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Oleander extract for COVID-19? That’s a hard ‘no’ experts say

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Thu, 08/26/2021 - 16:01

Oleandrin, a toxic cardiac glycoside found in the poisonous oleander plant, is making headlines as a potential treatment for COVID-19, raising concerns that uninformed people may eat the leaves of the plant and become ill or die.

CANCER CIFTCI/Getty Images

“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.

Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.

The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.

After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.

Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.

Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.

Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
 

In vitro study

Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.

In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.

“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.

On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”

But it’s a far cry from test tube to human, one expert cautioned.

“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.

“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.

Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.

“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.

This article first appeared on Medscape.com.

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Oleandrin, a toxic cardiac glycoside found in the poisonous oleander plant, is making headlines as a potential treatment for COVID-19, raising concerns that uninformed people may eat the leaves of the plant and become ill or die.

CANCER CIFTCI/Getty Images

“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.

Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.

The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.

After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.

Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.

Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.

Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
 

In vitro study

Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.

In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.

“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.

On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”

But it’s a far cry from test tube to human, one expert cautioned.

“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.

“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.

Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.

“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.

This article first appeared on Medscape.com.

Oleandrin, a toxic cardiac glycoside found in the poisonous oleander plant, is making headlines as a potential treatment for COVID-19, raising concerns that uninformed people may eat the leaves of the plant and become ill or die.

CANCER CIFTCI/Getty Images

“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.

Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.

The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.

After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.

Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.

Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.

Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
 

In vitro study

Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.

In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.

“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.

On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”

But it’s a far cry from test tube to human, one expert cautioned.

“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.

“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.

Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.

“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.

This article first appeared on Medscape.com.

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Non-COVID-19 clinical trials grind to a halt during pandemic

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Thu, 08/26/2021 - 16:01

The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.

A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.

“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.

The analysis was published online July 31 in the Journal of the American College of Cardiology.

The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”

The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).

Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”

He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.

“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”

As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”

He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.

The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.

Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.

“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.

“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
 

Stopped for lack of funding

Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.

The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.

Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.

The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.

Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.

“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.

In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.

At what cost? It will take years to sort that out, he said.

This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
 

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

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The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.

A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.

“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.

The analysis was published online July 31 in the Journal of the American College of Cardiology.

The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”

The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).

Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”

He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.

“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”

As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”

He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.

The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.

Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.

“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.

“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
 

Stopped for lack of funding

Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.

The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.

Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.

The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.

Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.

“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.

In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.

At what cost? It will take years to sort that out, he said.

This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
 

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

The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.

A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.

“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.

The analysis was published online July 31 in the Journal of the American College of Cardiology.

The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”

The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).

Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”

He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.

“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”

As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”

He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.

The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.

Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.

“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.

“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
 

Stopped for lack of funding

Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.

The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.

Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.

The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.

Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.

“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.

In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.

At what cost? It will take years to sort that out, he said.

This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
 

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

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Send kids to school safely if possible, supplement virtually

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The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.

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“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.

“Importantly, K-12 virtual schooling is not suited for all students or all families.”

In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
 

Not all virtual schools are equal

Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.

“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.

Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).

“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
 

Schools may be able to open safely

Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.

Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.

The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.

“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.

“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”

The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”

“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
 

Schools opening is a regional decision

Dr. Howard Smart

“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”

“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.

“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”

In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.

“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.

Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”

The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”

“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.

“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
 

 

 

It’s not just about education

Dr. Nathaniel Savio Beers

“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.

“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.

However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”

“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.

“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.

“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”

“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”

“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”

The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”

Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.

The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.

SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.
 

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The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.

monkeybusinessimages/Thinkstock

“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.

“Importantly, K-12 virtual schooling is not suited for all students or all families.”

In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
 

Not all virtual schools are equal

Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.

“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.

Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).

“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
 

Schools may be able to open safely

Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.

Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.

The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.

“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.

“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”

The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”

“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
 

Schools opening is a regional decision

Dr. Howard Smart

“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”

“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.

“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”

In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.

“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.

Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”

The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”

“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.

“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
 

 

 

It’s not just about education

Dr. Nathaniel Savio Beers

“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.

“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.

However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”

“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.

“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.

“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”

“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”

“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”

The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”

Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.

The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.

SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.
 

The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.

monkeybusinessimages/Thinkstock

“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.

“Importantly, K-12 virtual schooling is not suited for all students or all families.”

In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
 

Not all virtual schools are equal

Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.

“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.

Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).

“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
 

Schools may be able to open safely

Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.

Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.

The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.

“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.

“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”

The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”

“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
 

Schools opening is a regional decision

Dr. Howard Smart

“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”

“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.

“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”

In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.

“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.

Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”

The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”

“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.

“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
 

 

 

It’s not just about education

Dr. Nathaniel Savio Beers

“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.

“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.

However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”

“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.

“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.

“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”

“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”

“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”

The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”

Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.

The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.

SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.
 

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ASCO updates guideline for metastatic pancreatic cancer

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Changed
Wed, 05/26/2021 - 13:43

Early testing for actionable genomic alterations is now recommended for metastatic pancreatic cancer patients who progress on therapy or experience intolerable toxicity and who are potential candidates for additional treatment after first-line therapy, according to an American Society of Clinical Oncology guideline update.

Both germline and somatic testing, including for microsatellite instability/mismatch repair deficiency, BRCA mutations with known significance, and NTRK gene fusions, are recommended in this population, reported Davendra P.S. Sohal, MD, MPH, of the University of Cincinnati, and colleagues on ASCO’s expert panel. The update was published online Aug. 5 in the Journal of Clinical Oncology.

The ASCO guideline on clinical decision making for patients with metastatic pancreatic cancer was first published in 2016 to address initial assessment and first- and second-line treatment options, supportive care, and follow-up and was updated in 2018. The current update is based on new evidence of benefit with targeted therapy options after first-line therapy or as maintenance therapy.

The phase 3 POLO trial, for example, showed significantly improved progression-free survival with the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib for maintenance therapy after first-line treatment in patients with a germline BRCA1 or BRCA2 mutation and metastatic pancreatic cancer that had not progressed during first-line platinum-based chemotherapy. An integrated analysis of three studies showed that entrectinib, a potent inhibitor of tropomyosin receptor kinase (TRK) A, B, and C, safely induced durable and clinically meaningful responses in patients with NTRK fusion-positive solid tumors, and a phase 1-2 study showed that the highly selective TRK inhibitor larotrectinib had marked and durable antitumor activity in both children and adults with TRK fusion-positive solid tumors.

With respect to the new recommendation endorsing early testing for actionable genomic alterations (Recommendation 1.5), the authors noted that the results of testing can lead to treatment with PARP inhibitors, programmed death-1 (PD-1) checkpoint inhibitor therapy, TRK fusion inhibitors, and clinical trials of targeted therapies.

“Genomic testing is recommended as part of an initial assessment to ensure that the results of testing are available at the time of treatment decision where applicable after first-line therapy,” the new recommendation states.

A “qualifying statement” further notes that the decision to test should “involve a discussion between the patient and physician regarding the frequency of actionable findings, treatment implications of testing results, and genetic counseling related to germline testing.”

Recommendation 1.5 is rated by the panel as “strong” and is based on informal consensus.



The panel also added two recommendations on treatment options after first-line therapy:

  • Recommendation 3.1 calls for treatment with larotrectinib or entrectinib in patient with tumors harboring NTRK fusions.
  • Recommendation 3.3 states that patients with a germline BRCA1 or BCA2 mutation who have received first-line platinum-based chemotherapy without disease progression for at least 16 weeks can receive chemotherapy or PARP inhibition with olaparib.

The relevant evidence for these two recommendations is of low quality, but shows that the benefits outweigh the harms; the strength of both recommendations is “moderate.”

A qualifying statement for the latter notes that “the decision to continue treatment with chemotherapy or proceed to maintenance therapy with olaparib should be based on a discussion between the patient and the oncologist, including consideration of whether a maximum response and plateau in response to chemotherapy have been achieved, the level of cumulative toxicities associated with chemotherapy treatment, patient preference, convenience, toxicity, goals of care, cost, and clinical evidence, including a lack of overall survival benefit demonstrated in the POLO randomized controlled trial.”

This focused update includes minor modifications to three existing recommendations:

  • In addition to capecitabine or erlotinib, nab-paclitaxel is now included in Recommendation 2.3 as another possible add-on to gemcitabine alone for patients with either an Eastern Cooperative Oncology Group (ECOG) performance score of 2 or a comorbidity profile that precludes more aggressive regimens. The recommendation was also updated to encourage proactive dose and schedule adjustments to minimize toxicities.
  • Recommendation 3.5 now includes patients treated previously with a gemcitabine-based regimen in the criteria for the preferred second-line treatment combination of fluorouracil plus nanoliposomal irinotecan or fluorouracil plus irinotecan “where the former is unavailable.”
  • Recommendation 3.7 now includes nab-paclitaxel as an add-on option to gemcitabine, and nanoliposomal irinotecan as an add-on option to fluorouracil for second-line therapy – with proactive dose and schedule adjustments to minimize toxicities – in patients with ECOG performance score of 2 or a comorbidity profile that precludes more aggressive regimens.

These three minor modifications reflect new evidence in the first-line treatment setting, including from the FRAGRANCE trial, and are based on expert panel consensus. All other recommendations in the 2018 update are endorsed for the current update, which is available at the ASCO website.

Dr. Sohal reported honoraria from Foundation Medicine, and consulting or advisory roles with Perthera, Ability Pharma, and PierianDx. He reported research funding to his institution from Novartis, Celgene, OncoMed, Bayer, Genentech, Bristol Myers Squibb, Agios, Incyte, Loxo, and Rafael Pharmaceuticals.

SOURCE: Sohal D et al. J Clin Oncol. 2020 Aug 5. doi: 10.1200/JCO.20.01364.

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Early testing for actionable genomic alterations is now recommended for metastatic pancreatic cancer patients who progress on therapy or experience intolerable toxicity and who are potential candidates for additional treatment after first-line therapy, according to an American Society of Clinical Oncology guideline update.

Both germline and somatic testing, including for microsatellite instability/mismatch repair deficiency, BRCA mutations with known significance, and NTRK gene fusions, are recommended in this population, reported Davendra P.S. Sohal, MD, MPH, of the University of Cincinnati, and colleagues on ASCO’s expert panel. The update was published online Aug. 5 in the Journal of Clinical Oncology.

The ASCO guideline on clinical decision making for patients with metastatic pancreatic cancer was first published in 2016 to address initial assessment and first- and second-line treatment options, supportive care, and follow-up and was updated in 2018. The current update is based on new evidence of benefit with targeted therapy options after first-line therapy or as maintenance therapy.

The phase 3 POLO trial, for example, showed significantly improved progression-free survival with the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib for maintenance therapy after first-line treatment in patients with a germline BRCA1 or BRCA2 mutation and metastatic pancreatic cancer that had not progressed during first-line platinum-based chemotherapy. An integrated analysis of three studies showed that entrectinib, a potent inhibitor of tropomyosin receptor kinase (TRK) A, B, and C, safely induced durable and clinically meaningful responses in patients with NTRK fusion-positive solid tumors, and a phase 1-2 study showed that the highly selective TRK inhibitor larotrectinib had marked and durable antitumor activity in both children and adults with TRK fusion-positive solid tumors.

With respect to the new recommendation endorsing early testing for actionable genomic alterations (Recommendation 1.5), the authors noted that the results of testing can lead to treatment with PARP inhibitors, programmed death-1 (PD-1) checkpoint inhibitor therapy, TRK fusion inhibitors, and clinical trials of targeted therapies.

“Genomic testing is recommended as part of an initial assessment to ensure that the results of testing are available at the time of treatment decision where applicable after first-line therapy,” the new recommendation states.

A “qualifying statement” further notes that the decision to test should “involve a discussion between the patient and physician regarding the frequency of actionable findings, treatment implications of testing results, and genetic counseling related to germline testing.”

Recommendation 1.5 is rated by the panel as “strong” and is based on informal consensus.



The panel also added two recommendations on treatment options after first-line therapy:

  • Recommendation 3.1 calls for treatment with larotrectinib or entrectinib in patient with tumors harboring NTRK fusions.
  • Recommendation 3.3 states that patients with a germline BRCA1 or BCA2 mutation who have received first-line platinum-based chemotherapy without disease progression for at least 16 weeks can receive chemotherapy or PARP inhibition with olaparib.

The relevant evidence for these two recommendations is of low quality, but shows that the benefits outweigh the harms; the strength of both recommendations is “moderate.”

A qualifying statement for the latter notes that “the decision to continue treatment with chemotherapy or proceed to maintenance therapy with olaparib should be based on a discussion between the patient and the oncologist, including consideration of whether a maximum response and plateau in response to chemotherapy have been achieved, the level of cumulative toxicities associated with chemotherapy treatment, patient preference, convenience, toxicity, goals of care, cost, and clinical evidence, including a lack of overall survival benefit demonstrated in the POLO randomized controlled trial.”

This focused update includes minor modifications to three existing recommendations:

  • In addition to capecitabine or erlotinib, nab-paclitaxel is now included in Recommendation 2.3 as another possible add-on to gemcitabine alone for patients with either an Eastern Cooperative Oncology Group (ECOG) performance score of 2 or a comorbidity profile that precludes more aggressive regimens. The recommendation was also updated to encourage proactive dose and schedule adjustments to minimize toxicities.
  • Recommendation 3.5 now includes patients treated previously with a gemcitabine-based regimen in the criteria for the preferred second-line treatment combination of fluorouracil plus nanoliposomal irinotecan or fluorouracil plus irinotecan “where the former is unavailable.”
  • Recommendation 3.7 now includes nab-paclitaxel as an add-on option to gemcitabine, and nanoliposomal irinotecan as an add-on option to fluorouracil for second-line therapy – with proactive dose and schedule adjustments to minimize toxicities – in patients with ECOG performance score of 2 or a comorbidity profile that precludes more aggressive regimens.

These three minor modifications reflect new evidence in the first-line treatment setting, including from the FRAGRANCE trial, and are based on expert panel consensus. All other recommendations in the 2018 update are endorsed for the current update, which is available at the ASCO website.

Dr. Sohal reported honoraria from Foundation Medicine, and consulting or advisory roles with Perthera, Ability Pharma, and PierianDx. He reported research funding to his institution from Novartis, Celgene, OncoMed, Bayer, Genentech, Bristol Myers Squibb, Agios, Incyte, Loxo, and Rafael Pharmaceuticals.

SOURCE: Sohal D et al. J Clin Oncol. 2020 Aug 5. doi: 10.1200/JCO.20.01364.

Early testing for actionable genomic alterations is now recommended for metastatic pancreatic cancer patients who progress on therapy or experience intolerable toxicity and who are potential candidates for additional treatment after first-line therapy, according to an American Society of Clinical Oncology guideline update.

Both germline and somatic testing, including for microsatellite instability/mismatch repair deficiency, BRCA mutations with known significance, and NTRK gene fusions, are recommended in this population, reported Davendra P.S. Sohal, MD, MPH, of the University of Cincinnati, and colleagues on ASCO’s expert panel. The update was published online Aug. 5 in the Journal of Clinical Oncology.

The ASCO guideline on clinical decision making for patients with metastatic pancreatic cancer was first published in 2016 to address initial assessment and first- and second-line treatment options, supportive care, and follow-up and was updated in 2018. The current update is based on new evidence of benefit with targeted therapy options after first-line therapy or as maintenance therapy.

The phase 3 POLO trial, for example, showed significantly improved progression-free survival with the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib for maintenance therapy after first-line treatment in patients with a germline BRCA1 or BRCA2 mutation and metastatic pancreatic cancer that had not progressed during first-line platinum-based chemotherapy. An integrated analysis of three studies showed that entrectinib, a potent inhibitor of tropomyosin receptor kinase (TRK) A, B, and C, safely induced durable and clinically meaningful responses in patients with NTRK fusion-positive solid tumors, and a phase 1-2 study showed that the highly selective TRK inhibitor larotrectinib had marked and durable antitumor activity in both children and adults with TRK fusion-positive solid tumors.

With respect to the new recommendation endorsing early testing for actionable genomic alterations (Recommendation 1.5), the authors noted that the results of testing can lead to treatment with PARP inhibitors, programmed death-1 (PD-1) checkpoint inhibitor therapy, TRK fusion inhibitors, and clinical trials of targeted therapies.

“Genomic testing is recommended as part of an initial assessment to ensure that the results of testing are available at the time of treatment decision where applicable after first-line therapy,” the new recommendation states.

A “qualifying statement” further notes that the decision to test should “involve a discussion between the patient and physician regarding the frequency of actionable findings, treatment implications of testing results, and genetic counseling related to germline testing.”

Recommendation 1.5 is rated by the panel as “strong” and is based on informal consensus.



The panel also added two recommendations on treatment options after first-line therapy:

  • Recommendation 3.1 calls for treatment with larotrectinib or entrectinib in patient with tumors harboring NTRK fusions.
  • Recommendation 3.3 states that patients with a germline BRCA1 or BCA2 mutation who have received first-line platinum-based chemotherapy without disease progression for at least 16 weeks can receive chemotherapy or PARP inhibition with olaparib.

The relevant evidence for these two recommendations is of low quality, but shows that the benefits outweigh the harms; the strength of both recommendations is “moderate.”

A qualifying statement for the latter notes that “the decision to continue treatment with chemotherapy or proceed to maintenance therapy with olaparib should be based on a discussion between the patient and the oncologist, including consideration of whether a maximum response and plateau in response to chemotherapy have been achieved, the level of cumulative toxicities associated with chemotherapy treatment, patient preference, convenience, toxicity, goals of care, cost, and clinical evidence, including a lack of overall survival benefit demonstrated in the POLO randomized controlled trial.”

This focused update includes minor modifications to three existing recommendations:

  • In addition to capecitabine or erlotinib, nab-paclitaxel is now included in Recommendation 2.3 as another possible add-on to gemcitabine alone for patients with either an Eastern Cooperative Oncology Group (ECOG) performance score of 2 or a comorbidity profile that precludes more aggressive regimens. The recommendation was also updated to encourage proactive dose and schedule adjustments to minimize toxicities.
  • Recommendation 3.5 now includes patients treated previously with a gemcitabine-based regimen in the criteria for the preferred second-line treatment combination of fluorouracil plus nanoliposomal irinotecan or fluorouracil plus irinotecan “where the former is unavailable.”
  • Recommendation 3.7 now includes nab-paclitaxel as an add-on option to gemcitabine, and nanoliposomal irinotecan as an add-on option to fluorouracil for second-line therapy – with proactive dose and schedule adjustments to minimize toxicities – in patients with ECOG performance score of 2 or a comorbidity profile that precludes more aggressive regimens.

These three minor modifications reflect new evidence in the first-line treatment setting, including from the FRAGRANCE trial, and are based on expert panel consensus. All other recommendations in the 2018 update are endorsed for the current update, which is available at the ASCO website.

Dr. Sohal reported honoraria from Foundation Medicine, and consulting or advisory roles with Perthera, Ability Pharma, and PierianDx. He reported research funding to his institution from Novartis, Celgene, OncoMed, Bayer, Genentech, Bristol Myers Squibb, Agios, Incyte, Loxo, and Rafael Pharmaceuticals.

SOURCE: Sohal D et al. J Clin Oncol. 2020 Aug 5. doi: 10.1200/JCO.20.01364.

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Quality improvement program expands early childhood screening

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Changed
Sat, 08/22/2020 - 16:15

Primary care screening in several key areas including maternal depression and developmental delay increased significantly after practices implemented a quality improvement (QI) program, according to data from 19 pediatric primary care practices in 12 states.

FatCamera/Getty Images

Screening for developmental delay, maternal depression, and autism spectrum disorder are recommended by the American Academy of Pediatrics; screening for social-emotional problems and social determinants of health also are recommended. However, “Practices face challenges in implementing recommended screenings simultaneously,” wrote Kori B. Flower, MD, MPH, of the University of North Carolina at Chapel Hill, and colleagues in Pediatrics.

To support practices in screening, the researchers developed a national QI collaborative. “Aims were to improve screening processes, including screening, discussion, referral, and follow-up,” the researchers wrote.

In the study published in Pediatrics, the researchers reviewed data from 19 pediatric practices in 12 states, including independent, academic, hospital-affiliated, and multispecialty group practices and community health centers for diversity in type, size, location, and patient population.

The improvement program included two full-day sessions of in-person learning, separated by a 9-month action period that included virtual learning through webinars and online resources, monthly data collection to assess progress, and coaching. “Coaches used reports to guide virtual learning content and provide individual feedback to practices,” the researchers said.

Overall, after a year, the largest screening increases from baseline occurred for maternal depression (from 27% to 87%) and social determinants of health (from 26% to 76%). Screening also increased significantly for developmental delays (from 60% to 93%), and autism spectrum disorder (from 74% to 95%).

Statistically significant increases in discussion of screening results occurred for all screening areas: developmental delays (from 63% to 97%), autism spectrum disorder (from 51% to 93%), maternal depression (from 46% to 90%), and social determinants of health (from 19% to 73%).

In addition, significant increases in referrals were seen for development (from 53% to 86%) and maternal depression (from 23% to 100%).
 

EHR packages deficiencies seen as barrier

“Standard EHR packages often lack features for documenting and tracking screenings, and this was a persistent barrier to screening improvement,” Dr. Flower and associates noted. However, the percentage of practices citing EHR challenges as a barrier to screening decreased from 41% at baseline to 24% after the intervention.

Parents also reported increased discussion of screening and referrals, but “[o]n overall rating of care, the percentage of parents rating care as above average or best did not change,” but parents were not asked reasons for their care rating, the researchers wrote.

The study findings were limited by several factors including limited data quality control and insufficient data to assess the effects of screening interventions on other preventive services or other office-based factors such as revenue, the researchers noted. However, the results suggest that shared learning can help primary care practices increase screening.

“Careful attention to integrating screenings in visit flow and emphasizing their potential impact on child health can make implementation possible in multiple screening areas,” Dr. Flower and colleagues concluded.

 

 

Making measurable, meaningful practice change

Dr. Barbara J. Howard

Barbara J. Howard, MD, commented: “It is clear that using validated tools to screen have benefits in accuracy, equity, efficiency, and income. Increasingly, practices are being judged and paid based on ‘value,’ which is especially difficult to measure in pediatrics with its low rates of serious chronic conditions to assess. We pediatricians will be judged on use of proven methods instead, and screening is a major criterion and also, fortunately, one that is within our power to change.

“However, as this study shows, a great deal of effort and teamwork is needed to shift office workflows to incorporate screening, discussions, referral, and follow-up – all necessary processes for screening to be of value. It is broadly recognized in all industries, not just health care, that use of QI processes is a major force in facilitating change in standard practices. The American Board of Pediatrics, as well as the American Academy of Pediatrics, recognizes this need and has been assisting as well as requiring use of QI methods.

“This study specifically selected a range of practices characteristic of U.S. providers to demonstrate that both screening for multiple child health risk factors simultaneously and use of methods of QI can be feasible and effective for measurable and meaningful practice change. This should give all pediatricians encouragement to move forward in implementing changes in screening,” Dr. Howard, of Johns Hopkins University, Baltimore, said in an interview.

This study not only showed the effectiveness of change management, but also detailed the effort it required, including:

  • Use of monthly team meetings.
  • Collecting data from patients and team members.
  • Soliciting parent feedback.
  • Implementing new templates for care.
  • Use of tool translations or translator support.
  • Involving colocated professionals, residents, and students.
  • Assembling resources.
  • Attempting to invoke change in EHR vendor.

“There were expert coaches involved of national prominence and extensive QI experience. Even with all this support and effort, it should be noted that 74% of practices had participated in QI efforts previously, which should have made this project easier, and even then it took 6-7 months before measurable change in practice could be documented. In spite of the fact that actually getting help for problems identified is the goal, referrals were only marginally improved, and the tracking of referrals was not significantly improved even with all this effort,” Dr. Howard noted.

“Of note, the practices reported at the end of the project that fewer practices reported lack of time or resources for screening and referral. As a result of this publication, a slimmed down set of practice report measures might be chosen to make future QI efforts work and be measurable in meaningful ways. Instead of paper chart reviews, data from electronic screening could be automatically collected in the course of care. Referral processes could likewise be made electronic and automated, including tracking their success, not just those through a local EHR. Integration of Software as a Service with EHRs could make this data collection – that is essential to both QI and actual good care – seamless. Templates and checklists, as well as more incidental knowledge gained from this and other QI projects in pediatric practices, should be shared. While each practice operates somewhat differently, the differences are not that great and, in some cases, traditional ways of doing things would be fruitfully discarded,” suggested Dr. Howard, who was not involved in the study.

“While the pediatricians participated in the QI sessions, it is clear that the QI processes depend on the entire practice team, and generally, the team members more critical to success are not the doctor but the front desk receptionist, medical assistants, and the practice managers – as these individuals conduct or oversee workflow activities. Future QI interventions might include reinforcement and acknowledgment of these team members through inclusion in parallel continuing education activities from the American Association of Medical Assistants and the Medical Group Management Association continuing education credits,” she said.

Dr. Howard continued, “Of note, these studies were completed prior to the pandemic-related workflow changes including telehealth visits and requirements to minimize waiting room time and activities for the safety of patients and staff. These disruptive forces and the likelihood that telehealth alternatives will persist in primary care suggest that the traditional paper waiting room questionnaires are likely to have to give way to electronic alternatives. Using all electronic [approaches] will be the best unified workflow.”

The study was supported by the JPB Foundation through support to the American Academy of Pediatrics. The researchers had no financial conflicts to disclose. Dr. Howard is a pediatric founder of CHADIS, an online screening, decision support, patient education, and referral/tracking system in use nationally and implemented using QI processes. CHADIS is distributed by Total Child Health, of which Dr. Howard is president. Use of CHADIS for Part 4 Maintenance of Certification QI programs is under the ABMS portfolio sponsorship of the nonprofit Center for Promotion of Child Development through Primary Care, directed by her husband, Raymond Sturner, MD.

SOURCE: Flower KB et al. Pediatrics. 2020 Aug 7. doi: 10.1542/peds.2019-2328.

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Primary care screening in several key areas including maternal depression and developmental delay increased significantly after practices implemented a quality improvement (QI) program, according to data from 19 pediatric primary care practices in 12 states.

FatCamera/Getty Images

Screening for developmental delay, maternal depression, and autism spectrum disorder are recommended by the American Academy of Pediatrics; screening for social-emotional problems and social determinants of health also are recommended. However, “Practices face challenges in implementing recommended screenings simultaneously,” wrote Kori B. Flower, MD, MPH, of the University of North Carolina at Chapel Hill, and colleagues in Pediatrics.

To support practices in screening, the researchers developed a national QI collaborative. “Aims were to improve screening processes, including screening, discussion, referral, and follow-up,” the researchers wrote.

In the study published in Pediatrics, the researchers reviewed data from 19 pediatric practices in 12 states, including independent, academic, hospital-affiliated, and multispecialty group practices and community health centers for diversity in type, size, location, and patient population.

The improvement program included two full-day sessions of in-person learning, separated by a 9-month action period that included virtual learning through webinars and online resources, monthly data collection to assess progress, and coaching. “Coaches used reports to guide virtual learning content and provide individual feedback to practices,” the researchers said.

Overall, after a year, the largest screening increases from baseline occurred for maternal depression (from 27% to 87%) and social determinants of health (from 26% to 76%). Screening also increased significantly for developmental delays (from 60% to 93%), and autism spectrum disorder (from 74% to 95%).

Statistically significant increases in discussion of screening results occurred for all screening areas: developmental delays (from 63% to 97%), autism spectrum disorder (from 51% to 93%), maternal depression (from 46% to 90%), and social determinants of health (from 19% to 73%).

In addition, significant increases in referrals were seen for development (from 53% to 86%) and maternal depression (from 23% to 100%).
 

EHR packages deficiencies seen as barrier

“Standard EHR packages often lack features for documenting and tracking screenings, and this was a persistent barrier to screening improvement,” Dr. Flower and associates noted. However, the percentage of practices citing EHR challenges as a barrier to screening decreased from 41% at baseline to 24% after the intervention.

Parents also reported increased discussion of screening and referrals, but “[o]n overall rating of care, the percentage of parents rating care as above average or best did not change,” but parents were not asked reasons for their care rating, the researchers wrote.

The study findings were limited by several factors including limited data quality control and insufficient data to assess the effects of screening interventions on other preventive services or other office-based factors such as revenue, the researchers noted. However, the results suggest that shared learning can help primary care practices increase screening.

“Careful attention to integrating screenings in visit flow and emphasizing their potential impact on child health can make implementation possible in multiple screening areas,” Dr. Flower and colleagues concluded.

 

 

Making measurable, meaningful practice change

Dr. Barbara J. Howard

Barbara J. Howard, MD, commented: “It is clear that using validated tools to screen have benefits in accuracy, equity, efficiency, and income. Increasingly, practices are being judged and paid based on ‘value,’ which is especially difficult to measure in pediatrics with its low rates of serious chronic conditions to assess. We pediatricians will be judged on use of proven methods instead, and screening is a major criterion and also, fortunately, one that is within our power to change.

“However, as this study shows, a great deal of effort and teamwork is needed to shift office workflows to incorporate screening, discussions, referral, and follow-up – all necessary processes for screening to be of value. It is broadly recognized in all industries, not just health care, that use of QI processes is a major force in facilitating change in standard practices. The American Board of Pediatrics, as well as the American Academy of Pediatrics, recognizes this need and has been assisting as well as requiring use of QI methods.

“This study specifically selected a range of practices characteristic of U.S. providers to demonstrate that both screening for multiple child health risk factors simultaneously and use of methods of QI can be feasible and effective for measurable and meaningful practice change. This should give all pediatricians encouragement to move forward in implementing changes in screening,” Dr. Howard, of Johns Hopkins University, Baltimore, said in an interview.

This study not only showed the effectiveness of change management, but also detailed the effort it required, including:

  • Use of monthly team meetings.
  • Collecting data from patients and team members.
  • Soliciting parent feedback.
  • Implementing new templates for care.
  • Use of tool translations or translator support.
  • Involving colocated professionals, residents, and students.
  • Assembling resources.
  • Attempting to invoke change in EHR vendor.

“There were expert coaches involved of national prominence and extensive QI experience. Even with all this support and effort, it should be noted that 74% of practices had participated in QI efforts previously, which should have made this project easier, and even then it took 6-7 months before measurable change in practice could be documented. In spite of the fact that actually getting help for problems identified is the goal, referrals were only marginally improved, and the tracking of referrals was not significantly improved even with all this effort,” Dr. Howard noted.

“Of note, the practices reported at the end of the project that fewer practices reported lack of time or resources for screening and referral. As a result of this publication, a slimmed down set of practice report measures might be chosen to make future QI efforts work and be measurable in meaningful ways. Instead of paper chart reviews, data from electronic screening could be automatically collected in the course of care. Referral processes could likewise be made electronic and automated, including tracking their success, not just those through a local EHR. Integration of Software as a Service with EHRs could make this data collection – that is essential to both QI and actual good care – seamless. Templates and checklists, as well as more incidental knowledge gained from this and other QI projects in pediatric practices, should be shared. While each practice operates somewhat differently, the differences are not that great and, in some cases, traditional ways of doing things would be fruitfully discarded,” suggested Dr. Howard, who was not involved in the study.

“While the pediatricians participated in the QI sessions, it is clear that the QI processes depend on the entire practice team, and generally, the team members more critical to success are not the doctor but the front desk receptionist, medical assistants, and the practice managers – as these individuals conduct or oversee workflow activities. Future QI interventions might include reinforcement and acknowledgment of these team members through inclusion in parallel continuing education activities from the American Association of Medical Assistants and the Medical Group Management Association continuing education credits,” she said.

Dr. Howard continued, “Of note, these studies were completed prior to the pandemic-related workflow changes including telehealth visits and requirements to minimize waiting room time and activities for the safety of patients and staff. These disruptive forces and the likelihood that telehealth alternatives will persist in primary care suggest that the traditional paper waiting room questionnaires are likely to have to give way to electronic alternatives. Using all electronic [approaches] will be the best unified workflow.”

The study was supported by the JPB Foundation through support to the American Academy of Pediatrics. The researchers had no financial conflicts to disclose. Dr. Howard is a pediatric founder of CHADIS, an online screening, decision support, patient education, and referral/tracking system in use nationally and implemented using QI processes. CHADIS is distributed by Total Child Health, of which Dr. Howard is president. Use of CHADIS for Part 4 Maintenance of Certification QI programs is under the ABMS portfolio sponsorship of the nonprofit Center for Promotion of Child Development through Primary Care, directed by her husband, Raymond Sturner, MD.

SOURCE: Flower KB et al. Pediatrics. 2020 Aug 7. doi: 10.1542/peds.2019-2328.

Primary care screening in several key areas including maternal depression and developmental delay increased significantly after practices implemented a quality improvement (QI) program, according to data from 19 pediatric primary care practices in 12 states.

FatCamera/Getty Images

Screening for developmental delay, maternal depression, and autism spectrum disorder are recommended by the American Academy of Pediatrics; screening for social-emotional problems and social determinants of health also are recommended. However, “Practices face challenges in implementing recommended screenings simultaneously,” wrote Kori B. Flower, MD, MPH, of the University of North Carolina at Chapel Hill, and colleagues in Pediatrics.

To support practices in screening, the researchers developed a national QI collaborative. “Aims were to improve screening processes, including screening, discussion, referral, and follow-up,” the researchers wrote.

In the study published in Pediatrics, the researchers reviewed data from 19 pediatric practices in 12 states, including independent, academic, hospital-affiliated, and multispecialty group practices and community health centers for diversity in type, size, location, and patient population.

The improvement program included two full-day sessions of in-person learning, separated by a 9-month action period that included virtual learning through webinars and online resources, monthly data collection to assess progress, and coaching. “Coaches used reports to guide virtual learning content and provide individual feedback to practices,” the researchers said.

Overall, after a year, the largest screening increases from baseline occurred for maternal depression (from 27% to 87%) and social determinants of health (from 26% to 76%). Screening also increased significantly for developmental delays (from 60% to 93%), and autism spectrum disorder (from 74% to 95%).

Statistically significant increases in discussion of screening results occurred for all screening areas: developmental delays (from 63% to 97%), autism spectrum disorder (from 51% to 93%), maternal depression (from 46% to 90%), and social determinants of health (from 19% to 73%).

In addition, significant increases in referrals were seen for development (from 53% to 86%) and maternal depression (from 23% to 100%).
 

EHR packages deficiencies seen as barrier

“Standard EHR packages often lack features for documenting and tracking screenings, and this was a persistent barrier to screening improvement,” Dr. Flower and associates noted. However, the percentage of practices citing EHR challenges as a barrier to screening decreased from 41% at baseline to 24% after the intervention.

Parents also reported increased discussion of screening and referrals, but “[o]n overall rating of care, the percentage of parents rating care as above average or best did not change,” but parents were not asked reasons for their care rating, the researchers wrote.

The study findings were limited by several factors including limited data quality control and insufficient data to assess the effects of screening interventions on other preventive services or other office-based factors such as revenue, the researchers noted. However, the results suggest that shared learning can help primary care practices increase screening.

“Careful attention to integrating screenings in visit flow and emphasizing their potential impact on child health can make implementation possible in multiple screening areas,” Dr. Flower and colleagues concluded.

 

 

Making measurable, meaningful practice change

Dr. Barbara J. Howard

Barbara J. Howard, MD, commented: “It is clear that using validated tools to screen have benefits in accuracy, equity, efficiency, and income. Increasingly, practices are being judged and paid based on ‘value,’ which is especially difficult to measure in pediatrics with its low rates of serious chronic conditions to assess. We pediatricians will be judged on use of proven methods instead, and screening is a major criterion and also, fortunately, one that is within our power to change.

“However, as this study shows, a great deal of effort and teamwork is needed to shift office workflows to incorporate screening, discussions, referral, and follow-up – all necessary processes for screening to be of value. It is broadly recognized in all industries, not just health care, that use of QI processes is a major force in facilitating change in standard practices. The American Board of Pediatrics, as well as the American Academy of Pediatrics, recognizes this need and has been assisting as well as requiring use of QI methods.

“This study specifically selected a range of practices characteristic of U.S. providers to demonstrate that both screening for multiple child health risk factors simultaneously and use of methods of QI can be feasible and effective for measurable and meaningful practice change. This should give all pediatricians encouragement to move forward in implementing changes in screening,” Dr. Howard, of Johns Hopkins University, Baltimore, said in an interview.

This study not only showed the effectiveness of change management, but also detailed the effort it required, including:

  • Use of monthly team meetings.
  • Collecting data from patients and team members.
  • Soliciting parent feedback.
  • Implementing new templates for care.
  • Use of tool translations or translator support.
  • Involving colocated professionals, residents, and students.
  • Assembling resources.
  • Attempting to invoke change in EHR vendor.

“There were expert coaches involved of national prominence and extensive QI experience. Even with all this support and effort, it should be noted that 74% of practices had participated in QI efforts previously, which should have made this project easier, and even then it took 6-7 months before measurable change in practice could be documented. In spite of the fact that actually getting help for problems identified is the goal, referrals were only marginally improved, and the tracking of referrals was not significantly improved even with all this effort,” Dr. Howard noted.

“Of note, the practices reported at the end of the project that fewer practices reported lack of time or resources for screening and referral. As a result of this publication, a slimmed down set of practice report measures might be chosen to make future QI efforts work and be measurable in meaningful ways. Instead of paper chart reviews, data from electronic screening could be automatically collected in the course of care. Referral processes could likewise be made electronic and automated, including tracking their success, not just those through a local EHR. Integration of Software as a Service with EHRs could make this data collection – that is essential to both QI and actual good care – seamless. Templates and checklists, as well as more incidental knowledge gained from this and other QI projects in pediatric practices, should be shared. While each practice operates somewhat differently, the differences are not that great and, in some cases, traditional ways of doing things would be fruitfully discarded,” suggested Dr. Howard, who was not involved in the study.

“While the pediatricians participated in the QI sessions, it is clear that the QI processes depend on the entire practice team, and generally, the team members more critical to success are not the doctor but the front desk receptionist, medical assistants, and the practice managers – as these individuals conduct or oversee workflow activities. Future QI interventions might include reinforcement and acknowledgment of these team members through inclusion in parallel continuing education activities from the American Association of Medical Assistants and the Medical Group Management Association continuing education credits,” she said.

Dr. Howard continued, “Of note, these studies were completed prior to the pandemic-related workflow changes including telehealth visits and requirements to minimize waiting room time and activities for the safety of patients and staff. These disruptive forces and the likelihood that telehealth alternatives will persist in primary care suggest that the traditional paper waiting room questionnaires are likely to have to give way to electronic alternatives. Using all electronic [approaches] will be the best unified workflow.”

The study was supported by the JPB Foundation through support to the American Academy of Pediatrics. The researchers had no financial conflicts to disclose. Dr. Howard is a pediatric founder of CHADIS, an online screening, decision support, patient education, and referral/tracking system in use nationally and implemented using QI processes. CHADIS is distributed by Total Child Health, of which Dr. Howard is president. Use of CHADIS for Part 4 Maintenance of Certification QI programs is under the ABMS portfolio sponsorship of the nonprofit Center for Promotion of Child Development through Primary Care, directed by her husband, Raymond Sturner, MD.

SOURCE: Flower KB et al. Pediatrics. 2020 Aug 7. doi: 10.1542/peds.2019-2328.

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Only 40% of residents said training prepped them for COVID-19

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Thu, 08/26/2021 - 16:01

Most residents who were asked whether their training prepared them for COVID-19 in a Medscape survey said it had not or they weren’t sure.

Whereas 40% said they felt prepared, 30% said they did not feel prepared and 31% answered they were unsure. (Numbers were rounded, so some answers pushed above 100%.)

One quarter have $300,000 or more in student debt

The Medscape Residents Salary & Debt Report 2020, with data collected April 3 to June 1, found that nearly one in four residents (24%) had medical school debt of more than $300,000. Half (49%) had more than $200,000.

The data include answers from 1,659 U.S. medical residents.

For the sixth straight year, female residents were more satisfied with their pay than were their male colleagues. This year the satisfaction gap was 45% female compared with 42% male. That imbalance came despite their making nearly the same pay overall ($63,700 for men and $63,000 for women).

Among practicing physicians, the pay gap is much wider: Men make 25% more in primary care and 31% more in specialties.

More than a third of residents (34%) said they felt residents should make 26%-50% more than they do. Ten percent thought they should earn 76%-100% more.

For those not satisfied with pay, the top reasons were feeling the pay was too low for the hours worked (81%) or too low compared with other medical staff, such as physician assistants (PAs) or nurses (77% chose that answer).

As for hours worked, 31% of residents reported they spend more than 60 hours/week seeing patients.

The top-paying specialties, averaging $69,500, were allergy and immunology, hematology, plastic surgery, aesthetic medicine, rheumatology, and specialized surgery. The lowest paid were family medicine residents at $58,500.

In primary care, overall, most residents said they planned to specialize. Only 47% planned to continue to work in primary care. Male residents were much more likely to say they will subspecialize than were their female colleagues (52% vs. 35%).

More than 90% of residents say future pay has influenced their choice of specialty, though more men than women felt that way (93% vs. 86%).

Good relationships with others

Overall, residents reported good relationships with attending physicians and nurses.

Most (88%) said they had good or very good relationships with attending physicians, 10% said the relationships were fair, and 2% said they were poor.

In addition, 89% of residents said the amount of supervision was appropriate, 4% said there was too much, and 7% said there was too little.

Relationships with nurses/PAs were slightly less positive overall: Eighty-two percent reported good or very good relationships with nurses/PAs, 15% said those relationships were fair, and 3% said they were poor.

One respondent said: “Our relationships could be better, but I think everyone is just overwhelmed with COVID-19, so emotions are heightened.”

Another said: “It takes time to earn the respect from nurses.”

Seventy-seven percent said they were satisfied with their learning experience overall, 12% were neutral on the question, and 11% said they were dissatisfied or very dissatisfied.

Work-life balance is the top concern

Work-life balance continues to be the top concern for residents. More than one-quarter (27%) in residency years 1 through 4 listed that as the top concern, and even more (32%) of those in years 5 through 8 agreed.

That was followed by demands on time and fear of failure or making a serious mistake.

The survey indicates that benefit packages for residents have stayed much the same over the past 2 years with health insurance and paid time off for sick leave, vacation, and personal time most commonly reported at 89% and 87%, respectively.

Much less common were benefits including commuter assistance (parking, public transportation) at 24%, housing allowance (8%), and child care (4%).

The vast majority of residents reported doing scut work (unskilled tasks): More than half (54%) reported doing 1-10 hours/week and 22% did 11-20 hours/week. Regardless of the number of hours, however, 62% said the time spent performing these tasks was appropriate.
 

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

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Most residents who were asked whether their training prepared them for COVID-19 in a Medscape survey said it had not or they weren’t sure.

Whereas 40% said they felt prepared, 30% said they did not feel prepared and 31% answered they were unsure. (Numbers were rounded, so some answers pushed above 100%.)

One quarter have $300,000 or more in student debt

The Medscape Residents Salary & Debt Report 2020, with data collected April 3 to June 1, found that nearly one in four residents (24%) had medical school debt of more than $300,000. Half (49%) had more than $200,000.

The data include answers from 1,659 U.S. medical residents.

For the sixth straight year, female residents were more satisfied with their pay than were their male colleagues. This year the satisfaction gap was 45% female compared with 42% male. That imbalance came despite their making nearly the same pay overall ($63,700 for men and $63,000 for women).

Among practicing physicians, the pay gap is much wider: Men make 25% more in primary care and 31% more in specialties.

More than a third of residents (34%) said they felt residents should make 26%-50% more than they do. Ten percent thought they should earn 76%-100% more.

For those not satisfied with pay, the top reasons were feeling the pay was too low for the hours worked (81%) or too low compared with other medical staff, such as physician assistants (PAs) or nurses (77% chose that answer).

As for hours worked, 31% of residents reported they spend more than 60 hours/week seeing patients.

The top-paying specialties, averaging $69,500, were allergy and immunology, hematology, plastic surgery, aesthetic medicine, rheumatology, and specialized surgery. The lowest paid were family medicine residents at $58,500.

In primary care, overall, most residents said they planned to specialize. Only 47% planned to continue to work in primary care. Male residents were much more likely to say they will subspecialize than were their female colleagues (52% vs. 35%).

More than 90% of residents say future pay has influenced their choice of specialty, though more men than women felt that way (93% vs. 86%).

Good relationships with others

Overall, residents reported good relationships with attending physicians and nurses.

Most (88%) said they had good or very good relationships with attending physicians, 10% said the relationships were fair, and 2% said they were poor.

In addition, 89% of residents said the amount of supervision was appropriate, 4% said there was too much, and 7% said there was too little.

Relationships with nurses/PAs were slightly less positive overall: Eighty-two percent reported good or very good relationships with nurses/PAs, 15% said those relationships were fair, and 3% said they were poor.

One respondent said: “Our relationships could be better, but I think everyone is just overwhelmed with COVID-19, so emotions are heightened.”

Another said: “It takes time to earn the respect from nurses.”

Seventy-seven percent said they were satisfied with their learning experience overall, 12% were neutral on the question, and 11% said they were dissatisfied or very dissatisfied.

Work-life balance is the top concern

Work-life balance continues to be the top concern for residents. More than one-quarter (27%) in residency years 1 through 4 listed that as the top concern, and even more (32%) of those in years 5 through 8 agreed.

That was followed by demands on time and fear of failure or making a serious mistake.

The survey indicates that benefit packages for residents have stayed much the same over the past 2 years with health insurance and paid time off for sick leave, vacation, and personal time most commonly reported at 89% and 87%, respectively.

Much less common were benefits including commuter assistance (parking, public transportation) at 24%, housing allowance (8%), and child care (4%).

The vast majority of residents reported doing scut work (unskilled tasks): More than half (54%) reported doing 1-10 hours/week and 22% did 11-20 hours/week. Regardless of the number of hours, however, 62% said the time spent performing these tasks was appropriate.
 

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

Most residents who were asked whether their training prepared them for COVID-19 in a Medscape survey said it had not or they weren’t sure.

Whereas 40% said they felt prepared, 30% said they did not feel prepared and 31% answered they were unsure. (Numbers were rounded, so some answers pushed above 100%.)

One quarter have $300,000 or more in student debt

The Medscape Residents Salary & Debt Report 2020, with data collected April 3 to June 1, found that nearly one in four residents (24%) had medical school debt of more than $300,000. Half (49%) had more than $200,000.

The data include answers from 1,659 U.S. medical residents.

For the sixth straight year, female residents were more satisfied with their pay than were their male colleagues. This year the satisfaction gap was 45% female compared with 42% male. That imbalance came despite their making nearly the same pay overall ($63,700 for men and $63,000 for women).

Among practicing physicians, the pay gap is much wider: Men make 25% more in primary care and 31% more in specialties.

More than a third of residents (34%) said they felt residents should make 26%-50% more than they do. Ten percent thought they should earn 76%-100% more.

For those not satisfied with pay, the top reasons were feeling the pay was too low for the hours worked (81%) or too low compared with other medical staff, such as physician assistants (PAs) or nurses (77% chose that answer).

As for hours worked, 31% of residents reported they spend more than 60 hours/week seeing patients.

The top-paying specialties, averaging $69,500, were allergy and immunology, hematology, plastic surgery, aesthetic medicine, rheumatology, and specialized surgery. The lowest paid were family medicine residents at $58,500.

In primary care, overall, most residents said they planned to specialize. Only 47% planned to continue to work in primary care. Male residents were much more likely to say they will subspecialize than were their female colleagues (52% vs. 35%).

More than 90% of residents say future pay has influenced their choice of specialty, though more men than women felt that way (93% vs. 86%).

Good relationships with others

Overall, residents reported good relationships with attending physicians and nurses.

Most (88%) said they had good or very good relationships with attending physicians, 10% said the relationships were fair, and 2% said they were poor.

In addition, 89% of residents said the amount of supervision was appropriate, 4% said there was too much, and 7% said there was too little.

Relationships with nurses/PAs were slightly less positive overall: Eighty-two percent reported good or very good relationships with nurses/PAs, 15% said those relationships were fair, and 3% said they were poor.

One respondent said: “Our relationships could be better, but I think everyone is just overwhelmed with COVID-19, so emotions are heightened.”

Another said: “It takes time to earn the respect from nurses.”

Seventy-seven percent said they were satisfied with their learning experience overall, 12% were neutral on the question, and 11% said they were dissatisfied or very dissatisfied.

Work-life balance is the top concern

Work-life balance continues to be the top concern for residents. More than one-quarter (27%) in residency years 1 through 4 listed that as the top concern, and even more (32%) of those in years 5 through 8 agreed.

That was followed by demands on time and fear of failure or making a serious mistake.

The survey indicates that benefit packages for residents have stayed much the same over the past 2 years with health insurance and paid time off for sick leave, vacation, and personal time most commonly reported at 89% and 87%, respectively.

Much less common were benefits including commuter assistance (parking, public transportation) at 24%, housing allowance (8%), and child care (4%).

The vast majority of residents reported doing scut work (unskilled tasks): More than half (54%) reported doing 1-10 hours/week and 22% did 11-20 hours/week. Regardless of the number of hours, however, 62% said the time spent performing these tasks was appropriate.
 

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

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Financial planning in the COVID-19 era

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Thu, 08/26/2021 - 16:01

Less than a year ago, I wrote a column on retirement strategies; but that was before COVID-19 took down the economy, putting millions out of work and shuttering many of our offices. Add extraordinary racial tensions and an election year like no other, and 2020 has generated fear and uncertainty on an unprecedented level.

Dr. Joseph S. Eastern

Not surprisingly, my e-mail has been dominated for months by questions about the short- and long-term financial consequences of this annus horribilis on our practices and retirement plans. Most physicians have felt the downturn acutely, of course. Revenues have declined, non-COVID-19-related hospital visits plunged, and only recently have we seen hospitals resuming elective procedures. As I write this, my practice is approaching its prepandemic volume; but many patients have been avoiding hospitals and doctors’ offices for fear of COVID-19 exposure. With no real end in sight, who can say when this trend will finally correct itself?

Long term, the outlook is not nearly so grim. I have always written that downturns – even steep ones – are inevitable; and rather than fear them, you should expect them and plan for them. Younger physicians with riskier investments have plenty of time to rebound. Physicians nearing retirement, if they have done everything right, probably have the least to lose. Ideally, they will be at or near their savings target and will have transitioned to less vulnerable assets. And remember, you don’t need to have 100% of your retirement money to retire; a sound retirement plan will continue to generate investment returns as you move through retirement.

In short, the essentials of postpandemic financial planning remain the same as before: Make a plan and stick to it.

By way of a brief review, the basics of a good plan are a budget, an emergency fund, disability insurance, and retiring your debt as quickly as possible. All of these have been covered individually in previous columns.

An essential component of your plan should be a list of long-term goals – and it should be more specific than simply accumulating a pile of cash. What do you plan to accomplish with the money? If it’s travel, helping your grandkids with college expenses, hobbies, or something else, make a list. Review it regularly, and modify it if your goals change.

Time to trot out another hoary old cliché: Saving for retirement is a marathon, not a sprint. If the pandemic has temporarily derailed your retirement strategy – forcing you, for example, to make retirement account withdrawals to cover expenses, or raid your emergency fund – no worries! When things have stabilized, it’s time to recommit to your retirement plan. Once again, with so many other issues to deal with, retaining the services of a qualified financial professional is usually a far better strategy than going it alone.

Many readers have expressed the fear that their retirement savings would never recover from the COVID-19 hit – but my own financial adviser pointed out that as I write this, in August, conservative portfolio values are about level with similar portfolios on Jan. 1, 2020. “Good plans are built to withstand difficult times,” she said. “Sometimes staying the course is the most difficult, disciplined course of action.”

“If your gut tells you that things will only get worse,” writes Kimberly Lankford in AARP’s magazine, “know that your gut is a terrible economic forecaster.” The University of Michigan’s Index of Consumer Sentiment hit rock bottom in 2008, during the Great Recession; yet only 4 months later, the U.S. economy began its longest expansion in modern history. The point is that it is important to maintain a long-term approach, and not make changes based on short-term events.

COVID-19 (or whatever else comes along) then becomes a matter of statement pain, not long-term financial pain. The key to recovery has nothing to do with a financial change, an investment strategy change, or a holding change, and everything to do with realigning your long-term goals.

So, moving on from COVID-19 is actually quite simple: Fill your retirement plan to its legal limit and let it grow, tax-deferred. Then invest for the long term, with your target amount in mind. And once again, the earlier you start and the longer you stick with it, the better.

 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

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Less than a year ago, I wrote a column on retirement strategies; but that was before COVID-19 took down the economy, putting millions out of work and shuttering many of our offices. Add extraordinary racial tensions and an election year like no other, and 2020 has generated fear and uncertainty on an unprecedented level.

Dr. Joseph S. Eastern

Not surprisingly, my e-mail has been dominated for months by questions about the short- and long-term financial consequences of this annus horribilis on our practices and retirement plans. Most physicians have felt the downturn acutely, of course. Revenues have declined, non-COVID-19-related hospital visits plunged, and only recently have we seen hospitals resuming elective procedures. As I write this, my practice is approaching its prepandemic volume; but many patients have been avoiding hospitals and doctors’ offices for fear of COVID-19 exposure. With no real end in sight, who can say when this trend will finally correct itself?

Long term, the outlook is not nearly so grim. I have always written that downturns – even steep ones – are inevitable; and rather than fear them, you should expect them and plan for them. Younger physicians with riskier investments have plenty of time to rebound. Physicians nearing retirement, if they have done everything right, probably have the least to lose. Ideally, they will be at or near their savings target and will have transitioned to less vulnerable assets. And remember, you don’t need to have 100% of your retirement money to retire; a sound retirement plan will continue to generate investment returns as you move through retirement.

In short, the essentials of postpandemic financial planning remain the same as before: Make a plan and stick to it.

By way of a brief review, the basics of a good plan are a budget, an emergency fund, disability insurance, and retiring your debt as quickly as possible. All of these have been covered individually in previous columns.

An essential component of your plan should be a list of long-term goals – and it should be more specific than simply accumulating a pile of cash. What do you plan to accomplish with the money? If it’s travel, helping your grandkids with college expenses, hobbies, or something else, make a list. Review it regularly, and modify it if your goals change.

Time to trot out another hoary old cliché: Saving for retirement is a marathon, not a sprint. If the pandemic has temporarily derailed your retirement strategy – forcing you, for example, to make retirement account withdrawals to cover expenses, or raid your emergency fund – no worries! When things have stabilized, it’s time to recommit to your retirement plan. Once again, with so many other issues to deal with, retaining the services of a qualified financial professional is usually a far better strategy than going it alone.

Many readers have expressed the fear that their retirement savings would never recover from the COVID-19 hit – but my own financial adviser pointed out that as I write this, in August, conservative portfolio values are about level with similar portfolios on Jan. 1, 2020. “Good plans are built to withstand difficult times,” she said. “Sometimes staying the course is the most difficult, disciplined course of action.”

“If your gut tells you that things will only get worse,” writes Kimberly Lankford in AARP’s magazine, “know that your gut is a terrible economic forecaster.” The University of Michigan’s Index of Consumer Sentiment hit rock bottom in 2008, during the Great Recession; yet only 4 months later, the U.S. economy began its longest expansion in modern history. The point is that it is important to maintain a long-term approach, and not make changes based on short-term events.

COVID-19 (or whatever else comes along) then becomes a matter of statement pain, not long-term financial pain. The key to recovery has nothing to do with a financial change, an investment strategy change, or a holding change, and everything to do with realigning your long-term goals.

So, moving on from COVID-19 is actually quite simple: Fill your retirement plan to its legal limit and let it grow, tax-deferred. Then invest for the long term, with your target amount in mind. And once again, the earlier you start and the longer you stick with it, the better.

 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Less than a year ago, I wrote a column on retirement strategies; but that was before COVID-19 took down the economy, putting millions out of work and shuttering many of our offices. Add extraordinary racial tensions and an election year like no other, and 2020 has generated fear and uncertainty on an unprecedented level.

Dr. Joseph S. Eastern

Not surprisingly, my e-mail has been dominated for months by questions about the short- and long-term financial consequences of this annus horribilis on our practices and retirement plans. Most physicians have felt the downturn acutely, of course. Revenues have declined, non-COVID-19-related hospital visits plunged, and only recently have we seen hospitals resuming elective procedures. As I write this, my practice is approaching its prepandemic volume; but many patients have been avoiding hospitals and doctors’ offices for fear of COVID-19 exposure. With no real end in sight, who can say when this trend will finally correct itself?

Long term, the outlook is not nearly so grim. I have always written that downturns – even steep ones – are inevitable; and rather than fear them, you should expect them and plan for them. Younger physicians with riskier investments have plenty of time to rebound. Physicians nearing retirement, if they have done everything right, probably have the least to lose. Ideally, they will be at or near their savings target and will have transitioned to less vulnerable assets. And remember, you don’t need to have 100% of your retirement money to retire; a sound retirement plan will continue to generate investment returns as you move through retirement.

In short, the essentials of postpandemic financial planning remain the same as before: Make a plan and stick to it.

By way of a brief review, the basics of a good plan are a budget, an emergency fund, disability insurance, and retiring your debt as quickly as possible. All of these have been covered individually in previous columns.

An essential component of your plan should be a list of long-term goals – and it should be more specific than simply accumulating a pile of cash. What do you plan to accomplish with the money? If it’s travel, helping your grandkids with college expenses, hobbies, or something else, make a list. Review it regularly, and modify it if your goals change.

Time to trot out another hoary old cliché: Saving for retirement is a marathon, not a sprint. If the pandemic has temporarily derailed your retirement strategy – forcing you, for example, to make retirement account withdrawals to cover expenses, or raid your emergency fund – no worries! When things have stabilized, it’s time to recommit to your retirement plan. Once again, with so many other issues to deal with, retaining the services of a qualified financial professional is usually a far better strategy than going it alone.

Many readers have expressed the fear that their retirement savings would never recover from the COVID-19 hit – but my own financial adviser pointed out that as I write this, in August, conservative portfolio values are about level with similar portfolios on Jan. 1, 2020. “Good plans are built to withstand difficult times,” she said. “Sometimes staying the course is the most difficult, disciplined course of action.”

“If your gut tells you that things will only get worse,” writes Kimberly Lankford in AARP’s magazine, “know that your gut is a terrible economic forecaster.” The University of Michigan’s Index of Consumer Sentiment hit rock bottom in 2008, during the Great Recession; yet only 4 months later, the U.S. economy began its longest expansion in modern history. The point is that it is important to maintain a long-term approach, and not make changes based on short-term events.

COVID-19 (or whatever else comes along) then becomes a matter of statement pain, not long-term financial pain. The key to recovery has nothing to do with a financial change, an investment strategy change, or a holding change, and everything to do with realigning your long-term goals.

So, moving on from COVID-19 is actually quite simple: Fill your retirement plan to its legal limit and let it grow, tax-deferred. Then invest for the long term, with your target amount in mind. And once again, the earlier you start and the longer you stick with it, the better.

 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

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FDA authorizes new saliva COVID-19 test

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Thu, 08/26/2021 - 16:01

 

The FDA authorized a new type of saliva-based coronavirus test on August 15 that could cut down on the cost of testing and the time it takes to process results.

The emergency use authorization is for SalivaDirect, a diagnostic test created by the Yale School of Public Health. The test doesn’t require a special type of swab or collection tube — saliva can be collected in any sterile container, according to the FDA announcement.

The new test is “yet another testing innovation game changer that will reduce the demand for scarce testing resources,” Admiral Brett Giroir, MD, the assistant secretary for health and the COVID-19 testing coordinator, said in the statement.

The test also doesn’t require a special type of extractor, which is helpful because the extraction kits used to process other tests have faced shortages during the pandemic. The test can be used with different types of reagents and instruments already found in labs.

“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” Stephen Hahn, MD, the FDA commissioner, also said in the statement.

Yale will provide the instructions to labs as an “open source” protocol. The test doesn’t require any proprietary equipment or testing components, so labs across the country can assemble and use it based on the FDA guidelines. The testing method is available immediately and could be scaled up quickly in the next few weeks, according to a statement from Yale.

“This is a huge step forward to make testing more accessible,” Chantal Vogels, a postdoctoral fellow at Yale who led the lab development and test validation efforts, said in the statement.

The Yale team is further testing whether the saliva method can be used to find coronavirus cases among people who don’t have any symptoms and has been working with players and staff from the NBA. So far, the results have been accurate and similar to the nasal swabs for COVID-19, according to a preprint study published on medRxiv.

The research team wanted to get rid of the expensive collection tubes that other companies use to preserve the virus during processing, according to the Yale statement. They found that the virus is stable in saliva for long periods of time at warm temperatures and that special tubes aren’t necessary.

The FDA has authorized other saliva-based tests, according to ABC News, but SalivaDirect is the first that doesn’t require the extraction process used to test viral genetic material. Instead, the Yale process breaks down the saliva with an enzyme and applied heat. This type of testing could cost about $10, the Yale researchers said, and people can collect the saliva themselves under supervision.

“This, I hope, is a turning point,” Anne Wyllie, PhD, one of the lead researchers at Yale, told the news station.* “Expand testing capacity, inspire creativity and we can take competition to those labs charging a lot and bring prices down.”
 

This article first appeared on WebMD.com.

Correction, 8/25/20: An earlier version of this article misstated Dr. Wylie's academic degree.

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The FDA authorized a new type of saliva-based coronavirus test on August 15 that could cut down on the cost of testing and the time it takes to process results.

The emergency use authorization is for SalivaDirect, a diagnostic test created by the Yale School of Public Health. The test doesn’t require a special type of swab or collection tube — saliva can be collected in any sterile container, according to the FDA announcement.

The new test is “yet another testing innovation game changer that will reduce the demand for scarce testing resources,” Admiral Brett Giroir, MD, the assistant secretary for health and the COVID-19 testing coordinator, said in the statement.

The test also doesn’t require a special type of extractor, which is helpful because the extraction kits used to process other tests have faced shortages during the pandemic. The test can be used with different types of reagents and instruments already found in labs.

“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” Stephen Hahn, MD, the FDA commissioner, also said in the statement.

Yale will provide the instructions to labs as an “open source” protocol. The test doesn’t require any proprietary equipment or testing components, so labs across the country can assemble and use it based on the FDA guidelines. The testing method is available immediately and could be scaled up quickly in the next few weeks, according to a statement from Yale.

“This is a huge step forward to make testing more accessible,” Chantal Vogels, a postdoctoral fellow at Yale who led the lab development and test validation efforts, said in the statement.

The Yale team is further testing whether the saliva method can be used to find coronavirus cases among people who don’t have any symptoms and has been working with players and staff from the NBA. So far, the results have been accurate and similar to the nasal swabs for COVID-19, according to a preprint study published on medRxiv.

The research team wanted to get rid of the expensive collection tubes that other companies use to preserve the virus during processing, according to the Yale statement. They found that the virus is stable in saliva for long periods of time at warm temperatures and that special tubes aren’t necessary.

The FDA has authorized other saliva-based tests, according to ABC News, but SalivaDirect is the first that doesn’t require the extraction process used to test viral genetic material. Instead, the Yale process breaks down the saliva with an enzyme and applied heat. This type of testing could cost about $10, the Yale researchers said, and people can collect the saliva themselves under supervision.

“This, I hope, is a turning point,” Anne Wyllie, PhD, one of the lead researchers at Yale, told the news station.* “Expand testing capacity, inspire creativity and we can take competition to those labs charging a lot and bring prices down.”
 

This article first appeared on WebMD.com.

Correction, 8/25/20: An earlier version of this article misstated Dr. Wylie's academic degree.

 

The FDA authorized a new type of saliva-based coronavirus test on August 15 that could cut down on the cost of testing and the time it takes to process results.

The emergency use authorization is for SalivaDirect, a diagnostic test created by the Yale School of Public Health. The test doesn’t require a special type of swab or collection tube — saliva can be collected in any sterile container, according to the FDA announcement.

The new test is “yet another testing innovation game changer that will reduce the demand for scarce testing resources,” Admiral Brett Giroir, MD, the assistant secretary for health and the COVID-19 testing coordinator, said in the statement.

The test also doesn’t require a special type of extractor, which is helpful because the extraction kits used to process other tests have faced shortages during the pandemic. The test can be used with different types of reagents and instruments already found in labs.

“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” Stephen Hahn, MD, the FDA commissioner, also said in the statement.

Yale will provide the instructions to labs as an “open source” protocol. The test doesn’t require any proprietary equipment or testing components, so labs across the country can assemble and use it based on the FDA guidelines. The testing method is available immediately and could be scaled up quickly in the next few weeks, according to a statement from Yale.

“This is a huge step forward to make testing more accessible,” Chantal Vogels, a postdoctoral fellow at Yale who led the lab development and test validation efforts, said in the statement.

The Yale team is further testing whether the saliva method can be used to find coronavirus cases among people who don’t have any symptoms and has been working with players and staff from the NBA. So far, the results have been accurate and similar to the nasal swabs for COVID-19, according to a preprint study published on medRxiv.

The research team wanted to get rid of the expensive collection tubes that other companies use to preserve the virus during processing, according to the Yale statement. They found that the virus is stable in saliva for long periods of time at warm temperatures and that special tubes aren’t necessary.

The FDA has authorized other saliva-based tests, according to ABC News, but SalivaDirect is the first that doesn’t require the extraction process used to test viral genetic material. Instead, the Yale process breaks down the saliva with an enzyme and applied heat. This type of testing could cost about $10, the Yale researchers said, and people can collect the saliva themselves under supervision.

“This, I hope, is a turning point,” Anne Wyllie, PhD, one of the lead researchers at Yale, told the news station.* “Expand testing capacity, inspire creativity and we can take competition to those labs charging a lot and bring prices down.”
 

This article first appeared on WebMD.com.

Correction, 8/25/20: An earlier version of this article misstated Dr. Wylie's academic degree.

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Telemedicine checklist may smooth visits with older patients

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During the pandemic, physicians have raced to set up or expand telemedicine, uncovering both advantages and shortcomings. Now experts have developed a checklist of more than a dozen ideas to facilitate effective virtual visits with older adults.

Although many of the suggestions, published online in Annals of Internal Medicine, are useful for all patients, Carrie Nieman, MD, MPH, and Esther S. Oh, MD, PhD, developed the list with older patients in mind.

“I have a number of patients into their 90s and with hearing loss, and we have had very successful video-based telemedicine visits,” Dr. Nieman, with the Cochlear Center for Hearing and Public Health at Johns Hopkins Bloomberg School of Public Health in Baltimore said in an interview. “Age should not be considered synonymous with inability or unwillingness to use technology.”

Their recommendations included the following:

  • Assume some degree of hearing loss, which affects about two-thirds of adults aged 70 years and older.
  • Ask patients to wear headphones or a headset or confirm that they are wearing their hearing aids and are in a quiet location.
  • Use a headset.
  • When possible, use video and have the camera focused on your face.
  • Use captioning when available and provide a written summary of key points and instructions.
  • Pay attention to cues, such as nodding along or looking to a loved one, that suggest a patient may not be following the conversation.

“If cognitive impairment is suspected, several screening tools can be used over the telephone to identify individuals who may need more comprehensive, in-person assessment,” wrote Dr. Nieman and Dr. Oh, who is with the division of geriatric medicine and gerontology at Johns Hopkins University School of Medicine. For example, data suggest that a modified version of the Mini–Mental State Examination and the Delirium Symptom Interview could be useful tools. “A formal diagnosis of dementia is not recommended solely based on a telephone-based cognitive screening,” however, Dr. Nieman and Dr. Oh said.

For patients with hearing loss, video visits avoid a current limitation of in-person visits: face masks that hinder patients’ ability to read lips and other visual cues. “For many of us, we rely on these types of cues more than we think,” Dr. Nieman said in an interview.

“When you have doubts about whether you and your patient are on the same page, check in with the patient,” Dr. Nieman said. “When appropriate, having a loved one or a care partner join an encounter, or at least a portion of the encounter, can be helpful to both the patient and the provider.”

Many older patients unprepared

Millions of older patients may not have been ready for the rapid shift to telemedicine brought on by COVID-19, a recent study in JAMA Internal Medicine suggests. Between 32% and 38% of older adults in the United States may not have been ready for video visits, largely because of inexperience with technology. Approximately 20% could have difficulty with telephone visits because of problems hearing or communicating or because of dementia.

 

 

Kenneth Lam, MD, of the division of geriatrics at the University of California, San Francisco (UCSF), and colleagues arrived at these estimates after analyzing data from more than 4,500 participants in the National Health and Aging Trends Study that was conducted in 2018. The study is nationally representative of Medicare beneficiaries 65 years or older.

The aim of the study “was to call attention to what clinicians were already experiencing on the front lines,” Dr. Lam said. In an interview, he imagined two scenarios based on his colleagues’ accounts of telemedicine visits.

In one case, a 72-year-old woman logs into Zoom Health on her iPad without any trouble. “She explains she just pushed on the URL and everything loaded up and you have a great visit,” Dr. Lam said. “This is likely to be the case for over 50% of the older people you see; I share this picture to combat ageism, which is, truthfully, just inaccurate stereotyping of older people and gets in the way of actionable, data-driven policies.

“However, for around one in three older adults (and closer to three out of every four of those over the age of 85), you will book an appointment and they will say they don’t have an email address or a computer or know how to go online,” Dr. Lam said. “Or suppose they decide to try it out. ... Come appointment time, you log on and they pick up, but now their sound doesn’t work. They keep saying they can see you but they can’t hear you. ... They accidentally hang up. You place another call, and they ask if you can switch to a phone conversation instead.”

By phone, the physician can address concerns about the patient’s blood pressure, which the patient has been measuring daily. “But when it comes to looking at the swelling in their legs, you’re out of luck, and you’ve been on this call for 45 minutes,” Dr. Lam said.

Have a backup plan

Making sure patients are prepared and having a backup plan can help, said Kaitlin Willham, MD, of UCSF and the San Francisco VA Medical Center.

She says older patients fall into a wide range of categories in terms of skills and access to equipment. Knowing which category a patient falls into and having relevant support available to troubleshoot are important.

During the pandemic, Dr. Willham has conducted many more telemedicine visits with patients who are at their place of residence, whether a private home or a residential care facility. “Even outside of the current crisis, there are benefits to home video visits,” Dr. Willham said. “A home video visit can provide a more holistic view of the patient than an office visit, allowing the clinician to see how the person lives, what they might be challenged by. It allows the clinician to identify areas of intervention and, if there is a care partner, involving that person in the plan. If the visit starts without major technical or communication barriers, they are generally very well received.”

For patients with problems hearing for whom headphones or amplification devices are not available, “using a landline for the audio portion of the visit can help, as can having someone with the patient reiterate what was said,” Dr. Willham suggested. “Many video platforms also enable the clinician to type messages or share a screen with a live document. These options can work well when there is very severe or complete lack of hearing.”

Sometimes an in-person visit is the right way to go, even when technical hurdles can be overcome.

“Although many older adults are willing and able to learn to use telemedicine, an equitable health system should recognize that for some, such as those with dementia and social isolation, in-person visits are already difficult and telemedicine may be impossible,” Dr. Lam and coauthors wrote. “For these patients, clinics and geriatric models of care such as home visits are essential.”

Dr. Nieman, Dr. Oh, and one of Dr. Lam’s coauthors have received funding from the National Institutes of Health. Dr. Oh also has received funding from the Roberts Family Fund. Dr. Nieman serves as a board member of the nonprofit organization Access HEARS and is on the board of trustees of the Hearing Loss Association of America.
 

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

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During the pandemic, physicians have raced to set up or expand telemedicine, uncovering both advantages and shortcomings. Now experts have developed a checklist of more than a dozen ideas to facilitate effective virtual visits with older adults.

Although many of the suggestions, published online in Annals of Internal Medicine, are useful for all patients, Carrie Nieman, MD, MPH, and Esther S. Oh, MD, PhD, developed the list with older patients in mind.

“I have a number of patients into their 90s and with hearing loss, and we have had very successful video-based telemedicine visits,” Dr. Nieman, with the Cochlear Center for Hearing and Public Health at Johns Hopkins Bloomberg School of Public Health in Baltimore said in an interview. “Age should not be considered synonymous with inability or unwillingness to use technology.”

Their recommendations included the following:

  • Assume some degree of hearing loss, which affects about two-thirds of adults aged 70 years and older.
  • Ask patients to wear headphones or a headset or confirm that they are wearing their hearing aids and are in a quiet location.
  • Use a headset.
  • When possible, use video and have the camera focused on your face.
  • Use captioning when available and provide a written summary of key points and instructions.
  • Pay attention to cues, such as nodding along or looking to a loved one, that suggest a patient may not be following the conversation.

“If cognitive impairment is suspected, several screening tools can be used over the telephone to identify individuals who may need more comprehensive, in-person assessment,” wrote Dr. Nieman and Dr. Oh, who is with the division of geriatric medicine and gerontology at Johns Hopkins University School of Medicine. For example, data suggest that a modified version of the Mini–Mental State Examination and the Delirium Symptom Interview could be useful tools. “A formal diagnosis of dementia is not recommended solely based on a telephone-based cognitive screening,” however, Dr. Nieman and Dr. Oh said.

For patients with hearing loss, video visits avoid a current limitation of in-person visits: face masks that hinder patients’ ability to read lips and other visual cues. “For many of us, we rely on these types of cues more than we think,” Dr. Nieman said in an interview.

“When you have doubts about whether you and your patient are on the same page, check in with the patient,” Dr. Nieman said. “When appropriate, having a loved one or a care partner join an encounter, or at least a portion of the encounter, can be helpful to both the patient and the provider.”

Many older patients unprepared

Millions of older patients may not have been ready for the rapid shift to telemedicine brought on by COVID-19, a recent study in JAMA Internal Medicine suggests. Between 32% and 38% of older adults in the United States may not have been ready for video visits, largely because of inexperience with technology. Approximately 20% could have difficulty with telephone visits because of problems hearing or communicating or because of dementia.

 

 

Kenneth Lam, MD, of the division of geriatrics at the University of California, San Francisco (UCSF), and colleagues arrived at these estimates after analyzing data from more than 4,500 participants in the National Health and Aging Trends Study that was conducted in 2018. The study is nationally representative of Medicare beneficiaries 65 years or older.

The aim of the study “was to call attention to what clinicians were already experiencing on the front lines,” Dr. Lam said. In an interview, he imagined two scenarios based on his colleagues’ accounts of telemedicine visits.

In one case, a 72-year-old woman logs into Zoom Health on her iPad without any trouble. “She explains she just pushed on the URL and everything loaded up and you have a great visit,” Dr. Lam said. “This is likely to be the case for over 50% of the older people you see; I share this picture to combat ageism, which is, truthfully, just inaccurate stereotyping of older people and gets in the way of actionable, data-driven policies.

“However, for around one in three older adults (and closer to three out of every four of those over the age of 85), you will book an appointment and they will say they don’t have an email address or a computer or know how to go online,” Dr. Lam said. “Or suppose they decide to try it out. ... Come appointment time, you log on and they pick up, but now their sound doesn’t work. They keep saying they can see you but they can’t hear you. ... They accidentally hang up. You place another call, and they ask if you can switch to a phone conversation instead.”

By phone, the physician can address concerns about the patient’s blood pressure, which the patient has been measuring daily. “But when it comes to looking at the swelling in their legs, you’re out of luck, and you’ve been on this call for 45 minutes,” Dr. Lam said.

Have a backup plan

Making sure patients are prepared and having a backup plan can help, said Kaitlin Willham, MD, of UCSF and the San Francisco VA Medical Center.

She says older patients fall into a wide range of categories in terms of skills and access to equipment. Knowing which category a patient falls into and having relevant support available to troubleshoot are important.

During the pandemic, Dr. Willham has conducted many more telemedicine visits with patients who are at their place of residence, whether a private home or a residential care facility. “Even outside of the current crisis, there are benefits to home video visits,” Dr. Willham said. “A home video visit can provide a more holistic view of the patient than an office visit, allowing the clinician to see how the person lives, what they might be challenged by. It allows the clinician to identify areas of intervention and, if there is a care partner, involving that person in the plan. If the visit starts without major technical or communication barriers, they are generally very well received.”

For patients with problems hearing for whom headphones or amplification devices are not available, “using a landline for the audio portion of the visit can help, as can having someone with the patient reiterate what was said,” Dr. Willham suggested. “Many video platforms also enable the clinician to type messages or share a screen with a live document. These options can work well when there is very severe or complete lack of hearing.”

Sometimes an in-person visit is the right way to go, even when technical hurdles can be overcome.

“Although many older adults are willing and able to learn to use telemedicine, an equitable health system should recognize that for some, such as those with dementia and social isolation, in-person visits are already difficult and telemedicine may be impossible,” Dr. Lam and coauthors wrote. “For these patients, clinics and geriatric models of care such as home visits are essential.”

Dr. Nieman, Dr. Oh, and one of Dr. Lam’s coauthors have received funding from the National Institutes of Health. Dr. Oh also has received funding from the Roberts Family Fund. Dr. Nieman serves as a board member of the nonprofit organization Access HEARS and is on the board of trustees of the Hearing Loss Association of America.
 

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


During the pandemic, physicians have raced to set up or expand telemedicine, uncovering both advantages and shortcomings. Now experts have developed a checklist of more than a dozen ideas to facilitate effective virtual visits with older adults.

Although many of the suggestions, published online in Annals of Internal Medicine, are useful for all patients, Carrie Nieman, MD, MPH, and Esther S. Oh, MD, PhD, developed the list with older patients in mind.

“I have a number of patients into their 90s and with hearing loss, and we have had very successful video-based telemedicine visits,” Dr. Nieman, with the Cochlear Center for Hearing and Public Health at Johns Hopkins Bloomberg School of Public Health in Baltimore said in an interview. “Age should not be considered synonymous with inability or unwillingness to use technology.”

Their recommendations included the following:

  • Assume some degree of hearing loss, which affects about two-thirds of adults aged 70 years and older.
  • Ask patients to wear headphones or a headset or confirm that they are wearing their hearing aids and are in a quiet location.
  • Use a headset.
  • When possible, use video and have the camera focused on your face.
  • Use captioning when available and provide a written summary of key points and instructions.
  • Pay attention to cues, such as nodding along or looking to a loved one, that suggest a patient may not be following the conversation.

“If cognitive impairment is suspected, several screening tools can be used over the telephone to identify individuals who may need more comprehensive, in-person assessment,” wrote Dr. Nieman and Dr. Oh, who is with the division of geriatric medicine and gerontology at Johns Hopkins University School of Medicine. For example, data suggest that a modified version of the Mini–Mental State Examination and the Delirium Symptom Interview could be useful tools. “A formal diagnosis of dementia is not recommended solely based on a telephone-based cognitive screening,” however, Dr. Nieman and Dr. Oh said.

For patients with hearing loss, video visits avoid a current limitation of in-person visits: face masks that hinder patients’ ability to read lips and other visual cues. “For many of us, we rely on these types of cues more than we think,” Dr. Nieman said in an interview.

“When you have doubts about whether you and your patient are on the same page, check in with the patient,” Dr. Nieman said. “When appropriate, having a loved one or a care partner join an encounter, or at least a portion of the encounter, can be helpful to both the patient and the provider.”

Many older patients unprepared

Millions of older patients may not have been ready for the rapid shift to telemedicine brought on by COVID-19, a recent study in JAMA Internal Medicine suggests. Between 32% and 38% of older adults in the United States may not have been ready for video visits, largely because of inexperience with technology. Approximately 20% could have difficulty with telephone visits because of problems hearing or communicating or because of dementia.

 

 

Kenneth Lam, MD, of the division of geriatrics at the University of California, San Francisco (UCSF), and colleagues arrived at these estimates after analyzing data from more than 4,500 participants in the National Health and Aging Trends Study that was conducted in 2018. The study is nationally representative of Medicare beneficiaries 65 years or older.

The aim of the study “was to call attention to what clinicians were already experiencing on the front lines,” Dr. Lam said. In an interview, he imagined two scenarios based on his colleagues’ accounts of telemedicine visits.

In one case, a 72-year-old woman logs into Zoom Health on her iPad without any trouble. “She explains she just pushed on the URL and everything loaded up and you have a great visit,” Dr. Lam said. “This is likely to be the case for over 50% of the older people you see; I share this picture to combat ageism, which is, truthfully, just inaccurate stereotyping of older people and gets in the way of actionable, data-driven policies.

“However, for around one in three older adults (and closer to three out of every four of those over the age of 85), you will book an appointment and they will say they don’t have an email address or a computer or know how to go online,” Dr. Lam said. “Or suppose they decide to try it out. ... Come appointment time, you log on and they pick up, but now their sound doesn’t work. They keep saying they can see you but they can’t hear you. ... They accidentally hang up. You place another call, and they ask if you can switch to a phone conversation instead.”

By phone, the physician can address concerns about the patient’s blood pressure, which the patient has been measuring daily. “But when it comes to looking at the swelling in their legs, you’re out of luck, and you’ve been on this call for 45 minutes,” Dr. Lam said.

Have a backup plan

Making sure patients are prepared and having a backup plan can help, said Kaitlin Willham, MD, of UCSF and the San Francisco VA Medical Center.

She says older patients fall into a wide range of categories in terms of skills and access to equipment. Knowing which category a patient falls into and having relevant support available to troubleshoot are important.

During the pandemic, Dr. Willham has conducted many more telemedicine visits with patients who are at their place of residence, whether a private home or a residential care facility. “Even outside of the current crisis, there are benefits to home video visits,” Dr. Willham said. “A home video visit can provide a more holistic view of the patient than an office visit, allowing the clinician to see how the person lives, what they might be challenged by. It allows the clinician to identify areas of intervention and, if there is a care partner, involving that person in the plan. If the visit starts without major technical or communication barriers, they are generally very well received.”

For patients with problems hearing for whom headphones or amplification devices are not available, “using a landline for the audio portion of the visit can help, as can having someone with the patient reiterate what was said,” Dr. Willham suggested. “Many video platforms also enable the clinician to type messages or share a screen with a live document. These options can work well when there is very severe or complete lack of hearing.”

Sometimes an in-person visit is the right way to go, even when technical hurdles can be overcome.

“Although many older adults are willing and able to learn to use telemedicine, an equitable health system should recognize that for some, such as those with dementia and social isolation, in-person visits are already difficult and telemedicine may be impossible,” Dr. Lam and coauthors wrote. “For these patients, clinics and geriatric models of care such as home visits are essential.”

Dr. Nieman, Dr. Oh, and one of Dr. Lam’s coauthors have received funding from the National Institutes of Health. Dr. Oh also has received funding from the Roberts Family Fund. Dr. Nieman serves as a board member of the nonprofit organization Access HEARS and is on the board of trustees of the Hearing Loss Association of America.
 

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

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PPE shortage could last years without strategic plan, experts warn

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Shortages of personal protective equipment and medical supplies could persist for years without strategic government intervention, officials from health care and manufacturing industries have predicted.

Liliboas/iStock/Getty Images Plus

Officials said logistical challenges continue 7 months after the coronavirus reached the United States, as the flu season approaches and as some state emergency management agencies prepare for a fall surge in COVID-19 cases.

Although the disarray is not as widespread as it was this spring, hospitals said rolling shortages of supplies range from specialized beds to disposable isolation gowns to thermometers.

“A few weeks ago, we were having a very difficult time getting the sanitary wipes. You just couldn’t get them,” said Bernard Klein, MD, chief executive of Providence Holy Cross Medical Center in Mission Hills, Calif., near Los Angeles. “We actually had to manufacture our own.”

This same dynamic has played out across a number of critical supplies in his hospital. First masks, then isolation gowns and now a specialized bed that allows nurses to turn COVID-19 patients onto their bellies – equipment that helps workers with what can otherwise be a six-person job.

“We’ve seen whole families come to our hospital with COVID, and several members hospitalized at the same time,” said Dr. Klein. “It’s very, very sad.”

Testing supplies ran short as the predominantly Latino community served by Providence Holy Cross was hit hard by COVID, and even as nearby hospitals could process 15-minute tests.

“If we had a more coordinated response with a partnership between the medical field, the government and the private industry, it would help improve the supply chain to the areas that need it most,” Dr. Klein said.

Dr. Klein said he expected to deal with equipment and supply shortages throughout 2021, especially as flu season approaches.

“Most people focus on those N95 respirators,” said Carmela Coyle, CEO of the California Hospital Association, an industry group that represents more than 400 hospitals across one of America’s hardest-hit states.

She said she believed COVID-19-related supply challenges will persist through 2022.

“We have been challenged with shortages of isolation gowns, face shields, which you’re now starting to see in public places. Any one piece that’s in shortage or not available creates risk for patients and for health care workers,” said Ms. Coyle.

At the same time, trade associations representing manufacturers said persuading customers to shift to American suppliers had been difficult.

“I also have industry that’s working only at 10-20% capacity, who can make PPE in our own backyard, but have no orders,” said Kim Glas, CEO of the National Council of Textile Organizations, whose members make reusable cloth gowns.

Manufacturers in her organization have made “hundreds of millions of products,” but, without long-term government contracts, many are apprehensive to invest in the equipment needed to scale up the business and eventually lower prices.

“If there continues to be an upward trajectory of COVID-19 cases, not just in the U.S. but globally, you can see those supply chains breaking down again,” Ms. Glas said. “It is a health care security issue.”

For the past 2 decades, personal protective equipment was supplied to health care institutions in lean supply chains in the same way toilet paper was to grocery stores. Chains between major manufacturers and end users were so efficient, there was no need to stockpile goods.

But in March, the supply chain broke when major Asian PPE exporters embargoed materials or shut down just as demand increased exponentially. Thus, health care institutions were in much the same position as regular grocery shoppers, who were trying to buy great quantities of a product they never needed to stockpile before.

“I am very concerned about long-term PPE shortages for the foreseeable future,” said Susan Bailey, MD, president of the American Medical Association.

“There’s no question the situation is better than it was a couple of months ago,” said Bailey. However, many health care organizations, including her own, have struggled to obtain PPE. Bailey practices at a 10-doctor allergy clinic and was met with a 10,000-mask minimum when they tried to order N95 respirators.

“We have not seen evidence of a long-term strategic plan for the manufacture, acquisition and distribution of PPE” from the government, said Dr. Bailey. “The supply chain needs to be strengthened dramatically, and we need less dependence on foreign goods to manufacture our own PPE in the U.S.”

Some products have now come back to be made in the United States – although factories are not expected to be able to reach demand until mid-2021.

“A lot has been done in the last 6 months. We are largely out of the hole, and we have planted the seeds to render the United States self-sufficient,” said Dave Rousse, president of the Association of the Nonwoven Fabrics Industry.

In 2019, 850 tons of the material used in disposable masks was made in the United States. Around 10,000 tons is expected to be made in 2021, satisfying perhaps 80% of demand. But PPE is a suite of items – including gloves, gowns and face shields – not all of which have seen the same success.

“Thermometers are becoming a real issue,” said Cindy Juhas, chief strategy officer of CME, an American health care product distributor. “They’re expecting even a problem with needles and syringes for the amount of vaccines they have to make.”

Federal government efforts to address the supply chain have foundered. The Federal Emergency Management Agency, in charge of the COVID-19 response, told congressional interviewers in June it had “no involvement” in distributing PPE to hot spots.

Project Airbridge, an initiative headed by Jared Kushner, President Donald Trump’s son-in-law, flew PPE from international suppliers to the U.S. at taxpayer expense but was phased out. And the government has not responded to the AMA’s calls for more distribution data.

Arguably, Dr. Klein is among the best placed to weather such disruptions. He is part of a 51-hospital chain with purchasing power, and among the institutions that distributors prioritize when selling supplies. But tribulations continue even in hospitals, as shortages have pushed buyers to look directly for manufacturers, often through a swamp of companies that have sprung up overnight.

Now distributors are being called upon not just by their traditional customers – hospitals and long-term care homes – but by nearly every segment of society. First responders, schools, clinics and even food businesses are all buying medical equipment now.

“There’s going to be lots of other shortages we haven’t even thought about,” said Ms. Juhas.

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.

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Shortages of personal protective equipment and medical supplies could persist for years without strategic government intervention, officials from health care and manufacturing industries have predicted.

Liliboas/iStock/Getty Images Plus

Officials said logistical challenges continue 7 months after the coronavirus reached the United States, as the flu season approaches and as some state emergency management agencies prepare for a fall surge in COVID-19 cases.

Although the disarray is not as widespread as it was this spring, hospitals said rolling shortages of supplies range from specialized beds to disposable isolation gowns to thermometers.

“A few weeks ago, we were having a very difficult time getting the sanitary wipes. You just couldn’t get them,” said Bernard Klein, MD, chief executive of Providence Holy Cross Medical Center in Mission Hills, Calif., near Los Angeles. “We actually had to manufacture our own.”

This same dynamic has played out across a number of critical supplies in his hospital. First masks, then isolation gowns and now a specialized bed that allows nurses to turn COVID-19 patients onto their bellies – equipment that helps workers with what can otherwise be a six-person job.

“We’ve seen whole families come to our hospital with COVID, and several members hospitalized at the same time,” said Dr. Klein. “It’s very, very sad.”

Testing supplies ran short as the predominantly Latino community served by Providence Holy Cross was hit hard by COVID, and even as nearby hospitals could process 15-minute tests.

“If we had a more coordinated response with a partnership between the medical field, the government and the private industry, it would help improve the supply chain to the areas that need it most,” Dr. Klein said.

Dr. Klein said he expected to deal with equipment and supply shortages throughout 2021, especially as flu season approaches.

“Most people focus on those N95 respirators,” said Carmela Coyle, CEO of the California Hospital Association, an industry group that represents more than 400 hospitals across one of America’s hardest-hit states.

She said she believed COVID-19-related supply challenges will persist through 2022.

“We have been challenged with shortages of isolation gowns, face shields, which you’re now starting to see in public places. Any one piece that’s in shortage or not available creates risk for patients and for health care workers,” said Ms. Coyle.

At the same time, trade associations representing manufacturers said persuading customers to shift to American suppliers had been difficult.

“I also have industry that’s working only at 10-20% capacity, who can make PPE in our own backyard, but have no orders,” said Kim Glas, CEO of the National Council of Textile Organizations, whose members make reusable cloth gowns.

Manufacturers in her organization have made “hundreds of millions of products,” but, without long-term government contracts, many are apprehensive to invest in the equipment needed to scale up the business and eventually lower prices.

“If there continues to be an upward trajectory of COVID-19 cases, not just in the U.S. but globally, you can see those supply chains breaking down again,” Ms. Glas said. “It is a health care security issue.”

For the past 2 decades, personal protective equipment was supplied to health care institutions in lean supply chains in the same way toilet paper was to grocery stores. Chains between major manufacturers and end users were so efficient, there was no need to stockpile goods.

But in March, the supply chain broke when major Asian PPE exporters embargoed materials or shut down just as demand increased exponentially. Thus, health care institutions were in much the same position as regular grocery shoppers, who were trying to buy great quantities of a product they never needed to stockpile before.

“I am very concerned about long-term PPE shortages for the foreseeable future,” said Susan Bailey, MD, president of the American Medical Association.

“There’s no question the situation is better than it was a couple of months ago,” said Bailey. However, many health care organizations, including her own, have struggled to obtain PPE. Bailey practices at a 10-doctor allergy clinic and was met with a 10,000-mask minimum when they tried to order N95 respirators.

“We have not seen evidence of a long-term strategic plan for the manufacture, acquisition and distribution of PPE” from the government, said Dr. Bailey. “The supply chain needs to be strengthened dramatically, and we need less dependence on foreign goods to manufacture our own PPE in the U.S.”

Some products have now come back to be made in the United States – although factories are not expected to be able to reach demand until mid-2021.

“A lot has been done in the last 6 months. We are largely out of the hole, and we have planted the seeds to render the United States self-sufficient,” said Dave Rousse, president of the Association of the Nonwoven Fabrics Industry.

In 2019, 850 tons of the material used in disposable masks was made in the United States. Around 10,000 tons is expected to be made in 2021, satisfying perhaps 80% of demand. But PPE is a suite of items – including gloves, gowns and face shields – not all of which have seen the same success.

“Thermometers are becoming a real issue,” said Cindy Juhas, chief strategy officer of CME, an American health care product distributor. “They’re expecting even a problem with needles and syringes for the amount of vaccines they have to make.”

Federal government efforts to address the supply chain have foundered. The Federal Emergency Management Agency, in charge of the COVID-19 response, told congressional interviewers in June it had “no involvement” in distributing PPE to hot spots.

Project Airbridge, an initiative headed by Jared Kushner, President Donald Trump’s son-in-law, flew PPE from international suppliers to the U.S. at taxpayer expense but was phased out. And the government has not responded to the AMA’s calls for more distribution data.

Arguably, Dr. Klein is among the best placed to weather such disruptions. He is part of a 51-hospital chain with purchasing power, and among the institutions that distributors prioritize when selling supplies. But tribulations continue even in hospitals, as shortages have pushed buyers to look directly for manufacturers, often through a swamp of companies that have sprung up overnight.

Now distributors are being called upon not just by their traditional customers – hospitals and long-term care homes – but by nearly every segment of society. First responders, schools, clinics and even food businesses are all buying medical equipment now.

“There’s going to be lots of other shortages we haven’t even thought about,” said Ms. Juhas.

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.

Shortages of personal protective equipment and medical supplies could persist for years without strategic government intervention, officials from health care and manufacturing industries have predicted.

Liliboas/iStock/Getty Images Plus

Officials said logistical challenges continue 7 months after the coronavirus reached the United States, as the flu season approaches and as some state emergency management agencies prepare for a fall surge in COVID-19 cases.

Although the disarray is not as widespread as it was this spring, hospitals said rolling shortages of supplies range from specialized beds to disposable isolation gowns to thermometers.

“A few weeks ago, we were having a very difficult time getting the sanitary wipes. You just couldn’t get them,” said Bernard Klein, MD, chief executive of Providence Holy Cross Medical Center in Mission Hills, Calif., near Los Angeles. “We actually had to manufacture our own.”

This same dynamic has played out across a number of critical supplies in his hospital. First masks, then isolation gowns and now a specialized bed that allows nurses to turn COVID-19 patients onto their bellies – equipment that helps workers with what can otherwise be a six-person job.

“We’ve seen whole families come to our hospital with COVID, and several members hospitalized at the same time,” said Dr. Klein. “It’s very, very sad.”

Testing supplies ran short as the predominantly Latino community served by Providence Holy Cross was hit hard by COVID, and even as nearby hospitals could process 15-minute tests.

“If we had a more coordinated response with a partnership between the medical field, the government and the private industry, it would help improve the supply chain to the areas that need it most,” Dr. Klein said.

Dr. Klein said he expected to deal with equipment and supply shortages throughout 2021, especially as flu season approaches.

“Most people focus on those N95 respirators,” said Carmela Coyle, CEO of the California Hospital Association, an industry group that represents more than 400 hospitals across one of America’s hardest-hit states.

She said she believed COVID-19-related supply challenges will persist through 2022.

“We have been challenged with shortages of isolation gowns, face shields, which you’re now starting to see in public places. Any one piece that’s in shortage or not available creates risk for patients and for health care workers,” said Ms. Coyle.

At the same time, trade associations representing manufacturers said persuading customers to shift to American suppliers had been difficult.

“I also have industry that’s working only at 10-20% capacity, who can make PPE in our own backyard, but have no orders,” said Kim Glas, CEO of the National Council of Textile Organizations, whose members make reusable cloth gowns.

Manufacturers in her organization have made “hundreds of millions of products,” but, without long-term government contracts, many are apprehensive to invest in the equipment needed to scale up the business and eventually lower prices.

“If there continues to be an upward trajectory of COVID-19 cases, not just in the U.S. but globally, you can see those supply chains breaking down again,” Ms. Glas said. “It is a health care security issue.”

For the past 2 decades, personal protective equipment was supplied to health care institutions in lean supply chains in the same way toilet paper was to grocery stores. Chains between major manufacturers and end users were so efficient, there was no need to stockpile goods.

But in March, the supply chain broke when major Asian PPE exporters embargoed materials or shut down just as demand increased exponentially. Thus, health care institutions were in much the same position as regular grocery shoppers, who were trying to buy great quantities of a product they never needed to stockpile before.

“I am very concerned about long-term PPE shortages for the foreseeable future,” said Susan Bailey, MD, president of the American Medical Association.

“There’s no question the situation is better than it was a couple of months ago,” said Bailey. However, many health care organizations, including her own, have struggled to obtain PPE. Bailey practices at a 10-doctor allergy clinic and was met with a 10,000-mask minimum when they tried to order N95 respirators.

“We have not seen evidence of a long-term strategic plan for the manufacture, acquisition and distribution of PPE” from the government, said Dr. Bailey. “The supply chain needs to be strengthened dramatically, and we need less dependence on foreign goods to manufacture our own PPE in the U.S.”

Some products have now come back to be made in the United States – although factories are not expected to be able to reach demand until mid-2021.

“A lot has been done in the last 6 months. We are largely out of the hole, and we have planted the seeds to render the United States self-sufficient,” said Dave Rousse, president of the Association of the Nonwoven Fabrics Industry.

In 2019, 850 tons of the material used in disposable masks was made in the United States. Around 10,000 tons is expected to be made in 2021, satisfying perhaps 80% of demand. But PPE is a suite of items – including gloves, gowns and face shields – not all of which have seen the same success.

“Thermometers are becoming a real issue,” said Cindy Juhas, chief strategy officer of CME, an American health care product distributor. “They’re expecting even a problem with needles and syringes for the amount of vaccines they have to make.”

Federal government efforts to address the supply chain have foundered. The Federal Emergency Management Agency, in charge of the COVID-19 response, told congressional interviewers in June it had “no involvement” in distributing PPE to hot spots.

Project Airbridge, an initiative headed by Jared Kushner, President Donald Trump’s son-in-law, flew PPE from international suppliers to the U.S. at taxpayer expense but was phased out. And the government has not responded to the AMA’s calls for more distribution data.

Arguably, Dr. Klein is among the best placed to weather such disruptions. He is part of a 51-hospital chain with purchasing power, and among the institutions that distributors prioritize when selling supplies. But tribulations continue even in hospitals, as shortages have pushed buyers to look directly for manufacturers, often through a swamp of companies that have sprung up overnight.

Now distributors are being called upon not just by their traditional customers – hospitals and long-term care homes – but by nearly every segment of society. First responders, schools, clinics and even food businesses are all buying medical equipment now.

“There’s going to be lots of other shortages we haven’t even thought about,” said Ms. Juhas.

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.

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