The signature electrocardiographic sign indicating ST-segment-elevation MI may be a less-consistent indicator of actual STEMI at a time when patients with COVID-19 have come to overwhelm many hospital ICUs.

Many of the 18 such patients identified at six New York City hospitals who showed ST-segment elevation on their 12-lead ECG in the city’s first month of fighting the pandemic turned out to be free of either obstructive coronary artery disease by angiography or of regional wall-motion abnormalities (RWMA) by ECG, according to a letter published in the New England Journal of Medicine.

Those 10 patients in the 18-case series were said to have noncoronary myocardial injury, perhaps from myocarditis – a prevalent feature of severe COVID-19 – and the remaining 8 patients with obstructive coronary artery disease, RWMA, or both were diagnosed with STEMI. Of the latter patients, six went to the cath lab and five of those underwent percutaneous coronary intervention, Sripal Bangalore, MD, MHA, of New York University, and colleagues reported.

In an interview, Dr. Bangalore framed the case-series report as a caution against substituting fibrinolytic therapy for primary percutaneous coronary intervention in patients with STE while hospitals are unusually burdened by the COVID-19 pandemic and invasive procedures intensify the threat of SARS-CoV-2 exposure to clinicians.

The strategy was recently advanced as an option for highly selected patients in a statement from the American College of Cardiology and Society for Cardiovascular Angiography and Interventions (SCAI).

“During the COVID-19 pandemic, one of the main reasons fibrinolytic therapy has been pushed is to reduce the exposure to the cath-lab staff,” Dr. Bangalore observed. “But if you pursue that route, it’s problematic because more than half may not have obstructive disease and fibrinolytic therapy may not help. And if you give them fibrinolytics, you’re potentially increasing their risk of bleeding complications.

“The take-home from these 18 patients is that it’s very difficult to guess who is going to have obstructive disease and who is going to have nonobstructive disease,” Dr. Bangalore said. “Maybe we should assess these patients with not just an ECG but with a quick echo, then make a decision. Our practice so far has been to take these patients to the cath lab.”

The ACC/SCAI statement proposed that “fibrinolysis can be considered an option for the relatively stable STEMI patient with active COVID-19” after careful consideration of possible patient benefit versus the risks of cath-lab personnel exposure to the virus.

Only six patients in the current series, including five in the STEMI group, are reported to have had chest pain at about the time of STE, observed Michael J. Blaha, MD, MPH, of Johns Hopkins Hospital, Baltimore.

So, he said in an interview, “one of their points is that you have to take ST elevations with a grain of salt in this [COVID-19] era, because there are a lot of people presenting with ST elevations in the absence of chest pain.”

That, and the high prevalence of nonobstructive disease in the series, indeed argues against the use of fibrinolytic therapy in such patients, Dr. Blaha said.

Normally, when there is STE, “the pretest probability of STEMI is so high, and if you can’t make it to the cath lab for some reason, sure, it makes sense to give lytics.” However, he said, “COVID-19 is changing the clinical landscape. Now, with a variety of virus-mediated myocardial injury presentations, including myocarditis, the pretest probability of MI is lower.”

The current report “confirms that, in the COVID era, ST elevations are not diagnostic for MI and must be considered within the totality of clinical evidence, and a conservative approach to going to the cath lab is probably warranted,” Dr. Blaha said in an interview.

However, with the reduced pretest probability of STE for STEMI, he agreed, “I almost don’t see any scenario where I’d be comfortable, based on ECG changes alone, giving lytics at this time.”

Dr. Bangalore pointed out that all of the 18 patients in the series had elevated levels of the fibrin degradation product D-dimer, a biomarker that reflects ongoing hemostatic activation. Levels were higher in the 8 patients who ultimately received a STEMI diagnosis than in the remaining 10 patients.

But COVID-19 patients in general may have elevated D-dimer and “a lot of microthrombi,” he said. “So the question is, are those microthrombi also causal for any of the ECG changes we are also seeing?”

Aside from microthrombi, global hypoxia and myocarditis could be other potential causes of STE in COVID-19 patients in the absence of STEMI, Dr. Bangalore proposed. “At this point we just generally don’t know.”

Dr. Bangalore reported no conflicts; disclosures for the other authors are available at nejm.org. Dr. Blaha disclosed receiving grants from Amgen and serving on advisory boards for Amgen and other pharmaceutical companies.

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

The signature electrocardiographic sign indicating ST-segment-elevation MI may be a less-consistent indicator of actual STEMI at a time when patients with COVID-19 have come to overwhelm many hospital ICUs.

Many of the 18 such patients identified at six New York City hospitals who showed ST-segment elevation on their 12-lead ECG in the city’s first month of fighting the pandemic turned out to be free of either obstructive coronary artery disease by angiography or of regional wall-motion abnormalities (RWMA) by ECG, according to a letter published in the New England Journal of Medicine.

Those 10 patients in the 18-case series were said to have noncoronary myocardial injury, perhaps from myocarditis – a prevalent feature of severe COVID-19 – and the remaining 8 patients with obstructive coronary artery disease, RWMA, or both were diagnosed with STEMI. Of the latter patients, six went to the cath lab and five of those underwent percutaneous coronary intervention, Sripal Bangalore, MD, MHA, of New York University, and colleagues reported.

In an interview, Dr. Bangalore framed the case-series report as a caution against substituting fibrinolytic therapy for primary percutaneous coronary intervention in patients with STE while hospitals are unusually burdened by the COVID-19 pandemic and invasive procedures intensify the threat of SARS-CoV-2 exposure to clinicians.

The strategy was recently advanced as an option for highly selected patients in a statement from the American College of Cardiology and Society for Cardiovascular Angiography and Interventions (SCAI).

“During the COVID-19 pandemic, one of the main reasons fibrinolytic therapy has been pushed is to reduce the exposure to the cath-lab staff,” Dr. Bangalore observed. “But if you pursue that route, it’s problematic because more than half may not have obstructive disease and fibrinolytic therapy may not help. And if you give them fibrinolytics, you’re potentially increasing their risk of bleeding complications.

“The take-home from these 18 patients is that it’s very difficult to guess who is going to have obstructive disease and who is going to have nonobstructive disease,” Dr. Bangalore said. “Maybe we should assess these patients with not just an ECG but with a quick echo, then make a decision. Our practice so far has been to take these patients to the cath lab.”

The ACC/SCAI statement proposed that “fibrinolysis can be considered an option for the relatively stable STEMI patient with active COVID-19” after careful consideration of possible patient benefit versus the risks of cath-lab personnel exposure to the virus.

Only six patients in the current series, including five in the STEMI group, are reported to have had chest pain at about the time of STE, observed Michael J. Blaha, MD, MPH, of Johns Hopkins Hospital, Baltimore.

So, he said in an interview, “one of their points is that you have to take ST elevations with a grain of salt in this [COVID-19] era, because there are a lot of people presenting with ST elevations in the absence of chest pain.”

That, and the high prevalence of nonobstructive disease in the series, indeed argues against the use of fibrinolytic therapy in such patients, Dr. Blaha said.

Normally, when there is STE, “the pretest probability of STEMI is so high, and if you can’t make it to the cath lab for some reason, sure, it makes sense to give lytics.” However, he said, “COVID-19 is changing the clinical landscape. Now, with a variety of virus-mediated myocardial injury presentations, including myocarditis, the pretest probability of MI is lower.”

The current report “confirms that, in the COVID era, ST elevations are not diagnostic for MI and must be considered within the totality of clinical evidence, and a conservative approach to going to the cath lab is probably warranted,” Dr. Blaha said in an interview.

However, with the reduced pretest probability of STE for STEMI, he agreed, “I almost don’t see any scenario where I’d be comfortable, based on ECG changes alone, giving lytics at this time.”

Dr. Bangalore pointed out that all of the 18 patients in the series had elevated levels of the fibrin degradation product D-dimer, a biomarker that reflects ongoing hemostatic activation. Levels were higher in the 8 patients who ultimately received a STEMI diagnosis than in the remaining 10 patients.

But COVID-19 patients in general may have elevated D-dimer and “a lot of microthrombi,” he said. “So the question is, are those microthrombi also causal for any of the ECG changes we are also seeing?”

Aside from microthrombi, global hypoxia and myocarditis could be other potential causes of STE in COVID-19 patients in the absence of STEMI, Dr. Bangalore proposed. “At this point we just generally don’t know.”

Dr. Bangalore reported no conflicts; disclosures for the other authors are available at nejm.org. Dr. Blaha disclosed receiving grants from Amgen and serving on advisory boards for Amgen and other pharmaceutical companies.

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

The signature electrocardiographic sign indicating ST-segment-elevation MI may be a less-consistent indicator of actual STEMI at a time when patients with COVID-19 have come to overwhelm many hospital ICUs.

Many of the 18 such patients identified at six New York City hospitals who showed ST-segment elevation on their 12-lead ECG in the city’s first month of fighting the pandemic turned out to be free of either obstructive coronary artery disease by angiography or of regional wall-motion abnormalities (RWMA) by ECG, according to a letter published in the New England Journal of Medicine.

Those 10 patients in the 18-case series were said to have noncoronary myocardial injury, perhaps from myocarditis – a prevalent feature of severe COVID-19 – and the remaining 8 patients with obstructive coronary artery disease, RWMA, or both were diagnosed with STEMI. Of the latter patients, six went to the cath lab and five of those underwent percutaneous coronary intervention, Sripal Bangalore, MD, MHA, of New York University, and colleagues reported.

In an interview, Dr. Bangalore framed the case-series report as a caution against substituting fibrinolytic therapy for primary percutaneous coronary intervention in patients with STE while hospitals are unusually burdened by the COVID-19 pandemic and invasive procedures intensify the threat of SARS-CoV-2 exposure to clinicians.

The strategy was recently advanced as an option for highly selected patients in a statement from the American College of Cardiology and Society for Cardiovascular Angiography and Interventions (SCAI).

“During the COVID-19 pandemic, one of the main reasons fibrinolytic therapy has been pushed is to reduce the exposure to the cath-lab staff,” Dr. Bangalore observed. “But if you pursue that route, it’s problematic because more than half may not have obstructive disease and fibrinolytic therapy may not help. And if you give them fibrinolytics, you’re potentially increasing their risk of bleeding complications.

“The take-home from these 18 patients is that it’s very difficult to guess who is going to have obstructive disease and who is going to have nonobstructive disease,” Dr. Bangalore said. “Maybe we should assess these patients with not just an ECG but with a quick echo, then make a decision. Our practice so far has been to take these patients to the cath lab.”

The ACC/SCAI statement proposed that “fibrinolysis can be considered an option for the relatively stable STEMI patient with active COVID-19” after careful consideration of possible patient benefit versus the risks of cath-lab personnel exposure to the virus.

Only six patients in the current series, including five in the STEMI group, are reported to have had chest pain at about the time of STE, observed Michael J. Blaha, MD, MPH, of Johns Hopkins Hospital, Baltimore.

So, he said in an interview, “one of their points is that you have to take ST elevations with a grain of salt in this [COVID-19] era, because there are a lot of people presenting with ST elevations in the absence of chest pain.”

That, and the high prevalence of nonobstructive disease in the series, indeed argues against the use of fibrinolytic therapy in such patients, Dr. Blaha said.

Normally, when there is STE, “the pretest probability of STEMI is so high, and if you can’t make it to the cath lab for some reason, sure, it makes sense to give lytics.” However, he said, “COVID-19 is changing the clinical landscape. Now, with a variety of virus-mediated myocardial injury presentations, including myocarditis, the pretest probability of MI is lower.”

The current report “confirms that, in the COVID era, ST elevations are not diagnostic for MI and must be considered within the totality of clinical evidence, and a conservative approach to going to the cath lab is probably warranted,” Dr. Blaha said in an interview.

However, with the reduced pretest probability of STE for STEMI, he agreed, “I almost don’t see any scenario where I’d be comfortable, based on ECG changes alone, giving lytics at this time.”

Dr. Bangalore pointed out that all of the 18 patients in the series had elevated levels of the fibrin degradation product D-dimer, a biomarker that reflects ongoing hemostatic activation. Levels were higher in the 8 patients who ultimately received a STEMI diagnosis than in the remaining 10 patients.

But COVID-19 patients in general may have elevated D-dimer and “a lot of microthrombi,” he said. “So the question is, are those microthrombi also causal for any of the ECG changes we are also seeing?”

Aside from microthrombi, global hypoxia and myocarditis could be other potential causes of STE in COVID-19 patients in the absence of STEMI, Dr. Bangalore proposed. “At this point we just generally don’t know.”

Dr. Bangalore reported no conflicts; disclosures for the other authors are available at nejm.org. Dr. Blaha disclosed receiving grants from Amgen and serving on advisory boards for Amgen and other pharmaceutical companies.

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

Clinical question: How should we care for newborns born to mothers with COVID-19?

Krzysztof Maczkowiak/Thinkstock

• Neonates should be considered persons under investigation (PUIs) if they are born to mothers with diagnosed COVID-19 or with COVID-19 tests pending at the time of delivery.
• Neonatal clinicians should attend deliveries based on their center’s policies. If clinicians are required to perform stabilization they should use airborne, droplet, and contact personal protective equipment (PPE). This includes, gown, gloves, eye protection (goggles or face shield), and N95 respirator mask or an air-purifying respirator.
• Mother and newborn should be separated to minimize the infant’s risk of postnatal infection.
• Well newborns born at or near term may be admitted to areas physically separated from newborns unaffected by maternal COVID-19. Alternatively, a mother may room-in with her infant with 6 feet of separation between mother and infant. Newborn PUIs should be bathed as soon as possible.
• Newborns requiring intensive care should be admitted to a single negative-pressure room. Alternatively, COVID-19–exposed infants should be grouped with a minimum of 6 feet of separation, or placed in air temperature-controlled isolettes.
• Until the newborn PUI’s virologic status is known, clinical staff caring for the infant should use droplet and contact PPE. This includes gown, gloves, eye protection (goggles or face shield), and a standard surgical mask. Airborne, droplet, and contact precautions should be used for infants requiring CPAP or any form of mechanical ventilation.
• COVID-19–positive mothers who want to breastfeed may feed expressed breast milk using proper breast and hand hygiene or directly breastfeed their infants wearing a mask while practicing proper breast and hand hygiene.
• If testing is available, newborns should be tested for SARS-CoV-2 using molecular arrays. If testing is unavailable, clinicians may monitor newborns clinically. Infants should be tested if they require prolonged intensive care.
• Optimal timing and extent of testing is unknown. Tests should be performed around 24 hours of life and 48 hours of life. If discharge is planned for a well appearing infant before 48 hours of life, the clinician may choose not to do the 48-hour test. A single swab should be taken from the throat followed by the nasopharynx to perform the test.
• Newborns should receive all newborn care, including circumcision if requested.
• Infants who are asymptomatic with positive or pending SARS-CoV-2 tests may be discharged home with plans for frequent outpatient follow-up through 14 days after birth. Infants with negative SARS-CoV-2 testing should be discharged to the care of a noninfected caregiver. If the mother lives in the same household, she must keep a distance of 6 feet as often as possible. When not possible, the mother should wear a mask and practice hand hygiene. The mother may resume caring for her infant normally when she has been afebrile for more than 72 hours (without antipyretics) and has been asymptomatic for 7 days. Alternatively, the mother may resume care if she has two consecutive negative SARS-CoV-2 nasopharyngeal swabs taken more than 24 hours apart.
• Visitation to infants requiring intensive care should be limited for mothers with COVID-19 until her fever has resolved for more than 72 hours and has improvement of respiratory symptoms and has had two consecutive negative SARS-CoV-2 nasopharyngeal swabs taken more than 24 hours apart.

Bottom line: Clinicians should protect themselves with contact and droplet PPE at all times until the infant’s viral status is known. Clinicians should use airborne, contact, and droplet PPE when resuscitating the infant and/or when using CPAP/mechanical ventilation. Mothers should be encouraged to feed their infants expressed breast milk while practicing proper hygiene or directly breastfeed while wearing a mask and practicing proper hygiene. Viral testing of every infant born to a mother with COVID-19 should be performed after the infant is 24 hours old. Mothers should resume caring for their infants normally after they have met criteria suggesting they are no longer actively infected.

Article citation: Puopolo KM, Hudak ML, Kimberlin DW, Cummings J. Initial Guidance: Management of Infants born to Mothers with COVID-19. 2020 Apr 2. https://downloads.aap.org/AAP/PDF/COVID%2019%20Initial%20Newborn%20Guidance.pdf. Accessed Apr 2, 2020.
 

Dr. Kumar is a pediatric hospitalist at Cleveland Clinic Children’s. She is a clinical assistant professor of pediatrics at Case Western Reserve University, Cleveland, and serves as the Pediatrics Editor for The Hospitalist.

Clinical question: How should we care for newborns born to mothers with COVID-19?

Krzysztof Maczkowiak/Thinkstock

• Neonates should be considered persons under investigation (PUIs) if they are born to mothers with diagnosed COVID-19 or with COVID-19 tests pending at the time of delivery.
• Neonatal clinicians should attend deliveries based on their center’s policies. If clinicians are required to perform stabilization they should use airborne, droplet, and contact personal protective equipment (PPE). This includes, gown, gloves, eye protection (goggles or face shield), and N95 respirator mask or an air-purifying respirator.
• Mother and newborn should be separated to minimize the infant’s risk of postnatal infection.
• Well newborns born at or near term may be admitted to areas physically separated from newborns unaffected by maternal COVID-19. Alternatively, a mother may room-in with her infant with 6 feet of separation between mother and infant. Newborn PUIs should be bathed as soon as possible.
• Newborns requiring intensive care should be admitted to a single negative-pressure room. Alternatively, COVID-19–exposed infants should be grouped with a minimum of 6 feet of separation, or placed in air temperature-controlled isolettes.
• Until the newborn PUI’s virologic status is known, clinical staff caring for the infant should use droplet and contact PPE. This includes gown, gloves, eye protection (goggles or face shield), and a standard surgical mask. Airborne, droplet, and contact precautions should be used for infants requiring CPAP or any form of mechanical ventilation.
• COVID-19–positive mothers who want to breastfeed may feed expressed breast milk using proper breast and hand hygiene or directly breastfeed their infants wearing a mask while practicing proper breast and hand hygiene.
• If testing is available, newborns should be tested for SARS-CoV-2 using molecular arrays. If testing is unavailable, clinicians may monitor newborns clinically. Infants should be tested if they require prolonged intensive care.
• Optimal timing and extent of testing is unknown. Tests should be performed around 24 hours of life and 48 hours of life. If discharge is planned for a well appearing infant before 48 hours of life, the clinician may choose not to do the 48-hour test. A single swab should be taken from the throat followed by the nasopharynx to perform the test.
• Newborns should receive all newborn care, including circumcision if requested.
• Infants who are asymptomatic with positive or pending SARS-CoV-2 tests may be discharged home with plans for frequent outpatient follow-up through 14 days after birth. Infants with negative SARS-CoV-2 testing should be discharged to the care of a noninfected caregiver. If the mother lives in the same household, she must keep a distance of 6 feet as often as possible. When not possible, the mother should wear a mask and practice hand hygiene. The mother may resume caring for her infant normally when she has been afebrile for more than 72 hours (without antipyretics) and has been asymptomatic for 7 days. Alternatively, the mother may resume care if she has two consecutive negative SARS-CoV-2 nasopharyngeal swabs taken more than 24 hours apart.
• Visitation to infants requiring intensive care should be limited for mothers with COVID-19 until her fever has resolved for more than 72 hours and has improvement of respiratory symptoms and has had two consecutive negative SARS-CoV-2 nasopharyngeal swabs taken more than 24 hours apart.

Bottom line: Clinicians should protect themselves with contact and droplet PPE at all times until the infant’s viral status is known. Clinicians should use airborne, contact, and droplet PPE when resuscitating the infant and/or when using CPAP/mechanical ventilation. Mothers should be encouraged to feed their infants expressed breast milk while practicing proper hygiene or directly breastfeed while wearing a mask and practicing proper hygiene. Viral testing of every infant born to a mother with COVID-19 should be performed after the infant is 24 hours old. Mothers should resume caring for their infants normally after they have met criteria suggesting they are no longer actively infected.

Article citation: Puopolo KM, Hudak ML, Kimberlin DW, Cummings J. Initial Guidance: Management of Infants born to Mothers with COVID-19. 2020 Apr 2. https://downloads.aap.org/AAP/PDF/COVID%2019%20Initial%20Newborn%20Guidance.pdf. Accessed Apr 2, 2020.
 

Dr. Kumar is a pediatric hospitalist at Cleveland Clinic Children’s. She is a clinical assistant professor of pediatrics at Case Western Reserve University, Cleveland, and serves as the Pediatrics Editor for The Hospitalist.

Clinical question: How should we care for newborns born to mothers with COVID-19?

Krzysztof Maczkowiak/Thinkstock

• Neonates should be considered persons under investigation (PUIs) if they are born to mothers with diagnosed COVID-19 or with COVID-19 tests pending at the time of delivery.
• Neonatal clinicians should attend deliveries based on their center’s policies. If clinicians are required to perform stabilization they should use airborne, droplet, and contact personal protective equipment (PPE). This includes, gown, gloves, eye protection (goggles or face shield), and N95 respirator mask or an air-purifying respirator.
• Mother and newborn should be separated to minimize the infant’s risk of postnatal infection.
• Well newborns born at or near term may be admitted to areas physically separated from newborns unaffected by maternal COVID-19. Alternatively, a mother may room-in with her infant with 6 feet of separation between mother and infant. Newborn PUIs should be bathed as soon as possible.
• Newborns requiring intensive care should be admitted to a single negative-pressure room. Alternatively, COVID-19–exposed infants should be grouped with a minimum of 6 feet of separation, or placed in air temperature-controlled isolettes.
• Until the newborn PUI’s virologic status is known, clinical staff caring for the infant should use droplet and contact PPE. This includes gown, gloves, eye protection (goggles or face shield), and a standard surgical mask. Airborne, droplet, and contact precautions should be used for infants requiring CPAP or any form of mechanical ventilation.
• COVID-19–positive mothers who want to breastfeed may feed expressed breast milk using proper breast and hand hygiene or directly breastfeed their infants wearing a mask while practicing proper breast and hand hygiene.
• If testing is available, newborns should be tested for SARS-CoV-2 using molecular arrays. If testing is unavailable, clinicians may monitor newborns clinically. Infants should be tested if they require prolonged intensive care.
• Optimal timing and extent of testing is unknown. Tests should be performed around 24 hours of life and 48 hours of life. If discharge is planned for a well appearing infant before 48 hours of life, the clinician may choose not to do the 48-hour test. A single swab should be taken from the throat followed by the nasopharynx to perform the test.
• Newborns should receive all newborn care, including circumcision if requested.
• Infants who are asymptomatic with positive or pending SARS-CoV-2 tests may be discharged home with plans for frequent outpatient follow-up through 14 days after birth. Infants with negative SARS-CoV-2 testing should be discharged to the care of a noninfected caregiver. If the mother lives in the same household, she must keep a distance of 6 feet as often as possible. When not possible, the mother should wear a mask and practice hand hygiene. The mother may resume caring for her infant normally when she has been afebrile for more than 72 hours (without antipyretics) and has been asymptomatic for 7 days. Alternatively, the mother may resume care if she has two consecutive negative SARS-CoV-2 nasopharyngeal swabs taken more than 24 hours apart.
• Visitation to infants requiring intensive care should be limited for mothers with COVID-19 until her fever has resolved for more than 72 hours and has improvement of respiratory symptoms and has had two consecutive negative SARS-CoV-2 nasopharyngeal swabs taken more than 24 hours apart.

Bottom line: Clinicians should protect themselves with contact and droplet PPE at all times until the infant’s viral status is known. Clinicians should use airborne, contact, and droplet PPE when resuscitating the infant and/or when using CPAP/mechanical ventilation. Mothers should be encouraged to feed their infants expressed breast milk while practicing proper hygiene or directly breastfeed while wearing a mask and practicing proper hygiene. Viral testing of every infant born to a mother with COVID-19 should be performed after the infant is 24 hours old. Mothers should resume caring for their infants normally after they have met criteria suggesting they are no longer actively infected.

Article citation: Puopolo KM, Hudak ML, Kimberlin DW, Cummings J. Initial Guidance: Management of Infants born to Mothers with COVID-19. 2020 Apr 2. https://downloads.aap.org/AAP/PDF/COVID%2019%20Initial%20Newborn%20Guidance.pdf. Accessed Apr 2, 2020.
 

Dr. Kumar is a pediatric hospitalist at Cleveland Clinic Children’s. She is a clinical assistant professor of pediatrics at Case Western Reserve University, Cleveland, and serves as the Pediatrics Editor for The Hospitalist.

While triage of critical care resources should be a rare event during the COVID-19 crisis, failing to prepare for the worst-case scenario could have serious consequences, according to authors of recent reports that offer advice on how to prepare for surges in demand.

Courtesy NIAID-RML

Even modest numbers of critically ill COVID-19 patients have already rapidly overwhelmed existing hospital capacity in hard-hit areas including Italy, Spain, and New York City, said authors of an expert panel report released in CHEST.

“The ethical burden this places on hospitals, health systems, and society is enormous,” said Ryan C. Maves, MD, FCCP, of the Naval Medical Center in San Diego, lead author of the expert panel report from the Task Force for Mass Critical Care and the American College of Chest Physicians (CHEST).

Andrew Bowser/MDedge News

Mild surges call for a focus on increasing ECMO capacity, while a moderate surge may indicate a need to focus on allocating scarce resources, and a major surge may signal the need to limit or defer use of scarce resources, according to the guidance.

“If your health care system is stretched from a resource standpoint, at what point do you say, ‘we don’t even have the capability to even safely do ECMO, and so, perhaps we should not even be offering the support’?” Dr. Keller said in an interview. “That’s what we tried to get at in the paper – helping institutions think about how to prepare for that pandemic, and then when to make decisions on when it should and should not be offered.”
 

Critical care guidance for COVID-19

The guidance from the Task Force for Mass Critical Care and CHEST offers nine specific actions that authors suggest as part of a framework for communities to establish the infrastructure needed to triage critical care resources and “equitably” meet the needs of the largest number of COVID-19 patients.

“It is the goal of the task force to minimize the need for allocation of scarce resources as much as possible,” the authors stated.

The framework starts with surge planning that includes an inventory of intensive care unit resources such as ventilators, beds, supplies, and staff that could be marshaled to meet a surge in demand, followed by establishing “identification triggers” for triage initiation by a regional authority, should clinical demand reach a crisis stage.

The next step is preparing the triage system, which includes creating a committee at the regional level, identifying members of tertiary triage teams and the support structures they will need, and preparing and distributing training materials.

Agreeing on a triage protocol is important to ensure equitable targeting of resources, and how to allocate limited life-sustaining measures needs to be considered, according to the panel of experts. They also recommend adaptations to the standards of care such as modification of end-of-life care policies, support for health care workers, family, and the public, and consideration of pediatric issues including transport, concentration of care at specific centers, and potential increases in age thresholds to accommodate surges.
 

Barriers to triage?

When asked about potential barriers to rolling out a triage plan, Dr. Maves said the first is acknowledging the possible need for such a plan: “It is a difficult concept for most in critical care to accept – the idea that we may not be able to provide an individual patient with interventions that we consider routine,” he said.

Beyond acknowledging need, other potential barriers to successful implementation include the limited evidence base to support development of these protocols, as well as the need to address public trust.

“If a triage system is perceived as unjust or biased, or if people think that triage favors or excludes certain groups unfairly, it will undermine any system,” Dr. Maves said. “Making sure the public both understands and has input into system development is critical if we are going to be able to make this work.”

Dr. Maves and coauthors reported that some of the authors of their guidance are United States government employees or military service members, and that their opinions and assertions do not reflect the official views or position of those institutions. Dr. Keller reported no disclosures related to the ECMO guidance.

chestphysiciannews@chestnet.org

SOURCES: Maves RC et al. Chest. 2020 Apr 11. pii: S0012-3692(20)30691-7. doi: 10.1016/j.chest.2020.03.063; Seethara R and Keller SP. Ann Am Thorac Soc. 2020 Apr 15. doi: 10.1513/AnnalsATS.202003-233PS.

While triage of critical care resources should be a rare event during the COVID-19 crisis, failing to prepare for the worst-case scenario could have serious consequences, according to authors of recent reports that offer advice on how to prepare for surges in demand.

Courtesy NIAID-RML

Even modest numbers of critically ill COVID-19 patients have already rapidly overwhelmed existing hospital capacity in hard-hit areas including Italy, Spain, and New York City, said authors of an expert panel report released in CHEST.

“The ethical burden this places on hospitals, health systems, and society is enormous,” said Ryan C. Maves, MD, FCCP, of the Naval Medical Center in San Diego, lead author of the expert panel report from the Task Force for Mass Critical Care and the American College of Chest Physicians (CHEST).

Andrew Bowser/MDedge News

Mild surges call for a focus on increasing ECMO capacity, while a moderate surge may indicate a need to focus on allocating scarce resources, and a major surge may signal the need to limit or defer use of scarce resources, according to the guidance.

“If your health care system is stretched from a resource standpoint, at what point do you say, ‘we don’t even have the capability to even safely do ECMO, and so, perhaps we should not even be offering the support’?” Dr. Keller said in an interview. “That’s what we tried to get at in the paper – helping institutions think about how to prepare for that pandemic, and then when to make decisions on when it should and should not be offered.”
 

Critical care guidance for COVID-19

The guidance from the Task Force for Mass Critical Care and CHEST offers nine specific actions that authors suggest as part of a framework for communities to establish the infrastructure needed to triage critical care resources and “equitably” meet the needs of the largest number of COVID-19 patients.

“It is the goal of the task force to minimize the need for allocation of scarce resources as much as possible,” the authors stated.

The framework starts with surge planning that includes an inventory of intensive care unit resources such as ventilators, beds, supplies, and staff that could be marshaled to meet a surge in demand, followed by establishing “identification triggers” for triage initiation by a regional authority, should clinical demand reach a crisis stage.

The next step is preparing the triage system, which includes creating a committee at the regional level, identifying members of tertiary triage teams and the support structures they will need, and preparing and distributing training materials.

Agreeing on a triage protocol is important to ensure equitable targeting of resources, and how to allocate limited life-sustaining measures needs to be considered, according to the panel of experts. They also recommend adaptations to the standards of care such as modification of end-of-life care policies, support for health care workers, family, and the public, and consideration of pediatric issues including transport, concentration of care at specific centers, and potential increases in age thresholds to accommodate surges.
 

Barriers to triage?

When asked about potential barriers to rolling out a triage plan, Dr. Maves said the first is acknowledging the possible need for such a plan: “It is a difficult concept for most in critical care to accept – the idea that we may not be able to provide an individual patient with interventions that we consider routine,” he said.

Beyond acknowledging need, other potential barriers to successful implementation include the limited evidence base to support development of these protocols, as well as the need to address public trust.

“If a triage system is perceived as unjust or biased, or if people think that triage favors or excludes certain groups unfairly, it will undermine any system,” Dr. Maves said. “Making sure the public both understands and has input into system development is critical if we are going to be able to make this work.”

Dr. Maves and coauthors reported that some of the authors of their guidance are United States government employees or military service members, and that their opinions and assertions do not reflect the official views or position of those institutions. Dr. Keller reported no disclosures related to the ECMO guidance.

chestphysiciannews@chestnet.org

SOURCES: Maves RC et al. Chest. 2020 Apr 11. pii: S0012-3692(20)30691-7. doi: 10.1016/j.chest.2020.03.063; Seethara R and Keller SP. Ann Am Thorac Soc. 2020 Apr 15. doi: 10.1513/AnnalsATS.202003-233PS.

While triage of critical care resources should be a rare event during the COVID-19 crisis, failing to prepare for the worst-case scenario could have serious consequences, according to authors of recent reports that offer advice on how to prepare for surges in demand.

Courtesy NIAID-RML

Even modest numbers of critically ill COVID-19 patients have already rapidly overwhelmed existing hospital capacity in hard-hit areas including Italy, Spain, and New York City, said authors of an expert panel report released in CHEST.

“The ethical burden this places on hospitals, health systems, and society is enormous,” said Ryan C. Maves, MD, FCCP, of the Naval Medical Center in San Diego, lead author of the expert panel report from the Task Force for Mass Critical Care and the American College of Chest Physicians (CHEST).

Andrew Bowser/MDedge News

Mild surges call for a focus on increasing ECMO capacity, while a moderate surge may indicate a need to focus on allocating scarce resources, and a major surge may signal the need to limit or defer use of scarce resources, according to the guidance.

“If your health care system is stretched from a resource standpoint, at what point do you say, ‘we don’t even have the capability to even safely do ECMO, and so, perhaps we should not even be offering the support’?” Dr. Keller said in an interview. “That’s what we tried to get at in the paper – helping institutions think about how to prepare for that pandemic, and then when to make decisions on when it should and should not be offered.”
 

Critical care guidance for COVID-19

The guidance from the Task Force for Mass Critical Care and CHEST offers nine specific actions that authors suggest as part of a framework for communities to establish the infrastructure needed to triage critical care resources and “equitably” meet the needs of the largest number of COVID-19 patients.

“It is the goal of the task force to minimize the need for allocation of scarce resources as much as possible,” the authors stated.

The framework starts with surge planning that includes an inventory of intensive care unit resources such as ventilators, beds, supplies, and staff that could be marshaled to meet a surge in demand, followed by establishing “identification triggers” for triage initiation by a regional authority, should clinical demand reach a crisis stage.

The next step is preparing the triage system, which includes creating a committee at the regional level, identifying members of tertiary triage teams and the support structures they will need, and preparing and distributing training materials.

Agreeing on a triage protocol is important to ensure equitable targeting of resources, and how to allocate limited life-sustaining measures needs to be considered, according to the panel of experts. They also recommend adaptations to the standards of care such as modification of end-of-life care policies, support for health care workers, family, and the public, and consideration of pediatric issues including transport, concentration of care at specific centers, and potential increases in age thresholds to accommodate surges.
 

Barriers to triage?

When asked about potential barriers to rolling out a triage plan, Dr. Maves said the first is acknowledging the possible need for such a plan: “It is a difficult concept for most in critical care to accept – the idea that we may not be able to provide an individual patient with interventions that we consider routine,” he said.

Beyond acknowledging need, other potential barriers to successful implementation include the limited evidence base to support development of these protocols, as well as the need to address public trust.

“If a triage system is perceived as unjust or biased, or if people think that triage favors or excludes certain groups unfairly, it will undermine any system,” Dr. Maves said. “Making sure the public both understands and has input into system development is critical if we are going to be able to make this work.”

Dr. Maves and coauthors reported that some of the authors of their guidance are United States government employees or military service members, and that their opinions and assertions do not reflect the official views or position of those institutions. Dr. Keller reported no disclosures related to the ECMO guidance.

chestphysiciannews@chestnet.org

SOURCES: Maves RC et al. Chest. 2020 Apr 11. pii: S0012-3692(20)30691-7. doi: 10.1016/j.chest.2020.03.063; Seethara R and Keller SP. Ann Am Thorac Soc. 2020 Apr 15. doi: 10.1513/AnnalsATS.202003-233PS.

The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its safety review of ingenol mebutate (Picato), finding that the risks for skin cancer from the topical gel used to treat actinic keratosis outweigh the benefits.

Picato was cleared for marketing in the European Union in November 2012. The European Commission requested a safety review of the drug in September 2019 after data suggested a higher number of skin cancer cases, including cases of squamous cell carcinoma, in patients using it, as reported by Medscape Medical News.

In January 2020, use of Picato was suspended as a precaution while the PRAC review was underway. One month later, marketing authorization was withdrawn at the request of Leo Laboratories Ltd, which marketed the medicine.

The PRAC has now concluded its review of all available data on the risk for skin cancer in patients using Picato, including results of a study that compared Picato with imiquimod.

The review found “a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod,” the EMA said Friday in a news release.

“The committee also considered that Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis,” the EMA said.

The agency recommends that patients who have used Picato watch for unusual skin changes or growths, which may occur weeks to months after use, and seek medical advice if any occur.

Picato continues to be available in the United States, although the US Food and Drug Administration is also looking into its safety and risks.

This article first appeared on Medscape.com.

The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its safety review of ingenol mebutate (Picato), finding that the risks for skin cancer from the topical gel used to treat actinic keratosis outweigh the benefits.

Picato was cleared for marketing in the European Union in November 2012. The European Commission requested a safety review of the drug in September 2019 after data suggested a higher number of skin cancer cases, including cases of squamous cell carcinoma, in patients using it, as reported by Medscape Medical News.

In January 2020, use of Picato was suspended as a precaution while the PRAC review was underway. One month later, marketing authorization was withdrawn at the request of Leo Laboratories Ltd, which marketed the medicine.

The PRAC has now concluded its review of all available data on the risk for skin cancer in patients using Picato, including results of a study that compared Picato with imiquimod.

The review found “a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod,” the EMA said Friday in a news release.

“The committee also considered that Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis,” the EMA said.

The agency recommends that patients who have used Picato watch for unusual skin changes or growths, which may occur weeks to months after use, and seek medical advice if any occur.

Picato continues to be available in the United States, although the US Food and Drug Administration is also looking into its safety and risks.

This article first appeared on Medscape.com.

The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its safety review of ingenol mebutate (Picato), finding that the risks for skin cancer from the topical gel used to treat actinic keratosis outweigh the benefits.

Picato was cleared for marketing in the European Union in November 2012. The European Commission requested a safety review of the drug in September 2019 after data suggested a higher number of skin cancer cases, including cases of squamous cell carcinoma, in patients using it, as reported by Medscape Medical News.

In January 2020, use of Picato was suspended as a precaution while the PRAC review was underway. One month later, marketing authorization was withdrawn at the request of Leo Laboratories Ltd, which marketed the medicine.

The PRAC has now concluded its review of all available data on the risk for skin cancer in patients using Picato, including results of a study that compared Picato with imiquimod.

The review found “a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod,” the EMA said Friday in a news release.

“The committee also considered that Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis,” the EMA said.

The agency recommends that patients who have used Picato watch for unusual skin changes or growths, which may occur weeks to months after use, and seek medical advice if any occur.

Picato continues to be available in the United States, although the US Food and Drug Administration is also looking into its safety and risks.

This article first appeared on Medscape.com.

Boxing may help improve common nonmotor symptoms of Parkinson’s disease, new research suggests. In the study, patients with Parkinson’s disease who participated in a noncontact boxing program experienced improvement in nonmotor symptoms such as fatigue, depression, and anxiety, and had significantly better quality of life compared with their counterparts who did not engage in this type of exercise.

“We know we should be prescribing exercise for our Parkinson’s disease patients because more and more research shows it can delay the progression of the disease, but it can be overwhelming to know what type of exercise to prescribe to patients,” study investigator Danielle Larson, MD, a neurologist and movement disorders fellow at Northwestern University, Chicago, Illinois, told Medscape Medical News.

On a daily basis, patients at Dr. Larson’s clinic who have taken Rock Steady Boxing (RSB) classes “really endorse” this exercise, she said.

The findings were released March 4 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Global program

A form of noncontact boxing, RSB was created in 2006 for patients with Parkinson’s disease. A typical 90-minute class starts with stretching and cardiovascular exercises, then foot movements and stepping over obstacles.

“Parkinson’s disease patients are slowed down and have difficulty navigating around obstacles,” Dr. Larson noted.

The class also includes “speed training,” such as fast walking or running. In the boxing part of the class, participants use suspended punching bags.

Dr. Larson said the RSB program caters to all patients with Parkinson’s disease, “even those who need a walker for assistance.” Most RSB sites require a release from a physician to ensure patient safety, she said.

There are now about 43,500 participants at 871 RSB sites around the world.

Adults with Parkinson’s disease who were aware of RSB completed a 20-minute anonymous survey, distributed via email and social media by RSB Inc and the Parkinson Foundation.

Of 2,054 survey respondents, 1,709 were eligible for analysis. Of these, 1,333 were currently participating in RSB, 166 had previously participated, and 210 had never participated in the program.

For all three groups, researchers gathered demographic information, such as age, gender, and income, and asked respondents how long they had the condition, who takes care of their illness, etc.

Current and previous RSB participants were asked about the exercise. For example, they were asked how many classes on average they would take per week and whether specific symptoms had improved or not changed with their participation.

RSB participants had a mean age of 69 years, 59% were male, and 96% were white. Demographics were similar for the other groups, although Dr. Larson noted that the group that had never participated was relatively small.

There was no difference between the groups in terms of years since Parkinson’ disease diagnosis or use of a movement disorders specialist.

Less fatigue

Compared with nonparticipants, a higher percentage of participants were retired (76% vs. 65%, P < .01) and married/had a partner (85% vs. 80%, P = .03).

The symptoms for which participants reported at least a 50% improvement were mostly nonmotor symptoms. For example, participants had improvements in social life (70%), fatigue (63%), fear of falling (62%), depression (60%), and anxiety (59%).

More than 50% of respondents in the previous participant group also reported improvement in these symptoms, “just not to the same degree as the current participants,” Dr. Larson said.

“Those symptoms are difficult to treat in Parkinson’s disease,” she noted. “We really don’t have any good medications for those symptoms; so to report, for example, a 63% improvement in fatigue is pretty substantial.”

The survey included the Parkinson’s Disease Questionnaire–39 (PDQ-39). The questionnaire assesses factors associated with daily living, including relationships and the impact of Parkinson’s disease on functioning and well-being.

Compared with nonparticipants, current participants had better mean scores on the PDQ-39 (25 vs. 32, P < .01), which indicates better quality of life, Dr. Larson said. Previous participants had a higher (or worse) score than current participants, she added.

Largest study to date

Researchers also examined likelihood of exercising even with certain barriers, such as distance to the gym, bad weather, or fatigue using the Self Efficacy for Exercise (SEE) Scale. Current participants had better SEE scores compared with nonparticipants (54 vs. 48, P < .01).

“We can’t prove causality. We can’t say it was the RSB that improved their quality of life or their exercise self-efficacy, but at least there’s a correlation,” Dr. Larson said.

For the SEE, again, the previous participants had lower scores than current participants, she noted.

“An interpretation of this is that individuals who previously participated but stopped did so because they had lower exercise self-efficacy – which is the ability to self-motivate and stick with an exercise – to begin with,” she said.

As for Parkinson’s disease–related motor symptoms, the survey found some improvements. “People did report between 20% and 40% improvement on various motor symptoms,” but not more than 50% of respondents.

Dr. Larson noted that some motor symptoms such as tremor would not be expected to improve with exercise.

This study, the largest to date of RSB in patients with Parkinson’s disease, illustrates the benefits of this type of exercise intervention for these patients, she said.

“It’s a step in the right direction in showing that RSB, or noncontact boxing classes, can be a really good option for patients who have previously not been motivated to exercise, or maybe haven’t stuck with an exercise class, or maybe fatigue or anxiety or depression is a barrier for them to exercise.”

Patients who have experienced RSB praise its unique approach, in addition to generating friendships and promoting a sense of camaraderie and team spirit, Dr. Larson said.

“It’s almost like a support group inside an exercise class,” she noted. “We also see that people are really committed to the classes, whereas with other exercises it can be hard to get people to be motivated.”

Some 99% of current and 94% of previous participants indicated they would recommend RSB to others with Parkinson’s disease.

Interpret with caution

Commenting on the research, Michael S. Okun, MD, professor and chair of neurology, University of Florida Health, Gainesville, and medical director at the Parkinson’s Foundation, said many patients with Parkinson’s disease attend RSB classes and report that the regimen has a beneficial effect on symptoms and quality of life.

“The data from this study support these types of observations,” he said.

But Dr. Okun noted that caution is in order. “We should be careful not to overinterpret the results given that the methodology was survey-based,” he said.

To some extent, the results aren’t surprising, as multiple studies have already shown that exercise improves Parkinson’s disease symptoms and quality of life, Dr. Okun said. “We have no reason to believe that Rock Steady Boxing would not result in similar improvements.”

He stressed that a follow-up study will be necessary to better understand the potential benefits, both nonmotor and motor.

Also commenting, movement disorders specialist Anna DePold Hohler, MD, professor of neurology at Tufts University School of Medicine, Boston, and chair of neurology at St. Elizabeth’s Medical Center in Brighton, Massachusetts, said the new results “provide an added incentive” for patients to participate in RSB programs.

Such programs “should be started early and maintained,” Dr. Hohler added.

The study received no outside funding. The study authors have disclosed no relevant financial relationships. Drs. Okun and Hohler have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Boxing may help improve common nonmotor symptoms of Parkinson’s disease, new research suggests. In the study, patients with Parkinson’s disease who participated in a noncontact boxing program experienced improvement in nonmotor symptoms such as fatigue, depression, and anxiety, and had significantly better quality of life compared with their counterparts who did not engage in this type of exercise.

“We know we should be prescribing exercise for our Parkinson’s disease patients because more and more research shows it can delay the progression of the disease, but it can be overwhelming to know what type of exercise to prescribe to patients,” study investigator Danielle Larson, MD, a neurologist and movement disorders fellow at Northwestern University, Chicago, Illinois, told Medscape Medical News.

On a daily basis, patients at Dr. Larson’s clinic who have taken Rock Steady Boxing (RSB) classes “really endorse” this exercise, she said.

The findings were released March 4 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Global program

A form of noncontact boxing, RSB was created in 2006 for patients with Parkinson’s disease. A typical 90-minute class starts with stretching and cardiovascular exercises, then foot movements and stepping over obstacles.

“Parkinson’s disease patients are slowed down and have difficulty navigating around obstacles,” Dr. Larson noted.

The class also includes “speed training,” such as fast walking or running. In the boxing part of the class, participants use suspended punching bags.

Dr. Larson said the RSB program caters to all patients with Parkinson’s disease, “even those who need a walker for assistance.” Most RSB sites require a release from a physician to ensure patient safety, she said.

There are now about 43,500 participants at 871 RSB sites around the world.

Adults with Parkinson’s disease who were aware of RSB completed a 20-minute anonymous survey, distributed via email and social media by RSB Inc and the Parkinson Foundation.

Of 2,054 survey respondents, 1,709 were eligible for analysis. Of these, 1,333 were currently participating in RSB, 166 had previously participated, and 210 had never participated in the program.

For all three groups, researchers gathered demographic information, such as age, gender, and income, and asked respondents how long they had the condition, who takes care of their illness, etc.

Current and previous RSB participants were asked about the exercise. For example, they were asked how many classes on average they would take per week and whether specific symptoms had improved or not changed with their participation.

RSB participants had a mean age of 69 years, 59% were male, and 96% were white. Demographics were similar for the other groups, although Dr. Larson noted that the group that had never participated was relatively small.

There was no difference between the groups in terms of years since Parkinson’ disease diagnosis or use of a movement disorders specialist.

Less fatigue

Compared with nonparticipants, a higher percentage of participants were retired (76% vs. 65%, P < .01) and married/had a partner (85% vs. 80%, P = .03).

The symptoms for which participants reported at least a 50% improvement were mostly nonmotor symptoms. For example, participants had improvements in social life (70%), fatigue (63%), fear of falling (62%), depression (60%), and anxiety (59%).

More than 50% of respondents in the previous participant group also reported improvement in these symptoms, “just not to the same degree as the current participants,” Dr. Larson said.

“Those symptoms are difficult to treat in Parkinson’s disease,” she noted. “We really don’t have any good medications for those symptoms; so to report, for example, a 63% improvement in fatigue is pretty substantial.”

The survey included the Parkinson’s Disease Questionnaire–39 (PDQ-39). The questionnaire assesses factors associated with daily living, including relationships and the impact of Parkinson’s disease on functioning and well-being.

Compared with nonparticipants, current participants had better mean scores on the PDQ-39 (25 vs. 32, P < .01), which indicates better quality of life, Dr. Larson said. Previous participants had a higher (or worse) score than current participants, she added.

Largest study to date

Researchers also examined likelihood of exercising even with certain barriers, such as distance to the gym, bad weather, or fatigue using the Self Efficacy for Exercise (SEE) Scale. Current participants had better SEE scores compared with nonparticipants (54 vs. 48, P < .01).

“We can’t prove causality. We can’t say it was the RSB that improved their quality of life or their exercise self-efficacy, but at least there’s a correlation,” Dr. Larson said.

For the SEE, again, the previous participants had lower scores than current participants, she noted.

“An interpretation of this is that individuals who previously participated but stopped did so because they had lower exercise self-efficacy – which is the ability to self-motivate and stick with an exercise – to begin with,” she said.

As for Parkinson’s disease–related motor symptoms, the survey found some improvements. “People did report between 20% and 40% improvement on various motor symptoms,” but not more than 50% of respondents.

Dr. Larson noted that some motor symptoms such as tremor would not be expected to improve with exercise.

This study, the largest to date of RSB in patients with Parkinson’s disease, illustrates the benefits of this type of exercise intervention for these patients, she said.

“It’s a step in the right direction in showing that RSB, or noncontact boxing classes, can be a really good option for patients who have previously not been motivated to exercise, or maybe haven’t stuck with an exercise class, or maybe fatigue or anxiety or depression is a barrier for them to exercise.”

Patients who have experienced RSB praise its unique approach, in addition to generating friendships and promoting a sense of camaraderie and team spirit, Dr. Larson said.

“It’s almost like a support group inside an exercise class,” she noted. “We also see that people are really committed to the classes, whereas with other exercises it can be hard to get people to be motivated.”

Some 99% of current and 94% of previous participants indicated they would recommend RSB to others with Parkinson’s disease.

Interpret with caution

Commenting on the research, Michael S. Okun, MD, professor and chair of neurology, University of Florida Health, Gainesville, and medical director at the Parkinson’s Foundation, said many patients with Parkinson’s disease attend RSB classes and report that the regimen has a beneficial effect on symptoms and quality of life.

“The data from this study support these types of observations,” he said.

But Dr. Okun noted that caution is in order. “We should be careful not to overinterpret the results given that the methodology was survey-based,” he said.

To some extent, the results aren’t surprising, as multiple studies have already shown that exercise improves Parkinson’s disease symptoms and quality of life, Dr. Okun said. “We have no reason to believe that Rock Steady Boxing would not result in similar improvements.”

He stressed that a follow-up study will be necessary to better understand the potential benefits, both nonmotor and motor.

Also commenting, movement disorders specialist Anna DePold Hohler, MD, professor of neurology at Tufts University School of Medicine, Boston, and chair of neurology at St. Elizabeth’s Medical Center in Brighton, Massachusetts, said the new results “provide an added incentive” for patients to participate in RSB programs.

Such programs “should be started early and maintained,” Dr. Hohler added.

The study received no outside funding. The study authors have disclosed no relevant financial relationships. Drs. Okun and Hohler have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Boxing may help improve common nonmotor symptoms of Parkinson’s disease, new research suggests. In the study, patients with Parkinson’s disease who participated in a noncontact boxing program experienced improvement in nonmotor symptoms such as fatigue, depression, and anxiety, and had significantly better quality of life compared with their counterparts who did not engage in this type of exercise.

“We know we should be prescribing exercise for our Parkinson’s disease patients because more and more research shows it can delay the progression of the disease, but it can be overwhelming to know what type of exercise to prescribe to patients,” study investigator Danielle Larson, MD, a neurologist and movement disorders fellow at Northwestern University, Chicago, Illinois, told Medscape Medical News.

On a daily basis, patients at Dr. Larson’s clinic who have taken Rock Steady Boxing (RSB) classes “really endorse” this exercise, she said.

The findings were released March 4 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

Global program

A form of noncontact boxing, RSB was created in 2006 for patients with Parkinson’s disease. A typical 90-minute class starts with stretching and cardiovascular exercises, then foot movements and stepping over obstacles.

“Parkinson’s disease patients are slowed down and have difficulty navigating around obstacles,” Dr. Larson noted.

The class also includes “speed training,” such as fast walking or running. In the boxing part of the class, participants use suspended punching bags.

Dr. Larson said the RSB program caters to all patients with Parkinson’s disease, “even those who need a walker for assistance.” Most RSB sites require a release from a physician to ensure patient safety, she said.

There are now about 43,500 participants at 871 RSB sites around the world.

Adults with Parkinson’s disease who were aware of RSB completed a 20-minute anonymous survey, distributed via email and social media by RSB Inc and the Parkinson Foundation.

Of 2,054 survey respondents, 1,709 were eligible for analysis. Of these, 1,333 were currently participating in RSB, 166 had previously participated, and 210 had never participated in the program.

For all three groups, researchers gathered demographic information, such as age, gender, and income, and asked respondents how long they had the condition, who takes care of their illness, etc.

Current and previous RSB participants were asked about the exercise. For example, they were asked how many classes on average they would take per week and whether specific symptoms had improved or not changed with their participation.

RSB participants had a mean age of 69 years, 59% were male, and 96% were white. Demographics were similar for the other groups, although Dr. Larson noted that the group that had never participated was relatively small.

There was no difference between the groups in terms of years since Parkinson’ disease diagnosis or use of a movement disorders specialist.

Less fatigue

Compared with nonparticipants, a higher percentage of participants were retired (76% vs. 65%, P < .01) and married/had a partner (85% vs. 80%, P = .03).

The symptoms for which participants reported at least a 50% improvement were mostly nonmotor symptoms. For example, participants had improvements in social life (70%), fatigue (63%), fear of falling (62%), depression (60%), and anxiety (59%).

More than 50% of respondents in the previous participant group also reported improvement in these symptoms, “just not to the same degree as the current participants,” Dr. Larson said.

“Those symptoms are difficult to treat in Parkinson’s disease,” she noted. “We really don’t have any good medications for those symptoms; so to report, for example, a 63% improvement in fatigue is pretty substantial.”

The survey included the Parkinson’s Disease Questionnaire–39 (PDQ-39). The questionnaire assesses factors associated with daily living, including relationships and the impact of Parkinson’s disease on functioning and well-being.

Compared with nonparticipants, current participants had better mean scores on the PDQ-39 (25 vs. 32, P < .01), which indicates better quality of life, Dr. Larson said. Previous participants had a higher (or worse) score than current participants, she added.

Largest study to date

Researchers also examined likelihood of exercising even with certain barriers, such as distance to the gym, bad weather, or fatigue using the Self Efficacy for Exercise (SEE) Scale. Current participants had better SEE scores compared with nonparticipants (54 vs. 48, P < .01).

“We can’t prove causality. We can’t say it was the RSB that improved their quality of life or their exercise self-efficacy, but at least there’s a correlation,” Dr. Larson said.

For the SEE, again, the previous participants had lower scores than current participants, she noted.

“An interpretation of this is that individuals who previously participated but stopped did so because they had lower exercise self-efficacy – which is the ability to self-motivate and stick with an exercise – to begin with,” she said.

As for Parkinson’s disease–related motor symptoms, the survey found some improvements. “People did report between 20% and 40% improvement on various motor symptoms,” but not more than 50% of respondents.

Dr. Larson noted that some motor symptoms such as tremor would not be expected to improve with exercise.

This study, the largest to date of RSB in patients with Parkinson’s disease, illustrates the benefits of this type of exercise intervention for these patients, she said.

“It’s a step in the right direction in showing that RSB, or noncontact boxing classes, can be a really good option for patients who have previously not been motivated to exercise, or maybe haven’t stuck with an exercise class, or maybe fatigue or anxiety or depression is a barrier for them to exercise.”

Patients who have experienced RSB praise its unique approach, in addition to generating friendships and promoting a sense of camaraderie and team spirit, Dr. Larson said.

“It’s almost like a support group inside an exercise class,” she noted. “We also see that people are really committed to the classes, whereas with other exercises it can be hard to get people to be motivated.”

Some 99% of current and 94% of previous participants indicated they would recommend RSB to others with Parkinson’s disease.

Interpret with caution

Commenting on the research, Michael S. Okun, MD, professor and chair of neurology, University of Florida Health, Gainesville, and medical director at the Parkinson’s Foundation, said many patients with Parkinson’s disease attend RSB classes and report that the regimen has a beneficial effect on symptoms and quality of life.

“The data from this study support these types of observations,” he said.

But Dr. Okun noted that caution is in order. “We should be careful not to overinterpret the results given that the methodology was survey-based,” he said.

To some extent, the results aren’t surprising, as multiple studies have already shown that exercise improves Parkinson’s disease symptoms and quality of life, Dr. Okun said. “We have no reason to believe that Rock Steady Boxing would not result in similar improvements.”

He stressed that a follow-up study will be necessary to better understand the potential benefits, both nonmotor and motor.

Also commenting, movement disorders specialist Anna DePold Hohler, MD, professor of neurology at Tufts University School of Medicine, Boston, and chair of neurology at St. Elizabeth’s Medical Center in Brighton, Massachusetts, said the new results “provide an added incentive” for patients to participate in RSB programs.

Such programs “should be started early and maintained,” Dr. Hohler added.

The study received no outside funding. The study authors have disclosed no relevant financial relationships. Drs. Okun and Hohler have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Prognostic indexes have been developed recently to assess time to first treatment in early-stage chronic lymphocytic leukemia (CLL) patients. However, none of five indexes evaluated in a study showed more than a moderate prognostic value or were precise enough to permit clinical decisions to be made, according to a report by Spanish researchers.

Their study, published in Clinical Lymphoma, Myeloma and Leukemia, examined the comparative prognostic value of five prognostic indexes – the CLL-IPI, the Barcelona-Brno, the IPS-A, the CLL-01, and the Tailored approach – on evaluating 428 Binet A CLL patients from a multicenter Spanish database which contained the relevant necessary clinical and biological information. The predictive value of the scores was assessed with Harrell´s C index and receiver operating characteristic curve (area under the curve, AUC).

The researchers found a significant association between time to first treatment and risk subgroups for all the indexes used. The most accurate index was the IPS-A (Harrell´s C, 0.72; AUC, 0.76), followed by the CLL-01 (Harrell´s C, 0.69; AUC, 0.70), the CLL-IPI (Harrell´s C, .69; AUC, 0.69), the Barcelona-Brno (Harrell´s C: 0.67, AUC, 0.69) and the Tailored approach (Harrell´s C, 0.61 and 0.58, AUCs, 0.58 and 0.54).

However, the concordance between four of the five indexes (the Tailored approach was not included for technical reasons) compared was low (44%): 146 cases were classified as low risk with all four indexes tested, 36 as intermediate risk, and 4 as high risk. In the remaining 242 patients (56%) at least one discrepancy was detected in the allocation among prognostic subgroups between the indexes. However, only 12 patients (3%) were allocated as low and high risk at the same time with different indexes, showing the extremes of the discordance.

These data suggest that, although all of these indexes “significantly improve clinical staging and help physicians in routine clinical practice, it is necessary to harmonize larger cohorts of patients in order to define the best index for treatment decision making in the real world,” the authors stated.

“All the models had a moderate prognostic value to predict time to first therapy. ... None of them was precise enough to allow clinical decisions based exclusively on it,” the authors concluded.

The study was supported by grants from the Spanish government and a variety of nonprofit institutions. The authors reported no commercial disclosures.

mlesney@mdedge.com

SOURCE: Gascon y Marín IG et al. Clin Lymphoma Myeloma Leuk. 2020 Apr 13. doi: 10.1016/j.clml.2020.03.003.

Prognostic indexes have been developed recently to assess time to first treatment in early-stage chronic lymphocytic leukemia (CLL) patients. However, none of five indexes evaluated in a study showed more than a moderate prognostic value or were precise enough to permit clinical decisions to be made, according to a report by Spanish researchers.

Their study, published in Clinical Lymphoma, Myeloma and Leukemia, examined the comparative prognostic value of five prognostic indexes – the CLL-IPI, the Barcelona-Brno, the IPS-A, the CLL-01, and the Tailored approach – on evaluating 428 Binet A CLL patients from a multicenter Spanish database which contained the relevant necessary clinical and biological information. The predictive value of the scores was assessed with Harrell´s C index and receiver operating characteristic curve (area under the curve, AUC).

The researchers found a significant association between time to first treatment and risk subgroups for all the indexes used. The most accurate index was the IPS-A (Harrell´s C, 0.72; AUC, 0.76), followed by the CLL-01 (Harrell´s C, 0.69; AUC, 0.70), the CLL-IPI (Harrell´s C, .69; AUC, 0.69), the Barcelona-Brno (Harrell´s C: 0.67, AUC, 0.69) and the Tailored approach (Harrell´s C, 0.61 and 0.58, AUCs, 0.58 and 0.54).

However, the concordance between four of the five indexes (the Tailored approach was not included for technical reasons) compared was low (44%): 146 cases were classified as low risk with all four indexes tested, 36 as intermediate risk, and 4 as high risk. In the remaining 242 patients (56%) at least one discrepancy was detected in the allocation among prognostic subgroups between the indexes. However, only 12 patients (3%) were allocated as low and high risk at the same time with different indexes, showing the extremes of the discordance.

These data suggest that, although all of these indexes “significantly improve clinical staging and help physicians in routine clinical practice, it is necessary to harmonize larger cohorts of patients in order to define the best index for treatment decision making in the real world,” the authors stated.

“All the models had a moderate prognostic value to predict time to first therapy. ... None of them was precise enough to allow clinical decisions based exclusively on it,” the authors concluded.

The study was supported by grants from the Spanish government and a variety of nonprofit institutions. The authors reported no commercial disclosures.

mlesney@mdedge.com

SOURCE: Gascon y Marín IG et al. Clin Lymphoma Myeloma Leuk. 2020 Apr 13. doi: 10.1016/j.clml.2020.03.003.

Prognostic indexes have been developed recently to assess time to first treatment in early-stage chronic lymphocytic leukemia (CLL) patients. However, none of five indexes evaluated in a study showed more than a moderate prognostic value or were precise enough to permit clinical decisions to be made, according to a report by Spanish researchers.

Their study, published in Clinical Lymphoma, Myeloma and Leukemia, examined the comparative prognostic value of five prognostic indexes – the CLL-IPI, the Barcelona-Brno, the IPS-A, the CLL-01, and the Tailored approach – on evaluating 428 Binet A CLL patients from a multicenter Spanish database which contained the relevant necessary clinical and biological information. The predictive value of the scores was assessed with Harrell´s C index and receiver operating characteristic curve (area under the curve, AUC).

The researchers found a significant association between time to first treatment and risk subgroups for all the indexes used. The most accurate index was the IPS-A (Harrell´s C, 0.72; AUC, 0.76), followed by the CLL-01 (Harrell´s C, 0.69; AUC, 0.70), the CLL-IPI (Harrell´s C, .69; AUC, 0.69), the Barcelona-Brno (Harrell´s C: 0.67, AUC, 0.69) and the Tailored approach (Harrell´s C, 0.61 and 0.58, AUCs, 0.58 and 0.54).

However, the concordance between four of the five indexes (the Tailored approach was not included for technical reasons) compared was low (44%): 146 cases were classified as low risk with all four indexes tested, 36 as intermediate risk, and 4 as high risk. In the remaining 242 patients (56%) at least one discrepancy was detected in the allocation among prognostic subgroups between the indexes. However, only 12 patients (3%) were allocated as low and high risk at the same time with different indexes, showing the extremes of the discordance.

These data suggest that, although all of these indexes “significantly improve clinical staging and help physicians in routine clinical practice, it is necessary to harmonize larger cohorts of patients in order to define the best index for treatment decision making in the real world,” the authors stated.

“All the models had a moderate prognostic value to predict time to first therapy. ... None of them was precise enough to allow clinical decisions based exclusively on it,” the authors concluded.

The study was supported by grants from the Spanish government and a variety of nonprofit institutions. The authors reported no commercial disclosures.

mlesney@mdedge.com

SOURCE: Gascon y Marín IG et al. Clin Lymphoma Myeloma Leuk. 2020 Apr 13. doi: 10.1016/j.clml.2020.03.003.

Playing table tennis, also known as ping-pong, appears to improve motor symptoms in patients with Parkinson’s disease, new research suggests. The results of a small pilot study show that table ping-pong is a safe and effective rehabilitative intervention for patients with Parkinson’s disease that can be easily introduced, study investigator Shinsuke Fujioka, MD, Department of Neurology, Fukuoka University, Japan, told Medscape Medical News.

He emphasized that any rehabilitation for patients with Parkinson’s disease could be beneficial, especially during the early stages of their illness. “The most important thing is that patients have fun when doing rehabilitation.”

The findings were released February 25 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

All exercise beneficial

The idea of studying ping-pong as a therapy for patients with Parkinson’s disease originated when Dr. Fujioka heard about a patient who used a cane but no longer needed it after taking up the exercise as a weekly rehabilitation therapy.

“It’s apparent that the exercise can improve motor function of Parkinson’s disease. However, to date, the effects of the sport have not been well investigated for this patient population, so our study aimed to disclose the effects that table tennis can bring to patients with Parkinson’s disease,” said Dr. Fujioka.

The study included 12 patients with Parkinson’s disease – 10 women and two men. Mean age at disease onset was 67 years, and mean disease duration was 7 years. Mean stage on the Hoehn & Yahr scale, which assesses severity of Parkinson’s disease symptoms, was three, so most patients had balance problems.

Study participants played ping-pong at once-weekly 5-hour sessions that included rest breaks whenever they felt it was necessary.

Researchers assessed participants using the Unified Parkinson’s Disease Rating Scale (UPDRS) part I-IV. Parts II and III assess motor function whereas parts I and IV evaluate nonmotor function and motor complications, respectively.

The main motor symptoms of Parkinson’s disease include bradykinesia and muscle rigidity, tremor, and postural instability.

Researchers also assessed participants using the Montreal Cognitive Assessment (MoCA), Frontal Assessment Battery (FAB), Self-Rating Depression Scale (SDS), and Apathy scale.

Results showed that UPDRS part II significantly improved at 3 and 6 months (both P < 0.001), as did UPDRS part III (P = 0.002 at 3 months; P < 0.001 at 6 months).

Dr. Fujioka speculated, “twisting axial muscles when hitting a ping-pong ball may be the most efficacious for patients, especially for bradykinesia and balance problems.”
 

Significant improvement

Such findings may not be that surprising. Dr. Fujioka pointed to other rehabilitation therapies such as tai chi or tango that may also improve Parkinson’s disease motor symptoms.

For UPDRS part II, subscores of speech, saliva and drooling, dressing, handwriting, doing hobbies and other activities, getting out of bed, a car, or a deep chair, and walking and balance, significantly improved.

In addition, for UPDRS part III, subscores of facial expression, rigidity, postural stability, posture, bradykinesia, and kinetic tremor of the hands also significantly improved.

As for nonmotor symptoms such as mood, anxiety, depression, and apathy assessed in UPDRS part I, scores did not significantly change, which was also the case for part IV.

However, Dr. Fujioka pointed out that patient scores didn’t worsen. “Given the nature of disease, not worsening of nonmotor features can potentially be a good effect of the sport.” MoCA, FAB, SDS, and Apathy scale scores also did not change.

Dr. Fujioka noted that all participants enjoyed the table tennis rehabilitation, and “gradually smiled more during the study period.” All study participants continued the table tennis rehabilitation after the 6-month program.

Dr. Fujioka noted that although patients with Parkinson’s disease often have difficulty moving in a front-to-back direction, they can move relatively easily in a lateral direction.

“In that sense, table tennis is suitable for them,” he said. However, he added, court tennis, handball, and badminton may not be suitable for most patients with Parkinson’s disease.

One patient suffered a fall and another backache. Dr. Fujioka cautioned that more frequent ping-pong playing might increase the risk of adverse events.

He also suggests patients with Parkinson’s disease have their bone density checked before starting regular rehabilitation exercise as they are at increased risk for osteoporosis.

The investigators are currently organizing a prospective, multicenter randomized study to compare the effectiveness of table tennis with conventional rehabilitation and the Lee Silverman Voice Treatment, which is designed to increase vocal intensity in patients with Parkinson’s disease.
 

Fun, engaging

Commenting on the findings, Cynthia Comella, MD, professor emeritus, Neurological Sciences, Rush University Medical Center, New Philadelphia, Ohio, said ping-pong is a “fun and engaging” exercise for patients with Parkinson’s disease. Dr. Comella noted prior studies have shown many types of exercise are beneficial for patients with Parkinson’s disease “provided that they continue” with it.

In that regard, these new results are “promising,” she said. “It may be that this type of community generating, fun exercise would lead to a continuation of the exercise after a study is completed.”

A controlled trial that includes a post-study follow-up to evaluate compliance and continued benefit is needed, she said.

Purchase of equipment, including tables, rackets, and balls, was possible through funds donated by Hisako Kobayashi-Levin, which provides Murakami Karindoh Hospital with an annual fund to improve the quality of their rehabilitation program. The authors reported no relevant financial relationships.

This article first appeared on Medscape.com.

Playing table tennis, also known as ping-pong, appears to improve motor symptoms in patients with Parkinson’s disease, new research suggests. The results of a small pilot study show that table ping-pong is a safe and effective rehabilitative intervention for patients with Parkinson’s disease that can be easily introduced, study investigator Shinsuke Fujioka, MD, Department of Neurology, Fukuoka University, Japan, told Medscape Medical News.

He emphasized that any rehabilitation for patients with Parkinson’s disease could be beneficial, especially during the early stages of their illness. “The most important thing is that patients have fun when doing rehabilitation.”

The findings were released February 25 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

All exercise beneficial

The idea of studying ping-pong as a therapy for patients with Parkinson’s disease originated when Dr. Fujioka heard about a patient who used a cane but no longer needed it after taking up the exercise as a weekly rehabilitation therapy.

“It’s apparent that the exercise can improve motor function of Parkinson’s disease. However, to date, the effects of the sport have not been well investigated for this patient population, so our study aimed to disclose the effects that table tennis can bring to patients with Parkinson’s disease,” said Dr. Fujioka.

The study included 12 patients with Parkinson’s disease – 10 women and two men. Mean age at disease onset was 67 years, and mean disease duration was 7 years. Mean stage on the Hoehn & Yahr scale, which assesses severity of Parkinson’s disease symptoms, was three, so most patients had balance problems.

Study participants played ping-pong at once-weekly 5-hour sessions that included rest breaks whenever they felt it was necessary.

Researchers assessed participants using the Unified Parkinson’s Disease Rating Scale (UPDRS) part I-IV. Parts II and III assess motor function whereas parts I and IV evaluate nonmotor function and motor complications, respectively.

The main motor symptoms of Parkinson’s disease include bradykinesia and muscle rigidity, tremor, and postural instability.

Researchers also assessed participants using the Montreal Cognitive Assessment (MoCA), Frontal Assessment Battery (FAB), Self-Rating Depression Scale (SDS), and Apathy scale.

Results showed that UPDRS part II significantly improved at 3 and 6 months (both P < 0.001), as did UPDRS part III (P = 0.002 at 3 months; P < 0.001 at 6 months).

Dr. Fujioka speculated, “twisting axial muscles when hitting a ping-pong ball may be the most efficacious for patients, especially for bradykinesia and balance problems.”
 

Significant improvement

Such findings may not be that surprising. Dr. Fujioka pointed to other rehabilitation therapies such as tai chi or tango that may also improve Parkinson’s disease motor symptoms.

For UPDRS part II, subscores of speech, saliva and drooling, dressing, handwriting, doing hobbies and other activities, getting out of bed, a car, or a deep chair, and walking and balance, significantly improved.

In addition, for UPDRS part III, subscores of facial expression, rigidity, postural stability, posture, bradykinesia, and kinetic tremor of the hands also significantly improved.

As for nonmotor symptoms such as mood, anxiety, depression, and apathy assessed in UPDRS part I, scores did not significantly change, which was also the case for part IV.

However, Dr. Fujioka pointed out that patient scores didn’t worsen. “Given the nature of disease, not worsening of nonmotor features can potentially be a good effect of the sport.” MoCA, FAB, SDS, and Apathy scale scores also did not change.

Dr. Fujioka noted that all participants enjoyed the table tennis rehabilitation, and “gradually smiled more during the study period.” All study participants continued the table tennis rehabilitation after the 6-month program.

Dr. Fujioka noted that although patients with Parkinson’s disease often have difficulty moving in a front-to-back direction, they can move relatively easily in a lateral direction.

“In that sense, table tennis is suitable for them,” he said. However, he added, court tennis, handball, and badminton may not be suitable for most patients with Parkinson’s disease.

One patient suffered a fall and another backache. Dr. Fujioka cautioned that more frequent ping-pong playing might increase the risk of adverse events.

He also suggests patients with Parkinson’s disease have their bone density checked before starting regular rehabilitation exercise as they are at increased risk for osteoporosis.

The investigators are currently organizing a prospective, multicenter randomized study to compare the effectiveness of table tennis with conventional rehabilitation and the Lee Silverman Voice Treatment, which is designed to increase vocal intensity in patients with Parkinson’s disease.
 

Fun, engaging

Commenting on the findings, Cynthia Comella, MD, professor emeritus, Neurological Sciences, Rush University Medical Center, New Philadelphia, Ohio, said ping-pong is a “fun and engaging” exercise for patients with Parkinson’s disease. Dr. Comella noted prior studies have shown many types of exercise are beneficial for patients with Parkinson’s disease “provided that they continue” with it.

In that regard, these new results are “promising,” she said. “It may be that this type of community generating, fun exercise would lead to a continuation of the exercise after a study is completed.”

A controlled trial that includes a post-study follow-up to evaluate compliance and continued benefit is needed, she said.

Purchase of equipment, including tables, rackets, and balls, was possible through funds donated by Hisako Kobayashi-Levin, which provides Murakami Karindoh Hospital with an annual fund to improve the quality of their rehabilitation program. The authors reported no relevant financial relationships.

This article first appeared on Medscape.com.

Playing table tennis, also known as ping-pong, appears to improve motor symptoms in patients with Parkinson’s disease, new research suggests. The results of a small pilot study show that table ping-pong is a safe and effective rehabilitative intervention for patients with Parkinson’s disease that can be easily introduced, study investigator Shinsuke Fujioka, MD, Department of Neurology, Fukuoka University, Japan, told Medscape Medical News.

He emphasized that any rehabilitation for patients with Parkinson’s disease could be beneficial, especially during the early stages of their illness. “The most important thing is that patients have fun when doing rehabilitation.”

The findings were released February 25 ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology. The AAN canceled the meeting and released abstracts and access to presenters for press coverage.
 

All exercise beneficial

The idea of studying ping-pong as a therapy for patients with Parkinson’s disease originated when Dr. Fujioka heard about a patient who used a cane but no longer needed it after taking up the exercise as a weekly rehabilitation therapy.

“It’s apparent that the exercise can improve motor function of Parkinson’s disease. However, to date, the effects of the sport have not been well investigated for this patient population, so our study aimed to disclose the effects that table tennis can bring to patients with Parkinson’s disease,” said Dr. Fujioka.

The study included 12 patients with Parkinson’s disease – 10 women and two men. Mean age at disease onset was 67 years, and mean disease duration was 7 years. Mean stage on the Hoehn & Yahr scale, which assesses severity of Parkinson’s disease symptoms, was three, so most patients had balance problems.

Study participants played ping-pong at once-weekly 5-hour sessions that included rest breaks whenever they felt it was necessary.

Researchers assessed participants using the Unified Parkinson’s Disease Rating Scale (UPDRS) part I-IV. Parts II and III assess motor function whereas parts I and IV evaluate nonmotor function and motor complications, respectively.

The main motor symptoms of Parkinson’s disease include bradykinesia and muscle rigidity, tremor, and postural instability.

Researchers also assessed participants using the Montreal Cognitive Assessment (MoCA), Frontal Assessment Battery (FAB), Self-Rating Depression Scale (SDS), and Apathy scale.

Results showed that UPDRS part II significantly improved at 3 and 6 months (both P < 0.001), as did UPDRS part III (P = 0.002 at 3 months; P < 0.001 at 6 months).

Dr. Fujioka speculated, “twisting axial muscles when hitting a ping-pong ball may be the most efficacious for patients, especially for bradykinesia and balance problems.”
 

Significant improvement

Such findings may not be that surprising. Dr. Fujioka pointed to other rehabilitation therapies such as tai chi or tango that may also improve Parkinson’s disease motor symptoms.

For UPDRS part II, subscores of speech, saliva and drooling, dressing, handwriting, doing hobbies and other activities, getting out of bed, a car, or a deep chair, and walking and balance, significantly improved.

In addition, for UPDRS part III, subscores of facial expression, rigidity, postural stability, posture, bradykinesia, and kinetic tremor of the hands also significantly improved.

As for nonmotor symptoms such as mood, anxiety, depression, and apathy assessed in UPDRS part I, scores did not significantly change, which was also the case for part IV.

However, Dr. Fujioka pointed out that patient scores didn’t worsen. “Given the nature of disease, not worsening of nonmotor features can potentially be a good effect of the sport.” MoCA, FAB, SDS, and Apathy scale scores also did not change.

Dr. Fujioka noted that all participants enjoyed the table tennis rehabilitation, and “gradually smiled more during the study period.” All study participants continued the table tennis rehabilitation after the 6-month program.

Dr. Fujioka noted that although patients with Parkinson’s disease often have difficulty moving in a front-to-back direction, they can move relatively easily in a lateral direction.

“In that sense, table tennis is suitable for them,” he said. However, he added, court tennis, handball, and badminton may not be suitable for most patients with Parkinson’s disease.

One patient suffered a fall and another backache. Dr. Fujioka cautioned that more frequent ping-pong playing might increase the risk of adverse events.

He also suggests patients with Parkinson’s disease have their bone density checked before starting regular rehabilitation exercise as they are at increased risk for osteoporosis.

The investigators are currently organizing a prospective, multicenter randomized study to compare the effectiveness of table tennis with conventional rehabilitation and the Lee Silverman Voice Treatment, which is designed to increase vocal intensity in patients with Parkinson’s disease.
 

Fun, engaging

Commenting on the findings, Cynthia Comella, MD, professor emeritus, Neurological Sciences, Rush University Medical Center, New Philadelphia, Ohio, said ping-pong is a “fun and engaging” exercise for patients with Parkinson’s disease. Dr. Comella noted prior studies have shown many types of exercise are beneficial for patients with Parkinson’s disease “provided that they continue” with it.

In that regard, these new results are “promising,” she said. “It may be that this type of community generating, fun exercise would lead to a continuation of the exercise after a study is completed.”

A controlled trial that includes a post-study follow-up to evaluate compliance and continued benefit is needed, she said.

Purchase of equipment, including tables, rackets, and balls, was possible through funds donated by Hisako Kobayashi-Levin, which provides Murakami Karindoh Hospital with an annual fund to improve the quality of their rehabilitation program. The authors reported no relevant financial relationships.

This article first appeared on Medscape.com.

SARS CoV-2 (severe acute respiratory syndrome corona-
virus 2) has challenged us all and will continue to do so for at least the next several months. This novel virus has uncovered our medical hubris and our collective failure to acknowledge our vulnerability in the face of biological threats. As government, public health, health systems, medical professionals, and individuals struggle to grasp its enormous impact, we must recognize and seize the opportunities for leadership that the coronavirus disease (COVID-19) pandemic presents to us as physicians.

For too long we have abdicated responsibility for driving change in the US health system to politicians, administrators, and those not on the front line of care delivery. We can, however, reclaim our voice and position of influence in 2 primary spheres: first, as ObGyns we have the specific clinical knowledge and experience required to help guide our institutions in the care of our patients under new and ever-changing circumstances; second, beyond our clinical role as ObGyns, we are servant leaders to whom the public, the government, our trainees, and our clinical teams turn for guidance.

Foundations for policy development

Disaster planning in hospitals and public health systems rarely includes consideration for pregnant and delivering patients. As ObGyns, we must create policies and procedures using the best available evidence—which is slim—and, in the absence of evidence, use our clinical and scientific expertise both to optimize patient care and to minimize risk to the health care team.

At this point in time there is much we do not know, such as whether viral particles in blood are contagious, amniotic fluid contains infectious droplets, or newborns are in danger if they room-in with an infected mother. What we do know is that the evidence will evolve and that our policies and procedures must be fluid and allow for rapid change. Here are some guiding principles for such policies.

Maximize telemedicine and remote monitoring

Labor and delivery (L&D) is an emergency department in which people are triaged from the outside. Systems should incorporate the best guidance from the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists while reducing infection exposure to staff, laboring patients, and newborns. One way to limit traffic in the triage area is to have a seasoned clinician perform phone triage for women who think they need evaluation for labor.

Maintain universal caution and precautions

All people entering L&D should be presumed to be COVID-19 positive, according to early evidence reported from Columbia University in New York City.¹ After remote or off-site phone triage determines that evaluation is needed in L&D, a transporter could ensure that all people escorted to L&D undergo a rapid COVID-19 test, wear a mask, and wash their hands. Until point-of-care testing is available, we must adopt safety precautions, since current data suggest that asymptomatic people may shed the infectious virus.

Both vaginal and cesarean deliveries expose everyone in the room to respiratory droplets. Common sense tells us that the laboring patient and her support person should wear a mask and that caregivers should be protected with N95 masks as well as face shields. If this were standard for every laboring patient, exposure during emergency situations might be minimized.

Continue to: Maximize support during labor...

Maximize support during labor

We should not need to ban partners and support people. Solid evidence demonstrates that support in labor improves outcomes, reduces the need for cesarean delivery, and increases patient satisfaction. We can and should protect staff and patients by requiring everyone to wear a mask.

Symptomatic patients, of course, require additional measures and personal protective equipment (PPE) to reduce the risk of infection among the health care team. These should be identical to the measures the hospital infectious disease experts have implemented in the intensive care unit.

Champion continuous quality improvement

It is our responsibility to implement continuous quality improvement processes so that we can respond to data that become available, and this begins with collecting our own local data.

We have sparse data on the risks of miscarriage, congenital anomalies, and preterm birth, but there have been anecdotal reports of both early miscarriage and premature labor. Given the known increased risk for severe disease with influenza during pregnancy, we understandably are concerned about how our pregnant patients will fare. There are also unknowns with respect to fetal exposure risk. During this pandemic we must capture such data within our own systems and share aggregated, de-identified data broadly and swiftly if real signals indicate a need for change in procedures or policy.

In the meantime, we can apply our expertise and best judgment to work within teams that include all stakeholders—administrators, nurses, engineers, pediatricians, infectious disease experts, and public members—to establish policies that respond to the best current evidence.

Protect vulnerable team members

SARS CoV-2 is highly contagious. Thus far, data do not suggest that pregnant women are at higher risk for severe disease, but we must assume that working in the hospital environment among many COVID-19 patients increases the risk for exposure. With so many current unknowns, it may be prudent to keep pregnant health care workers out of clinical areas in the hospital and reassign them to other duties when feasible. Medical students nationwide similarly have been removed from clinical rotations to minimize their exposure risk as well as to preserve scarce PPE.

These decisions are difficult for all involved, and shared decision making between administrators, clinical leaders, and pregnant staff that promotes transparency, honesty, and openness is key. Since the risk is unknown and financial consequences may result for both the hospital and the staff member, open discussion and thoughtful policies that can be revised as new information is obtained will help achieve the best possible resolution to a difficult situation.

Continue to: ObGyns as servant leaders...

ObGyns as servant leaders

COVID-19 challenges us to balance individual and public health considerations while also considering the economic and social consequences of actions. The emergence of this novel pathogen and its rapid global spread are frightening both to an uninformed public and to our skeptical government officials. Beyond our immediate clinical responsibilities, how should we as knowledgeable professionals respond?

Servant leaders commit to service and support and mentor those around them with empathy and collaboration. Servant leaders have the strategic vision to continuously grow, change, and improve at all times, but especially during a crisis. COVID-19 challenges us to be those servant leaders. To do so we must:

Promote and exhibit transparency by speaking truth to power and communicating with empathy for patients, staff, and those on the front lines who daily place themselves and their families at risk to ensure that we have essential services. Amplifying the needs and concerns of the frontline workers can drive those in power to develop practical and useful solutions.

Nurses and physicians have been threatened, and some actually terminated from their positions, because they publicly disclosed their institutions’ working conditions, lack of PPE, and unpreparedness. For example, a decorated US Navy captain was stripped of his command for writing a letter to drive action in managing a COVID-19 outbreak on the confined quarters of his ship. Such public health heroes have exhibited professionalism and leadership, placing the health and well-being of their colleagues, peers, and patients above their own careers. If we all spoke up with honesty and openness, we could have profound impact.

Hold ourselves and others accountable for scientific rigor and honesty. We must acknowledge what we do not know and be straightforward in discussing risks and benefits. The uncertainty surrounding the COVID-19 public health crisis has created anxiety among health care workers, public-facing workers, government officials, and the public. We should not speculate but rather speak clearly and openly about our knowledge deficits.

The US culture in health care drives us to prefer action over inaction. “Doing something” feels proactive, and we are conditioned to think of doing something as a less risky strategy than watchful waiting. In this time of uncertainty, we must be wary of unproven and potentially harmful interventions, and we must use our best judgment and expertise to study procedures and medications that have potential benefit.

Be collaborative and creative in crafting practical workarounds that can be implemented at scale. New processes implemented in the past month to accommodate our new socially and physically distant reality include telemedicine for prenatal care, home monitoring of blood pressure, remote physiologic monitoring of blood sugars for diabetic patients, reviewing digital images to provide remote wound care, and home pulse oximetry to assess COVID-19–positive patients at home.

More workarounds are needed to support women’s ongoing health needs. Our expertise should guide those strategies while we strive to optimize outcomes, minimize resource utilization, and reduce exposure risk for ourselves, our staff, and our patients.

Advocate for systems to collect and analyze robust data so we can adjust interventions rapidly as new information arises. As we navigate the pandemic, the lack of evidence to inform decisions and treatment challenges us daily. We should use the current crisis to promote strategies that will support rapid, comprehensive data collection during disasters. Knowledge truly is power, and without it we are forced to improvise and speculate.

ObGyns must insist that data collection includes all pregnancies—not only those positive for COVID-19 since the testing has been sporadic and imperfect—and that the data are stratified by age, gender, race and ethnicity, and sociodemographics. This would enable us to learn as much as possible as quickly as possible and would therefore inform our responses for the current SARS CoV-2 pandemic as well as for the next disaster.

Continue to: Acknowledge the limitations of the system...

Acknowledge the limitations of the system and be wise stewards of resources. Our health care system does not have sufficient resources to manage patients with severe COVID-19 and the “usual” emergencies like stroke, myocardial infarction, ectopic pregnancy, and broken bones.

Disaster planning should include a regional triage system that can take incoming calls and direct emergency medical technicians, ambulances, and private citizens to appropriate facilities and direct those who do not require urgent medical care away from those facilities.

We must incorporate principles from battlefield medicine, because this is a battle, and we are at war. That means there will be difficult decisions. It is better to engage a regional team of experts to create a system for triage and care delivery than for each provider and institution to be forced by a void in leadership to go it individually. We should engage with government and public health officials to optimize both cure and care. Although we are unable to save everyone, we can work to ensure comfort and care for all.

Demonstrate compassion and caring for patients and each other. During the COVID-19 pandemic crisis, we can each channel our best selves to support and protect each other physically and emotionally. Many of us chose ObGyn because it is generally a “happy” specialty. None of us entered medicine to watch people die or to be unable to comfort them, to be unable to allow their families to be with them, to be unable to “do something.”

A crucial part of disaster planning and response is to prepare for the second victims: those of us forced to keep going through our emotional distress because there is no time to debrief and process our pain. Frontline caregivers need support and help now as well as after the surge passes. We need to speak up to ensure there is adequate PPE, creative staffing, and supportive resources to help caregivers process their anxiety, fatigue, and distress.

Take the lead

Every crisis brings both risk and opportunity. The COVID-19 pandemic provides ObGyns the chance to have a louder voice and a meaningful seat at the table as new and creative policies must be implemented at every level. We can use this opportunity to recapture our roles as champions for women and leaders within our health care system.

Critical steps in servant leadership include speaking up with honesty, transparency, and openness; taking risks to disclose inequities, dangerous conditions, and inadequate resources; and committing ourselves to each other, our teams, and the public. When we take these steps, we will be the driving force for a cohesive, reasoned, structured, and compassionate response to the COVID-19 crisis. As we seize this opportunity to lead, we will rekindle our passion for medicine, caring for the sick, and protecting the well. ●

SARS CoV-2 (severe acute respiratory syndrome corona-
virus 2) has challenged us all and will continue to do so for at least the next several months. This novel virus has uncovered our medical hubris and our collective failure to acknowledge our vulnerability in the face of biological threats. As government, public health, health systems, medical professionals, and individuals struggle to grasp its enormous impact, we must recognize and seize the opportunities for leadership that the coronavirus disease (COVID-19) pandemic presents to us as physicians.

For too long we have abdicated responsibility for driving change in the US health system to politicians, administrators, and those not on the front line of care delivery. We can, however, reclaim our voice and position of influence in 2 primary spheres: first, as ObGyns we have the specific clinical knowledge and experience required to help guide our institutions in the care of our patients under new and ever-changing circumstances; second, beyond our clinical role as ObGyns, we are servant leaders to whom the public, the government, our trainees, and our clinical teams turn for guidance.

Foundations for policy development

Disaster planning in hospitals and public health systems rarely includes consideration for pregnant and delivering patients. As ObGyns, we must create policies and procedures using the best available evidence—which is slim—and, in the absence of evidence, use our clinical and scientific expertise both to optimize patient care and to minimize risk to the health care team.

At this point in time there is much we do not know, such as whether viral particles in blood are contagious, amniotic fluid contains infectious droplets, or newborns are in danger if they room-in with an infected mother. What we do know is that the evidence will evolve and that our policies and procedures must be fluid and allow for rapid change. Here are some guiding principles for such policies.

Maximize telemedicine and remote monitoring

Labor and delivery (L&D) is an emergency department in which people are triaged from the outside. Systems should incorporate the best guidance from the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists while reducing infection exposure to staff, laboring patients, and newborns. One way to limit traffic in the triage area is to have a seasoned clinician perform phone triage for women who think they need evaluation for labor.

Maintain universal caution and precautions

All people entering L&D should be presumed to be COVID-19 positive, according to early evidence reported from Columbia University in New York City.¹ After remote or off-site phone triage determines that evaluation is needed in L&D, a transporter could ensure that all people escorted to L&D undergo a rapid COVID-19 test, wear a mask, and wash their hands. Until point-of-care testing is available, we must adopt safety precautions, since current data suggest that asymptomatic people may shed the infectious virus.

Both vaginal and cesarean deliveries expose everyone in the room to respiratory droplets. Common sense tells us that the laboring patient and her support person should wear a mask and that caregivers should be protected with N95 masks as well as face shields. If this were standard for every laboring patient, exposure during emergency situations might be minimized.

Continue to: Maximize support during labor...

Maximize support during labor

We should not need to ban partners and support people. Solid evidence demonstrates that support in labor improves outcomes, reduces the need for cesarean delivery, and increases patient satisfaction. We can and should protect staff and patients by requiring everyone to wear a mask.

Symptomatic patients, of course, require additional measures and personal protective equipment (PPE) to reduce the risk of infection among the health care team. These should be identical to the measures the hospital infectious disease experts have implemented in the intensive care unit.

Champion continuous quality improvement

It is our responsibility to implement continuous quality improvement processes so that we can respond to data that become available, and this begins with collecting our own local data.

We have sparse data on the risks of miscarriage, congenital anomalies, and preterm birth, but there have been anecdotal reports of both early miscarriage and premature labor. Given the known increased risk for severe disease with influenza during pregnancy, we understandably are concerned about how our pregnant patients will fare. There are also unknowns with respect to fetal exposure risk. During this pandemic we must capture such data within our own systems and share aggregated, de-identified data broadly and swiftly if real signals indicate a need for change in procedures or policy.

In the meantime, we can apply our expertise and best judgment to work within teams that include all stakeholders—administrators, nurses, engineers, pediatricians, infectious disease experts, and public members—to establish policies that respond to the best current evidence.

Protect vulnerable team members

SARS CoV-2 is highly contagious. Thus far, data do not suggest that pregnant women are at higher risk for severe disease, but we must assume that working in the hospital environment among many COVID-19 patients increases the risk for exposure. With so many current unknowns, it may be prudent to keep pregnant health care workers out of clinical areas in the hospital and reassign them to other duties when feasible. Medical students nationwide similarly have been removed from clinical rotations to minimize their exposure risk as well as to preserve scarce PPE.

These decisions are difficult for all involved, and shared decision making between administrators, clinical leaders, and pregnant staff that promotes transparency, honesty, and openness is key. Since the risk is unknown and financial consequences may result for both the hospital and the staff member, open discussion and thoughtful policies that can be revised as new information is obtained will help achieve the best possible resolution to a difficult situation.

Continue to: ObGyns as servant leaders...

ObGyns as servant leaders

COVID-19 challenges us to balance individual and public health considerations while also considering the economic and social consequences of actions. The emergence of this novel pathogen and its rapid global spread are frightening both to an uninformed public and to our skeptical government officials. Beyond our immediate clinical responsibilities, how should we as knowledgeable professionals respond?

Servant leaders commit to service and support and mentor those around them with empathy and collaboration. Servant leaders have the strategic vision to continuously grow, change, and improve at all times, but especially during a crisis. COVID-19 challenges us to be those servant leaders. To do so we must:

Promote and exhibit transparency by speaking truth to power and communicating with empathy for patients, staff, and those on the front lines who daily place themselves and their families at risk to ensure that we have essential services. Amplifying the needs and concerns of the frontline workers can drive those in power to develop practical and useful solutions.

Nurses and physicians have been threatened, and some actually terminated from their positions, because they publicly disclosed their institutions’ working conditions, lack of PPE, and unpreparedness. For example, a decorated US Navy captain was stripped of his command for writing a letter to drive action in managing a COVID-19 outbreak on the confined quarters of his ship. Such public health heroes have exhibited professionalism and leadership, placing the health and well-being of their colleagues, peers, and patients above their own careers. If we all spoke up with honesty and openness, we could have profound impact.

Hold ourselves and others accountable for scientific rigor and honesty. We must acknowledge what we do not know and be straightforward in discussing risks and benefits. The uncertainty surrounding the COVID-19 public health crisis has created anxiety among health care workers, public-facing workers, government officials, and the public. We should not speculate but rather speak clearly and openly about our knowledge deficits.

The US culture in health care drives us to prefer action over inaction. “Doing something” feels proactive, and we are conditioned to think of doing something as a less risky strategy than watchful waiting. In this time of uncertainty, we must be wary of unproven and potentially harmful interventions, and we must use our best judgment and expertise to study procedures and medications that have potential benefit.

Be collaborative and creative in crafting practical workarounds that can be implemented at scale. New processes implemented in the past month to accommodate our new socially and physically distant reality include telemedicine for prenatal care, home monitoring of blood pressure, remote physiologic monitoring of blood sugars for diabetic patients, reviewing digital images to provide remote wound care, and home pulse oximetry to assess COVID-19–positive patients at home.

More workarounds are needed to support women’s ongoing health needs. Our expertise should guide those strategies while we strive to optimize outcomes, minimize resource utilization, and reduce exposure risk for ourselves, our staff, and our patients.

Advocate for systems to collect and analyze robust data so we can adjust interventions rapidly as new information arises. As we navigate the pandemic, the lack of evidence to inform decisions and treatment challenges us daily. We should use the current crisis to promote strategies that will support rapid, comprehensive data collection during disasters. Knowledge truly is power, and without it we are forced to improvise and speculate.

ObGyns must insist that data collection includes all pregnancies—not only those positive for COVID-19 since the testing has been sporadic and imperfect—and that the data are stratified by age, gender, race and ethnicity, and sociodemographics. This would enable us to learn as much as possible as quickly as possible and would therefore inform our responses for the current SARS CoV-2 pandemic as well as for the next disaster.

Continue to: Acknowledge the limitations of the system...

Acknowledge the limitations of the system and be wise stewards of resources. Our health care system does not have sufficient resources to manage patients with severe COVID-19 and the “usual” emergencies like stroke, myocardial infarction, ectopic pregnancy, and broken bones.

Disaster planning should include a regional triage system that can take incoming calls and direct emergency medical technicians, ambulances, and private citizens to appropriate facilities and direct those who do not require urgent medical care away from those facilities.

We must incorporate principles from battlefield medicine, because this is a battle, and we are at war. That means there will be difficult decisions. It is better to engage a regional team of experts to create a system for triage and care delivery than for each provider and institution to be forced by a void in leadership to go it individually. We should engage with government and public health officials to optimize both cure and care. Although we are unable to save everyone, we can work to ensure comfort and care for all.

Demonstrate compassion and caring for patients and each other. During the COVID-19 pandemic crisis, we can each channel our best selves to support and protect each other physically and emotionally. Many of us chose ObGyn because it is generally a “happy” specialty. None of us entered medicine to watch people die or to be unable to comfort them, to be unable to allow their families to be with them, to be unable to “do something.”

A crucial part of disaster planning and response is to prepare for the second victims: those of us forced to keep going through our emotional distress because there is no time to debrief and process our pain. Frontline caregivers need support and help now as well as after the surge passes. We need to speak up to ensure there is adequate PPE, creative staffing, and supportive resources to help caregivers process their anxiety, fatigue, and distress.

Take the lead

Every crisis brings both risk and opportunity. The COVID-19 pandemic provides ObGyns the chance to have a louder voice and a meaningful seat at the table as new and creative policies must be implemented at every level. We can use this opportunity to recapture our roles as champions for women and leaders within our health care system.

Critical steps in servant leadership include speaking up with honesty, transparency, and openness; taking risks to disclose inequities, dangerous conditions, and inadequate resources; and committing ourselves to each other, our teams, and the public. When we take these steps, we will be the driving force for a cohesive, reasoned, structured, and compassionate response to the COVID-19 crisis. As we seize this opportunity to lead, we will rekindle our passion for medicine, caring for the sick, and protecting the well. ●

SARS CoV-2 (severe acute respiratory syndrome corona-
virus 2) has challenged us all and will continue to do so for at least the next several months. This novel virus has uncovered our medical hubris and our collective failure to acknowledge our vulnerability in the face of biological threats. As government, public health, health systems, medical professionals, and individuals struggle to grasp its enormous impact, we must recognize and seize the opportunities for leadership that the coronavirus disease (COVID-19) pandemic presents to us as physicians.

For too long we have abdicated responsibility for driving change in the US health system to politicians, administrators, and those not on the front line of care delivery. We can, however, reclaim our voice and position of influence in 2 primary spheres: first, as ObGyns we have the specific clinical knowledge and experience required to help guide our institutions in the care of our patients under new and ever-changing circumstances; second, beyond our clinical role as ObGyns, we are servant leaders to whom the public, the government, our trainees, and our clinical teams turn for guidance.

Foundations for policy development

Disaster planning in hospitals and public health systems rarely includes consideration for pregnant and delivering patients. As ObGyns, we must create policies and procedures using the best available evidence—which is slim—and, in the absence of evidence, use our clinical and scientific expertise both to optimize patient care and to minimize risk to the health care team.

At this point in time there is much we do not know, such as whether viral particles in blood are contagious, amniotic fluid contains infectious droplets, or newborns are in danger if they room-in with an infected mother. What we do know is that the evidence will evolve and that our policies and procedures must be fluid and allow for rapid change. Here are some guiding principles for such policies.

Maximize telemedicine and remote monitoring

Labor and delivery (L&D) is an emergency department in which people are triaged from the outside. Systems should incorporate the best guidance from the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists while reducing infection exposure to staff, laboring patients, and newborns. One way to limit traffic in the triage area is to have a seasoned clinician perform phone triage for women who think they need evaluation for labor.

Maintain universal caution and precautions

All people entering L&D should be presumed to be COVID-19 positive, according to early evidence reported from Columbia University in New York City.¹ After remote or off-site phone triage determines that evaluation is needed in L&D, a transporter could ensure that all people escorted to L&D undergo a rapid COVID-19 test, wear a mask, and wash their hands. Until point-of-care testing is available, we must adopt safety precautions, since current data suggest that asymptomatic people may shed the infectious virus.

Both vaginal and cesarean deliveries expose everyone in the room to respiratory droplets. Common sense tells us that the laboring patient and her support person should wear a mask and that caregivers should be protected with N95 masks as well as face shields. If this were standard for every laboring patient, exposure during emergency situations might be minimized.

Continue to: Maximize support during labor...

Maximize support during labor

We should not need to ban partners and support people. Solid evidence demonstrates that support in labor improves outcomes, reduces the need for cesarean delivery, and increases patient satisfaction. We can and should protect staff and patients by requiring everyone to wear a mask.

Symptomatic patients, of course, require additional measures and personal protective equipment (PPE) to reduce the risk of infection among the health care team. These should be identical to the measures the hospital infectious disease experts have implemented in the intensive care unit.

Champion continuous quality improvement

It is our responsibility to implement continuous quality improvement processes so that we can respond to data that become available, and this begins with collecting our own local data.

We have sparse data on the risks of miscarriage, congenital anomalies, and preterm birth, but there have been anecdotal reports of both early miscarriage and premature labor. Given the known increased risk for severe disease with influenza during pregnancy, we understandably are concerned about how our pregnant patients will fare. There are also unknowns with respect to fetal exposure risk. During this pandemic we must capture such data within our own systems and share aggregated, de-identified data broadly and swiftly if real signals indicate a need for change in procedures or policy.

In the meantime, we can apply our expertise and best judgment to work within teams that include all stakeholders—administrators, nurses, engineers, pediatricians, infectious disease experts, and public members—to establish policies that respond to the best current evidence.

Protect vulnerable team members

SARS CoV-2 is highly contagious. Thus far, data do not suggest that pregnant women are at higher risk for severe disease, but we must assume that working in the hospital environment among many COVID-19 patients increases the risk for exposure. With so many current unknowns, it may be prudent to keep pregnant health care workers out of clinical areas in the hospital and reassign them to other duties when feasible. Medical students nationwide similarly have been removed from clinical rotations to minimize their exposure risk as well as to preserve scarce PPE.

These decisions are difficult for all involved, and shared decision making between administrators, clinical leaders, and pregnant staff that promotes transparency, honesty, and openness is key. Since the risk is unknown and financial consequences may result for both the hospital and the staff member, open discussion and thoughtful policies that can be revised as new information is obtained will help achieve the best possible resolution to a difficult situation.

Continue to: ObGyns as servant leaders...

ObGyns as servant leaders

COVID-19 challenges us to balance individual and public health considerations while also considering the economic and social consequences of actions. The emergence of this novel pathogen and its rapid global spread are frightening both to an uninformed public and to our skeptical government officials. Beyond our immediate clinical responsibilities, how should we as knowledgeable professionals respond?

Servant leaders commit to service and support and mentor those around them with empathy and collaboration. Servant leaders have the strategic vision to continuously grow, change, and improve at all times, but especially during a crisis. COVID-19 challenges us to be those servant leaders. To do so we must:

Promote and exhibit transparency by speaking truth to power and communicating with empathy for patients, staff, and those on the front lines who daily place themselves and their families at risk to ensure that we have essential services. Amplifying the needs and concerns of the frontline workers can drive those in power to develop practical and useful solutions.

Nurses and physicians have been threatened, and some actually terminated from their positions, because they publicly disclosed their institutions’ working conditions, lack of PPE, and unpreparedness. For example, a decorated US Navy captain was stripped of his command for writing a letter to drive action in managing a COVID-19 outbreak on the confined quarters of his ship. Such public health heroes have exhibited professionalism and leadership, placing the health and well-being of their colleagues, peers, and patients above their own careers. If we all spoke up with honesty and openness, we could have profound impact.

Hold ourselves and others accountable for scientific rigor and honesty. We must acknowledge what we do not know and be straightforward in discussing risks and benefits. The uncertainty surrounding the COVID-19 public health crisis has created anxiety among health care workers, public-facing workers, government officials, and the public. We should not speculate but rather speak clearly and openly about our knowledge deficits.

The US culture in health care drives us to prefer action over inaction. “Doing something” feels proactive, and we are conditioned to think of doing something as a less risky strategy than watchful waiting. In this time of uncertainty, we must be wary of unproven and potentially harmful interventions, and we must use our best judgment and expertise to study procedures and medications that have potential benefit.

Be collaborative and creative in crafting practical workarounds that can be implemented at scale. New processes implemented in the past month to accommodate our new socially and physically distant reality include telemedicine for prenatal care, home monitoring of blood pressure, remote physiologic monitoring of blood sugars for diabetic patients, reviewing digital images to provide remote wound care, and home pulse oximetry to assess COVID-19–positive patients at home.

More workarounds are needed to support women’s ongoing health needs. Our expertise should guide those strategies while we strive to optimize outcomes, minimize resource utilization, and reduce exposure risk for ourselves, our staff, and our patients.

Advocate for systems to collect and analyze robust data so we can adjust interventions rapidly as new information arises. As we navigate the pandemic, the lack of evidence to inform decisions and treatment challenges us daily. We should use the current crisis to promote strategies that will support rapid, comprehensive data collection during disasters. Knowledge truly is power, and without it we are forced to improvise and speculate.

ObGyns must insist that data collection includes all pregnancies—not only those positive for COVID-19 since the testing has been sporadic and imperfect—and that the data are stratified by age, gender, race and ethnicity, and sociodemographics. This would enable us to learn as much as possible as quickly as possible and would therefore inform our responses for the current SARS CoV-2 pandemic as well as for the next disaster.

Continue to: Acknowledge the limitations of the system...

Acknowledge the limitations of the system and be wise stewards of resources. Our health care system does not have sufficient resources to manage patients with severe COVID-19 and the “usual” emergencies like stroke, myocardial infarction, ectopic pregnancy, and broken bones.

Disaster planning should include a regional triage system that can take incoming calls and direct emergency medical technicians, ambulances, and private citizens to appropriate facilities and direct those who do not require urgent medical care away from those facilities.

We must incorporate principles from battlefield medicine, because this is a battle, and we are at war. That means there will be difficult decisions. It is better to engage a regional team of experts to create a system for triage and care delivery than for each provider and institution to be forced by a void in leadership to go it individually. We should engage with government and public health officials to optimize both cure and care. Although we are unable to save everyone, we can work to ensure comfort and care for all.

Demonstrate compassion and caring for patients and each other. During the COVID-19 pandemic crisis, we can each channel our best selves to support and protect each other physically and emotionally. Many of us chose ObGyn because it is generally a “happy” specialty. None of us entered medicine to watch people die or to be unable to comfort them, to be unable to allow their families to be with them, to be unable to “do something.”

A crucial part of disaster planning and response is to prepare for the second victims: those of us forced to keep going through our emotional distress because there is no time to debrief and process our pain. Frontline caregivers need support and help now as well as after the surge passes. We need to speak up to ensure there is adequate PPE, creative staffing, and supportive resources to help caregivers process their anxiety, fatigue, and distress.

Take the lead

Every crisis brings both risk and opportunity. The COVID-19 pandemic provides ObGyns the chance to have a louder voice and a meaningful seat at the table as new and creative policies must be implemented at every level. We can use this opportunity to recapture our roles as champions for women and leaders within our health care system.

Critical steps in servant leadership include speaking up with honesty, transparency, and openness; taking risks to disclose inequities, dangerous conditions, and inadequate resources; and committing ourselves to each other, our teams, and the public. When we take these steps, we will be the driving force for a cohesive, reasoned, structured, and compassionate response to the COVID-19 crisis. As we seize this opportunity to lead, we will rekindle our passion for medicine, caring for the sick, and protecting the well. ●

Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.

Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.

A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.

This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.

“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”

The article was published April 16 in Nature Medicine.

The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.

The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.

Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.

“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
 

Restructuring care

Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.

“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”

For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.

As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.

The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.

Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.

To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.

To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.

Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
 

Capacity of facilities

Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.

The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.

In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.

Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.

The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.

“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
 

Future research

Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:

• Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
• Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
• Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
• Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.

Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.

A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.

This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.

“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”

The article was published April 16 in Nature Medicine.

The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.

The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.

Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.

“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
 

Restructuring care

Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.

“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”

For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.

As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.

The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.

Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.

To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.

To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.

Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
 

Capacity of facilities

Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.

The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.

In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.

Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.

The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.

“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
 

Future research

Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:

• Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
• Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
• Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
• Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.

Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.

A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.

This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.

“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”

The article was published April 16 in Nature Medicine.

The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.

The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.

Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.

“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
 

Restructuring care

Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.

“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”

For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.

As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.

The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.

Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.

To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.

To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.

Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
 

Capacity of facilities

Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.

The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.

In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.

Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.

The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.

“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
 

Future research

Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:

• Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
• Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
• Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
• Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Hospitalized COVID-19 patients with hypertension and on treatment with an renin-angiotensin system inhibiting drug had significantly better survival, compared with similar hypertensive patients not on these drugs, in observational, propensity score–matched analyses that drew from a pool of more than 3,430 patients hospitalized at any of nine Chinese hospitals during December 2019–February 2020.

Courtesy CDC

“Among patients with hypertension hospitalized with COVID-19, inpatient treatment with ACEI [ACE inhibitor]/ARB [angiotensin receptor blocker] was associated with lower risk of all-cause mortality, compared with ACEI/ARB nonusers, during 28 days of follow-up. While study interpretation needs to consider the potential for residual confounders, it is unlikely that inpatient ACEI/ARB would be associated with an increased risk of mortality,” wrote Peng Zhang, MD, a cardiology researcher at Renmin Hospital of Wuhan University, China, and coauthors in Circulations Research, buttressing recent recommendations from several medical societies to maintain COVID-19 patients on these drugs.

“Our findings in this paper provide evidence supporting continuous use of ACEI/ARB for patients with hypertension infected with SARS-COV-2,” wrote the authors, backing up recent recommendations from cardiology societies that called for not stopping ACEI/ARB prescriptions in patients at risk for contracting or already have COVID-19 infection, including a statement from the American College of Cardiology, American Heart Association, and Heart Failure Society of America, and also guidance from the European Society of Cardiology.

The study included 1,128 patients with a history of hypertension, including 188 (17%) who received an ACEI/ARB drug during hospitalization. During 28-day follow-up, 99 died (9%), including 7 deaths among the 188 patients (4%) on an ACEI/ARB drug and 92 deaths among the 940 other hypertensive patients (10%).

The authors ran several analyses to try to adjust for the influence of possible confounders. A mixed-effect Cox model with four adjusted variables showed that treatment with an ACEI/ARB drug was tied to a statistically significant 58% lower death rate, compared with patients not receiving these drugs.

The researchers also ran several propensity score–adjusted analyses. One matched 174 of the patients who received an ACEI/ARB drug with 522 who did not, and comparing these two matched arms showed that ACEI/ARB use was linked with a statistically significant 63% cut in mortality, compared with patients not getting these drugs. A second propensity score–matched analysis first excluded the 383 patients who were hypertensive but received no antihypertensive medication during hospitalization. From the remaining 745 patients who received at least one antihypertensive medication, the authors identified 181 patients who received an ACEI/ARB and propensity-score matched them with 181 hypertensive patients on a different medication class, finding that ACEI/ARB use linked with a statistically significant 71% lower rate of all-cause mortality.

Additional analyses also showed that patients with hypertension had a statistically significant, 41% increased rate of all-cause death, compared with patients without hypertension, and another propensity score–matched analysis showed that among hypertensives treatment with an ACEI/ARB drug was linked with a statistically significant 68% reduced rate of septic shock.

Although this report was received with caution and some skepticism, it was also acknowledged as a step forward in the creation of an evidence base addressing ACEI/ARB treatment during COVID-19 infection.

“These drugs are lifesaving and should not be discontinued” for patients with hypertension, heart failure, and other cardiovascular disease, commented Gian Paolo Rossi, MD, professor and chair of medicine and director of the high blood pressure unit at the University of Padua (Italy). The analysis by Zhang and associates included the largest number of hospitalized COVID-19 patients with hypertension yet reported to assess the impact of treatment with ACEI/ARB drugs, and adds important evidence in favor of continuing these drugs in patients who develop COVID-19 infection, Dr. Rossi said in an interview. He recently coauthored a review that argued against ACEI/ARB discontinuation in COVID-19 patients based on previously reported evidence (Elife. 2020 Apr 6. doi: 10.7554/eLife.57278).

But other researchers take a wary view of the potential impact of ACEI/ARB agents. “If ACEI/ARB therapy increases ACE2 and the virus down-regulates it, and because ACE2 is the viral entry port into cells, why would ACE2-mediated down-regulation of the renin-angiotensin-aldosterone system lead to amelioration of [COVID-19] disease?” asked Laurence W. Busse, MD, a critical care physician at Emory University, Atlanta. “A number of issues could potentially confound the results, including the definition of COVID-19 and imbalance of antiviral therapy,” added Dr. Busse, who recently coauthored an editorial that posited using angiotensin II (Giapreza), an approved vasopressor drug, as an alternative renin-angiotensin system intervention for COVID-19 patients including both those in shock as well as potentially those not in shock (Crit Care. 2020 Apr 7. doi: 10.1186/s13054-020-02862-1). Despite these caveats, the new Chinese findings reported by Dr. Zhang and associates “are hypothesis generating and worth further exploration.”

The authors of an editorial that accompanied the Zhang study in Circulation Research made similar points. “While the investigators used standard techniques to attempt to reduce bias in this observational study via propensity matching, it is not a randomized study and the residual confounding inherent to this approach renders the conclusions hypothesis generating at best,” wrote Ravi V. Shah, MD, and two coauthors in the editorial (Circ Res. 2020 Apr 17. doi: 10.1161/CIRCRESAHA.120.317174). They also agreed with the several society statements that have supported continued use of ACEI/ARB drugs in COVID-19 patients. “Withdrawal of these medications in the context of those conditions in which they have proven benefit (e.g., heart failure with reduced left ventricular ejection fraction) may actually inflict more harm than good,” they warned. “In the end we must rely on randomized clinical science,” and while this level of evidence is currently lacking, “the study by Zhang and colleagues is a direct step toward that goal.”

Dr. Zhang and coauthors had no commercial disclosures. Dr. Rossi and Dr. Busse had no disclosures. The authors of the Circulation Research editorial reported several disclosures.

mzoler@mdedge.com

SOURCE: Zhang P et al. Circ Res. 2020 Apr 17. doi: 10.1161/CIRCRESAHA.120.317134.

Hospitalized COVID-19 patients with hypertension and on treatment with an renin-angiotensin system inhibiting drug had significantly better survival, compared with similar hypertensive patients not on these drugs, in observational, propensity score–matched analyses that drew from a pool of more than 3,430 patients hospitalized at any of nine Chinese hospitals during December 2019–February 2020.

Courtesy CDC

“Among patients with hypertension hospitalized with COVID-19, inpatient treatment with ACEI [ACE inhibitor]/ARB [angiotensin receptor blocker] was associated with lower risk of all-cause mortality, compared with ACEI/ARB nonusers, during 28 days of follow-up. While study interpretation needs to consider the potential for residual confounders, it is unlikely that inpatient ACEI/ARB would be associated with an increased risk of mortality,” wrote Peng Zhang, MD, a cardiology researcher at Renmin Hospital of Wuhan University, China, and coauthors in Circulations Research, buttressing recent recommendations from several medical societies to maintain COVID-19 patients on these drugs.

“Our findings in this paper provide evidence supporting continuous use of ACEI/ARB for patients with hypertension infected with SARS-COV-2,” wrote the authors, backing up recent recommendations from cardiology societies that called for not stopping ACEI/ARB prescriptions in patients at risk for contracting or already have COVID-19 infection, including a statement from the American College of Cardiology, American Heart Association, and Heart Failure Society of America, and also guidance from the European Society of Cardiology.

The study included 1,128 patients with a history of hypertension, including 188 (17%) who received an ACEI/ARB drug during hospitalization. During 28-day follow-up, 99 died (9%), including 7 deaths among the 188 patients (4%) on an ACEI/ARB drug and 92 deaths among the 940 other hypertensive patients (10%).

The authors ran several analyses to try to adjust for the influence of possible confounders. A mixed-effect Cox model with four adjusted variables showed that treatment with an ACEI/ARB drug was tied to a statistically significant 58% lower death rate, compared with patients not receiving these drugs.

The researchers also ran several propensity score–adjusted analyses. One matched 174 of the patients who received an ACEI/ARB drug with 522 who did not, and comparing these two matched arms showed that ACEI/ARB use was linked with a statistically significant 63% cut in mortality, compared with patients not getting these drugs. A second propensity score–matched analysis first excluded the 383 patients who were hypertensive but received no antihypertensive medication during hospitalization. From the remaining 745 patients who received at least one antihypertensive medication, the authors identified 181 patients who received an ACEI/ARB and propensity-score matched them with 181 hypertensive patients on a different medication class, finding that ACEI/ARB use linked with a statistically significant 71% lower rate of all-cause mortality.

Additional analyses also showed that patients with hypertension had a statistically significant, 41% increased rate of all-cause death, compared with patients without hypertension, and another propensity score–matched analysis showed that among hypertensives treatment with an ACEI/ARB drug was linked with a statistically significant 68% reduced rate of septic shock.

Although this report was received with caution and some skepticism, it was also acknowledged as a step forward in the creation of an evidence base addressing ACEI/ARB treatment during COVID-19 infection.

“These drugs are lifesaving and should not be discontinued” for patients with hypertension, heart failure, and other cardiovascular disease, commented Gian Paolo Rossi, MD, professor and chair of medicine and director of the high blood pressure unit at the University of Padua (Italy). The analysis by Zhang and associates included the largest number of hospitalized COVID-19 patients with hypertension yet reported to assess the impact of treatment with ACEI/ARB drugs, and adds important evidence in favor of continuing these drugs in patients who develop COVID-19 infection, Dr. Rossi said in an interview. He recently coauthored a review that argued against ACEI/ARB discontinuation in COVID-19 patients based on previously reported evidence (Elife. 2020 Apr 6. doi: 10.7554/eLife.57278).

But other researchers take a wary view of the potential impact of ACEI/ARB agents. “If ACEI/ARB therapy increases ACE2 and the virus down-regulates it, and because ACE2 is the viral entry port into cells, why would ACE2-mediated down-regulation of the renin-angiotensin-aldosterone system lead to amelioration of [COVID-19] disease?” asked Laurence W. Busse, MD, a critical care physician at Emory University, Atlanta. “A number of issues could potentially confound the results, including the definition of COVID-19 and imbalance of antiviral therapy,” added Dr. Busse, who recently coauthored an editorial that posited using angiotensin II (Giapreza), an approved vasopressor drug, as an alternative renin-angiotensin system intervention for COVID-19 patients including both those in shock as well as potentially those not in shock (Crit Care. 2020 Apr 7. doi: 10.1186/s13054-020-02862-1). Despite these caveats, the new Chinese findings reported by Dr. Zhang and associates “are hypothesis generating and worth further exploration.”

The authors of an editorial that accompanied the Zhang study in Circulation Research made similar points. “While the investigators used standard techniques to attempt to reduce bias in this observational study via propensity matching, it is not a randomized study and the residual confounding inherent to this approach renders the conclusions hypothesis generating at best,” wrote Ravi V. Shah, MD, and two coauthors in the editorial (Circ Res. 2020 Apr 17. doi: 10.1161/CIRCRESAHA.120.317174). They also agreed with the several society statements that have supported continued use of ACEI/ARB drugs in COVID-19 patients. “Withdrawal of these medications in the context of those conditions in which they have proven benefit (e.g., heart failure with reduced left ventricular ejection fraction) may actually inflict more harm than good,” they warned. “In the end we must rely on randomized clinical science,” and while this level of evidence is currently lacking, “the study by Zhang and colleagues is a direct step toward that goal.”

Dr. Zhang and coauthors had no commercial disclosures. Dr. Rossi and Dr. Busse had no disclosures. The authors of the Circulation Research editorial reported several disclosures.

mzoler@mdedge.com

SOURCE: Zhang P et al. Circ Res. 2020 Apr 17. doi: 10.1161/CIRCRESAHA.120.317134.

Hospitalized COVID-19 patients with hypertension and on treatment with an renin-angiotensin system inhibiting drug had significantly better survival, compared with similar hypertensive patients not on these drugs, in observational, propensity score–matched analyses that drew from a pool of more than 3,430 patients hospitalized at any of nine Chinese hospitals during December 2019–February 2020.

Courtesy CDC

“Among patients with hypertension hospitalized with COVID-19, inpatient treatment with ACEI [ACE inhibitor]/ARB [angiotensin receptor blocker] was associated with lower risk of all-cause mortality, compared with ACEI/ARB nonusers, during 28 days of follow-up. While study interpretation needs to consider the potential for residual confounders, it is unlikely that inpatient ACEI/ARB would be associated with an increased risk of mortality,” wrote Peng Zhang, MD, a cardiology researcher at Renmin Hospital of Wuhan University, China, and coauthors in Circulations Research, buttressing recent recommendations from several medical societies to maintain COVID-19 patients on these drugs.

“Our findings in this paper provide evidence supporting continuous use of ACEI/ARB for patients with hypertension infected with SARS-COV-2,” wrote the authors, backing up recent recommendations from cardiology societies that called for not stopping ACEI/ARB prescriptions in patients at risk for contracting or already have COVID-19 infection, including a statement from the American College of Cardiology, American Heart Association, and Heart Failure Society of America, and also guidance from the European Society of Cardiology.

The study included 1,128 patients with a history of hypertension, including 188 (17%) who received an ACEI/ARB drug during hospitalization. During 28-day follow-up, 99 died (9%), including 7 deaths among the 188 patients (4%) on an ACEI/ARB drug and 92 deaths among the 940 other hypertensive patients (10%).

The authors ran several analyses to try to adjust for the influence of possible confounders. A mixed-effect Cox model with four adjusted variables showed that treatment with an ACEI/ARB drug was tied to a statistically significant 58% lower death rate, compared with patients not receiving these drugs.

The researchers also ran several propensity score–adjusted analyses. One matched 174 of the patients who received an ACEI/ARB drug with 522 who did not, and comparing these two matched arms showed that ACEI/ARB use was linked with a statistically significant 63% cut in mortality, compared with patients not getting these drugs. A second propensity score–matched analysis first excluded the 383 patients who were hypertensive but received no antihypertensive medication during hospitalization. From the remaining 745 patients who received at least one antihypertensive medication, the authors identified 181 patients who received an ACEI/ARB and propensity-score matched them with 181 hypertensive patients on a different medication class, finding that ACEI/ARB use linked with a statistically significant 71% lower rate of all-cause mortality.

Additional analyses also showed that patients with hypertension had a statistically significant, 41% increased rate of all-cause death, compared with patients without hypertension, and another propensity score–matched analysis showed that among hypertensives treatment with an ACEI/ARB drug was linked with a statistically significant 68% reduced rate of septic shock.

Although this report was received with caution and some skepticism, it was also acknowledged as a step forward in the creation of an evidence base addressing ACEI/ARB treatment during COVID-19 infection.

“These drugs are lifesaving and should not be discontinued” for patients with hypertension, heart failure, and other cardiovascular disease, commented Gian Paolo Rossi, MD, professor and chair of medicine and director of the high blood pressure unit at the University of Padua (Italy). The analysis by Zhang and associates included the largest number of hospitalized COVID-19 patients with hypertension yet reported to assess the impact of treatment with ACEI/ARB drugs, and adds important evidence in favor of continuing these drugs in patients who develop COVID-19 infection, Dr. Rossi said in an interview. He recently coauthored a review that argued against ACEI/ARB discontinuation in COVID-19 patients based on previously reported evidence (Elife. 2020 Apr 6. doi: 10.7554/eLife.57278).

But other researchers take a wary view of the potential impact of ACEI/ARB agents. “If ACEI/ARB therapy increases ACE2 and the virus down-regulates it, and because ACE2 is the viral entry port into cells, why would ACE2-mediated down-regulation of the renin-angiotensin-aldosterone system lead to amelioration of [COVID-19] disease?” asked Laurence W. Busse, MD, a critical care physician at Emory University, Atlanta. “A number of issues could potentially confound the results, including the definition of COVID-19 and imbalance of antiviral therapy,” added Dr. Busse, who recently coauthored an editorial that posited using angiotensin II (Giapreza), an approved vasopressor drug, as an alternative renin-angiotensin system intervention for COVID-19 patients including both those in shock as well as potentially those not in shock (Crit Care. 2020 Apr 7. doi: 10.1186/s13054-020-02862-1). Despite these caveats, the new Chinese findings reported by Dr. Zhang and associates “are hypothesis generating and worth further exploration.”

The authors of an editorial that accompanied the Zhang study in Circulation Research made similar points. “While the investigators used standard techniques to attempt to reduce bias in this observational study via propensity matching, it is not a randomized study and the residual confounding inherent to this approach renders the conclusions hypothesis generating at best,” wrote Ravi V. Shah, MD, and two coauthors in the editorial (Circ Res. 2020 Apr 17. doi: 10.1161/CIRCRESAHA.120.317174). They also agreed with the several society statements that have supported continued use of ACEI/ARB drugs in COVID-19 patients. “Withdrawal of these medications in the context of those conditions in which they have proven benefit (e.g., heart failure with reduced left ventricular ejection fraction) may actually inflict more harm than good,” they warned. “In the end we must rely on randomized clinical science,” and while this level of evidence is currently lacking, “the study by Zhang and colleagues is a direct step toward that goal.”

Dr. Zhang and coauthors had no commercial disclosures. Dr. Rossi and Dr. Busse had no disclosures. The authors of the Circulation Research editorial reported several disclosures.

mzoler@mdedge.com

SOURCE: Zhang P et al. Circ Res. 2020 Apr 17. doi: 10.1161/CIRCRESAHA.120.317134.