The Hospitalist

Background: Critically ill patients are often vitamin D deficient, but no large randomized trials have investigated whether early vitamin D supplementation can affect clinical outcomes.

Study design: Multicenter, randomized, double-blind, placebo-controlled phase 3 trial.Setting: 44 U.S. hospitals, during April 2017–July 2018.

Synopsis: The study enrolled 1,078 patients with 25-hydroxyvitamin D levels < 20 ng/mL who were critically ill (defined as patients being admitted to the ICU with one or more risk factor for lung injury or death). Participants were randomized to early administration of a single dose of 540,000 IUs of enteral vitamin D₃ or placebo. The authors did not identify a statistically significant difference in the 90-day all-cause mortality between the two groups. Additionally, there were no significant differences in length of stay, ventilator-free days or serious adverse outcomes between the two groups.

Bottom line: Early administration of high-dose enteral vitamin D₃ did not decrease 90-day all-cause mortality in critically ill, vitamin D–deficient patients.

Citation: Ginde A et al. Early high-dose vitamin D₃ for critically ill, vitamin D–deficient patients. N Engl J Med. 2019 Dec 26; 281:2529-40.

Dr. Persaud is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, both in Boston.

Background: Critically ill patients are often vitamin D deficient, but no large randomized trials have investigated whether early vitamin D supplementation can affect clinical outcomes.

Study design: Multicenter, randomized, double-blind, placebo-controlled phase 3 trial.Setting: 44 U.S. hospitals, during April 2017–July 2018.

Synopsis: The study enrolled 1,078 patients with 25-hydroxyvitamin D levels < 20 ng/mL who were critically ill (defined as patients being admitted to the ICU with one or more risk factor for lung injury or death). Participants were randomized to early administration of a single dose of 540,000 IUs of enteral vitamin D₃ or placebo. The authors did not identify a statistically significant difference in the 90-day all-cause mortality between the two groups. Additionally, there were no significant differences in length of stay, ventilator-free days or serious adverse outcomes between the two groups.

Bottom line: Early administration of high-dose enteral vitamin D₃ did not decrease 90-day all-cause mortality in critically ill, vitamin D–deficient patients.

Citation: Ginde A et al. Early high-dose vitamin D₃ for critically ill, vitamin D–deficient patients. N Engl J Med. 2019 Dec 26; 281:2529-40.

Dr. Persaud is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, both in Boston.

Background: Critically ill patients are often vitamin D deficient, but no large randomized trials have investigated whether early vitamin D supplementation can affect clinical outcomes.

Study design: Multicenter, randomized, double-blind, placebo-controlled phase 3 trial.Setting: 44 U.S. hospitals, during April 2017–July 2018.

Synopsis: The study enrolled 1,078 patients with 25-hydroxyvitamin D levels < 20 ng/mL who were critically ill (defined as patients being admitted to the ICU with one or more risk factor for lung injury or death). Participants were randomized to early administration of a single dose of 540,000 IUs of enteral vitamin D₃ or placebo. The authors did not identify a statistically significant difference in the 90-day all-cause mortality between the two groups. Additionally, there were no significant differences in length of stay, ventilator-free days or serious adverse outcomes between the two groups.

Bottom line: Early administration of high-dose enteral vitamin D₃ did not decrease 90-day all-cause mortality in critically ill, vitamin D–deficient patients.

Citation: Ginde A et al. Early high-dose vitamin D₃ for critically ill, vitamin D–deficient patients. N Engl J Med. 2019 Dec 26; 281:2529-40.

Dr. Persaud is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, both in Boston.

Inhibiting granulocyte/macrophage–colony stimulating factor (GM-CSF) with mavrilimumab prevented some patients with severe COVID-19 pneumonia and hyperinflammation from needing mechanical ventilation and reduced their risk of dying versus placebo in a phase 2 study.

There was no difference in outcomes between the two doses of mavrilimumab used in the trial (6 mg/kg or 10 mg/kg) and combined data showed a higher percentage of patients achieving the primary endpoint of being alive and free of mechanical ventilation at 29 days, at 87%, versus placebo, at 74%.

The P value was 0.12, “which achieved the prespecified evidentiary standard of 0.2,” according to Lara Pupim, MD, vice president of clinical research and development at Kiniksa Pharmaceuticals in Lexington, Mass.

Importantly, there was a 61% reduction in the risk of dying if patients had received mavrilimumab rather than placebo, she reported at the annual European Congress of Rheumatology. Mortality at day 29 was 21% in the placebo arm but just 8% in the combined mavrilimumab arms (P = .07).

Hendrik Schulze-Koops, MD, called it a “surprising study” and that “the outcome is very spectacular” in his short appraisal of the study during the Clinical Highlights session on the final day of the congress.

Mavrilimumab was “a compound that we would not have thought that would have such an impact on the outcome of COVID-19 infected patients,” Dr. Schulze-Koops of Ludwig Maximilian University of Munich added.

In this small study, “there was a consistent suggestion of a biological effect across key endpoints,” Richard Conway, MBChB, PhD, a consultant rheumatologist at St. James’s Hospital in Dublin, pointed out in an interview.

“Similar to tocilizumab, the benefits with mavrilimumab appear to be in addition to those seen with glucocorticoids, as 96% of patients received dexamethasone,” Dr. Conway observed. Furthermore, nearly one-third received antiviral or remdesivir treatment.

“This study was likely underpowered to assess a clinically meaningful benefit,” he said, adding that “there is insufficient evidence at present to begin using mavrilimumab as an alternative to currently available agents.” That said, “these results are promising for future studies.”

Rationale for GM-CSF inhibition with mavrilimumab in COVID-19 pneumonia

“The cytokine GM-CSF is vital to both lung homeostasis and regulation of inflammation in autoimmunity,” Dr. Pupim explained.

She added that “GM-CSF is implicated in the mechanism of aberrant immune cell infiltration and activation in the lungs, and it may contribute to respiratory failure and death in patients with severe COVID-19 pneumonia and systemic hyperinflammation.”

The efficacy and safety of blocking GM-CSF with mavrilimumab have been shown previously in phase 2 studies in other diseases, Dr. Pupim noted. This includes patients with rheumatoid arthritis and those with giant cell arteritis.

“It was hypothesized that GM-CSF receptor–alpha blockade may reduce infiltration of pathogenic cells into the lung and may suppress inflammation in COVID-19 pneumonia in hyperinflammation,” she explained.

Study details and other outcome results

The study presented by Dr. Pupim was a phase 2/3 double-blind, placebo-controlled trial predominantly conducted in Brazil, the United States, and South Africa, with some participation in Peru and Chile.

Patients were eligible for inclusion if they had had a positive COVID-19 test within 14 days of randomization and had been hospitalized but not ventilated. Evidence of bilateral pneumonia on chest x-ray or CT scan and clinical laboratory evidence indicative of hyperinflammation were also prerequisites for study enrollment.

The ongoing study comprised two cohorts, Dr. Pupim explained: patients who have not been ventilated and those who have recently been ventilated. Dr. Pupim presented the data on the nonventilated cohort, noting that there was a total of 116 patients aged a mean of 57 years.

Patients were randomized to one of three treatment arms: two groups received a single intravenous infusion of mavrilimumab, either 6 mg/kg or 10 mg/kg, and the third group got a placebo.

“Using a time-to-event approach, looking at mechanical ventilation-free survival, mavrilimumab recipients experienced a 65% reduction in the risk of mechanical ventilation or death,” Dr. Pupim said (P = .0175).

“Separation in the Kaplan-Meier curves was evident very early after study drug administration,” she added.

There were trends toward a faster benefit with mavrilimumab than placebo in two other key secondary endpoints: the median time to achieving a two-point clinical improvement (7 vs. 11 days) and the median time to room air (7 vs. 9 days).

Timing of mavrilimumab administration and safety

Study coauthor and chief clinical development officer at Kiniksa, Arian Pano, MD, answered questions on the presentation. When asked about the timing of giving mavrilimumab, he said: “Based on these data it is before they go to ventilation, as soon as you have symptoms of hyperinflammation and a need for oxygen.”

Mavrilimumab is given as a single infusion “and has been well tolerated; virtually no interruptions occurred in this study.”

No serious adverse events related to mavrilimumab were seen, and adverse events, including secondary infections, which are known complications of COVID-19, occurred less frequently in mavrilimumab recipients, compared with placebo.

Dr. Pupim reported that there was a case of tuberculosis in one patient treated with mavrilimumab (10 mg/kg). That case had occurred in an “endemic area for tuberculosis,” and the patient had been screened before entry but only via a sputum sample.

“Prior to these events, the patient received high-dose corticosteroids, a known risk factor for reactivation of TB, and thus the potential additive contribution of mavrilimumab, if any, is uncertain.” Dr. Pupim said.

“Thrombotic events, another known complication of COVID-19, occurred in the placebo arm only,” she added.

Dr. Pano commented that the study has now “seamlessly continued to phase 3. So, basically, we did not stop the study. At the end of phase 2, we just locked the database and collected the data.” Both the 6 mg/kg and 10 mg/kg are being studied, but it’s “very likely [that] 6 mg/kg could be the dose that we may bring forward to the clinic in terms of registration, but that’s at this point in time. We will need to wait for the phase 3 data,” he observed. Those findings will hopefully be available later this year.

Kiniksa funded the study. Dr. Pupim, Dr. Pano, and multiple study coinvestigators are employees of the company.

Dr. Schulze-Koops was not involved in the study and had no specific disclosures. Dr. Conway had no financial disclosures to make in relation to his comments.

Inhibiting granulocyte/macrophage–colony stimulating factor (GM-CSF) with mavrilimumab prevented some patients with severe COVID-19 pneumonia and hyperinflammation from needing mechanical ventilation and reduced their risk of dying versus placebo in a phase 2 study.

There was no difference in outcomes between the two doses of mavrilimumab used in the trial (6 mg/kg or 10 mg/kg) and combined data showed a higher percentage of patients achieving the primary endpoint of being alive and free of mechanical ventilation at 29 days, at 87%, versus placebo, at 74%.

The P value was 0.12, “which achieved the prespecified evidentiary standard of 0.2,” according to Lara Pupim, MD, vice president of clinical research and development at Kiniksa Pharmaceuticals in Lexington, Mass.

Importantly, there was a 61% reduction in the risk of dying if patients had received mavrilimumab rather than placebo, she reported at the annual European Congress of Rheumatology. Mortality at day 29 was 21% in the placebo arm but just 8% in the combined mavrilimumab arms (P = .07).

Hendrik Schulze-Koops, MD, called it a “surprising study” and that “the outcome is very spectacular” in his short appraisal of the study during the Clinical Highlights session on the final day of the congress.

Mavrilimumab was “a compound that we would not have thought that would have such an impact on the outcome of COVID-19 infected patients,” Dr. Schulze-Koops of Ludwig Maximilian University of Munich added.

In this small study, “there was a consistent suggestion of a biological effect across key endpoints,” Richard Conway, MBChB, PhD, a consultant rheumatologist at St. James’s Hospital in Dublin, pointed out in an interview.

“Similar to tocilizumab, the benefits with mavrilimumab appear to be in addition to those seen with glucocorticoids, as 96% of patients received dexamethasone,” Dr. Conway observed. Furthermore, nearly one-third received antiviral or remdesivir treatment.

“This study was likely underpowered to assess a clinically meaningful benefit,” he said, adding that “there is insufficient evidence at present to begin using mavrilimumab as an alternative to currently available agents.” That said, “these results are promising for future studies.”

Rationale for GM-CSF inhibition with mavrilimumab in COVID-19 pneumonia

“The cytokine GM-CSF is vital to both lung homeostasis and regulation of inflammation in autoimmunity,” Dr. Pupim explained.

She added that “GM-CSF is implicated in the mechanism of aberrant immune cell infiltration and activation in the lungs, and it may contribute to respiratory failure and death in patients with severe COVID-19 pneumonia and systemic hyperinflammation.”

The efficacy and safety of blocking GM-CSF with mavrilimumab have been shown previously in phase 2 studies in other diseases, Dr. Pupim noted. This includes patients with rheumatoid arthritis and those with giant cell arteritis.

“It was hypothesized that GM-CSF receptor–alpha blockade may reduce infiltration of pathogenic cells into the lung and may suppress inflammation in COVID-19 pneumonia in hyperinflammation,” she explained.

Study details and other outcome results

The study presented by Dr. Pupim was a phase 2/3 double-blind, placebo-controlled trial predominantly conducted in Brazil, the United States, and South Africa, with some participation in Peru and Chile.

Patients were eligible for inclusion if they had had a positive COVID-19 test within 14 days of randomization and had been hospitalized but not ventilated. Evidence of bilateral pneumonia on chest x-ray or CT scan and clinical laboratory evidence indicative of hyperinflammation were also prerequisites for study enrollment.

The ongoing study comprised two cohorts, Dr. Pupim explained: patients who have not been ventilated and those who have recently been ventilated. Dr. Pupim presented the data on the nonventilated cohort, noting that there was a total of 116 patients aged a mean of 57 years.

Patients were randomized to one of three treatment arms: two groups received a single intravenous infusion of mavrilimumab, either 6 mg/kg or 10 mg/kg, and the third group got a placebo.

“Using a time-to-event approach, looking at mechanical ventilation-free survival, mavrilimumab recipients experienced a 65% reduction in the risk of mechanical ventilation or death,” Dr. Pupim said (P = .0175).

“Separation in the Kaplan-Meier curves was evident very early after study drug administration,” she added.

There were trends toward a faster benefit with mavrilimumab than placebo in two other key secondary endpoints: the median time to achieving a two-point clinical improvement (7 vs. 11 days) and the median time to room air (7 vs. 9 days).

Timing of mavrilimumab administration and safety

Study coauthor and chief clinical development officer at Kiniksa, Arian Pano, MD, answered questions on the presentation. When asked about the timing of giving mavrilimumab, he said: “Based on these data it is before they go to ventilation, as soon as you have symptoms of hyperinflammation and a need for oxygen.”

Mavrilimumab is given as a single infusion “and has been well tolerated; virtually no interruptions occurred in this study.”

No serious adverse events related to mavrilimumab were seen, and adverse events, including secondary infections, which are known complications of COVID-19, occurred less frequently in mavrilimumab recipients, compared with placebo.

Dr. Pupim reported that there was a case of tuberculosis in one patient treated with mavrilimumab (10 mg/kg). That case had occurred in an “endemic area for tuberculosis,” and the patient had been screened before entry but only via a sputum sample.

“Prior to these events, the patient received high-dose corticosteroids, a known risk factor for reactivation of TB, and thus the potential additive contribution of mavrilimumab, if any, is uncertain.” Dr. Pupim said.

“Thrombotic events, another known complication of COVID-19, occurred in the placebo arm only,” she added.

Dr. Pano commented that the study has now “seamlessly continued to phase 3. So, basically, we did not stop the study. At the end of phase 2, we just locked the database and collected the data.” Both the 6 mg/kg and 10 mg/kg are being studied, but it’s “very likely [that] 6 mg/kg could be the dose that we may bring forward to the clinic in terms of registration, but that’s at this point in time. We will need to wait for the phase 3 data,” he observed. Those findings will hopefully be available later this year.

Kiniksa funded the study. Dr. Pupim, Dr. Pano, and multiple study coinvestigators are employees of the company.

Dr. Schulze-Koops was not involved in the study and had no specific disclosures. Dr. Conway had no financial disclosures to make in relation to his comments.

Inhibiting granulocyte/macrophage–colony stimulating factor (GM-CSF) with mavrilimumab prevented some patients with severe COVID-19 pneumonia and hyperinflammation from needing mechanical ventilation and reduced their risk of dying versus placebo in a phase 2 study.

There was no difference in outcomes between the two doses of mavrilimumab used in the trial (6 mg/kg or 10 mg/kg) and combined data showed a higher percentage of patients achieving the primary endpoint of being alive and free of mechanical ventilation at 29 days, at 87%, versus placebo, at 74%.

The P value was 0.12, “which achieved the prespecified evidentiary standard of 0.2,” according to Lara Pupim, MD, vice president of clinical research and development at Kiniksa Pharmaceuticals in Lexington, Mass.

Importantly, there was a 61% reduction in the risk of dying if patients had received mavrilimumab rather than placebo, she reported at the annual European Congress of Rheumatology. Mortality at day 29 was 21% in the placebo arm but just 8% in the combined mavrilimumab arms (P = .07).

Hendrik Schulze-Koops, MD, called it a “surprising study” and that “the outcome is very spectacular” in his short appraisal of the study during the Clinical Highlights session on the final day of the congress.

Mavrilimumab was “a compound that we would not have thought that would have such an impact on the outcome of COVID-19 infected patients,” Dr. Schulze-Koops of Ludwig Maximilian University of Munich added.

In this small study, “there was a consistent suggestion of a biological effect across key endpoints,” Richard Conway, MBChB, PhD, a consultant rheumatologist at St. James’s Hospital in Dublin, pointed out in an interview.

“Similar to tocilizumab, the benefits with mavrilimumab appear to be in addition to those seen with glucocorticoids, as 96% of patients received dexamethasone,” Dr. Conway observed. Furthermore, nearly one-third received antiviral or remdesivir treatment.

“This study was likely underpowered to assess a clinically meaningful benefit,” he said, adding that “there is insufficient evidence at present to begin using mavrilimumab as an alternative to currently available agents.” That said, “these results are promising for future studies.”

Rationale for GM-CSF inhibition with mavrilimumab in COVID-19 pneumonia

“The cytokine GM-CSF is vital to both lung homeostasis and regulation of inflammation in autoimmunity,” Dr. Pupim explained.

She added that “GM-CSF is implicated in the mechanism of aberrant immune cell infiltration and activation in the lungs, and it may contribute to respiratory failure and death in patients with severe COVID-19 pneumonia and systemic hyperinflammation.”

The efficacy and safety of blocking GM-CSF with mavrilimumab have been shown previously in phase 2 studies in other diseases, Dr. Pupim noted. This includes patients with rheumatoid arthritis and those with giant cell arteritis.

“It was hypothesized that GM-CSF receptor–alpha blockade may reduce infiltration of pathogenic cells into the lung and may suppress inflammation in COVID-19 pneumonia in hyperinflammation,” she explained.

Study details and other outcome results

The study presented by Dr. Pupim was a phase 2/3 double-blind, placebo-controlled trial predominantly conducted in Brazil, the United States, and South Africa, with some participation in Peru and Chile.

Patients were eligible for inclusion if they had had a positive COVID-19 test within 14 days of randomization and had been hospitalized but not ventilated. Evidence of bilateral pneumonia on chest x-ray or CT scan and clinical laboratory evidence indicative of hyperinflammation were also prerequisites for study enrollment.

The ongoing study comprised two cohorts, Dr. Pupim explained: patients who have not been ventilated and those who have recently been ventilated. Dr. Pupim presented the data on the nonventilated cohort, noting that there was a total of 116 patients aged a mean of 57 years.

Patients were randomized to one of three treatment arms: two groups received a single intravenous infusion of mavrilimumab, either 6 mg/kg or 10 mg/kg, and the third group got a placebo.

“Using a time-to-event approach, looking at mechanical ventilation-free survival, mavrilimumab recipients experienced a 65% reduction in the risk of mechanical ventilation or death,” Dr. Pupim said (P = .0175).

“Separation in the Kaplan-Meier curves was evident very early after study drug administration,” she added.

There were trends toward a faster benefit with mavrilimumab than placebo in two other key secondary endpoints: the median time to achieving a two-point clinical improvement (7 vs. 11 days) and the median time to room air (7 vs. 9 days).

Timing of mavrilimumab administration and safety

Study coauthor and chief clinical development officer at Kiniksa, Arian Pano, MD, answered questions on the presentation. When asked about the timing of giving mavrilimumab, he said: “Based on these data it is before they go to ventilation, as soon as you have symptoms of hyperinflammation and a need for oxygen.”

Mavrilimumab is given as a single infusion “and has been well tolerated; virtually no interruptions occurred in this study.”

No serious adverse events related to mavrilimumab were seen, and adverse events, including secondary infections, which are known complications of COVID-19, occurred less frequently in mavrilimumab recipients, compared with placebo.

Dr. Pupim reported that there was a case of tuberculosis in one patient treated with mavrilimumab (10 mg/kg). That case had occurred in an “endemic area for tuberculosis,” and the patient had been screened before entry but only via a sputum sample.

“Prior to these events, the patient received high-dose corticosteroids, a known risk factor for reactivation of TB, and thus the potential additive contribution of mavrilimumab, if any, is uncertain.” Dr. Pupim said.

“Thrombotic events, another known complication of COVID-19, occurred in the placebo arm only,” she added.

Dr. Pano commented that the study has now “seamlessly continued to phase 3. So, basically, we did not stop the study. At the end of phase 2, we just locked the database and collected the data.” Both the 6 mg/kg and 10 mg/kg are being studied, but it’s “very likely [that] 6 mg/kg could be the dose that we may bring forward to the clinic in terms of registration, but that’s at this point in time. We will need to wait for the phase 3 data,” he observed. Those findings will hopefully be available later this year.

Kiniksa funded the study. Dr. Pupim, Dr. Pano, and multiple study coinvestigators are employees of the company.

Dr. Schulze-Koops was not involved in the study and had no specific disclosures. Dr. Conway had no financial disclosures to make in relation to his comments.

Background: Providing hospital-level care at home for select patients has proven to reduce health care cost, usage, and readmission rates, while maintaining quality and safety in other developed countries but few studies exist in the United States.

Dr. Persaud is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, both in Boston.

Background: Providing hospital-level care at home for select patients has proven to reduce health care cost, usage, and readmission rates, while maintaining quality and safety in other developed countries but few studies exist in the United States.

Dr. Persaud is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, both in Boston.

Background: Providing hospital-level care at home for select patients has proven to reduce health care cost, usage, and readmission rates, while maintaining quality and safety in other developed countries but few studies exist in the United States.

Dr. Persaud is a hospitalist, Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, both in Boston.

I remember sitting at the pool in San Diego. I had been there before many years prior – one of my first medical conferences. I remember the clinking of metal sail stays in the morning breeze.

Flying out this time I packed a few surgical masks. I guiltily picked up an N95 from the hospital floors the day before leaving, but then left it at home thinking it overkill. I still have it in a ziplock bag a year later – it’s our emergency “what-if-we-have-to-care-for-one-another-with-COVID-in-this-tiny-house-full-of-kids” N95. Not that my husband has been fit tested. At the time, neither was I.

I returned after the conference to befuddlement over how we might fit test thousands of people, racing COVID to the front door. An overly complicated task, as we didn’t even know who was supposed to be responsible for orchestrating such an effort. We didn’t even know if we could spare the N95s.

Still in California, I sat by the pool wondering if anyone would acknowledge the impending new reality. At the conference we were told “don’t shake hands, don’t touch your face, wash your hands a lot.” I gave a workshop without a mask. I ate dinner in an actual restaurant worried only about gluten free soy sauce. I sat in a lecture hall with almost 5,000 people. I started to have a conversation with a friend from Seattle, but he needed to leave because they found a positive patient in his hospital. I listened to a prerecorded webinar by the pool from our chief safety officer saying there was a plan. I was not reassured.

When we flew home the world had already changed. There were patients in New York now. Masks had appeared in the airport news stand. Yet we breathed the air in the closed space of the red eye and forgot to be concerned. At work that Monday I asked my team – fist to 5, how worried are you about this? Brave faces and side eyes at each other and a lot of 1s or 2s held up in the air. My job this week, I told them, is to get you all to a 5.

I was working with a resident who 2 months prior I had told, as we worked together in the lounge, I don’t think you’re going to China on vacation. She hadn’t gone, of course. I wasn’t going on spring break either. On one of my last train rides a commuter friend (remember those?) told me we’ll all feel a lot better once we realize that none of us are going to get to do any of the things we want to do.

The med students were still there, helping the team and hanging onto their education. I told everyone not to see any patient with a respiratory complaint until we first discussed the case. On the third day of service I had to call infection control because a hypoxic febrile patient had come to the floor without isolation orders. “Are we testing?” No, I was informed, she hadn’t had exposures, hadn’t travelled. Speechless that we were screening for travel to Italy while living with one tiny state between us and the American epicenter, I can now recall thinking that our infection control officer did not sound well rested.

My N95 was still in a baggy at home. The PAPRS hadn’t appeared yet. Literally no one could agree what kind of mask the CDC or infection control or the ID consultant of the day recommended – today we are using surgical masks, I was told. Thursday will likely be different. “Anyway, she doesn’t sound like she has it.” I walked to the floors.

My med student started presenting our septic viral pneumonia patient including the very well done exam that I previously forbade him from obtaining. What happened to not seeing respiratory patients, I asked. Oh, they said, well night float said it didn’t sound like COVID. Insufficiently convinced by our second year resident’s unjustifiably overconfident, though ultimately correct, assessment – I held my head in my hands and give my first hallway COVID chalk talk of the new era. Complete with telling the team to question everything they thought they knew now including everything I said except “be careful.” That was about when Philadelphia ran out of toilet paper.

That weekend I sat in front of a bay of computers as our Medical Officer of the Day. Air traffic control for ED patients coming in for a landing on medical teams, I watched the new biohazard warnings line up indicating respiratory isolation patients waiting for a bed. I watched CRPs and D-dimers, and looked for leukopenia. I vowed I would follow up on tests to hone my COVID illness script. I soon realized that tests lie anyway.

By the end of that week we’d fallen through the looking glass. The old rules didn’t apply. We weren’t going to China, or Arizona; we didn’t know when the med students were coming back; the jobs we had were not the jobs we signed up for but were those that the world needed us to do; we couldn’t trust our intuition or our tests; we had no experts – and yet we started to grow the humble beginnings of expertise like spring garden sprouts.

In a chaotic world, seeds of order take shape and then scatter like a screensaver. The skills needed to manage chaos are different from those that leaders use in simple ordered times. Order cannot be pulled from chaos by force of will or cleverness, nor can it be delegated, cascaded, demanded, or launched. Order emerges when communities that are receptive to learning see patterns through noise, and slowly, lovingly, coax moments of stability into being.
 

Dr. Jaffe is division director for hospital medicine in the Department of Medicine at Thomas Jefferson University Hospital in Philadelphia.

I remember sitting at the pool in San Diego. I had been there before many years prior – one of my first medical conferences. I remember the clinking of metal sail stays in the morning breeze.

Flying out this time I packed a few surgical masks. I guiltily picked up an N95 from the hospital floors the day before leaving, but then left it at home thinking it overkill. I still have it in a ziplock bag a year later – it’s our emergency “what-if-we-have-to-care-for-one-another-with-COVID-in-this-tiny-house-full-of-kids” N95. Not that my husband has been fit tested. At the time, neither was I.

I returned after the conference to befuddlement over how we might fit test thousands of people, racing COVID to the front door. An overly complicated task, as we didn’t even know who was supposed to be responsible for orchestrating such an effort. We didn’t even know if we could spare the N95s.

Still in California, I sat by the pool wondering if anyone would acknowledge the impending new reality. At the conference we were told “don’t shake hands, don’t touch your face, wash your hands a lot.” I gave a workshop without a mask. I ate dinner in an actual restaurant worried only about gluten free soy sauce. I sat in a lecture hall with almost 5,000 people. I started to have a conversation with a friend from Seattle, but he needed to leave because they found a positive patient in his hospital. I listened to a prerecorded webinar by the pool from our chief safety officer saying there was a plan. I was not reassured.

When we flew home the world had already changed. There were patients in New York now. Masks had appeared in the airport news stand. Yet we breathed the air in the closed space of the red eye and forgot to be concerned. At work that Monday I asked my team – fist to 5, how worried are you about this? Brave faces and side eyes at each other and a lot of 1s or 2s held up in the air. My job this week, I told them, is to get you all to a 5.

I was working with a resident who 2 months prior I had told, as we worked together in the lounge, I don’t think you’re going to China on vacation. She hadn’t gone, of course. I wasn’t going on spring break either. On one of my last train rides a commuter friend (remember those?) told me we’ll all feel a lot better once we realize that none of us are going to get to do any of the things we want to do.

The med students were still there, helping the team and hanging onto their education. I told everyone not to see any patient with a respiratory complaint until we first discussed the case. On the third day of service I had to call infection control because a hypoxic febrile patient had come to the floor without isolation orders. “Are we testing?” No, I was informed, she hadn’t had exposures, hadn’t travelled. Speechless that we were screening for travel to Italy while living with one tiny state between us and the American epicenter, I can now recall thinking that our infection control officer did not sound well rested.

My N95 was still in a baggy at home. The PAPRS hadn’t appeared yet. Literally no one could agree what kind of mask the CDC or infection control or the ID consultant of the day recommended – today we are using surgical masks, I was told. Thursday will likely be different. “Anyway, she doesn’t sound like she has it.” I walked to the floors.

My med student started presenting our septic viral pneumonia patient including the very well done exam that I previously forbade him from obtaining. What happened to not seeing respiratory patients, I asked. Oh, they said, well night float said it didn’t sound like COVID. Insufficiently convinced by our second year resident’s unjustifiably overconfident, though ultimately correct, assessment – I held my head in my hands and give my first hallway COVID chalk talk of the new era. Complete with telling the team to question everything they thought they knew now including everything I said except “be careful.” That was about when Philadelphia ran out of toilet paper.

That weekend I sat in front of a bay of computers as our Medical Officer of the Day. Air traffic control for ED patients coming in for a landing on medical teams, I watched the new biohazard warnings line up indicating respiratory isolation patients waiting for a bed. I watched CRPs and D-dimers, and looked for leukopenia. I vowed I would follow up on tests to hone my COVID illness script. I soon realized that tests lie anyway.

By the end of that week we’d fallen through the looking glass. The old rules didn’t apply. We weren’t going to China, or Arizona; we didn’t know when the med students were coming back; the jobs we had were not the jobs we signed up for but were those that the world needed us to do; we couldn’t trust our intuition or our tests; we had no experts – and yet we started to grow the humble beginnings of expertise like spring garden sprouts.

In a chaotic world, seeds of order take shape and then scatter like a screensaver. The skills needed to manage chaos are different from those that leaders use in simple ordered times. Order cannot be pulled from chaos by force of will or cleverness, nor can it be delegated, cascaded, demanded, or launched. Order emerges when communities that are receptive to learning see patterns through noise, and slowly, lovingly, coax moments of stability into being.
 

Dr. Jaffe is division director for hospital medicine in the Department of Medicine at Thomas Jefferson University Hospital in Philadelphia.

I remember sitting at the pool in San Diego. I had been there before many years prior – one of my first medical conferences. I remember the clinking of metal sail stays in the morning breeze.

Flying out this time I packed a few surgical masks. I guiltily picked up an N95 from the hospital floors the day before leaving, but then left it at home thinking it overkill. I still have it in a ziplock bag a year later – it’s our emergency “what-if-we-have-to-care-for-one-another-with-COVID-in-this-tiny-house-full-of-kids” N95. Not that my husband has been fit tested. At the time, neither was I.

I returned after the conference to befuddlement over how we might fit test thousands of people, racing COVID to the front door. An overly complicated task, as we didn’t even know who was supposed to be responsible for orchestrating such an effort. We didn’t even know if we could spare the N95s.

Still in California, I sat by the pool wondering if anyone would acknowledge the impending new reality. At the conference we were told “don’t shake hands, don’t touch your face, wash your hands a lot.” I gave a workshop without a mask. I ate dinner in an actual restaurant worried only about gluten free soy sauce. I sat in a lecture hall with almost 5,000 people. I started to have a conversation with a friend from Seattle, but he needed to leave because they found a positive patient in his hospital. I listened to a prerecorded webinar by the pool from our chief safety officer saying there was a plan. I was not reassured.

When we flew home the world had already changed. There were patients in New York now. Masks had appeared in the airport news stand. Yet we breathed the air in the closed space of the red eye and forgot to be concerned. At work that Monday I asked my team – fist to 5, how worried are you about this? Brave faces and side eyes at each other and a lot of 1s or 2s held up in the air. My job this week, I told them, is to get you all to a 5.

I was working with a resident who 2 months prior I had told, as we worked together in the lounge, I don’t think you’re going to China on vacation. She hadn’t gone, of course. I wasn’t going on spring break either. On one of my last train rides a commuter friend (remember those?) told me we’ll all feel a lot better once we realize that none of us are going to get to do any of the things we want to do.

The med students were still there, helping the team and hanging onto their education. I told everyone not to see any patient with a respiratory complaint until we first discussed the case. On the third day of service I had to call infection control because a hypoxic febrile patient had come to the floor without isolation orders. “Are we testing?” No, I was informed, she hadn’t had exposures, hadn’t travelled. Speechless that we were screening for travel to Italy while living with one tiny state between us and the American epicenter, I can now recall thinking that our infection control officer did not sound well rested.

My N95 was still in a baggy at home. The PAPRS hadn’t appeared yet. Literally no one could agree what kind of mask the CDC or infection control or the ID consultant of the day recommended – today we are using surgical masks, I was told. Thursday will likely be different. “Anyway, she doesn’t sound like she has it.” I walked to the floors.

My med student started presenting our septic viral pneumonia patient including the very well done exam that I previously forbade him from obtaining. What happened to not seeing respiratory patients, I asked. Oh, they said, well night float said it didn’t sound like COVID. Insufficiently convinced by our second year resident’s unjustifiably overconfident, though ultimately correct, assessment – I held my head in my hands and give my first hallway COVID chalk talk of the new era. Complete with telling the team to question everything they thought they knew now including everything I said except “be careful.” That was about when Philadelphia ran out of toilet paper.

That weekend I sat in front of a bay of computers as our Medical Officer of the Day. Air traffic control for ED patients coming in for a landing on medical teams, I watched the new biohazard warnings line up indicating respiratory isolation patients waiting for a bed. I watched CRPs and D-dimers, and looked for leukopenia. I vowed I would follow up on tests to hone my COVID illness script. I soon realized that tests lie anyway.

By the end of that week we’d fallen through the looking glass. The old rules didn’t apply. We weren’t going to China, or Arizona; we didn’t know when the med students were coming back; the jobs we had were not the jobs we signed up for but were those that the world needed us to do; we couldn’t trust our intuition or our tests; we had no experts – and yet we started to grow the humble beginnings of expertise like spring garden sprouts.

In a chaotic world, seeds of order take shape and then scatter like a screensaver. The skills needed to manage chaos are different from those that leaders use in simple ordered times. Order cannot be pulled from chaos by force of will or cleverness, nor can it be delegated, cascaded, demanded, or launched. Order emerges when communities that are receptive to learning see patterns through noise, and slowly, lovingly, coax moments of stability into being.
 

Dr. Jaffe is division director for hospital medicine in the Department of Medicine at Thomas Jefferson University Hospital in Philadelphia.

Background: With more than 500 cases of NSF reported during 1997-2007, a black box warning advises against use of all GBCAs in at-risk CKD patients. However, newer literature has shown that group II GBCAs may have lower risks of causing NSF. The risk to patients with CKD IV and V is not clear.

Dr. Midha is a hospitalist at Beth Israel Deaconess Medical Center, instructor of medicine, Boston University, and part-time instructor in medicine, Harvard Medical School, all in Boston.

Background: With more than 500 cases of NSF reported during 1997-2007, a black box warning advises against use of all GBCAs in at-risk CKD patients. However, newer literature has shown that group II GBCAs may have lower risks of causing NSF. The risk to patients with CKD IV and V is not clear.

Dr. Midha is a hospitalist at Beth Israel Deaconess Medical Center, instructor of medicine, Boston University, and part-time instructor in medicine, Harvard Medical School, all in Boston.

Background: With more than 500 cases of NSF reported during 1997-2007, a black box warning advises against use of all GBCAs in at-risk CKD patients. However, newer literature has shown that group II GBCAs may have lower risks of causing NSF. The risk to patients with CKD IV and V is not clear.

Dr. Midha is a hospitalist at Beth Israel Deaconess Medical Center, instructor of medicine, Boston University, and part-time instructor in medicine, Harvard Medical School, all in Boston.

The CDC director is urging parents to vaccinate their teenagers against COVID-19, citing a study that shows increasing hospitalizations rates for adolescents.

“I am deeply concerned by the numbers of hospitalized adolescents and saddened to see the number of adolescents who required treatment in intensive care units or mechanical ventilation,” CDC Director Rochelle Walensky, MD, said in a statement.

While urging teenagers to wear masks and take precautions around others, she asked “parents, relatives, and close friends to join me and talk with teens about the importance of these prevention strategies and to encourage them to get vaccinated.”

Dr. Walensky referred to the CDC’s Morbidity and Mortality Weekly Report that showed adolescent hospitalizations peaked at 2.1 per 100,000 in early January 2021, then dropped to 0.6 per 100,000 in mid-March.

Alarmingly, hospitalizations rose to 1.3 per 100,000 in April, and a number of teens required serious interventions.

“Among hospitalized adolescents, nearly one-third required intensive care unit admission, and 5% required invasive mechanical ventilation,” the report said. No deaths occurred.

The study looked at 376 adolescents aged 12-17 who were hospitalized and tested positive for coronavirus. Of that group, 204 were hospitalized for COVID-19 and the other 172 were hospitalized for reasons not directly related to COVID-19.

Of the 204 hospitalized for COVID-19, 70.6% had an underlying medical condition such as obesity or chronic lung disease.

The study noted that children and teenagers have lower hospitalization rates and generally show less severe symptoms than do older people.

Possible causes for the rise in adolescent COVID-19 hospitalizations include the arrival of variants, the growing number of children returning to in-person education, and the changes in mask-wearing and other safety precautions, the study said.

The American Academy of Pediatrics said that as of May 27, 4 million children have tested positive for COVID-19 since the pandemic began, with about 34,500 new child cases reported for the week ending May 27.

The AAP said children have represented 14.1% of total cases since the pandemic began, but for the week ending May 27, children represented 24.3% of new reported weekly COVID-19 cases.

On May 10, the FDA granted emergency use authorization for the Pfizer coronavirus vaccine to be given to children aged 12-15 years. Previously, the FDA had authorized the Pfizer vaccine for people aged 16 years and up, whereas the Moderna and Johnson & Johnson vaccines are authorized for people aged 18 years and up.

“Vaccination is our way out of this pandemic,” Dr. Walensky said in her statement. “I continue to see promising signs in CDC data that we are nearing the end of this pandemic in this country; however, we all have to do our part and get vaccinated to cross the finish line.”
 

A version of this article was first published on WebMD.com.

The CDC director is urging parents to vaccinate their teenagers against COVID-19, citing a study that shows increasing hospitalizations rates for adolescents.

“I am deeply concerned by the numbers of hospitalized adolescents and saddened to see the number of adolescents who required treatment in intensive care units or mechanical ventilation,” CDC Director Rochelle Walensky, MD, said in a statement.

While urging teenagers to wear masks and take precautions around others, she asked “parents, relatives, and close friends to join me and talk with teens about the importance of these prevention strategies and to encourage them to get vaccinated.”

Dr. Walensky referred to the CDC’s Morbidity and Mortality Weekly Report that showed adolescent hospitalizations peaked at 2.1 per 100,000 in early January 2021, then dropped to 0.6 per 100,000 in mid-March.

Alarmingly, hospitalizations rose to 1.3 per 100,000 in April, and a number of teens required serious interventions.

“Among hospitalized adolescents, nearly one-third required intensive care unit admission, and 5% required invasive mechanical ventilation,” the report said. No deaths occurred.

The study looked at 376 adolescents aged 12-17 who were hospitalized and tested positive for coronavirus. Of that group, 204 were hospitalized for COVID-19 and the other 172 were hospitalized for reasons not directly related to COVID-19.

Of the 204 hospitalized for COVID-19, 70.6% had an underlying medical condition such as obesity or chronic lung disease.

The study noted that children and teenagers have lower hospitalization rates and generally show less severe symptoms than do older people.

Possible causes for the rise in adolescent COVID-19 hospitalizations include the arrival of variants, the growing number of children returning to in-person education, and the changes in mask-wearing and other safety precautions, the study said.

The American Academy of Pediatrics said that as of May 27, 4 million children have tested positive for COVID-19 since the pandemic began, with about 34,500 new child cases reported for the week ending May 27.

The AAP said children have represented 14.1% of total cases since the pandemic began, but for the week ending May 27, children represented 24.3% of new reported weekly COVID-19 cases.

On May 10, the FDA granted emergency use authorization for the Pfizer coronavirus vaccine to be given to children aged 12-15 years. Previously, the FDA had authorized the Pfizer vaccine for people aged 16 years and up, whereas the Moderna and Johnson & Johnson vaccines are authorized for people aged 18 years and up.

“Vaccination is our way out of this pandemic,” Dr. Walensky said in her statement. “I continue to see promising signs in CDC data that we are nearing the end of this pandemic in this country; however, we all have to do our part and get vaccinated to cross the finish line.”
 

A version of this article was first published on WebMD.com.

The CDC director is urging parents to vaccinate their teenagers against COVID-19, citing a study that shows increasing hospitalizations rates for adolescents.

“I am deeply concerned by the numbers of hospitalized adolescents and saddened to see the number of adolescents who required treatment in intensive care units or mechanical ventilation,” CDC Director Rochelle Walensky, MD, said in a statement.

While urging teenagers to wear masks and take precautions around others, she asked “parents, relatives, and close friends to join me and talk with teens about the importance of these prevention strategies and to encourage them to get vaccinated.”

Dr. Walensky referred to the CDC’s Morbidity and Mortality Weekly Report that showed adolescent hospitalizations peaked at 2.1 per 100,000 in early January 2021, then dropped to 0.6 per 100,000 in mid-March.

Alarmingly, hospitalizations rose to 1.3 per 100,000 in April, and a number of teens required serious interventions.

“Among hospitalized adolescents, nearly one-third required intensive care unit admission, and 5% required invasive mechanical ventilation,” the report said. No deaths occurred.

The study looked at 376 adolescents aged 12-17 who were hospitalized and tested positive for coronavirus. Of that group, 204 were hospitalized for COVID-19 and the other 172 were hospitalized for reasons not directly related to COVID-19.

Of the 204 hospitalized for COVID-19, 70.6% had an underlying medical condition such as obesity or chronic lung disease.

The study noted that children and teenagers have lower hospitalization rates and generally show less severe symptoms than do older people.

Possible causes for the rise in adolescent COVID-19 hospitalizations include the arrival of variants, the growing number of children returning to in-person education, and the changes in mask-wearing and other safety precautions, the study said.

The American Academy of Pediatrics said that as of May 27, 4 million children have tested positive for COVID-19 since the pandemic began, with about 34,500 new child cases reported for the week ending May 27.

The AAP said children have represented 14.1% of total cases since the pandemic began, but for the week ending May 27, children represented 24.3% of new reported weekly COVID-19 cases.

On May 10, the FDA granted emergency use authorization for the Pfizer coronavirus vaccine to be given to children aged 12-15 years. Previously, the FDA had authorized the Pfizer vaccine for people aged 16 years and up, whereas the Moderna and Johnson & Johnson vaccines are authorized for people aged 18 years and up.

“Vaccination is our way out of this pandemic,” Dr. Walensky said in her statement. “I continue to see promising signs in CDC data that we are nearing the end of this pandemic in this country; however, we all have to do our part and get vaccinated to cross the finish line.”
 

A version of this article was first published on WebMD.com.

Background: Prior studies have examined the impact of hospital system mergers on health care costs, but few studies have previously examined impact on quality and patient experience.

Study design: Retrospective, difference-in-difference analysis.

Setting: 2,232 U.S. hospitals during 2007-2016.

Synopsis: The authors identified 2,232 hospitals, including 246 hospitals that were acquired between 2009 and 2013 and 1,986 control hospitals that were not acquired during this period. They used a difference-in-difference analysis to compare hospital performance on quality and patient experience measures from before and after an acquisition to concurrent changes in control hospitals. Hospital acquisition was associated with a significant decline in measured patient experience. There was no significant differential change in 30-day readmission or mortality. Although there was an association between acquisition and significant improvement in clinical process metrics, the authors found that this improvement occurred almost entirely prior to acquisition.

Bottom line: Hospital acquisition was associated with worse experience for patients and had no significant impact on readmission or mortality rates.

Citation: Beaulieu ND et al. Changes in quality of care after hospital mergers and acquisitions. N Engl J Med. 2020 Jan 2;382:51-9.

Dr. Midha is a hospitalist at Beth Israel Deaconess Medical Center, instructor of medicine, Boston University, and part-time instructor in medicine, Harvard Medical School, all in Boston.

Background: Prior studies have examined the impact of hospital system mergers on health care costs, but few studies have previously examined impact on quality and patient experience.

Study design: Retrospective, difference-in-difference analysis.

Setting: 2,232 U.S. hospitals during 2007-2016.

Synopsis: The authors identified 2,232 hospitals, including 246 hospitals that were acquired between 2009 and 2013 and 1,986 control hospitals that were not acquired during this period. They used a difference-in-difference analysis to compare hospital performance on quality and patient experience measures from before and after an acquisition to concurrent changes in control hospitals. Hospital acquisition was associated with a significant decline in measured patient experience. There was no significant differential change in 30-day readmission or mortality. Although there was an association between acquisition and significant improvement in clinical process metrics, the authors found that this improvement occurred almost entirely prior to acquisition.

Bottom line: Hospital acquisition was associated with worse experience for patients and had no significant impact on readmission or mortality rates.

Citation: Beaulieu ND et al. Changes in quality of care after hospital mergers and acquisitions. N Engl J Med. 2020 Jan 2;382:51-9.

Dr. Midha is a hospitalist at Beth Israel Deaconess Medical Center, instructor of medicine, Boston University, and part-time instructor in medicine, Harvard Medical School, all in Boston.

Background: Prior studies have examined the impact of hospital system mergers on health care costs, but few studies have previously examined impact on quality and patient experience.

Study design: Retrospective, difference-in-difference analysis.

Setting: 2,232 U.S. hospitals during 2007-2016.

Synopsis: The authors identified 2,232 hospitals, including 246 hospitals that were acquired between 2009 and 2013 and 1,986 control hospitals that were not acquired during this period. They used a difference-in-difference analysis to compare hospital performance on quality and patient experience measures from before and after an acquisition to concurrent changes in control hospitals. Hospital acquisition was associated with a significant decline in measured patient experience. There was no significant differential change in 30-day readmission or mortality. Although there was an association between acquisition and significant improvement in clinical process metrics, the authors found that this improvement occurred almost entirely prior to acquisition.

Bottom line: Hospital acquisition was associated with worse experience for patients and had no significant impact on readmission or mortality rates.

Citation: Beaulieu ND et al. Changes in quality of care after hospital mergers and acquisitions. N Engl J Med. 2020 Jan 2;382:51-9.

Dr. Midha is a hospitalist at Beth Israel Deaconess Medical Center, instructor of medicine, Boston University, and part-time instructor in medicine, Harvard Medical School, all in Boston.

Converge 2021 session

Racial and Gender Equity in Your PHM Program

Presenters

Jorge Ganem, MD, FAAP, and Vanessa N. Durand, DO, FAAP

Session summary

Dr. Ganem, associate professor of pediatrics at the University of Texas at Austin and director of pediatric hospital medicine at Dell Children’s Medical Center, and Dr. Durand, assistant professor of pediatrics at Drexel University and pediatric hospitalist at St. Christopher’s Hospital for Children, Philadelphia, presented an engaging session regarding gender equity in the workplace during SHM Converge 2021.

Dr. Ganem and Dr. Durand first presented data to illustrate the gender equity problem. They touched on the mental burden underrepresented minorities face professionally. Dr. Ganem and Dr. Durand discussed cognitive biases, defined allyship, sponsorship, and mentorship and shared how to distinguish between the three. They concluded their session with concrete ways to narrow gaps in equity in hospital medicine programs.

The highlights of this session included evidence-based “best-practices” that pediatric hospital medicine divisions can adopt. One important theme was regarding metrics. Dr. Ganem and Dr. Durand shared how important it is to evaluate divisions for pay and diversity gaps. Armed with these data, programs can be more effective in developing solutions. Some solutions provided by the presenters included “blind” interviews where traditional “cognitive metrics” (i.e., board scores) are not shared with interviewers to minimize anchoring and confirmation biases. Instead, interviewers should focus on the experiences and attributes of the job that the applicant can hopefully embody. This could be accomplished using a holistic review tool from the Association of American Medical Colleges.

One of the most powerful ideas shared in this session was a quote from a Harvard student shown in a video regarding bias and racism where he said, “Nothing in all the world is more dangerous than sincere ignorance and conscious stupidity.” Changes will only happen if we make them happen.

Key takeaways

• Racial and gender equity are problems that are undeniable, even in pediatrics.
• Be wary of conscious biases and the mental burden placed unfairly on underrepresented minorities in your institution.
• Becoming an amplifier, a sponsor, or a champion are ways to make a small individual difference.
• Measure your program’s data and commit to making change using evidence-based actions and assessments aimed at decreasing bias and increasing equity.

References

Association of American Medical Colleges. Holistic Review. 2021. www.aamc.org/services/member-capacity-building/holistic-review.

Dr. Singh is a board-certified pediatric hospitalist at Stanford University and Lucile Packard Children’s Hospital Stanford, both in Palo Alto, Calif. He is a native Texan living in the San Francisco Bay area with his wife and two young boys. His nonclinical passions include bedside communication and inpatient health care information technology.

Converge 2021 session

Racial and Gender Equity in Your PHM Program

Presenters

Jorge Ganem, MD, FAAP, and Vanessa N. Durand, DO, FAAP

Session summary

Dr. Ganem, associate professor of pediatrics at the University of Texas at Austin and director of pediatric hospital medicine at Dell Children’s Medical Center, and Dr. Durand, assistant professor of pediatrics at Drexel University and pediatric hospitalist at St. Christopher’s Hospital for Children, Philadelphia, presented an engaging session regarding gender equity in the workplace during SHM Converge 2021.

Dr. Ganem and Dr. Durand first presented data to illustrate the gender equity problem. They touched on the mental burden underrepresented minorities face professionally. Dr. Ganem and Dr. Durand discussed cognitive biases, defined allyship, sponsorship, and mentorship and shared how to distinguish between the three. They concluded their session with concrete ways to narrow gaps in equity in hospital medicine programs.

The highlights of this session included evidence-based “best-practices” that pediatric hospital medicine divisions can adopt. One important theme was regarding metrics. Dr. Ganem and Dr. Durand shared how important it is to evaluate divisions for pay and diversity gaps. Armed with these data, programs can be more effective in developing solutions. Some solutions provided by the presenters included “blind” interviews where traditional “cognitive metrics” (i.e., board scores) are not shared with interviewers to minimize anchoring and confirmation biases. Instead, interviewers should focus on the experiences and attributes of the job that the applicant can hopefully embody. This could be accomplished using a holistic review tool from the Association of American Medical Colleges.

One of the most powerful ideas shared in this session was a quote from a Harvard student shown in a video regarding bias and racism where he said, “Nothing in all the world is more dangerous than sincere ignorance and conscious stupidity.” Changes will only happen if we make them happen.

Key takeaways

• Racial and gender equity are problems that are undeniable, even in pediatrics.
• Be wary of conscious biases and the mental burden placed unfairly on underrepresented minorities in your institution.
• Becoming an amplifier, a sponsor, or a champion are ways to make a small individual difference.
• Measure your program’s data and commit to making change using evidence-based actions and assessments aimed at decreasing bias and increasing equity.

References

Association of American Medical Colleges. Holistic Review. 2021. www.aamc.org/services/member-capacity-building/holistic-review.

Dr. Singh is a board-certified pediatric hospitalist at Stanford University and Lucile Packard Children’s Hospital Stanford, both in Palo Alto, Calif. He is a native Texan living in the San Francisco Bay area with his wife and two young boys. His nonclinical passions include bedside communication and inpatient health care information technology.

Converge 2021 session

Racial and Gender Equity in Your PHM Program

Presenters

Jorge Ganem, MD, FAAP, and Vanessa N. Durand, DO, FAAP

Session summary

Dr. Ganem, associate professor of pediatrics at the University of Texas at Austin and director of pediatric hospital medicine at Dell Children’s Medical Center, and Dr. Durand, assistant professor of pediatrics at Drexel University and pediatric hospitalist at St. Christopher’s Hospital for Children, Philadelphia, presented an engaging session regarding gender equity in the workplace during SHM Converge 2021.

Dr. Ganem and Dr. Durand first presented data to illustrate the gender equity problem. They touched on the mental burden underrepresented minorities face professionally. Dr. Ganem and Dr. Durand discussed cognitive biases, defined allyship, sponsorship, and mentorship and shared how to distinguish between the three. They concluded their session with concrete ways to narrow gaps in equity in hospital medicine programs.

The highlights of this session included evidence-based “best-practices” that pediatric hospital medicine divisions can adopt. One important theme was regarding metrics. Dr. Ganem and Dr. Durand shared how important it is to evaluate divisions for pay and diversity gaps. Armed with these data, programs can be more effective in developing solutions. Some solutions provided by the presenters included “blind” interviews where traditional “cognitive metrics” (i.e., board scores) are not shared with interviewers to minimize anchoring and confirmation biases. Instead, interviewers should focus on the experiences and attributes of the job that the applicant can hopefully embody. This could be accomplished using a holistic review tool from the Association of American Medical Colleges.

One of the most powerful ideas shared in this session was a quote from a Harvard student shown in a video regarding bias and racism where he said, “Nothing in all the world is more dangerous than sincere ignorance and conscious stupidity.” Changes will only happen if we make them happen.

Key takeaways

• Racial and gender equity are problems that are undeniable, even in pediatrics.
• Be wary of conscious biases and the mental burden placed unfairly on underrepresented minorities in your institution.
• Becoming an amplifier, a sponsor, or a champion are ways to make a small individual difference.
• Measure your program’s data and commit to making change using evidence-based actions and assessments aimed at decreasing bias and increasing equity.

References

Association of American Medical Colleges. Holistic Review. 2021. www.aamc.org/services/member-capacity-building/holistic-review.

Dr. Singh is a board-certified pediatric hospitalist at Stanford University and Lucile Packard Children’s Hospital Stanford, both in Palo Alto, Calif. He is a native Texan living in the San Francisco Bay area with his wife and two young boys. His nonclinical passions include bedside communication and inpatient health care information technology.

Converge 2021 session

COVID-19 in Children

Presenter

Philip Zachariah, MD, MPH

Session summary

Children have been less severely affected by COVID-19 than adults (hospitalization rates around 5%). However, once hospitalized, ICU admission rates in children have been similar to adults, around 30%. Mortality has been 1%-2%. Risk factors for more severe acute SARS CoV-2 infections include age extremes, minorities, obesity, medical complexity, immunocompromised pediatric patients, and asthma.

Multisystem-inflammatory-syndrome-in-children (MIS-C) continues to present among persistently febrile children with multisystem findings and the history of acute COVID-19 infection in prior 3-6 weeks. There seems to be a link between the immunological defects in type I and II interferon production, as autoantibodies to type I interferon may predispose to severe disease. Dr. Zachariah of Columbia University Medical Center in New York, discussed the recent study exploring intravenous immunoglobulin (IVIG) alone versus IVIG and steroids as treatment options for MIS-C. So far, the failure rates in IVIG-alone group were higher (51%) versus IVIG and steroids (9%).

Besides MIS-C, many neurological manifestations of COVID-19 have been seen among children including GBS, seizures, encephalitis, cranial neuropathies, and demyelination cases. Diabetic ketoacidosis (DKA), secondary hemophagocytic lymphohistiocytosis (HLH), and pseudo-appendicitis have all been described in the literature, however, larger case control studied are needed.

In children, clinical vascular thrombotic events (VTEs) are rare. Anticoagulant thromboprophylaxis is suggested for hospitalized patients with COVID-19–related illness, whose D-dimer is >5 times upper limit of normal values and who have one or more non–COVID-19 related clinical risk factors for hospital acquired VTEs.

Key takeaways

• Once hospitalized, the ICU admission rates for children have been similar to those in adults, ~30%.
• MIS-C is showing lower failure rates if treated with IVIG and steroids, and most reliable laboratory findings should be elevated C-reactive protein, lymphopenia, and elevated brain natriuretic peptide.
• In hospitalized children with COVID-19, clinical VTEs are rare.

Dr. Giordano is an associate professor of pediatrics at Columbia University Medical Center in New York. She is a pediatric hospitalist with expertise in pediatric surgical comanagement

Converge 2021 session

COVID-19 in Children

Presenter

Philip Zachariah, MD, MPH

Session summary

Children have been less severely affected by COVID-19 than adults (hospitalization rates around 5%). However, once hospitalized, ICU admission rates in children have been similar to adults, around 30%. Mortality has been 1%-2%. Risk factors for more severe acute SARS CoV-2 infections include age extremes, minorities, obesity, medical complexity, immunocompromised pediatric patients, and asthma.

Multisystem-inflammatory-syndrome-in-children (MIS-C) continues to present among persistently febrile children with multisystem findings and the history of acute COVID-19 infection in prior 3-6 weeks. There seems to be a link between the immunological defects in type I and II interferon production, as autoantibodies to type I interferon may predispose to severe disease. Dr. Zachariah of Columbia University Medical Center in New York, discussed the recent study exploring intravenous immunoglobulin (IVIG) alone versus IVIG and steroids as treatment options for MIS-C. So far, the failure rates in IVIG-alone group were higher (51%) versus IVIG and steroids (9%).

Besides MIS-C, many neurological manifestations of COVID-19 have been seen among children including GBS, seizures, encephalitis, cranial neuropathies, and demyelination cases. Diabetic ketoacidosis (DKA), secondary hemophagocytic lymphohistiocytosis (HLH), and pseudo-appendicitis have all been described in the literature, however, larger case control studied are needed.

In children, clinical vascular thrombotic events (VTEs) are rare. Anticoagulant thromboprophylaxis is suggested for hospitalized patients with COVID-19–related illness, whose D-dimer is >5 times upper limit of normal values and who have one or more non–COVID-19 related clinical risk factors for hospital acquired VTEs.

Key takeaways

• Once hospitalized, the ICU admission rates for children have been similar to those in adults, ~30%.
• MIS-C is showing lower failure rates if treated with IVIG and steroids, and most reliable laboratory findings should be elevated C-reactive protein, lymphopenia, and elevated brain natriuretic peptide.
• In hospitalized children with COVID-19, clinical VTEs are rare.

Dr. Giordano is an associate professor of pediatrics at Columbia University Medical Center in New York. She is a pediatric hospitalist with expertise in pediatric surgical comanagement

Converge 2021 session

COVID-19 in Children

Presenter

Philip Zachariah, MD, MPH

Session summary

Children have been less severely affected by COVID-19 than adults (hospitalization rates around 5%). However, once hospitalized, ICU admission rates in children have been similar to adults, around 30%. Mortality has been 1%-2%. Risk factors for more severe acute SARS CoV-2 infections include age extremes, minorities, obesity, medical complexity, immunocompromised pediatric patients, and asthma.

Multisystem-inflammatory-syndrome-in-children (MIS-C) continues to present among persistently febrile children with multisystem findings and the history of acute COVID-19 infection in prior 3-6 weeks. There seems to be a link between the immunological defects in type I and II interferon production, as autoantibodies to type I interferon may predispose to severe disease. Dr. Zachariah of Columbia University Medical Center in New York, discussed the recent study exploring intravenous immunoglobulin (IVIG) alone versus IVIG and steroids as treatment options for MIS-C. So far, the failure rates in IVIG-alone group were higher (51%) versus IVIG and steroids (9%).

Besides MIS-C, many neurological manifestations of COVID-19 have been seen among children including GBS, seizures, encephalitis, cranial neuropathies, and demyelination cases. Diabetic ketoacidosis (DKA), secondary hemophagocytic lymphohistiocytosis (HLH), and pseudo-appendicitis have all been described in the literature, however, larger case control studied are needed.

In children, clinical vascular thrombotic events (VTEs) are rare. Anticoagulant thromboprophylaxis is suggested for hospitalized patients with COVID-19–related illness, whose D-dimer is >5 times upper limit of normal values and who have one or more non–COVID-19 related clinical risk factors for hospital acquired VTEs.

Key takeaways

• Once hospitalized, the ICU admission rates for children have been similar to those in adults, ~30%.
• MIS-C is showing lower failure rates if treated with IVIG and steroids, and most reliable laboratory findings should be elevated C-reactive protein, lymphopenia, and elevated brain natriuretic peptide.
• In hospitalized children with COVID-19, clinical VTEs are rare.

Dr. Giordano is an associate professor of pediatrics at Columbia University Medical Center in New York. She is a pediatric hospitalist with expertise in pediatric surgical comanagement

A group of 117 people who work at the Houston Methodist Health System has filed a lawsuit against the medical center, objecting to its policy of requiring employees and contractors to be vaccinated against COVID-19 or risk losing their jobs.

Plaintiffs include Jennifer Bridges, RN, a medical-surgical nurse at the hospital who has become the public face and voice of health care workers who object to mandatory vaccination, as well as Bob Nevens, the hospital’s director of corporate risk.

Mr. Nevens said the hospital was requiring him to be vaccinated even though he doesn’t treat patients and has been working from home for most of the past year.

“My civil rights and liberties have been trampled on,” he said in comments posted on an online petition. “My right to protect myself from unknown side effects of these vaccines has been placed below the optics of ‘leading medicine,’ “ he said.

Mr. Nevens says in his comments that he was fired on April 15, although the lawsuit says he is currently employed by the hospital’s corporate office.

The Texas attorney who filed the lawsuit, Jared Woodfill, is known to champion conservative causes. In March 2020, he challenged Harris County’s stay-at-home order, charging that it violated religious liberty. He was chairman of the Harris County Republican Party for more than a decade. His website says he is a frequent guest on the local Fox News affiliate.

The lawsuit hinges on a section of the federal law that authorizes emergency use of medical products – US Code 360bbb-3.

That law says that individuals to whom the product is administered should be informed “of the option to accept or refuse administration of the product, of the consequence, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”

Legal experts are split as to what the provision means for vaccination mandates. Courts have not yet weighed in with their interpretations of the law.

The petition also repeats a popular antivaccination argument that likens requiring a vaccine approved for emergency use to the kind of medical experimentation performed by Nazi doctors on Jewish prisoners in concentration camps. It says forcing people to choose between an experimental vaccine and a job is a violation of the Nuremberg Code, which says that people must voluntarily and knowingly consent to participating in research.

The vaccines have already been tested in clinical trials. People who are getting them now are not part of those studies, though vaccine manufacturers, regulators, and safety experts are still watching closely for any sign of problems tied to the new shots.

It is true, however, that the emergency use authorization granted by the U.S. Food and Drug Administraiton sped up the process of getting the vaccines onto market. Vaccine manufacturers are currently completing the process of submitting documentation required for a full biologics license application, the mechanism the FDA uses for full approval.

Houston Methodist sent an email to employees in April notifying them that they had until June 7 to start the vaccination process or apply for a medical or religious exemption. Those who decide not to will be terminated.

Marc Boom, MD, the health care system’s president and CEO, has explained that the policy is in place to protect patients and that it was the first hospital in the United States to require it. Since then, other hospitals, including the University of Pennsylvania Health System, have required COVID vaccines.

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

A group of 117 people who work at the Houston Methodist Health System has filed a lawsuit against the medical center, objecting to its policy of requiring employees and contractors to be vaccinated against COVID-19 or risk losing their jobs.

Plaintiffs include Jennifer Bridges, RN, a medical-surgical nurse at the hospital who has become the public face and voice of health care workers who object to mandatory vaccination, as well as Bob Nevens, the hospital’s director of corporate risk.

Mr. Nevens said the hospital was requiring him to be vaccinated even though he doesn’t treat patients and has been working from home for most of the past year.

“My civil rights and liberties have been trampled on,” he said in comments posted on an online petition. “My right to protect myself from unknown side effects of these vaccines has been placed below the optics of ‘leading medicine,’ “ he said.

Mr. Nevens says in his comments that he was fired on April 15, although the lawsuit says he is currently employed by the hospital’s corporate office.

The Texas attorney who filed the lawsuit, Jared Woodfill, is known to champion conservative causes. In March 2020, he challenged Harris County’s stay-at-home order, charging that it violated religious liberty. He was chairman of the Harris County Republican Party for more than a decade. His website says he is a frequent guest on the local Fox News affiliate.

The lawsuit hinges on a section of the federal law that authorizes emergency use of medical products – US Code 360bbb-3.

That law says that individuals to whom the product is administered should be informed “of the option to accept or refuse administration of the product, of the consequence, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”

Legal experts are split as to what the provision means for vaccination mandates. Courts have not yet weighed in with their interpretations of the law.

The petition also repeats a popular antivaccination argument that likens requiring a vaccine approved for emergency use to the kind of medical experimentation performed by Nazi doctors on Jewish prisoners in concentration camps. It says forcing people to choose between an experimental vaccine and a job is a violation of the Nuremberg Code, which says that people must voluntarily and knowingly consent to participating in research.

The vaccines have already been tested in clinical trials. People who are getting them now are not part of those studies, though vaccine manufacturers, regulators, and safety experts are still watching closely for any sign of problems tied to the new shots.

It is true, however, that the emergency use authorization granted by the U.S. Food and Drug Administraiton sped up the process of getting the vaccines onto market. Vaccine manufacturers are currently completing the process of submitting documentation required for a full biologics license application, the mechanism the FDA uses for full approval.

Houston Methodist sent an email to employees in April notifying them that they had until June 7 to start the vaccination process or apply for a medical or religious exemption. Those who decide not to will be terminated.

Marc Boom, MD, the health care system’s president and CEO, has explained that the policy is in place to protect patients and that it was the first hospital in the United States to require it. Since then, other hospitals, including the University of Pennsylvania Health System, have required COVID vaccines.

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

A group of 117 people who work at the Houston Methodist Health System has filed a lawsuit against the medical center, objecting to its policy of requiring employees and contractors to be vaccinated against COVID-19 or risk losing their jobs.

Plaintiffs include Jennifer Bridges, RN, a medical-surgical nurse at the hospital who has become the public face and voice of health care workers who object to mandatory vaccination, as well as Bob Nevens, the hospital’s director of corporate risk.

Mr. Nevens said the hospital was requiring him to be vaccinated even though he doesn’t treat patients and has been working from home for most of the past year.

“My civil rights and liberties have been trampled on,” he said in comments posted on an online petition. “My right to protect myself from unknown side effects of these vaccines has been placed below the optics of ‘leading medicine,’ “ he said.

Mr. Nevens says in his comments that he was fired on April 15, although the lawsuit says he is currently employed by the hospital’s corporate office.

The Texas attorney who filed the lawsuit, Jared Woodfill, is known to champion conservative causes. In March 2020, he challenged Harris County’s stay-at-home order, charging that it violated religious liberty. He was chairman of the Harris County Republican Party for more than a decade. His website says he is a frequent guest on the local Fox News affiliate.

The lawsuit hinges on a section of the federal law that authorizes emergency use of medical products – US Code 360bbb-3.

That law says that individuals to whom the product is administered should be informed “of the option to accept or refuse administration of the product, of the consequence, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”

Legal experts are split as to what the provision means for vaccination mandates. Courts have not yet weighed in with their interpretations of the law.

The petition also repeats a popular antivaccination argument that likens requiring a vaccine approved for emergency use to the kind of medical experimentation performed by Nazi doctors on Jewish prisoners in concentration camps. It says forcing people to choose between an experimental vaccine and a job is a violation of the Nuremberg Code, which says that people must voluntarily and knowingly consent to participating in research.

The vaccines have already been tested in clinical trials. People who are getting them now are not part of those studies, though vaccine manufacturers, regulators, and safety experts are still watching closely for any sign of problems tied to the new shots.

It is true, however, that the emergency use authorization granted by the U.S. Food and Drug Administraiton sped up the process of getting the vaccines onto market. Vaccine manufacturers are currently completing the process of submitting documentation required for a full biologics license application, the mechanism the FDA uses for full approval.

Houston Methodist sent an email to employees in April notifying them that they had until June 7 to start the vaccination process or apply for a medical or religious exemption. Those who decide not to will be terminated.

Marc Boom, MD, the health care system’s president and CEO, has explained that the policy is in place to protect patients and that it was the first hospital in the United States to require it. Since then, other hospitals, including the University of Pennsylvania Health System, have required COVID vaccines.

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