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The public’s trust in science
Having been a bench research scientist 30 years ago, I am flabbergasted at what is and is not currently possible. In a few weeks, scientists sequenced a novel coronavirus and used the genetic sequence to select candidate molecules for a vaccine. But we still can’t reliably say how much protection a cloth mask provides. Worse yet, even if/when we could reliably quantify contagion, it isn’t clear that the public will believe us anyhow.
The good news is that the public worldwide did believe scientists about the threat of a pandemic and the need to flatten the curve. Saving lives has not been about the strength of an antibiotic or the skill in managing a ventilator, but the credibility of medical scientists. The degree of acceptance was variable and subject to a variety of delays caused by regional politicians, but The bad news is that the public’s trust in that scientific advice has waned, the willingness to accept onerous restrictions has fatigued, and the cooperation for maintaining these social changes is evaporating.
I will leave pontificating about the spread of COVID-19 to other experts in other forums. My focus is on the public’s trust in the professionalism of physicians, nurses, medical scientists, and the health care industry as a whole. That trust has been our most valuable tool in fighting the pandemic so far. There have been situations in which weaknesses in modern science have let society down during the pandemic of the century. In my February 2020 column, at the beginning of the outbreak, a month before it was declared a pandemic, when its magnitude was still unclear, I emphasized the importance of having a trusted scientific spokesperson providing timely, accurate information to the public. That, obviously, did not happen in the United States and the degree of the ensuing disaster is still to be revealed.
Scientists have made some wrong decisions about this novel threat. The advice on masks is an illustrative example. For many years, infection control nurses have insisted that medical students wear a mask to protect themselves, even if they were observing rounds from just inside the doorway of a room of a baby with bronchiolitis. The landfills are full of briefly worn surgical masks. Now the story goes: Surgical masks don’t protect staff; they protect others. Changes like that contribute to a credibility gap.
For 3 months, there was conflicting advice about the appropriateness of masks. In early March 2020, some health care workers were disciplined for wearing personal masks. Now, most scientists recommend the public use masks to reduce contagion. Significant subgroups in the U.S. population have refused, mostly to signal their contrarian politics. In June there was an anecdote of a success story from the Show Me state of Missouri, where a mask is credited for preventing an outbreak from a sick hair stylist.
It is hard to find something more reliable than an anecdote. On June 1, a meta-analysis funded by the World Health Organization was published online by Lancet. It supports the idea that masks are beneficial. It is mostly forest plots, so you can try to interpret it yourself. There were 172 observational studies in the systematic review, and the meta-analysis contains 44 relevant comparative studies and 0 randomized controlled trials. Most of those forest plots have an I2 of 75% or worse, which to me indicates that they are not much more reliable than a good anecdote. My primary conclusion was that modern academic science, in an era with a shortage of toilet paper, should convert to printing on soft tissue paper.
It is important to note that the guesstimated overall benefit of cloth masks was a relative risk of 0.30. That benefit is easily nullified if the false security of a mask causes people to congregate together in groups three times larger or for three times more minutes. N95 masks were more effective.
A different article was published in PNAS on June 11. Its senior author was awarded the Nobel Prize in Chemistry in 1995. That article touted the benefits of masks. The article is facing heavy criticism for flaws in methodology and flaws in the peer review process. A long list of signatories have joined a letter asking for the article’s retraction.
This article, when combined with the two instances of prominent articles being retracted in the prior month by the New England Journal of Medicine and The Lancet, is accumulating evidence the peer review system is not working as intended.
There are many heroes in this pandemic, from the frontline health care workers in hotspots to the grocery workers and cleaning staff. There is hope, indeed some faith, that medical scientists in the foreseeable future will provide treatments and a vaccine for this viral plague. This month, the credibility of scientists again plays a major role as communities respond to outbreaks related to reopening the economy. Let’s celebrate the victories, resolve to fix the impure system, and restore a high level of public trust in science. Lives depend on it.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at [email protected].
Having been a bench research scientist 30 years ago, I am flabbergasted at what is and is not currently possible. In a few weeks, scientists sequenced a novel coronavirus and used the genetic sequence to select candidate molecules for a vaccine. But we still can’t reliably say how much protection a cloth mask provides. Worse yet, even if/when we could reliably quantify contagion, it isn’t clear that the public will believe us anyhow.
The good news is that the public worldwide did believe scientists about the threat of a pandemic and the need to flatten the curve. Saving lives has not been about the strength of an antibiotic or the skill in managing a ventilator, but the credibility of medical scientists. The degree of acceptance was variable and subject to a variety of delays caused by regional politicians, but The bad news is that the public’s trust in that scientific advice has waned, the willingness to accept onerous restrictions has fatigued, and the cooperation for maintaining these social changes is evaporating.
I will leave pontificating about the spread of COVID-19 to other experts in other forums. My focus is on the public’s trust in the professionalism of physicians, nurses, medical scientists, and the health care industry as a whole. That trust has been our most valuable tool in fighting the pandemic so far. There have been situations in which weaknesses in modern science have let society down during the pandemic of the century. In my February 2020 column, at the beginning of the outbreak, a month before it was declared a pandemic, when its magnitude was still unclear, I emphasized the importance of having a trusted scientific spokesperson providing timely, accurate information to the public. That, obviously, did not happen in the United States and the degree of the ensuing disaster is still to be revealed.
Scientists have made some wrong decisions about this novel threat. The advice on masks is an illustrative example. For many years, infection control nurses have insisted that medical students wear a mask to protect themselves, even if they were observing rounds from just inside the doorway of a room of a baby with bronchiolitis. The landfills are full of briefly worn surgical masks. Now the story goes: Surgical masks don’t protect staff; they protect others. Changes like that contribute to a credibility gap.
For 3 months, there was conflicting advice about the appropriateness of masks. In early March 2020, some health care workers were disciplined for wearing personal masks. Now, most scientists recommend the public use masks to reduce contagion. Significant subgroups in the U.S. population have refused, mostly to signal their contrarian politics. In June there was an anecdote of a success story from the Show Me state of Missouri, where a mask is credited for preventing an outbreak from a sick hair stylist.
It is hard to find something more reliable than an anecdote. On June 1, a meta-analysis funded by the World Health Organization was published online by Lancet. It supports the idea that masks are beneficial. It is mostly forest plots, so you can try to interpret it yourself. There were 172 observational studies in the systematic review, and the meta-analysis contains 44 relevant comparative studies and 0 randomized controlled trials. Most of those forest plots have an I2 of 75% or worse, which to me indicates that they are not much more reliable than a good anecdote. My primary conclusion was that modern academic science, in an era with a shortage of toilet paper, should convert to printing on soft tissue paper.
It is important to note that the guesstimated overall benefit of cloth masks was a relative risk of 0.30. That benefit is easily nullified if the false security of a mask causes people to congregate together in groups three times larger or for three times more minutes. N95 masks were more effective.
A different article was published in PNAS on June 11. Its senior author was awarded the Nobel Prize in Chemistry in 1995. That article touted the benefits of masks. The article is facing heavy criticism for flaws in methodology and flaws in the peer review process. A long list of signatories have joined a letter asking for the article’s retraction.
This article, when combined with the two instances of prominent articles being retracted in the prior month by the New England Journal of Medicine and The Lancet, is accumulating evidence the peer review system is not working as intended.
There are many heroes in this pandemic, from the frontline health care workers in hotspots to the grocery workers and cleaning staff. There is hope, indeed some faith, that medical scientists in the foreseeable future will provide treatments and a vaccine for this viral plague. This month, the credibility of scientists again plays a major role as communities respond to outbreaks related to reopening the economy. Let’s celebrate the victories, resolve to fix the impure system, and restore a high level of public trust in science. Lives depend on it.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at [email protected].
Having been a bench research scientist 30 years ago, I am flabbergasted at what is and is not currently possible. In a few weeks, scientists sequenced a novel coronavirus and used the genetic sequence to select candidate molecules for a vaccine. But we still can’t reliably say how much protection a cloth mask provides. Worse yet, even if/when we could reliably quantify contagion, it isn’t clear that the public will believe us anyhow.
The good news is that the public worldwide did believe scientists about the threat of a pandemic and the need to flatten the curve. Saving lives has not been about the strength of an antibiotic or the skill in managing a ventilator, but the credibility of medical scientists. The degree of acceptance was variable and subject to a variety of delays caused by regional politicians, but The bad news is that the public’s trust in that scientific advice has waned, the willingness to accept onerous restrictions has fatigued, and the cooperation for maintaining these social changes is evaporating.
I will leave pontificating about the spread of COVID-19 to other experts in other forums. My focus is on the public’s trust in the professionalism of physicians, nurses, medical scientists, and the health care industry as a whole. That trust has been our most valuable tool in fighting the pandemic so far. There have been situations in which weaknesses in modern science have let society down during the pandemic of the century. In my February 2020 column, at the beginning of the outbreak, a month before it was declared a pandemic, when its magnitude was still unclear, I emphasized the importance of having a trusted scientific spokesperson providing timely, accurate information to the public. That, obviously, did not happen in the United States and the degree of the ensuing disaster is still to be revealed.
Scientists have made some wrong decisions about this novel threat. The advice on masks is an illustrative example. For many years, infection control nurses have insisted that medical students wear a mask to protect themselves, even if they were observing rounds from just inside the doorway of a room of a baby with bronchiolitis. The landfills are full of briefly worn surgical masks. Now the story goes: Surgical masks don’t protect staff; they protect others. Changes like that contribute to a credibility gap.
For 3 months, there was conflicting advice about the appropriateness of masks. In early March 2020, some health care workers were disciplined for wearing personal masks. Now, most scientists recommend the public use masks to reduce contagion. Significant subgroups in the U.S. population have refused, mostly to signal their contrarian politics. In June there was an anecdote of a success story from the Show Me state of Missouri, where a mask is credited for preventing an outbreak from a sick hair stylist.
It is hard to find something more reliable than an anecdote. On June 1, a meta-analysis funded by the World Health Organization was published online by Lancet. It supports the idea that masks are beneficial. It is mostly forest plots, so you can try to interpret it yourself. There were 172 observational studies in the systematic review, and the meta-analysis contains 44 relevant comparative studies and 0 randomized controlled trials. Most of those forest plots have an I2 of 75% or worse, which to me indicates that they are not much more reliable than a good anecdote. My primary conclusion was that modern academic science, in an era with a shortage of toilet paper, should convert to printing on soft tissue paper.
It is important to note that the guesstimated overall benefit of cloth masks was a relative risk of 0.30. That benefit is easily nullified if the false security of a mask causes people to congregate together in groups three times larger or for three times more minutes. N95 masks were more effective.
A different article was published in PNAS on June 11. Its senior author was awarded the Nobel Prize in Chemistry in 1995. That article touted the benefits of masks. The article is facing heavy criticism for flaws in methodology and flaws in the peer review process. A long list of signatories have joined a letter asking for the article’s retraction.
This article, when combined with the two instances of prominent articles being retracted in the prior month by the New England Journal of Medicine and The Lancet, is accumulating evidence the peer review system is not working as intended.
There are many heroes in this pandemic, from the frontline health care workers in hotspots to the grocery workers and cleaning staff. There is hope, indeed some faith, that medical scientists in the foreseeable future will provide treatments and a vaccine for this viral plague. This month, the credibility of scientists again plays a major role as communities respond to outbreaks related to reopening the economy. Let’s celebrate the victories, resolve to fix the impure system, and restore a high level of public trust in science. Lives depend on it.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at [email protected].
COVID-19 symptoms can linger for months
Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.
In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that
Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:
- Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
- About 32% of patients had one or two symptoms and 55% had three or more
- None had fever or other signs and symptoms of acute illness
- About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
- About 44% reported worsened quality of life on the EuroQol visual analog scale.
The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.
The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”
Patients can also enroll in a training program in which breathing status is monitored.
In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.
“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.
As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.
The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.
“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.
The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.
In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that
Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:
- Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
- About 32% of patients had one or two symptoms and 55% had three or more
- None had fever or other signs and symptoms of acute illness
- About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
- About 44% reported worsened quality of life on the EuroQol visual analog scale.
The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.
The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”
Patients can also enroll in a training program in which breathing status is monitored.
In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.
“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.
As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.
The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.
“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.
The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.
In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that
Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:
- Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
- About 32% of patients had one or two symptoms and 55% had three or more
- None had fever or other signs and symptoms of acute illness
- About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
- About 44% reported worsened quality of life on the EuroQol visual analog scale.
The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.
The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”
Patients can also enroll in a training program in which breathing status is monitored.
In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.
“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.
As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.
The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.
“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.
The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Intubation boxes may do more harm than good in COVID-19 risk
Clear aerosol boxes designed to keep COVID-19 patients’ airborne droplets from infecting health care workers during intubation may actually increase providers’ exposure to the virus, a small study suggests.
Joanna P. Simpson, MbChB, an intensivist in the department of anaesthesia and perioperative medicine at Eastern Health in Melbourne, and colleagues tested five models of barriers used for protection while intubating simulated “patients” with COVID-19 and compared the interventions with a control of having no protection. They published their findings online in Anaesthesia.
Coauthor Peter Chan, MBBS, also an intensivist at Eastern Health, said in an interview that the virus essentially concentrates inside the box and because the box has holes on the sides to allow providers’ arms in, the gaps “act as nozzles, so when a patient coughs, it creates a sudden wave of air that pushes all these particles out the path of least resistance” and into the face of the intubator.
Their institution stopped using any such aerosol-containment devices during intubation until safety can be proven.
Many forms for boxes
The boxes take different forms and are made by various designers and manufacturers around the world, including in the United States, but they generally cover the head and upper body of patients and allow providers to reach through holes to intubate.
The U.S. Food and Drug Administration on May 1 issued an emergency use authorization (EUA) for “protective barrier enclosures ... to prevent [health care provider] exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to personal protective equipment [PPE].”
Others refer to them as “intubation boxes.” A search of GoFundMe campaigns showed hundreds of campaigns for intubation boxes.
Dr. Simpson and colleagues used an in-situ simulation model to evaluate laryngoscopist exposure to airborne particles sized 0.3-5.0 mcm using five aerosol containment devices (aerosol box, sealed box with suction, sealed box without suction, vertical drapes, and horizontal drapes) compared with no aerosol containment device.
Nebulized saline was used in an aerosol-generating model for 300 seconds, at which point the devices were removed to gauge particle spread for another 60 seconds.
Compared with no device use, the sealed intubation box with suction resulted in a decreased exposure for particle sizes of 0.3, 0.5, 1.0, and 2.5 mcm – but not 5.0 mcm – over all time periods (P = .003 for all time periods, which ranged from 30 to 360 seconds).
Conversely, the aerosol box, compared with no device use, showed an increase in 1.0, 2.5, and 5.0 mcm airborne-particle exposure at 300 seconds (P = .002, 0.008, and .002, respectively). Compared with no device use, neither horizontal nor vertical drapes showed any difference in any particle size exposure at any time.
The researchers used seven volunteers who took turns acting as the patient or the intubator. As each of the seven volunteers did all six trials (the five interventions plus no intervention), the study generated 42 sets of results.
More evidence passive boxes are ineffective
Plastic surgeon Dave Turer, MD, MS, who is also an electrical and biomedical engineer, and some emergency physician colleagues had doubts about these boxes early on and wrote about the need for thorough testing.
He told this news organization, “I find it kind of infuriating that if you search for ‘intubation box’ there are all these companies making claims that are totally unsubstantiated.”
A desperate need to stop the virus is leading to unacceptable practices, he said.
His team at the University of Pittsburgh Medical Center in Pennsylvania tested commercially available boxes using white vapor to simulate patients› exhaled breath and found the vapor billowed into the surrounding environment.
He said Simpson and colleagues had similar findings: The boxes didn’t contain the patients’ breaths and may even increase the stream heading toward intubators.
Dr. Turer said his team has designed a different kind of box, without armholes for the intubators, and with active airflow and filtering and have submitted their design and research to the FDA for an EUA.
The FDA’s current EUA is for boxes “that are no different from a face shield or a splash shield,” Dr. Turer said, adding that “they specifically state that they are not designed or intended to contain aerosol.”
He said while this study is a good start, his team’s findings will help demonstrate why the common passive boxes should not be used.
One of the most prevalent designs, he pointed out, was one by Taiwanese anesthesiologist Hsien Yung Lai that was widely circulated in March.
David W. Kaczka, MD, PhD, associate professor of anesthesia, biomedical engineering, and radiology at University of Iowa in Iowa City, is one of the researchers who modified that design and made prototypes. He said in an interview he thinks the study conclusion by Simpson et al is “not as dismal as the authors are making it out to be.”
He pointed to the relative success of the sealed box with suction. His team’s adapted model added a suction port to generate a negative pressure field around the patient.
The biggest critique he had of the study, Dr. Kaczka said, was a lack of a true control group.
“They tested all their conditions with nebulized saline,” he pointed out. “I think a more appropriately designed study would have also looked at a group where no saline was being nebulized and see what the particle counts were afterwards. It’s not clear how the device would distinguish between a particle coming from a saline nebulizer vs. coming from a simulated patient vs. coming from the laryngoscopist.”
He also noted that what comes out of a patient is not going to be saline and will have different density and viscosity.
That said, the study by Dr. Simpson and colleagues highlights the need to take a hard look at these boxes with more research, he said, adding, “I think there’s some hope there.”
He noted that a letter to the editor by Boston researchers, published online April 3 in the New England Journal of Medicine, describes how they used fluorescent dye forced from a balloon to simulate a patient’s cough to see whether an aerosol box protected intubators.
That letter concludes, “We suggest that our ad hoc barrier enclosure provided a modicum of additional protection and could be considered to be an adjunct to standard PPE.”
The Anaesthesia findings come as a second global wave becomes more likely as does awareness of the potential of airborne droplets to spread the virus.
Scientists from 32 countries warned the World Health Organization that the spread of COVID-19 through airborne droplets may have been severely underestimated.
On Wednesday, the World Health Organization formally acknowledged evidence regarding potential spread of the virus through these droplets and on Thursday issued an updated brief.
Intellectual property surrounding the device invented by Dr. Turer’s team is owned by UPMC. Dr. Chan and Dr. Kaczka have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Clear aerosol boxes designed to keep COVID-19 patients’ airborne droplets from infecting health care workers during intubation may actually increase providers’ exposure to the virus, a small study suggests.
Joanna P. Simpson, MbChB, an intensivist in the department of anaesthesia and perioperative medicine at Eastern Health in Melbourne, and colleagues tested five models of barriers used for protection while intubating simulated “patients” with COVID-19 and compared the interventions with a control of having no protection. They published their findings online in Anaesthesia.
Coauthor Peter Chan, MBBS, also an intensivist at Eastern Health, said in an interview that the virus essentially concentrates inside the box and because the box has holes on the sides to allow providers’ arms in, the gaps “act as nozzles, so when a patient coughs, it creates a sudden wave of air that pushes all these particles out the path of least resistance” and into the face of the intubator.
Their institution stopped using any such aerosol-containment devices during intubation until safety can be proven.
Many forms for boxes
The boxes take different forms and are made by various designers and manufacturers around the world, including in the United States, but they generally cover the head and upper body of patients and allow providers to reach through holes to intubate.
The U.S. Food and Drug Administration on May 1 issued an emergency use authorization (EUA) for “protective barrier enclosures ... to prevent [health care provider] exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to personal protective equipment [PPE].”
Others refer to them as “intubation boxes.” A search of GoFundMe campaigns showed hundreds of campaigns for intubation boxes.
Dr. Simpson and colleagues used an in-situ simulation model to evaluate laryngoscopist exposure to airborne particles sized 0.3-5.0 mcm using five aerosol containment devices (aerosol box, sealed box with suction, sealed box without suction, vertical drapes, and horizontal drapes) compared with no aerosol containment device.
Nebulized saline was used in an aerosol-generating model for 300 seconds, at which point the devices were removed to gauge particle spread for another 60 seconds.
Compared with no device use, the sealed intubation box with suction resulted in a decreased exposure for particle sizes of 0.3, 0.5, 1.0, and 2.5 mcm – but not 5.0 mcm – over all time periods (P = .003 for all time periods, which ranged from 30 to 360 seconds).
Conversely, the aerosol box, compared with no device use, showed an increase in 1.0, 2.5, and 5.0 mcm airborne-particle exposure at 300 seconds (P = .002, 0.008, and .002, respectively). Compared with no device use, neither horizontal nor vertical drapes showed any difference in any particle size exposure at any time.
The researchers used seven volunteers who took turns acting as the patient or the intubator. As each of the seven volunteers did all six trials (the five interventions plus no intervention), the study generated 42 sets of results.
More evidence passive boxes are ineffective
Plastic surgeon Dave Turer, MD, MS, who is also an electrical and biomedical engineer, and some emergency physician colleagues had doubts about these boxes early on and wrote about the need for thorough testing.
He told this news organization, “I find it kind of infuriating that if you search for ‘intubation box’ there are all these companies making claims that are totally unsubstantiated.”
A desperate need to stop the virus is leading to unacceptable practices, he said.
His team at the University of Pittsburgh Medical Center in Pennsylvania tested commercially available boxes using white vapor to simulate patients› exhaled breath and found the vapor billowed into the surrounding environment.
He said Simpson and colleagues had similar findings: The boxes didn’t contain the patients’ breaths and may even increase the stream heading toward intubators.
Dr. Turer said his team has designed a different kind of box, without armholes for the intubators, and with active airflow and filtering and have submitted their design and research to the FDA for an EUA.
The FDA’s current EUA is for boxes “that are no different from a face shield or a splash shield,” Dr. Turer said, adding that “they specifically state that they are not designed or intended to contain aerosol.”
He said while this study is a good start, his team’s findings will help demonstrate why the common passive boxes should not be used.
One of the most prevalent designs, he pointed out, was one by Taiwanese anesthesiologist Hsien Yung Lai that was widely circulated in March.
David W. Kaczka, MD, PhD, associate professor of anesthesia, biomedical engineering, and radiology at University of Iowa in Iowa City, is one of the researchers who modified that design and made prototypes. He said in an interview he thinks the study conclusion by Simpson et al is “not as dismal as the authors are making it out to be.”
He pointed to the relative success of the sealed box with suction. His team’s adapted model added a suction port to generate a negative pressure field around the patient.
The biggest critique he had of the study, Dr. Kaczka said, was a lack of a true control group.
“They tested all their conditions with nebulized saline,” he pointed out. “I think a more appropriately designed study would have also looked at a group where no saline was being nebulized and see what the particle counts were afterwards. It’s not clear how the device would distinguish between a particle coming from a saline nebulizer vs. coming from a simulated patient vs. coming from the laryngoscopist.”
He also noted that what comes out of a patient is not going to be saline and will have different density and viscosity.
That said, the study by Dr. Simpson and colleagues highlights the need to take a hard look at these boxes with more research, he said, adding, “I think there’s some hope there.”
He noted that a letter to the editor by Boston researchers, published online April 3 in the New England Journal of Medicine, describes how they used fluorescent dye forced from a balloon to simulate a patient’s cough to see whether an aerosol box protected intubators.
That letter concludes, “We suggest that our ad hoc barrier enclosure provided a modicum of additional protection and could be considered to be an adjunct to standard PPE.”
The Anaesthesia findings come as a second global wave becomes more likely as does awareness of the potential of airborne droplets to spread the virus.
Scientists from 32 countries warned the World Health Organization that the spread of COVID-19 through airborne droplets may have been severely underestimated.
On Wednesday, the World Health Organization formally acknowledged evidence regarding potential spread of the virus through these droplets and on Thursday issued an updated brief.
Intellectual property surrounding the device invented by Dr. Turer’s team is owned by UPMC. Dr. Chan and Dr. Kaczka have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Clear aerosol boxes designed to keep COVID-19 patients’ airborne droplets from infecting health care workers during intubation may actually increase providers’ exposure to the virus, a small study suggests.
Joanna P. Simpson, MbChB, an intensivist in the department of anaesthesia and perioperative medicine at Eastern Health in Melbourne, and colleagues tested five models of barriers used for protection while intubating simulated “patients” with COVID-19 and compared the interventions with a control of having no protection. They published their findings online in Anaesthesia.
Coauthor Peter Chan, MBBS, also an intensivist at Eastern Health, said in an interview that the virus essentially concentrates inside the box and because the box has holes on the sides to allow providers’ arms in, the gaps “act as nozzles, so when a patient coughs, it creates a sudden wave of air that pushes all these particles out the path of least resistance” and into the face of the intubator.
Their institution stopped using any such aerosol-containment devices during intubation until safety can be proven.
Many forms for boxes
The boxes take different forms and are made by various designers and manufacturers around the world, including in the United States, but they generally cover the head and upper body of patients and allow providers to reach through holes to intubate.
The U.S. Food and Drug Administration on May 1 issued an emergency use authorization (EUA) for “protective barrier enclosures ... to prevent [health care provider] exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to personal protective equipment [PPE].”
Others refer to them as “intubation boxes.” A search of GoFundMe campaigns showed hundreds of campaigns for intubation boxes.
Dr. Simpson and colleagues used an in-situ simulation model to evaluate laryngoscopist exposure to airborne particles sized 0.3-5.0 mcm using five aerosol containment devices (aerosol box, sealed box with suction, sealed box without suction, vertical drapes, and horizontal drapes) compared with no aerosol containment device.
Nebulized saline was used in an aerosol-generating model for 300 seconds, at which point the devices were removed to gauge particle spread for another 60 seconds.
Compared with no device use, the sealed intubation box with suction resulted in a decreased exposure for particle sizes of 0.3, 0.5, 1.0, and 2.5 mcm – but not 5.0 mcm – over all time periods (P = .003 for all time periods, which ranged from 30 to 360 seconds).
Conversely, the aerosol box, compared with no device use, showed an increase in 1.0, 2.5, and 5.0 mcm airborne-particle exposure at 300 seconds (P = .002, 0.008, and .002, respectively). Compared with no device use, neither horizontal nor vertical drapes showed any difference in any particle size exposure at any time.
The researchers used seven volunteers who took turns acting as the patient or the intubator. As each of the seven volunteers did all six trials (the five interventions plus no intervention), the study generated 42 sets of results.
More evidence passive boxes are ineffective
Plastic surgeon Dave Turer, MD, MS, who is also an electrical and biomedical engineer, and some emergency physician colleagues had doubts about these boxes early on and wrote about the need for thorough testing.
He told this news organization, “I find it kind of infuriating that if you search for ‘intubation box’ there are all these companies making claims that are totally unsubstantiated.”
A desperate need to stop the virus is leading to unacceptable practices, he said.
His team at the University of Pittsburgh Medical Center in Pennsylvania tested commercially available boxes using white vapor to simulate patients› exhaled breath and found the vapor billowed into the surrounding environment.
He said Simpson and colleagues had similar findings: The boxes didn’t contain the patients’ breaths and may even increase the stream heading toward intubators.
Dr. Turer said his team has designed a different kind of box, without armholes for the intubators, and with active airflow and filtering and have submitted their design and research to the FDA for an EUA.
The FDA’s current EUA is for boxes “that are no different from a face shield or a splash shield,” Dr. Turer said, adding that “they specifically state that they are not designed or intended to contain aerosol.”
He said while this study is a good start, his team’s findings will help demonstrate why the common passive boxes should not be used.
One of the most prevalent designs, he pointed out, was one by Taiwanese anesthesiologist Hsien Yung Lai that was widely circulated in March.
David W. Kaczka, MD, PhD, associate professor of anesthesia, biomedical engineering, and radiology at University of Iowa in Iowa City, is one of the researchers who modified that design and made prototypes. He said in an interview he thinks the study conclusion by Simpson et al is “not as dismal as the authors are making it out to be.”
He pointed to the relative success of the sealed box with suction. His team’s adapted model added a suction port to generate a negative pressure field around the patient.
The biggest critique he had of the study, Dr. Kaczka said, was a lack of a true control group.
“They tested all their conditions with nebulized saline,” he pointed out. “I think a more appropriately designed study would have also looked at a group where no saline was being nebulized and see what the particle counts were afterwards. It’s not clear how the device would distinguish between a particle coming from a saline nebulizer vs. coming from a simulated patient vs. coming from the laryngoscopist.”
He also noted that what comes out of a patient is not going to be saline and will have different density and viscosity.
That said, the study by Dr. Simpson and colleagues highlights the need to take a hard look at these boxes with more research, he said, adding, “I think there’s some hope there.”
He noted that a letter to the editor by Boston researchers, published online April 3 in the New England Journal of Medicine, describes how they used fluorescent dye forced from a balloon to simulate a patient’s cough to see whether an aerosol box protected intubators.
That letter concludes, “We suggest that our ad hoc barrier enclosure provided a modicum of additional protection and could be considered to be an adjunct to standard PPE.”
The Anaesthesia findings come as a second global wave becomes more likely as does awareness of the potential of airborne droplets to spread the virus.
Scientists from 32 countries warned the World Health Organization that the spread of COVID-19 through airborne droplets may have been severely underestimated.
On Wednesday, the World Health Organization formally acknowledged evidence regarding potential spread of the virus through these droplets and on Thursday issued an updated brief.
Intellectual property surrounding the device invented by Dr. Turer’s team is owned by UPMC. Dr. Chan and Dr. Kaczka have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Six snags docs hit when seeing patients again
Sachin Dave, MD, an internist in Greenwood, Ind., never thought he’d tell his patients to avoid coming into the office. But these days, he must balance the need for face-to-face visits with the risk for COVID-19 transmission. Although he connects with most patients by telehealth, some patients still demand in-office care.
“My older patients actually insist on coming to see me in person,” said Dr. Dave, who is part of Indiana Internal Medicine Consultants, a large group practice near Indianapolis. “I have to tell them it’s not safe.”
It’s a minor hitch as his practice ramps up again – but one of those things you can’t overlook, he said. “We need to educate our patients and communicate the risk to them.”
senior vice president of patient safety and risk management for the Doctors Company, a physician-owned malpractice insurer. “It’s about minimizing risk.”
As practices increase patient volume, physicians are juggling a desire for a return to patient care and increased revenue with a need to maximize patient and staff safety. Avoiding some of these common snags may help make the transition smoother.
1. Unclear or nonexistent polices and protocols
Some physicians know what general rules they want to follow, but they haven’t conveyed them in a readily available document. Although you and your staff may have a sense of what they are, patients may be less aware of how mandatory you consider them. It’s important to develop a formal framework that you will follow and to make sure patients and staff know it.
Dr. Dave and colleagues have stringent safety protocols in place for the small percentage of patients he does feel a need to be seen in person. Masks are mandatory for staff and patients. The waiting room is set up for social distancing. If it begins getting crowded, patients are asked to wait in their cars until an exam room is ready.
“I’m not going to see a patient who refuses to put a mask on, because when I put a mask on, I’m trying to protect my patients,” said Dr. Dave. He makes it clear that he expects the same from his patients; they must wear a mask to protect his staff and himself.
“I am going to let them in with the caveat that they don’t have qualms about wearing a mask. If they have qualms about wearing a mask, then I have qualms about seeing them in person,” he said.
Be sure that all patients understand and will adhere to your protocols before they come to the office. Patients should be triaged over the phone before arriving, according to Centers for Disease Control and Prevention recommendations. (Remember that refusing assessment or care could lead to issues of patient abandonment.)
When you don’t really have a framework to follow, you don’t really know what the structure is going to be and how your practice is going to provide care. The question is, how do you build a framework for right now? said Ron Holder, chief operations officer of the Medical Group Management Association. “The first step is do no harm.”
2. Trying to see too many patients too soon
On average, practices have reported a 55% decrease in revenue and a 60% decrease in patient volume since the beginning of the COVID-19 crisis, according to the MGMA. It’s natural that many want to ramp up immediately and go back to their prior patient volume. But they need to take it slow and ensure that the correct safety protocols are in place, Mr. Holder said.
For example, telehealth is still reimbursable at parity, so physicians should keep taking advantage of that. MGMA’s practice reopening checklist has links to additional resources and considerations.
Some doctors want to see an overload of patients and want to get back to how they practiced before the pandemic, says orthopedic surgeon Charles Ruotolo, MD, president of Total Orthopedics and Sports Medicine in Massapequa, N.Y., and chairman of the department of orthopedics, Nassau University Medical Center, East Meadow, N.Y., “but at the same time, you know we still have to limit how many people are coming into the office.”
It’s not fair if some doctors in your practice are seeing 45 patients daily as they did previously whereas others are seeing half that many, he explained. “We must remain cognizant and constantly review schedules and remember we have to still keep the numbers down.”
“COVID is not going to be completely over in our lifetime,” says Evan Levine, MD, a cardiologist in Ridgefield, Conn. Taking advantage of technologies is one way to reduce risk.
He predicts that the demand will continue to increase as patients become more comfortable with virtual visits. Using Bluetooth and WiFi devices to assess patients is no longer futuristic and can help reduce the number of people in the waiting room, according to Dr. Levine, a solo practitioner and author of “What Your Doctor Won’t (or Can’t) Tell You.” “That’s a very good thing, especially as we look to fall and to flu season.”
3. Undercommunicating with patients and staff
Don’t assume patients know that you’ve opened back up and are seeing people in the office, Mr. Holder said. Update your practice website, send letters or newsletters to patients’ homes, maintain telephone and email contact, and post signs at the facility explaining your reopening process. The CDC has an excellent phone script that practices can adapt. Everyone should know what to expect and what’s expected of them.
He advised overcommunicating – more than you think is necessary – to your staff and patients. Tell them about the extra steps you’re taking. Let them know that their safety and health are the most important thing and that you are taking all these extra measures to make sure that they feel comfortable.
Keep staff appraised of policy changes. Stress what you’re doing to ensure the safety of your team members. “Even though you could be doing all those things, if you’re not communicating, then no one knows it,” said Mr. Holder.
He predicted the practices that emerge stronger from this crisis will be those with great patient education that have built up a lot of goodwill. Patients should know they can go to this practice’s patient portal as a trusted resource about COVID-19 and safety-related measures. This approach will pay dividends over the long term.
4. Giving inadequate staff training and holding too-high expectations
Staff members are scared, really scared, Ms. Bashaw said. Some may not return because they’re unsure what to expect; others may have to stay home to care for children or older relatives. Clear guidance on what is being done to ensure everyone’s safety, what is expected from staff, and flexibility with scheduling can help address these issues.
Most practices’ staff are not used to donning and removing personal protective equipment, and they’re not used to wearing masks when working with patients. Expect some mistakes.
“We had a scenario where a provider was in a room with an older patient, and the provider pulled his mask down so the patient could hear him better. He then kept the mask down while giving the patient an injection. When the family found out, they were very upset,” Ms. Bashaw related. “It was done with good intentions, to improve communication, but it’s a slip-up that could have found him liable if she became ill.”
Dr. Ruotolo had to implement new policies throughout his practice’s multiple locations in the New York metro area. They encompassed everything from staggering appointments and staff to establishing designated employee eating areas so front desk staff weren’t taking their masks off to snack.
Having specific guidelines for staff helps reassure patients that safety protocols are being adhered to. “Patients want to see we’re all doing the right thing,” he said.
Have those policies clearly written so everyone’s on the same page, Dr. Ruotolo advised. Also make sure staff knows what the rules are for patients.
Dr. Ruotolo’s reception staff hand every patient a disinfectant wipe when they arrive. They are asked to wipe down the check-in kiosk before and after using it. Assistants know not to cut corners when disinfecting exam rooms, equipment, or tables. “It’s the little things you have to think about, and make sure it’s reiterated with your staff so they’re doing it.”
If your practice isn’t back up to full staffing volume, it’s a good idea to cross train staff members so some jobs overlap, suggests Mr. Holder. Although smaller practices may already do this, at larger practices, staff members’ roles may be more specific. “You may be able to pull employees from other positions in the practice, but it’s a good idea to have some redundancy.”
5. Neglecting to document everything – even more so than before
The standard of care is changing every day, and so are the regulations, says Ms. Bashaw. Many physicians who work in larger practices or for health systems don’t take advantage of internal risk management departments, which can help them keep tabs on all of these changes.
Writing down simple protocols and having a consistent work flow are extremely important right now. What have you told staff and patients? Are they comfortable with how you’re minimizing their risk? Physicians can find a seven-page checklist that helps practitioners organize and methodically go through reopening process at the Doctors Company website.
Implementing state and local statutes or public health requirements and keeping track of when things stop and start can be complex, says Ms. Bashaw. Take a look at your pre–COVID-19 policies and procedures, and make sure you’re on top of the current standards for your office, including staff education. The most important step is connecting with your local public health authority and taking direction from them.
Ms. Bashaw strongly encouraged physicians to conduct huddles with their staff; it’s an evidence-based leadership practice that’s important from a medical malpractice perspective. Review the day’s game plan, then conduct a debriefing at the end of the day.
Discuss what worked well, what didn’t, and what tomorrow looks like. And be sure to document it all. “A standard routine and debrief gets everyone on the same page and shows due diligence,” she said.
Keep an administrative file so 2 years down the road, you remember what you did and when. That way, if there’s a problem or a breach or the standard isn’t adhered to, it’s documented in the file. Note what happened and when and what was done to mitigate it or what corrective action was taken.
All practices need to stay on top of regulatory changes. Smaller practices don’t have full-time staff dedicated to monitoring what’s happening in Washington. Associations such as the MGMA can help target what’s important and actionable.
6. Forgetting about your own and your staff’s physical and mental health
Physicians need to be worried about burnout and mental health problems from their team members, their colleagues, their patients, and themselves, according to Mr. Holder.
“There’s a mental exhaustion that is just pervasive in the world and the United States right now about all this COVID stuff and stress, not to mention all the other things that are going on,” he said.
That’s going to carry over, so physicians must make sure there’s a positive culture at the practice, where everyone’s taking care of and watching out for each other.
A version of this article originally appeared on Medscape.com.
Sachin Dave, MD, an internist in Greenwood, Ind., never thought he’d tell his patients to avoid coming into the office. But these days, he must balance the need for face-to-face visits with the risk for COVID-19 transmission. Although he connects with most patients by telehealth, some patients still demand in-office care.
“My older patients actually insist on coming to see me in person,” said Dr. Dave, who is part of Indiana Internal Medicine Consultants, a large group practice near Indianapolis. “I have to tell them it’s not safe.”
It’s a minor hitch as his practice ramps up again – but one of those things you can’t overlook, he said. “We need to educate our patients and communicate the risk to them.”
senior vice president of patient safety and risk management for the Doctors Company, a physician-owned malpractice insurer. “It’s about minimizing risk.”
As practices increase patient volume, physicians are juggling a desire for a return to patient care and increased revenue with a need to maximize patient and staff safety. Avoiding some of these common snags may help make the transition smoother.
1. Unclear or nonexistent polices and protocols
Some physicians know what general rules they want to follow, but they haven’t conveyed them in a readily available document. Although you and your staff may have a sense of what they are, patients may be less aware of how mandatory you consider them. It’s important to develop a formal framework that you will follow and to make sure patients and staff know it.
Dr. Dave and colleagues have stringent safety protocols in place for the small percentage of patients he does feel a need to be seen in person. Masks are mandatory for staff and patients. The waiting room is set up for social distancing. If it begins getting crowded, patients are asked to wait in their cars until an exam room is ready.
“I’m not going to see a patient who refuses to put a mask on, because when I put a mask on, I’m trying to protect my patients,” said Dr. Dave. He makes it clear that he expects the same from his patients; they must wear a mask to protect his staff and himself.
“I am going to let them in with the caveat that they don’t have qualms about wearing a mask. If they have qualms about wearing a mask, then I have qualms about seeing them in person,” he said.
Be sure that all patients understand and will adhere to your protocols before they come to the office. Patients should be triaged over the phone before arriving, according to Centers for Disease Control and Prevention recommendations. (Remember that refusing assessment or care could lead to issues of patient abandonment.)
When you don’t really have a framework to follow, you don’t really know what the structure is going to be and how your practice is going to provide care. The question is, how do you build a framework for right now? said Ron Holder, chief operations officer of the Medical Group Management Association. “The first step is do no harm.”
2. Trying to see too many patients too soon
On average, practices have reported a 55% decrease in revenue and a 60% decrease in patient volume since the beginning of the COVID-19 crisis, according to the MGMA. It’s natural that many want to ramp up immediately and go back to their prior patient volume. But they need to take it slow and ensure that the correct safety protocols are in place, Mr. Holder said.
For example, telehealth is still reimbursable at parity, so physicians should keep taking advantage of that. MGMA’s practice reopening checklist has links to additional resources and considerations.
Some doctors want to see an overload of patients and want to get back to how they practiced before the pandemic, says orthopedic surgeon Charles Ruotolo, MD, president of Total Orthopedics and Sports Medicine in Massapequa, N.Y., and chairman of the department of orthopedics, Nassau University Medical Center, East Meadow, N.Y., “but at the same time, you know we still have to limit how many people are coming into the office.”
It’s not fair if some doctors in your practice are seeing 45 patients daily as they did previously whereas others are seeing half that many, he explained. “We must remain cognizant and constantly review schedules and remember we have to still keep the numbers down.”
“COVID is not going to be completely over in our lifetime,” says Evan Levine, MD, a cardiologist in Ridgefield, Conn. Taking advantage of technologies is one way to reduce risk.
He predicts that the demand will continue to increase as patients become more comfortable with virtual visits. Using Bluetooth and WiFi devices to assess patients is no longer futuristic and can help reduce the number of people in the waiting room, according to Dr. Levine, a solo practitioner and author of “What Your Doctor Won’t (or Can’t) Tell You.” “That’s a very good thing, especially as we look to fall and to flu season.”
3. Undercommunicating with patients and staff
Don’t assume patients know that you’ve opened back up and are seeing people in the office, Mr. Holder said. Update your practice website, send letters or newsletters to patients’ homes, maintain telephone and email contact, and post signs at the facility explaining your reopening process. The CDC has an excellent phone script that practices can adapt. Everyone should know what to expect and what’s expected of them.
He advised overcommunicating – more than you think is necessary – to your staff and patients. Tell them about the extra steps you’re taking. Let them know that their safety and health are the most important thing and that you are taking all these extra measures to make sure that they feel comfortable.
Keep staff appraised of policy changes. Stress what you’re doing to ensure the safety of your team members. “Even though you could be doing all those things, if you’re not communicating, then no one knows it,” said Mr. Holder.
He predicted the practices that emerge stronger from this crisis will be those with great patient education that have built up a lot of goodwill. Patients should know they can go to this practice’s patient portal as a trusted resource about COVID-19 and safety-related measures. This approach will pay dividends over the long term.
4. Giving inadequate staff training and holding too-high expectations
Staff members are scared, really scared, Ms. Bashaw said. Some may not return because they’re unsure what to expect; others may have to stay home to care for children or older relatives. Clear guidance on what is being done to ensure everyone’s safety, what is expected from staff, and flexibility with scheduling can help address these issues.
Most practices’ staff are not used to donning and removing personal protective equipment, and they’re not used to wearing masks when working with patients. Expect some mistakes.
“We had a scenario where a provider was in a room with an older patient, and the provider pulled his mask down so the patient could hear him better. He then kept the mask down while giving the patient an injection. When the family found out, they were very upset,” Ms. Bashaw related. “It was done with good intentions, to improve communication, but it’s a slip-up that could have found him liable if she became ill.”
Dr. Ruotolo had to implement new policies throughout his practice’s multiple locations in the New York metro area. They encompassed everything from staggering appointments and staff to establishing designated employee eating areas so front desk staff weren’t taking their masks off to snack.
Having specific guidelines for staff helps reassure patients that safety protocols are being adhered to. “Patients want to see we’re all doing the right thing,” he said.
Have those policies clearly written so everyone’s on the same page, Dr. Ruotolo advised. Also make sure staff knows what the rules are for patients.
Dr. Ruotolo’s reception staff hand every patient a disinfectant wipe when they arrive. They are asked to wipe down the check-in kiosk before and after using it. Assistants know not to cut corners when disinfecting exam rooms, equipment, or tables. “It’s the little things you have to think about, and make sure it’s reiterated with your staff so they’re doing it.”
If your practice isn’t back up to full staffing volume, it’s a good idea to cross train staff members so some jobs overlap, suggests Mr. Holder. Although smaller practices may already do this, at larger practices, staff members’ roles may be more specific. “You may be able to pull employees from other positions in the practice, but it’s a good idea to have some redundancy.”
5. Neglecting to document everything – even more so than before
The standard of care is changing every day, and so are the regulations, says Ms. Bashaw. Many physicians who work in larger practices or for health systems don’t take advantage of internal risk management departments, which can help them keep tabs on all of these changes.
Writing down simple protocols and having a consistent work flow are extremely important right now. What have you told staff and patients? Are they comfortable with how you’re minimizing their risk? Physicians can find a seven-page checklist that helps practitioners organize and methodically go through reopening process at the Doctors Company website.
Implementing state and local statutes or public health requirements and keeping track of when things stop and start can be complex, says Ms. Bashaw. Take a look at your pre–COVID-19 policies and procedures, and make sure you’re on top of the current standards for your office, including staff education. The most important step is connecting with your local public health authority and taking direction from them.
Ms. Bashaw strongly encouraged physicians to conduct huddles with their staff; it’s an evidence-based leadership practice that’s important from a medical malpractice perspective. Review the day’s game plan, then conduct a debriefing at the end of the day.
Discuss what worked well, what didn’t, and what tomorrow looks like. And be sure to document it all. “A standard routine and debrief gets everyone on the same page and shows due diligence,” she said.
Keep an administrative file so 2 years down the road, you remember what you did and when. That way, if there’s a problem or a breach or the standard isn’t adhered to, it’s documented in the file. Note what happened and when and what was done to mitigate it or what corrective action was taken.
All practices need to stay on top of regulatory changes. Smaller practices don’t have full-time staff dedicated to monitoring what’s happening in Washington. Associations such as the MGMA can help target what’s important and actionable.
6. Forgetting about your own and your staff’s physical and mental health
Physicians need to be worried about burnout and mental health problems from their team members, their colleagues, their patients, and themselves, according to Mr. Holder.
“There’s a mental exhaustion that is just pervasive in the world and the United States right now about all this COVID stuff and stress, not to mention all the other things that are going on,” he said.
That’s going to carry over, so physicians must make sure there’s a positive culture at the practice, where everyone’s taking care of and watching out for each other.
A version of this article originally appeared on Medscape.com.
Sachin Dave, MD, an internist in Greenwood, Ind., never thought he’d tell his patients to avoid coming into the office. But these days, he must balance the need for face-to-face visits with the risk for COVID-19 transmission. Although he connects with most patients by telehealth, some patients still demand in-office care.
“My older patients actually insist on coming to see me in person,” said Dr. Dave, who is part of Indiana Internal Medicine Consultants, a large group practice near Indianapolis. “I have to tell them it’s not safe.”
It’s a minor hitch as his practice ramps up again – but one of those things you can’t overlook, he said. “We need to educate our patients and communicate the risk to them.”
senior vice president of patient safety and risk management for the Doctors Company, a physician-owned malpractice insurer. “It’s about minimizing risk.”
As practices increase patient volume, physicians are juggling a desire for a return to patient care and increased revenue with a need to maximize patient and staff safety. Avoiding some of these common snags may help make the transition smoother.
1. Unclear or nonexistent polices and protocols
Some physicians know what general rules they want to follow, but they haven’t conveyed them in a readily available document. Although you and your staff may have a sense of what they are, patients may be less aware of how mandatory you consider them. It’s important to develop a formal framework that you will follow and to make sure patients and staff know it.
Dr. Dave and colleagues have stringent safety protocols in place for the small percentage of patients he does feel a need to be seen in person. Masks are mandatory for staff and patients. The waiting room is set up for social distancing. If it begins getting crowded, patients are asked to wait in their cars until an exam room is ready.
“I’m not going to see a patient who refuses to put a mask on, because when I put a mask on, I’m trying to protect my patients,” said Dr. Dave. He makes it clear that he expects the same from his patients; they must wear a mask to protect his staff and himself.
“I am going to let them in with the caveat that they don’t have qualms about wearing a mask. If they have qualms about wearing a mask, then I have qualms about seeing them in person,” he said.
Be sure that all patients understand and will adhere to your protocols before they come to the office. Patients should be triaged over the phone before arriving, according to Centers for Disease Control and Prevention recommendations. (Remember that refusing assessment or care could lead to issues of patient abandonment.)
When you don’t really have a framework to follow, you don’t really know what the structure is going to be and how your practice is going to provide care. The question is, how do you build a framework for right now? said Ron Holder, chief operations officer of the Medical Group Management Association. “The first step is do no harm.”
2. Trying to see too many patients too soon
On average, practices have reported a 55% decrease in revenue and a 60% decrease in patient volume since the beginning of the COVID-19 crisis, according to the MGMA. It’s natural that many want to ramp up immediately and go back to their prior patient volume. But they need to take it slow and ensure that the correct safety protocols are in place, Mr. Holder said.
For example, telehealth is still reimbursable at parity, so physicians should keep taking advantage of that. MGMA’s practice reopening checklist has links to additional resources and considerations.
Some doctors want to see an overload of patients and want to get back to how they practiced before the pandemic, says orthopedic surgeon Charles Ruotolo, MD, president of Total Orthopedics and Sports Medicine in Massapequa, N.Y., and chairman of the department of orthopedics, Nassau University Medical Center, East Meadow, N.Y., “but at the same time, you know we still have to limit how many people are coming into the office.”
It’s not fair if some doctors in your practice are seeing 45 patients daily as they did previously whereas others are seeing half that many, he explained. “We must remain cognizant and constantly review schedules and remember we have to still keep the numbers down.”
“COVID is not going to be completely over in our lifetime,” says Evan Levine, MD, a cardiologist in Ridgefield, Conn. Taking advantage of technologies is one way to reduce risk.
He predicts that the demand will continue to increase as patients become more comfortable with virtual visits. Using Bluetooth and WiFi devices to assess patients is no longer futuristic and can help reduce the number of people in the waiting room, according to Dr. Levine, a solo practitioner and author of “What Your Doctor Won’t (or Can’t) Tell You.” “That’s a very good thing, especially as we look to fall and to flu season.”
3. Undercommunicating with patients and staff
Don’t assume patients know that you’ve opened back up and are seeing people in the office, Mr. Holder said. Update your practice website, send letters or newsletters to patients’ homes, maintain telephone and email contact, and post signs at the facility explaining your reopening process. The CDC has an excellent phone script that practices can adapt. Everyone should know what to expect and what’s expected of them.
He advised overcommunicating – more than you think is necessary – to your staff and patients. Tell them about the extra steps you’re taking. Let them know that their safety and health are the most important thing and that you are taking all these extra measures to make sure that they feel comfortable.
Keep staff appraised of policy changes. Stress what you’re doing to ensure the safety of your team members. “Even though you could be doing all those things, if you’re not communicating, then no one knows it,” said Mr. Holder.
He predicted the practices that emerge stronger from this crisis will be those with great patient education that have built up a lot of goodwill. Patients should know they can go to this practice’s patient portal as a trusted resource about COVID-19 and safety-related measures. This approach will pay dividends over the long term.
4. Giving inadequate staff training and holding too-high expectations
Staff members are scared, really scared, Ms. Bashaw said. Some may not return because they’re unsure what to expect; others may have to stay home to care for children or older relatives. Clear guidance on what is being done to ensure everyone’s safety, what is expected from staff, and flexibility with scheduling can help address these issues.
Most practices’ staff are not used to donning and removing personal protective equipment, and they’re not used to wearing masks when working with patients. Expect some mistakes.
“We had a scenario where a provider was in a room with an older patient, and the provider pulled his mask down so the patient could hear him better. He then kept the mask down while giving the patient an injection. When the family found out, they were very upset,” Ms. Bashaw related. “It was done with good intentions, to improve communication, but it’s a slip-up that could have found him liable if she became ill.”
Dr. Ruotolo had to implement new policies throughout his practice’s multiple locations in the New York metro area. They encompassed everything from staggering appointments and staff to establishing designated employee eating areas so front desk staff weren’t taking their masks off to snack.
Having specific guidelines for staff helps reassure patients that safety protocols are being adhered to. “Patients want to see we’re all doing the right thing,” he said.
Have those policies clearly written so everyone’s on the same page, Dr. Ruotolo advised. Also make sure staff knows what the rules are for patients.
Dr. Ruotolo’s reception staff hand every patient a disinfectant wipe when they arrive. They are asked to wipe down the check-in kiosk before and after using it. Assistants know not to cut corners when disinfecting exam rooms, equipment, or tables. “It’s the little things you have to think about, and make sure it’s reiterated with your staff so they’re doing it.”
If your practice isn’t back up to full staffing volume, it’s a good idea to cross train staff members so some jobs overlap, suggests Mr. Holder. Although smaller practices may already do this, at larger practices, staff members’ roles may be more specific. “You may be able to pull employees from other positions in the practice, but it’s a good idea to have some redundancy.”
5. Neglecting to document everything – even more so than before
The standard of care is changing every day, and so are the regulations, says Ms. Bashaw. Many physicians who work in larger practices or for health systems don’t take advantage of internal risk management departments, which can help them keep tabs on all of these changes.
Writing down simple protocols and having a consistent work flow are extremely important right now. What have you told staff and patients? Are they comfortable with how you’re minimizing their risk? Physicians can find a seven-page checklist that helps practitioners organize and methodically go through reopening process at the Doctors Company website.
Implementing state and local statutes or public health requirements and keeping track of when things stop and start can be complex, says Ms. Bashaw. Take a look at your pre–COVID-19 policies and procedures, and make sure you’re on top of the current standards for your office, including staff education. The most important step is connecting with your local public health authority and taking direction from them.
Ms. Bashaw strongly encouraged physicians to conduct huddles with their staff; it’s an evidence-based leadership practice that’s important from a medical malpractice perspective. Review the day’s game plan, then conduct a debriefing at the end of the day.
Discuss what worked well, what didn’t, and what tomorrow looks like. And be sure to document it all. “A standard routine and debrief gets everyone on the same page and shows due diligence,” she said.
Keep an administrative file so 2 years down the road, you remember what you did and when. That way, if there’s a problem or a breach or the standard isn’t adhered to, it’s documented in the file. Note what happened and when and what was done to mitigate it or what corrective action was taken.
All practices need to stay on top of regulatory changes. Smaller practices don’t have full-time staff dedicated to monitoring what’s happening in Washington. Associations such as the MGMA can help target what’s important and actionable.
6. Forgetting about your own and your staff’s physical and mental health
Physicians need to be worried about burnout and mental health problems from their team members, their colleagues, their patients, and themselves, according to Mr. Holder.
“There’s a mental exhaustion that is just pervasive in the world and the United States right now about all this COVID stuff and stress, not to mention all the other things that are going on,” he said.
That’s going to carry over, so physicians must make sure there’s a positive culture at the practice, where everyone’s taking care of and watching out for each other.
A version of this article originally appeared on Medscape.com.
Wave, surge, or tsunami
Different COVID-19 models and predicting inpatient bed capacity
The COVID-19 pandemic is one of the defining moments in history for this generation’s health care leaders. In 2019, most of us wrongly assumed that this virus would be similar to the past viral epidemics and pandemics such as 2002 severe acute respiratory syndrome–CoV in Asia, 2009 H1N1 influenza in the United States, 2012 Middle East respiratory syndrome–CoV in Saudi Arabia, and 2014-2016 Ebola in West Africa. Moreover, we understood that the 50% fatality rate of Ebola, a single-stranded RNA virus, was deadly on the continent of Africa, but its transmission was through direct contact with blood or other bodily fluids. Hence, the infectivity of Ebola to the general public was lower than SARS-CoV-2, which is spread by respiratory droplets and contact routes in addition to being the virus that causes COVID-19.1 Many of us did not expect that SARS-CoV-2, a single-stranded RNA virus consisting of 32 kilobytes, would reach the shores of the United States from the Hubei province of China, the northern Lombardy region of Italy, or other initial hotspots. We could not imagine its effects would be so devastating from an economic and medical perspective. Until it did.
The first reported case of SARS-CoV-2 was on Jan. 20, 2020 in Snohomish County, Wash., and the first known death from COVID-19 occurred on Feb. 6, 2020 in Santa Clara County, Calif.2,3 Since then, the United States has lost over 135,000 people from COVID-19 with death(s) reported in every state and the highest number of overall deaths of any country in the world.4 At the beginning of 2020, at our institution, Wake Forest Baptist Health System in Winston-Salem, N.C., we began preparing for the wave, surge, or tsunami of inpatients that was coming. Plans were afoot to increase our staff, even perhaps by hiring out-of-state physicians and nurses if needed, and every possible bed was considered within the system. It was not an if, but rather a when, as to the arrival of COVID-19.
Epidemiologists and biostatisticians developed predictive COVID-19 models so that health care leaders could plan accordingly, especially those patients that required critical care or inpatient medical care. These predictive models have been used across the globe and can be categorized into three groups: Susceptible-Exposed-Infectious-Recovered, Agent-Based, and Curve Fitting Extrapolation.5 Our original predictions were based on the Institute for Health Metrics and Evaluation model from Washington state (Curve Fitting Extrapolation). It creates projections from COVID-19 mortality data and assumes a 3% infection rate. Other health systems in our region used the COVID-19 Hospital Impact Model for Epidemics–University of Pennsylvania model. It pins its suppositions on hospitalized COVID-19 patients, regional infection rates, and hospital market shares. Lastly, the agent-based mode, such as the Global Epidemic and Mobility Project, takes simulated populations and forecasts the spread of SARS-CoV-2 anchoring on the interplay of individuals and groups. The assumptions are created secondary to the interactions of people, time, health care interventions, and public health policies.
Based on these predictive simulations, health systems have spent countless hours of planning and have utilized resources for the anticipated needs related to beds, ventilators, supplies, and staffing. Frontline staff were retrained how to don and doff personal protective equipment. Our teams were ready if we saw a wave of 250, a surge of 500, or a tsunami of 750 COVID-19 inpatients. We were prepared to run into the fire fully knowing the personal risks and consequences.
But, as yet, the tsunami in North Carolina has never come. On April 21, 2020, the COVID-19 mortality data in North Carolina peaked at 34 deaths, with the total number of deaths standing at 1,510 as of July 13, 2020.6 A surge did not hit our institutional shores at Wake Forest Baptist Health. As we looked through the proverbial back window and hear about the tsunami in Houston, Texas, we are very thankful that the tsunami turned out to be a small wave so far in North Carolina. We are grateful that there were fewer deaths than expected. The dust is settling now and the question, spoken or unspoken, is: “How could we be so wrong with our predictions?”
Models have strengths and weaknesses and none are perfect.7 There is an old aphorism in statistics that is often attributed to George Box that says: “All models are wrong but some are useful.”8 Predictions and projections are good, but not perfect. Our measurements and tests should not only be accurate, but also be as precise as possible.9 Moreover, the assumptions we make should be on solid ground. Since the beginning of the pandemic, there may have been undercounts and delays in reporting. The assumptions of the effects of social distancing may have been inaccurate. Just as important, the lack of early testing in our pandemic and the relatively limited testing currently available provide challenges not only in attributing past deaths to COVID-19, but also with planning and public health measures. To be fair, the tsunami that turned out to be a small wave in North Carolina may be caused by the strong leadership from politicians, public health officials, and health system leaders for their stay-at-home decree and vigorous public health measures in our state.
Some of the health systems in the United States have created “reemergence plans” to care for those patients who have stayed at home for the past several months. Elective surgeries and procedures have begun in different regions of the United States and will likely continue reopening into the late summer. Nevertheless, challenges and opportunities continue to abound during these difficult times of COVID-19. The tsunamis or surges will continue to occur in the United States and the premature reopening of some of the public places and businesses have not helped our collective efforts. In addition, the personal costs have been and will be immeasurable. Many of us have lost loved ones, been laid off, or face mental health crises because of the social isolation and false news.
COVID-19 is here to stay and will be with us for the foreseeable future. Health care providers have been literally risking their lives to serve the public and we will continue to do so. Hitting the target of needed inpatient beds and critical care beds is critically important and is tough without accurate data. We simply have inadequate and unreliable data of COVID-19 incidence and prevalence rates in the communities that we serve. More available testing would allow frontline health care providers and health care leaders to match hospital demand to supply, at individual hospitals and within the health care system. Moreover, contact tracing capabilities would give us the opportunity to isolate individuals and extinguish population-based hotspots.
We may have seen the first wave, but other waves of COVID-19 in North Carolina are sure to come. Since the partial reopening of North Carolina on May 8, 2020, coupled with pockets of nonadherence to social distancing and mask wearing, we expect a second wave sooner rather than later. Interestingly, daily new lab-confirmed COVID-19 cases in North Carolina have been on the rise, with the highest one-day total occurring on June 12, 2020 with 1,768 cases reported.6 As a result, North Carolina Gov. Roy Cooper and Secretary of the North Carolina Department of Health and Human Services, Dr. Mandy Cohen, placed a temporary pause on the Phase 2 reopening plan and mandated masks in public on June 24, 2020. It is unclear whether these intermittent daily spikes in lab-confirmed COVID-19 cases are a foreshadowing of our next wave, surge, or tsunami, or just an anomaly. Only time will tell, but as Jim Kim, MD, PhD, has stated so well, there is still time for social distancing, contact tracing, testing, isolation, and treatment.10 There is still time for us, for our loved ones, for our hospital systems, and for our public health system.
Dr. Huang is the executive medical director and service line director of general medicine and hospital medicine within the Wake Forest Baptist Health System and associate professor of internal medicine at Wake Forest School of Medicine. Dr. Lippert is assistant professor of internal medicine at Wake Forest School of Medicine. Mr. Payne is the associate vice president of Wake Forest Baptist Health. He is responsible for engineering, facilities planning & design as well as environmental health and safety departments. Dr. Pariyadath is comedical director of the Patient Flow Operations Center which facilitates patient placement throughout the Wake Forest Baptist Health system. He is also the associate medical director for the adult emergency department. Dr. Sunkara is assistant professor of internal medicine at Wake Forest School of Medicine. He is the medical director for hospital medicine units and the newly established PUI unit.
Acknowledgments
The authors would like to thank Julie Freischlag, MD; Kevin High, MD, MS; Gary Rosenthal, MD; Wayne Meredith, MD;Russ Howerton, MD; Mike Waid, Andrea Fernandez, MD; Brian Hiestand, MD; the Wake Forest Baptist Health System COVID-19 task force, the Operations Center, and the countless frontline staff at all five hospitals within the Wake Forest Baptist Health System.
References
1. World Health Organization. Modes of transmission of virus causing COVID-19: Implications for IPC precaution recommendations. 2020 June 30. https://www.who.int/news-room/commentaries/detail/modes-of-transmission-of-virus-causing-covid-19-implications-for-ipc-precaution-recommendations.
2. Holshue et al. First case of 2019 novel coronavirus in the United States. N Engl J Med. 2020;382: 929-36.
3. Fuller T, Baker M. Coronavirus death in California came weeks before first known U.S. death. New York Times. 2020 Apr 22. https://www.nytimes.com/2020/04/22/us/coronavirus-first-united-states-death.html.
4. Johns Hopkins Coronavirus Resource Center. https://coronavirus.jhu.edu/us-map. Accessed 2020 May 28.
5. Michaud J et al. COVID-19 models: Can they tell us what we want to know? 2020 April 16. https://www.kff.org/coronavirus-policy-watch/covid-19-models.
6. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed 2020 June 30.
7. Jewell N et al. Caution warranted: Using the Institute for Health Metrics and Evaluation Model for predicting the course of the COVID-19 pandemic. Ann Intern Med. 2020;173:1-3.
8. Box G. Science and statistics. J Am Stat Assoc. 1972;71:791-9.
9. Shapiro DE. The interpretation of diagnostic tests. Stat Methods Med Res. 1999;8:113-34.
10. Kim J. It is not too late to go on the offense against the coronavirus. The New Yorker. 2020 Apr 20. https://www.newyorker.com/science/medical-dispatch/its-not-too-late-to-go-on-offense-against-the-coronavirus.
Different COVID-19 models and predicting inpatient bed capacity
Different COVID-19 models and predicting inpatient bed capacity
The COVID-19 pandemic is one of the defining moments in history for this generation’s health care leaders. In 2019, most of us wrongly assumed that this virus would be similar to the past viral epidemics and pandemics such as 2002 severe acute respiratory syndrome–CoV in Asia, 2009 H1N1 influenza in the United States, 2012 Middle East respiratory syndrome–CoV in Saudi Arabia, and 2014-2016 Ebola in West Africa. Moreover, we understood that the 50% fatality rate of Ebola, a single-stranded RNA virus, was deadly on the continent of Africa, but its transmission was through direct contact with blood or other bodily fluids. Hence, the infectivity of Ebola to the general public was lower than SARS-CoV-2, which is spread by respiratory droplets and contact routes in addition to being the virus that causes COVID-19.1 Many of us did not expect that SARS-CoV-2, a single-stranded RNA virus consisting of 32 kilobytes, would reach the shores of the United States from the Hubei province of China, the northern Lombardy region of Italy, or other initial hotspots. We could not imagine its effects would be so devastating from an economic and medical perspective. Until it did.
The first reported case of SARS-CoV-2 was on Jan. 20, 2020 in Snohomish County, Wash., and the first known death from COVID-19 occurred on Feb. 6, 2020 in Santa Clara County, Calif.2,3 Since then, the United States has lost over 135,000 people from COVID-19 with death(s) reported in every state and the highest number of overall deaths of any country in the world.4 At the beginning of 2020, at our institution, Wake Forest Baptist Health System in Winston-Salem, N.C., we began preparing for the wave, surge, or tsunami of inpatients that was coming. Plans were afoot to increase our staff, even perhaps by hiring out-of-state physicians and nurses if needed, and every possible bed was considered within the system. It was not an if, but rather a when, as to the arrival of COVID-19.
Epidemiologists and biostatisticians developed predictive COVID-19 models so that health care leaders could plan accordingly, especially those patients that required critical care or inpatient medical care. These predictive models have been used across the globe and can be categorized into three groups: Susceptible-Exposed-Infectious-Recovered, Agent-Based, and Curve Fitting Extrapolation.5 Our original predictions were based on the Institute for Health Metrics and Evaluation model from Washington state (Curve Fitting Extrapolation). It creates projections from COVID-19 mortality data and assumes a 3% infection rate. Other health systems in our region used the COVID-19 Hospital Impact Model for Epidemics–University of Pennsylvania model. It pins its suppositions on hospitalized COVID-19 patients, regional infection rates, and hospital market shares. Lastly, the agent-based mode, such as the Global Epidemic and Mobility Project, takes simulated populations and forecasts the spread of SARS-CoV-2 anchoring on the interplay of individuals and groups. The assumptions are created secondary to the interactions of people, time, health care interventions, and public health policies.
Based on these predictive simulations, health systems have spent countless hours of planning and have utilized resources for the anticipated needs related to beds, ventilators, supplies, and staffing. Frontline staff were retrained how to don and doff personal protective equipment. Our teams were ready if we saw a wave of 250, a surge of 500, or a tsunami of 750 COVID-19 inpatients. We were prepared to run into the fire fully knowing the personal risks and consequences.
But, as yet, the tsunami in North Carolina has never come. On April 21, 2020, the COVID-19 mortality data in North Carolina peaked at 34 deaths, with the total number of deaths standing at 1,510 as of July 13, 2020.6 A surge did not hit our institutional shores at Wake Forest Baptist Health. As we looked through the proverbial back window and hear about the tsunami in Houston, Texas, we are very thankful that the tsunami turned out to be a small wave so far in North Carolina. We are grateful that there were fewer deaths than expected. The dust is settling now and the question, spoken or unspoken, is: “How could we be so wrong with our predictions?”
Models have strengths and weaknesses and none are perfect.7 There is an old aphorism in statistics that is often attributed to George Box that says: “All models are wrong but some are useful.”8 Predictions and projections are good, but not perfect. Our measurements and tests should not only be accurate, but also be as precise as possible.9 Moreover, the assumptions we make should be on solid ground. Since the beginning of the pandemic, there may have been undercounts and delays in reporting. The assumptions of the effects of social distancing may have been inaccurate. Just as important, the lack of early testing in our pandemic and the relatively limited testing currently available provide challenges not only in attributing past deaths to COVID-19, but also with planning and public health measures. To be fair, the tsunami that turned out to be a small wave in North Carolina may be caused by the strong leadership from politicians, public health officials, and health system leaders for their stay-at-home decree and vigorous public health measures in our state.
Some of the health systems in the United States have created “reemergence plans” to care for those patients who have stayed at home for the past several months. Elective surgeries and procedures have begun in different regions of the United States and will likely continue reopening into the late summer. Nevertheless, challenges and opportunities continue to abound during these difficult times of COVID-19. The tsunamis or surges will continue to occur in the United States and the premature reopening of some of the public places and businesses have not helped our collective efforts. In addition, the personal costs have been and will be immeasurable. Many of us have lost loved ones, been laid off, or face mental health crises because of the social isolation and false news.
COVID-19 is here to stay and will be with us for the foreseeable future. Health care providers have been literally risking their lives to serve the public and we will continue to do so. Hitting the target of needed inpatient beds and critical care beds is critically important and is tough without accurate data. We simply have inadequate and unreliable data of COVID-19 incidence and prevalence rates in the communities that we serve. More available testing would allow frontline health care providers and health care leaders to match hospital demand to supply, at individual hospitals and within the health care system. Moreover, contact tracing capabilities would give us the opportunity to isolate individuals and extinguish population-based hotspots.
We may have seen the first wave, but other waves of COVID-19 in North Carolina are sure to come. Since the partial reopening of North Carolina on May 8, 2020, coupled with pockets of nonadherence to social distancing and mask wearing, we expect a second wave sooner rather than later. Interestingly, daily new lab-confirmed COVID-19 cases in North Carolina have been on the rise, with the highest one-day total occurring on June 12, 2020 with 1,768 cases reported.6 As a result, North Carolina Gov. Roy Cooper and Secretary of the North Carolina Department of Health and Human Services, Dr. Mandy Cohen, placed a temporary pause on the Phase 2 reopening plan and mandated masks in public on June 24, 2020. It is unclear whether these intermittent daily spikes in lab-confirmed COVID-19 cases are a foreshadowing of our next wave, surge, or tsunami, or just an anomaly. Only time will tell, but as Jim Kim, MD, PhD, has stated so well, there is still time for social distancing, contact tracing, testing, isolation, and treatment.10 There is still time for us, for our loved ones, for our hospital systems, and for our public health system.
Dr. Huang is the executive medical director and service line director of general medicine and hospital medicine within the Wake Forest Baptist Health System and associate professor of internal medicine at Wake Forest School of Medicine. Dr. Lippert is assistant professor of internal medicine at Wake Forest School of Medicine. Mr. Payne is the associate vice president of Wake Forest Baptist Health. He is responsible for engineering, facilities planning & design as well as environmental health and safety departments. Dr. Pariyadath is comedical director of the Patient Flow Operations Center which facilitates patient placement throughout the Wake Forest Baptist Health system. He is also the associate medical director for the adult emergency department. Dr. Sunkara is assistant professor of internal medicine at Wake Forest School of Medicine. He is the medical director for hospital medicine units and the newly established PUI unit.
Acknowledgments
The authors would like to thank Julie Freischlag, MD; Kevin High, MD, MS; Gary Rosenthal, MD; Wayne Meredith, MD;Russ Howerton, MD; Mike Waid, Andrea Fernandez, MD; Brian Hiestand, MD; the Wake Forest Baptist Health System COVID-19 task force, the Operations Center, and the countless frontline staff at all five hospitals within the Wake Forest Baptist Health System.
References
1. World Health Organization. Modes of transmission of virus causing COVID-19: Implications for IPC precaution recommendations. 2020 June 30. https://www.who.int/news-room/commentaries/detail/modes-of-transmission-of-virus-causing-covid-19-implications-for-ipc-precaution-recommendations.
2. Holshue et al. First case of 2019 novel coronavirus in the United States. N Engl J Med. 2020;382: 929-36.
3. Fuller T, Baker M. Coronavirus death in California came weeks before first known U.S. death. New York Times. 2020 Apr 22. https://www.nytimes.com/2020/04/22/us/coronavirus-first-united-states-death.html.
4. Johns Hopkins Coronavirus Resource Center. https://coronavirus.jhu.edu/us-map. Accessed 2020 May 28.
5. Michaud J et al. COVID-19 models: Can they tell us what we want to know? 2020 April 16. https://www.kff.org/coronavirus-policy-watch/covid-19-models.
6. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed 2020 June 30.
7. Jewell N et al. Caution warranted: Using the Institute for Health Metrics and Evaluation Model for predicting the course of the COVID-19 pandemic. Ann Intern Med. 2020;173:1-3.
8. Box G. Science and statistics. J Am Stat Assoc. 1972;71:791-9.
9. Shapiro DE. The interpretation of diagnostic tests. Stat Methods Med Res. 1999;8:113-34.
10. Kim J. It is not too late to go on the offense against the coronavirus. The New Yorker. 2020 Apr 20. https://www.newyorker.com/science/medical-dispatch/its-not-too-late-to-go-on-offense-against-the-coronavirus.
The COVID-19 pandemic is one of the defining moments in history for this generation’s health care leaders. In 2019, most of us wrongly assumed that this virus would be similar to the past viral epidemics and pandemics such as 2002 severe acute respiratory syndrome–CoV in Asia, 2009 H1N1 influenza in the United States, 2012 Middle East respiratory syndrome–CoV in Saudi Arabia, and 2014-2016 Ebola in West Africa. Moreover, we understood that the 50% fatality rate of Ebola, a single-stranded RNA virus, was deadly on the continent of Africa, but its transmission was through direct contact with blood or other bodily fluids. Hence, the infectivity of Ebola to the general public was lower than SARS-CoV-2, which is spread by respiratory droplets and contact routes in addition to being the virus that causes COVID-19.1 Many of us did not expect that SARS-CoV-2, a single-stranded RNA virus consisting of 32 kilobytes, would reach the shores of the United States from the Hubei province of China, the northern Lombardy region of Italy, or other initial hotspots. We could not imagine its effects would be so devastating from an economic and medical perspective. Until it did.
The first reported case of SARS-CoV-2 was on Jan. 20, 2020 in Snohomish County, Wash., and the first known death from COVID-19 occurred on Feb. 6, 2020 in Santa Clara County, Calif.2,3 Since then, the United States has lost over 135,000 people from COVID-19 with death(s) reported in every state and the highest number of overall deaths of any country in the world.4 At the beginning of 2020, at our institution, Wake Forest Baptist Health System in Winston-Salem, N.C., we began preparing for the wave, surge, or tsunami of inpatients that was coming. Plans were afoot to increase our staff, even perhaps by hiring out-of-state physicians and nurses if needed, and every possible bed was considered within the system. It was not an if, but rather a when, as to the arrival of COVID-19.
Epidemiologists and biostatisticians developed predictive COVID-19 models so that health care leaders could plan accordingly, especially those patients that required critical care or inpatient medical care. These predictive models have been used across the globe and can be categorized into three groups: Susceptible-Exposed-Infectious-Recovered, Agent-Based, and Curve Fitting Extrapolation.5 Our original predictions were based on the Institute for Health Metrics and Evaluation model from Washington state (Curve Fitting Extrapolation). It creates projections from COVID-19 mortality data and assumes a 3% infection rate. Other health systems in our region used the COVID-19 Hospital Impact Model for Epidemics–University of Pennsylvania model. It pins its suppositions on hospitalized COVID-19 patients, regional infection rates, and hospital market shares. Lastly, the agent-based mode, such as the Global Epidemic and Mobility Project, takes simulated populations and forecasts the spread of SARS-CoV-2 anchoring on the interplay of individuals and groups. The assumptions are created secondary to the interactions of people, time, health care interventions, and public health policies.
Based on these predictive simulations, health systems have spent countless hours of planning and have utilized resources for the anticipated needs related to beds, ventilators, supplies, and staffing. Frontline staff were retrained how to don and doff personal protective equipment. Our teams were ready if we saw a wave of 250, a surge of 500, or a tsunami of 750 COVID-19 inpatients. We were prepared to run into the fire fully knowing the personal risks and consequences.
But, as yet, the tsunami in North Carolina has never come. On April 21, 2020, the COVID-19 mortality data in North Carolina peaked at 34 deaths, with the total number of deaths standing at 1,510 as of July 13, 2020.6 A surge did not hit our institutional shores at Wake Forest Baptist Health. As we looked through the proverbial back window and hear about the tsunami in Houston, Texas, we are very thankful that the tsunami turned out to be a small wave so far in North Carolina. We are grateful that there were fewer deaths than expected. The dust is settling now and the question, spoken or unspoken, is: “How could we be so wrong with our predictions?”
Models have strengths and weaknesses and none are perfect.7 There is an old aphorism in statistics that is often attributed to George Box that says: “All models are wrong but some are useful.”8 Predictions and projections are good, but not perfect. Our measurements and tests should not only be accurate, but also be as precise as possible.9 Moreover, the assumptions we make should be on solid ground. Since the beginning of the pandemic, there may have been undercounts and delays in reporting. The assumptions of the effects of social distancing may have been inaccurate. Just as important, the lack of early testing in our pandemic and the relatively limited testing currently available provide challenges not only in attributing past deaths to COVID-19, but also with planning and public health measures. To be fair, the tsunami that turned out to be a small wave in North Carolina may be caused by the strong leadership from politicians, public health officials, and health system leaders for their stay-at-home decree and vigorous public health measures in our state.
Some of the health systems in the United States have created “reemergence plans” to care for those patients who have stayed at home for the past several months. Elective surgeries and procedures have begun in different regions of the United States and will likely continue reopening into the late summer. Nevertheless, challenges and opportunities continue to abound during these difficult times of COVID-19. The tsunamis or surges will continue to occur in the United States and the premature reopening of some of the public places and businesses have not helped our collective efforts. In addition, the personal costs have been and will be immeasurable. Many of us have lost loved ones, been laid off, or face mental health crises because of the social isolation and false news.
COVID-19 is here to stay and will be with us for the foreseeable future. Health care providers have been literally risking their lives to serve the public and we will continue to do so. Hitting the target of needed inpatient beds and critical care beds is critically important and is tough without accurate data. We simply have inadequate and unreliable data of COVID-19 incidence and prevalence rates in the communities that we serve. More available testing would allow frontline health care providers and health care leaders to match hospital demand to supply, at individual hospitals and within the health care system. Moreover, contact tracing capabilities would give us the opportunity to isolate individuals and extinguish population-based hotspots.
We may have seen the first wave, but other waves of COVID-19 in North Carolina are sure to come. Since the partial reopening of North Carolina on May 8, 2020, coupled with pockets of nonadherence to social distancing and mask wearing, we expect a second wave sooner rather than later. Interestingly, daily new lab-confirmed COVID-19 cases in North Carolina have been on the rise, with the highest one-day total occurring on June 12, 2020 with 1,768 cases reported.6 As a result, North Carolina Gov. Roy Cooper and Secretary of the North Carolina Department of Health and Human Services, Dr. Mandy Cohen, placed a temporary pause on the Phase 2 reopening plan and mandated masks in public on June 24, 2020. It is unclear whether these intermittent daily spikes in lab-confirmed COVID-19 cases are a foreshadowing of our next wave, surge, or tsunami, or just an anomaly. Only time will tell, but as Jim Kim, MD, PhD, has stated so well, there is still time for social distancing, contact tracing, testing, isolation, and treatment.10 There is still time for us, for our loved ones, for our hospital systems, and for our public health system.
Dr. Huang is the executive medical director and service line director of general medicine and hospital medicine within the Wake Forest Baptist Health System and associate professor of internal medicine at Wake Forest School of Medicine. Dr. Lippert is assistant professor of internal medicine at Wake Forest School of Medicine. Mr. Payne is the associate vice president of Wake Forest Baptist Health. He is responsible for engineering, facilities planning & design as well as environmental health and safety departments. Dr. Pariyadath is comedical director of the Patient Flow Operations Center which facilitates patient placement throughout the Wake Forest Baptist Health system. He is also the associate medical director for the adult emergency department. Dr. Sunkara is assistant professor of internal medicine at Wake Forest School of Medicine. He is the medical director for hospital medicine units and the newly established PUI unit.
Acknowledgments
The authors would like to thank Julie Freischlag, MD; Kevin High, MD, MS; Gary Rosenthal, MD; Wayne Meredith, MD;Russ Howerton, MD; Mike Waid, Andrea Fernandez, MD; Brian Hiestand, MD; the Wake Forest Baptist Health System COVID-19 task force, the Operations Center, and the countless frontline staff at all five hospitals within the Wake Forest Baptist Health System.
References
1. World Health Organization. Modes of transmission of virus causing COVID-19: Implications for IPC precaution recommendations. 2020 June 30. https://www.who.int/news-room/commentaries/detail/modes-of-transmission-of-virus-causing-covid-19-implications-for-ipc-precaution-recommendations.
2. Holshue et al. First case of 2019 novel coronavirus in the United States. N Engl J Med. 2020;382: 929-36.
3. Fuller T, Baker M. Coronavirus death in California came weeks before first known U.S. death. New York Times. 2020 Apr 22. https://www.nytimes.com/2020/04/22/us/coronavirus-first-united-states-death.html.
4. Johns Hopkins Coronavirus Resource Center. https://coronavirus.jhu.edu/us-map. Accessed 2020 May 28.
5. Michaud J et al. COVID-19 models: Can they tell us what we want to know? 2020 April 16. https://www.kff.org/coronavirus-policy-watch/covid-19-models.
6. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed 2020 June 30.
7. Jewell N et al. Caution warranted: Using the Institute for Health Metrics and Evaluation Model for predicting the course of the COVID-19 pandemic. Ann Intern Med. 2020;173:1-3.
8. Box G. Science and statistics. J Am Stat Assoc. 1972;71:791-9.
9. Shapiro DE. The interpretation of diagnostic tests. Stat Methods Med Res. 1999;8:113-34.
10. Kim J. It is not too late to go on the offense against the coronavirus. The New Yorker. 2020 Apr 20. https://www.newyorker.com/science/medical-dispatch/its-not-too-late-to-go-on-offense-against-the-coronavirus.
Hep C sofosbuvir/daclatasvir combo promising for COVID-19
research from an open-label Iranian study shows.
And the good news is that the treatment combination “already has a well-established safety profile in the treatment of hepatitis C,” said investigator Andrew Hill, PhD, from the University of Liverpool, United Kingdom.
But although the results look promising, they are preliminary, he cautioned. The combination could follow the path of ritonavir plus lopinavir (Kaletra, AbbVie Pharmaceuticals) or hydroxychloroquine (Plaquenil, Sanofi Pharmaceuticals), which showed promise early but did not perform as hoped in large randomized controlled trials.
“We need to remember that conducting research amidst a pandemic with overwhelmed hospitals is a clear challenge, and we cannot be sure of success,” he added.
Three Trials, 176 Patients
Data collected during a four-site trial of the combination treatment in Tehran during an early spike in cases in Iran were presented at the Virtual COVID-19 Conference 2020 by Hannah Wentzel, a masters student in public health at Imperial College London and a member of Hill’s team.
All 66 study participants were diagnosed with moderate to severe COVID-19 and were treated with standard care, which consisted of hydroxychloroquine 200 mg twice daily with or without the combination of lopinavir plus ritonavir 250 mg twice daily.
The 33 patients randomized to the treatment group also received the combination of sofosbuvir plus daclatasvir 460 mg once daily. These patients were slightly younger and more likely to be men than were those in the standard-care group, but the differences were not significant.
All participants were treated for 14 days, and then the researchers assessed fever, respiration rate, and blood oxygen saturation.
More patients in the treatment group than in the standard-care group had recovered at 14 days (88% vs 67%), but the difference was not significant.
However, median time to clinical recovery, which took into account death as a competing risk, was significantly faster in the treatment group than in the standard-care group (6 vs 11 days; P = .041).
The researchers then pooled their Tehran data with those from two other trials of the sofosbuvir plus daclatasvir combination conducted in Iran: one in the city of Sari with 48 patients and one in the city of Abadan with 62 patients.
A meta-analysis showed that clinical recovery in 14 days was 14% better in the treatment group than in the control group in the Sari study, 32% better in the Tehran study, and 82% better in the Abadan study. However, in a sensitivity analysis, because “the trial in Abadan was not properly randomized,” only the improvements in the Sari and Tehran studies were significant, Wentzel reported.
The meta-analysis also showed that patients in the treatment groups were 70% more likely than those in the standard-care groups to survive.
However, the treatment regimens in the standard-care groups of the three studies were all different, reflecting evolving national treatment guidelines in Iran at the time. And SARS-CoV-2 viral loads were not measured in any of the trials, so the effects of the different drugs on the virus itself could not be assessed.
Still, overall, “sofosbuvir and daclatasvir is associated with faster discharge from hospital and improved survival,” Wentzel said.
These findings are hopeful, “provocative, and encouraging,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and he echoed Hill’s call to “get these kinds of studies into randomized controlled trials.”
But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on.
Results from three double-blind randomized controlled trials – one each in Iran, Egypt, and South Africa – with an estimated cumulative enrollment of about 2,000 patients, are expected in October, Hill reported.
“Having gone through feeling so desperate to help people and try new things, it’s really important to do these trials,” said Kristen Marks, MD, from Weill Cornell Medicine in New York City.
“You get tempted to just kind of throw anything at people. And I think we really have to have science to guide us,” she told Medscape Medical News.
This article first appeared on Medscape.com.
research from an open-label Iranian study shows.
And the good news is that the treatment combination “already has a well-established safety profile in the treatment of hepatitis C,” said investigator Andrew Hill, PhD, from the University of Liverpool, United Kingdom.
But although the results look promising, they are preliminary, he cautioned. The combination could follow the path of ritonavir plus lopinavir (Kaletra, AbbVie Pharmaceuticals) or hydroxychloroquine (Plaquenil, Sanofi Pharmaceuticals), which showed promise early but did not perform as hoped in large randomized controlled trials.
“We need to remember that conducting research amidst a pandemic with overwhelmed hospitals is a clear challenge, and we cannot be sure of success,” he added.
Three Trials, 176 Patients
Data collected during a four-site trial of the combination treatment in Tehran during an early spike in cases in Iran were presented at the Virtual COVID-19 Conference 2020 by Hannah Wentzel, a masters student in public health at Imperial College London and a member of Hill’s team.
All 66 study participants were diagnosed with moderate to severe COVID-19 and were treated with standard care, which consisted of hydroxychloroquine 200 mg twice daily with or without the combination of lopinavir plus ritonavir 250 mg twice daily.
The 33 patients randomized to the treatment group also received the combination of sofosbuvir plus daclatasvir 460 mg once daily. These patients were slightly younger and more likely to be men than were those in the standard-care group, but the differences were not significant.
All participants were treated for 14 days, and then the researchers assessed fever, respiration rate, and blood oxygen saturation.
More patients in the treatment group than in the standard-care group had recovered at 14 days (88% vs 67%), but the difference was not significant.
However, median time to clinical recovery, which took into account death as a competing risk, was significantly faster in the treatment group than in the standard-care group (6 vs 11 days; P = .041).
The researchers then pooled their Tehran data with those from two other trials of the sofosbuvir plus daclatasvir combination conducted in Iran: one in the city of Sari with 48 patients and one in the city of Abadan with 62 patients.
A meta-analysis showed that clinical recovery in 14 days was 14% better in the treatment group than in the control group in the Sari study, 32% better in the Tehran study, and 82% better in the Abadan study. However, in a sensitivity analysis, because “the trial in Abadan was not properly randomized,” only the improvements in the Sari and Tehran studies were significant, Wentzel reported.
The meta-analysis also showed that patients in the treatment groups were 70% more likely than those in the standard-care groups to survive.
However, the treatment regimens in the standard-care groups of the three studies were all different, reflecting evolving national treatment guidelines in Iran at the time. And SARS-CoV-2 viral loads were not measured in any of the trials, so the effects of the different drugs on the virus itself could not be assessed.
Still, overall, “sofosbuvir and daclatasvir is associated with faster discharge from hospital and improved survival,” Wentzel said.
These findings are hopeful, “provocative, and encouraging,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and he echoed Hill’s call to “get these kinds of studies into randomized controlled trials.”
But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on.
Results from three double-blind randomized controlled trials – one each in Iran, Egypt, and South Africa – with an estimated cumulative enrollment of about 2,000 patients, are expected in October, Hill reported.
“Having gone through feeling so desperate to help people and try new things, it’s really important to do these trials,” said Kristen Marks, MD, from Weill Cornell Medicine in New York City.
“You get tempted to just kind of throw anything at people. And I think we really have to have science to guide us,” she told Medscape Medical News.
This article first appeared on Medscape.com.
research from an open-label Iranian study shows.
And the good news is that the treatment combination “already has a well-established safety profile in the treatment of hepatitis C,” said investigator Andrew Hill, PhD, from the University of Liverpool, United Kingdom.
But although the results look promising, they are preliminary, he cautioned. The combination could follow the path of ritonavir plus lopinavir (Kaletra, AbbVie Pharmaceuticals) or hydroxychloroquine (Plaquenil, Sanofi Pharmaceuticals), which showed promise early but did not perform as hoped in large randomized controlled trials.
“We need to remember that conducting research amidst a pandemic with overwhelmed hospitals is a clear challenge, and we cannot be sure of success,” he added.
Three Trials, 176 Patients
Data collected during a four-site trial of the combination treatment in Tehran during an early spike in cases in Iran were presented at the Virtual COVID-19 Conference 2020 by Hannah Wentzel, a masters student in public health at Imperial College London and a member of Hill’s team.
All 66 study participants were diagnosed with moderate to severe COVID-19 and were treated with standard care, which consisted of hydroxychloroquine 200 mg twice daily with or without the combination of lopinavir plus ritonavir 250 mg twice daily.
The 33 patients randomized to the treatment group also received the combination of sofosbuvir plus daclatasvir 460 mg once daily. These patients were slightly younger and more likely to be men than were those in the standard-care group, but the differences were not significant.
All participants were treated for 14 days, and then the researchers assessed fever, respiration rate, and blood oxygen saturation.
More patients in the treatment group than in the standard-care group had recovered at 14 days (88% vs 67%), but the difference was not significant.
However, median time to clinical recovery, which took into account death as a competing risk, was significantly faster in the treatment group than in the standard-care group (6 vs 11 days; P = .041).
The researchers then pooled their Tehran data with those from two other trials of the sofosbuvir plus daclatasvir combination conducted in Iran: one in the city of Sari with 48 patients and one in the city of Abadan with 62 patients.
A meta-analysis showed that clinical recovery in 14 days was 14% better in the treatment group than in the control group in the Sari study, 32% better in the Tehran study, and 82% better in the Abadan study. However, in a sensitivity analysis, because “the trial in Abadan was not properly randomized,” only the improvements in the Sari and Tehran studies were significant, Wentzel reported.
The meta-analysis also showed that patients in the treatment groups were 70% more likely than those in the standard-care groups to survive.
However, the treatment regimens in the standard-care groups of the three studies were all different, reflecting evolving national treatment guidelines in Iran at the time. And SARS-CoV-2 viral loads were not measured in any of the trials, so the effects of the different drugs on the virus itself could not be assessed.
Still, overall, “sofosbuvir and daclatasvir is associated with faster discharge from hospital and improved survival,” Wentzel said.
These findings are hopeful, “provocative, and encouraging,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and he echoed Hill’s call to “get these kinds of studies into randomized controlled trials.”
But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on.
Results from three double-blind randomized controlled trials – one each in Iran, Egypt, and South Africa – with an estimated cumulative enrollment of about 2,000 patients, are expected in October, Hill reported.
“Having gone through feeling so desperate to help people and try new things, it’s really important to do these trials,” said Kristen Marks, MD, from Weill Cornell Medicine in New York City.
“You get tempted to just kind of throw anything at people. And I think we really have to have science to guide us,” she told Medscape Medical News.
This article first appeared on Medscape.com.
Medical societies advise on vitamin D in midst of COVID-19
Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.
The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.
They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.
The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”
It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”
The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.
Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.
What role for vitamin D in COVID-19?
Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.
During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.
However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.
“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.
Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”
Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.
A version of this article originally appeared on Medscape.com.
Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.
The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.
They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.
The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”
It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”
The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.
Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.
What role for vitamin D in COVID-19?
Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.
During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.
However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.
“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.
Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”
Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.
A version of this article originally appeared on Medscape.com.
Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.
The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.
They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.
The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”
It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”
The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.
Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.
What role for vitamin D in COVID-19?
Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.
During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.
However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.
“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.
Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”
Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.
A version of this article originally appeared on Medscape.com.
Hyperglycemia predicts COVID-19 death even without diabetes
new research indicates.
The findings, from a retrospective analysis of 605 patients with COVID-19 seen at two hospitals in Wuhan, China, were published online July 10 in Diabetologia by Sufei Wang, of the department of respiratory and critical care medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and colleagues.
Several previous studies have demonstrated a link between hyperglycemia and worse outcomes in COVID-19, and at least one diabetes diagnosis, but this is the first to focus specifically on that group of patients.
Wang and colleagues found that a fasting blood glucose of 7.0 mmol/L (126 mg/dL) or greater on admission – present in 45.6% of those without a prior diabetes diagnosis – was an independent predictor of 28-day mortality.
Although A1c data weren’t analyzed, the population is believed to include both individuals with preexisting but undiagnosed diabetes and those without diabetes who have acute stress hyperglycemia.
“Glycemic testing and control should be recommended for all COVID-19 patients even if they do not have preexisting diabetes, as most COVID-19 patients are prone to glucose metabolic disorders,” they emphasized.
“Addressing elevated fasting blood glucose at an early stage can help clinicians better manage the condition and lower the mortality risk of COVID-19 patients,” Wang and colleagues noted.
Hyperglycemia predicts COVID-19 death, complications
The study involved consecutive patients with COVID-19 and definitive 28-day outcome and fasting blood glucose measurement on admission to two Wuhan-area hospitals between Jan. 24 to Feb. 10, 2020. A total of 605 patients did not have a previous diabetes diagnosis. They were a median age of 59 years and 53.2% were men.
Just over half, 54.4%, had a fasting blood glucose below 6.1 mmol/L (110.0 mg/dL). The rest had dysglycemia: 16.5% had a fasting blood glucose of 6.1-6.9 mmol/L (110-125 mg/dL), considered the prediabetes range, and 29.1% had a fasting blood glucose of 7 mmol/L (126 mg/dL) or above, the cutoff for diabetes.
“These results indicate that our study included both undiagnosed diabetic patients and nondiabetic patients with hyperglycemia caused by an acute blood glucose disorder,” the authors noted.
Over 28 days of hospitalization, 18.8% (114) of the patients died and 39.2% developed one or more in-hospital complications.
The authors used the CRB-65 score, which assigns 1 point for each of four indicators – confusion, respiratory rate >30 breaths/min, systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤60 mm Hg, and age ≥65 years – to assess pneumonia severity.
Just over half, 55.2%, had a CRB-65 score of 0, 43.1% had a score of 1-2, and 1.7% had a score of 3-4.
In multivariable analysis, significant independent predictors of 28-day mortality were age (hazard ratio, 1.02), male sex (HR, 1.75), CRB-65 score 1-2 (HR, 2.68), CRB-65 score 3-4 (HR, 5.25), and fasting blood glucose ≥7.0 mmol/L (HR, 2.30).
Compared with patients with normal glucose (<6.1 mmol/L), 28-day mortality was twice as high (HR, 2.06) for those with a fasting blood glucose of 6.1-6.9 mmol/L and more than threefold higher for ≥7.0 mmol/L (HR, 3.54).
Pneumonia severity also predicted 28-day mortality, with hazard ratios of 4.35 and 13.80 for patients with CRB-65 scores of 1-2 and 3-4, respectively, compared with 0.
Inhospital complications, including acute respiratory distress syndrome or acute cardiac, kidney, or liver injury or cerebrovascular accident, occurred in 14.2%, 7.9%, and 17.0% of those in the lowest to highest fasting blood glucose groups.
Complications were more than twice as common in patients with a fasting blood glucose of 6.1-6.9 mmol/L (HR, 2.61) and four times more common (HR, 3.99) among those with a fasting blood glucose ≥7.0 mmol/L, compared with those with normoglycemia.
The study was supported by the National Natural Science Foundation of China and Major Projects of the National Science and Technology. The authors have reported no relevant financial relationships.
This article first appeared on Medscape.com.
new research indicates.
The findings, from a retrospective analysis of 605 patients with COVID-19 seen at two hospitals in Wuhan, China, were published online July 10 in Diabetologia by Sufei Wang, of the department of respiratory and critical care medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and colleagues.
Several previous studies have demonstrated a link between hyperglycemia and worse outcomes in COVID-19, and at least one diabetes diagnosis, but this is the first to focus specifically on that group of patients.
Wang and colleagues found that a fasting blood glucose of 7.0 mmol/L (126 mg/dL) or greater on admission – present in 45.6% of those without a prior diabetes diagnosis – was an independent predictor of 28-day mortality.
Although A1c data weren’t analyzed, the population is believed to include both individuals with preexisting but undiagnosed diabetes and those without diabetes who have acute stress hyperglycemia.
“Glycemic testing and control should be recommended for all COVID-19 patients even if they do not have preexisting diabetes, as most COVID-19 patients are prone to glucose metabolic disorders,” they emphasized.
“Addressing elevated fasting blood glucose at an early stage can help clinicians better manage the condition and lower the mortality risk of COVID-19 patients,” Wang and colleagues noted.
Hyperglycemia predicts COVID-19 death, complications
The study involved consecutive patients with COVID-19 and definitive 28-day outcome and fasting blood glucose measurement on admission to two Wuhan-area hospitals between Jan. 24 to Feb. 10, 2020. A total of 605 patients did not have a previous diabetes diagnosis. They were a median age of 59 years and 53.2% were men.
Just over half, 54.4%, had a fasting blood glucose below 6.1 mmol/L (110.0 mg/dL). The rest had dysglycemia: 16.5% had a fasting blood glucose of 6.1-6.9 mmol/L (110-125 mg/dL), considered the prediabetes range, and 29.1% had a fasting blood glucose of 7 mmol/L (126 mg/dL) or above, the cutoff for diabetes.
“These results indicate that our study included both undiagnosed diabetic patients and nondiabetic patients with hyperglycemia caused by an acute blood glucose disorder,” the authors noted.
Over 28 days of hospitalization, 18.8% (114) of the patients died and 39.2% developed one or more in-hospital complications.
The authors used the CRB-65 score, which assigns 1 point for each of four indicators – confusion, respiratory rate >30 breaths/min, systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤60 mm Hg, and age ≥65 years – to assess pneumonia severity.
Just over half, 55.2%, had a CRB-65 score of 0, 43.1% had a score of 1-2, and 1.7% had a score of 3-4.
In multivariable analysis, significant independent predictors of 28-day mortality were age (hazard ratio, 1.02), male sex (HR, 1.75), CRB-65 score 1-2 (HR, 2.68), CRB-65 score 3-4 (HR, 5.25), and fasting blood glucose ≥7.0 mmol/L (HR, 2.30).
Compared with patients with normal glucose (<6.1 mmol/L), 28-day mortality was twice as high (HR, 2.06) for those with a fasting blood glucose of 6.1-6.9 mmol/L and more than threefold higher for ≥7.0 mmol/L (HR, 3.54).
Pneumonia severity also predicted 28-day mortality, with hazard ratios of 4.35 and 13.80 for patients with CRB-65 scores of 1-2 and 3-4, respectively, compared with 0.
Inhospital complications, including acute respiratory distress syndrome or acute cardiac, kidney, or liver injury or cerebrovascular accident, occurred in 14.2%, 7.9%, and 17.0% of those in the lowest to highest fasting blood glucose groups.
Complications were more than twice as common in patients with a fasting blood glucose of 6.1-6.9 mmol/L (HR, 2.61) and four times more common (HR, 3.99) among those with a fasting blood glucose ≥7.0 mmol/L, compared with those with normoglycemia.
The study was supported by the National Natural Science Foundation of China and Major Projects of the National Science and Technology. The authors have reported no relevant financial relationships.
This article first appeared on Medscape.com.
new research indicates.
The findings, from a retrospective analysis of 605 patients with COVID-19 seen at two hospitals in Wuhan, China, were published online July 10 in Diabetologia by Sufei Wang, of the department of respiratory and critical care medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and colleagues.
Several previous studies have demonstrated a link between hyperglycemia and worse outcomes in COVID-19, and at least one diabetes diagnosis, but this is the first to focus specifically on that group of patients.
Wang and colleagues found that a fasting blood glucose of 7.0 mmol/L (126 mg/dL) or greater on admission – present in 45.6% of those without a prior diabetes diagnosis – was an independent predictor of 28-day mortality.
Although A1c data weren’t analyzed, the population is believed to include both individuals with preexisting but undiagnosed diabetes and those without diabetes who have acute stress hyperglycemia.
“Glycemic testing and control should be recommended for all COVID-19 patients even if they do not have preexisting diabetes, as most COVID-19 patients are prone to glucose metabolic disorders,” they emphasized.
“Addressing elevated fasting blood glucose at an early stage can help clinicians better manage the condition and lower the mortality risk of COVID-19 patients,” Wang and colleagues noted.
Hyperglycemia predicts COVID-19 death, complications
The study involved consecutive patients with COVID-19 and definitive 28-day outcome and fasting blood glucose measurement on admission to two Wuhan-area hospitals between Jan. 24 to Feb. 10, 2020. A total of 605 patients did not have a previous diabetes diagnosis. They were a median age of 59 years and 53.2% were men.
Just over half, 54.4%, had a fasting blood glucose below 6.1 mmol/L (110.0 mg/dL). The rest had dysglycemia: 16.5% had a fasting blood glucose of 6.1-6.9 mmol/L (110-125 mg/dL), considered the prediabetes range, and 29.1% had a fasting blood glucose of 7 mmol/L (126 mg/dL) or above, the cutoff for diabetes.
“These results indicate that our study included both undiagnosed diabetic patients and nondiabetic patients with hyperglycemia caused by an acute blood glucose disorder,” the authors noted.
Over 28 days of hospitalization, 18.8% (114) of the patients died and 39.2% developed one or more in-hospital complications.
The authors used the CRB-65 score, which assigns 1 point for each of four indicators – confusion, respiratory rate >30 breaths/min, systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤60 mm Hg, and age ≥65 years – to assess pneumonia severity.
Just over half, 55.2%, had a CRB-65 score of 0, 43.1% had a score of 1-2, and 1.7% had a score of 3-4.
In multivariable analysis, significant independent predictors of 28-day mortality were age (hazard ratio, 1.02), male sex (HR, 1.75), CRB-65 score 1-2 (HR, 2.68), CRB-65 score 3-4 (HR, 5.25), and fasting blood glucose ≥7.0 mmol/L (HR, 2.30).
Compared with patients with normal glucose (<6.1 mmol/L), 28-day mortality was twice as high (HR, 2.06) for those with a fasting blood glucose of 6.1-6.9 mmol/L and more than threefold higher for ≥7.0 mmol/L (HR, 3.54).
Pneumonia severity also predicted 28-day mortality, with hazard ratios of 4.35 and 13.80 for patients with CRB-65 scores of 1-2 and 3-4, respectively, compared with 0.
Inhospital complications, including acute respiratory distress syndrome or acute cardiac, kidney, or liver injury or cerebrovascular accident, occurred in 14.2%, 7.9%, and 17.0% of those in the lowest to highest fasting blood glucose groups.
Complications were more than twice as common in patients with a fasting blood glucose of 6.1-6.9 mmol/L (HR, 2.61) and four times more common (HR, 3.99) among those with a fasting blood glucose ≥7.0 mmol/L, compared with those with normoglycemia.
The study was supported by the National Natural Science Foundation of China and Major Projects of the National Science and Technology. The authors have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Infants around the world with bronchiolitis received excess tests despite guidelines
While guidelines for bronchiolitis aim to reduce gratuitous tests and treatments, one-third of infants presenting at EDs with bronchiolitis receive an unnecessary intervention, according to a new global study.
For infants with symptoms of bronchiolitis, viral testing, blood tests, and chest x-rays are discouraged in most cases. Antibiotics are not recommended as treatment.
In a study published in Pediatrics, Amy Zipursky, MD, of the Hospital for Sick Children and the University of Toronto, and colleagues, reviewed records for 2,359 infants aged 2-11 months diagnosed with bronchiolitis during the year 2013. The data came from a network of 38 EDs in the Australia, Canada, Ireland, New Zealand, Portugal, Spain, the United Kingdom, and the United States.
Dr. Zipursky and colleagues found that, while 8% of infants in the cohort had been treated with antibiotics, 33% had received at least one nonrecommended test, with rates ranging widely across regions. In the United Kingdom and Ireland, for example, only 15% received such a test, compared with 50% in Spain and Portugal.
Of the children given antibiotics, two-thirds had suspected bacterial infections, the researchers found. Antibiotic use was highest in the United States, at 11% of infants seen for bronchiolitis, and lowest in the United Kingdom and Ireland at 4%. Administration of chest x-rays – which occurred in nearly a quarter of the cohort – increased the likelihood of antibiotics being administered (odds ratio, 2.29; 95% confidence interval, 1.62-3.24) independent of fever or severe symptoms.
The most common nonrecommended tests performed in the study were:
- Nasopharyngeal viral testing without admission to hospital (n = 591).
- Chest x-ray without ICU admission (n = 507).
- Complete blood counts (n = 222).
- Blood cultures (n = 129).
- Urinalysis in the absence of fever (n = 86).
- Febrile infants 3 months of age or less had blood cultures (n = 49).
In some treatment centers the rate of nonrecommended tests performed was 6%, while others saw rates of 74%.
“Despite the evidence that laboratory testing rarely impacts bronchiolitis management and that bacterial infections in bronchiolitis are uncommon, our study reveals that these tests continue to be performed frequently in many parts of the world,” Dr. Zipursky and colleagues wrote in their analysis.
“Plausible reasons may include ‘automatic’ blood draws with intravenous placement, uncertainty about institutional policies, perceived need for reassurance about the diagnosis, perception of ‘doing something,’ and parental desire for a viral label,” the authors surmised. “Because parental pressure to provide interventions may be a driver of care in infants with bronchiolitis in some countries, ED clinicians need to have higher confidence in the evidence-based bronchiolitis care and convey this trust to families.”
The researchers listed among the weaknesses of their study its retrospective design, and that results from x-rays and lab tests performed were not available.
In an editorial comment accompanying the study, Joseph J. Zorc, MD, of Children’s Hospital of Philadelphia and the University of Pennsylvania in Philadelphia, noted that some of the regional differences seen in the study may be attributable to different clinical criteria used to diagnose bronchiolitis. In the United Kingdom, for example, national guidelines include the presence of crackles, while in North America guidelines focus on wheeze. “Perhaps clinicians in the United Kingdom accept the presence of crackles as an expected finding in infant with bronchiolitis and are less likely to order imaging,” Dr. Zorc said (Pediatrics. 2020 Jul 13;146[2]:e20193684).
He also pointed out that the coronavirus pandemic caused by SARS-CoV-2 (COVID- 19) could have an impact on global testing and treatment practices for bronchiolitis, as coronaviruses are a known cause of bronchiolitis. The Pediatric Emergency Research Network, comprising the 38 EDs from which Dr. Zipursky and colleagues drew their data, is conducting a prospective study looking at pediatric disease caused by SARS-CoV-2.
The “collaboration of international networks of pediatric emergency providers is an encouraging sign of potential opportunities to come ... [providing] an opportunity to evaluate variation that can lead to innovation,” Dr. Zorc concluded.
Dr. Zipursky and colleagues reported no external funding or relevant financial disclosures. Dr. Zorc reported no relevant conflicts of interest.
SOURCE: Zipursky A et al. Pediatrics. 2020 Jul 13;146(2):e2020002311.
While guidelines for bronchiolitis aim to reduce gratuitous tests and treatments, one-third of infants presenting at EDs with bronchiolitis receive an unnecessary intervention, according to a new global study.
For infants with symptoms of bronchiolitis, viral testing, blood tests, and chest x-rays are discouraged in most cases. Antibiotics are not recommended as treatment.
In a study published in Pediatrics, Amy Zipursky, MD, of the Hospital for Sick Children and the University of Toronto, and colleagues, reviewed records for 2,359 infants aged 2-11 months diagnosed with bronchiolitis during the year 2013. The data came from a network of 38 EDs in the Australia, Canada, Ireland, New Zealand, Portugal, Spain, the United Kingdom, and the United States.
Dr. Zipursky and colleagues found that, while 8% of infants in the cohort had been treated with antibiotics, 33% had received at least one nonrecommended test, with rates ranging widely across regions. In the United Kingdom and Ireland, for example, only 15% received such a test, compared with 50% in Spain and Portugal.
Of the children given antibiotics, two-thirds had suspected bacterial infections, the researchers found. Antibiotic use was highest in the United States, at 11% of infants seen for bronchiolitis, and lowest in the United Kingdom and Ireland at 4%. Administration of chest x-rays – which occurred in nearly a quarter of the cohort – increased the likelihood of antibiotics being administered (odds ratio, 2.29; 95% confidence interval, 1.62-3.24) independent of fever or severe symptoms.
The most common nonrecommended tests performed in the study were:
- Nasopharyngeal viral testing without admission to hospital (n = 591).
- Chest x-ray without ICU admission (n = 507).
- Complete blood counts (n = 222).
- Blood cultures (n = 129).
- Urinalysis in the absence of fever (n = 86).
- Febrile infants 3 months of age or less had blood cultures (n = 49).
In some treatment centers the rate of nonrecommended tests performed was 6%, while others saw rates of 74%.
“Despite the evidence that laboratory testing rarely impacts bronchiolitis management and that bacterial infections in bronchiolitis are uncommon, our study reveals that these tests continue to be performed frequently in many parts of the world,” Dr. Zipursky and colleagues wrote in their analysis.
“Plausible reasons may include ‘automatic’ blood draws with intravenous placement, uncertainty about institutional policies, perceived need for reassurance about the diagnosis, perception of ‘doing something,’ and parental desire for a viral label,” the authors surmised. “Because parental pressure to provide interventions may be a driver of care in infants with bronchiolitis in some countries, ED clinicians need to have higher confidence in the evidence-based bronchiolitis care and convey this trust to families.”
The researchers listed among the weaknesses of their study its retrospective design, and that results from x-rays and lab tests performed were not available.
In an editorial comment accompanying the study, Joseph J. Zorc, MD, of Children’s Hospital of Philadelphia and the University of Pennsylvania in Philadelphia, noted that some of the regional differences seen in the study may be attributable to different clinical criteria used to diagnose bronchiolitis. In the United Kingdom, for example, national guidelines include the presence of crackles, while in North America guidelines focus on wheeze. “Perhaps clinicians in the United Kingdom accept the presence of crackles as an expected finding in infant with bronchiolitis and are less likely to order imaging,” Dr. Zorc said (Pediatrics. 2020 Jul 13;146[2]:e20193684).
He also pointed out that the coronavirus pandemic caused by SARS-CoV-2 (COVID- 19) could have an impact on global testing and treatment practices for bronchiolitis, as coronaviruses are a known cause of bronchiolitis. The Pediatric Emergency Research Network, comprising the 38 EDs from which Dr. Zipursky and colleagues drew their data, is conducting a prospective study looking at pediatric disease caused by SARS-CoV-2.
The “collaboration of international networks of pediatric emergency providers is an encouraging sign of potential opportunities to come ... [providing] an opportunity to evaluate variation that can lead to innovation,” Dr. Zorc concluded.
Dr. Zipursky and colleagues reported no external funding or relevant financial disclosures. Dr. Zorc reported no relevant conflicts of interest.
SOURCE: Zipursky A et al. Pediatrics. 2020 Jul 13;146(2):e2020002311.
While guidelines for bronchiolitis aim to reduce gratuitous tests and treatments, one-third of infants presenting at EDs with bronchiolitis receive an unnecessary intervention, according to a new global study.
For infants with symptoms of bronchiolitis, viral testing, blood tests, and chest x-rays are discouraged in most cases. Antibiotics are not recommended as treatment.
In a study published in Pediatrics, Amy Zipursky, MD, of the Hospital for Sick Children and the University of Toronto, and colleagues, reviewed records for 2,359 infants aged 2-11 months diagnosed with bronchiolitis during the year 2013. The data came from a network of 38 EDs in the Australia, Canada, Ireland, New Zealand, Portugal, Spain, the United Kingdom, and the United States.
Dr. Zipursky and colleagues found that, while 8% of infants in the cohort had been treated with antibiotics, 33% had received at least one nonrecommended test, with rates ranging widely across regions. In the United Kingdom and Ireland, for example, only 15% received such a test, compared with 50% in Spain and Portugal.
Of the children given antibiotics, two-thirds had suspected bacterial infections, the researchers found. Antibiotic use was highest in the United States, at 11% of infants seen for bronchiolitis, and lowest in the United Kingdom and Ireland at 4%. Administration of chest x-rays – which occurred in nearly a quarter of the cohort – increased the likelihood of antibiotics being administered (odds ratio, 2.29; 95% confidence interval, 1.62-3.24) independent of fever or severe symptoms.
The most common nonrecommended tests performed in the study were:
- Nasopharyngeal viral testing without admission to hospital (n = 591).
- Chest x-ray without ICU admission (n = 507).
- Complete blood counts (n = 222).
- Blood cultures (n = 129).
- Urinalysis in the absence of fever (n = 86).
- Febrile infants 3 months of age or less had blood cultures (n = 49).
In some treatment centers the rate of nonrecommended tests performed was 6%, while others saw rates of 74%.
“Despite the evidence that laboratory testing rarely impacts bronchiolitis management and that bacterial infections in bronchiolitis are uncommon, our study reveals that these tests continue to be performed frequently in many parts of the world,” Dr. Zipursky and colleagues wrote in their analysis.
“Plausible reasons may include ‘automatic’ blood draws with intravenous placement, uncertainty about institutional policies, perceived need for reassurance about the diagnosis, perception of ‘doing something,’ and parental desire for a viral label,” the authors surmised. “Because parental pressure to provide interventions may be a driver of care in infants with bronchiolitis in some countries, ED clinicians need to have higher confidence in the evidence-based bronchiolitis care and convey this trust to families.”
The researchers listed among the weaknesses of their study its retrospective design, and that results from x-rays and lab tests performed were not available.
In an editorial comment accompanying the study, Joseph J. Zorc, MD, of Children’s Hospital of Philadelphia and the University of Pennsylvania in Philadelphia, noted that some of the regional differences seen in the study may be attributable to different clinical criteria used to diagnose bronchiolitis. In the United Kingdom, for example, national guidelines include the presence of crackles, while in North America guidelines focus on wheeze. “Perhaps clinicians in the United Kingdom accept the presence of crackles as an expected finding in infant with bronchiolitis and are less likely to order imaging,” Dr. Zorc said (Pediatrics. 2020 Jul 13;146[2]:e20193684).
He also pointed out that the coronavirus pandemic caused by SARS-CoV-2 (COVID- 19) could have an impact on global testing and treatment practices for bronchiolitis, as coronaviruses are a known cause of bronchiolitis. The Pediatric Emergency Research Network, comprising the 38 EDs from which Dr. Zipursky and colleagues drew their data, is conducting a prospective study looking at pediatric disease caused by SARS-CoV-2.
The “collaboration of international networks of pediatric emergency providers is an encouraging sign of potential opportunities to come ... [providing] an opportunity to evaluate variation that can lead to innovation,” Dr. Zorc concluded.
Dr. Zipursky and colleagues reported no external funding or relevant financial disclosures. Dr. Zorc reported no relevant conflicts of interest.
SOURCE: Zipursky A et al. Pediatrics. 2020 Jul 13;146(2):e2020002311.
FROM PEDIATRICS
Key clinical point:
Major finding: In a global cohort, 33% of infants received at least one nonrecommended test, most commonly viral tests, chest x-rays, and blood cultures.
Study details: A retrospective cohort of 2,359 infants aged 2-11 months seen in 38 EDs in developed countries.
Disclosures: Dr. Zipursky and colleagues reported no external funding or relevant financial disclosures.
Source: Zipursky A et al. Pediatrics. 2020 Jul 13;146(2):e2020002311.
Patients who refuse to wear masks: Responses that won’t get you sued
What do you do now?
Your waiting room is filled with mask-wearing individuals, except for one person. Your staff offers a mask to this person, citing your office policy of requiring masks for all persons in order to prevent asymptomatic COVID-19 spread, and the patient refuses to put it on.
What can you/should you/must you do? Are you required to see a patient who refuses to wear a mask? If you ask the patient to leave without being seen, can you be accused of patient abandonment? If you allow the patient to stay, could you be liable for negligence for exposing others to a deadly illness?
The rules on mask-wearing, while initially downright confusing, have inexorably come to a rough consensus. By governors’ orders, masks are now mandatory in most states, though when and where they are required varies. For example, effective July 7, the governor of Washington has ordered that a business not allow a customer to enter without a face covering.
Nor do we have case law to help us determine whether patient abandonment would apply if a patient is sent home without being seen.
We can apply the legal principles and cases from other situations to this one, however, to tell us what constitutes negligence or patient abandonment. The practical questions, legally, are who might sue and on what basis?
Who might sue?
Someone who is injured in a public place may sue the owner for negligence if the owner knew or should have known of a danger and didn’t do anything about it. For example, individuals have sued grocery stores successfully after they slipped on a banana peel and fell. If, say, the banana peel was black, that indicates that it had been there for a while, and judges have found that the store management should have known about it and removed it.
Compare the banana peel scenario with the scenario where most news outlets and health departments are telling people, every day, to wear masks while in indoor public spaces, yet owners of a medical practice or facility allow individuals who are not wearing masks to sit in their waiting room. If an individual who was also in the waiting room with the unmasked individual develops COVID-19 2 days later, the ill individual may sue the medical practice for negligence for not removing the unmasked individual.
What about the individual’s responsibility to move away from the person not wearing a mask? That is the aspect of this scenario that attorneys and experts could argue about, for days, in a court case. But to go back to the banana peel case, one could argue that a customer in a grocery store should be looking out for banana peels on the floor and avoid them, yet courts have assigned liability to grocery stores when customers slip and fall.
Let’s review the four elements of negligence which a plaintiff would need to prove:
- Duty: Obligation of one person to another
- Breach: Improper act or omission, in the context of proper behavior to avoid imposing undue risks of harm to other persons and their property
- Damage
- Causation: That the act or omission caused the harm
Those who run medical offices and facilities have a duty to provide reasonably safe public spaces. Unmasked individuals are a risk to others nearby, so the “breach” element is satisfied if a practice fails to impose safety measures. Causation could be proven, or at least inferred, if contact tracing of an individual with COVID-19 showed that the only contact likely to have exposed the ill individual to the virus was an unmasked individual in a medical practice’s waiting room, especially if the unmasked individual was COVID-19 positive before, during, or shortly after the visit to the practice.
What about patient abandonment?
“Patient abandonment” is the legal term for terminating the physician-patient relationship in such a manner that the patient is denied necessary medical care. It is a form of negligence.
Refusing to see a patient unless the patient wears a mask is not denying care, in this attorney’s view, but rather establishing reasonable conditions for getting care. The patient simply needs to put on a mask.
What about the patient who refuses to wear a mask for medical reasons? There are exceptions in most of the governors’ orders for individuals with medical conditions that preclude covering nose and mouth with a mask. A medical office is the perfect place to test an individual’s ability or inability to breathe well while wearing a mask. “Put the mask on and we’ll see how you do” is a reasonable response. Monitor the patient visually and apply a pulse oximeter with mask off and mask on.
One physician recently wrote about measuring her own oxygen levels while wearing four different masks for 5 minutes each, with no change in breathing.
Editor’s note: Read more about mask exemptions in a Medscape interview with pulmonologist Albert Rizzo, MD, chief medical officer of the American Lung Association.
What are some practical tips?
Assuming that a patient is not in acute distress, options in this scenario include:
- Send the patient home and offer a return visit if masked or when the pandemic is over.
- Offer a telehealth visit, with the patient at home.
What if the unmasked person is not a patient but the companion of a patient? What if the individual refusing to wear a mask is an employee? In neither of these two hypotheticals is there a basis for legal action against a practice whose policy requires that everyone wear masks on the premises.
A companion who arrives without a mask should leave the office. An employee who refuses to mask up could be sent home. If the employee has a disability covered by the Americans with Disabilities Act, then the practice may need to make reasonable accommodations so that the employee works in a room alone if unable to work from home.
Those who manage medical practices should check the websites of the state health department and medical societies at least weekly, to see whether the agencies have issued guidance. For example, the Texas Medical Association has issued limited guidance.
A version of this article originally appeared on Medscape.com.
What do you do now?
Your waiting room is filled with mask-wearing individuals, except for one person. Your staff offers a mask to this person, citing your office policy of requiring masks for all persons in order to prevent asymptomatic COVID-19 spread, and the patient refuses to put it on.
What can you/should you/must you do? Are you required to see a patient who refuses to wear a mask? If you ask the patient to leave without being seen, can you be accused of patient abandonment? If you allow the patient to stay, could you be liable for negligence for exposing others to a deadly illness?
The rules on mask-wearing, while initially downright confusing, have inexorably come to a rough consensus. By governors’ orders, masks are now mandatory in most states, though when and where they are required varies. For example, effective July 7, the governor of Washington has ordered that a business not allow a customer to enter without a face covering.
Nor do we have case law to help us determine whether patient abandonment would apply if a patient is sent home without being seen.
We can apply the legal principles and cases from other situations to this one, however, to tell us what constitutes negligence or patient abandonment. The practical questions, legally, are who might sue and on what basis?
Who might sue?
Someone who is injured in a public place may sue the owner for negligence if the owner knew or should have known of a danger and didn’t do anything about it. For example, individuals have sued grocery stores successfully after they slipped on a banana peel and fell. If, say, the banana peel was black, that indicates that it had been there for a while, and judges have found that the store management should have known about it and removed it.
Compare the banana peel scenario with the scenario where most news outlets and health departments are telling people, every day, to wear masks while in indoor public spaces, yet owners of a medical practice or facility allow individuals who are not wearing masks to sit in their waiting room. If an individual who was also in the waiting room with the unmasked individual develops COVID-19 2 days later, the ill individual may sue the medical practice for negligence for not removing the unmasked individual.
What about the individual’s responsibility to move away from the person not wearing a mask? That is the aspect of this scenario that attorneys and experts could argue about, for days, in a court case. But to go back to the banana peel case, one could argue that a customer in a grocery store should be looking out for banana peels on the floor and avoid them, yet courts have assigned liability to grocery stores when customers slip and fall.
Let’s review the four elements of negligence which a plaintiff would need to prove:
- Duty: Obligation of one person to another
- Breach: Improper act or omission, in the context of proper behavior to avoid imposing undue risks of harm to other persons and their property
- Damage
- Causation: That the act or omission caused the harm
Those who run medical offices and facilities have a duty to provide reasonably safe public spaces. Unmasked individuals are a risk to others nearby, so the “breach” element is satisfied if a practice fails to impose safety measures. Causation could be proven, or at least inferred, if contact tracing of an individual with COVID-19 showed that the only contact likely to have exposed the ill individual to the virus was an unmasked individual in a medical practice’s waiting room, especially if the unmasked individual was COVID-19 positive before, during, or shortly after the visit to the practice.
What about patient abandonment?
“Patient abandonment” is the legal term for terminating the physician-patient relationship in such a manner that the patient is denied necessary medical care. It is a form of negligence.
Refusing to see a patient unless the patient wears a mask is not denying care, in this attorney’s view, but rather establishing reasonable conditions for getting care. The patient simply needs to put on a mask.
What about the patient who refuses to wear a mask for medical reasons? There are exceptions in most of the governors’ orders for individuals with medical conditions that preclude covering nose and mouth with a mask. A medical office is the perfect place to test an individual’s ability or inability to breathe well while wearing a mask. “Put the mask on and we’ll see how you do” is a reasonable response. Monitor the patient visually and apply a pulse oximeter with mask off and mask on.
One physician recently wrote about measuring her own oxygen levels while wearing four different masks for 5 minutes each, with no change in breathing.
Editor’s note: Read more about mask exemptions in a Medscape interview with pulmonologist Albert Rizzo, MD, chief medical officer of the American Lung Association.
What are some practical tips?
Assuming that a patient is not in acute distress, options in this scenario include:
- Send the patient home and offer a return visit if masked or when the pandemic is over.
- Offer a telehealth visit, with the patient at home.
What if the unmasked person is not a patient but the companion of a patient? What if the individual refusing to wear a mask is an employee? In neither of these two hypotheticals is there a basis for legal action against a practice whose policy requires that everyone wear masks on the premises.
A companion who arrives without a mask should leave the office. An employee who refuses to mask up could be sent home. If the employee has a disability covered by the Americans with Disabilities Act, then the practice may need to make reasonable accommodations so that the employee works in a room alone if unable to work from home.
Those who manage medical practices should check the websites of the state health department and medical societies at least weekly, to see whether the agencies have issued guidance. For example, the Texas Medical Association has issued limited guidance.
A version of this article originally appeared on Medscape.com.
What do you do now?
Your waiting room is filled with mask-wearing individuals, except for one person. Your staff offers a mask to this person, citing your office policy of requiring masks for all persons in order to prevent asymptomatic COVID-19 spread, and the patient refuses to put it on.
What can you/should you/must you do? Are you required to see a patient who refuses to wear a mask? If you ask the patient to leave without being seen, can you be accused of patient abandonment? If you allow the patient to stay, could you be liable for negligence for exposing others to a deadly illness?
The rules on mask-wearing, while initially downright confusing, have inexorably come to a rough consensus. By governors’ orders, masks are now mandatory in most states, though when and where they are required varies. For example, effective July 7, the governor of Washington has ordered that a business not allow a customer to enter without a face covering.
Nor do we have case law to help us determine whether patient abandonment would apply if a patient is sent home without being seen.
We can apply the legal principles and cases from other situations to this one, however, to tell us what constitutes negligence or patient abandonment. The practical questions, legally, are who might sue and on what basis?
Who might sue?
Someone who is injured in a public place may sue the owner for negligence if the owner knew or should have known of a danger and didn’t do anything about it. For example, individuals have sued grocery stores successfully after they slipped on a banana peel and fell. If, say, the banana peel was black, that indicates that it had been there for a while, and judges have found that the store management should have known about it and removed it.
Compare the banana peel scenario with the scenario where most news outlets and health departments are telling people, every day, to wear masks while in indoor public spaces, yet owners of a medical practice or facility allow individuals who are not wearing masks to sit in their waiting room. If an individual who was also in the waiting room with the unmasked individual develops COVID-19 2 days later, the ill individual may sue the medical practice for negligence for not removing the unmasked individual.
What about the individual’s responsibility to move away from the person not wearing a mask? That is the aspect of this scenario that attorneys and experts could argue about, for days, in a court case. But to go back to the banana peel case, one could argue that a customer in a grocery store should be looking out for banana peels on the floor and avoid them, yet courts have assigned liability to grocery stores when customers slip and fall.
Let’s review the four elements of negligence which a plaintiff would need to prove:
- Duty: Obligation of one person to another
- Breach: Improper act or omission, in the context of proper behavior to avoid imposing undue risks of harm to other persons and their property
- Damage
- Causation: That the act or omission caused the harm
Those who run medical offices and facilities have a duty to provide reasonably safe public spaces. Unmasked individuals are a risk to others nearby, so the “breach” element is satisfied if a practice fails to impose safety measures. Causation could be proven, or at least inferred, if contact tracing of an individual with COVID-19 showed that the only contact likely to have exposed the ill individual to the virus was an unmasked individual in a medical practice’s waiting room, especially if the unmasked individual was COVID-19 positive before, during, or shortly after the visit to the practice.
What about patient abandonment?
“Patient abandonment” is the legal term for terminating the physician-patient relationship in such a manner that the patient is denied necessary medical care. It is a form of negligence.
Refusing to see a patient unless the patient wears a mask is not denying care, in this attorney’s view, but rather establishing reasonable conditions for getting care. The patient simply needs to put on a mask.
What about the patient who refuses to wear a mask for medical reasons? There are exceptions in most of the governors’ orders for individuals with medical conditions that preclude covering nose and mouth with a mask. A medical office is the perfect place to test an individual’s ability or inability to breathe well while wearing a mask. “Put the mask on and we’ll see how you do” is a reasonable response. Monitor the patient visually and apply a pulse oximeter with mask off and mask on.
One physician recently wrote about measuring her own oxygen levels while wearing four different masks for 5 minutes each, with no change in breathing.
Editor’s note: Read more about mask exemptions in a Medscape interview with pulmonologist Albert Rizzo, MD, chief medical officer of the American Lung Association.
What are some practical tips?
Assuming that a patient is not in acute distress, options in this scenario include:
- Send the patient home and offer a return visit if masked or when the pandemic is over.
- Offer a telehealth visit, with the patient at home.
What if the unmasked person is not a patient but the companion of a patient? What if the individual refusing to wear a mask is an employee? In neither of these two hypotheticals is there a basis for legal action against a practice whose policy requires that everyone wear masks on the premises.
A companion who arrives without a mask should leave the office. An employee who refuses to mask up could be sent home. If the employee has a disability covered by the Americans with Disabilities Act, then the practice may need to make reasonable accommodations so that the employee works in a room alone if unable to work from home.
Those who manage medical practices should check the websites of the state health department and medical societies at least weekly, to see whether the agencies have issued guidance. For example, the Texas Medical Association has issued limited guidance.
A version of this article originally appeared on Medscape.com.