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The SGLT2 inhibitor dapagliflozin scored a clear win in a randomized, controlled trial with more than 300 U.S. patients with heart failure with preserved ejection fraction (HFpEF), showing a significant and clinically meaningful benefit for the primary endpoint, a KCCQ measure of symptoms and physical limitations, after 12 weeks of treatment.

These results in the PRESERVED-HF study follow closely on the heals of the initial report from the EMPEROR-Preserved trial that showed a benefit from a different sodium-glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin (Jardiance) in nearly 6,000 randomized patients for the primary endpoint of preventing cardiovascular death or hospitalizations for heart failure.

In PRESERVED-HF, patients with HFpEF who received a standard, once-daily dose of dapagliflozin (Farxiga) had an average 5.8-point improvement in their condition as measured by the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS), the study’s primary endpoint.

This is “the first study to demonstrate that an SGLT2 inhibitor dapagliflozin significantly improves symptoms, physical limitations, and 6-minute walking distance in patients with HFpEF,” Mikhail N. Kosiborod, MD, reported at the annual scientific meeting of the Heart Failure Society of America. The secondary endpoint of 6-minute walking distance “has been very difficult to improve in many previous studies of other treatments” tested in patients with HFpEF, noted Dr. Kosiborod, a cardiologist and codirector of the Cardiometabolic Center of Excellence at Saint Luke’s Mid-America Heart Institute.

The results are “highly complementary” to the findings from large outcome trials, such as the findings from EMPEROR-Preserved, he said, and collectively the recent findings from these studies of SGLT2 inhibitors in patients with HFpEF identify drugs in this class as a “new treatment option” for patients with a disorder that until now had no treatment with unequivocally proven efficacy and safety.
 

‘Impressive and unprecedented’ findings

The findings are “really impressive and unprecedented,” said Milton Packer, MD, a cardiologist at Baylor University Medical Center in Dallas who was not involved in the study. “This is the largest KCCQ benefit ever seen in either patients with HFpEF or in patients with heart failure with reduced ejection fraction,” said Dr. Packer, one of the investigators who led the EMPEROR-Preserved trial.

MDedge News

PRESERVED-HF randomized 324 patients diagnosed with heart failure and with a left ventricular ejection fraction of 45% or higher at any of 26 U.S. centers, with 304 patients completing the planned final analysis after 12 weeks on treatment. Patients could be in New York Heart Association (NYHA) functional class II-IV, they had to have a baseline N-terminal pro-brain natriuretic peptide (NT-proBNP) level of at least 225 pg/mL (or higher if they also had atrial fibrillation), and they required at least one of three markers of established heart failure: recent hospitalization for heart failure or an urgent outpatient visit that required treatment with an IV diuretic, elevated filling pressure measured by left or right catheterization, or structural heart disease detected by echocardiography.

The average age of the enrolled patients was 70 years, and they had been diagnosed with heart failure for about 3 years; 57% were women, 30% were African American, and their median body mass index was 35 kg/m². Roughly 42% had NYHA class III or IV disease, 56% had type 2 diabetes, their median estimated glomerular filtration rate was about 55 mL/min per 1.73m², their median KCCQ-CS score at baseline was about 62, and their average 6-minute walk distance was 244 m.

These and other features of the enrolled population define a distinctly U.S. patient population, stressed Dr. Kosiborod, professor of medicine at the University of Missouri–Kansas City.

“The patients we enrolled are the patients we see in U.S. clinical practice,” he said in an interview. Importantly, the patient profile of a median BMI of 35 kg/m², a median KCCQ-CS score of 62 – “quite low,” noted Dr. Kosiborod – and having more than 40% of patients in NYHA functional class III defines a study population with a substantially greater burden of obesity, symptoms, and functional impairment compared with those enrolled in prior trials involving patients with HFpEF such as EMPEROR-Preserved.
 

Results complement findings from larger trials

PRESERVED-HF was an investigator-initiated study designed to inform clinical practice, not as a pivotal trial like EMPEROR-Preserved, which aims to gather evidence to support a new indication for regulatory approval. (On Sept. 9, 2021, the Food and Drug Administration granted empagliflozin “breakthrough therapy” status for treating HFpEF based on the EMPEROR-Preserved results, which will fast-track the agency’s decision on this indication.)

Dr. Kosiborod noted that he and his associates designed PRESERVED-HF with adequate patient numbers to power a statistically valid assessment of effect on KCCQ-CS score. While the new findings will not by themselves lead to a new indication for dapagliflozin to treat patients with HFpEF, they will potentially complement the pending results of another trial, DELIVER, by showing efficacy and safety in a uniquely U.S. patient population. DELIVER is a pivotal, global trial of dapagliflozin in more than 6,000 patients with HFpEF that’s on track to report findings in 2022.

Dr. Kosiborod also stressed that dapagliflozin has U.S.-approved indications for treating patients with type 2 diabetes, and for patients with chronic kidney disease, and that a majority of patients enrolled in PRESERVED-HF had one or both of these conditions. That makes the new findings especially compelling for patients with either type 2 diabetes or chronic kidney disease and HFpEF who are not already receiving an SGLT2 inhibitor.

Other findings that he reported showed a range of benefits consistent with the primary endpoint, including the KCCQ overall summary score, which also showed a significant 4.5-point average increase over placebo after 12 weeks. Analysis by the percentage of patients achieving at least a 5-point improvement in the KCCQ clinical summary score (the threshold for a clinically meaningful improvement) showed that about 45% of patients treated with dapagliflozin reached this mark compared with roughly 35% of patients in the placebo arm, indicating a number needed to treat of nine to have one additional patient achieve this threshold after 12 weeks. Average improvement in 6-minute walk distance was about 20 m with dapagliflozin compared with placebo.

No heterogeneity of effect by baseline ejection fraction.

Subgroup analyses showed no heterogeneity of response across 12 different ways of subdividing the study population, including age, sex, race, diabetes status, and BMI. The median left ventricular ejection fraction among enrolled patients was 60%, and the findings showed identical KCCQ improvements among patients with ejection fractions less than the median and those with an ejection fraction above the median.

This last finding was especially relevant because the EMPEROR-Preserved results showed a possible signal of heterogeneity by ejection fraction and an attenuated effect among patients with HFpEF and an ejection fraction above the 60%-65% range, although the certainty of this finding is currently controversial.

The impact of empagliflozin on KCCQ clinical summary score in EMPEROR-Preserved showed an average incremental improvement of 1.32 points compared with placebo, a significant difference, but more modest than the increment from dapagliflozin treatment seen in PRESERVED-HF. Dr. Kosiborod hypothesized that this difference might be mostly because of the different patient populations enrolled in the two studies.

Dr. Kosiborod noted that a report on the PRESERVED-HF results will soon appear in Nature Medicine.

PRESERVED-HF was funded by AstraZeneca, which markets dapagliflozin (Farxiga), but the trials’ design and conduct were independent of this funding source. Dr. Kosiborod has been a consultant to AstraZeneca and numerous other companies, and he has received research funding from AstraZeneca and Boehringer Ingelheim. Dr. Packer has had financial relationships with AstraZeneca and numerous other companies.

[email protected]

The SGLT2 inhibitor dapagliflozin scored a clear win in a randomized, controlled trial with more than 300 U.S. patients with heart failure with preserved ejection fraction (HFpEF), showing a significant and clinically meaningful benefit for the primary endpoint, a KCCQ measure of symptoms and physical limitations, after 12 weeks of treatment.

These results in the PRESERVED-HF study follow closely on the heals of the initial report from the EMPEROR-Preserved trial that showed a benefit from a different sodium-glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin (Jardiance) in nearly 6,000 randomized patients for the primary endpoint of preventing cardiovascular death or hospitalizations for heart failure.

In PRESERVED-HF, patients with HFpEF who received a standard, once-daily dose of dapagliflozin (Farxiga) had an average 5.8-point improvement in their condition as measured by the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS), the study’s primary endpoint.

This is “the first study to demonstrate that an SGLT2 inhibitor dapagliflozin significantly improves symptoms, physical limitations, and 6-minute walking distance in patients with HFpEF,” Mikhail N. Kosiborod, MD, reported at the annual scientific meeting of the Heart Failure Society of America. The secondary endpoint of 6-minute walking distance “has been very difficult to improve in many previous studies of other treatments” tested in patients with HFpEF, noted Dr. Kosiborod, a cardiologist and codirector of the Cardiometabolic Center of Excellence at Saint Luke’s Mid-America Heart Institute.

The results are “highly complementary” to the findings from large outcome trials, such as the findings from EMPEROR-Preserved, he said, and collectively the recent findings from these studies of SGLT2 inhibitors in patients with HFpEF identify drugs in this class as a “new treatment option” for patients with a disorder that until now had no treatment with unequivocally proven efficacy and safety.
 

‘Impressive and unprecedented’ findings

The findings are “really impressive and unprecedented,” said Milton Packer, MD, a cardiologist at Baylor University Medical Center in Dallas who was not involved in the study. “This is the largest KCCQ benefit ever seen in either patients with HFpEF or in patients with heart failure with reduced ejection fraction,” said Dr. Packer, one of the investigators who led the EMPEROR-Preserved trial.

MDedge News

PRESERVED-HF randomized 324 patients diagnosed with heart failure and with a left ventricular ejection fraction of 45% or higher at any of 26 U.S. centers, with 304 patients completing the planned final analysis after 12 weeks on treatment. Patients could be in New York Heart Association (NYHA) functional class II-IV, they had to have a baseline N-terminal pro-brain natriuretic peptide (NT-proBNP) level of at least 225 pg/mL (or higher if they also had atrial fibrillation), and they required at least one of three markers of established heart failure: recent hospitalization for heart failure or an urgent outpatient visit that required treatment with an IV diuretic, elevated filling pressure measured by left or right catheterization, or structural heart disease detected by echocardiography.

The average age of the enrolled patients was 70 years, and they had been diagnosed with heart failure for about 3 years; 57% were women, 30% were African American, and their median body mass index was 35 kg/m². Roughly 42% had NYHA class III or IV disease, 56% had type 2 diabetes, their median estimated glomerular filtration rate was about 55 mL/min per 1.73m², their median KCCQ-CS score at baseline was about 62, and their average 6-minute walk distance was 244 m.

These and other features of the enrolled population define a distinctly U.S. patient population, stressed Dr. Kosiborod, professor of medicine at the University of Missouri–Kansas City.

“The patients we enrolled are the patients we see in U.S. clinical practice,” he said in an interview. Importantly, the patient profile of a median BMI of 35 kg/m², a median KCCQ-CS score of 62 – “quite low,” noted Dr. Kosiborod – and having more than 40% of patients in NYHA functional class III defines a study population with a substantially greater burden of obesity, symptoms, and functional impairment compared with those enrolled in prior trials involving patients with HFpEF such as EMPEROR-Preserved.
 

Results complement findings from larger trials

PRESERVED-HF was an investigator-initiated study designed to inform clinical practice, not as a pivotal trial like EMPEROR-Preserved, which aims to gather evidence to support a new indication for regulatory approval. (On Sept. 9, 2021, the Food and Drug Administration granted empagliflozin “breakthrough therapy” status for treating HFpEF based on the EMPEROR-Preserved results, which will fast-track the agency’s decision on this indication.)

Dr. Kosiborod noted that he and his associates designed PRESERVED-HF with adequate patient numbers to power a statistically valid assessment of effect on KCCQ-CS score. While the new findings will not by themselves lead to a new indication for dapagliflozin to treat patients with HFpEF, they will potentially complement the pending results of another trial, DELIVER, by showing efficacy and safety in a uniquely U.S. patient population. DELIVER is a pivotal, global trial of dapagliflozin in more than 6,000 patients with HFpEF that’s on track to report findings in 2022.

Dr. Kosiborod also stressed that dapagliflozin has U.S.-approved indications for treating patients with type 2 diabetes, and for patients with chronic kidney disease, and that a majority of patients enrolled in PRESERVED-HF had one or both of these conditions. That makes the new findings especially compelling for patients with either type 2 diabetes or chronic kidney disease and HFpEF who are not already receiving an SGLT2 inhibitor.

Other findings that he reported showed a range of benefits consistent with the primary endpoint, including the KCCQ overall summary score, which also showed a significant 4.5-point average increase over placebo after 12 weeks. Analysis by the percentage of patients achieving at least a 5-point improvement in the KCCQ clinical summary score (the threshold for a clinically meaningful improvement) showed that about 45% of patients treated with dapagliflozin reached this mark compared with roughly 35% of patients in the placebo arm, indicating a number needed to treat of nine to have one additional patient achieve this threshold after 12 weeks. Average improvement in 6-minute walk distance was about 20 m with dapagliflozin compared with placebo.

No heterogeneity of effect by baseline ejection fraction.

Subgroup analyses showed no heterogeneity of response across 12 different ways of subdividing the study population, including age, sex, race, diabetes status, and BMI. The median left ventricular ejection fraction among enrolled patients was 60%, and the findings showed identical KCCQ improvements among patients with ejection fractions less than the median and those with an ejection fraction above the median.

This last finding was especially relevant because the EMPEROR-Preserved results showed a possible signal of heterogeneity by ejection fraction and an attenuated effect among patients with HFpEF and an ejection fraction above the 60%-65% range, although the certainty of this finding is currently controversial.

The impact of empagliflozin on KCCQ clinical summary score in EMPEROR-Preserved showed an average incremental improvement of 1.32 points compared with placebo, a significant difference, but more modest than the increment from dapagliflozin treatment seen in PRESERVED-HF. Dr. Kosiborod hypothesized that this difference might be mostly because of the different patient populations enrolled in the two studies.

Dr. Kosiborod noted that a report on the PRESERVED-HF results will soon appear in Nature Medicine.

PRESERVED-HF was funded by AstraZeneca, which markets dapagliflozin (Farxiga), but the trials’ design and conduct were independent of this funding source. Dr. Kosiborod has been a consultant to AstraZeneca and numerous other companies, and he has received research funding from AstraZeneca and Boehringer Ingelheim. Dr. Packer has had financial relationships with AstraZeneca and numerous other companies.

[email protected]

The SGLT2 inhibitor dapagliflozin scored a clear win in a randomized, controlled trial with more than 300 U.S. patients with heart failure with preserved ejection fraction (HFpEF), showing a significant and clinically meaningful benefit for the primary endpoint, a KCCQ measure of symptoms and physical limitations, after 12 weeks of treatment.

These results in the PRESERVED-HF study follow closely on the heals of the initial report from the EMPEROR-Preserved trial that showed a benefit from a different sodium-glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin (Jardiance) in nearly 6,000 randomized patients for the primary endpoint of preventing cardiovascular death or hospitalizations for heart failure.

In PRESERVED-HF, patients with HFpEF who received a standard, once-daily dose of dapagliflozin (Farxiga) had an average 5.8-point improvement in their condition as measured by the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS), the study’s primary endpoint.

This is “the first study to demonstrate that an SGLT2 inhibitor dapagliflozin significantly improves symptoms, physical limitations, and 6-minute walking distance in patients with HFpEF,” Mikhail N. Kosiborod, MD, reported at the annual scientific meeting of the Heart Failure Society of America. The secondary endpoint of 6-minute walking distance “has been very difficult to improve in many previous studies of other treatments” tested in patients with HFpEF, noted Dr. Kosiborod, a cardiologist and codirector of the Cardiometabolic Center of Excellence at Saint Luke’s Mid-America Heart Institute.

The results are “highly complementary” to the findings from large outcome trials, such as the findings from EMPEROR-Preserved, he said, and collectively the recent findings from these studies of SGLT2 inhibitors in patients with HFpEF identify drugs in this class as a “new treatment option” for patients with a disorder that until now had no treatment with unequivocally proven efficacy and safety.
 

‘Impressive and unprecedented’ findings

The findings are “really impressive and unprecedented,” said Milton Packer, MD, a cardiologist at Baylor University Medical Center in Dallas who was not involved in the study. “This is the largest KCCQ benefit ever seen in either patients with HFpEF or in patients with heart failure with reduced ejection fraction,” said Dr. Packer, one of the investigators who led the EMPEROR-Preserved trial.

MDedge News

PRESERVED-HF randomized 324 patients diagnosed with heart failure and with a left ventricular ejection fraction of 45% or higher at any of 26 U.S. centers, with 304 patients completing the planned final analysis after 12 weeks on treatment. Patients could be in New York Heart Association (NYHA) functional class II-IV, they had to have a baseline N-terminal pro-brain natriuretic peptide (NT-proBNP) level of at least 225 pg/mL (or higher if they also had atrial fibrillation), and they required at least one of three markers of established heart failure: recent hospitalization for heart failure or an urgent outpatient visit that required treatment with an IV diuretic, elevated filling pressure measured by left or right catheterization, or structural heart disease detected by echocardiography.

The average age of the enrolled patients was 70 years, and they had been diagnosed with heart failure for about 3 years; 57% were women, 30% were African American, and their median body mass index was 35 kg/m². Roughly 42% had NYHA class III or IV disease, 56% had type 2 diabetes, their median estimated glomerular filtration rate was about 55 mL/min per 1.73m², their median KCCQ-CS score at baseline was about 62, and their average 6-minute walk distance was 244 m.

These and other features of the enrolled population define a distinctly U.S. patient population, stressed Dr. Kosiborod, professor of medicine at the University of Missouri–Kansas City.

“The patients we enrolled are the patients we see in U.S. clinical practice,” he said in an interview. Importantly, the patient profile of a median BMI of 35 kg/m², a median KCCQ-CS score of 62 – “quite low,” noted Dr. Kosiborod – and having more than 40% of patients in NYHA functional class III defines a study population with a substantially greater burden of obesity, symptoms, and functional impairment compared with those enrolled in prior trials involving patients with HFpEF such as EMPEROR-Preserved.
 

Results complement findings from larger trials

PRESERVED-HF was an investigator-initiated study designed to inform clinical practice, not as a pivotal trial like EMPEROR-Preserved, which aims to gather evidence to support a new indication for regulatory approval. (On Sept. 9, 2021, the Food and Drug Administration granted empagliflozin “breakthrough therapy” status for treating HFpEF based on the EMPEROR-Preserved results, which will fast-track the agency’s decision on this indication.)

Dr. Kosiborod noted that he and his associates designed PRESERVED-HF with adequate patient numbers to power a statistically valid assessment of effect on KCCQ-CS score. While the new findings will not by themselves lead to a new indication for dapagliflozin to treat patients with HFpEF, they will potentially complement the pending results of another trial, DELIVER, by showing efficacy and safety in a uniquely U.S. patient population. DELIVER is a pivotal, global trial of dapagliflozin in more than 6,000 patients with HFpEF that’s on track to report findings in 2022.

Dr. Kosiborod also stressed that dapagliflozin has U.S.-approved indications for treating patients with type 2 diabetes, and for patients with chronic kidney disease, and that a majority of patients enrolled in PRESERVED-HF had one or both of these conditions. That makes the new findings especially compelling for patients with either type 2 diabetes or chronic kidney disease and HFpEF who are not already receiving an SGLT2 inhibitor.

Other findings that he reported showed a range of benefits consistent with the primary endpoint, including the KCCQ overall summary score, which also showed a significant 4.5-point average increase over placebo after 12 weeks. Analysis by the percentage of patients achieving at least a 5-point improvement in the KCCQ clinical summary score (the threshold for a clinically meaningful improvement) showed that about 45% of patients treated with dapagliflozin reached this mark compared with roughly 35% of patients in the placebo arm, indicating a number needed to treat of nine to have one additional patient achieve this threshold after 12 weeks. Average improvement in 6-minute walk distance was about 20 m with dapagliflozin compared with placebo.

No heterogeneity of effect by baseline ejection fraction.

Subgroup analyses showed no heterogeneity of response across 12 different ways of subdividing the study population, including age, sex, race, diabetes status, and BMI. The median left ventricular ejection fraction among enrolled patients was 60%, and the findings showed identical KCCQ improvements among patients with ejection fractions less than the median and those with an ejection fraction above the median.

This last finding was especially relevant because the EMPEROR-Preserved results showed a possible signal of heterogeneity by ejection fraction and an attenuated effect among patients with HFpEF and an ejection fraction above the 60%-65% range, although the certainty of this finding is currently controversial.

The impact of empagliflozin on KCCQ clinical summary score in EMPEROR-Preserved showed an average incremental improvement of 1.32 points compared with placebo, a significant difference, but more modest than the increment from dapagliflozin treatment seen in PRESERVED-HF. Dr. Kosiborod hypothesized that this difference might be mostly because of the different patient populations enrolled in the two studies.

Dr. Kosiborod noted that a report on the PRESERVED-HF results will soon appear in Nature Medicine.

PRESERVED-HF was funded by AstraZeneca, which markets dapagliflozin (Farxiga), but the trials’ design and conduct were independent of this funding source. Dr. Kosiborod has been a consultant to AstraZeneca and numerous other companies, and he has received research funding from AstraZeneca and Boehringer Ingelheim. Dr. Packer has had financial relationships with AstraZeneca and numerous other companies.

[email protected]

The 30-day mortality rate was significantly lower among hospitalized patients treated by full-time clinicians, compared with those treated by part-time clinicians, in a new study.

The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.

The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.

Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).

The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.

Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).

The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
 

Possible explanations for worse patient outcomes

“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.

The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.

The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.

However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.

Clinician work issues have renewed relevance

“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.

“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.

Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.

“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.

“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.

“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.

The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.

The 30-day mortality rate was significantly lower among hospitalized patients treated by full-time clinicians, compared with those treated by part-time clinicians, in a new study.

The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.

The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.

Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).

The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.

Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).

The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
 

Possible explanations for worse patient outcomes

“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.

The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.

The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.

However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.

Clinician work issues have renewed relevance

“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.

“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.

Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.

“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.

“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.

“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.

The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.

The 30-day mortality rate was significantly lower among hospitalized patients treated by full-time clinicians, compared with those treated by part-time clinicians, in a new study.

The number of physicians working part time in the United States has increased by nearly 11% since 1993, and as more physicians opt for part-time work, quality of care deserves further study, the investigators wrote in JAMA Internal Medicine. Most studies comparing outcomes for patients treated by full-timers and part-timers have focused on outpatient care settings, where mortality is low and the potential for confounding is high, according to the study authors Hirotaka Kato, PhD, of Keio University in Tokyo, and colleagues. The new study, in contrast, is based on data from nearly 400,000 hospitalizations.

The researchers conducted a cross-sectional analysis on a 20% random sample of Medicare patients aged 65 years and older who were treated by a hospitalist for an emergency medical condition between 2011 and 2016. They examined associations between the number of days per year worked by hospitalists and they 30-day mortality rates among the patients they treated. The researchers analyzed a total of 392,797 hospitalizations in which patients were treated by 19,170 hospitalists. The mean age of the hospitalists was 41 years; 39% were female. Clinician work days were divided into quartiles.

Overall, the 30-day mortality was significantly higher among patients treated by clinicians in the bottom quartile with the fewest number of days worked, compared with those treated by clinicians in the top quartile with the most days worked (10.5% vs. 9.6%). The rates were similar in the second and third quartiles (10.0% and 9.5%).

The average number of days worked clinically per year was 57.6 in the lowest quartile versus 163.3 in the highest quartile, a 65% difference. No significant associations were noted between days worked and patient outcomes with regard to physician age, gender, or hospital teaching status.

Hospital 30-day readmission rates were examined as a secondary outcome, but there was no association between patient readmission and the number of days worked by the clinician. The adjusted 30-day readmission rate for clinicians in the bottom quartile of days worked, compared with those in the top quartile, was 15.3% versus 15.2% (P = .61).

The researchers found no difference in patients’ severity of illness (defined by expected mortality) or reason for admission between physicians in the different quartiles of days worked. They eliminated confounding from hospital-level differences by comparing outcomes of patients between physicians in the same hospital.
 

Possible explanations for worse patient outcomes

“As the number of physicians who engage in part-time clinical work continues to increase, these findings should lead to careful consideration by health systems to reevaluate preventive measures to address potential unintended patient harm,” the researchers wrote.

The researchers proposed several reasons for the association between fewer clinical work days and worse patient outcomes. First, physicians putting in less clinical time may be less updated on the latest guidelines, their skills may decline with less frequent patient care, and they may be less familiar with the nurses, medical assistants, and support staff, which may contribute to poor teamwork. The researchers also stated that some part-time physicians may need to balance nonclinical responsibilities, such as research or administrative tasks, concurrently with inpatient care. “It is also possible that physicians with less clinical knowledge or skills select to become part-time physicians, whereas physicians with higher clinical performance decide to work full time,” they noted.

The study findings were limited by several factors including the observational design and potential for unmeasured confounding variables, and the results may not generalize to younger patients or surgical patients, the researchers noted. Also, the study did not include care by hospitalists that was not billed, days in which clinicians treated non-Medicare patients or patients not part of the Medicare sample, or information about the reasons for clinicians’ part-time work.

However, the results were strengthened by the large sample size, and suggest the need for better institutional support to maintain the clinical performance of physicians who may be balancing a range of obligations, they concluded.

Clinician work issues have renewed relevance

“The data in this paper are from 2016 and earlier, but it is possibly event more relevant today than then,” Eileen Barrett, MD, of the University of New Mexico, Albuquerque, said in an interview. “The pandemic has exacerbated stressors being experienced by physicians and other health care workers, including higher clinical workloads and burnout, and spotlighted gendered effects on women in the workforce, which is likely to drive more physicians to part-time work.

“Reporting these findings now is so important so they can contribute to a shared mental model of the challenges physicians and hospitals face as we seek solutions to deliver high-quality and high-value care with an engaged, professionally fulfilled workforce,” she emphasized.

Dr. Barrett said she was surprised that the study did not show differences in readmission rates depending on the number of shifts worked, and also that the results were not different when considering expected mortality.

“However unpopular it may be to say so, physicians and administrators should assume these results apply to their practice unless they have examined their own data and know it does not,” Dr. Barrett said. “With that in mind, hospitals, administrators, and regulatory bodies have an urgent need to examine and reduce the forces driving physicians to part-time clinical work. Some of these factors include the absence of childcare, excessive paperwork, burnout, administrative duties, and valued experiences such as teaching, leadership, and research that keep clinicians from the bedside.

“Additionally, steps should be taken to reduce the administrative complexity that makes providing the best care to patients difficult and requires hospitalists to create ‘workarounds,’ because those who work fewer clinical hours may not know how to do these, nor how to advocate for their patients,” Dr. Barrett emphasized.

“Additional research is needed to determine how mortality varies by number of clinical shifts for pediatric and obstetric patients who are infrequently covered by Medicare, also how the pandemic and increasing administrative complexity since the time the data was obtained affect patient care,” Dr. Barrett noted.

The study was supported by a grant from the Japan Society for the Promotion of Science to lead author Dr. Kato, who had no financial conflicts to disclose. Dr. Barrett, who serves on the editorial advisory board of Internal Medicine News, had no financial conflicts.

A new study may help doctors assess the long-term risk for major bleeding if anticoagulation for unprovoked venous thromboembolisms (VTE) is continued beyond 3-6 months.

The meta-analysis of data from 27 studies with 17,202 patients was published in the Annals of Internal Medicine. According to two of the paper’s coauthors, Faizan Khan, MSc, and Marc A. Rodger, MD, it “provides best available estimates of long-term bleeding risk with different anticoagulants in patients with unprovoked VTE,” including subgroups at increased risk.

Patients at increased risk for major bleeding include those who are older; those using antiplatelet therapy; and patients with kidney disease, a history of bleeding, or anemia, noted the coauthors, who work for the Ottawa Hospital Research Institute.

The researchers focused on randomized controlled trials (RCTs) and prospective cohort studies that reported major bleeding among patients with a first unprovoked or weakly provoked VTE who received oral anticoagulation for at least 6 months beyond an initial anticoagulant treatment course of at least 3 months.

The investigators analyzed data from 14 RCTs and 13 cohort studies. In all, 9,982 patients received a vitamin K antagonist (VKA), and 7,220 received a direct oral anticoagulant (DOAC).

The incidence of major bleeding per 100 person-years was 1.7 events with VKAs, compared with 1.1 events with DOACs. The researchers estimated that the 5-year cumulative incidence of major bleeding with VKAs was 6.3%. The available data for DOACs were insufficient to estimate the incidence of major bleeding beyond 1 year.

“This information can help clinicians counsel patients and inform shared decision-making about extended therapy,” the researchers said.

Risks of serious bleeding ‘not trivial’

Margaret Fang, MD, with the University of California, San Francisco, agreed that the study can help clinicians and patients weigh the risks of extended anticoagulation for common types of VTE.

The study also “highlights that the risks of serious bleeding are not trivial” and points out gaps in the literature regarding the long-term use of DOACs for extended VTE therapy, Dr. Fang said.

Better ways to predict which patients will develop bleeding on anticoagulants are needed, Dr. Fang added. “It will also be important to establish which of the various therapies for preventing recurrent VTE – full dose versus lowered dose, or even aspirin – has the best balance of safety and efficacy,” she said.

‘Standardized approach’ for identifying high-risk patients lacking

Clinical practice guidelines recommend indefinite anticoagulation for an unprovoked VTE, except when patients are at high risk of bleeding, the authors noted. But clinicians lack a “standardized approach to identify patients at high risk of bleeding,” Mr. Khan and Dr. Rodger said. “Evidence from randomized trials on net long-term benefit of extended therapy is limited, and current guideline recommendations are largely based on expert consensus opinion. Major bleeding events are two to three times more likely to be fatal than recurrent VTE events, so extended therapy is not always associated with a net mortality benefit, particularly in patients at low risk of recurrent VTE or high risk of bleeding.”

The analysis indicates that there is “a clinically meaningful difference in long-term risk for anticoagulant-related major bleeding among patients with a first unprovoked VTE stratified according to presence or absence of the following risk factors: age older than 65 years, creatinine clearance less than 50 mL/min, history of bleeding, concomitant use of antiplatelet therapy, and hemoglobin level less than 100 g/L,” the authors said.

For example, the researchers found that the incidence of major bleeding was higher among those older than 65 years, compared with younger patients (incidence rate ratio, 1.84 with VKAs and 2.92 with DOACs), and among those with creatinine clearance less than 50 mL/min (IRR, 2.83 with VKAs and 3.71 with DOACs).

The case-fatality rate of major bleeding was 8.3% with VKAs and 9.7% with DOACs.

The study received funding from the Canadian Institutes of Health Research. Some of the coauthors are employees of or have financial ties to pharmaceutical companies. Mr. Khan, Dr. Rodger, and Dr. Fang had no relevant disclosures.

[email protected]

A new study may help doctors assess the long-term risk for major bleeding if anticoagulation for unprovoked venous thromboembolisms (VTE) is continued beyond 3-6 months.

The meta-analysis of data from 27 studies with 17,202 patients was published in the Annals of Internal Medicine. According to two of the paper’s coauthors, Faizan Khan, MSc, and Marc A. Rodger, MD, it “provides best available estimates of long-term bleeding risk with different anticoagulants in patients with unprovoked VTE,” including subgroups at increased risk.

Patients at increased risk for major bleeding include those who are older; those using antiplatelet therapy; and patients with kidney disease, a history of bleeding, or anemia, noted the coauthors, who work for the Ottawa Hospital Research Institute.

The researchers focused on randomized controlled trials (RCTs) and prospective cohort studies that reported major bleeding among patients with a first unprovoked or weakly provoked VTE who received oral anticoagulation for at least 6 months beyond an initial anticoagulant treatment course of at least 3 months.

The investigators analyzed data from 14 RCTs and 13 cohort studies. In all, 9,982 patients received a vitamin K antagonist (VKA), and 7,220 received a direct oral anticoagulant (DOAC).

The incidence of major bleeding per 100 person-years was 1.7 events with VKAs, compared with 1.1 events with DOACs. The researchers estimated that the 5-year cumulative incidence of major bleeding with VKAs was 6.3%. The available data for DOACs were insufficient to estimate the incidence of major bleeding beyond 1 year.

“This information can help clinicians counsel patients and inform shared decision-making about extended therapy,” the researchers said.

Risks of serious bleeding ‘not trivial’

Margaret Fang, MD, with the University of California, San Francisco, agreed that the study can help clinicians and patients weigh the risks of extended anticoagulation for common types of VTE.

The study also “highlights that the risks of serious bleeding are not trivial” and points out gaps in the literature regarding the long-term use of DOACs for extended VTE therapy, Dr. Fang said.

Better ways to predict which patients will develop bleeding on anticoagulants are needed, Dr. Fang added. “It will also be important to establish which of the various therapies for preventing recurrent VTE – full dose versus lowered dose, or even aspirin – has the best balance of safety and efficacy,” she said.

‘Standardized approach’ for identifying high-risk patients lacking

Clinical practice guidelines recommend indefinite anticoagulation for an unprovoked VTE, except when patients are at high risk of bleeding, the authors noted. But clinicians lack a “standardized approach to identify patients at high risk of bleeding,” Mr. Khan and Dr. Rodger said. “Evidence from randomized trials on net long-term benefit of extended therapy is limited, and current guideline recommendations are largely based on expert consensus opinion. Major bleeding events are two to three times more likely to be fatal than recurrent VTE events, so extended therapy is not always associated with a net mortality benefit, particularly in patients at low risk of recurrent VTE or high risk of bleeding.”

The analysis indicates that there is “a clinically meaningful difference in long-term risk for anticoagulant-related major bleeding among patients with a first unprovoked VTE stratified according to presence or absence of the following risk factors: age older than 65 years, creatinine clearance less than 50 mL/min, history of bleeding, concomitant use of antiplatelet therapy, and hemoglobin level less than 100 g/L,” the authors said.

For example, the researchers found that the incidence of major bleeding was higher among those older than 65 years, compared with younger patients (incidence rate ratio, 1.84 with VKAs and 2.92 with DOACs), and among those with creatinine clearance less than 50 mL/min (IRR, 2.83 with VKAs and 3.71 with DOACs).

The case-fatality rate of major bleeding was 8.3% with VKAs and 9.7% with DOACs.

The study received funding from the Canadian Institutes of Health Research. Some of the coauthors are employees of or have financial ties to pharmaceutical companies. Mr. Khan, Dr. Rodger, and Dr. Fang had no relevant disclosures.

[email protected]

A new study may help doctors assess the long-term risk for major bleeding if anticoagulation for unprovoked venous thromboembolisms (VTE) is continued beyond 3-6 months.

The meta-analysis of data from 27 studies with 17,202 patients was published in the Annals of Internal Medicine. According to two of the paper’s coauthors, Faizan Khan, MSc, and Marc A. Rodger, MD, it “provides best available estimates of long-term bleeding risk with different anticoagulants in patients with unprovoked VTE,” including subgroups at increased risk.

Patients at increased risk for major bleeding include those who are older; those using antiplatelet therapy; and patients with kidney disease, a history of bleeding, or anemia, noted the coauthors, who work for the Ottawa Hospital Research Institute.

The researchers focused on randomized controlled trials (RCTs) and prospective cohort studies that reported major bleeding among patients with a first unprovoked or weakly provoked VTE who received oral anticoagulation for at least 6 months beyond an initial anticoagulant treatment course of at least 3 months.

The investigators analyzed data from 14 RCTs and 13 cohort studies. In all, 9,982 patients received a vitamin K antagonist (VKA), and 7,220 received a direct oral anticoagulant (DOAC).

The incidence of major bleeding per 100 person-years was 1.7 events with VKAs, compared with 1.1 events with DOACs. The researchers estimated that the 5-year cumulative incidence of major bleeding with VKAs was 6.3%. The available data for DOACs were insufficient to estimate the incidence of major bleeding beyond 1 year.

“This information can help clinicians counsel patients and inform shared decision-making about extended therapy,” the researchers said.

Risks of serious bleeding ‘not trivial’

Margaret Fang, MD, with the University of California, San Francisco, agreed that the study can help clinicians and patients weigh the risks of extended anticoagulation for common types of VTE.

The study also “highlights that the risks of serious bleeding are not trivial” and points out gaps in the literature regarding the long-term use of DOACs for extended VTE therapy, Dr. Fang said.

Better ways to predict which patients will develop bleeding on anticoagulants are needed, Dr. Fang added. “It will also be important to establish which of the various therapies for preventing recurrent VTE – full dose versus lowered dose, or even aspirin – has the best balance of safety and efficacy,” she said.

‘Standardized approach’ for identifying high-risk patients lacking

Clinical practice guidelines recommend indefinite anticoagulation for an unprovoked VTE, except when patients are at high risk of bleeding, the authors noted. But clinicians lack a “standardized approach to identify patients at high risk of bleeding,” Mr. Khan and Dr. Rodger said. “Evidence from randomized trials on net long-term benefit of extended therapy is limited, and current guideline recommendations are largely based on expert consensus opinion. Major bleeding events are two to three times more likely to be fatal than recurrent VTE events, so extended therapy is not always associated with a net mortality benefit, particularly in patients at low risk of recurrent VTE or high risk of bleeding.”

The analysis indicates that there is “a clinically meaningful difference in long-term risk for anticoagulant-related major bleeding among patients with a first unprovoked VTE stratified according to presence or absence of the following risk factors: age older than 65 years, creatinine clearance less than 50 mL/min, history of bleeding, concomitant use of antiplatelet therapy, and hemoglobin level less than 100 g/L,” the authors said.

For example, the researchers found that the incidence of major bleeding was higher among those older than 65 years, compared with younger patients (incidence rate ratio, 1.84 with VKAs and 2.92 with DOACs), and among those with creatinine clearance less than 50 mL/min (IRR, 2.83 with VKAs and 3.71 with DOACs).

The case-fatality rate of major bleeding was 8.3% with VKAs and 9.7% with DOACs.

The study received funding from the Canadian Institutes of Health Research. Some of the coauthors are employees of or have financial ties to pharmaceutical companies. Mr. Khan, Dr. Rodger, and Dr. Fang had no relevant disclosures.

[email protected]

At 18 months into the COVID-19 pandemic, many of the direct and indirect effects of SARS-CoV-2 on people with diabetes have become clearer, but knowledge gaps remain, say epidemiologists.

“COVID-19 has had a devastating effect on the population with diabetes, and conversely, the high prevalence of diabetes and uncontrolled diabetes has exacerbated the problem,” Edward W. Gregg, PhD, Imperial College London, lead author of a new literature review, told this news organization.

“As it becomes clear that the COVID-19 pandemic will be with us in different forms for the foreseeable future, the emphasis for people with diabetes needs to be continued primary care, glycemic management, and vaccination to reduce the long-term impact of COVID-19 in this population,” he added.

In data, mostly from case series, the review shows that more than one-third of people hospitalized with COVID-19 have diabetes. It is published in the September issue of Diabetes Care.

People with diabetes are more than three times as likely to be hospitalized for COVID-19 than those without diabetes, even after adjustment for age, sex, and other underlying conditions. Diabetes also accounts for 30%-40% of severe COVID-19 cases and deaths. Among those with diabetes hospitalized for COVID-19, 21%-43% require intensive care, and the case fatality rate is about 25%.

In one of the few multivariate analyses that examined type 1 and type 2 diabetes separately, conducted in the U.K., the odds of in-hospital COVID-19–related deaths, compared with people without diabetes, were almost three times higher (odds ratio, 2.9) for individuals with type 1 diabetes and almost twice as high (OR, 1.8) for those with type 2, after adjustment for comorbidities.

The causes of death appear to be a combination of factors specific to the SARS-CoV-2 infection and to diabetes-related factors, Dr. Gregg said in an interview.

“Much of the increased risk is due to the fact that people with diabetes have more comorbid factors, but there are many other mechanisms that appear to further increase risk, including the inflammatory and immune responses of people with diabetes, and hyperglycemia appears to have an exacerbating effect by itself.”
 

Elevated glucose is clear risk factor for COVID-19 severity

Elevated A1c was identified among several other overall predictors of poor COVID-19 outcomes, including obesity as well as comorbid kidney and cardiovascular disease.

High blood glucose levels at the time of admission in people with previously diagnosed or undiagnosed diabetes emerged as a clear predictor of worse outcomes. For example, among 605 people hospitalized with COVID-19 in China, those with fasting plasma glucose 6.1-6.9 mmol/L (110-125 mg/dL) and ≥7 mmol/L (126 mg/dL) had odds ratios of poor outcomes within 28 days of 2.6 and 4.0 compared with FPG <6.1 mmol/L (110 mg/dL).

Population-based studies in the U.K. found that A1c levels measured months before COVID-19 hospitalization were associated with risk for intensive care unit admission and/or death, particularly among those with type 1 diabetes. Overall, the death rate was 36% higher for those with A1c of 9%-9.9% versus 6.5%-7%.

Despite the link between high A1c and death, there is as yet no clear evidence that normalizing blood glucose levels minimizes COVID-19 severity, Dr. Gregg said.

“There are data that suggest poor glycemic control is associated with higher risk of poor outcomes. This is indirect evidence that managing blood sugar will help, but more direct evidence is needed.”
 

Evidence gaps identified

Dr. Gregg and co-authors Marisa Sophiea, PhD, MSc, and Misghina Weldegiorgis, PhD, BSc, also from Imperial College London, identify three areas in which more data are needed.

First, more information is needed to determine whether exposure, infection, and hospitalization risks differ by diabetes status and how those factors affect outcomes. The same studies would also be important to identify how factors such as behavior, masking, and lockdown policies, risk factor control, and household/community environments affect risk in people with diabetes.

Second, studies are needed to better understand indirect effects of the pandemic, such as care and management factors. Some of these, such as the advent of telehealth, may turn out to be beneficial in the long run, they note.

Finally, the pandemic has “brought a wealth of natural experiments,” such as how vaccination programs and other interventions are affecting people with diabetes specifically. Finally, population studies are needed in many parts of the world beyond the U.S. and the U.K., where most of that work has been done thus far.

“Many of the most important unanswered questions lie in the potential indirect and long-term impact of the pandemic that require population-based studies,” Dr. Gregg said. “Most of our knowledge so far is from case series, which only assess patients from the time of hospitalization.”

Indeed, very little data are available for people with diabetes who get COVID-19 but are not hospitalized, so it’s not known whether they have a longer duration of illness or are at greater risk for “long COVID” than those without diabetes who experience COVID-19 at home.

“I have not seen published data on this yet, and it’s an important unanswered question,” Dr. Gregg said.  

The authors have disclosed no relevant financial relationships.

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

At 18 months into the COVID-19 pandemic, many of the direct and indirect effects of SARS-CoV-2 on people with diabetes have become clearer, but knowledge gaps remain, say epidemiologists.

“COVID-19 has had a devastating effect on the population with diabetes, and conversely, the high prevalence of diabetes and uncontrolled diabetes has exacerbated the problem,” Edward W. Gregg, PhD, Imperial College London, lead author of a new literature review, told this news organization.

“As it becomes clear that the COVID-19 pandemic will be with us in different forms for the foreseeable future, the emphasis for people with diabetes needs to be continued primary care, glycemic management, and vaccination to reduce the long-term impact of COVID-19 in this population,” he added.

In data, mostly from case series, the review shows that more than one-third of people hospitalized with COVID-19 have diabetes. It is published in the September issue of Diabetes Care.

People with diabetes are more than three times as likely to be hospitalized for COVID-19 than those without diabetes, even after adjustment for age, sex, and other underlying conditions. Diabetes also accounts for 30%-40% of severe COVID-19 cases and deaths. Among those with diabetes hospitalized for COVID-19, 21%-43% require intensive care, and the case fatality rate is about 25%.

In one of the few multivariate analyses that examined type 1 and type 2 diabetes separately, conducted in the U.K., the odds of in-hospital COVID-19–related deaths, compared with people without diabetes, were almost three times higher (odds ratio, 2.9) for individuals with type 1 diabetes and almost twice as high (OR, 1.8) for those with type 2, after adjustment for comorbidities.

The causes of death appear to be a combination of factors specific to the SARS-CoV-2 infection and to diabetes-related factors, Dr. Gregg said in an interview.

“Much of the increased risk is due to the fact that people with diabetes have more comorbid factors, but there are many other mechanisms that appear to further increase risk, including the inflammatory and immune responses of people with diabetes, and hyperglycemia appears to have an exacerbating effect by itself.”
 

Elevated glucose is clear risk factor for COVID-19 severity

Elevated A1c was identified among several other overall predictors of poor COVID-19 outcomes, including obesity as well as comorbid kidney and cardiovascular disease.

High blood glucose levels at the time of admission in people with previously diagnosed or undiagnosed diabetes emerged as a clear predictor of worse outcomes. For example, among 605 people hospitalized with COVID-19 in China, those with fasting plasma glucose 6.1-6.9 mmol/L (110-125 mg/dL) and ≥7 mmol/L (126 mg/dL) had odds ratios of poor outcomes within 28 days of 2.6 and 4.0 compared with FPG <6.1 mmol/L (110 mg/dL).

Population-based studies in the U.K. found that A1c levels measured months before COVID-19 hospitalization were associated with risk for intensive care unit admission and/or death, particularly among those with type 1 diabetes. Overall, the death rate was 36% higher for those with A1c of 9%-9.9% versus 6.5%-7%.

Despite the link between high A1c and death, there is as yet no clear evidence that normalizing blood glucose levels minimizes COVID-19 severity, Dr. Gregg said.

“There are data that suggest poor glycemic control is associated with higher risk of poor outcomes. This is indirect evidence that managing blood sugar will help, but more direct evidence is needed.”
 

Evidence gaps identified

Dr. Gregg and co-authors Marisa Sophiea, PhD, MSc, and Misghina Weldegiorgis, PhD, BSc, also from Imperial College London, identify three areas in which more data are needed.

First, more information is needed to determine whether exposure, infection, and hospitalization risks differ by diabetes status and how those factors affect outcomes. The same studies would also be important to identify how factors such as behavior, masking, and lockdown policies, risk factor control, and household/community environments affect risk in people with diabetes.

Second, studies are needed to better understand indirect effects of the pandemic, such as care and management factors. Some of these, such as the advent of telehealth, may turn out to be beneficial in the long run, they note.

Finally, the pandemic has “brought a wealth of natural experiments,” such as how vaccination programs and other interventions are affecting people with diabetes specifically. Finally, population studies are needed in many parts of the world beyond the U.S. and the U.K., where most of that work has been done thus far.

“Many of the most important unanswered questions lie in the potential indirect and long-term impact of the pandemic that require population-based studies,” Dr. Gregg said. “Most of our knowledge so far is from case series, which only assess patients from the time of hospitalization.”

Indeed, very little data are available for people with diabetes who get COVID-19 but are not hospitalized, so it’s not known whether they have a longer duration of illness or are at greater risk for “long COVID” than those without diabetes who experience COVID-19 at home.

“I have not seen published data on this yet, and it’s an important unanswered question,” Dr. Gregg said.  

The authors have disclosed no relevant financial relationships.

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

At 18 months into the COVID-19 pandemic, many of the direct and indirect effects of SARS-CoV-2 on people with diabetes have become clearer, but knowledge gaps remain, say epidemiologists.

“COVID-19 has had a devastating effect on the population with diabetes, and conversely, the high prevalence of diabetes and uncontrolled diabetes has exacerbated the problem,” Edward W. Gregg, PhD, Imperial College London, lead author of a new literature review, told this news organization.

“As it becomes clear that the COVID-19 pandemic will be with us in different forms for the foreseeable future, the emphasis for people with diabetes needs to be continued primary care, glycemic management, and vaccination to reduce the long-term impact of COVID-19 in this population,” he added.

In data, mostly from case series, the review shows that more than one-third of people hospitalized with COVID-19 have diabetes. It is published in the September issue of Diabetes Care.

People with diabetes are more than three times as likely to be hospitalized for COVID-19 than those without diabetes, even after adjustment for age, sex, and other underlying conditions. Diabetes also accounts for 30%-40% of severe COVID-19 cases and deaths. Among those with diabetes hospitalized for COVID-19, 21%-43% require intensive care, and the case fatality rate is about 25%.

In one of the few multivariate analyses that examined type 1 and type 2 diabetes separately, conducted in the U.K., the odds of in-hospital COVID-19–related deaths, compared with people without diabetes, were almost three times higher (odds ratio, 2.9) for individuals with type 1 diabetes and almost twice as high (OR, 1.8) for those with type 2, after adjustment for comorbidities.

The causes of death appear to be a combination of factors specific to the SARS-CoV-2 infection and to diabetes-related factors, Dr. Gregg said in an interview.

“Much of the increased risk is due to the fact that people with diabetes have more comorbid factors, but there are many other mechanisms that appear to further increase risk, including the inflammatory and immune responses of people with diabetes, and hyperglycemia appears to have an exacerbating effect by itself.”
 

Elevated glucose is clear risk factor for COVID-19 severity

Elevated A1c was identified among several other overall predictors of poor COVID-19 outcomes, including obesity as well as comorbid kidney and cardiovascular disease.

High blood glucose levels at the time of admission in people with previously diagnosed or undiagnosed diabetes emerged as a clear predictor of worse outcomes. For example, among 605 people hospitalized with COVID-19 in China, those with fasting plasma glucose 6.1-6.9 mmol/L (110-125 mg/dL) and ≥7 mmol/L (126 mg/dL) had odds ratios of poor outcomes within 28 days of 2.6 and 4.0 compared with FPG <6.1 mmol/L (110 mg/dL).

Population-based studies in the U.K. found that A1c levels measured months before COVID-19 hospitalization were associated with risk for intensive care unit admission and/or death, particularly among those with type 1 diabetes. Overall, the death rate was 36% higher for those with A1c of 9%-9.9% versus 6.5%-7%.

Despite the link between high A1c and death, there is as yet no clear evidence that normalizing blood glucose levels minimizes COVID-19 severity, Dr. Gregg said.

“There are data that suggest poor glycemic control is associated with higher risk of poor outcomes. This is indirect evidence that managing blood sugar will help, but more direct evidence is needed.”
 

Evidence gaps identified

Dr. Gregg and co-authors Marisa Sophiea, PhD, MSc, and Misghina Weldegiorgis, PhD, BSc, also from Imperial College London, identify three areas in which more data are needed.

First, more information is needed to determine whether exposure, infection, and hospitalization risks differ by diabetes status and how those factors affect outcomes. The same studies would also be important to identify how factors such as behavior, masking, and lockdown policies, risk factor control, and household/community environments affect risk in people with diabetes.

Second, studies are needed to better understand indirect effects of the pandemic, such as care and management factors. Some of these, such as the advent of telehealth, may turn out to be beneficial in the long run, they note.

Finally, the pandemic has “brought a wealth of natural experiments,” such as how vaccination programs and other interventions are affecting people with diabetes specifically. Finally, population studies are needed in many parts of the world beyond the U.S. and the U.K., where most of that work has been done thus far.

“Many of the most important unanswered questions lie in the potential indirect and long-term impact of the pandemic that require population-based studies,” Dr. Gregg said. “Most of our knowledge so far is from case series, which only assess patients from the time of hospitalization.”

Indeed, very little data are available for people with diabetes who get COVID-19 but are not hospitalized, so it’s not known whether they have a longer duration of illness or are at greater risk for “long COVID” than those without diabetes who experience COVID-19 at home.

“I have not seen published data on this yet, and it’s an important unanswered question,” Dr. Gregg said.  

The authors have disclosed no relevant financial relationships.

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

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

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

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

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

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

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

Friday, July 16, 2021, marked the end of a week on duty in the hospital, and it was time to celebrate with a nice dinner out with my wife, since COVID-19 masking requirements had been lifted in our part of California for people like us who were fully vaccinated.

We always loved a nice dinner out and missed it so much during the pandemic. Unlike 6 months earlier, when I was administering dexamethasone, remdesivir, and high-flow oxygen to half of the patients on my panel, not a single patient was diagnosed with COVID-19, much less treated for it, during the previous week. We were doing so well in Sacramento that the hospital visitation rules had been relaxed and vaccinated patients were not required to have a negative COVID-19 test prior to hospital admission.

Saturday was game 5 of the NBA finals, so we had two couples join us for the game at our house; no masks because we were all vaccinated. On Sunday, we visited our neighbors who had just had a new baby boy and made them the gift of some baby books. The new mom had struggled with the decision of whether to get vaccinated during her pregnancy, but eventually decided to complete the vaccination cycle prior to delivery. She was fully immune at the time of the baby’s birth, wisely wanting the baby to have passive immunity through her. We kept an appropriate distance, and never touched baby or mom, but since masking guidelines had been lifted for the vaccinated,we didn’t bother with them.

On Monday, I felt a little something in my nose but still pursued my usual workout. Interestingly, my performance wasn’t up to my usual standards. There was a meeting that evening that I had to prepare for, when all of a sudden I felt very fatigued. I lay down and slept for a good hour, which disrupted my preparation. I warned the participants that I was feeling a little under the weather, but they wanted to proceed. At this point, I decided it was time to start wearing a mask again.

More meetings on Tuesday morning, but I made sure that I was fully masked. That little thing in my nose had blown up into a full-scale rhinitis, requiring Kleenex and decongestants. Plus, the fatigue was hitting me very hard. “Dang!” I thought. “I haven’t had a cold since 2019. All those COVID-19 precautions not only worked against COVID-19 (which I never got) but also worked against the common cold, which I had now.”

I finished up my meetings and laid down for a good hour and a half. As the father of two, I had plenty of experience with the common cold, and I knew that plenty of rest and hydration was the key to kicking this thing. Besides, my 55th birthday was coming up, and I wanted to make sure I was fully recovered for the festivities my wife was planning for me. Nonetheless, I scheduled myself for a COVID-19 test. I knew this couldn’t be COVID-19 because I was fully vaccinated, but it was hitting me so hard. It had to be a virus that my body had never seen before; maybe the human metapneumovirus. That was my line of reasoning, anyway.

Wednesday was another day on the couch because of continued severe fatigue and myalgias. I figured another good day of rest would help me kick this cold in time for my birthday celebration. Then the COVID-19 results came back positive. “How could this be? I was vaccinated?!” Admittedly I had been more relaxed with masking, per the CDC and county guidelines, but I always wore a mask when I was seeing patients in the hospital. Yeah, I wasn’t wearing an N95 anymore, and I had given up my goggles months ago, but we just weren’t seeing much COVID-19 anymore, so a plain surgical mask was all that was required and seemed sufficient. I had been reading articles about the new Delta variant that was becoming dominant across the country, and reports were that the vaccine was still effective against the Delta variant. However, I was experiencing the COVID-19 vaccine breakthrough infection because of the remarkable talent the Delta variant has for replicating and producing high levels of viremia.

My first thoughts were for my family, of course. As my illness unfolded, I had kept checking in with them to see if they had any of these “cold” symptoms I had; none of them did. When my test came back positive, we all went into quarantine immediately and they went to get tested; all of them were negative. Next, I contacted the people I had been meeting with that week and warned them that I had tested positive. Despite my mask, and their fully vaccinated status, they needed to get tested. They did, and they were negative. I realized that I was probably contagious, though asymptomatic, on Saturday night when we had friends over to watch the NBA finals. Yeah, everyone was vaccinated, but if I could get sick from this new Delta variant, they could too. The public health department sent me a survey when they found out about my positive test, and they pinpointed Saturday as the day I started to be contagious. I told my friends that I was probably contagious when they were over for the game, and that they should get tested. They did, and everyone came back negative for COVID-19.

Wait a minute; what about Sunday night? The newborn baby and the sleep-deprived mom. Oh no! I was contagious then as well. We kept our distance, and were only there for about 10 minutes, but if I felt bad from COVID-19, I felt worse for exposing them to the virus.

I am no Anthony Fauci, and I am grateful that we have had levelheaded scientists like him to lead us through this terrible experience. I am sure there will be many papers written about COVID-19 breakthrough infections in the future, but I have many thoughts from this experience. First, my practice of wearing an N95 and goggles for all patients, not just COVID-19 patients, during the height of the pandemic was effective. Prior to getting vaccinated, my antibody tests were negative, so I never contracted the illness when I stuck to this regimen. Second, we all want to get back to something that looks like “normal,” but because there are large unvaccinated populations in the community the virus will continue to propagate and evolve, and hence everyone is at risk. While the guidelines said it was okay to ease up on our restrictions, because so many people are not vaccinated, we all must continue to keep our guard up. Third, would a booster shot have saved me from this fate? Because I was on the front lines of the pandemic as a hospitalist, I was also among the first members of my community to get vaccinated, receiving my second shot on Jan. 14, 2021. My wife was not in any risk group, was not on any vaccine priority list, and didn’t complete the series until early April. If I was going to give the infection to anyone, it would have been her. Not only did she never develop symptoms, but she also repeatedly tested negative, as did everyone else that I was in contact with when I was most contagious. The thing that was different about me from everyone else was that I had gotten the vaccine well ahead of them. Had my immunity waned over the months?

The good news is that, while I wouldn’t characterize what I had as “mild,” it certainly wasn’t protracted. Yes, I was a good boy, and did the basics: stay hydrated and get plenty of sleep. I was really bad off for about 3 days, and I hate to think what it would have been like if I had coexisting conditions such as asthma or diabetes. We all know what a bad case of COVID-19 looks like in the unvaccinated, with months in the hospital, intravenous infusions, and high-flow oxygen for the lucky ones. I had nothing remotely like that. The dominant symptom I had was incapacitating fatigue and significant body aches. The second night I had some major chills, sweats, and wild dreams. From a respiratory standpoint, I had bad rhinitis and a wicked cough for a while that tapered off. My oxygen saturations dropped into the mid 90’s, but never below 94%. But if I had been ten times sicker, I doubt I would have survived. I was on quarantine for 10 days but I highly doubt I was at all contagious by day 5, based on my symptoms and the fact that nobody around me turned COVID positive with repeat testing.

I was so relieved that none of my contacts when I was most contagious turned positive for COVID-19. Though not scientific, I find that illustrative. While I should have canceled my meetings on Monday and Tuesday, everybody knew I had a “cold” and nobody wanted to cancel. Nobody thought it possible that I had COVID-19, especially me. The Delta variant is notorious for generating high levels of viremia, yet I didn’t get anybody sick, not even my wife. That suggests to me that, while the vaccine doesn’t eliminate the risk of infection – which we already knew – it probably significantly reduced my infectivity. For that I am very grateful. Now that I can say that I had the COVID-19 experience, I can tell you it feels terrible. But I would have felt much worse if I had gotten others ill. My personal belief is that while the vaccine didn’t save me from disease, it dramatically truncated my illness, and significantly reduced my risk of passing the virus on to my friends and family.

So where did I contract the virus? We were unmasked at dinner on Friday night, which was acceptable in Yolo County at that time. By the way, I actually live in Yolo County, not YOLO (you only live once) county. You can imagine the latter would be a bit more loosey-goosey with the masking requirements. That notwithstanding, I don’t think the dinner was where I picked it up because it was too short of an incubation period. My wife and I obviously reacted differently, as I discussed, but we were both at the restaurant. She didn’t get COVID-19 and I did. I think that I probably picked it up at the hospital, because, while I was wearing a mask there, I was only wearing a surgical mask, not an N95. And I wasn’t wearing goggles anymore. While none of my patients were officially diagnosed with COVID-19, I was encountering a lot of people, getting in relatively close contact, and guidelines were being relaxed, including preadmission COVID-19 testing.

I was an outlier, as I have pointed out; none of my other close contacts contracted COVID-19. A lot of politics and public opinion is driven by outlier cases, and even pure fabrications these days; we certainly can’t create public health policy based on an outlier. I am not suggesting that my experience is any basis for rewriting the rules of COVID-19. The experience has given me pause to think through many facets of this horrible illness we have had to deal with in so many ways, however. And I have also reexamined my own practice for protecting myself in the hospital. Clearly what I was doing in the height of the pandemic was effective, and my more relaxed recent practices were not. Now that I am fully recovered after a relatively unique encounter with the condition, I look forward to seeing what the scientists and public policy makers do with COVID-19 vaccine breakthrough cases. So, between us hospitalist friends and colleagues, regardless of the policy guidelines, I say we keep on masking.

Dr. McIlraith is the founding chairman of the hospital medicine department at Mercy Medical Group in Sacramento. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016.

Friday, July 16, 2021, marked the end of a week on duty in the hospital, and it was time to celebrate with a nice dinner out with my wife, since COVID-19 masking requirements had been lifted in our part of California for people like us who were fully vaccinated.

We always loved a nice dinner out and missed it so much during the pandemic. Unlike 6 months earlier, when I was administering dexamethasone, remdesivir, and high-flow oxygen to half of the patients on my panel, not a single patient was diagnosed with COVID-19, much less treated for it, during the previous week. We were doing so well in Sacramento that the hospital visitation rules had been relaxed and vaccinated patients were not required to have a negative COVID-19 test prior to hospital admission.

Saturday was game 5 of the NBA finals, so we had two couples join us for the game at our house; no masks because we were all vaccinated. On Sunday, we visited our neighbors who had just had a new baby boy and made them the gift of some baby books. The new mom had struggled with the decision of whether to get vaccinated during her pregnancy, but eventually decided to complete the vaccination cycle prior to delivery. She was fully immune at the time of the baby’s birth, wisely wanting the baby to have passive immunity through her. We kept an appropriate distance, and never touched baby or mom, but since masking guidelines had been lifted for the vaccinated,we didn’t bother with them.

On Monday, I felt a little something in my nose but still pursued my usual workout. Interestingly, my performance wasn’t up to my usual standards. There was a meeting that evening that I had to prepare for, when all of a sudden I felt very fatigued. I lay down and slept for a good hour, which disrupted my preparation. I warned the participants that I was feeling a little under the weather, but they wanted to proceed. At this point, I decided it was time to start wearing a mask again.

More meetings on Tuesday morning, but I made sure that I was fully masked. That little thing in my nose had blown up into a full-scale rhinitis, requiring Kleenex and decongestants. Plus, the fatigue was hitting me very hard. “Dang!” I thought. “I haven’t had a cold since 2019. All those COVID-19 precautions not only worked against COVID-19 (which I never got) but also worked against the common cold, which I had now.”

I finished up my meetings and laid down for a good hour and a half. As the father of two, I had plenty of experience with the common cold, and I knew that plenty of rest and hydration was the key to kicking this thing. Besides, my 55th birthday was coming up, and I wanted to make sure I was fully recovered for the festivities my wife was planning for me. Nonetheless, I scheduled myself for a COVID-19 test. I knew this couldn’t be COVID-19 because I was fully vaccinated, but it was hitting me so hard. It had to be a virus that my body had never seen before; maybe the human metapneumovirus. That was my line of reasoning, anyway.

Wednesday was another day on the couch because of continued severe fatigue and myalgias. I figured another good day of rest would help me kick this cold in time for my birthday celebration. Then the COVID-19 results came back positive. “How could this be? I was vaccinated?!” Admittedly I had been more relaxed with masking, per the CDC and county guidelines, but I always wore a mask when I was seeing patients in the hospital. Yeah, I wasn’t wearing an N95 anymore, and I had given up my goggles months ago, but we just weren’t seeing much COVID-19 anymore, so a plain surgical mask was all that was required and seemed sufficient. I had been reading articles about the new Delta variant that was becoming dominant across the country, and reports were that the vaccine was still effective against the Delta variant. However, I was experiencing the COVID-19 vaccine breakthrough infection because of the remarkable talent the Delta variant has for replicating and producing high levels of viremia.

My first thoughts were for my family, of course. As my illness unfolded, I had kept checking in with them to see if they had any of these “cold” symptoms I had; none of them did. When my test came back positive, we all went into quarantine immediately and they went to get tested; all of them were negative. Next, I contacted the people I had been meeting with that week and warned them that I had tested positive. Despite my mask, and their fully vaccinated status, they needed to get tested. They did, and they were negative. I realized that I was probably contagious, though asymptomatic, on Saturday night when we had friends over to watch the NBA finals. Yeah, everyone was vaccinated, but if I could get sick from this new Delta variant, they could too. The public health department sent me a survey when they found out about my positive test, and they pinpointed Saturday as the day I started to be contagious. I told my friends that I was probably contagious when they were over for the game, and that they should get tested. They did, and everyone came back negative for COVID-19.

Wait a minute; what about Sunday night? The newborn baby and the sleep-deprived mom. Oh no! I was contagious then as well. We kept our distance, and were only there for about 10 minutes, but if I felt bad from COVID-19, I felt worse for exposing them to the virus.

I am no Anthony Fauci, and I am grateful that we have had levelheaded scientists like him to lead us through this terrible experience. I am sure there will be many papers written about COVID-19 breakthrough infections in the future, but I have many thoughts from this experience. First, my practice of wearing an N95 and goggles for all patients, not just COVID-19 patients, during the height of the pandemic was effective. Prior to getting vaccinated, my antibody tests were negative, so I never contracted the illness when I stuck to this regimen. Second, we all want to get back to something that looks like “normal,” but because there are large unvaccinated populations in the community the virus will continue to propagate and evolve, and hence everyone is at risk. While the guidelines said it was okay to ease up on our restrictions, because so many people are not vaccinated, we all must continue to keep our guard up. Third, would a booster shot have saved me from this fate? Because I was on the front lines of the pandemic as a hospitalist, I was also among the first members of my community to get vaccinated, receiving my second shot on Jan. 14, 2021. My wife was not in any risk group, was not on any vaccine priority list, and didn’t complete the series until early April. If I was going to give the infection to anyone, it would have been her. Not only did she never develop symptoms, but she also repeatedly tested negative, as did everyone else that I was in contact with when I was most contagious. The thing that was different about me from everyone else was that I had gotten the vaccine well ahead of them. Had my immunity waned over the months?

The good news is that, while I wouldn’t characterize what I had as “mild,” it certainly wasn’t protracted. Yes, I was a good boy, and did the basics: stay hydrated and get plenty of sleep. I was really bad off for about 3 days, and I hate to think what it would have been like if I had coexisting conditions such as asthma or diabetes. We all know what a bad case of COVID-19 looks like in the unvaccinated, with months in the hospital, intravenous infusions, and high-flow oxygen for the lucky ones. I had nothing remotely like that. The dominant symptom I had was incapacitating fatigue and significant body aches. The second night I had some major chills, sweats, and wild dreams. From a respiratory standpoint, I had bad rhinitis and a wicked cough for a while that tapered off. My oxygen saturations dropped into the mid 90’s, but never below 94%. But if I had been ten times sicker, I doubt I would have survived. I was on quarantine for 10 days but I highly doubt I was at all contagious by day 5, based on my symptoms and the fact that nobody around me turned COVID positive with repeat testing.

I was so relieved that none of my contacts when I was most contagious turned positive for COVID-19. Though not scientific, I find that illustrative. While I should have canceled my meetings on Monday and Tuesday, everybody knew I had a “cold” and nobody wanted to cancel. Nobody thought it possible that I had COVID-19, especially me. The Delta variant is notorious for generating high levels of viremia, yet I didn’t get anybody sick, not even my wife. That suggests to me that, while the vaccine doesn’t eliminate the risk of infection – which we already knew – it probably significantly reduced my infectivity. For that I am very grateful. Now that I can say that I had the COVID-19 experience, I can tell you it feels terrible. But I would have felt much worse if I had gotten others ill. My personal belief is that while the vaccine didn’t save me from disease, it dramatically truncated my illness, and significantly reduced my risk of passing the virus on to my friends and family.

So where did I contract the virus? We were unmasked at dinner on Friday night, which was acceptable in Yolo County at that time. By the way, I actually live in Yolo County, not YOLO (you only live once) county. You can imagine the latter would be a bit more loosey-goosey with the masking requirements. That notwithstanding, I don’t think the dinner was where I picked it up because it was too short of an incubation period. My wife and I obviously reacted differently, as I discussed, but we were both at the restaurant. She didn’t get COVID-19 and I did. I think that I probably picked it up at the hospital, because, while I was wearing a mask there, I was only wearing a surgical mask, not an N95. And I wasn’t wearing goggles anymore. While none of my patients were officially diagnosed with COVID-19, I was encountering a lot of people, getting in relatively close contact, and guidelines were being relaxed, including preadmission COVID-19 testing.

I was an outlier, as I have pointed out; none of my other close contacts contracted COVID-19. A lot of politics and public opinion is driven by outlier cases, and even pure fabrications these days; we certainly can’t create public health policy based on an outlier. I am not suggesting that my experience is any basis for rewriting the rules of COVID-19. The experience has given me pause to think through many facets of this horrible illness we have had to deal with in so many ways, however. And I have also reexamined my own practice for protecting myself in the hospital. Clearly what I was doing in the height of the pandemic was effective, and my more relaxed recent practices were not. Now that I am fully recovered after a relatively unique encounter with the condition, I look forward to seeing what the scientists and public policy makers do with COVID-19 vaccine breakthrough cases. So, between us hospitalist friends and colleagues, regardless of the policy guidelines, I say we keep on masking.

Dr. McIlraith is the founding chairman of the hospital medicine department at Mercy Medical Group in Sacramento. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016.

Friday, July 16, 2021, marked the end of a week on duty in the hospital, and it was time to celebrate with a nice dinner out with my wife, since COVID-19 masking requirements had been lifted in our part of California for people like us who were fully vaccinated.

We always loved a nice dinner out and missed it so much during the pandemic. Unlike 6 months earlier, when I was administering dexamethasone, remdesivir, and high-flow oxygen to half of the patients on my panel, not a single patient was diagnosed with COVID-19, much less treated for it, during the previous week. We were doing so well in Sacramento that the hospital visitation rules had been relaxed and vaccinated patients were not required to have a negative COVID-19 test prior to hospital admission.

Saturday was game 5 of the NBA finals, so we had two couples join us for the game at our house; no masks because we were all vaccinated. On Sunday, we visited our neighbors who had just had a new baby boy and made them the gift of some baby books. The new mom had struggled with the decision of whether to get vaccinated during her pregnancy, but eventually decided to complete the vaccination cycle prior to delivery. She was fully immune at the time of the baby’s birth, wisely wanting the baby to have passive immunity through her. We kept an appropriate distance, and never touched baby or mom, but since masking guidelines had been lifted for the vaccinated,we didn’t bother with them.

On Monday, I felt a little something in my nose but still pursued my usual workout. Interestingly, my performance wasn’t up to my usual standards. There was a meeting that evening that I had to prepare for, when all of a sudden I felt very fatigued. I lay down and slept for a good hour, which disrupted my preparation. I warned the participants that I was feeling a little under the weather, but they wanted to proceed. At this point, I decided it was time to start wearing a mask again.

More meetings on Tuesday morning, but I made sure that I was fully masked. That little thing in my nose had blown up into a full-scale rhinitis, requiring Kleenex and decongestants. Plus, the fatigue was hitting me very hard. “Dang!” I thought. “I haven’t had a cold since 2019. All those COVID-19 precautions not only worked against COVID-19 (which I never got) but also worked against the common cold, which I had now.”

I finished up my meetings and laid down for a good hour and a half. As the father of two, I had plenty of experience with the common cold, and I knew that plenty of rest and hydration was the key to kicking this thing. Besides, my 55th birthday was coming up, and I wanted to make sure I was fully recovered for the festivities my wife was planning for me. Nonetheless, I scheduled myself for a COVID-19 test. I knew this couldn’t be COVID-19 because I was fully vaccinated, but it was hitting me so hard. It had to be a virus that my body had never seen before; maybe the human metapneumovirus. That was my line of reasoning, anyway.

Wednesday was another day on the couch because of continued severe fatigue and myalgias. I figured another good day of rest would help me kick this cold in time for my birthday celebration. Then the COVID-19 results came back positive. “How could this be? I was vaccinated?!” Admittedly I had been more relaxed with masking, per the CDC and county guidelines, but I always wore a mask when I was seeing patients in the hospital. Yeah, I wasn’t wearing an N95 anymore, and I had given up my goggles months ago, but we just weren’t seeing much COVID-19 anymore, so a plain surgical mask was all that was required and seemed sufficient. I had been reading articles about the new Delta variant that was becoming dominant across the country, and reports were that the vaccine was still effective against the Delta variant. However, I was experiencing the COVID-19 vaccine breakthrough infection because of the remarkable talent the Delta variant has for replicating and producing high levels of viremia.

My first thoughts were for my family, of course. As my illness unfolded, I had kept checking in with them to see if they had any of these “cold” symptoms I had; none of them did. When my test came back positive, we all went into quarantine immediately and they went to get tested; all of them were negative. Next, I contacted the people I had been meeting with that week and warned them that I had tested positive. Despite my mask, and their fully vaccinated status, they needed to get tested. They did, and they were negative. I realized that I was probably contagious, though asymptomatic, on Saturday night when we had friends over to watch the NBA finals. Yeah, everyone was vaccinated, but if I could get sick from this new Delta variant, they could too. The public health department sent me a survey when they found out about my positive test, and they pinpointed Saturday as the day I started to be contagious. I told my friends that I was probably contagious when they were over for the game, and that they should get tested. They did, and everyone came back negative for COVID-19.

Wait a minute; what about Sunday night? The newborn baby and the sleep-deprived mom. Oh no! I was contagious then as well. We kept our distance, and were only there for about 10 minutes, but if I felt bad from COVID-19, I felt worse for exposing them to the virus.

I am no Anthony Fauci, and I am grateful that we have had levelheaded scientists like him to lead us through this terrible experience. I am sure there will be many papers written about COVID-19 breakthrough infections in the future, but I have many thoughts from this experience. First, my practice of wearing an N95 and goggles for all patients, not just COVID-19 patients, during the height of the pandemic was effective. Prior to getting vaccinated, my antibody tests were negative, so I never contracted the illness when I stuck to this regimen. Second, we all want to get back to something that looks like “normal,” but because there are large unvaccinated populations in the community the virus will continue to propagate and evolve, and hence everyone is at risk. While the guidelines said it was okay to ease up on our restrictions, because so many people are not vaccinated, we all must continue to keep our guard up. Third, would a booster shot have saved me from this fate? Because I was on the front lines of the pandemic as a hospitalist, I was also among the first members of my community to get vaccinated, receiving my second shot on Jan. 14, 2021. My wife was not in any risk group, was not on any vaccine priority list, and didn’t complete the series until early April. If I was going to give the infection to anyone, it would have been her. Not only did she never develop symptoms, but she also repeatedly tested negative, as did everyone else that I was in contact with when I was most contagious. The thing that was different about me from everyone else was that I had gotten the vaccine well ahead of them. Had my immunity waned over the months?

The good news is that, while I wouldn’t characterize what I had as “mild,” it certainly wasn’t protracted. Yes, I was a good boy, and did the basics: stay hydrated and get plenty of sleep. I was really bad off for about 3 days, and I hate to think what it would have been like if I had coexisting conditions such as asthma or diabetes. We all know what a bad case of COVID-19 looks like in the unvaccinated, with months in the hospital, intravenous infusions, and high-flow oxygen for the lucky ones. I had nothing remotely like that. The dominant symptom I had was incapacitating fatigue and significant body aches. The second night I had some major chills, sweats, and wild dreams. From a respiratory standpoint, I had bad rhinitis and a wicked cough for a while that tapered off. My oxygen saturations dropped into the mid 90’s, but never below 94%. But if I had been ten times sicker, I doubt I would have survived. I was on quarantine for 10 days but I highly doubt I was at all contagious by day 5, based on my symptoms and the fact that nobody around me turned COVID positive with repeat testing.

I was so relieved that none of my contacts when I was most contagious turned positive for COVID-19. Though not scientific, I find that illustrative. While I should have canceled my meetings on Monday and Tuesday, everybody knew I had a “cold” and nobody wanted to cancel. Nobody thought it possible that I had COVID-19, especially me. The Delta variant is notorious for generating high levels of viremia, yet I didn’t get anybody sick, not even my wife. That suggests to me that, while the vaccine doesn’t eliminate the risk of infection – which we already knew – it probably significantly reduced my infectivity. For that I am very grateful. Now that I can say that I had the COVID-19 experience, I can tell you it feels terrible. But I would have felt much worse if I had gotten others ill. My personal belief is that while the vaccine didn’t save me from disease, it dramatically truncated my illness, and significantly reduced my risk of passing the virus on to my friends and family.

So where did I contract the virus? We were unmasked at dinner on Friday night, which was acceptable in Yolo County at that time. By the way, I actually live in Yolo County, not YOLO (you only live once) county. You can imagine the latter would be a bit more loosey-goosey with the masking requirements. That notwithstanding, I don’t think the dinner was where I picked it up because it was too short of an incubation period. My wife and I obviously reacted differently, as I discussed, but we were both at the restaurant. She didn’t get COVID-19 and I did. I think that I probably picked it up at the hospital, because, while I was wearing a mask there, I was only wearing a surgical mask, not an N95. And I wasn’t wearing goggles anymore. While none of my patients were officially diagnosed with COVID-19, I was encountering a lot of people, getting in relatively close contact, and guidelines were being relaxed, including preadmission COVID-19 testing.

I was an outlier, as I have pointed out; none of my other close contacts contracted COVID-19. A lot of politics and public opinion is driven by outlier cases, and even pure fabrications these days; we certainly can’t create public health policy based on an outlier. I am not suggesting that my experience is any basis for rewriting the rules of COVID-19. The experience has given me pause to think through many facets of this horrible illness we have had to deal with in so many ways, however. And I have also reexamined my own practice for protecting myself in the hospital. Clearly what I was doing in the height of the pandemic was effective, and my more relaxed recent practices were not. Now that I am fully recovered after a relatively unique encounter with the condition, I look forward to seeing what the scientists and public policy makers do with COVID-19 vaccine breakthrough cases. So, between us hospitalist friends and colleagues, regardless of the policy guidelines, I say we keep on masking.

Dr. McIlraith is the founding chairman of the hospital medicine department at Mercy Medical Group in Sacramento. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016.

A year after the start of the COVID-19 pandemic, as the United States was getting a reprieve in new cases from its winter surge, the opposite was happening in the rest of the world. In India, a deadly second wave hit, crippling the health care system in the country for months.

Yugandhar Bhatt, MBBS, MD, a consultant pulmonologist with Yashoda Hospital–Malakpet in Hyderabad, India, told this news organization that someone looking at his hospital before the pandemic – a 400-bed multispecialty care unit – would see patients being treated for respiratory failure secondary to exacerbation of chronic obstructive pulmonary disease, bronchial asthma, community-acquired pneumonia, and heart failure. About 30-40 patients per day were treated on an outpatient basis, and more than 30 people were admitted as inpatients.

“After [the] COVID-19 surge, our hospital totally divided into COVID and non-COVID [wards], in which COVID patients occupied 70% of [the] total,” he said. About half of COVID-19 patients were in the ICU, with half of those patients requiring supplemental oxygen.

During the first wave in India, which lasted from May to December 2020, 50% of patients who were intubated were discharged. The percentage of extubated patients decreased to 20% in the second wave, Dr. Bhatt said.

The death toll during the second wave of COVID-19 cases was unlike anything India has seen previously. Between March 1 and June 29, 2021, an estimated 19.24 million individuals were newly infected with COVID-19 and 241,206 patients died, according to Our World in Data, a project of the Global Change Data Lab. When the second wave peaked on May 22, more than 4,000 people were dying each day.

“All hospitals [in India] were treating COVID-19 more than any other acute or chronic disease,” Ramesh Adhikari, MD, MS, SFHM, a hospitalist with Franciscan Health in Lafayette, Ind., said in an interview.

Challenges arose in treating COVID-19 in India that ran counter to how medicine was usually performed. Physicians were seeing more inpatient cases than usual – and more patients in general. The change, Dr. Adhikari said, forced health care providers to think outside the box.
 

An ‘on-the-fly’ hospitalist model

Patients in India access health care by visiting a hospital or primary health center and then are referred out to consultants – specialist doctors – if needed. While India has universal health coverage, it is a multi-payer system that includes approximately 37% of the population covered under the government plan, a large number of private health care facilities and no caps on cost-sharing for the patient. Initiatives like Rashtriya Swasthya Bima Yojana in 2008 and Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana in 2018 have attempted to close the gap and raise the number of lower-income individuals in India covered under the government plan and reduce out-of-pocket spending. Out-of-pocket payments still consist of about 70% of total health expenditures, according to the Commonwealth Fund.

“There is not much scope for a hospitalist because it’s so cash driven,” Shyam Odeti, MD, SFHM, section chief, hospital medicine, at the Carilion Clinic in Roanoke, Va., said in an interview. “For a hospitalist, there is no urgency in getting them out of the hospital. There was no need for much efficiency before.”

The first issue during the second wave was figuring out which consultants would care for COVID-19 patients. As there is no dedicated specialty for infectious disease in India, the responsibilities fell to internists and critical care medicine consultants who volunteered. Both are considered small specialties in India. They became “makeshift hospitalists” who learned as they went and became the experts in COVID-19 care, treating their own patients while making themselves available for consultations, Dr. Odeti said.

While no official hospital medicine model in India exists like in the United States, the second COVID-19 surge caused these consultants to begin thinking like hospitalists. Tenets of hospital medicine – like team-based treatment across specialties – arose out of necessity during the crisis. “They were trying to implement a hospitalist model because that’s the only way they could treat COVID-19,” said Dr. Adhikari, an editorial advisory board member for the Hospitalist.

“Even in the U.S. when we started the hospitalist model, it started out of necessity. It’s a combination of creating efficiencies and improving quality,” Dr. Odeti said. “It’s the same thing in India. It’s borne of necessity, but it was [done] at a rapid pace.”
 

Problems with patient flow

The next issue was triaging patients in the hospital based on COVID-19 severity. When the second wave began, hospitals in India ran out of beds and experienced staff shortages like in many countries. But this situation “was unusual for the health system,” according to Dr. Odeti, who is also an editorial board member for the Hospitalist.

“We never had that issue. There were so many patients wanting to come to the hospital, and so there was this rush.” There was no process to triage patients to determine who needed to stay. “Everybody got put into the hospital,” he said.

Once it was determined who would take care of patients with COVID-19, access to supplies became the primary problem, Dr. Adhikari explained. Lack of oxygen, ventilators, and critical medicines like the antiviral drug remdesivir were and continue to be in short supply. “I had friends who [said] they could not admit patients because they were worried if their oxygen supply [went] low in the middle of the night. They will treat the patients who were already admitted versus taking new patients. That had caused problems for the administrators,” Dr. Adhikari added.

It is also a source of additional stress for the physicians. Where patients flow through a hospital medicine model in the United States, a system that might include case managers, social workers, pharmacists, physician advocates, and other professionals to keep a patient’s care on track, the physician is the go-to person in India for patient care. While physicians provide access to medications and remain available to a patient’s family, those duties become much harder when caring for a greater number of patients during the pandemic. “That has led to some unrealistic expectations among the patients,” Dr. Adhikari said.

Dr. Bhatt said “more than half” of a physician’s time in India is spent counseling patients on concerns about COVID-19. “Awareness about the disease is limited from the patient and patient’s family perspective, as [there is] too much apprehension toward the nature of [the] disease,” he added. “Theoretical discussions collected from social media” obstruct the physician from executing his or her duties.

Physicians in India have had to contend with physical violence from patients and individuals on the street, Dr. Adhikari added. Workplace violence was already a concern – for years, the Indian Medical Association has cited a statistic that 75% of doctors in India have experienced violence at work (Indian J Psychiatry. 2019 Apr;61[Suppl 4]:S782-5). But the threat of violence against physicians has sharply increased during the COVID-19 pandemic. Disruptions to daily life through lockdowns “made people fearful, anxious, and sometimes they have found it difficult to access emergency treatment,” according to a letter published by Karthikeyan Iyengar and colleagues in the Postgraduate Medical Journal. In response to the restlessness, irritation, and despair resulting from hospitals closing their doors, “people have shown their frustration by verbally abusing and threatening to physically assault doctors and other health care workers,” the authors wrote.
 

A telemedicine boon in India

Back in the United States, hospitalists with family and friends in India were trying to figure out how to help. Some were working through the day, only to answer calls and WhatsApp messages from loved ones at night. “Everyone knows a physician or someone who’s your colleague, who owns a hospital or runs a hospital, or one of the family members is sick,” Dr. Adhikari said.

These U.S.-based hospitalists were burning the candle at both ends, helping with the pandemic in both countries. Physicians in India were posing questions to U.S. colleagues who they saw as having the most recent evidence for COVID-19 treatment. Out of the 180 physicians he trained with in India, Dr. Odeti said 110 of the physicians were in a large WhatsApp group chat that was constantly exchanging messages and serving as “kind of a friendly support group.”

In Dr. Odeti’s group chat, physicians helped one another find hospital beds for patients who reached out to them. “The first couple of weeks, there was no proper way for people to know where [patients] were based. There was no way to find if this hospital had a bed, so they reached out to any doctors they knew,” he said.

While he said it was emotionally draining, “at the same time, we felt a responsibility toward colleagues in India,” Dr. Odeti said, noting that as COVID-19 cases have decreased in India, the requests have been less frequent.

Because of concerns about traveling to India during the pandemic while on a J-1, H-1B, or other visa with the United States, directly helping friends and family in India seemed out of reach. But many hospitalists of Indian origin instead turned to telemedicine to help their colleagues. Telemedicine had already been steadily growing in India, but was accelerated by the pandemic. The current ratio of doctors to patients in India is 0.62 to 1,000 – lower than recommendations from the World Health Organization. That makes telemedicine a unique opportunity for one physician in India to reach many patients regardless of location.

Dr. Adhikari said he helped out his colleagues in India by performing consults for their patients. “They were just worried because they did not ‘know where to go, or what to get,” he said. “I was treating more patients in India than I was actually treating here.”

In March 2020, the Indian Ministry of Health and Family Welfare released telemedicine practice guidelines for the country, which relaxed regulations on privacy requirements and has been credited in part for giving telemedicine an additional boost during the pandemic. “That makes it easy for people to reach out but also has its own problems,” Dr. Adhikari said.

Monitoring of milder COVID-19 cases that don’t require hospitalization can be performed by a nurse who calls every few hours to check on a patient, make recommendations, and text treatment plans. “The telemedicine platforms are being adopted really fast,” Dr. Adhikari said. “The platforms were built in no time.”

According to NewZoo, a games market data analytics company, India has 345.9 million smartphone users as of 2019 – the second highest number of users in the world after China. Dr. Odeti said he believes telemedicine will be widely adopted.

“In India, they are very proactive in accepting these kinds of methods, so I’m sure they will,” he said. “Governments were trying to do it before the pandemic, because access to care is a problem in India. There are villages which are very, very remote.”
 

Reversion to old systems

After the peak in late May, new COVID-19 cases in India began to decrease, and the second wave waned on a national level. Hospitals began to get the supplies they needed, beds are available, and patients aren’t as sick as before, according to Dr. Adhikari. The federal government has begun issuing supplies to patients in each state, including COVID-19 vaccines. “The peak for the second wave is gone,” he said.

What remains is a group of physicians trained in how to triage patients and create efficiencies in a hospital setting. Could those skills be put to use elsewhere in India after the pandemic?

According to Dr. Bhatt, the patient care model is likely to revert to the system that existed before. “Whatever the changes, interims of bed occupancy, cost of ICU will be temporary [and] will change to normal,” he said. “But awareness about masks [and] sanitizing methods will be permanent.”

Dr. Adhikari believes that not utilizing the skills of newly minted hospitalists in India would be a missed opportunity. “This is a silver lining from COVID-19, that hospital medicine plays a vital role in the sickest patients, whether it is in India or the U.S. or anywhere,” he said. “I think the model of hospital medicine should be adopted. It’s not: ‘Should it really be adopted or not?’ It should be. There is a huge potential in doing inpatient coordinated [care], having people dedicated in the hospital.”

There are tangible benefits to creating efficiencies in India’s health system, Dr. Odeti said. Length of stay for sicker patients “was much longer” at 10-14 days during the second wave, compared with the United States, before lowering to around 5 days. “These hospitals right now are learning the efficient ways of doing it: when to send [patients] out, how to send them out, how to [perform] service-based practices, creating processes which were nonexistent before.”

While he doesn’t personally believe physicians will adopt a full-fledged hospitalist model unless the payer structure in India changes, “these people are at an advantage with this extra set of skills,” he said. “I think all the knowledge that these people have are going to come in handy.”
 

Opportunities for growth

Dr. Odeti sees the potential for the hospitalist model to grow in India – if not into its own specialty, then in how critical care consultants handle sicker patients and handoffs.

“The critical care clinician cannot keep the patient from the time they are admitted to the ICU until the discharge, so there will be a need for the transition,” Dr. Odeti said. “In the past, there were not many capabilities in Indian health systems to take care of these extremely sick patients, and now it is evolving. I think that is one more thing that will help.”

Dr. Adhikari said hospital systems in India are beginning to realize how having dedicated hospital physicians could benefit them. In India, “if you’re sick, you go to your doctor, you get treated and you disappear,” he said. The next time, you may see the same doctor or a completely different doctor. “There’s no system there, so it’s really hard for hospital medicine as such because patients, when they are very sick, they just come to the ER. They’re not followed by their primary care.”

Anecdotally, Dr. Odeti sees patients already adapting to having access to a physician for asking questions normally answered by primary care physicians. “I think primary care will come into play,” he said. “When I was doing a Zoom call for patients, they were asking me questions about sciatica. I think they are getting comfortable with this technology.”

A hospitalist model could even be applied to specific diseases with a large population of patients. Hospital administrators “have seen this for the first time, how efficient it could be if they had their own hospitalists and actually run it. So that’s the part that has crossed their minds,” Dr. Adhikari said. “How they will apply it going forward, other than during the COVID-19 pandemic, depends on the size of the hospital and the volume of the patients for a particular disease.”

“You can see in certain areas there is large growth for hospital medicine. But to rise to the level of the United States and how we do it, India needs bigger health systems to adopt the model,” Dr. Adhikari said.

A year after the start of the COVID-19 pandemic, as the United States was getting a reprieve in new cases from its winter surge, the opposite was happening in the rest of the world. In India, a deadly second wave hit, crippling the health care system in the country for months.

Yugandhar Bhatt, MBBS, MD, a consultant pulmonologist with Yashoda Hospital–Malakpet in Hyderabad, India, told this news organization that someone looking at his hospital before the pandemic – a 400-bed multispecialty care unit – would see patients being treated for respiratory failure secondary to exacerbation of chronic obstructive pulmonary disease, bronchial asthma, community-acquired pneumonia, and heart failure. About 30-40 patients per day were treated on an outpatient basis, and more than 30 people were admitted as inpatients.

“After [the] COVID-19 surge, our hospital totally divided into COVID and non-COVID [wards], in which COVID patients occupied 70% of [the] total,” he said. About half of COVID-19 patients were in the ICU, with half of those patients requiring supplemental oxygen.

During the first wave in India, which lasted from May to December 2020, 50% of patients who were intubated were discharged. The percentage of extubated patients decreased to 20% in the second wave, Dr. Bhatt said.

The death toll during the second wave of COVID-19 cases was unlike anything India has seen previously. Between March 1 and June 29, 2021, an estimated 19.24 million individuals were newly infected with COVID-19 and 241,206 patients died, according to Our World in Data, a project of the Global Change Data Lab. When the second wave peaked on May 22, more than 4,000 people were dying each day.

“All hospitals [in India] were treating COVID-19 more than any other acute or chronic disease,” Ramesh Adhikari, MD, MS, SFHM, a hospitalist with Franciscan Health in Lafayette, Ind., said in an interview.

Challenges arose in treating COVID-19 in India that ran counter to how medicine was usually performed. Physicians were seeing more inpatient cases than usual – and more patients in general. The change, Dr. Adhikari said, forced health care providers to think outside the box.
 

An ‘on-the-fly’ hospitalist model

Patients in India access health care by visiting a hospital or primary health center and then are referred out to consultants – specialist doctors – if needed. While India has universal health coverage, it is a multi-payer system that includes approximately 37% of the population covered under the government plan, a large number of private health care facilities and no caps on cost-sharing for the patient. Initiatives like Rashtriya Swasthya Bima Yojana in 2008 and Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana in 2018 have attempted to close the gap and raise the number of lower-income individuals in India covered under the government plan and reduce out-of-pocket spending. Out-of-pocket payments still consist of about 70% of total health expenditures, according to the Commonwealth Fund.

“There is not much scope for a hospitalist because it’s so cash driven,” Shyam Odeti, MD, SFHM, section chief, hospital medicine, at the Carilion Clinic in Roanoke, Va., said in an interview. “For a hospitalist, there is no urgency in getting them out of the hospital. There was no need for much efficiency before.”

The first issue during the second wave was figuring out which consultants would care for COVID-19 patients. As there is no dedicated specialty for infectious disease in India, the responsibilities fell to internists and critical care medicine consultants who volunteered. Both are considered small specialties in India. They became “makeshift hospitalists” who learned as they went and became the experts in COVID-19 care, treating their own patients while making themselves available for consultations, Dr. Odeti said.

While no official hospital medicine model in India exists like in the United States, the second COVID-19 surge caused these consultants to begin thinking like hospitalists. Tenets of hospital medicine – like team-based treatment across specialties – arose out of necessity during the crisis. “They were trying to implement a hospitalist model because that’s the only way they could treat COVID-19,” said Dr. Adhikari, an editorial advisory board member for the Hospitalist.

“Even in the U.S. when we started the hospitalist model, it started out of necessity. It’s a combination of creating efficiencies and improving quality,” Dr. Odeti said. “It’s the same thing in India. It’s borne of necessity, but it was [done] at a rapid pace.”
 

Problems with patient flow

The next issue was triaging patients in the hospital based on COVID-19 severity. When the second wave began, hospitals in India ran out of beds and experienced staff shortages like in many countries. But this situation “was unusual for the health system,” according to Dr. Odeti, who is also an editorial board member for the Hospitalist.

“We never had that issue. There were so many patients wanting to come to the hospital, and so there was this rush.” There was no process to triage patients to determine who needed to stay. “Everybody got put into the hospital,” he said.

Once it was determined who would take care of patients with COVID-19, access to supplies became the primary problem, Dr. Adhikari explained. Lack of oxygen, ventilators, and critical medicines like the antiviral drug remdesivir were and continue to be in short supply. “I had friends who [said] they could not admit patients because they were worried if their oxygen supply [went] low in the middle of the night. They will treat the patients who were already admitted versus taking new patients. That had caused problems for the administrators,” Dr. Adhikari added.

It is also a source of additional stress for the physicians. Where patients flow through a hospital medicine model in the United States, a system that might include case managers, social workers, pharmacists, physician advocates, and other professionals to keep a patient’s care on track, the physician is the go-to person in India for patient care. While physicians provide access to medications and remain available to a patient’s family, those duties become much harder when caring for a greater number of patients during the pandemic. “That has led to some unrealistic expectations among the patients,” Dr. Adhikari said.

Dr. Bhatt said “more than half” of a physician’s time in India is spent counseling patients on concerns about COVID-19. “Awareness about the disease is limited from the patient and patient’s family perspective, as [there is] too much apprehension toward the nature of [the] disease,” he added. “Theoretical discussions collected from social media” obstruct the physician from executing his or her duties.

Physicians in India have had to contend with physical violence from patients and individuals on the street, Dr. Adhikari added. Workplace violence was already a concern – for years, the Indian Medical Association has cited a statistic that 75% of doctors in India have experienced violence at work (Indian J Psychiatry. 2019 Apr;61[Suppl 4]:S782-5). But the threat of violence against physicians has sharply increased during the COVID-19 pandemic. Disruptions to daily life through lockdowns “made people fearful, anxious, and sometimes they have found it difficult to access emergency treatment,” according to a letter published by Karthikeyan Iyengar and colleagues in the Postgraduate Medical Journal. In response to the restlessness, irritation, and despair resulting from hospitals closing their doors, “people have shown their frustration by verbally abusing and threatening to physically assault doctors and other health care workers,” the authors wrote.
 

A telemedicine boon in India

Back in the United States, hospitalists with family and friends in India were trying to figure out how to help. Some were working through the day, only to answer calls and WhatsApp messages from loved ones at night. “Everyone knows a physician or someone who’s your colleague, who owns a hospital or runs a hospital, or one of the family members is sick,” Dr. Adhikari said.

These U.S.-based hospitalists were burning the candle at both ends, helping with the pandemic in both countries. Physicians in India were posing questions to U.S. colleagues who they saw as having the most recent evidence for COVID-19 treatment. Out of the 180 physicians he trained with in India, Dr. Odeti said 110 of the physicians were in a large WhatsApp group chat that was constantly exchanging messages and serving as “kind of a friendly support group.”

In Dr. Odeti’s group chat, physicians helped one another find hospital beds for patients who reached out to them. “The first couple of weeks, there was no proper way for people to know where [patients] were based. There was no way to find if this hospital had a bed, so they reached out to any doctors they knew,” he said.

While he said it was emotionally draining, “at the same time, we felt a responsibility toward colleagues in India,” Dr. Odeti said, noting that as COVID-19 cases have decreased in India, the requests have been less frequent.

Because of concerns about traveling to India during the pandemic while on a J-1, H-1B, or other visa with the United States, directly helping friends and family in India seemed out of reach. But many hospitalists of Indian origin instead turned to telemedicine to help their colleagues. Telemedicine had already been steadily growing in India, but was accelerated by the pandemic. The current ratio of doctors to patients in India is 0.62 to 1,000 – lower than recommendations from the World Health Organization. That makes telemedicine a unique opportunity for one physician in India to reach many patients regardless of location.

Dr. Adhikari said he helped out his colleagues in India by performing consults for their patients. “They were just worried because they did not ‘know where to go, or what to get,” he said. “I was treating more patients in India than I was actually treating here.”

In March 2020, the Indian Ministry of Health and Family Welfare released telemedicine practice guidelines for the country, which relaxed regulations on privacy requirements and has been credited in part for giving telemedicine an additional boost during the pandemic. “That makes it easy for people to reach out but also has its own problems,” Dr. Adhikari said.

Monitoring of milder COVID-19 cases that don’t require hospitalization can be performed by a nurse who calls every few hours to check on a patient, make recommendations, and text treatment plans. “The telemedicine platforms are being adopted really fast,” Dr. Adhikari said. “The platforms were built in no time.”

According to NewZoo, a games market data analytics company, India has 345.9 million smartphone users as of 2019 – the second highest number of users in the world after China. Dr. Odeti said he believes telemedicine will be widely adopted.

“In India, they are very proactive in accepting these kinds of methods, so I’m sure they will,” he said. “Governments were trying to do it before the pandemic, because access to care is a problem in India. There are villages which are very, very remote.”
 

Reversion to old systems

After the peak in late May, new COVID-19 cases in India began to decrease, and the second wave waned on a national level. Hospitals began to get the supplies they needed, beds are available, and patients aren’t as sick as before, according to Dr. Adhikari. The federal government has begun issuing supplies to patients in each state, including COVID-19 vaccines. “The peak for the second wave is gone,” he said.

What remains is a group of physicians trained in how to triage patients and create efficiencies in a hospital setting. Could those skills be put to use elsewhere in India after the pandemic?

According to Dr. Bhatt, the patient care model is likely to revert to the system that existed before. “Whatever the changes, interims of bed occupancy, cost of ICU will be temporary [and] will change to normal,” he said. “But awareness about masks [and] sanitizing methods will be permanent.”

Dr. Adhikari believes that not utilizing the skills of newly minted hospitalists in India would be a missed opportunity. “This is a silver lining from COVID-19, that hospital medicine plays a vital role in the sickest patients, whether it is in India or the U.S. or anywhere,” he said. “I think the model of hospital medicine should be adopted. It’s not: ‘Should it really be adopted or not?’ It should be. There is a huge potential in doing inpatient coordinated [care], having people dedicated in the hospital.”

There are tangible benefits to creating efficiencies in India’s health system, Dr. Odeti said. Length of stay for sicker patients “was much longer” at 10-14 days during the second wave, compared with the United States, before lowering to around 5 days. “These hospitals right now are learning the efficient ways of doing it: when to send [patients] out, how to send them out, how to [perform] service-based practices, creating processes which were nonexistent before.”

While he doesn’t personally believe physicians will adopt a full-fledged hospitalist model unless the payer structure in India changes, “these people are at an advantage with this extra set of skills,” he said. “I think all the knowledge that these people have are going to come in handy.”
 

Opportunities for growth

Dr. Odeti sees the potential for the hospitalist model to grow in India – if not into its own specialty, then in how critical care consultants handle sicker patients and handoffs.

“The critical care clinician cannot keep the patient from the time they are admitted to the ICU until the discharge, so there will be a need for the transition,” Dr. Odeti said. “In the past, there were not many capabilities in Indian health systems to take care of these extremely sick patients, and now it is evolving. I think that is one more thing that will help.”

Dr. Adhikari said hospital systems in India are beginning to realize how having dedicated hospital physicians could benefit them. In India, “if you’re sick, you go to your doctor, you get treated and you disappear,” he said. The next time, you may see the same doctor or a completely different doctor. “There’s no system there, so it’s really hard for hospital medicine as such because patients, when they are very sick, they just come to the ER. They’re not followed by their primary care.”

Anecdotally, Dr. Odeti sees patients already adapting to having access to a physician for asking questions normally answered by primary care physicians. “I think primary care will come into play,” he said. “When I was doing a Zoom call for patients, they were asking me questions about sciatica. I think they are getting comfortable with this technology.”

A hospitalist model could even be applied to specific diseases with a large population of patients. Hospital administrators “have seen this for the first time, how efficient it could be if they had their own hospitalists and actually run it. So that’s the part that has crossed their minds,” Dr. Adhikari said. “How they will apply it going forward, other than during the COVID-19 pandemic, depends on the size of the hospital and the volume of the patients for a particular disease.”

“You can see in certain areas there is large growth for hospital medicine. But to rise to the level of the United States and how we do it, India needs bigger health systems to adopt the model,” Dr. Adhikari said.

A year after the start of the COVID-19 pandemic, as the United States was getting a reprieve in new cases from its winter surge, the opposite was happening in the rest of the world. In India, a deadly second wave hit, crippling the health care system in the country for months.

Yugandhar Bhatt, MBBS, MD, a consultant pulmonologist with Yashoda Hospital–Malakpet in Hyderabad, India, told this news organization that someone looking at his hospital before the pandemic – a 400-bed multispecialty care unit – would see patients being treated for respiratory failure secondary to exacerbation of chronic obstructive pulmonary disease, bronchial asthma, community-acquired pneumonia, and heart failure. About 30-40 patients per day were treated on an outpatient basis, and more than 30 people were admitted as inpatients.

“After [the] COVID-19 surge, our hospital totally divided into COVID and non-COVID [wards], in which COVID patients occupied 70% of [the] total,” he said. About half of COVID-19 patients were in the ICU, with half of those patients requiring supplemental oxygen.

During the first wave in India, which lasted from May to December 2020, 50% of patients who were intubated were discharged. The percentage of extubated patients decreased to 20% in the second wave, Dr. Bhatt said.

The death toll during the second wave of COVID-19 cases was unlike anything India has seen previously. Between March 1 and June 29, 2021, an estimated 19.24 million individuals were newly infected with COVID-19 and 241,206 patients died, according to Our World in Data, a project of the Global Change Data Lab. When the second wave peaked on May 22, more than 4,000 people were dying each day.

“All hospitals [in India] were treating COVID-19 more than any other acute or chronic disease,” Ramesh Adhikari, MD, MS, SFHM, a hospitalist with Franciscan Health in Lafayette, Ind., said in an interview.

Challenges arose in treating COVID-19 in India that ran counter to how medicine was usually performed. Physicians were seeing more inpatient cases than usual – and more patients in general. The change, Dr. Adhikari said, forced health care providers to think outside the box.
 

An ‘on-the-fly’ hospitalist model

Patients in India access health care by visiting a hospital or primary health center and then are referred out to consultants – specialist doctors – if needed. While India has universal health coverage, it is a multi-payer system that includes approximately 37% of the population covered under the government plan, a large number of private health care facilities and no caps on cost-sharing for the patient. Initiatives like Rashtriya Swasthya Bima Yojana in 2008 and Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana in 2018 have attempted to close the gap and raise the number of lower-income individuals in India covered under the government plan and reduce out-of-pocket spending. Out-of-pocket payments still consist of about 70% of total health expenditures, according to the Commonwealth Fund.

“There is not much scope for a hospitalist because it’s so cash driven,” Shyam Odeti, MD, SFHM, section chief, hospital medicine, at the Carilion Clinic in Roanoke, Va., said in an interview. “For a hospitalist, there is no urgency in getting them out of the hospital. There was no need for much efficiency before.”

The first issue during the second wave was figuring out which consultants would care for COVID-19 patients. As there is no dedicated specialty for infectious disease in India, the responsibilities fell to internists and critical care medicine consultants who volunteered. Both are considered small specialties in India. They became “makeshift hospitalists” who learned as they went and became the experts in COVID-19 care, treating their own patients while making themselves available for consultations, Dr. Odeti said.

While no official hospital medicine model in India exists like in the United States, the second COVID-19 surge caused these consultants to begin thinking like hospitalists. Tenets of hospital medicine – like team-based treatment across specialties – arose out of necessity during the crisis. “They were trying to implement a hospitalist model because that’s the only way they could treat COVID-19,” said Dr. Adhikari, an editorial advisory board member for the Hospitalist.

“Even in the U.S. when we started the hospitalist model, it started out of necessity. It’s a combination of creating efficiencies and improving quality,” Dr. Odeti said. “It’s the same thing in India. It’s borne of necessity, but it was [done] at a rapid pace.”
 

Problems with patient flow

The next issue was triaging patients in the hospital based on COVID-19 severity. When the second wave began, hospitals in India ran out of beds and experienced staff shortages like in many countries. But this situation “was unusual for the health system,” according to Dr. Odeti, who is also an editorial board member for the Hospitalist.

“We never had that issue. There were so many patients wanting to come to the hospital, and so there was this rush.” There was no process to triage patients to determine who needed to stay. “Everybody got put into the hospital,” he said.

Once it was determined who would take care of patients with COVID-19, access to supplies became the primary problem, Dr. Adhikari explained. Lack of oxygen, ventilators, and critical medicines like the antiviral drug remdesivir were and continue to be in short supply. “I had friends who [said] they could not admit patients because they were worried if their oxygen supply [went] low in the middle of the night. They will treat the patients who were already admitted versus taking new patients. That had caused problems for the administrators,” Dr. Adhikari added.

It is also a source of additional stress for the physicians. Where patients flow through a hospital medicine model in the United States, a system that might include case managers, social workers, pharmacists, physician advocates, and other professionals to keep a patient’s care on track, the physician is the go-to person in India for patient care. While physicians provide access to medications and remain available to a patient’s family, those duties become much harder when caring for a greater number of patients during the pandemic. “That has led to some unrealistic expectations among the patients,” Dr. Adhikari said.

Dr. Bhatt said “more than half” of a physician’s time in India is spent counseling patients on concerns about COVID-19. “Awareness about the disease is limited from the patient and patient’s family perspective, as [there is] too much apprehension toward the nature of [the] disease,” he added. “Theoretical discussions collected from social media” obstruct the physician from executing his or her duties.

Physicians in India have had to contend with physical violence from patients and individuals on the street, Dr. Adhikari added. Workplace violence was already a concern – for years, the Indian Medical Association has cited a statistic that 75% of doctors in India have experienced violence at work (Indian J Psychiatry. 2019 Apr;61[Suppl 4]:S782-5). But the threat of violence against physicians has sharply increased during the COVID-19 pandemic. Disruptions to daily life through lockdowns “made people fearful, anxious, and sometimes they have found it difficult to access emergency treatment,” according to a letter published by Karthikeyan Iyengar and colleagues in the Postgraduate Medical Journal. In response to the restlessness, irritation, and despair resulting from hospitals closing their doors, “people have shown their frustration by verbally abusing and threatening to physically assault doctors and other health care workers,” the authors wrote.
 

A telemedicine boon in India

Back in the United States, hospitalists with family and friends in India were trying to figure out how to help. Some were working through the day, only to answer calls and WhatsApp messages from loved ones at night. “Everyone knows a physician or someone who’s your colleague, who owns a hospital or runs a hospital, or one of the family members is sick,” Dr. Adhikari said.

These U.S.-based hospitalists were burning the candle at both ends, helping with the pandemic in both countries. Physicians in India were posing questions to U.S. colleagues who they saw as having the most recent evidence for COVID-19 treatment. Out of the 180 physicians he trained with in India, Dr. Odeti said 110 of the physicians were in a large WhatsApp group chat that was constantly exchanging messages and serving as “kind of a friendly support group.”

In Dr. Odeti’s group chat, physicians helped one another find hospital beds for patients who reached out to them. “The first couple of weeks, there was no proper way for people to know where [patients] were based. There was no way to find if this hospital had a bed, so they reached out to any doctors they knew,” he said.

While he said it was emotionally draining, “at the same time, we felt a responsibility toward colleagues in India,” Dr. Odeti said, noting that as COVID-19 cases have decreased in India, the requests have been less frequent.

Because of concerns about traveling to India during the pandemic while on a J-1, H-1B, or other visa with the United States, directly helping friends and family in India seemed out of reach. But many hospitalists of Indian origin instead turned to telemedicine to help their colleagues. Telemedicine had already been steadily growing in India, but was accelerated by the pandemic. The current ratio of doctors to patients in India is 0.62 to 1,000 – lower than recommendations from the World Health Organization. That makes telemedicine a unique opportunity for one physician in India to reach many patients regardless of location.

Dr. Adhikari said he helped out his colleagues in India by performing consults for their patients. “They were just worried because they did not ‘know where to go, or what to get,” he said. “I was treating more patients in India than I was actually treating here.”

In March 2020, the Indian Ministry of Health and Family Welfare released telemedicine practice guidelines for the country, which relaxed regulations on privacy requirements and has been credited in part for giving telemedicine an additional boost during the pandemic. “That makes it easy for people to reach out but also has its own problems,” Dr. Adhikari said.

Monitoring of milder COVID-19 cases that don’t require hospitalization can be performed by a nurse who calls every few hours to check on a patient, make recommendations, and text treatment plans. “The telemedicine platforms are being adopted really fast,” Dr. Adhikari said. “The platforms were built in no time.”

According to NewZoo, a games market data analytics company, India has 345.9 million smartphone users as of 2019 – the second highest number of users in the world after China. Dr. Odeti said he believes telemedicine will be widely adopted.

“In India, they are very proactive in accepting these kinds of methods, so I’m sure they will,” he said. “Governments were trying to do it before the pandemic, because access to care is a problem in India. There are villages which are very, very remote.”
 

Reversion to old systems

After the peak in late May, new COVID-19 cases in India began to decrease, and the second wave waned on a national level. Hospitals began to get the supplies they needed, beds are available, and patients aren’t as sick as before, according to Dr. Adhikari. The federal government has begun issuing supplies to patients in each state, including COVID-19 vaccines. “The peak for the second wave is gone,” he said.

What remains is a group of physicians trained in how to triage patients and create efficiencies in a hospital setting. Could those skills be put to use elsewhere in India after the pandemic?

According to Dr. Bhatt, the patient care model is likely to revert to the system that existed before. “Whatever the changes, interims of bed occupancy, cost of ICU will be temporary [and] will change to normal,” he said. “But awareness about masks [and] sanitizing methods will be permanent.”

Dr. Adhikari believes that not utilizing the skills of newly minted hospitalists in India would be a missed opportunity. “This is a silver lining from COVID-19, that hospital medicine plays a vital role in the sickest patients, whether it is in India or the U.S. or anywhere,” he said. “I think the model of hospital medicine should be adopted. It’s not: ‘Should it really be adopted or not?’ It should be. There is a huge potential in doing inpatient coordinated [care], having people dedicated in the hospital.”

There are tangible benefits to creating efficiencies in India’s health system, Dr. Odeti said. Length of stay for sicker patients “was much longer” at 10-14 days during the second wave, compared with the United States, before lowering to around 5 days. “These hospitals right now are learning the efficient ways of doing it: when to send [patients] out, how to send them out, how to [perform] service-based practices, creating processes which were nonexistent before.”

While he doesn’t personally believe physicians will adopt a full-fledged hospitalist model unless the payer structure in India changes, “these people are at an advantage with this extra set of skills,” he said. “I think all the knowledge that these people have are going to come in handy.”
 

Opportunities for growth

Dr. Odeti sees the potential for the hospitalist model to grow in India – if not into its own specialty, then in how critical care consultants handle sicker patients and handoffs.

“The critical care clinician cannot keep the patient from the time they are admitted to the ICU until the discharge, so there will be a need for the transition,” Dr. Odeti said. “In the past, there were not many capabilities in Indian health systems to take care of these extremely sick patients, and now it is evolving. I think that is one more thing that will help.”

Dr. Adhikari said hospital systems in India are beginning to realize how having dedicated hospital physicians could benefit them. In India, “if you’re sick, you go to your doctor, you get treated and you disappear,” he said. The next time, you may see the same doctor or a completely different doctor. “There’s no system there, so it’s really hard for hospital medicine as such because patients, when they are very sick, they just come to the ER. They’re not followed by their primary care.”

Anecdotally, Dr. Odeti sees patients already adapting to having access to a physician for asking questions normally answered by primary care physicians. “I think primary care will come into play,” he said. “When I was doing a Zoom call for patients, they were asking me questions about sciatica. I think they are getting comfortable with this technology.”

A hospitalist model could even be applied to specific diseases with a large population of patients. Hospital administrators “have seen this for the first time, how efficient it could be if they had their own hospitalists and actually run it. So that’s the part that has crossed their minds,” Dr. Adhikari said. “How they will apply it going forward, other than during the COVID-19 pandemic, depends on the size of the hospital and the volume of the patients for a particular disease.”

“You can see in certain areas there is large growth for hospital medicine. But to rise to the level of the United States and how we do it, India needs bigger health systems to adopt the model,” Dr. Adhikari said.

Here’s some encouraging news for once regarding SARS-CoV-2 infections: A study of young adults for whom prepandemic spirometry data were available showed that COVID-19 did not have a significant impact on lung function, even among patients with asthma.

Among 853 Swedish men and women (mean age, 22 years) who were part of a birth cohort study, there were no significant differences in either forced expiratory volume in 1 second (FEV₁) or in the ratio of FEV1 to forced vital capacity, reported Ida Mogensen, MD, PhD, a postdoctoral fellow at the Karolinska Institute in Stockholm.

“We found no effect of COVID-19 on spirometric lung function in generally healthy adults,” she said in an oral abstract presented at the European Respiratory Society 2021 International Congress.

The findings echo those of a small study that involved 73 children and adolescents with COVID-19 and 45 uninfected control persons. The investigators in that study, which was also presented at ERS 2021, found that there were no significant differences in the frequency of abnormal pulmonary function measures between case patients and control patients (abstract OA1303).

“The findings from these two studies provide important reassurance about the impact of COVID infection on lung function in children and young adults,” commented Anita Simonds, MD, an honorary consultant in respiratory and sleep medicine at the Royal Brompton Hospital, London.

“We know already that this group is less likely to suffer severe illness if they contract the virus, and these studies, which importantly include comparator groups without COVID-19, show that they are also less likely to suffer long-term consequences with respect to lung function,” she said. Dr. Simonds was not involved in either study.
 

Young adult study

Dr. Mogenson and colleagues assessed data on 853 participants in the BAMSE Project, a prospective birth cohort study that included 4,089 children born in Stockholm from 1994 to 1996. Of the participants, 147 had asthma. They have been regularly followed with questionnaires on respiratory symptoms and medications. In addition, at 8 and 16 years’ follow-up, spirometry measures and fractional exhaled nitric oxide (FeNO) levels were assessed, allergic sensitization tests were administered, and blood eosinophil levels were measured.

In 2020 and 2021, during the pandemic, the participants underwent spirometry testing and were assessed for antibodies against SARS-CoV-2, and they self-reported use of inhaled corticosteroids.

The investigators defined asthma as any physician diagnosis and asthma symptoms and/or asthma medication use within the previous year. Participants were determined to be COVID-19 seropositive if they had IgG antibodies to the SARS-CoV-2 spike greater than 25.09 AU/mL, IgM antibodies greater than 14.42 AU/mL, or IgA antibodies greater than 2.61 AU/mL, as measured with enzyme-linked immunosorbent assay.

Participants who had been vaccinated against COVID-19 were excluded.
 

No significant decreases

A total of 243 participants, including 38 with asthma, were seropositive for SARS-CoV-2 antibodies. The mean change in lung function from before the pandemic to the study end date during the pandemic were not significantly different between seropositive participants and seronegative participants or IgM-positive participants and seronegative participants.

Similarly, there were no significant differences in lung function between seropositive and seronegative participants in an analysis that was adjusted for sex, body mass index, smoking status, or prepandemic lung function.

Although there was a trend toward slightly lower function among seropositive participants with asthma in comparison with seronegative patients with asthma, it was not statistically significant, Dr. Mogenson said.

There were also no significant decreases in lung function from the prepandemic measure to the present in any of the inflammatory parameters, including blood eosinophil levels, FeNO, allergic sensitization, or inhaled corticosteroid use.
 

Potential misclassification

In the question-and-answer period that followed the presentation, session comoderator Sam Bayat, MD, PhD, from the University of Grenoble (France), who was not involved in the study, noted that “some subjects can have positive serology without any symptoms, while others can have symptomatic disease and a couple of months later they have negative serology.”

He asked Dr. Mogenson whether they had included in their study participants with symptomatic COVID-19 and whether that would change the findings.

“We did not have access to RNA testing, so we only had serology, and of course some participants could be wrongly classified to have disease – probably around 15%,” she acknowledged.

She noted that there were no significant changes in lung function among patients who reported having respiratory symptoms.

The study was funded by the Swedish Research Council, the Swedish Heart-Lung Foundation, the Swedish Research Council for Health, Working Life and Welfare, the Karolinska Institutet, Formas, the European Research Council, and Region Stockholm. Dr. Mogenson, Dr. Simonds, and Dr. Bayat disclosed no relevant financial relationships.

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

Here’s some encouraging news for once regarding SARS-CoV-2 infections: A study of young adults for whom prepandemic spirometry data were available showed that COVID-19 did not have a significant impact on lung function, even among patients with asthma.

Among 853 Swedish men and women (mean age, 22 years) who were part of a birth cohort study, there were no significant differences in either forced expiratory volume in 1 second (FEV₁) or in the ratio of FEV1 to forced vital capacity, reported Ida Mogensen, MD, PhD, a postdoctoral fellow at the Karolinska Institute in Stockholm.

“We found no effect of COVID-19 on spirometric lung function in generally healthy adults,” she said in an oral abstract presented at the European Respiratory Society 2021 International Congress.

The findings echo those of a small study that involved 73 children and adolescents with COVID-19 and 45 uninfected control persons. The investigators in that study, which was also presented at ERS 2021, found that there were no significant differences in the frequency of abnormal pulmonary function measures between case patients and control patients (abstract OA1303).

“The findings from these two studies provide important reassurance about the impact of COVID infection on lung function in children and young adults,” commented Anita Simonds, MD, an honorary consultant in respiratory and sleep medicine at the Royal Brompton Hospital, London.

“We know already that this group is less likely to suffer severe illness if they contract the virus, and these studies, which importantly include comparator groups without COVID-19, show that they are also less likely to suffer long-term consequences with respect to lung function,” she said. Dr. Simonds was not involved in either study.
 

Young adult study

Dr. Mogenson and colleagues assessed data on 853 participants in the BAMSE Project, a prospective birth cohort study that included 4,089 children born in Stockholm from 1994 to 1996. Of the participants, 147 had asthma. They have been regularly followed with questionnaires on respiratory symptoms and medications. In addition, at 8 and 16 years’ follow-up, spirometry measures and fractional exhaled nitric oxide (FeNO) levels were assessed, allergic sensitization tests were administered, and blood eosinophil levels were measured.

In 2020 and 2021, during the pandemic, the participants underwent spirometry testing and were assessed for antibodies against SARS-CoV-2, and they self-reported use of inhaled corticosteroids.

The investigators defined asthma as any physician diagnosis and asthma symptoms and/or asthma medication use within the previous year. Participants were determined to be COVID-19 seropositive if they had IgG antibodies to the SARS-CoV-2 spike greater than 25.09 AU/mL, IgM antibodies greater than 14.42 AU/mL, or IgA antibodies greater than 2.61 AU/mL, as measured with enzyme-linked immunosorbent assay.

Participants who had been vaccinated against COVID-19 were excluded.
 

No significant decreases

A total of 243 participants, including 38 with asthma, were seropositive for SARS-CoV-2 antibodies. The mean change in lung function from before the pandemic to the study end date during the pandemic were not significantly different between seropositive participants and seronegative participants or IgM-positive participants and seronegative participants.

Similarly, there were no significant differences in lung function between seropositive and seronegative participants in an analysis that was adjusted for sex, body mass index, smoking status, or prepandemic lung function.

Although there was a trend toward slightly lower function among seropositive participants with asthma in comparison with seronegative patients with asthma, it was not statistically significant, Dr. Mogenson said.

There were also no significant decreases in lung function from the prepandemic measure to the present in any of the inflammatory parameters, including blood eosinophil levels, FeNO, allergic sensitization, or inhaled corticosteroid use.
 

Potential misclassification

In the question-and-answer period that followed the presentation, session comoderator Sam Bayat, MD, PhD, from the University of Grenoble (France), who was not involved in the study, noted that “some subjects can have positive serology without any symptoms, while others can have symptomatic disease and a couple of months later they have negative serology.”

He asked Dr. Mogenson whether they had included in their study participants with symptomatic COVID-19 and whether that would change the findings.

“We did not have access to RNA testing, so we only had serology, and of course some participants could be wrongly classified to have disease – probably around 15%,” she acknowledged.

She noted that there were no significant changes in lung function among patients who reported having respiratory symptoms.

The study was funded by the Swedish Research Council, the Swedish Heart-Lung Foundation, the Swedish Research Council for Health, Working Life and Welfare, the Karolinska Institutet, Formas, the European Research Council, and Region Stockholm. Dr. Mogenson, Dr. Simonds, and Dr. Bayat disclosed no relevant financial relationships.

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

Here’s some encouraging news for once regarding SARS-CoV-2 infections: A study of young adults for whom prepandemic spirometry data were available showed that COVID-19 did not have a significant impact on lung function, even among patients with asthma.

Among 853 Swedish men and women (mean age, 22 years) who were part of a birth cohort study, there were no significant differences in either forced expiratory volume in 1 second (FEV₁) or in the ratio of FEV1 to forced vital capacity, reported Ida Mogensen, MD, PhD, a postdoctoral fellow at the Karolinska Institute in Stockholm.

“We found no effect of COVID-19 on spirometric lung function in generally healthy adults,” she said in an oral abstract presented at the European Respiratory Society 2021 International Congress.

The findings echo those of a small study that involved 73 children and adolescents with COVID-19 and 45 uninfected control persons. The investigators in that study, which was also presented at ERS 2021, found that there were no significant differences in the frequency of abnormal pulmonary function measures between case patients and control patients (abstract OA1303).

“The findings from these two studies provide important reassurance about the impact of COVID infection on lung function in children and young adults,” commented Anita Simonds, MD, an honorary consultant in respiratory and sleep medicine at the Royal Brompton Hospital, London.

“We know already that this group is less likely to suffer severe illness if they contract the virus, and these studies, which importantly include comparator groups without COVID-19, show that they are also less likely to suffer long-term consequences with respect to lung function,” she said. Dr. Simonds was not involved in either study.
 

Young adult study

Dr. Mogenson and colleagues assessed data on 853 participants in the BAMSE Project, a prospective birth cohort study that included 4,089 children born in Stockholm from 1994 to 1996. Of the participants, 147 had asthma. They have been regularly followed with questionnaires on respiratory symptoms and medications. In addition, at 8 and 16 years’ follow-up, spirometry measures and fractional exhaled nitric oxide (FeNO) levels were assessed, allergic sensitization tests were administered, and blood eosinophil levels were measured.

In 2020 and 2021, during the pandemic, the participants underwent spirometry testing and were assessed for antibodies against SARS-CoV-2, and they self-reported use of inhaled corticosteroids.

The investigators defined asthma as any physician diagnosis and asthma symptoms and/or asthma medication use within the previous year. Participants were determined to be COVID-19 seropositive if they had IgG antibodies to the SARS-CoV-2 spike greater than 25.09 AU/mL, IgM antibodies greater than 14.42 AU/mL, or IgA antibodies greater than 2.61 AU/mL, as measured with enzyme-linked immunosorbent assay.

Participants who had been vaccinated against COVID-19 were excluded.
 

No significant decreases

A total of 243 participants, including 38 with asthma, were seropositive for SARS-CoV-2 antibodies. The mean change in lung function from before the pandemic to the study end date during the pandemic were not significantly different between seropositive participants and seronegative participants or IgM-positive participants and seronegative participants.

Similarly, there were no significant differences in lung function between seropositive and seronegative participants in an analysis that was adjusted for sex, body mass index, smoking status, or prepandemic lung function.

Although there was a trend toward slightly lower function among seropositive participants with asthma in comparison with seronegative patients with asthma, it was not statistically significant, Dr. Mogenson said.

There were also no significant decreases in lung function from the prepandemic measure to the present in any of the inflammatory parameters, including blood eosinophil levels, FeNO, allergic sensitization, or inhaled corticosteroid use.
 

Potential misclassification

In the question-and-answer period that followed the presentation, session comoderator Sam Bayat, MD, PhD, from the University of Grenoble (France), who was not involved in the study, noted that “some subjects can have positive serology without any symptoms, while others can have symptomatic disease and a couple of months later they have negative serology.”

He asked Dr. Mogenson whether they had included in their study participants with symptomatic COVID-19 and whether that would change the findings.

“We did not have access to RNA testing, so we only had serology, and of course some participants could be wrongly classified to have disease – probably around 15%,” she acknowledged.

She noted that there were no significant changes in lung function among patients who reported having respiratory symptoms.

The study was funded by the Swedish Research Council, the Swedish Heart-Lung Foundation, the Swedish Research Council for Health, Working Life and Welfare, the Karolinska Institutet, Formas, the European Research Council, and Region Stockholm. Dr. Mogenson, Dr. Simonds, and Dr. Bayat disclosed no relevant financial relationships.

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

Observational data indicate that the number of hospitalizations for cardiac arrests linked to opioid use roughly doubled from 2012 to 2018.

“This was an observational study, so we cannot conclude that all of the arrests were caused by opioids, but the findings do suggest the opioid epidemic is a contributor to increasing rates,” Senada S. Malik, of the University of New England, Portland, Maine, reported at the virtual annual congress of the European Society of Cardiology.

The data were drawn from the Nationwide Inpatient Sample (NIS) from 2012 to 2018, the most recent period available. Cardiac arrests were considered opioid related if there was a secondary diagnosis of opioid disease. The rates of opioid-associated hospitalizations for these types of cardiac arrests climbed from about 800 per year in 2012 to 1,500 per year in 2018, a trend that was statistically significant (P < .05).

The profile of patients with an opioid-associated cardiac arrest was different from those without secondary diagnosis of opioid disease. This included a younger age and lower rates of comorbidities: heart failure (21.2% vs. 40.6%; P < .05), renal failure (14.3% vs. 30.2%; P < .05), diabetes (19.5% vs. 35.4%; P < .05), and hypertension (43.4% vs. 64.9%; P < .05).
 

Mortality from opioid-associated cardiac arrest is lower

These features might explain the lower rate of in-hospital mortality for opioid-associated cardiac arrests (56.7% vs. 61.2%), according to Ms. Malik, who performed this research in collaboration with Wilbert S. Aronow, MD, director of cardiology research, Westchester Medical Center, Valhalla, N.Y.

When compared to those without a history of opioid use on admission, those with opioid-associated cardiac arrest were more likely to be depressed (18.8% vs. 9.0%), to smoke (37.0% vs. 21.8%) and to abuse alcohol (16.9% vs. 7.1%), according to the NIS data.

While these findings are based on cardiac arrests brought to a hospital, some opioid-induced cardiac arrests never result in hospital admission, according to data included in a recently issued scientific statement from the American Heart Association.

Rate of opioid-associated cardiac arrests underestimated

In that statement, which was focused on opioid-associated out-of-hospital cardiac arrests (OA-OHCA), numerous studies were cited to support the conclusion that these events are common and underestimated. One problem is that opioid-induced cardiac arrests are not always accurately differentiated from cardiac arrests induced by use of other substances, such as barbiturates, cocaine, or alcohol.

For this and other reasons, the data are inconsistent. One study based on emergency medical service (EMS) response data concluded that 9% of all out-of-hospital cardiac arrests are opioid associated.

In another study using potentially more accurate autopsy data, 60% of the non–cardiac-associated cardiac arrests were found to occur in individuals with potentially lethal serum concentrations of opioids. As 40% of out-of-hospital cardiac arrests were considered non–cardiac related, this suggested that 15% of all out-of-hospital cardiac arrests are opioid related.

In the NIS data, the incident curves of opioid-related cardiac arrests appeared to be flattening in 2018, the last year of data collection, but there was no indication they were declining.
 

Patterns of opioid-induced cardiac arrests evolving

The patterns of opioid-induced cardiac arrest have changed and are likely to continue to change in response to the evolving opioid epidemic, according to the AHA scientific statement. The authors described three waves of opioid abuse. The first, which was related to the promotion of prescription opioids to treat chronic pain that ultimately led to high rates of opioid addiction, peaked in 2012 when rates of these prescriptions began to fall. At that time a second wave, attributed to patients switching to less expensive nonprescription heroin, was already underway. A third wave, attributed to growth in the use of synthetic opioids, such as fentanyl, began in 2013 and is ongoing, according to data cited in the AHA statement.

Recognizing the role of opioids in rising rates of cardiac arrest is important for promoting strategies of effective treatment and prevention, according to Cameron Dezfulian, MD, medical director of the adult congenital heart disease program at Texas Children’s Hospital, Houston. Dr. Dezfulian was vice chair and leader of the writing committee for the AHA scientific statement on OA-OHCA. He said there are plenty of data to support the need for greater attention to the role of opioids in cardiac arrest.

“The recent data affirms the trends many of us have observed without our emergency rooms and ICUs: a steady increase in the proportion of OA-OHCA, primarily in young and otherwise healthy individuals,” he said.

He calls not only for more awareness at the front lines of health are but also for a more comprehensive approach.

“Public health policies and community- and hospital-based interventions are needed to reduce the mortality due to OA-OHCA, which is distinct from the traditional cardiac etiology,” Dr. Dezfulian said.

In opioid-induced cardiac arrest, as in other types of cardiac arrest, prompt initiation of cardiopulmonary resuscitation is essential, but early administration of the opioid antagonist naloxone can also be lifesaving, according to treatment strategies outlined in the AHA scientific statement. The fact that OA-OHCA typically occur in patients with structurally and electrophysiologically normal hearts is emphasized in the AHA statement. So is the enormous public health toll of OA-OHCA.

Death due to opioid overdose, which includes cardiac arrests, is now the leading cause of mortality in the U.S. among individuals between the ages of 25 and 64 years, according to the statement.

Ms. Malik reports no potential conflicts of interest. Dr. Dezfulian reports a financial relationship with Mallinckrodt.

Observational data indicate that the number of hospitalizations for cardiac arrests linked to opioid use roughly doubled from 2012 to 2018.

“This was an observational study, so we cannot conclude that all of the arrests were caused by opioids, but the findings do suggest the opioid epidemic is a contributor to increasing rates,” Senada S. Malik, of the University of New England, Portland, Maine, reported at the virtual annual congress of the European Society of Cardiology.

The data were drawn from the Nationwide Inpatient Sample (NIS) from 2012 to 2018, the most recent period available. Cardiac arrests were considered opioid related if there was a secondary diagnosis of opioid disease. The rates of opioid-associated hospitalizations for these types of cardiac arrests climbed from about 800 per year in 2012 to 1,500 per year in 2018, a trend that was statistically significant (P < .05).

The profile of patients with an opioid-associated cardiac arrest was different from those without secondary diagnosis of opioid disease. This included a younger age and lower rates of comorbidities: heart failure (21.2% vs. 40.6%; P < .05), renal failure (14.3% vs. 30.2%; P < .05), diabetes (19.5% vs. 35.4%; P < .05), and hypertension (43.4% vs. 64.9%; P < .05).
 

Mortality from opioid-associated cardiac arrest is lower

These features might explain the lower rate of in-hospital mortality for opioid-associated cardiac arrests (56.7% vs. 61.2%), according to Ms. Malik, who performed this research in collaboration with Wilbert S. Aronow, MD, director of cardiology research, Westchester Medical Center, Valhalla, N.Y.

When compared to those without a history of opioid use on admission, those with opioid-associated cardiac arrest were more likely to be depressed (18.8% vs. 9.0%), to smoke (37.0% vs. 21.8%) and to abuse alcohol (16.9% vs. 7.1%), according to the NIS data.

While these findings are based on cardiac arrests brought to a hospital, some opioid-induced cardiac arrests never result in hospital admission, according to data included in a recently issued scientific statement from the American Heart Association.

Rate of opioid-associated cardiac arrests underestimated

In that statement, which was focused on opioid-associated out-of-hospital cardiac arrests (OA-OHCA), numerous studies were cited to support the conclusion that these events are common and underestimated. One problem is that opioid-induced cardiac arrests are not always accurately differentiated from cardiac arrests induced by use of other substances, such as barbiturates, cocaine, or alcohol.

For this and other reasons, the data are inconsistent. One study based on emergency medical service (EMS) response data concluded that 9% of all out-of-hospital cardiac arrests are opioid associated.

In another study using potentially more accurate autopsy data, 60% of the non–cardiac-associated cardiac arrests were found to occur in individuals with potentially lethal serum concentrations of opioids. As 40% of out-of-hospital cardiac arrests were considered non–cardiac related, this suggested that 15% of all out-of-hospital cardiac arrests are opioid related.

In the NIS data, the incident curves of opioid-related cardiac arrests appeared to be flattening in 2018, the last year of data collection, but there was no indication they were declining.
 

Patterns of opioid-induced cardiac arrests evolving

The patterns of opioid-induced cardiac arrest have changed and are likely to continue to change in response to the evolving opioid epidemic, according to the AHA scientific statement. The authors described three waves of opioid abuse. The first, which was related to the promotion of prescription opioids to treat chronic pain that ultimately led to high rates of opioid addiction, peaked in 2012 when rates of these prescriptions began to fall. At that time a second wave, attributed to patients switching to less expensive nonprescription heroin, was already underway. A third wave, attributed to growth in the use of synthetic opioids, such as fentanyl, began in 2013 and is ongoing, according to data cited in the AHA statement.

Recognizing the role of opioids in rising rates of cardiac arrest is important for promoting strategies of effective treatment and prevention, according to Cameron Dezfulian, MD, medical director of the adult congenital heart disease program at Texas Children’s Hospital, Houston. Dr. Dezfulian was vice chair and leader of the writing committee for the AHA scientific statement on OA-OHCA. He said there are plenty of data to support the need for greater attention to the role of opioids in cardiac arrest.

“The recent data affirms the trends many of us have observed without our emergency rooms and ICUs: a steady increase in the proportion of OA-OHCA, primarily in young and otherwise healthy individuals,” he said.

He calls not only for more awareness at the front lines of health are but also for a more comprehensive approach.

“Public health policies and community- and hospital-based interventions are needed to reduce the mortality due to OA-OHCA, which is distinct from the traditional cardiac etiology,” Dr. Dezfulian said.

In opioid-induced cardiac arrest, as in other types of cardiac arrest, prompt initiation of cardiopulmonary resuscitation is essential, but early administration of the opioid antagonist naloxone can also be lifesaving, according to treatment strategies outlined in the AHA scientific statement. The fact that OA-OHCA typically occur in patients with structurally and electrophysiologically normal hearts is emphasized in the AHA statement. So is the enormous public health toll of OA-OHCA.

Death due to opioid overdose, which includes cardiac arrests, is now the leading cause of mortality in the U.S. among individuals between the ages of 25 and 64 years, according to the statement.

Ms. Malik reports no potential conflicts of interest. Dr. Dezfulian reports a financial relationship with Mallinckrodt.

Observational data indicate that the number of hospitalizations for cardiac arrests linked to opioid use roughly doubled from 2012 to 2018.

“This was an observational study, so we cannot conclude that all of the arrests were caused by opioids, but the findings do suggest the opioid epidemic is a contributor to increasing rates,” Senada S. Malik, of the University of New England, Portland, Maine, reported at the virtual annual congress of the European Society of Cardiology.

The data were drawn from the Nationwide Inpatient Sample (NIS) from 2012 to 2018, the most recent period available. Cardiac arrests were considered opioid related if there was a secondary diagnosis of opioid disease. The rates of opioid-associated hospitalizations for these types of cardiac arrests climbed from about 800 per year in 2012 to 1,500 per year in 2018, a trend that was statistically significant (P < .05).

The profile of patients with an opioid-associated cardiac arrest was different from those without secondary diagnosis of opioid disease. This included a younger age and lower rates of comorbidities: heart failure (21.2% vs. 40.6%; P < .05), renal failure (14.3% vs. 30.2%; P < .05), diabetes (19.5% vs. 35.4%; P < .05), and hypertension (43.4% vs. 64.9%; P < .05).
 

Mortality from opioid-associated cardiac arrest is lower

These features might explain the lower rate of in-hospital mortality for opioid-associated cardiac arrests (56.7% vs. 61.2%), according to Ms. Malik, who performed this research in collaboration with Wilbert S. Aronow, MD, director of cardiology research, Westchester Medical Center, Valhalla, N.Y.

When compared to those without a history of opioid use on admission, those with opioid-associated cardiac arrest were more likely to be depressed (18.8% vs. 9.0%), to smoke (37.0% vs. 21.8%) and to abuse alcohol (16.9% vs. 7.1%), according to the NIS data.

While these findings are based on cardiac arrests brought to a hospital, some opioid-induced cardiac arrests never result in hospital admission, according to data included in a recently issued scientific statement from the American Heart Association.

Rate of opioid-associated cardiac arrests underestimated

In that statement, which was focused on opioid-associated out-of-hospital cardiac arrests (OA-OHCA), numerous studies were cited to support the conclusion that these events are common and underestimated. One problem is that opioid-induced cardiac arrests are not always accurately differentiated from cardiac arrests induced by use of other substances, such as barbiturates, cocaine, or alcohol.

For this and other reasons, the data are inconsistent. One study based on emergency medical service (EMS) response data concluded that 9% of all out-of-hospital cardiac arrests are opioid associated.

In another study using potentially more accurate autopsy data, 60% of the non–cardiac-associated cardiac arrests were found to occur in individuals with potentially lethal serum concentrations of opioids. As 40% of out-of-hospital cardiac arrests were considered non–cardiac related, this suggested that 15% of all out-of-hospital cardiac arrests are opioid related.

In the NIS data, the incident curves of opioid-related cardiac arrests appeared to be flattening in 2018, the last year of data collection, but there was no indication they were declining.
 

Patterns of opioid-induced cardiac arrests evolving

The patterns of opioid-induced cardiac arrest have changed and are likely to continue to change in response to the evolving opioid epidemic, according to the AHA scientific statement. The authors described three waves of opioid abuse. The first, which was related to the promotion of prescription opioids to treat chronic pain that ultimately led to high rates of opioid addiction, peaked in 2012 when rates of these prescriptions began to fall. At that time a second wave, attributed to patients switching to less expensive nonprescription heroin, was already underway. A third wave, attributed to growth in the use of synthetic opioids, such as fentanyl, began in 2013 and is ongoing, according to data cited in the AHA statement.

Recognizing the role of opioids in rising rates of cardiac arrest is important for promoting strategies of effective treatment and prevention, according to Cameron Dezfulian, MD, medical director of the adult congenital heart disease program at Texas Children’s Hospital, Houston. Dr. Dezfulian was vice chair and leader of the writing committee for the AHA scientific statement on OA-OHCA. He said there are plenty of data to support the need for greater attention to the role of opioids in cardiac arrest.

“The recent data affirms the trends many of us have observed without our emergency rooms and ICUs: a steady increase in the proportion of OA-OHCA, primarily in young and otherwise healthy individuals,” he said.

He calls not only for more awareness at the front lines of health are but also for a more comprehensive approach.

“Public health policies and community- and hospital-based interventions are needed to reduce the mortality due to OA-OHCA, which is distinct from the traditional cardiac etiology,” Dr. Dezfulian said.

In opioid-induced cardiac arrest, as in other types of cardiac arrest, prompt initiation of cardiopulmonary resuscitation is essential, but early administration of the opioid antagonist naloxone can also be lifesaving, according to treatment strategies outlined in the AHA scientific statement. The fact that OA-OHCA typically occur in patients with structurally and electrophysiologically normal hearts is emphasized in the AHA statement. So is the enormous public health toll of OA-OHCA.

Death due to opioid overdose, which includes cardiac arrests, is now the leading cause of mortality in the U.S. among individuals between the ages of 25 and 64 years, according to the statement.

Ms. Malik reports no potential conflicts of interest. Dr. Dezfulian reports a financial relationship with Mallinckrodt.

President Joe Biden has announced a host of new plans to rein in COVID-19’s runaway transmission in the United States, including sweeping vaccine mandates that will affect 100 million American workers, nearly two-thirds of the country’s workforce.

itsmejust/Thinkstock

“As your president, I’m announcing tonight a new plan to get more Americans vaccinated to combat those blocking public health,” he said Sept. 9.

As part of a six-part plan unveiled in a speech from the State Dining Room of the White House, President Biden said he would require vaccinations for nearly 4 million federal workers and the employees of companies that contract with the federal government.

He has also directed the Occupational Safety and Health Administration to develop a rule that will require large employers -- those with at least 100 employees -- to ensure their workers are vaccinated or tested weekly.

Nearly 17 million health care workers will face new vaccine mandates as part of the conditions of participation in the Medicare and Medicaid programs.

President Biden said the federal government will require staff at federally funded Head Start programs and schools to be vaccinated. He’s also calling on all states to mandate vaccines for teachers.

“A distinct minority of Americans, supported by a distinct minority of elected officials, are keeping us from turning the corner,” PresidentBiden said. “These pandemic politics, as I refer to them, are making people sick, causing unvaccinated people to die.”

One public health official said he was glad to see the president’s bold action.

“What I saw today was the federal government trying to use its powers to create greater safety in the American population,” said Ashish K. Jha, MD, dean of the school of public health at Brown University, Providence, R.I., in a call with reporters after the speech.

National Nurses United, the largest union of registered nurses in the United States, issued a statement in support of President Biden’s new vaccination requirements, but pushed back on his language.

“…as advocates for public health, registered nurses want to be extremely clear: There is no such thing as a pandemic of only the unvaccinated. The science of epidemiology tells us there is just one deadly, global pandemic that has not yet ended, and we are all in it together. To get out of it, we must act together. All of us,” the statement says.

A host of other professional groups, including the American Medical Association and the Association of State and Territorial Health Officials, also issued statements of support for President Biden’s plan.

But the plan was not well received by all.

“I will pursue every legal option available to the state of Georgia to stop this blatantly unlawful overreach by the Biden Administration,” said Georgia Governor Brian Kemp, a Republican, in a Tweet.

The National Council for Occupational Safety and Health called the plan “a missed opportunity” because it failed to include workplace protections for essential workers such as grocery, postal, and transit workers.

“Social distancing, improved ventilation, shift rotation, and protective equipment to reduce exposure are important components of an overall plan to reduce risk and stop the virus. These tools are missing from the new steps President Biden announced today,” said Jessica Martinez, co-executive director of the group.

In addition to the new vaccination requirements, President Biden said extra doses would be on the way for people who have already been fully vaccinated in order to protect against waning immunity, starting on Sept. 20. But he noted that those plans would be contingent on the Food and Drug Administration’s approval for third doses and the Centers for Disease Control and Prevention’s recommendation of the shots.

President Biden pledged to use the Defense Production Act to ramp up production of at-home tests, which have been selling out across the nation as the Delta variant spreads.

He also announced plans to expand access to COVID-19 testing, including offering testing for free at thousands of pharmacies nationwide and getting major retailers to sell at-home COVID-19 tests at cost.

The BinaxNow test kit, which currently retails for $23.99, will now cost about $15 for two tests at Kroger, Amazon, and Walmart, according to the White House. Food banks and community health centers will get free tests, too.

He called on states to set up COVID-19 testing programs at all schools.

Jha said that in his view, the big, game-changing news out of the president’s speech was the expansion of testing.

“Our country has failed to deploy tests in a way that can really bring this pandemic under control,” Jha said. “There are plenty of reasons, data, experience to indicate that if these were widely available, it would make a dramatic difference in reducing infection numbers across our country.”.

Dr. Jha said the private market had not worked effectively to make testing more widely available, so it was “absolutely a requirement of the federal government to step in and make testing more widely available,” he said.

President Biden also announced new economic stimulus programs, saying he’s expanding loan programs to small businesses and streamlining the loan forgiveness process.

President Biden said he’s boosting help for overburdened hospitals, doubling the number of federal surge response teams sent to hard-hit areas to reduce the strain on local health care workers. He said he would increase the pace of antibody treatments to states by 50%.

“We made so much progress during the past 7 months of this pandemic. Even so, we remain at a critical moment, a critical time,” he said. “We have the tools. Now, we just have to finish the job with truth, with science, with confidence and together as one nation.”

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

President Joe Biden has announced a host of new plans to rein in COVID-19’s runaway transmission in the United States, including sweeping vaccine mandates that will affect 100 million American workers, nearly two-thirds of the country’s workforce.

itsmejust/Thinkstock

“As your president, I’m announcing tonight a new plan to get more Americans vaccinated to combat those blocking public health,” he said Sept. 9.

As part of a six-part plan unveiled in a speech from the State Dining Room of the White House, President Biden said he would require vaccinations for nearly 4 million federal workers and the employees of companies that contract with the federal government.

He has also directed the Occupational Safety and Health Administration to develop a rule that will require large employers -- those with at least 100 employees -- to ensure their workers are vaccinated or tested weekly.

Nearly 17 million health care workers will face new vaccine mandates as part of the conditions of participation in the Medicare and Medicaid programs.

President Biden said the federal government will require staff at federally funded Head Start programs and schools to be vaccinated. He’s also calling on all states to mandate vaccines for teachers.

“A distinct minority of Americans, supported by a distinct minority of elected officials, are keeping us from turning the corner,” PresidentBiden said. “These pandemic politics, as I refer to them, are making people sick, causing unvaccinated people to die.”

One public health official said he was glad to see the president’s bold action.

“What I saw today was the federal government trying to use its powers to create greater safety in the American population,” said Ashish K. Jha, MD, dean of the school of public health at Brown University, Providence, R.I., in a call with reporters after the speech.

National Nurses United, the largest union of registered nurses in the United States, issued a statement in support of President Biden’s new vaccination requirements, but pushed back on his language.

“…as advocates for public health, registered nurses want to be extremely clear: There is no such thing as a pandemic of only the unvaccinated. The science of epidemiology tells us there is just one deadly, global pandemic that has not yet ended, and we are all in it together. To get out of it, we must act together. All of us,” the statement says.

A host of other professional groups, including the American Medical Association and the Association of State and Territorial Health Officials, also issued statements of support for President Biden’s plan.

But the plan was not well received by all.

“I will pursue every legal option available to the state of Georgia to stop this blatantly unlawful overreach by the Biden Administration,” said Georgia Governor Brian Kemp, a Republican, in a Tweet.

The National Council for Occupational Safety and Health called the plan “a missed opportunity” because it failed to include workplace protections for essential workers such as grocery, postal, and transit workers.

“Social distancing, improved ventilation, shift rotation, and protective equipment to reduce exposure are important components of an overall plan to reduce risk and stop the virus. These tools are missing from the new steps President Biden announced today,” said Jessica Martinez, co-executive director of the group.

In addition to the new vaccination requirements, President Biden said extra doses would be on the way for people who have already been fully vaccinated in order to protect against waning immunity, starting on Sept. 20. But he noted that those plans would be contingent on the Food and Drug Administration’s approval for third doses and the Centers for Disease Control and Prevention’s recommendation of the shots.

President Biden pledged to use the Defense Production Act to ramp up production of at-home tests, which have been selling out across the nation as the Delta variant spreads.

He also announced plans to expand access to COVID-19 testing, including offering testing for free at thousands of pharmacies nationwide and getting major retailers to sell at-home COVID-19 tests at cost.

The BinaxNow test kit, which currently retails for $23.99, will now cost about $15 for two tests at Kroger, Amazon, and Walmart, according to the White House. Food banks and community health centers will get free tests, too.

He called on states to set up COVID-19 testing programs at all schools.

Jha said that in his view, the big, game-changing news out of the president’s speech was the expansion of testing.

“Our country has failed to deploy tests in a way that can really bring this pandemic under control,” Jha said. “There are plenty of reasons, data, experience to indicate that if these were widely available, it would make a dramatic difference in reducing infection numbers across our country.”.

Dr. Jha said the private market had not worked effectively to make testing more widely available, so it was “absolutely a requirement of the federal government to step in and make testing more widely available,” he said.

President Biden also announced new economic stimulus programs, saying he’s expanding loan programs to small businesses and streamlining the loan forgiveness process.

President Biden said he’s boosting help for overburdened hospitals, doubling the number of federal surge response teams sent to hard-hit areas to reduce the strain on local health care workers. He said he would increase the pace of antibody treatments to states by 50%.

“We made so much progress during the past 7 months of this pandemic. Even so, we remain at a critical moment, a critical time,” he said. “We have the tools. Now, we just have to finish the job with truth, with science, with confidence and together as one nation.”

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

President Joe Biden has announced a host of new plans to rein in COVID-19’s runaway transmission in the United States, including sweeping vaccine mandates that will affect 100 million American workers, nearly two-thirds of the country’s workforce.

itsmejust/Thinkstock

“As your president, I’m announcing tonight a new plan to get more Americans vaccinated to combat those blocking public health,” he said Sept. 9.

As part of a six-part plan unveiled in a speech from the State Dining Room of the White House, President Biden said he would require vaccinations for nearly 4 million federal workers and the employees of companies that contract with the federal government.

He has also directed the Occupational Safety and Health Administration to develop a rule that will require large employers -- those with at least 100 employees -- to ensure their workers are vaccinated or tested weekly.

Nearly 17 million health care workers will face new vaccine mandates as part of the conditions of participation in the Medicare and Medicaid programs.

President Biden said the federal government will require staff at federally funded Head Start programs and schools to be vaccinated. He’s also calling on all states to mandate vaccines for teachers.

“A distinct minority of Americans, supported by a distinct minority of elected officials, are keeping us from turning the corner,” PresidentBiden said. “These pandemic politics, as I refer to them, are making people sick, causing unvaccinated people to die.”

One public health official said he was glad to see the president’s bold action.

“What I saw today was the federal government trying to use its powers to create greater safety in the American population,” said Ashish K. Jha, MD, dean of the school of public health at Brown University, Providence, R.I., in a call with reporters after the speech.

National Nurses United, the largest union of registered nurses in the United States, issued a statement in support of President Biden’s new vaccination requirements, but pushed back on his language.

“…as advocates for public health, registered nurses want to be extremely clear: There is no such thing as a pandemic of only the unvaccinated. The science of epidemiology tells us there is just one deadly, global pandemic that has not yet ended, and we are all in it together. To get out of it, we must act together. All of us,” the statement says.

A host of other professional groups, including the American Medical Association and the Association of State and Territorial Health Officials, also issued statements of support for President Biden’s plan.

But the plan was not well received by all.

“I will pursue every legal option available to the state of Georgia to stop this blatantly unlawful overreach by the Biden Administration,” said Georgia Governor Brian Kemp, a Republican, in a Tweet.

The National Council for Occupational Safety and Health called the plan “a missed opportunity” because it failed to include workplace protections for essential workers such as grocery, postal, and transit workers.

“Social distancing, improved ventilation, shift rotation, and protective equipment to reduce exposure are important components of an overall plan to reduce risk and stop the virus. These tools are missing from the new steps President Biden announced today,” said Jessica Martinez, co-executive director of the group.

In addition to the new vaccination requirements, President Biden said extra doses would be on the way for people who have already been fully vaccinated in order to protect against waning immunity, starting on Sept. 20. But he noted that those plans would be contingent on the Food and Drug Administration’s approval for third doses and the Centers for Disease Control and Prevention’s recommendation of the shots.

President Biden pledged to use the Defense Production Act to ramp up production of at-home tests, which have been selling out across the nation as the Delta variant spreads.

He also announced plans to expand access to COVID-19 testing, including offering testing for free at thousands of pharmacies nationwide and getting major retailers to sell at-home COVID-19 tests at cost.

The BinaxNow test kit, which currently retails for $23.99, will now cost about $15 for two tests at Kroger, Amazon, and Walmart, according to the White House. Food banks and community health centers will get free tests, too.

He called on states to set up COVID-19 testing programs at all schools.

Jha said that in his view, the big, game-changing news out of the president’s speech was the expansion of testing.

“Our country has failed to deploy tests in a way that can really bring this pandemic under control,” Jha said. “There are plenty of reasons, data, experience to indicate that if these were widely available, it would make a dramatic difference in reducing infection numbers across our country.”.

Dr. Jha said the private market had not worked effectively to make testing more widely available, so it was “absolutely a requirement of the federal government to step in and make testing more widely available,” he said.

President Biden also announced new economic stimulus programs, saying he’s expanding loan programs to small businesses and streamlining the loan forgiveness process.

President Biden said he’s boosting help for overburdened hospitals, doubling the number of federal surge response teams sent to hard-hit areas to reduce the strain on local health care workers. He said he would increase the pace of antibody treatments to states by 50%.

“We made so much progress during the past 7 months of this pandemic. Even so, we remain at a critical moment, a critical time,” he said. “We have the tools. Now, we just have to finish the job with truth, with science, with confidence and together as one nation.”

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