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Triple-antiviral combo speeds COVID-19 recovery

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A triple-antiviral therapy regimen of interferon-beta1, lopinavir/ritonavir, and ribavirin shortened median time to COVID-19 viral negativity by 5 days in a small trial from Hong Kong.

Courtesy NIAID-RML

In an open-label, randomized phase 2 trial in patients with mild or moderate COVID-19 infections, the median time to viral negativity by nasopharyngeal swab was 7 days for 86 patients assigned to receive a 14-day course of lopinavir 400 mg and ritonavir 100 mg every 12 hours, ribavirin 400 mg every 12 hours, and three doses of 8 million international units of interferon beta-1b on alternate days, compared with a median time to negativity of 12 days for patients treated with lopinavir/ritonavir alone (P = .0010), wrote Ivan Fan-Ngai Hung, MD, from Gleaneagles Hospital in Hong Kong, and colleagues.

“Triple-antiviral therapy with interferon beta-1b, lopinavir/ritonavir, and ribavirin were safe and superior to lopinavir/ritonavir alone in shortening virus shedding, alleviating symptoms, and facilitating discharge of patients with mild to moderate COVID-19,” they wrote in a study published online in The Lancet.

Patients who received the combination also had significantly shorter time to complete alleviation of symptoms as assessed by a National Early Warning Score 2 (NEWS2, a system for detecting clinical deterioration in patients with acute illnesses) score of 0 (4 vs. 8 days, respectively; hazard ratio 3.92, P < .0001), and to a Sequential Organ Failure Assessment (SOFA) score of 0 (3 vs. 8 days, HR 1.89, P = .041).

The median hospital stay was 9 days for patients treated with the combination, compared with 14.5 days for controls (HR 2.72, P = .016).

In most patients treated with the combination, SARS-CoV-2 viral load was effectively suppressed in all clinical specimens, including nasopharyngeal swabs, throat and posterior oropharyngeal saliva, and stool.

In addition, serum levels of interleukin 6 (IL-6) – an inflammatory cytokine implicated in the cytokine storm frequently seen in patients with severe COVID-19 infections – were significantly lower on treatment days 2, 6, and 8 in patients treated with the combination, compared with those treated with lopinavir/ritonavir alone.

“Our trial demonstrates that early treatment of mild to moderate COVID-19 with a triple combination of antiviral drugs may rapidly suppress the amount of virus in a patient’s body, relieve symptoms, and reduce the risk to health care workers by reducing the duration and quantity of viral shedding (when the virus is detectable and potentially transmissible). Furthermore, the treatment combination appeared safe and well tolerated by patients,” said lead investigator Professor Kwok-Yung Yuen from the University of Hong Kong, in a statement.

“Despite these encouraging findings,” he continued, “we must confirm in larger phase 3 trials that interferon beta-1b alone or in combination with other drugs is effective in patients with more severe illness (in whom the virus has had more time to replicate).”

Plausible rationale

Benjamin Medoff, MD, chief of the division of pulmonary and critical care medicine at Massachusetts General Hospital in Boston, who was not involved in the study, said in an interview that the biologic rationale for the combination is plausible.

 

 

“I think this is a promising study that suggests that a regimen of interferon beta-1b, lopinavir/ritonavir, and ribavirin can shorten the duration of infection and improve symptoms in COVID-19 patients especially if started early in disease, in less than 7 days of symptom onset,” he said in reply to a request for expert analysis.

“The open-label nature and small size of the study limits the broad use of the regimen as noted by the authors, and it’s important to emphasize that the subjects enrolled did not have very severe disease (not in the ICU). However, the study does suggest that a larger truly randomized study is warranted,” he said.

AIDS drugs repurposed

Lopinavir/ritonavir is commonly used to treat HIV/AIDS throughout the world, and the investigators had previously reported that the antiviral agents combined with ribavirin reduced deaths and the need for intensive ventilator support among patients with SARS-CoV, the betacoronavirus that causes severe acute respiratory syndrome (SARS), and antivirals have shown in vitro activity against both SARS-CoV and MERS-CoV, the closely related pathogen that causes Middle East respiratory syndrome.

“ However the viral load of SARS and MERS peaks at around day 7-10 after symptom onset, whereas the viral load of COVID-19 peaks at the time of presentation, similar to influenza. Experience from the treatment of patients with influenza who are admitted to hospital suggested that a combination of multiple antiviral drugs is more effective than single-drug treatments in this setting of patients with a high viral load at presentation,” the investigators wrote.

To test this, they enrolled adults patients admitted to one of six Hong Kong Hospitals for virologically confirmed COVID-19 infections from Feb. 10 through March 20, 2020.

A total of 86 patients were randomly assigned to the combination and 41 to lopinavir/ritonavir alone as controls, at doses described above.

Patients who entered the trial within less than 7 days of symptom onset received the triple combination, with interferon dosing adjusted according to the day that treatment started. Patients recruited 1 or 2 days after symptom onset received three doses of interferon, patients started on day 3 or 4 received two doses, and those started on days 5 or 6 received one interferon dose. Patients recruited 7 days or later from symptom onset did not receive interferon beta-1b because of its proinflammatory effects.

In post-hoc analysis by day of treatment initiation, clinical and virological outcomes (except stool samples) were superior in patients admitted less than 7 days after symptom onset for the 52 patients who received a least one interferon dose plus lopinavir/ritonavir and ribavirin, compared with 24 patients randomized to the control arm (lopinavir/ritonavir only). In contrast, among patients admitted and started on treatment at day 7 or later after symptom onset, there were no differences between those who received lopinavir/ritonavir alone or combined with ribavirin.

Adverse events were reported in 41 of 86 patients in the combination group and 20 of 41 patients in the control arm. The most common adverse events were diarrhea, occurring in 52 of all 127 patients, fever in 48, nausea in 43, and elevated alanine transaminase level in 18. The side effects generally resolved within 3 days of the start of treatments.

There were no serious adverse events reported in the combination group. One patient in the control group had impaired hepatic enzymes requiring discontinuation of treatment. No patients died during the study.

The study was funded by the Shaw Foundation, Richard and Carol Yu, May Tam Mak Mei Yin, and Sanming Project of Medicine. The authors and Dr. Medoff declared no competing interests.

SOURCE: Hung IFN et al. Lancet. 2020 May 8. doi: 10.1016/S0140-6736(20)31101-6.

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A triple-antiviral therapy regimen of interferon-beta1, lopinavir/ritonavir, and ribavirin shortened median time to COVID-19 viral negativity by 5 days in a small trial from Hong Kong.

Courtesy NIAID-RML

In an open-label, randomized phase 2 trial in patients with mild or moderate COVID-19 infections, the median time to viral negativity by nasopharyngeal swab was 7 days for 86 patients assigned to receive a 14-day course of lopinavir 400 mg and ritonavir 100 mg every 12 hours, ribavirin 400 mg every 12 hours, and three doses of 8 million international units of interferon beta-1b on alternate days, compared with a median time to negativity of 12 days for patients treated with lopinavir/ritonavir alone (P = .0010), wrote Ivan Fan-Ngai Hung, MD, from Gleaneagles Hospital in Hong Kong, and colleagues.

“Triple-antiviral therapy with interferon beta-1b, lopinavir/ritonavir, and ribavirin were safe and superior to lopinavir/ritonavir alone in shortening virus shedding, alleviating symptoms, and facilitating discharge of patients with mild to moderate COVID-19,” they wrote in a study published online in The Lancet.

Patients who received the combination also had significantly shorter time to complete alleviation of symptoms as assessed by a National Early Warning Score 2 (NEWS2, a system for detecting clinical deterioration in patients with acute illnesses) score of 0 (4 vs. 8 days, respectively; hazard ratio 3.92, P < .0001), and to a Sequential Organ Failure Assessment (SOFA) score of 0 (3 vs. 8 days, HR 1.89, P = .041).

The median hospital stay was 9 days for patients treated with the combination, compared with 14.5 days for controls (HR 2.72, P = .016).

In most patients treated with the combination, SARS-CoV-2 viral load was effectively suppressed in all clinical specimens, including nasopharyngeal swabs, throat and posterior oropharyngeal saliva, and stool.

In addition, serum levels of interleukin 6 (IL-6) – an inflammatory cytokine implicated in the cytokine storm frequently seen in patients with severe COVID-19 infections – were significantly lower on treatment days 2, 6, and 8 in patients treated with the combination, compared with those treated with lopinavir/ritonavir alone.

“Our trial demonstrates that early treatment of mild to moderate COVID-19 with a triple combination of antiviral drugs may rapidly suppress the amount of virus in a patient’s body, relieve symptoms, and reduce the risk to health care workers by reducing the duration and quantity of viral shedding (when the virus is detectable and potentially transmissible). Furthermore, the treatment combination appeared safe and well tolerated by patients,” said lead investigator Professor Kwok-Yung Yuen from the University of Hong Kong, in a statement.

“Despite these encouraging findings,” he continued, “we must confirm in larger phase 3 trials that interferon beta-1b alone or in combination with other drugs is effective in patients with more severe illness (in whom the virus has had more time to replicate).”

Plausible rationale

Benjamin Medoff, MD, chief of the division of pulmonary and critical care medicine at Massachusetts General Hospital in Boston, who was not involved in the study, said in an interview that the biologic rationale for the combination is plausible.

 

 

“I think this is a promising study that suggests that a regimen of interferon beta-1b, lopinavir/ritonavir, and ribavirin can shorten the duration of infection and improve symptoms in COVID-19 patients especially if started early in disease, in less than 7 days of symptom onset,” he said in reply to a request for expert analysis.

“The open-label nature and small size of the study limits the broad use of the regimen as noted by the authors, and it’s important to emphasize that the subjects enrolled did not have very severe disease (not in the ICU). However, the study does suggest that a larger truly randomized study is warranted,” he said.

AIDS drugs repurposed

Lopinavir/ritonavir is commonly used to treat HIV/AIDS throughout the world, and the investigators had previously reported that the antiviral agents combined with ribavirin reduced deaths and the need for intensive ventilator support among patients with SARS-CoV, the betacoronavirus that causes severe acute respiratory syndrome (SARS), and antivirals have shown in vitro activity against both SARS-CoV and MERS-CoV, the closely related pathogen that causes Middle East respiratory syndrome.

“ However the viral load of SARS and MERS peaks at around day 7-10 after symptom onset, whereas the viral load of COVID-19 peaks at the time of presentation, similar to influenza. Experience from the treatment of patients with influenza who are admitted to hospital suggested that a combination of multiple antiviral drugs is more effective than single-drug treatments in this setting of patients with a high viral load at presentation,” the investigators wrote.

To test this, they enrolled adults patients admitted to one of six Hong Kong Hospitals for virologically confirmed COVID-19 infections from Feb. 10 through March 20, 2020.

A total of 86 patients were randomly assigned to the combination and 41 to lopinavir/ritonavir alone as controls, at doses described above.

Patients who entered the trial within less than 7 days of symptom onset received the triple combination, with interferon dosing adjusted according to the day that treatment started. Patients recruited 1 or 2 days after symptom onset received three doses of interferon, patients started on day 3 or 4 received two doses, and those started on days 5 or 6 received one interferon dose. Patients recruited 7 days or later from symptom onset did not receive interferon beta-1b because of its proinflammatory effects.

In post-hoc analysis by day of treatment initiation, clinical and virological outcomes (except stool samples) were superior in patients admitted less than 7 days after symptom onset for the 52 patients who received a least one interferon dose plus lopinavir/ritonavir and ribavirin, compared with 24 patients randomized to the control arm (lopinavir/ritonavir only). In contrast, among patients admitted and started on treatment at day 7 or later after symptom onset, there were no differences between those who received lopinavir/ritonavir alone or combined with ribavirin.

Adverse events were reported in 41 of 86 patients in the combination group and 20 of 41 patients in the control arm. The most common adverse events were diarrhea, occurring in 52 of all 127 patients, fever in 48, nausea in 43, and elevated alanine transaminase level in 18. The side effects generally resolved within 3 days of the start of treatments.

There were no serious adverse events reported in the combination group. One patient in the control group had impaired hepatic enzymes requiring discontinuation of treatment. No patients died during the study.

The study was funded by the Shaw Foundation, Richard and Carol Yu, May Tam Mak Mei Yin, and Sanming Project of Medicine. The authors and Dr. Medoff declared no competing interests.

SOURCE: Hung IFN et al. Lancet. 2020 May 8. doi: 10.1016/S0140-6736(20)31101-6.

 

A triple-antiviral therapy regimen of interferon-beta1, lopinavir/ritonavir, and ribavirin shortened median time to COVID-19 viral negativity by 5 days in a small trial from Hong Kong.

Courtesy NIAID-RML

In an open-label, randomized phase 2 trial in patients with mild or moderate COVID-19 infections, the median time to viral negativity by nasopharyngeal swab was 7 days for 86 patients assigned to receive a 14-day course of lopinavir 400 mg and ritonavir 100 mg every 12 hours, ribavirin 400 mg every 12 hours, and three doses of 8 million international units of interferon beta-1b on alternate days, compared with a median time to negativity of 12 days for patients treated with lopinavir/ritonavir alone (P = .0010), wrote Ivan Fan-Ngai Hung, MD, from Gleaneagles Hospital in Hong Kong, and colleagues.

“Triple-antiviral therapy with interferon beta-1b, lopinavir/ritonavir, and ribavirin were safe and superior to lopinavir/ritonavir alone in shortening virus shedding, alleviating symptoms, and facilitating discharge of patients with mild to moderate COVID-19,” they wrote in a study published online in The Lancet.

Patients who received the combination also had significantly shorter time to complete alleviation of symptoms as assessed by a National Early Warning Score 2 (NEWS2, a system for detecting clinical deterioration in patients with acute illnesses) score of 0 (4 vs. 8 days, respectively; hazard ratio 3.92, P < .0001), and to a Sequential Organ Failure Assessment (SOFA) score of 0 (3 vs. 8 days, HR 1.89, P = .041).

The median hospital stay was 9 days for patients treated with the combination, compared with 14.5 days for controls (HR 2.72, P = .016).

In most patients treated with the combination, SARS-CoV-2 viral load was effectively suppressed in all clinical specimens, including nasopharyngeal swabs, throat and posterior oropharyngeal saliva, and stool.

In addition, serum levels of interleukin 6 (IL-6) – an inflammatory cytokine implicated in the cytokine storm frequently seen in patients with severe COVID-19 infections – were significantly lower on treatment days 2, 6, and 8 in patients treated with the combination, compared with those treated with lopinavir/ritonavir alone.

“Our trial demonstrates that early treatment of mild to moderate COVID-19 with a triple combination of antiviral drugs may rapidly suppress the amount of virus in a patient’s body, relieve symptoms, and reduce the risk to health care workers by reducing the duration and quantity of viral shedding (when the virus is detectable and potentially transmissible). Furthermore, the treatment combination appeared safe and well tolerated by patients,” said lead investigator Professor Kwok-Yung Yuen from the University of Hong Kong, in a statement.

“Despite these encouraging findings,” he continued, “we must confirm in larger phase 3 trials that interferon beta-1b alone or in combination with other drugs is effective in patients with more severe illness (in whom the virus has had more time to replicate).”

Plausible rationale

Benjamin Medoff, MD, chief of the division of pulmonary and critical care medicine at Massachusetts General Hospital in Boston, who was not involved in the study, said in an interview that the biologic rationale for the combination is plausible.

 

 

“I think this is a promising study that suggests that a regimen of interferon beta-1b, lopinavir/ritonavir, and ribavirin can shorten the duration of infection and improve symptoms in COVID-19 patients especially if started early in disease, in less than 7 days of symptom onset,” he said in reply to a request for expert analysis.

“The open-label nature and small size of the study limits the broad use of the regimen as noted by the authors, and it’s important to emphasize that the subjects enrolled did not have very severe disease (not in the ICU). However, the study does suggest that a larger truly randomized study is warranted,” he said.

AIDS drugs repurposed

Lopinavir/ritonavir is commonly used to treat HIV/AIDS throughout the world, and the investigators had previously reported that the antiviral agents combined with ribavirin reduced deaths and the need for intensive ventilator support among patients with SARS-CoV, the betacoronavirus that causes severe acute respiratory syndrome (SARS), and antivirals have shown in vitro activity against both SARS-CoV and MERS-CoV, the closely related pathogen that causes Middle East respiratory syndrome.

“ However the viral load of SARS and MERS peaks at around day 7-10 after symptom onset, whereas the viral load of COVID-19 peaks at the time of presentation, similar to influenza. Experience from the treatment of patients with influenza who are admitted to hospital suggested that a combination of multiple antiviral drugs is more effective than single-drug treatments in this setting of patients with a high viral load at presentation,” the investigators wrote.

To test this, they enrolled adults patients admitted to one of six Hong Kong Hospitals for virologically confirmed COVID-19 infections from Feb. 10 through March 20, 2020.

A total of 86 patients were randomly assigned to the combination and 41 to lopinavir/ritonavir alone as controls, at doses described above.

Patients who entered the trial within less than 7 days of symptom onset received the triple combination, with interferon dosing adjusted according to the day that treatment started. Patients recruited 1 or 2 days after symptom onset received three doses of interferon, patients started on day 3 or 4 received two doses, and those started on days 5 or 6 received one interferon dose. Patients recruited 7 days or later from symptom onset did not receive interferon beta-1b because of its proinflammatory effects.

In post-hoc analysis by day of treatment initiation, clinical and virological outcomes (except stool samples) were superior in patients admitted less than 7 days after symptom onset for the 52 patients who received a least one interferon dose plus lopinavir/ritonavir and ribavirin, compared with 24 patients randomized to the control arm (lopinavir/ritonavir only). In contrast, among patients admitted and started on treatment at day 7 or later after symptom onset, there were no differences between those who received lopinavir/ritonavir alone or combined with ribavirin.

Adverse events were reported in 41 of 86 patients in the combination group and 20 of 41 patients in the control arm. The most common adverse events were diarrhea, occurring in 52 of all 127 patients, fever in 48, nausea in 43, and elevated alanine transaminase level in 18. The side effects generally resolved within 3 days of the start of treatments.

There were no serious adverse events reported in the combination group. One patient in the control group had impaired hepatic enzymes requiring discontinuation of treatment. No patients died during the study.

The study was funded by the Shaw Foundation, Richard and Carol Yu, May Tam Mak Mei Yin, and Sanming Project of Medicine. The authors and Dr. Medoff declared no competing interests.

SOURCE: Hung IFN et al. Lancet. 2020 May 8. doi: 10.1016/S0140-6736(20)31101-6.

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Evolocumab safe, well-tolerated in HIV+ patients

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Evolocumab proved effective, well tolerated, and safe for the treatment of refractory dyslipidemia in persons living with HIV in the phase 3, randomized, double-blind BEIJERINCK study.

At 24 weeks, nearly three-quarters of patients randomized to evolocumab (Repatha) achieved at least a 50% reduction in LDL cholesterol while on maximally tolerated background lipid lowering with a statin and/or other drugs. This was accompanied by significant reductions in other atherogenic lipids, Franck Boccara, MD, PhD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Evolocumab thus shows the potential to help fill a major unmet need for more effective treatment of dyslipidemia in HIV-positive patients, who number an estimated 38 million worldwide, including 1.1 million in the United States. Access to highly active antiretroviral therapies has transformed HIV infection into a chronic manageable disease, but this major advance has been accompanied by a rate of premature atherosclerotic cardiovascular disease that’s nearly twice that of the general population, observed Dr. Boccara, a cardiologist at Sorbonne University, Paris.

The BEIJERINCK study included 464 HIV-infected patients in the United States and 14 other countries on five continents. Participants had a mean baseline LDL cholesterol of 133 mg/dL and triglycerides of about 190 mg/dL while on maximally tolerated lipid-lowering therapy. They had been diagnosed with HIV an average of 18 years earlier. One-third of them had known atherosclerotic cardiovascular disease. More than one-quarter of participants were cigarette smokers. Patients were randomized 2:1 to 24 weeks of double-blind subcutaneous evolocumab at 420 mg once monthly or placebo, then an additional 24 weeks of open-label evolocumab for all.



The primary endpoint was change in LDL from baseline to week 24: a 56.2% reduction in the evolocumab group and a 0.7% increase with placebo. About 73% of patients on evolocumab achieved at least a 50% reduction in LDL cholesterol, as did less than 1% of controls. Likewise, 73% of the evolocumab group got their LDL cholesterol below 70 mg/dL, compared with 7.9% with placebo.

The evolocumab group also experienced favorable placebo-subtracted differences from baseline of 23% in triglycerides, 27% in lipoprotein(a), and 22% in very-low-density lipoprotein cholesterol.

As was the case in the earlier, much larger landmark clinical trials, evolocumab was well tolerated in BEIJERINCK, with a side effect profile similar to placebo. Notably, there was no increase in liver abnormalities in evolocumab-treated patients on highly active antiretroviral therapy, and no one developed evolocumab neutralizing antibodies.

Dr. Boccara reported receiving a research grant from Amgen, the study sponsor, as well as lecture fees from several other pharmaceutical companies.

Simultaneous with the presentation at ACC 2020, the primary results of the BEIJERINCK study were published online (J Am Coll Cardiol. 2020 Mar 19. doi: 10.1016/j.jacc.2020.03.025).

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Evolocumab proved effective, well tolerated, and safe for the treatment of refractory dyslipidemia in persons living with HIV in the phase 3, randomized, double-blind BEIJERINCK study.

At 24 weeks, nearly three-quarters of patients randomized to evolocumab (Repatha) achieved at least a 50% reduction in LDL cholesterol while on maximally tolerated background lipid lowering with a statin and/or other drugs. This was accompanied by significant reductions in other atherogenic lipids, Franck Boccara, MD, PhD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Evolocumab thus shows the potential to help fill a major unmet need for more effective treatment of dyslipidemia in HIV-positive patients, who number an estimated 38 million worldwide, including 1.1 million in the United States. Access to highly active antiretroviral therapies has transformed HIV infection into a chronic manageable disease, but this major advance has been accompanied by a rate of premature atherosclerotic cardiovascular disease that’s nearly twice that of the general population, observed Dr. Boccara, a cardiologist at Sorbonne University, Paris.

The BEIJERINCK study included 464 HIV-infected patients in the United States and 14 other countries on five continents. Participants had a mean baseline LDL cholesterol of 133 mg/dL and triglycerides of about 190 mg/dL while on maximally tolerated lipid-lowering therapy. They had been diagnosed with HIV an average of 18 years earlier. One-third of them had known atherosclerotic cardiovascular disease. More than one-quarter of participants were cigarette smokers. Patients were randomized 2:1 to 24 weeks of double-blind subcutaneous evolocumab at 420 mg once monthly or placebo, then an additional 24 weeks of open-label evolocumab for all.



The primary endpoint was change in LDL from baseline to week 24: a 56.2% reduction in the evolocumab group and a 0.7% increase with placebo. About 73% of patients on evolocumab achieved at least a 50% reduction in LDL cholesterol, as did less than 1% of controls. Likewise, 73% of the evolocumab group got their LDL cholesterol below 70 mg/dL, compared with 7.9% with placebo.

The evolocumab group also experienced favorable placebo-subtracted differences from baseline of 23% in triglycerides, 27% in lipoprotein(a), and 22% in very-low-density lipoprotein cholesterol.

As was the case in the earlier, much larger landmark clinical trials, evolocumab was well tolerated in BEIJERINCK, with a side effect profile similar to placebo. Notably, there was no increase in liver abnormalities in evolocumab-treated patients on highly active antiretroviral therapy, and no one developed evolocumab neutralizing antibodies.

Dr. Boccara reported receiving a research grant from Amgen, the study sponsor, as well as lecture fees from several other pharmaceutical companies.

Simultaneous with the presentation at ACC 2020, the primary results of the BEIJERINCK study were published online (J Am Coll Cardiol. 2020 Mar 19. doi: 10.1016/j.jacc.2020.03.025).

Evolocumab proved effective, well tolerated, and safe for the treatment of refractory dyslipidemia in persons living with HIV in the phase 3, randomized, double-blind BEIJERINCK study.

At 24 weeks, nearly three-quarters of patients randomized to evolocumab (Repatha) achieved at least a 50% reduction in LDL cholesterol while on maximally tolerated background lipid lowering with a statin and/or other drugs. This was accompanied by significant reductions in other atherogenic lipids, Franck Boccara, MD, PhD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Evolocumab thus shows the potential to help fill a major unmet need for more effective treatment of dyslipidemia in HIV-positive patients, who number an estimated 38 million worldwide, including 1.1 million in the United States. Access to highly active antiretroviral therapies has transformed HIV infection into a chronic manageable disease, but this major advance has been accompanied by a rate of premature atherosclerotic cardiovascular disease that’s nearly twice that of the general population, observed Dr. Boccara, a cardiologist at Sorbonne University, Paris.

The BEIJERINCK study included 464 HIV-infected patients in the United States and 14 other countries on five continents. Participants had a mean baseline LDL cholesterol of 133 mg/dL and triglycerides of about 190 mg/dL while on maximally tolerated lipid-lowering therapy. They had been diagnosed with HIV an average of 18 years earlier. One-third of them had known atherosclerotic cardiovascular disease. More than one-quarter of participants were cigarette smokers. Patients were randomized 2:1 to 24 weeks of double-blind subcutaneous evolocumab at 420 mg once monthly or placebo, then an additional 24 weeks of open-label evolocumab for all.



The primary endpoint was change in LDL from baseline to week 24: a 56.2% reduction in the evolocumab group and a 0.7% increase with placebo. About 73% of patients on evolocumab achieved at least a 50% reduction in LDL cholesterol, as did less than 1% of controls. Likewise, 73% of the evolocumab group got their LDL cholesterol below 70 mg/dL, compared with 7.9% with placebo.

The evolocumab group also experienced favorable placebo-subtracted differences from baseline of 23% in triglycerides, 27% in lipoprotein(a), and 22% in very-low-density lipoprotein cholesterol.

As was the case in the earlier, much larger landmark clinical trials, evolocumab was well tolerated in BEIJERINCK, with a side effect profile similar to placebo. Notably, there was no increase in liver abnormalities in evolocumab-treated patients on highly active antiretroviral therapy, and no one developed evolocumab neutralizing antibodies.

Dr. Boccara reported receiving a research grant from Amgen, the study sponsor, as well as lecture fees from several other pharmaceutical companies.

Simultaneous with the presentation at ACC 2020, the primary results of the BEIJERINCK study were published online (J Am Coll Cardiol. 2020 Mar 19. doi: 10.1016/j.jacc.2020.03.025).

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How to expand the APP role in a crisis

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An opportunity to better appreciate the value of PAs, NPs

Advanced practice providers – physician assistants and nurse practitioners – at the 733-bed Emory University Hospital in Atlanta are playing an expanded role in the admission of patients into the hospital, particularly those suspected of having COVID-19.

Susan Ortiz

Before the pandemic crisis, evaluation visits by the APP would have been reviewed on the same day by the supervising physician through an in-person encounter with the patient. The new protocol is not outside of scope-of-practice regulations for APPs in Georgia or of the hospital’s bylaws. But it offers a way to help limit the overall exposure of hospital staff to patients suspected of COVID-19 infection, and the total amount of time providers spend in such patients’ room. Just one provider now needs to meet the patient during the admissions process, while the attending physician can fulfill a requirement for seeing the patient within 24 hours during rounds the following day. Emergency encounters would still be done as needed.

These protocols point toward future conversations about the limits to APPs’ scope of practice, and whether more expansive approaches could be widely adopted once the current crisis is over, say advocates for the APPs’ role.

“Our APPs are primarily doing the admissions to the hospital of COVID patients and of non-COVID patients, as we’ve always done. But with COVID-infected or -suspected patients, we’re trying to minimize exposure for our providers,” explained Susan Ortiz, a certified PA, lead APP at Emory University Hospital. “In this way, we can also see more patients more efficiently.” Ms. Ortiz said she finds in talking to other APP leads in the Emory system that “each facility has its own culture and way of doing things. But for the most part, they’re all trying to do something to limit providers’ time in patients’ rooms.”

In response to the rapidly moving crisis, tactics to limit personnel in COVID patients’ rooms to the “absolutely essential” include gathering much of the needed history and other information requested from the patient by telephone, Ms. Ortiz said. This can be done either over the patient’s own cell phone or a phone placed in the room by hospital staff. Family members may be called to supplement this information, with the patient’s consent.

Once vital sign monitoring equipment is hooked up, it is possible to monitor the patient’s vital signs remotely without making frequent trips into the room. That way, in-person vital sign monitoring doesn’t need to happen routinely – at least not as often. One observation by clinicians on Ms. Ortiz’s team: listening for lung sounds with a stethoscope has not been shown to alter treatment for these patients. Once a chest X-ray shows structural changes in a patient’s lung, all lung exams are going to sound bad.

The admitting provider still needs to meet the patient in person for part of the admission visit and physical exam, but the amount of time spent in close personal contact with the patient can be much shorter, Ms. Ortiz said. For patients who are admitted, if there is a question about difficulty swallowing, they will see a speech pathologist, and if evidence of malnutrition, a nutritionist. “But we have to be extremely thoughtful about when people go into the room. So we are not ordering these ancillary services as routinely as we do during non-COVID times,” she said.

 

 

Appropriate levels of fear

Emory’s hospitalists are communicating daily about a rapidly changing situation. “We get a note by email every day, and we have a Dropbox account for downloading more information,” Ms. Ortiz said. A joint on-call system is used to provide backup coverage of APPs at the seven Emory hospitals. When replacement shifts need filling in a hurry, practitioners are able to obtain emergency credentials at any of the other hospitals. “It’s a voluntary process to sign up to be on-call,” Ms. Ortiz said. So far, that has been sufficient.

All staff have their own level of “appropriate fear” of this infection, Ms. Ortiz noted. “We have an extremely supportive group here to back up those of us who, for good reason, don’t want to be admitting the COVID patients.” Ms. Ortiz opted out of doing COVID admissions because her husband’s health places him at particular risk. “But with the cross-coverage we have, sometimes I’ll provide assistance when needed if a patient is suspected of being infected.” APPs are critical to Emory’s hospital medicine group – not ancillaries. “Everyone here feels that way. So we want to give them a lot of support. We’re all pitching in, doing it together,” she said.

Dr. Jessica Nave

“We said when we started with this, a couple of weeks before the surge started, that you could volunteer to see COVID patients,” said Emory hospitalist Jessica Nave, MD. “As we came to realize that the demand would be greater, we said you would need to opt out of seeing these patients, rather than opt in, and have a reason for doing so.” An example is pregnant staff, of which there seems to be a lot at Emory right now, Dr. Nave said, or those who are immunocompromised for other reasons. Those who don’t opt out are seeing the majority of the COVID patients, depending on actual need.

Dr. Nave is married to another hospitalist at Emory. “We can’t isolate from each other or our children. He and I have a regimented protocol for how we handle the risk, which includes taking off our shoes and clothes in the garage, showering and wiping down every place we might have touched. But those steps are not guarantees.” Other staff at Emory are isolating from their families for weeks at a time. Emory has a conference hotel offering discounted rates to staff. Nine physicians at Emory have been tested for the infection based on presenting symptoms, but at press time none had tested positive.

Streamlining code blue

Another area in which Emory has revised its policies in response to COVID-19 is for in-hospital cardiac arrest code response. Codes are inherently unpredictable, and crowd control has always been an issue for them, Dr. Nave said. “Historically, you could have 15 or more people show up when a code was called. Now, more than ever, we need to limit the number of people involved, for the same reason, avoiding unnecessary patient contact.”

The hospital’s Resuscitation Committee took the lead on developing a new policy, approved by the its Critical Care Committee and COVID Task Force, to limit the number of professionals in the room when running a code to an essential six: two doing chest compression, two managing airways, a code leader, and a critical care nurse. Outside the patient’s door, wearing the same personal protective equipment (PPE), are a pharmacist, recorder, and runner. “If you’re not one of those nine, you don’t need to be involved and should leave the area,” Dr. Nave said.

Staff have been instructed that they need to don appropriate PPE, including gown, mask, and eye wear, before entering the room for a code – even if that delays the start of intervention. “We’ve also made a code kit for each unit with quickly accessible gowns and masks. It should be used only for code blues.”

Increasing flexibility for the team

PAs and NPs in other locations are also exploring opportunities for gearing up to play larger roles in hospital care in the current crisis situation. The American Association of Physician Assistants has urged all U.S. governors to issue executive orders to waive state-specific licensing requirements for physician supervision or collaboration during the crisis, in order to increase flexibility of health care teams to deploy APPs.

AAPA believes the supervisory requirement is the biggest current barrier to mobilizing PAs and NPs. That includes those who have been furloughed from outpatient or other settings but are limited in their ability to contribute to the COVID crisis by the need to sign a supervision agreement with a physician at a new hospital.

Tracy Cardin

The crisis is creating an opportunity to better appreciate the value PAs and NPs bring to health care, said Tracy Cardin, ACNP-BC, SFHM, vice president for advanced practice providers at Sound Physicians, a national hospitalist company based in Tacoma, Wash. The company recently sent a memo to the leadership of hospital sites at which it has contracts, requesting suspension of the hospitals’ requirements for a daily physician supervisory visit for APPs – which can be a hurdle when trying to leverage all hands on deck in the crisis.

NPs and PAs are stepping up and volunteering for COVID patients, Ms. Cardin said. Some have even taken leaves from their jobs to go to New York to help out at the epicenter of the U.S. crisis. “They want to make a difference. We’ve been deploying nonhospital medicine APPs from surgery, primary care, and elsewhere, embedding them on the hospital medicine team.”

Before the crisis, APPs at Sound Physicians weren’t always able to practice at the top of their licenses, depending on the hospital setting, added Alicia Scheffer, CNP, the company’s Great Lakes regional director for APPs. “Then COVID-19 showed up and really expedited conversations about how to maximize caseloads using APPs and about the fear of failing patients due to lack of capacity.”

Courtesy Sound Physicians
Alicia Scheffer

In several locales, Sound Physicians is using quarantined providers to do telephone triage, or staffing ICUs with APPs backed up by telemedicine. “In APP-led ICUs, where the nurses are leading, they are intubating patients, placing central lines, things we weren’t allowed to do before,” Ms. Scheffer said.

 

 

A spirit of improvisation

There is a lot of tension at Emory University Hospital these days, reflecting the fears and uncertainties about the crisis, Dr. Nave said. “But there’s also a strangely powerful camaraderie like I’ve never seen before. When you walk onto the COVID units, you feel immediately bonded to the nurses, the techs, the phlebotomists. And you feel like you could talk about anything.”

Changes such as those made at Emory, have been talked about for a while, for example when hospitalists are having a busy night, she said. “But because this is a big cultural change, some physicians resisted it. We trust our APPs. But if the doctor’s name is on a patient chart, they want to see the patient – just for their own comfort level.”

Ms. Ortiz thinks the experience with the COVID crisis could help to advance the conversation about the appropriate role for APPs and their scope of practice in hospital medicine, once the current crisis has passed. “People were used to always doing things a certain way. This experience, hopefully, will get us to the point where attending physicians have more comfort with the APP’s ability to act autonomously,” she said.

“We’ve also talked about piloting telemedicine examinations using Zoom,” Dr. Nave added. “It’s making us think a lot of remote cross-coverage could be done that way. We’ve talked about using the hospital’s iPads with patients. This crisis really makes you think you want to innovate, in a spirit of improvisation,” she said. “Now is the time to try some of these things.”

Editors note: During the COVID-19 pandemic, many hospitals are seeing unprecedented volumes of patients requiring hospital medicine groups to stretch their current resources and recruit providers from outside their groups to bolster their inpatient services. The Society of Hospital Medicine has put together the following stepwise guide for onboarding traditional outpatient and subspecialty-based providers to work on general medicine wards: COVID-19 nonhospitalist onboarding resources.

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An opportunity to better appreciate the value of PAs, NPs

An opportunity to better appreciate the value of PAs, NPs

Advanced practice providers – physician assistants and nurse practitioners – at the 733-bed Emory University Hospital in Atlanta are playing an expanded role in the admission of patients into the hospital, particularly those suspected of having COVID-19.

Susan Ortiz

Before the pandemic crisis, evaluation visits by the APP would have been reviewed on the same day by the supervising physician through an in-person encounter with the patient. The new protocol is not outside of scope-of-practice regulations for APPs in Georgia or of the hospital’s bylaws. But it offers a way to help limit the overall exposure of hospital staff to patients suspected of COVID-19 infection, and the total amount of time providers spend in such patients’ room. Just one provider now needs to meet the patient during the admissions process, while the attending physician can fulfill a requirement for seeing the patient within 24 hours during rounds the following day. Emergency encounters would still be done as needed.

These protocols point toward future conversations about the limits to APPs’ scope of practice, and whether more expansive approaches could be widely adopted once the current crisis is over, say advocates for the APPs’ role.

“Our APPs are primarily doing the admissions to the hospital of COVID patients and of non-COVID patients, as we’ve always done. But with COVID-infected or -suspected patients, we’re trying to minimize exposure for our providers,” explained Susan Ortiz, a certified PA, lead APP at Emory University Hospital. “In this way, we can also see more patients more efficiently.” Ms. Ortiz said she finds in talking to other APP leads in the Emory system that “each facility has its own culture and way of doing things. But for the most part, they’re all trying to do something to limit providers’ time in patients’ rooms.”

In response to the rapidly moving crisis, tactics to limit personnel in COVID patients’ rooms to the “absolutely essential” include gathering much of the needed history and other information requested from the patient by telephone, Ms. Ortiz said. This can be done either over the patient’s own cell phone or a phone placed in the room by hospital staff. Family members may be called to supplement this information, with the patient’s consent.

Once vital sign monitoring equipment is hooked up, it is possible to monitor the patient’s vital signs remotely without making frequent trips into the room. That way, in-person vital sign monitoring doesn’t need to happen routinely – at least not as often. One observation by clinicians on Ms. Ortiz’s team: listening for lung sounds with a stethoscope has not been shown to alter treatment for these patients. Once a chest X-ray shows structural changes in a patient’s lung, all lung exams are going to sound bad.

The admitting provider still needs to meet the patient in person for part of the admission visit and physical exam, but the amount of time spent in close personal contact with the patient can be much shorter, Ms. Ortiz said. For patients who are admitted, if there is a question about difficulty swallowing, they will see a speech pathologist, and if evidence of malnutrition, a nutritionist. “But we have to be extremely thoughtful about when people go into the room. So we are not ordering these ancillary services as routinely as we do during non-COVID times,” she said.

 

 

Appropriate levels of fear

Emory’s hospitalists are communicating daily about a rapidly changing situation. “We get a note by email every day, and we have a Dropbox account for downloading more information,” Ms. Ortiz said. A joint on-call system is used to provide backup coverage of APPs at the seven Emory hospitals. When replacement shifts need filling in a hurry, practitioners are able to obtain emergency credentials at any of the other hospitals. “It’s a voluntary process to sign up to be on-call,” Ms. Ortiz said. So far, that has been sufficient.

All staff have their own level of “appropriate fear” of this infection, Ms. Ortiz noted. “We have an extremely supportive group here to back up those of us who, for good reason, don’t want to be admitting the COVID patients.” Ms. Ortiz opted out of doing COVID admissions because her husband’s health places him at particular risk. “But with the cross-coverage we have, sometimes I’ll provide assistance when needed if a patient is suspected of being infected.” APPs are critical to Emory’s hospital medicine group – not ancillaries. “Everyone here feels that way. So we want to give them a lot of support. We’re all pitching in, doing it together,” she said.

Dr. Jessica Nave

“We said when we started with this, a couple of weeks before the surge started, that you could volunteer to see COVID patients,” said Emory hospitalist Jessica Nave, MD. “As we came to realize that the demand would be greater, we said you would need to opt out of seeing these patients, rather than opt in, and have a reason for doing so.” An example is pregnant staff, of which there seems to be a lot at Emory right now, Dr. Nave said, or those who are immunocompromised for other reasons. Those who don’t opt out are seeing the majority of the COVID patients, depending on actual need.

Dr. Nave is married to another hospitalist at Emory. “We can’t isolate from each other or our children. He and I have a regimented protocol for how we handle the risk, which includes taking off our shoes and clothes in the garage, showering and wiping down every place we might have touched. But those steps are not guarantees.” Other staff at Emory are isolating from their families for weeks at a time. Emory has a conference hotel offering discounted rates to staff. Nine physicians at Emory have been tested for the infection based on presenting symptoms, but at press time none had tested positive.

Streamlining code blue

Another area in which Emory has revised its policies in response to COVID-19 is for in-hospital cardiac arrest code response. Codes are inherently unpredictable, and crowd control has always been an issue for them, Dr. Nave said. “Historically, you could have 15 or more people show up when a code was called. Now, more than ever, we need to limit the number of people involved, for the same reason, avoiding unnecessary patient contact.”

The hospital’s Resuscitation Committee took the lead on developing a new policy, approved by the its Critical Care Committee and COVID Task Force, to limit the number of professionals in the room when running a code to an essential six: two doing chest compression, two managing airways, a code leader, and a critical care nurse. Outside the patient’s door, wearing the same personal protective equipment (PPE), are a pharmacist, recorder, and runner. “If you’re not one of those nine, you don’t need to be involved and should leave the area,” Dr. Nave said.

Staff have been instructed that they need to don appropriate PPE, including gown, mask, and eye wear, before entering the room for a code – even if that delays the start of intervention. “We’ve also made a code kit for each unit with quickly accessible gowns and masks. It should be used only for code blues.”

Increasing flexibility for the team

PAs and NPs in other locations are also exploring opportunities for gearing up to play larger roles in hospital care in the current crisis situation. The American Association of Physician Assistants has urged all U.S. governors to issue executive orders to waive state-specific licensing requirements for physician supervision or collaboration during the crisis, in order to increase flexibility of health care teams to deploy APPs.

AAPA believes the supervisory requirement is the biggest current barrier to mobilizing PAs and NPs. That includes those who have been furloughed from outpatient or other settings but are limited in their ability to contribute to the COVID crisis by the need to sign a supervision agreement with a physician at a new hospital.

Tracy Cardin

The crisis is creating an opportunity to better appreciate the value PAs and NPs bring to health care, said Tracy Cardin, ACNP-BC, SFHM, vice president for advanced practice providers at Sound Physicians, a national hospitalist company based in Tacoma, Wash. The company recently sent a memo to the leadership of hospital sites at which it has contracts, requesting suspension of the hospitals’ requirements for a daily physician supervisory visit for APPs – which can be a hurdle when trying to leverage all hands on deck in the crisis.

NPs and PAs are stepping up and volunteering for COVID patients, Ms. Cardin said. Some have even taken leaves from their jobs to go to New York to help out at the epicenter of the U.S. crisis. “They want to make a difference. We’ve been deploying nonhospital medicine APPs from surgery, primary care, and elsewhere, embedding them on the hospital medicine team.”

Before the crisis, APPs at Sound Physicians weren’t always able to practice at the top of their licenses, depending on the hospital setting, added Alicia Scheffer, CNP, the company’s Great Lakes regional director for APPs. “Then COVID-19 showed up and really expedited conversations about how to maximize caseloads using APPs and about the fear of failing patients due to lack of capacity.”

Courtesy Sound Physicians
Alicia Scheffer

In several locales, Sound Physicians is using quarantined providers to do telephone triage, or staffing ICUs with APPs backed up by telemedicine. “In APP-led ICUs, where the nurses are leading, they are intubating patients, placing central lines, things we weren’t allowed to do before,” Ms. Scheffer said.

 

 

A spirit of improvisation

There is a lot of tension at Emory University Hospital these days, reflecting the fears and uncertainties about the crisis, Dr. Nave said. “But there’s also a strangely powerful camaraderie like I’ve never seen before. When you walk onto the COVID units, you feel immediately bonded to the nurses, the techs, the phlebotomists. And you feel like you could talk about anything.”

Changes such as those made at Emory, have been talked about for a while, for example when hospitalists are having a busy night, she said. “But because this is a big cultural change, some physicians resisted it. We trust our APPs. But if the doctor’s name is on a patient chart, they want to see the patient – just for their own comfort level.”

Ms. Ortiz thinks the experience with the COVID crisis could help to advance the conversation about the appropriate role for APPs and their scope of practice in hospital medicine, once the current crisis has passed. “People were used to always doing things a certain way. This experience, hopefully, will get us to the point where attending physicians have more comfort with the APP’s ability to act autonomously,” she said.

“We’ve also talked about piloting telemedicine examinations using Zoom,” Dr. Nave added. “It’s making us think a lot of remote cross-coverage could be done that way. We’ve talked about using the hospital’s iPads with patients. This crisis really makes you think you want to innovate, in a spirit of improvisation,” she said. “Now is the time to try some of these things.”

Editors note: During the COVID-19 pandemic, many hospitals are seeing unprecedented volumes of patients requiring hospital medicine groups to stretch their current resources and recruit providers from outside their groups to bolster their inpatient services. The Society of Hospital Medicine has put together the following stepwise guide for onboarding traditional outpatient and subspecialty-based providers to work on general medicine wards: COVID-19 nonhospitalist onboarding resources.

Advanced practice providers – physician assistants and nurse practitioners – at the 733-bed Emory University Hospital in Atlanta are playing an expanded role in the admission of patients into the hospital, particularly those suspected of having COVID-19.

Susan Ortiz

Before the pandemic crisis, evaluation visits by the APP would have been reviewed on the same day by the supervising physician through an in-person encounter with the patient. The new protocol is not outside of scope-of-practice regulations for APPs in Georgia or of the hospital’s bylaws. But it offers a way to help limit the overall exposure of hospital staff to patients suspected of COVID-19 infection, and the total amount of time providers spend in such patients’ room. Just one provider now needs to meet the patient during the admissions process, while the attending physician can fulfill a requirement for seeing the patient within 24 hours during rounds the following day. Emergency encounters would still be done as needed.

These protocols point toward future conversations about the limits to APPs’ scope of practice, and whether more expansive approaches could be widely adopted once the current crisis is over, say advocates for the APPs’ role.

“Our APPs are primarily doing the admissions to the hospital of COVID patients and of non-COVID patients, as we’ve always done. But with COVID-infected or -suspected patients, we’re trying to minimize exposure for our providers,” explained Susan Ortiz, a certified PA, lead APP at Emory University Hospital. “In this way, we can also see more patients more efficiently.” Ms. Ortiz said she finds in talking to other APP leads in the Emory system that “each facility has its own culture and way of doing things. But for the most part, they’re all trying to do something to limit providers’ time in patients’ rooms.”

In response to the rapidly moving crisis, tactics to limit personnel in COVID patients’ rooms to the “absolutely essential” include gathering much of the needed history and other information requested from the patient by telephone, Ms. Ortiz said. This can be done either over the patient’s own cell phone or a phone placed in the room by hospital staff. Family members may be called to supplement this information, with the patient’s consent.

Once vital sign monitoring equipment is hooked up, it is possible to monitor the patient’s vital signs remotely without making frequent trips into the room. That way, in-person vital sign monitoring doesn’t need to happen routinely – at least not as often. One observation by clinicians on Ms. Ortiz’s team: listening for lung sounds with a stethoscope has not been shown to alter treatment for these patients. Once a chest X-ray shows structural changes in a patient’s lung, all lung exams are going to sound bad.

The admitting provider still needs to meet the patient in person for part of the admission visit and physical exam, but the amount of time spent in close personal contact with the patient can be much shorter, Ms. Ortiz said. For patients who are admitted, if there is a question about difficulty swallowing, they will see a speech pathologist, and if evidence of malnutrition, a nutritionist. “But we have to be extremely thoughtful about when people go into the room. So we are not ordering these ancillary services as routinely as we do during non-COVID times,” she said.

 

 

Appropriate levels of fear

Emory’s hospitalists are communicating daily about a rapidly changing situation. “We get a note by email every day, and we have a Dropbox account for downloading more information,” Ms. Ortiz said. A joint on-call system is used to provide backup coverage of APPs at the seven Emory hospitals. When replacement shifts need filling in a hurry, practitioners are able to obtain emergency credentials at any of the other hospitals. “It’s a voluntary process to sign up to be on-call,” Ms. Ortiz said. So far, that has been sufficient.

All staff have their own level of “appropriate fear” of this infection, Ms. Ortiz noted. “We have an extremely supportive group here to back up those of us who, for good reason, don’t want to be admitting the COVID patients.” Ms. Ortiz opted out of doing COVID admissions because her husband’s health places him at particular risk. “But with the cross-coverage we have, sometimes I’ll provide assistance when needed if a patient is suspected of being infected.” APPs are critical to Emory’s hospital medicine group – not ancillaries. “Everyone here feels that way. So we want to give them a lot of support. We’re all pitching in, doing it together,” she said.

Dr. Jessica Nave

“We said when we started with this, a couple of weeks before the surge started, that you could volunteer to see COVID patients,” said Emory hospitalist Jessica Nave, MD. “As we came to realize that the demand would be greater, we said you would need to opt out of seeing these patients, rather than opt in, and have a reason for doing so.” An example is pregnant staff, of which there seems to be a lot at Emory right now, Dr. Nave said, or those who are immunocompromised for other reasons. Those who don’t opt out are seeing the majority of the COVID patients, depending on actual need.

Dr. Nave is married to another hospitalist at Emory. “We can’t isolate from each other or our children. He and I have a regimented protocol for how we handle the risk, which includes taking off our shoes and clothes in the garage, showering and wiping down every place we might have touched. But those steps are not guarantees.” Other staff at Emory are isolating from their families for weeks at a time. Emory has a conference hotel offering discounted rates to staff. Nine physicians at Emory have been tested for the infection based on presenting symptoms, but at press time none had tested positive.

Streamlining code blue

Another area in which Emory has revised its policies in response to COVID-19 is for in-hospital cardiac arrest code response. Codes are inherently unpredictable, and crowd control has always been an issue for them, Dr. Nave said. “Historically, you could have 15 or more people show up when a code was called. Now, more than ever, we need to limit the number of people involved, for the same reason, avoiding unnecessary patient contact.”

The hospital’s Resuscitation Committee took the lead on developing a new policy, approved by the its Critical Care Committee and COVID Task Force, to limit the number of professionals in the room when running a code to an essential six: two doing chest compression, two managing airways, a code leader, and a critical care nurse. Outside the patient’s door, wearing the same personal protective equipment (PPE), are a pharmacist, recorder, and runner. “If you’re not one of those nine, you don’t need to be involved and should leave the area,” Dr. Nave said.

Staff have been instructed that they need to don appropriate PPE, including gown, mask, and eye wear, before entering the room for a code – even if that delays the start of intervention. “We’ve also made a code kit for each unit with quickly accessible gowns and masks. It should be used only for code blues.”

Increasing flexibility for the team

PAs and NPs in other locations are also exploring opportunities for gearing up to play larger roles in hospital care in the current crisis situation. The American Association of Physician Assistants has urged all U.S. governors to issue executive orders to waive state-specific licensing requirements for physician supervision or collaboration during the crisis, in order to increase flexibility of health care teams to deploy APPs.

AAPA believes the supervisory requirement is the biggest current barrier to mobilizing PAs and NPs. That includes those who have been furloughed from outpatient or other settings but are limited in their ability to contribute to the COVID crisis by the need to sign a supervision agreement with a physician at a new hospital.

Tracy Cardin

The crisis is creating an opportunity to better appreciate the value PAs and NPs bring to health care, said Tracy Cardin, ACNP-BC, SFHM, vice president for advanced practice providers at Sound Physicians, a national hospitalist company based in Tacoma, Wash. The company recently sent a memo to the leadership of hospital sites at which it has contracts, requesting suspension of the hospitals’ requirements for a daily physician supervisory visit for APPs – which can be a hurdle when trying to leverage all hands on deck in the crisis.

NPs and PAs are stepping up and volunteering for COVID patients, Ms. Cardin said. Some have even taken leaves from their jobs to go to New York to help out at the epicenter of the U.S. crisis. “They want to make a difference. We’ve been deploying nonhospital medicine APPs from surgery, primary care, and elsewhere, embedding them on the hospital medicine team.”

Before the crisis, APPs at Sound Physicians weren’t always able to practice at the top of their licenses, depending on the hospital setting, added Alicia Scheffer, CNP, the company’s Great Lakes regional director for APPs. “Then COVID-19 showed up and really expedited conversations about how to maximize caseloads using APPs and about the fear of failing patients due to lack of capacity.”

Courtesy Sound Physicians
Alicia Scheffer

In several locales, Sound Physicians is using quarantined providers to do telephone triage, or staffing ICUs with APPs backed up by telemedicine. “In APP-led ICUs, where the nurses are leading, they are intubating patients, placing central lines, things we weren’t allowed to do before,” Ms. Scheffer said.

 

 

A spirit of improvisation

There is a lot of tension at Emory University Hospital these days, reflecting the fears and uncertainties about the crisis, Dr. Nave said. “But there’s also a strangely powerful camaraderie like I’ve never seen before. When you walk onto the COVID units, you feel immediately bonded to the nurses, the techs, the phlebotomists. And you feel like you could talk about anything.”

Changes such as those made at Emory, have been talked about for a while, for example when hospitalists are having a busy night, she said. “But because this is a big cultural change, some physicians resisted it. We trust our APPs. But if the doctor’s name is on a patient chart, they want to see the patient – just for their own comfort level.”

Ms. Ortiz thinks the experience with the COVID crisis could help to advance the conversation about the appropriate role for APPs and their scope of practice in hospital medicine, once the current crisis has passed. “People were used to always doing things a certain way. This experience, hopefully, will get us to the point where attending physicians have more comfort with the APP’s ability to act autonomously,” she said.

“We’ve also talked about piloting telemedicine examinations using Zoom,” Dr. Nave added. “It’s making us think a lot of remote cross-coverage could be done that way. We’ve talked about using the hospital’s iPads with patients. This crisis really makes you think you want to innovate, in a spirit of improvisation,” she said. “Now is the time to try some of these things.”

Editors note: During the COVID-19 pandemic, many hospitals are seeing unprecedented volumes of patients requiring hospital medicine groups to stretch their current resources and recruit providers from outside their groups to bolster their inpatient services. The Society of Hospital Medicine has put together the following stepwise guide for onboarding traditional outpatient and subspecialty-based providers to work on general medicine wards: COVID-19 nonhospitalist onboarding resources.

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How to responsibly engage with social media during disasters

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A few months into the COVID-19 pandemic, social media’s role in the rapid spread of information is undeniable. From the beginning, Chinese ophthalmologist Li Wenliang, MD, first raised the alarm to his classmates through WeChat, a messaging and social media app. Since that time, individuals, groups, organizations, government agencies, and mass media outlets have used social media to share ideas and disseminate information. Individuals check in on loved ones and update others on their own safety. Networks of clinicians discuss patient presentations, new therapeutics, management strategies, and institutional protocols. Multiple organizations including the Federal Emergency Management Agency, the Centers for Disease Control and Prevention, and the World Health Organization use Facebook, Instagram, or Twitter accounts to provide updates on ongoing efforts and spread public health messaging.

Unfortunately, not all information is trustworthy. Social media outlets have been used to spread misinformation and conspiracy theories, and to promote false treatments. Google, YouTube, and Facebook are now actively trying to reduce the viral spread of misleading information and to block hoaxes. With the increasing amount of news and information consumed and disseminated via social media, clinicians need to critically appraise information presented on those platforms, and to be familiar with how to use them to disseminate informed, effective, and responsible information.
 

Appraisal of social media content

Traditional scholarly communication exists in many forms and includes observations, anecdotes, perspectives, case reports, and research. Each form involves differing levels of academic rigor and standards of evaluation. Electronic content and online resources pose a unique challenge because there is no standardized method for assessing impact and quality. Proposed scales for evaluation of online resources such as Medical Education Translational Resources: Impact and Quality (METRIQ),1 Academic Life in Emergency Medicine Approved Instructional Resources (AliEM AIR) scoring system,2 and the Social Media Index3 are promising and can be used to guide critical appraisal of social media content.

Dr. Dennis Ren

The same skepticism and critical thinking applied to traditional resources should be applied when evaluating online resources. The scales listed above include questions such as:

  • How accurate is the data presented and conclusions drawn?
  • Does the content reflect evidence-based medicine?
  • Has the content undergone an editorial process?
  • Who are the authors and what are their credentials?
  • Are there potential biases or conflicts of interest present?
  • Have references been cited?
  • How does this content affect/change clinical practice?

While these proposed review metrics may not apply to all forms of social media content, clinicians should be discerning when consuming or disseminating online content.
 

Strategies for effective communication on social media

In addition to appraising social media content, clinicians also should be able to craft effective messages on social media to spread trustworthy content. The CDC offers guidelines and best practices for social media communication4,5 and the WHO has created a framework for effective communications.6 Both organizations recognize social media as a powerful communication tool that has the potential to greatly impact public health efforts.

Dr. Joelle Simpson

Some key principles highlighted from these sources include the following:

  • Identify an audience and make messages relevant. Taking time to listen to key stakeholders within the target audience (individuals, health care providers, communities, policy-makers, organizations) allows for better understanding of baseline knowledge, attitudes, and beliefs that may drive concerns and ultimately helps to tailor the messaging.
  • Make messages accessible. Certain social media platforms are more often utilized for specific target audiences. Verbiage used should take into account the health literacy of the audience. A friendly, professional, conversational tone encourages interaction and dialogue.
  • Engage the audience by offering something actionable. Changing behavior is a daunting task that involves multiple steps. Encouraging behavioral changes initially at an individual level has the potential to influence community practices and policies.
  • Communication should be timely. It should address current and urgent topics. Keep abreast of the situation as it evolves to ensure messaging stays relevant. Deliver consistent messaging and updates.
  • Sources must be credible. It is important to be transparent about expertise and honest about what is known and unknown about the topic.
  • Content should be understandable. In addition to using plain language, visual aids and real stories can be used to reinforce messages.

Use social media responsibly

Clinicians have a responsibility to use social media to disseminate credible content, refute misleading content, and create accurate content. When clinicians share health-related information via social media, it should be appraised skeptically and crafted responsibly because that message can have profound implications on public health. Mixed messaging that is contradictory, inconsistent, or unclear can lead to panic and confusion. By recognizing the important role of social media in access to information and as a tool for public health messaging and crisis communication, clinicians have an obligation to consider both the positive and negative impacts as messengers in that space.

Dr. Ren is a pediatric emergency medicine fellow at Children’s National Hospital, Washington. Dr. Simpson is a pediatric emergency medicine attending and medical director of emergency preparedness of Children’s National Hospital. They do not have any disclosures or conflicts of interest. Email Dr. Ren and Dr. Simpson at pdnews@mdedge.com.

References

1. AEM Educ Train. 2019;3(4):387-92.

2. Ann Emerg Med. 2016;68(6):729-35.

3. Ann Emerg Med. 2018;72(6):696-702.

4. CDC Guide to Writing for Social Media.

5. The Health Communicator’s Social Media Toolkit.

6. WHO Strategic Communications Framework for effective communications.

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A few months into the COVID-19 pandemic, social media’s role in the rapid spread of information is undeniable. From the beginning, Chinese ophthalmologist Li Wenliang, MD, first raised the alarm to his classmates through WeChat, a messaging and social media app. Since that time, individuals, groups, organizations, government agencies, and mass media outlets have used social media to share ideas and disseminate information. Individuals check in on loved ones and update others on their own safety. Networks of clinicians discuss patient presentations, new therapeutics, management strategies, and institutional protocols. Multiple organizations including the Federal Emergency Management Agency, the Centers for Disease Control and Prevention, and the World Health Organization use Facebook, Instagram, or Twitter accounts to provide updates on ongoing efforts and spread public health messaging.

Unfortunately, not all information is trustworthy. Social media outlets have been used to spread misinformation and conspiracy theories, and to promote false treatments. Google, YouTube, and Facebook are now actively trying to reduce the viral spread of misleading information and to block hoaxes. With the increasing amount of news and information consumed and disseminated via social media, clinicians need to critically appraise information presented on those platforms, and to be familiar with how to use them to disseminate informed, effective, and responsible information.
 

Appraisal of social media content

Traditional scholarly communication exists in many forms and includes observations, anecdotes, perspectives, case reports, and research. Each form involves differing levels of academic rigor and standards of evaluation. Electronic content and online resources pose a unique challenge because there is no standardized method for assessing impact and quality. Proposed scales for evaluation of online resources such as Medical Education Translational Resources: Impact and Quality (METRIQ),1 Academic Life in Emergency Medicine Approved Instructional Resources (AliEM AIR) scoring system,2 and the Social Media Index3 are promising and can be used to guide critical appraisal of social media content.

Dr. Dennis Ren

The same skepticism and critical thinking applied to traditional resources should be applied when evaluating online resources. The scales listed above include questions such as:

  • How accurate is the data presented and conclusions drawn?
  • Does the content reflect evidence-based medicine?
  • Has the content undergone an editorial process?
  • Who are the authors and what are their credentials?
  • Are there potential biases or conflicts of interest present?
  • Have references been cited?
  • How does this content affect/change clinical practice?

While these proposed review metrics may not apply to all forms of social media content, clinicians should be discerning when consuming or disseminating online content.
 

Strategies for effective communication on social media

In addition to appraising social media content, clinicians also should be able to craft effective messages on social media to spread trustworthy content. The CDC offers guidelines and best practices for social media communication4,5 and the WHO has created a framework for effective communications.6 Both organizations recognize social media as a powerful communication tool that has the potential to greatly impact public health efforts.

Dr. Joelle Simpson

Some key principles highlighted from these sources include the following:

  • Identify an audience and make messages relevant. Taking time to listen to key stakeholders within the target audience (individuals, health care providers, communities, policy-makers, organizations) allows for better understanding of baseline knowledge, attitudes, and beliefs that may drive concerns and ultimately helps to tailor the messaging.
  • Make messages accessible. Certain social media platforms are more often utilized for specific target audiences. Verbiage used should take into account the health literacy of the audience. A friendly, professional, conversational tone encourages interaction and dialogue.
  • Engage the audience by offering something actionable. Changing behavior is a daunting task that involves multiple steps. Encouraging behavioral changes initially at an individual level has the potential to influence community practices and policies.
  • Communication should be timely. It should address current and urgent topics. Keep abreast of the situation as it evolves to ensure messaging stays relevant. Deliver consistent messaging and updates.
  • Sources must be credible. It is important to be transparent about expertise and honest about what is known and unknown about the topic.
  • Content should be understandable. In addition to using plain language, visual aids and real stories can be used to reinforce messages.

Use social media responsibly

Clinicians have a responsibility to use social media to disseminate credible content, refute misleading content, and create accurate content. When clinicians share health-related information via social media, it should be appraised skeptically and crafted responsibly because that message can have profound implications on public health. Mixed messaging that is contradictory, inconsistent, or unclear can lead to panic and confusion. By recognizing the important role of social media in access to information and as a tool for public health messaging and crisis communication, clinicians have an obligation to consider both the positive and negative impacts as messengers in that space.

Dr. Ren is a pediatric emergency medicine fellow at Children’s National Hospital, Washington. Dr. Simpson is a pediatric emergency medicine attending and medical director of emergency preparedness of Children’s National Hospital. They do not have any disclosures or conflicts of interest. Email Dr. Ren and Dr. Simpson at pdnews@mdedge.com.

References

1. AEM Educ Train. 2019;3(4):387-92.

2. Ann Emerg Med. 2016;68(6):729-35.

3. Ann Emerg Med. 2018;72(6):696-702.

4. CDC Guide to Writing for Social Media.

5. The Health Communicator’s Social Media Toolkit.

6. WHO Strategic Communications Framework for effective communications.

A few months into the COVID-19 pandemic, social media’s role in the rapid spread of information is undeniable. From the beginning, Chinese ophthalmologist Li Wenliang, MD, first raised the alarm to his classmates through WeChat, a messaging and social media app. Since that time, individuals, groups, organizations, government agencies, and mass media outlets have used social media to share ideas and disseminate information. Individuals check in on loved ones and update others on their own safety. Networks of clinicians discuss patient presentations, new therapeutics, management strategies, and institutional protocols. Multiple organizations including the Federal Emergency Management Agency, the Centers for Disease Control and Prevention, and the World Health Organization use Facebook, Instagram, or Twitter accounts to provide updates on ongoing efforts and spread public health messaging.

Unfortunately, not all information is trustworthy. Social media outlets have been used to spread misinformation and conspiracy theories, and to promote false treatments. Google, YouTube, and Facebook are now actively trying to reduce the viral spread of misleading information and to block hoaxes. With the increasing amount of news and information consumed and disseminated via social media, clinicians need to critically appraise information presented on those platforms, and to be familiar with how to use them to disseminate informed, effective, and responsible information.
 

Appraisal of social media content

Traditional scholarly communication exists in many forms and includes observations, anecdotes, perspectives, case reports, and research. Each form involves differing levels of academic rigor and standards of evaluation. Electronic content and online resources pose a unique challenge because there is no standardized method for assessing impact and quality. Proposed scales for evaluation of online resources such as Medical Education Translational Resources: Impact and Quality (METRIQ),1 Academic Life in Emergency Medicine Approved Instructional Resources (AliEM AIR) scoring system,2 and the Social Media Index3 are promising and can be used to guide critical appraisal of social media content.

Dr. Dennis Ren

The same skepticism and critical thinking applied to traditional resources should be applied when evaluating online resources. The scales listed above include questions such as:

  • How accurate is the data presented and conclusions drawn?
  • Does the content reflect evidence-based medicine?
  • Has the content undergone an editorial process?
  • Who are the authors and what are their credentials?
  • Are there potential biases or conflicts of interest present?
  • Have references been cited?
  • How does this content affect/change clinical practice?

While these proposed review metrics may not apply to all forms of social media content, clinicians should be discerning when consuming or disseminating online content.
 

Strategies for effective communication on social media

In addition to appraising social media content, clinicians also should be able to craft effective messages on social media to spread trustworthy content. The CDC offers guidelines and best practices for social media communication4,5 and the WHO has created a framework for effective communications.6 Both organizations recognize social media as a powerful communication tool that has the potential to greatly impact public health efforts.

Dr. Joelle Simpson

Some key principles highlighted from these sources include the following:

  • Identify an audience and make messages relevant. Taking time to listen to key stakeholders within the target audience (individuals, health care providers, communities, policy-makers, organizations) allows for better understanding of baseline knowledge, attitudes, and beliefs that may drive concerns and ultimately helps to tailor the messaging.
  • Make messages accessible. Certain social media platforms are more often utilized for specific target audiences. Verbiage used should take into account the health literacy of the audience. A friendly, professional, conversational tone encourages interaction and dialogue.
  • Engage the audience by offering something actionable. Changing behavior is a daunting task that involves multiple steps. Encouraging behavioral changes initially at an individual level has the potential to influence community practices and policies.
  • Communication should be timely. It should address current and urgent topics. Keep abreast of the situation as it evolves to ensure messaging stays relevant. Deliver consistent messaging and updates.
  • Sources must be credible. It is important to be transparent about expertise and honest about what is known and unknown about the topic.
  • Content should be understandable. In addition to using plain language, visual aids and real stories can be used to reinforce messages.

Use social media responsibly

Clinicians have a responsibility to use social media to disseminate credible content, refute misleading content, and create accurate content. When clinicians share health-related information via social media, it should be appraised skeptically and crafted responsibly because that message can have profound implications on public health. Mixed messaging that is contradictory, inconsistent, or unclear can lead to panic and confusion. By recognizing the important role of social media in access to information and as a tool for public health messaging and crisis communication, clinicians have an obligation to consider both the positive and negative impacts as messengers in that space.

Dr. Ren is a pediatric emergency medicine fellow at Children’s National Hospital, Washington. Dr. Simpson is a pediatric emergency medicine attending and medical director of emergency preparedness of Children’s National Hospital. They do not have any disclosures or conflicts of interest. Email Dr. Ren and Dr. Simpson at pdnews@mdedge.com.

References

1. AEM Educ Train. 2019;3(4):387-92.

2. Ann Emerg Med. 2016;68(6):729-35.

3. Ann Emerg Med. 2018;72(6):696-702.

4. CDC Guide to Writing for Social Media.

5. The Health Communicator’s Social Media Toolkit.

6. WHO Strategic Communications Framework for effective communications.

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What does COVID-19 mean for child safety?

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In my home county of San Diego, school closure has meant some 800,000 children staying home.1 Parents love and are committed to care for their children, but as these parents struggle with food insecurity and mass unemployment, local pediatricians are joining their national colleagues in worrying about rising rates of child abuse.

monkeybusinessimages/iStock/Getty Images


Dr. Gwendolyn Wright, a local pediatrician at Scripps Coastal Medical Center, San Diego, explains. “Obviously, it’s easy for tempers to flare,” during this stressful time, “so there is increased risk for child abuse. And there’s no one else with eyes on the kids. Usually, there would be teachers at schools and other childcare workers who would have eyes on the kid. And now there is none of that extra protection.”

2018 data from the National Child Abuse and Neglect Data System showed that in 91.7% of child abuse cases, one or more parent perpetrated the abuse.2 Prior reporting in our county showed that calls to the child abuse hotline went down nearly 60% a week after school closure.3 However, this is not necessarily good news. NCANDS data show that educational personnel report 20% of child abuse cases – far more than the number of cases reported by social services, medical professionals, or family members.2

Teachers, childcare workers, law enforcement, and medical professionals all are mandated reporters, meaning that they are legally obligated to report any suspected cases of child abuse to Child Welfare Services. Accordingly, they receive training on how to spot signs of child abuse.

Sometimes, the signs are obvious, sometimes subtle. Subtle injuries are called “sentinel” injuries. In a landmark study published in Pediatrics in 2013, a “sentinel” injury was defined as “a previous injury reported in the medical history that was suspicious for abuse because the infant could not cruise, or the explanation was implausible.” Sentinel injuries can be mild bruising or oral injuries in a young infant. These injuries suggest “there may be escalating and repeated violence toward the infant” that can culminate in death.4,5

In this study, severely abused infants were 4.4 times more likely to initially have come to the doctor with a sentinel injury. Of concern, 42% of parents of definitely abused children reported that a medical provider was aware of the sentinel injury. Of these cases, 56% did not show evidence that a professional was worried about abuse. These data show that medical professionals do miss cases of child abuse.

Dr. Sejal N. Parekh

The cost of child abuse is real and lifelong. According to a policy statement from the American Academy of Pediatrics Council on Child Abuse and Neglect, a quarter of kids who suffer abusive head trauma die. Of the survivors, nearly 70% “have some degree of lasting neurological impairment.”5

Given the potentially disastrous consequences of child abuse, we must stay vigilant about child abuse. In our own profession, we must educate trainees and update experienced pediatricians about suspecting child abuse and reporting. For example, child abuse can be suspected and reported based on telemedicine interactions. The burden of proof for reporting child abuse is only “reasonable suspicion,” not “beyond a reasonable doubt.” In our communities, we must engage with local Child Welfare Services workers and educate them about sentinel injuries. And finally, in our practices, we must build families up with awareness, resources, and coping mechanisms to prevent abuse from happening in the first place.

Dr. Helen C. Wang, associate professor of pediatrics at the University of California, San Diego, talks to parents about managing stress early and often. She says, “I start counseling families at the prenatal visit. I do talk to families about what they liked to do before children. What brought you joy? What communities do you spend time with? And what have you been doing now?”

It can be hard to reconcile prior hobbies with the current recommendations of social distancing. “Now it’s more ‘Do FaceTime’ and ‘Do Zoom’ and spend more time with your extended family,” says Dr. Wang.

By caring for themselves, parents can better protect their children from mistreatment and injury. Healthychildren.org, the parent-facing website of the AAP, offers several tips for parenting in times of stress.

In this unusual time of COVID-19, it is more important than ever to provide parents with suggestions and strategies that will help them – and their children – survive this health crisis. By educating ourselves and our communities about child abuse, we as pediatricians can fulfill our mandate in keeping kids healthy and thriving.
 

Dr. Parekh is a pediatric resident at University of California, San Diego. She has no financial disclosures. Email Dr. Parekh at pdnews@mdedge.com.

References

1. Early childhood age group in California. kidsdata.org.

2. U.S. Department of Health & Human Services, Administration for Children and Families, Administration on Children, Youth and Families, Children’s Bureau. (2020). Child Maltreatment 2018.

3. Hong Joe. School closures lead to troubling drop in child abuse reports. KPBS. 2020 Mar 27.

4. Pediatrics. 2013 Apr;131(4):701-7.

5. Pediatrics. 2020;145(4):e20200203.

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In my home county of San Diego, school closure has meant some 800,000 children staying home.1 Parents love and are committed to care for their children, but as these parents struggle with food insecurity and mass unemployment, local pediatricians are joining their national colleagues in worrying about rising rates of child abuse.

monkeybusinessimages/iStock/Getty Images


Dr. Gwendolyn Wright, a local pediatrician at Scripps Coastal Medical Center, San Diego, explains. “Obviously, it’s easy for tempers to flare,” during this stressful time, “so there is increased risk for child abuse. And there’s no one else with eyes on the kids. Usually, there would be teachers at schools and other childcare workers who would have eyes on the kid. And now there is none of that extra protection.”

2018 data from the National Child Abuse and Neglect Data System showed that in 91.7% of child abuse cases, one or more parent perpetrated the abuse.2 Prior reporting in our county showed that calls to the child abuse hotline went down nearly 60% a week after school closure.3 However, this is not necessarily good news. NCANDS data show that educational personnel report 20% of child abuse cases – far more than the number of cases reported by social services, medical professionals, or family members.2

Teachers, childcare workers, law enforcement, and medical professionals all are mandated reporters, meaning that they are legally obligated to report any suspected cases of child abuse to Child Welfare Services. Accordingly, they receive training on how to spot signs of child abuse.

Sometimes, the signs are obvious, sometimes subtle. Subtle injuries are called “sentinel” injuries. In a landmark study published in Pediatrics in 2013, a “sentinel” injury was defined as “a previous injury reported in the medical history that was suspicious for abuse because the infant could not cruise, or the explanation was implausible.” Sentinel injuries can be mild bruising or oral injuries in a young infant. These injuries suggest “there may be escalating and repeated violence toward the infant” that can culminate in death.4,5

In this study, severely abused infants were 4.4 times more likely to initially have come to the doctor with a sentinel injury. Of concern, 42% of parents of definitely abused children reported that a medical provider was aware of the sentinel injury. Of these cases, 56% did not show evidence that a professional was worried about abuse. These data show that medical professionals do miss cases of child abuse.

Dr. Sejal N. Parekh

The cost of child abuse is real and lifelong. According to a policy statement from the American Academy of Pediatrics Council on Child Abuse and Neglect, a quarter of kids who suffer abusive head trauma die. Of the survivors, nearly 70% “have some degree of lasting neurological impairment.”5

Given the potentially disastrous consequences of child abuse, we must stay vigilant about child abuse. In our own profession, we must educate trainees and update experienced pediatricians about suspecting child abuse and reporting. For example, child abuse can be suspected and reported based on telemedicine interactions. The burden of proof for reporting child abuse is only “reasonable suspicion,” not “beyond a reasonable doubt.” In our communities, we must engage with local Child Welfare Services workers and educate them about sentinel injuries. And finally, in our practices, we must build families up with awareness, resources, and coping mechanisms to prevent abuse from happening in the first place.

Dr. Helen C. Wang, associate professor of pediatrics at the University of California, San Diego, talks to parents about managing stress early and often. She says, “I start counseling families at the prenatal visit. I do talk to families about what they liked to do before children. What brought you joy? What communities do you spend time with? And what have you been doing now?”

It can be hard to reconcile prior hobbies with the current recommendations of social distancing. “Now it’s more ‘Do FaceTime’ and ‘Do Zoom’ and spend more time with your extended family,” says Dr. Wang.

By caring for themselves, parents can better protect their children from mistreatment and injury. Healthychildren.org, the parent-facing website of the AAP, offers several tips for parenting in times of stress.

In this unusual time of COVID-19, it is more important than ever to provide parents with suggestions and strategies that will help them – and their children – survive this health crisis. By educating ourselves and our communities about child abuse, we as pediatricians can fulfill our mandate in keeping kids healthy and thriving.
 

Dr. Parekh is a pediatric resident at University of California, San Diego. She has no financial disclosures. Email Dr. Parekh at pdnews@mdedge.com.

References

1. Early childhood age group in California. kidsdata.org.

2. U.S. Department of Health & Human Services, Administration for Children and Families, Administration on Children, Youth and Families, Children’s Bureau. (2020). Child Maltreatment 2018.

3. Hong Joe. School closures lead to troubling drop in child abuse reports. KPBS. 2020 Mar 27.

4. Pediatrics. 2013 Apr;131(4):701-7.

5. Pediatrics. 2020;145(4):e20200203.

In my home county of San Diego, school closure has meant some 800,000 children staying home.1 Parents love and are committed to care for their children, but as these parents struggle with food insecurity and mass unemployment, local pediatricians are joining their national colleagues in worrying about rising rates of child abuse.

monkeybusinessimages/iStock/Getty Images


Dr. Gwendolyn Wright, a local pediatrician at Scripps Coastal Medical Center, San Diego, explains. “Obviously, it’s easy for tempers to flare,” during this stressful time, “so there is increased risk for child abuse. And there’s no one else with eyes on the kids. Usually, there would be teachers at schools and other childcare workers who would have eyes on the kid. And now there is none of that extra protection.”

2018 data from the National Child Abuse and Neglect Data System showed that in 91.7% of child abuse cases, one or more parent perpetrated the abuse.2 Prior reporting in our county showed that calls to the child abuse hotline went down nearly 60% a week after school closure.3 However, this is not necessarily good news. NCANDS data show that educational personnel report 20% of child abuse cases – far more than the number of cases reported by social services, medical professionals, or family members.2

Teachers, childcare workers, law enforcement, and medical professionals all are mandated reporters, meaning that they are legally obligated to report any suspected cases of child abuse to Child Welfare Services. Accordingly, they receive training on how to spot signs of child abuse.

Sometimes, the signs are obvious, sometimes subtle. Subtle injuries are called “sentinel” injuries. In a landmark study published in Pediatrics in 2013, a “sentinel” injury was defined as “a previous injury reported in the medical history that was suspicious for abuse because the infant could not cruise, or the explanation was implausible.” Sentinel injuries can be mild bruising or oral injuries in a young infant. These injuries suggest “there may be escalating and repeated violence toward the infant” that can culminate in death.4,5

In this study, severely abused infants were 4.4 times more likely to initially have come to the doctor with a sentinel injury. Of concern, 42% of parents of definitely abused children reported that a medical provider was aware of the sentinel injury. Of these cases, 56% did not show evidence that a professional was worried about abuse. These data show that medical professionals do miss cases of child abuse.

Dr. Sejal N. Parekh

The cost of child abuse is real and lifelong. According to a policy statement from the American Academy of Pediatrics Council on Child Abuse and Neglect, a quarter of kids who suffer abusive head trauma die. Of the survivors, nearly 70% “have some degree of lasting neurological impairment.”5

Given the potentially disastrous consequences of child abuse, we must stay vigilant about child abuse. In our own profession, we must educate trainees and update experienced pediatricians about suspecting child abuse and reporting. For example, child abuse can be suspected and reported based on telemedicine interactions. The burden of proof for reporting child abuse is only “reasonable suspicion,” not “beyond a reasonable doubt.” In our communities, we must engage with local Child Welfare Services workers and educate them about sentinel injuries. And finally, in our practices, we must build families up with awareness, resources, and coping mechanisms to prevent abuse from happening in the first place.

Dr. Helen C. Wang, associate professor of pediatrics at the University of California, San Diego, talks to parents about managing stress early and often. She says, “I start counseling families at the prenatal visit. I do talk to families about what they liked to do before children. What brought you joy? What communities do you spend time with? And what have you been doing now?”

It can be hard to reconcile prior hobbies with the current recommendations of social distancing. “Now it’s more ‘Do FaceTime’ and ‘Do Zoom’ and spend more time with your extended family,” says Dr. Wang.

By caring for themselves, parents can better protect their children from mistreatment and injury. Healthychildren.org, the parent-facing website of the AAP, offers several tips for parenting in times of stress.

In this unusual time of COVID-19, it is more important than ever to provide parents with suggestions and strategies that will help them – and their children – survive this health crisis. By educating ourselves and our communities about child abuse, we as pediatricians can fulfill our mandate in keeping kids healthy and thriving.
 

Dr. Parekh is a pediatric resident at University of California, San Diego. She has no financial disclosures. Email Dr. Parekh at pdnews@mdedge.com.

References

1. Early childhood age group in California. kidsdata.org.

2. U.S. Department of Health & Human Services, Administration for Children and Families, Administration on Children, Youth and Families, Children’s Bureau. (2020). Child Maltreatment 2018.

3. Hong Joe. School closures lead to troubling drop in child abuse reports. KPBS. 2020 Mar 27.

4. Pediatrics. 2013 Apr;131(4):701-7.

5. Pediatrics. 2020;145(4):e20200203.

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Societies offer advice on treating osteoporosis patients during pandemic

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Five leading bone health organizations have gotten together to provide new recommendations for managing patients with osteoporosis during the COVID-19 pandemic.

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The joint guidance – released by the American Society for Bone and Mineral Research (ASBMR), the American Association of Clinical Endocrinologists, the Endocrine Society, the European Calcified Tissue Society, and the National Osteoporosis Foundation – offered both general and specific recommendations for patients whose osteoporosis treatment plan is either continuing or has been disrupted during the COVID-19 pandemic.

Among the general recommendations are to initiate oral bisphosphonate therapy over either the telephone or through a video visit, with no delays for patients at high risk of fracture. They also noted that, as elective procedures, bone mineral density examinations may need to be postponed.

For patients already on osteoporosis medications – such as oral and IV bisphosphonates, denosumab, estrogen, raloxifene, teriparatide, abaloparatide, and romosozumab – they recommend continuing treatment whenever possible. “There is no evidence that any osteoporosis therapy increases the risk or severity of COVID-19 infection or alters the disease course,” they wrote. They did add, however, that COVID-19 may increase the risk of hypercoagulable complications and so caution should be exercised when treating patients with estrogen or raloxifene.

Separately, in a letter to the editor published in the Journal of Clinical Endocrinology and Metabolism (doi: 10.1210/clinem/dgaa254), Ruban Dhaliwal, MD, MPH, of the State University of New York, Syracuse, and coauthors concur in regard to raloxifene. They wrote that, because of the increased risk of thromboembolic events related to COVID-19, “it is best to discontinue raloxifene, which is also associated with such risk.”

The joint statement recognizes current social distancing policies and therefore recommends avoiding standard pretreatment labs prior to IV bisphosphonate and/or denosumab administration if previous labs were normal and the patient’s recent health has been deemed “stable.” Lab evaluation is recommended, however, for patients with fluctuating renal function and for those at higher risk of developing hypocalcemia.



The statement also provides potential alternative methods for delivering parenteral osteoporosis treatments, including off-site clinics, home delivery and administration, self-injection of denosumab and/or romosozumab, and drive-through administration of denosumab and/or romosozumab. They acknowledged the complications surrounding each alternative, including residents of “socioeconomically challenged communities” being unable to reach clinics if public transportation is not available and the “important medicolegal issues” to consider around self-injection.

For all patients whose treatments have been disrupted, the authors recommend frequent reevaluation “with the goal to resume the original osteoporosis treatment plan once circumstances allow.” As for specific recommendations, patients on denosumab who will not be treatable within 7 months of their previous injection should be transitioned to oral bisphosphonate if at all possible. For patients with underlying gastrointestinal disorders, they recommend monthly ibandronate or weekly/monthly risedronate; for patients with chronic renal insufficiency, they recommend an off-label regimen of lower dose oral bisphosphonate.

For patients on teriparatide or abaloparatide who will be unable to receive continued treatment, they recommend a delay in treatment. If that delay goes beyond several months, they recommend a temporary transition to oral bisphosphonate. For patients on romosozumab who will be unable to receive continued treatment, they also recommend a delay in treatment and a temporary transition to oral bisphosphonate. Finally, they expressed confidence that patients on IV bisphosphonates will not be harmed by treatment delays, even those of several months.

“I think we could fall into a trap during this era of the pandemic and fail to address patients’ underlying chronic conditions, even though those comorbidities will end up greatly affecting their overall health,” said incoming ASBMR president Suzanne Jan de Beur, MD, of the Johns Hopkins University, Baltimore. “As we continue to care for our patients, we need to keep chronic conditions like osteoporosis on the radar screen and not stop diagnosing people at risk or those who present with fractures. Even when we can’t perform full screening tests due to distancing policies, we need to be vigilant for those patients who need treatment and administer the treatments we have available as needed.”

The statement’s authors acknowledged the limitations of their recommendations, noting that “there is a paucity of data to provide clear guidance” and as such they were “based primarily on expert opinion.”

The authors from the five organizations did not disclose any conflicts of interest.

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Five leading bone health organizations have gotten together to provide new recommendations for managing patients with osteoporosis during the COVID-19 pandemic.

iStock/Thinkstock

The joint guidance – released by the American Society for Bone and Mineral Research (ASBMR), the American Association of Clinical Endocrinologists, the Endocrine Society, the European Calcified Tissue Society, and the National Osteoporosis Foundation – offered both general and specific recommendations for patients whose osteoporosis treatment plan is either continuing or has been disrupted during the COVID-19 pandemic.

Among the general recommendations are to initiate oral bisphosphonate therapy over either the telephone or through a video visit, with no delays for patients at high risk of fracture. They also noted that, as elective procedures, bone mineral density examinations may need to be postponed.

For patients already on osteoporosis medications – such as oral and IV bisphosphonates, denosumab, estrogen, raloxifene, teriparatide, abaloparatide, and romosozumab – they recommend continuing treatment whenever possible. “There is no evidence that any osteoporosis therapy increases the risk or severity of COVID-19 infection or alters the disease course,” they wrote. They did add, however, that COVID-19 may increase the risk of hypercoagulable complications and so caution should be exercised when treating patients with estrogen or raloxifene.

Separately, in a letter to the editor published in the Journal of Clinical Endocrinology and Metabolism (doi: 10.1210/clinem/dgaa254), Ruban Dhaliwal, MD, MPH, of the State University of New York, Syracuse, and coauthors concur in regard to raloxifene. They wrote that, because of the increased risk of thromboembolic events related to COVID-19, “it is best to discontinue raloxifene, which is also associated with such risk.”

The joint statement recognizes current social distancing policies and therefore recommends avoiding standard pretreatment labs prior to IV bisphosphonate and/or denosumab administration if previous labs were normal and the patient’s recent health has been deemed “stable.” Lab evaluation is recommended, however, for patients with fluctuating renal function and for those at higher risk of developing hypocalcemia.



The statement also provides potential alternative methods for delivering parenteral osteoporosis treatments, including off-site clinics, home delivery and administration, self-injection of denosumab and/or romosozumab, and drive-through administration of denosumab and/or romosozumab. They acknowledged the complications surrounding each alternative, including residents of “socioeconomically challenged communities” being unable to reach clinics if public transportation is not available and the “important medicolegal issues” to consider around self-injection.

For all patients whose treatments have been disrupted, the authors recommend frequent reevaluation “with the goal to resume the original osteoporosis treatment plan once circumstances allow.” As for specific recommendations, patients on denosumab who will not be treatable within 7 months of their previous injection should be transitioned to oral bisphosphonate if at all possible. For patients with underlying gastrointestinal disorders, they recommend monthly ibandronate or weekly/monthly risedronate; for patients with chronic renal insufficiency, they recommend an off-label regimen of lower dose oral bisphosphonate.

For patients on teriparatide or abaloparatide who will be unable to receive continued treatment, they recommend a delay in treatment. If that delay goes beyond several months, they recommend a temporary transition to oral bisphosphonate. For patients on romosozumab who will be unable to receive continued treatment, they also recommend a delay in treatment and a temporary transition to oral bisphosphonate. Finally, they expressed confidence that patients on IV bisphosphonates will not be harmed by treatment delays, even those of several months.

“I think we could fall into a trap during this era of the pandemic and fail to address patients’ underlying chronic conditions, even though those comorbidities will end up greatly affecting their overall health,” said incoming ASBMR president Suzanne Jan de Beur, MD, of the Johns Hopkins University, Baltimore. “As we continue to care for our patients, we need to keep chronic conditions like osteoporosis on the radar screen and not stop diagnosing people at risk or those who present with fractures. Even when we can’t perform full screening tests due to distancing policies, we need to be vigilant for those patients who need treatment and administer the treatments we have available as needed.”

The statement’s authors acknowledged the limitations of their recommendations, noting that “there is a paucity of data to provide clear guidance” and as such they were “based primarily on expert opinion.”

The authors from the five organizations did not disclose any conflicts of interest.

Five leading bone health organizations have gotten together to provide new recommendations for managing patients with osteoporosis during the COVID-19 pandemic.

iStock/Thinkstock

The joint guidance – released by the American Society for Bone and Mineral Research (ASBMR), the American Association of Clinical Endocrinologists, the Endocrine Society, the European Calcified Tissue Society, and the National Osteoporosis Foundation – offered both general and specific recommendations for patients whose osteoporosis treatment plan is either continuing or has been disrupted during the COVID-19 pandemic.

Among the general recommendations are to initiate oral bisphosphonate therapy over either the telephone or through a video visit, with no delays for patients at high risk of fracture. They also noted that, as elective procedures, bone mineral density examinations may need to be postponed.

For patients already on osteoporosis medications – such as oral and IV bisphosphonates, denosumab, estrogen, raloxifene, teriparatide, abaloparatide, and romosozumab – they recommend continuing treatment whenever possible. “There is no evidence that any osteoporosis therapy increases the risk or severity of COVID-19 infection or alters the disease course,” they wrote. They did add, however, that COVID-19 may increase the risk of hypercoagulable complications and so caution should be exercised when treating patients with estrogen or raloxifene.

Separately, in a letter to the editor published in the Journal of Clinical Endocrinology and Metabolism (doi: 10.1210/clinem/dgaa254), Ruban Dhaliwal, MD, MPH, of the State University of New York, Syracuse, and coauthors concur in regard to raloxifene. They wrote that, because of the increased risk of thromboembolic events related to COVID-19, “it is best to discontinue raloxifene, which is also associated with such risk.”

The joint statement recognizes current social distancing policies and therefore recommends avoiding standard pretreatment labs prior to IV bisphosphonate and/or denosumab administration if previous labs were normal and the patient’s recent health has been deemed “stable.” Lab evaluation is recommended, however, for patients with fluctuating renal function and for those at higher risk of developing hypocalcemia.



The statement also provides potential alternative methods for delivering parenteral osteoporosis treatments, including off-site clinics, home delivery and administration, self-injection of denosumab and/or romosozumab, and drive-through administration of denosumab and/or romosozumab. They acknowledged the complications surrounding each alternative, including residents of “socioeconomically challenged communities” being unable to reach clinics if public transportation is not available and the “important medicolegal issues” to consider around self-injection.

For all patients whose treatments have been disrupted, the authors recommend frequent reevaluation “with the goal to resume the original osteoporosis treatment plan once circumstances allow.” As for specific recommendations, patients on denosumab who will not be treatable within 7 months of their previous injection should be transitioned to oral bisphosphonate if at all possible. For patients with underlying gastrointestinal disorders, they recommend monthly ibandronate or weekly/monthly risedronate; for patients with chronic renal insufficiency, they recommend an off-label regimen of lower dose oral bisphosphonate.

For patients on teriparatide or abaloparatide who will be unable to receive continued treatment, they recommend a delay in treatment. If that delay goes beyond several months, they recommend a temporary transition to oral bisphosphonate. For patients on romosozumab who will be unable to receive continued treatment, they also recommend a delay in treatment and a temporary transition to oral bisphosphonate. Finally, they expressed confidence that patients on IV bisphosphonates will not be harmed by treatment delays, even those of several months.

“I think we could fall into a trap during this era of the pandemic and fail to address patients’ underlying chronic conditions, even though those comorbidities will end up greatly affecting their overall health,” said incoming ASBMR president Suzanne Jan de Beur, MD, of the Johns Hopkins University, Baltimore. “As we continue to care for our patients, we need to keep chronic conditions like osteoporosis on the radar screen and not stop diagnosing people at risk or those who present with fractures. Even when we can’t perform full screening tests due to distancing policies, we need to be vigilant for those patients who need treatment and administer the treatments we have available as needed.”

The statement’s authors acknowledged the limitations of their recommendations, noting that “there is a paucity of data to provide clear guidance” and as such they were “based primarily on expert opinion.”

The authors from the five organizations did not disclose any conflicts of interest.

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FDA approves Fensolvi for central precocious puberty treatment

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The Food and Drug Administration has approved leuprolide acetate (Fensolvi) for treating children aged 2 years and older with central precocious puberty.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Approval was based on results from a multicenter, open-label, single-arm, phase 3 study of 64 children with central precocious puberty, a rare disease described as onset of puberty before age 8 years in girls and before age 9 in boys. The primary study endpoint was achieved, with 87% of children achieving a serum luteinizing-hormone concentration of less than 4 IU/L within 6 months post injection. Sex hormones were suppressed to prepubertal levels, and clinical signs of puberty were halted or reversed.

Adverse events during the study were mostly mild or moderate; none led to withdrawal from the study. The most common adverse events reported were injection-site pain (31%), nasopharyngitis (22%), and fever (17%).

“Children with CPP require treatment for several years and missing treatment or stopping treatment too soon may lead to significant short stature and misalignment between chronological age and physical and emotional development. Fensolvi offers treating physicians and their patients with CPP a safe and effective treatment option that is administered twice a year with a small injection volume that has the potential to improve compliance,” Karen Klein, MD, of Rady Children’s Hospital in San Diego, said in the press release.

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The Food and Drug Administration has approved leuprolide acetate (Fensolvi) for treating children aged 2 years and older with central precocious puberty.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Approval was based on results from a multicenter, open-label, single-arm, phase 3 study of 64 children with central precocious puberty, a rare disease described as onset of puberty before age 8 years in girls and before age 9 in boys. The primary study endpoint was achieved, with 87% of children achieving a serum luteinizing-hormone concentration of less than 4 IU/L within 6 months post injection. Sex hormones were suppressed to prepubertal levels, and clinical signs of puberty were halted or reversed.

Adverse events during the study were mostly mild or moderate; none led to withdrawal from the study. The most common adverse events reported were injection-site pain (31%), nasopharyngitis (22%), and fever (17%).

“Children with CPP require treatment for several years and missing treatment or stopping treatment too soon may lead to significant short stature and misalignment between chronological age and physical and emotional development. Fensolvi offers treating physicians and their patients with CPP a safe and effective treatment option that is administered twice a year with a small injection volume that has the potential to improve compliance,” Karen Klein, MD, of Rady Children’s Hospital in San Diego, said in the press release.

The Food and Drug Administration has approved leuprolide acetate (Fensolvi) for treating children aged 2 years and older with central precocious puberty.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Approval was based on results from a multicenter, open-label, single-arm, phase 3 study of 64 children with central precocious puberty, a rare disease described as onset of puberty before age 8 years in girls and before age 9 in boys. The primary study endpoint was achieved, with 87% of children achieving a serum luteinizing-hormone concentration of less than 4 IU/L within 6 months post injection. Sex hormones were suppressed to prepubertal levels, and clinical signs of puberty were halted or reversed.

Adverse events during the study were mostly mild or moderate; none led to withdrawal from the study. The most common adverse events reported were injection-site pain (31%), nasopharyngitis (22%), and fever (17%).

“Children with CPP require treatment for several years and missing treatment or stopping treatment too soon may lead to significant short stature and misalignment between chronological age and physical and emotional development. Fensolvi offers treating physicians and their patients with CPP a safe and effective treatment option that is administered twice a year with a small injection volume that has the potential to improve compliance,” Karen Klein, MD, of Rady Children’s Hospital in San Diego, said in the press release.

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COVID-19 in pregnancy: Supplement oxygen if saturation dips below 94%

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Oxygen supplementation for pregnant women with COVID-19 should begin when saturations fall below 94%, according to physicians in the divisions of maternal-fetal medicine and surgical critical care at the University of Texas Medical Branch at Galveston.

Courtesy NIAID-RML

That’s a bit higher than the 92% cut point for nonpregnant women, but necessary due to the increased oxygen demand and oxygen partial pressure in pregnancy. The goal is a saturation of 94%-96%, said Luis Pacheco, MD, a maternal-fetal medicine and critical care specialist at the university, and associates.

Most pregnant women with coronavirus disease 2019 (COVID-19) will have mild disease, but some might require respiratory support, so Dr. Pacheco and associates addressed the issue in a commentary in Obstetrics & Gynecology.

Women on respiratory support should lie prone if under 20 weeks’ gestation to help with posterior lung recruitment and oxygenation.

If conventional oxygen therapy isn’t enough, high-flow nasal cannula (HFNC) at 60 L/min and 100% oxygen should be the next step, not positive-pressure ventilation. Positive pressure, another option, kicks off aerosols that increase the risk of viral transmission to medical staff. “This makes high-flow nasal cannula the first-line option for patients not responding to conventional oxygen therapy but who are not yet candidates for endotracheal intubation,” the team said. If women do well, the fraction of inspired oxygen should be weaned before the nasal cannula flow is decreased.

However, if they continue to struggle with dyspnea, tachypnea, and oxygen saturation after 30-60 minutes on HFNC, it’s time for mechanical ventilation, and fast. “Delays in recognizing early failure of high-flow nasal cannula ... may result in life-threatening hypoxemia at the time of induction and intubation (especially in pregnant patients with difficult airway anatomy),” the authors said.

For birth, Dr. Pacheco and associates recommended controlled delivery, likely cesarean, if respiration continues to deteriorate despite intubation, especially after 28 weeks’ gestation, instead of waiting for fetal distress and an ICU delivery. A single course of steroids is reasonable to help fetal lung development beforehand, if indicated.

As for fluid strategy during respiratory support, pregnant women are at higher risk for pulmonary edema with lung inflammation, so the authors cautioned against giving maintenance fluids, and said “if daily positive fluid balances are present, combined with worsening respiratory status, the use of furosemide (10-20 mg intravenously every 12 hours) may be indicated.”

For women stable on conventional oxygen therapy or HFNC, they suggested daily nonstress tests starting at 25 weeks’ gestation instead of continuous monitoring, to minimize the COVID-19 transmission risk for staff.

The team cautioned against nebulized treatments and sputum-inducing agents when possible as this may aerosolize the virus.

There was no external funding for the report, and the authors didn’t have any relevant financial disclosures.

SOURCE: Pacheco LD et al. Obstet Gynecol. 2020 Apr 29. doi: 10.1097/AOG.0000000000003929.

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Oxygen supplementation for pregnant women with COVID-19 should begin when saturations fall below 94%, according to physicians in the divisions of maternal-fetal medicine and surgical critical care at the University of Texas Medical Branch at Galveston.

Courtesy NIAID-RML

That’s a bit higher than the 92% cut point for nonpregnant women, but necessary due to the increased oxygen demand and oxygen partial pressure in pregnancy. The goal is a saturation of 94%-96%, said Luis Pacheco, MD, a maternal-fetal medicine and critical care specialist at the university, and associates.

Most pregnant women with coronavirus disease 2019 (COVID-19) will have mild disease, but some might require respiratory support, so Dr. Pacheco and associates addressed the issue in a commentary in Obstetrics & Gynecology.

Women on respiratory support should lie prone if under 20 weeks’ gestation to help with posterior lung recruitment and oxygenation.

If conventional oxygen therapy isn’t enough, high-flow nasal cannula (HFNC) at 60 L/min and 100% oxygen should be the next step, not positive-pressure ventilation. Positive pressure, another option, kicks off aerosols that increase the risk of viral transmission to medical staff. “This makes high-flow nasal cannula the first-line option for patients not responding to conventional oxygen therapy but who are not yet candidates for endotracheal intubation,” the team said. If women do well, the fraction of inspired oxygen should be weaned before the nasal cannula flow is decreased.

However, if they continue to struggle with dyspnea, tachypnea, and oxygen saturation after 30-60 minutes on HFNC, it’s time for mechanical ventilation, and fast. “Delays in recognizing early failure of high-flow nasal cannula ... may result in life-threatening hypoxemia at the time of induction and intubation (especially in pregnant patients with difficult airway anatomy),” the authors said.

For birth, Dr. Pacheco and associates recommended controlled delivery, likely cesarean, if respiration continues to deteriorate despite intubation, especially after 28 weeks’ gestation, instead of waiting for fetal distress and an ICU delivery. A single course of steroids is reasonable to help fetal lung development beforehand, if indicated.

As for fluid strategy during respiratory support, pregnant women are at higher risk for pulmonary edema with lung inflammation, so the authors cautioned against giving maintenance fluids, and said “if daily positive fluid balances are present, combined with worsening respiratory status, the use of furosemide (10-20 mg intravenously every 12 hours) may be indicated.”

For women stable on conventional oxygen therapy or HFNC, they suggested daily nonstress tests starting at 25 weeks’ gestation instead of continuous monitoring, to minimize the COVID-19 transmission risk for staff.

The team cautioned against nebulized treatments and sputum-inducing agents when possible as this may aerosolize the virus.

There was no external funding for the report, and the authors didn’t have any relevant financial disclosures.

SOURCE: Pacheco LD et al. Obstet Gynecol. 2020 Apr 29. doi: 10.1097/AOG.0000000000003929.

Oxygen supplementation for pregnant women with COVID-19 should begin when saturations fall below 94%, according to physicians in the divisions of maternal-fetal medicine and surgical critical care at the University of Texas Medical Branch at Galveston.

Courtesy NIAID-RML

That’s a bit higher than the 92% cut point for nonpregnant women, but necessary due to the increased oxygen demand and oxygen partial pressure in pregnancy. The goal is a saturation of 94%-96%, said Luis Pacheco, MD, a maternal-fetal medicine and critical care specialist at the university, and associates.

Most pregnant women with coronavirus disease 2019 (COVID-19) will have mild disease, but some might require respiratory support, so Dr. Pacheco and associates addressed the issue in a commentary in Obstetrics & Gynecology.

Women on respiratory support should lie prone if under 20 weeks’ gestation to help with posterior lung recruitment and oxygenation.

If conventional oxygen therapy isn’t enough, high-flow nasal cannula (HFNC) at 60 L/min and 100% oxygen should be the next step, not positive-pressure ventilation. Positive pressure, another option, kicks off aerosols that increase the risk of viral transmission to medical staff. “This makes high-flow nasal cannula the first-line option for patients not responding to conventional oxygen therapy but who are not yet candidates for endotracheal intubation,” the team said. If women do well, the fraction of inspired oxygen should be weaned before the nasal cannula flow is decreased.

However, if they continue to struggle with dyspnea, tachypnea, and oxygen saturation after 30-60 minutes on HFNC, it’s time for mechanical ventilation, and fast. “Delays in recognizing early failure of high-flow nasal cannula ... may result in life-threatening hypoxemia at the time of induction and intubation (especially in pregnant patients with difficult airway anatomy),” the authors said.

For birth, Dr. Pacheco and associates recommended controlled delivery, likely cesarean, if respiration continues to deteriorate despite intubation, especially after 28 weeks’ gestation, instead of waiting for fetal distress and an ICU delivery. A single course of steroids is reasonable to help fetal lung development beforehand, if indicated.

As for fluid strategy during respiratory support, pregnant women are at higher risk for pulmonary edema with lung inflammation, so the authors cautioned against giving maintenance fluids, and said “if daily positive fluid balances are present, combined with worsening respiratory status, the use of furosemide (10-20 mg intravenously every 12 hours) may be indicated.”

For women stable on conventional oxygen therapy or HFNC, they suggested daily nonstress tests starting at 25 weeks’ gestation instead of continuous monitoring, to minimize the COVID-19 transmission risk for staff.

The team cautioned against nebulized treatments and sputum-inducing agents when possible as this may aerosolize the virus.

There was no external funding for the report, and the authors didn’t have any relevant financial disclosures.

SOURCE: Pacheco LD et al. Obstet Gynecol. 2020 Apr 29. doi: 10.1097/AOG.0000000000003929.

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With life in the balance, a pediatric palliative care program expands its work to adults

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In late March of 2020, when it became clear that hospitals in the greater New York City area would face a capacity crisis in caring for seriously ill patients with COVID-19, members of the leadership team at the Children’s Hospital at Montefiore (CHAM) in the Bronx, N.Y., convened to draft a response plan.

Courtesy Montefiore Health System
The Children's Hospital at Montefiore.

The recommendations put into action that day included moving the hospital’s emergency department from the lower level to the fourth floor, increasing the age limit for patients seen in the ED from 21 years of age to 30 and freeing up an entire hospital floor and a half to accommodate the anticipated surge of patients with COVID-19 admitted to Montefiore’s interconnected adult hospital, according to Sarah E. Norris, MD.

“We made multiple moves all at once,” said Dr. Norris, director of pediatric palliative care at CHAM. “It struck everyone as logical that palliative care had to be expanded, because all of the news we had received as the surge came to New York from around the world was full of death and uncertainty, and would require thoughtful conversations about end-of-life wishes at critical times and how to really respect the person and understand their values.”

Dr. Sarah E. Norris

When Dr. Norris left the leadership team meeting, she returned to her office, put her face in her hands, and sobbed as she began to process the gravity of what was ahead. “I cried because I knew that so many families were going to suffer a heartbreak, no matter how much we could do,” she said.
 

Stitching the QUILT

Over the next few days, Dr. Norris began recruiting colleagues from the large Montefiore Health System – most of whom she did not know – who met criteria for work deployment to expand CHAM’s palliative care program of clinician to 27 clinicians consisting of pediatricians, nurse practitioners, and psychologists, to meet the projected needs of COVID-19 patients and their families.

Some candidates for the effort, known as the Quality in Life Team (QUILT), were 65 years of age or older, considered at high risk for developing COVID-19-related complications themselves. Others were immunocompromised or had medical conditions that would not allow them to have direct contact with COVID-19 patients. “There were also clinicians in other parts of our health system whose practice hours were going to be severely reduced,” said Dr. Norris, who is board-certified in general pediatrics and in hospice and palliative care medicine.

Once she assembled QUILT, members participated in a 1-day rapid training webinar covering the basics of palliative care and grief, and readied themselves for one of three roles: physicians to provide face-to-face palliative care in CHAM; supportive callers to provide support to patients with COVID-19 and their families between 12:00-8:00 p.m. each day; and bereavement callers to reach out to families who lost loved ones to COVID-19 and provide grief counseling for 3 weeks.

“This allows families to have at least two contacts a day from the hospital: one from the medical team that’s giving them technical, medical information, and another from members of the QUILT team,” Dr. Norris said. “We provide support for the worry, anxiety, and fear that we know creeps in when you’re separated from your family member, especially during a pandemic when you watch TV and there’s a death count rising.”

During her early meetings with QUILT members via Zoom or on the phone, Dr. Norris encouraged them to stretch their skill sets and mindsets as they shifted from caring for children and adolescents to mostly adults. “Pediatricians are all about family; that’s why we get into this,” she said. “We’re used to treating your kids, but then, suddenly, the parent becomes our patient, like in COVID-19, or the grandparent becomes our patient. We treat you all the same; you’re part of our family. There has been no adult who has died ‘within our house’ that has died alone. There has either been a staff member at their bedside, or when possible, a family member. We are witnessing life until the last breath here.”
 

 

 

‘They have no loved ones with them’

One day, members of CHAM’s medical team contacted Dr. Norris about a patient with COVID-19 who’d been cared for by Montefiore clinicians all of his young life. The boy’s mother, who did not speak English, was at his bedside in the ICU, and the clinicians asked Dr. Norris to speak with her by cell phone while they prepared him for intubation.

“We were looking at each other through a glass window wall in our ICU,” Dr. Norris recalled. “I talked to her the entire time the team worked to put him on the breathing machine, through an interpreter. I asked her to tell me about her son and about her family, and she did. We developed a warm relationship. After that, every day I would see her son through the glass window wall. Every couple of days, I would have the privilege of talking to his mother by phone. At one point, she asked me, ‘Dr. Norris, do you think his lungs will heal?’ I had to tell her no. Almost selfishly, I was relieved we were on the phone, because she cried, and so did I. When he died, she was able to be by his side.”

Frederick J. Kaskel, MD, PhD, joined QUILT as a supportive caller after being asked to go home during his on-call shift on St. Patrick’s Day at CHAM, where he serves as chief emeritus of nephrology. “I was told that I was deemed to be at high risk because of my age,” the 75-year-old said. “The next day, a junior person took over for me, and 2 days later she got sick with COVID-19. She’s fine but she was home for 3 weeks sick as a dog. It was scary.”

Dr. Frederick J. Kaskel

In his role as a supportive caller, Dr. Kaskel found himself engaged in his share of detective work, trying to find phone numbers of next of kin for patients hospitalized with COVID-19. “When they come into the ER, they may not have been with a loved one or a family member; they may have been brought in by an EMT,” he said. “Some of them speak little English and others have little documentation with them. It takes a lot of work to get phone numbers.”

Once Dr. Kaskel reaches a loved one by phone, he introduces himself as a member of the QUILT team. “I tell them I’m not calling to update the medical status but just to talk to them about their loved one,” he said. “Then I usually ask, ‘So, how are you doing with this? The stress is enormous, the uncertainties.’ Then they open up and express their fears. I’ve had a lot of people say, ‘we have no money, and I don’t know how we’re going to pay rent for the apartment. We have to line up for food.’ I also ask what they do to alleviate stress. One guy said, ‘I drink a lot, but I’m careful.’ ”

Dr. Kaskel, who is also a past president of the American Society of Pediatric Nephrology, applies that same personable approach in daily conversations with adult patients hospitalized at CHAM with COVID-19, the majority of whom are African Americans in their 30s, 40s, and 50s. “Invariably, they ask, ‘Has my loved one been updated as to my status?’ ” he said. “The second thing they often say is, ‘I’m worried about infecting other people, but I also worry if I’m going to get through this. I’m really afraid I’m going to die.’ I say, ‘You have a wonderful team keeping track of you. They’re seeing you all the time and making changes to your medicines.’ ”

When patients express their fear of dying from the virus, Dr. Kaskel asks them how they’re coping with that fear. Most tell him that they pray.

“If they don’t answer, I ask if they have any hobbies, like ‘Are you watching TV? Are you reading? Do you have your cell phone?’ ” he said. “Then they open up and say things like, ‘I’m listening to music on the cell phone,’ or ‘I’m FaceTiming with my loved ones.’ The use of FaceTime is crucial, because they are in a hospital, critically ill, potentially dying alone with strangers. This really hit me on the first day [of this work]. They have no loved ones with them. They have strangers: the CHAM nurses, the medical residents, the social workers, and the doctors.”
 

 

 

No hospital cheeseburgers

QUILT began its work on April 6, and at one time provided palliative care services for a peak of 92 mostly adult patients with COVID-19. The supportive callers made 249 individual connections with patients and family members by phone from April 6-13, 162 connections from April 13-19, and 130 connections from April 20-26, according to Dr. Norris. As of April 28, the CHAM inpatient census of patients aged 18 years and over with COVID-19 was 42, “and we’re making 130 connections by phone to patients and family members each day,” she said.

QUILT bereavement callers are following 30 families, providing 3 weeks of acute grief counseling from the date of death. “A sad truth is that, here in New York, our entire funeral, burial, cremation system is overwhelmed in volume,” Dr. Norris said. “Only half of the patients we’re following 3 weeks out have been able to have their family member buried or cremated; many are still waiting. What strikes me here is that pediatricians are often partners in care. With time, we’re partners in care in heartbreak, and in the occasional victory. We mourn patients who have died. We’ve had colleagues who died from COVID-19 right here at our hospital. But we stand together like a family.”

Courtesy Dr. Sarah E. Norris
Dr. Sarah E. Norris

Dr. Norris recalled an older woman who came into CHAM’s ICU on a ventilator, critically ill from COVID-19. She called her husband at home every day with updates. “I got to know her husband, and I got to know her through him,” Dr. Norris said. “We talked every single day and she was able to graduate off of the breathing tube and out of the ICU, which was amazing.” The woman was moved to a floor in the adult hospital, but Dr. Norris continues to visit her and to provide her husband with updates, “because I’m devoted to them,” she said.

Recently, physicians in the adult hospital consulted with Dr. Norris about the woman. “They were trying to figure out what to do with her next,” she said. “Could she go home, or did she need rehab? They said, ‘We called you, Dr. Norris, because her husband thinks he can take her home.’ We know that COVID-19 really weakens people, so I went over to see her myself. I thought, ‘No single person could take care of an adult so weak at home.’ So, I called her husband and said, ‘I’m here with your wife, and I have to tell you; if she were my mother, I couldn’t take her home today. I need you to trust me.’ He said, ‘OK. We trust you and know that you have her best interest at heart.’ ”

Dr. Kaskel relayed the story of an older patient who was slowly recovering from COVID-19. During a phone call, he asked the man if there was anything he wanted at that moment.

“He said, ‘I’d love to see my wife and my children and my grandkids. I know I’m going to see them again, but right now, doc, if you could get me a cheeseburger with lettuce and tomato and ketchup and French fries from outside of the hospital, I’d be the happiest man in the world.’

I said, ‘What’s the matter with the cheeseburger made at the hospital?’

He said, ‘No! They can’t make the cheeseburger I want.’

I promised him I’d relay that message to the social worker responsible for the patient. I told her please, if you buy this for him, I’ll pay you back.”
 

Self-care and the next chapter

Twice each week, QUILT members gather in front of their computer monitors for mandatory Zoom meetings facilitated by two psychologists to share challenges, best practices, and to discuss the difficult work they’re doing. “We meet, because you cannot help someone if you cannot help yourself,” Dr. Norris said. “We have been encouraged each and every meeting to practice self-compassion, and to recognize that things happen during a pandemic – some will be the best you can do.”

She described organizing and serving on QUILT as a grounding experience with important lessons for the delivery of health care after the pandemic subsides and the team members return to their respective practices. “I think we’ve all gained a greater sense of humility, and we understand that the badge I wear every day does not protect me from becoming a patient, or from having my own family fall ill,” she said. “Here, we think about it very simply: ‘I’m going to treat you like you’re part of my own family.’ ”

Dr. Kaskel said that serving on QUILT as a supportive caller is an experience he won’t soon forget.

“The human bond is so accessible if you accept it,” he said. “If someone is an introvert that might not be able to draw out a stranger on the phone, then [he or she] shouldn’t do this [work]. But the fact that you can make a bond with someone that you’re not even seeing in person and know that both sides of this phone call are getting good vibes, that’s a remarkable feeling that I never really knew before, because I’ve never really had to do that before. It brings up feelings like I had after 9/11 – a unified approach to surviving this as people, as a community, the idea that ‘we will get through this,’ even though it’s totally different than anything before. The idea that there’s still hope. Those are things you can’t put a price on.”

An article about how CHAM transformed to provide care to adult COVID-19 patients was published online May 4, 2020, in the Journal of Pediatrics: doi: 10.1016/j.jpeds.2020.04.060.

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In late March of 2020, when it became clear that hospitals in the greater New York City area would face a capacity crisis in caring for seriously ill patients with COVID-19, members of the leadership team at the Children’s Hospital at Montefiore (CHAM) in the Bronx, N.Y., convened to draft a response plan.

Courtesy Montefiore Health System
The Children's Hospital at Montefiore.

The recommendations put into action that day included moving the hospital’s emergency department from the lower level to the fourth floor, increasing the age limit for patients seen in the ED from 21 years of age to 30 and freeing up an entire hospital floor and a half to accommodate the anticipated surge of patients with COVID-19 admitted to Montefiore’s interconnected adult hospital, according to Sarah E. Norris, MD.

“We made multiple moves all at once,” said Dr. Norris, director of pediatric palliative care at CHAM. “It struck everyone as logical that palliative care had to be expanded, because all of the news we had received as the surge came to New York from around the world was full of death and uncertainty, and would require thoughtful conversations about end-of-life wishes at critical times and how to really respect the person and understand their values.”

Dr. Sarah E. Norris

When Dr. Norris left the leadership team meeting, she returned to her office, put her face in her hands, and sobbed as she began to process the gravity of what was ahead. “I cried because I knew that so many families were going to suffer a heartbreak, no matter how much we could do,” she said.
 

Stitching the QUILT

Over the next few days, Dr. Norris began recruiting colleagues from the large Montefiore Health System – most of whom she did not know – who met criteria for work deployment to expand CHAM’s palliative care program of clinician to 27 clinicians consisting of pediatricians, nurse practitioners, and psychologists, to meet the projected needs of COVID-19 patients and their families.

Some candidates for the effort, known as the Quality in Life Team (QUILT), were 65 years of age or older, considered at high risk for developing COVID-19-related complications themselves. Others were immunocompromised or had medical conditions that would not allow them to have direct contact with COVID-19 patients. “There were also clinicians in other parts of our health system whose practice hours were going to be severely reduced,” said Dr. Norris, who is board-certified in general pediatrics and in hospice and palliative care medicine.

Once she assembled QUILT, members participated in a 1-day rapid training webinar covering the basics of palliative care and grief, and readied themselves for one of three roles: physicians to provide face-to-face palliative care in CHAM; supportive callers to provide support to patients with COVID-19 and their families between 12:00-8:00 p.m. each day; and bereavement callers to reach out to families who lost loved ones to COVID-19 and provide grief counseling for 3 weeks.

“This allows families to have at least two contacts a day from the hospital: one from the medical team that’s giving them technical, medical information, and another from members of the QUILT team,” Dr. Norris said. “We provide support for the worry, anxiety, and fear that we know creeps in when you’re separated from your family member, especially during a pandemic when you watch TV and there’s a death count rising.”

During her early meetings with QUILT members via Zoom or on the phone, Dr. Norris encouraged them to stretch their skill sets and mindsets as they shifted from caring for children and adolescents to mostly adults. “Pediatricians are all about family; that’s why we get into this,” she said. “We’re used to treating your kids, but then, suddenly, the parent becomes our patient, like in COVID-19, or the grandparent becomes our patient. We treat you all the same; you’re part of our family. There has been no adult who has died ‘within our house’ that has died alone. There has either been a staff member at their bedside, or when possible, a family member. We are witnessing life until the last breath here.”
 

 

 

‘They have no loved ones with them’

One day, members of CHAM’s medical team contacted Dr. Norris about a patient with COVID-19 who’d been cared for by Montefiore clinicians all of his young life. The boy’s mother, who did not speak English, was at his bedside in the ICU, and the clinicians asked Dr. Norris to speak with her by cell phone while they prepared him for intubation.

“We were looking at each other through a glass window wall in our ICU,” Dr. Norris recalled. “I talked to her the entire time the team worked to put him on the breathing machine, through an interpreter. I asked her to tell me about her son and about her family, and she did. We developed a warm relationship. After that, every day I would see her son through the glass window wall. Every couple of days, I would have the privilege of talking to his mother by phone. At one point, she asked me, ‘Dr. Norris, do you think his lungs will heal?’ I had to tell her no. Almost selfishly, I was relieved we were on the phone, because she cried, and so did I. When he died, she was able to be by his side.”

Frederick J. Kaskel, MD, PhD, joined QUILT as a supportive caller after being asked to go home during his on-call shift on St. Patrick’s Day at CHAM, where he serves as chief emeritus of nephrology. “I was told that I was deemed to be at high risk because of my age,” the 75-year-old said. “The next day, a junior person took over for me, and 2 days later she got sick with COVID-19. She’s fine but she was home for 3 weeks sick as a dog. It was scary.”

Dr. Frederick J. Kaskel

In his role as a supportive caller, Dr. Kaskel found himself engaged in his share of detective work, trying to find phone numbers of next of kin for patients hospitalized with COVID-19. “When they come into the ER, they may not have been with a loved one or a family member; they may have been brought in by an EMT,” he said. “Some of them speak little English and others have little documentation with them. It takes a lot of work to get phone numbers.”

Once Dr. Kaskel reaches a loved one by phone, he introduces himself as a member of the QUILT team. “I tell them I’m not calling to update the medical status but just to talk to them about their loved one,” he said. “Then I usually ask, ‘So, how are you doing with this? The stress is enormous, the uncertainties.’ Then they open up and express their fears. I’ve had a lot of people say, ‘we have no money, and I don’t know how we’re going to pay rent for the apartment. We have to line up for food.’ I also ask what they do to alleviate stress. One guy said, ‘I drink a lot, but I’m careful.’ ”

Dr. Kaskel, who is also a past president of the American Society of Pediatric Nephrology, applies that same personable approach in daily conversations with adult patients hospitalized at CHAM with COVID-19, the majority of whom are African Americans in their 30s, 40s, and 50s. “Invariably, they ask, ‘Has my loved one been updated as to my status?’ ” he said. “The second thing they often say is, ‘I’m worried about infecting other people, but I also worry if I’m going to get through this. I’m really afraid I’m going to die.’ I say, ‘You have a wonderful team keeping track of you. They’re seeing you all the time and making changes to your medicines.’ ”

When patients express their fear of dying from the virus, Dr. Kaskel asks them how they’re coping with that fear. Most tell him that they pray.

“If they don’t answer, I ask if they have any hobbies, like ‘Are you watching TV? Are you reading? Do you have your cell phone?’ ” he said. “Then they open up and say things like, ‘I’m listening to music on the cell phone,’ or ‘I’m FaceTiming with my loved ones.’ The use of FaceTime is crucial, because they are in a hospital, critically ill, potentially dying alone with strangers. This really hit me on the first day [of this work]. They have no loved ones with them. They have strangers: the CHAM nurses, the medical residents, the social workers, and the doctors.”
 

 

 

No hospital cheeseburgers

QUILT began its work on April 6, and at one time provided palliative care services for a peak of 92 mostly adult patients with COVID-19. The supportive callers made 249 individual connections with patients and family members by phone from April 6-13, 162 connections from April 13-19, and 130 connections from April 20-26, according to Dr. Norris. As of April 28, the CHAM inpatient census of patients aged 18 years and over with COVID-19 was 42, “and we’re making 130 connections by phone to patients and family members each day,” she said.

QUILT bereavement callers are following 30 families, providing 3 weeks of acute grief counseling from the date of death. “A sad truth is that, here in New York, our entire funeral, burial, cremation system is overwhelmed in volume,” Dr. Norris said. “Only half of the patients we’re following 3 weeks out have been able to have their family member buried or cremated; many are still waiting. What strikes me here is that pediatricians are often partners in care. With time, we’re partners in care in heartbreak, and in the occasional victory. We mourn patients who have died. We’ve had colleagues who died from COVID-19 right here at our hospital. But we stand together like a family.”

Courtesy Dr. Sarah E. Norris
Dr. Sarah E. Norris

Dr. Norris recalled an older woman who came into CHAM’s ICU on a ventilator, critically ill from COVID-19. She called her husband at home every day with updates. “I got to know her husband, and I got to know her through him,” Dr. Norris said. “We talked every single day and she was able to graduate off of the breathing tube and out of the ICU, which was amazing.” The woman was moved to a floor in the adult hospital, but Dr. Norris continues to visit her and to provide her husband with updates, “because I’m devoted to them,” she said.

Recently, physicians in the adult hospital consulted with Dr. Norris about the woman. “They were trying to figure out what to do with her next,” she said. “Could she go home, or did she need rehab? They said, ‘We called you, Dr. Norris, because her husband thinks he can take her home.’ We know that COVID-19 really weakens people, so I went over to see her myself. I thought, ‘No single person could take care of an adult so weak at home.’ So, I called her husband and said, ‘I’m here with your wife, and I have to tell you; if she were my mother, I couldn’t take her home today. I need you to trust me.’ He said, ‘OK. We trust you and know that you have her best interest at heart.’ ”

Dr. Kaskel relayed the story of an older patient who was slowly recovering from COVID-19. During a phone call, he asked the man if there was anything he wanted at that moment.

“He said, ‘I’d love to see my wife and my children and my grandkids. I know I’m going to see them again, but right now, doc, if you could get me a cheeseburger with lettuce and tomato and ketchup and French fries from outside of the hospital, I’d be the happiest man in the world.’

I said, ‘What’s the matter with the cheeseburger made at the hospital?’

He said, ‘No! They can’t make the cheeseburger I want.’

I promised him I’d relay that message to the social worker responsible for the patient. I told her please, if you buy this for him, I’ll pay you back.”
 

Self-care and the next chapter

Twice each week, QUILT members gather in front of their computer monitors for mandatory Zoom meetings facilitated by two psychologists to share challenges, best practices, and to discuss the difficult work they’re doing. “We meet, because you cannot help someone if you cannot help yourself,” Dr. Norris said. “We have been encouraged each and every meeting to practice self-compassion, and to recognize that things happen during a pandemic – some will be the best you can do.”

She described organizing and serving on QUILT as a grounding experience with important lessons for the delivery of health care after the pandemic subsides and the team members return to their respective practices. “I think we’ve all gained a greater sense of humility, and we understand that the badge I wear every day does not protect me from becoming a patient, or from having my own family fall ill,” she said. “Here, we think about it very simply: ‘I’m going to treat you like you’re part of my own family.’ ”

Dr. Kaskel said that serving on QUILT as a supportive caller is an experience he won’t soon forget.

“The human bond is so accessible if you accept it,” he said. “If someone is an introvert that might not be able to draw out a stranger on the phone, then [he or she] shouldn’t do this [work]. But the fact that you can make a bond with someone that you’re not even seeing in person and know that both sides of this phone call are getting good vibes, that’s a remarkable feeling that I never really knew before, because I’ve never really had to do that before. It brings up feelings like I had after 9/11 – a unified approach to surviving this as people, as a community, the idea that ‘we will get through this,’ even though it’s totally different than anything before. The idea that there’s still hope. Those are things you can’t put a price on.”

An article about how CHAM transformed to provide care to adult COVID-19 patients was published online May 4, 2020, in the Journal of Pediatrics: doi: 10.1016/j.jpeds.2020.04.060.

In late March of 2020, when it became clear that hospitals in the greater New York City area would face a capacity crisis in caring for seriously ill patients with COVID-19, members of the leadership team at the Children’s Hospital at Montefiore (CHAM) in the Bronx, N.Y., convened to draft a response plan.

Courtesy Montefiore Health System
The Children's Hospital at Montefiore.

The recommendations put into action that day included moving the hospital’s emergency department from the lower level to the fourth floor, increasing the age limit for patients seen in the ED from 21 years of age to 30 and freeing up an entire hospital floor and a half to accommodate the anticipated surge of patients with COVID-19 admitted to Montefiore’s interconnected adult hospital, according to Sarah E. Norris, MD.

“We made multiple moves all at once,” said Dr. Norris, director of pediatric palliative care at CHAM. “It struck everyone as logical that palliative care had to be expanded, because all of the news we had received as the surge came to New York from around the world was full of death and uncertainty, and would require thoughtful conversations about end-of-life wishes at critical times and how to really respect the person and understand their values.”

Dr. Sarah E. Norris

When Dr. Norris left the leadership team meeting, she returned to her office, put her face in her hands, and sobbed as she began to process the gravity of what was ahead. “I cried because I knew that so many families were going to suffer a heartbreak, no matter how much we could do,” she said.
 

Stitching the QUILT

Over the next few days, Dr. Norris began recruiting colleagues from the large Montefiore Health System – most of whom she did not know – who met criteria for work deployment to expand CHAM’s palliative care program of clinician to 27 clinicians consisting of pediatricians, nurse practitioners, and psychologists, to meet the projected needs of COVID-19 patients and their families.

Some candidates for the effort, known as the Quality in Life Team (QUILT), were 65 years of age or older, considered at high risk for developing COVID-19-related complications themselves. Others were immunocompromised or had medical conditions that would not allow them to have direct contact with COVID-19 patients. “There were also clinicians in other parts of our health system whose practice hours were going to be severely reduced,” said Dr. Norris, who is board-certified in general pediatrics and in hospice and palliative care medicine.

Once she assembled QUILT, members participated in a 1-day rapid training webinar covering the basics of palliative care and grief, and readied themselves for one of three roles: physicians to provide face-to-face palliative care in CHAM; supportive callers to provide support to patients with COVID-19 and their families between 12:00-8:00 p.m. each day; and bereavement callers to reach out to families who lost loved ones to COVID-19 and provide grief counseling for 3 weeks.

“This allows families to have at least two contacts a day from the hospital: one from the medical team that’s giving them technical, medical information, and another from members of the QUILT team,” Dr. Norris said. “We provide support for the worry, anxiety, and fear that we know creeps in when you’re separated from your family member, especially during a pandemic when you watch TV and there’s a death count rising.”

During her early meetings with QUILT members via Zoom or on the phone, Dr. Norris encouraged them to stretch their skill sets and mindsets as they shifted from caring for children and adolescents to mostly adults. “Pediatricians are all about family; that’s why we get into this,” she said. “We’re used to treating your kids, but then, suddenly, the parent becomes our patient, like in COVID-19, or the grandparent becomes our patient. We treat you all the same; you’re part of our family. There has been no adult who has died ‘within our house’ that has died alone. There has either been a staff member at their bedside, or when possible, a family member. We are witnessing life until the last breath here.”
 

 

 

‘They have no loved ones with them’

One day, members of CHAM’s medical team contacted Dr. Norris about a patient with COVID-19 who’d been cared for by Montefiore clinicians all of his young life. The boy’s mother, who did not speak English, was at his bedside in the ICU, and the clinicians asked Dr. Norris to speak with her by cell phone while they prepared him for intubation.

“We were looking at each other through a glass window wall in our ICU,” Dr. Norris recalled. “I talked to her the entire time the team worked to put him on the breathing machine, through an interpreter. I asked her to tell me about her son and about her family, and she did. We developed a warm relationship. After that, every day I would see her son through the glass window wall. Every couple of days, I would have the privilege of talking to his mother by phone. At one point, she asked me, ‘Dr. Norris, do you think his lungs will heal?’ I had to tell her no. Almost selfishly, I was relieved we were on the phone, because she cried, and so did I. When he died, she was able to be by his side.”

Frederick J. Kaskel, MD, PhD, joined QUILT as a supportive caller after being asked to go home during his on-call shift on St. Patrick’s Day at CHAM, where he serves as chief emeritus of nephrology. “I was told that I was deemed to be at high risk because of my age,” the 75-year-old said. “The next day, a junior person took over for me, and 2 days later she got sick with COVID-19. She’s fine but she was home for 3 weeks sick as a dog. It was scary.”

Dr. Frederick J. Kaskel

In his role as a supportive caller, Dr. Kaskel found himself engaged in his share of detective work, trying to find phone numbers of next of kin for patients hospitalized with COVID-19. “When they come into the ER, they may not have been with a loved one or a family member; they may have been brought in by an EMT,” he said. “Some of them speak little English and others have little documentation with them. It takes a lot of work to get phone numbers.”

Once Dr. Kaskel reaches a loved one by phone, he introduces himself as a member of the QUILT team. “I tell them I’m not calling to update the medical status but just to talk to them about their loved one,” he said. “Then I usually ask, ‘So, how are you doing with this? The stress is enormous, the uncertainties.’ Then they open up and express their fears. I’ve had a lot of people say, ‘we have no money, and I don’t know how we’re going to pay rent for the apartment. We have to line up for food.’ I also ask what they do to alleviate stress. One guy said, ‘I drink a lot, but I’m careful.’ ”

Dr. Kaskel, who is also a past president of the American Society of Pediatric Nephrology, applies that same personable approach in daily conversations with adult patients hospitalized at CHAM with COVID-19, the majority of whom are African Americans in their 30s, 40s, and 50s. “Invariably, they ask, ‘Has my loved one been updated as to my status?’ ” he said. “The second thing they often say is, ‘I’m worried about infecting other people, but I also worry if I’m going to get through this. I’m really afraid I’m going to die.’ I say, ‘You have a wonderful team keeping track of you. They’re seeing you all the time and making changes to your medicines.’ ”

When patients express their fear of dying from the virus, Dr. Kaskel asks them how they’re coping with that fear. Most tell him that they pray.

“If they don’t answer, I ask if they have any hobbies, like ‘Are you watching TV? Are you reading? Do you have your cell phone?’ ” he said. “Then they open up and say things like, ‘I’m listening to music on the cell phone,’ or ‘I’m FaceTiming with my loved ones.’ The use of FaceTime is crucial, because they are in a hospital, critically ill, potentially dying alone with strangers. This really hit me on the first day [of this work]. They have no loved ones with them. They have strangers: the CHAM nurses, the medical residents, the social workers, and the doctors.”
 

 

 

No hospital cheeseburgers

QUILT began its work on April 6, and at one time provided palliative care services for a peak of 92 mostly adult patients with COVID-19. The supportive callers made 249 individual connections with patients and family members by phone from April 6-13, 162 connections from April 13-19, and 130 connections from April 20-26, according to Dr. Norris. As of April 28, the CHAM inpatient census of patients aged 18 years and over with COVID-19 was 42, “and we’re making 130 connections by phone to patients and family members each day,” she said.

QUILT bereavement callers are following 30 families, providing 3 weeks of acute grief counseling from the date of death. “A sad truth is that, here in New York, our entire funeral, burial, cremation system is overwhelmed in volume,” Dr. Norris said. “Only half of the patients we’re following 3 weeks out have been able to have their family member buried or cremated; many are still waiting. What strikes me here is that pediatricians are often partners in care. With time, we’re partners in care in heartbreak, and in the occasional victory. We mourn patients who have died. We’ve had colleagues who died from COVID-19 right here at our hospital. But we stand together like a family.”

Courtesy Dr. Sarah E. Norris
Dr. Sarah E. Norris

Dr. Norris recalled an older woman who came into CHAM’s ICU on a ventilator, critically ill from COVID-19. She called her husband at home every day with updates. “I got to know her husband, and I got to know her through him,” Dr. Norris said. “We talked every single day and she was able to graduate off of the breathing tube and out of the ICU, which was amazing.” The woman was moved to a floor in the adult hospital, but Dr. Norris continues to visit her and to provide her husband with updates, “because I’m devoted to them,” she said.

Recently, physicians in the adult hospital consulted with Dr. Norris about the woman. “They were trying to figure out what to do with her next,” she said. “Could she go home, or did she need rehab? They said, ‘We called you, Dr. Norris, because her husband thinks he can take her home.’ We know that COVID-19 really weakens people, so I went over to see her myself. I thought, ‘No single person could take care of an adult so weak at home.’ So, I called her husband and said, ‘I’m here with your wife, and I have to tell you; if she were my mother, I couldn’t take her home today. I need you to trust me.’ He said, ‘OK. We trust you and know that you have her best interest at heart.’ ”

Dr. Kaskel relayed the story of an older patient who was slowly recovering from COVID-19. During a phone call, he asked the man if there was anything he wanted at that moment.

“He said, ‘I’d love to see my wife and my children and my grandkids. I know I’m going to see them again, but right now, doc, if you could get me a cheeseburger with lettuce and tomato and ketchup and French fries from outside of the hospital, I’d be the happiest man in the world.’

I said, ‘What’s the matter with the cheeseburger made at the hospital?’

He said, ‘No! They can’t make the cheeseburger I want.’

I promised him I’d relay that message to the social worker responsible for the patient. I told her please, if you buy this for him, I’ll pay you back.”
 

Self-care and the next chapter

Twice each week, QUILT members gather in front of their computer monitors for mandatory Zoom meetings facilitated by two psychologists to share challenges, best practices, and to discuss the difficult work they’re doing. “We meet, because you cannot help someone if you cannot help yourself,” Dr. Norris said. “We have been encouraged each and every meeting to practice self-compassion, and to recognize that things happen during a pandemic – some will be the best you can do.”

She described organizing and serving on QUILT as a grounding experience with important lessons for the delivery of health care after the pandemic subsides and the team members return to their respective practices. “I think we’ve all gained a greater sense of humility, and we understand that the badge I wear every day does not protect me from becoming a patient, or from having my own family fall ill,” she said. “Here, we think about it very simply: ‘I’m going to treat you like you’re part of my own family.’ ”

Dr. Kaskel said that serving on QUILT as a supportive caller is an experience he won’t soon forget.

“The human bond is so accessible if you accept it,” he said. “If someone is an introvert that might not be able to draw out a stranger on the phone, then [he or she] shouldn’t do this [work]. But the fact that you can make a bond with someone that you’re not even seeing in person and know that both sides of this phone call are getting good vibes, that’s a remarkable feeling that I never really knew before, because I’ve never really had to do that before. It brings up feelings like I had after 9/11 – a unified approach to surviving this as people, as a community, the idea that ‘we will get through this,’ even though it’s totally different than anything before. The idea that there’s still hope. Those are things you can’t put a price on.”

An article about how CHAM transformed to provide care to adult COVID-19 patients was published online May 4, 2020, in the Journal of Pediatrics: doi: 10.1016/j.jpeds.2020.04.060.

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L-thyroxine no help for older patients with symptomatic SCH

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A new analysis of the large, randomized TRUST trial shows that L-thyroxine does not improve pronounced symptoms in older people with subclinical hypothyroidism.

The original trial established that the synthetic hormone did not improve symptoms in the overall trial population, a finding that called into question the routine prescribing of thyroid medication for this patient group.

But questions lingered as to whether patients with a higher burden of symptoms might still benefit from treatment with L-thyroxine.

For their research, published in Annals of Internal Medicine, Maria de Montmollin, MD, of the University of Bern (Switzerland), looked at results for 638 subjects randomized to L-thyroxine treatment (50 mcg daily for most patients) or placebo and followed for at least 1 year in the Thyroid Hormone Therapy for Older Adults With Subclinical Hypothyroidism (TRUST) trial (N Engl J Med. 2017;376:2534-2544). All were 65 years or older and met the criteria for subclinical hypothyroidism, defined as persistent elevated TSH levels (4.60-19.99 mIU/L) in combination with a normal free-thyroxine level.

Dr. de Montmollin and her colleagues identified 132 participants with high hypothyroid symptom burden at baseline and 133 patients with high scores for tiredness, using the Thyroid-Related Quality-of-Life Patient-Reported Outcome Questionnaire. Cutoffs were a baseline symptoms score of higher than 30 (on a 1-100 scale), or a tiredness score of over 40.

At 1 year, researchers saw no statistically significant improvements in either measure for the L-thyroxine treated patients, compared with placebo.

Among the patients with high symptom burden, those on L-thyroxine saw a score improvement of –12.3 points, compared with –10.4 for those on placebo, for an adjusted between-group difference of –2.0 (95% confidence interval, –5.5 to 1.5; P = 0.27). Tiredness scores also improved similarly, dropping 8.9 points for L-thyroxine–treated patients, compared with –10.9 for those receiving placebo, for an adjusted between-group difference of 0.0 (95% CI, –4.1 to 4.0; P = 0.99).

Dr. de Montmollin and colleagues also noted no significant between-group differences in two secondary measures they looked at in the study: patient self-reported quality of life and handgrip strength, an objective measure of weakness.

The results “do not support the hypothesis that the subgroup of adults with SCH [subclinical hypothyroidism] and high symptom burden before treatment benefit from L-thyroxine therapy,” the investigators wrote in their analysis. “This may be because of regression to the mean, the natural history of SCH, or the placebo effect and may explain why many persons with symptomatic SCH and their treating physicians are convinced that L-thyroxine is beneficial,” they added.

In an interview, Dr. de Montmollin commented that treating physicians “should reconsider prescribing or offering L-thyroxine to older adults with SCH, even those with consistent symptoms, because there is no clear evidence for its benefit in treating SCH to date and a risk of harm related to overtreatment is still possible. In addition, it is associated with unnecessary costs for the patient and for the health system.”

The investigators mentioned several limitations to their study, including its post hoc design and a small sample size. Additionally, they wrote, the findings “cannot exclude the possibility that a rare subgroup with greater symptom burden would benefit from L-thyroxine therapy” or that more aggressive treatment leading to lower TSH levels would confer benefit.

The study was sponsored by the National Health Service Greater Glasgow and Clyde Health Board, while the TRUST trial was sponsored by the European Union and with medication donated by Merck. Dr. de Montmollin and her coauthors disclosed no financial ties to industry.

SOURCE: De Montmollin et al. Ann Intern Med 2020 May 5. doi: 10.7326/M19-3193.

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A new analysis of the large, randomized TRUST trial shows that L-thyroxine does not improve pronounced symptoms in older people with subclinical hypothyroidism.

The original trial established that the synthetic hormone did not improve symptoms in the overall trial population, a finding that called into question the routine prescribing of thyroid medication for this patient group.

But questions lingered as to whether patients with a higher burden of symptoms might still benefit from treatment with L-thyroxine.

For their research, published in Annals of Internal Medicine, Maria de Montmollin, MD, of the University of Bern (Switzerland), looked at results for 638 subjects randomized to L-thyroxine treatment (50 mcg daily for most patients) or placebo and followed for at least 1 year in the Thyroid Hormone Therapy for Older Adults With Subclinical Hypothyroidism (TRUST) trial (N Engl J Med. 2017;376:2534-2544). All were 65 years or older and met the criteria for subclinical hypothyroidism, defined as persistent elevated TSH levels (4.60-19.99 mIU/L) in combination with a normal free-thyroxine level.

Dr. de Montmollin and her colleagues identified 132 participants with high hypothyroid symptom burden at baseline and 133 patients with high scores for tiredness, using the Thyroid-Related Quality-of-Life Patient-Reported Outcome Questionnaire. Cutoffs were a baseline symptoms score of higher than 30 (on a 1-100 scale), or a tiredness score of over 40.

At 1 year, researchers saw no statistically significant improvements in either measure for the L-thyroxine treated patients, compared with placebo.

Among the patients with high symptom burden, those on L-thyroxine saw a score improvement of –12.3 points, compared with –10.4 for those on placebo, for an adjusted between-group difference of –2.0 (95% confidence interval, –5.5 to 1.5; P = 0.27). Tiredness scores also improved similarly, dropping 8.9 points for L-thyroxine–treated patients, compared with –10.9 for those receiving placebo, for an adjusted between-group difference of 0.0 (95% CI, –4.1 to 4.0; P = 0.99).

Dr. de Montmollin and colleagues also noted no significant between-group differences in two secondary measures they looked at in the study: patient self-reported quality of life and handgrip strength, an objective measure of weakness.

The results “do not support the hypothesis that the subgroup of adults with SCH [subclinical hypothyroidism] and high symptom burden before treatment benefit from L-thyroxine therapy,” the investigators wrote in their analysis. “This may be because of regression to the mean, the natural history of SCH, or the placebo effect and may explain why many persons with symptomatic SCH and their treating physicians are convinced that L-thyroxine is beneficial,” they added.

In an interview, Dr. de Montmollin commented that treating physicians “should reconsider prescribing or offering L-thyroxine to older adults with SCH, even those with consistent symptoms, because there is no clear evidence for its benefit in treating SCH to date and a risk of harm related to overtreatment is still possible. In addition, it is associated with unnecessary costs for the patient and for the health system.”

The investigators mentioned several limitations to their study, including its post hoc design and a small sample size. Additionally, they wrote, the findings “cannot exclude the possibility that a rare subgroup with greater symptom burden would benefit from L-thyroxine therapy” or that more aggressive treatment leading to lower TSH levels would confer benefit.

The study was sponsored by the National Health Service Greater Glasgow and Clyde Health Board, while the TRUST trial was sponsored by the European Union and with medication donated by Merck. Dr. de Montmollin and her coauthors disclosed no financial ties to industry.

SOURCE: De Montmollin et al. Ann Intern Med 2020 May 5. doi: 10.7326/M19-3193.

 

A new analysis of the large, randomized TRUST trial shows that L-thyroxine does not improve pronounced symptoms in older people with subclinical hypothyroidism.

The original trial established that the synthetic hormone did not improve symptoms in the overall trial population, a finding that called into question the routine prescribing of thyroid medication for this patient group.

But questions lingered as to whether patients with a higher burden of symptoms might still benefit from treatment with L-thyroxine.

For their research, published in Annals of Internal Medicine, Maria de Montmollin, MD, of the University of Bern (Switzerland), looked at results for 638 subjects randomized to L-thyroxine treatment (50 mcg daily for most patients) or placebo and followed for at least 1 year in the Thyroid Hormone Therapy for Older Adults With Subclinical Hypothyroidism (TRUST) trial (N Engl J Med. 2017;376:2534-2544). All were 65 years or older and met the criteria for subclinical hypothyroidism, defined as persistent elevated TSH levels (4.60-19.99 mIU/L) in combination with a normal free-thyroxine level.

Dr. de Montmollin and her colleagues identified 132 participants with high hypothyroid symptom burden at baseline and 133 patients with high scores for tiredness, using the Thyroid-Related Quality-of-Life Patient-Reported Outcome Questionnaire. Cutoffs were a baseline symptoms score of higher than 30 (on a 1-100 scale), or a tiredness score of over 40.

At 1 year, researchers saw no statistically significant improvements in either measure for the L-thyroxine treated patients, compared with placebo.

Among the patients with high symptom burden, those on L-thyroxine saw a score improvement of –12.3 points, compared with –10.4 for those on placebo, for an adjusted between-group difference of –2.0 (95% confidence interval, –5.5 to 1.5; P = 0.27). Tiredness scores also improved similarly, dropping 8.9 points for L-thyroxine–treated patients, compared with –10.9 for those receiving placebo, for an adjusted between-group difference of 0.0 (95% CI, –4.1 to 4.0; P = 0.99).

Dr. de Montmollin and colleagues also noted no significant between-group differences in two secondary measures they looked at in the study: patient self-reported quality of life and handgrip strength, an objective measure of weakness.

The results “do not support the hypothesis that the subgroup of adults with SCH [subclinical hypothyroidism] and high symptom burden before treatment benefit from L-thyroxine therapy,” the investigators wrote in their analysis. “This may be because of regression to the mean, the natural history of SCH, or the placebo effect and may explain why many persons with symptomatic SCH and their treating physicians are convinced that L-thyroxine is beneficial,” they added.

In an interview, Dr. de Montmollin commented that treating physicians “should reconsider prescribing or offering L-thyroxine to older adults with SCH, even those with consistent symptoms, because there is no clear evidence for its benefit in treating SCH to date and a risk of harm related to overtreatment is still possible. In addition, it is associated with unnecessary costs for the patient and for the health system.”

The investigators mentioned several limitations to their study, including its post hoc design and a small sample size. Additionally, they wrote, the findings “cannot exclude the possibility that a rare subgroup with greater symptom burden would benefit from L-thyroxine therapy” or that more aggressive treatment leading to lower TSH levels would confer benefit.

The study was sponsored by the National Health Service Greater Glasgow and Clyde Health Board, while the TRUST trial was sponsored by the European Union and with medication donated by Merck. Dr. de Montmollin and her coauthors disclosed no financial ties to industry.

SOURCE: De Montmollin et al. Ann Intern Med 2020 May 5. doi: 10.7326/M19-3193.

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