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Physicians, make a plan to vote
In March 2020, following the announcement of the United States’ first death related to COVID-19, many physicians began using their voices to discuss the shortage of personal protective equipment (PPE). Many physicians, myself included, petitioned elected leaders at the community, state, and federal levels to address the PPE shortage.
Historically, physicians have advocated for improved public health. From seat belt laws in the 1980s and 1990s to the Affordable Care Act in the 2000s, physicians have testified at the community, state, and federal levels to advocate for the health and safety of our patients and the public. Yet while we have been making our voices heard, we are often silent at the ballot box.
In the 1996 and 2000 elections, physicians voted 9% less often than the general public, and compared with lawyers – professionals with similar educational attainment and finances – physicians voted 22% less often.1 It is unclear why physicians are less likely to vote. In a 2016 article, David Grande, MD, and Katrina Armstrong, MD, postulated that physicians may not vote because our work hours create barriers to visiting polls.2
Despite our lack of engagement at the ballot box, voting is important to improving our patients’ social determinants of health. In a recently published systematic review, the authors found several studies supporting the association between voting and social determinants of health. Their review found that, when large numbers of people from communities participated in voting, it translated into greater influence over determining who held political power in that community. Those with power introduced and supported policies responding to their constituents’ needs, ultimately influencing their constituents’ social determinants of health.3 By voting, we as physicians are helping to address the social determinants of health in our communities.
Many medical students have been doing their part to improve the social determinants of health in their communities by pledging to vote. In 2018, the American Medical Student Association launched their “Med Out the Vote” initiative prior to the election. The organization called on all health care providers and providers in training to pledge to vote in the election.4 They are continuing these efforts for the 2020 elections.
We should join our nation’s medical students by also pledging to vote. To begin, we can all Make A Plan To Vote. Each plan should include the following:
- Register to vote: In many states eligible voters can register online.
- Request an absentee ballot: Many states require registered voters to request absentee ballots online or by mail.
- Vote: Submit an absentee ballot prior to election or vote in-person on election day. Some counties allow voting early in person.
In practice, our plans will differ slightly because each state has its own election laws.
This election season let us ensure all physician voices are heard. Make A Plan To Vote for your patients and communities.
Dr. Kumar is the pediatric editor of The Hospitalist. She is clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University and a pediatric hospitalist at Cleveland Clinic Children’s.
References
1. Grande D et al. Do Doctors Vote? J Gen Intern Med. 2007 May;22(5):585-9.
2. Grande D, Armstrong K. Will Physicians Vote? Ann Intern Med. 2016;165:814-5.
3. Brown CL et al. Voting, health and interventions in healthcare settings: A scoping review. Public Health Rev. 2020 Jul. doi: 10.1186/s40985-020-00133-6.
4. American Medical Student Association. AMSA Launches Med Out the Vote Campaign, Call to Action. 2018 Jul 29. Accessed 2020 Sep 14. https://www.amsa.org/about/amsa-press-room/amsa-launches-med-out-the-vote-campaign-call-to-action/
In March 2020, following the announcement of the United States’ first death related to COVID-19, many physicians began using their voices to discuss the shortage of personal protective equipment (PPE). Many physicians, myself included, petitioned elected leaders at the community, state, and federal levels to address the PPE shortage.
Historically, physicians have advocated for improved public health. From seat belt laws in the 1980s and 1990s to the Affordable Care Act in the 2000s, physicians have testified at the community, state, and federal levels to advocate for the health and safety of our patients and the public. Yet while we have been making our voices heard, we are often silent at the ballot box.
In the 1996 and 2000 elections, physicians voted 9% less often than the general public, and compared with lawyers – professionals with similar educational attainment and finances – physicians voted 22% less often.1 It is unclear why physicians are less likely to vote. In a 2016 article, David Grande, MD, and Katrina Armstrong, MD, postulated that physicians may not vote because our work hours create barriers to visiting polls.2
Despite our lack of engagement at the ballot box, voting is important to improving our patients’ social determinants of health. In a recently published systematic review, the authors found several studies supporting the association between voting and social determinants of health. Their review found that, when large numbers of people from communities participated in voting, it translated into greater influence over determining who held political power in that community. Those with power introduced and supported policies responding to their constituents’ needs, ultimately influencing their constituents’ social determinants of health.3 By voting, we as physicians are helping to address the social determinants of health in our communities.
Many medical students have been doing their part to improve the social determinants of health in their communities by pledging to vote. In 2018, the American Medical Student Association launched their “Med Out the Vote” initiative prior to the election. The organization called on all health care providers and providers in training to pledge to vote in the election.4 They are continuing these efforts for the 2020 elections.
We should join our nation’s medical students by also pledging to vote. To begin, we can all Make A Plan To Vote. Each plan should include the following:
- Register to vote: In many states eligible voters can register online.
- Request an absentee ballot: Many states require registered voters to request absentee ballots online or by mail.
- Vote: Submit an absentee ballot prior to election or vote in-person on election day. Some counties allow voting early in person.
In practice, our plans will differ slightly because each state has its own election laws.
This election season let us ensure all physician voices are heard. Make A Plan To Vote for your patients and communities.
Dr. Kumar is the pediatric editor of The Hospitalist. She is clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University and a pediatric hospitalist at Cleveland Clinic Children’s.
References
1. Grande D et al. Do Doctors Vote? J Gen Intern Med. 2007 May;22(5):585-9.
2. Grande D, Armstrong K. Will Physicians Vote? Ann Intern Med. 2016;165:814-5.
3. Brown CL et al. Voting, health and interventions in healthcare settings: A scoping review. Public Health Rev. 2020 Jul. doi: 10.1186/s40985-020-00133-6.
4. American Medical Student Association. AMSA Launches Med Out the Vote Campaign, Call to Action. 2018 Jul 29. Accessed 2020 Sep 14. https://www.amsa.org/about/amsa-press-room/amsa-launches-med-out-the-vote-campaign-call-to-action/
In March 2020, following the announcement of the United States’ first death related to COVID-19, many physicians began using their voices to discuss the shortage of personal protective equipment (PPE). Many physicians, myself included, petitioned elected leaders at the community, state, and federal levels to address the PPE shortage.
Historically, physicians have advocated for improved public health. From seat belt laws in the 1980s and 1990s to the Affordable Care Act in the 2000s, physicians have testified at the community, state, and federal levels to advocate for the health and safety of our patients and the public. Yet while we have been making our voices heard, we are often silent at the ballot box.
In the 1996 and 2000 elections, physicians voted 9% less often than the general public, and compared with lawyers – professionals with similar educational attainment and finances – physicians voted 22% less often.1 It is unclear why physicians are less likely to vote. In a 2016 article, David Grande, MD, and Katrina Armstrong, MD, postulated that physicians may not vote because our work hours create barriers to visiting polls.2
Despite our lack of engagement at the ballot box, voting is important to improving our patients’ social determinants of health. In a recently published systematic review, the authors found several studies supporting the association between voting and social determinants of health. Their review found that, when large numbers of people from communities participated in voting, it translated into greater influence over determining who held political power in that community. Those with power introduced and supported policies responding to their constituents’ needs, ultimately influencing their constituents’ social determinants of health.3 By voting, we as physicians are helping to address the social determinants of health in our communities.
Many medical students have been doing their part to improve the social determinants of health in their communities by pledging to vote. In 2018, the American Medical Student Association launched their “Med Out the Vote” initiative prior to the election. The organization called on all health care providers and providers in training to pledge to vote in the election.4 They are continuing these efforts for the 2020 elections.
We should join our nation’s medical students by also pledging to vote. To begin, we can all Make A Plan To Vote. Each plan should include the following:
- Register to vote: In many states eligible voters can register online.
- Request an absentee ballot: Many states require registered voters to request absentee ballots online or by mail.
- Vote: Submit an absentee ballot prior to election or vote in-person on election day. Some counties allow voting early in person.
In practice, our plans will differ slightly because each state has its own election laws.
This election season let us ensure all physician voices are heard. Make A Plan To Vote for your patients and communities.
Dr. Kumar is the pediatric editor of The Hospitalist. She is clinical assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University and a pediatric hospitalist at Cleveland Clinic Children’s.
References
1. Grande D et al. Do Doctors Vote? J Gen Intern Med. 2007 May;22(5):585-9.
2. Grande D, Armstrong K. Will Physicians Vote? Ann Intern Med. 2016;165:814-5.
3. Brown CL et al. Voting, health and interventions in healthcare settings: A scoping review. Public Health Rev. 2020 Jul. doi: 10.1186/s40985-020-00133-6.
4. American Medical Student Association. AMSA Launches Med Out the Vote Campaign, Call to Action. 2018 Jul 29. Accessed 2020 Sep 14. https://www.amsa.org/about/amsa-press-room/amsa-launches-med-out-the-vote-campaign-call-to-action/
COVID-19 airway management: Expert tips on infection control
As continue to evolve, practicing vigilant transmission-based infection control precautions remains essential.
This starts with observing droplet precautions to prevent exposure to droplets larger than 5 microns in size, Charles Griffis, PhD, CRNA, said at a Society for Critical Care Medicine virtual meeting: COVID-19: What’s Next. “These are particles exhaled from infected persons and which fall within around 6 feet and involve an exposure time of 15 or more minutes of contact,” said Dr. Griffis, of the department of anesthesiology at the University of Southern California, Los Angeles. “We will always observe standard precautions, which include hand hygiene, gloves, hair and eye cover, medical mask, and face shield. We will observe these at all times for all patients and layer our transmission-based precautions on top.”
During aerosol-producing procedures such as airway management maneuvers, tracheostomies, and bronchoscopies, very fine microscopic particles less than 5 microns in size are produced, which remain airborne for potentially many hours and travel long distances. “We will add an N95 mask or a powered air-purifying respirator (PAPR) device to filter out tiny particles in addition to our ever-present standard precautions,” he said. “Contact precautions are indicated for direct contact with patient saliva, blood, urine, and stool. In addition to standard precautions, we’re going to add an impermeable gown and we’ll continue with gloves, eye protection, and shoe covers. The message is to all of us. We have to observe all of the infection precautions that all of us have learned and trained in to avoid exposure.”
In terms of airway management for infected patients for elective procedures and surgery, recommendations based on current and previous coronavirus outbreaks suggest that all patients get polymerase chain reaction (PCR) tested within 24-48 hours of elective procedures or surgeries. If positive, they should be quarantined for 10-14 days and then, if asymptomatic, these patients may be retested or they can be regarded as negative. “Patients who are PCR positive with active infection and active symptoms receive only urgent or emergent care in most settings,” said Dr. Griffis, a member of the American Association of Nurse Anesthetists Infection Control Advisory Panel. “The care provided to our patients, whether they’re positive or not, is individualized per patient needs and institutional policy. Some folks have made the decision to treat all patients as infected and to use airborne precautions for all aerosol-producing procedures for all patients all the time.”
When a COVID-19 patient requires emergent or urgent airway management because of respiratory failure or some other surgical or procedural intervention necessitating airway management, preprocedural planning is key, he continued. This means establishing the steps in airway management scenarios for infected patients and rehearsing those steps in each ICU setting with key personnel such as nurses, respiratory therapists, and medical staff. “You want to make sure that the PPE is readily available and determine and limit the number of personnel that are going to enter the patient’s room or area for airway management,” Dr. Griffis said. “Have all the airway equipment and drugs immediately available. Perhaps you could organize them in a cart which is decontaminated after every use.”
He also recommends forming an intubation team for ICUs and perhaps even for ORs, where the most experienced clinicians perform airway management. “This helps to avoid unnecessary airway manipulation and minimizes personnel exposure and time to airway establishment,” he said.
Always attempt to house the infected patient in an airborne isolation, negative-pressure room, with a minimum of 12 exchanges per hour and which will take 35 minutes for 99.99% removal of airborne contaminants after airway management. “These numbers are important to remember for room turnover safety,” he said.
Patient factors to review during airway management include assessing the past medical history, inspecting the airway and considering the patient’s current physiological status as time permits. Previously in the pandemic, intubation was used earlier in the disease course, but now data suggest that patients do better without intubation if possible (Am J Trop Med Hyg. 2020;102[6]. doi: 10.4269/aitmh.20-0283). “This is because the pathophysiology of COVID-19 is such that the lung tissue is predisposed to iatrogenic barotrauma damage from positive-pressure ventilation,” Dr. Griffis said. “In addition, COVID patients appear to tolerate significant hypoxemia without distress in many cases. Therefore, many clinicians now hold off on intubation until the hypoxemic patient begins exhibiting signs and symptoms of respiratory distress.”
Options for delivering noninvasive airway support for COVID-19 patients include high-flow nasal cannula and noninvasive positive-pressure ventilation via CPAP or BiPAP. To mitigate the associated aerosol production, consider applying a surgical mask, helmet, or face mask over the airway device/patient’s face. “Another measure that has proven helpful in general respiratory support is to actually put the patient in a prone position to help redistribute ventilation throughout the lungs,” Dr. Griffis said (see Resp Care. 2015;60[11]:1660-87).
To prepare for the actual intubation procedure, gather two expert intubators who are going to be entering the patient’s room. The team should perform hand hygiene and don full PPE prior to entry. “It’s recommended that you consider wearing double gloves for the intubation,” he said. “Have the airway equipment easily accessible in a central location on a cart or in a kit, and use disposable, single-use equipment if possible. All of the usual intubation equipment to maintain a clear airway and give positive pressure ventilation should be arranged for easy access. A video laryngoscope should be used, if possible, for greater accuracy and reduced procedure time. Ready access to sedation and muscle relaxant drugs must be assured at all times.”
For the intubation procedure itself, Dr. Griffis recommends ensuring that an oxygen source, positive-pressure ventilation, and suction and resuscitation drugs and equipment are available per institutional protocol. Assign one person outside the room to coordinate supplies and assistance. “Preoxygenate the patient as permitted by clinical status,” he said. “A nonrebreathing oxygen mask can be used if sufficient spontaneous ventilation is present. Assess the airway, check and arrange equipment for easy access, and develop the safest airway management plan. Consider a rapid sequence induction and intubation as the first option.” Avoid positive-pressure ventilation or awake fiber optic intubation unless absolutely necessary, thus avoiding aerosol production. “Only ventilate the patient after the endotracheal tube cuff is inflated, to avoid aerosol release,” he said.
For intubation, administer airway procedural drugs and insert the laryngoscope – ideally a video laryngoscope if available. Intubate the trachea under direct vision, inflate the cuff, and remove outer gloves. Then attach the Ambu bag with a 99% filtration efficiency, heat-and-moisture exchange filter; and proceed to ventilate the patient, checking for chest rise, breath sounds, and CO2 production. “Discard contaminated equipment in designated bins and secure the tube,” Dr. Griffis advised. “Attach the ventilator with an HMEF filter to protect the ventilator circuit and inner parts of the machine. Recheck your breath sounds, CO2 production, and oxygen saturation, and adjust your vent settings as indicated.”
For post intubation, Dr. Griffis recommends securing contaminated discardable equipment in biohazard-labeled bins or bags, safely doffing your PPE, and retaining your N95 mask in the room. Remove your inner gloves, perform hand hygiene with soap and water if available, with alcohol-based hand rub if not, then don clean gloves. Exit the room, safely transporting any contaminated equipment that will be reused such as a cart or video laryngoscope to decontamination areas for processing. “Once clear of the room, order your chest x-ray to confirm your tube position per institutional protocol, understanding that radiology techs are all going to be following infection control procedures and wearing their PPE,” he said.
For extubation, Dr. Griffis recommends excusing all nonessential personnel from the patient room and assigning an assistant outside the room for necessary help. An experienced airway management expert should evaluate the patient wearing full PPE and be double-gloved. “If the extubation criteria are met, suction the pharynx and extubate,” he said. “Remove outer gloves and apply desired oxygen delivery equipment to the patient and assess respiratory status and vital signs for stability.” Next, discard all contaminated equipment in designated bins, doff contaminated PPE, and retain your N95 mask. Doff inner gloves, perform hand hygiene, and don clean gloves. “Exit the room, hand off contaminated equipment that is reusable, doff your gloves outside, do hand hygiene, then proceed to change your scrubs and complete your own personal hygiene measures,” he said.
Dr. Griffis reported having no financial disclosures.
“While the PPE used for intubation of a coronavirus patient is certainly more than the typical droplet precautions observed when intubating any other patient, the process and best practices aren’t terribly different from usual standard of care: Ensuring all necessary equipment is readily available with backup plans should the airway be difficult,” said Megan Conroy, MD, assistant professor of clinical medicine at The Ohio State University.
“We’ve been streamlining the team that’s present in the room for intubations of COVID patients, but I’m always amazed at the team members that stand at the ready to lend additional assistance just from the other side of the door. So while fewer personnel may be exposed, I wouldn’t consider the team needed for intubation to actually be much smaller, we’re just functioning differently.
In my practice the decision of when to intubate, clinically, doesn’t vary too much from any other form of severe ARDS. We may tolerate higher FiO2 requirements on heated high-flow nasal cannula if the patient exhibits acceptable work of breathing, but I wouldn’t advise allowing a patient to remain hypoxemic with oxygen needs unmet by noninvasive methods out of fear of intubation or ventilator management. In my opinion, this simply delays a necessary therapy and only makes for a higher risk intubation. Certainly, the decision to intubate is never based on only one single data point, but takes an expert assessment of the whole clinical picture.
I’d assert that it’s true in every disease that patients do better if it’s possible to avoid intubation – but I would argue that the ability to avoid intubation is determined primarily by the disease course and clinical scenario, and not by whether the physician wishes to avoid intubation or not. If I can safely manage a patient off of a ventilator, I will always do so, COVID or otherwise. I think in this phase of the pandemic, patients ‘do better without intubation’ because those who didn’t require intubation were inherently doing better!”
As continue to evolve, practicing vigilant transmission-based infection control precautions remains essential.
This starts with observing droplet precautions to prevent exposure to droplets larger than 5 microns in size, Charles Griffis, PhD, CRNA, said at a Society for Critical Care Medicine virtual meeting: COVID-19: What’s Next. “These are particles exhaled from infected persons and which fall within around 6 feet and involve an exposure time of 15 or more minutes of contact,” said Dr. Griffis, of the department of anesthesiology at the University of Southern California, Los Angeles. “We will always observe standard precautions, which include hand hygiene, gloves, hair and eye cover, medical mask, and face shield. We will observe these at all times for all patients and layer our transmission-based precautions on top.”
During aerosol-producing procedures such as airway management maneuvers, tracheostomies, and bronchoscopies, very fine microscopic particles less than 5 microns in size are produced, which remain airborne for potentially many hours and travel long distances. “We will add an N95 mask or a powered air-purifying respirator (PAPR) device to filter out tiny particles in addition to our ever-present standard precautions,” he said. “Contact precautions are indicated for direct contact with patient saliva, blood, urine, and stool. In addition to standard precautions, we’re going to add an impermeable gown and we’ll continue with gloves, eye protection, and shoe covers. The message is to all of us. We have to observe all of the infection precautions that all of us have learned and trained in to avoid exposure.”
In terms of airway management for infected patients for elective procedures and surgery, recommendations based on current and previous coronavirus outbreaks suggest that all patients get polymerase chain reaction (PCR) tested within 24-48 hours of elective procedures or surgeries. If positive, they should be quarantined for 10-14 days and then, if asymptomatic, these patients may be retested or they can be regarded as negative. “Patients who are PCR positive with active infection and active symptoms receive only urgent or emergent care in most settings,” said Dr. Griffis, a member of the American Association of Nurse Anesthetists Infection Control Advisory Panel. “The care provided to our patients, whether they’re positive or not, is individualized per patient needs and institutional policy. Some folks have made the decision to treat all patients as infected and to use airborne precautions for all aerosol-producing procedures for all patients all the time.”
When a COVID-19 patient requires emergent or urgent airway management because of respiratory failure or some other surgical or procedural intervention necessitating airway management, preprocedural planning is key, he continued. This means establishing the steps in airway management scenarios for infected patients and rehearsing those steps in each ICU setting with key personnel such as nurses, respiratory therapists, and medical staff. “You want to make sure that the PPE is readily available and determine and limit the number of personnel that are going to enter the patient’s room or area for airway management,” Dr. Griffis said. “Have all the airway equipment and drugs immediately available. Perhaps you could organize them in a cart which is decontaminated after every use.”
He also recommends forming an intubation team for ICUs and perhaps even for ORs, where the most experienced clinicians perform airway management. “This helps to avoid unnecessary airway manipulation and minimizes personnel exposure and time to airway establishment,” he said.
Always attempt to house the infected patient in an airborne isolation, negative-pressure room, with a minimum of 12 exchanges per hour and which will take 35 minutes for 99.99% removal of airborne contaminants after airway management. “These numbers are important to remember for room turnover safety,” he said.
Patient factors to review during airway management include assessing the past medical history, inspecting the airway and considering the patient’s current physiological status as time permits. Previously in the pandemic, intubation was used earlier in the disease course, but now data suggest that patients do better without intubation if possible (Am J Trop Med Hyg. 2020;102[6]. doi: 10.4269/aitmh.20-0283). “This is because the pathophysiology of COVID-19 is such that the lung tissue is predisposed to iatrogenic barotrauma damage from positive-pressure ventilation,” Dr. Griffis said. “In addition, COVID patients appear to tolerate significant hypoxemia without distress in many cases. Therefore, many clinicians now hold off on intubation until the hypoxemic patient begins exhibiting signs and symptoms of respiratory distress.”
Options for delivering noninvasive airway support for COVID-19 patients include high-flow nasal cannula and noninvasive positive-pressure ventilation via CPAP or BiPAP. To mitigate the associated aerosol production, consider applying a surgical mask, helmet, or face mask over the airway device/patient’s face. “Another measure that has proven helpful in general respiratory support is to actually put the patient in a prone position to help redistribute ventilation throughout the lungs,” Dr. Griffis said (see Resp Care. 2015;60[11]:1660-87).
To prepare for the actual intubation procedure, gather two expert intubators who are going to be entering the patient’s room. The team should perform hand hygiene and don full PPE prior to entry. “It’s recommended that you consider wearing double gloves for the intubation,” he said. “Have the airway equipment easily accessible in a central location on a cart or in a kit, and use disposable, single-use equipment if possible. All of the usual intubation equipment to maintain a clear airway and give positive pressure ventilation should be arranged for easy access. A video laryngoscope should be used, if possible, for greater accuracy and reduced procedure time. Ready access to sedation and muscle relaxant drugs must be assured at all times.”
For the intubation procedure itself, Dr. Griffis recommends ensuring that an oxygen source, positive-pressure ventilation, and suction and resuscitation drugs and equipment are available per institutional protocol. Assign one person outside the room to coordinate supplies and assistance. “Preoxygenate the patient as permitted by clinical status,” he said. “A nonrebreathing oxygen mask can be used if sufficient spontaneous ventilation is present. Assess the airway, check and arrange equipment for easy access, and develop the safest airway management plan. Consider a rapid sequence induction and intubation as the first option.” Avoid positive-pressure ventilation or awake fiber optic intubation unless absolutely necessary, thus avoiding aerosol production. “Only ventilate the patient after the endotracheal tube cuff is inflated, to avoid aerosol release,” he said.
For intubation, administer airway procedural drugs and insert the laryngoscope – ideally a video laryngoscope if available. Intubate the trachea under direct vision, inflate the cuff, and remove outer gloves. Then attach the Ambu bag with a 99% filtration efficiency, heat-and-moisture exchange filter; and proceed to ventilate the patient, checking for chest rise, breath sounds, and CO2 production. “Discard contaminated equipment in designated bins and secure the tube,” Dr. Griffis advised. “Attach the ventilator with an HMEF filter to protect the ventilator circuit and inner parts of the machine. Recheck your breath sounds, CO2 production, and oxygen saturation, and adjust your vent settings as indicated.”
For post intubation, Dr. Griffis recommends securing contaminated discardable equipment in biohazard-labeled bins or bags, safely doffing your PPE, and retaining your N95 mask in the room. Remove your inner gloves, perform hand hygiene with soap and water if available, with alcohol-based hand rub if not, then don clean gloves. Exit the room, safely transporting any contaminated equipment that will be reused such as a cart or video laryngoscope to decontamination areas for processing. “Once clear of the room, order your chest x-ray to confirm your tube position per institutional protocol, understanding that radiology techs are all going to be following infection control procedures and wearing their PPE,” he said.
For extubation, Dr. Griffis recommends excusing all nonessential personnel from the patient room and assigning an assistant outside the room for necessary help. An experienced airway management expert should evaluate the patient wearing full PPE and be double-gloved. “If the extubation criteria are met, suction the pharynx and extubate,” he said. “Remove outer gloves and apply desired oxygen delivery equipment to the patient and assess respiratory status and vital signs for stability.” Next, discard all contaminated equipment in designated bins, doff contaminated PPE, and retain your N95 mask. Doff inner gloves, perform hand hygiene, and don clean gloves. “Exit the room, hand off contaminated equipment that is reusable, doff your gloves outside, do hand hygiene, then proceed to change your scrubs and complete your own personal hygiene measures,” he said.
Dr. Griffis reported having no financial disclosures.
“While the PPE used for intubation of a coronavirus patient is certainly more than the typical droplet precautions observed when intubating any other patient, the process and best practices aren’t terribly different from usual standard of care: Ensuring all necessary equipment is readily available with backup plans should the airway be difficult,” said Megan Conroy, MD, assistant professor of clinical medicine at The Ohio State University.
“We’ve been streamlining the team that’s present in the room for intubations of COVID patients, but I’m always amazed at the team members that stand at the ready to lend additional assistance just from the other side of the door. So while fewer personnel may be exposed, I wouldn’t consider the team needed for intubation to actually be much smaller, we’re just functioning differently.
In my practice the decision of when to intubate, clinically, doesn’t vary too much from any other form of severe ARDS. We may tolerate higher FiO2 requirements on heated high-flow nasal cannula if the patient exhibits acceptable work of breathing, but I wouldn’t advise allowing a patient to remain hypoxemic with oxygen needs unmet by noninvasive methods out of fear of intubation or ventilator management. In my opinion, this simply delays a necessary therapy and only makes for a higher risk intubation. Certainly, the decision to intubate is never based on only one single data point, but takes an expert assessment of the whole clinical picture.
I’d assert that it’s true in every disease that patients do better if it’s possible to avoid intubation – but I would argue that the ability to avoid intubation is determined primarily by the disease course and clinical scenario, and not by whether the physician wishes to avoid intubation or not. If I can safely manage a patient off of a ventilator, I will always do so, COVID or otherwise. I think in this phase of the pandemic, patients ‘do better without intubation’ because those who didn’t require intubation were inherently doing better!”
As continue to evolve, practicing vigilant transmission-based infection control precautions remains essential.
This starts with observing droplet precautions to prevent exposure to droplets larger than 5 microns in size, Charles Griffis, PhD, CRNA, said at a Society for Critical Care Medicine virtual meeting: COVID-19: What’s Next. “These are particles exhaled from infected persons and which fall within around 6 feet and involve an exposure time of 15 or more minutes of contact,” said Dr. Griffis, of the department of anesthesiology at the University of Southern California, Los Angeles. “We will always observe standard precautions, which include hand hygiene, gloves, hair and eye cover, medical mask, and face shield. We will observe these at all times for all patients and layer our transmission-based precautions on top.”
During aerosol-producing procedures such as airway management maneuvers, tracheostomies, and bronchoscopies, very fine microscopic particles less than 5 microns in size are produced, which remain airborne for potentially many hours and travel long distances. “We will add an N95 mask or a powered air-purifying respirator (PAPR) device to filter out tiny particles in addition to our ever-present standard precautions,” he said. “Contact precautions are indicated for direct contact with patient saliva, blood, urine, and stool. In addition to standard precautions, we’re going to add an impermeable gown and we’ll continue with gloves, eye protection, and shoe covers. The message is to all of us. We have to observe all of the infection precautions that all of us have learned and trained in to avoid exposure.”
In terms of airway management for infected patients for elective procedures and surgery, recommendations based on current and previous coronavirus outbreaks suggest that all patients get polymerase chain reaction (PCR) tested within 24-48 hours of elective procedures or surgeries. If positive, they should be quarantined for 10-14 days and then, if asymptomatic, these patients may be retested or they can be regarded as negative. “Patients who are PCR positive with active infection and active symptoms receive only urgent or emergent care in most settings,” said Dr. Griffis, a member of the American Association of Nurse Anesthetists Infection Control Advisory Panel. “The care provided to our patients, whether they’re positive or not, is individualized per patient needs and institutional policy. Some folks have made the decision to treat all patients as infected and to use airborne precautions for all aerosol-producing procedures for all patients all the time.”
When a COVID-19 patient requires emergent or urgent airway management because of respiratory failure or some other surgical or procedural intervention necessitating airway management, preprocedural planning is key, he continued. This means establishing the steps in airway management scenarios for infected patients and rehearsing those steps in each ICU setting with key personnel such as nurses, respiratory therapists, and medical staff. “You want to make sure that the PPE is readily available and determine and limit the number of personnel that are going to enter the patient’s room or area for airway management,” Dr. Griffis said. “Have all the airway equipment and drugs immediately available. Perhaps you could organize them in a cart which is decontaminated after every use.”
He also recommends forming an intubation team for ICUs and perhaps even for ORs, where the most experienced clinicians perform airway management. “This helps to avoid unnecessary airway manipulation and minimizes personnel exposure and time to airway establishment,” he said.
Always attempt to house the infected patient in an airborne isolation, negative-pressure room, with a minimum of 12 exchanges per hour and which will take 35 minutes for 99.99% removal of airborne contaminants after airway management. “These numbers are important to remember for room turnover safety,” he said.
Patient factors to review during airway management include assessing the past medical history, inspecting the airway and considering the patient’s current physiological status as time permits. Previously in the pandemic, intubation was used earlier in the disease course, but now data suggest that patients do better without intubation if possible (Am J Trop Med Hyg. 2020;102[6]. doi: 10.4269/aitmh.20-0283). “This is because the pathophysiology of COVID-19 is such that the lung tissue is predisposed to iatrogenic barotrauma damage from positive-pressure ventilation,” Dr. Griffis said. “In addition, COVID patients appear to tolerate significant hypoxemia without distress in many cases. Therefore, many clinicians now hold off on intubation until the hypoxemic patient begins exhibiting signs and symptoms of respiratory distress.”
Options for delivering noninvasive airway support for COVID-19 patients include high-flow nasal cannula and noninvasive positive-pressure ventilation via CPAP or BiPAP. To mitigate the associated aerosol production, consider applying a surgical mask, helmet, or face mask over the airway device/patient’s face. “Another measure that has proven helpful in general respiratory support is to actually put the patient in a prone position to help redistribute ventilation throughout the lungs,” Dr. Griffis said (see Resp Care. 2015;60[11]:1660-87).
To prepare for the actual intubation procedure, gather two expert intubators who are going to be entering the patient’s room. The team should perform hand hygiene and don full PPE prior to entry. “It’s recommended that you consider wearing double gloves for the intubation,” he said. “Have the airway equipment easily accessible in a central location on a cart or in a kit, and use disposable, single-use equipment if possible. All of the usual intubation equipment to maintain a clear airway and give positive pressure ventilation should be arranged for easy access. A video laryngoscope should be used, if possible, for greater accuracy and reduced procedure time. Ready access to sedation and muscle relaxant drugs must be assured at all times.”
For the intubation procedure itself, Dr. Griffis recommends ensuring that an oxygen source, positive-pressure ventilation, and suction and resuscitation drugs and equipment are available per institutional protocol. Assign one person outside the room to coordinate supplies and assistance. “Preoxygenate the patient as permitted by clinical status,” he said. “A nonrebreathing oxygen mask can be used if sufficient spontaneous ventilation is present. Assess the airway, check and arrange equipment for easy access, and develop the safest airway management plan. Consider a rapid sequence induction and intubation as the first option.” Avoid positive-pressure ventilation or awake fiber optic intubation unless absolutely necessary, thus avoiding aerosol production. “Only ventilate the patient after the endotracheal tube cuff is inflated, to avoid aerosol release,” he said.
For intubation, administer airway procedural drugs and insert the laryngoscope – ideally a video laryngoscope if available. Intubate the trachea under direct vision, inflate the cuff, and remove outer gloves. Then attach the Ambu bag with a 99% filtration efficiency, heat-and-moisture exchange filter; and proceed to ventilate the patient, checking for chest rise, breath sounds, and CO2 production. “Discard contaminated equipment in designated bins and secure the tube,” Dr. Griffis advised. “Attach the ventilator with an HMEF filter to protect the ventilator circuit and inner parts of the machine. Recheck your breath sounds, CO2 production, and oxygen saturation, and adjust your vent settings as indicated.”
For post intubation, Dr. Griffis recommends securing contaminated discardable equipment in biohazard-labeled bins or bags, safely doffing your PPE, and retaining your N95 mask in the room. Remove your inner gloves, perform hand hygiene with soap and water if available, with alcohol-based hand rub if not, then don clean gloves. Exit the room, safely transporting any contaminated equipment that will be reused such as a cart or video laryngoscope to decontamination areas for processing. “Once clear of the room, order your chest x-ray to confirm your tube position per institutional protocol, understanding that radiology techs are all going to be following infection control procedures and wearing their PPE,” he said.
For extubation, Dr. Griffis recommends excusing all nonessential personnel from the patient room and assigning an assistant outside the room for necessary help. An experienced airway management expert should evaluate the patient wearing full PPE and be double-gloved. “If the extubation criteria are met, suction the pharynx and extubate,” he said. “Remove outer gloves and apply desired oxygen delivery equipment to the patient and assess respiratory status and vital signs for stability.” Next, discard all contaminated equipment in designated bins, doff contaminated PPE, and retain your N95 mask. Doff inner gloves, perform hand hygiene, and don clean gloves. “Exit the room, hand off contaminated equipment that is reusable, doff your gloves outside, do hand hygiene, then proceed to change your scrubs and complete your own personal hygiene measures,” he said.
Dr. Griffis reported having no financial disclosures.
“While the PPE used for intubation of a coronavirus patient is certainly more than the typical droplet precautions observed when intubating any other patient, the process and best practices aren’t terribly different from usual standard of care: Ensuring all necessary equipment is readily available with backup plans should the airway be difficult,” said Megan Conroy, MD, assistant professor of clinical medicine at The Ohio State University.
“We’ve been streamlining the team that’s present in the room for intubations of COVID patients, but I’m always amazed at the team members that stand at the ready to lend additional assistance just from the other side of the door. So while fewer personnel may be exposed, I wouldn’t consider the team needed for intubation to actually be much smaller, we’re just functioning differently.
In my practice the decision of when to intubate, clinically, doesn’t vary too much from any other form of severe ARDS. We may tolerate higher FiO2 requirements on heated high-flow nasal cannula if the patient exhibits acceptable work of breathing, but I wouldn’t advise allowing a patient to remain hypoxemic with oxygen needs unmet by noninvasive methods out of fear of intubation or ventilator management. In my opinion, this simply delays a necessary therapy and only makes for a higher risk intubation. Certainly, the decision to intubate is never based on only one single data point, but takes an expert assessment of the whole clinical picture.
I’d assert that it’s true in every disease that patients do better if it’s possible to avoid intubation – but I would argue that the ability to avoid intubation is determined primarily by the disease course and clinical scenario, and not by whether the physician wishes to avoid intubation or not. If I can safely manage a patient off of a ventilator, I will always do so, COVID or otherwise. I think in this phase of the pandemic, patients ‘do better without intubation’ because those who didn’t require intubation were inherently doing better!”
FROM AN SCCM VIRTUAL MEETING
J&J’s one-shot COVID-19 vaccine advances to phase 3 testing
The National Institute of Allergy and Infectious Diseases, which is aiding Johnson & Johnson with development, described this in a news release as the fourth phase 3 clinical trial of evaluating an investigational vaccine for coronavirus disease.
This NIAID tally tracks products likely to be presented soon for Food and Drug Administration approval. (The World Health Organization’s COVID vaccine tracker lists nine candidates as having reached this stage, including products developed in Russia and China.)
As many as 60,000 volunteers will be enrolled in the trial, with about 215 clinical research sites expected to participate, NIAID said. The vaccine will be tested in the United States and abroad.
The start of this test, known as the ENSEMBLE trial, follows positive results from a Phase 1/2a clinical study, which involved a single vaccination. The results of this study have been submitted to medRxiv and are set to be published online imminently.
New Brunswick, N.J–based J&J said it intends to offer the vaccine on “a not-for-profit basis for emergency pandemic use.” If testing proceeds well, J&J might seek an emergency use clearance for the vaccine, which could possibly allow the first batches to be made available in early 2021.
J&J’s vaccine is unusual in that it will be tested based on a single dose, while other advanced candidates have been tested in two-dose regimens.
J&J on Wednesday also released the study protocol for its phase 3 test. The developers of the other late-stage COVID vaccine candidates also have done this, as reported by Medscape Medical News. Because of the great interest in the COVID vaccine, the American Medical Association had last month asked the FDA to keep physicians informed of their COVID-19 vaccine review process.
Trials and tribulations
One of these experimental COVID vaccines already has had a setback in phase 3 testing, which is a fairly routine occurrence in drug development. But with a pandemic still causing deaths and disrupting lives around the world, there has been intense interest in each step of the effort to develop a COVID vaccine.
AstraZeneca PLC earlier this month announced a temporary cessation of all their coronavirus vaccine trials to investigate an “unexplained illness” that arose in a participant, as reported by Medscape Medical News.
On September 12, AstraZeneca announced that clinical trials for the AZD1222, which it developed with Oxford University, had resumed in the United Kingdom. On Wednesday, CNBC said Health and Human Services Secretary Alex Azar told the news station that AstraZeneca’s late-stage coronavirus vaccine trial in the United States remains on hold until safety concerns are resolved, a critical issue with all the fast-track COVID vaccines now being tested.
“Look at the AstraZeneca program, phase 3 clinical trial, a lot of hope. [A] single serious adverse event report in the United Kingdom, global shutdown, and [a] hold of the clinical trials,” Mr. Azar told CNBC.
The New York Times has reported on concerns stemming from serious neurologic illnesses in two participants, both women, who received AstraZeneca’s experimental vaccine in Britain.
The Senate Health, Education, Labor and Pensions Committee on Wednesday separately held a hearing with the leaders of the FDA and the Centers of Disease Control and Prevention, allowing an airing of lawmakers’ concerns about a potential rush to approve a COVID vaccine.
Details of J&J trial
The J&J trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. It also is designed to examine whether the vaccine can prevent COVID-19 requiring medical intervention and if the vaccine can prevent milder cases of COVID-19 and asymptomatic SARS-CoV-2 infection, NIAID said.
Principal investigators for the phase 3 trial of the J & J vaccine are Paul A. Goepfert, MD, director of the Alabama Vaccine Research Clinic at the University of Alabama in Birmingham; Beatriz Grinsztejn, MD, PhD, director of the Laboratory of Clinical Research on HIV/AIDS at the Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, MBBCh, president and chief executive officer of the South African Medical Research Council and coprincipal investigator of the HIV Vaccine Trials Network.
This article first appeared on Medscape.com.
The National Institute of Allergy and Infectious Diseases, which is aiding Johnson & Johnson with development, described this in a news release as the fourth phase 3 clinical trial of evaluating an investigational vaccine for coronavirus disease.
This NIAID tally tracks products likely to be presented soon for Food and Drug Administration approval. (The World Health Organization’s COVID vaccine tracker lists nine candidates as having reached this stage, including products developed in Russia and China.)
As many as 60,000 volunteers will be enrolled in the trial, with about 215 clinical research sites expected to participate, NIAID said. The vaccine will be tested in the United States and abroad.
The start of this test, known as the ENSEMBLE trial, follows positive results from a Phase 1/2a clinical study, which involved a single vaccination. The results of this study have been submitted to medRxiv and are set to be published online imminently.
New Brunswick, N.J–based J&J said it intends to offer the vaccine on “a not-for-profit basis for emergency pandemic use.” If testing proceeds well, J&J might seek an emergency use clearance for the vaccine, which could possibly allow the first batches to be made available in early 2021.
J&J’s vaccine is unusual in that it will be tested based on a single dose, while other advanced candidates have been tested in two-dose regimens.
J&J on Wednesday also released the study protocol for its phase 3 test. The developers of the other late-stage COVID vaccine candidates also have done this, as reported by Medscape Medical News. Because of the great interest in the COVID vaccine, the American Medical Association had last month asked the FDA to keep physicians informed of their COVID-19 vaccine review process.
Trials and tribulations
One of these experimental COVID vaccines already has had a setback in phase 3 testing, which is a fairly routine occurrence in drug development. But with a pandemic still causing deaths and disrupting lives around the world, there has been intense interest in each step of the effort to develop a COVID vaccine.
AstraZeneca PLC earlier this month announced a temporary cessation of all their coronavirus vaccine trials to investigate an “unexplained illness” that arose in a participant, as reported by Medscape Medical News.
On September 12, AstraZeneca announced that clinical trials for the AZD1222, which it developed with Oxford University, had resumed in the United Kingdom. On Wednesday, CNBC said Health and Human Services Secretary Alex Azar told the news station that AstraZeneca’s late-stage coronavirus vaccine trial in the United States remains on hold until safety concerns are resolved, a critical issue with all the fast-track COVID vaccines now being tested.
“Look at the AstraZeneca program, phase 3 clinical trial, a lot of hope. [A] single serious adverse event report in the United Kingdom, global shutdown, and [a] hold of the clinical trials,” Mr. Azar told CNBC.
The New York Times has reported on concerns stemming from serious neurologic illnesses in two participants, both women, who received AstraZeneca’s experimental vaccine in Britain.
The Senate Health, Education, Labor and Pensions Committee on Wednesday separately held a hearing with the leaders of the FDA and the Centers of Disease Control and Prevention, allowing an airing of lawmakers’ concerns about a potential rush to approve a COVID vaccine.
Details of J&J trial
The J&J trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. It also is designed to examine whether the vaccine can prevent COVID-19 requiring medical intervention and if the vaccine can prevent milder cases of COVID-19 and asymptomatic SARS-CoV-2 infection, NIAID said.
Principal investigators for the phase 3 trial of the J & J vaccine are Paul A. Goepfert, MD, director of the Alabama Vaccine Research Clinic at the University of Alabama in Birmingham; Beatriz Grinsztejn, MD, PhD, director of the Laboratory of Clinical Research on HIV/AIDS at the Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, MBBCh, president and chief executive officer of the South African Medical Research Council and coprincipal investigator of the HIV Vaccine Trials Network.
This article first appeared on Medscape.com.
The National Institute of Allergy and Infectious Diseases, which is aiding Johnson & Johnson with development, described this in a news release as the fourth phase 3 clinical trial of evaluating an investigational vaccine for coronavirus disease.
This NIAID tally tracks products likely to be presented soon for Food and Drug Administration approval. (The World Health Organization’s COVID vaccine tracker lists nine candidates as having reached this stage, including products developed in Russia and China.)
As many as 60,000 volunteers will be enrolled in the trial, with about 215 clinical research sites expected to participate, NIAID said. The vaccine will be tested in the United States and abroad.
The start of this test, known as the ENSEMBLE trial, follows positive results from a Phase 1/2a clinical study, which involved a single vaccination. The results of this study have been submitted to medRxiv and are set to be published online imminently.
New Brunswick, N.J–based J&J said it intends to offer the vaccine on “a not-for-profit basis for emergency pandemic use.” If testing proceeds well, J&J might seek an emergency use clearance for the vaccine, which could possibly allow the first batches to be made available in early 2021.
J&J’s vaccine is unusual in that it will be tested based on a single dose, while other advanced candidates have been tested in two-dose regimens.
J&J on Wednesday also released the study protocol for its phase 3 test. The developers of the other late-stage COVID vaccine candidates also have done this, as reported by Medscape Medical News. Because of the great interest in the COVID vaccine, the American Medical Association had last month asked the FDA to keep physicians informed of their COVID-19 vaccine review process.
Trials and tribulations
One of these experimental COVID vaccines already has had a setback in phase 3 testing, which is a fairly routine occurrence in drug development. But with a pandemic still causing deaths and disrupting lives around the world, there has been intense interest in each step of the effort to develop a COVID vaccine.
AstraZeneca PLC earlier this month announced a temporary cessation of all their coronavirus vaccine trials to investigate an “unexplained illness” that arose in a participant, as reported by Medscape Medical News.
On September 12, AstraZeneca announced that clinical trials for the AZD1222, which it developed with Oxford University, had resumed in the United Kingdom. On Wednesday, CNBC said Health and Human Services Secretary Alex Azar told the news station that AstraZeneca’s late-stage coronavirus vaccine trial in the United States remains on hold until safety concerns are resolved, a critical issue with all the fast-track COVID vaccines now being tested.
“Look at the AstraZeneca program, phase 3 clinical trial, a lot of hope. [A] single serious adverse event report in the United Kingdom, global shutdown, and [a] hold of the clinical trials,” Mr. Azar told CNBC.
The New York Times has reported on concerns stemming from serious neurologic illnesses in two participants, both women, who received AstraZeneca’s experimental vaccine in Britain.
The Senate Health, Education, Labor and Pensions Committee on Wednesday separately held a hearing with the leaders of the FDA and the Centers of Disease Control and Prevention, allowing an airing of lawmakers’ concerns about a potential rush to approve a COVID vaccine.
Details of J&J trial
The J&J trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. It also is designed to examine whether the vaccine can prevent COVID-19 requiring medical intervention and if the vaccine can prevent milder cases of COVID-19 and asymptomatic SARS-CoV-2 infection, NIAID said.
Principal investigators for the phase 3 trial of the J & J vaccine are Paul A. Goepfert, MD, director of the Alabama Vaccine Research Clinic at the University of Alabama in Birmingham; Beatriz Grinsztejn, MD, PhD, director of the Laboratory of Clinical Research on HIV/AIDS at the Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, MBBCh, president and chief executive officer of the South African Medical Research Council and coprincipal investigator of the HIV Vaccine Trials Network.
This article first appeared on Medscape.com.
CDC playbook prepares states for rollout of COVID-19 vaccine if one is approved
States have begun preparing to distribute a COVID-19 vaccine if one is approved, a CDC official said today.
The CDC released guidance for states on Sept. 16 titled COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. The document discusses vaccine ordering, storage, and handling and says that states should submit their plans for vaccine distribution to the agency by Oct. 16.
“Every jurisdiction is heavily involved right now in their plan development,” CDC official Janell Routh, MD, told the Advisory Committee on Immunization Practices during its Sept. 22 meeting. “It was really impressive to me that, even though the playbook only went out last week, states and jurisdictions have been thinking about this for quite some time.”
However, one committee member suggested that setting a deadline before more safety, efficacy, and storage information is known may be premature.
“I cannot imagine that we will actually know the final storage requirements for this vaccine by Oct. 16, which makes me a little concerned about finalizing state plans,” said Helen “Keipp” Talbot, MD, MPH, associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn. “We also don’t know the best populations yet when it comes to efficacy and safety.”
Dr. Routh said the CDC is asking states to plan on the basis of assumptions. “We know those plans will constantly be improving, changing, as we learn more information,” Dr. Routh said. States agreed to return a plan 30 days after the playbook was released, which is how the Oct. 16 deadline was established, she said.
States are encouraged to think broadly. Plans may include contingencies for a product that requires ultracold storage or for distributing more than one vaccine product, Dr. Routh said.
“One goal is to be ready on the first day that we can actually distribute vaccine,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the meeting. “Our colleagues in Operation Warp Speed say that they expect there will be vaccine as early as November, and therefore we need to be ready so there is no delay in distributing that vaccine. And that phase, that early phase, is really close upon us.”
Many states have already developed plans, and the CDC is providing technical assistance as needed to monitor the plans regularly, Dr. Routh said.
Key issues identified
From holding pilot meetings with five jurisdictions, officials learned that public confidence in the vaccine is among states’ greatest concerns, Dr. Routh said. In addition, distribution is resource intensive, and social distancing adds logistical complexity.
Specific guidance on whom to vaccinate in the early stages will smooth the process, officials suggested during the pilot meetings. For the first several weeks, vaccine doses may be limited to priority populations, such as health care workers.
“This interim playbook is a living document,” Dr. Routh emphasized. “We definitely plan to update the content regularly as we learn more information about what vaccines and when they will be released.”
During the early stages of COVID-19 vaccination, officials plan to implement an enhanced monitoring program in which vaccine recipients would complete surveys about adverse events, in addition to the traditional vaccine safety monitoring programs that already exist, officials said.
A version of this article originally appeared on Medscape.com.
States have begun preparing to distribute a COVID-19 vaccine if one is approved, a CDC official said today.
The CDC released guidance for states on Sept. 16 titled COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. The document discusses vaccine ordering, storage, and handling and says that states should submit their plans for vaccine distribution to the agency by Oct. 16.
“Every jurisdiction is heavily involved right now in their plan development,” CDC official Janell Routh, MD, told the Advisory Committee on Immunization Practices during its Sept. 22 meeting. “It was really impressive to me that, even though the playbook only went out last week, states and jurisdictions have been thinking about this for quite some time.”
However, one committee member suggested that setting a deadline before more safety, efficacy, and storage information is known may be premature.
“I cannot imagine that we will actually know the final storage requirements for this vaccine by Oct. 16, which makes me a little concerned about finalizing state plans,” said Helen “Keipp” Talbot, MD, MPH, associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn. “We also don’t know the best populations yet when it comes to efficacy and safety.”
Dr. Routh said the CDC is asking states to plan on the basis of assumptions. “We know those plans will constantly be improving, changing, as we learn more information,” Dr. Routh said. States agreed to return a plan 30 days after the playbook was released, which is how the Oct. 16 deadline was established, she said.
States are encouraged to think broadly. Plans may include contingencies for a product that requires ultracold storage or for distributing more than one vaccine product, Dr. Routh said.
“One goal is to be ready on the first day that we can actually distribute vaccine,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the meeting. “Our colleagues in Operation Warp Speed say that they expect there will be vaccine as early as November, and therefore we need to be ready so there is no delay in distributing that vaccine. And that phase, that early phase, is really close upon us.”
Many states have already developed plans, and the CDC is providing technical assistance as needed to monitor the plans regularly, Dr. Routh said.
Key issues identified
From holding pilot meetings with five jurisdictions, officials learned that public confidence in the vaccine is among states’ greatest concerns, Dr. Routh said. In addition, distribution is resource intensive, and social distancing adds logistical complexity.
Specific guidance on whom to vaccinate in the early stages will smooth the process, officials suggested during the pilot meetings. For the first several weeks, vaccine doses may be limited to priority populations, such as health care workers.
“This interim playbook is a living document,” Dr. Routh emphasized. “We definitely plan to update the content regularly as we learn more information about what vaccines and when they will be released.”
During the early stages of COVID-19 vaccination, officials plan to implement an enhanced monitoring program in which vaccine recipients would complete surveys about adverse events, in addition to the traditional vaccine safety monitoring programs that already exist, officials said.
A version of this article originally appeared on Medscape.com.
States have begun preparing to distribute a COVID-19 vaccine if one is approved, a CDC official said today.
The CDC released guidance for states on Sept. 16 titled COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. The document discusses vaccine ordering, storage, and handling and says that states should submit their plans for vaccine distribution to the agency by Oct. 16.
“Every jurisdiction is heavily involved right now in their plan development,” CDC official Janell Routh, MD, told the Advisory Committee on Immunization Practices during its Sept. 22 meeting. “It was really impressive to me that, even though the playbook only went out last week, states and jurisdictions have been thinking about this for quite some time.”
However, one committee member suggested that setting a deadline before more safety, efficacy, and storage information is known may be premature.
“I cannot imagine that we will actually know the final storage requirements for this vaccine by Oct. 16, which makes me a little concerned about finalizing state plans,” said Helen “Keipp” Talbot, MD, MPH, associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn. “We also don’t know the best populations yet when it comes to efficacy and safety.”
Dr. Routh said the CDC is asking states to plan on the basis of assumptions. “We know those plans will constantly be improving, changing, as we learn more information,” Dr. Routh said. States agreed to return a plan 30 days after the playbook was released, which is how the Oct. 16 deadline was established, she said.
States are encouraged to think broadly. Plans may include contingencies for a product that requires ultracold storage or for distributing more than one vaccine product, Dr. Routh said.
“One goal is to be ready on the first day that we can actually distribute vaccine,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the meeting. “Our colleagues in Operation Warp Speed say that they expect there will be vaccine as early as November, and therefore we need to be ready so there is no delay in distributing that vaccine. And that phase, that early phase, is really close upon us.”
Many states have already developed plans, and the CDC is providing technical assistance as needed to monitor the plans regularly, Dr. Routh said.
Key issues identified
From holding pilot meetings with five jurisdictions, officials learned that public confidence in the vaccine is among states’ greatest concerns, Dr. Routh said. In addition, distribution is resource intensive, and social distancing adds logistical complexity.
Specific guidance on whom to vaccinate in the early stages will smooth the process, officials suggested during the pilot meetings. For the first several weeks, vaccine doses may be limited to priority populations, such as health care workers.
“This interim playbook is a living document,” Dr. Routh emphasized. “We definitely plan to update the content regularly as we learn more information about what vaccines and when they will be released.”
During the early stages of COVID-19 vaccination, officials plan to implement an enhanced monitoring program in which vaccine recipients would complete surveys about adverse events, in addition to the traditional vaccine safety monitoring programs that already exist, officials said.
A version of this article originally appeared on Medscape.com.
Social media and health information: Empowering or misleading?
The search engine giants, Dr. Google or Dr. Bing, are visited by most of our patients before seeking medical help. In 1976, medical student Tom Ferguson, MD, first coined the term e-Patient. It means a health consumer who uses the Internet to gather information about a medical condition for themselves or on behalf of family and friends and uses electronic communication tools to cope with medical conditions. Dr. Ferguson described e-Patients as “empowered medical consumers.”1
During the COVID-19 pandemic, social media and networking platforms – such as Facebook, Twitter, Instagram, Snapchat, YouTube, WhatsApp, online health support groups – are used increasingly by e-Patients to gather critical health information. Health care providers often take a conflicted stand on the use of social media. Though we want our patients to read about their illnesses and make informed choices, we often get frustrated by misdiagnoses, misinformation, and disinformation that comes with it.
According to a study investigating the differential diffusion of news stories distributed on Twitter from 2006 to 2017, fake news was considered more novel than true news, and people were more likely to share novel information.2 Bots accelerated the spread of true and fake news at the same rate, implying that fake news spreads more than the truth because humans, not robots, are more likely to spread it. Social media has promoted some of the best health campaigns, like public cancer awareness, the ALS Ice Bucket Challenge, World Heart Day, and others. At the same time, it has also provided a platform for antivaccination activists, dangerous and unproven alternative cancer therapies, weight loss pills, and nutrition plans.
According to a Pew Research Center survey, 72% of adult Internet users had searched online for information about a range of health issues of their own or for others in the past 12 months.3 A survey from 2019-2020 showed that those who relied on social media for news were among the least knowledgeable about key facts during the COVID-19 outbreak.4 About 74% of public posts about COVID-19 were linked to news organizations, while just 1% linked to health and science sites.5 While social media has emerged as one of the most significant health information sources, it famously has only a few safeguards in place against medical misinformation. Requiring responsibility and regulations for accurate or evidence-based information walks a thin line on infringing freedom of speech. Medical misinformation related to COVID-19 has become as contagious as the virus itself.
In February 2020, the World Health Organization warned that a massive ‘Infodemic’ had accompanied the COVID-19 outbreak, with an overabundance of information, some accurate and some not, making it difficult for people to find reliable sources and trustworthy information.6 The Black immunity myth, groups opposing vaccines, campaigns against 5G mobile phone networks, suggestions that SARS-CoV-2 was an engineered bioweapon, and online rumors leading to mob attacks in India and mass poisonings in Iran are some of the misleading health information that has circulated related to COVID-19.
In the Web 2.0 era, in which credible health information comes packaged with divisive and misleading information, social media’s full impact on health care, health outcomes, and mental health has yet to be explored. Social networks and media sharing networks have recently announced initiatives to stop misinformation and disinformation by fact-checking, flagging, issuing warnings, and deleting misinformation or misleading content. Providing links to more and correct information and partnering with health and science organizations can also encourage the spread of verifiable information.
While we have yet to see if social media safeguards are adequate, the medical community needs to proactively educate patients on the appropriate use of social media for health information, e-Health literacy, and media health literacy. Like health care providers evaluating scientific papers, we need to cultivate e-Patients’ ability to seek, evaluate, understand, and convey health information from electronic sources. Although the measurement and training tools for e-Health and media health literacy are still scarce, a good place to start could be to have simple conversations with patients. Encouraging patients to critically analyze online information, use credible social media sources, and recognizing the warnings, red flags, and links on unreliable information are some of the discussions worth considering. Equally important is to discourage patients from changing health behaviors or practices based on unverified social media resources and discussing the possible impact of medical misinformation.
A practical approach for e-Patients could be to ask the Five Ws, considered fundamental in information gathering: Who, What, Why, When, and Where.7,8
- Who runs the website? Examine the authors, sponsors, and sources. Federal agencies’ website addresses end in “.gov,” educational institutions maintain “.edu,” large professional or nonprofit organizations often use “.org,” and commercial websites use “.com.”
- What is offered, and What is the evidence? Does it provide unbelievable solutions or quick, miracle cures?
- Why was the site created? Is the mission or goal to inform, explain, or sell health or medical products? Check details on “About This Site” or “About Us.”
- When was the information written or the webpage last updated?
- Where are the privacy policies? Is your privacy protected?
The anonymity of sources, sponsors, financial interests, or the lack of medical credentials and reputable medical research, the use of testimonials as evidence, outdated or incomplete information, and emotional or exaggerated language should raise suspicion about the reliability of the information. Tools like the online tutorial and a checklist from the National Institute of Health’s National Library of Medicine can also be offered to e-Patients to learn how to evaluate health information online.9,10
Online health support groups widely used by patients can be an additional layer of support but can also be a source of misinformation. Since they have fewer gatekeepers than traditional face-to-face communication, keeping a check on the credibility of the information can be difficult. Support groups affiliated with local hospitals or national organizations, or those endorsed by well-known scientific societies, can be encouraged instead of less credible sources. Some online support groups, run by non–health care professionals but with experienced and reliable scientific panels, can be useful resources. However, patients must check for the credibility and reliability of the information.
Lastly, just as hospitalists take a social history of our patients, we could also ask for a “social media history” to understand patients’ sources of health information. We can then guide them toward more credible sources to make them truly empowered medical consumers.
Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.
References
1. Nelson R. Informatics: Empowering ePatients to drive health care reform - part I. Online J Issues Nurs. 2016 Sep 13;21(3):9.
2. Vosoughi S et al. The spread of true and false news online. Science. 2012;359(6380):1146-51.
3. Fox S. The social life of health information. Pew Research Center: Fact Tank. 2014 Jan 15. Accessed 2020 Jul 31.
4. Mitchel A, Jurkowitz M, Oliphant JB, Shearer E. Americans Who Mainly Get Their News on Social Media Are Less Engaged, Less Knowledgeable. Pew Research Center: Journalism & Media. 2020 Jul 30. Accessed 2020 Jul 31.
5. Stocking G, Matsa KE, Khuzam M. As COVID-19 Emerged in U.S., Facebook Posts About It Appeared in a Wide Range of Public Pages, Groups Pew Research Center: Journalism & Media. 2020 Jun 24. Accessed 2020 Jul 31.
6. Munich Security Conference. World Health Organization. 2020 Feb 15. Accessed 2020 Jul 31.
7. Levin-Zamir D, Bertschi I. Media health literacy, eHealth literacy, and the role of the social environment in context. Int J Environ Res Public Health. 2018 Aug 3;15(8):1643.
8. Online Health Information: Is It Reliable? National Institute on Aging, National Institutes of Health. 2018 Oct 31. Accessed 2020 Aug 10.
9. How To Evaluate Health Information on the Internet: Questions and Answers. Office of Dietary Supplements, National Institutes of Health. 2011 Jun 24. Accessed 2020 Aug 10.
10. Evaluating Internet Health Information: A Tutorial From the National Library of Medicine. Medline Plus. 2020 Mar 6. Accessed 2020 Aug 10.
The search engine giants, Dr. Google or Dr. Bing, are visited by most of our patients before seeking medical help. In 1976, medical student Tom Ferguson, MD, first coined the term e-Patient. It means a health consumer who uses the Internet to gather information about a medical condition for themselves or on behalf of family and friends and uses electronic communication tools to cope with medical conditions. Dr. Ferguson described e-Patients as “empowered medical consumers.”1
During the COVID-19 pandemic, social media and networking platforms – such as Facebook, Twitter, Instagram, Snapchat, YouTube, WhatsApp, online health support groups – are used increasingly by e-Patients to gather critical health information. Health care providers often take a conflicted stand on the use of social media. Though we want our patients to read about their illnesses and make informed choices, we often get frustrated by misdiagnoses, misinformation, and disinformation that comes with it.
According to a study investigating the differential diffusion of news stories distributed on Twitter from 2006 to 2017, fake news was considered more novel than true news, and people were more likely to share novel information.2 Bots accelerated the spread of true and fake news at the same rate, implying that fake news spreads more than the truth because humans, not robots, are more likely to spread it. Social media has promoted some of the best health campaigns, like public cancer awareness, the ALS Ice Bucket Challenge, World Heart Day, and others. At the same time, it has also provided a platform for antivaccination activists, dangerous and unproven alternative cancer therapies, weight loss pills, and nutrition plans.
According to a Pew Research Center survey, 72% of adult Internet users had searched online for information about a range of health issues of their own or for others in the past 12 months.3 A survey from 2019-2020 showed that those who relied on social media for news were among the least knowledgeable about key facts during the COVID-19 outbreak.4 About 74% of public posts about COVID-19 were linked to news organizations, while just 1% linked to health and science sites.5 While social media has emerged as one of the most significant health information sources, it famously has only a few safeguards in place against medical misinformation. Requiring responsibility and regulations for accurate or evidence-based information walks a thin line on infringing freedom of speech. Medical misinformation related to COVID-19 has become as contagious as the virus itself.
In February 2020, the World Health Organization warned that a massive ‘Infodemic’ had accompanied the COVID-19 outbreak, with an overabundance of information, some accurate and some not, making it difficult for people to find reliable sources and trustworthy information.6 The Black immunity myth, groups opposing vaccines, campaigns against 5G mobile phone networks, suggestions that SARS-CoV-2 was an engineered bioweapon, and online rumors leading to mob attacks in India and mass poisonings in Iran are some of the misleading health information that has circulated related to COVID-19.
In the Web 2.0 era, in which credible health information comes packaged with divisive and misleading information, social media’s full impact on health care, health outcomes, and mental health has yet to be explored. Social networks and media sharing networks have recently announced initiatives to stop misinformation and disinformation by fact-checking, flagging, issuing warnings, and deleting misinformation or misleading content. Providing links to more and correct information and partnering with health and science organizations can also encourage the spread of verifiable information.
While we have yet to see if social media safeguards are adequate, the medical community needs to proactively educate patients on the appropriate use of social media for health information, e-Health literacy, and media health literacy. Like health care providers evaluating scientific papers, we need to cultivate e-Patients’ ability to seek, evaluate, understand, and convey health information from electronic sources. Although the measurement and training tools for e-Health and media health literacy are still scarce, a good place to start could be to have simple conversations with patients. Encouraging patients to critically analyze online information, use credible social media sources, and recognizing the warnings, red flags, and links on unreliable information are some of the discussions worth considering. Equally important is to discourage patients from changing health behaviors or practices based on unverified social media resources and discussing the possible impact of medical misinformation.
A practical approach for e-Patients could be to ask the Five Ws, considered fundamental in information gathering: Who, What, Why, When, and Where.7,8
- Who runs the website? Examine the authors, sponsors, and sources. Federal agencies’ website addresses end in “.gov,” educational institutions maintain “.edu,” large professional or nonprofit organizations often use “.org,” and commercial websites use “.com.”
- What is offered, and What is the evidence? Does it provide unbelievable solutions or quick, miracle cures?
- Why was the site created? Is the mission or goal to inform, explain, or sell health or medical products? Check details on “About This Site” or “About Us.”
- When was the information written or the webpage last updated?
- Where are the privacy policies? Is your privacy protected?
The anonymity of sources, sponsors, financial interests, or the lack of medical credentials and reputable medical research, the use of testimonials as evidence, outdated or incomplete information, and emotional or exaggerated language should raise suspicion about the reliability of the information. Tools like the online tutorial and a checklist from the National Institute of Health’s National Library of Medicine can also be offered to e-Patients to learn how to evaluate health information online.9,10
Online health support groups widely used by patients can be an additional layer of support but can also be a source of misinformation. Since they have fewer gatekeepers than traditional face-to-face communication, keeping a check on the credibility of the information can be difficult. Support groups affiliated with local hospitals or national organizations, or those endorsed by well-known scientific societies, can be encouraged instead of less credible sources. Some online support groups, run by non–health care professionals but with experienced and reliable scientific panels, can be useful resources. However, patients must check for the credibility and reliability of the information.
Lastly, just as hospitalists take a social history of our patients, we could also ask for a “social media history” to understand patients’ sources of health information. We can then guide them toward more credible sources to make them truly empowered medical consumers.
Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.
References
1. Nelson R. Informatics: Empowering ePatients to drive health care reform - part I. Online J Issues Nurs. 2016 Sep 13;21(3):9.
2. Vosoughi S et al. The spread of true and false news online. Science. 2012;359(6380):1146-51.
3. Fox S. The social life of health information. Pew Research Center: Fact Tank. 2014 Jan 15. Accessed 2020 Jul 31.
4. Mitchel A, Jurkowitz M, Oliphant JB, Shearer E. Americans Who Mainly Get Their News on Social Media Are Less Engaged, Less Knowledgeable. Pew Research Center: Journalism & Media. 2020 Jul 30. Accessed 2020 Jul 31.
5. Stocking G, Matsa KE, Khuzam M. As COVID-19 Emerged in U.S., Facebook Posts About It Appeared in a Wide Range of Public Pages, Groups Pew Research Center: Journalism & Media. 2020 Jun 24. Accessed 2020 Jul 31.
6. Munich Security Conference. World Health Organization. 2020 Feb 15. Accessed 2020 Jul 31.
7. Levin-Zamir D, Bertschi I. Media health literacy, eHealth literacy, and the role of the social environment in context. Int J Environ Res Public Health. 2018 Aug 3;15(8):1643.
8. Online Health Information: Is It Reliable? National Institute on Aging, National Institutes of Health. 2018 Oct 31. Accessed 2020 Aug 10.
9. How To Evaluate Health Information on the Internet: Questions and Answers. Office of Dietary Supplements, National Institutes of Health. 2011 Jun 24. Accessed 2020 Aug 10.
10. Evaluating Internet Health Information: A Tutorial From the National Library of Medicine. Medline Plus. 2020 Mar 6. Accessed 2020 Aug 10.
The search engine giants, Dr. Google or Dr. Bing, are visited by most of our patients before seeking medical help. In 1976, medical student Tom Ferguson, MD, first coined the term e-Patient. It means a health consumer who uses the Internet to gather information about a medical condition for themselves or on behalf of family and friends and uses electronic communication tools to cope with medical conditions. Dr. Ferguson described e-Patients as “empowered medical consumers.”1
During the COVID-19 pandemic, social media and networking platforms – such as Facebook, Twitter, Instagram, Snapchat, YouTube, WhatsApp, online health support groups – are used increasingly by e-Patients to gather critical health information. Health care providers often take a conflicted stand on the use of social media. Though we want our patients to read about their illnesses and make informed choices, we often get frustrated by misdiagnoses, misinformation, and disinformation that comes with it.
According to a study investigating the differential diffusion of news stories distributed on Twitter from 2006 to 2017, fake news was considered more novel than true news, and people were more likely to share novel information.2 Bots accelerated the spread of true and fake news at the same rate, implying that fake news spreads more than the truth because humans, not robots, are more likely to spread it. Social media has promoted some of the best health campaigns, like public cancer awareness, the ALS Ice Bucket Challenge, World Heart Day, and others. At the same time, it has also provided a platform for antivaccination activists, dangerous and unproven alternative cancer therapies, weight loss pills, and nutrition plans.
According to a Pew Research Center survey, 72% of adult Internet users had searched online for information about a range of health issues of their own or for others in the past 12 months.3 A survey from 2019-2020 showed that those who relied on social media for news were among the least knowledgeable about key facts during the COVID-19 outbreak.4 About 74% of public posts about COVID-19 were linked to news organizations, while just 1% linked to health and science sites.5 While social media has emerged as one of the most significant health information sources, it famously has only a few safeguards in place against medical misinformation. Requiring responsibility and regulations for accurate or evidence-based information walks a thin line on infringing freedom of speech. Medical misinformation related to COVID-19 has become as contagious as the virus itself.
In February 2020, the World Health Organization warned that a massive ‘Infodemic’ had accompanied the COVID-19 outbreak, with an overabundance of information, some accurate and some not, making it difficult for people to find reliable sources and trustworthy information.6 The Black immunity myth, groups opposing vaccines, campaigns against 5G mobile phone networks, suggestions that SARS-CoV-2 was an engineered bioweapon, and online rumors leading to mob attacks in India and mass poisonings in Iran are some of the misleading health information that has circulated related to COVID-19.
In the Web 2.0 era, in which credible health information comes packaged with divisive and misleading information, social media’s full impact on health care, health outcomes, and mental health has yet to be explored. Social networks and media sharing networks have recently announced initiatives to stop misinformation and disinformation by fact-checking, flagging, issuing warnings, and deleting misinformation or misleading content. Providing links to more and correct information and partnering with health and science organizations can also encourage the spread of verifiable information.
While we have yet to see if social media safeguards are adequate, the medical community needs to proactively educate patients on the appropriate use of social media for health information, e-Health literacy, and media health literacy. Like health care providers evaluating scientific papers, we need to cultivate e-Patients’ ability to seek, evaluate, understand, and convey health information from electronic sources. Although the measurement and training tools for e-Health and media health literacy are still scarce, a good place to start could be to have simple conversations with patients. Encouraging patients to critically analyze online information, use credible social media sources, and recognizing the warnings, red flags, and links on unreliable information are some of the discussions worth considering. Equally important is to discourage patients from changing health behaviors or practices based on unverified social media resources and discussing the possible impact of medical misinformation.
A practical approach for e-Patients could be to ask the Five Ws, considered fundamental in information gathering: Who, What, Why, When, and Where.7,8
- Who runs the website? Examine the authors, sponsors, and sources. Federal agencies’ website addresses end in “.gov,” educational institutions maintain “.edu,” large professional or nonprofit organizations often use “.org,” and commercial websites use “.com.”
- What is offered, and What is the evidence? Does it provide unbelievable solutions or quick, miracle cures?
- Why was the site created? Is the mission or goal to inform, explain, or sell health or medical products? Check details on “About This Site” or “About Us.”
- When was the information written or the webpage last updated?
- Where are the privacy policies? Is your privacy protected?
The anonymity of sources, sponsors, financial interests, or the lack of medical credentials and reputable medical research, the use of testimonials as evidence, outdated or incomplete information, and emotional or exaggerated language should raise suspicion about the reliability of the information. Tools like the online tutorial and a checklist from the National Institute of Health’s National Library of Medicine can also be offered to e-Patients to learn how to evaluate health information online.9,10
Online health support groups widely used by patients can be an additional layer of support but can also be a source of misinformation. Since they have fewer gatekeepers than traditional face-to-face communication, keeping a check on the credibility of the information can be difficult. Support groups affiliated with local hospitals or national organizations, or those endorsed by well-known scientific societies, can be encouraged instead of less credible sources. Some online support groups, run by non–health care professionals but with experienced and reliable scientific panels, can be useful resources. However, patients must check for the credibility and reliability of the information.
Lastly, just as hospitalists take a social history of our patients, we could also ask for a “social media history” to understand patients’ sources of health information. We can then guide them toward more credible sources to make them truly empowered medical consumers.
Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.
References
1. Nelson R. Informatics: Empowering ePatients to drive health care reform - part I. Online J Issues Nurs. 2016 Sep 13;21(3):9.
2. Vosoughi S et al. The spread of true and false news online. Science. 2012;359(6380):1146-51.
3. Fox S. The social life of health information. Pew Research Center: Fact Tank. 2014 Jan 15. Accessed 2020 Jul 31.
4. Mitchel A, Jurkowitz M, Oliphant JB, Shearer E. Americans Who Mainly Get Their News on Social Media Are Less Engaged, Less Knowledgeable. Pew Research Center: Journalism & Media. 2020 Jul 30. Accessed 2020 Jul 31.
5. Stocking G, Matsa KE, Khuzam M. As COVID-19 Emerged in U.S., Facebook Posts About It Appeared in a Wide Range of Public Pages, Groups Pew Research Center: Journalism & Media. 2020 Jun 24. Accessed 2020 Jul 31.
6. Munich Security Conference. World Health Organization. 2020 Feb 15. Accessed 2020 Jul 31.
7. Levin-Zamir D, Bertschi I. Media health literacy, eHealth literacy, and the role of the social environment in context. Int J Environ Res Public Health. 2018 Aug 3;15(8):1643.
8. Online Health Information: Is It Reliable? National Institute on Aging, National Institutes of Health. 2018 Oct 31. Accessed 2020 Aug 10.
9. How To Evaluate Health Information on the Internet: Questions and Answers. Office of Dietary Supplements, National Institutes of Health. 2011 Jun 24. Accessed 2020 Aug 10.
10. Evaluating Internet Health Information: A Tutorial From the National Library of Medicine. Medline Plus. 2020 Mar 6. Accessed 2020 Aug 10.
Three major COVID vaccine developers release detailed trial protocols
Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.
On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.
The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.
“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
AstraZeneca takes a shot at transparency
The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.
The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.
“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.
“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
Moderna methodology
The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.
A statement that was requested from ModernaTX was not received by press time.
Pfizer protocol
In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.
Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.
“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.
“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.
If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.
Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
A positive move
“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.
“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.
Kruse has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.
On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.
The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.
“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
AstraZeneca takes a shot at transparency
The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.
The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.
“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.
“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
Moderna methodology
The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.
A statement that was requested from ModernaTX was not received by press time.
Pfizer protocol
In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.
Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.
“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.
“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.
If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.
Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
A positive move
“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.
“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.
Kruse has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.
On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.
The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.
“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
AstraZeneca takes a shot at transparency
The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.
The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.
“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.
“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
Moderna methodology
The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.
A statement that was requested from ModernaTX was not received by press time.
Pfizer protocol
In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.
Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.
“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.
“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.
If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.
Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
A positive move
“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.
“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.
Kruse has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Children’s share of COVID-19 burden continues to increase
Children continue to represent an increasing proportion of reported COVID-19 cases in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The previous week, children represented 10.0% of all cases, and that proportion has continued to rise throughout the pandemic, the AAP and CHA report shows.
Looking at just new cases for the latest week, the 38,000+ pediatric cases made up almost 17% of the 228,396 cases reported for all ages, compared with 16% and 15% the two previous weeks. For the weeks ending Aug. 13 and Aug. 6, the corresponding figures were 8% and 13%, based on the data in the AAP/CHA report, which cover 49 states (New York City but not New York state), the District of Columbia, Puerto Rico, and Guam.
The state with the highest proportion of child COVID-19 cases as of Sept. 17 was Wyoming, with 20.6%, followed by North Dakota at 18.3% and Tennessee at 17.9%. New York City has a cumulative rate of just 3.4%, but New Jersey is the state with the lowest rate at 3.6%. Florida comes in at 5.9% but is using an age range of 0-14 years for children, and Texas has a rate of 6.0% but has reported ages for only 8% of confirmed cases, the AAP and CHA noted.
Severe illness, however, continues to be rare in children. The overall hospitalization rate for children was down to 1.7% among the 26 jurisdictions providing ages as Sept. 17 – down from 1.8% the week before and 2.3% on Aug. 20. The death rate is just 0.02% among 43 jurisdictions, the report said.
Children continue to represent an increasing proportion of reported COVID-19 cases in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The previous week, children represented 10.0% of all cases, and that proportion has continued to rise throughout the pandemic, the AAP and CHA report shows.
Looking at just new cases for the latest week, the 38,000+ pediatric cases made up almost 17% of the 228,396 cases reported for all ages, compared with 16% and 15% the two previous weeks. For the weeks ending Aug. 13 and Aug. 6, the corresponding figures were 8% and 13%, based on the data in the AAP/CHA report, which cover 49 states (New York City but not New York state), the District of Columbia, Puerto Rico, and Guam.
The state with the highest proportion of child COVID-19 cases as of Sept. 17 was Wyoming, with 20.6%, followed by North Dakota at 18.3% and Tennessee at 17.9%. New York City has a cumulative rate of just 3.4%, but New Jersey is the state with the lowest rate at 3.6%. Florida comes in at 5.9% but is using an age range of 0-14 years for children, and Texas has a rate of 6.0% but has reported ages for only 8% of confirmed cases, the AAP and CHA noted.
Severe illness, however, continues to be rare in children. The overall hospitalization rate for children was down to 1.7% among the 26 jurisdictions providing ages as Sept. 17 – down from 1.8% the week before and 2.3% on Aug. 20. The death rate is just 0.02% among 43 jurisdictions, the report said.
Children continue to represent an increasing proportion of reported COVID-19 cases in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The previous week, children represented 10.0% of all cases, and that proportion has continued to rise throughout the pandemic, the AAP and CHA report shows.
Looking at just new cases for the latest week, the 38,000+ pediatric cases made up almost 17% of the 228,396 cases reported for all ages, compared with 16% and 15% the two previous weeks. For the weeks ending Aug. 13 and Aug. 6, the corresponding figures were 8% and 13%, based on the data in the AAP/CHA report, which cover 49 states (New York City but not New York state), the District of Columbia, Puerto Rico, and Guam.
The state with the highest proportion of child COVID-19 cases as of Sept. 17 was Wyoming, with 20.6%, followed by North Dakota at 18.3% and Tennessee at 17.9%. New York City has a cumulative rate of just 3.4%, but New Jersey is the state with the lowest rate at 3.6%. Florida comes in at 5.9% but is using an age range of 0-14 years for children, and Texas has a rate of 6.0% but has reported ages for only 8% of confirmed cases, the AAP and CHA noted.
Severe illness, however, continues to be rare in children. The overall hospitalization rate for children was down to 1.7% among the 26 jurisdictions providing ages as Sept. 17 – down from 1.8% the week before and 2.3% on Aug. 20. The death rate is just 0.02% among 43 jurisdictions, the report said.
Signs of an ‘October vaccine surprise’ alarm career scientists
who have pledged not to release any vaccine unless it’s proved safe and effective.
In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Mr. Trump – who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA – will take matters into his own hands, running roughshod over the usual regulatory process.
It would reflect another attempt by a norm-breaking administration, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions. Mr. Trump has repeatedly contradicted the advice of senior scientists on COVID-19 while pushing controversial treatments for the disease.
If the executive branch were to overrule the FDA’s scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.
The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health & Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokesperson Caitlin Oakley said Mr. Azar’s decision had no bearing on the vaccine approval process.
Vaccines are typically approved by the FDA. Alternatively, Mr. Azar – who reports directly to Mr. Trump – can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.
“Yes, this scenario is certainly possible legally and politically,” said Jerry Avorn, MD, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”
Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.
Physicians might refuse to administer a vaccine approved with inadequate data, said Preeti Malani, MD, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54% of Americans would not submit to a COVID-19 vaccine authorized before Election Day.
After this story was published, an HHS official said that Mr. Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.
“The idea the Secretary would approve or authorize a vaccine over the FDA’s objections is preposterous and betrays ignorance of the transparent process that we’re following for the development of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.
White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.
Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”
Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.
Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop COVID-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.
Mr. Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed 200,000 American lives will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.
The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”
Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.
Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year, although the final analysis could take place next spring.
Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.
AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.
Scientists have warned for months that the Trump administration could try to win the election with an “October surprise,” authorizing a vaccine that hasn’t been fully tested. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.
“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”
In an opinion piece published in the Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”
But the administration has demonstrated a willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two COVID-19 treatments that were boosted by the president but lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.
Mr. Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.
Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any COVID-19 vaccines.
A senior FDA official who oversees vaccine approvals, Peter Marks, MD, has said he will quit if his agency rubber-stamps an unproven COVID-19 vaccine.
“I think there would be an outcry from the public health community second to none, which is my worst nightmare – my worst nightmare – because we will so confuse the public,” said Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.
Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Dr. Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”
In the New England Journal editorial, Dr. Avorn and coauthor Aaron Kesselheim, MD, wondered whether Mr. Trump might invoke the 1950 Defense Production Act to force reluctant drug companies to manufacture their vaccines.
But Mr. Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.
Also, he noted that Mr. Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
who have pledged not to release any vaccine unless it’s proved safe and effective.
In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Mr. Trump – who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA – will take matters into his own hands, running roughshod over the usual regulatory process.
It would reflect another attempt by a norm-breaking administration, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions. Mr. Trump has repeatedly contradicted the advice of senior scientists on COVID-19 while pushing controversial treatments for the disease.
If the executive branch were to overrule the FDA’s scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.
The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health & Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokesperson Caitlin Oakley said Mr. Azar’s decision had no bearing on the vaccine approval process.
Vaccines are typically approved by the FDA. Alternatively, Mr. Azar – who reports directly to Mr. Trump – can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.
“Yes, this scenario is certainly possible legally and politically,” said Jerry Avorn, MD, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”
Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.
Physicians might refuse to administer a vaccine approved with inadequate data, said Preeti Malani, MD, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54% of Americans would not submit to a COVID-19 vaccine authorized before Election Day.
After this story was published, an HHS official said that Mr. Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.
“The idea the Secretary would approve or authorize a vaccine over the FDA’s objections is preposterous and betrays ignorance of the transparent process that we’re following for the development of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.
White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.
Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”
Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.
Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop COVID-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.
Mr. Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed 200,000 American lives will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.
The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”
Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.
Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year, although the final analysis could take place next spring.
Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.
AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.
Scientists have warned for months that the Trump administration could try to win the election with an “October surprise,” authorizing a vaccine that hasn’t been fully tested. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.
“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”
In an opinion piece published in the Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”
But the administration has demonstrated a willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two COVID-19 treatments that were boosted by the president but lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.
Mr. Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.
Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any COVID-19 vaccines.
A senior FDA official who oversees vaccine approvals, Peter Marks, MD, has said he will quit if his agency rubber-stamps an unproven COVID-19 vaccine.
“I think there would be an outcry from the public health community second to none, which is my worst nightmare – my worst nightmare – because we will so confuse the public,” said Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.
Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Dr. Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”
In the New England Journal editorial, Dr. Avorn and coauthor Aaron Kesselheim, MD, wondered whether Mr. Trump might invoke the 1950 Defense Production Act to force reluctant drug companies to manufacture their vaccines.
But Mr. Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.
Also, he noted that Mr. Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
who have pledged not to release any vaccine unless it’s proved safe and effective.
In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Mr. Trump – who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA – will take matters into his own hands, running roughshod over the usual regulatory process.
It would reflect another attempt by a norm-breaking administration, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions. Mr. Trump has repeatedly contradicted the advice of senior scientists on COVID-19 while pushing controversial treatments for the disease.
If the executive branch were to overrule the FDA’s scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.
The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health & Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokesperson Caitlin Oakley said Mr. Azar’s decision had no bearing on the vaccine approval process.
Vaccines are typically approved by the FDA. Alternatively, Mr. Azar – who reports directly to Mr. Trump – can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.
“Yes, this scenario is certainly possible legally and politically,” said Jerry Avorn, MD, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”
Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.
Physicians might refuse to administer a vaccine approved with inadequate data, said Preeti Malani, MD, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54% of Americans would not submit to a COVID-19 vaccine authorized before Election Day.
After this story was published, an HHS official said that Mr. Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.
“The idea the Secretary would approve or authorize a vaccine over the FDA’s objections is preposterous and betrays ignorance of the transparent process that we’re following for the development of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.
White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.
Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”
Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.
Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop COVID-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.
Mr. Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed 200,000 American lives will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.
The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”
Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.
Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year, although the final analysis could take place next spring.
Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.
AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.
Scientists have warned for months that the Trump administration could try to win the election with an “October surprise,” authorizing a vaccine that hasn’t been fully tested. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.
“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”
In an opinion piece published in the Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”
But the administration has demonstrated a willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two COVID-19 treatments that were boosted by the president but lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.
Mr. Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.
Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any COVID-19 vaccines.
A senior FDA official who oversees vaccine approvals, Peter Marks, MD, has said he will quit if his agency rubber-stamps an unproven COVID-19 vaccine.
“I think there would be an outcry from the public health community second to none, which is my worst nightmare – my worst nightmare – because we will so confuse the public,” said Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.
Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Dr. Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”
In the New England Journal editorial, Dr. Avorn and coauthor Aaron Kesselheim, MD, wondered whether Mr. Trump might invoke the 1950 Defense Production Act to force reluctant drug companies to manufacture their vaccines.
But Mr. Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.
Also, he noted that Mr. Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
The path to leadership
It was 6 a.m. on a rainy, cold Pacific Northwest morning as I walked from my apartment to the hospital, dodging puddles and dreaming of the mediocre-yet-hot physician-lounge coffee. Another long day full of clinical and administrative tasks awaited me.
I was 6 months’ pregnant with our first child and working my sixth 12-hour shift in a row. We had recently lost our medical director, and the C-suite had offered me the role. The day ahead seemed like an enormous mountain to climb.
I felt tired and more than a little overwhelmed. But I whispered to myself: “Today is going to be a fantastic day. I will not fail my team. I will not fail my patients!”
Physician leadership starts with a decision
The timing of this call to leadership had not been ideal. There’s probably never a perfect time to step into a medical director role. And my situation was no exception.
In addition to the baby on the way, my husband was traveling a lot for work. Also, the job of a medical director seemed a little daunting – especially to a young physician leading a team for the first time.
But I knew that leadership was my calling. While I didn’t yet have decades of experience, I had been selected as the chief resident in internal medicine, completed a nephrology fellowship, and mentored several medical students and residents along my career path.
I also knew that I was passionate about supporting my patients and hospitalist team. I’d previously served as associate medical director in charge of quality, readmission reduction, and patient experience. Having achieved the highest patient satisfaction scores on the team for 2 consecutive years, I was specially tasked to improve our team’s HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores.
These experiences taught me that coaching with positive reinforcement was in my blood. This gave me the courage to face my tallest mountain yet.
No one climbs a mountain alone
I also stepped into my new physician leadership role with amazing support. Our outgoing medical director had recommended me, and my entire team was rooting for me. My spouse was 100% behind the idea.
What’s more, I had received amazing feedback from patients throughout my 3 years at the hospital. I had papered an entire office wall with their thank-you notes. I even had a quilt that an 85-year-old patient’s wife made to thank me for my compassionate care.
As I weighed my decision, I realized that I had a higher calling to be a true advocate for my patients. I loved what I did. Each day, I resolved to bring my best and most authentic self for them – no matter how drained I felt.
My team and patients needed me now, not at some more convenient time down the road. A medical director job was the natural next step for me. And so, I resolved to climb the mountain.
Climbing through storms
Stepping into a medical director job forced me to grow into a completely new person. So maybe starting that role during pregnancy was a great metaphor!
Each day, there was immense pressure to perform, to deliver quality outcomes, and to simultaneously meet expectations of the C-suite as well as my hospitalist team. There was no room for failure, because too much was at stake.
Looking back today, I wouldn’t trade the experience for anything. The medical director role was one of the most gratifying experiences in my life, and I am truly thankful for it.
A leader’s role truly boils down to working tirelessly to collaborate with different care teams. It’s important to care not only about our patients but also about our fellow hospitalists. We can do this by truly leading by example – be it picking up extra shifts, covering holidays so team members can be with family, or coming in at 10 p.m. to round with your night team.
I was also able to bring a unique perspective to the hospital C-suite meetings as a woman, an immigrant, and a true “mama bear” – not only of my infant son but also of my team.
My first year as a medical director required more commitment and heart than I could have imagined. But all this hard work paid off when our hospitalist group received the coveted Best Team Award for most improved quality outcomes, financial performance, and patient experience.
The summit is the beginning
My first medical director job fueled my passion for patient satisfaction even further. I now serve as the director of patient experience for the more than 4,200 clinicians at Vituity. Together we care for more than 6.5 million lives a year across the country.
In 2019, I coached 300 physicians and hospital leaders on communication, collaboration, and service recovery skills, leading to significant improvement in their HCAHPS scores. I was delighted to receive the Vituity Distinguished Service Award for my contributions. It’s such an honor to be instrumental in impacting patient care at a larger scale.
This year, I was invited to serve as vice chair of the Society for Hospital Medicine’s patient experience committee and to join the executive board of the SHM San Francisco chapter. Together, we have created a COVID-19 patient communication resource and reached out to our hospitalists to provide them with a space to share their stories during this pandemic. I am so excited to share my knowledge and passion with clinicians across the country given the wide reach of Vituity & SHM!
Many hospitalists shy away from leadership roles. The mountain is tough to scale, but the view from the top is worth it. The key is to start, even if you don’t feel ready. I am here to tell you it can be done!
Dr. Mehta is a hospitalist and director of quality & performance and patient experience at Vituity in Emeryville, Calif. She is vice chair of the SHM patient experience committee and executive board member of the SHM San Francisco Bay Area chapter.
It was 6 a.m. on a rainy, cold Pacific Northwest morning as I walked from my apartment to the hospital, dodging puddles and dreaming of the mediocre-yet-hot physician-lounge coffee. Another long day full of clinical and administrative tasks awaited me.
I was 6 months’ pregnant with our first child and working my sixth 12-hour shift in a row. We had recently lost our medical director, and the C-suite had offered me the role. The day ahead seemed like an enormous mountain to climb.
I felt tired and more than a little overwhelmed. But I whispered to myself: “Today is going to be a fantastic day. I will not fail my team. I will not fail my patients!”
Physician leadership starts with a decision
The timing of this call to leadership had not been ideal. There’s probably never a perfect time to step into a medical director role. And my situation was no exception.
In addition to the baby on the way, my husband was traveling a lot for work. Also, the job of a medical director seemed a little daunting – especially to a young physician leading a team for the first time.
But I knew that leadership was my calling. While I didn’t yet have decades of experience, I had been selected as the chief resident in internal medicine, completed a nephrology fellowship, and mentored several medical students and residents along my career path.
I also knew that I was passionate about supporting my patients and hospitalist team. I’d previously served as associate medical director in charge of quality, readmission reduction, and patient experience. Having achieved the highest patient satisfaction scores on the team for 2 consecutive years, I was specially tasked to improve our team’s HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores.
These experiences taught me that coaching with positive reinforcement was in my blood. This gave me the courage to face my tallest mountain yet.
No one climbs a mountain alone
I also stepped into my new physician leadership role with amazing support. Our outgoing medical director had recommended me, and my entire team was rooting for me. My spouse was 100% behind the idea.
What’s more, I had received amazing feedback from patients throughout my 3 years at the hospital. I had papered an entire office wall with their thank-you notes. I even had a quilt that an 85-year-old patient’s wife made to thank me for my compassionate care.
As I weighed my decision, I realized that I had a higher calling to be a true advocate for my patients. I loved what I did. Each day, I resolved to bring my best and most authentic self for them – no matter how drained I felt.
My team and patients needed me now, not at some more convenient time down the road. A medical director job was the natural next step for me. And so, I resolved to climb the mountain.
Climbing through storms
Stepping into a medical director job forced me to grow into a completely new person. So maybe starting that role during pregnancy was a great metaphor!
Each day, there was immense pressure to perform, to deliver quality outcomes, and to simultaneously meet expectations of the C-suite as well as my hospitalist team. There was no room for failure, because too much was at stake.
Looking back today, I wouldn’t trade the experience for anything. The medical director role was one of the most gratifying experiences in my life, and I am truly thankful for it.
A leader’s role truly boils down to working tirelessly to collaborate with different care teams. It’s important to care not only about our patients but also about our fellow hospitalists. We can do this by truly leading by example – be it picking up extra shifts, covering holidays so team members can be with family, or coming in at 10 p.m. to round with your night team.
I was also able to bring a unique perspective to the hospital C-suite meetings as a woman, an immigrant, and a true “mama bear” – not only of my infant son but also of my team.
My first year as a medical director required more commitment and heart than I could have imagined. But all this hard work paid off when our hospitalist group received the coveted Best Team Award for most improved quality outcomes, financial performance, and patient experience.
The summit is the beginning
My first medical director job fueled my passion for patient satisfaction even further. I now serve as the director of patient experience for the more than 4,200 clinicians at Vituity. Together we care for more than 6.5 million lives a year across the country.
In 2019, I coached 300 physicians and hospital leaders on communication, collaboration, and service recovery skills, leading to significant improvement in their HCAHPS scores. I was delighted to receive the Vituity Distinguished Service Award for my contributions. It’s such an honor to be instrumental in impacting patient care at a larger scale.
This year, I was invited to serve as vice chair of the Society for Hospital Medicine’s patient experience committee and to join the executive board of the SHM San Francisco chapter. Together, we have created a COVID-19 patient communication resource and reached out to our hospitalists to provide them with a space to share their stories during this pandemic. I am so excited to share my knowledge and passion with clinicians across the country given the wide reach of Vituity & SHM!
Many hospitalists shy away from leadership roles. The mountain is tough to scale, but the view from the top is worth it. The key is to start, even if you don’t feel ready. I am here to tell you it can be done!
Dr. Mehta is a hospitalist and director of quality & performance and patient experience at Vituity in Emeryville, Calif. She is vice chair of the SHM patient experience committee and executive board member of the SHM San Francisco Bay Area chapter.
It was 6 a.m. on a rainy, cold Pacific Northwest morning as I walked from my apartment to the hospital, dodging puddles and dreaming of the mediocre-yet-hot physician-lounge coffee. Another long day full of clinical and administrative tasks awaited me.
I was 6 months’ pregnant with our first child and working my sixth 12-hour shift in a row. We had recently lost our medical director, and the C-suite had offered me the role. The day ahead seemed like an enormous mountain to climb.
I felt tired and more than a little overwhelmed. But I whispered to myself: “Today is going to be a fantastic day. I will not fail my team. I will not fail my patients!”
Physician leadership starts with a decision
The timing of this call to leadership had not been ideal. There’s probably never a perfect time to step into a medical director role. And my situation was no exception.
In addition to the baby on the way, my husband was traveling a lot for work. Also, the job of a medical director seemed a little daunting – especially to a young physician leading a team for the first time.
But I knew that leadership was my calling. While I didn’t yet have decades of experience, I had been selected as the chief resident in internal medicine, completed a nephrology fellowship, and mentored several medical students and residents along my career path.
I also knew that I was passionate about supporting my patients and hospitalist team. I’d previously served as associate medical director in charge of quality, readmission reduction, and patient experience. Having achieved the highest patient satisfaction scores on the team for 2 consecutive years, I was specially tasked to improve our team’s HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores.
These experiences taught me that coaching with positive reinforcement was in my blood. This gave me the courage to face my tallest mountain yet.
No one climbs a mountain alone
I also stepped into my new physician leadership role with amazing support. Our outgoing medical director had recommended me, and my entire team was rooting for me. My spouse was 100% behind the idea.
What’s more, I had received amazing feedback from patients throughout my 3 years at the hospital. I had papered an entire office wall with their thank-you notes. I even had a quilt that an 85-year-old patient’s wife made to thank me for my compassionate care.
As I weighed my decision, I realized that I had a higher calling to be a true advocate for my patients. I loved what I did. Each day, I resolved to bring my best and most authentic self for them – no matter how drained I felt.
My team and patients needed me now, not at some more convenient time down the road. A medical director job was the natural next step for me. And so, I resolved to climb the mountain.
Climbing through storms
Stepping into a medical director job forced me to grow into a completely new person. So maybe starting that role during pregnancy was a great metaphor!
Each day, there was immense pressure to perform, to deliver quality outcomes, and to simultaneously meet expectations of the C-suite as well as my hospitalist team. There was no room for failure, because too much was at stake.
Looking back today, I wouldn’t trade the experience for anything. The medical director role was one of the most gratifying experiences in my life, and I am truly thankful for it.
A leader’s role truly boils down to working tirelessly to collaborate with different care teams. It’s important to care not only about our patients but also about our fellow hospitalists. We can do this by truly leading by example – be it picking up extra shifts, covering holidays so team members can be with family, or coming in at 10 p.m. to round with your night team.
I was also able to bring a unique perspective to the hospital C-suite meetings as a woman, an immigrant, and a true “mama bear” – not only of my infant son but also of my team.
My first year as a medical director required more commitment and heart than I could have imagined. But all this hard work paid off when our hospitalist group received the coveted Best Team Award for most improved quality outcomes, financial performance, and patient experience.
The summit is the beginning
My first medical director job fueled my passion for patient satisfaction even further. I now serve as the director of patient experience for the more than 4,200 clinicians at Vituity. Together we care for more than 6.5 million lives a year across the country.
In 2019, I coached 300 physicians and hospital leaders on communication, collaboration, and service recovery skills, leading to significant improvement in their HCAHPS scores. I was delighted to receive the Vituity Distinguished Service Award for my contributions. It’s such an honor to be instrumental in impacting patient care at a larger scale.
This year, I was invited to serve as vice chair of the Society for Hospital Medicine’s patient experience committee and to join the executive board of the SHM San Francisco chapter. Together, we have created a COVID-19 patient communication resource and reached out to our hospitalists to provide them with a space to share their stories during this pandemic. I am so excited to share my knowledge and passion with clinicians across the country given the wide reach of Vituity & SHM!
Many hospitalists shy away from leadership roles. The mountain is tough to scale, but the view from the top is worth it. The key is to start, even if you don’t feel ready. I am here to tell you it can be done!
Dr. Mehta is a hospitalist and director of quality & performance and patient experience at Vituity in Emeryville, Calif. She is vice chair of the SHM patient experience committee and executive board member of the SHM San Francisco Bay Area chapter.
CDC adds then retracts aerosols as main COVID-19 mode of transmission
The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.
CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.
However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”
Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”
Previous information
Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.
Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”
The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”
On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).
The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.
WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.
The CDC update was made Friday without announcement.
“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”
Again Monday, there was no announcement that information had changed.
Update added air purifiers for prevention
The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.
The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
This article first appeared on Medscape.com.
The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.
CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.
However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”
Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”
Previous information
Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.
Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”
The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”
On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).
The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.
WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.
The CDC update was made Friday without announcement.
“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”
Again Monday, there was no announcement that information had changed.
Update added air purifiers for prevention
The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.
The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
This article first appeared on Medscape.com.
The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.
CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.
However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”
Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”
Previous information
Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.
Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”
The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”
On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).
The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.
WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.
The CDC update was made Friday without announcement.
“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”
Again Monday, there was no announcement that information had changed.
Update added air purifiers for prevention
The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.
The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
This article first appeared on Medscape.com.