Infectious Disease Practitioner

Despite slightly decreasing numbers of pregnant women hospitalized with influenza, the rate of morbidity among those who do have influenza has substantially increased from 2000 to 2015, likely due in part to an increase in comorbidities.

Maternal patients who have influenza while hospitalized for delivery are twice as likely to develop severe maternal morbidity than are those without influenza, according to findings from a new study presented at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Pregnant women were also at substantially greater risk of sepsis or shock, needing mechanical ventilation, and acute respiratory distress syndrome. In fact, rates of overall severe maternal morbidity and of influenza-related complications have increased in maternal patients with influenza by more than 200% from 2000 to 2015.

“It was striking to see how the rate of delivery hospitalizations complicated by influenza has remained relatively stable with a small decline, but the rates of severe maternal morbidity were increasing and so markedly among those with influenza,” Timothy Wen, MD, MPH, a maternal-fetal medicine clinical fellow at the University of California, San Francisco, said in an interview. “The findings suggest that influenza may either be a contributor to rising rates of severe maternal morbidity or synergistically amplifying existing comorbidities to worsen outcomes,” he said during his presentation.

The increased risk of influenza complications in pregnant women became particularly apparent during the 2009-2010 H1N1 influenza pandemic. “Physiologic and immunologic changes predispose pregnant patients to higher risk for complications such as pneumonia, intensive care unit admission, and inpatient mortality,” Dr. Wen told attendees. But data have been scarce since H1N1.

The researchers conducted a cross-sectional analysis of delivery hospitalizations from 2000 to 2015 using the Nationwide Inpatient Sample, which includes about 20% of all U.S. inpatient hospitalizations from all payers. They looked at all maternal patients aged 15-54 who had a diagnosis of influenza. In looking at potential associations between influenza and morbidity, they adjusted their calculations for maternal age, payer status, median income, and race/ethnicity as well as the hospital factors of location, teaching status, and region. They also adjusted for a dozen clinical factors.

Of 62.7 million hospitalizations, 0.67% involved severe maternal mortality, including the following influenza complications:

• 0.02% with shock/sepsis.
• 0.01% needing mechanical ventilation.
• 0.04% with acute respiratory distress syndrome.

The 182,228 patients with influenza represented a rate of 29 cases per 10,000 deliveries, and 2.09% of them involved severe maternal morbidity, compared to severe maternal morbidity in just 0.66% of deliveries without influenza.

When looking specifically at rates of shock/sepsis, mechanical ventilation, and acute respiratory distress syndrome, the data revealed similar trends, with substantially higher proportions of patients with influenza experiencing these complications compared to maternal patients without influenza. For example, 0.3% of patients with influenza developed shock/sepsis whereas only 0.04% of patients without influenza did. Acute respiratory distress syndrome was similarly more common in patients with flu (0.45% vs. 0.04%), as was the need for mechanical ventilation (0.09% vs. 0.01%).

During the 15-year study period, the rate of maternal hospitalizations with influenza infections declined about 1.5%, from 30 to 24 per 10,000 deliveries. But trends with severe maternal morbidity in patients with influenza went in the other direction, increasing more than 200% over 15 years, from 100 to 342 cases of severe maternal morbidity per 10,000 patients with influenza. An increase also occurred in patients without influenza, but it was more modest, a nearly 50% increase, from 53 to 79 cases per 10,000 hospitalizations.

From year to year, severe maternal morbidity increased 5.3% annually among hospitalizations with influenza – more than twice the rate of a 2.4% annual increase among hospitalizations without influenza.

The researchers found that influenza is linked to twice the risk of severe maternal morbidity (adjusted risk ratio [aRR] = 2.08, P < .01). There were similarly higher risks with influenza of sepsis/shock (aRR = 3.23), mechanical ventilation (aRR = 6.04), and acute respiratory distress syndrome (aRR = 5.76; all P < .01).

Among the possible reasons for the increase in influenza morbidity – despite a decrease in influenza infections in this population – is the increase in the medical complexity of the patient population, Dr. Wen said.

“Patients who are getting pregnant today likely have more comorbid conditions (chronic hypertension, obesity, pregestational diabetes mellitus, etc.) than they did decades prior,” Dr. Wen said. “Clinically, it means that we have a baseline patient population at a higher risk of susceptibility for influenza and its complications.”

Maternal influenza immunization rates have meanwhile stagnated, Dr. Wen added. Influenza “is something that we know is preventable, or at least mitigated, by a vaccine,” he said. “Our results serve as a reminder for clinicians to continue counseling on the importance of influenza vaccination among pregnant patients, and even in those who are planning to become pregnant.”

He said these findings suggest the need for a low threshold for treating pregnant patients who have influenza symptoms with over-the-counter therapies or closely monitoring them.

Adetola Louis-Jacques, MD, of the University of South Florida, Tampa, found the increase in morbidity in those with flu particularly unexpected and concerning.

Despite slightly decreasing numbers of pregnant women hospitalized with influenza, the rate of morbidity among those who do have influenza has substantially increased from 2000 to 2015, likely due in part to an increase in comorbidities.

Maternal patients who have influenza while hospitalized for delivery are twice as likely to develop severe maternal morbidity than are those without influenza, according to findings from a new study presented at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Pregnant women were also at substantially greater risk of sepsis or shock, needing mechanical ventilation, and acute respiratory distress syndrome. In fact, rates of overall severe maternal morbidity and of influenza-related complications have increased in maternal patients with influenza by more than 200% from 2000 to 2015.

“It was striking to see how the rate of delivery hospitalizations complicated by influenza has remained relatively stable with a small decline, but the rates of severe maternal morbidity were increasing and so markedly among those with influenza,” Timothy Wen, MD, MPH, a maternal-fetal medicine clinical fellow at the University of California, San Francisco, said in an interview. “The findings suggest that influenza may either be a contributor to rising rates of severe maternal morbidity or synergistically amplifying existing comorbidities to worsen outcomes,” he said during his presentation.

The increased risk of influenza complications in pregnant women became particularly apparent during the 2009-2010 H1N1 influenza pandemic. “Physiologic and immunologic changes predispose pregnant patients to higher risk for complications such as pneumonia, intensive care unit admission, and inpatient mortality,” Dr. Wen told attendees. But data have been scarce since H1N1.

The researchers conducted a cross-sectional analysis of delivery hospitalizations from 2000 to 2015 using the Nationwide Inpatient Sample, which includes about 20% of all U.S. inpatient hospitalizations from all payers. They looked at all maternal patients aged 15-54 who had a diagnosis of influenza. In looking at potential associations between influenza and morbidity, they adjusted their calculations for maternal age, payer status, median income, and race/ethnicity as well as the hospital factors of location, teaching status, and region. They also adjusted for a dozen clinical factors.

Of 62.7 million hospitalizations, 0.67% involved severe maternal mortality, including the following influenza complications:

• 0.02% with shock/sepsis.
• 0.01% needing mechanical ventilation.
• 0.04% with acute respiratory distress syndrome.

The 182,228 patients with influenza represented a rate of 29 cases per 10,000 deliveries, and 2.09% of them involved severe maternal morbidity, compared to severe maternal morbidity in just 0.66% of deliveries without influenza.

When looking specifically at rates of shock/sepsis, mechanical ventilation, and acute respiratory distress syndrome, the data revealed similar trends, with substantially higher proportions of patients with influenza experiencing these complications compared to maternal patients without influenza. For example, 0.3% of patients with influenza developed shock/sepsis whereas only 0.04% of patients without influenza did. Acute respiratory distress syndrome was similarly more common in patients with flu (0.45% vs. 0.04%), as was the need for mechanical ventilation (0.09% vs. 0.01%).

During the 15-year study period, the rate of maternal hospitalizations with influenza infections declined about 1.5%, from 30 to 24 per 10,000 deliveries. But trends with severe maternal morbidity in patients with influenza went in the other direction, increasing more than 200% over 15 years, from 100 to 342 cases of severe maternal morbidity per 10,000 patients with influenza. An increase also occurred in patients without influenza, but it was more modest, a nearly 50% increase, from 53 to 79 cases per 10,000 hospitalizations.

From year to year, severe maternal morbidity increased 5.3% annually among hospitalizations with influenza – more than twice the rate of a 2.4% annual increase among hospitalizations without influenza.

The researchers found that influenza is linked to twice the risk of severe maternal morbidity (adjusted risk ratio [aRR] = 2.08, P < .01). There were similarly higher risks with influenza of sepsis/shock (aRR = 3.23), mechanical ventilation (aRR = 6.04), and acute respiratory distress syndrome (aRR = 5.76; all P < .01).

Among the possible reasons for the increase in influenza morbidity – despite a decrease in influenza infections in this population – is the increase in the medical complexity of the patient population, Dr. Wen said.

“Patients who are getting pregnant today likely have more comorbid conditions (chronic hypertension, obesity, pregestational diabetes mellitus, etc.) than they did decades prior,” Dr. Wen said. “Clinically, it means that we have a baseline patient population at a higher risk of susceptibility for influenza and its complications.”

Maternal influenza immunization rates have meanwhile stagnated, Dr. Wen added. Influenza “is something that we know is preventable, or at least mitigated, by a vaccine,” he said. “Our results serve as a reminder for clinicians to continue counseling on the importance of influenza vaccination among pregnant patients, and even in those who are planning to become pregnant.”

He said these findings suggest the need for a low threshold for treating pregnant patients who have influenza symptoms with over-the-counter therapies or closely monitoring them.

Adetola Louis-Jacques, MD, of the University of South Florida, Tampa, found the increase in morbidity in those with flu particularly unexpected and concerning.

Despite slightly decreasing numbers of pregnant women hospitalized with influenza, the rate of morbidity among those who do have influenza has substantially increased from 2000 to 2015, likely due in part to an increase in comorbidities.

Maternal patients who have influenza while hospitalized for delivery are twice as likely to develop severe maternal morbidity than are those without influenza, according to findings from a new study presented at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Pregnant women were also at substantially greater risk of sepsis or shock, needing mechanical ventilation, and acute respiratory distress syndrome. In fact, rates of overall severe maternal morbidity and of influenza-related complications have increased in maternal patients with influenza by more than 200% from 2000 to 2015.

“It was striking to see how the rate of delivery hospitalizations complicated by influenza has remained relatively stable with a small decline, but the rates of severe maternal morbidity were increasing and so markedly among those with influenza,” Timothy Wen, MD, MPH, a maternal-fetal medicine clinical fellow at the University of California, San Francisco, said in an interview. “The findings suggest that influenza may either be a contributor to rising rates of severe maternal morbidity or synergistically amplifying existing comorbidities to worsen outcomes,” he said during his presentation.

The increased risk of influenza complications in pregnant women became particularly apparent during the 2009-2010 H1N1 influenza pandemic. “Physiologic and immunologic changes predispose pregnant patients to higher risk for complications such as pneumonia, intensive care unit admission, and inpatient mortality,” Dr. Wen told attendees. But data have been scarce since H1N1.

The researchers conducted a cross-sectional analysis of delivery hospitalizations from 2000 to 2015 using the Nationwide Inpatient Sample, which includes about 20% of all U.S. inpatient hospitalizations from all payers. They looked at all maternal patients aged 15-54 who had a diagnosis of influenza. In looking at potential associations between influenza and morbidity, they adjusted their calculations for maternal age, payer status, median income, and race/ethnicity as well as the hospital factors of location, teaching status, and region. They also adjusted for a dozen clinical factors.

Of 62.7 million hospitalizations, 0.67% involved severe maternal mortality, including the following influenza complications:

• 0.02% with shock/sepsis.
• 0.01% needing mechanical ventilation.
• 0.04% with acute respiratory distress syndrome.

The 182,228 patients with influenza represented a rate of 29 cases per 10,000 deliveries, and 2.09% of them involved severe maternal morbidity, compared to severe maternal morbidity in just 0.66% of deliveries without influenza.

When looking specifically at rates of shock/sepsis, mechanical ventilation, and acute respiratory distress syndrome, the data revealed similar trends, with substantially higher proportions of patients with influenza experiencing these complications compared to maternal patients without influenza. For example, 0.3% of patients with influenza developed shock/sepsis whereas only 0.04% of patients without influenza did. Acute respiratory distress syndrome was similarly more common in patients with flu (0.45% vs. 0.04%), as was the need for mechanical ventilation (0.09% vs. 0.01%).

During the 15-year study period, the rate of maternal hospitalizations with influenza infections declined about 1.5%, from 30 to 24 per 10,000 deliveries. But trends with severe maternal morbidity in patients with influenza went in the other direction, increasing more than 200% over 15 years, from 100 to 342 cases of severe maternal morbidity per 10,000 patients with influenza. An increase also occurred in patients without influenza, but it was more modest, a nearly 50% increase, from 53 to 79 cases per 10,000 hospitalizations.

From year to year, severe maternal morbidity increased 5.3% annually among hospitalizations with influenza – more than twice the rate of a 2.4% annual increase among hospitalizations without influenza.

The researchers found that influenza is linked to twice the risk of severe maternal morbidity (adjusted risk ratio [aRR] = 2.08, P < .01). There were similarly higher risks with influenza of sepsis/shock (aRR = 3.23), mechanical ventilation (aRR = 6.04), and acute respiratory distress syndrome (aRR = 5.76; all P < .01).

Among the possible reasons for the increase in influenza morbidity – despite a decrease in influenza infections in this population – is the increase in the medical complexity of the patient population, Dr. Wen said.

“Patients who are getting pregnant today likely have more comorbid conditions (chronic hypertension, obesity, pregestational diabetes mellitus, etc.) than they did decades prior,” Dr. Wen said. “Clinically, it means that we have a baseline patient population at a higher risk of susceptibility for influenza and its complications.”

Maternal influenza immunization rates have meanwhile stagnated, Dr. Wen added. Influenza “is something that we know is preventable, or at least mitigated, by a vaccine,” he said. “Our results serve as a reminder for clinicians to continue counseling on the importance of influenza vaccination among pregnant patients, and even in those who are planning to become pregnant.”

He said these findings suggest the need for a low threshold for treating pregnant patients who have influenza symptoms with over-the-counter therapies or closely monitoring them.

Adetola Louis-Jacques, MD, of the University of South Florida, Tampa, found the increase in morbidity in those with flu particularly unexpected and concerning.

Work load, not personal vulnerability, may be at the root of the current physician burnout crisis, a recent study has concluded.

The cutting-edge research utilized cognitive theory and work load analysis to get at the source of burnout among practitioners. The findings indicate that, although some institutions continue to emphasize personal responsibility of physicians to address the issue, it may be the amount and structure of the work itself that triggers burnout in doctors.

“We evaluated the cognitive load of a clinical workday in a national sample of U.S. physicians and its relationship with burnout and professional satisfaction,” wrote Elizabeth Harry, MD, SFHM, a hospitalist at the University of Colorado at Denver, Aurora and coauthors. The results were reported in the Joint Commission Journal on Quality and Patient Safety.

The researchers investigated whether task load correlated with burnout scores in a large national study of U.S. physicians from October 2017 to March 2018.

As the delivery of health care becomes more complex, physicians are charged with ever-increasing amount of administrative and cognitive tasks. Recent evidence indicates that this growing complexity of work is tied to a greater risk of burnout in physicians, compared with workers in other fields. Cognitive load theory, pioneered by psychologist Jonathan Sweller, identified limitations in working memory that humans depend on to carry out cognitive tasks. Cognitive load refers to the amount of working memory used, which can be reduced in the presence of external emotional or physiological stressors. While a potential link between cognitive load and burnout may seem self-evident, the correlation between the cognitive load of physicians and burnout has not been evaluated in a large-scale study until recently.

wutwhanfoto/Getty Images

Physician task load (PTL) was measured using the National Aeronautics and Space Administration Task Load Index (NASA-TLX), a validated questionnaire frequently used to evaluate the cognitive load of work environments, including health care environments. Four domains (perception of effort and mental, physical, and temporal demands) were used to calculate the total PTL score.

Burnout was evaluated using the Emotional Exhaustion and Depersonalization scales of the Maslach Burnout Inventory, a validated tool considered the gold standard for measurement.

The survey sample consisted of physicians of all specialties and was assembled using the American Medical Association Physician Masterfile, an almost complete record of all U.S. physicians independent of AMA membership. All responses were anonymous and participation was voluntary.
 

Results

Among 30,456 physicians who received the survey, 5,197 (17.1%) responded. In total, 5,276 physicians were included in the analysis.

The median age of respondents was 53 years, and 61.8% self-identified as male. Twenty-four specialties were identified: 23.8% were from a primary care discipline and internal medicine represented the largest respondent group (12.1%).

Almost half of respondents (49.7%) worked in private practice, and 44.8% had been in practice for 21 years or longer.

Overall, 44.0% had at least one symptom of burnout, 38.8% of participants scored in the high range for emotional exhaustion, and 27.4% scored in the high range for depersonalization. The mean score in task load dimension varied by specialty.

The mean PTL score was 260.9 (standard deviation, 71.4). The specialties with the highest PTL score were emergency medicine (369.8), urology (353.7), general surgery subspecialties (343.9), internal medicine subspecialties (342.2), and radiology (341.6).

Aside from specialty, PTL scores also varied by practice setting, gender, age, number of hours worked per week, number of nights on call per week, and years in practice.

The researchers observed a dose response relationship between PTL and risk of burnout. For every 40-point (10%) reduction in PTL, there was 33% lower odds of experiencing burnout (odds ratio, 0.67; 95% confidence interval, 0.65-0.70; P < .0001). Multivariable analyses also indicated that PTL was a significant predictor of burnout, independent of practice setting, specialty, age, gender, and hours worked.
 

Organizational strategies to reduce physician burnout

Coauthors of the study, Tait D. Shanafelt, MD, professor of medicine at Stanford (Calif.) University and Colin P. West, MD, PhD, of the Mayo Clinic in Rochester, Minn., are both experts on physician well-being and are passionate about finding new ways to reduce physician distress and improving health care delivery.

“Authentic efforts to address this problem must move beyond personal resilience,” Dr. Shanafelt said in an interview. “Organizations that fail to get serious about this issue are going to be left behind and struggle in the war for talent.

“Much like our efforts to improve quality, advancing clinician well-being requires organizations to make it a priority and establish the structure, process, and leadership to promote the desired outcomes,” said Dr. Shanafelt.

One potential strategy for improvement is appointing a chief wellness officer, a dedicated individual within the health care system that leads the organizational effort, explained Dr. Shanafelt. “Over 30 vanguard institutions across the United States have already taken this step.”

Dr. West, a coauthor of the study, explained that conducting an analysis of PTL is fairly straightforward for hospitals and individual institutions. “The NASA-TLX tool is widely available, free to use, and not overly complex, and it could be used to provide insight into physician effort and mental, physical, and temporal demand levels,” he said in an interview.

“Deeper evaluations could follow to identify specific potential solutions, particularly system-level approaches to alleviate PTL,” Dr. West explained. “In the short term, such analyses and solutions would have costs, but helping physicians work more optimally and with less chronic strain from excessive task load would save far more than these costs overall.”

Dr. West also noted that physician burnout is very expensive to a health care system, and strategies to promote physician well-being would be a prudent financial decision long term for health care organizations.

Dr. Harry, lead author of the study, agreed with Dr. West, noting that “quality improvement literature has demonstrated that improvements in inefficiencies that lead to increased demand in the workplace often has the benefit of reduced cost.

“Many studies have demonstrated the risk of turnover due to burnout and the significant cost of physician turn over,” she said in an interview. “This cost avoidance is well worth the investment in improved operations to minimize unnecessary task load.”

Dr. Harry also recommended the NASA-TLX tool as a free resource for health systems and organizations. She noted that future studies will further validate the reliability of the tool.

“At the core, we need to focus on system redesign at both the micro and the macro level,” Dr. Harry said. “Each health system will need to assess inefficiencies in their work flow, while regulatory bodies need to consider the downstream task load of mandates and reporting requirements, all of which contribute to more cognitive load.”

The study was supported by funding from the Stanford Medicine WellMD Center, the American Medical Association, and the Mayo Clinic department of medicine program on physician well-being. Coauthors Lotte N. Dyrbye, MD, and Dr. Shanafelt are coinventors of the Physician Well-being Index, Medical Student Well-Being Index, Nurse Well-Being, and Well-Being Index. Mayo Clinic holds the copyright to these instruments and has licensed them for external use. Dr. Dyrbye and Dr. Shanafelt receive a portion of any royalties paid to Mayo Clinic. All other authors reported no conflicts of interest.

Work load, not personal vulnerability, may be at the root of the current physician burnout crisis, a recent study has concluded.

The cutting-edge research utilized cognitive theory and work load analysis to get at the source of burnout among practitioners. The findings indicate that, although some institutions continue to emphasize personal responsibility of physicians to address the issue, it may be the amount and structure of the work itself that triggers burnout in doctors.

“We evaluated the cognitive load of a clinical workday in a national sample of U.S. physicians and its relationship with burnout and professional satisfaction,” wrote Elizabeth Harry, MD, SFHM, a hospitalist at the University of Colorado at Denver, Aurora and coauthors. The results were reported in the Joint Commission Journal on Quality and Patient Safety.

The researchers investigated whether task load correlated with burnout scores in a large national study of U.S. physicians from October 2017 to March 2018.

As the delivery of health care becomes more complex, physicians are charged with ever-increasing amount of administrative and cognitive tasks. Recent evidence indicates that this growing complexity of work is tied to a greater risk of burnout in physicians, compared with workers in other fields. Cognitive load theory, pioneered by psychologist Jonathan Sweller, identified limitations in working memory that humans depend on to carry out cognitive tasks. Cognitive load refers to the amount of working memory used, which can be reduced in the presence of external emotional or physiological stressors. While a potential link between cognitive load and burnout may seem self-evident, the correlation between the cognitive load of physicians and burnout has not been evaluated in a large-scale study until recently.

wutwhanfoto/Getty Images

Physician task load (PTL) was measured using the National Aeronautics and Space Administration Task Load Index (NASA-TLX), a validated questionnaire frequently used to evaluate the cognitive load of work environments, including health care environments. Four domains (perception of effort and mental, physical, and temporal demands) were used to calculate the total PTL score.

Burnout was evaluated using the Emotional Exhaustion and Depersonalization scales of the Maslach Burnout Inventory, a validated tool considered the gold standard for measurement.

The survey sample consisted of physicians of all specialties and was assembled using the American Medical Association Physician Masterfile, an almost complete record of all U.S. physicians independent of AMA membership. All responses were anonymous and participation was voluntary.
 

Results

Among 30,456 physicians who received the survey, 5,197 (17.1%) responded. In total, 5,276 physicians were included in the analysis.

The median age of respondents was 53 years, and 61.8% self-identified as male. Twenty-four specialties were identified: 23.8% were from a primary care discipline and internal medicine represented the largest respondent group (12.1%).

Almost half of respondents (49.7%) worked in private practice, and 44.8% had been in practice for 21 years or longer.

Overall, 44.0% had at least one symptom of burnout, 38.8% of participants scored in the high range for emotional exhaustion, and 27.4% scored in the high range for depersonalization. The mean score in task load dimension varied by specialty.

The mean PTL score was 260.9 (standard deviation, 71.4). The specialties with the highest PTL score were emergency medicine (369.8), urology (353.7), general surgery subspecialties (343.9), internal medicine subspecialties (342.2), and radiology (341.6).

Aside from specialty, PTL scores also varied by practice setting, gender, age, number of hours worked per week, number of nights on call per week, and years in practice.

The researchers observed a dose response relationship between PTL and risk of burnout. For every 40-point (10%) reduction in PTL, there was 33% lower odds of experiencing burnout (odds ratio, 0.67; 95% confidence interval, 0.65-0.70; P < .0001). Multivariable analyses also indicated that PTL was a significant predictor of burnout, independent of practice setting, specialty, age, gender, and hours worked.
 

Organizational strategies to reduce physician burnout

Coauthors of the study, Tait D. Shanafelt, MD, professor of medicine at Stanford (Calif.) University and Colin P. West, MD, PhD, of the Mayo Clinic in Rochester, Minn., are both experts on physician well-being and are passionate about finding new ways to reduce physician distress and improving health care delivery.

“Authentic efforts to address this problem must move beyond personal resilience,” Dr. Shanafelt said in an interview. “Organizations that fail to get serious about this issue are going to be left behind and struggle in the war for talent.

“Much like our efforts to improve quality, advancing clinician well-being requires organizations to make it a priority and establish the structure, process, and leadership to promote the desired outcomes,” said Dr. Shanafelt.

One potential strategy for improvement is appointing a chief wellness officer, a dedicated individual within the health care system that leads the organizational effort, explained Dr. Shanafelt. “Over 30 vanguard institutions across the United States have already taken this step.”

Dr. West, a coauthor of the study, explained that conducting an analysis of PTL is fairly straightforward for hospitals and individual institutions. “The NASA-TLX tool is widely available, free to use, and not overly complex, and it could be used to provide insight into physician effort and mental, physical, and temporal demand levels,” he said in an interview.

“Deeper evaluations could follow to identify specific potential solutions, particularly system-level approaches to alleviate PTL,” Dr. West explained. “In the short term, such analyses and solutions would have costs, but helping physicians work more optimally and with less chronic strain from excessive task load would save far more than these costs overall.”

Dr. West also noted that physician burnout is very expensive to a health care system, and strategies to promote physician well-being would be a prudent financial decision long term for health care organizations.

Dr. Harry, lead author of the study, agreed with Dr. West, noting that “quality improvement literature has demonstrated that improvements in inefficiencies that lead to increased demand in the workplace often has the benefit of reduced cost.

“Many studies have demonstrated the risk of turnover due to burnout and the significant cost of physician turn over,” she said in an interview. “This cost avoidance is well worth the investment in improved operations to minimize unnecessary task load.”

Dr. Harry also recommended the NASA-TLX tool as a free resource for health systems and organizations. She noted that future studies will further validate the reliability of the tool.

“At the core, we need to focus on system redesign at both the micro and the macro level,” Dr. Harry said. “Each health system will need to assess inefficiencies in their work flow, while regulatory bodies need to consider the downstream task load of mandates and reporting requirements, all of which contribute to more cognitive load.”

The study was supported by funding from the Stanford Medicine WellMD Center, the American Medical Association, and the Mayo Clinic department of medicine program on physician well-being. Coauthors Lotte N. Dyrbye, MD, and Dr. Shanafelt are coinventors of the Physician Well-being Index, Medical Student Well-Being Index, Nurse Well-Being, and Well-Being Index. Mayo Clinic holds the copyright to these instruments and has licensed them for external use. Dr. Dyrbye and Dr. Shanafelt receive a portion of any royalties paid to Mayo Clinic. All other authors reported no conflicts of interest.

Work load, not personal vulnerability, may be at the root of the current physician burnout crisis, a recent study has concluded.

The cutting-edge research utilized cognitive theory and work load analysis to get at the source of burnout among practitioners. The findings indicate that, although some institutions continue to emphasize personal responsibility of physicians to address the issue, it may be the amount and structure of the work itself that triggers burnout in doctors.

“We evaluated the cognitive load of a clinical workday in a national sample of U.S. physicians and its relationship with burnout and professional satisfaction,” wrote Elizabeth Harry, MD, SFHM, a hospitalist at the University of Colorado at Denver, Aurora and coauthors. The results were reported in the Joint Commission Journal on Quality and Patient Safety.

The researchers investigated whether task load correlated with burnout scores in a large national study of U.S. physicians from October 2017 to March 2018.

As the delivery of health care becomes more complex, physicians are charged with ever-increasing amount of administrative and cognitive tasks. Recent evidence indicates that this growing complexity of work is tied to a greater risk of burnout in physicians, compared with workers in other fields. Cognitive load theory, pioneered by psychologist Jonathan Sweller, identified limitations in working memory that humans depend on to carry out cognitive tasks. Cognitive load refers to the amount of working memory used, which can be reduced in the presence of external emotional or physiological stressors. While a potential link between cognitive load and burnout may seem self-evident, the correlation between the cognitive load of physicians and burnout has not been evaluated in a large-scale study until recently.

wutwhanfoto/Getty Images

Physician task load (PTL) was measured using the National Aeronautics and Space Administration Task Load Index (NASA-TLX), a validated questionnaire frequently used to evaluate the cognitive load of work environments, including health care environments. Four domains (perception of effort and mental, physical, and temporal demands) were used to calculate the total PTL score.

Burnout was evaluated using the Emotional Exhaustion and Depersonalization scales of the Maslach Burnout Inventory, a validated tool considered the gold standard for measurement.

The survey sample consisted of physicians of all specialties and was assembled using the American Medical Association Physician Masterfile, an almost complete record of all U.S. physicians independent of AMA membership. All responses were anonymous and participation was voluntary.
 

Results

Among 30,456 physicians who received the survey, 5,197 (17.1%) responded. In total, 5,276 physicians were included in the analysis.

The median age of respondents was 53 years, and 61.8% self-identified as male. Twenty-four specialties were identified: 23.8% were from a primary care discipline and internal medicine represented the largest respondent group (12.1%).

Almost half of respondents (49.7%) worked in private practice, and 44.8% had been in practice for 21 years or longer.

Overall, 44.0% had at least one symptom of burnout, 38.8% of participants scored in the high range for emotional exhaustion, and 27.4% scored in the high range for depersonalization. The mean score in task load dimension varied by specialty.

The mean PTL score was 260.9 (standard deviation, 71.4). The specialties with the highest PTL score were emergency medicine (369.8), urology (353.7), general surgery subspecialties (343.9), internal medicine subspecialties (342.2), and radiology (341.6).

Aside from specialty, PTL scores also varied by practice setting, gender, age, number of hours worked per week, number of nights on call per week, and years in practice.

The researchers observed a dose response relationship between PTL and risk of burnout. For every 40-point (10%) reduction in PTL, there was 33% lower odds of experiencing burnout (odds ratio, 0.67; 95% confidence interval, 0.65-0.70; P < .0001). Multivariable analyses also indicated that PTL was a significant predictor of burnout, independent of practice setting, specialty, age, gender, and hours worked.
 

Organizational strategies to reduce physician burnout

Coauthors of the study, Tait D. Shanafelt, MD, professor of medicine at Stanford (Calif.) University and Colin P. West, MD, PhD, of the Mayo Clinic in Rochester, Minn., are both experts on physician well-being and are passionate about finding new ways to reduce physician distress and improving health care delivery.

“Authentic efforts to address this problem must move beyond personal resilience,” Dr. Shanafelt said in an interview. “Organizations that fail to get serious about this issue are going to be left behind and struggle in the war for talent.

“Much like our efforts to improve quality, advancing clinician well-being requires organizations to make it a priority and establish the structure, process, and leadership to promote the desired outcomes,” said Dr. Shanafelt.

One potential strategy for improvement is appointing a chief wellness officer, a dedicated individual within the health care system that leads the organizational effort, explained Dr. Shanafelt. “Over 30 vanguard institutions across the United States have already taken this step.”

Dr. West, a coauthor of the study, explained that conducting an analysis of PTL is fairly straightforward for hospitals and individual institutions. “The NASA-TLX tool is widely available, free to use, and not overly complex, and it could be used to provide insight into physician effort and mental, physical, and temporal demand levels,” he said in an interview.

“Deeper evaluations could follow to identify specific potential solutions, particularly system-level approaches to alleviate PTL,” Dr. West explained. “In the short term, such analyses and solutions would have costs, but helping physicians work more optimally and with less chronic strain from excessive task load would save far more than these costs overall.”

Dr. West also noted that physician burnout is very expensive to a health care system, and strategies to promote physician well-being would be a prudent financial decision long term for health care organizations.

Dr. Harry, lead author of the study, agreed with Dr. West, noting that “quality improvement literature has demonstrated that improvements in inefficiencies that lead to increased demand in the workplace often has the benefit of reduced cost.

“Many studies have demonstrated the risk of turnover due to burnout and the significant cost of physician turn over,” she said in an interview. “This cost avoidance is well worth the investment in improved operations to minimize unnecessary task load.”

Dr. Harry also recommended the NASA-TLX tool as a free resource for health systems and organizations. She noted that future studies will further validate the reliability of the tool.

“At the core, we need to focus on system redesign at both the micro and the macro level,” Dr. Harry said. “Each health system will need to assess inefficiencies in their work flow, while regulatory bodies need to consider the downstream task load of mandates and reporting requirements, all of which contribute to more cognitive load.”

The study was supported by funding from the Stanford Medicine WellMD Center, the American Medical Association, and the Mayo Clinic department of medicine program on physician well-being. Coauthors Lotte N. Dyrbye, MD, and Dr. Shanafelt are coinventors of the Physician Well-being Index, Medical Student Well-Being Index, Nurse Well-Being, and Well-Being Index. Mayo Clinic holds the copyright to these instruments and has licensed them for external use. Dr. Dyrbye and Dr. Shanafelt receive a portion of any royalties paid to Mayo Clinic. All other authors reported no conflicts of interest.

Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, walked through a multiagency attack plan for halting the spread of three COVID-19 variants earlier this week.

As part of JAMA’s Q&A series with JAMA editor in chief Howard Bauchner, MD, Dr. Walensky referenced the blueprint she coathored with Anthony Fauci, MD, the nation’s top infectious disease expert, and Henry T. Walke, MD, MPH, of the CDC, which was published on Feb. 17 in JAMA.

In the viewpoint article, they explain that the Department of Health & Human Services has established the SARS-CoV-2 Interagency Group to improve coordination among the CDC, the National Institutes of Health, the Food and Drug Administration, the Biomedical Advanced Research and Development Authority, the Department of Agriculture, and the Department of Defense.

Dr. Walensky said the first objective is to reinforce vigilance regarding public health mitigation strategies to decrease the amount of virus that’s circulating.

As part of that strategy, she said, the CDC strongly urges against nonessential travel.

In addition, public health leaders are working on a surveillance system to better understand the SARS-CoV-2 variants. That will take ramping up genome sequencing of the SARS-CoV-2 virus and ensuring that sampling is geographically representative.

She said the CDC is partnering with state health labs to obtain about 750 samples every week and is teaming up with commercial labs and academic centers to obtain an interim target of 6,000 samples per week.

She acknowledged the United States “is not where we need to be” with sequencing but has come a long way since January. At that time, they were sequencing 250 samples every week; they are currently sequencing thousands each week.

Data analysis is another concern: “We need to be able to understand at the basic science level what the information means,” Dr. Walensky said.

Researchers aren’t sure how the variants might affect use of convalescent plasma or monoclonal antibody treatments. It is expected that 5% of persons who are vaccinated against COVID-19 will nevertheless contract the disease. Sequencing will help answer whether such persons who have been vaccinated and who subsequently contract the virus are among those 5% or whether have been infected by a variant that evades the vaccine.

Accelerating vaccine administration globally and in the United States is essential, Dr. Walensky said.

As of Feb. 17, 56 million doses had been administered in the United States.
 

Top three threats

She updated the numbers on the three biggest variant threats.

Regarding B.1.1.7, which originated in the United Kingdom, she said: “So far, we’ve had over 1,200 cases in 41 states.” She noted that the variant is likely to be about 50% more transmissible and 30% to 50% more virulent.

“So far, it looks like that strain doesn’t have any real decrease in susceptibility to our vaccines,” she said.

The strain from South Africa (B.1.351) has been found in 19 cases in the United States.

The P.1. variant, which originated in Brazil, has been identified in two cases in two states.
 

Outlook for March and April

Dr. Bauchner asked Dr. Walensky what she envisions for March and April. He noted that public optimism is high in light of the continued reductions in COVID-19 case numbers, hospitalizations, and deaths, as well as the fact that warmer weather is coming and that more vaccinations are on the horizon.

“While I really am hopeful for what could happen in March and April,” Dr. Walensky said, “I really do know that this could go bad so fast. We saw it in November. We saw it in December.”

CDC models have projected that, by March, the more transmissible B.1.1.7 strain is likely to be the dominant strain, she reiterated.

“I worry that it will be spring, and we will all have had enough,” Dr. Walensky said. She noted that some states are already relaxing mask mandates.

“Around that time, life will look and feel a little better, and the motivation for those who might be vaccine hesitant may be diminished,” she said.

Dr. Bauchner also asked her to weigh in on whether a third vaccine, from Johnson & Johnson (J&J), may soon gain FDA emergency-use authorization – and whether its lower expected efficacy rate may result in a tiered system of vaccinations, with higher-risk populations receiving the more efficacious vaccines.

Dr. Walensky said more data are needed before that question can be answered.

“It may very well be that the data point us to the best populations in which to use this vaccine,” she said.

In phase 3 data, the J&J vaccine was shown to be 72% effective in the United States for moderate to severe disease.

Dr. Walensky said it’s important to remember that the projected efficacy for that vaccine is higher than that for the flu shot as well as many other vaccines currently in use for other diseases.

She said it also has several advantages. The vaccine has less-stringent storage requirements, requires just one dose, and protects against hospitalization and death, although it’s less efficacious in protecting against contracting the disease.

“I think many people would opt to get that one if they could get it sooner,” she said.

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

Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, walked through a multiagency attack plan for halting the spread of three COVID-19 variants earlier this week.

As part of JAMA’s Q&A series with JAMA editor in chief Howard Bauchner, MD, Dr. Walensky referenced the blueprint she coathored with Anthony Fauci, MD, the nation’s top infectious disease expert, and Henry T. Walke, MD, MPH, of the CDC, which was published on Feb. 17 in JAMA.

In the viewpoint article, they explain that the Department of Health & Human Services has established the SARS-CoV-2 Interagency Group to improve coordination among the CDC, the National Institutes of Health, the Food and Drug Administration, the Biomedical Advanced Research and Development Authority, the Department of Agriculture, and the Department of Defense.

Dr. Walensky said the first objective is to reinforce vigilance regarding public health mitigation strategies to decrease the amount of virus that’s circulating.

As part of that strategy, she said, the CDC strongly urges against nonessential travel.

In addition, public health leaders are working on a surveillance system to better understand the SARS-CoV-2 variants. That will take ramping up genome sequencing of the SARS-CoV-2 virus and ensuring that sampling is geographically representative.

She said the CDC is partnering with state health labs to obtain about 750 samples every week and is teaming up with commercial labs and academic centers to obtain an interim target of 6,000 samples per week.

She acknowledged the United States “is not where we need to be” with sequencing but has come a long way since January. At that time, they were sequencing 250 samples every week; they are currently sequencing thousands each week.

Data analysis is another concern: “We need to be able to understand at the basic science level what the information means,” Dr. Walensky said.

Researchers aren’t sure how the variants might affect use of convalescent plasma or monoclonal antibody treatments. It is expected that 5% of persons who are vaccinated against COVID-19 will nevertheless contract the disease. Sequencing will help answer whether such persons who have been vaccinated and who subsequently contract the virus are among those 5% or whether have been infected by a variant that evades the vaccine.

Accelerating vaccine administration globally and in the United States is essential, Dr. Walensky said.

As of Feb. 17, 56 million doses had been administered in the United States.
 

Top three threats

She updated the numbers on the three biggest variant threats.

Regarding B.1.1.7, which originated in the United Kingdom, she said: “So far, we’ve had over 1,200 cases in 41 states.” She noted that the variant is likely to be about 50% more transmissible and 30% to 50% more virulent.

“So far, it looks like that strain doesn’t have any real decrease in susceptibility to our vaccines,” she said.

The strain from South Africa (B.1.351) has been found in 19 cases in the United States.

The P.1. variant, which originated in Brazil, has been identified in two cases in two states.
 

Outlook for March and April

Dr. Bauchner asked Dr. Walensky what she envisions for March and April. He noted that public optimism is high in light of the continued reductions in COVID-19 case numbers, hospitalizations, and deaths, as well as the fact that warmer weather is coming and that more vaccinations are on the horizon.

“While I really am hopeful for what could happen in March and April,” Dr. Walensky said, “I really do know that this could go bad so fast. We saw it in November. We saw it in December.”

CDC models have projected that, by March, the more transmissible B.1.1.7 strain is likely to be the dominant strain, she reiterated.

“I worry that it will be spring, and we will all have had enough,” Dr. Walensky said. She noted that some states are already relaxing mask mandates.

“Around that time, life will look and feel a little better, and the motivation for those who might be vaccine hesitant may be diminished,” she said.

Dr. Bauchner also asked her to weigh in on whether a third vaccine, from Johnson & Johnson (J&J), may soon gain FDA emergency-use authorization – and whether its lower expected efficacy rate may result in a tiered system of vaccinations, with higher-risk populations receiving the more efficacious vaccines.

Dr. Walensky said more data are needed before that question can be answered.

“It may very well be that the data point us to the best populations in which to use this vaccine,” she said.

In phase 3 data, the J&J vaccine was shown to be 72% effective in the United States for moderate to severe disease.

Dr. Walensky said it’s important to remember that the projected efficacy for that vaccine is higher than that for the flu shot as well as many other vaccines currently in use for other diseases.

She said it also has several advantages. The vaccine has less-stringent storage requirements, requires just one dose, and protects against hospitalization and death, although it’s less efficacious in protecting against contracting the disease.

“I think many people would opt to get that one if they could get it sooner,” she said.

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

Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, walked through a multiagency attack plan for halting the spread of three COVID-19 variants earlier this week.

As part of JAMA’s Q&A series with JAMA editor in chief Howard Bauchner, MD, Dr. Walensky referenced the blueprint she coathored with Anthony Fauci, MD, the nation’s top infectious disease expert, and Henry T. Walke, MD, MPH, of the CDC, which was published on Feb. 17 in JAMA.

In the viewpoint article, they explain that the Department of Health & Human Services has established the SARS-CoV-2 Interagency Group to improve coordination among the CDC, the National Institutes of Health, the Food and Drug Administration, the Biomedical Advanced Research and Development Authority, the Department of Agriculture, and the Department of Defense.

Dr. Walensky said the first objective is to reinforce vigilance regarding public health mitigation strategies to decrease the amount of virus that’s circulating.

As part of that strategy, she said, the CDC strongly urges against nonessential travel.

In addition, public health leaders are working on a surveillance system to better understand the SARS-CoV-2 variants. That will take ramping up genome sequencing of the SARS-CoV-2 virus and ensuring that sampling is geographically representative.

She said the CDC is partnering with state health labs to obtain about 750 samples every week and is teaming up with commercial labs and academic centers to obtain an interim target of 6,000 samples per week.

She acknowledged the United States “is not where we need to be” with sequencing but has come a long way since January. At that time, they were sequencing 250 samples every week; they are currently sequencing thousands each week.

Data analysis is another concern: “We need to be able to understand at the basic science level what the information means,” Dr. Walensky said.

Researchers aren’t sure how the variants might affect use of convalescent plasma or monoclonal antibody treatments. It is expected that 5% of persons who are vaccinated against COVID-19 will nevertheless contract the disease. Sequencing will help answer whether such persons who have been vaccinated and who subsequently contract the virus are among those 5% or whether have been infected by a variant that evades the vaccine.

Accelerating vaccine administration globally and in the United States is essential, Dr. Walensky said.

As of Feb. 17, 56 million doses had been administered in the United States.
 

Top three threats

She updated the numbers on the three biggest variant threats.

Regarding B.1.1.7, which originated in the United Kingdom, she said: “So far, we’ve had over 1,200 cases in 41 states.” She noted that the variant is likely to be about 50% more transmissible and 30% to 50% more virulent.

“So far, it looks like that strain doesn’t have any real decrease in susceptibility to our vaccines,” she said.

The strain from South Africa (B.1.351) has been found in 19 cases in the United States.

The P.1. variant, which originated in Brazil, has been identified in two cases in two states.
 

Outlook for March and April

Dr. Bauchner asked Dr. Walensky what she envisions for March and April. He noted that public optimism is high in light of the continued reductions in COVID-19 case numbers, hospitalizations, and deaths, as well as the fact that warmer weather is coming and that more vaccinations are on the horizon.

“While I really am hopeful for what could happen in March and April,” Dr. Walensky said, “I really do know that this could go bad so fast. We saw it in November. We saw it in December.”

CDC models have projected that, by March, the more transmissible B.1.1.7 strain is likely to be the dominant strain, she reiterated.

“I worry that it will be spring, and we will all have had enough,” Dr. Walensky said. She noted that some states are already relaxing mask mandates.

“Around that time, life will look and feel a little better, and the motivation for those who might be vaccine hesitant may be diminished,” she said.

Dr. Bauchner also asked her to weigh in on whether a third vaccine, from Johnson & Johnson (J&J), may soon gain FDA emergency-use authorization – and whether its lower expected efficacy rate may result in a tiered system of vaccinations, with higher-risk populations receiving the more efficacious vaccines.

Dr. Walensky said more data are needed before that question can be answered.

“It may very well be that the data point us to the best populations in which to use this vaccine,” she said.

In phase 3 data, the J&J vaccine was shown to be 72% effective in the United States for moderate to severe disease.

Dr. Walensky said it’s important to remember that the projected efficacy for that vaccine is higher than that for the flu shot as well as many other vaccines currently in use for other diseases.

She said it also has several advantages. The vaccine has less-stringent storage requirements, requires just one dose, and protects against hospitalization and death, although it’s less efficacious in protecting against contracting the disease.

“I think many people would opt to get that one if they could get it sooner,” she said.

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

The long-term neurologic symptoms such as “brain fog” experienced by some patients with COVID-19 may be caused by a unique pathology – the occlusion of brain capillaries by large megakaryocyte cells, a new report suggests.

The authors report five separate post-mortem cases from patients who died with COVID-19 in which large cells resembling megakaryocytes were identified in cortical capillaries. Immunohistochemistry subsequently confirmed their megakaryocyte identity.

They point out that the finding is of interest as – to their knowledge – megakaryocytes have not been found in the brain before.

The observations are described in a research letter published online Feb. 12 in JAMA Neurology.
 

Bone marrow cells in the brain

Lead author David Nauen, MD, PhD, a neuropathologist from Johns Hopkins University, Baltimore, reported that he identified these cells in the first analysis of post-mortem brain tissue from a patient who had COVID-19.

“Some other viruses cause changes in the brain such as encephalopathy, and as neurologic symptoms are often reported in COVID-19, I was curious to see if similar effects were seen in brain post-mortem samples from patients who had died with the infection,” Dr. Nauen said.

On his first analysis of the brain tissue of a patient who had COVID-19, Dr. Nauen saw no evidence of viral encephalitis, but he observed some “unusually large” cells in the brain capillaries.

“I was taken aback; I couldn’t figure out what they were. Then I realized these cells were megakaryocytes from the bone marrow. I have never seen these cells in the brain before. I asked several colleagues and none of them had either. After extensive literature searches, I could find no evidence of megakaryocytes being in the brain,” Dr. Nauen noted.

Megakaryocytes, he explained, are “very large cells, and the brain capillaries are very small – just large enough to let red blood cells and lymphocytes pass through. To see these very large cells in such vessels is extremely unusual. It looks like they are causing occlusions.”  

By occluding flow through individual capillaries, these large cells could cause ischemic alteration in a distinct pattern, potentially resulting in an atypical form of neurologic impairment, the authors suggest.

“This might alter the hemodynamics and put pressure on other vessels, possibly contributing to the increased risk of stroke that has been reported in COVID-19,” Dr. Nauen said. None of the samples he examined came from patients with COVID-19 who had had a stroke, he reported.

Other than the presence of megakaryocytes in the capillaries, the brain looked normal, he said. He has now examined samples from 15 brains of patients who had COVID-19 and megakaryocytes have been found in the brain capillaries in five cases.
 

New neurologic complication

Classic encephalitis found with other viruses has not been reported in brain post-mortem examinations from patients who had COVID-19, Dr. Nauen noted. “The cognitive issues such as grogginess associated with COVID-19 would indicate problems with the cortex but that hasn’t been documented. This occlusion of a multitude of tiny vessels by megalokaryocytes may offer some explanation of the cognitive issues. This is a new kind of vascular insult seen on pathology, and suggests a new kind of neurologic complication,” he added.

The big question is what these megakaryocytes are doing in the brain.

“Megakaryocytes are bone marrow cells. They are not immune cells. Their job is to produce platelets to help the blood clot. They are not normally found outside the bone marrow, but they have been reported in other organs in COVID-19 patients.

“But the big puzzle associated with finding them in the brain is how they get through the very fine network of blood vessels in the lungs. The geometry just doesn’t work. We don’t know which part of the COVID inflammatory response makes this happen,” said Dr. Nauen.

The authors suggest one possibility is that altered endothelial or other signaling is recruiting megakaryocytes into the circulation and somehow permitting them to pass through the lungs.

“We need to try and understand if there is anything distinctive about these megakaryocytes – which proteins are they expressing that may explain why they are behaving in such an unusual way,” said Dr. Nauen.

Noting that many patients with severe COVID-19 have problems with clotting, and megakaryocytes are part of the clotting system, he speculated that some sort of aberrant message is being sent to these cells.

“It is notable that we found megakaryocytes in cortical capillaries in 33% of cases examined. Because the standard brain autopsy sections taken sampled at random [are] only a minute portion of the cortical volume, finding these cells suggests the total burden could be considerable,” the authors wrote.

Dr. Nauen added that to his knowledge, this is the first report of such observations, and the next step is to look for similar findings in larger sample sizes.

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

The long-term neurologic symptoms such as “brain fog” experienced by some patients with COVID-19 may be caused by a unique pathology – the occlusion of brain capillaries by large megakaryocyte cells, a new report suggests.

The authors report five separate post-mortem cases from patients who died with COVID-19 in which large cells resembling megakaryocytes were identified in cortical capillaries. Immunohistochemistry subsequently confirmed their megakaryocyte identity.

They point out that the finding is of interest as – to their knowledge – megakaryocytes have not been found in the brain before.

The observations are described in a research letter published online Feb. 12 in JAMA Neurology.
 

Bone marrow cells in the brain

Lead author David Nauen, MD, PhD, a neuropathologist from Johns Hopkins University, Baltimore, reported that he identified these cells in the first analysis of post-mortem brain tissue from a patient who had COVID-19.

“Some other viruses cause changes in the brain such as encephalopathy, and as neurologic symptoms are often reported in COVID-19, I was curious to see if similar effects were seen in brain post-mortem samples from patients who had died with the infection,” Dr. Nauen said.

On his first analysis of the brain tissue of a patient who had COVID-19, Dr. Nauen saw no evidence of viral encephalitis, but he observed some “unusually large” cells in the brain capillaries.

“I was taken aback; I couldn’t figure out what they were. Then I realized these cells were megakaryocytes from the bone marrow. I have never seen these cells in the brain before. I asked several colleagues and none of them had either. After extensive literature searches, I could find no evidence of megakaryocytes being in the brain,” Dr. Nauen noted.

Megakaryocytes, he explained, are “very large cells, and the brain capillaries are very small – just large enough to let red blood cells and lymphocytes pass through. To see these very large cells in such vessels is extremely unusual. It looks like they are causing occlusions.”  

By occluding flow through individual capillaries, these large cells could cause ischemic alteration in a distinct pattern, potentially resulting in an atypical form of neurologic impairment, the authors suggest.

“This might alter the hemodynamics and put pressure on other vessels, possibly contributing to the increased risk of stroke that has been reported in COVID-19,” Dr. Nauen said. None of the samples he examined came from patients with COVID-19 who had had a stroke, he reported.

Other than the presence of megakaryocytes in the capillaries, the brain looked normal, he said. He has now examined samples from 15 brains of patients who had COVID-19 and megakaryocytes have been found in the brain capillaries in five cases.
 

New neurologic complication

Classic encephalitis found with other viruses has not been reported in brain post-mortem examinations from patients who had COVID-19, Dr. Nauen noted. “The cognitive issues such as grogginess associated with COVID-19 would indicate problems with the cortex but that hasn’t been documented. This occlusion of a multitude of tiny vessels by megalokaryocytes may offer some explanation of the cognitive issues. This is a new kind of vascular insult seen on pathology, and suggests a new kind of neurologic complication,” he added.

The big question is what these megakaryocytes are doing in the brain.

“Megakaryocytes are bone marrow cells. They are not immune cells. Their job is to produce platelets to help the blood clot. They are not normally found outside the bone marrow, but they have been reported in other organs in COVID-19 patients.

“But the big puzzle associated with finding them in the brain is how they get through the very fine network of blood vessels in the lungs. The geometry just doesn’t work. We don’t know which part of the COVID inflammatory response makes this happen,” said Dr. Nauen.

The authors suggest one possibility is that altered endothelial or other signaling is recruiting megakaryocytes into the circulation and somehow permitting them to pass through the lungs.

“We need to try and understand if there is anything distinctive about these megakaryocytes – which proteins are they expressing that may explain why they are behaving in such an unusual way,” said Dr. Nauen.

Noting that many patients with severe COVID-19 have problems with clotting, and megakaryocytes are part of the clotting system, he speculated that some sort of aberrant message is being sent to these cells.

“It is notable that we found megakaryocytes in cortical capillaries in 33% of cases examined. Because the standard brain autopsy sections taken sampled at random [are] only a minute portion of the cortical volume, finding these cells suggests the total burden could be considerable,” the authors wrote.

Dr. Nauen added that to his knowledge, this is the first report of such observations, and the next step is to look for similar findings in larger sample sizes.

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

The long-term neurologic symptoms such as “brain fog” experienced by some patients with COVID-19 may be caused by a unique pathology – the occlusion of brain capillaries by large megakaryocyte cells, a new report suggests.

The authors report five separate post-mortem cases from patients who died with COVID-19 in which large cells resembling megakaryocytes were identified in cortical capillaries. Immunohistochemistry subsequently confirmed their megakaryocyte identity.

They point out that the finding is of interest as – to their knowledge – megakaryocytes have not been found in the brain before.

The observations are described in a research letter published online Feb. 12 in JAMA Neurology.
 

Bone marrow cells in the brain

Lead author David Nauen, MD, PhD, a neuropathologist from Johns Hopkins University, Baltimore, reported that he identified these cells in the first analysis of post-mortem brain tissue from a patient who had COVID-19.

“Some other viruses cause changes in the brain such as encephalopathy, and as neurologic symptoms are often reported in COVID-19, I was curious to see if similar effects were seen in brain post-mortem samples from patients who had died with the infection,” Dr. Nauen said.

On his first analysis of the brain tissue of a patient who had COVID-19, Dr. Nauen saw no evidence of viral encephalitis, but he observed some “unusually large” cells in the brain capillaries.

“I was taken aback; I couldn’t figure out what they were. Then I realized these cells were megakaryocytes from the bone marrow. I have never seen these cells in the brain before. I asked several colleagues and none of them had either. After extensive literature searches, I could find no evidence of megakaryocytes being in the brain,” Dr. Nauen noted.

Megakaryocytes, he explained, are “very large cells, and the brain capillaries are very small – just large enough to let red blood cells and lymphocytes pass through. To see these very large cells in such vessels is extremely unusual. It looks like they are causing occlusions.”  

By occluding flow through individual capillaries, these large cells could cause ischemic alteration in a distinct pattern, potentially resulting in an atypical form of neurologic impairment, the authors suggest.

“This might alter the hemodynamics and put pressure on other vessels, possibly contributing to the increased risk of stroke that has been reported in COVID-19,” Dr. Nauen said. None of the samples he examined came from patients with COVID-19 who had had a stroke, he reported.

Other than the presence of megakaryocytes in the capillaries, the brain looked normal, he said. He has now examined samples from 15 brains of patients who had COVID-19 and megakaryocytes have been found in the brain capillaries in five cases.
 

New neurologic complication

Classic encephalitis found with other viruses has not been reported in brain post-mortem examinations from patients who had COVID-19, Dr. Nauen noted. “The cognitive issues such as grogginess associated with COVID-19 would indicate problems with the cortex but that hasn’t been documented. This occlusion of a multitude of tiny vessels by megalokaryocytes may offer some explanation of the cognitive issues. This is a new kind of vascular insult seen on pathology, and suggests a new kind of neurologic complication,” he added.

The big question is what these megakaryocytes are doing in the brain.

“Megakaryocytes are bone marrow cells. They are not immune cells. Their job is to produce platelets to help the blood clot. They are not normally found outside the bone marrow, but they have been reported in other organs in COVID-19 patients.

“But the big puzzle associated with finding them in the brain is how they get through the very fine network of blood vessels in the lungs. The geometry just doesn’t work. We don’t know which part of the COVID inflammatory response makes this happen,” said Dr. Nauen.

The authors suggest one possibility is that altered endothelial or other signaling is recruiting megakaryocytes into the circulation and somehow permitting them to pass through the lungs.

“We need to try and understand if there is anything distinctive about these megakaryocytes – which proteins are they expressing that may explain why they are behaving in such an unusual way,” said Dr. Nauen.

Noting that many patients with severe COVID-19 have problems with clotting, and megakaryocytes are part of the clotting system, he speculated that some sort of aberrant message is being sent to these cells.

“It is notable that we found megakaryocytes in cortical capillaries in 33% of cases examined. Because the standard brain autopsy sections taken sampled at random [are] only a minute portion of the cortical volume, finding these cells suggests the total burden could be considerable,” the authors wrote.

Dr. Nauen added that to his knowledge, this is the first report of such observations, and the next step is to look for similar findings in larger sample sizes.

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

Dried blood spot testing showed sensitivity comparable to saliva as a screening method for congenital cytomegalovirus infection in newborns, based on data from more than 12,000 newborns.

Congenital cytomegalovirus (cCMV) is a common congenital virus in the United States, but remains underrecognized, wrote Sheila C. Dollard, PhD, of the Centers for Disease Control and Prevention in Atlanta, and colleagues.

“Given the burden associated with cCMV and the proven benefits of treatment and early intervention for some affected infants, there has been growing interest in universal newborn screening,” but an ideal screening strategy has yet to be determined, they said.

In a population-based cohort study published in JAMA Pediatrics, the researchers screened 12,554 newborns in Minnesota, including 56 with confirmed CMV infection. The newborns were screened for cCMV via dried blood spots (DBS) and saliva collected 1-2 days after birth. The DBS were tested for CMV DNA via polymerase chain reaction (PCR) at the University of Minnesota (UMN) and the CDC.

The overall sensitivity rate was 85.7% for a combination of laboratory results from the UMN and the CDC, which had separate sensitivities of 73.2% and 76.8%, respectively.

The specificity of the combined results was 100.0% (100% from both UMN and CDC), the combined positive predictive value was 98.0% (100.0% from UMN, 97.7% from CDC), and the combined negative predictive value was 99.9% (99.9% from both UMN and CDC).

By comparison, saliva swab test results showed sensitivity of 92.9%, specificity of 99.9%, positive predictive value of 86.7%, and negative predictive value of 100.0%.

The study findings were limited by several factors including the false-positive and false-negative results from saliva screening. Overall, the false-positive rate was 0.06%, which is comparable to rates from other screening techniques, the researchers said. “The recent Food and Drug Administration approval of a point-of-care neonatal saliva CMV test (Meridian Bioscience), underscores the importance of further clarifying the role of false-positive saliva CMV test results and underscores the requirement for urine confirmation for diagnosis of cCMV,” they added.

However, the study findings support the acceptability and feasibility of cCMV screening, as parents reported generally positive attitudes about the process, the researchers said.

The study is ongoing, and designed to follow infants with confirmed cCMV for up to age 4 years to assess clinical outcomes, they added. “Diagnostic methods are always improving, and therefore, our results show the potential of DBS to provide low-cost CMV screening with smooth integration of sample collection, laboratory testing, and follow-up,” they concluded.
 

Findings lay foundation for widespread use

“By using enhanced PCR methods, Dollard et al. have rekindled the hope that NBDBS [newborn dried blood spots] testing may be a viable method for large-scale, universal newborn screening for congenital CMV,” Gail J. Demmler-Harrison, MD, of Texas Children’s Hospital, Houston, wrote in an accompanying editorial. Congenital CMV is a common infection, but accurate prevalence remains uncertain because not all newborns are tested, she noted. Detection of CMV currently may involve urine, saliva, and blood, but challenges to the use of these methods include “a variety of constantly evolving DNA detection methods,” she said.

Although urine and saliva samples have been proposed for universal screening, they would require the creation of new sample collection and testing programs. “The routine of collecting the NBDBS samples on all newborns and the logistics of routing them to central laboratories and then reporting results to caregivers is already in place and are strengths of NBDBS samples for universal newborn screening,” but had been limited by a less sensitive platform than urine or saliva, said Dr. Demmler-Harrison.

“The results in the study by Dollard et al. may be a total game changer for the NBDBS proponents,” she emphasized. “Furthermore, scientists who have adapted even more sensitive DNA detection assays, such as the loop-mediated isothermal assay for detection of DNA in clinical samples from newborns, may be able to adapt loop-mediated isothermal assay methodology to detect CMV DNA in NBDBS,” she added.

“By adapting the collection methods, by using optimal filter paper to enhance DNA adherence, by improving DNA elution procedures, and by developing novel amplification and detection methods, NBDBS may soon meet the challenge and reach the sensitivity and specificity necessary for universal screening for congenital CMV,” she concluded.

The study was supported by the CDC, the Minnesota Department of Health, the National Vaccine Program Office (U.S. federal government), and the University of South Carolina Disability Research and Dissemination Center.

Dr. Dollard and Dr. Demmler-Harrison had no financial conflicts to disclose.

Dried blood spot testing showed sensitivity comparable to saliva as a screening method for congenital cytomegalovirus infection in newborns, based on data from more than 12,000 newborns.

Congenital cytomegalovirus (cCMV) is a common congenital virus in the United States, but remains underrecognized, wrote Sheila C. Dollard, PhD, of the Centers for Disease Control and Prevention in Atlanta, and colleagues.

“Given the burden associated with cCMV and the proven benefits of treatment and early intervention for some affected infants, there has been growing interest in universal newborn screening,” but an ideal screening strategy has yet to be determined, they said.

In a population-based cohort study published in JAMA Pediatrics, the researchers screened 12,554 newborns in Minnesota, including 56 with confirmed CMV infection. The newborns were screened for cCMV via dried blood spots (DBS) and saliva collected 1-2 days after birth. The DBS were tested for CMV DNA via polymerase chain reaction (PCR) at the University of Minnesota (UMN) and the CDC.

The overall sensitivity rate was 85.7% for a combination of laboratory results from the UMN and the CDC, which had separate sensitivities of 73.2% and 76.8%, respectively.

The specificity of the combined results was 100.0% (100% from both UMN and CDC), the combined positive predictive value was 98.0% (100.0% from UMN, 97.7% from CDC), and the combined negative predictive value was 99.9% (99.9% from both UMN and CDC).

By comparison, saliva swab test results showed sensitivity of 92.9%, specificity of 99.9%, positive predictive value of 86.7%, and negative predictive value of 100.0%.

The study findings were limited by several factors including the false-positive and false-negative results from saliva screening. Overall, the false-positive rate was 0.06%, which is comparable to rates from other screening techniques, the researchers said. “The recent Food and Drug Administration approval of a point-of-care neonatal saliva CMV test (Meridian Bioscience), underscores the importance of further clarifying the role of false-positive saliva CMV test results and underscores the requirement for urine confirmation for diagnosis of cCMV,” they added.

However, the study findings support the acceptability and feasibility of cCMV screening, as parents reported generally positive attitudes about the process, the researchers said.

The study is ongoing, and designed to follow infants with confirmed cCMV for up to age 4 years to assess clinical outcomes, they added. “Diagnostic methods are always improving, and therefore, our results show the potential of DBS to provide low-cost CMV screening with smooth integration of sample collection, laboratory testing, and follow-up,” they concluded.
 

Findings lay foundation for widespread use

“By using enhanced PCR methods, Dollard et al. have rekindled the hope that NBDBS [newborn dried blood spots] testing may be a viable method for large-scale, universal newborn screening for congenital CMV,” Gail J. Demmler-Harrison, MD, of Texas Children’s Hospital, Houston, wrote in an accompanying editorial. Congenital CMV is a common infection, but accurate prevalence remains uncertain because not all newborns are tested, she noted. Detection of CMV currently may involve urine, saliva, and blood, but challenges to the use of these methods include “a variety of constantly evolving DNA detection methods,” she said.

Although urine and saliva samples have been proposed for universal screening, they would require the creation of new sample collection and testing programs. “The routine of collecting the NBDBS samples on all newborns and the logistics of routing them to central laboratories and then reporting results to caregivers is already in place and are strengths of NBDBS samples for universal newborn screening,” but had been limited by a less sensitive platform than urine or saliva, said Dr. Demmler-Harrison.

“The results in the study by Dollard et al. may be a total game changer for the NBDBS proponents,” she emphasized. “Furthermore, scientists who have adapted even more sensitive DNA detection assays, such as the loop-mediated isothermal assay for detection of DNA in clinical samples from newborns, may be able to adapt loop-mediated isothermal assay methodology to detect CMV DNA in NBDBS,” she added.

“By adapting the collection methods, by using optimal filter paper to enhance DNA adherence, by improving DNA elution procedures, and by developing novel amplification and detection methods, NBDBS may soon meet the challenge and reach the sensitivity and specificity necessary for universal screening for congenital CMV,” she concluded.

The study was supported by the CDC, the Minnesota Department of Health, the National Vaccine Program Office (U.S. federal government), and the University of South Carolina Disability Research and Dissemination Center.

Dr. Dollard and Dr. Demmler-Harrison had no financial conflicts to disclose.

Dried blood spot testing showed sensitivity comparable to saliva as a screening method for congenital cytomegalovirus infection in newborns, based on data from more than 12,000 newborns.

Congenital cytomegalovirus (cCMV) is a common congenital virus in the United States, but remains underrecognized, wrote Sheila C. Dollard, PhD, of the Centers for Disease Control and Prevention in Atlanta, and colleagues.

“Given the burden associated with cCMV and the proven benefits of treatment and early intervention for some affected infants, there has been growing interest in universal newborn screening,” but an ideal screening strategy has yet to be determined, they said.

In a population-based cohort study published in JAMA Pediatrics, the researchers screened 12,554 newborns in Minnesota, including 56 with confirmed CMV infection. The newborns were screened for cCMV via dried blood spots (DBS) and saliva collected 1-2 days after birth. The DBS were tested for CMV DNA via polymerase chain reaction (PCR) at the University of Minnesota (UMN) and the CDC.

The overall sensitivity rate was 85.7% for a combination of laboratory results from the UMN and the CDC, which had separate sensitivities of 73.2% and 76.8%, respectively.

The specificity of the combined results was 100.0% (100% from both UMN and CDC), the combined positive predictive value was 98.0% (100.0% from UMN, 97.7% from CDC), and the combined negative predictive value was 99.9% (99.9% from both UMN and CDC).

By comparison, saliva swab test results showed sensitivity of 92.9%, specificity of 99.9%, positive predictive value of 86.7%, and negative predictive value of 100.0%.

The study findings were limited by several factors including the false-positive and false-negative results from saliva screening. Overall, the false-positive rate was 0.06%, which is comparable to rates from other screening techniques, the researchers said. “The recent Food and Drug Administration approval of a point-of-care neonatal saliva CMV test (Meridian Bioscience), underscores the importance of further clarifying the role of false-positive saliva CMV test results and underscores the requirement for urine confirmation for diagnosis of cCMV,” they added.

However, the study findings support the acceptability and feasibility of cCMV screening, as parents reported generally positive attitudes about the process, the researchers said.

The study is ongoing, and designed to follow infants with confirmed cCMV for up to age 4 years to assess clinical outcomes, they added. “Diagnostic methods are always improving, and therefore, our results show the potential of DBS to provide low-cost CMV screening with smooth integration of sample collection, laboratory testing, and follow-up,” they concluded.
 

Findings lay foundation for widespread use

“By using enhanced PCR methods, Dollard et al. have rekindled the hope that NBDBS [newborn dried blood spots] testing may be a viable method for large-scale, universal newborn screening for congenital CMV,” Gail J. Demmler-Harrison, MD, of Texas Children’s Hospital, Houston, wrote in an accompanying editorial. Congenital CMV is a common infection, but accurate prevalence remains uncertain because not all newborns are tested, she noted. Detection of CMV currently may involve urine, saliva, and blood, but challenges to the use of these methods include “a variety of constantly evolving DNA detection methods,” she said.

Although urine and saliva samples have been proposed for universal screening, they would require the creation of new sample collection and testing programs. “The routine of collecting the NBDBS samples on all newborns and the logistics of routing them to central laboratories and then reporting results to caregivers is already in place and are strengths of NBDBS samples for universal newborn screening,” but had been limited by a less sensitive platform than urine or saliva, said Dr. Demmler-Harrison.

“The results in the study by Dollard et al. may be a total game changer for the NBDBS proponents,” she emphasized. “Furthermore, scientists who have adapted even more sensitive DNA detection assays, such as the loop-mediated isothermal assay for detection of DNA in clinical samples from newborns, may be able to adapt loop-mediated isothermal assay methodology to detect CMV DNA in NBDBS,” she added.

“By adapting the collection methods, by using optimal filter paper to enhance DNA adherence, by improving DNA elution procedures, and by developing novel amplification and detection methods, NBDBS may soon meet the challenge and reach the sensitivity and specificity necessary for universal screening for congenital CMV,” she concluded.

The study was supported by the CDC, the Minnesota Department of Health, the National Vaccine Program Office (U.S. federal government), and the University of South Carolina Disability Research and Dissemination Center.

Dr. Dollard and Dr. Demmler-Harrison had no financial conflicts to disclose.

New COVID-19 cases in children continue to drop each week, but the total number of cases has now surpassed 3 million since the start of the pandemic, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

There were just over 99,000 new cases reported during the week of Feb. 5-11, the lowest number since early November and the fourth consecutive week with a decline. It was still enough, though, to bring the total to 3.03 million children infected with SARS-CoV-19 in the United States, the AAP and the CHA said in their weekly report.

The nation also hit a couple of other ignominious milestones. The cumulative rate of COVID-19 infection now stands at 4,030 per 100,000, so 4% of all children have been infected. Also, children represented 16.9% of all new cases for the week, which equals the highest proportion seen throughout the pandemic, based on data from health departments in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

There have been 241 COVID-19–related deaths in children so far, with 14 reported during the week of Feb. 5-11. Kansas just recorded its first pediatric death, which leaves 10 states that have had no fatalities. Texas, with 39 deaths, has had more than any other state, among the 43 that are reporting mortality by age, the AAP/CHA report showed.

[email protected]

New COVID-19 cases in children continue to drop each week, but the total number of cases has now surpassed 3 million since the start of the pandemic, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

There were just over 99,000 new cases reported during the week of Feb. 5-11, the lowest number since early November and the fourth consecutive week with a decline. It was still enough, though, to bring the total to 3.03 million children infected with SARS-CoV-19 in the United States, the AAP and the CHA said in their weekly report.

The nation also hit a couple of other ignominious milestones. The cumulative rate of COVID-19 infection now stands at 4,030 per 100,000, so 4% of all children have been infected. Also, children represented 16.9% of all new cases for the week, which equals the highest proportion seen throughout the pandemic, based on data from health departments in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

There have been 241 COVID-19–related deaths in children so far, with 14 reported during the week of Feb. 5-11. Kansas just recorded its first pediatric death, which leaves 10 states that have had no fatalities. Texas, with 39 deaths, has had more than any other state, among the 43 that are reporting mortality by age, the AAP/CHA report showed.

[email protected]

New COVID-19 cases in children continue to drop each week, but the total number of cases has now surpassed 3 million since the start of the pandemic, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

There were just over 99,000 new cases reported during the week of Feb. 5-11, the lowest number since early November and the fourth consecutive week with a decline. It was still enough, though, to bring the total to 3.03 million children infected with SARS-CoV-19 in the United States, the AAP and the CHA said in their weekly report.

The nation also hit a couple of other ignominious milestones. The cumulative rate of COVID-19 infection now stands at 4,030 per 100,000, so 4% of all children have been infected. Also, children represented 16.9% of all new cases for the week, which equals the highest proportion seen throughout the pandemic, based on data from health departments in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

There have been 241 COVID-19–related deaths in children so far, with 14 reported during the week of Feb. 5-11. Kansas just recorded its first pediatric death, which leaves 10 states that have had no fatalities. Texas, with 39 deaths, has had more than any other state, among the 43 that are reporting mortality by age, the AAP/CHA report showed.

[email protected]

Doctors are learning about new rules coming this April that encourage open and transparent communication among patients, families, and clinicians. The rules, putting into effect the bipartisan 21st Century Cures Act, mandate offering patients access to notes (“open notes”) written by clinicians in electronic medical records.

A recent article from this news organization noted that for many doctors this represents both a sudden and troubling change in practice. For others, the rules codify what they have been doing as a matter of routine for a decade. Spurred by the OpenNotes movement, at least 55 million Americans are already offered access to their clinical notes, including, since 2013, more than 9 million veterans with access to the Blue Button function in Veterans Affairs practices and hospitals.

The practice is spreading beyond the United States to other countries, including Canada, Sweden, Norway, Estonia, and the United Kingdom.

In this commentary, we review what patients, clinicians, and policymakers have been learning about open notes.
 

The patient experience

What do patients experience? In a survey of more than 22,000 patients who read notes in three diverse health systems, more than 90% reported having a good grasp of what their doctors and other clinicians had written, and very few (3%) reported being very confused by what they read. About two-thirds described reading their notes as very important for taking care of their health, remembering details of their visits and their care plans, and understanding why a medication was prescribed.

Indeed, in a clinically exciting finding, 14% of survey respondents reported that reading their notes made them more likely to take their medications as their doctors wished. With about half of Americans with chronic illness failing to take their medicines as prescribed, which sometimes leads to compromised outcomes and associated unnecessary costs (estimated at $300 billion annually), these reports of increased adherence should be taken very seriously.

Some doctors anticipate that open notes will erode patient communication. A growing body of research reveals just the opposite. In multiple surveys, patients describe open notes as “extending the visit,” strengthening collaboration and teamwork with their doctor. Quite possibly, the invitation to read notes may in itself increase trust. Such benefits appear especially pronounced among patients who are older, less educated, are persons of color or Hispanic, or who do not speak English at home.

And in several studies, more than a third of patients also report sharing their notes with others, with older and chronically ill patients in particular sharing access with family and friends who are their care partners.

On the other hand, a small minority of patients (5%) do report being more worried by what they read. It’s unknown whether this is because they are better informed about their care or because baseline anxiety levels increase. Doctors expect also that some patients, particularly those with cancer or serious mental illness, will be upset by their notes. So far, evidence does not support that specific concern.

Conversely, withholding, delaying, or blocking notes may be a source of anxiety or even stigmatization. When clinicians find themselves worried about sharing notes, we suggest that they discuss with their patients the benefits and risks. Recall also that transparency facilitates freedom of choice; patients make their own decision, and quite a few choose to leave notes unread.

Finding mistakes early and preventing harm are important goals for health care, and open notes can make care safer. Inevitably, medical records contain errors, omissions, and inaccuracies. In a large patient survey, 21% reported finding an error in their notes, and 42% perceived the error to be serious.

Moreover, 25% of doctors with more than a year’s experience with open notes reported patients finding errors that they (the doctors) considered “serious.” In 2015, the National Academy of Medicine cited open notes as a mechanism for improving diagnostic accuracy. In regard to possible legal action from patients, most attorneys, patients, and doctors agree that more transparent communication will build trust overall and, if anything, diminish litigation. We know of no instances so far of lawsuits deriving from open notes.
 

The physician experience

Doctors may worry that open notes will impede workflow, that they will be compelled to “dumb down” their documentation to avoid causing offense or anxiety, and that patients will demand changes to what is written. Here, extensive survey research should allay such fears and expectations. In a survey of more than 1,600 clinicians with at least 1 year of experience with open notes, reports of disruption to workflow were uncommon.

Most doctors (84%) reported that patients contacted them with questions about their notes “less than monthly or never.” Approximately two-thirds (62%) reported spending the same amount of time writing visit notes.

After implementing open notes, many doctors do report being more mindful about their documentation. For example, 41% reported changing how they used language such as “patient denies” or “noncompliant,” and 18% reported changing their use of medical jargon or abbreviations. Might these changes undermine the utility of medical notes? A majority of doctors surveyed (78%) said no, reporting that, after implementing open notes, the value of their documentation was the same or better.

Innovations spotlight difficult and often longstanding challenges. Open notes highlight the complex role of medical records in preserving privacy, especially in the spectrum of abuse, whether domestic or involving elders, children or sexual transgressions. For families with adolescents, issues concerning confidentiality can become a two-way street, and federal and state rules at times provide conflicting and idiosyncratic guidance. It is important to emphasize that the new rules permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties.

Perhaps think of open notes as a new medicine designed to help the vast majority of those who use it but with side effects and even contraindications for a few. Doctors can step in to minimize risks to vulnerable individuals, and imaginative and creative solutions to complex issues may emerge. In a growing number of practices serving adolescents, clinicians can now create two notes, with some elements of care visible on a patient portal and others held privately or visible only to the adolescent.
 

The shared experience

Overall, when it comes to documenting sensitive social information, open notes may act as a useful catalyst prompting deeper discussion about personal details clinically important to record, as opposed to those perhaps best left unwritten.

The implementation of open notes nationwide calls for exciting explorations. How can transparent systems maximize benefits for targeted populations in diverse settings? For patients with mental illness, can notes become part of the therapy? Given that care partners often report more benefit from reading notes than do patients themselves, how can they be mobilized to maximize their contributions to those acutely ill on hospital floors, or to family members with Alzheimer’s or in long-term care facilities?

How can we harness emerging technologies to translate notes and medical records into other languages or support lower literacy levels, while preserving the clinical detail in the notes? Should patients contribute to their own notes, cogenerating them with their clinicians? Experiments for “OurNotes” interventions are underway, and early reports from both patients and doctors hold considerable promise.

Ownership of medical records is evolving. Once firmly held by clinicians, electronic technologies have rapidly led to what may best be viewed currently as joint ownership by clinicians and patients. As apps evolve further and issues with interoperability of records diminish, it is likely that patients will eventually take control. Then it will be up to patients what to carry in their records. Clinicians will advise, but patients will decide.

The new rules herald clear changes in the fabric of care, and after a decade of study we anticipate that the benefits well outweigh the harms. But in the short run, it’s wrong to predict an avalanche. Two decades ago, when patient portals first revealed laboratory test findings to patients, doctors expected cataclysmic change in their practices. It did not occur. The vast majority of patients who registered on portals benefited and few disturbed their doctors.

Similarly, after notes were first unblinded by the OpenNotes research teams, the question we were asked most commonly by the primary care doctors who volunteered was whether the computers were actually displaying their notes. Even though many patients read them carefully, the doctors heard little from them. Clinicians have now reported the same experience in several subsequent studies.

Patients are resourceful, turning quickly to friends or the Internet for answers to their questions. They know how busy doctors are and don’t want to bother them if at all possible. When notes do trigger questions, the time taken to respond is probably offset by silence from other patients finding answers to their own questions in notes they read.

We believe that clinicians should embrace the spirit of the rules and also view them as HIPAA catching up with a computerized universe. As the new practice takes hold, ambiguities will diminish as further experience and research evolve. Warner V. Slack, MD, the first doctor to ask patients to talk to computers, opined that patients are the “largest and least utilized resource in health care.” Open and transparent communication through electronic medical records may mobilize patients (and their families) far more effectively. Patients will almost certainly benefit. Remembering Dr. Slack’s prophecy, we believe that clinicians will too.

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

Doctors are learning about new rules coming this April that encourage open and transparent communication among patients, families, and clinicians. The rules, putting into effect the bipartisan 21st Century Cures Act, mandate offering patients access to notes (“open notes”) written by clinicians in electronic medical records.

A recent article from this news organization noted that for many doctors this represents both a sudden and troubling change in practice. For others, the rules codify what they have been doing as a matter of routine for a decade. Spurred by the OpenNotes movement, at least 55 million Americans are already offered access to their clinical notes, including, since 2013, more than 9 million veterans with access to the Blue Button function in Veterans Affairs practices and hospitals.

The practice is spreading beyond the United States to other countries, including Canada, Sweden, Norway, Estonia, and the United Kingdom.

In this commentary, we review what patients, clinicians, and policymakers have been learning about open notes.
 

The patient experience

What do patients experience? In a survey of more than 22,000 patients who read notes in three diverse health systems, more than 90% reported having a good grasp of what their doctors and other clinicians had written, and very few (3%) reported being very confused by what they read. About two-thirds described reading their notes as very important for taking care of their health, remembering details of their visits and their care plans, and understanding why a medication was prescribed.

Indeed, in a clinically exciting finding, 14% of survey respondents reported that reading their notes made them more likely to take their medications as their doctors wished. With about half of Americans with chronic illness failing to take their medicines as prescribed, which sometimes leads to compromised outcomes and associated unnecessary costs (estimated at $300 billion annually), these reports of increased adherence should be taken very seriously.

Some doctors anticipate that open notes will erode patient communication. A growing body of research reveals just the opposite. In multiple surveys, patients describe open notes as “extending the visit,” strengthening collaboration and teamwork with their doctor. Quite possibly, the invitation to read notes may in itself increase trust. Such benefits appear especially pronounced among patients who are older, less educated, are persons of color or Hispanic, or who do not speak English at home.

And in several studies, more than a third of patients also report sharing their notes with others, with older and chronically ill patients in particular sharing access with family and friends who are their care partners.

On the other hand, a small minority of patients (5%) do report being more worried by what they read. It’s unknown whether this is because they are better informed about their care or because baseline anxiety levels increase. Doctors expect also that some patients, particularly those with cancer or serious mental illness, will be upset by their notes. So far, evidence does not support that specific concern.

Conversely, withholding, delaying, or blocking notes may be a source of anxiety or even stigmatization. When clinicians find themselves worried about sharing notes, we suggest that they discuss with their patients the benefits and risks. Recall also that transparency facilitates freedom of choice; patients make their own decision, and quite a few choose to leave notes unread.

Finding mistakes early and preventing harm are important goals for health care, and open notes can make care safer. Inevitably, medical records contain errors, omissions, and inaccuracies. In a large patient survey, 21% reported finding an error in their notes, and 42% perceived the error to be serious.

Moreover, 25% of doctors with more than a year’s experience with open notes reported patients finding errors that they (the doctors) considered “serious.” In 2015, the National Academy of Medicine cited open notes as a mechanism for improving diagnostic accuracy. In regard to possible legal action from patients, most attorneys, patients, and doctors agree that more transparent communication will build trust overall and, if anything, diminish litigation. We know of no instances so far of lawsuits deriving from open notes.
 

The physician experience

Doctors may worry that open notes will impede workflow, that they will be compelled to “dumb down” their documentation to avoid causing offense or anxiety, and that patients will demand changes to what is written. Here, extensive survey research should allay such fears and expectations. In a survey of more than 1,600 clinicians with at least 1 year of experience with open notes, reports of disruption to workflow were uncommon.

Most doctors (84%) reported that patients contacted them with questions about their notes “less than monthly or never.” Approximately two-thirds (62%) reported spending the same amount of time writing visit notes.

After implementing open notes, many doctors do report being more mindful about their documentation. For example, 41% reported changing how they used language such as “patient denies” or “noncompliant,” and 18% reported changing their use of medical jargon or abbreviations. Might these changes undermine the utility of medical notes? A majority of doctors surveyed (78%) said no, reporting that, after implementing open notes, the value of their documentation was the same or better.

Innovations spotlight difficult and often longstanding challenges. Open notes highlight the complex role of medical records in preserving privacy, especially in the spectrum of abuse, whether domestic or involving elders, children or sexual transgressions. For families with adolescents, issues concerning confidentiality can become a two-way street, and federal and state rules at times provide conflicting and idiosyncratic guidance. It is important to emphasize that the new rules permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties.

Perhaps think of open notes as a new medicine designed to help the vast majority of those who use it but with side effects and even contraindications for a few. Doctors can step in to minimize risks to vulnerable individuals, and imaginative and creative solutions to complex issues may emerge. In a growing number of practices serving adolescents, clinicians can now create two notes, with some elements of care visible on a patient portal and others held privately or visible only to the adolescent.
 

The shared experience

Overall, when it comes to documenting sensitive social information, open notes may act as a useful catalyst prompting deeper discussion about personal details clinically important to record, as opposed to those perhaps best left unwritten.

The implementation of open notes nationwide calls for exciting explorations. How can transparent systems maximize benefits for targeted populations in diverse settings? For patients with mental illness, can notes become part of the therapy? Given that care partners often report more benefit from reading notes than do patients themselves, how can they be mobilized to maximize their contributions to those acutely ill on hospital floors, or to family members with Alzheimer’s or in long-term care facilities?

How can we harness emerging technologies to translate notes and medical records into other languages or support lower literacy levels, while preserving the clinical detail in the notes? Should patients contribute to their own notes, cogenerating them with their clinicians? Experiments for “OurNotes” interventions are underway, and early reports from both patients and doctors hold considerable promise.

Ownership of medical records is evolving. Once firmly held by clinicians, electronic technologies have rapidly led to what may best be viewed currently as joint ownership by clinicians and patients. As apps evolve further and issues with interoperability of records diminish, it is likely that patients will eventually take control. Then it will be up to patients what to carry in their records. Clinicians will advise, but patients will decide.

The new rules herald clear changes in the fabric of care, and after a decade of study we anticipate that the benefits well outweigh the harms. But in the short run, it’s wrong to predict an avalanche. Two decades ago, when patient portals first revealed laboratory test findings to patients, doctors expected cataclysmic change in their practices. It did not occur. The vast majority of patients who registered on portals benefited and few disturbed their doctors.

Similarly, after notes were first unblinded by the OpenNotes research teams, the question we were asked most commonly by the primary care doctors who volunteered was whether the computers were actually displaying their notes. Even though many patients read them carefully, the doctors heard little from them. Clinicians have now reported the same experience in several subsequent studies.

Patients are resourceful, turning quickly to friends or the Internet for answers to their questions. They know how busy doctors are and don’t want to bother them if at all possible. When notes do trigger questions, the time taken to respond is probably offset by silence from other patients finding answers to their own questions in notes they read.

We believe that clinicians should embrace the spirit of the rules and also view them as HIPAA catching up with a computerized universe. As the new practice takes hold, ambiguities will diminish as further experience and research evolve. Warner V. Slack, MD, the first doctor to ask patients to talk to computers, opined that patients are the “largest and least utilized resource in health care.” Open and transparent communication through electronic medical records may mobilize patients (and their families) far more effectively. Patients will almost certainly benefit. Remembering Dr. Slack’s prophecy, we believe that clinicians will too.

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

Doctors are learning about new rules coming this April that encourage open and transparent communication among patients, families, and clinicians. The rules, putting into effect the bipartisan 21st Century Cures Act, mandate offering patients access to notes (“open notes”) written by clinicians in electronic medical records.

A recent article from this news organization noted that for many doctors this represents both a sudden and troubling change in practice. For others, the rules codify what they have been doing as a matter of routine for a decade. Spurred by the OpenNotes movement, at least 55 million Americans are already offered access to their clinical notes, including, since 2013, more than 9 million veterans with access to the Blue Button function in Veterans Affairs practices and hospitals.

The practice is spreading beyond the United States to other countries, including Canada, Sweden, Norway, Estonia, and the United Kingdom.

In this commentary, we review what patients, clinicians, and policymakers have been learning about open notes.
 

The patient experience

What do patients experience? In a survey of more than 22,000 patients who read notes in three diverse health systems, more than 90% reported having a good grasp of what their doctors and other clinicians had written, and very few (3%) reported being very confused by what they read. About two-thirds described reading their notes as very important for taking care of their health, remembering details of their visits and their care plans, and understanding why a medication was prescribed.

Indeed, in a clinically exciting finding, 14% of survey respondents reported that reading their notes made them more likely to take their medications as their doctors wished. With about half of Americans with chronic illness failing to take their medicines as prescribed, which sometimes leads to compromised outcomes and associated unnecessary costs (estimated at $300 billion annually), these reports of increased adherence should be taken very seriously.

Some doctors anticipate that open notes will erode patient communication. A growing body of research reveals just the opposite. In multiple surveys, patients describe open notes as “extending the visit,” strengthening collaboration and teamwork with their doctor. Quite possibly, the invitation to read notes may in itself increase trust. Such benefits appear especially pronounced among patients who are older, less educated, are persons of color or Hispanic, or who do not speak English at home.

And in several studies, more than a third of patients also report sharing their notes with others, with older and chronically ill patients in particular sharing access with family and friends who are their care partners.

On the other hand, a small minority of patients (5%) do report being more worried by what they read. It’s unknown whether this is because they are better informed about their care or because baseline anxiety levels increase. Doctors expect also that some patients, particularly those with cancer or serious mental illness, will be upset by their notes. So far, evidence does not support that specific concern.

Conversely, withholding, delaying, or blocking notes may be a source of anxiety or even stigmatization. When clinicians find themselves worried about sharing notes, we suggest that they discuss with their patients the benefits and risks. Recall also that transparency facilitates freedom of choice; patients make their own decision, and quite a few choose to leave notes unread.

Finding mistakes early and preventing harm are important goals for health care, and open notes can make care safer. Inevitably, medical records contain errors, omissions, and inaccuracies. In a large patient survey, 21% reported finding an error in their notes, and 42% perceived the error to be serious.

Moreover, 25% of doctors with more than a year’s experience with open notes reported patients finding errors that they (the doctors) considered “serious.” In 2015, the National Academy of Medicine cited open notes as a mechanism for improving diagnostic accuracy. In regard to possible legal action from patients, most attorneys, patients, and doctors agree that more transparent communication will build trust overall and, if anything, diminish litigation. We know of no instances so far of lawsuits deriving from open notes.
 

The physician experience

Doctors may worry that open notes will impede workflow, that they will be compelled to “dumb down” their documentation to avoid causing offense or anxiety, and that patients will demand changes to what is written. Here, extensive survey research should allay such fears and expectations. In a survey of more than 1,600 clinicians with at least 1 year of experience with open notes, reports of disruption to workflow were uncommon.

Most doctors (84%) reported that patients contacted them with questions about their notes “less than monthly or never.” Approximately two-thirds (62%) reported spending the same amount of time writing visit notes.

After implementing open notes, many doctors do report being more mindful about their documentation. For example, 41% reported changing how they used language such as “patient denies” or “noncompliant,” and 18% reported changing their use of medical jargon or abbreviations. Might these changes undermine the utility of medical notes? A majority of doctors surveyed (78%) said no, reporting that, after implementing open notes, the value of their documentation was the same or better.

Innovations spotlight difficult and often longstanding challenges. Open notes highlight the complex role of medical records in preserving privacy, especially in the spectrum of abuse, whether domestic or involving elders, children or sexual transgressions. For families with adolescents, issues concerning confidentiality can become a two-way street, and federal and state rules at times provide conflicting and idiosyncratic guidance. It is important to emphasize that the new rules permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties.

Perhaps think of open notes as a new medicine designed to help the vast majority of those who use it but with side effects and even contraindications for a few. Doctors can step in to minimize risks to vulnerable individuals, and imaginative and creative solutions to complex issues may emerge. In a growing number of practices serving adolescents, clinicians can now create two notes, with some elements of care visible on a patient portal and others held privately or visible only to the adolescent.
 

The shared experience

Overall, when it comes to documenting sensitive social information, open notes may act as a useful catalyst prompting deeper discussion about personal details clinically important to record, as opposed to those perhaps best left unwritten.

The implementation of open notes nationwide calls for exciting explorations. How can transparent systems maximize benefits for targeted populations in diverse settings? For patients with mental illness, can notes become part of the therapy? Given that care partners often report more benefit from reading notes than do patients themselves, how can they be mobilized to maximize their contributions to those acutely ill on hospital floors, or to family members with Alzheimer’s or in long-term care facilities?

How can we harness emerging technologies to translate notes and medical records into other languages or support lower literacy levels, while preserving the clinical detail in the notes? Should patients contribute to their own notes, cogenerating them with their clinicians? Experiments for “OurNotes” interventions are underway, and early reports from both patients and doctors hold considerable promise.

Ownership of medical records is evolving. Once firmly held by clinicians, electronic technologies have rapidly led to what may best be viewed currently as joint ownership by clinicians and patients. As apps evolve further and issues with interoperability of records diminish, it is likely that patients will eventually take control. Then it will be up to patients what to carry in their records. Clinicians will advise, but patients will decide.

The new rules herald clear changes in the fabric of care, and after a decade of study we anticipate that the benefits well outweigh the harms. But in the short run, it’s wrong to predict an avalanche. Two decades ago, when patient portals first revealed laboratory test findings to patients, doctors expected cataclysmic change in their practices. It did not occur. The vast majority of patients who registered on portals benefited and few disturbed their doctors.

Similarly, after notes were first unblinded by the OpenNotes research teams, the question we were asked most commonly by the primary care doctors who volunteered was whether the computers were actually displaying their notes. Even though many patients read them carefully, the doctors heard little from them. Clinicians have now reported the same experience in several subsequent studies.

Patients are resourceful, turning quickly to friends or the Internet for answers to their questions. They know how busy doctors are and don’t want to bother them if at all possible. When notes do trigger questions, the time taken to respond is probably offset by silence from other patients finding answers to their own questions in notes they read.

We believe that clinicians should embrace the spirit of the rules and also view them as HIPAA catching up with a computerized universe. As the new practice takes hold, ambiguities will diminish as further experience and research evolve. Warner V. Slack, MD, the first doctor to ask patients to talk to computers, opined that patients are the “largest and least utilized resource in health care.” Open and transparent communication through electronic medical records may mobilize patients (and their families) far more effectively. Patients will almost certainly benefit. Remembering Dr. Slack’s prophecy, we believe that clinicians will too.

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

An increasingly common question I’m receiving is: What should private practices do if a patient or employee tests positive for COVID-19, or has been exposed to someone who has?

As always, it depends, but here is some general advice: The specifics will vary depending on state/local laws, or your particular situation.

First, you need to determine the level of exposure, and whether it requires action. According to the Centers for Disease Control and Prevention, actionable exposure occurs 2 days prior to the onset of illness, and lasts 10 days after onset.

If action is required, you’ll need to determine who needs to quarantine and who needs to be tested. Vaccinated employees who have been exposed to suspected or confirmed COVID-19 are not required to quarantine or be tested if they are fully vaccinated and have remained asymptomatic since the exposure. Those employees should, however, follow all the usual precautions (masks, social distancing, handwashing, etc.) with increased diligence. Remind them that no vaccine is 100% effective, and suggest they self-monitor for symptoms (fever, cough, shortness of breath, etc.)

All other exposed employees should be tested. A negative test means an individual was not infected at the time the sample was collected, but that does not mean an individual will not get sick later. Some providers are retesting on days 5 and 7 post exposure.

Some experts advise that you monitor exposed employees (vaccinated or not) yourself, with daily temperature readings and inquiries regarding symptoms, and perhaps a daily pulse oximetry check, for 14 days following exposure. Document these screenings in writing. Anyone testing positive or developing a fever or other symptoms should, of course, be sent home and seek medical treatment as necessary.

Employees who develop symptoms or test positive for COVID-19 should remain out of work until all CDC “return-to-work” criteria are met. At this writing, the basic criteria include:

• At least 10 days pass after symptoms first appeared
• At least 24 hours pass after last fever without the use of fever-reducing medications
• Cough, shortness of breath, and any other symptoms improve

Anyone who is significantly immunocompromised may need more time at home, and probably consultation with an infectious disease specialist.

Your facility should be thoroughly cleaned after the exposure. Close off all areas used by the sick individual, and clean and disinfect all areas such as offices, doorknobs, bathrooms, common areas, and shared electronic equipment. Of course, the cleaners should wear gowns, gloves, masks, and goggles. Some practices are hiring cleaning crews to professionally disinfect their offices. Once the area has been disinfected, it can be reopened for use. Workers without close contact with the person who is sick can return to work immediately after disinfection.

If the potential infected area is widespread and cannot be isolated to a room or rooms where doors can be shut, it may be prudent to temporarily close your office, send staff home, and divert patients to other locations if they cannot be rescheduled. Once your facility is cleaned and disinfected and staff have been cleared, your office may reopen.

Use enhanced precautions for any staff or patients who are immunocompromised, or otherwise fall into the high-risk category, to keep them out of the path of potential exposure areas and allow them to self-quarantine if they desire.

You should continue following existing leave policies (paid time off, vacation, sick, short-term disability, leave of absence, Family and Medical Leave Act, and Americans with Disabilities Act). If the employee was exposed at work, contact your workers’ compensation carrier regarding lost wages. Unless your state laws specify otherwise, you are under no obligation to pay beyond your policies, but you may do so if you choose.

Of course, you can take proactive steps to prevent unnecessary exposure and avoid closures in the first place; for example:

• Call patients prior to their visit, or question them upon arrival, regarding fever, shortness of breath, and other COVID-19 symptoms.
• Check employees’ temperatures every morning.
• Check patients’ temperatures as they enter the office.
• Require everyone, patients and employees alike, to wear face coverings.
• Ask patients to leave friends and family members at home.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].

An increasingly common question I’m receiving is: What should private practices do if a patient or employee tests positive for COVID-19, or has been exposed to someone who has?

As always, it depends, but here is some general advice: The specifics will vary depending on state/local laws, or your particular situation.

First, you need to determine the level of exposure, and whether it requires action. According to the Centers for Disease Control and Prevention, actionable exposure occurs 2 days prior to the onset of illness, and lasts 10 days after onset.

If action is required, you’ll need to determine who needs to quarantine and who needs to be tested. Vaccinated employees who have been exposed to suspected or confirmed COVID-19 are not required to quarantine or be tested if they are fully vaccinated and have remained asymptomatic since the exposure. Those employees should, however, follow all the usual precautions (masks, social distancing, handwashing, etc.) with increased diligence. Remind them that no vaccine is 100% effective, and suggest they self-monitor for symptoms (fever, cough, shortness of breath, etc.)

All other exposed employees should be tested. A negative test means an individual was not infected at the time the sample was collected, but that does not mean an individual will not get sick later. Some providers are retesting on days 5 and 7 post exposure.

Some experts advise that you monitor exposed employees (vaccinated or not) yourself, with daily temperature readings and inquiries regarding symptoms, and perhaps a daily pulse oximetry check, for 14 days following exposure. Document these screenings in writing. Anyone testing positive or developing a fever or other symptoms should, of course, be sent home and seek medical treatment as necessary.

Employees who develop symptoms or test positive for COVID-19 should remain out of work until all CDC “return-to-work” criteria are met. At this writing, the basic criteria include:

• At least 10 days pass after symptoms first appeared
• At least 24 hours pass after last fever without the use of fever-reducing medications
• Cough, shortness of breath, and any other symptoms improve

Anyone who is significantly immunocompromised may need more time at home, and probably consultation with an infectious disease specialist.

Your facility should be thoroughly cleaned after the exposure. Close off all areas used by the sick individual, and clean and disinfect all areas such as offices, doorknobs, bathrooms, common areas, and shared electronic equipment. Of course, the cleaners should wear gowns, gloves, masks, and goggles. Some practices are hiring cleaning crews to professionally disinfect their offices. Once the area has been disinfected, it can be reopened for use. Workers without close contact with the person who is sick can return to work immediately after disinfection.

If the potential infected area is widespread and cannot be isolated to a room or rooms where doors can be shut, it may be prudent to temporarily close your office, send staff home, and divert patients to other locations if they cannot be rescheduled. Once your facility is cleaned and disinfected and staff have been cleared, your office may reopen.

Use enhanced precautions for any staff or patients who are immunocompromised, or otherwise fall into the high-risk category, to keep them out of the path of potential exposure areas and allow them to self-quarantine if they desire.

You should continue following existing leave policies (paid time off, vacation, sick, short-term disability, leave of absence, Family and Medical Leave Act, and Americans with Disabilities Act). If the employee was exposed at work, contact your workers’ compensation carrier regarding lost wages. Unless your state laws specify otherwise, you are under no obligation to pay beyond your policies, but you may do so if you choose.

Of course, you can take proactive steps to prevent unnecessary exposure and avoid closures in the first place; for example:

• Call patients prior to their visit, or question them upon arrival, regarding fever, shortness of breath, and other COVID-19 symptoms.
• Check employees’ temperatures every morning.
• Check patients’ temperatures as they enter the office.
• Require everyone, patients and employees alike, to wear face coverings.
• Ask patients to leave friends and family members at home.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].

An increasingly common question I’m receiving is: What should private practices do if a patient or employee tests positive for COVID-19, or has been exposed to someone who has?

As always, it depends, but here is some general advice: The specifics will vary depending on state/local laws, or your particular situation.

First, you need to determine the level of exposure, and whether it requires action. According to the Centers for Disease Control and Prevention, actionable exposure occurs 2 days prior to the onset of illness, and lasts 10 days after onset.

If action is required, you’ll need to determine who needs to quarantine and who needs to be tested. Vaccinated employees who have been exposed to suspected or confirmed COVID-19 are not required to quarantine or be tested if they are fully vaccinated and have remained asymptomatic since the exposure. Those employees should, however, follow all the usual precautions (masks, social distancing, handwashing, etc.) with increased diligence. Remind them that no vaccine is 100% effective, and suggest they self-monitor for symptoms (fever, cough, shortness of breath, etc.)

All other exposed employees should be tested. A negative test means an individual was not infected at the time the sample was collected, but that does not mean an individual will not get sick later. Some providers are retesting on days 5 and 7 post exposure.

Some experts advise that you monitor exposed employees (vaccinated or not) yourself, with daily temperature readings and inquiries regarding symptoms, and perhaps a daily pulse oximetry check, for 14 days following exposure. Document these screenings in writing. Anyone testing positive or developing a fever or other symptoms should, of course, be sent home and seek medical treatment as necessary.

Employees who develop symptoms or test positive for COVID-19 should remain out of work until all CDC “return-to-work” criteria are met. At this writing, the basic criteria include:

• At least 10 days pass after symptoms first appeared
• At least 24 hours pass after last fever without the use of fever-reducing medications
• Cough, shortness of breath, and any other symptoms improve

Anyone who is significantly immunocompromised may need more time at home, and probably consultation with an infectious disease specialist.

Your facility should be thoroughly cleaned after the exposure. Close off all areas used by the sick individual, and clean and disinfect all areas such as offices, doorknobs, bathrooms, common areas, and shared electronic equipment. Of course, the cleaners should wear gowns, gloves, masks, and goggles. Some practices are hiring cleaning crews to professionally disinfect their offices. Once the area has been disinfected, it can be reopened for use. Workers without close contact with the person who is sick can return to work immediately after disinfection.

If the potential infected area is widespread and cannot be isolated to a room or rooms where doors can be shut, it may be prudent to temporarily close your office, send staff home, and divert patients to other locations if they cannot be rescheduled. Once your facility is cleaned and disinfected and staff have been cleared, your office may reopen.

Use enhanced precautions for any staff or patients who are immunocompromised, or otherwise fall into the high-risk category, to keep them out of the path of potential exposure areas and allow them to self-quarantine if they desire.

You should continue following existing leave policies (paid time off, vacation, sick, short-term disability, leave of absence, Family and Medical Leave Act, and Americans with Disabilities Act). If the employee was exposed at work, contact your workers’ compensation carrier regarding lost wages. Unless your state laws specify otherwise, you are under no obligation to pay beyond your policies, but you may do so if you choose.

Of course, you can take proactive steps to prevent unnecessary exposure and avoid closures in the first place; for example:

• Call patients prior to their visit, or question them upon arrival, regarding fever, shortness of breath, and other COVID-19 symptoms.
• Check employees’ temperatures every morning.
• Check patients’ temperatures as they enter the office.
• Require everyone, patients and employees alike, to wear face coverings.
• Ask patients to leave friends and family members at home.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at [email protected].

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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

For pediatric patients with respiratory tract infections (RTIs), immediately prescribing antibiotics may do more harm than good, based on prospective data from 436 children treated by primary care pediatricians in Spain.

In the largest trial of its kind to date, children who were immediately prescribed antibiotics showed no significant difference in symptom severity or duration from those who received a delayed prescription for antibiotics, or no prescription at all; yet those in the immediate-prescription group had a higher rate of gastrointestinal adverse events, reported lead author Gemma Mas-Dalmau, MD, of the Sant Pau Institute for Biomedical Research, Barcelona, and colleagues.

“Most RTIs are self-limiting, and antibiotics hardly alter the course of the condition, yet antibiotics are frequently prescribed for these conditions,” the investigators wrote in Pediatrics. “Antibiotic prescription for RTIs in children is especially considered to be inappropriately high.”

This clinical behavior is driven by several factors, according to Dr. Mas-Dalmau and colleagues, including limited diagnostics in primary care, pressure to meet parental expectations, and concern for possible complications if antibiotics are withheld or delayed.

In an accompanying editorial, Jeffrey S. Gerber, MD, PhD and Bonnie F. Offit, MD, of Children’s Hospital of Philadelphia, noted that “children in the United States receive more than one antibiotic prescription per year, driven largely by acute RTIs.”

Dr. Gerber and Dr. Offit noted that some RTIs are indeed caused by bacteria, and therefore benefit from antibiotics, but it’s “not always easy” to identify these cases.

“Primary care, urgent care, and emergency medicine clinicians have a hard job,” they wrote.

According to the Centers for Disease Control and Prevention, delayed prescription of antibiotics, in which a prescription is filled upon persistence or worsening of symptoms, can balance clinical caution and antibiotic stewardship.

“An example of this approach is acute otitis media, in which delayed prescribing has been shown to safely reduce antibiotic exposure,” wrote Dr. Gerber and Dr. Offit.

In a 2017 Cochrane systematic review of both adults and children with RTIs, antibiotic prescriptions, whether immediate, delayed, or not given at all, had no significant effect on most symptoms or complications. Although several randomized trials have evaluated delayed antibiotic prescriptions in children, Dr. Mas-Dalmau and colleagues described the current body of evidence as “scant.”

The present study built upon this knowledge base by prospectively following 436 children treated at 39 primary care centers in Spain from 2012 to 2016. Patients were between 2 and 14 years of age and presented for rhinosinusitis, pharyngitis, acute otitis media, or acute bronchitis. Inclusion in the study required the pediatrician to have “reasonable doubts about the need to prescribe an antibiotic.” Clinics with access to rapid streptococcal testing did not enroll patients with pharyngitis.

Patients were randomized in approximately equal groups to receive either immediate prescription of antibiotics, delayed prescription, or no prescription. In the delayed group, caregivers were advised to fill prescriptions if any of following three events occurred:

• No symptom improvement after a certain amount of days, depending on presenting complaint (acute otitis media, 4 days; pharyngitis, 7 days; acute rhinosinusitis, 15 days; acute bronchitis, 20 days).
• Temperature of at least 39° C after 24 hours, or at least 38° C but less than 39° C after 48 hours.
• Patient feeling “much worse.”

Primary outcomes were severity and duration of symptoms over 30 days, while secondary outcomes included antibiotic use over 30 days, additional unscheduled visits to primary care over 30 days, and parental satisfaction and beliefs regarding antibiotic efficacy.

In the final dataset, 148 patients received immediate antibiotic prescriptions, while 146 received delayed prescriptions, and 142 received no prescription. Rate of antibiotic use was highest in the immediate prescription group, at 96%, versus 25.3% in the delayed group and 12% among those who received no prescription upon first presentation (P < .001).

Although the mean duration of severe symptoms was longest in the delayed-prescription group, at 12.4 days, versus 10.9 days in the no-prescription group and 10.1 days in the immediate-prescription group, these differences were not statistically significant (P = .539). Median score for greatest severity of any symptom was also similar across groups. Secondary outcomes echoed this pattern, in which reconsultation rates and caregiver satisfaction were statistically similar regardless of treatment type.

In contrast, patients who received immediate antibiotic prescriptions had a significantly higher rate of gastrointestinal adverse events (8.8%) than those who received a delayed prescription (3.4%) or no prescription (2.8%; P = .037).

“Delayed antibiotic prescription is an efficacious and safe strategy for reducing inappropriate antibiotic treatment of uncomplicated RTIs in children when the doctor has reasonable doubts regarding the indication,” the investigators concluded. “[It] is therefore a useful tool for addressing the public health issue of bacterial resistance. However, no antibiotic prescription remains the recommended strategy when it is clear that antibiotics are not indicated, like in most cases of acute bronchitis.”

“These data are reassuring,” wrote Dr. Gerber and Dr. Offit; however, they went on to suggest that the data “might not substantially move the needle.”

“With rare exceptions, children with acute pharyngitis should first receive a group A streptococcal test,” they wrote. “If results are positive, all patients should get antibiotics; if results are negative, no one gets them. Acute bronchitis (whatever that is in children) is viral. Acute sinusitis with persistent symptoms (the most commonly diagnosed variety) already has a delayed option, and the current study ... was not powered for this outcome. We are left with acute otitis media, which dominated enrollment but already has an evidence-based guideline.”

Still, Dr. Gerber and Dr. Offit suggested that the findings should further encourage pediatricians to prescribe antibiotics judiciously, and when elected, to choose the shortest duration and narrowest spectrum possible.

In a joint comment, Rana El Feghaly, MD, MSCI, director of outpatient antibiotic stewardship at Children’s Mercy, Kansas City, and her colleague, Mary Anne Jackson, MD, noted that the findings are “in accordance” with the 2017 Cochrane review.

Dr. Feghaly and Dr. Jackson said that these new data provide greater support for conservative use of antibiotics, which is badly needed, considering approximately 50% of outpatient prescriptions are unnecessary or inappropriate .

Delayed antibiotic prescription is part of a multifaceted approach to the issue, they said, joining “communication skills training, antibiotic justification documentation, audit and feedback reporting with peer comparison, diagnostic stewardship, [and] the use of clinician education on practice-based guidelines.”

“Leveraging delayed antibiotic prescription may be an excellent way to combat antibiotic overuse in the outpatient setting, while avoiding provider and parental fear of the ‘no antibiotic’ approach,” Dr. Feghaly and Dr. Jackson said.

Karlyn Kinsella, MD, of Pediatric Associates of Cheshire, Conn., suggested that clinicians discuss these findings with parents who request antibiotics for “otitis, pharyngitis, bronchitis, or sinusitis.”

“We can cite this study that antibiotics have no effect on symptom duration or severity for these illnesses,” Dr. Kinsella said. “Of course, our clinical opinion in each case takes precedent.”

According to Dr. Kinsella, conversations with parents also need to cover reasonable expectations, as the study did, with clear time frames for each condition in which children should start to get better.

“I think this is really key in our anticipatory guidance so that patients know what to expect,” she said.

The study was funded by Instituto de Salud Carlos III, the European Union, and the Spanish Ministry of Health, Social Services, and Equality. The investigators and interviewees reported no conflicts of interest.

For pediatric patients with respiratory tract infections (RTIs), immediately prescribing antibiotics may do more harm than good, based on prospective data from 436 children treated by primary care pediatricians in Spain.

In the largest trial of its kind to date, children who were immediately prescribed antibiotics showed no significant difference in symptom severity or duration from those who received a delayed prescription for antibiotics, or no prescription at all; yet those in the immediate-prescription group had a higher rate of gastrointestinal adverse events, reported lead author Gemma Mas-Dalmau, MD, of the Sant Pau Institute for Biomedical Research, Barcelona, and colleagues.

“Most RTIs are self-limiting, and antibiotics hardly alter the course of the condition, yet antibiotics are frequently prescribed for these conditions,” the investigators wrote in Pediatrics. “Antibiotic prescription for RTIs in children is especially considered to be inappropriately high.”

This clinical behavior is driven by several factors, according to Dr. Mas-Dalmau and colleagues, including limited diagnostics in primary care, pressure to meet parental expectations, and concern for possible complications if antibiotics are withheld or delayed.

In an accompanying editorial, Jeffrey S. Gerber, MD, PhD and Bonnie F. Offit, MD, of Children’s Hospital of Philadelphia, noted that “children in the United States receive more than one antibiotic prescription per year, driven largely by acute RTIs.”

Dr. Gerber and Dr. Offit noted that some RTIs are indeed caused by bacteria, and therefore benefit from antibiotics, but it’s “not always easy” to identify these cases.

“Primary care, urgent care, and emergency medicine clinicians have a hard job,” they wrote.

According to the Centers for Disease Control and Prevention, delayed prescription of antibiotics, in which a prescription is filled upon persistence or worsening of symptoms, can balance clinical caution and antibiotic stewardship.

“An example of this approach is acute otitis media, in which delayed prescribing has been shown to safely reduce antibiotic exposure,” wrote Dr. Gerber and Dr. Offit.

In a 2017 Cochrane systematic review of both adults and children with RTIs, antibiotic prescriptions, whether immediate, delayed, or not given at all, had no significant effect on most symptoms or complications. Although several randomized trials have evaluated delayed antibiotic prescriptions in children, Dr. Mas-Dalmau and colleagues described the current body of evidence as “scant.”

The present study built upon this knowledge base by prospectively following 436 children treated at 39 primary care centers in Spain from 2012 to 2016. Patients were between 2 and 14 years of age and presented for rhinosinusitis, pharyngitis, acute otitis media, or acute bronchitis. Inclusion in the study required the pediatrician to have “reasonable doubts about the need to prescribe an antibiotic.” Clinics with access to rapid streptococcal testing did not enroll patients with pharyngitis.

Patients were randomized in approximately equal groups to receive either immediate prescription of antibiotics, delayed prescription, or no prescription. In the delayed group, caregivers were advised to fill prescriptions if any of following three events occurred:

• No symptom improvement after a certain amount of days, depending on presenting complaint (acute otitis media, 4 days; pharyngitis, 7 days; acute rhinosinusitis, 15 days; acute bronchitis, 20 days).
• Temperature of at least 39° C after 24 hours, or at least 38° C but less than 39° C after 48 hours.
• Patient feeling “much worse.”

Primary outcomes were severity and duration of symptoms over 30 days, while secondary outcomes included antibiotic use over 30 days, additional unscheduled visits to primary care over 30 days, and parental satisfaction and beliefs regarding antibiotic efficacy.

In the final dataset, 148 patients received immediate antibiotic prescriptions, while 146 received delayed prescriptions, and 142 received no prescription. Rate of antibiotic use was highest in the immediate prescription group, at 96%, versus 25.3% in the delayed group and 12% among those who received no prescription upon first presentation (P < .001).

Although the mean duration of severe symptoms was longest in the delayed-prescription group, at 12.4 days, versus 10.9 days in the no-prescription group and 10.1 days in the immediate-prescription group, these differences were not statistically significant (P = .539). Median score for greatest severity of any symptom was also similar across groups. Secondary outcomes echoed this pattern, in which reconsultation rates and caregiver satisfaction were statistically similar regardless of treatment type.

In contrast, patients who received immediate antibiotic prescriptions had a significantly higher rate of gastrointestinal adverse events (8.8%) than those who received a delayed prescription (3.4%) or no prescription (2.8%; P = .037).

“Delayed antibiotic prescription is an efficacious and safe strategy for reducing inappropriate antibiotic treatment of uncomplicated RTIs in children when the doctor has reasonable doubts regarding the indication,” the investigators concluded. “[It] is therefore a useful tool for addressing the public health issue of bacterial resistance. However, no antibiotic prescription remains the recommended strategy when it is clear that antibiotics are not indicated, like in most cases of acute bronchitis.”

“These data are reassuring,” wrote Dr. Gerber and Dr. Offit; however, they went on to suggest that the data “might not substantially move the needle.”

“With rare exceptions, children with acute pharyngitis should first receive a group A streptococcal test,” they wrote. “If results are positive, all patients should get antibiotics; if results are negative, no one gets them. Acute bronchitis (whatever that is in children) is viral. Acute sinusitis with persistent symptoms (the most commonly diagnosed variety) already has a delayed option, and the current study ... was not powered for this outcome. We are left with acute otitis media, which dominated enrollment but already has an evidence-based guideline.”

Still, Dr. Gerber and Dr. Offit suggested that the findings should further encourage pediatricians to prescribe antibiotics judiciously, and when elected, to choose the shortest duration and narrowest spectrum possible.

In a joint comment, Rana El Feghaly, MD, MSCI, director of outpatient antibiotic stewardship at Children’s Mercy, Kansas City, and her colleague, Mary Anne Jackson, MD, noted that the findings are “in accordance” with the 2017 Cochrane review.

Dr. Feghaly and Dr. Jackson said that these new data provide greater support for conservative use of antibiotics, which is badly needed, considering approximately 50% of outpatient prescriptions are unnecessary or inappropriate .

Delayed antibiotic prescription is part of a multifaceted approach to the issue, they said, joining “communication skills training, antibiotic justification documentation, audit and feedback reporting with peer comparison, diagnostic stewardship, [and] the use of clinician education on practice-based guidelines.”

“Leveraging delayed antibiotic prescription may be an excellent way to combat antibiotic overuse in the outpatient setting, while avoiding provider and parental fear of the ‘no antibiotic’ approach,” Dr. Feghaly and Dr. Jackson said.

Karlyn Kinsella, MD, of Pediatric Associates of Cheshire, Conn., suggested that clinicians discuss these findings with parents who request antibiotics for “otitis, pharyngitis, bronchitis, or sinusitis.”

“We can cite this study that antibiotics have no effect on symptom duration or severity for these illnesses,” Dr. Kinsella said. “Of course, our clinical opinion in each case takes precedent.”

According to Dr. Kinsella, conversations with parents also need to cover reasonable expectations, as the study did, with clear time frames for each condition in which children should start to get better.

“I think this is really key in our anticipatory guidance so that patients know what to expect,” she said.

The study was funded by Instituto de Salud Carlos III, the European Union, and the Spanish Ministry of Health, Social Services, and Equality. The investigators and interviewees reported no conflicts of interest.

For pediatric patients with respiratory tract infections (RTIs), immediately prescribing antibiotics may do more harm than good, based on prospective data from 436 children treated by primary care pediatricians in Spain.

In the largest trial of its kind to date, children who were immediately prescribed antibiotics showed no significant difference in symptom severity or duration from those who received a delayed prescription for antibiotics, or no prescription at all; yet those in the immediate-prescription group had a higher rate of gastrointestinal adverse events, reported lead author Gemma Mas-Dalmau, MD, of the Sant Pau Institute for Biomedical Research, Barcelona, and colleagues.

“Most RTIs are self-limiting, and antibiotics hardly alter the course of the condition, yet antibiotics are frequently prescribed for these conditions,” the investigators wrote in Pediatrics. “Antibiotic prescription for RTIs in children is especially considered to be inappropriately high.”

This clinical behavior is driven by several factors, according to Dr. Mas-Dalmau and colleagues, including limited diagnostics in primary care, pressure to meet parental expectations, and concern for possible complications if antibiotics are withheld or delayed.

In an accompanying editorial, Jeffrey S. Gerber, MD, PhD and Bonnie F. Offit, MD, of Children’s Hospital of Philadelphia, noted that “children in the United States receive more than one antibiotic prescription per year, driven largely by acute RTIs.”

Dr. Gerber and Dr. Offit noted that some RTIs are indeed caused by bacteria, and therefore benefit from antibiotics, but it’s “not always easy” to identify these cases.

“Primary care, urgent care, and emergency medicine clinicians have a hard job,” they wrote.

According to the Centers for Disease Control and Prevention, delayed prescription of antibiotics, in which a prescription is filled upon persistence or worsening of symptoms, can balance clinical caution and antibiotic stewardship.

“An example of this approach is acute otitis media, in which delayed prescribing has been shown to safely reduce antibiotic exposure,” wrote Dr. Gerber and Dr. Offit.

In a 2017 Cochrane systematic review of both adults and children with RTIs, antibiotic prescriptions, whether immediate, delayed, or not given at all, had no significant effect on most symptoms or complications. Although several randomized trials have evaluated delayed antibiotic prescriptions in children, Dr. Mas-Dalmau and colleagues described the current body of evidence as “scant.”

The present study built upon this knowledge base by prospectively following 436 children treated at 39 primary care centers in Spain from 2012 to 2016. Patients were between 2 and 14 years of age and presented for rhinosinusitis, pharyngitis, acute otitis media, or acute bronchitis. Inclusion in the study required the pediatrician to have “reasonable doubts about the need to prescribe an antibiotic.” Clinics with access to rapid streptococcal testing did not enroll patients with pharyngitis.

Patients were randomized in approximately equal groups to receive either immediate prescription of antibiotics, delayed prescription, or no prescription. In the delayed group, caregivers were advised to fill prescriptions if any of following three events occurred:

• No symptom improvement after a certain amount of days, depending on presenting complaint (acute otitis media, 4 days; pharyngitis, 7 days; acute rhinosinusitis, 15 days; acute bronchitis, 20 days).
• Temperature of at least 39° C after 24 hours, or at least 38° C but less than 39° C after 48 hours.
• Patient feeling “much worse.”

Primary outcomes were severity and duration of symptoms over 30 days, while secondary outcomes included antibiotic use over 30 days, additional unscheduled visits to primary care over 30 days, and parental satisfaction and beliefs regarding antibiotic efficacy.

In the final dataset, 148 patients received immediate antibiotic prescriptions, while 146 received delayed prescriptions, and 142 received no prescription. Rate of antibiotic use was highest in the immediate prescription group, at 96%, versus 25.3% in the delayed group and 12% among those who received no prescription upon first presentation (P < .001).

Although the mean duration of severe symptoms was longest in the delayed-prescription group, at 12.4 days, versus 10.9 days in the no-prescription group and 10.1 days in the immediate-prescription group, these differences were not statistically significant (P = .539). Median score for greatest severity of any symptom was also similar across groups. Secondary outcomes echoed this pattern, in which reconsultation rates and caregiver satisfaction were statistically similar regardless of treatment type.

In contrast, patients who received immediate antibiotic prescriptions had a significantly higher rate of gastrointestinal adverse events (8.8%) than those who received a delayed prescription (3.4%) or no prescription (2.8%; P = .037).

“Delayed antibiotic prescription is an efficacious and safe strategy for reducing inappropriate antibiotic treatment of uncomplicated RTIs in children when the doctor has reasonable doubts regarding the indication,” the investigators concluded. “[It] is therefore a useful tool for addressing the public health issue of bacterial resistance. However, no antibiotic prescription remains the recommended strategy when it is clear that antibiotics are not indicated, like in most cases of acute bronchitis.”

“These data are reassuring,” wrote Dr. Gerber and Dr. Offit; however, they went on to suggest that the data “might not substantially move the needle.”

“With rare exceptions, children with acute pharyngitis should first receive a group A streptococcal test,” they wrote. “If results are positive, all patients should get antibiotics; if results are negative, no one gets them. Acute bronchitis (whatever that is in children) is viral. Acute sinusitis with persistent symptoms (the most commonly diagnosed variety) already has a delayed option, and the current study ... was not powered for this outcome. We are left with acute otitis media, which dominated enrollment but already has an evidence-based guideline.”

Still, Dr. Gerber and Dr. Offit suggested that the findings should further encourage pediatricians to prescribe antibiotics judiciously, and when elected, to choose the shortest duration and narrowest spectrum possible.

In a joint comment, Rana El Feghaly, MD, MSCI, director of outpatient antibiotic stewardship at Children’s Mercy, Kansas City, and her colleague, Mary Anne Jackson, MD, noted that the findings are “in accordance” with the 2017 Cochrane review.

Dr. Feghaly and Dr. Jackson said that these new data provide greater support for conservative use of antibiotics, which is badly needed, considering approximately 50% of outpatient prescriptions are unnecessary or inappropriate .

Delayed antibiotic prescription is part of a multifaceted approach to the issue, they said, joining “communication skills training, antibiotic justification documentation, audit and feedback reporting with peer comparison, diagnostic stewardship, [and] the use of clinician education on practice-based guidelines.”

“Leveraging delayed antibiotic prescription may be an excellent way to combat antibiotic overuse in the outpatient setting, while avoiding provider and parental fear of the ‘no antibiotic’ approach,” Dr. Feghaly and Dr. Jackson said.

Karlyn Kinsella, MD, of Pediatric Associates of Cheshire, Conn., suggested that clinicians discuss these findings with parents who request antibiotics for “otitis, pharyngitis, bronchitis, or sinusitis.”

“We can cite this study that antibiotics have no effect on symptom duration or severity for these illnesses,” Dr. Kinsella said. “Of course, our clinical opinion in each case takes precedent.”

According to Dr. Kinsella, conversations with parents also need to cover reasonable expectations, as the study did, with clear time frames for each condition in which children should start to get better.

“I think this is really key in our anticipatory guidance so that patients know what to expect,” she said.

The study was funded by Instituto de Salud Carlos III, the European Union, and the Spanish Ministry of Health, Social Services, and Equality. The investigators and interviewees reported no conflicts of interest.