-employed) physicians. Most unaffiliated physicians were known to be board-certified in family medicine, internal medicine, or pediatrics.

Unaffiliated physicians were not given access to the health system’s electronic medical record. Instead, all their patient histories, exams, assessments, plans, impressions, and discharge instructions were scanned into the electronic medical record system by other staff the next day.
 

Unaffiliated doctors were more than twice as likely to prescribe antibiotics

The researchers extracted data on all 257 virtual ARI visits from the electronic health record system, including prescriptions and medication therapeutic class. They performed multivariable logistic regression, adjusting for patient age and time of visit (weekday vs. weekend; day vs. overnight).

Antibiotic prescription rates were similar between weekday and weekend visits, and between day and night visits. Regardless of provider status, older patients were more likely to be prescribed antibiotics (P = .01). 

Overall, affiliated physicians prescribed antibiotics during 18% of visits, whereas vendor physicians prescribed antibiotics during 37% of visits. After adjustments, the odds were 2.3 times higher that a patient in a telehealth visit with a vendor provider would be prescribed antibiotics (95% confidence interval, 1.1-4.5).

The predicted antibiotic prescribing rate for ARI was 19% (95% confidence interval, 13%-25%) for affiliated providers vs. 35% (95% CI, 22%-47%) for unaffiliated providers, an average marginal effect of 15% (95% CI, 2%-29%). The difference was even greater (average marginal effect 20%, 95% CI, 4%-35%) when children and patients over 65 were excluded.
 

Consistent, high-quality care and antibiotic stewardship are needed in all settings

Three experts who were not involved in the study commented on the study.

Joshua W. Elder, MD, MPH, MHS, medical director of Telehealth Express Care (direct-to-consumer telemedicine) at UC Davis Health in Sacramento, Calif., said, “An important unanswered question is how factors such as communication (policy and procedures, practice guidelines), connection (electronic health records), and reimbursement and incentives that health system and vendor-based providers received impacted this outcome.

“As the volume of virtual practices grows, most health systems will need to create a hybrid between health-system-employed and vendor-and/or-payer-supplied physicians,” he added. “Finding ways to create similar quality and outcomes will be essential in the evolving digital health infrastructure being developed.”

Charles Teixeira, DO, an infectious disease specialist at the Medical University of South Carolina in Charleston, said that this study highlighted the need to consistently provide high-quality, evidence-based care regardless of the encounter setting.

“It was important to compare the prescribing practices for commonly used medications, especially those as important as antibiotics,” he added. “Overprescribing antibiotics can have a progressive, long-term effect on a community and increase the risk for patients to develop multidrug-resistant bacteria.”

Jeffrey A. Linder, MD, MPH, the chief of general internal medicine and geriatrics in the department of medicine at Northwestern University in Chicago, commended the authors for investigating the quality of telehealth.

“The major limitation,” he found, “is that the investigators lumped all ARI visits – including those that are potentially antibiotic appropriate (e.g., otitis media, pharyngitis, sinusitis), those that are non–antibiotic appropriate (e.g., bronchitis, influenza, laryngitis, URI, viral syndrome), and those that are nonspecific symptoms (e.g., cough, congestion, fever, sore throat) – into the same category.”

No clinical information was collected or presented that would enable the reader to tell if these two groups of physicians were evaluating different patient populations or even if they just diagnosed patients differently,” he added.

“Our study did not delve into why we saw the difference,” Dr. Li explained. “Exploring potential reasons further will have important implications for how to optimally deliver care via telehealth.”

All authors and independent experts have disclosed no relevant financial relationships. The study received no financial support.

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

The Food and Drug Administration has approved a combination nivolumab/relatlimab-rmbw immune checkpoint inhibitor (Opdualag) for unresectable or metastatic melanoma in adults and children 12 years or older, according to the drug’s manufacturer, Bristol-Myers Squibb.

Approval was based on the company’s RELATIVITY-047 trial, which found a median progression-free survival (PFS) of 10.1 months among 355 patients randomly assigned to the combination therapy compared with 4.6 months among 359 patients who received nivolumab alone (hazard ratio, 0.75; P = .0055).

In the combination therapy group, 18.9% of patients reported a grade 3/4 drug-related adverse event, compared with 9.7% in the nivolumab group; 14.6% of patients in the combination group had drug-related adverse events leading to discontinuation versus 6.7% of those receiving monotherapy, the company noted in a press release.

Relatlimab is the company’s third immune checkpoint inhibitor to reach the U.S. market, joining the PD-1 inhibitor nivolumab and the CTLA-4 blocker ipilimumab. Relatlimab targets LAG-3, a cell-surface receptor found on activated CD4+ T cells.

Nivolumab plus ipilimumab is currently the standard of care for previously untreated metastatic or inoperable melanoma. Both combinations produce similar PFS, but the incidence of grade 3/4 adverse events is higher with ipilimumab, according to a Jan. 6, 2022, editorial in the New England Journal of Medicine.

Musculoskeletal pain, fatigue, rash, pruritus, and diarrhea were the most common adverse reactions with combination nivolumab/relatlimab, occurring in 20% or more of RELATIVITY-047 trial participants.

Adrenal insufficiency, anemia, colitis, pneumonia, and myocardial infarction were the most frequent serious adverse reactions, but each occurred in less than 2% of patients. There were three fatal adverse events in the trial caused by hemophagocytic lymphohistiocytosis, acute lung edema, and pneumonitis.

The approved dosage is 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks.

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

The Food and Drug Administration has approved a combination nivolumab/relatlimab-rmbw immune checkpoint inhibitor (Opdualag) for unresectable or metastatic melanoma in adults and children 12 years or older, according to the drug’s manufacturer, Bristol-Myers Squibb.

Approval was based on the company’s RELATIVITY-047 trial, which found a median progression-free survival (PFS) of 10.1 months among 355 patients randomly assigned to the combination therapy compared with 4.6 months among 359 patients who received nivolumab alone (hazard ratio, 0.75; P = .0055).

In the combination therapy group, 18.9% of patients reported a grade 3/4 drug-related adverse event, compared with 9.7% in the nivolumab group; 14.6% of patients in the combination group had drug-related adverse events leading to discontinuation versus 6.7% of those receiving monotherapy, the company noted in a press release.

Relatlimab is the company’s third immune checkpoint inhibitor to reach the U.S. market, joining the PD-1 inhibitor nivolumab and the CTLA-4 blocker ipilimumab. Relatlimab targets LAG-3, a cell-surface receptor found on activated CD4+ T cells.

Nivolumab plus ipilimumab is currently the standard of care for previously untreated metastatic or inoperable melanoma. Both combinations produce similar PFS, but the incidence of grade 3/4 adverse events is higher with ipilimumab, according to a Jan. 6, 2022, editorial in the New England Journal of Medicine.

Musculoskeletal pain, fatigue, rash, pruritus, and diarrhea were the most common adverse reactions with combination nivolumab/relatlimab, occurring in 20% or more of RELATIVITY-047 trial participants.

Adrenal insufficiency, anemia, colitis, pneumonia, and myocardial infarction were the most frequent serious adverse reactions, but each occurred in less than 2% of patients. There were three fatal adverse events in the trial caused by hemophagocytic lymphohistiocytosis, acute lung edema, and pneumonitis.

The approved dosage is 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks.

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

The Food and Drug Administration has approved a combination nivolumab/relatlimab-rmbw immune checkpoint inhibitor (Opdualag) for unresectable or metastatic melanoma in adults and children 12 years or older, according to the drug’s manufacturer, Bristol-Myers Squibb.

Approval was based on the company’s RELATIVITY-047 trial, which found a median progression-free survival (PFS) of 10.1 months among 355 patients randomly assigned to the combination therapy compared with 4.6 months among 359 patients who received nivolumab alone (hazard ratio, 0.75; P = .0055).

In the combination therapy group, 18.9% of patients reported a grade 3/4 drug-related adverse event, compared with 9.7% in the nivolumab group; 14.6% of patients in the combination group had drug-related adverse events leading to discontinuation versus 6.7% of those receiving monotherapy, the company noted in a press release.

Relatlimab is the company’s third immune checkpoint inhibitor to reach the U.S. market, joining the PD-1 inhibitor nivolumab and the CTLA-4 blocker ipilimumab. Relatlimab targets LAG-3, a cell-surface receptor found on activated CD4+ T cells.

Nivolumab plus ipilimumab is currently the standard of care for previously untreated metastatic or inoperable melanoma. Both combinations produce similar PFS, but the incidence of grade 3/4 adverse events is higher with ipilimumab, according to a Jan. 6, 2022, editorial in the New England Journal of Medicine.

Musculoskeletal pain, fatigue, rash, pruritus, and diarrhea were the most common adverse reactions with combination nivolumab/relatlimab, occurring in 20% or more of RELATIVITY-047 trial participants.

Adrenal insufficiency, anemia, colitis, pneumonia, and myocardial infarction were the most frequent serious adverse reactions, but each occurred in less than 2% of patients. There were three fatal adverse events in the trial caused by hemophagocytic lymphohistiocytosis, acute lung edema, and pneumonitis.

The approved dosage is 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks.

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

Key takeaways

Results from a retrospective, observational, case-control study of more than 20,000 people from a single U.S. medical center showed a statistically significant but clinically insignificant increase in A1c in people following COVID-19 infection, in both those with and without diabetes.

After people received a diagnosis of COVID-19 infection, they were 40% more likely to also receive a diagnosis of type 2 diabetes, compared with people who tested negative for COVID-19, a difference that was significant and could be explained by the increased medical care received by people who test positive for COVID-19.

The risk of incident diabetic ketoacidosis (DKA) among people who tested positive for COVID-19 was significantly higher among those with pre-existing type 2 diabetes, those using insulin, and among Black individuals.
 

Why this matters

The authors said that their study is the first report of evidence that infection with COVID-19 affects A1c levels in a large, real-world clinical cohort.

Until now, the impact of COVID-19 infection on A1c remained unclear. Results from previous studies indicated that COVID-19 infection may increase A1c levels, but the studied cohorts were small and lacked uninfected controls.

The current study included 8,755 people infected with COVID-19, had data from both before and after the infection on diabetes status and A1c levels, and also included many matched, uninfected people who served as controls.
 

Study design

Data came from a Cleveland Clinic registry that included 81,093 people who tested positive for COVID-19 between March 2020 and May 2021 and 153,034 matched individuals who tested negative for COVID-19 during the same period.

The researchers retrospectively selected patients with an A1c recorded within 12 months before their COVID-19 test, as well as a second A1c value recorded within 12 months after COVID-19 testing. This produced a study cohort of 8,755 COVID-positive people and 11,998 matched people who tested negative for COVID-19.

To evaluate the risk of DKA onset after COVID-19 infection, the authors identified two sub-cohorts that excluded those with a history of DKA. The sub-cohorts were 701 people with type 1 diabetes and 21,830 with type 2 diabetes.
 

Key results

The investigators found a statistically significant but clinically insignificant A1c increase following a positive COVID-19 test, an average A1c increase of 0.06 percentage points. Those who tested negative for COVID-19 had a clinically insignificant change in their average A1c level that was of borderline statistical significance, an average increase of 0.02 percentage points (P = .05).

The statistically significant but clinically insignificant increase in A1c following infection with COVID-19 was similar in people with and without type 2 diabetes prior to infection.

In patients with type 2 diabetes who became infected with COVID-19, the researchers saw significant positive associations between higher A1c levels before infection and time to hospitalization (hazard ratio, 1.07), need for assisted breathing (HR, 1.06), and ICU admission (HR, 1.07).

Following a COVID-19 infection, people were 40% more likely to receive a diagnosis of incident type 2 diabetes, compared with matched uninfected people. The authors said a possible explanation is that after diagnosis of COVID-19, infected people in general received more intensified care that led to better identification of those with underlying type 2 diabetes.

The 701 people included with pre-existing type 1 diabetes showed no significant difference in their rate of developing DKA between those infected and not infected with COVID-19.

Among the 21,830 people with pre-existing type 2 diabetes, the DKA risk was a significant 35% greater for those who were infected with COVID-19, compared with those who were uninfected. The magnitude of this increased relative risk was even higher among the patients with type 2 diabetes who used insulin as part of their treatment.  

The difference in DKA risk didn’t differ between Black and White patients who were not infected with COVID-19, but among those infected by COVID-19, Black patients were more than twice as likely to be diagnosed with DKA, compared with White patients, a significant difference.

Black patients with type 2 diabetes who became infected with COVID-19 had a significant (63%) increased rate of DKA compared with Black patients with type 2 diabetes who remained uninfected.
 

Limitations

The study included patients with A1c measurements made up to 12 months prior to their COVID-19 test, and hence comorbid conditions, medication changes during this period, or other factors may have affected subsequent A1c levels. To address this, the authors also assessed outcomes at 3- and 6-month intervals, which produced results consistent with the 12-month findings.

The researchers did not have A1c values for many of the more than 234,000 people in the entire registry who underwent COVID-19 testing from March 2020-May 2021 at the Cleveland Clinic, omissions that may have biased the study cohort.

This was a single-center study. Some patients may have received care outside of the center, hence records of those episodes could not be included.
 

Disclosures

The study received no commercial funding. Four authors received consulting and speaker honoraria and research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Corcept Therapeutics, Diasome, Eli Lilly, Merck, Novo Nordisk, and Sanofi. Three authors have intellectual property related to treatment decisionmaking in the context of type 2 diabetes.

This is a summary of a preprint research study “Impacts of COVID-19 on glycemia and risk of diabetic ketoacidosis,” written by researchers at the Cleveland Clinic on medRxiv. The study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org.

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

Key takeaways

Results from a retrospective, observational, case-control study of more than 20,000 people from a single U.S. medical center showed a statistically significant but clinically insignificant increase in A1c in people following COVID-19 infection, in both those with and without diabetes.

After people received a diagnosis of COVID-19 infection, they were 40% more likely to also receive a diagnosis of type 2 diabetes, compared with people who tested negative for COVID-19, a difference that was significant and could be explained by the increased medical care received by people who test positive for COVID-19.

The risk of incident diabetic ketoacidosis (DKA) among people who tested positive for COVID-19 was significantly higher among those with pre-existing type 2 diabetes, those using insulin, and among Black individuals.
 

Why this matters

The authors said that their study is the first report of evidence that infection with COVID-19 affects A1c levels in a large, real-world clinical cohort.

Until now, the impact of COVID-19 infection on A1c remained unclear. Results from previous studies indicated that COVID-19 infection may increase A1c levels, but the studied cohorts were small and lacked uninfected controls.

The current study included 8,755 people infected with COVID-19, had data from both before and after the infection on diabetes status and A1c levels, and also included many matched, uninfected people who served as controls.
 

Study design

Data came from a Cleveland Clinic registry that included 81,093 people who tested positive for COVID-19 between March 2020 and May 2021 and 153,034 matched individuals who tested negative for COVID-19 during the same period.

The researchers retrospectively selected patients with an A1c recorded within 12 months before their COVID-19 test, as well as a second A1c value recorded within 12 months after COVID-19 testing. This produced a study cohort of 8,755 COVID-positive people and 11,998 matched people who tested negative for COVID-19.

To evaluate the risk of DKA onset after COVID-19 infection, the authors identified two sub-cohorts that excluded those with a history of DKA. The sub-cohorts were 701 people with type 1 diabetes and 21,830 with type 2 diabetes.
 

Key results

The investigators found a statistically significant but clinically insignificant A1c increase following a positive COVID-19 test, an average A1c increase of 0.06 percentage points. Those who tested negative for COVID-19 had a clinically insignificant change in their average A1c level that was of borderline statistical significance, an average increase of 0.02 percentage points (P = .05).

The statistically significant but clinically insignificant increase in A1c following infection with COVID-19 was similar in people with and without type 2 diabetes prior to infection.

In patients with type 2 diabetes who became infected with COVID-19, the researchers saw significant positive associations between higher A1c levels before infection and time to hospitalization (hazard ratio, 1.07), need for assisted breathing (HR, 1.06), and ICU admission (HR, 1.07).

Following a COVID-19 infection, people were 40% more likely to receive a diagnosis of incident type 2 diabetes, compared with matched uninfected people. The authors said a possible explanation is that after diagnosis of COVID-19, infected people in general received more intensified care that led to better identification of those with underlying type 2 diabetes.

The 701 people included with pre-existing type 1 diabetes showed no significant difference in their rate of developing DKA between those infected and not infected with COVID-19.

Among the 21,830 people with pre-existing type 2 diabetes, the DKA risk was a significant 35% greater for those who were infected with COVID-19, compared with those who were uninfected. The magnitude of this increased relative risk was even higher among the patients with type 2 diabetes who used insulin as part of their treatment.  

The difference in DKA risk didn’t differ between Black and White patients who were not infected with COVID-19, but among those infected by COVID-19, Black patients were more than twice as likely to be diagnosed with DKA, compared with White patients, a significant difference.

Black patients with type 2 diabetes who became infected with COVID-19 had a significant (63%) increased rate of DKA compared with Black patients with type 2 diabetes who remained uninfected.
 

Limitations

The study included patients with A1c measurements made up to 12 months prior to their COVID-19 test, and hence comorbid conditions, medication changes during this period, or other factors may have affected subsequent A1c levels. To address this, the authors also assessed outcomes at 3- and 6-month intervals, which produced results consistent with the 12-month findings.

The researchers did not have A1c values for many of the more than 234,000 people in the entire registry who underwent COVID-19 testing from March 2020-May 2021 at the Cleveland Clinic, omissions that may have biased the study cohort.

This was a single-center study. Some patients may have received care outside of the center, hence records of those episodes could not be included.
 

Disclosures

The study received no commercial funding. Four authors received consulting and speaker honoraria and research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Corcept Therapeutics, Diasome, Eli Lilly, Merck, Novo Nordisk, and Sanofi. Three authors have intellectual property related to treatment decisionmaking in the context of type 2 diabetes.

This is a summary of a preprint research study “Impacts of COVID-19 on glycemia and risk of diabetic ketoacidosis,” written by researchers at the Cleveland Clinic on medRxiv. The study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org.

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

Key takeaways

Results from a retrospective, observational, case-control study of more than 20,000 people from a single U.S. medical center showed a statistically significant but clinically insignificant increase in A1c in people following COVID-19 infection, in both those with and without diabetes.

After people received a diagnosis of COVID-19 infection, they were 40% more likely to also receive a diagnosis of type 2 diabetes, compared with people who tested negative for COVID-19, a difference that was significant and could be explained by the increased medical care received by people who test positive for COVID-19.

The risk of incident diabetic ketoacidosis (DKA) among people who tested positive for COVID-19 was significantly higher among those with pre-existing type 2 diabetes, those using insulin, and among Black individuals.
 

Why this matters

The authors said that their study is the first report of evidence that infection with COVID-19 affects A1c levels in a large, real-world clinical cohort.

Until now, the impact of COVID-19 infection on A1c remained unclear. Results from previous studies indicated that COVID-19 infection may increase A1c levels, but the studied cohorts were small and lacked uninfected controls.

The current study included 8,755 people infected with COVID-19, had data from both before and after the infection on diabetes status and A1c levels, and also included many matched, uninfected people who served as controls.
 

Study design

Data came from a Cleveland Clinic registry that included 81,093 people who tested positive for COVID-19 between March 2020 and May 2021 and 153,034 matched individuals who tested negative for COVID-19 during the same period.

The researchers retrospectively selected patients with an A1c recorded within 12 months before their COVID-19 test, as well as a second A1c value recorded within 12 months after COVID-19 testing. This produced a study cohort of 8,755 COVID-positive people and 11,998 matched people who tested negative for COVID-19.

To evaluate the risk of DKA onset after COVID-19 infection, the authors identified two sub-cohorts that excluded those with a history of DKA. The sub-cohorts were 701 people with type 1 diabetes and 21,830 with type 2 diabetes.
 

Key results

The investigators found a statistically significant but clinically insignificant A1c increase following a positive COVID-19 test, an average A1c increase of 0.06 percentage points. Those who tested negative for COVID-19 had a clinically insignificant change in their average A1c level that was of borderline statistical significance, an average increase of 0.02 percentage points (P = .05).

The statistically significant but clinically insignificant increase in A1c following infection with COVID-19 was similar in people with and without type 2 diabetes prior to infection.

In patients with type 2 diabetes who became infected with COVID-19, the researchers saw significant positive associations between higher A1c levels before infection and time to hospitalization (hazard ratio, 1.07), need for assisted breathing (HR, 1.06), and ICU admission (HR, 1.07).

Following a COVID-19 infection, people were 40% more likely to receive a diagnosis of incident type 2 diabetes, compared with matched uninfected people. The authors said a possible explanation is that after diagnosis of COVID-19, infected people in general received more intensified care that led to better identification of those with underlying type 2 diabetes.

The 701 people included with pre-existing type 1 diabetes showed no significant difference in their rate of developing DKA between those infected and not infected with COVID-19.

Among the 21,830 people with pre-existing type 2 diabetes, the DKA risk was a significant 35% greater for those who were infected with COVID-19, compared with those who were uninfected. The magnitude of this increased relative risk was even higher among the patients with type 2 diabetes who used insulin as part of their treatment.  

The difference in DKA risk didn’t differ between Black and White patients who were not infected with COVID-19, but among those infected by COVID-19, Black patients were more than twice as likely to be diagnosed with DKA, compared with White patients, a significant difference.

Black patients with type 2 diabetes who became infected with COVID-19 had a significant (63%) increased rate of DKA compared with Black patients with type 2 diabetes who remained uninfected.
 

Limitations

The study included patients with A1c measurements made up to 12 months prior to their COVID-19 test, and hence comorbid conditions, medication changes during this period, or other factors may have affected subsequent A1c levels. To address this, the authors also assessed outcomes at 3- and 6-month intervals, which produced results consistent with the 12-month findings.

The researchers did not have A1c values for many of the more than 234,000 people in the entire registry who underwent COVID-19 testing from March 2020-May 2021 at the Cleveland Clinic, omissions that may have biased the study cohort.

This was a single-center study. Some patients may have received care outside of the center, hence records of those episodes could not be included.
 

Disclosures

The study received no commercial funding. Four authors received consulting and speaker honoraria and research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Corcept Therapeutics, Diasome, Eli Lilly, Merck, Novo Nordisk, and Sanofi. Three authors have intellectual property related to treatment decisionmaking in the context of type 2 diabetes.

This is a summary of a preprint research study “Impacts of COVID-19 on glycemia and risk of diabetic ketoacidosis,” written by researchers at the Cleveland Clinic on medRxiv. The study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org.

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

While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.

“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”

The patient safety measure, which will take effect on July 1, specifically prohibits the misappropriation of medical specialty titles such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.

“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
 

What’s in a title?

The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.

Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.

“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
 

Medical groups speak out

Several professional medical groups have voiced their opposition to medical title misappropriation.

Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.

The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.

In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.

While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.

A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.

The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”

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

While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.

“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”

The patient safety measure, which will take effect on July 1, specifically prohibits the misappropriation of medical specialty titles such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.

“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
 

What’s in a title?

The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.

Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.

“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
 

Medical groups speak out

Several professional medical groups have voiced their opposition to medical title misappropriation.

Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.

The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.

In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.

While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.

A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.

The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”

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

While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.

“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”

The patient safety measure, which will take effect on July 1, specifically prohibits the misappropriation of medical specialty titles such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.

“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
 

What’s in a title?

The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.

Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.

“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
 

Medical groups speak out

Several professional medical groups have voiced their opposition to medical title misappropriation.

Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.

The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.

In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.

While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.

A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.

The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”

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

U.S. health officials are watching the steady climb in COVID-19 cases in the United Kingdom, which tends to signal what could happen next in the United States, according to NPR.

Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.

“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.

“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.

Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.

“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”

Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.

Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.

“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.

“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”

The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.

The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.

BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.

The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.

The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.

Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.

The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.

“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.

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

U.S. health officials are watching the steady climb in COVID-19 cases in the United Kingdom, which tends to signal what could happen next in the United States, according to NPR.

Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.

“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.

“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.

Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.

“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”

Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.

Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.

“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.

“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”

The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.

The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.

BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.

The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.

The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.

Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.

The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.

“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.

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

U.S. health officials are watching the steady climb in COVID-19 cases in the United Kingdom, which tends to signal what could happen next in the United States, according to NPR.

Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.

“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.

“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.

Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.

“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”

Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.

Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.

“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.

“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”

The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.

The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.

BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.

The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.

The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.

Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.

The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.

“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.

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

Results of the phase 2 ZUMA-12 trial suggest that axicabtagene ciloleucel (axi-cel), a chimeric antigen receptor (CAR) T-cell therapy approved to treat certain types of lymphoma, also shows promise as a treatment for another group of lymphoma patients – those with high-risk large B-cell lymphoma (LBCL) who failed two rounds of standard chemoimmunotherapy. In fact, a study author said, first-line treatment with this therapy could help usher some patients toward a cure.

The results appeared March 21, 2022, in Nature Medicine.

“The high efficacy with manageable safety profile suggest that further evaluation of axi-cel in first-line setting in patients with high-risk LBCL is warranted in a randomized, phase 3 trial comparing it to standard chemoimmunotherapy,” study lead author Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center, Houston, said in an interview.

According to Dr. Neelapu, “patients with high-risk LBCL include those with high-intermediate or high International Prognostic Index score and those with certain molecular subtypes such as double- or triple-hit lymphoma. These patients have lower response rates and lower progression-free and overall survival with standard chemoimmunotherapy.”

Treatment of these patients can be especially challenging because they are underrepresented in clinical research, hematologist Michael Dickinson, MBBS, of the Peter MacCallum Cancer Center in Melbourne, said in an interview. “They often have disease that requires urgent treatment, so there is no time to recruit them into trials. A feature of ZUMA-12 is that it allowed patients to be recruited after short exposure to chemotherapy, which means that higher-risk patients could successfully be recruited into the trial.”

Axi-cel is already Food and Drug Administration approved for treatment of relapsed or refractory LBCL after 2 or more lines of systemic therapy plus relapsed or refractory follicular lymphoma, also after two or more lines of systemic therapy, Dr. Neelapu said.

For this study, researchers administered the treatment to 40 subjects with high-risk disease from 2019-2020 (median age, 61 years; 68% male; 95% at disease stage III or IV).

The researchers reported that 78% of 37 patients in the primary efficacy analysis reached complete response rate (95% confidence interval, 62-90); the median time to first complete response rate was 30 days (range, 27-207). About 89% of these subjects reached the secondary endpoint of objective response rate (95% CI, 75-97); the median time to first objective response was 29 days (range, 27-207).

At a median follow-up of 15.9 months, 73% were still in objective response.

“This is quite remarkable,” Dr. Neelapu said. “The durability of more than 70% is far higher than what would be expected with standard chemoimmunotherapy in these patients – under 40% durability with standard chemoimmunotherapy. Also, axi-cel induces durable responses in about 40% of patients in second- and third-line setting. However, when used as part of first-line therapy in this study, durable responses were observed in more than 70% of patients, suggesting that the efficacy of axi-cel may be much higher when used in first-line setting.”

Dr. Neelapu added: “Although the follow-up is short, it is highly likely that the majority of the patients with ongoing response beyond 1 year will likely be cured of their lymphoma.”

As for side effects, no treatment-related grade 5 events occurred, but 18 patients (45%) experienced serious adverse events. Grade 3 or higher cytokine release syndrome occurred in three patients (8%) and nine experienced neurologic events (23%).

“The majority of the higher-grade adverse events observed were due to cytopenias, which were expected due to the conditioning therapy,” Dr. Neelapu said. “Such cytopenias would also have been expected if these patients had received standard chemoimmunotherapy.”

Six patients (15%) died, 4 of progressive disease after going forward to other therapies.

As for cost, Dr. Neelapu said it should be similar to that of axi-cel as an FDA-approved third-line therapy. Axi-cel is highly expensive. Research has suggested that CAR T-cell therapy can boost costs beyond standard chemotherapy by $350,000-$490,000 with gains of 2-8 years of life (J Med Econ. Jan-Dec 2021;24[1]:458-68).

The study was funded by Kite. The authors reported various disclosures.

Results of the phase 2 ZUMA-12 trial suggest that axicabtagene ciloleucel (axi-cel), a chimeric antigen receptor (CAR) T-cell therapy approved to treat certain types of lymphoma, also shows promise as a treatment for another group of lymphoma patients – those with high-risk large B-cell lymphoma (LBCL) who failed two rounds of standard chemoimmunotherapy. In fact, a study author said, first-line treatment with this therapy could help usher some patients toward a cure.

The results appeared March 21, 2022, in Nature Medicine.

“The high efficacy with manageable safety profile suggest that further evaluation of axi-cel in first-line setting in patients with high-risk LBCL is warranted in a randomized, phase 3 trial comparing it to standard chemoimmunotherapy,” study lead author Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center, Houston, said in an interview.

According to Dr. Neelapu, “patients with high-risk LBCL include those with high-intermediate or high International Prognostic Index score and those with certain molecular subtypes such as double- or triple-hit lymphoma. These patients have lower response rates and lower progression-free and overall survival with standard chemoimmunotherapy.”

Treatment of these patients can be especially challenging because they are underrepresented in clinical research, hematologist Michael Dickinson, MBBS, of the Peter MacCallum Cancer Center in Melbourne, said in an interview. “They often have disease that requires urgent treatment, so there is no time to recruit them into trials. A feature of ZUMA-12 is that it allowed patients to be recruited after short exposure to chemotherapy, which means that higher-risk patients could successfully be recruited into the trial.”

Axi-cel is already Food and Drug Administration approved for treatment of relapsed or refractory LBCL after 2 or more lines of systemic therapy plus relapsed or refractory follicular lymphoma, also after two or more lines of systemic therapy, Dr. Neelapu said.

For this study, researchers administered the treatment to 40 subjects with high-risk disease from 2019-2020 (median age, 61 years; 68% male; 95% at disease stage III or IV).

The researchers reported that 78% of 37 patients in the primary efficacy analysis reached complete response rate (95% confidence interval, 62-90); the median time to first complete response rate was 30 days (range, 27-207). About 89% of these subjects reached the secondary endpoint of objective response rate (95% CI, 75-97); the median time to first objective response was 29 days (range, 27-207).

At a median follow-up of 15.9 months, 73% were still in objective response.

“This is quite remarkable,” Dr. Neelapu said. “The durability of more than 70% is far higher than what would be expected with standard chemoimmunotherapy in these patients – under 40% durability with standard chemoimmunotherapy. Also, axi-cel induces durable responses in about 40% of patients in second- and third-line setting. However, when used as part of first-line therapy in this study, durable responses were observed in more than 70% of patients, suggesting that the efficacy of axi-cel may be much higher when used in first-line setting.”

Dr. Neelapu added: “Although the follow-up is short, it is highly likely that the majority of the patients with ongoing response beyond 1 year will likely be cured of their lymphoma.”

As for side effects, no treatment-related grade 5 events occurred, but 18 patients (45%) experienced serious adverse events. Grade 3 or higher cytokine release syndrome occurred in three patients (8%) and nine experienced neurologic events (23%).

“The majority of the higher-grade adverse events observed were due to cytopenias, which were expected due to the conditioning therapy,” Dr. Neelapu said. “Such cytopenias would also have been expected if these patients had received standard chemoimmunotherapy.”

Six patients (15%) died, 4 of progressive disease after going forward to other therapies.

As for cost, Dr. Neelapu said it should be similar to that of axi-cel as an FDA-approved third-line therapy. Axi-cel is highly expensive. Research has suggested that CAR T-cell therapy can boost costs beyond standard chemotherapy by $350,000-$490,000 with gains of 2-8 years of life (J Med Econ. Jan-Dec 2021;24[1]:458-68).

The study was funded by Kite. The authors reported various disclosures.

Results of the phase 2 ZUMA-12 trial suggest that axicabtagene ciloleucel (axi-cel), a chimeric antigen receptor (CAR) T-cell therapy approved to treat certain types of lymphoma, also shows promise as a treatment for another group of lymphoma patients – those with high-risk large B-cell lymphoma (LBCL) who failed two rounds of standard chemoimmunotherapy. In fact, a study author said, first-line treatment with this therapy could help usher some patients toward a cure.

The results appeared March 21, 2022, in Nature Medicine.

“The high efficacy with manageable safety profile suggest that further evaluation of axi-cel in first-line setting in patients with high-risk LBCL is warranted in a randomized, phase 3 trial comparing it to standard chemoimmunotherapy,” study lead author Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center, Houston, said in an interview.

According to Dr. Neelapu, “patients with high-risk LBCL include those with high-intermediate or high International Prognostic Index score and those with certain molecular subtypes such as double- or triple-hit lymphoma. These patients have lower response rates and lower progression-free and overall survival with standard chemoimmunotherapy.”

Treatment of these patients can be especially challenging because they are underrepresented in clinical research, hematologist Michael Dickinson, MBBS, of the Peter MacCallum Cancer Center in Melbourne, said in an interview. “They often have disease that requires urgent treatment, so there is no time to recruit them into trials. A feature of ZUMA-12 is that it allowed patients to be recruited after short exposure to chemotherapy, which means that higher-risk patients could successfully be recruited into the trial.”

Axi-cel is already Food and Drug Administration approved for treatment of relapsed or refractory LBCL after 2 or more lines of systemic therapy plus relapsed or refractory follicular lymphoma, also after two or more lines of systemic therapy, Dr. Neelapu said.

For this study, researchers administered the treatment to 40 subjects with high-risk disease from 2019-2020 (median age, 61 years; 68% male; 95% at disease stage III or IV).

The researchers reported that 78% of 37 patients in the primary efficacy analysis reached complete response rate (95% confidence interval, 62-90); the median time to first complete response rate was 30 days (range, 27-207). About 89% of these subjects reached the secondary endpoint of objective response rate (95% CI, 75-97); the median time to first objective response was 29 days (range, 27-207).

At a median follow-up of 15.9 months, 73% were still in objective response.

“This is quite remarkable,” Dr. Neelapu said. “The durability of more than 70% is far higher than what would be expected with standard chemoimmunotherapy in these patients – under 40% durability with standard chemoimmunotherapy. Also, axi-cel induces durable responses in about 40% of patients in second- and third-line setting. However, when used as part of first-line therapy in this study, durable responses were observed in more than 70% of patients, suggesting that the efficacy of axi-cel may be much higher when used in first-line setting.”

Dr. Neelapu added: “Although the follow-up is short, it is highly likely that the majority of the patients with ongoing response beyond 1 year will likely be cured of their lymphoma.”

As for side effects, no treatment-related grade 5 events occurred, but 18 patients (45%) experienced serious adverse events. Grade 3 or higher cytokine release syndrome occurred in three patients (8%) and nine experienced neurologic events (23%).

“The majority of the higher-grade adverse events observed were due to cytopenias, which were expected due to the conditioning therapy,” Dr. Neelapu said. “Such cytopenias would also have been expected if these patients had received standard chemoimmunotherapy.”

Six patients (15%) died, 4 of progressive disease after going forward to other therapies.

As for cost, Dr. Neelapu said it should be similar to that of axi-cel as an FDA-approved third-line therapy. Axi-cel is highly expensive. Research has suggested that CAR T-cell therapy can boost costs beyond standard chemotherapy by $350,000-$490,000 with gains of 2-8 years of life (J Med Econ. Jan-Dec 2021;24[1]:458-68).

The study was funded by Kite. The authors reported various disclosures.

Aerosolized hydrogen peroxide (aHP) can significantly reduce Clostridioides difficile infection (CDI) and is an effective disinfection system, suggests a study published in the American Journal of Infection Control.

C. difficile is the most common cause of health care–associated infection and increasingly occurs outside acute care hospitals. CDI symptoms can range from mild diarrhea to life-threatening colitis and sepsis, sometimes requiring urgent colon removal.

The Centers for Disease Control and Prevention has reported that, in the United States, 223,900 people required hospitalization for CDI and at least 12,800 died in 2017. Because of its large toll, CDI is grouped with antimicrobial-resistant “threat” organisms that often accompany it. People older than age 65 are at particular risk for disease, and at least 20% of patients experience recurrence.

In health care facilities, C. difficile is transmitted by bacterial spores that readily contaminate surfaces in patients’ rooms, from handrails to bedside tables to light switches and knobs. The spores are resistant to disinfectants, and rooms are often cleaned with bleach solutions. But those bleach fumes are irritating and may cause bronchospasm for patients with asthma or chronic obstructive pulmonary disease, and so alternative cleaning agents are needed.

In a retrospective study of an acute-care facility in Philadelphia, researchers compared the incidence of health care–associated CDI (HA-CDI) at the facility before and after adding aHP to other infection control practices. The aHP process produces an aerosolized dry-mist fog that contains a specified percentage of hydrogen peroxide. The fog is used after the room has been physically cleaned, settling on exposed surfaces and killing any remaining C. difficile spores.

The aHP mixture also contains 0.01% ionic silver. The study lead was Christopher L. Truitt, PhD, of Wayland Baptist University. Dr. Truitt told this news organization that hydrogen peroxide affects the endospore layer of the C. difficile organism and allows the “ionic silver to get into the cell and is shown to bind to enzymes and inactivate those inside the cell and actually improve the efficacy.”

Asked whether it’s the silver or the peroxide that disinfects, Dr. Truitt replied: “I can’t answer that. We don’t know if it’s the silver or the hydrogen peroxide. The commercially available chemical that’s used in that machine is a proprietary set-up ... with EPA approval as a sporicidal.”

In the baseline 27-month period, the hospital tallied 120 HA-CDI cases. After aHP was introduced, they counted just 72 cases over 33 months, a 41% decrease in the facility’s HA-CDI rate, from 4.6 per 10,000 patient-days to 2.7 per 10,000 patient-days (P < .001).

There was also a progressive decrease in hospital-onset CDI even after aHP was introduced, from 5.4 per 10,000 patient-days in 2015 to 1.4 per 10,000 patient-days in 2019.

Yoav Golan, MD, of Tufts University, Boston, told this news organization there were two major study limitations. “One is the fact that they did not control for other interventions that may have an effect on C. difficile: antibiotic stewardship and infection control,” he explained. This limitation was noted by the study authors and may explain the continued decline in infections after the introduction of aHP. The other limitation was not using a crossover study design.

“I would argue that they should have provided a little more information about their own practices in their own hospital when it comes to intensification of infection control [and] when it comes to a stewardship and changes that they’ve made to antibiotic usage,” Dr. Golan continued. “The description of changes over time and those practices would have allowed us to better understand the impact of the hydrogen peroxide intervention.”

Despite his criticisms, Dr. Golan concluded: “I think that the study is important. I think their intervention is unique in a way that they’ve been using an aerosolizing system that’s using a relatively high concentration of hydrogen peroxide. I think that there’s enough in this paper to suggest that using such a system may have an impact on the environment, and through that, on dissemination.”

Dr. Truitt added that a next step would be to compare aHP with ultraviolet light, which is commonly used to disinfect hospital rooms.

Dr. Truitt is chief science officer at Infection Controls, dba Germblast, a proprietary service that uses cold-mist hydrogen peroxide and other modalities to disinfect surfaces. Dr. Golan has reported being a consultant for Merck, Seres Therapeutics, Vedanta Biosciences, and Ferring Pharmaceuticals.

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

Aerosolized hydrogen peroxide (aHP) can significantly reduce Clostridioides difficile infection (CDI) and is an effective disinfection system, suggests a study published in the American Journal of Infection Control.

C. difficile is the most common cause of health care–associated infection and increasingly occurs outside acute care hospitals. CDI symptoms can range from mild diarrhea to life-threatening colitis and sepsis, sometimes requiring urgent colon removal.

The Centers for Disease Control and Prevention has reported that, in the United States, 223,900 people required hospitalization for CDI and at least 12,800 died in 2017. Because of its large toll, CDI is grouped with antimicrobial-resistant “threat” organisms that often accompany it. People older than age 65 are at particular risk for disease, and at least 20% of patients experience recurrence.

In health care facilities, C. difficile is transmitted by bacterial spores that readily contaminate surfaces in patients’ rooms, from handrails to bedside tables to light switches and knobs. The spores are resistant to disinfectants, and rooms are often cleaned with bleach solutions. But those bleach fumes are irritating and may cause bronchospasm for patients with asthma or chronic obstructive pulmonary disease, and so alternative cleaning agents are needed.

In a retrospective study of an acute-care facility in Philadelphia, researchers compared the incidence of health care–associated CDI (HA-CDI) at the facility before and after adding aHP to other infection control practices. The aHP process produces an aerosolized dry-mist fog that contains a specified percentage of hydrogen peroxide. The fog is used after the room has been physically cleaned, settling on exposed surfaces and killing any remaining C. difficile spores.

The aHP mixture also contains 0.01% ionic silver. The study lead was Christopher L. Truitt, PhD, of Wayland Baptist University. Dr. Truitt told this news organization that hydrogen peroxide affects the endospore layer of the C. difficile organism and allows the “ionic silver to get into the cell and is shown to bind to enzymes and inactivate those inside the cell and actually improve the efficacy.”

Asked whether it’s the silver or the peroxide that disinfects, Dr. Truitt replied: “I can’t answer that. We don’t know if it’s the silver or the hydrogen peroxide. The commercially available chemical that’s used in that machine is a proprietary set-up ... with EPA approval as a sporicidal.”

In the baseline 27-month period, the hospital tallied 120 HA-CDI cases. After aHP was introduced, they counted just 72 cases over 33 months, a 41% decrease in the facility’s HA-CDI rate, from 4.6 per 10,000 patient-days to 2.7 per 10,000 patient-days (P < .001).

There was also a progressive decrease in hospital-onset CDI even after aHP was introduced, from 5.4 per 10,000 patient-days in 2015 to 1.4 per 10,000 patient-days in 2019.

Yoav Golan, MD, of Tufts University, Boston, told this news organization there were two major study limitations. “One is the fact that they did not control for other interventions that may have an effect on C. difficile: antibiotic stewardship and infection control,” he explained. This limitation was noted by the study authors and may explain the continued decline in infections after the introduction of aHP. The other limitation was not using a crossover study design.

“I would argue that they should have provided a little more information about their own practices in their own hospital when it comes to intensification of infection control [and] when it comes to a stewardship and changes that they’ve made to antibiotic usage,” Dr. Golan continued. “The description of changes over time and those practices would have allowed us to better understand the impact of the hydrogen peroxide intervention.”

Despite his criticisms, Dr. Golan concluded: “I think that the study is important. I think their intervention is unique in a way that they’ve been using an aerosolizing system that’s using a relatively high concentration of hydrogen peroxide. I think that there’s enough in this paper to suggest that using such a system may have an impact on the environment, and through that, on dissemination.”

Dr. Truitt added that a next step would be to compare aHP with ultraviolet light, which is commonly used to disinfect hospital rooms.

Dr. Truitt is chief science officer at Infection Controls, dba Germblast, a proprietary service that uses cold-mist hydrogen peroxide and other modalities to disinfect surfaces. Dr. Golan has reported being a consultant for Merck, Seres Therapeutics, Vedanta Biosciences, and Ferring Pharmaceuticals.

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

Aerosolized hydrogen peroxide (aHP) can significantly reduce Clostridioides difficile infection (CDI) and is an effective disinfection system, suggests a study published in the American Journal of Infection Control.

C. difficile is the most common cause of health care–associated infection and increasingly occurs outside acute care hospitals. CDI symptoms can range from mild diarrhea to life-threatening colitis and sepsis, sometimes requiring urgent colon removal.

The Centers for Disease Control and Prevention has reported that, in the United States, 223,900 people required hospitalization for CDI and at least 12,800 died in 2017. Because of its large toll, CDI is grouped with antimicrobial-resistant “threat” organisms that often accompany it. People older than age 65 are at particular risk for disease, and at least 20% of patients experience recurrence.

In health care facilities, C. difficile is transmitted by bacterial spores that readily contaminate surfaces in patients’ rooms, from handrails to bedside tables to light switches and knobs. The spores are resistant to disinfectants, and rooms are often cleaned with bleach solutions. But those bleach fumes are irritating and may cause bronchospasm for patients with asthma or chronic obstructive pulmonary disease, and so alternative cleaning agents are needed.

In a retrospective study of an acute-care facility in Philadelphia, researchers compared the incidence of health care–associated CDI (HA-CDI) at the facility before and after adding aHP to other infection control practices. The aHP process produces an aerosolized dry-mist fog that contains a specified percentage of hydrogen peroxide. The fog is used after the room has been physically cleaned, settling on exposed surfaces and killing any remaining C. difficile spores.

The aHP mixture also contains 0.01% ionic silver. The study lead was Christopher L. Truitt, PhD, of Wayland Baptist University. Dr. Truitt told this news organization that hydrogen peroxide affects the endospore layer of the C. difficile organism and allows the “ionic silver to get into the cell and is shown to bind to enzymes and inactivate those inside the cell and actually improve the efficacy.”

Asked whether it’s the silver or the peroxide that disinfects, Dr. Truitt replied: “I can’t answer that. We don’t know if it’s the silver or the hydrogen peroxide. The commercially available chemical that’s used in that machine is a proprietary set-up ... with EPA approval as a sporicidal.”

In the baseline 27-month period, the hospital tallied 120 HA-CDI cases. After aHP was introduced, they counted just 72 cases over 33 months, a 41% decrease in the facility’s HA-CDI rate, from 4.6 per 10,000 patient-days to 2.7 per 10,000 patient-days (P < .001).

There was also a progressive decrease in hospital-onset CDI even after aHP was introduced, from 5.4 per 10,000 patient-days in 2015 to 1.4 per 10,000 patient-days in 2019.

Yoav Golan, MD, of Tufts University, Boston, told this news organization there were two major study limitations. “One is the fact that they did not control for other interventions that may have an effect on C. difficile: antibiotic stewardship and infection control,” he explained. This limitation was noted by the study authors and may explain the continued decline in infections after the introduction of aHP. The other limitation was not using a crossover study design.

“I would argue that they should have provided a little more information about their own practices in their own hospital when it comes to intensification of infection control [and] when it comes to a stewardship and changes that they’ve made to antibiotic usage,” Dr. Golan continued. “The description of changes over time and those practices would have allowed us to better understand the impact of the hydrogen peroxide intervention.”

Despite his criticisms, Dr. Golan concluded: “I think that the study is important. I think their intervention is unique in a way that they’ve been using an aerosolizing system that’s using a relatively high concentration of hydrogen peroxide. I think that there’s enough in this paper to suggest that using such a system may have an impact on the environment, and through that, on dissemination.”

Dr. Truitt added that a next step would be to compare aHP with ultraviolet light, which is commonly used to disinfect hospital rooms.

Dr. Truitt is chief science officer at Infection Controls, dba Germblast, a proprietary service that uses cold-mist hydrogen peroxide and other modalities to disinfect surfaces. Dr. Golan has reported being a consultant for Merck, Seres Therapeutics, Vedanta Biosciences, and Ferring Pharmaceuticals.

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

COVID-19 patients who are successfully weaned off a ventilator may take days, or even weeks, to regain consciousness, especially those who experienced episodes of hypoxemia while intubated, a new study shows.

“As we started to see the first patients waking up after successful COVID-19 ICU treatments, we also encountered many patients who remained comatose for days and weeks and then regained consciousness to become fully oriented,” co-senior investigator Nicholas Schiff, MD, with NewYork-Presbyterian/Weill Cornell Medical Center, says in a news release.

The findings have immediate implications regarding life-sustaining therapies for unresponsive COVID-19 patients, the investigators note.

“In critical care medicine, one of our main tasks is to advise families about planning in the event a patient does not regain consciousness,” said co-senior author Jan Claassen, MD, with New York-Presbyterian/Columbia University Irving Medical Center. 

“Our findings suggest that for patients with severe COVID, the decision to withdraw life support shouldn’t be based solely on prolonged periods of unconsciousness, as these patients may eventually recover,” Dr. Claassen adds.

The study was published online March 7 in Annals of Neurology.
 

Slow road back

The researchers examined 795 intubated patients with severe COVID-19 at three medical centers in New York during the first wave of the pandemic (March-July 2020). All patients had impaired consciousness (Glasgow Coma Scale [GCS] motor score less than 6) on day 7 of intubation.

A total of 571 patients (72%) survived and regained consciousness.

The median time to recovery of consciousness was 30 days. One-quarter of the patients recovered consciousness 10 days or longer after they stopped receiving ventilator support and 10% took 23 days or longer to recover.

Time to recovery of consciousness was associated with hypoxemia. The hazard ratio was 0.56 (95% confidence interval, 0.46-0.68) with arterial partial pressure of oxygen (PaO2) less than or equal to 55 mm Hg and 0.88 (95% CI, 0.85-0.91) with a PaO2 less than or equal to 70 mm Hg.

Each additional day of hypoxemia decreased the odds of recovery of consciousness after accounting for confounding factors including sedation.

These findings were confirmed among patients without any imaging evidence of structural brain injury and in a non-overlapping cohort of 427 patients from the second wave of the pandemic (October-April 2021).

“These findings provide us with more accurate information to guide families who are deciding whether to continue life-sustaining therapy in unconscious COVID-19 patients,” co-senior author Brian Edlow, MD, with Massachusetts General Hospital and Harvard Medical School in Boston, says in the news release.

“Encouragingly,” adds Dr. Claassen, “our study shows that the vast majority of unconscious COVID patients recover consciousness, but it is important to consider that we did not look at the quality of recovery. That’s something that should be the focus of long-term follow-up studies.”

The study was supported by the James S. McDonnell Foundation (JSMF). Dr. Schiff, Dr. Claassen, and Dr. Edlow have disclosed no relevant financial relationships.

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

COVID-19 patients who are successfully weaned off a ventilator may take days, or even weeks, to regain consciousness, especially those who experienced episodes of hypoxemia while intubated, a new study shows.

“As we started to see the first patients waking up after successful COVID-19 ICU treatments, we also encountered many patients who remained comatose for days and weeks and then regained consciousness to become fully oriented,” co-senior investigator Nicholas Schiff, MD, with NewYork-Presbyterian/Weill Cornell Medical Center, says in a news release.

The findings have immediate implications regarding life-sustaining therapies for unresponsive COVID-19 patients, the investigators note.

“In critical care medicine, one of our main tasks is to advise families about planning in the event a patient does not regain consciousness,” said co-senior author Jan Claassen, MD, with New York-Presbyterian/Columbia University Irving Medical Center. 

“Our findings suggest that for patients with severe COVID, the decision to withdraw life support shouldn’t be based solely on prolonged periods of unconsciousness, as these patients may eventually recover,” Dr. Claassen adds.

The study was published online March 7 in Annals of Neurology.
 

Slow road back

The researchers examined 795 intubated patients with severe COVID-19 at three medical centers in New York during the first wave of the pandemic (March-July 2020). All patients had impaired consciousness (Glasgow Coma Scale [GCS] motor score less than 6) on day 7 of intubation.

A total of 571 patients (72%) survived and regained consciousness.

The median time to recovery of consciousness was 30 days. One-quarter of the patients recovered consciousness 10 days or longer after they stopped receiving ventilator support and 10% took 23 days or longer to recover.

Time to recovery of consciousness was associated with hypoxemia. The hazard ratio was 0.56 (95% confidence interval, 0.46-0.68) with arterial partial pressure of oxygen (PaO2) less than or equal to 55 mm Hg and 0.88 (95% CI, 0.85-0.91) with a PaO2 less than or equal to 70 mm Hg.

Each additional day of hypoxemia decreased the odds of recovery of consciousness after accounting for confounding factors including sedation.

These findings were confirmed among patients without any imaging evidence of structural brain injury and in a non-overlapping cohort of 427 patients from the second wave of the pandemic (October-April 2021).

“These findings provide us with more accurate information to guide families who are deciding whether to continue life-sustaining therapy in unconscious COVID-19 patients,” co-senior author Brian Edlow, MD, with Massachusetts General Hospital and Harvard Medical School in Boston, says in the news release.

“Encouragingly,” adds Dr. Claassen, “our study shows that the vast majority of unconscious COVID patients recover consciousness, but it is important to consider that we did not look at the quality of recovery. That’s something that should be the focus of long-term follow-up studies.”

The study was supported by the James S. McDonnell Foundation (JSMF). Dr. Schiff, Dr. Claassen, and Dr. Edlow have disclosed no relevant financial relationships.

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

COVID-19 patients who are successfully weaned off a ventilator may take days, or even weeks, to regain consciousness, especially those who experienced episodes of hypoxemia while intubated, a new study shows.

“As we started to see the first patients waking up after successful COVID-19 ICU treatments, we also encountered many patients who remained comatose for days and weeks and then regained consciousness to become fully oriented,” co-senior investigator Nicholas Schiff, MD, with NewYork-Presbyterian/Weill Cornell Medical Center, says in a news release.

The findings have immediate implications regarding life-sustaining therapies for unresponsive COVID-19 patients, the investigators note.

“In critical care medicine, one of our main tasks is to advise families about planning in the event a patient does not regain consciousness,” said co-senior author Jan Claassen, MD, with New York-Presbyterian/Columbia University Irving Medical Center. 

“Our findings suggest that for patients with severe COVID, the decision to withdraw life support shouldn’t be based solely on prolonged periods of unconsciousness, as these patients may eventually recover,” Dr. Claassen adds.

The study was published online March 7 in Annals of Neurology.
 

Slow road back

The researchers examined 795 intubated patients with severe COVID-19 at three medical centers in New York during the first wave of the pandemic (March-July 2020). All patients had impaired consciousness (Glasgow Coma Scale [GCS] motor score less than 6) on day 7 of intubation.

A total of 571 patients (72%) survived and regained consciousness.

The median time to recovery of consciousness was 30 days. One-quarter of the patients recovered consciousness 10 days or longer after they stopped receiving ventilator support and 10% took 23 days or longer to recover.

Time to recovery of consciousness was associated with hypoxemia. The hazard ratio was 0.56 (95% confidence interval, 0.46-0.68) with arterial partial pressure of oxygen (PaO2) less than or equal to 55 mm Hg and 0.88 (95% CI, 0.85-0.91) with a PaO2 less than or equal to 70 mm Hg.

Each additional day of hypoxemia decreased the odds of recovery of consciousness after accounting for confounding factors including sedation.

These findings were confirmed among patients without any imaging evidence of structural brain injury and in a non-overlapping cohort of 427 patients from the second wave of the pandemic (October-April 2021).

“These findings provide us with more accurate information to guide families who are deciding whether to continue life-sustaining therapy in unconscious COVID-19 patients,” co-senior author Brian Edlow, MD, with Massachusetts General Hospital and Harvard Medical School in Boston, says in the news release.

“Encouragingly,” adds Dr. Claassen, “our study shows that the vast majority of unconscious COVID patients recover consciousness, but it is important to consider that we did not look at the quality of recovery. That’s something that should be the focus of long-term follow-up studies.”

The study was supported by the James S. McDonnell Foundation (JSMF). Dr. Schiff, Dr. Claassen, and Dr. Edlow have disclosed no relevant financial relationships.

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

A new study has drawn attention to inaccurate measurement of LDL-cholesterol levels in some patients with current assays, which could lead to incorrect therapeutic approaches.

The patient groups most affected are those with high levels of the lipoprotein Lp(a), in whom LDL-cholesterol levels are being overestimated in current laboratory tests, the authors say.

“Current laboratory assays all have the limitation that they cannot measure or report LDL cholesterol accurately. They are actually measuring the combination of LDL and Lp(a),” senior study author Sotirios Tsimikas, MD, University of California, San Diego, explained to this news organization.

“Lp(a) can be lowered a little with niacin and PCSK9 inhibitors, but both have a quite a weak effect, and statins increase Lp(a). However, there are now multiple RNA-based therapeutics specifically targeting Lp(a) in clinical development,” he said.

At present, Lp(a) cholesterol has to be mathematically estimated, most commonly with the Dahlén formula, because of the lack of a validated, quantitative method to measure Lp(a) cholesterol, Dr. Tsimikas says.  

For the current study, the researchers used a novel, quantitative, sensitive method to directly measure Lp(a) cholesterol, then applied this method to data from a recent study with the one of the new Lp(a)-lowering drugs in development – pelacarsen – which was conducted in patients with elevated Lp(a) levels.

Results showed that direct Lp(a)-cholesterol assessment, and subtracting this value from the laboratory LDL-cholesterol value, provides a more accurate reflection of the baseline and change in LDL cholesterol, the authors report. In the current study, corrected LDL cholesterol was 13 to 16 mg/dL lower than laboratory-reported LDL cholesterol.

Using the corrected LDL-cholesterol results, the study showed that pelacarsen significantly decreases Lp(a) cholesterol, with neutral to modest effects on LDL.

The study also suggests that the current method of calculating Lp(a) cholesterol, and then deriving a corrected LDL cholesterol – the Dahlén formula – is not accurate. 

“The Dahlén formula relies on the assumption that Lp(a) cholesterol is universally a fixed 30% of Lp(a) mass, but this usually isn’t the case. The Dahlén formula needs to be discontinued. It can be highly inaccurate,” Dr. Tsimikas said.  

Important implications

In an accompanying editorial, Guillaume Paré, MD, Michael Chong, PhD student, and Pedrum Mohammadi-Shemirani, BSc, all of McMaster University, Hamilton, Ont., say the current findings have three important clinical implications.

“First, they provide further proof that in individuals with elevated Lp(a), the contribution of Lp(a)-cholesterol to LDL-cholesterol is non-negligible using standard assays, with 13-16 mg/dL lower LDL-cholesterol post-correction.”

Secondly, the editorialists point out that these new findings confirm that the effect of Lp(a) inhibitors is likely to be mostly confined to Lp(a), “as would be expected.”

Finally, “and perhaps more importantly, the authors highlight the need to improve clinical reporting of lipid fractions to properly treat LDL-cholesterol and Lp(a) in high-risk patients,” they note.

“The report paves the way for future studies investigating the clinical utility of these additional measurements to initiate and monitor lipid-lowering therapy,” they conclude.

The clinical trial was funded by Ionis Pharmaceuticals, and the direct Lp(a)-cholesterol measurements were funded by Novartis through a research grant to the University of California, San Diego. Dr. Tsimikas is an employee of Ionis Pharmaceuticals and of the University of California, San Diego, and he is a cofounder of Covicept Therapeutics. He is also a coinventor and receives royalties from patents owned by UCSD on oxidation-specific antibodies and on biomarkers related to oxidized lipoproteins, as well as a cofounder and has equity interest in Oxitope and Kleanthi Diagnostics.

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

A new study has drawn attention to inaccurate measurement of LDL-cholesterol levels in some patients with current assays, which could lead to incorrect therapeutic approaches.

The patient groups most affected are those with high levels of the lipoprotein Lp(a), in whom LDL-cholesterol levels are being overestimated in current laboratory tests, the authors say.

“Current laboratory assays all have the limitation that they cannot measure or report LDL cholesterol accurately. They are actually measuring the combination of LDL and Lp(a),” senior study author Sotirios Tsimikas, MD, University of California, San Diego, explained to this news organization.

“Lp(a) can be lowered a little with niacin and PCSK9 inhibitors, but both have a quite a weak effect, and statins increase Lp(a). However, there are now multiple RNA-based therapeutics specifically targeting Lp(a) in clinical development,” he said.

At present, Lp(a) cholesterol has to be mathematically estimated, most commonly with the Dahlén formula, because of the lack of a validated, quantitative method to measure Lp(a) cholesterol, Dr. Tsimikas says.  

For the current study, the researchers used a novel, quantitative, sensitive method to directly measure Lp(a) cholesterol, then applied this method to data from a recent study with the one of the new Lp(a)-lowering drugs in development – pelacarsen – which was conducted in patients with elevated Lp(a) levels.

Results showed that direct Lp(a)-cholesterol assessment, and subtracting this value from the laboratory LDL-cholesterol value, provides a more accurate reflection of the baseline and change in LDL cholesterol, the authors report. In the current study, corrected LDL cholesterol was 13 to 16 mg/dL lower than laboratory-reported LDL cholesterol.

Using the corrected LDL-cholesterol results, the study showed that pelacarsen significantly decreases Lp(a) cholesterol, with neutral to modest effects on LDL.

The study also suggests that the current method of calculating Lp(a) cholesterol, and then deriving a corrected LDL cholesterol – the Dahlén formula – is not accurate. 

“The Dahlén formula relies on the assumption that Lp(a) cholesterol is universally a fixed 30% of Lp(a) mass, but this usually isn’t the case. The Dahlén formula needs to be discontinued. It can be highly inaccurate,” Dr. Tsimikas said.  

Important implications

In an accompanying editorial, Guillaume Paré, MD, Michael Chong, PhD student, and Pedrum Mohammadi-Shemirani, BSc, all of McMaster University, Hamilton, Ont., say the current findings have three important clinical implications.

“First, they provide further proof that in individuals with elevated Lp(a), the contribution of Lp(a)-cholesterol to LDL-cholesterol is non-negligible using standard assays, with 13-16 mg/dL lower LDL-cholesterol post-correction.”

Secondly, the editorialists point out that these new findings confirm that the effect of Lp(a) inhibitors is likely to be mostly confined to Lp(a), “as would be expected.”

Finally, “and perhaps more importantly, the authors highlight the need to improve clinical reporting of lipid fractions to properly treat LDL-cholesterol and Lp(a) in high-risk patients,” they note.

“The report paves the way for future studies investigating the clinical utility of these additional measurements to initiate and monitor lipid-lowering therapy,” they conclude.

The clinical trial was funded by Ionis Pharmaceuticals, and the direct Lp(a)-cholesterol measurements were funded by Novartis through a research grant to the University of California, San Diego. Dr. Tsimikas is an employee of Ionis Pharmaceuticals and of the University of California, San Diego, and he is a cofounder of Covicept Therapeutics. He is also a coinventor and receives royalties from patents owned by UCSD on oxidation-specific antibodies and on biomarkers related to oxidized lipoproteins, as well as a cofounder and has equity interest in Oxitope and Kleanthi Diagnostics.

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

A new study has drawn attention to inaccurate measurement of LDL-cholesterol levels in some patients with current assays, which could lead to incorrect therapeutic approaches.

The patient groups most affected are those with high levels of the lipoprotein Lp(a), in whom LDL-cholesterol levels are being overestimated in current laboratory tests, the authors say.

“Current laboratory assays all have the limitation that they cannot measure or report LDL cholesterol accurately. They are actually measuring the combination of LDL and Lp(a),” senior study author Sotirios Tsimikas, MD, University of California, San Diego, explained to this news organization.

“Lp(a) can be lowered a little with niacin and PCSK9 inhibitors, but both have a quite a weak effect, and statins increase Lp(a). However, there are now multiple RNA-based therapeutics specifically targeting Lp(a) in clinical development,” he said.

At present, Lp(a) cholesterol has to be mathematically estimated, most commonly with the Dahlén formula, because of the lack of a validated, quantitative method to measure Lp(a) cholesterol, Dr. Tsimikas says.  

For the current study, the researchers used a novel, quantitative, sensitive method to directly measure Lp(a) cholesterol, then applied this method to data from a recent study with the one of the new Lp(a)-lowering drugs in development – pelacarsen – which was conducted in patients with elevated Lp(a) levels.

Results showed that direct Lp(a)-cholesterol assessment, and subtracting this value from the laboratory LDL-cholesterol value, provides a more accurate reflection of the baseline and change in LDL cholesterol, the authors report. In the current study, corrected LDL cholesterol was 13 to 16 mg/dL lower than laboratory-reported LDL cholesterol.

Using the corrected LDL-cholesterol results, the study showed that pelacarsen significantly decreases Lp(a) cholesterol, with neutral to modest effects on LDL.

The study also suggests that the current method of calculating Lp(a) cholesterol, and then deriving a corrected LDL cholesterol – the Dahlén formula – is not accurate. 

“The Dahlén formula relies on the assumption that Lp(a) cholesterol is universally a fixed 30% of Lp(a) mass, but this usually isn’t the case. The Dahlén formula needs to be discontinued. It can be highly inaccurate,” Dr. Tsimikas said.  

Important implications

In an accompanying editorial, Guillaume Paré, MD, Michael Chong, PhD student, and Pedrum Mohammadi-Shemirani, BSc, all of McMaster University, Hamilton, Ont., say the current findings have three important clinical implications.

“First, they provide further proof that in individuals with elevated Lp(a), the contribution of Lp(a)-cholesterol to LDL-cholesterol is non-negligible using standard assays, with 13-16 mg/dL lower LDL-cholesterol post-correction.”

Secondly, the editorialists point out that these new findings confirm that the effect of Lp(a) inhibitors is likely to be mostly confined to Lp(a), “as would be expected.”

Finally, “and perhaps more importantly, the authors highlight the need to improve clinical reporting of lipid fractions to properly treat LDL-cholesterol and Lp(a) in high-risk patients,” they note.

“The report paves the way for future studies investigating the clinical utility of these additional measurements to initiate and monitor lipid-lowering therapy,” they conclude.

The clinical trial was funded by Ionis Pharmaceuticals, and the direct Lp(a)-cholesterol measurements were funded by Novartis through a research grant to the University of California, San Diego. Dr. Tsimikas is an employee of Ionis Pharmaceuticals and of the University of California, San Diego, and he is a cofounder of Covicept Therapeutics. He is also a coinventor and receives royalties from patents owned by UCSD on oxidation-specific antibodies and on biomarkers related to oxidized lipoproteins, as well as a cofounder and has equity interest in Oxitope and Kleanthi Diagnostics.

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

As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al¹ reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al² explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al³ report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al⁴ discuss efforts to improve comorbidity capture at their institution, and Uche et al⁵ present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; [email protected]

As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al¹ reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al² explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al³ report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al⁴ discuss efforts to improve comorbidity capture at their institution, and Uche et al⁵ present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; [email protected]

As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al¹ reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al² explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al³ report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al⁴ discuss efforts to improve comorbidity capture at their institution, and Uche et al⁵ present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; [email protected]