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Clinicians petition government for national quarantine
Clinicians across the United States are petitioning the federal government to follow the lead of South Korea, China, and other nations by imposing an immediate nationwide quarantine to slow the inevitable spread of COVID-19. Without federal action, the creators say, their lives and the lives of their colleagues, patients, and families are being put at increased risk.
In addition to the quarantine, the petition, posted on the website Change.org, calls on U.S. leaders to institute emergency production and distribution of personal protective equipment for healthcare workers and to rapidly increase access to testing.
The petition – which garnered more than 40,000 signatures in just 12 hours and as of this writing was approaching 94,000 – was started by an apolitical Facebook group to focus attention on what members see as the most critical issues for clinicians: slowing the spread of the virus through a coast-to-coast quarantine, protection of medical personnel with adequate supplies of essential equipment, and widespread testing.
“We started this group last Friday out of the realization that clinicians needed information about the outbreak and weren’t getting it,” said coadministrator Jessica McIntyre, MD, a pediatric hospitalist at Elliot Hospital in Manchester, N.H.
“We wanted to get ahead of it and connect with people before we were in the trenches experiencing it and to see what other programs were doing. From a local perspective, it has been really hard to see what people are doing in other states, especially when the protocols in our own states are changing every single day as we collect more information,” she said in an interview.
The Horse Has Bolted
A family medicine physician in Illinois helped launch the Facebook group. She asked that her name not be used but said in an interview that earlier actions may have prevented or at least delayed the need for the more draconian measures that her group is recommending.
“Clearly South Korea is one of the superstars as far as response has gone, but the concern we have in the United States is that we’re well beyond that point – we needed to be testing people over a month ago, in the hope of preventing a quarantine,” she said in an interview.
According to National Public Radio, as of March 13, South Korea had conducted 3,600 tests per million population, compared with five per million in the United States.
“I think the most concerning part is to see where Italy is now and where we are in comparison. Our ICUs have not yet overflowed, but I think we’re definitely looking at that in the next few weeks – hopefully longer, but I suspect that it will happen shortly,” she continued.
She cited work by Harvard University biostatistician Xihong Lin, PhD, that shows that when health authorities in Wuhan, China – widely cited as the epicenter of the global pandemic – cordoned off the city, the infection rate dropped from one person infecting 3.8 others to one infecting 1.25, thereby significantly slowing the rate of transmission.
“This is absolutely what we need to be doing,” she said.
Real News
Within 3 days of its creation, the online group had accrued more than 80,000 members with advanced medical training, including MDs, DOs, physician assistants, nurse practitioners, and certified registered nurse anesthetists.
“A lot of us were already very busy with our day-to-day work outside of COVID-19, and I think a lot of us felt unsure about where to get the best information,” said coadministrator David Janssen, MD, a family medicine physician in group practice in Sioux Center, Iowa,
“If you turn on the TV, there’s a lot of politicizing of the issue, and there’s a lot of good information, but also a lot of bad information. When health care providers talk to other health care providers, that’s often how we get our information and how we learn,” he said in an interview.
The COVID-19 U.S. Physicians/APP Facebook group includes 20 volunteer moderators who handle hundreds of posts per hour from persons seeking information on the novel coronavirus, what to tell patients, and how to protect themselves.
“It’s been wonderful to see how providers have been helping other providers sort through issues. Teaching hospitals have their hands on the latest research, but a lot of people like myself are at small community hospitals, critical-access hospitals, where we may have a lot of questions but don’t necessarily have the answers readily available to us,” Dr. Janssen said.
Dr. Janssen said that his community of about 8,000 residents initially had only four COVID-19 testing kits, or one for every 2,000 people. The situation has since improved, and more tests are now available, he added.
Dr. McIntyre, Dr. Janssen, and the Illinois family physician have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Clinicians across the United States are petitioning the federal government to follow the lead of South Korea, China, and other nations by imposing an immediate nationwide quarantine to slow the inevitable spread of COVID-19. Without federal action, the creators say, their lives and the lives of their colleagues, patients, and families are being put at increased risk.
In addition to the quarantine, the petition, posted on the website Change.org, calls on U.S. leaders to institute emergency production and distribution of personal protective equipment for healthcare workers and to rapidly increase access to testing.
The petition – which garnered more than 40,000 signatures in just 12 hours and as of this writing was approaching 94,000 – was started by an apolitical Facebook group to focus attention on what members see as the most critical issues for clinicians: slowing the spread of the virus through a coast-to-coast quarantine, protection of medical personnel with adequate supplies of essential equipment, and widespread testing.
“We started this group last Friday out of the realization that clinicians needed information about the outbreak and weren’t getting it,” said coadministrator Jessica McIntyre, MD, a pediatric hospitalist at Elliot Hospital in Manchester, N.H.
“We wanted to get ahead of it and connect with people before we were in the trenches experiencing it and to see what other programs were doing. From a local perspective, it has been really hard to see what people are doing in other states, especially when the protocols in our own states are changing every single day as we collect more information,” she said in an interview.
The Horse Has Bolted
A family medicine physician in Illinois helped launch the Facebook group. She asked that her name not be used but said in an interview that earlier actions may have prevented or at least delayed the need for the more draconian measures that her group is recommending.
“Clearly South Korea is one of the superstars as far as response has gone, but the concern we have in the United States is that we’re well beyond that point – we needed to be testing people over a month ago, in the hope of preventing a quarantine,” she said in an interview.
According to National Public Radio, as of March 13, South Korea had conducted 3,600 tests per million population, compared with five per million in the United States.
“I think the most concerning part is to see where Italy is now and where we are in comparison. Our ICUs have not yet overflowed, but I think we’re definitely looking at that in the next few weeks – hopefully longer, but I suspect that it will happen shortly,” she continued.
She cited work by Harvard University biostatistician Xihong Lin, PhD, that shows that when health authorities in Wuhan, China – widely cited as the epicenter of the global pandemic – cordoned off the city, the infection rate dropped from one person infecting 3.8 others to one infecting 1.25, thereby significantly slowing the rate of transmission.
“This is absolutely what we need to be doing,” she said.
Real News
Within 3 days of its creation, the online group had accrued more than 80,000 members with advanced medical training, including MDs, DOs, physician assistants, nurse practitioners, and certified registered nurse anesthetists.
“A lot of us were already very busy with our day-to-day work outside of COVID-19, and I think a lot of us felt unsure about where to get the best information,” said coadministrator David Janssen, MD, a family medicine physician in group practice in Sioux Center, Iowa,
“If you turn on the TV, there’s a lot of politicizing of the issue, and there’s a lot of good information, but also a lot of bad information. When health care providers talk to other health care providers, that’s often how we get our information and how we learn,” he said in an interview.
The COVID-19 U.S. Physicians/APP Facebook group includes 20 volunteer moderators who handle hundreds of posts per hour from persons seeking information on the novel coronavirus, what to tell patients, and how to protect themselves.
“It’s been wonderful to see how providers have been helping other providers sort through issues. Teaching hospitals have their hands on the latest research, but a lot of people like myself are at small community hospitals, critical-access hospitals, where we may have a lot of questions but don’t necessarily have the answers readily available to us,” Dr. Janssen said.
Dr. Janssen said that his community of about 8,000 residents initially had only four COVID-19 testing kits, or one for every 2,000 people. The situation has since improved, and more tests are now available, he added.
Dr. McIntyre, Dr. Janssen, and the Illinois family physician have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Clinicians across the United States are petitioning the federal government to follow the lead of South Korea, China, and other nations by imposing an immediate nationwide quarantine to slow the inevitable spread of COVID-19. Without federal action, the creators say, their lives and the lives of their colleagues, patients, and families are being put at increased risk.
In addition to the quarantine, the petition, posted on the website Change.org, calls on U.S. leaders to institute emergency production and distribution of personal protective equipment for healthcare workers and to rapidly increase access to testing.
The petition – which garnered more than 40,000 signatures in just 12 hours and as of this writing was approaching 94,000 – was started by an apolitical Facebook group to focus attention on what members see as the most critical issues for clinicians: slowing the spread of the virus through a coast-to-coast quarantine, protection of medical personnel with adequate supplies of essential equipment, and widespread testing.
“We started this group last Friday out of the realization that clinicians needed information about the outbreak and weren’t getting it,” said coadministrator Jessica McIntyre, MD, a pediatric hospitalist at Elliot Hospital in Manchester, N.H.
“We wanted to get ahead of it and connect with people before we were in the trenches experiencing it and to see what other programs were doing. From a local perspective, it has been really hard to see what people are doing in other states, especially when the protocols in our own states are changing every single day as we collect more information,” she said in an interview.
The Horse Has Bolted
A family medicine physician in Illinois helped launch the Facebook group. She asked that her name not be used but said in an interview that earlier actions may have prevented or at least delayed the need for the more draconian measures that her group is recommending.
“Clearly South Korea is one of the superstars as far as response has gone, but the concern we have in the United States is that we’re well beyond that point – we needed to be testing people over a month ago, in the hope of preventing a quarantine,” she said in an interview.
According to National Public Radio, as of March 13, South Korea had conducted 3,600 tests per million population, compared with five per million in the United States.
“I think the most concerning part is to see where Italy is now and where we are in comparison. Our ICUs have not yet overflowed, but I think we’re definitely looking at that in the next few weeks – hopefully longer, but I suspect that it will happen shortly,” she continued.
She cited work by Harvard University biostatistician Xihong Lin, PhD, that shows that when health authorities in Wuhan, China – widely cited as the epicenter of the global pandemic – cordoned off the city, the infection rate dropped from one person infecting 3.8 others to one infecting 1.25, thereby significantly slowing the rate of transmission.
“This is absolutely what we need to be doing,” she said.
Real News
Within 3 days of its creation, the online group had accrued more than 80,000 members with advanced medical training, including MDs, DOs, physician assistants, nurse practitioners, and certified registered nurse anesthetists.
“A lot of us were already very busy with our day-to-day work outside of COVID-19, and I think a lot of us felt unsure about where to get the best information,” said coadministrator David Janssen, MD, a family medicine physician in group practice in Sioux Center, Iowa,
“If you turn on the TV, there’s a lot of politicizing of the issue, and there’s a lot of good information, but also a lot of bad information. When health care providers talk to other health care providers, that’s often how we get our information and how we learn,” he said in an interview.
The COVID-19 U.S. Physicians/APP Facebook group includes 20 volunteer moderators who handle hundreds of posts per hour from persons seeking information on the novel coronavirus, what to tell patients, and how to protect themselves.
“It’s been wonderful to see how providers have been helping other providers sort through issues. Teaching hospitals have their hands on the latest research, but a lot of people like myself are at small community hospitals, critical-access hospitals, where we may have a lot of questions but don’t necessarily have the answers readily available to us,” Dr. Janssen said.
Dr. Janssen said that his community of about 8,000 residents initially had only four COVID-19 testing kits, or one for every 2,000 people. The situation has since improved, and more tests are now available, he added.
Dr. McIntyre, Dr. Janssen, and the Illinois family physician have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Microdiscectomy lessens pain intensity after persistent sciatica
Microdiscectomy could significantly reduce pain intensity at 6 months in people with chronic sciatica caused by lumbar disc herniation, a randomized controlled trial has found.
Researchers reported the outcomes of a single-center trial in the New England Journal of Medicine in which 128 patients with chronic sciatica resulting from lumbar disc herniation were randomized either to microdiscectomy or 6 months of standardized nonoperative care, followed by surgery if required.
Chris S. Bailey, MD, of the Schulich School of Medicine and Dentistry at Western University in Toronto, Ontario, and coauthors wrote that, while the majority of patients with sciatica from acute herniation of the lumbar disc improve with conservative care, there is little study comparing surgery with conservative care in patients whose symptoms have lasted longer than 3 months.
In this study, all patients had experienced unilateral radiculopathy for 4-12 months. Those randomized to surgery were operated on a median of 3.1 weeks after enrollment, while those randomized to nonsurgical treatment received education on exercise, functioning, and the use of oral analgesics, as well as active physiotherapy and epidural glucocorticoid injections if needed.
At 6 months, the surgical group showed significantly lower visual analog scale scores for leg-pain intensity, compared with the nonsurgical group (2.8 vs. 5.2; 95% confidence interval, 1.4-3.4; P < .001) and the difference persisted at 1 year (2.6 vs. 4.7).
In an editorial accompanying the study, Andrew J. Schoenfeld, MD, and James D. Kang, MD, of the department of orthopedic surgery at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, described the results in this group of patients with persistent sciatica as “encouraging,” and suggested the improvement may be because the surgery achieves more rapid decompression of the compressed nerve.
“Patients in the current trial who were assigned to undergo surgery received the intervention relatively quickly, at a median of 3 weeks, and it is reasonable to conclude that expeditious removal of the nerve compression minimized the potential for long-term persistence of pain,” they wrote.
Among the 64 patients who were randomized to nonsurgical treatment, 22 (34%) crossed over to undergo surgery at a median of 11 months after enrollment in the study. These patients tended to be younger at baseline, and less likely to have an asymmetrical decrease in reflexes.
The intention-to-treat analysis found a similar rate of surgical adverse events in the group initially randomized to surgery and the group who crossed over to have surgery (6% vs. 8%). Two patients in the surgical group and one in the crossover group experienced superficial wound infections, while two patients in the crossover group and one in the surgical group experienced new-onset postoperative neuropathic pain. Two patients in the surgical group also had a recurrence of their herniation; one underwent further surgery for it 250 days after the initial procedure, and the other did not.
The secondary outcomes of the study were disability score, physical health, mental health, back pain intensity, satisfaction with treatment, and employment status. All these showed differences that favored the surgical intervention, but “the absence of a prespecified plan for adjustment for multiple comparisons does not allow for clinical inferences from secondary outcomes.”
The authors noted that some previous randomized trials have shown that surgery was better than conservative care among patients with lumbar disc herniation for the first 6 months, but those trials largely focused on patients who had had symptoms for less than 4 months at the time of the intervention. The results of these trials had also been mixed; some trials in patients with shorter duration of symptoms found little or no benefit of surgery over conservative care.
“The decision about whether to recommend discectomy or nonsurgical treatment in this population is controversial because a longer duration of symptoms has been correlated with a poorer outcome associated with lumbar discectomy in some studies,” they wrote. “However, patients may prefer to avoid surgery if they think that nonsurgical treatment could be successful or if they anticipate a risk from surgery.”
There was the risk for selection bias in the study, the authors said, because both surgeons and patients might have been less inclined to go with nonsurgical care in cases of more severe sciatic pain. However they said patients did not have the option of choosing to have surgery at the center outside the trial, which should have minimized that risk.
The authors of the editorial noted that while the study limited itself to patients who had had symptoms for 4-12 months, it didn’t account for other clinical factors that might impact the outcome of discectomy, such as the size of disc herniation or extent of nerve compression.
They also pointed out that questions still remained about which patients were more likely to benefit from immediate surgical intervention and how long nonsurgical care should be trialed before recommending surgery.
The study was supported by a grant from the Physicians’ Services Incorporated Foundation. None of the study authors reported conflicts of interest. Dr. Kang reported grants from Pfizer, personal fees from DePuy (Johnson & Johnson), nonfinancial support from Stryker, owning stock in ALung and Cardiorobotics, and serving on a scientific advisory board for OnPoint Surgical, outside the submitted work. Dr. Schoenfeld reported grants from the National Institute for Arthritis and Musculoskeletal and Skin Diseases, the Orthopaedic Research and Education Foundation, and the U.S. Department of Defense, outside the submitted work.
SOURCE: Bailey C et al. N Engl J Med. 2020;382:1093-102.
Microdiscectomy could significantly reduce pain intensity at 6 months in people with chronic sciatica caused by lumbar disc herniation, a randomized controlled trial has found.
Researchers reported the outcomes of a single-center trial in the New England Journal of Medicine in which 128 patients with chronic sciatica resulting from lumbar disc herniation were randomized either to microdiscectomy or 6 months of standardized nonoperative care, followed by surgery if required.
Chris S. Bailey, MD, of the Schulich School of Medicine and Dentistry at Western University in Toronto, Ontario, and coauthors wrote that, while the majority of patients with sciatica from acute herniation of the lumbar disc improve with conservative care, there is little study comparing surgery with conservative care in patients whose symptoms have lasted longer than 3 months.
In this study, all patients had experienced unilateral radiculopathy for 4-12 months. Those randomized to surgery were operated on a median of 3.1 weeks after enrollment, while those randomized to nonsurgical treatment received education on exercise, functioning, and the use of oral analgesics, as well as active physiotherapy and epidural glucocorticoid injections if needed.
At 6 months, the surgical group showed significantly lower visual analog scale scores for leg-pain intensity, compared with the nonsurgical group (2.8 vs. 5.2; 95% confidence interval, 1.4-3.4; P < .001) and the difference persisted at 1 year (2.6 vs. 4.7).
In an editorial accompanying the study, Andrew J. Schoenfeld, MD, and James D. Kang, MD, of the department of orthopedic surgery at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, described the results in this group of patients with persistent sciatica as “encouraging,” and suggested the improvement may be because the surgery achieves more rapid decompression of the compressed nerve.
“Patients in the current trial who were assigned to undergo surgery received the intervention relatively quickly, at a median of 3 weeks, and it is reasonable to conclude that expeditious removal of the nerve compression minimized the potential for long-term persistence of pain,” they wrote.
Among the 64 patients who were randomized to nonsurgical treatment, 22 (34%) crossed over to undergo surgery at a median of 11 months after enrollment in the study. These patients tended to be younger at baseline, and less likely to have an asymmetrical decrease in reflexes.
The intention-to-treat analysis found a similar rate of surgical adverse events in the group initially randomized to surgery and the group who crossed over to have surgery (6% vs. 8%). Two patients in the surgical group and one in the crossover group experienced superficial wound infections, while two patients in the crossover group and one in the surgical group experienced new-onset postoperative neuropathic pain. Two patients in the surgical group also had a recurrence of their herniation; one underwent further surgery for it 250 days after the initial procedure, and the other did not.
The secondary outcomes of the study were disability score, physical health, mental health, back pain intensity, satisfaction with treatment, and employment status. All these showed differences that favored the surgical intervention, but “the absence of a prespecified plan for adjustment for multiple comparisons does not allow for clinical inferences from secondary outcomes.”
The authors noted that some previous randomized trials have shown that surgery was better than conservative care among patients with lumbar disc herniation for the first 6 months, but those trials largely focused on patients who had had symptoms for less than 4 months at the time of the intervention. The results of these trials had also been mixed; some trials in patients with shorter duration of symptoms found little or no benefit of surgery over conservative care.
“The decision about whether to recommend discectomy or nonsurgical treatment in this population is controversial because a longer duration of symptoms has been correlated with a poorer outcome associated with lumbar discectomy in some studies,” they wrote. “However, patients may prefer to avoid surgery if they think that nonsurgical treatment could be successful or if they anticipate a risk from surgery.”
There was the risk for selection bias in the study, the authors said, because both surgeons and patients might have been less inclined to go with nonsurgical care in cases of more severe sciatic pain. However they said patients did not have the option of choosing to have surgery at the center outside the trial, which should have minimized that risk.
The authors of the editorial noted that while the study limited itself to patients who had had symptoms for 4-12 months, it didn’t account for other clinical factors that might impact the outcome of discectomy, such as the size of disc herniation or extent of nerve compression.
They also pointed out that questions still remained about which patients were more likely to benefit from immediate surgical intervention and how long nonsurgical care should be trialed before recommending surgery.
The study was supported by a grant from the Physicians’ Services Incorporated Foundation. None of the study authors reported conflicts of interest. Dr. Kang reported grants from Pfizer, personal fees from DePuy (Johnson & Johnson), nonfinancial support from Stryker, owning stock in ALung and Cardiorobotics, and serving on a scientific advisory board for OnPoint Surgical, outside the submitted work. Dr. Schoenfeld reported grants from the National Institute for Arthritis and Musculoskeletal and Skin Diseases, the Orthopaedic Research and Education Foundation, and the U.S. Department of Defense, outside the submitted work.
SOURCE: Bailey C et al. N Engl J Med. 2020;382:1093-102.
Microdiscectomy could significantly reduce pain intensity at 6 months in people with chronic sciatica caused by lumbar disc herniation, a randomized controlled trial has found.
Researchers reported the outcomes of a single-center trial in the New England Journal of Medicine in which 128 patients with chronic sciatica resulting from lumbar disc herniation were randomized either to microdiscectomy or 6 months of standardized nonoperative care, followed by surgery if required.
Chris S. Bailey, MD, of the Schulich School of Medicine and Dentistry at Western University in Toronto, Ontario, and coauthors wrote that, while the majority of patients with sciatica from acute herniation of the lumbar disc improve with conservative care, there is little study comparing surgery with conservative care in patients whose symptoms have lasted longer than 3 months.
In this study, all patients had experienced unilateral radiculopathy for 4-12 months. Those randomized to surgery were operated on a median of 3.1 weeks after enrollment, while those randomized to nonsurgical treatment received education on exercise, functioning, and the use of oral analgesics, as well as active physiotherapy and epidural glucocorticoid injections if needed.
At 6 months, the surgical group showed significantly lower visual analog scale scores for leg-pain intensity, compared with the nonsurgical group (2.8 vs. 5.2; 95% confidence interval, 1.4-3.4; P < .001) and the difference persisted at 1 year (2.6 vs. 4.7).
In an editorial accompanying the study, Andrew J. Schoenfeld, MD, and James D. Kang, MD, of the department of orthopedic surgery at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, described the results in this group of patients with persistent sciatica as “encouraging,” and suggested the improvement may be because the surgery achieves more rapid decompression of the compressed nerve.
“Patients in the current trial who were assigned to undergo surgery received the intervention relatively quickly, at a median of 3 weeks, and it is reasonable to conclude that expeditious removal of the nerve compression minimized the potential for long-term persistence of pain,” they wrote.
Among the 64 patients who were randomized to nonsurgical treatment, 22 (34%) crossed over to undergo surgery at a median of 11 months after enrollment in the study. These patients tended to be younger at baseline, and less likely to have an asymmetrical decrease in reflexes.
The intention-to-treat analysis found a similar rate of surgical adverse events in the group initially randomized to surgery and the group who crossed over to have surgery (6% vs. 8%). Two patients in the surgical group and one in the crossover group experienced superficial wound infections, while two patients in the crossover group and one in the surgical group experienced new-onset postoperative neuropathic pain. Two patients in the surgical group also had a recurrence of their herniation; one underwent further surgery for it 250 days after the initial procedure, and the other did not.
The secondary outcomes of the study were disability score, physical health, mental health, back pain intensity, satisfaction with treatment, and employment status. All these showed differences that favored the surgical intervention, but “the absence of a prespecified plan for adjustment for multiple comparisons does not allow for clinical inferences from secondary outcomes.”
The authors noted that some previous randomized trials have shown that surgery was better than conservative care among patients with lumbar disc herniation for the first 6 months, but those trials largely focused on patients who had had symptoms for less than 4 months at the time of the intervention. The results of these trials had also been mixed; some trials in patients with shorter duration of symptoms found little or no benefit of surgery over conservative care.
“The decision about whether to recommend discectomy or nonsurgical treatment in this population is controversial because a longer duration of symptoms has been correlated with a poorer outcome associated with lumbar discectomy in some studies,” they wrote. “However, patients may prefer to avoid surgery if they think that nonsurgical treatment could be successful or if they anticipate a risk from surgery.”
There was the risk for selection bias in the study, the authors said, because both surgeons and patients might have been less inclined to go with nonsurgical care in cases of more severe sciatic pain. However they said patients did not have the option of choosing to have surgery at the center outside the trial, which should have minimized that risk.
The authors of the editorial noted that while the study limited itself to patients who had had symptoms for 4-12 months, it didn’t account for other clinical factors that might impact the outcome of discectomy, such as the size of disc herniation or extent of nerve compression.
They also pointed out that questions still remained about which patients were more likely to benefit from immediate surgical intervention and how long nonsurgical care should be trialed before recommending surgery.
The study was supported by a grant from the Physicians’ Services Incorporated Foundation. None of the study authors reported conflicts of interest. Dr. Kang reported grants from Pfizer, personal fees from DePuy (Johnson & Johnson), nonfinancial support from Stryker, owning stock in ALung and Cardiorobotics, and serving on a scientific advisory board for OnPoint Surgical, outside the submitted work. Dr. Schoenfeld reported grants from the National Institute for Arthritis and Musculoskeletal and Skin Diseases, the Orthopaedic Research and Education Foundation, and the U.S. Department of Defense, outside the submitted work.
SOURCE: Bailey C et al. N Engl J Med. 2020;382:1093-102.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Surgery may improve pain intensity in patients with persistent sciatica from lumbar disc herniation.
Major finding: Patients with persistent sciatica who underwent microdiscectomy had significantly lower leg pain intensity at 6 months.
Study details: Randomized controlled trial in 128 patients with chronic sciatica from lumbar disc herniation.
Disclosures: The study was supported by a grant from the Physicians’ Services Incorporated Foundation. None of the study authors reported conflicts of interest.
Source: Bailey C et al. N Engl J Med. 2020;382:1093-102.
COVID-19 in pregnant women and the impact on newborns
Clinical question: How does infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pregnant mothers affect their newborns?
Background: A novel coronavirus, now named SARS-CoV-2 by the World Health Organization (previously referred to as 2019-nCoV), is currently causing a worldwide pandemic. It is believed to have originated in Hubei province, China, but is now rapidly spreading in other countries. Although its effects are most severe in the elderly, SARS-CoV-2 has been infecting younger patients, including pregnant women. The effect of COVID-19, the disease caused by SARS-CoV-2, in pregnant women on their newborn children, is unknown, as is the nature of perinatal transmission of SARS-CoV-2.
Study design: Retrospective analysis.
Setting: Five hospitals in Hubei province, China.
Synopsis: Researchers retrospectively analyzed the clinical features and outcomes of 10 neonates (including two twins) born to nine mothers with confirmed SARS-CoV-2 infection in five hospitals in Hubei province, China, during Jan. 20–Feb. 5, 2020. The mothers were, on average, 30 years of age, but their prior state of health was not described. SARS-CoV-2 infection was confirmed in eight mothers by SARS-CoV-2 nucleic acid testing (NAT). The twins’ mother was diagnosed with COVID-19 based on chest CT scan showing viral interstitial pneumonia with other causes of fever and lung infection being “excluded,” despite a negative SARS-CoV-2 NAT test.
Symptoms occurred in the following:
- Before delivery in four mothers, three of whom were treated with oseltamivir (Tamiflu) after delivery.
- On the day of delivery in two mothers, one of whom was treated with oseltamivir and nebulized inhaled interferon after delivery.
- After delivery in three mothers.
Seven mothers delivered by cesarean section and two by vaginal delivery. Prenatal complications included intrauterine distress in six mothers, premature rupture of membranes in three (5-7 hours before onset of true labor), abnormal amniotic fluid in two, “abnormal” umbilical cord in two, and placenta previa in one.
The neonates born to these mothers included two females and eight males; four were full-term and six were premature (degree of prematurity not described). Symptoms first observed in these newborns included shortness of breath (six), fevers (two), tachycardia (one), and vomiting, feeding intolerance, “bloating,” refusing milk, and “gastric bleeding.” Chest radiographs were abnormal in seven newborns, including evidence of “infection” (four), neonatal respiratory distress syndrome (two), and pneumothorax (one). Two cases were described in detail:
- A neonate delivered at 34+5/7 weeks gestational age, was admitted due to shortness of breath and “moaning.” Eight days later, the neonate developed refractory shock, multiple organ failure, disseminated intravascular coagulation requiring transfusions of platelets, red blood cells, and plasma. He died on the ninth day.
- A neonate delivered at 34+6 weeks gestational age and was admitted 25 minutes after delivery due to shortness of breath and “moaning.” He required 2 days of noninvasive support/oxygen therapy and was observed to later develop “oxygen fluctuations” and thrombocytopenia at 3 days of life. The neonate was treated with “respiratory support,” intravenous immunoglobulin, transfusions of platelets and plasma, hydrocortisone (5 mg/kg per day for 6 days), low-dose heparin (2 units/kg per hr for 6 days), and low molecular weight heparin (2 units/kg per hr for 6 days). He was described to be “cured” 15 days later.
All nine neonates underwent pharyngeal swabs for SARS-CoV-2 NAT, and all were negative.
Bottom line: Although data are currently very limited, neonates born to mothers with COVID-19 appear to be at risk for adverse outcomes, including fetal distress, respiratory distress, thrombocytopenia associated with abnormal liver function, and death. There was no evidence of vertical transmission in this study.
Citation: Zhu H et al. Clinical analysis of 10 neonates born to mothers with 2019-nCoV pneumonia. Transl Pediatr. 2020 Feb;9(1):51-60.
Dr. Chang is chief of pediatric hospital medicine at Baystate Children’s Hospital in Springfield, Mass., and associate professor of pediatrics at the University of Massachusetts, also in Springfield.
Clinical question: How does infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pregnant mothers affect their newborns?
Background: A novel coronavirus, now named SARS-CoV-2 by the World Health Organization (previously referred to as 2019-nCoV), is currently causing a worldwide pandemic. It is believed to have originated in Hubei province, China, but is now rapidly spreading in other countries. Although its effects are most severe in the elderly, SARS-CoV-2 has been infecting younger patients, including pregnant women. The effect of COVID-19, the disease caused by SARS-CoV-2, in pregnant women on their newborn children, is unknown, as is the nature of perinatal transmission of SARS-CoV-2.
Study design: Retrospective analysis.
Setting: Five hospitals in Hubei province, China.
Synopsis: Researchers retrospectively analyzed the clinical features and outcomes of 10 neonates (including two twins) born to nine mothers with confirmed SARS-CoV-2 infection in five hospitals in Hubei province, China, during Jan. 20–Feb. 5, 2020. The mothers were, on average, 30 years of age, but their prior state of health was not described. SARS-CoV-2 infection was confirmed in eight mothers by SARS-CoV-2 nucleic acid testing (NAT). The twins’ mother was diagnosed with COVID-19 based on chest CT scan showing viral interstitial pneumonia with other causes of fever and lung infection being “excluded,” despite a negative SARS-CoV-2 NAT test.
Symptoms occurred in the following:
- Before delivery in four mothers, three of whom were treated with oseltamivir (Tamiflu) after delivery.
- On the day of delivery in two mothers, one of whom was treated with oseltamivir and nebulized inhaled interferon after delivery.
- After delivery in three mothers.
Seven mothers delivered by cesarean section and two by vaginal delivery. Prenatal complications included intrauterine distress in six mothers, premature rupture of membranes in three (5-7 hours before onset of true labor), abnormal amniotic fluid in two, “abnormal” umbilical cord in two, and placenta previa in one.
The neonates born to these mothers included two females and eight males; four were full-term and six were premature (degree of prematurity not described). Symptoms first observed in these newborns included shortness of breath (six), fevers (two), tachycardia (one), and vomiting, feeding intolerance, “bloating,” refusing milk, and “gastric bleeding.” Chest radiographs were abnormal in seven newborns, including evidence of “infection” (four), neonatal respiratory distress syndrome (two), and pneumothorax (one). Two cases were described in detail:
- A neonate delivered at 34+5/7 weeks gestational age, was admitted due to shortness of breath and “moaning.” Eight days later, the neonate developed refractory shock, multiple organ failure, disseminated intravascular coagulation requiring transfusions of platelets, red blood cells, and plasma. He died on the ninth day.
- A neonate delivered at 34+6 weeks gestational age and was admitted 25 minutes after delivery due to shortness of breath and “moaning.” He required 2 days of noninvasive support/oxygen therapy and was observed to later develop “oxygen fluctuations” and thrombocytopenia at 3 days of life. The neonate was treated with “respiratory support,” intravenous immunoglobulin, transfusions of platelets and plasma, hydrocortisone (5 mg/kg per day for 6 days), low-dose heparin (2 units/kg per hr for 6 days), and low molecular weight heparin (2 units/kg per hr for 6 days). He was described to be “cured” 15 days later.
All nine neonates underwent pharyngeal swabs for SARS-CoV-2 NAT, and all were negative.
Bottom line: Although data are currently very limited, neonates born to mothers with COVID-19 appear to be at risk for adverse outcomes, including fetal distress, respiratory distress, thrombocytopenia associated with abnormal liver function, and death. There was no evidence of vertical transmission in this study.
Citation: Zhu H et al. Clinical analysis of 10 neonates born to mothers with 2019-nCoV pneumonia. Transl Pediatr. 2020 Feb;9(1):51-60.
Dr. Chang is chief of pediatric hospital medicine at Baystate Children’s Hospital in Springfield, Mass., and associate professor of pediatrics at the University of Massachusetts, also in Springfield.
Clinical question: How does infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pregnant mothers affect their newborns?
Background: A novel coronavirus, now named SARS-CoV-2 by the World Health Organization (previously referred to as 2019-nCoV), is currently causing a worldwide pandemic. It is believed to have originated in Hubei province, China, but is now rapidly spreading in other countries. Although its effects are most severe in the elderly, SARS-CoV-2 has been infecting younger patients, including pregnant women. The effect of COVID-19, the disease caused by SARS-CoV-2, in pregnant women on their newborn children, is unknown, as is the nature of perinatal transmission of SARS-CoV-2.
Study design: Retrospective analysis.
Setting: Five hospitals in Hubei province, China.
Synopsis: Researchers retrospectively analyzed the clinical features and outcomes of 10 neonates (including two twins) born to nine mothers with confirmed SARS-CoV-2 infection in five hospitals in Hubei province, China, during Jan. 20–Feb. 5, 2020. The mothers were, on average, 30 years of age, but their prior state of health was not described. SARS-CoV-2 infection was confirmed in eight mothers by SARS-CoV-2 nucleic acid testing (NAT). The twins’ mother was diagnosed with COVID-19 based on chest CT scan showing viral interstitial pneumonia with other causes of fever and lung infection being “excluded,” despite a negative SARS-CoV-2 NAT test.
Symptoms occurred in the following:
- Before delivery in four mothers, three of whom were treated with oseltamivir (Tamiflu) after delivery.
- On the day of delivery in two mothers, one of whom was treated with oseltamivir and nebulized inhaled interferon after delivery.
- After delivery in three mothers.
Seven mothers delivered by cesarean section and two by vaginal delivery. Prenatal complications included intrauterine distress in six mothers, premature rupture of membranes in three (5-7 hours before onset of true labor), abnormal amniotic fluid in two, “abnormal” umbilical cord in two, and placenta previa in one.
The neonates born to these mothers included two females and eight males; four were full-term and six were premature (degree of prematurity not described). Symptoms first observed in these newborns included shortness of breath (six), fevers (two), tachycardia (one), and vomiting, feeding intolerance, “bloating,” refusing milk, and “gastric bleeding.” Chest radiographs were abnormal in seven newborns, including evidence of “infection” (four), neonatal respiratory distress syndrome (two), and pneumothorax (one). Two cases were described in detail:
- A neonate delivered at 34+5/7 weeks gestational age, was admitted due to shortness of breath and “moaning.” Eight days later, the neonate developed refractory shock, multiple organ failure, disseminated intravascular coagulation requiring transfusions of platelets, red blood cells, and plasma. He died on the ninth day.
- A neonate delivered at 34+6 weeks gestational age and was admitted 25 minutes after delivery due to shortness of breath and “moaning.” He required 2 days of noninvasive support/oxygen therapy and was observed to later develop “oxygen fluctuations” and thrombocytopenia at 3 days of life. The neonate was treated with “respiratory support,” intravenous immunoglobulin, transfusions of platelets and plasma, hydrocortisone (5 mg/kg per day for 6 days), low-dose heparin (2 units/kg per hr for 6 days), and low molecular weight heparin (2 units/kg per hr for 6 days). He was described to be “cured” 15 days later.
All nine neonates underwent pharyngeal swabs for SARS-CoV-2 NAT, and all were negative.
Bottom line: Although data are currently very limited, neonates born to mothers with COVID-19 appear to be at risk for adverse outcomes, including fetal distress, respiratory distress, thrombocytopenia associated with abnormal liver function, and death. There was no evidence of vertical transmission in this study.
Citation: Zhu H et al. Clinical analysis of 10 neonates born to mothers with 2019-nCoV pneumonia. Transl Pediatr. 2020 Feb;9(1):51-60.
Dr. Chang is chief of pediatric hospital medicine at Baystate Children’s Hospital in Springfield, Mass., and associate professor of pediatrics at the University of Massachusetts, also in Springfield.
Hospitalist movers and shakers – March 2020
Swati Mehta, MD, recently was honored as the lone hospitalist on the National Executive Physician Council for Beryl Institute (Nashville, Tenn.). Only 24 total physicians were selected to the council. Dr. Mehta also was named the 2019 Distinguished Physician Award winner at Vituity (Emeryville, Calif.), where she is the executive director of quality and performance.
A nocturnist at Sequoia Hospital (Redwood City, Calif.), Dr. Mehta is a member of the Society of Hospital Medicine’s Patient Experience interest group.
Shannon Phillips, MD, SFHM, has been named to the National Quality Forum’s Board of Directors for 2020. The chief patient experience officer at Intermountain Healthcare (Salt Lake City, Utah), she also is a recent member of the Performance Measurement and Reporting Committee.
Dr. Phillips, whose focus at Intermountain is on catalyzing safety, quality, and experience of care, was named a 2018 Becker’s Hospital Review Hospital and Health System CXO to Know. Previously, she worked at the Cleveland Clinic, where she was its first patient safety officer and an associate chief quality officer.
Vineet Arora, MD, MHM, has been elected as a new member of the National Academy of Medicine, which honors pioneering scientific and professional achievements within the field.
An academic hospitalist at the University of Chicago, Dr. Arora specializes in improving the learning environment for her medical trainees, as well as maintaining a high level of quality, safety, and care for patients. She also is considered an expert in using social media and other new technology to enhance medical education.
The National Academy of Medicine stated that Dr. Arora’s honor was “for pioneering work to optimize resident fatigue and patient safety during long shifts.”
Edmondo Robinson, MD, SFHM, has been named senior vice president and chief digital innovation officer at Moffitt Cancer Center (Tampa, Fla.). The chief digital innovation officer position is a newly created position that the veteran physician has assumed. Dr. Robinson has 16 years’ experience in clinical and technological work.
In this new position, Dr. Robinson, a practicing academic hospitalist, will head Moffitt’s digital innovation while looking to create and test new services, programs, partnerships, and technologies.
Dr. Robinson comes to Moffitt after serving as chief transformation officer and senior vice president at ChristianaCare (Wilmington, Del.). A teacher at Sidney Kimmel Medical College, Philadelphia, Dr. Robinson was the founding medical director of ChristianaCare Hospitalist Partners.
Relias Healthcare (Tupelo, Miss.) has begun providing hospitalist and emergency medicine services for North Mississippi Health Services’ Gilmore-Amory Trauma Center. Relias, a multistate company that has partnered with more than 150 providers, now has a role at four different North Mississippi Health Services facilities.
Mednax (Sunrise, Fla.) has added Arcenio Chacon and Associated Pediatricians of Homestead, a pediatric critical care and hospital practice, as an affiliate.
Chacon and Associated Pediatricians are based out of Miami and have served Baptist Health South Florida for more than 25 years. The four-physician practice provides critical care and pediatric hospitalist services at Baptist Children’s Hospital (Miami) and hospitalist services at Miami Cancer Institute and Homestead (Fla.) Hospital.
Mednax is a health solutions company that provides subspecialty service in all 50 states. Established in 1979, Mednax partners with hospitals, health systems, and health care facilities to offer clinical services, as well as revenue cycle management, patient engagement, and perioperative improvement consulting services.
Swati Mehta, MD, recently was honored as the lone hospitalist on the National Executive Physician Council for Beryl Institute (Nashville, Tenn.). Only 24 total physicians were selected to the council. Dr. Mehta also was named the 2019 Distinguished Physician Award winner at Vituity (Emeryville, Calif.), where she is the executive director of quality and performance.
A nocturnist at Sequoia Hospital (Redwood City, Calif.), Dr. Mehta is a member of the Society of Hospital Medicine’s Patient Experience interest group.
Shannon Phillips, MD, SFHM, has been named to the National Quality Forum’s Board of Directors for 2020. The chief patient experience officer at Intermountain Healthcare (Salt Lake City, Utah), she also is a recent member of the Performance Measurement and Reporting Committee.
Dr. Phillips, whose focus at Intermountain is on catalyzing safety, quality, and experience of care, was named a 2018 Becker’s Hospital Review Hospital and Health System CXO to Know. Previously, she worked at the Cleveland Clinic, where she was its first patient safety officer and an associate chief quality officer.
Vineet Arora, MD, MHM, has been elected as a new member of the National Academy of Medicine, which honors pioneering scientific and professional achievements within the field.
An academic hospitalist at the University of Chicago, Dr. Arora specializes in improving the learning environment for her medical trainees, as well as maintaining a high level of quality, safety, and care for patients. She also is considered an expert in using social media and other new technology to enhance medical education.
The National Academy of Medicine stated that Dr. Arora’s honor was “for pioneering work to optimize resident fatigue and patient safety during long shifts.”
Edmondo Robinson, MD, SFHM, has been named senior vice president and chief digital innovation officer at Moffitt Cancer Center (Tampa, Fla.). The chief digital innovation officer position is a newly created position that the veteran physician has assumed. Dr. Robinson has 16 years’ experience in clinical and technological work.
In this new position, Dr. Robinson, a practicing academic hospitalist, will head Moffitt’s digital innovation while looking to create and test new services, programs, partnerships, and technologies.
Dr. Robinson comes to Moffitt after serving as chief transformation officer and senior vice president at ChristianaCare (Wilmington, Del.). A teacher at Sidney Kimmel Medical College, Philadelphia, Dr. Robinson was the founding medical director of ChristianaCare Hospitalist Partners.
Relias Healthcare (Tupelo, Miss.) has begun providing hospitalist and emergency medicine services for North Mississippi Health Services’ Gilmore-Amory Trauma Center. Relias, a multistate company that has partnered with more than 150 providers, now has a role at four different North Mississippi Health Services facilities.
Mednax (Sunrise, Fla.) has added Arcenio Chacon and Associated Pediatricians of Homestead, a pediatric critical care and hospital practice, as an affiliate.
Chacon and Associated Pediatricians are based out of Miami and have served Baptist Health South Florida for more than 25 years. The four-physician practice provides critical care and pediatric hospitalist services at Baptist Children’s Hospital (Miami) and hospitalist services at Miami Cancer Institute and Homestead (Fla.) Hospital.
Mednax is a health solutions company that provides subspecialty service in all 50 states. Established in 1979, Mednax partners with hospitals, health systems, and health care facilities to offer clinical services, as well as revenue cycle management, patient engagement, and perioperative improvement consulting services.
Swati Mehta, MD, recently was honored as the lone hospitalist on the National Executive Physician Council for Beryl Institute (Nashville, Tenn.). Only 24 total physicians were selected to the council. Dr. Mehta also was named the 2019 Distinguished Physician Award winner at Vituity (Emeryville, Calif.), where she is the executive director of quality and performance.
A nocturnist at Sequoia Hospital (Redwood City, Calif.), Dr. Mehta is a member of the Society of Hospital Medicine’s Patient Experience interest group.
Shannon Phillips, MD, SFHM, has been named to the National Quality Forum’s Board of Directors for 2020. The chief patient experience officer at Intermountain Healthcare (Salt Lake City, Utah), she also is a recent member of the Performance Measurement and Reporting Committee.
Dr. Phillips, whose focus at Intermountain is on catalyzing safety, quality, and experience of care, was named a 2018 Becker’s Hospital Review Hospital and Health System CXO to Know. Previously, she worked at the Cleveland Clinic, where she was its first patient safety officer and an associate chief quality officer.
Vineet Arora, MD, MHM, has been elected as a new member of the National Academy of Medicine, which honors pioneering scientific and professional achievements within the field.
An academic hospitalist at the University of Chicago, Dr. Arora specializes in improving the learning environment for her medical trainees, as well as maintaining a high level of quality, safety, and care for patients. She also is considered an expert in using social media and other new technology to enhance medical education.
The National Academy of Medicine stated that Dr. Arora’s honor was “for pioneering work to optimize resident fatigue and patient safety during long shifts.”
Edmondo Robinson, MD, SFHM, has been named senior vice president and chief digital innovation officer at Moffitt Cancer Center (Tampa, Fla.). The chief digital innovation officer position is a newly created position that the veteran physician has assumed. Dr. Robinson has 16 years’ experience in clinical and technological work.
In this new position, Dr. Robinson, a practicing academic hospitalist, will head Moffitt’s digital innovation while looking to create and test new services, programs, partnerships, and technologies.
Dr. Robinson comes to Moffitt after serving as chief transformation officer and senior vice president at ChristianaCare (Wilmington, Del.). A teacher at Sidney Kimmel Medical College, Philadelphia, Dr. Robinson was the founding medical director of ChristianaCare Hospitalist Partners.
Relias Healthcare (Tupelo, Miss.) has begun providing hospitalist and emergency medicine services for North Mississippi Health Services’ Gilmore-Amory Trauma Center. Relias, a multistate company that has partnered with more than 150 providers, now has a role at four different North Mississippi Health Services facilities.
Mednax (Sunrise, Fla.) has added Arcenio Chacon and Associated Pediatricians of Homestead, a pediatric critical care and hospital practice, as an affiliate.
Chacon and Associated Pediatricians are based out of Miami and have served Baptist Health South Florida for more than 25 years. The four-physician practice provides critical care and pediatric hospitalist services at Baptist Children’s Hospital (Miami) and hospitalist services at Miami Cancer Institute and Homestead (Fla.) Hospital.
Mednax is a health solutions company that provides subspecialty service in all 50 states. Established in 1979, Mednax partners with hospitals, health systems, and health care facilities to offer clinical services, as well as revenue cycle management, patient engagement, and perioperative improvement consulting services.
COVID-19: U.S. cardiology groups reaffirm continued use of RAAS-active drugs
Controversy continued over the potential effect of drugs that interfere with the renin-angiotensin-aldosterone system via the angiotensin-converting enzymes (ACE) may have on exacerbating infection with the SARS-CoV-2 virus that causes COVID-19.
A joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America on March 17 gave full, unqualified support to maintaining patients on drugs that work this way, specifically the ACE inhibitors and angiotensin-receptor blockers (ARBs), which together form a long-standing cornerstone of treatment for hypertension, heart failure, and ischemic heart disease.
The three societies “recommend continuation” of ACE inhibitors or ARBs “for all patients already prescribed.” The statement went on to say that patients already diagnosed with a COVID-19 infection “should be fully evaluated before adding or removing any treatments, and any changes to their treatment should be based on the latest scientific evidence and shared decision making with their physician and health care team.”
“We understand the concern – as it has become clear that people with cardiovascular disease are at much higher risk of serious complications including death from COVID-19. However, we have reviewed the latest research – the evidence does not confirm the need to discontinue ACE inhibitors or ARBs, and we strongly recommend all physicians to consider the individual needs of each patient before making any changes to ACE-inhibitor or ARB treatment regimens,” said Robert A. Harrington, MD, president of the American Heart Association and professor and chair of medicine at Stanford (Calif.) University, in the statement.
“There are no experimental or clinical data demonstrating beneficial or adverse outcomes among COVID-19 patients using ACE-inhibitor or ARB medications,” added Richard J. Kovacs, MD, president of the American College of Cardiology and professor of cardiology at Indiana University in Indianapolis.
The “latest research” referred to in the statement likely focuses on a report that had appeared less than a week earlier in a British journal that hypothesized a possible increase in the susceptibility of human epithelial cells of the lungs, intestine, kidneys, and blood vessels exposed to these or certain other drugs, like the thiazolidinedione oral diabetes drugs or ibuprofen, because they cause up-regulation of the ACE2 protein in cell membranes, and ACE2 is the primary cell-surface receptor that allows the SARS-CoV-2 virus to enter.
“We therefore hypothesize that diabetes and hypertension treatment with ACE2-stimulating drugs increases the risk of developing severe and fatal COVID-19,” wrote Michael Roth, MD, and his associates in their recent article (Lancet Resp Med. 2020 Mar 11. doi: 10.1016/S2213-2600[20]30116-8). While the potential clinical impact of an increase in the number of ACE2 molecules in a cell’s surface membrane remains uninvestigated, the risk this phenomenon poses should mean that patients taking these drugs should receive heightened monitoring for COVID-19 disease, suggested Dr. Roth, a professor of biomedicine who specializes in studying inflammatory lung diseases including asthma, and associates.
However, others who have considered the impact that ACE inhibitors and ARBs might have on ACE2 and COVID-19 infections have noted that the picture is not simple. “Higher ACE2 expression following chronically medicating SARS‐CoV‐2 infected patients with AT1R [angiotensin receptor 1] blockers, while seemingly paradoxical, may protect them against acute lung injury rather than putting them at higher risk to develop SARS. This may be accounted for by two complementary mechanisms: blocking the excessive angiotensin‐mediated AT1R activation caused by the viral infection, as well as up-regulating ACE2, thereby reducing angiotensin production by ACE and increasing the production” of a vasodilating form of angiotensin, wrote David Gurwitz, PhD, in a recently published editorial (Drug Dev Res. 2020 Mar 4. doi: 10.1002/ddr.21656). A data-mining approach may allow researchers to determine whether patients who received drugs that interfere with angiotensin 1 function prior to being diagnosed with a COVID-19 infection had a better disease outcome, suggested Dr. Gurwitz, a molecular geneticist at Tel Aviv University in Jerusalem.
The statement from the three U.S. cardiology societies came a few days following a similar statement of support for ongoing use of ACE inhibitors and ARBs from the European Society of Cardiology’s Council on Hypertension.
Dr. Harrington, Dr. Kovacs, Dr. Roth, and Dr. Gurwitz had no relevant disclosures.
Controversy continued over the potential effect of drugs that interfere with the renin-angiotensin-aldosterone system via the angiotensin-converting enzymes (ACE) may have on exacerbating infection with the SARS-CoV-2 virus that causes COVID-19.
A joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America on March 17 gave full, unqualified support to maintaining patients on drugs that work this way, specifically the ACE inhibitors and angiotensin-receptor blockers (ARBs), which together form a long-standing cornerstone of treatment for hypertension, heart failure, and ischemic heart disease.
The three societies “recommend continuation” of ACE inhibitors or ARBs “for all patients already prescribed.” The statement went on to say that patients already diagnosed with a COVID-19 infection “should be fully evaluated before adding or removing any treatments, and any changes to their treatment should be based on the latest scientific evidence and shared decision making with their physician and health care team.”
“We understand the concern – as it has become clear that people with cardiovascular disease are at much higher risk of serious complications including death from COVID-19. However, we have reviewed the latest research – the evidence does not confirm the need to discontinue ACE inhibitors or ARBs, and we strongly recommend all physicians to consider the individual needs of each patient before making any changes to ACE-inhibitor or ARB treatment regimens,” said Robert A. Harrington, MD, president of the American Heart Association and professor and chair of medicine at Stanford (Calif.) University, in the statement.
“There are no experimental or clinical data demonstrating beneficial or adverse outcomes among COVID-19 patients using ACE-inhibitor or ARB medications,” added Richard J. Kovacs, MD, president of the American College of Cardiology and professor of cardiology at Indiana University in Indianapolis.
The “latest research” referred to in the statement likely focuses on a report that had appeared less than a week earlier in a British journal that hypothesized a possible increase in the susceptibility of human epithelial cells of the lungs, intestine, kidneys, and blood vessels exposed to these or certain other drugs, like the thiazolidinedione oral diabetes drugs or ibuprofen, because they cause up-regulation of the ACE2 protein in cell membranes, and ACE2 is the primary cell-surface receptor that allows the SARS-CoV-2 virus to enter.
“We therefore hypothesize that diabetes and hypertension treatment with ACE2-stimulating drugs increases the risk of developing severe and fatal COVID-19,” wrote Michael Roth, MD, and his associates in their recent article (Lancet Resp Med. 2020 Mar 11. doi: 10.1016/S2213-2600[20]30116-8). While the potential clinical impact of an increase in the number of ACE2 molecules in a cell’s surface membrane remains uninvestigated, the risk this phenomenon poses should mean that patients taking these drugs should receive heightened monitoring for COVID-19 disease, suggested Dr. Roth, a professor of biomedicine who specializes in studying inflammatory lung diseases including asthma, and associates.
However, others who have considered the impact that ACE inhibitors and ARBs might have on ACE2 and COVID-19 infections have noted that the picture is not simple. “Higher ACE2 expression following chronically medicating SARS‐CoV‐2 infected patients with AT1R [angiotensin receptor 1] blockers, while seemingly paradoxical, may protect them against acute lung injury rather than putting them at higher risk to develop SARS. This may be accounted for by two complementary mechanisms: blocking the excessive angiotensin‐mediated AT1R activation caused by the viral infection, as well as up-regulating ACE2, thereby reducing angiotensin production by ACE and increasing the production” of a vasodilating form of angiotensin, wrote David Gurwitz, PhD, in a recently published editorial (Drug Dev Res. 2020 Mar 4. doi: 10.1002/ddr.21656). A data-mining approach may allow researchers to determine whether patients who received drugs that interfere with angiotensin 1 function prior to being diagnosed with a COVID-19 infection had a better disease outcome, suggested Dr. Gurwitz, a molecular geneticist at Tel Aviv University in Jerusalem.
The statement from the three U.S. cardiology societies came a few days following a similar statement of support for ongoing use of ACE inhibitors and ARBs from the European Society of Cardiology’s Council on Hypertension.
Dr. Harrington, Dr. Kovacs, Dr. Roth, and Dr. Gurwitz had no relevant disclosures.
Controversy continued over the potential effect of drugs that interfere with the renin-angiotensin-aldosterone system via the angiotensin-converting enzymes (ACE) may have on exacerbating infection with the SARS-CoV-2 virus that causes COVID-19.
A joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America on March 17 gave full, unqualified support to maintaining patients on drugs that work this way, specifically the ACE inhibitors and angiotensin-receptor blockers (ARBs), which together form a long-standing cornerstone of treatment for hypertension, heart failure, and ischemic heart disease.
The three societies “recommend continuation” of ACE inhibitors or ARBs “for all patients already prescribed.” The statement went on to say that patients already diagnosed with a COVID-19 infection “should be fully evaluated before adding or removing any treatments, and any changes to their treatment should be based on the latest scientific evidence and shared decision making with their physician and health care team.”
“We understand the concern – as it has become clear that people with cardiovascular disease are at much higher risk of serious complications including death from COVID-19. However, we have reviewed the latest research – the evidence does not confirm the need to discontinue ACE inhibitors or ARBs, and we strongly recommend all physicians to consider the individual needs of each patient before making any changes to ACE-inhibitor or ARB treatment regimens,” said Robert A. Harrington, MD, president of the American Heart Association and professor and chair of medicine at Stanford (Calif.) University, in the statement.
“There are no experimental or clinical data demonstrating beneficial or adverse outcomes among COVID-19 patients using ACE-inhibitor or ARB medications,” added Richard J. Kovacs, MD, president of the American College of Cardiology and professor of cardiology at Indiana University in Indianapolis.
The “latest research” referred to in the statement likely focuses on a report that had appeared less than a week earlier in a British journal that hypothesized a possible increase in the susceptibility of human epithelial cells of the lungs, intestine, kidneys, and blood vessels exposed to these or certain other drugs, like the thiazolidinedione oral diabetes drugs or ibuprofen, because they cause up-regulation of the ACE2 protein in cell membranes, and ACE2 is the primary cell-surface receptor that allows the SARS-CoV-2 virus to enter.
“We therefore hypothesize that diabetes and hypertension treatment with ACE2-stimulating drugs increases the risk of developing severe and fatal COVID-19,” wrote Michael Roth, MD, and his associates in their recent article (Lancet Resp Med. 2020 Mar 11. doi: 10.1016/S2213-2600[20]30116-8). While the potential clinical impact of an increase in the number of ACE2 molecules in a cell’s surface membrane remains uninvestigated, the risk this phenomenon poses should mean that patients taking these drugs should receive heightened monitoring for COVID-19 disease, suggested Dr. Roth, a professor of biomedicine who specializes in studying inflammatory lung diseases including asthma, and associates.
However, others who have considered the impact that ACE inhibitors and ARBs might have on ACE2 and COVID-19 infections have noted that the picture is not simple. “Higher ACE2 expression following chronically medicating SARS‐CoV‐2 infected patients with AT1R [angiotensin receptor 1] blockers, while seemingly paradoxical, may protect them against acute lung injury rather than putting them at higher risk to develop SARS. This may be accounted for by two complementary mechanisms: blocking the excessive angiotensin‐mediated AT1R activation caused by the viral infection, as well as up-regulating ACE2, thereby reducing angiotensin production by ACE and increasing the production” of a vasodilating form of angiotensin, wrote David Gurwitz, PhD, in a recently published editorial (Drug Dev Res. 2020 Mar 4. doi: 10.1002/ddr.21656). A data-mining approach may allow researchers to determine whether patients who received drugs that interfere with angiotensin 1 function prior to being diagnosed with a COVID-19 infection had a better disease outcome, suggested Dr. Gurwitz, a molecular geneticist at Tel Aviv University in Jerusalem.
The statement from the three U.S. cardiology societies came a few days following a similar statement of support for ongoing use of ACE inhibitors and ARBs from the European Society of Cardiology’s Council on Hypertension.
Dr. Harrington, Dr. Kovacs, Dr. Roth, and Dr. Gurwitz had no relevant disclosures.
Study identifies two distinct type 1 diabetes ‘endotypes’
Two histologically distinct “endotypes” of type 1 diabetes, T1DE1 and T1DE2, have been identified in children based on their age at diagnosis
The findings were published online March 15 in Diabetologia by Pia Leete, PhD, of the Institute of Biomedical and Clinical Science, University of Exeter Medical School, UK, and colleagues.
The results suggest that the immune attack is far more aggressive and the islets more inflamed in the younger-onset group (T1DE1) and less intense in the older-onset group (T1DE2), the authors explain.
“We’re extremely excited to find evidence that type 1 diabetes is two separate conditions: T1DE1 and T1DE2. The significance of this could be enormous in helping us to understand what causes the illness and in unlocking avenues to prevent future generations of children from getting type 1 diabetes,” said senior author Noel G. Morgan, PhD, also of the University of Exeter, in a statement.
Morgan added that the discovery “might also lead to new treatments if we can find ways to reactivate dormant insulin-producing cells in the older age group. This would be a significant step towards the holy grail to find a cure for some people.”
Endotypes can inform immune interventions
The study involved an immunohistological analysis of proinsulin and insulin distribution in the islets of pancreas samples recovered from 19 youth who died soon after (<2 years) onset of type 1 diabetes and from 13 with onset more than 5 years prior to harvesting. Those results were compared with C-peptide and proinsulin measurements in 171 living individuals with type 1 diabetes of longer than 5 years duration.
The Exeter team has previously reported that the immune cell profiles in the inflamed islets of children younger than 7 years of age soon after the diagnosis of type 1 diabetes seem to be distinctly different for those in children aged 13 and older at diagnosis. The younger group at diagnosis (termed “T1DE1”) retained a lower proportion of insulin-containing islets than did the older-onset group (“T1DE2”).
Those aged 7-12 at diagnosis could belong to either group, but there was no continuum. Rather, they appeared to align distinctly with one or the other “endotype,” Leete and colleagues say.
In the new analysis, proinsulin processing was aberrant to a much greater degree among children diagnosed with type 1 diabetes prior to age 7 years than among those diagnosed after age 12 years, with the profiles of proinsulin processing correlating with the previously defined immune cell profiles.
For those aged 7-12, the proinsulin distribution in islets directly correlated with their immune phenotypes, either T1DE1 or T1DE2.
And among the living patients, circulating proinsulin:C-peptide ratios were elevated in the <7-year onset group compared with the ≥13-year group, even 5 years after diagnosis.
“Together, these data imply that, when considered alongside age at diagnosis, measurement of the ratio of proinsulin to C-peptide may represent a convenient biomarker to distinguish the endotypes defined here,” Leete and colleagues say.
The two-endotype proposal isn’t meant to suggest that “a simple dichotomy will ultimately be sufficient to account for the entire heterogeneity seen in people developing type 1 diabetes,” the authors stress. Rather, additional endotypes will likely be defined as more variables are considered.
They write, “Recognition of such differences should inform the design of future immunotherapeutic interventions designed to arrest disease progression.”
The research was sponsored by Diabetes UK and JDRF.
This article first appeared on Medscape.com.
Two histologically distinct “endotypes” of type 1 diabetes, T1DE1 and T1DE2, have been identified in children based on their age at diagnosis
The findings were published online March 15 in Diabetologia by Pia Leete, PhD, of the Institute of Biomedical and Clinical Science, University of Exeter Medical School, UK, and colleagues.
The results suggest that the immune attack is far more aggressive and the islets more inflamed in the younger-onset group (T1DE1) and less intense in the older-onset group (T1DE2), the authors explain.
“We’re extremely excited to find evidence that type 1 diabetes is two separate conditions: T1DE1 and T1DE2. The significance of this could be enormous in helping us to understand what causes the illness and in unlocking avenues to prevent future generations of children from getting type 1 diabetes,” said senior author Noel G. Morgan, PhD, also of the University of Exeter, in a statement.
Morgan added that the discovery “might also lead to new treatments if we can find ways to reactivate dormant insulin-producing cells in the older age group. This would be a significant step towards the holy grail to find a cure for some people.”
Endotypes can inform immune interventions
The study involved an immunohistological analysis of proinsulin and insulin distribution in the islets of pancreas samples recovered from 19 youth who died soon after (<2 years) onset of type 1 diabetes and from 13 with onset more than 5 years prior to harvesting. Those results were compared with C-peptide and proinsulin measurements in 171 living individuals with type 1 diabetes of longer than 5 years duration.
The Exeter team has previously reported that the immune cell profiles in the inflamed islets of children younger than 7 years of age soon after the diagnosis of type 1 diabetes seem to be distinctly different for those in children aged 13 and older at diagnosis. The younger group at diagnosis (termed “T1DE1”) retained a lower proportion of insulin-containing islets than did the older-onset group (“T1DE2”).
Those aged 7-12 at diagnosis could belong to either group, but there was no continuum. Rather, they appeared to align distinctly with one or the other “endotype,” Leete and colleagues say.
In the new analysis, proinsulin processing was aberrant to a much greater degree among children diagnosed with type 1 diabetes prior to age 7 years than among those diagnosed after age 12 years, with the profiles of proinsulin processing correlating with the previously defined immune cell profiles.
For those aged 7-12, the proinsulin distribution in islets directly correlated with their immune phenotypes, either T1DE1 or T1DE2.
And among the living patients, circulating proinsulin:C-peptide ratios were elevated in the <7-year onset group compared with the ≥13-year group, even 5 years after diagnosis.
“Together, these data imply that, when considered alongside age at diagnosis, measurement of the ratio of proinsulin to C-peptide may represent a convenient biomarker to distinguish the endotypes defined here,” Leete and colleagues say.
The two-endotype proposal isn’t meant to suggest that “a simple dichotomy will ultimately be sufficient to account for the entire heterogeneity seen in people developing type 1 diabetes,” the authors stress. Rather, additional endotypes will likely be defined as more variables are considered.
They write, “Recognition of such differences should inform the design of future immunotherapeutic interventions designed to arrest disease progression.”
The research was sponsored by Diabetes UK and JDRF.
This article first appeared on Medscape.com.
Two histologically distinct “endotypes” of type 1 diabetes, T1DE1 and T1DE2, have been identified in children based on their age at diagnosis
The findings were published online March 15 in Diabetologia by Pia Leete, PhD, of the Institute of Biomedical and Clinical Science, University of Exeter Medical School, UK, and colleagues.
The results suggest that the immune attack is far more aggressive and the islets more inflamed in the younger-onset group (T1DE1) and less intense in the older-onset group (T1DE2), the authors explain.
“We’re extremely excited to find evidence that type 1 diabetes is two separate conditions: T1DE1 and T1DE2. The significance of this could be enormous in helping us to understand what causes the illness and in unlocking avenues to prevent future generations of children from getting type 1 diabetes,” said senior author Noel G. Morgan, PhD, also of the University of Exeter, in a statement.
Morgan added that the discovery “might also lead to new treatments if we can find ways to reactivate dormant insulin-producing cells in the older age group. This would be a significant step towards the holy grail to find a cure for some people.”
Endotypes can inform immune interventions
The study involved an immunohistological analysis of proinsulin and insulin distribution in the islets of pancreas samples recovered from 19 youth who died soon after (<2 years) onset of type 1 diabetes and from 13 with onset more than 5 years prior to harvesting. Those results were compared with C-peptide and proinsulin measurements in 171 living individuals with type 1 diabetes of longer than 5 years duration.
The Exeter team has previously reported that the immune cell profiles in the inflamed islets of children younger than 7 years of age soon after the diagnosis of type 1 diabetes seem to be distinctly different for those in children aged 13 and older at diagnosis. The younger group at diagnosis (termed “T1DE1”) retained a lower proportion of insulin-containing islets than did the older-onset group (“T1DE2”).
Those aged 7-12 at diagnosis could belong to either group, but there was no continuum. Rather, they appeared to align distinctly with one or the other “endotype,” Leete and colleagues say.
In the new analysis, proinsulin processing was aberrant to a much greater degree among children diagnosed with type 1 diabetes prior to age 7 years than among those diagnosed after age 12 years, with the profiles of proinsulin processing correlating with the previously defined immune cell profiles.
For those aged 7-12, the proinsulin distribution in islets directly correlated with their immune phenotypes, either T1DE1 or T1DE2.
And among the living patients, circulating proinsulin:C-peptide ratios were elevated in the <7-year onset group compared with the ≥13-year group, even 5 years after diagnosis.
“Together, these data imply that, when considered alongside age at diagnosis, measurement of the ratio of proinsulin to C-peptide may represent a convenient biomarker to distinguish the endotypes defined here,” Leete and colleagues say.
The two-endotype proposal isn’t meant to suggest that “a simple dichotomy will ultimately be sufficient to account for the entire heterogeneity seen in people developing type 1 diabetes,” the authors stress. Rather, additional endotypes will likely be defined as more variables are considered.
They write, “Recognition of such differences should inform the design of future immunotherapeutic interventions designed to arrest disease progression.”
The research was sponsored by Diabetes UK and JDRF.
This article first appeared on Medscape.com.
Should physicians with OUDs return to practice after treatment?
New review points to importance of sustained recovery
A new article in the Journal of the Neurological Sciences provides an impressive review of research on the complex impairments produced by a wide range of drugs of abuse with a close look at physicians and other health care professionals.1
This review breaks new ground in outlining fitness for duty as an important outcome of the state physician health programs (PHPs). In addition, the review and case report by Alexandria G. Polles, MD, and colleagues are a response to the growing call for the state PHP system of care management to explicitly endorse the use of medication-assisted treatment, specifically the use of buprenorphine and methadone, in the treatment of physicians diagnosed with opioid use disorder (OUD). , because of the elevated rate of substance use disorders among physicians and the safety-sensitive nature of the practice of medicine.
Medication-assisted treatment (MAT)2 for opioid use disorders now dominates the field of treatment in terms of prescribing and also funding to address the opioid overdose crisis. MAT generally includes naltrexone and injectable naltrexone, though those antagonist medications have been used successfully for many decades by PHPs.3 However, to understand the controversy over the use of MAT in the care management of physicians first requires an understanding of state PHPs and how those programs oversee the care of physicians diagnosed with substance use disorders (SUDs), including OUDs.
A national blueprint study of PHPs showed that care begins with a formal diagnostic evaluation.4 Only when a diagnosis of an SUD is established is a physician referred to the attention of a state PHP, and a monitoring contract is signed. PHPs typically do not offer any direct treatment; instead, they manage the care of physician participants in programs in which the PHPs have confidence. Formal addiction treatment most often is 30 days of residential treatment, but many physicians receive intensive outpatient treatment.
After completing an episode of formal treatment, physicians are closely monitored, usually for 5 years, through random drug and alcohol tests, and work site monitors. They are required to engage in intensive recovery support, typically 12-step fellowships but also other alternative recovery support programs. Comorbid conditions, including mental health disorders, are also treated. Managing PHPs have no sanctions for noncompliance; however, importantly, they do offer a safe haven from state medical licensing boards for physicians who are compliant with their recommendations and who remain abstinent from any use of alcohol, marijuana, illicit drugs, or other nonmedical drug use.
The national blueprint study included 16 state PHPs and reviewed single episodes of PHP care for 908 physicians. Complete abstinence from any use of alcohol, marijuana, or other drugs was required of all physicians for monitoring periods of at least 5 years. During the extended period, 78% of the physicians did not have a single positive or missed test. Two-thirds of physicians who had one positive or missed test did not have a second. About a dozen publications have resulted from this national study, including an analysis of the roughly one-third of the physicians who were diagnosed with OUD.5
A sample of 702 PHP participants was grouped based on primary drug at intake: alcohol only, any opioid with or without alcohol, and nonopioid drugs. No significant differences were found among these groups in the percentage who completed PHP contracts, failed to complete their contract, or extended their contract and continued to be monitored. Only one physician received methadone to treat chronic pain. None received opioid agonists to treat their opioid use disorder. Opioid antagonist medication (naltrexone) was used for 40 physicians, or 5.7% of the total sample: 2 physicians (1%) from the alcohol-only group; 35 physicians (10.3%) from the any opioid group, and 3 physicians (1.9%) from nonopioid group.
The second fact that needs to be understood is that medical practice in relationship to SUDs is treated by state licensing boards as a safety-sensitive job, analogous to commercial airline pilots who have the Human Intervention Motivation Study (HIMS),6 which is their own care management program analogous to that of PHPs. A similar program exists for attorneys known as Commission on Lawyer Assistance Programs (CoLAP).7 Fitness for duty and prevention of harm are major concerns in occupations such as those of physicians, commercial truck drivers, and people working in the nuclear power industry, all of whom have similar safety protections requiring no drug use.
A third fact that deserves special attention is that the unique system of care management for physicians began in the early 1970s. It grew out of employee assistance programs, led then and often now by physicians who are themselves in recovery from SUDs. Many of the successful addiction treatment tools used today come from extensive research of their use in PHPs. Contingency management, 12 steps, caduceus recovery, cognitive-behavioral therapy, and treatment outcomes defined in years are examples in which PHP research helped change treatment and long-term management of SUDs in non-PHP populations.
Dr. Polles and colleagues provide an impressive and comprehensive summary of the issues involved in the new interest in providing the physicians with OUD under PHP care management the option of using buprenorphine or methadone. Such a model within an abstinence-based framework is now being pioneered by a variety of programs, from COAT8 at West Virginia University, Morgantown, to the Hazelden Betty Ford Foundation.9 In those programs, patients with OUD are offered the option of using buprenorphine, methadone, or naltrexone as well as the option of using none of those medications in an extended abstinence-based intensive treatment. The authors impressively and fairly summarize the evidence on whether there are cognitive or behavioral deficits associated with the therapeutic use of either buprenorphine or methadone, which might make them unacceptable for physicians. The strongest evidence that these medicines are not necessary in the treatment of OUDs in PHPs is the outstanding outcomes PHPs produce without use of these two medications. If skeptical of the use of medications for OUD treatment in PHP care management, Dr. Polles and colleagues are open to experiments to test the effects of this option just as Florida PHP programs pioneered contracts that included mandatory naltrexone.10 West Virginia University, the Hazelden Betty Ford Foundation, and other programs should be tested to evaluate just how safe, effective, and attractive such an option would be to physicians.
Many, if not most, SUD treatment programs that use MAT are not associated with the intensive psychological treatment or extended participation in recovery support, such as the 12-step fellowships. MAT is viewed as a harm reduction strategy rather than conceptualized as an abstinence-oriented treatment. For example, there is seldom a “sobriety date” among individuals in MAT, i.e., the last day the individual used any substance of abuse, including alcohol and marijuana. These are, however, central features of PHP care, and they are features of the Hazelden Betty Ford Foundation’s definition of recovery11 and use of MAT.
Dr. Polles and colleagues call attention to the unique care management of the PHP for all SUDs, not just for OUDs, because the PHPs set the standard for returning physicians to work who have the fitness and cognitive skills to first do no harm. They emphasize the importance of making sustained recovery the expected outcome of SUD treatment. There is a robust literature on the ways in which this distinctive system of care management shows the path forward for addiction treatment generally to regularly achieve 5-year recovery.12 The current controversy over the potential use of buprenorphine and buprenorphine plus naloxone in PHPs is a useful entry into this far larger issue of the potential for PHPs to show the path forward for the addiction treatment field.
Dr. DuPont, the first director of the National Institute on Drug Abuse (NIDA), is president of the Institute for Behavior and Health Inc., a nonprofit drug-policy research organization in Rockville, Md. He has no disclosures. Dr. Gold is professor of psychiatry (adjunct) at Washington University in St. Louis. He is also the 17th Distinguished Alumni Professor at the University of Florida Gainesville. He has no disclosures.
References
1. Polles AG et al. J Neurol Sci. 2020 Jan 30;411:116714.
2. Oesterle TS et al. Mayo Clin Proc. 2019 Oct;94(10):2072-86.
3. Srivastava AB and Gold MS. Cerebrum. 2018 Sep-Oct; cer-13-8.
4. DuPont RL et al. J Subst Abuse Treat. 2009 Mar 1;36(2):159-71.
5. Merlo LJ et al. J Subst Abuse Treat. 2016 May 1;64:47-54.
6. Human Intervention Motivation Study (HIMS): An Occupational Substance Abuse Treatment Program.
7. Commission on Lawyer Assistance Programs (CoLAP).
8. Lander LR et al. J Neurol Sci. 2020;411:116712-8.
9. Klein AA et al. J Subst Abuse Treat. 2019;104:51-63.
10. Merlo LJ et al. J Addict Med. 2012;5(4):279-83.
11. Betty Ford Consensus Panel. J Subst Abuse Treat. 2007 Oct;33(3):221-8.
12. Carr GD et al. “Physician health programs: The U.S. model.” In KJ Brower and MB Riba, (eds.) Physician Mental Health and Well-Being (pp. 265-94). Cham, Switzerland: Springer International Publishing, 2017.
New review points to importance of sustained recovery
New review points to importance of sustained recovery
A new article in the Journal of the Neurological Sciences provides an impressive review of research on the complex impairments produced by a wide range of drugs of abuse with a close look at physicians and other health care professionals.1
This review breaks new ground in outlining fitness for duty as an important outcome of the state physician health programs (PHPs). In addition, the review and case report by Alexandria G. Polles, MD, and colleagues are a response to the growing call for the state PHP system of care management to explicitly endorse the use of medication-assisted treatment, specifically the use of buprenorphine and methadone, in the treatment of physicians diagnosed with opioid use disorder (OUD). , because of the elevated rate of substance use disorders among physicians and the safety-sensitive nature of the practice of medicine.
Medication-assisted treatment (MAT)2 for opioid use disorders now dominates the field of treatment in terms of prescribing and also funding to address the opioid overdose crisis. MAT generally includes naltrexone and injectable naltrexone, though those antagonist medications have been used successfully for many decades by PHPs.3 However, to understand the controversy over the use of MAT in the care management of physicians first requires an understanding of state PHPs and how those programs oversee the care of physicians diagnosed with substance use disorders (SUDs), including OUDs.
A national blueprint study of PHPs showed that care begins with a formal diagnostic evaluation.4 Only when a diagnosis of an SUD is established is a physician referred to the attention of a state PHP, and a monitoring contract is signed. PHPs typically do not offer any direct treatment; instead, they manage the care of physician participants in programs in which the PHPs have confidence. Formal addiction treatment most often is 30 days of residential treatment, but many physicians receive intensive outpatient treatment.
After completing an episode of formal treatment, physicians are closely monitored, usually for 5 years, through random drug and alcohol tests, and work site monitors. They are required to engage in intensive recovery support, typically 12-step fellowships but also other alternative recovery support programs. Comorbid conditions, including mental health disorders, are also treated. Managing PHPs have no sanctions for noncompliance; however, importantly, they do offer a safe haven from state medical licensing boards for physicians who are compliant with their recommendations and who remain abstinent from any use of alcohol, marijuana, illicit drugs, or other nonmedical drug use.
The national blueprint study included 16 state PHPs and reviewed single episodes of PHP care for 908 physicians. Complete abstinence from any use of alcohol, marijuana, or other drugs was required of all physicians for monitoring periods of at least 5 years. During the extended period, 78% of the physicians did not have a single positive or missed test. Two-thirds of physicians who had one positive or missed test did not have a second. About a dozen publications have resulted from this national study, including an analysis of the roughly one-third of the physicians who were diagnosed with OUD.5
A sample of 702 PHP participants was grouped based on primary drug at intake: alcohol only, any opioid with or without alcohol, and nonopioid drugs. No significant differences were found among these groups in the percentage who completed PHP contracts, failed to complete their contract, or extended their contract and continued to be monitored. Only one physician received methadone to treat chronic pain. None received opioid agonists to treat their opioid use disorder. Opioid antagonist medication (naltrexone) was used for 40 physicians, or 5.7% of the total sample: 2 physicians (1%) from the alcohol-only group; 35 physicians (10.3%) from the any opioid group, and 3 physicians (1.9%) from nonopioid group.
The second fact that needs to be understood is that medical practice in relationship to SUDs is treated by state licensing boards as a safety-sensitive job, analogous to commercial airline pilots who have the Human Intervention Motivation Study (HIMS),6 which is their own care management program analogous to that of PHPs. A similar program exists for attorneys known as Commission on Lawyer Assistance Programs (CoLAP).7 Fitness for duty and prevention of harm are major concerns in occupations such as those of physicians, commercial truck drivers, and people working in the nuclear power industry, all of whom have similar safety protections requiring no drug use.
A third fact that deserves special attention is that the unique system of care management for physicians began in the early 1970s. It grew out of employee assistance programs, led then and often now by physicians who are themselves in recovery from SUDs. Many of the successful addiction treatment tools used today come from extensive research of their use in PHPs. Contingency management, 12 steps, caduceus recovery, cognitive-behavioral therapy, and treatment outcomes defined in years are examples in which PHP research helped change treatment and long-term management of SUDs in non-PHP populations.
Dr. Polles and colleagues provide an impressive and comprehensive summary of the issues involved in the new interest in providing the physicians with OUD under PHP care management the option of using buprenorphine or methadone. Such a model within an abstinence-based framework is now being pioneered by a variety of programs, from COAT8 at West Virginia University, Morgantown, to the Hazelden Betty Ford Foundation.9 In those programs, patients with OUD are offered the option of using buprenorphine, methadone, or naltrexone as well as the option of using none of those medications in an extended abstinence-based intensive treatment. The authors impressively and fairly summarize the evidence on whether there are cognitive or behavioral deficits associated with the therapeutic use of either buprenorphine or methadone, which might make them unacceptable for physicians. The strongest evidence that these medicines are not necessary in the treatment of OUDs in PHPs is the outstanding outcomes PHPs produce without use of these two medications. If skeptical of the use of medications for OUD treatment in PHP care management, Dr. Polles and colleagues are open to experiments to test the effects of this option just as Florida PHP programs pioneered contracts that included mandatory naltrexone.10 West Virginia University, the Hazelden Betty Ford Foundation, and other programs should be tested to evaluate just how safe, effective, and attractive such an option would be to physicians.
Many, if not most, SUD treatment programs that use MAT are not associated with the intensive psychological treatment or extended participation in recovery support, such as the 12-step fellowships. MAT is viewed as a harm reduction strategy rather than conceptualized as an abstinence-oriented treatment. For example, there is seldom a “sobriety date” among individuals in MAT, i.e., the last day the individual used any substance of abuse, including alcohol and marijuana. These are, however, central features of PHP care, and they are features of the Hazelden Betty Ford Foundation’s definition of recovery11 and use of MAT.
Dr. Polles and colleagues call attention to the unique care management of the PHP for all SUDs, not just for OUDs, because the PHPs set the standard for returning physicians to work who have the fitness and cognitive skills to first do no harm. They emphasize the importance of making sustained recovery the expected outcome of SUD treatment. There is a robust literature on the ways in which this distinctive system of care management shows the path forward for addiction treatment generally to regularly achieve 5-year recovery.12 The current controversy over the potential use of buprenorphine and buprenorphine plus naloxone in PHPs is a useful entry into this far larger issue of the potential for PHPs to show the path forward for the addiction treatment field.
Dr. DuPont, the first director of the National Institute on Drug Abuse (NIDA), is president of the Institute for Behavior and Health Inc., a nonprofit drug-policy research organization in Rockville, Md. He has no disclosures. Dr. Gold is professor of psychiatry (adjunct) at Washington University in St. Louis. He is also the 17th Distinguished Alumni Professor at the University of Florida Gainesville. He has no disclosures.
References
1. Polles AG et al. J Neurol Sci. 2020 Jan 30;411:116714.
2. Oesterle TS et al. Mayo Clin Proc. 2019 Oct;94(10):2072-86.
3. Srivastava AB and Gold MS. Cerebrum. 2018 Sep-Oct; cer-13-8.
4. DuPont RL et al. J Subst Abuse Treat. 2009 Mar 1;36(2):159-71.
5. Merlo LJ et al. J Subst Abuse Treat. 2016 May 1;64:47-54.
6. Human Intervention Motivation Study (HIMS): An Occupational Substance Abuse Treatment Program.
7. Commission on Lawyer Assistance Programs (CoLAP).
8. Lander LR et al. J Neurol Sci. 2020;411:116712-8.
9. Klein AA et al. J Subst Abuse Treat. 2019;104:51-63.
10. Merlo LJ et al. J Addict Med. 2012;5(4):279-83.
11. Betty Ford Consensus Panel. J Subst Abuse Treat. 2007 Oct;33(3):221-8.
12. Carr GD et al. “Physician health programs: The U.S. model.” In KJ Brower and MB Riba, (eds.) Physician Mental Health and Well-Being (pp. 265-94). Cham, Switzerland: Springer International Publishing, 2017.
A new article in the Journal of the Neurological Sciences provides an impressive review of research on the complex impairments produced by a wide range of drugs of abuse with a close look at physicians and other health care professionals.1
This review breaks new ground in outlining fitness for duty as an important outcome of the state physician health programs (PHPs). In addition, the review and case report by Alexandria G. Polles, MD, and colleagues are a response to the growing call for the state PHP system of care management to explicitly endorse the use of medication-assisted treatment, specifically the use of buprenorphine and methadone, in the treatment of physicians diagnosed with opioid use disorder (OUD). , because of the elevated rate of substance use disorders among physicians and the safety-sensitive nature of the practice of medicine.
Medication-assisted treatment (MAT)2 for opioid use disorders now dominates the field of treatment in terms of prescribing and also funding to address the opioid overdose crisis. MAT generally includes naltrexone and injectable naltrexone, though those antagonist medications have been used successfully for many decades by PHPs.3 However, to understand the controversy over the use of MAT in the care management of physicians first requires an understanding of state PHPs and how those programs oversee the care of physicians diagnosed with substance use disorders (SUDs), including OUDs.
A national blueprint study of PHPs showed that care begins with a formal diagnostic evaluation.4 Only when a diagnosis of an SUD is established is a physician referred to the attention of a state PHP, and a monitoring contract is signed. PHPs typically do not offer any direct treatment; instead, they manage the care of physician participants in programs in which the PHPs have confidence. Formal addiction treatment most often is 30 days of residential treatment, but many physicians receive intensive outpatient treatment.
After completing an episode of formal treatment, physicians are closely monitored, usually for 5 years, through random drug and alcohol tests, and work site monitors. They are required to engage in intensive recovery support, typically 12-step fellowships but also other alternative recovery support programs. Comorbid conditions, including mental health disorders, are also treated. Managing PHPs have no sanctions for noncompliance; however, importantly, they do offer a safe haven from state medical licensing boards for physicians who are compliant with their recommendations and who remain abstinent from any use of alcohol, marijuana, illicit drugs, or other nonmedical drug use.
The national blueprint study included 16 state PHPs and reviewed single episodes of PHP care for 908 physicians. Complete abstinence from any use of alcohol, marijuana, or other drugs was required of all physicians for monitoring periods of at least 5 years. During the extended period, 78% of the physicians did not have a single positive or missed test. Two-thirds of physicians who had one positive or missed test did not have a second. About a dozen publications have resulted from this national study, including an analysis of the roughly one-third of the physicians who were diagnosed with OUD.5
A sample of 702 PHP participants was grouped based on primary drug at intake: alcohol only, any opioid with or without alcohol, and nonopioid drugs. No significant differences were found among these groups in the percentage who completed PHP contracts, failed to complete their contract, or extended their contract and continued to be monitored. Only one physician received methadone to treat chronic pain. None received opioid agonists to treat their opioid use disorder. Opioid antagonist medication (naltrexone) was used for 40 physicians, or 5.7% of the total sample: 2 physicians (1%) from the alcohol-only group; 35 physicians (10.3%) from the any opioid group, and 3 physicians (1.9%) from nonopioid group.
The second fact that needs to be understood is that medical practice in relationship to SUDs is treated by state licensing boards as a safety-sensitive job, analogous to commercial airline pilots who have the Human Intervention Motivation Study (HIMS),6 which is their own care management program analogous to that of PHPs. A similar program exists for attorneys known as Commission on Lawyer Assistance Programs (CoLAP).7 Fitness for duty and prevention of harm are major concerns in occupations such as those of physicians, commercial truck drivers, and people working in the nuclear power industry, all of whom have similar safety protections requiring no drug use.
A third fact that deserves special attention is that the unique system of care management for physicians began in the early 1970s. It grew out of employee assistance programs, led then and often now by physicians who are themselves in recovery from SUDs. Many of the successful addiction treatment tools used today come from extensive research of their use in PHPs. Contingency management, 12 steps, caduceus recovery, cognitive-behavioral therapy, and treatment outcomes defined in years are examples in which PHP research helped change treatment and long-term management of SUDs in non-PHP populations.
Dr. Polles and colleagues provide an impressive and comprehensive summary of the issues involved in the new interest in providing the physicians with OUD under PHP care management the option of using buprenorphine or methadone. Such a model within an abstinence-based framework is now being pioneered by a variety of programs, from COAT8 at West Virginia University, Morgantown, to the Hazelden Betty Ford Foundation.9 In those programs, patients with OUD are offered the option of using buprenorphine, methadone, or naltrexone as well as the option of using none of those medications in an extended abstinence-based intensive treatment. The authors impressively and fairly summarize the evidence on whether there are cognitive or behavioral deficits associated with the therapeutic use of either buprenorphine or methadone, which might make them unacceptable for physicians. The strongest evidence that these medicines are not necessary in the treatment of OUDs in PHPs is the outstanding outcomes PHPs produce without use of these two medications. If skeptical of the use of medications for OUD treatment in PHP care management, Dr. Polles and colleagues are open to experiments to test the effects of this option just as Florida PHP programs pioneered contracts that included mandatory naltrexone.10 West Virginia University, the Hazelden Betty Ford Foundation, and other programs should be tested to evaluate just how safe, effective, and attractive such an option would be to physicians.
Many, if not most, SUD treatment programs that use MAT are not associated with the intensive psychological treatment or extended participation in recovery support, such as the 12-step fellowships. MAT is viewed as a harm reduction strategy rather than conceptualized as an abstinence-oriented treatment. For example, there is seldom a “sobriety date” among individuals in MAT, i.e., the last day the individual used any substance of abuse, including alcohol and marijuana. These are, however, central features of PHP care, and they are features of the Hazelden Betty Ford Foundation’s definition of recovery11 and use of MAT.
Dr. Polles and colleagues call attention to the unique care management of the PHP for all SUDs, not just for OUDs, because the PHPs set the standard for returning physicians to work who have the fitness and cognitive skills to first do no harm. They emphasize the importance of making sustained recovery the expected outcome of SUD treatment. There is a robust literature on the ways in which this distinctive system of care management shows the path forward for addiction treatment generally to regularly achieve 5-year recovery.12 The current controversy over the potential use of buprenorphine and buprenorphine plus naloxone in PHPs is a useful entry into this far larger issue of the potential for PHPs to show the path forward for the addiction treatment field.
Dr. DuPont, the first director of the National Institute on Drug Abuse (NIDA), is president of the Institute for Behavior and Health Inc., a nonprofit drug-policy research organization in Rockville, Md. He has no disclosures. Dr. Gold is professor of psychiatry (adjunct) at Washington University in St. Louis. He is also the 17th Distinguished Alumni Professor at the University of Florida Gainesville. He has no disclosures.
References
1. Polles AG et al. J Neurol Sci. 2020 Jan 30;411:116714.
2. Oesterle TS et al. Mayo Clin Proc. 2019 Oct;94(10):2072-86.
3. Srivastava AB and Gold MS. Cerebrum. 2018 Sep-Oct; cer-13-8.
4. DuPont RL et al. J Subst Abuse Treat. 2009 Mar 1;36(2):159-71.
5. Merlo LJ et al. J Subst Abuse Treat. 2016 May 1;64:47-54.
6. Human Intervention Motivation Study (HIMS): An Occupational Substance Abuse Treatment Program.
7. Commission on Lawyer Assistance Programs (CoLAP).
8. Lander LR et al. J Neurol Sci. 2020;411:116712-8.
9. Klein AA et al. J Subst Abuse Treat. 2019;104:51-63.
10. Merlo LJ et al. J Addict Med. 2012;5(4):279-83.
11. Betty Ford Consensus Panel. J Subst Abuse Treat. 2007 Oct;33(3):221-8.
12. Carr GD et al. “Physician health programs: The U.S. model.” In KJ Brower and MB Riba, (eds.) Physician Mental Health and Well-Being (pp. 265-94). Cham, Switzerland: Springer International Publishing, 2017.
HPV vaccine-chemo combo prolongs cervical cancer survival
Longer survival was observed in women who had a stronger immune response to an investigational human papillomavirus (HPV) vaccine while treated with standard chemotherapy for advanced, metastatic, or recurrent cervical cancer.
The results, from a phase 1/2 study, showed that women with a vaccine-induced immune response higher than the median had a median overall survival of 16.8 months, compared with a median overall survival of 11.2 months for women with an immune response lower than the median (hazard ratio, 0.491; P = .012).
Cornelis “Kees” Melief, MD, chief scientific officer of ISA Pharmaceuticals in Leiden, the Netherlands, and colleagues reported these findings in Science Translational Medicine.
The researchers previously evaluated the HPV16 vaccine, ISA101, in combination with carboplatin and paclitaxel in a pilot study. Results showed that carboplatin and paclitaxel reduced abnormally high numbers of immunosuppressive myeloid cells, which allowed for “much stronger” ISA101-induced tumor immunity.
To investigate further, the researchers tested the chemotherapy-ISA101 combination in a phase 1/2 study (NCT02128126) of 79 women with advanced, metastatic, or recurrent HPV16-positive cervical cancer.
The patients received the vaccine 2 weeks after starting the second, third, and fourth cycles of chemotherapy. They received various doses of the vaccine (20, 40, 100, or 300 mcg) with or without pegylated type 1 interferon (1 mcg/kg body weight).
“ISA101 was generally safe and well tolerated in that its safety profile was not different from chemotherapy alone,” Dr. Melief and colleagues wrote.
Chemotherapy-associated adverse events occurred in 98.9% of patients, with more than 80% of patients reporting adverse events possibly related to the vaccine or interferon-alpha. However, less than 16% of patients withdrew from the study because of an adverse event.
Of the 72 patients evaluable for efficacy, 43% experienced tumor regression, and 43% had stable disease. The researchers observed regression of the target lesion in 29 of 59 patients with a measurable target lesion.
The team noted that, since all patients received chemotherapy, it is “difficult to interpret short-term clinical outcomes as being due to chemotherapy alone or to the combination,” although they noted that the use of interferon-alpha did not seem to provide any additional benefit.
“Eleven of 14 patients still alive at the end of the study displayed a strong vaccine-induced response and included 9 patients with FIGO stage IVa/IVb cancer who had a mean OS [overall survival] of 3 years,” the researchers noted.
Considering that patients with higher vaccine-induced immune responses lived longer, the researchers concluded that “chemoimmunotherapy can be exploited to the benefit of patients with advanced cancer based on a defined mode of action.”
This trial was funded by ISA Pharmaceuticals and a Dutch Cancer Society grant. Investigators disclosed relationships with ISA Pharmaceuticals and other companies.
SOURCE: Melief CJM et al. Sci Transl Med. 2020;12:eaaz8235.
Longer survival was observed in women who had a stronger immune response to an investigational human papillomavirus (HPV) vaccine while treated with standard chemotherapy for advanced, metastatic, or recurrent cervical cancer.
The results, from a phase 1/2 study, showed that women with a vaccine-induced immune response higher than the median had a median overall survival of 16.8 months, compared with a median overall survival of 11.2 months for women with an immune response lower than the median (hazard ratio, 0.491; P = .012).
Cornelis “Kees” Melief, MD, chief scientific officer of ISA Pharmaceuticals in Leiden, the Netherlands, and colleagues reported these findings in Science Translational Medicine.
The researchers previously evaluated the HPV16 vaccine, ISA101, in combination with carboplatin and paclitaxel in a pilot study. Results showed that carboplatin and paclitaxel reduced abnormally high numbers of immunosuppressive myeloid cells, which allowed for “much stronger” ISA101-induced tumor immunity.
To investigate further, the researchers tested the chemotherapy-ISA101 combination in a phase 1/2 study (NCT02128126) of 79 women with advanced, metastatic, or recurrent HPV16-positive cervical cancer.
The patients received the vaccine 2 weeks after starting the second, third, and fourth cycles of chemotherapy. They received various doses of the vaccine (20, 40, 100, or 300 mcg) with or without pegylated type 1 interferon (1 mcg/kg body weight).
“ISA101 was generally safe and well tolerated in that its safety profile was not different from chemotherapy alone,” Dr. Melief and colleagues wrote.
Chemotherapy-associated adverse events occurred in 98.9% of patients, with more than 80% of patients reporting adverse events possibly related to the vaccine or interferon-alpha. However, less than 16% of patients withdrew from the study because of an adverse event.
Of the 72 patients evaluable for efficacy, 43% experienced tumor regression, and 43% had stable disease. The researchers observed regression of the target lesion in 29 of 59 patients with a measurable target lesion.
The team noted that, since all patients received chemotherapy, it is “difficult to interpret short-term clinical outcomes as being due to chemotherapy alone or to the combination,” although they noted that the use of interferon-alpha did not seem to provide any additional benefit.
“Eleven of 14 patients still alive at the end of the study displayed a strong vaccine-induced response and included 9 patients with FIGO stage IVa/IVb cancer who had a mean OS [overall survival] of 3 years,” the researchers noted.
Considering that patients with higher vaccine-induced immune responses lived longer, the researchers concluded that “chemoimmunotherapy can be exploited to the benefit of patients with advanced cancer based on a defined mode of action.”
This trial was funded by ISA Pharmaceuticals and a Dutch Cancer Society grant. Investigators disclosed relationships with ISA Pharmaceuticals and other companies.
SOURCE: Melief CJM et al. Sci Transl Med. 2020;12:eaaz8235.
Longer survival was observed in women who had a stronger immune response to an investigational human papillomavirus (HPV) vaccine while treated with standard chemotherapy for advanced, metastatic, or recurrent cervical cancer.
The results, from a phase 1/2 study, showed that women with a vaccine-induced immune response higher than the median had a median overall survival of 16.8 months, compared with a median overall survival of 11.2 months for women with an immune response lower than the median (hazard ratio, 0.491; P = .012).
Cornelis “Kees” Melief, MD, chief scientific officer of ISA Pharmaceuticals in Leiden, the Netherlands, and colleagues reported these findings in Science Translational Medicine.
The researchers previously evaluated the HPV16 vaccine, ISA101, in combination with carboplatin and paclitaxel in a pilot study. Results showed that carboplatin and paclitaxel reduced abnormally high numbers of immunosuppressive myeloid cells, which allowed for “much stronger” ISA101-induced tumor immunity.
To investigate further, the researchers tested the chemotherapy-ISA101 combination in a phase 1/2 study (NCT02128126) of 79 women with advanced, metastatic, or recurrent HPV16-positive cervical cancer.
The patients received the vaccine 2 weeks after starting the second, third, and fourth cycles of chemotherapy. They received various doses of the vaccine (20, 40, 100, or 300 mcg) with or without pegylated type 1 interferon (1 mcg/kg body weight).
“ISA101 was generally safe and well tolerated in that its safety profile was not different from chemotherapy alone,” Dr. Melief and colleagues wrote.
Chemotherapy-associated adverse events occurred in 98.9% of patients, with more than 80% of patients reporting adverse events possibly related to the vaccine or interferon-alpha. However, less than 16% of patients withdrew from the study because of an adverse event.
Of the 72 patients evaluable for efficacy, 43% experienced tumor regression, and 43% had stable disease. The researchers observed regression of the target lesion in 29 of 59 patients with a measurable target lesion.
The team noted that, since all patients received chemotherapy, it is “difficult to interpret short-term clinical outcomes as being due to chemotherapy alone or to the combination,” although they noted that the use of interferon-alpha did not seem to provide any additional benefit.
“Eleven of 14 patients still alive at the end of the study displayed a strong vaccine-induced response and included 9 patients with FIGO stage IVa/IVb cancer who had a mean OS [overall survival] of 3 years,” the researchers noted.
Considering that patients with higher vaccine-induced immune responses lived longer, the researchers concluded that “chemoimmunotherapy can be exploited to the benefit of patients with advanced cancer based on a defined mode of action.”
This trial was funded by ISA Pharmaceuticals and a Dutch Cancer Society grant. Investigators disclosed relationships with ISA Pharmaceuticals and other companies.
SOURCE: Melief CJM et al. Sci Transl Med. 2020;12:eaaz8235.
FROM SCIENCE TRANSLATIONAL MEDICINE
Key clinical point: There may be an overall survival benefit of combining human papillomavirus vaccination with standard-of-care chemotherapy for cervical cancer.
Major finding: The median overall survival was 16.8 months for patients with immune responses to the vaccine that were higher than the median and 11.2 months for patients with immune responses lower than the median (hazard ratio, 0.491; P = .012).
Study details: A phase 1/2 study of 77 women with HPV16-positive advanced, metastatic, or recurrent cervical cancer.
Disclosures: The study was funded by ISA Pharmaceuticals and a Dutch Cancer Society grant. Investigators disclosed relationships with ISA Pharmaceuticals and other companies.
Source: Melief CJM et al. Sci Transl Med. 2020;12:eaaz8235.
COVID-19 during pregnancy: How would you proceed in this case of a novel and ominous emerging pathogen?
CASE Pregnant patient with fever who has travel history to Italy
A 28-year-old primigravid woman at 12 weeks’ gestation just returned from a 2-week vacation in Italy. She requests medical evaluation because of malaise; fever; chills; rhinorrhea; mild dyspnea; a dry, nonproductive cough; and diarrhea. On physical examination, her temperature is 38.6° C (101.5° F), pulse 104 bpm, respirations 22/minute, and blood pressure 100/70 mm Hg. Auscultation of the lungs demonstrates scattered rales, rhonchi, and expiratory wheezes in both posterior lung fields. The fetal heart rate is 168 bpm. What are the most likely diagnoses? What diagnostic tests are indicated? And what clinical treatment is indicated?
In the presented case scenario, the patient’s symptoms are consistent with a viral influenza. Her recent travel history certainly makes coronavirus disease 2019 (COVID-19) the most likely diagnosis.
COVID-19, caused by a novel new coronavirus, has evolved with lightning speed since it was first identified in early December 2019.1 The disease originated in Wuhan, China. Its epicenter is now in Europe, and over 100 countries and regions have reported cases. New cases in the United States are being identified daily, and there is no clear end to the outbreak. Several areas of the United States have been particularly hard hit by this disease: Seattle, New Orleans, and New York City.
COVID-19 has provoked widespread unsettledness in many populations and an extraordinary response from public health officials, large corporations, professional organizations, and financial markets. We are learning more about somewhat unfamiliar public health concepts such as quarantine, containment, mitigation, reproduction number (R), and “flattening the curve.” Disneyland and Walt Disney World are now temporarily closed. Professional and collegiate sports organizations have cancelled or suspended games and tournaments. Scientific and trade association meetings have been postponed or cancelled. Broadway, Carnegie Hall, and the Metropolitan Museum of Art have now “turned out the lights.” The Centers for Disease Control and Prevention has recommended that everyone avoid gatherings that include more than 10 other persons.
This article will review the evolving epidemiology of COVID-19, describe the usual clinical manifestations of the disease, highlight the key diagnostic tests, and present guidelines for treatment. It will review the limited information currently available about the impact of COVID-19 in pregnant women. The review will conclude by describing measures that individuals can employ to prevent acquisition or transmission of infection and then by highlighting key “unanswered questions” about this new and ominous pathogen (TABLE).
Continue to: What we know about epidemiology...
What we know about epidemiology
COVID-19 is caused by a novel new coronavirus that shares some genetic overlap with the viruses that caused Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).2 The first case of COVID-19 was reported on December 1, 2019, from Wuhan, China.1 Within a very short period of time the disease has spread throughout the world, and on March 11, 2020, the World Health Organization (WHO) declared the infection to be a true pandemic. The countries with the highest prevalence of COVID-19 include China, South Korea, Iran, Italy, France, Spain, and the United States. However, more than 100 other countries and regions have reported cases. As of the first week of April, approximately 1 million persons in the world have been diagnosed with COVID-19. Of those infected, slightly more than 50,000 deaths have occurred. At the time of this writing, 234,483 cases have been documented in the United States, and current estimates indicate that approximately 7% of the population in the country could become infected.1,3,4
The virus responsible for COVID-19 is a single-stranded, enveloped RNA virus. Like its counterparts that caused SARS and MERS, this virus originates in animals, primarily bats. The early cases seem to have resulted from patient contact with exotic animals displayed in the Huanan Seafood Wholesale Market.1
The virus is transmitted directly by respiratory droplets and by close surface-to-hand contact with infected respiratory secretions. The virus appears to remain viable on environmental surfaces for 1 to 3 days, although the degree of infectivity over time is not well delineated. With direct exposure to respiratory droplets, the infectivity is relatively high; approximately 2 to 3 individuals become infected as the result of contact with an infected patient. By contrast, the “reproduction number (R)” for influenza is closer to 1.2,5
Certain persons appear to be at increased risk for developing infection and becoming seriously ill2,6:
- persons older than age 60
- persons with underlying medical illness
- persons who are immunosuppressed.
The reported range in the case fatality rate (CFR) varies from 1% to 13%, with the higher rates concentrated in older patients with comorbidities.3 These initial reports of high CFRs may be misleading because in the initial phases of this pandemic many patients with mild or no symptoms were not tested, and, thus, the overall prevalence of infection is not clear. By way of comparison, the CRF for influenza A and B is about 0.1%.2
Of note, the number of reported cases in the pediatric population is low, and the outcomes in these individuals are much better than in the older population.2,3,6 At present, there are only two reports of COVID-19 in pregnancy; these two studies include 18 women and 19 infants.7,8 The frequency of preterm delivery was 50% in these reports. Sixteen of the 18 patients were delivered by cesarean delivery; at least 6 of these procedures were performed for a non-reassuring fetal heart rate tracing. No maternal deaths were identified, and no cases of vertical transmission occurred.
We must remember that the number of patients described in these two reports is very small. Although the initial reports are favorable, in other influenza epidemics, pregnant women have not fared so well and have experienced disproportionately higher rates of morbidity and mortality.2
Reported clinical manifestations
The incubation period of COVID-19 ranges from 2 to 14 days; the median is 5.2 days. Many patients with proven COVID-19 infection are asymptomatic. When clinical findings are present, they usually are relatively mild and include low-grade fever, myalgias, arthralgias, sore throat, mild dyspnea, and a dry nonproductive cough. Some patients also may experience diarrhea. Of course, these findings are also consistent with influenza A or B or atypical pneumonia. One key to differentiation is the patient’s history of recent travel to an area of high COVID-19 prevalence or contact with a person who has been in one of these areas and who is clinically ill.2,3,9,10
In some patients, notably those who are older than 65 years of age and/or who have underlying medical illnesses, the respiratory manifestations are more prominent.6 These patients may develop severe dyspnea, pneumonia, adult respiratory distress syndrome (ARDS), multiorgan failure, and septic shock. Interestingly, the more severe manifestations tend to occur during the second week of the illness. In this group of more severely ill patients requiring hospitalization, 17% to 29% develop ARDS, and 23% to 32% require admission to the intensive care unit.2,6
Pregnant patients who become severely ill may be at risk for spontaneous miscarriage and preterm labor. With profound maternal hypoxia, fetal heart rate abnormalities may become apparent. To date, no clearly proven cases of vertical transmission of infection to the newborn have been identified. However, as noted above, current reports only include 18 pregnancies and 19 infants.2,3,7,8,11
Continue to: Diagnostic testing...
Diagnostic testing
Infected patients may have a decreased peripheral white blood cell count, with a specific decrease in the number of lymphocytes. Thrombocytopenia may be present, as well as an elevation in the hepatic transaminase enzymes (ALT, AST).2
X-ray, chest CT, and RT-PCR. The three most important diagnostic tests are chest x-ray, chest computed tomography (CT) scan, and real-time PCR (RT-PCR) or nucleic acid amplification test (NAAT).2,6 Specimens for RT-PCR or NAAT should be obtained from the oropharynx and nasopharynx using a synthetic-tipped applicator with an aluminum shaft. Patients who are intubated should have specimens obtained by broncho-alveolar lavage. The virus also has been recovered from blood and stool, but not yet from urine, amniotic fluid, placenta, cord blood, or breast milk.2
CT and chest x-ray show characteristic ground-glass opacities in both lung fields, combined with multiple areas of consolidation. Chest imaging is particularly helpful when the patient has all the major clinical manifestations, but the initial RT-PCR or NAAT is negative.
Treatment
Fortunately, most infected persons can be treated as outpatients. Because this condition may be confused with influenza A or B, initial treatment with a drug such as oseltamivir 75 mg orally twice daily for five days is very reasonable.9 Supportive therapy is critically important in this clinical setting. Acetaminophen, up to 3,000 mg/d in divided doses, or ibuprofen, up to 2,400 mg/d in divided doses, can be used to reduce fever and relieve myalgias and arthralgias. The latter drug, of course, should not be used in pregnant women. The patient should be encouraged to rest and to stay well hydrated. Loperamide can be used to treat diarrhea, 4 mg orally initially, then 2 mg orally after each loose stool up to a maximum of 16 mg/d. Pregnant patients should be cautioned to watch for signs of preterm labor.9,12 Patients should remain in relative isolation at home until they are free of signs of illness and they test negative for COVID-19.
For patients who are more severely ill at initial evaluation or who deteriorate while undergoing outpatient management, hospitalization is indicated.2,6 Patients should be placed in rooms that provide protection against aerosolized infection. They should receive supplemental oxygen and be observed closely for signs of superimposed bacterial infection. Depending upon the suspected bacterial pathogen, appropriate antibiotics may include ceftriaxone, which targets Streptococcus pneumoniae, Hemophilus influenzae, and Moraxella catarrhalis; azithromycin, which targets mycoplasmas; and vancomycin, which specifically covers Staphylococcus aureus. Health care workers should wear appropriate personal protective equipment when interacting with these patients, including cap, N95 mask, face shield, gloves, gown, and shoe covers. If a woman with COVID-19 has delivered, and the pediatrician permits rooming in, the isolette should be positioned at least 6 feet away from the mother. The mother should use a mechanical breast pump to obtain milk and then have another family member feed the baby until the mother tests negative for the virus. The breast pump needs to be cleaned meticulously after each use. The number of visitors to the mother’s room should be strictly limited.3,9
At the present time, there is no specific antiviral drug approved by the US Food and Drug Administration for treatment of COVID-19. The National Institutes of Health is currently conducting a trial of remdesivir for affected patients.13 The drug is also available from the manufacturer outside of this trial on a “compassionate use” basis. Another treatment regimen receiving extensive publicity is the combination of azithromycin and hydroxychloroquine. Its effectiveness has not been confirmed in a properly designed randomized trial.
Prevention hinges on commonsense precautions
Although vaccine trials are underway, public health authorities estimate that a vaccine will not be commercially available for at least 12 to 18 months. Therefore, independent of “community/organizational” mitigation programs, individuals should observe the following commonsense precautions to minimize their risk of contracting or transmitting COVID-192,3,5,14:
- Eliminate any nonessential travel, particularly by plane or cruise ship.
- Avoid events that draw large crowds, such as concerts, theater performances, movies, and even religious services.
- When out in public, try to maintain a distance of 6 feet from others
- Remain at home if you feel ill, particularly if you have respiratory symptoms.
- Cough or sneeze into your sleeve rather than your bare hand.
- Avoid handshakes.
- Wash your hands frequently in warm soapy water for at least 20 seconds, particularly after touching environmental surfaces such as counter tops and handrails.
- If you use hand sanitizers, they should have an alcohol content of at least 60%.
- Clean environmental surfaces frequently with a dilute bleach solution.
CASE Resolved
The clinical manifestations displayed by this patient are consistent with viral influenza. The recent travel history to one of the European epicenters makes COVID-19 the most likely diagnosis. The patient should have a chest CT scan and a RT-PCR or NAAT to confirm the diagnosis. If the diagnosis is confirmed, she and her close contacts should be self-quarantined at home for 14 days. She should receive appropriate supportive care with anti-pyretics, analgesics, and anti-diarrhea agents. If she develops signs of serious respiratory compromise, she should be admitted to an isolation room in the hospital for intensive respiratory therapy and close observation for superimposed bacterial pneumonia.
- Holshue ML, DeBolt C, Lindquist S, et al; Washington State 2019-nCoV Case Investigation Team. First case of 2019 novel coronavirus in the United States. N Engl J Med. 2020;382:929-936.
- Rasmussen SA, Smulian JC, Lednicky JA, et al. Coronavirus disease 2019 (COVID-19) and pregnancy: what obstetricians need to know. Am J Obstet Gynecol. February 24, 2020. doi: 10.1016/j.ajog.2020.02.017.
- Rasmussen SA, Jamieson DJ. Coronavirus disease 2019 (COVID-19) and pregnancy: responding to a rapidly evolving situation [in press]. Obstet Gynecol. 2020.
- Centers for Disease Control and Prevention. Coronavirus disease 2019: Cases in US. CDC website. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed March 18, 2020.
- Wang H, Wang Z, Dong Y, et al. Phase-adjusted estimation of the number of Coronavirus Disease 2019 cases in Wuhan, China. Cell Discov. 2020;6:10.
- Zhu N, Zhang D, Wang W, et al. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020;382:727-733.
- Chen H, Guo J, Wang C, et al. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020;395;809-815.
- Lei D, Wang C, Li C, et al. Clinical characteristics of pregnancy with the 2019 novel coronavirus disease (COVID-19) infection. Chin J Perinat Med. 2020:23.
- Dotters-Katz S, Hughes BL. Coronavirus (COVID-19) and pregnancy: what maternal-fetal medicine subspecialists need to know. Society for Maternal-Fetal Medicine. March 17, 2020. https://s3.amazonaws.com/cdn.smfm.org/media/2267/COVID19-_updated_3-17-20_PDF.pdf. Accessed March 17, 2020.
- Perlman S. Another decade, another coronavirus. N Engl J Med. 2020;382:760-762.
- Yang H, Wang C, Poon LC. Novel coronavirus infection and pregnancy. Ultrasound Obstet Gynecol. March 5, 2020. doi:10.1002/uog.22006.
- American College of Obstetricians and Gynecologists. Practice Advisory: novel coronavirus 2019 (COVID-19). March 13, 2020. https://www.acog.org/Clinical-Guidance-and-Publications/Practice-Advisories/Practice-Advisory-Novel-Coronavirus2019?IsMobileSet=false. Accessed March 17, 2020.
- National Institutes of Health. NIH clinical trial of remdesivir to treat COVID-19 begins. February 25, 2020. https://www.nih.gov/news-events/news-releases/nih-clinical-trial-remdesivir-treat-covid-19-begins. Accessed March 17, 2020.
- Munster VJ, Koopmans M, Van Doremalen N, et al. A novel coronavirus emerging in China – key questions for impact assessment. N Engl J Med. 2020;382:692-694.
CASE Pregnant patient with fever who has travel history to Italy
A 28-year-old primigravid woman at 12 weeks’ gestation just returned from a 2-week vacation in Italy. She requests medical evaluation because of malaise; fever; chills; rhinorrhea; mild dyspnea; a dry, nonproductive cough; and diarrhea. On physical examination, her temperature is 38.6° C (101.5° F), pulse 104 bpm, respirations 22/minute, and blood pressure 100/70 mm Hg. Auscultation of the lungs demonstrates scattered rales, rhonchi, and expiratory wheezes in both posterior lung fields. The fetal heart rate is 168 bpm. What are the most likely diagnoses? What diagnostic tests are indicated? And what clinical treatment is indicated?
In the presented case scenario, the patient’s symptoms are consistent with a viral influenza. Her recent travel history certainly makes coronavirus disease 2019 (COVID-19) the most likely diagnosis.
COVID-19, caused by a novel new coronavirus, has evolved with lightning speed since it was first identified in early December 2019.1 The disease originated in Wuhan, China. Its epicenter is now in Europe, and over 100 countries and regions have reported cases. New cases in the United States are being identified daily, and there is no clear end to the outbreak. Several areas of the United States have been particularly hard hit by this disease: Seattle, New Orleans, and New York City.
COVID-19 has provoked widespread unsettledness in many populations and an extraordinary response from public health officials, large corporations, professional organizations, and financial markets. We are learning more about somewhat unfamiliar public health concepts such as quarantine, containment, mitigation, reproduction number (R), and “flattening the curve.” Disneyland and Walt Disney World are now temporarily closed. Professional and collegiate sports organizations have cancelled or suspended games and tournaments. Scientific and trade association meetings have been postponed or cancelled. Broadway, Carnegie Hall, and the Metropolitan Museum of Art have now “turned out the lights.” The Centers for Disease Control and Prevention has recommended that everyone avoid gatherings that include more than 10 other persons.
This article will review the evolving epidemiology of COVID-19, describe the usual clinical manifestations of the disease, highlight the key diagnostic tests, and present guidelines for treatment. It will review the limited information currently available about the impact of COVID-19 in pregnant women. The review will conclude by describing measures that individuals can employ to prevent acquisition or transmission of infection and then by highlighting key “unanswered questions” about this new and ominous pathogen (TABLE).
Continue to: What we know about epidemiology...
What we know about epidemiology
COVID-19 is caused by a novel new coronavirus that shares some genetic overlap with the viruses that caused Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).2 The first case of COVID-19 was reported on December 1, 2019, from Wuhan, China.1 Within a very short period of time the disease has spread throughout the world, and on March 11, 2020, the World Health Organization (WHO) declared the infection to be a true pandemic. The countries with the highest prevalence of COVID-19 include China, South Korea, Iran, Italy, France, Spain, and the United States. However, more than 100 other countries and regions have reported cases. As of the first week of April, approximately 1 million persons in the world have been diagnosed with COVID-19. Of those infected, slightly more than 50,000 deaths have occurred. At the time of this writing, 234,483 cases have been documented in the United States, and current estimates indicate that approximately 7% of the population in the country could become infected.1,3,4
The virus responsible for COVID-19 is a single-stranded, enveloped RNA virus. Like its counterparts that caused SARS and MERS, this virus originates in animals, primarily bats. The early cases seem to have resulted from patient contact with exotic animals displayed in the Huanan Seafood Wholesale Market.1
The virus is transmitted directly by respiratory droplets and by close surface-to-hand contact with infected respiratory secretions. The virus appears to remain viable on environmental surfaces for 1 to 3 days, although the degree of infectivity over time is not well delineated. With direct exposure to respiratory droplets, the infectivity is relatively high; approximately 2 to 3 individuals become infected as the result of contact with an infected patient. By contrast, the “reproduction number (R)” for influenza is closer to 1.2,5
Certain persons appear to be at increased risk for developing infection and becoming seriously ill2,6:
- persons older than age 60
- persons with underlying medical illness
- persons who are immunosuppressed.
The reported range in the case fatality rate (CFR) varies from 1% to 13%, with the higher rates concentrated in older patients with comorbidities.3 These initial reports of high CFRs may be misleading because in the initial phases of this pandemic many patients with mild or no symptoms were not tested, and, thus, the overall prevalence of infection is not clear. By way of comparison, the CRF for influenza A and B is about 0.1%.2
Of note, the number of reported cases in the pediatric population is low, and the outcomes in these individuals are much better than in the older population.2,3,6 At present, there are only two reports of COVID-19 in pregnancy; these two studies include 18 women and 19 infants.7,8 The frequency of preterm delivery was 50% in these reports. Sixteen of the 18 patients were delivered by cesarean delivery; at least 6 of these procedures were performed for a non-reassuring fetal heart rate tracing. No maternal deaths were identified, and no cases of vertical transmission occurred.
We must remember that the number of patients described in these two reports is very small. Although the initial reports are favorable, in other influenza epidemics, pregnant women have not fared so well and have experienced disproportionately higher rates of morbidity and mortality.2
Reported clinical manifestations
The incubation period of COVID-19 ranges from 2 to 14 days; the median is 5.2 days. Many patients with proven COVID-19 infection are asymptomatic. When clinical findings are present, they usually are relatively mild and include low-grade fever, myalgias, arthralgias, sore throat, mild dyspnea, and a dry nonproductive cough. Some patients also may experience diarrhea. Of course, these findings are also consistent with influenza A or B or atypical pneumonia. One key to differentiation is the patient’s history of recent travel to an area of high COVID-19 prevalence or contact with a person who has been in one of these areas and who is clinically ill.2,3,9,10
In some patients, notably those who are older than 65 years of age and/or who have underlying medical illnesses, the respiratory manifestations are more prominent.6 These patients may develop severe dyspnea, pneumonia, adult respiratory distress syndrome (ARDS), multiorgan failure, and septic shock. Interestingly, the more severe manifestations tend to occur during the second week of the illness. In this group of more severely ill patients requiring hospitalization, 17% to 29% develop ARDS, and 23% to 32% require admission to the intensive care unit.2,6
Pregnant patients who become severely ill may be at risk for spontaneous miscarriage and preterm labor. With profound maternal hypoxia, fetal heart rate abnormalities may become apparent. To date, no clearly proven cases of vertical transmission of infection to the newborn have been identified. However, as noted above, current reports only include 18 pregnancies and 19 infants.2,3,7,8,11
Continue to: Diagnostic testing...
Diagnostic testing
Infected patients may have a decreased peripheral white blood cell count, with a specific decrease in the number of lymphocytes. Thrombocytopenia may be present, as well as an elevation in the hepatic transaminase enzymes (ALT, AST).2
X-ray, chest CT, and RT-PCR. The three most important diagnostic tests are chest x-ray, chest computed tomography (CT) scan, and real-time PCR (RT-PCR) or nucleic acid amplification test (NAAT).2,6 Specimens for RT-PCR or NAAT should be obtained from the oropharynx and nasopharynx using a synthetic-tipped applicator with an aluminum shaft. Patients who are intubated should have specimens obtained by broncho-alveolar lavage. The virus also has been recovered from blood and stool, but not yet from urine, amniotic fluid, placenta, cord blood, or breast milk.2
CT and chest x-ray show characteristic ground-glass opacities in both lung fields, combined with multiple areas of consolidation. Chest imaging is particularly helpful when the patient has all the major clinical manifestations, but the initial RT-PCR or NAAT is negative.
Treatment
Fortunately, most infected persons can be treated as outpatients. Because this condition may be confused with influenza A or B, initial treatment with a drug such as oseltamivir 75 mg orally twice daily for five days is very reasonable.9 Supportive therapy is critically important in this clinical setting. Acetaminophen, up to 3,000 mg/d in divided doses, or ibuprofen, up to 2,400 mg/d in divided doses, can be used to reduce fever and relieve myalgias and arthralgias. The latter drug, of course, should not be used in pregnant women. The patient should be encouraged to rest and to stay well hydrated. Loperamide can be used to treat diarrhea, 4 mg orally initially, then 2 mg orally after each loose stool up to a maximum of 16 mg/d. Pregnant patients should be cautioned to watch for signs of preterm labor.9,12 Patients should remain in relative isolation at home until they are free of signs of illness and they test negative for COVID-19.
For patients who are more severely ill at initial evaluation or who deteriorate while undergoing outpatient management, hospitalization is indicated.2,6 Patients should be placed in rooms that provide protection against aerosolized infection. They should receive supplemental oxygen and be observed closely for signs of superimposed bacterial infection. Depending upon the suspected bacterial pathogen, appropriate antibiotics may include ceftriaxone, which targets Streptococcus pneumoniae, Hemophilus influenzae, and Moraxella catarrhalis; azithromycin, which targets mycoplasmas; and vancomycin, which specifically covers Staphylococcus aureus. Health care workers should wear appropriate personal protective equipment when interacting with these patients, including cap, N95 mask, face shield, gloves, gown, and shoe covers. If a woman with COVID-19 has delivered, and the pediatrician permits rooming in, the isolette should be positioned at least 6 feet away from the mother. The mother should use a mechanical breast pump to obtain milk and then have another family member feed the baby until the mother tests negative for the virus. The breast pump needs to be cleaned meticulously after each use. The number of visitors to the mother’s room should be strictly limited.3,9
At the present time, there is no specific antiviral drug approved by the US Food and Drug Administration for treatment of COVID-19. The National Institutes of Health is currently conducting a trial of remdesivir for affected patients.13 The drug is also available from the manufacturer outside of this trial on a “compassionate use” basis. Another treatment regimen receiving extensive publicity is the combination of azithromycin and hydroxychloroquine. Its effectiveness has not been confirmed in a properly designed randomized trial.
Prevention hinges on commonsense precautions
Although vaccine trials are underway, public health authorities estimate that a vaccine will not be commercially available for at least 12 to 18 months. Therefore, independent of “community/organizational” mitigation programs, individuals should observe the following commonsense precautions to minimize their risk of contracting or transmitting COVID-192,3,5,14:
- Eliminate any nonessential travel, particularly by plane or cruise ship.
- Avoid events that draw large crowds, such as concerts, theater performances, movies, and even religious services.
- When out in public, try to maintain a distance of 6 feet from others
- Remain at home if you feel ill, particularly if you have respiratory symptoms.
- Cough or sneeze into your sleeve rather than your bare hand.
- Avoid handshakes.
- Wash your hands frequently in warm soapy water for at least 20 seconds, particularly after touching environmental surfaces such as counter tops and handrails.
- If you use hand sanitizers, they should have an alcohol content of at least 60%.
- Clean environmental surfaces frequently with a dilute bleach solution.
CASE Resolved
The clinical manifestations displayed by this patient are consistent with viral influenza. The recent travel history to one of the European epicenters makes COVID-19 the most likely diagnosis. The patient should have a chest CT scan and a RT-PCR or NAAT to confirm the diagnosis. If the diagnosis is confirmed, she and her close contacts should be self-quarantined at home for 14 days. She should receive appropriate supportive care with anti-pyretics, analgesics, and anti-diarrhea agents. If she develops signs of serious respiratory compromise, she should be admitted to an isolation room in the hospital for intensive respiratory therapy and close observation for superimposed bacterial pneumonia.
CASE Pregnant patient with fever who has travel history to Italy
A 28-year-old primigravid woman at 12 weeks’ gestation just returned from a 2-week vacation in Italy. She requests medical evaluation because of malaise; fever; chills; rhinorrhea; mild dyspnea; a dry, nonproductive cough; and diarrhea. On physical examination, her temperature is 38.6° C (101.5° F), pulse 104 bpm, respirations 22/minute, and blood pressure 100/70 mm Hg. Auscultation of the lungs demonstrates scattered rales, rhonchi, and expiratory wheezes in both posterior lung fields. The fetal heart rate is 168 bpm. What are the most likely diagnoses? What diagnostic tests are indicated? And what clinical treatment is indicated?
In the presented case scenario, the patient’s symptoms are consistent with a viral influenza. Her recent travel history certainly makes coronavirus disease 2019 (COVID-19) the most likely diagnosis.
COVID-19, caused by a novel new coronavirus, has evolved with lightning speed since it was first identified in early December 2019.1 The disease originated in Wuhan, China. Its epicenter is now in Europe, and over 100 countries and regions have reported cases. New cases in the United States are being identified daily, and there is no clear end to the outbreak. Several areas of the United States have been particularly hard hit by this disease: Seattle, New Orleans, and New York City.
COVID-19 has provoked widespread unsettledness in many populations and an extraordinary response from public health officials, large corporations, professional organizations, and financial markets. We are learning more about somewhat unfamiliar public health concepts such as quarantine, containment, mitigation, reproduction number (R), and “flattening the curve.” Disneyland and Walt Disney World are now temporarily closed. Professional and collegiate sports organizations have cancelled or suspended games and tournaments. Scientific and trade association meetings have been postponed or cancelled. Broadway, Carnegie Hall, and the Metropolitan Museum of Art have now “turned out the lights.” The Centers for Disease Control and Prevention has recommended that everyone avoid gatherings that include more than 10 other persons.
This article will review the evolving epidemiology of COVID-19, describe the usual clinical manifestations of the disease, highlight the key diagnostic tests, and present guidelines for treatment. It will review the limited information currently available about the impact of COVID-19 in pregnant women. The review will conclude by describing measures that individuals can employ to prevent acquisition or transmission of infection and then by highlighting key “unanswered questions” about this new and ominous pathogen (TABLE).
Continue to: What we know about epidemiology...
What we know about epidemiology
COVID-19 is caused by a novel new coronavirus that shares some genetic overlap with the viruses that caused Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).2 The first case of COVID-19 was reported on December 1, 2019, from Wuhan, China.1 Within a very short period of time the disease has spread throughout the world, and on March 11, 2020, the World Health Organization (WHO) declared the infection to be a true pandemic. The countries with the highest prevalence of COVID-19 include China, South Korea, Iran, Italy, France, Spain, and the United States. However, more than 100 other countries and regions have reported cases. As of the first week of April, approximately 1 million persons in the world have been diagnosed with COVID-19. Of those infected, slightly more than 50,000 deaths have occurred. At the time of this writing, 234,483 cases have been documented in the United States, and current estimates indicate that approximately 7% of the population in the country could become infected.1,3,4
The virus responsible for COVID-19 is a single-stranded, enveloped RNA virus. Like its counterparts that caused SARS and MERS, this virus originates in animals, primarily bats. The early cases seem to have resulted from patient contact with exotic animals displayed in the Huanan Seafood Wholesale Market.1
The virus is transmitted directly by respiratory droplets and by close surface-to-hand contact with infected respiratory secretions. The virus appears to remain viable on environmental surfaces for 1 to 3 days, although the degree of infectivity over time is not well delineated. With direct exposure to respiratory droplets, the infectivity is relatively high; approximately 2 to 3 individuals become infected as the result of contact with an infected patient. By contrast, the “reproduction number (R)” for influenza is closer to 1.2,5
Certain persons appear to be at increased risk for developing infection and becoming seriously ill2,6:
- persons older than age 60
- persons with underlying medical illness
- persons who are immunosuppressed.
The reported range in the case fatality rate (CFR) varies from 1% to 13%, with the higher rates concentrated in older patients with comorbidities.3 These initial reports of high CFRs may be misleading because in the initial phases of this pandemic many patients with mild or no symptoms were not tested, and, thus, the overall prevalence of infection is not clear. By way of comparison, the CRF for influenza A and B is about 0.1%.2
Of note, the number of reported cases in the pediatric population is low, and the outcomes in these individuals are much better than in the older population.2,3,6 At present, there are only two reports of COVID-19 in pregnancy; these two studies include 18 women and 19 infants.7,8 The frequency of preterm delivery was 50% in these reports. Sixteen of the 18 patients were delivered by cesarean delivery; at least 6 of these procedures were performed for a non-reassuring fetal heart rate tracing. No maternal deaths were identified, and no cases of vertical transmission occurred.
We must remember that the number of patients described in these two reports is very small. Although the initial reports are favorable, in other influenza epidemics, pregnant women have not fared so well and have experienced disproportionately higher rates of morbidity and mortality.2
Reported clinical manifestations
The incubation period of COVID-19 ranges from 2 to 14 days; the median is 5.2 days. Many patients with proven COVID-19 infection are asymptomatic. When clinical findings are present, they usually are relatively mild and include low-grade fever, myalgias, arthralgias, sore throat, mild dyspnea, and a dry nonproductive cough. Some patients also may experience diarrhea. Of course, these findings are also consistent with influenza A or B or atypical pneumonia. One key to differentiation is the patient’s history of recent travel to an area of high COVID-19 prevalence or contact with a person who has been in one of these areas and who is clinically ill.2,3,9,10
In some patients, notably those who are older than 65 years of age and/or who have underlying medical illnesses, the respiratory manifestations are more prominent.6 These patients may develop severe dyspnea, pneumonia, adult respiratory distress syndrome (ARDS), multiorgan failure, and septic shock. Interestingly, the more severe manifestations tend to occur during the second week of the illness. In this group of more severely ill patients requiring hospitalization, 17% to 29% develop ARDS, and 23% to 32% require admission to the intensive care unit.2,6
Pregnant patients who become severely ill may be at risk for spontaneous miscarriage and preterm labor. With profound maternal hypoxia, fetal heart rate abnormalities may become apparent. To date, no clearly proven cases of vertical transmission of infection to the newborn have been identified. However, as noted above, current reports only include 18 pregnancies and 19 infants.2,3,7,8,11
Continue to: Diagnostic testing...
Diagnostic testing
Infected patients may have a decreased peripheral white blood cell count, with a specific decrease in the number of lymphocytes. Thrombocytopenia may be present, as well as an elevation in the hepatic transaminase enzymes (ALT, AST).2
X-ray, chest CT, and RT-PCR. The three most important diagnostic tests are chest x-ray, chest computed tomography (CT) scan, and real-time PCR (RT-PCR) or nucleic acid amplification test (NAAT).2,6 Specimens for RT-PCR or NAAT should be obtained from the oropharynx and nasopharynx using a synthetic-tipped applicator with an aluminum shaft. Patients who are intubated should have specimens obtained by broncho-alveolar lavage. The virus also has been recovered from blood and stool, but not yet from urine, amniotic fluid, placenta, cord blood, or breast milk.2
CT and chest x-ray show characteristic ground-glass opacities in both lung fields, combined with multiple areas of consolidation. Chest imaging is particularly helpful when the patient has all the major clinical manifestations, but the initial RT-PCR or NAAT is negative.
Treatment
Fortunately, most infected persons can be treated as outpatients. Because this condition may be confused with influenza A or B, initial treatment with a drug such as oseltamivir 75 mg orally twice daily for five days is very reasonable.9 Supportive therapy is critically important in this clinical setting. Acetaminophen, up to 3,000 mg/d in divided doses, or ibuprofen, up to 2,400 mg/d in divided doses, can be used to reduce fever and relieve myalgias and arthralgias. The latter drug, of course, should not be used in pregnant women. The patient should be encouraged to rest and to stay well hydrated. Loperamide can be used to treat diarrhea, 4 mg orally initially, then 2 mg orally after each loose stool up to a maximum of 16 mg/d. Pregnant patients should be cautioned to watch for signs of preterm labor.9,12 Patients should remain in relative isolation at home until they are free of signs of illness and they test negative for COVID-19.
For patients who are more severely ill at initial evaluation or who deteriorate while undergoing outpatient management, hospitalization is indicated.2,6 Patients should be placed in rooms that provide protection against aerosolized infection. They should receive supplemental oxygen and be observed closely for signs of superimposed bacterial infection. Depending upon the suspected bacterial pathogen, appropriate antibiotics may include ceftriaxone, which targets Streptococcus pneumoniae, Hemophilus influenzae, and Moraxella catarrhalis; azithromycin, which targets mycoplasmas; and vancomycin, which specifically covers Staphylococcus aureus. Health care workers should wear appropriate personal protective equipment when interacting with these patients, including cap, N95 mask, face shield, gloves, gown, and shoe covers. If a woman with COVID-19 has delivered, and the pediatrician permits rooming in, the isolette should be positioned at least 6 feet away from the mother. The mother should use a mechanical breast pump to obtain milk and then have another family member feed the baby until the mother tests negative for the virus. The breast pump needs to be cleaned meticulously after each use. The number of visitors to the mother’s room should be strictly limited.3,9
At the present time, there is no specific antiviral drug approved by the US Food and Drug Administration for treatment of COVID-19. The National Institutes of Health is currently conducting a trial of remdesivir for affected patients.13 The drug is also available from the manufacturer outside of this trial on a “compassionate use” basis. Another treatment regimen receiving extensive publicity is the combination of azithromycin and hydroxychloroquine. Its effectiveness has not been confirmed in a properly designed randomized trial.
Prevention hinges on commonsense precautions
Although vaccine trials are underway, public health authorities estimate that a vaccine will not be commercially available for at least 12 to 18 months. Therefore, independent of “community/organizational” mitigation programs, individuals should observe the following commonsense precautions to minimize their risk of contracting or transmitting COVID-192,3,5,14:
- Eliminate any nonessential travel, particularly by plane or cruise ship.
- Avoid events that draw large crowds, such as concerts, theater performances, movies, and even religious services.
- When out in public, try to maintain a distance of 6 feet from others
- Remain at home if you feel ill, particularly if you have respiratory symptoms.
- Cough or sneeze into your sleeve rather than your bare hand.
- Avoid handshakes.
- Wash your hands frequently in warm soapy water for at least 20 seconds, particularly after touching environmental surfaces such as counter tops and handrails.
- If you use hand sanitizers, they should have an alcohol content of at least 60%.
- Clean environmental surfaces frequently with a dilute bleach solution.
CASE Resolved
The clinical manifestations displayed by this patient are consistent with viral influenza. The recent travel history to one of the European epicenters makes COVID-19 the most likely diagnosis. The patient should have a chest CT scan and a RT-PCR or NAAT to confirm the diagnosis. If the diagnosis is confirmed, she and her close contacts should be self-quarantined at home for 14 days. She should receive appropriate supportive care with anti-pyretics, analgesics, and anti-diarrhea agents. If she develops signs of serious respiratory compromise, she should be admitted to an isolation room in the hospital for intensive respiratory therapy and close observation for superimposed bacterial pneumonia.
- Holshue ML, DeBolt C, Lindquist S, et al; Washington State 2019-nCoV Case Investigation Team. First case of 2019 novel coronavirus in the United States. N Engl J Med. 2020;382:929-936.
- Rasmussen SA, Smulian JC, Lednicky JA, et al. Coronavirus disease 2019 (COVID-19) and pregnancy: what obstetricians need to know. Am J Obstet Gynecol. February 24, 2020. doi: 10.1016/j.ajog.2020.02.017.
- Rasmussen SA, Jamieson DJ. Coronavirus disease 2019 (COVID-19) and pregnancy: responding to a rapidly evolving situation [in press]. Obstet Gynecol. 2020.
- Centers for Disease Control and Prevention. Coronavirus disease 2019: Cases in US. CDC website. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed March 18, 2020.
- Wang H, Wang Z, Dong Y, et al. Phase-adjusted estimation of the number of Coronavirus Disease 2019 cases in Wuhan, China. Cell Discov. 2020;6:10.
- Zhu N, Zhang D, Wang W, et al. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020;382:727-733.
- Chen H, Guo J, Wang C, et al. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020;395;809-815.
- Lei D, Wang C, Li C, et al. Clinical characteristics of pregnancy with the 2019 novel coronavirus disease (COVID-19) infection. Chin J Perinat Med. 2020:23.
- Dotters-Katz S, Hughes BL. Coronavirus (COVID-19) and pregnancy: what maternal-fetal medicine subspecialists need to know. Society for Maternal-Fetal Medicine. March 17, 2020. https://s3.amazonaws.com/cdn.smfm.org/media/2267/COVID19-_updated_3-17-20_PDF.pdf. Accessed March 17, 2020.
- Perlman S. Another decade, another coronavirus. N Engl J Med. 2020;382:760-762.
- Yang H, Wang C, Poon LC. Novel coronavirus infection and pregnancy. Ultrasound Obstet Gynecol. March 5, 2020. doi:10.1002/uog.22006.
- American College of Obstetricians and Gynecologists. Practice Advisory: novel coronavirus 2019 (COVID-19). March 13, 2020. https://www.acog.org/Clinical-Guidance-and-Publications/Practice-Advisories/Practice-Advisory-Novel-Coronavirus2019?IsMobileSet=false. Accessed March 17, 2020.
- National Institutes of Health. NIH clinical trial of remdesivir to treat COVID-19 begins. February 25, 2020. https://www.nih.gov/news-events/news-releases/nih-clinical-trial-remdesivir-treat-covid-19-begins. Accessed March 17, 2020.
- Munster VJ, Koopmans M, Van Doremalen N, et al. A novel coronavirus emerging in China – key questions for impact assessment. N Engl J Med. 2020;382:692-694.
- Holshue ML, DeBolt C, Lindquist S, et al; Washington State 2019-nCoV Case Investigation Team. First case of 2019 novel coronavirus in the United States. N Engl J Med. 2020;382:929-936.
- Rasmussen SA, Smulian JC, Lednicky JA, et al. Coronavirus disease 2019 (COVID-19) and pregnancy: what obstetricians need to know. Am J Obstet Gynecol. February 24, 2020. doi: 10.1016/j.ajog.2020.02.017.
- Rasmussen SA, Jamieson DJ. Coronavirus disease 2019 (COVID-19) and pregnancy: responding to a rapidly evolving situation [in press]. Obstet Gynecol. 2020.
- Centers for Disease Control and Prevention. Coronavirus disease 2019: Cases in US. CDC website. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed March 18, 2020.
- Wang H, Wang Z, Dong Y, et al. Phase-adjusted estimation of the number of Coronavirus Disease 2019 cases in Wuhan, China. Cell Discov. 2020;6:10.
- Zhu N, Zhang D, Wang W, et al. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020;382:727-733.
- Chen H, Guo J, Wang C, et al. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020;395;809-815.
- Lei D, Wang C, Li C, et al. Clinical characteristics of pregnancy with the 2019 novel coronavirus disease (COVID-19) infection. Chin J Perinat Med. 2020:23.
- Dotters-Katz S, Hughes BL. Coronavirus (COVID-19) and pregnancy: what maternal-fetal medicine subspecialists need to know. Society for Maternal-Fetal Medicine. March 17, 2020. https://s3.amazonaws.com/cdn.smfm.org/media/2267/COVID19-_updated_3-17-20_PDF.pdf. Accessed March 17, 2020.
- Perlman S. Another decade, another coronavirus. N Engl J Med. 2020;382:760-762.
- Yang H, Wang C, Poon LC. Novel coronavirus infection and pregnancy. Ultrasound Obstet Gynecol. March 5, 2020. doi:10.1002/uog.22006.
- American College of Obstetricians and Gynecologists. Practice Advisory: novel coronavirus 2019 (COVID-19). March 13, 2020. https://www.acog.org/Clinical-Guidance-and-Publications/Practice-Advisories/Practice-Advisory-Novel-Coronavirus2019?IsMobileSet=false. Accessed March 17, 2020.
- National Institutes of Health. NIH clinical trial of remdesivir to treat COVID-19 begins. February 25, 2020. https://www.nih.gov/news-events/news-releases/nih-clinical-trial-remdesivir-treat-covid-19-begins. Accessed March 17, 2020.
- Munster VJ, Koopmans M, Van Doremalen N, et al. A novel coronavirus emerging in China – key questions for impact assessment. N Engl J Med. 2020;382:692-694.
COVID-19 guidance for children’s health care providers
We are in uncharted waters with national and local states of emergency, schools and most activities being shut down, and rapidly evolving strategies on managing the COVID-19 outbreak. Everyone’s anxiety is appropriately high. As health care providers for children, you are facing changes in your personal life at home and in practice, likely including setting up televisits, trying to assess which patients to see, managing staffing challenges, and facing potential cash flow issues as expenses continue but revenue may fall short. And, of course, you will address a host of novel questions and concerns from the families you care for.
Your top priorities are to stay calm while offering clear recommendations on testing, quarantine, and treatment with guidance from our federal and local public health agencies. By providing clear guidance on the medical issues, you will offer substantial reassurance to families. But even with a medical plan in place, this remains a confusing and anxiety-provoking moment, one without much precedent in most people’s lives or in our national experience. Our aim is to complement that guidance by offering you some principles to help families manage the stress and anxiety that the disruptions and uncertainties that this public health emergency has created.
Offer clear, open, regular, and child-centered communication
If you have an email mailing list of your parents, you may want to summarize information you are gathering with a note they can expect at a specified time each day. You could request them to email you questions that then can be included as an FAQ (frequently asked questions).
Most children will have noticed people wearing face masks, or dramatic scenes on the news with hospital workers in full protective gear, breathlessly reporting growing numbers of the infected and the deceased. At a minimum, they are being commanded to wash hands and to not touch their faces (which is challenging enough for adults!), and are probably overhearing conversations about quarantines and contagion as well as family concerns about jobs and family finances. Many children are managing extended school closures and some are even managing the quarantine or serious illness of a loved one. When children overhear frightening news from distressed adults, they are going to become anxious and afraid themselves. Parents should remember to find out what their children have seen, heard, or understood about what is going on, and they should correct misinformation or misunderstandings with clear explanations. They also should find out what their children are curious about. “What has you wondering about that?” is a great response when children have questions, in order to make sure you get at any underlying worry.
It is fine to not have an answer to every question. It is difficult to offer clear explanations about something that we don’t yet fully understand, and it is fine to acknowledge what we don’t know. “That’s a great question. Let’s look together at the CDC [Centers for Disease Control and Prevention] website.” Offering to look for answers or information together can be a powerful way to model how to handle uncertainty. And always couch answers with appropriate (not false) reassurance: “Children and young adults appear to be very safe from this illness, but we want to take care to protect those that are older or already sick.”
Remember most children set their anxiety level based on their parent’s anxiety, and part of being child centered in your communication includes offering information in an age-appropriate manner. Preschool-aged children (up to 5 years) still have magical thinking. They are prone to finding masks and gowns scary and to assume that school stopping may be because they did something wrong. Tell them about the new illness, and about the doctors and officials working hard to keep people safe. Reassure them about all of the adults working hard together to understand the illness and take care of people who are sick. Their sense of time is less logical, so you may have to tell them more than once. Reassure them that children do not get very sick from this illness, but they can carry and spread it, like having paint on their hands, so they need to wash their hands often to take good care of other people.
School-age children (aged roughly 5-12 years) are better equipped cognitively to understand the seriousness of this outbreak. They are built to master new situations, but are prone to anxiety as they don’t yet have the emotional maturity to tolerate uncertainty or unfairness. Explain what is known without euphemisms, be truly curious about what their questions are, and look for answers together. Often what they need is to see you being calm in the face of uncertainty, bearing the strong feelings that may come, and preserving curiosity and compassion for others.
Adolescents also will need all of this support, and can be curious about more abstract implications (political, ethical, financial). Do not be surprised when they ask sophisticated questions, but still are focused on the personal disruptions or sacrifices (a canceled dance or sports meet, concerns about academic performance). Adolescence is a time of intense preoccupation with their emerging identity and relationships; it is normal for them to experience events in a way that may seem selfish, especially if it disrupts their time with friends. Remind parents to offer compassion and validation, while acknowledging that shared sacrifice and discomfort are a part of every individual’s experience when a society must respond to such a large challenge.
Be mindful of children’s vulnerabilities
Being child centered goes beyond thinking about their age and developmental stage. Parents are the experts on their children and will know about any particular vulnerabilities to the stresses of this serious outbreak. Children who are prone to anxiety or suffer from anxiety disorders may be more prone to silent worry. It is especially important to check in with them often, find out what they know and what they are worried about, and remind them to “never worry alone.” It also is important to continue with any recommended treatment, avoiding accommodation of their anxieties, except when it is required by public health protocols (i.e., staying home from school). Children with developmental disabilities may require additional support to change behaviors (hand washing) and may be more sensitive to changes in routine. And children with learning disabilities or special services in school may require additional support or structure during a prolonged period at home.
Preserve routines and structure
Routines and predictability are important to the sense of stability and well-being of most children (and adults). While disruptions are unavoidable, preserve what routines you can, and establish some new ones. For children who are out of school for several weeks, set up a consistent home routine, with a similar wake-up and bedtime, and a “school schedule.” There may be academic activities like reading or work sheets. If the parents’ work is disrupted, they can homeschool, shoring up weak academic areas or enhancing areas of interest. Be sure to preserve time for physical activity and social connections within this new framework. Social time does not require physical proximity, and can happen by screen or phone. Physical activity should be outside if at all possible. Predictability, preserved expectations (academic and otherwise), physical exercise, social connection, and consistent sleep will go a long way in protecting everyone’s ability to manage the disruptions of this epidemic.
Find opportunity in the disruption
Many families have been on a treadmill of work, school, and activities that have left little unscheduled time or spontaneity. Recommend looking at this disruption as a rare opportunity to slow down, spend time together, listen, learn more about one another, and even to have fun. Families could play board games, card games, watch movies together, or even read aloud. They might discover it is the time to try new hobbies (knitting, learning a new language or instrument), or to teach each other new skills. You might learn something new, or something new about your children. You also will offer a model of finding the opportunity in adversity, and even offer them some wonderful memories from a difficult time.
Take care of the vulnerable and ease others’ hardships
Without a doubt, this will be a difficult time for many people, medically, financially, and emotionally. One powerful strategy to build resilience in our children and strengthen our communities is to think with children about ways to help those who are most at risk or burdened by this challenge. Perhaps they want to make cards or FaceTime calls to older relatives who may be otherwise isolated. They may want to consider ways to support the work of first responders, even just with appreciation. They may want to reach out to elderly neighbors and offer to get groceries or other needed supplies for them. Balancing appropriate self-care with a focus on the needs of those who are more vulnerable or burdened than ourselves is a powerful way to show our children how communities pull together in a challenging time; enhance their feeling of connectedness; and build resilience in them, in our families, and in our communities.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com
We are in uncharted waters with national and local states of emergency, schools and most activities being shut down, and rapidly evolving strategies on managing the COVID-19 outbreak. Everyone’s anxiety is appropriately high. As health care providers for children, you are facing changes in your personal life at home and in practice, likely including setting up televisits, trying to assess which patients to see, managing staffing challenges, and facing potential cash flow issues as expenses continue but revenue may fall short. And, of course, you will address a host of novel questions and concerns from the families you care for.
Your top priorities are to stay calm while offering clear recommendations on testing, quarantine, and treatment with guidance from our federal and local public health agencies. By providing clear guidance on the medical issues, you will offer substantial reassurance to families. But even with a medical plan in place, this remains a confusing and anxiety-provoking moment, one without much precedent in most people’s lives or in our national experience. Our aim is to complement that guidance by offering you some principles to help families manage the stress and anxiety that the disruptions and uncertainties that this public health emergency has created.
Offer clear, open, regular, and child-centered communication
If you have an email mailing list of your parents, you may want to summarize information you are gathering with a note they can expect at a specified time each day. You could request them to email you questions that then can be included as an FAQ (frequently asked questions).
Most children will have noticed people wearing face masks, or dramatic scenes on the news with hospital workers in full protective gear, breathlessly reporting growing numbers of the infected and the deceased. At a minimum, they are being commanded to wash hands and to not touch their faces (which is challenging enough for adults!), and are probably overhearing conversations about quarantines and contagion as well as family concerns about jobs and family finances. Many children are managing extended school closures and some are even managing the quarantine or serious illness of a loved one. When children overhear frightening news from distressed adults, they are going to become anxious and afraid themselves. Parents should remember to find out what their children have seen, heard, or understood about what is going on, and they should correct misinformation or misunderstandings with clear explanations. They also should find out what their children are curious about. “What has you wondering about that?” is a great response when children have questions, in order to make sure you get at any underlying worry.
It is fine to not have an answer to every question. It is difficult to offer clear explanations about something that we don’t yet fully understand, and it is fine to acknowledge what we don’t know. “That’s a great question. Let’s look together at the CDC [Centers for Disease Control and Prevention] website.” Offering to look for answers or information together can be a powerful way to model how to handle uncertainty. And always couch answers with appropriate (not false) reassurance: “Children and young adults appear to be very safe from this illness, but we want to take care to protect those that are older or already sick.”
Remember most children set their anxiety level based on their parent’s anxiety, and part of being child centered in your communication includes offering information in an age-appropriate manner. Preschool-aged children (up to 5 years) still have magical thinking. They are prone to finding masks and gowns scary and to assume that school stopping may be because they did something wrong. Tell them about the new illness, and about the doctors and officials working hard to keep people safe. Reassure them about all of the adults working hard together to understand the illness and take care of people who are sick. Their sense of time is less logical, so you may have to tell them more than once. Reassure them that children do not get very sick from this illness, but they can carry and spread it, like having paint on their hands, so they need to wash their hands often to take good care of other people.
School-age children (aged roughly 5-12 years) are better equipped cognitively to understand the seriousness of this outbreak. They are built to master new situations, but are prone to anxiety as they don’t yet have the emotional maturity to tolerate uncertainty or unfairness. Explain what is known without euphemisms, be truly curious about what their questions are, and look for answers together. Often what they need is to see you being calm in the face of uncertainty, bearing the strong feelings that may come, and preserving curiosity and compassion for others.
Adolescents also will need all of this support, and can be curious about more abstract implications (political, ethical, financial). Do not be surprised when they ask sophisticated questions, but still are focused on the personal disruptions or sacrifices (a canceled dance or sports meet, concerns about academic performance). Adolescence is a time of intense preoccupation with their emerging identity and relationships; it is normal for them to experience events in a way that may seem selfish, especially if it disrupts their time with friends. Remind parents to offer compassion and validation, while acknowledging that shared sacrifice and discomfort are a part of every individual’s experience when a society must respond to such a large challenge.
Be mindful of children’s vulnerabilities
Being child centered goes beyond thinking about their age and developmental stage. Parents are the experts on their children and will know about any particular vulnerabilities to the stresses of this serious outbreak. Children who are prone to anxiety or suffer from anxiety disorders may be more prone to silent worry. It is especially important to check in with them often, find out what they know and what they are worried about, and remind them to “never worry alone.” It also is important to continue with any recommended treatment, avoiding accommodation of their anxieties, except when it is required by public health protocols (i.e., staying home from school). Children with developmental disabilities may require additional support to change behaviors (hand washing) and may be more sensitive to changes in routine. And children with learning disabilities or special services in school may require additional support or structure during a prolonged period at home.
Preserve routines and structure
Routines and predictability are important to the sense of stability and well-being of most children (and adults). While disruptions are unavoidable, preserve what routines you can, and establish some new ones. For children who are out of school for several weeks, set up a consistent home routine, with a similar wake-up and bedtime, and a “school schedule.” There may be academic activities like reading or work sheets. If the parents’ work is disrupted, they can homeschool, shoring up weak academic areas or enhancing areas of interest. Be sure to preserve time for physical activity and social connections within this new framework. Social time does not require physical proximity, and can happen by screen or phone. Physical activity should be outside if at all possible. Predictability, preserved expectations (academic and otherwise), physical exercise, social connection, and consistent sleep will go a long way in protecting everyone’s ability to manage the disruptions of this epidemic.
Find opportunity in the disruption
Many families have been on a treadmill of work, school, and activities that have left little unscheduled time or spontaneity. Recommend looking at this disruption as a rare opportunity to slow down, spend time together, listen, learn more about one another, and even to have fun. Families could play board games, card games, watch movies together, or even read aloud. They might discover it is the time to try new hobbies (knitting, learning a new language or instrument), or to teach each other new skills. You might learn something new, or something new about your children. You also will offer a model of finding the opportunity in adversity, and even offer them some wonderful memories from a difficult time.
Take care of the vulnerable and ease others’ hardships
Without a doubt, this will be a difficult time for many people, medically, financially, and emotionally. One powerful strategy to build resilience in our children and strengthen our communities is to think with children about ways to help those who are most at risk or burdened by this challenge. Perhaps they want to make cards or FaceTime calls to older relatives who may be otherwise isolated. They may want to consider ways to support the work of first responders, even just with appreciation. They may want to reach out to elderly neighbors and offer to get groceries or other needed supplies for them. Balancing appropriate self-care with a focus on the needs of those who are more vulnerable or burdened than ourselves is a powerful way to show our children how communities pull together in a challenging time; enhance their feeling of connectedness; and build resilience in them, in our families, and in our communities.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com
We are in uncharted waters with national and local states of emergency, schools and most activities being shut down, and rapidly evolving strategies on managing the COVID-19 outbreak. Everyone’s anxiety is appropriately high. As health care providers for children, you are facing changes in your personal life at home and in practice, likely including setting up televisits, trying to assess which patients to see, managing staffing challenges, and facing potential cash flow issues as expenses continue but revenue may fall short. And, of course, you will address a host of novel questions and concerns from the families you care for.
Your top priorities are to stay calm while offering clear recommendations on testing, quarantine, and treatment with guidance from our federal and local public health agencies. By providing clear guidance on the medical issues, you will offer substantial reassurance to families. But even with a medical plan in place, this remains a confusing and anxiety-provoking moment, one without much precedent in most people’s lives or in our national experience. Our aim is to complement that guidance by offering you some principles to help families manage the stress and anxiety that the disruptions and uncertainties that this public health emergency has created.
Offer clear, open, regular, and child-centered communication
If you have an email mailing list of your parents, you may want to summarize information you are gathering with a note they can expect at a specified time each day. You could request them to email you questions that then can be included as an FAQ (frequently asked questions).
Most children will have noticed people wearing face masks, or dramatic scenes on the news with hospital workers in full protective gear, breathlessly reporting growing numbers of the infected and the deceased. At a minimum, they are being commanded to wash hands and to not touch their faces (which is challenging enough for adults!), and are probably overhearing conversations about quarantines and contagion as well as family concerns about jobs and family finances. Many children are managing extended school closures and some are even managing the quarantine or serious illness of a loved one. When children overhear frightening news from distressed adults, they are going to become anxious and afraid themselves. Parents should remember to find out what their children have seen, heard, or understood about what is going on, and they should correct misinformation or misunderstandings with clear explanations. They also should find out what their children are curious about. “What has you wondering about that?” is a great response when children have questions, in order to make sure you get at any underlying worry.
It is fine to not have an answer to every question. It is difficult to offer clear explanations about something that we don’t yet fully understand, and it is fine to acknowledge what we don’t know. “That’s a great question. Let’s look together at the CDC [Centers for Disease Control and Prevention] website.” Offering to look for answers or information together can be a powerful way to model how to handle uncertainty. And always couch answers with appropriate (not false) reassurance: “Children and young adults appear to be very safe from this illness, but we want to take care to protect those that are older or already sick.”
Remember most children set their anxiety level based on their parent’s anxiety, and part of being child centered in your communication includes offering information in an age-appropriate manner. Preschool-aged children (up to 5 years) still have magical thinking. They are prone to finding masks and gowns scary and to assume that school stopping may be because they did something wrong. Tell them about the new illness, and about the doctors and officials working hard to keep people safe. Reassure them about all of the adults working hard together to understand the illness and take care of people who are sick. Their sense of time is less logical, so you may have to tell them more than once. Reassure them that children do not get very sick from this illness, but they can carry and spread it, like having paint on their hands, so they need to wash their hands often to take good care of other people.
School-age children (aged roughly 5-12 years) are better equipped cognitively to understand the seriousness of this outbreak. They are built to master new situations, but are prone to anxiety as they don’t yet have the emotional maturity to tolerate uncertainty or unfairness. Explain what is known without euphemisms, be truly curious about what their questions are, and look for answers together. Often what they need is to see you being calm in the face of uncertainty, bearing the strong feelings that may come, and preserving curiosity and compassion for others.
Adolescents also will need all of this support, and can be curious about more abstract implications (political, ethical, financial). Do not be surprised when they ask sophisticated questions, but still are focused on the personal disruptions or sacrifices (a canceled dance or sports meet, concerns about academic performance). Adolescence is a time of intense preoccupation with their emerging identity and relationships; it is normal for them to experience events in a way that may seem selfish, especially if it disrupts their time with friends. Remind parents to offer compassion and validation, while acknowledging that shared sacrifice and discomfort are a part of every individual’s experience when a society must respond to such a large challenge.
Be mindful of children’s vulnerabilities
Being child centered goes beyond thinking about their age and developmental stage. Parents are the experts on their children and will know about any particular vulnerabilities to the stresses of this serious outbreak. Children who are prone to anxiety or suffer from anxiety disorders may be more prone to silent worry. It is especially important to check in with them often, find out what they know and what they are worried about, and remind them to “never worry alone.” It also is important to continue with any recommended treatment, avoiding accommodation of their anxieties, except when it is required by public health protocols (i.e., staying home from school). Children with developmental disabilities may require additional support to change behaviors (hand washing) and may be more sensitive to changes in routine. And children with learning disabilities or special services in school may require additional support or structure during a prolonged period at home.
Preserve routines and structure
Routines and predictability are important to the sense of stability and well-being of most children (and adults). While disruptions are unavoidable, preserve what routines you can, and establish some new ones. For children who are out of school for several weeks, set up a consistent home routine, with a similar wake-up and bedtime, and a “school schedule.” There may be academic activities like reading or work sheets. If the parents’ work is disrupted, they can homeschool, shoring up weak academic areas or enhancing areas of interest. Be sure to preserve time for physical activity and social connections within this new framework. Social time does not require physical proximity, and can happen by screen or phone. Physical activity should be outside if at all possible. Predictability, preserved expectations (academic and otherwise), physical exercise, social connection, and consistent sleep will go a long way in protecting everyone’s ability to manage the disruptions of this epidemic.
Find opportunity in the disruption
Many families have been on a treadmill of work, school, and activities that have left little unscheduled time or spontaneity. Recommend looking at this disruption as a rare opportunity to slow down, spend time together, listen, learn more about one another, and even to have fun. Families could play board games, card games, watch movies together, or even read aloud. They might discover it is the time to try new hobbies (knitting, learning a new language or instrument), or to teach each other new skills. You might learn something new, or something new about your children. You also will offer a model of finding the opportunity in adversity, and even offer them some wonderful memories from a difficult time.
Take care of the vulnerable and ease others’ hardships
Without a doubt, this will be a difficult time for many people, medically, financially, and emotionally. One powerful strategy to build resilience in our children and strengthen our communities is to think with children about ways to help those who are most at risk or burdened by this challenge. Perhaps they want to make cards or FaceTime calls to older relatives who may be otherwise isolated. They may want to consider ways to support the work of first responders, even just with appreciation. They may want to reach out to elderly neighbors and offer to get groceries or other needed supplies for them. Balancing appropriate self-care with a focus on the needs of those who are more vulnerable or burdened than ourselves is a powerful way to show our children how communities pull together in a challenging time; enhance their feeling of connectedness; and build resilience in them, in our families, and in our communities.
Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com