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Many hydroxychloroquine COVID-19 prophylaxis trials lack ECG screening
Many planned randomized trials to test the efficacy of hydroxychloroquine or related drugs for preventing COVID-19 infection have, as of the end of April 2020, failed to include ECG assessment to either exclude people at the highest risk for possibly developing a life-threatening cardiac arrhythmia or to flag people who achieve a dangerous QTc interval on treatment, according to an analysis of the posted designs of several dozen studies.
Hydroxychloroquine, the related agent chloroquine, and azithromycin have all recently received attention as potentially effective but unproven agents for both reducing the severity and duration of established COVID-19 infection as well as possibly preventing or mitigating an incident infection. As of April 30, 155 randomized, control trials listed on a major index for pending and in-progress trials, clinicaltrials.gov, had designs that intended to randomized an overall total of more than 85,000 healthy people to receive hydroxychloroquine or chloroquine, in some cases in combination with azithromycin, to test their efficacy and safety for COVID-19 prophylaxis, Michael H. Gollob, MD, said in an article posted by the Journal of the American College of Cardiology (2020 May 11. doi: 10.1016/j.jacc.2020.05.008).
The problem is that all three agents are documented to potentially produce lengthening of the corrected QT interval (QTc), and if this happens in a person who starts treatment with a QTc on the high end, the incremental prolongation from drug treatment could push their heart rhythm into a range where their risk for a life-threatening arrhythmia becomes substantial, said Dr. Gollob, a cardiac arrhythmia researcher at Toronto General Hospital and the University of Toronto. As a consequence, he recommended excluding from these prophylaxis trials anyone with a resting QTc at baseline assessment of greater than 450 msec, as well as discontinuing treatment from anyone who develops a resting QTc of more than 480 ms while on treatment.
“Though this may seem like a conservative value for subject withdrawal from a study, this is a prudent QTc cut-off, particularly when the severity of the adverse event, sudden death, may be worse than the study endpoint” of reduced incidence of COVID-19 infection, he wrote in his opinion piece.
“We cannot provide an accurate number for elevated risk” faced by people whose QTc climbs above these thresholds, “but we know that events will occur, which is why most trials that involve QT-prolonging drugs typically have an ECG exclusion criterion of QTc greater than 450 msec,” Dr. Gollob said in an interview.
His analysis of the 155 planned randomized prophylaxis trials on clinicaltrials.gov that he examined in detail had enrollment goals that would translate into more than 85,000 uninfected people who would receive hydroxychloroquine or chloroquine plus, in come cases, azithromycin. Only six relatively small studies from among these 155 included a plan for ECG screening and monitoring in its design, he noted. “It is reasonable to estimate that among the 80,000 patients randomized to a QT-prolonging drug [without ECG screening or monitoring] there will certainly be arrhythmic events.” If some of these people were to then die from a drug-induced arrhythmic event that could have been prevented by ECG screening or monitoring, it would be a “tragedy,” Dr. Gollob said.
“It is not only inexplicable, but also inexcusable that clinical investigators would dare to include healthy individuals in a clinical trial involving QT-prolonging medications without bothering to screen their electrocardiogram,” commented Sami Viskin, MD, an electrophysiologist at Tel Aviv Sourasky Medical Center. “The fact that we needed Dr. Gollob to ring this alarm is, itself, shocking,” he said in an interview.
“ECG screening is a good option to minimize the risk. You don’t eliminate the risk, but you can minimize it,” commented Arthur Wilde, MD, a cardiac electrophysiologist and professor of medicine at the Academic Medical Center in Amsterdam. Both Dr. Viskin and Dr. Wilde agreed with the QTc interval thresholds Dr. Gollob recommended using for excluding or discontinuing study participants.
In his commentary, Dr. Gollob estimated that if 85,000 otherwise healthy adults were randomized to received a drug that can increase the QTc interval, as many as about 3,400 people (4%) in the group could statistically be expected to have an especially high vulnerability to QT prolongation because of genetic variants they might carry that collectively have roughly this prevalence. In some people of African heritage, the prevalence of genetic risk for excessive QTc lengthening can be even higher, approaching about 10%, noted Dr. Wilde.
Dr. Gollob hoped the concerns he raised will prompt the organizers of many of these studies to revise their design, and he said he already knew of one study based in Toronto that recently added an ECG-monitoring strategy in response to the concerns he raised. He expressed optimism that more studies will follow.
“It’s a real issue to have these trials designed without ECG exclusions or monitoring. I’m glad that Dr. Gollob sent this warning, because he is right. ECG monitoring during treatment is important so you can stop the treatment in time,” Dr. Wilde said. Dr. Wilde also noted that many, if not most, of the studies listed on clinicaltrials.gov may not actually launch.
In April, representatives from several cardiology societies coauthored a document of considerations when using hydroxychloroquine, chloroquine, or azithromycin to treat patients with a diagnosed COVID-19 infection, and highlighted a QTc interval of 500 msec or greater as flagging patients who should no longer receive these drugs (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). For patients who do not yet have COVID-19 disease and the goal from treatment is prevention the potential efficacy of these drugs is reasonable to explore, but “does not exclude the need to minimize risk to research participants, especially when enrolling healthy subjects,” Dr. Gollob said.
Dr. Gollob, Dr. Viskin, and Dr. Wilde had no relevant financial disclosures.
Many planned randomized trials to test the efficacy of hydroxychloroquine or related drugs for preventing COVID-19 infection have, as of the end of April 2020, failed to include ECG assessment to either exclude people at the highest risk for possibly developing a life-threatening cardiac arrhythmia or to flag people who achieve a dangerous QTc interval on treatment, according to an analysis of the posted designs of several dozen studies.
Hydroxychloroquine, the related agent chloroquine, and azithromycin have all recently received attention as potentially effective but unproven agents for both reducing the severity and duration of established COVID-19 infection as well as possibly preventing or mitigating an incident infection. As of April 30, 155 randomized, control trials listed on a major index for pending and in-progress trials, clinicaltrials.gov, had designs that intended to randomized an overall total of more than 85,000 healthy people to receive hydroxychloroquine or chloroquine, in some cases in combination with azithromycin, to test their efficacy and safety for COVID-19 prophylaxis, Michael H. Gollob, MD, said in an article posted by the Journal of the American College of Cardiology (2020 May 11. doi: 10.1016/j.jacc.2020.05.008).
The problem is that all three agents are documented to potentially produce lengthening of the corrected QT interval (QTc), and if this happens in a person who starts treatment with a QTc on the high end, the incremental prolongation from drug treatment could push their heart rhythm into a range where their risk for a life-threatening arrhythmia becomes substantial, said Dr. Gollob, a cardiac arrhythmia researcher at Toronto General Hospital and the University of Toronto. As a consequence, he recommended excluding from these prophylaxis trials anyone with a resting QTc at baseline assessment of greater than 450 msec, as well as discontinuing treatment from anyone who develops a resting QTc of more than 480 ms while on treatment.
“Though this may seem like a conservative value for subject withdrawal from a study, this is a prudent QTc cut-off, particularly when the severity of the adverse event, sudden death, may be worse than the study endpoint” of reduced incidence of COVID-19 infection, he wrote in his opinion piece.
“We cannot provide an accurate number for elevated risk” faced by people whose QTc climbs above these thresholds, “but we know that events will occur, which is why most trials that involve QT-prolonging drugs typically have an ECG exclusion criterion of QTc greater than 450 msec,” Dr. Gollob said in an interview.
His analysis of the 155 planned randomized prophylaxis trials on clinicaltrials.gov that he examined in detail had enrollment goals that would translate into more than 85,000 uninfected people who would receive hydroxychloroquine or chloroquine plus, in come cases, azithromycin. Only six relatively small studies from among these 155 included a plan for ECG screening and monitoring in its design, he noted. “It is reasonable to estimate that among the 80,000 patients randomized to a QT-prolonging drug [without ECG screening or monitoring] there will certainly be arrhythmic events.” If some of these people were to then die from a drug-induced arrhythmic event that could have been prevented by ECG screening or monitoring, it would be a “tragedy,” Dr. Gollob said.
“It is not only inexplicable, but also inexcusable that clinical investigators would dare to include healthy individuals in a clinical trial involving QT-prolonging medications without bothering to screen their electrocardiogram,” commented Sami Viskin, MD, an electrophysiologist at Tel Aviv Sourasky Medical Center. “The fact that we needed Dr. Gollob to ring this alarm is, itself, shocking,” he said in an interview.
“ECG screening is a good option to minimize the risk. You don’t eliminate the risk, but you can minimize it,” commented Arthur Wilde, MD, a cardiac electrophysiologist and professor of medicine at the Academic Medical Center in Amsterdam. Both Dr. Viskin and Dr. Wilde agreed with the QTc interval thresholds Dr. Gollob recommended using for excluding or discontinuing study participants.
In his commentary, Dr. Gollob estimated that if 85,000 otherwise healthy adults were randomized to received a drug that can increase the QTc interval, as many as about 3,400 people (4%) in the group could statistically be expected to have an especially high vulnerability to QT prolongation because of genetic variants they might carry that collectively have roughly this prevalence. In some people of African heritage, the prevalence of genetic risk for excessive QTc lengthening can be even higher, approaching about 10%, noted Dr. Wilde.
Dr. Gollob hoped the concerns he raised will prompt the organizers of many of these studies to revise their design, and he said he already knew of one study based in Toronto that recently added an ECG-monitoring strategy in response to the concerns he raised. He expressed optimism that more studies will follow.
“It’s a real issue to have these trials designed without ECG exclusions or monitoring. I’m glad that Dr. Gollob sent this warning, because he is right. ECG monitoring during treatment is important so you can stop the treatment in time,” Dr. Wilde said. Dr. Wilde also noted that many, if not most, of the studies listed on clinicaltrials.gov may not actually launch.
In April, representatives from several cardiology societies coauthored a document of considerations when using hydroxychloroquine, chloroquine, or azithromycin to treat patients with a diagnosed COVID-19 infection, and highlighted a QTc interval of 500 msec or greater as flagging patients who should no longer receive these drugs (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). For patients who do not yet have COVID-19 disease and the goal from treatment is prevention the potential efficacy of these drugs is reasonable to explore, but “does not exclude the need to minimize risk to research participants, especially when enrolling healthy subjects,” Dr. Gollob said.
Dr. Gollob, Dr. Viskin, and Dr. Wilde had no relevant financial disclosures.
Many planned randomized trials to test the efficacy of hydroxychloroquine or related drugs for preventing COVID-19 infection have, as of the end of April 2020, failed to include ECG assessment to either exclude people at the highest risk for possibly developing a life-threatening cardiac arrhythmia or to flag people who achieve a dangerous QTc interval on treatment, according to an analysis of the posted designs of several dozen studies.
Hydroxychloroquine, the related agent chloroquine, and azithromycin have all recently received attention as potentially effective but unproven agents for both reducing the severity and duration of established COVID-19 infection as well as possibly preventing or mitigating an incident infection. As of April 30, 155 randomized, control trials listed on a major index for pending and in-progress trials, clinicaltrials.gov, had designs that intended to randomized an overall total of more than 85,000 healthy people to receive hydroxychloroquine or chloroquine, in some cases in combination with azithromycin, to test their efficacy and safety for COVID-19 prophylaxis, Michael H. Gollob, MD, said in an article posted by the Journal of the American College of Cardiology (2020 May 11. doi: 10.1016/j.jacc.2020.05.008).
The problem is that all three agents are documented to potentially produce lengthening of the corrected QT interval (QTc), and if this happens in a person who starts treatment with a QTc on the high end, the incremental prolongation from drug treatment could push their heart rhythm into a range where their risk for a life-threatening arrhythmia becomes substantial, said Dr. Gollob, a cardiac arrhythmia researcher at Toronto General Hospital and the University of Toronto. As a consequence, he recommended excluding from these prophylaxis trials anyone with a resting QTc at baseline assessment of greater than 450 msec, as well as discontinuing treatment from anyone who develops a resting QTc of more than 480 ms while on treatment.
“Though this may seem like a conservative value for subject withdrawal from a study, this is a prudent QTc cut-off, particularly when the severity of the adverse event, sudden death, may be worse than the study endpoint” of reduced incidence of COVID-19 infection, he wrote in his opinion piece.
“We cannot provide an accurate number for elevated risk” faced by people whose QTc climbs above these thresholds, “but we know that events will occur, which is why most trials that involve QT-prolonging drugs typically have an ECG exclusion criterion of QTc greater than 450 msec,” Dr. Gollob said in an interview.
His analysis of the 155 planned randomized prophylaxis trials on clinicaltrials.gov that he examined in detail had enrollment goals that would translate into more than 85,000 uninfected people who would receive hydroxychloroquine or chloroquine plus, in come cases, azithromycin. Only six relatively small studies from among these 155 included a plan for ECG screening and monitoring in its design, he noted. “It is reasonable to estimate that among the 80,000 patients randomized to a QT-prolonging drug [without ECG screening or monitoring] there will certainly be arrhythmic events.” If some of these people were to then die from a drug-induced arrhythmic event that could have been prevented by ECG screening or monitoring, it would be a “tragedy,” Dr. Gollob said.
“It is not only inexplicable, but also inexcusable that clinical investigators would dare to include healthy individuals in a clinical trial involving QT-prolonging medications without bothering to screen their electrocardiogram,” commented Sami Viskin, MD, an electrophysiologist at Tel Aviv Sourasky Medical Center. “The fact that we needed Dr. Gollob to ring this alarm is, itself, shocking,” he said in an interview.
“ECG screening is a good option to minimize the risk. You don’t eliminate the risk, but you can minimize it,” commented Arthur Wilde, MD, a cardiac electrophysiologist and professor of medicine at the Academic Medical Center in Amsterdam. Both Dr. Viskin and Dr. Wilde agreed with the QTc interval thresholds Dr. Gollob recommended using for excluding or discontinuing study participants.
In his commentary, Dr. Gollob estimated that if 85,000 otherwise healthy adults were randomized to received a drug that can increase the QTc interval, as many as about 3,400 people (4%) in the group could statistically be expected to have an especially high vulnerability to QT prolongation because of genetic variants they might carry that collectively have roughly this prevalence. In some people of African heritage, the prevalence of genetic risk for excessive QTc lengthening can be even higher, approaching about 10%, noted Dr. Wilde.
Dr. Gollob hoped the concerns he raised will prompt the organizers of many of these studies to revise their design, and he said he already knew of one study based in Toronto that recently added an ECG-monitoring strategy in response to the concerns he raised. He expressed optimism that more studies will follow.
“It’s a real issue to have these trials designed without ECG exclusions or monitoring. I’m glad that Dr. Gollob sent this warning, because he is right. ECG monitoring during treatment is important so you can stop the treatment in time,” Dr. Wilde said. Dr. Wilde also noted that many, if not most, of the studies listed on clinicaltrials.gov may not actually launch.
In April, representatives from several cardiology societies coauthored a document of considerations when using hydroxychloroquine, chloroquine, or azithromycin to treat patients with a diagnosed COVID-19 infection, and highlighted a QTc interval of 500 msec or greater as flagging patients who should no longer receive these drugs (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). For patients who do not yet have COVID-19 disease and the goal from treatment is prevention the potential efficacy of these drugs is reasonable to explore, but “does not exclude the need to minimize risk to research participants, especially when enrolling healthy subjects,” Dr. Gollob said.
Dr. Gollob, Dr. Viskin, and Dr. Wilde had no relevant financial disclosures.
REPORTING FROM JACC
COVID-19: Telehealth at the forefront of the pandemic
On Jan. 20, 2020, the first confirmed case of the 2019 novel coronavirus in the United States was admitted to Providence Regional Medical Center in Everett, Wash. Less than 3 months later, the COVID-19 pandemic has put enormous stress on the U.S. health care system, which is confronting acute resource shortage because of the surge of acute and critically ill patients, health care provider safety and burnout, and an ongoing need for managing vulnerable populations while minimizing the infection spread.
With the onset of these unprecedented challenges, telehealth has emerged as a powerful new resource for health care providers, hospitals, and health care systems across the country. This article offers a summary of government regulations that enabled telehealth expansion, and provides an overview of how two health care organizations, Providence St. Joseph Health and Sound Physicians, are employing telehealth services to combat the COVID-19 health care crisis.
The government response: Telehealth expansion
In response to the pandemic, the Centers for Medicare and Medicaid Services (CMS) have significantly increased access to telehealth services for Medicare and Medicaid beneficiaries. CMS swiftly put measures in place such as:
- Expanding telehealth beyond rural areas.
- Adding 80 services that can be provided in all settings, including patient homes
- Allowing providers to bill for telehealth visits at the same rate as in-person visits.
The U.S. Department of Health and Human Services also aided this effort by:
- Waiving requirements that physicians or other health care professionals must have licenses in the state in which they provide services, if they have an equivalent license from another state.
- Waving penalties for HIPAA violations against health care providers that serve patients in good faith through everyday communications technologies, such as FaceTime or Skype
Without prior regulatory and reimbursement restrictions, telehealth rapidly became a powerful tool in helping to solve some of the problems brought about by the COVID-19 pandemic.
Providence Telehealth for COVID-19
Providence St. Joseph Health is a not-for-profit health care system operating 51 hospitals and 1,085 clinics across Alaska, California, Montana, New Mexico, Oregon, Texas, and Washington. Providence has developed an enterprise telemedicine network with more than 100 virtual programs. Several of these services – including Telestroke, Telepsychiatry, TeleICU, and Telehospitalist – have been scaled across several states as a clinical cloud. More than 400 telemedicine endpoints are deployed, such as robotic carts and fixed InTouch TVs. In fact, the first U.S. COVID-19 patient was treated at Providence Regional Medical Center in Everett, Wash., using the telemedical robot Vici from InTouch Health.
According to Todd Czartoski, MD, chief medical technology officer at Providence, “while telehealth has been around for many years, COVID-19 opened a lot of people’s eyes to the value of virtual care delivery.”
Providence’s telehealth response to COVID-19 has encompassed five main areas: COVID-19 home care, COVID-19 acute care, ambulatory virtual visits, behavioral health concierge (BHC) expansion, and additional support for outside partnerships.
COVID-19 Home Care
Providence rapidly deployed home monitoring for nearly 2,000 positive or presumptive COVID-19 patients. Those symptomatic, clinically stable patients are given a thermometer and a pulse oximeter, and are monitored from home by a central team of nurses and physicians using the Xealth and Twistle programs.
Providence is evaluating expansion of home monitoring to other diagnoses, including higher acuity conditions.
COVID-19 Acute Care
TeleTriage expedites the triage of suspected COVID-19 patients and reduces the use of personal protective equipment (PPE) by 50% per patient per day. To date, TeleTriage has resulted in the conservation of more than 90,000 PPE units.
TeleHospitalist services expanded from traditional night coverage to caring for patients in COVID-19 units around the clock. Currently, there are 25 telehospitalists who practice both in-person and virtual medicine.
TeleICU offers remote management of more than 180 ICU beds across 17 hospitals from two central command centers in Washington state and Alaska. The services include night-time intensivist and ICU nurse coverage, including medication and ventilator management, and family conferences. COVID-19 increased the demand for TeleICU, with anticipated expansion to more than 300 beds.
Core TeleSpecialty services include TeleStroke and TelePsychiatry across 135 remote sites.
Ambulatory Virtual Visits
Providence launched the COVID-19 hub microsite to help educate patients by providing accurate and timely information. A chatbot named Grace helps screen patients who are worried about COVID-19. Grace also suggests next steps, such as a video visit with a patient’s primary care provider or a visit using Express Care/Virtual team, a direct-to-consumer service available to patients within and outside of the health care system.
In less than 2 weeks, Providence enabled virtual visits for more than 7,000 outpatient providers, with more than 14,000 alternative visits now occurring daily. This has allowed primary and specialty providers to continue to manage their patient panels remotely. The number of Express Care/Virtual visits increased from 60 to more than 1,000 per day.
BHC Expansion
In the effort to improve care for its caregivers, Providence launched a behavioral health concierge (BHC) service that offers employees and their dependents virtual access to licensed mental health professionals. Over the last half of 2019, BHC provided more than 1,000 phone and virtual visits, depending on the individual preference of patients. Notably, 21% percent of users were physicians; 65% of users were seen the same day and 100% of users were seen within 48 hours.
COVID-19 increased demand for services that initially started in Seattle and rapidly expanded to Montana, Oregon, and California.
Outside Partnerships
Providence has established partnerships with outside facilities by providing services to 135 sites across eight states. COVID-19 accelerated the employment of new services, including TeleICU.
Telemedicine at Sound Physicians
Sound Physicians is a national physician-founded and -led organization that provides emergency medicine, critical care, hospital medicine, population health, and physician advisory services. Five years ago, Sound launched a telemedicine service line. I spoke with Brian Carpenter, MD, national medical director for TeleHospitalist Services at Sound, to learn about his experience implementing Telehospitalist programs across 22 hospitals and 22 skilled nursing facilities.
Prior to COVID-19, Sound offered a spectrum of telemedicine services including night-time telephonic cross coverage, as well as video-assisted admissions, transfers, and rapid responses. In 2019, Sound Telehospitalists received 88,000 connect requests, including 6,400 video-assisted new admissions and 82 rapid responses. Typically, one physician covers four to eight hospitals with back-up available for surges. The team uses a predictive model for staffing and developed an acuity-based algorithm to ensure that patients in distress are evaluated immediately, new stable admissions on average are seen within 12 minutes, and order clarifications are provided within 30 minutes.
The COVID-19 pandemic created an urgent demand for providers to support an overwhelmed health care system. Without the traditional barriers to implementation – such as lack of acceptance by medical staff, nurses and patients, strict state licensing and technology requirements, lack of reimbursement, and delays in hospital credentialing – Sound was able to develop a rapid implementation model for telemedicine services. Currently, four new hospitals are in the active implementation phase, with 40 more hospitals in the pipeline.
Implementing a telemedicine program at your hospital
In order to successfully launch a telemedicine program, Dr. Carpenter outlined the following critical implementation steps:
- In collaboration with local leadership, define the problem you are trying to solve, which helps inform the scope of the telemedicine practice and technology requirements (for example, night-time cross-coverage vs. full telemedicine service).
- Complete a discovery process (for example, existing workflow for patient admission and transfer) with the end-goal of developing a workflow and rules of engagement.
- Obtain hospital credentialing/privileges and EMR access.
- Train end-users, including physicians and nurse telepresenters.
Dr. Carpenter offered this advice to those considering a telemedicine program: “Telemedicine is not just about technology; a true telemedicine program encompasses change management, workflow development, end-user training, compliance, and mechanisms for continuous process improvement. We want to make things better for the physicians, nurses, and patients.”
Telehealth is offering support to health care providers on the front lines, patients in need of care, and health care systems managing the unprecedented surges in volume.
Dr. Farah is a hospitalist, physician adviser, and Lean Six Sigma Black Belt. She is a performance improvement consultant based in Corvallis, Ore., and a member of The Hospitalist’s editorial advisory board.
On Jan. 20, 2020, the first confirmed case of the 2019 novel coronavirus in the United States was admitted to Providence Regional Medical Center in Everett, Wash. Less than 3 months later, the COVID-19 pandemic has put enormous stress on the U.S. health care system, which is confronting acute resource shortage because of the surge of acute and critically ill patients, health care provider safety and burnout, and an ongoing need for managing vulnerable populations while minimizing the infection spread.
With the onset of these unprecedented challenges, telehealth has emerged as a powerful new resource for health care providers, hospitals, and health care systems across the country. This article offers a summary of government regulations that enabled telehealth expansion, and provides an overview of how two health care organizations, Providence St. Joseph Health and Sound Physicians, are employing telehealth services to combat the COVID-19 health care crisis.
The government response: Telehealth expansion
In response to the pandemic, the Centers for Medicare and Medicaid Services (CMS) have significantly increased access to telehealth services for Medicare and Medicaid beneficiaries. CMS swiftly put measures in place such as:
- Expanding telehealth beyond rural areas.
- Adding 80 services that can be provided in all settings, including patient homes
- Allowing providers to bill for telehealth visits at the same rate as in-person visits.
The U.S. Department of Health and Human Services also aided this effort by:
- Waiving requirements that physicians or other health care professionals must have licenses in the state in which they provide services, if they have an equivalent license from another state.
- Waving penalties for HIPAA violations against health care providers that serve patients in good faith through everyday communications technologies, such as FaceTime or Skype
Without prior regulatory and reimbursement restrictions, telehealth rapidly became a powerful tool in helping to solve some of the problems brought about by the COVID-19 pandemic.
Providence Telehealth for COVID-19
Providence St. Joseph Health is a not-for-profit health care system operating 51 hospitals and 1,085 clinics across Alaska, California, Montana, New Mexico, Oregon, Texas, and Washington. Providence has developed an enterprise telemedicine network with more than 100 virtual programs. Several of these services – including Telestroke, Telepsychiatry, TeleICU, and Telehospitalist – have been scaled across several states as a clinical cloud. More than 400 telemedicine endpoints are deployed, such as robotic carts and fixed InTouch TVs. In fact, the first U.S. COVID-19 patient was treated at Providence Regional Medical Center in Everett, Wash., using the telemedical robot Vici from InTouch Health.
According to Todd Czartoski, MD, chief medical technology officer at Providence, “while telehealth has been around for many years, COVID-19 opened a lot of people’s eyes to the value of virtual care delivery.”
Providence’s telehealth response to COVID-19 has encompassed five main areas: COVID-19 home care, COVID-19 acute care, ambulatory virtual visits, behavioral health concierge (BHC) expansion, and additional support for outside partnerships.
COVID-19 Home Care
Providence rapidly deployed home monitoring for nearly 2,000 positive or presumptive COVID-19 patients. Those symptomatic, clinically stable patients are given a thermometer and a pulse oximeter, and are monitored from home by a central team of nurses and physicians using the Xealth and Twistle programs.
Providence is evaluating expansion of home monitoring to other diagnoses, including higher acuity conditions.
COVID-19 Acute Care
TeleTriage expedites the triage of suspected COVID-19 patients and reduces the use of personal protective equipment (PPE) by 50% per patient per day. To date, TeleTriage has resulted in the conservation of more than 90,000 PPE units.
TeleHospitalist services expanded from traditional night coverage to caring for patients in COVID-19 units around the clock. Currently, there are 25 telehospitalists who practice both in-person and virtual medicine.
TeleICU offers remote management of more than 180 ICU beds across 17 hospitals from two central command centers in Washington state and Alaska. The services include night-time intensivist and ICU nurse coverage, including medication and ventilator management, and family conferences. COVID-19 increased the demand for TeleICU, with anticipated expansion to more than 300 beds.
Core TeleSpecialty services include TeleStroke and TelePsychiatry across 135 remote sites.
Ambulatory Virtual Visits
Providence launched the COVID-19 hub microsite to help educate patients by providing accurate and timely information. A chatbot named Grace helps screen patients who are worried about COVID-19. Grace also suggests next steps, such as a video visit with a patient’s primary care provider or a visit using Express Care/Virtual team, a direct-to-consumer service available to patients within and outside of the health care system.
In less than 2 weeks, Providence enabled virtual visits for more than 7,000 outpatient providers, with more than 14,000 alternative visits now occurring daily. This has allowed primary and specialty providers to continue to manage their patient panels remotely. The number of Express Care/Virtual visits increased from 60 to more than 1,000 per day.
BHC Expansion
In the effort to improve care for its caregivers, Providence launched a behavioral health concierge (BHC) service that offers employees and their dependents virtual access to licensed mental health professionals. Over the last half of 2019, BHC provided more than 1,000 phone and virtual visits, depending on the individual preference of patients. Notably, 21% percent of users were physicians; 65% of users were seen the same day and 100% of users were seen within 48 hours.
COVID-19 increased demand for services that initially started in Seattle and rapidly expanded to Montana, Oregon, and California.
Outside Partnerships
Providence has established partnerships with outside facilities by providing services to 135 sites across eight states. COVID-19 accelerated the employment of new services, including TeleICU.
Telemedicine at Sound Physicians
Sound Physicians is a national physician-founded and -led organization that provides emergency medicine, critical care, hospital medicine, population health, and physician advisory services. Five years ago, Sound launched a telemedicine service line. I spoke with Brian Carpenter, MD, national medical director for TeleHospitalist Services at Sound, to learn about his experience implementing Telehospitalist programs across 22 hospitals and 22 skilled nursing facilities.
Prior to COVID-19, Sound offered a spectrum of telemedicine services including night-time telephonic cross coverage, as well as video-assisted admissions, transfers, and rapid responses. In 2019, Sound Telehospitalists received 88,000 connect requests, including 6,400 video-assisted new admissions and 82 rapid responses. Typically, one physician covers four to eight hospitals with back-up available for surges. The team uses a predictive model for staffing and developed an acuity-based algorithm to ensure that patients in distress are evaluated immediately, new stable admissions on average are seen within 12 minutes, and order clarifications are provided within 30 minutes.
The COVID-19 pandemic created an urgent demand for providers to support an overwhelmed health care system. Without the traditional barriers to implementation – such as lack of acceptance by medical staff, nurses and patients, strict state licensing and technology requirements, lack of reimbursement, and delays in hospital credentialing – Sound was able to develop a rapid implementation model for telemedicine services. Currently, four new hospitals are in the active implementation phase, with 40 more hospitals in the pipeline.
Implementing a telemedicine program at your hospital
In order to successfully launch a telemedicine program, Dr. Carpenter outlined the following critical implementation steps:
- In collaboration with local leadership, define the problem you are trying to solve, which helps inform the scope of the telemedicine practice and technology requirements (for example, night-time cross-coverage vs. full telemedicine service).
- Complete a discovery process (for example, existing workflow for patient admission and transfer) with the end-goal of developing a workflow and rules of engagement.
- Obtain hospital credentialing/privileges and EMR access.
- Train end-users, including physicians and nurse telepresenters.
Dr. Carpenter offered this advice to those considering a telemedicine program: “Telemedicine is not just about technology; a true telemedicine program encompasses change management, workflow development, end-user training, compliance, and mechanisms for continuous process improvement. We want to make things better for the physicians, nurses, and patients.”
Telehealth is offering support to health care providers on the front lines, patients in need of care, and health care systems managing the unprecedented surges in volume.
Dr. Farah is a hospitalist, physician adviser, and Lean Six Sigma Black Belt. She is a performance improvement consultant based in Corvallis, Ore., and a member of The Hospitalist’s editorial advisory board.
On Jan. 20, 2020, the first confirmed case of the 2019 novel coronavirus in the United States was admitted to Providence Regional Medical Center in Everett, Wash. Less than 3 months later, the COVID-19 pandemic has put enormous stress on the U.S. health care system, which is confronting acute resource shortage because of the surge of acute and critically ill patients, health care provider safety and burnout, and an ongoing need for managing vulnerable populations while minimizing the infection spread.
With the onset of these unprecedented challenges, telehealth has emerged as a powerful new resource for health care providers, hospitals, and health care systems across the country. This article offers a summary of government regulations that enabled telehealth expansion, and provides an overview of how two health care organizations, Providence St. Joseph Health and Sound Physicians, are employing telehealth services to combat the COVID-19 health care crisis.
The government response: Telehealth expansion
In response to the pandemic, the Centers for Medicare and Medicaid Services (CMS) have significantly increased access to telehealth services for Medicare and Medicaid beneficiaries. CMS swiftly put measures in place such as:
- Expanding telehealth beyond rural areas.
- Adding 80 services that can be provided in all settings, including patient homes
- Allowing providers to bill for telehealth visits at the same rate as in-person visits.
The U.S. Department of Health and Human Services also aided this effort by:
- Waiving requirements that physicians or other health care professionals must have licenses in the state in which they provide services, if they have an equivalent license from another state.
- Waving penalties for HIPAA violations against health care providers that serve patients in good faith through everyday communications technologies, such as FaceTime or Skype
Without prior regulatory and reimbursement restrictions, telehealth rapidly became a powerful tool in helping to solve some of the problems brought about by the COVID-19 pandemic.
Providence Telehealth for COVID-19
Providence St. Joseph Health is a not-for-profit health care system operating 51 hospitals and 1,085 clinics across Alaska, California, Montana, New Mexico, Oregon, Texas, and Washington. Providence has developed an enterprise telemedicine network with more than 100 virtual programs. Several of these services – including Telestroke, Telepsychiatry, TeleICU, and Telehospitalist – have been scaled across several states as a clinical cloud. More than 400 telemedicine endpoints are deployed, such as robotic carts and fixed InTouch TVs. In fact, the first U.S. COVID-19 patient was treated at Providence Regional Medical Center in Everett, Wash., using the telemedical robot Vici from InTouch Health.
According to Todd Czartoski, MD, chief medical technology officer at Providence, “while telehealth has been around for many years, COVID-19 opened a lot of people’s eyes to the value of virtual care delivery.”
Providence’s telehealth response to COVID-19 has encompassed five main areas: COVID-19 home care, COVID-19 acute care, ambulatory virtual visits, behavioral health concierge (BHC) expansion, and additional support for outside partnerships.
COVID-19 Home Care
Providence rapidly deployed home monitoring for nearly 2,000 positive or presumptive COVID-19 patients. Those symptomatic, clinically stable patients are given a thermometer and a pulse oximeter, and are monitored from home by a central team of nurses and physicians using the Xealth and Twistle programs.
Providence is evaluating expansion of home monitoring to other diagnoses, including higher acuity conditions.
COVID-19 Acute Care
TeleTriage expedites the triage of suspected COVID-19 patients and reduces the use of personal protective equipment (PPE) by 50% per patient per day. To date, TeleTriage has resulted in the conservation of more than 90,000 PPE units.
TeleHospitalist services expanded from traditional night coverage to caring for patients in COVID-19 units around the clock. Currently, there are 25 telehospitalists who practice both in-person and virtual medicine.
TeleICU offers remote management of more than 180 ICU beds across 17 hospitals from two central command centers in Washington state and Alaska. The services include night-time intensivist and ICU nurse coverage, including medication and ventilator management, and family conferences. COVID-19 increased the demand for TeleICU, with anticipated expansion to more than 300 beds.
Core TeleSpecialty services include TeleStroke and TelePsychiatry across 135 remote sites.
Ambulatory Virtual Visits
Providence launched the COVID-19 hub microsite to help educate patients by providing accurate and timely information. A chatbot named Grace helps screen patients who are worried about COVID-19. Grace also suggests next steps, such as a video visit with a patient’s primary care provider or a visit using Express Care/Virtual team, a direct-to-consumer service available to patients within and outside of the health care system.
In less than 2 weeks, Providence enabled virtual visits for more than 7,000 outpatient providers, with more than 14,000 alternative visits now occurring daily. This has allowed primary and specialty providers to continue to manage their patient panels remotely. The number of Express Care/Virtual visits increased from 60 to more than 1,000 per day.
BHC Expansion
In the effort to improve care for its caregivers, Providence launched a behavioral health concierge (BHC) service that offers employees and their dependents virtual access to licensed mental health professionals. Over the last half of 2019, BHC provided more than 1,000 phone and virtual visits, depending on the individual preference of patients. Notably, 21% percent of users were physicians; 65% of users were seen the same day and 100% of users were seen within 48 hours.
COVID-19 increased demand for services that initially started in Seattle and rapidly expanded to Montana, Oregon, and California.
Outside Partnerships
Providence has established partnerships with outside facilities by providing services to 135 sites across eight states. COVID-19 accelerated the employment of new services, including TeleICU.
Telemedicine at Sound Physicians
Sound Physicians is a national physician-founded and -led organization that provides emergency medicine, critical care, hospital medicine, population health, and physician advisory services. Five years ago, Sound launched a telemedicine service line. I spoke with Brian Carpenter, MD, national medical director for TeleHospitalist Services at Sound, to learn about his experience implementing Telehospitalist programs across 22 hospitals and 22 skilled nursing facilities.
Prior to COVID-19, Sound offered a spectrum of telemedicine services including night-time telephonic cross coverage, as well as video-assisted admissions, transfers, and rapid responses. In 2019, Sound Telehospitalists received 88,000 connect requests, including 6,400 video-assisted new admissions and 82 rapid responses. Typically, one physician covers four to eight hospitals with back-up available for surges. The team uses a predictive model for staffing and developed an acuity-based algorithm to ensure that patients in distress are evaluated immediately, new stable admissions on average are seen within 12 minutes, and order clarifications are provided within 30 minutes.
The COVID-19 pandemic created an urgent demand for providers to support an overwhelmed health care system. Without the traditional barriers to implementation – such as lack of acceptance by medical staff, nurses and patients, strict state licensing and technology requirements, lack of reimbursement, and delays in hospital credentialing – Sound was able to develop a rapid implementation model for telemedicine services. Currently, four new hospitals are in the active implementation phase, with 40 more hospitals in the pipeline.
Implementing a telemedicine program at your hospital
In order to successfully launch a telemedicine program, Dr. Carpenter outlined the following critical implementation steps:
- In collaboration with local leadership, define the problem you are trying to solve, which helps inform the scope of the telemedicine practice and technology requirements (for example, night-time cross-coverage vs. full telemedicine service).
- Complete a discovery process (for example, existing workflow for patient admission and transfer) with the end-goal of developing a workflow and rules of engagement.
- Obtain hospital credentialing/privileges and EMR access.
- Train end-users, including physicians and nurse telepresenters.
Dr. Carpenter offered this advice to those considering a telemedicine program: “Telemedicine is not just about technology; a true telemedicine program encompasses change management, workflow development, end-user training, compliance, and mechanisms for continuous process improvement. We want to make things better for the physicians, nurses, and patients.”
Telehealth is offering support to health care providers on the front lines, patients in need of care, and health care systems managing the unprecedented surges in volume.
Dr. Farah is a hospitalist, physician adviser, and Lean Six Sigma Black Belt. She is a performance improvement consultant based in Corvallis, Ore., and a member of The Hospitalist’s editorial advisory board.
Neurologists are not electricians. Nor are we internists.
Recently, like in other major cities, Phoenix had a flyover by the Blue Angels to honor frontline health care workers. My kids and I watched it. While I think the gesture is nice, in my mind it brings up questions about whether the money for it could have been better spent elsewhere. But that’s not the point of my column.
Watching the whole thing, I couldn’t help but think about my role in the crisis. While I have friends on the front lines, I’m certainly not there. I’m probably as close to back line as you can be without being retired.
This is simply the nature of my practice. I’m primarily outpatient. Inpatient consults are few and far between in the era of the neuro-hospitalist. I still see patients, both by video and in person. If someone wants to come in and see me, I’ll be available if I’m able.
I see a lot of conditions, but no one is going to a neurologist to be evaluated for COVID-19. Nor should they. Even though there are reports of neurological complications of the disease, none of them are outpatient issues or presenting symptoms.
I was asked if I’d volunteer to practice inpatient general medicine in a pinch, and my answer to that would have to be no. This isn’t cowardice, as one person accused me of. I’ve been to the hospital and seen patients since this started.
I’m no more an internist than I am an electrician. Like other neurologists of my era, I did a 1-year general medicine internship. For me, that was in 1993. I haven’t practiced it since, nor have I kept up on it except as it crosses into neurology.
A lot has changed in the last 27 years in my field alone.
So I sit in my office doing what I always have: Trying to provide the best care I can to those who do need my services as a neurologist.
I may not be on the front line in our current crisis, but for those who seek my help I’m still front and center for them. And I will be until I retire.
Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.
Recently, like in other major cities, Phoenix had a flyover by the Blue Angels to honor frontline health care workers. My kids and I watched it. While I think the gesture is nice, in my mind it brings up questions about whether the money for it could have been better spent elsewhere. But that’s not the point of my column.
Watching the whole thing, I couldn’t help but think about my role in the crisis. While I have friends on the front lines, I’m certainly not there. I’m probably as close to back line as you can be without being retired.
This is simply the nature of my practice. I’m primarily outpatient. Inpatient consults are few and far between in the era of the neuro-hospitalist. I still see patients, both by video and in person. If someone wants to come in and see me, I’ll be available if I’m able.
I see a lot of conditions, but no one is going to a neurologist to be evaluated for COVID-19. Nor should they. Even though there are reports of neurological complications of the disease, none of them are outpatient issues or presenting symptoms.
I was asked if I’d volunteer to practice inpatient general medicine in a pinch, and my answer to that would have to be no. This isn’t cowardice, as one person accused me of. I’ve been to the hospital and seen patients since this started.
I’m no more an internist than I am an electrician. Like other neurologists of my era, I did a 1-year general medicine internship. For me, that was in 1993. I haven’t practiced it since, nor have I kept up on it except as it crosses into neurology.
A lot has changed in the last 27 years in my field alone.
So I sit in my office doing what I always have: Trying to provide the best care I can to those who do need my services as a neurologist.
I may not be on the front line in our current crisis, but for those who seek my help I’m still front and center for them. And I will be until I retire.
Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.
Recently, like in other major cities, Phoenix had a flyover by the Blue Angels to honor frontline health care workers. My kids and I watched it. While I think the gesture is nice, in my mind it brings up questions about whether the money for it could have been better spent elsewhere. But that’s not the point of my column.
Watching the whole thing, I couldn’t help but think about my role in the crisis. While I have friends on the front lines, I’m certainly not there. I’m probably as close to back line as you can be without being retired.
This is simply the nature of my practice. I’m primarily outpatient. Inpatient consults are few and far between in the era of the neuro-hospitalist. I still see patients, both by video and in person. If someone wants to come in and see me, I’ll be available if I’m able.
I see a lot of conditions, but no one is going to a neurologist to be evaluated for COVID-19. Nor should they. Even though there are reports of neurological complications of the disease, none of them are outpatient issues or presenting symptoms.
I was asked if I’d volunteer to practice inpatient general medicine in a pinch, and my answer to that would have to be no. This isn’t cowardice, as one person accused me of. I’ve been to the hospital and seen patients since this started.
I’m no more an internist than I am an electrician. Like other neurologists of my era, I did a 1-year general medicine internship. For me, that was in 1993. I haven’t practiced it since, nor have I kept up on it except as it crosses into neurology.
A lot has changed in the last 27 years in my field alone.
So I sit in my office doing what I always have: Trying to provide the best care I can to those who do need my services as a neurologist.
I may not be on the front line in our current crisis, but for those who seek my help I’m still front and center for them. And I will be until I retire.
Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.
Will we be wearing masks years from now?
Yesterday during an office visit I was adjusting my mask when a patient suddenly said, “What if this is the new normal? What if we still have to wear masks years from now?”
An interesting thought. That might even be the case. I mean, the COVID-19 pandemic definitely has changed our world. On the other hand, there are far worse things to have to do.
Masks, to some extent, have already become a part of our society, I see more people out and about with them than without. Like lunchboxes, they’ve transitioned from utilitarian to fashion statements. I see Darth Vader, Batman, Hello Kitty, Pokemon, and many other characters on them.
Humans have, after all, adapted to wearing all kinds of things. At some point our ancestors discovered they could walk around outside more comfortably with a covering on their feet. Then they discovered that socks prevent chafing. Now shoes and socks are worn worldwide, available for many different purposes in varied colors, styles, and cultures.
Why should masks be any different? Just because they’re new doesn’t mean they’re bad.
Obviously, I’m exaggerating. I don’t want to wear a mask full time, either. They’re hot and uncomfortable and, for people with certain respiratory issues, impossible. I live in Phoenix and I definitely don’t want to go through one of our summers wearing a face mask.
But at the same time, This makes me wonder when we’ll start to phase them out. The virus isn’t going anywhere, so the breaking point will be when there’s either an effective vaccine administered to most of the population, or enough people have had the virus that herd immunity takes effect.
Until then, I have no problem with wearing a mask and asking patients who can to please do so when they come in. I see a lot of people who are elderly and/or immune suppressed. I don’t want them to get sick. Or me. Or my family.
If wearing a mask through the Phoenix summer is a sacrifice that will lead to better health for all, it’s not a big one in the grand scheme of things.
Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.
Yesterday during an office visit I was adjusting my mask when a patient suddenly said, “What if this is the new normal? What if we still have to wear masks years from now?”
An interesting thought. That might even be the case. I mean, the COVID-19 pandemic definitely has changed our world. On the other hand, there are far worse things to have to do.
Masks, to some extent, have already become a part of our society, I see more people out and about with them than without. Like lunchboxes, they’ve transitioned from utilitarian to fashion statements. I see Darth Vader, Batman, Hello Kitty, Pokemon, and many other characters on them.
Humans have, after all, adapted to wearing all kinds of things. At some point our ancestors discovered they could walk around outside more comfortably with a covering on their feet. Then they discovered that socks prevent chafing. Now shoes and socks are worn worldwide, available for many different purposes in varied colors, styles, and cultures.
Why should masks be any different? Just because they’re new doesn’t mean they’re bad.
Obviously, I’m exaggerating. I don’t want to wear a mask full time, either. They’re hot and uncomfortable and, for people with certain respiratory issues, impossible. I live in Phoenix and I definitely don’t want to go through one of our summers wearing a face mask.
But at the same time, This makes me wonder when we’ll start to phase them out. The virus isn’t going anywhere, so the breaking point will be when there’s either an effective vaccine administered to most of the population, or enough people have had the virus that herd immunity takes effect.
Until then, I have no problem with wearing a mask and asking patients who can to please do so when they come in. I see a lot of people who are elderly and/or immune suppressed. I don’t want them to get sick. Or me. Or my family.
If wearing a mask through the Phoenix summer is a sacrifice that will lead to better health for all, it’s not a big one in the grand scheme of things.
Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.
Yesterday during an office visit I was adjusting my mask when a patient suddenly said, “What if this is the new normal? What if we still have to wear masks years from now?”
An interesting thought. That might even be the case. I mean, the COVID-19 pandemic definitely has changed our world. On the other hand, there are far worse things to have to do.
Masks, to some extent, have already become a part of our society, I see more people out and about with them than without. Like lunchboxes, they’ve transitioned from utilitarian to fashion statements. I see Darth Vader, Batman, Hello Kitty, Pokemon, and many other characters on them.
Humans have, after all, adapted to wearing all kinds of things. At some point our ancestors discovered they could walk around outside more comfortably with a covering on their feet. Then they discovered that socks prevent chafing. Now shoes and socks are worn worldwide, available for many different purposes in varied colors, styles, and cultures.
Why should masks be any different? Just because they’re new doesn’t mean they’re bad.
Obviously, I’m exaggerating. I don’t want to wear a mask full time, either. They’re hot and uncomfortable and, for people with certain respiratory issues, impossible. I live in Phoenix and I definitely don’t want to go through one of our summers wearing a face mask.
But at the same time, This makes me wonder when we’ll start to phase them out. The virus isn’t going anywhere, so the breaking point will be when there’s either an effective vaccine administered to most of the population, or enough people have had the virus that herd immunity takes effect.
Until then, I have no problem with wearing a mask and asking patients who can to please do so when they come in. I see a lot of people who are elderly and/or immune suppressed. I don’t want them to get sick. Or me. Or my family.
If wearing a mask through the Phoenix summer is a sacrifice that will lead to better health for all, it’s not a big one in the grand scheme of things.
Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.
Practice During the Pandemic
The first installment of my new column was obsolete on arrival. It referred to walking abroad at midday, with no mention of masks and social distancing. The whole thing was so February 2020.
My last day in the office was in mid-March. Friday the 13th.
, using stored and forwarded images.
What I had in mind was visits by patients in nursing homes or too sick at home to come in. It always bothered me to see very aged and infirm patients brought to the office at great inconvenience and expense for what often turned out to be problems like xerosis or eczema that could have been managed quite well remotely.
The HMO never got back to me, though. There were too many hurdles, mostly bureaucratic rather than medical. Would insurance pay? What about consent? Malpractice? It has been interesting to watch the current crisis sweep away the inertia of such obstacles, including licensure considerations (seeing patients across state lines for cutaneous purposes). People get around to fixing the roof when it pours. Perhaps next time there will be tests, masks, respirators. Perhaps.
Seeing patients remotely has acquainted me with all the technical headaches everyone stuck at home talks and jokes about: Balky transmission (What did you say after, “and then the blood ...”?); patients who can’t figure out how to log on, or start the video, or unmute themselves, and on and on. Picture resolution is not great, as anyone knows from watching TV newscasters interview talking heads stuck in their homes.
I was never all that image-conscious, but my beard has grown fuller and my hair unkempter. Even though I sit at my desk, I do take care to keep my trousers on. Not taking any chances.
Everyone agonizes over what the “new normal” may be. Will people come back to doctors’ offices? Will practices survive economically if many patients don’t return to the office? Stay tuned. For a long time.
Mostly, though, remote visits seem to work. Helped if needed by additional, better-resolution emailed photos, it’s possible to make useful decisions, including which lesions can wait for in-person evaluation, until ...
... Until what? In an effort to keep this column up-to-the-nanosecond, I am writing it as many countries tentatively “open up.” Careful analysis of the knowledge behind this world-wide project shows ... not much. It seems to come down to some educated guesswork about what might work and what the risks might be, which leads to advice that differs widely from state to state and country to country. It’s as if people everywhere just decided that locking everyone down is a real drag, is financially ruinous, has a duration both uncertain and longer than most people and governments think they can handle, so let’s get out there and “be careful,” whatever that is said to mean.
And the risks? Well, more people will get sick and some will die. How many “extra” deaths are ethically acceptable? Thoughtful people are working on that. They’ll get back sometime to those who are still around.
I don’t blame anyone for our staggering ignorance about this terrifying new reality. But absorbing the ignorance in real time is not reassuring.
I have nothing but sympathy for those who are not emeritus, who have practices to sustain and families to feed. I didn’t ask to be born 73 years ago, and take no credit for having done so. So much of what happens to us depends on when and where we were born – two factors for which we deserve absolutely no credit – that it’s a wonder we take such pride in praising ourselves for what we think we accomplish. Having no better choice, we do the best we can.
Meantime, I am in a “high-risk” category. If I were obese, I could try to lose weight. But my risk factor is age, which tends not to decline. Risk-wise, there is just one way to exit my group.
So I don’t expect to get back to the office anytime soon. To paraphrase a comedian who shall remain nameless: I don’t want to live on in the hearts of men. I want to live on in my house.
Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now semiretired, after 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available online. Write to him at dermnews@mdedge.com.
The first installment of my new column was obsolete on arrival. It referred to walking abroad at midday, with no mention of masks and social distancing. The whole thing was so February 2020.
My last day in the office was in mid-March. Friday the 13th.
, using stored and forwarded images.
What I had in mind was visits by patients in nursing homes or too sick at home to come in. It always bothered me to see very aged and infirm patients brought to the office at great inconvenience and expense for what often turned out to be problems like xerosis or eczema that could have been managed quite well remotely.
The HMO never got back to me, though. There were too many hurdles, mostly bureaucratic rather than medical. Would insurance pay? What about consent? Malpractice? It has been interesting to watch the current crisis sweep away the inertia of such obstacles, including licensure considerations (seeing patients across state lines for cutaneous purposes). People get around to fixing the roof when it pours. Perhaps next time there will be tests, masks, respirators. Perhaps.
Seeing patients remotely has acquainted me with all the technical headaches everyone stuck at home talks and jokes about: Balky transmission (What did you say after, “and then the blood ...”?); patients who can’t figure out how to log on, or start the video, or unmute themselves, and on and on. Picture resolution is not great, as anyone knows from watching TV newscasters interview talking heads stuck in their homes.
I was never all that image-conscious, but my beard has grown fuller and my hair unkempter. Even though I sit at my desk, I do take care to keep my trousers on. Not taking any chances.
Everyone agonizes over what the “new normal” may be. Will people come back to doctors’ offices? Will practices survive economically if many patients don’t return to the office? Stay tuned. For a long time.
Mostly, though, remote visits seem to work. Helped if needed by additional, better-resolution emailed photos, it’s possible to make useful decisions, including which lesions can wait for in-person evaluation, until ...
... Until what? In an effort to keep this column up-to-the-nanosecond, I am writing it as many countries tentatively “open up.” Careful analysis of the knowledge behind this world-wide project shows ... not much. It seems to come down to some educated guesswork about what might work and what the risks might be, which leads to advice that differs widely from state to state and country to country. It’s as if people everywhere just decided that locking everyone down is a real drag, is financially ruinous, has a duration both uncertain and longer than most people and governments think they can handle, so let’s get out there and “be careful,” whatever that is said to mean.
And the risks? Well, more people will get sick and some will die. How many “extra” deaths are ethically acceptable? Thoughtful people are working on that. They’ll get back sometime to those who are still around.
I don’t blame anyone for our staggering ignorance about this terrifying new reality. But absorbing the ignorance in real time is not reassuring.
I have nothing but sympathy for those who are not emeritus, who have practices to sustain and families to feed. I didn’t ask to be born 73 years ago, and take no credit for having done so. So much of what happens to us depends on when and where we were born – two factors for which we deserve absolutely no credit – that it’s a wonder we take such pride in praising ourselves for what we think we accomplish. Having no better choice, we do the best we can.
Meantime, I am in a “high-risk” category. If I were obese, I could try to lose weight. But my risk factor is age, which tends not to decline. Risk-wise, there is just one way to exit my group.
So I don’t expect to get back to the office anytime soon. To paraphrase a comedian who shall remain nameless: I don’t want to live on in the hearts of men. I want to live on in my house.
Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now semiretired, after 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available online. Write to him at dermnews@mdedge.com.
The first installment of my new column was obsolete on arrival. It referred to walking abroad at midday, with no mention of masks and social distancing. The whole thing was so February 2020.
My last day in the office was in mid-March. Friday the 13th.
, using stored and forwarded images.
What I had in mind was visits by patients in nursing homes or too sick at home to come in. It always bothered me to see very aged and infirm patients brought to the office at great inconvenience and expense for what often turned out to be problems like xerosis or eczema that could have been managed quite well remotely.
The HMO never got back to me, though. There were too many hurdles, mostly bureaucratic rather than medical. Would insurance pay? What about consent? Malpractice? It has been interesting to watch the current crisis sweep away the inertia of such obstacles, including licensure considerations (seeing patients across state lines for cutaneous purposes). People get around to fixing the roof when it pours. Perhaps next time there will be tests, masks, respirators. Perhaps.
Seeing patients remotely has acquainted me with all the technical headaches everyone stuck at home talks and jokes about: Balky transmission (What did you say after, “and then the blood ...”?); patients who can’t figure out how to log on, or start the video, or unmute themselves, and on and on. Picture resolution is not great, as anyone knows from watching TV newscasters interview talking heads stuck in their homes.
I was never all that image-conscious, but my beard has grown fuller and my hair unkempter. Even though I sit at my desk, I do take care to keep my trousers on. Not taking any chances.
Everyone agonizes over what the “new normal” may be. Will people come back to doctors’ offices? Will practices survive economically if many patients don’t return to the office? Stay tuned. For a long time.
Mostly, though, remote visits seem to work. Helped if needed by additional, better-resolution emailed photos, it’s possible to make useful decisions, including which lesions can wait for in-person evaluation, until ...
... Until what? In an effort to keep this column up-to-the-nanosecond, I am writing it as many countries tentatively “open up.” Careful analysis of the knowledge behind this world-wide project shows ... not much. It seems to come down to some educated guesswork about what might work and what the risks might be, which leads to advice that differs widely from state to state and country to country. It’s as if people everywhere just decided that locking everyone down is a real drag, is financially ruinous, has a duration both uncertain and longer than most people and governments think they can handle, so let’s get out there and “be careful,” whatever that is said to mean.
And the risks? Well, more people will get sick and some will die. How many “extra” deaths are ethically acceptable? Thoughtful people are working on that. They’ll get back sometime to those who are still around.
I don’t blame anyone for our staggering ignorance about this terrifying new reality. But absorbing the ignorance in real time is not reassuring.
I have nothing but sympathy for those who are not emeritus, who have practices to sustain and families to feed. I didn’t ask to be born 73 years ago, and take no credit for having done so. So much of what happens to us depends on when and where we were born – two factors for which we deserve absolutely no credit – that it’s a wonder we take such pride in praising ourselves for what we think we accomplish. Having no better choice, we do the best we can.
Meantime, I am in a “high-risk” category. If I were obese, I could try to lose weight. But my risk factor is age, which tends not to decline. Risk-wise, there is just one way to exit my group.
So I don’t expect to get back to the office anytime soon. To paraphrase a comedian who shall remain nameless: I don’t want to live on in the hearts of men. I want to live on in my house.
Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now semiretired, after 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available online. Write to him at dermnews@mdedge.com.
Triple-antiviral combo speeds COVID-19 recovery
A triple-antiviral therapy regimen of interferon-beta1, lopinavir/ritonavir, and ribavirin shortened median time to COVID-19 viral negativity by 5 days in a small trial from Hong Kong.
In an open-label, randomized phase 2 trial in patients with mild or moderate COVID-19 infections, the median time to viral negativity by nasopharyngeal swab was 7 days for 86 patients assigned to receive a 14-day course of lopinavir 400 mg and ritonavir 100 mg every 12 hours, ribavirin 400 mg every 12 hours, and three doses of 8 million international units of interferon beta-1b on alternate days, compared with a median time to negativity of 12 days for patients treated with lopinavir/ritonavir alone (P = .0010), wrote Ivan Fan-Ngai Hung, MD, from Gleaneagles Hospital in Hong Kong, and colleagues.
“Triple-antiviral therapy with interferon beta-1b, lopinavir/ritonavir, and ribavirin were safe and superior to lopinavir/ritonavir alone in shortening virus shedding, alleviating symptoms, and facilitating discharge of patients with mild to moderate COVID-19,” they wrote in a study published online in The Lancet.
Patients who received the combination also had significantly shorter time to complete alleviation of symptoms as assessed by a National Early Warning Score 2 (NEWS2, a system for detecting clinical deterioration in patients with acute illnesses) score of 0 (4 vs. 8 days, respectively; hazard ratio 3.92, P < .0001), and to a Sequential Organ Failure Assessment (SOFA) score of 0 (3 vs. 8 days, HR 1.89, P = .041).
The median hospital stay was 9 days for patients treated with the combination, compared with 14.5 days for controls (HR 2.72, P = .016).
In most patients treated with the combination, SARS-CoV-2 viral load was effectively suppressed in all clinical specimens, including nasopharyngeal swabs, throat and posterior oropharyngeal saliva, and stool.
In addition, serum levels of interleukin 6 (IL-6) – an inflammatory cytokine implicated in the cytokine storm frequently seen in patients with severe COVID-19 infections – were significantly lower on treatment days 2, 6, and 8 in patients treated with the combination, compared with those treated with lopinavir/ritonavir alone.
“Our trial demonstrates that early treatment of mild to moderate COVID-19 with a triple combination of antiviral drugs may rapidly suppress the amount of virus in a patient’s body, relieve symptoms, and reduce the risk to health care workers by reducing the duration and quantity of viral shedding (when the virus is detectable and potentially transmissible). Furthermore, the treatment combination appeared safe and well tolerated by patients,” said lead investigator Professor Kwok-Yung Yuen from the University of Hong Kong, in a statement.
“Despite these encouraging findings,” he continued, “we must confirm in larger phase 3 trials that interferon beta-1b alone or in combination with other drugs is effective in patients with more severe illness (in whom the virus has had more time to replicate).”
Plausible rationale
Benjamin Medoff, MD, chief of the division of pulmonary and critical care medicine at Massachusetts General Hospital in Boston, who was not involved in the study, said in an interview that the biologic rationale for the combination is plausible.
“I think this is a promising study that suggests that a regimen of interferon beta-1b, lopinavir/ritonavir, and ribavirin can shorten the duration of infection and improve symptoms in COVID-19 patients especially if started early in disease, in less than 7 days of symptom onset,” he said in reply to a request for expert analysis.
“The open-label nature and small size of the study limits the broad use of the regimen as noted by the authors, and it’s important to emphasize that the subjects enrolled did not have very severe disease (not in the ICU). However, the study does suggest that a larger truly randomized study is warranted,” he said.
AIDS drugs repurposed
Lopinavir/ritonavir is commonly used to treat HIV/AIDS throughout the world, and the investigators had previously reported that the antiviral agents combined with ribavirin reduced deaths and the need for intensive ventilator support among patients with SARS-CoV, the betacoronavirus that causes severe acute respiratory syndrome (SARS), and antivirals have shown in vitro activity against both SARS-CoV and MERS-CoV, the closely related pathogen that causes Middle East respiratory syndrome.
“ However the viral load of SARS and MERS peaks at around day 7-10 after symptom onset, whereas the viral load of COVID-19 peaks at the time of presentation, similar to influenza. Experience from the treatment of patients with influenza who are admitted to hospital suggested that a combination of multiple antiviral drugs is more effective than single-drug treatments in this setting of patients with a high viral load at presentation,” the investigators wrote.
To test this, they enrolled adults patients admitted to one of six Hong Kong Hospitals for virologically confirmed COVID-19 infections from Feb. 10 through March 20, 2020.
A total of 86 patients were randomly assigned to the combination and 41 to lopinavir/ritonavir alone as controls, at doses described above.
Patients who entered the trial within less than 7 days of symptom onset received the triple combination, with interferon dosing adjusted according to the day that treatment started. Patients recruited 1 or 2 days after symptom onset received three doses of interferon, patients started on day 3 or 4 received two doses, and those started on days 5 or 6 received one interferon dose. Patients recruited 7 days or later from symptom onset did not receive interferon beta-1b because of its proinflammatory effects.
In post-hoc analysis by day of treatment initiation, clinical and virological outcomes (except stool samples) were superior in patients admitted less than 7 days after symptom onset for the 52 patients who received a least one interferon dose plus lopinavir/ritonavir and ribavirin, compared with 24 patients randomized to the control arm (lopinavir/ritonavir only). In contrast, among patients admitted and started on treatment at day 7 or later after symptom onset, there were no differences between those who received lopinavir/ritonavir alone or combined with ribavirin.
Adverse events were reported in 41 of 86 patients in the combination group and 20 of 41 patients in the control arm. The most common adverse events were diarrhea, occurring in 52 of all 127 patients, fever in 48, nausea in 43, and elevated alanine transaminase level in 18. The side effects generally resolved within 3 days of the start of treatments.
There were no serious adverse events reported in the combination group. One patient in the control group had impaired hepatic enzymes requiring discontinuation of treatment. No patients died during the study.
The study was funded by the Shaw Foundation, Richard and Carol Yu, May Tam Mak Mei Yin, and Sanming Project of Medicine. The authors and Dr. Medoff declared no competing interests.
SOURCE: Hung IFN et al. Lancet. 2020 May 8. doi: 10.1016/S0140-6736(20)31101-6.
A triple-antiviral therapy regimen of interferon-beta1, lopinavir/ritonavir, and ribavirin shortened median time to COVID-19 viral negativity by 5 days in a small trial from Hong Kong.
In an open-label, randomized phase 2 trial in patients with mild or moderate COVID-19 infections, the median time to viral negativity by nasopharyngeal swab was 7 days for 86 patients assigned to receive a 14-day course of lopinavir 400 mg and ritonavir 100 mg every 12 hours, ribavirin 400 mg every 12 hours, and three doses of 8 million international units of interferon beta-1b on alternate days, compared with a median time to negativity of 12 days for patients treated with lopinavir/ritonavir alone (P = .0010), wrote Ivan Fan-Ngai Hung, MD, from Gleaneagles Hospital in Hong Kong, and colleagues.
“Triple-antiviral therapy with interferon beta-1b, lopinavir/ritonavir, and ribavirin were safe and superior to lopinavir/ritonavir alone in shortening virus shedding, alleviating symptoms, and facilitating discharge of patients with mild to moderate COVID-19,” they wrote in a study published online in The Lancet.
Patients who received the combination also had significantly shorter time to complete alleviation of symptoms as assessed by a National Early Warning Score 2 (NEWS2, a system for detecting clinical deterioration in patients with acute illnesses) score of 0 (4 vs. 8 days, respectively; hazard ratio 3.92, P < .0001), and to a Sequential Organ Failure Assessment (SOFA) score of 0 (3 vs. 8 days, HR 1.89, P = .041).
The median hospital stay was 9 days for patients treated with the combination, compared with 14.5 days for controls (HR 2.72, P = .016).
In most patients treated with the combination, SARS-CoV-2 viral load was effectively suppressed in all clinical specimens, including nasopharyngeal swabs, throat and posterior oropharyngeal saliva, and stool.
In addition, serum levels of interleukin 6 (IL-6) – an inflammatory cytokine implicated in the cytokine storm frequently seen in patients with severe COVID-19 infections – were significantly lower on treatment days 2, 6, and 8 in patients treated with the combination, compared with those treated with lopinavir/ritonavir alone.
“Our trial demonstrates that early treatment of mild to moderate COVID-19 with a triple combination of antiviral drugs may rapidly suppress the amount of virus in a patient’s body, relieve symptoms, and reduce the risk to health care workers by reducing the duration and quantity of viral shedding (when the virus is detectable and potentially transmissible). Furthermore, the treatment combination appeared safe and well tolerated by patients,” said lead investigator Professor Kwok-Yung Yuen from the University of Hong Kong, in a statement.
“Despite these encouraging findings,” he continued, “we must confirm in larger phase 3 trials that interferon beta-1b alone or in combination with other drugs is effective in patients with more severe illness (in whom the virus has had more time to replicate).”
Plausible rationale
Benjamin Medoff, MD, chief of the division of pulmonary and critical care medicine at Massachusetts General Hospital in Boston, who was not involved in the study, said in an interview that the biologic rationale for the combination is plausible.
“I think this is a promising study that suggests that a regimen of interferon beta-1b, lopinavir/ritonavir, and ribavirin can shorten the duration of infection and improve symptoms in COVID-19 patients especially if started early in disease, in less than 7 days of symptom onset,” he said in reply to a request for expert analysis.
“The open-label nature and small size of the study limits the broad use of the regimen as noted by the authors, and it’s important to emphasize that the subjects enrolled did not have very severe disease (not in the ICU). However, the study does suggest that a larger truly randomized study is warranted,” he said.
AIDS drugs repurposed
Lopinavir/ritonavir is commonly used to treat HIV/AIDS throughout the world, and the investigators had previously reported that the antiviral agents combined with ribavirin reduced deaths and the need for intensive ventilator support among patients with SARS-CoV, the betacoronavirus that causes severe acute respiratory syndrome (SARS), and antivirals have shown in vitro activity against both SARS-CoV and MERS-CoV, the closely related pathogen that causes Middle East respiratory syndrome.
“ However the viral load of SARS and MERS peaks at around day 7-10 after symptom onset, whereas the viral load of COVID-19 peaks at the time of presentation, similar to influenza. Experience from the treatment of patients with influenza who are admitted to hospital suggested that a combination of multiple antiviral drugs is more effective than single-drug treatments in this setting of patients with a high viral load at presentation,” the investigators wrote.
To test this, they enrolled adults patients admitted to one of six Hong Kong Hospitals for virologically confirmed COVID-19 infections from Feb. 10 through March 20, 2020.
A total of 86 patients were randomly assigned to the combination and 41 to lopinavir/ritonavir alone as controls, at doses described above.
Patients who entered the trial within less than 7 days of symptom onset received the triple combination, with interferon dosing adjusted according to the day that treatment started. Patients recruited 1 or 2 days after symptom onset received three doses of interferon, patients started on day 3 or 4 received two doses, and those started on days 5 or 6 received one interferon dose. Patients recruited 7 days or later from symptom onset did not receive interferon beta-1b because of its proinflammatory effects.
In post-hoc analysis by day of treatment initiation, clinical and virological outcomes (except stool samples) were superior in patients admitted less than 7 days after symptom onset for the 52 patients who received a least one interferon dose plus lopinavir/ritonavir and ribavirin, compared with 24 patients randomized to the control arm (lopinavir/ritonavir only). In contrast, among patients admitted and started on treatment at day 7 or later after symptom onset, there were no differences between those who received lopinavir/ritonavir alone or combined with ribavirin.
Adverse events were reported in 41 of 86 patients in the combination group and 20 of 41 patients in the control arm. The most common adverse events were diarrhea, occurring in 52 of all 127 patients, fever in 48, nausea in 43, and elevated alanine transaminase level in 18. The side effects generally resolved within 3 days of the start of treatments.
There were no serious adverse events reported in the combination group. One patient in the control group had impaired hepatic enzymes requiring discontinuation of treatment. No patients died during the study.
The study was funded by the Shaw Foundation, Richard and Carol Yu, May Tam Mak Mei Yin, and Sanming Project of Medicine. The authors and Dr. Medoff declared no competing interests.
SOURCE: Hung IFN et al. Lancet. 2020 May 8. doi: 10.1016/S0140-6736(20)31101-6.
A triple-antiviral therapy regimen of interferon-beta1, lopinavir/ritonavir, and ribavirin shortened median time to COVID-19 viral negativity by 5 days in a small trial from Hong Kong.
In an open-label, randomized phase 2 trial in patients with mild or moderate COVID-19 infections, the median time to viral negativity by nasopharyngeal swab was 7 days for 86 patients assigned to receive a 14-day course of lopinavir 400 mg and ritonavir 100 mg every 12 hours, ribavirin 400 mg every 12 hours, and three doses of 8 million international units of interferon beta-1b on alternate days, compared with a median time to negativity of 12 days for patients treated with lopinavir/ritonavir alone (P = .0010), wrote Ivan Fan-Ngai Hung, MD, from Gleaneagles Hospital in Hong Kong, and colleagues.
“Triple-antiviral therapy with interferon beta-1b, lopinavir/ritonavir, and ribavirin were safe and superior to lopinavir/ritonavir alone in shortening virus shedding, alleviating symptoms, and facilitating discharge of patients with mild to moderate COVID-19,” they wrote in a study published online in The Lancet.
Patients who received the combination also had significantly shorter time to complete alleviation of symptoms as assessed by a National Early Warning Score 2 (NEWS2, a system for detecting clinical deterioration in patients with acute illnesses) score of 0 (4 vs. 8 days, respectively; hazard ratio 3.92, P < .0001), and to a Sequential Organ Failure Assessment (SOFA) score of 0 (3 vs. 8 days, HR 1.89, P = .041).
The median hospital stay was 9 days for patients treated with the combination, compared with 14.5 days for controls (HR 2.72, P = .016).
In most patients treated with the combination, SARS-CoV-2 viral load was effectively suppressed in all clinical specimens, including nasopharyngeal swabs, throat and posterior oropharyngeal saliva, and stool.
In addition, serum levels of interleukin 6 (IL-6) – an inflammatory cytokine implicated in the cytokine storm frequently seen in patients with severe COVID-19 infections – were significantly lower on treatment days 2, 6, and 8 in patients treated with the combination, compared with those treated with lopinavir/ritonavir alone.
“Our trial demonstrates that early treatment of mild to moderate COVID-19 with a triple combination of antiviral drugs may rapidly suppress the amount of virus in a patient’s body, relieve symptoms, and reduce the risk to health care workers by reducing the duration and quantity of viral shedding (when the virus is detectable and potentially transmissible). Furthermore, the treatment combination appeared safe and well tolerated by patients,” said lead investigator Professor Kwok-Yung Yuen from the University of Hong Kong, in a statement.
“Despite these encouraging findings,” he continued, “we must confirm in larger phase 3 trials that interferon beta-1b alone or in combination with other drugs is effective in patients with more severe illness (in whom the virus has had more time to replicate).”
Plausible rationale
Benjamin Medoff, MD, chief of the division of pulmonary and critical care medicine at Massachusetts General Hospital in Boston, who was not involved in the study, said in an interview that the biologic rationale for the combination is plausible.
“I think this is a promising study that suggests that a regimen of interferon beta-1b, lopinavir/ritonavir, and ribavirin can shorten the duration of infection and improve symptoms in COVID-19 patients especially if started early in disease, in less than 7 days of symptom onset,” he said in reply to a request for expert analysis.
“The open-label nature and small size of the study limits the broad use of the regimen as noted by the authors, and it’s important to emphasize that the subjects enrolled did not have very severe disease (not in the ICU). However, the study does suggest that a larger truly randomized study is warranted,” he said.
AIDS drugs repurposed
Lopinavir/ritonavir is commonly used to treat HIV/AIDS throughout the world, and the investigators had previously reported that the antiviral agents combined with ribavirin reduced deaths and the need for intensive ventilator support among patients with SARS-CoV, the betacoronavirus that causes severe acute respiratory syndrome (SARS), and antivirals have shown in vitro activity against both SARS-CoV and MERS-CoV, the closely related pathogen that causes Middle East respiratory syndrome.
“ However the viral load of SARS and MERS peaks at around day 7-10 after symptom onset, whereas the viral load of COVID-19 peaks at the time of presentation, similar to influenza. Experience from the treatment of patients with influenza who are admitted to hospital suggested that a combination of multiple antiviral drugs is more effective than single-drug treatments in this setting of patients with a high viral load at presentation,” the investigators wrote.
To test this, they enrolled adults patients admitted to one of six Hong Kong Hospitals for virologically confirmed COVID-19 infections from Feb. 10 through March 20, 2020.
A total of 86 patients were randomly assigned to the combination and 41 to lopinavir/ritonavir alone as controls, at doses described above.
Patients who entered the trial within less than 7 days of symptom onset received the triple combination, with interferon dosing adjusted according to the day that treatment started. Patients recruited 1 or 2 days after symptom onset received three doses of interferon, patients started on day 3 or 4 received two doses, and those started on days 5 or 6 received one interferon dose. Patients recruited 7 days or later from symptom onset did not receive interferon beta-1b because of its proinflammatory effects.
In post-hoc analysis by day of treatment initiation, clinical and virological outcomes (except stool samples) were superior in patients admitted less than 7 days after symptom onset for the 52 patients who received a least one interferon dose plus lopinavir/ritonavir and ribavirin, compared with 24 patients randomized to the control arm (lopinavir/ritonavir only). In contrast, among patients admitted and started on treatment at day 7 or later after symptom onset, there were no differences between those who received lopinavir/ritonavir alone or combined with ribavirin.
Adverse events were reported in 41 of 86 patients in the combination group and 20 of 41 patients in the control arm. The most common adverse events were diarrhea, occurring in 52 of all 127 patients, fever in 48, nausea in 43, and elevated alanine transaminase level in 18. The side effects generally resolved within 3 days of the start of treatments.
There were no serious adverse events reported in the combination group. One patient in the control group had impaired hepatic enzymes requiring discontinuation of treatment. No patients died during the study.
The study was funded by the Shaw Foundation, Richard and Carol Yu, May Tam Mak Mei Yin, and Sanming Project of Medicine. The authors and Dr. Medoff declared no competing interests.
SOURCE: Hung IFN et al. Lancet. 2020 May 8. doi: 10.1016/S0140-6736(20)31101-6.
FROM THE LANCET
How to expand the APP role in a crisis
An opportunity to better appreciate the value of PAs, NPs
Advanced practice providers – physician assistants and nurse practitioners – at the 733-bed Emory University Hospital in Atlanta are playing an expanded role in the admission of patients into the hospital, particularly those suspected of having COVID-19.
Before the pandemic crisis, evaluation visits by the APP would have been reviewed on the same day by the supervising physician through an in-person encounter with the patient. The new protocol is not outside of scope-of-practice regulations for APPs in Georgia or of the hospital’s bylaws. But it offers a way to help limit the overall exposure of hospital staff to patients suspected of COVID-19 infection, and the total amount of time providers spend in such patients’ room. Just one provider now needs to meet the patient during the admissions process, while the attending physician can fulfill a requirement for seeing the patient within 24 hours during rounds the following day. Emergency encounters would still be done as needed.
These protocols point toward future conversations about the limits to APPs’ scope of practice, and whether more expansive approaches could be widely adopted once the current crisis is over, say advocates for the APPs’ role.
“Our APPs are primarily doing the admissions to the hospital of COVID patients and of non-COVID patients, as we’ve always done. But with COVID-infected or -suspected patients, we’re trying to minimize exposure for our providers,” explained Susan Ortiz, a certified PA, lead APP at Emory University Hospital. “In this way, we can also see more patients more efficiently.” Ms. Ortiz said she finds in talking to other APP leads in the Emory system that “each facility has its own culture and way of doing things. But for the most part, they’re all trying to do something to limit providers’ time in patients’ rooms.”
In response to the rapidly moving crisis, tactics to limit personnel in COVID patients’ rooms to the “absolutely essential” include gathering much of the needed history and other information requested from the patient by telephone, Ms. Ortiz said. This can be done either over the patient’s own cell phone or a phone placed in the room by hospital staff. Family members may be called to supplement this information, with the patient’s consent.
Once vital sign monitoring equipment is hooked up, it is possible to monitor the patient’s vital signs remotely without making frequent trips into the room. That way, in-person vital sign monitoring doesn’t need to happen routinely – at least not as often. One observation by clinicians on Ms. Ortiz’s team: listening for lung sounds with a stethoscope has not been shown to alter treatment for these patients. Once a chest X-ray shows structural changes in a patient’s lung, all lung exams are going to sound bad.
The admitting provider still needs to meet the patient in person for part of the admission visit and physical exam, but the amount of time spent in close personal contact with the patient can be much shorter, Ms. Ortiz said. For patients who are admitted, if there is a question about difficulty swallowing, they will see a speech pathologist, and if evidence of malnutrition, a nutritionist. “But we have to be extremely thoughtful about when people go into the room. So we are not ordering these ancillary services as routinely as we do during non-COVID times,” she said.
Appropriate levels of fear
Emory’s hospitalists are communicating daily about a rapidly changing situation. “We get a note by email every day, and we have a Dropbox account for downloading more information,” Ms. Ortiz said. A joint on-call system is used to provide backup coverage of APPs at the seven Emory hospitals. When replacement shifts need filling in a hurry, practitioners are able to obtain emergency credentials at any of the other hospitals. “It’s a voluntary process to sign up to be on-call,” Ms. Ortiz said. So far, that has been sufficient.
All staff have their own level of “appropriate fear” of this infection, Ms. Ortiz noted. “We have an extremely supportive group here to back up those of us who, for good reason, don’t want to be admitting the COVID patients.” Ms. Ortiz opted out of doing COVID admissions because her husband’s health places him at particular risk. “But with the cross-coverage we have, sometimes I’ll provide assistance when needed if a patient is suspected of being infected.” APPs are critical to Emory’s hospital medicine group – not ancillaries. “Everyone here feels that way. So we want to give them a lot of support. We’re all pitching in, doing it together,” she said.
“We said when we started with this, a couple of weeks before the surge started, that you could volunteer to see COVID patients,” said Emory hospitalist Jessica Nave, MD. “As we came to realize that the demand would be greater, we said you would need to opt out of seeing these patients, rather than opt in, and have a reason for doing so.” An example is pregnant staff, of which there seems to be a lot at Emory right now, Dr. Nave said, or those who are immunocompromised for other reasons. Those who don’t opt out are seeing the majority of the COVID patients, depending on actual need.
Dr. Nave is married to another hospitalist at Emory. “We can’t isolate from each other or our children. He and I have a regimented protocol for how we handle the risk, which includes taking off our shoes and clothes in the garage, showering and wiping down every place we might have touched. But those steps are not guarantees.” Other staff at Emory are isolating from their families for weeks at a time. Emory has a conference hotel offering discounted rates to staff. Nine physicians at Emory have been tested for the infection based on presenting symptoms, but at press time none had tested positive.
Streamlining code blue
Another area in which Emory has revised its policies in response to COVID-19 is for in-hospital cardiac arrest code response. Codes are inherently unpredictable, and crowd control has always been an issue for them, Dr. Nave said. “Historically, you could have 15 or more people show up when a code was called. Now, more than ever, we need to limit the number of people involved, for the same reason, avoiding unnecessary patient contact.”
The hospital’s Resuscitation Committee took the lead on developing a new policy, approved by the its Critical Care Committee and COVID Task Force, to limit the number of professionals in the room when running a code to an essential six: two doing chest compression, two managing airways, a code leader, and a critical care nurse. Outside the patient’s door, wearing the same personal protective equipment (PPE), are a pharmacist, recorder, and runner. “If you’re not one of those nine, you don’t need to be involved and should leave the area,” Dr. Nave said.
Staff have been instructed that they need to don appropriate PPE, including gown, mask, and eye wear, before entering the room for a code – even if that delays the start of intervention. “We’ve also made a code kit for each unit with quickly accessible gowns and masks. It should be used only for code blues.”
Increasing flexibility for the team
PAs and NPs in other locations are also exploring opportunities for gearing up to play larger roles in hospital care in the current crisis situation. The American Association of Physician Assistants has urged all U.S. governors to issue executive orders to waive state-specific licensing requirements for physician supervision or collaboration during the crisis, in order to increase flexibility of health care teams to deploy APPs.
AAPA believes the supervisory requirement is the biggest current barrier to mobilizing PAs and NPs. That includes those who have been furloughed from outpatient or other settings but are limited in their ability to contribute to the COVID crisis by the need to sign a supervision agreement with a physician at a new hospital.
The crisis is creating an opportunity to better appreciate the value PAs and NPs bring to health care, said Tracy Cardin, ACNP-BC, SFHM, vice president for advanced practice providers at Sound Physicians, a national hospitalist company based in Tacoma, Wash. The company recently sent a memo to the leadership of hospital sites at which it has contracts, requesting suspension of the hospitals’ requirements for a daily physician supervisory visit for APPs – which can be a hurdle when trying to leverage all hands on deck in the crisis.
NPs and PAs are stepping up and volunteering for COVID patients, Ms. Cardin said. Some have even taken leaves from their jobs to go to New York to help out at the epicenter of the U.S. crisis. “They want to make a difference. We’ve been deploying nonhospital medicine APPs from surgery, primary care, and elsewhere, embedding them on the hospital medicine team.”
Before the crisis, APPs at Sound Physicians weren’t always able to practice at the top of their licenses, depending on the hospital setting, added Alicia Scheffer, CNP, the company’s Great Lakes regional director for APPs. “Then COVID-19 showed up and really expedited conversations about how to maximize caseloads using APPs and about the fear of failing patients due to lack of capacity.”
In several locales, Sound Physicians is using quarantined providers to do telephone triage, or staffing ICUs with APPs backed up by telemedicine. “In APP-led ICUs, where the nurses are leading, they are intubating patients, placing central lines, things we weren’t allowed to do before,” Ms. Scheffer said.
A spirit of improvisation
There is a lot of tension at Emory University Hospital these days, reflecting the fears and uncertainties about the crisis, Dr. Nave said. “But there’s also a strangely powerful camaraderie like I’ve never seen before. When you walk onto the COVID units, you feel immediately bonded to the nurses, the techs, the phlebotomists. And you feel like you could talk about anything.”
Changes such as those made at Emory, have been talked about for a while, for example when hospitalists are having a busy night, she said. “But because this is a big cultural change, some physicians resisted it. We trust our APPs. But if the doctor’s name is on a patient chart, they want to see the patient – just for their own comfort level.”
Ms. Ortiz thinks the experience with the COVID crisis could help to advance the conversation about the appropriate role for APPs and their scope of practice in hospital medicine, once the current crisis has passed. “People were used to always doing things a certain way. This experience, hopefully, will get us to the point where attending physicians have more comfort with the APP’s ability to act autonomously,” she said.
“We’ve also talked about piloting telemedicine examinations using Zoom,” Dr. Nave added. “It’s making us think a lot of remote cross-coverage could be done that way. We’ve talked about using the hospital’s iPads with patients. This crisis really makes you think you want to innovate, in a spirit of improvisation,” she said. “Now is the time to try some of these things.”
Editors note: During the COVID-19 pandemic, many hospitals are seeing unprecedented volumes of patients requiring hospital medicine groups to stretch their current resources and recruit providers from outside their groups to bolster their inpatient services. The Society of Hospital Medicine has put together the following stepwise guide for onboarding traditional outpatient and subspecialty-based providers to work on general medicine wards: COVID-19 nonhospitalist onboarding resources.
An opportunity to better appreciate the value of PAs, NPs
An opportunity to better appreciate the value of PAs, NPs
Advanced practice providers – physician assistants and nurse practitioners – at the 733-bed Emory University Hospital in Atlanta are playing an expanded role in the admission of patients into the hospital, particularly those suspected of having COVID-19.
Before the pandemic crisis, evaluation visits by the APP would have been reviewed on the same day by the supervising physician through an in-person encounter with the patient. The new protocol is not outside of scope-of-practice regulations for APPs in Georgia or of the hospital’s bylaws. But it offers a way to help limit the overall exposure of hospital staff to patients suspected of COVID-19 infection, and the total amount of time providers spend in such patients’ room. Just one provider now needs to meet the patient during the admissions process, while the attending physician can fulfill a requirement for seeing the patient within 24 hours during rounds the following day. Emergency encounters would still be done as needed.
These protocols point toward future conversations about the limits to APPs’ scope of practice, and whether more expansive approaches could be widely adopted once the current crisis is over, say advocates for the APPs’ role.
“Our APPs are primarily doing the admissions to the hospital of COVID patients and of non-COVID patients, as we’ve always done. But with COVID-infected or -suspected patients, we’re trying to minimize exposure for our providers,” explained Susan Ortiz, a certified PA, lead APP at Emory University Hospital. “In this way, we can also see more patients more efficiently.” Ms. Ortiz said she finds in talking to other APP leads in the Emory system that “each facility has its own culture and way of doing things. But for the most part, they’re all trying to do something to limit providers’ time in patients’ rooms.”
In response to the rapidly moving crisis, tactics to limit personnel in COVID patients’ rooms to the “absolutely essential” include gathering much of the needed history and other information requested from the patient by telephone, Ms. Ortiz said. This can be done either over the patient’s own cell phone or a phone placed in the room by hospital staff. Family members may be called to supplement this information, with the patient’s consent.
Once vital sign monitoring equipment is hooked up, it is possible to monitor the patient’s vital signs remotely without making frequent trips into the room. That way, in-person vital sign monitoring doesn’t need to happen routinely – at least not as often. One observation by clinicians on Ms. Ortiz’s team: listening for lung sounds with a stethoscope has not been shown to alter treatment for these patients. Once a chest X-ray shows structural changes in a patient’s lung, all lung exams are going to sound bad.
The admitting provider still needs to meet the patient in person for part of the admission visit and physical exam, but the amount of time spent in close personal contact with the patient can be much shorter, Ms. Ortiz said. For patients who are admitted, if there is a question about difficulty swallowing, they will see a speech pathologist, and if evidence of malnutrition, a nutritionist. “But we have to be extremely thoughtful about when people go into the room. So we are not ordering these ancillary services as routinely as we do during non-COVID times,” she said.
Appropriate levels of fear
Emory’s hospitalists are communicating daily about a rapidly changing situation. “We get a note by email every day, and we have a Dropbox account for downloading more information,” Ms. Ortiz said. A joint on-call system is used to provide backup coverage of APPs at the seven Emory hospitals. When replacement shifts need filling in a hurry, practitioners are able to obtain emergency credentials at any of the other hospitals. “It’s a voluntary process to sign up to be on-call,” Ms. Ortiz said. So far, that has been sufficient.
All staff have their own level of “appropriate fear” of this infection, Ms. Ortiz noted. “We have an extremely supportive group here to back up those of us who, for good reason, don’t want to be admitting the COVID patients.” Ms. Ortiz opted out of doing COVID admissions because her husband’s health places him at particular risk. “But with the cross-coverage we have, sometimes I’ll provide assistance when needed if a patient is suspected of being infected.” APPs are critical to Emory’s hospital medicine group – not ancillaries. “Everyone here feels that way. So we want to give them a lot of support. We’re all pitching in, doing it together,” she said.
“We said when we started with this, a couple of weeks before the surge started, that you could volunteer to see COVID patients,” said Emory hospitalist Jessica Nave, MD. “As we came to realize that the demand would be greater, we said you would need to opt out of seeing these patients, rather than opt in, and have a reason for doing so.” An example is pregnant staff, of which there seems to be a lot at Emory right now, Dr. Nave said, or those who are immunocompromised for other reasons. Those who don’t opt out are seeing the majority of the COVID patients, depending on actual need.
Dr. Nave is married to another hospitalist at Emory. “We can’t isolate from each other or our children. He and I have a regimented protocol for how we handle the risk, which includes taking off our shoes and clothes in the garage, showering and wiping down every place we might have touched. But those steps are not guarantees.” Other staff at Emory are isolating from their families for weeks at a time. Emory has a conference hotel offering discounted rates to staff. Nine physicians at Emory have been tested for the infection based on presenting symptoms, but at press time none had tested positive.
Streamlining code blue
Another area in which Emory has revised its policies in response to COVID-19 is for in-hospital cardiac arrest code response. Codes are inherently unpredictable, and crowd control has always been an issue for them, Dr. Nave said. “Historically, you could have 15 or more people show up when a code was called. Now, more than ever, we need to limit the number of people involved, for the same reason, avoiding unnecessary patient contact.”
The hospital’s Resuscitation Committee took the lead on developing a new policy, approved by the its Critical Care Committee and COVID Task Force, to limit the number of professionals in the room when running a code to an essential six: two doing chest compression, two managing airways, a code leader, and a critical care nurse. Outside the patient’s door, wearing the same personal protective equipment (PPE), are a pharmacist, recorder, and runner. “If you’re not one of those nine, you don’t need to be involved and should leave the area,” Dr. Nave said.
Staff have been instructed that they need to don appropriate PPE, including gown, mask, and eye wear, before entering the room for a code – even if that delays the start of intervention. “We’ve also made a code kit for each unit with quickly accessible gowns and masks. It should be used only for code blues.”
Increasing flexibility for the team
PAs and NPs in other locations are also exploring opportunities for gearing up to play larger roles in hospital care in the current crisis situation. The American Association of Physician Assistants has urged all U.S. governors to issue executive orders to waive state-specific licensing requirements for physician supervision or collaboration during the crisis, in order to increase flexibility of health care teams to deploy APPs.
AAPA believes the supervisory requirement is the biggest current barrier to mobilizing PAs and NPs. That includes those who have been furloughed from outpatient or other settings but are limited in their ability to contribute to the COVID crisis by the need to sign a supervision agreement with a physician at a new hospital.
The crisis is creating an opportunity to better appreciate the value PAs and NPs bring to health care, said Tracy Cardin, ACNP-BC, SFHM, vice president for advanced practice providers at Sound Physicians, a national hospitalist company based in Tacoma, Wash. The company recently sent a memo to the leadership of hospital sites at which it has contracts, requesting suspension of the hospitals’ requirements for a daily physician supervisory visit for APPs – which can be a hurdle when trying to leverage all hands on deck in the crisis.
NPs and PAs are stepping up and volunteering for COVID patients, Ms. Cardin said. Some have even taken leaves from their jobs to go to New York to help out at the epicenter of the U.S. crisis. “They want to make a difference. We’ve been deploying nonhospital medicine APPs from surgery, primary care, and elsewhere, embedding them on the hospital medicine team.”
Before the crisis, APPs at Sound Physicians weren’t always able to practice at the top of their licenses, depending on the hospital setting, added Alicia Scheffer, CNP, the company’s Great Lakes regional director for APPs. “Then COVID-19 showed up and really expedited conversations about how to maximize caseloads using APPs and about the fear of failing patients due to lack of capacity.”
In several locales, Sound Physicians is using quarantined providers to do telephone triage, or staffing ICUs with APPs backed up by telemedicine. “In APP-led ICUs, where the nurses are leading, they are intubating patients, placing central lines, things we weren’t allowed to do before,” Ms. Scheffer said.
A spirit of improvisation
There is a lot of tension at Emory University Hospital these days, reflecting the fears and uncertainties about the crisis, Dr. Nave said. “But there’s also a strangely powerful camaraderie like I’ve never seen before. When you walk onto the COVID units, you feel immediately bonded to the nurses, the techs, the phlebotomists. And you feel like you could talk about anything.”
Changes such as those made at Emory, have been talked about for a while, for example when hospitalists are having a busy night, she said. “But because this is a big cultural change, some physicians resisted it. We trust our APPs. But if the doctor’s name is on a patient chart, they want to see the patient – just for their own comfort level.”
Ms. Ortiz thinks the experience with the COVID crisis could help to advance the conversation about the appropriate role for APPs and their scope of practice in hospital medicine, once the current crisis has passed. “People were used to always doing things a certain way. This experience, hopefully, will get us to the point where attending physicians have more comfort with the APP’s ability to act autonomously,” she said.
“We’ve also talked about piloting telemedicine examinations using Zoom,” Dr. Nave added. “It’s making us think a lot of remote cross-coverage could be done that way. We’ve talked about using the hospital’s iPads with patients. This crisis really makes you think you want to innovate, in a spirit of improvisation,” she said. “Now is the time to try some of these things.”
Editors note: During the COVID-19 pandemic, many hospitals are seeing unprecedented volumes of patients requiring hospital medicine groups to stretch their current resources and recruit providers from outside their groups to bolster their inpatient services. The Society of Hospital Medicine has put together the following stepwise guide for onboarding traditional outpatient and subspecialty-based providers to work on general medicine wards: COVID-19 nonhospitalist onboarding resources.
Advanced practice providers – physician assistants and nurse practitioners – at the 733-bed Emory University Hospital in Atlanta are playing an expanded role in the admission of patients into the hospital, particularly those suspected of having COVID-19.
Before the pandemic crisis, evaluation visits by the APP would have been reviewed on the same day by the supervising physician through an in-person encounter with the patient. The new protocol is not outside of scope-of-practice regulations for APPs in Georgia or of the hospital’s bylaws. But it offers a way to help limit the overall exposure of hospital staff to patients suspected of COVID-19 infection, and the total amount of time providers spend in such patients’ room. Just one provider now needs to meet the patient during the admissions process, while the attending physician can fulfill a requirement for seeing the patient within 24 hours during rounds the following day. Emergency encounters would still be done as needed.
These protocols point toward future conversations about the limits to APPs’ scope of practice, and whether more expansive approaches could be widely adopted once the current crisis is over, say advocates for the APPs’ role.
“Our APPs are primarily doing the admissions to the hospital of COVID patients and of non-COVID patients, as we’ve always done. But with COVID-infected or -suspected patients, we’re trying to minimize exposure for our providers,” explained Susan Ortiz, a certified PA, lead APP at Emory University Hospital. “In this way, we can also see more patients more efficiently.” Ms. Ortiz said she finds in talking to other APP leads in the Emory system that “each facility has its own culture and way of doing things. But for the most part, they’re all trying to do something to limit providers’ time in patients’ rooms.”
In response to the rapidly moving crisis, tactics to limit personnel in COVID patients’ rooms to the “absolutely essential” include gathering much of the needed history and other information requested from the patient by telephone, Ms. Ortiz said. This can be done either over the patient’s own cell phone or a phone placed in the room by hospital staff. Family members may be called to supplement this information, with the patient’s consent.
Once vital sign monitoring equipment is hooked up, it is possible to monitor the patient’s vital signs remotely without making frequent trips into the room. That way, in-person vital sign monitoring doesn’t need to happen routinely – at least not as often. One observation by clinicians on Ms. Ortiz’s team: listening for lung sounds with a stethoscope has not been shown to alter treatment for these patients. Once a chest X-ray shows structural changes in a patient’s lung, all lung exams are going to sound bad.
The admitting provider still needs to meet the patient in person for part of the admission visit and physical exam, but the amount of time spent in close personal contact with the patient can be much shorter, Ms. Ortiz said. For patients who are admitted, if there is a question about difficulty swallowing, they will see a speech pathologist, and if evidence of malnutrition, a nutritionist. “But we have to be extremely thoughtful about when people go into the room. So we are not ordering these ancillary services as routinely as we do during non-COVID times,” she said.
Appropriate levels of fear
Emory’s hospitalists are communicating daily about a rapidly changing situation. “We get a note by email every day, and we have a Dropbox account for downloading more information,” Ms. Ortiz said. A joint on-call system is used to provide backup coverage of APPs at the seven Emory hospitals. When replacement shifts need filling in a hurry, practitioners are able to obtain emergency credentials at any of the other hospitals. “It’s a voluntary process to sign up to be on-call,” Ms. Ortiz said. So far, that has been sufficient.
All staff have their own level of “appropriate fear” of this infection, Ms. Ortiz noted. “We have an extremely supportive group here to back up those of us who, for good reason, don’t want to be admitting the COVID patients.” Ms. Ortiz opted out of doing COVID admissions because her husband’s health places him at particular risk. “But with the cross-coverage we have, sometimes I’ll provide assistance when needed if a patient is suspected of being infected.” APPs are critical to Emory’s hospital medicine group – not ancillaries. “Everyone here feels that way. So we want to give them a lot of support. We’re all pitching in, doing it together,” she said.
“We said when we started with this, a couple of weeks before the surge started, that you could volunteer to see COVID patients,” said Emory hospitalist Jessica Nave, MD. “As we came to realize that the demand would be greater, we said you would need to opt out of seeing these patients, rather than opt in, and have a reason for doing so.” An example is pregnant staff, of which there seems to be a lot at Emory right now, Dr. Nave said, or those who are immunocompromised for other reasons. Those who don’t opt out are seeing the majority of the COVID patients, depending on actual need.
Dr. Nave is married to another hospitalist at Emory. “We can’t isolate from each other or our children. He and I have a regimented protocol for how we handle the risk, which includes taking off our shoes and clothes in the garage, showering and wiping down every place we might have touched. But those steps are not guarantees.” Other staff at Emory are isolating from their families for weeks at a time. Emory has a conference hotel offering discounted rates to staff. Nine physicians at Emory have been tested for the infection based on presenting symptoms, but at press time none had tested positive.
Streamlining code blue
Another area in which Emory has revised its policies in response to COVID-19 is for in-hospital cardiac arrest code response. Codes are inherently unpredictable, and crowd control has always been an issue for them, Dr. Nave said. “Historically, you could have 15 or more people show up when a code was called. Now, more than ever, we need to limit the number of people involved, for the same reason, avoiding unnecessary patient contact.”
The hospital’s Resuscitation Committee took the lead on developing a new policy, approved by the its Critical Care Committee and COVID Task Force, to limit the number of professionals in the room when running a code to an essential six: two doing chest compression, two managing airways, a code leader, and a critical care nurse. Outside the patient’s door, wearing the same personal protective equipment (PPE), are a pharmacist, recorder, and runner. “If you’re not one of those nine, you don’t need to be involved and should leave the area,” Dr. Nave said.
Staff have been instructed that they need to don appropriate PPE, including gown, mask, and eye wear, before entering the room for a code – even if that delays the start of intervention. “We’ve also made a code kit for each unit with quickly accessible gowns and masks. It should be used only for code blues.”
Increasing flexibility for the team
PAs and NPs in other locations are also exploring opportunities for gearing up to play larger roles in hospital care in the current crisis situation. The American Association of Physician Assistants has urged all U.S. governors to issue executive orders to waive state-specific licensing requirements for physician supervision or collaboration during the crisis, in order to increase flexibility of health care teams to deploy APPs.
AAPA believes the supervisory requirement is the biggest current barrier to mobilizing PAs and NPs. That includes those who have been furloughed from outpatient or other settings but are limited in their ability to contribute to the COVID crisis by the need to sign a supervision agreement with a physician at a new hospital.
The crisis is creating an opportunity to better appreciate the value PAs and NPs bring to health care, said Tracy Cardin, ACNP-BC, SFHM, vice president for advanced practice providers at Sound Physicians, a national hospitalist company based in Tacoma, Wash. The company recently sent a memo to the leadership of hospital sites at which it has contracts, requesting suspension of the hospitals’ requirements for a daily physician supervisory visit for APPs – which can be a hurdle when trying to leverage all hands on deck in the crisis.
NPs and PAs are stepping up and volunteering for COVID patients, Ms. Cardin said. Some have even taken leaves from their jobs to go to New York to help out at the epicenter of the U.S. crisis. “They want to make a difference. We’ve been deploying nonhospital medicine APPs from surgery, primary care, and elsewhere, embedding them on the hospital medicine team.”
Before the crisis, APPs at Sound Physicians weren’t always able to practice at the top of their licenses, depending on the hospital setting, added Alicia Scheffer, CNP, the company’s Great Lakes regional director for APPs. “Then COVID-19 showed up and really expedited conversations about how to maximize caseloads using APPs and about the fear of failing patients due to lack of capacity.”
In several locales, Sound Physicians is using quarantined providers to do telephone triage, or staffing ICUs with APPs backed up by telemedicine. “In APP-led ICUs, where the nurses are leading, they are intubating patients, placing central lines, things we weren’t allowed to do before,” Ms. Scheffer said.
A spirit of improvisation
There is a lot of tension at Emory University Hospital these days, reflecting the fears and uncertainties about the crisis, Dr. Nave said. “But there’s also a strangely powerful camaraderie like I’ve never seen before. When you walk onto the COVID units, you feel immediately bonded to the nurses, the techs, the phlebotomists. And you feel like you could talk about anything.”
Changes such as those made at Emory, have been talked about for a while, for example when hospitalists are having a busy night, she said. “But because this is a big cultural change, some physicians resisted it. We trust our APPs. But if the doctor’s name is on a patient chart, they want to see the patient – just for their own comfort level.”
Ms. Ortiz thinks the experience with the COVID crisis could help to advance the conversation about the appropriate role for APPs and their scope of practice in hospital medicine, once the current crisis has passed. “People were used to always doing things a certain way. This experience, hopefully, will get us to the point where attending physicians have more comfort with the APP’s ability to act autonomously,” she said.
“We’ve also talked about piloting telemedicine examinations using Zoom,” Dr. Nave added. “It’s making us think a lot of remote cross-coverage could be done that way. We’ve talked about using the hospital’s iPads with patients. This crisis really makes you think you want to innovate, in a spirit of improvisation,” she said. “Now is the time to try some of these things.”
Editors note: During the COVID-19 pandemic, many hospitals are seeing unprecedented volumes of patients requiring hospital medicine groups to stretch their current resources and recruit providers from outside their groups to bolster their inpatient services. The Society of Hospital Medicine has put together the following stepwise guide for onboarding traditional outpatient and subspecialty-based providers to work on general medicine wards: COVID-19 nonhospitalist onboarding resources.
How to responsibly engage with social media during disasters
A few months into the COVID-19 pandemic, social media’s role in the rapid spread of information is undeniable. From the beginning, Chinese ophthalmologist Li Wenliang, MD, first raised the alarm to his classmates through WeChat, a messaging and social media app. Since that time, individuals, groups, organizations, government agencies, and mass media outlets have used social media to share ideas and disseminate information. Individuals check in on loved ones and update others on their own safety. Networks of clinicians discuss patient presentations, new therapeutics, management strategies, and institutional protocols. Multiple organizations including the Federal Emergency Management Agency, the Centers for Disease Control and Prevention, and the World Health Organization use Facebook, Instagram, or Twitter accounts to provide updates on ongoing efforts and spread public health messaging.
Unfortunately, not all information is trustworthy. Social media outlets have been used to spread misinformation and conspiracy theories, and to promote false treatments. Google, YouTube, and Facebook are now actively trying to reduce the viral spread of misleading information and to block hoaxes. With the increasing amount of news and information consumed and disseminated via social media, clinicians need to critically appraise information presented on those platforms, and to be familiar with how to use them to disseminate informed, effective, and responsible information.
Appraisal of social media content
Traditional scholarly communication exists in many forms and includes observations, anecdotes, perspectives, case reports, and research. Each form involves differing levels of academic rigor and standards of evaluation. Electronic content and online resources pose a unique challenge because there is no standardized method for assessing impact and quality. Proposed scales for evaluation of online resources such as Medical Education Translational Resources: Impact and Quality (METRIQ),1 Academic Life in Emergency Medicine Approved Instructional Resources (AliEM AIR) scoring system,2 and the Social Media Index3 are promising and can be used to guide critical appraisal of social media content.
The same skepticism and critical thinking applied to traditional resources should be applied when evaluating online resources. The scales listed above include questions such as:
- How accurate is the data presented and conclusions drawn?
- Does the content reflect evidence-based medicine?
- Has the content undergone an editorial process?
- Who are the authors and what are their credentials?
- Are there potential biases or conflicts of interest present?
- Have references been cited?
- How does this content affect/change clinical practice?
While these proposed review metrics may not apply to all forms of social media content, clinicians should be discerning when consuming or disseminating online content.
Strategies for effective communication on social media
In addition to appraising social media content, clinicians also should be able to craft effective messages on social media to spread trustworthy content. The CDC offers guidelines and best practices for social media communication4,5 and the WHO has created a framework for effective communications.6 Both organizations recognize social media as a powerful communication tool that has the potential to greatly impact public health efforts.
Some key principles highlighted from these sources include the following:
- Identify an audience and make messages relevant. Taking time to listen to key stakeholders within the target audience (individuals, health care providers, communities, policy-makers, organizations) allows for better understanding of baseline knowledge, attitudes, and beliefs that may drive concerns and ultimately helps to tailor the messaging.
- Make messages accessible. Certain social media platforms are more often utilized for specific target audiences. Verbiage used should take into account the health literacy of the audience. A friendly, professional, conversational tone encourages interaction and dialogue.
- Engage the audience by offering something actionable. Changing behavior is a daunting task that involves multiple steps. Encouraging behavioral changes initially at an individual level has the potential to influence community practices and policies.
- Communication should be timely. It should address current and urgent topics. Keep abreast of the situation as it evolves to ensure messaging stays relevant. Deliver consistent messaging and updates.
- Sources must be credible. It is important to be transparent about expertise and honest about what is known and unknown about the topic.
- Content should be understandable. In addition to using plain language, visual aids and real stories can be used to reinforce messages.
Use social media responsibly
Clinicians have a responsibility to use social media to disseminate credible content, refute misleading content, and create accurate content. When clinicians share health-related information via social media, it should be appraised skeptically and crafted responsibly because that message can have profound implications on public health. Mixed messaging that is contradictory, inconsistent, or unclear can lead to panic and confusion. By recognizing the important role of social media in access to information and as a tool for public health messaging and crisis communication, clinicians have an obligation to consider both the positive and negative impacts as messengers in that space.
Dr. Ren is a pediatric emergency medicine fellow at Children’s National Hospital, Washington. Dr. Simpson is a pediatric emergency medicine attending and medical director of emergency preparedness of Children’s National Hospital. They do not have any disclosures or conflicts of interest. Email Dr. Ren and Dr. Simpson at pdnews@mdedge.com.
References
1. AEM Educ Train. 2019;3(4):387-92.
2. Ann Emerg Med. 2016;68(6):729-35.
3. Ann Emerg Med. 2018;72(6):696-702.
4. CDC Guide to Writing for Social Media.
5. The Health Communicator’s Social Media Toolkit.
6. WHO Strategic Communications Framework for effective communications.
A few months into the COVID-19 pandemic, social media’s role in the rapid spread of information is undeniable. From the beginning, Chinese ophthalmologist Li Wenliang, MD, first raised the alarm to his classmates through WeChat, a messaging and social media app. Since that time, individuals, groups, organizations, government agencies, and mass media outlets have used social media to share ideas and disseminate information. Individuals check in on loved ones and update others on their own safety. Networks of clinicians discuss patient presentations, new therapeutics, management strategies, and institutional protocols. Multiple organizations including the Federal Emergency Management Agency, the Centers for Disease Control and Prevention, and the World Health Organization use Facebook, Instagram, or Twitter accounts to provide updates on ongoing efforts and spread public health messaging.
Unfortunately, not all information is trustworthy. Social media outlets have been used to spread misinformation and conspiracy theories, and to promote false treatments. Google, YouTube, and Facebook are now actively trying to reduce the viral spread of misleading information and to block hoaxes. With the increasing amount of news and information consumed and disseminated via social media, clinicians need to critically appraise information presented on those platforms, and to be familiar with how to use them to disseminate informed, effective, and responsible information.
Appraisal of social media content
Traditional scholarly communication exists in many forms and includes observations, anecdotes, perspectives, case reports, and research. Each form involves differing levels of academic rigor and standards of evaluation. Electronic content and online resources pose a unique challenge because there is no standardized method for assessing impact and quality. Proposed scales for evaluation of online resources such as Medical Education Translational Resources: Impact and Quality (METRIQ),1 Academic Life in Emergency Medicine Approved Instructional Resources (AliEM AIR) scoring system,2 and the Social Media Index3 are promising and can be used to guide critical appraisal of social media content.
The same skepticism and critical thinking applied to traditional resources should be applied when evaluating online resources. The scales listed above include questions such as:
- How accurate is the data presented and conclusions drawn?
- Does the content reflect evidence-based medicine?
- Has the content undergone an editorial process?
- Who are the authors and what are their credentials?
- Are there potential biases or conflicts of interest present?
- Have references been cited?
- How does this content affect/change clinical practice?
While these proposed review metrics may not apply to all forms of social media content, clinicians should be discerning when consuming or disseminating online content.
Strategies for effective communication on social media
In addition to appraising social media content, clinicians also should be able to craft effective messages on social media to spread trustworthy content. The CDC offers guidelines and best practices for social media communication4,5 and the WHO has created a framework for effective communications.6 Both organizations recognize social media as a powerful communication tool that has the potential to greatly impact public health efforts.
Some key principles highlighted from these sources include the following:
- Identify an audience and make messages relevant. Taking time to listen to key stakeholders within the target audience (individuals, health care providers, communities, policy-makers, organizations) allows for better understanding of baseline knowledge, attitudes, and beliefs that may drive concerns and ultimately helps to tailor the messaging.
- Make messages accessible. Certain social media platforms are more often utilized for specific target audiences. Verbiage used should take into account the health literacy of the audience. A friendly, professional, conversational tone encourages interaction and dialogue.
- Engage the audience by offering something actionable. Changing behavior is a daunting task that involves multiple steps. Encouraging behavioral changes initially at an individual level has the potential to influence community practices and policies.
- Communication should be timely. It should address current and urgent topics. Keep abreast of the situation as it evolves to ensure messaging stays relevant. Deliver consistent messaging and updates.
- Sources must be credible. It is important to be transparent about expertise and honest about what is known and unknown about the topic.
- Content should be understandable. In addition to using plain language, visual aids and real stories can be used to reinforce messages.
Use social media responsibly
Clinicians have a responsibility to use social media to disseminate credible content, refute misleading content, and create accurate content. When clinicians share health-related information via social media, it should be appraised skeptically and crafted responsibly because that message can have profound implications on public health. Mixed messaging that is contradictory, inconsistent, or unclear can lead to panic and confusion. By recognizing the important role of social media in access to information and as a tool for public health messaging and crisis communication, clinicians have an obligation to consider both the positive and negative impacts as messengers in that space.
Dr. Ren is a pediatric emergency medicine fellow at Children’s National Hospital, Washington. Dr. Simpson is a pediatric emergency medicine attending and medical director of emergency preparedness of Children’s National Hospital. They do not have any disclosures or conflicts of interest. Email Dr. Ren and Dr. Simpson at pdnews@mdedge.com.
References
1. AEM Educ Train. 2019;3(4):387-92.
2. Ann Emerg Med. 2016;68(6):729-35.
3. Ann Emerg Med. 2018;72(6):696-702.
4. CDC Guide to Writing for Social Media.
5. The Health Communicator’s Social Media Toolkit.
6. WHO Strategic Communications Framework for effective communications.
A few months into the COVID-19 pandemic, social media’s role in the rapid spread of information is undeniable. From the beginning, Chinese ophthalmologist Li Wenliang, MD, first raised the alarm to his classmates through WeChat, a messaging and social media app. Since that time, individuals, groups, organizations, government agencies, and mass media outlets have used social media to share ideas and disseminate information. Individuals check in on loved ones and update others on their own safety. Networks of clinicians discuss patient presentations, new therapeutics, management strategies, and institutional protocols. Multiple organizations including the Federal Emergency Management Agency, the Centers for Disease Control and Prevention, and the World Health Organization use Facebook, Instagram, or Twitter accounts to provide updates on ongoing efforts and spread public health messaging.
Unfortunately, not all information is trustworthy. Social media outlets have been used to spread misinformation and conspiracy theories, and to promote false treatments. Google, YouTube, and Facebook are now actively trying to reduce the viral spread of misleading information and to block hoaxes. With the increasing amount of news and information consumed and disseminated via social media, clinicians need to critically appraise information presented on those platforms, and to be familiar with how to use them to disseminate informed, effective, and responsible information.
Appraisal of social media content
Traditional scholarly communication exists in many forms and includes observations, anecdotes, perspectives, case reports, and research. Each form involves differing levels of academic rigor and standards of evaluation. Electronic content and online resources pose a unique challenge because there is no standardized method for assessing impact and quality. Proposed scales for evaluation of online resources such as Medical Education Translational Resources: Impact and Quality (METRIQ),1 Academic Life in Emergency Medicine Approved Instructional Resources (AliEM AIR) scoring system,2 and the Social Media Index3 are promising and can be used to guide critical appraisal of social media content.
The same skepticism and critical thinking applied to traditional resources should be applied when evaluating online resources. The scales listed above include questions such as:
- How accurate is the data presented and conclusions drawn?
- Does the content reflect evidence-based medicine?
- Has the content undergone an editorial process?
- Who are the authors and what are their credentials?
- Are there potential biases or conflicts of interest present?
- Have references been cited?
- How does this content affect/change clinical practice?
While these proposed review metrics may not apply to all forms of social media content, clinicians should be discerning when consuming or disseminating online content.
Strategies for effective communication on social media
In addition to appraising social media content, clinicians also should be able to craft effective messages on social media to spread trustworthy content. The CDC offers guidelines and best practices for social media communication4,5 and the WHO has created a framework for effective communications.6 Both organizations recognize social media as a powerful communication tool that has the potential to greatly impact public health efforts.
Some key principles highlighted from these sources include the following:
- Identify an audience and make messages relevant. Taking time to listen to key stakeholders within the target audience (individuals, health care providers, communities, policy-makers, organizations) allows for better understanding of baseline knowledge, attitudes, and beliefs that may drive concerns and ultimately helps to tailor the messaging.
- Make messages accessible. Certain social media platforms are more often utilized for specific target audiences. Verbiage used should take into account the health literacy of the audience. A friendly, professional, conversational tone encourages interaction and dialogue.
- Engage the audience by offering something actionable. Changing behavior is a daunting task that involves multiple steps. Encouraging behavioral changes initially at an individual level has the potential to influence community practices and policies.
- Communication should be timely. It should address current and urgent topics. Keep abreast of the situation as it evolves to ensure messaging stays relevant. Deliver consistent messaging and updates.
- Sources must be credible. It is important to be transparent about expertise and honest about what is known and unknown about the topic.
- Content should be understandable. In addition to using plain language, visual aids and real stories can be used to reinforce messages.
Use social media responsibly
Clinicians have a responsibility to use social media to disseminate credible content, refute misleading content, and create accurate content. When clinicians share health-related information via social media, it should be appraised skeptically and crafted responsibly because that message can have profound implications on public health. Mixed messaging that is contradictory, inconsistent, or unclear can lead to panic and confusion. By recognizing the important role of social media in access to information and as a tool for public health messaging and crisis communication, clinicians have an obligation to consider both the positive and negative impacts as messengers in that space.
Dr. Ren is a pediatric emergency medicine fellow at Children’s National Hospital, Washington. Dr. Simpson is a pediatric emergency medicine attending and medical director of emergency preparedness of Children’s National Hospital. They do not have any disclosures or conflicts of interest. Email Dr. Ren and Dr. Simpson at pdnews@mdedge.com.
References
1. AEM Educ Train. 2019;3(4):387-92.
2. Ann Emerg Med. 2016;68(6):729-35.
3. Ann Emerg Med. 2018;72(6):696-702.
4. CDC Guide to Writing for Social Media.
5. The Health Communicator’s Social Media Toolkit.
6. WHO Strategic Communications Framework for effective communications.
What does COVID-19 mean for child safety?
In my home county of San Diego, school closure has meant some 800,000 children staying home.1 Parents love and are committed to care for their children, but as these parents struggle with food insecurity and mass unemployment, local pediatricians are joining their national colleagues in worrying about rising rates of child abuse.
Dr. Gwendolyn Wright, a local pediatrician at Scripps Coastal Medical Center, San Diego, explains. “Obviously, it’s easy for tempers to flare,” during this stressful time, “so there is increased risk for child abuse. And there’s no one else with eyes on the kids. Usually, there would be teachers at schools and other childcare workers who would have eyes on the kid. And now there is none of that extra protection.”
2018 data from the National Child Abuse and Neglect Data System showed that in 91.7% of child abuse cases, one or more parent perpetrated the abuse.2 Prior reporting in our county showed that calls to the child abuse hotline went down nearly 60% a week after school closure.3 However, this is not necessarily good news. NCANDS data show that educational personnel report 20% of child abuse cases – far more than the number of cases reported by social services, medical professionals, or family members.2
Teachers, childcare workers, law enforcement, and medical professionals all are mandated reporters, meaning that they are legally obligated to report any suspected cases of child abuse to Child Welfare Services. Accordingly, they receive training on how to spot signs of child abuse.
Sometimes, the signs are obvious, sometimes subtle. Subtle injuries are called “sentinel” injuries. In a landmark study published in Pediatrics in 2013, a “sentinel” injury was defined as “a previous injury reported in the medical history that was suspicious for abuse because the infant could not cruise, or the explanation was implausible.” Sentinel injuries can be mild bruising or oral injuries in a young infant. These injuries suggest “there may be escalating and repeated violence toward the infant” that can culminate in death.4,5
In this study, severely abused infants were 4.4 times more likely to initially have come to the doctor with a sentinel injury. Of concern, 42% of parents of definitely abused children reported that a medical provider was aware of the sentinel injury. Of these cases, 56% did not show evidence that a professional was worried about abuse. These data show that medical professionals do miss cases of child abuse.
The cost of child abuse is real and lifelong. According to a policy statement from the American Academy of Pediatrics Council on Child Abuse and Neglect, a quarter of kids who suffer abusive head trauma die. Of the survivors, nearly 70% “have some degree of lasting neurological impairment.”5
Given the potentially disastrous consequences of child abuse, we must stay vigilant about child abuse. In our own profession, we must educate trainees and update experienced pediatricians about suspecting child abuse and reporting. For example, child abuse can be suspected and reported based on telemedicine interactions. The burden of proof for reporting child abuse is only “reasonable suspicion,” not “beyond a reasonable doubt.” In our communities, we must engage with local Child Welfare Services workers and educate them about sentinel injuries. And finally, in our practices, we must build families up with awareness, resources, and coping mechanisms to prevent abuse from happening in the first place.
Dr. Helen C. Wang, associate professor of pediatrics at the University of California, San Diego, talks to parents about managing stress early and often. She says, “I start counseling families at the prenatal visit. I do talk to families about what they liked to do before children. What brought you joy? What communities do you spend time with? And what have you been doing now?”
It can be hard to reconcile prior hobbies with the current recommendations of social distancing. “Now it’s more ‘Do FaceTime’ and ‘Do Zoom’ and spend more time with your extended family,” says Dr. Wang.
By caring for themselves, parents can better protect their children from mistreatment and injury. Healthychildren.org, the parent-facing website of the AAP, offers several tips for parenting in times of stress.
In this unusual time of COVID-19, it is more important than ever to provide parents with suggestions and strategies that will help them – and their children – survive this health crisis. By educating ourselves and our communities about child abuse, we as pediatricians can fulfill our mandate in keeping kids healthy and thriving.
Dr. Parekh is a pediatric resident at University of California, San Diego. She has no financial disclosures. Email Dr. Parekh at pdnews@mdedge.com.
References
1. Early childhood age group in California. kidsdata.org.
2. U.S. Department of Health & Human Services, Administration for Children and Families, Administration on Children, Youth and Families, Children’s Bureau. (2020). Child Maltreatment 2018.
3. Hong Joe. “School closures lead to troubling drop in child abuse reports.” KPBS. 2020 Mar 27.
4. Pediatrics. 2013 Apr;131(4):701-7.
5. Pediatrics. 2020;145(4):e20200203.
In my home county of San Diego, school closure has meant some 800,000 children staying home.1 Parents love and are committed to care for their children, but as these parents struggle with food insecurity and mass unemployment, local pediatricians are joining their national colleagues in worrying about rising rates of child abuse.
Dr. Gwendolyn Wright, a local pediatrician at Scripps Coastal Medical Center, San Diego, explains. “Obviously, it’s easy for tempers to flare,” during this stressful time, “so there is increased risk for child abuse. And there’s no one else with eyes on the kids. Usually, there would be teachers at schools and other childcare workers who would have eyes on the kid. And now there is none of that extra protection.”
2018 data from the National Child Abuse and Neglect Data System showed that in 91.7% of child abuse cases, one or more parent perpetrated the abuse.2 Prior reporting in our county showed that calls to the child abuse hotline went down nearly 60% a week after school closure.3 However, this is not necessarily good news. NCANDS data show that educational personnel report 20% of child abuse cases – far more than the number of cases reported by social services, medical professionals, or family members.2
Teachers, childcare workers, law enforcement, and medical professionals all are mandated reporters, meaning that they are legally obligated to report any suspected cases of child abuse to Child Welfare Services. Accordingly, they receive training on how to spot signs of child abuse.
Sometimes, the signs are obvious, sometimes subtle. Subtle injuries are called “sentinel” injuries. In a landmark study published in Pediatrics in 2013, a “sentinel” injury was defined as “a previous injury reported in the medical history that was suspicious for abuse because the infant could not cruise, or the explanation was implausible.” Sentinel injuries can be mild bruising or oral injuries in a young infant. These injuries suggest “there may be escalating and repeated violence toward the infant” that can culminate in death.4,5
In this study, severely abused infants were 4.4 times more likely to initially have come to the doctor with a sentinel injury. Of concern, 42% of parents of definitely abused children reported that a medical provider was aware of the sentinel injury. Of these cases, 56% did not show evidence that a professional was worried about abuse. These data show that medical professionals do miss cases of child abuse.
The cost of child abuse is real and lifelong. According to a policy statement from the American Academy of Pediatrics Council on Child Abuse and Neglect, a quarter of kids who suffer abusive head trauma die. Of the survivors, nearly 70% “have some degree of lasting neurological impairment.”5
Given the potentially disastrous consequences of child abuse, we must stay vigilant about child abuse. In our own profession, we must educate trainees and update experienced pediatricians about suspecting child abuse and reporting. For example, child abuse can be suspected and reported based on telemedicine interactions. The burden of proof for reporting child abuse is only “reasonable suspicion,” not “beyond a reasonable doubt.” In our communities, we must engage with local Child Welfare Services workers and educate them about sentinel injuries. And finally, in our practices, we must build families up with awareness, resources, and coping mechanisms to prevent abuse from happening in the first place.
Dr. Helen C. Wang, associate professor of pediatrics at the University of California, San Diego, talks to parents about managing stress early and often. She says, “I start counseling families at the prenatal visit. I do talk to families about what they liked to do before children. What brought you joy? What communities do you spend time with? And what have you been doing now?”
It can be hard to reconcile prior hobbies with the current recommendations of social distancing. “Now it’s more ‘Do FaceTime’ and ‘Do Zoom’ and spend more time with your extended family,” says Dr. Wang.
By caring for themselves, parents can better protect their children from mistreatment and injury. Healthychildren.org, the parent-facing website of the AAP, offers several tips for parenting in times of stress.
In this unusual time of COVID-19, it is more important than ever to provide parents with suggestions and strategies that will help them – and their children – survive this health crisis. By educating ourselves and our communities about child abuse, we as pediatricians can fulfill our mandate in keeping kids healthy and thriving.
Dr. Parekh is a pediatric resident at University of California, San Diego. She has no financial disclosures. Email Dr. Parekh at pdnews@mdedge.com.
References
1. Early childhood age group in California. kidsdata.org.
2. U.S. Department of Health & Human Services, Administration for Children and Families, Administration on Children, Youth and Families, Children’s Bureau. (2020). Child Maltreatment 2018.
3. Hong Joe. “School closures lead to troubling drop in child abuse reports.” KPBS. 2020 Mar 27.
4. Pediatrics. 2013 Apr;131(4):701-7.
5. Pediatrics. 2020;145(4):e20200203.
In my home county of San Diego, school closure has meant some 800,000 children staying home.1 Parents love and are committed to care for their children, but as these parents struggle with food insecurity and mass unemployment, local pediatricians are joining their national colleagues in worrying about rising rates of child abuse.
Dr. Gwendolyn Wright, a local pediatrician at Scripps Coastal Medical Center, San Diego, explains. “Obviously, it’s easy for tempers to flare,” during this stressful time, “so there is increased risk for child abuse. And there’s no one else with eyes on the kids. Usually, there would be teachers at schools and other childcare workers who would have eyes on the kid. And now there is none of that extra protection.”
2018 data from the National Child Abuse and Neglect Data System showed that in 91.7% of child abuse cases, one or more parent perpetrated the abuse.2 Prior reporting in our county showed that calls to the child abuse hotline went down nearly 60% a week after school closure.3 However, this is not necessarily good news. NCANDS data show that educational personnel report 20% of child abuse cases – far more than the number of cases reported by social services, medical professionals, or family members.2
Teachers, childcare workers, law enforcement, and medical professionals all are mandated reporters, meaning that they are legally obligated to report any suspected cases of child abuse to Child Welfare Services. Accordingly, they receive training on how to spot signs of child abuse.
Sometimes, the signs are obvious, sometimes subtle. Subtle injuries are called “sentinel” injuries. In a landmark study published in Pediatrics in 2013, a “sentinel” injury was defined as “a previous injury reported in the medical history that was suspicious for abuse because the infant could not cruise, or the explanation was implausible.” Sentinel injuries can be mild bruising or oral injuries in a young infant. These injuries suggest “there may be escalating and repeated violence toward the infant” that can culminate in death.4,5
In this study, severely abused infants were 4.4 times more likely to initially have come to the doctor with a sentinel injury. Of concern, 42% of parents of definitely abused children reported that a medical provider was aware of the sentinel injury. Of these cases, 56% did not show evidence that a professional was worried about abuse. These data show that medical professionals do miss cases of child abuse.
The cost of child abuse is real and lifelong. According to a policy statement from the American Academy of Pediatrics Council on Child Abuse and Neglect, a quarter of kids who suffer abusive head trauma die. Of the survivors, nearly 70% “have some degree of lasting neurological impairment.”5
Given the potentially disastrous consequences of child abuse, we must stay vigilant about child abuse. In our own profession, we must educate trainees and update experienced pediatricians about suspecting child abuse and reporting. For example, child abuse can be suspected and reported based on telemedicine interactions. The burden of proof for reporting child abuse is only “reasonable suspicion,” not “beyond a reasonable doubt.” In our communities, we must engage with local Child Welfare Services workers and educate them about sentinel injuries. And finally, in our practices, we must build families up with awareness, resources, and coping mechanisms to prevent abuse from happening in the first place.
Dr. Helen C. Wang, associate professor of pediatrics at the University of California, San Diego, talks to parents about managing stress early and often. She says, “I start counseling families at the prenatal visit. I do talk to families about what they liked to do before children. What brought you joy? What communities do you spend time with? And what have you been doing now?”
It can be hard to reconcile prior hobbies with the current recommendations of social distancing. “Now it’s more ‘Do FaceTime’ and ‘Do Zoom’ and spend more time with your extended family,” says Dr. Wang.
By caring for themselves, parents can better protect their children from mistreatment and injury. Healthychildren.org, the parent-facing website of the AAP, offers several tips for parenting in times of stress.
In this unusual time of COVID-19, it is more important than ever to provide parents with suggestions and strategies that will help them – and their children – survive this health crisis. By educating ourselves and our communities about child abuse, we as pediatricians can fulfill our mandate in keeping kids healthy and thriving.
Dr. Parekh is a pediatric resident at University of California, San Diego. She has no financial disclosures. Email Dr. Parekh at pdnews@mdedge.com.
References
1. Early childhood age group in California. kidsdata.org.
2. U.S. Department of Health & Human Services, Administration for Children and Families, Administration on Children, Youth and Families, Children’s Bureau. (2020). Child Maltreatment 2018.
3. Hong Joe. “School closures lead to troubling drop in child abuse reports.” KPBS. 2020 Mar 27.
4. Pediatrics. 2013 Apr;131(4):701-7.
5. Pediatrics. 2020;145(4):e20200203.
Societies offer advice on treating osteoporosis patients during pandemic
Five leading bone health organizations have gotten together to provide new recommendations for managing patients with osteoporosis during the COVID-19 pandemic.
The joint guidance – released by the American Society for Bone and Mineral Research (ASBMR), the American Association of Clinical Endocrinologists, the Endocrine Society, the European Calcified Tissue Society, and the National Osteoporosis Foundation – offered both general and specific recommendations for patients whose osteoporosis treatment plan is either continuing or has been disrupted during the COVID-19 pandemic.
Among the general recommendations are to initiate oral bisphosphonate therapy over either the telephone or through a video visit, with no delays for patients at high risk of fracture. They also noted that, as elective procedures, bone mineral density examinations may need to be postponed.
For patients already on osteoporosis medications – such as oral and IV bisphosphonates, denosumab, estrogen, raloxifene, teriparatide, abaloparatide, and romosozumab – they recommend continuing treatment whenever possible. “There is no evidence that any osteoporosis therapy increases the risk or severity of COVID-19 infection or alters the disease course,” they wrote. They did add, however, that COVID-19 may increase the risk of hypercoagulable complications and so caution should be exercised when treating patients with estrogen or raloxifene.
Separately, in a letter to the editor published in the Journal of Clinical Endocrinology and Metabolism (doi: 10.1210/clinem/dgaa254), Ruban Dhaliwal, MD, MPH, of the State University of New York, Syracuse, and coauthors concur in regard to raloxifene. They wrote that, because of the increased risk of thromboembolic events related to COVID-19, “it is best to discontinue raloxifene, which is also associated with such risk.”
The joint statement recognizes current social distancing policies and therefore recommends avoiding standard pretreatment labs prior to IV bisphosphonate and/or denosumab administration if previous labs were normal and the patient’s recent health has been deemed “stable.” Lab evaluation is recommended, however, for patients with fluctuating renal function and for those at higher risk of developing hypocalcemia.
The statement also provides potential alternative methods for delivering parenteral osteoporosis treatments, including off-site clinics, home delivery and administration, self-injection of denosumab and/or romosozumab, and drive-through administration of denosumab and/or romosozumab. They acknowledged the complications surrounding each alternative, including residents of “socioeconomically challenged communities” being unable to reach clinics if public transportation is not available and the “important medicolegal issues” to consider around self-injection.
For all patients whose treatments have been disrupted, the authors recommend frequent reevaluation “with the goal to resume the original osteoporosis treatment plan once circumstances allow.” As for specific recommendations, patients on denosumab who will not be treatable within 7 months of their previous injection should be transitioned to oral bisphosphonate if at all possible. For patients with underlying gastrointestinal disorders, they recommend monthly ibandronate or weekly/monthly risedronate; for patients with chronic renal insufficiency, they recommend an off-label regimen of lower dose oral bisphosphonate.
For patients on teriparatide or abaloparatide who will be unable to receive continued treatment, they recommend a delay in treatment. If that delay goes beyond several months, they recommend a temporary transition to oral bisphosphonate. For patients on romosozumab who will be unable to receive continued treatment, they also recommend a delay in treatment and a temporary transition to oral bisphosphonate. Finally, they expressed confidence that patients on IV bisphosphonates will not be harmed by treatment delays, even those of several months.
“I think we could fall into a trap during this era of the pandemic and fail to address patients’ underlying chronic conditions, even though those comorbidities will end up greatly affecting their overall health,” said incoming ASBMR president Suzanne Jan de Beur, MD, of the Johns Hopkins University, Baltimore. “As we continue to care for our patients, we need to keep chronic conditions like osteoporosis on the radar screen and not stop diagnosing people at risk or those who present with fractures. Even when we can’t perform full screening tests due to distancing policies, we need to be vigilant for those patients who need treatment and administer the treatments we have available as needed.”
The statement’s authors acknowledged the limitations of their recommendations, noting that “there is a paucity of data to provide clear guidance” and as such they were “based primarily on expert opinion.”
The authors from the five organizations did not disclose any conflicts of interest.
Five leading bone health organizations have gotten together to provide new recommendations for managing patients with osteoporosis during the COVID-19 pandemic.
The joint guidance – released by the American Society for Bone and Mineral Research (ASBMR), the American Association of Clinical Endocrinologists, the Endocrine Society, the European Calcified Tissue Society, and the National Osteoporosis Foundation – offered both general and specific recommendations for patients whose osteoporosis treatment plan is either continuing or has been disrupted during the COVID-19 pandemic.
Among the general recommendations are to initiate oral bisphosphonate therapy over either the telephone or through a video visit, with no delays for patients at high risk of fracture. They also noted that, as elective procedures, bone mineral density examinations may need to be postponed.
For patients already on osteoporosis medications – such as oral and IV bisphosphonates, denosumab, estrogen, raloxifene, teriparatide, abaloparatide, and romosozumab – they recommend continuing treatment whenever possible. “There is no evidence that any osteoporosis therapy increases the risk or severity of COVID-19 infection or alters the disease course,” they wrote. They did add, however, that COVID-19 may increase the risk of hypercoagulable complications and so caution should be exercised when treating patients with estrogen or raloxifene.
Separately, in a letter to the editor published in the Journal of Clinical Endocrinology and Metabolism (doi: 10.1210/clinem/dgaa254), Ruban Dhaliwal, MD, MPH, of the State University of New York, Syracuse, and coauthors concur in regard to raloxifene. They wrote that, because of the increased risk of thromboembolic events related to COVID-19, “it is best to discontinue raloxifene, which is also associated with such risk.”
The joint statement recognizes current social distancing policies and therefore recommends avoiding standard pretreatment labs prior to IV bisphosphonate and/or denosumab administration if previous labs were normal and the patient’s recent health has been deemed “stable.” Lab evaluation is recommended, however, for patients with fluctuating renal function and for those at higher risk of developing hypocalcemia.
The statement also provides potential alternative methods for delivering parenteral osteoporosis treatments, including off-site clinics, home delivery and administration, self-injection of denosumab and/or romosozumab, and drive-through administration of denosumab and/or romosozumab. They acknowledged the complications surrounding each alternative, including residents of “socioeconomically challenged communities” being unable to reach clinics if public transportation is not available and the “important medicolegal issues” to consider around self-injection.
For all patients whose treatments have been disrupted, the authors recommend frequent reevaluation “with the goal to resume the original osteoporosis treatment plan once circumstances allow.” As for specific recommendations, patients on denosumab who will not be treatable within 7 months of their previous injection should be transitioned to oral bisphosphonate if at all possible. For patients with underlying gastrointestinal disorders, they recommend monthly ibandronate or weekly/monthly risedronate; for patients with chronic renal insufficiency, they recommend an off-label regimen of lower dose oral bisphosphonate.
For patients on teriparatide or abaloparatide who will be unable to receive continued treatment, they recommend a delay in treatment. If that delay goes beyond several months, they recommend a temporary transition to oral bisphosphonate. For patients on romosozumab who will be unable to receive continued treatment, they also recommend a delay in treatment and a temporary transition to oral bisphosphonate. Finally, they expressed confidence that patients on IV bisphosphonates will not be harmed by treatment delays, even those of several months.
“I think we could fall into a trap during this era of the pandemic and fail to address patients’ underlying chronic conditions, even though those comorbidities will end up greatly affecting their overall health,” said incoming ASBMR president Suzanne Jan de Beur, MD, of the Johns Hopkins University, Baltimore. “As we continue to care for our patients, we need to keep chronic conditions like osteoporosis on the radar screen and not stop diagnosing people at risk or those who present with fractures. Even when we can’t perform full screening tests due to distancing policies, we need to be vigilant for those patients who need treatment and administer the treatments we have available as needed.”
The statement’s authors acknowledged the limitations of their recommendations, noting that “there is a paucity of data to provide clear guidance” and as such they were “based primarily on expert opinion.”
The authors from the five organizations did not disclose any conflicts of interest.
Five leading bone health organizations have gotten together to provide new recommendations for managing patients with osteoporosis during the COVID-19 pandemic.
The joint guidance – released by the American Society for Bone and Mineral Research (ASBMR), the American Association of Clinical Endocrinologists, the Endocrine Society, the European Calcified Tissue Society, and the National Osteoporosis Foundation – offered both general and specific recommendations for patients whose osteoporosis treatment plan is either continuing or has been disrupted during the COVID-19 pandemic.
Among the general recommendations are to initiate oral bisphosphonate therapy over either the telephone or through a video visit, with no delays for patients at high risk of fracture. They also noted that, as elective procedures, bone mineral density examinations may need to be postponed.
For patients already on osteoporosis medications – such as oral and IV bisphosphonates, denosumab, estrogen, raloxifene, teriparatide, abaloparatide, and romosozumab – they recommend continuing treatment whenever possible. “There is no evidence that any osteoporosis therapy increases the risk or severity of COVID-19 infection or alters the disease course,” they wrote. They did add, however, that COVID-19 may increase the risk of hypercoagulable complications and so caution should be exercised when treating patients with estrogen or raloxifene.
Separately, in a letter to the editor published in the Journal of Clinical Endocrinology and Metabolism (doi: 10.1210/clinem/dgaa254), Ruban Dhaliwal, MD, MPH, of the State University of New York, Syracuse, and coauthors concur in regard to raloxifene. They wrote that, because of the increased risk of thromboembolic events related to COVID-19, “it is best to discontinue raloxifene, which is also associated with such risk.”
The joint statement recognizes current social distancing policies and therefore recommends avoiding standard pretreatment labs prior to IV bisphosphonate and/or denosumab administration if previous labs were normal and the patient’s recent health has been deemed “stable.” Lab evaluation is recommended, however, for patients with fluctuating renal function and for those at higher risk of developing hypocalcemia.
The statement also provides potential alternative methods for delivering parenteral osteoporosis treatments, including off-site clinics, home delivery and administration, self-injection of denosumab and/or romosozumab, and drive-through administration of denosumab and/or romosozumab. They acknowledged the complications surrounding each alternative, including residents of “socioeconomically challenged communities” being unable to reach clinics if public transportation is not available and the “important medicolegal issues” to consider around self-injection.
For all patients whose treatments have been disrupted, the authors recommend frequent reevaluation “with the goal to resume the original osteoporosis treatment plan once circumstances allow.” As for specific recommendations, patients on denosumab who will not be treatable within 7 months of their previous injection should be transitioned to oral bisphosphonate if at all possible. For patients with underlying gastrointestinal disorders, they recommend monthly ibandronate or weekly/monthly risedronate; for patients with chronic renal insufficiency, they recommend an off-label regimen of lower dose oral bisphosphonate.
For patients on teriparatide or abaloparatide who will be unable to receive continued treatment, they recommend a delay in treatment. If that delay goes beyond several months, they recommend a temporary transition to oral bisphosphonate. For patients on romosozumab who will be unable to receive continued treatment, they also recommend a delay in treatment and a temporary transition to oral bisphosphonate. Finally, they expressed confidence that patients on IV bisphosphonates will not be harmed by treatment delays, even those of several months.
“I think we could fall into a trap during this era of the pandemic and fail to address patients’ underlying chronic conditions, even though those comorbidities will end up greatly affecting their overall health,” said incoming ASBMR president Suzanne Jan de Beur, MD, of the Johns Hopkins University, Baltimore. “As we continue to care for our patients, we need to keep chronic conditions like osteoporosis on the radar screen and not stop diagnosing people at risk or those who present with fractures. Even when we can’t perform full screening tests due to distancing policies, we need to be vigilant for those patients who need treatment and administer the treatments we have available as needed.”
The statement’s authors acknowledged the limitations of their recommendations, noting that “there is a paucity of data to provide clear guidance” and as such they were “based primarily on expert opinion.”
The authors from the five organizations did not disclose any conflicts of interest.