Patients being treated for RA or spondyloarthritis who develop symptoms of COVID-19 do not appear to be at higher risk of respiratory or life-threatening complications, results from a new study in Italy suggest.

Such patients, the study authors wrote, do not need to be taken off their immunosuppressive medications if they develop COVID-19 symptoms.

In a letter published in Annals of the Rheumatic Diseases, Sara Monti, MD, and colleagues in the rheumatology department of the Fondazione IRCCS Policlinico in San Matteo, Italy, described results from an observational cohort of 320 patients (68% women; mean age, 55 years) with RA or spondyloarthritis from a single outpatient clinic. The vast majority of subjects (92%) were taking biologic disease-modifying antirheumatic drugs (bDMARD), including tumor necrosis factor inhibitors, while the rest were taking targeted synthetic DMARDs (tsDMARD).

Four patients in the cohort developed laboratory-confirmed COVID-19; another four developed symptoms highly suggestive of the disease but did not receive confirmatory testing, and five had contact with a confirmed COVID-19 case but did not develop symptoms of COVID-19.

Among the eight confirmed and suspected COVID-19 patients, only one was hospitalized. All temporarily withdrew bDMARD or tsDMARD treatment at symptom onset.

“To date, there have been no significant relapses of the rheumatic disease,” Dr. Monti and colleagues reported. “None of the patients with a confirmed diagnosis of COVID-19 or with a highly suggestive clinical picture developed severe respiratory complications or died. Only one patient, aged 65, required admission to hospital and low-flow oxygen supplementation for a few days.”

The findings “do not allow any conclusions on the incidence rate of SARS-CoV-2 infection in patients with rheumatic diseases, nor on the overall outcome of immunocompromised patients affected by COVID-19,” the investigators cautioned, adding that such patients should receive careful attention and follow-up. “However, our preliminary experience shows that patients with chronic arthritis treated with bDMARDs or tsDMARDs do not seem to be at increased risk of respiratory or life-threatening complications from SARS-CoV-2, compared with the general population.”

Dr. Monti and colleagues noted that, during previous outbreaks of other coronaviruses, no increased mortality was reported for people taking immunosuppressive drugs for a range of conditions, including autoimmune diseases.

“These data can support rheumatologists [in] avoiding the unjustifiable preventive withdrawal of DMARDs, which could lead to an increased risk of relapses and morbidity from the chronic rheumatological condition,” the researchers concluded.

Dr. Monti and colleagues reported no outside funding or financial conflicts of interest.

SOURCE: Monti S et al. Ann Rheum Dis. 2020 April 2. doi: 10.1136/annrheumdis-2020-217424.

Patients being treated for RA or spondyloarthritis who develop symptoms of COVID-19 do not appear to be at higher risk of respiratory or life-threatening complications, results from a new study in Italy suggest.

Such patients, the study authors wrote, do not need to be taken off their immunosuppressive medications if they develop COVID-19 symptoms.

In a letter published in Annals of the Rheumatic Diseases, Sara Monti, MD, and colleagues in the rheumatology department of the Fondazione IRCCS Policlinico in San Matteo, Italy, described results from an observational cohort of 320 patients (68% women; mean age, 55 years) with RA or spondyloarthritis from a single outpatient clinic. The vast majority of subjects (92%) were taking biologic disease-modifying antirheumatic drugs (bDMARD), including tumor necrosis factor inhibitors, while the rest were taking targeted synthetic DMARDs (tsDMARD).

Four patients in the cohort developed laboratory-confirmed COVID-19; another four developed symptoms highly suggestive of the disease but did not receive confirmatory testing, and five had contact with a confirmed COVID-19 case but did not develop symptoms of COVID-19.

Among the eight confirmed and suspected COVID-19 patients, only one was hospitalized. All temporarily withdrew bDMARD or tsDMARD treatment at symptom onset.

“To date, there have been no significant relapses of the rheumatic disease,” Dr. Monti and colleagues reported. “None of the patients with a confirmed diagnosis of COVID-19 or with a highly suggestive clinical picture developed severe respiratory complications or died. Only one patient, aged 65, required admission to hospital and low-flow oxygen supplementation for a few days.”

The findings “do not allow any conclusions on the incidence rate of SARS-CoV-2 infection in patients with rheumatic diseases, nor on the overall outcome of immunocompromised patients affected by COVID-19,” the investigators cautioned, adding that such patients should receive careful attention and follow-up. “However, our preliminary experience shows that patients with chronic arthritis treated with bDMARDs or tsDMARDs do not seem to be at increased risk of respiratory or life-threatening complications from SARS-CoV-2, compared with the general population.”

Dr. Monti and colleagues noted that, during previous outbreaks of other coronaviruses, no increased mortality was reported for people taking immunosuppressive drugs for a range of conditions, including autoimmune diseases.

“These data can support rheumatologists [in] avoiding the unjustifiable preventive withdrawal of DMARDs, which could lead to an increased risk of relapses and morbidity from the chronic rheumatological condition,” the researchers concluded.

Dr. Monti and colleagues reported no outside funding or financial conflicts of interest.

SOURCE: Monti S et al. Ann Rheum Dis. 2020 April 2. doi: 10.1136/annrheumdis-2020-217424.

Patients being treated for RA or spondyloarthritis who develop symptoms of COVID-19 do not appear to be at higher risk of respiratory or life-threatening complications, results from a new study in Italy suggest.

Such patients, the study authors wrote, do not need to be taken off their immunosuppressive medications if they develop COVID-19 symptoms.

In a letter published in Annals of the Rheumatic Diseases, Sara Monti, MD, and colleagues in the rheumatology department of the Fondazione IRCCS Policlinico in San Matteo, Italy, described results from an observational cohort of 320 patients (68% women; mean age, 55 years) with RA or spondyloarthritis from a single outpatient clinic. The vast majority of subjects (92%) were taking biologic disease-modifying antirheumatic drugs (bDMARD), including tumor necrosis factor inhibitors, while the rest were taking targeted synthetic DMARDs (tsDMARD).

Four patients in the cohort developed laboratory-confirmed COVID-19; another four developed symptoms highly suggestive of the disease but did not receive confirmatory testing, and five had contact with a confirmed COVID-19 case but did not develop symptoms of COVID-19.

Among the eight confirmed and suspected COVID-19 patients, only one was hospitalized. All temporarily withdrew bDMARD or tsDMARD treatment at symptom onset.

“To date, there have been no significant relapses of the rheumatic disease,” Dr. Monti and colleagues reported. “None of the patients with a confirmed diagnosis of COVID-19 or with a highly suggestive clinical picture developed severe respiratory complications or died. Only one patient, aged 65, required admission to hospital and low-flow oxygen supplementation for a few days.”

The findings “do not allow any conclusions on the incidence rate of SARS-CoV-2 infection in patients with rheumatic diseases, nor on the overall outcome of immunocompromised patients affected by COVID-19,” the investigators cautioned, adding that such patients should receive careful attention and follow-up. “However, our preliminary experience shows that patients with chronic arthritis treated with bDMARDs or tsDMARDs do not seem to be at increased risk of respiratory or life-threatening complications from SARS-CoV-2, compared with the general population.”

Dr. Monti and colleagues noted that, during previous outbreaks of other coronaviruses, no increased mortality was reported for people taking immunosuppressive drugs for a range of conditions, including autoimmune diseases.

“These data can support rheumatologists [in] avoiding the unjustifiable preventive withdrawal of DMARDs, which could lead to an increased risk of relapses and morbidity from the chronic rheumatological condition,” the researchers concluded.

Dr. Monti and colleagues reported no outside funding or financial conflicts of interest.

SOURCE: Monti S et al. Ann Rheum Dis. 2020 April 2. doi: 10.1136/annrheumdis-2020-217424.

More than three-quarters of cancer clinical research programs have experienced operational changes during the COVID-19 pandemic, according to a survey conducted by the Association of Community Cancer Centers (ACCC) during a recent webinar.

The webinar included insights into how some cancer research programs have adapted to the pandemic, a review of guidance for conducting cancer trials during this time, and a discussion of how the cancer research landscape may be affected by COVID-19 going forward.

The webinar was led by Randall A. Oyer, MD, president of the ACCC and medical director of the oncology program at Penn Medicine Lancaster General Health in Pennsylvania.

The impact of COVID-19 on cancer research

Dr. Oyer observed that planning and implementation for COVID-19–related illness at U.S. health care institutions has had a predictable effect of limiting patient access and staff availability for nonessential services.

Coronavirus-related exposure and/or illness has relegated cancer research to a lower-level priority. As a result, ACCC institutions have made adjustments in their cancer research programs, including moving clinical research coordinators off-campus and deploying them in clinical areas.

New clinical trials have not been opened. In some cases, new accruals have been halted, particularly for registry, prevention, and symptom control trials.

Standards that have changed and those that have not

Guidance documents for conducting clinical trials during the pandemic have been developed by the Food and Drug Administration, the National Cancer Institute’s Cancer Therapy Evaluation Program and Central Institutional Review Board, and the National Institutes of Health’s Office of Extramural Research. Industry sponsors and parent institutions of research programs have also disseminated guidance.

Among other topics, guidance documents have addressed:

• How COVID-19-related protocol deviations will be judged at monitoring visits and audits
• Missed office visits and endpoint evaluations
• Providing investigational oral medications to patients via mail and potential issues of medication unavailability
• Processes for patients to have interim visits with providers at external institutions, including providers who may not be personally engaged in or credentialed for the research trial
• Potential delays in submitting protocol amendments for institutional review board (IRB) review
• Recommendations for patients confirmed or suspected of having a coronavirus infection.

Dr. Oyer emphasized that patient safety must remain the highest priority for patient management, on or off study. He advised continuing investigational therapy when potential benefit from treatment is anticipated and identifying alternative methods to face-to-face visits for monitoring and access to treatment.

Dr. Oyer urged programs to:

• Maintain good clinical practice standards
• Consult with sponsors and IRBs when questions arise but implement changes that affect patient safety prior to IRB review if necessary
• Document all deviations and COVID-19 related adaptations in a log or spreadsheet in anticipation of future questions from sponsors, monitors, and other entities.

New questions and considerations

In the short-term, Dr. Oyer predicts fewer available trials and a decreased rate of accrual to existing studies. This may result in delays in trial completion and the possibility of redesign for some trials.

He predicts the emergence of COVID-19-focused research questions, including those assessing the course of coronavirus infection in various malignant settings and the impact of cancer-directed treatments and supportive care interventions (e.g., treatment for graft-versus-host disease) on response to COVID-19.

To facilitate developing a clinically and research-relevant database, Dr. Oyer stressed the importance of documentation in the research record, reporting infections as serious adverse events. Documentation should specify whether the infection was confirmed or suspected coronavirus or related to another organism.

In general, when coronavirus infection is strongly suspected, Dr. Oyer said investigational treatments should be interrupted, but study-specific criteria will be forthcoming on that issue.
 

Looking to the future

For patients with advanced cancers, clinical trials provide an important option for hope and clinical benefit. Disrupting the conduct of clinical trials could endanger the lives of participants and delay the emergence of promising treatments and diagnostic tests.

When the coronavirus pandemic recedes, advancing knowledge and treatments for cancer will demand renewed commitment across the oncology care community.

Going forward, Dr. Oyer advised that clinical research staff protect their own health and the safety of trial participants. He encouraged programs to work with sponsors and IRBs to solve logistical problems and clarify individual issues.

He was optimistic that resumption of more normal conduct of studies will enable the successful completion of ongoing trials, enhanced by the creative solutions that were devised during the crisis and by additional prospective, clinically annotated, carefully recorded data from academic and community research sites.


Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

More than three-quarters of cancer clinical research programs have experienced operational changes during the COVID-19 pandemic, according to a survey conducted by the Association of Community Cancer Centers (ACCC) during a recent webinar.

The webinar included insights into how some cancer research programs have adapted to the pandemic, a review of guidance for conducting cancer trials during this time, and a discussion of how the cancer research landscape may be affected by COVID-19 going forward.

The webinar was led by Randall A. Oyer, MD, president of the ACCC and medical director of the oncology program at Penn Medicine Lancaster General Health in Pennsylvania.

The impact of COVID-19 on cancer research

Dr. Oyer observed that planning and implementation for COVID-19–related illness at U.S. health care institutions has had a predictable effect of limiting patient access and staff availability for nonessential services.

Coronavirus-related exposure and/or illness has relegated cancer research to a lower-level priority. As a result, ACCC institutions have made adjustments in their cancer research programs, including moving clinical research coordinators off-campus and deploying them in clinical areas.

New clinical trials have not been opened. In some cases, new accruals have been halted, particularly for registry, prevention, and symptom control trials.

Standards that have changed and those that have not

Guidance documents for conducting clinical trials during the pandemic have been developed by the Food and Drug Administration, the National Cancer Institute’s Cancer Therapy Evaluation Program and Central Institutional Review Board, and the National Institutes of Health’s Office of Extramural Research. Industry sponsors and parent institutions of research programs have also disseminated guidance.

Among other topics, guidance documents have addressed:

• How COVID-19-related protocol deviations will be judged at monitoring visits and audits
• Missed office visits and endpoint evaluations
• Providing investigational oral medications to patients via mail and potential issues of medication unavailability
• Processes for patients to have interim visits with providers at external institutions, including providers who may not be personally engaged in or credentialed for the research trial
• Potential delays in submitting protocol amendments for institutional review board (IRB) review
• Recommendations for patients confirmed or suspected of having a coronavirus infection.

Dr. Oyer emphasized that patient safety must remain the highest priority for patient management, on or off study. He advised continuing investigational therapy when potential benefit from treatment is anticipated and identifying alternative methods to face-to-face visits for monitoring and access to treatment.

Dr. Oyer urged programs to:

• Maintain good clinical practice standards
• Consult with sponsors and IRBs when questions arise but implement changes that affect patient safety prior to IRB review if necessary
• Document all deviations and COVID-19 related adaptations in a log or spreadsheet in anticipation of future questions from sponsors, monitors, and other entities.

New questions and considerations

In the short-term, Dr. Oyer predicts fewer available trials and a decreased rate of accrual to existing studies. This may result in delays in trial completion and the possibility of redesign for some trials.

He predicts the emergence of COVID-19-focused research questions, including those assessing the course of coronavirus infection in various malignant settings and the impact of cancer-directed treatments and supportive care interventions (e.g., treatment for graft-versus-host disease) on response to COVID-19.

To facilitate developing a clinically and research-relevant database, Dr. Oyer stressed the importance of documentation in the research record, reporting infections as serious adverse events. Documentation should specify whether the infection was confirmed or suspected coronavirus or related to another organism.

In general, when coronavirus infection is strongly suspected, Dr. Oyer said investigational treatments should be interrupted, but study-specific criteria will be forthcoming on that issue.
 

Looking to the future

For patients with advanced cancers, clinical trials provide an important option for hope and clinical benefit. Disrupting the conduct of clinical trials could endanger the lives of participants and delay the emergence of promising treatments and diagnostic tests.

When the coronavirus pandemic recedes, advancing knowledge and treatments for cancer will demand renewed commitment across the oncology care community.

Going forward, Dr. Oyer advised that clinical research staff protect their own health and the safety of trial participants. He encouraged programs to work with sponsors and IRBs to solve logistical problems and clarify individual issues.

He was optimistic that resumption of more normal conduct of studies will enable the successful completion of ongoing trials, enhanced by the creative solutions that were devised during the crisis and by additional prospective, clinically annotated, carefully recorded data from academic and community research sites.


Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

More than three-quarters of cancer clinical research programs have experienced operational changes during the COVID-19 pandemic, according to a survey conducted by the Association of Community Cancer Centers (ACCC) during a recent webinar.

The webinar included insights into how some cancer research programs have adapted to the pandemic, a review of guidance for conducting cancer trials during this time, and a discussion of how the cancer research landscape may be affected by COVID-19 going forward.

The webinar was led by Randall A. Oyer, MD, president of the ACCC and medical director of the oncology program at Penn Medicine Lancaster General Health in Pennsylvania.

The impact of COVID-19 on cancer research

Dr. Oyer observed that planning and implementation for COVID-19–related illness at U.S. health care institutions has had a predictable effect of limiting patient access and staff availability for nonessential services.

Coronavirus-related exposure and/or illness has relegated cancer research to a lower-level priority. As a result, ACCC institutions have made adjustments in their cancer research programs, including moving clinical research coordinators off-campus and deploying them in clinical areas.

New clinical trials have not been opened. In some cases, new accruals have been halted, particularly for registry, prevention, and symptom control trials.

Standards that have changed and those that have not

Guidance documents for conducting clinical trials during the pandemic have been developed by the Food and Drug Administration, the National Cancer Institute’s Cancer Therapy Evaluation Program and Central Institutional Review Board, and the National Institutes of Health’s Office of Extramural Research. Industry sponsors and parent institutions of research programs have also disseminated guidance.

Among other topics, guidance documents have addressed:

• How COVID-19-related protocol deviations will be judged at monitoring visits and audits
• Missed office visits and endpoint evaluations
• Providing investigational oral medications to patients via mail and potential issues of medication unavailability
• Processes for patients to have interim visits with providers at external institutions, including providers who may not be personally engaged in or credentialed for the research trial
• Potential delays in submitting protocol amendments for institutional review board (IRB) review
• Recommendations for patients confirmed or suspected of having a coronavirus infection.

Dr. Oyer emphasized that patient safety must remain the highest priority for patient management, on or off study. He advised continuing investigational therapy when potential benefit from treatment is anticipated and identifying alternative methods to face-to-face visits for monitoring and access to treatment.

Dr. Oyer urged programs to:

• Maintain good clinical practice standards
• Consult with sponsors and IRBs when questions arise but implement changes that affect patient safety prior to IRB review if necessary
• Document all deviations and COVID-19 related adaptations in a log or spreadsheet in anticipation of future questions from sponsors, monitors, and other entities.

New questions and considerations

In the short-term, Dr. Oyer predicts fewer available trials and a decreased rate of accrual to existing studies. This may result in delays in trial completion and the possibility of redesign for some trials.

He predicts the emergence of COVID-19-focused research questions, including those assessing the course of coronavirus infection in various malignant settings and the impact of cancer-directed treatments and supportive care interventions (e.g., treatment for graft-versus-host disease) on response to COVID-19.

To facilitate developing a clinically and research-relevant database, Dr. Oyer stressed the importance of documentation in the research record, reporting infections as serious adverse events. Documentation should specify whether the infection was confirmed or suspected coronavirus or related to another organism.

In general, when coronavirus infection is strongly suspected, Dr. Oyer said investigational treatments should be interrupted, but study-specific criteria will be forthcoming on that issue.
 

Looking to the future

For patients with advanced cancers, clinical trials provide an important option for hope and clinical benefit. Disrupting the conduct of clinical trials could endanger the lives of participants and delay the emergence of promising treatments and diagnostic tests.

When the coronavirus pandemic recedes, advancing knowledge and treatments for cancer will demand renewed commitment across the oncology care community.

Going forward, Dr. Oyer advised that clinical research staff protect their own health and the safety of trial participants. He encouraged programs to work with sponsors and IRBs to solve logistical problems and clarify individual issues.

He was optimistic that resumption of more normal conduct of studies will enable the successful completion of ongoing trials, enhanced by the creative solutions that were devised during the crisis and by additional prospective, clinically annotated, carefully recorded data from academic and community research sites.


Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

The coronavirus disease 2019 (COVID-19) pandemic affects us in many ways. Pediatric patients, interestingly, are largely unaffected clinically by this disease. Less than 1% of documented infections occur in children under 10 years old, according to a review of over 72,000 cases from China.¹ In that review, most children were asymptomatic or had mild illness, only three required intensive care, and only one death had been reported as of March 10, 2020. This is in stark contrast to the shocking morbidity and mortality statistics we are becoming all too familiar with on the adult side.

From a social standpoint, however, our pediatric patients’ lives have been turned upside down. Their schedules and routines upended, their education and friendships interrupted, and many are likely experiencing real anxiety and fear.² For countless children, school is a major source of social, emotional, and nutritional support that has been cut off. Some will lose parents, grandparents, or other loved ones to this disease. Parents will lose jobs and will be unable to afford necessities. Pediatric patients will experience delays of procedures or treatments because of the pandemic. Some have projected that rates of child abuse will increase as has been reported during natural disasters.³

Pediatricians around the country are coming together to tackle these issues in creative ways, including the rapid expansion of virtual/telehealth programs. The school systems are developing strategies to deliver online content, and even food, to their students’ homes. Hopefully these tactics will mitigate some of the potential effects on the mental and physical well-being of these patients.

How about my kids? Will they be all right? I am lucky that my husband and I will have jobs throughout this ordeal. Unfortunately, given my role as a hospitalist and my husband’s as a pulmonary/critical care physician, these same jobs that will keep our kids nourished and supported pose the greatest threat to them. As health care workers, we are worried about protecting our families, which may include vulnerable members. The Spanish health ministry announced that medical professionals account for approximately one in eight documented COVID-19 infections in Spain.⁴ With inadequate supplies of personal protective equipment (PPE) in our own nation, we are concerned that our statistics could be similar.

There are multiple strategies to protect ourselves and our families during this difficult time. First, appropriate PPE is essential and integrity with the process must be maintained always. Hospital leaders can protect us by tirelessly working to acquire PPE. In Grand Rapids, Mich., our health system has partnered with multiple local manufacturing companies, including Steelcase, who are producing PPE for our workforce.⁵ Leaders can diligently update their system’s PPE recommendations to be in line with the latest CDC recommendations and disseminate the information regularly. Hospitalists should frequently check with their Infection Prevention department to make sure they understand if there have been any changes to the recommendations. Innovative solutions for sterilization of PPE, stethoscopes, badges and other equipment, such as with the use of UV boxes or hydrogen peroxide vapor,⁶ should be explored to minimize contamination. Hospitalists should bring a set of clothes and shoes to change into upon arrival to work and to change out of prior to leaving the hospital.

We must also keep our heads strong. Currently the anxiety amongst physicians is palpable but there is solidarity. Hospital leaders must ensure that hospitalists have easy access to free mental health resources, such as virtual counseling. Wellness teams must rise to the occasion with innovative tactics to support us. For example, Spectrum Health’s wellness team is sponsoring a blog where physicians can discuss COVID-19–related challenges openly. Hospitalist leaders should ensure that there is a structure for debriefing after critical incidents, which are sure to increase in frequency. Email lists and discussion boards sponsored by professional society also provide a collaborative venue for some of these discussions. We must take advantage of these resources and communicate with each other.

For me, in the end it comes back to the kids. My kids and most pediatric patients are not likely to be hospitalized from COVID-19, but they are also not immune to the toll that fighting this pandemic will take on our families. We took an oath to protect our patients, but what do we owe to our own children? At a minimum we can optimize how we protect ourselves every day, both physically and mentally. As we come together as a strong community to fight this pandemic, in addition to saving lives, we are working to ensure that, in the end, the kids will be all right.
 

Dr. Hadley is chief of pediatric hospital medicine at Spectrum Health/Helen DeVos Children’s Hospital in Grand Rapids, Mich., and clinical assistant professor at Michigan State University, East Lansing.

References

1. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: Summary of a report of 72 314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648.

2. Hagan JF Jr; American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health; Task Force on Terrorism. Psychosocial implications of disaster or terrorism on children: A guide for the pediatrician. Pediatrics. 2005;116(3):787-795.

3. Gearhart S et al. The impact of natural disasters on domestic violence: An analysis of reports of simple assault in Florida (1997-2007). Violence Gend. 2018 Jun. doi: 10.1089/vio.2017.0077.

4. Minder R, Peltier E. Virus knocks thousands of health workers out of action in Europe. The New York Times. March 24, 2020.

5. McVicar B. West Michigan businesses hustle to produce medical supplies amid coronavirus pandemic. MLive. March 25, 2020.

6. Kenney PA et al. Hydrogen Peroxide Vapor sterilization of N95 respirators for reuse. medRxiv preprint. 2020 Mar. doi: 10.1101/2020.03.24.20041087.
 

The coronavirus disease 2019 (COVID-19) pandemic affects us in many ways. Pediatric patients, interestingly, are largely unaffected clinically by this disease. Less than 1% of documented infections occur in children under 10 years old, according to a review of over 72,000 cases from China.¹ In that review, most children were asymptomatic or had mild illness, only three required intensive care, and only one death had been reported as of March 10, 2020. This is in stark contrast to the shocking morbidity and mortality statistics we are becoming all too familiar with on the adult side.

From a social standpoint, however, our pediatric patients’ lives have been turned upside down. Their schedules and routines upended, their education and friendships interrupted, and many are likely experiencing real anxiety and fear.² For countless children, school is a major source of social, emotional, and nutritional support that has been cut off. Some will lose parents, grandparents, or other loved ones to this disease. Parents will lose jobs and will be unable to afford necessities. Pediatric patients will experience delays of procedures or treatments because of the pandemic. Some have projected that rates of child abuse will increase as has been reported during natural disasters.³

Pediatricians around the country are coming together to tackle these issues in creative ways, including the rapid expansion of virtual/telehealth programs. The school systems are developing strategies to deliver online content, and even food, to their students’ homes. Hopefully these tactics will mitigate some of the potential effects on the mental and physical well-being of these patients.

How about my kids? Will they be all right? I am lucky that my husband and I will have jobs throughout this ordeal. Unfortunately, given my role as a hospitalist and my husband’s as a pulmonary/critical care physician, these same jobs that will keep our kids nourished and supported pose the greatest threat to them. As health care workers, we are worried about protecting our families, which may include vulnerable members. The Spanish health ministry announced that medical professionals account for approximately one in eight documented COVID-19 infections in Spain.⁴ With inadequate supplies of personal protective equipment (PPE) in our own nation, we are concerned that our statistics could be similar.

There are multiple strategies to protect ourselves and our families during this difficult time. First, appropriate PPE is essential and integrity with the process must be maintained always. Hospital leaders can protect us by tirelessly working to acquire PPE. In Grand Rapids, Mich., our health system has partnered with multiple local manufacturing companies, including Steelcase, who are producing PPE for our workforce.⁵ Leaders can diligently update their system’s PPE recommendations to be in line with the latest CDC recommendations and disseminate the information regularly. Hospitalists should frequently check with their Infection Prevention department to make sure they understand if there have been any changes to the recommendations. Innovative solutions for sterilization of PPE, stethoscopes, badges and other equipment, such as with the use of UV boxes or hydrogen peroxide vapor,⁶ should be explored to minimize contamination. Hospitalists should bring a set of clothes and shoes to change into upon arrival to work and to change out of prior to leaving the hospital.

We must also keep our heads strong. Currently the anxiety amongst physicians is palpable but there is solidarity. Hospital leaders must ensure that hospitalists have easy access to free mental health resources, such as virtual counseling. Wellness teams must rise to the occasion with innovative tactics to support us. For example, Spectrum Health’s wellness team is sponsoring a blog where physicians can discuss COVID-19–related challenges openly. Hospitalist leaders should ensure that there is a structure for debriefing after critical incidents, which are sure to increase in frequency. Email lists and discussion boards sponsored by professional society also provide a collaborative venue for some of these discussions. We must take advantage of these resources and communicate with each other.

For me, in the end it comes back to the kids. My kids and most pediatric patients are not likely to be hospitalized from COVID-19, but they are also not immune to the toll that fighting this pandemic will take on our families. We took an oath to protect our patients, but what do we owe to our own children? At a minimum we can optimize how we protect ourselves every day, both physically and mentally. As we come together as a strong community to fight this pandemic, in addition to saving lives, we are working to ensure that, in the end, the kids will be all right.
 

Dr. Hadley is chief of pediatric hospital medicine at Spectrum Health/Helen DeVos Children’s Hospital in Grand Rapids, Mich., and clinical assistant professor at Michigan State University, East Lansing.

References

1. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: Summary of a report of 72 314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648.

2. Hagan JF Jr; American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health; Task Force on Terrorism. Psychosocial implications of disaster or terrorism on children: A guide for the pediatrician. Pediatrics. 2005;116(3):787-795.

3. Gearhart S et al. The impact of natural disasters on domestic violence: An analysis of reports of simple assault in Florida (1997-2007). Violence Gend. 2018 Jun. doi: 10.1089/vio.2017.0077.

4. Minder R, Peltier E. Virus knocks thousands of health workers out of action in Europe. The New York Times. March 24, 2020.

5. McVicar B. West Michigan businesses hustle to produce medical supplies amid coronavirus pandemic. MLive. March 25, 2020.

6. Kenney PA et al. Hydrogen Peroxide Vapor sterilization of N95 respirators for reuse. medRxiv preprint. 2020 Mar. doi: 10.1101/2020.03.24.20041087.
 

The coronavirus disease 2019 (COVID-19) pandemic affects us in many ways. Pediatric patients, interestingly, are largely unaffected clinically by this disease. Less than 1% of documented infections occur in children under 10 years old, according to a review of over 72,000 cases from China.¹ In that review, most children were asymptomatic or had mild illness, only three required intensive care, and only one death had been reported as of March 10, 2020. This is in stark contrast to the shocking morbidity and mortality statistics we are becoming all too familiar with on the adult side.

From a social standpoint, however, our pediatric patients’ lives have been turned upside down. Their schedules and routines upended, their education and friendships interrupted, and many are likely experiencing real anxiety and fear.² For countless children, school is a major source of social, emotional, and nutritional support that has been cut off. Some will lose parents, grandparents, or other loved ones to this disease. Parents will lose jobs and will be unable to afford necessities. Pediatric patients will experience delays of procedures or treatments because of the pandemic. Some have projected that rates of child abuse will increase as has been reported during natural disasters.³

Pediatricians around the country are coming together to tackle these issues in creative ways, including the rapid expansion of virtual/telehealth programs. The school systems are developing strategies to deliver online content, and even food, to their students’ homes. Hopefully these tactics will mitigate some of the potential effects on the mental and physical well-being of these patients.

How about my kids? Will they be all right? I am lucky that my husband and I will have jobs throughout this ordeal. Unfortunately, given my role as a hospitalist and my husband’s as a pulmonary/critical care physician, these same jobs that will keep our kids nourished and supported pose the greatest threat to them. As health care workers, we are worried about protecting our families, which may include vulnerable members. The Spanish health ministry announced that medical professionals account for approximately one in eight documented COVID-19 infections in Spain.⁴ With inadequate supplies of personal protective equipment (PPE) in our own nation, we are concerned that our statistics could be similar.

There are multiple strategies to protect ourselves and our families during this difficult time. First, appropriate PPE is essential and integrity with the process must be maintained always. Hospital leaders can protect us by tirelessly working to acquire PPE. In Grand Rapids, Mich., our health system has partnered with multiple local manufacturing companies, including Steelcase, who are producing PPE for our workforce.⁵ Leaders can diligently update their system’s PPE recommendations to be in line with the latest CDC recommendations and disseminate the information regularly. Hospitalists should frequently check with their Infection Prevention department to make sure they understand if there have been any changes to the recommendations. Innovative solutions for sterilization of PPE, stethoscopes, badges and other equipment, such as with the use of UV boxes or hydrogen peroxide vapor,⁶ should be explored to minimize contamination. Hospitalists should bring a set of clothes and shoes to change into upon arrival to work and to change out of prior to leaving the hospital.

We must also keep our heads strong. Currently the anxiety amongst physicians is palpable but there is solidarity. Hospital leaders must ensure that hospitalists have easy access to free mental health resources, such as virtual counseling. Wellness teams must rise to the occasion with innovative tactics to support us. For example, Spectrum Health’s wellness team is sponsoring a blog where physicians can discuss COVID-19–related challenges openly. Hospitalist leaders should ensure that there is a structure for debriefing after critical incidents, which are sure to increase in frequency. Email lists and discussion boards sponsored by professional society also provide a collaborative venue for some of these discussions. We must take advantage of these resources and communicate with each other.

For me, in the end it comes back to the kids. My kids and most pediatric patients are not likely to be hospitalized from COVID-19, but they are also not immune to the toll that fighting this pandemic will take on our families. We took an oath to protect our patients, but what do we owe to our own children? At a minimum we can optimize how we protect ourselves every day, both physically and mentally. As we come together as a strong community to fight this pandemic, in addition to saving lives, we are working to ensure that, in the end, the kids will be all right.
 

Dr. Hadley is chief of pediatric hospital medicine at Spectrum Health/Helen DeVos Children’s Hospital in Grand Rapids, Mich., and clinical assistant professor at Michigan State University, East Lansing.

References

1. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: Summary of a report of 72 314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648.

2. Hagan JF Jr; American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health; Task Force on Terrorism. Psychosocial implications of disaster or terrorism on children: A guide for the pediatrician. Pediatrics. 2005;116(3):787-795.

3. Gearhart S et al. The impact of natural disasters on domestic violence: An analysis of reports of simple assault in Florida (1997-2007). Violence Gend. 2018 Jun. doi: 10.1089/vio.2017.0077.

4. Minder R, Peltier E. Virus knocks thousands of health workers out of action in Europe. The New York Times. March 24, 2020.

5. McVicar B. West Michigan businesses hustle to produce medical supplies amid coronavirus pandemic. MLive. March 25, 2020.

6. Kenney PA et al. Hydrogen Peroxide Vapor sterilization of N95 respirators for reuse. medRxiv preprint. 2020 Mar. doi: 10.1101/2020.03.24.20041087.
 

The pandemic of coronavirus disease 2019 (COVID-19) is confronting the modern world like nothing else before. With over 20 million individuals expected to require hospitalization in the US, this health crisis may become a generation-defining moment for healthcare systems and the field of hospital medicine.¹ The specific challenges facing hospital medicine are comparable to running a sprint and a marathon—at the same time. For the sprint underway, hospitalists must learn to respond to a rapidly changing environment in which critical decisions are made within hours and days. At the same time, hospitalists need to plan for the marathon of increased clinical needs over the coming months, the possibility of burnout, and concerns about staff well-­being. Although runners typically focus on either the sprint or the marathon, healthcare systems and hospital medicine providers will need to simultaneously prepare for both types of races.

Over the past several weeks, hospital medicine leaders have been rapidly responding to an evolving crisis. Leaders and clinicians are quickly learning how to restructure clinical operations, negotiate the short supply of personal protective equipment (PPE), and manage delays in COVID-19 testing. In these areas, our hospitalist group has experienced a steep learning curve. In addition to the strategies outlined in the Table, we will share here our experiences and insights on managing and preparing for the COVID-19 pandemic.

Communication Is Central

During the sprint, focused, regular communication is imperative to ameliorate anxiety and fear. A study of crisis communication after 9/11 found that, for employees, good communication from leadership was one of the most valued factors.² Communications experts also note that, in times of crisis, leaders have a special role in communication, specifically around demystifying the situation, providing hope, and maintaining transparency.³

Mental bandwidth may be limited in a stressful environment, so efforts should be taken to maximize the value of each communication. Information on hospital metrics should be provided regularly, including the number of COVID-19 cases, the status of clinical services and staffing, hospital capacity, and resource availability.⁴ Although the ubiquity and ease of email is convenient, recognize that providers are likely receiving email updates from multiple layers within your healthcare organization. To guard against losing important information, we use the same templated format for daily email updates with changes highlighted, which allows busy clinicians to digest pertinent information easily.⁵ Finally, consider having a single individual be responsible for collating COVID-19–related emails sent to your group. Although clinicians may want to share the most recent studies or their clinical experiences with a group email, instead have them send this information to a single individual who can organize these materials and share them on a regular basis.

To keep two-way communication channels open in a busy, asynchronous environment, consider having a centralized shared document in which providers can give real-time feedback to capture on-the-ground experiences or share questions they would like answered. Within our group, we found that centralizing our conversation in a shared document eliminated redundancy, focused our meetings, and kept everyone up to date. Additionally, regularly scheduled meetings may need to be adapted to a remote format (eg, Zoom, WebEx) as clinicians are asked to work from home when not on clinical service. Finally, recognize that virtual meetings require a different skill set than that required by in-person meetings, including reestablishment of social norms and technology preparation.⁶

Optimize Your Staffing

Hospital volumes could increase to as high as 270% of current hospital bed capacities during this pandemic.¹ This surge is further complicated by the effort involved in caring for these patients, given their increased medical complexity, the use of new protocols, and the extra time needed to update staff and family. As the workload intensifies, staffing models and operations will also need to adapt.

First, optimize your inpatient resources based on the changes your hospital system is making. For instance, as elective surgeries were cancelled, we dissolved our surgical comanagement and consult services to better accommodate our hospitals’ needs. Further, consider using advanced practice providers (eg, physician assistants and nurse practitioners) released from their clinical duties to help with inpatient care in the event of a surge. If your hospital has trainees (eg, residents or fellows), consider reassigning those whose rotations have been postponed to newly created inpatient teams; trainees often have strong institutional knowledge and understanding of hospital protocols and resources.

Second, use hospitalists for their most relevant skills. Hospitalists are pluripotent clinicians who are comfortable with high-­acuity patients and can fit into a myriad of clinical positions. The initial instinct at our institution was to mobilize hospitalists across all areas of increasing needs in the hospital (eg, screening clinics,⁷ advice phone lines for patients, or in the Emergency Department), but we quickly recognized that the hospitalist group is a finite resource. We focused our hospitalists’ clinical work on the expanding inpatient needs and allowed other outpatient or procedure-based specialties that have less inpatient experience to fill the broader institutional gaps.

Finally, consider long-term implications of staffing decisions. Leaders are making challenging coverage decisions that can affect the morale and autonomy of staff. Does backup staffing happen on a volunteer basis? Who fills the need—those with less clinical time or those with fewer personal obligations? When a staffing model is challenged and your group is making such decisions, engaged communication again becomes paramount.

Experts believe that we are only at the beginning of this crisis, one for which we don’t know what the end looks like or when it will come. With this in mind, hospital medicine leadership must plan for the long-term implications of the lengthy race ahead. Recognizing that morale, motivation, and burnout will be issues to deal with on the horizon, a focus on sustainability and wellness will become increasingly important as the marathon continues. To date, we’ve found the following principles to be helpful.

Delegate Responsibilities

Hospitals will not be able to survive COVID-19 through the efforts of single individuals. Instead, consider creating “operational champion” roles for frontline clinicians. These individuals can lead in specific areas (eg, PPE, updates on COVID-19 testing, discharge protocols) and act as conduits for information, updates, and resources for your group. At our institution, such operational meetings and activities take hours out of each day. By creating a breadth of leadership roles, our group has spread the operational workload while still allowing clinicians to care for patients, avoid burnout, and build autonomy and opportunities for both personal and professional growth. While for most institutions, these positions are temporary and not compensated with salary or time, the contribution to the group should be recognized both now and in the future.

Focus on Wellness

Providers are battling a laundry list of both clinical and personal stressors. The Centers for Disease Control and Prevention has already recognized that stress and mental health are going to be large hurdles for both patients and providers during this crisis.⁸ From the beginning, hospitalist leadership should be attuned to physician wellness and be aware that burnout, mental and physical exhaustion, and the possibility of contracting COVID-19 will be issues in the coming weeks and months. Volunteerism is built into the physician’s work ethic, but we must be mindful about its cost for long-term staffing demands. In addition, scarce medical resources add an additional moral strain for clinicians as they face tough allocation decisions, as we’ve seen with our Italian colleagues.⁹

As regular meetings around COVID-19 have become commonplace, we’ve made sure to set aside defined time for staff to discuss and reflect on their experiences. Doing so has allowed our clinicians to feel heard and to acknowledge the difficulties they are facing in their clinical duties. Leaders should also consider frequent check-ins with individual providers. At our institution, the first positive COVID-19 patient did not radically change any protocol that was in place, but a check-in with the hospitalist on service that day proved helpful for a debrief and processing opportunity. Individual conversations can help those on the front lines feel supported and remind them they are not operating alone in an anonymous vacuum.

Continue by celebrating small victories because this marathon is not going to end with an obvious finish line or a singular moment in which everyone can rejoice. A negative test, a patient with a good outcome, and a donation of PPE are all opportunities to celebrate. It may be what keeps us going when there is no end in sight. We have relied on these celebrations and moments of levity as an integral part of our regular group meetings.

At the end of this pandemic, just as we hope that our social distancing feels like an overreaction, we similarly hope that our sprint to build capacity ends up being unnecessary as well. As we wrote this Perspectives piece, uncertainty about the extent, length, and impact of this pandemic still existed. By the time it is published it may be that the sprint is over, and the marathon is beginning. Or, if our wildest hopes come true, there will be no marathon to run at all.

The pandemic of coronavirus disease 2019 (COVID-19) is confronting the modern world like nothing else before. With over 20 million individuals expected to require hospitalization in the US, this health crisis may become a generation-defining moment for healthcare systems and the field of hospital medicine.¹ The specific challenges facing hospital medicine are comparable to running a sprint and a marathon—at the same time. For the sprint underway, hospitalists must learn to respond to a rapidly changing environment in which critical decisions are made within hours and days. At the same time, hospitalists need to plan for the marathon of increased clinical needs over the coming months, the possibility of burnout, and concerns about staff well-­being. Although runners typically focus on either the sprint or the marathon, healthcare systems and hospital medicine providers will need to simultaneously prepare for both types of races.

Over the past several weeks, hospital medicine leaders have been rapidly responding to an evolving crisis. Leaders and clinicians are quickly learning how to restructure clinical operations, negotiate the short supply of personal protective equipment (PPE), and manage delays in COVID-19 testing. In these areas, our hospitalist group has experienced a steep learning curve. In addition to the strategies outlined in the Table, we will share here our experiences and insights on managing and preparing for the COVID-19 pandemic.

Communication Is Central

During the sprint, focused, regular communication is imperative to ameliorate anxiety and fear. A study of crisis communication after 9/11 found that, for employees, good communication from leadership was one of the most valued factors.² Communications experts also note that, in times of crisis, leaders have a special role in communication, specifically around demystifying the situation, providing hope, and maintaining transparency.³

Mental bandwidth may be limited in a stressful environment, so efforts should be taken to maximize the value of each communication. Information on hospital metrics should be provided regularly, including the number of COVID-19 cases, the status of clinical services and staffing, hospital capacity, and resource availability.⁴ Although the ubiquity and ease of email is convenient, recognize that providers are likely receiving email updates from multiple layers within your healthcare organization. To guard against losing important information, we use the same templated format for daily email updates with changes highlighted, which allows busy clinicians to digest pertinent information easily.⁵ Finally, consider having a single individual be responsible for collating COVID-19–related emails sent to your group. Although clinicians may want to share the most recent studies or their clinical experiences with a group email, instead have them send this information to a single individual who can organize these materials and share them on a regular basis.

To keep two-way communication channels open in a busy, asynchronous environment, consider having a centralized shared document in which providers can give real-time feedback to capture on-the-ground experiences or share questions they would like answered. Within our group, we found that centralizing our conversation in a shared document eliminated redundancy, focused our meetings, and kept everyone up to date. Additionally, regularly scheduled meetings may need to be adapted to a remote format (eg, Zoom, WebEx) as clinicians are asked to work from home when not on clinical service. Finally, recognize that virtual meetings require a different skill set than that required by in-person meetings, including reestablishment of social norms and technology preparation.⁶

Optimize Your Staffing

Hospital volumes could increase to as high as 270% of current hospital bed capacities during this pandemic.¹ This surge is further complicated by the effort involved in caring for these patients, given their increased medical complexity, the use of new protocols, and the extra time needed to update staff and family. As the workload intensifies, staffing models and operations will also need to adapt.

First, optimize your inpatient resources based on the changes your hospital system is making. For instance, as elective surgeries were cancelled, we dissolved our surgical comanagement and consult services to better accommodate our hospitals’ needs. Further, consider using advanced practice providers (eg, physician assistants and nurse practitioners) released from their clinical duties to help with inpatient care in the event of a surge. If your hospital has trainees (eg, residents or fellows), consider reassigning those whose rotations have been postponed to newly created inpatient teams; trainees often have strong institutional knowledge and understanding of hospital protocols and resources.

Second, use hospitalists for their most relevant skills. Hospitalists are pluripotent clinicians who are comfortable with high-­acuity patients and can fit into a myriad of clinical positions. The initial instinct at our institution was to mobilize hospitalists across all areas of increasing needs in the hospital (eg, screening clinics,⁷ advice phone lines for patients, or in the Emergency Department), but we quickly recognized that the hospitalist group is a finite resource. We focused our hospitalists’ clinical work on the expanding inpatient needs and allowed other outpatient or procedure-based specialties that have less inpatient experience to fill the broader institutional gaps.

Finally, consider long-term implications of staffing decisions. Leaders are making challenging coverage decisions that can affect the morale and autonomy of staff. Does backup staffing happen on a volunteer basis? Who fills the need—those with less clinical time or those with fewer personal obligations? When a staffing model is challenged and your group is making such decisions, engaged communication again becomes paramount.

Experts believe that we are only at the beginning of this crisis, one for which we don’t know what the end looks like or when it will come. With this in mind, hospital medicine leadership must plan for the long-term implications of the lengthy race ahead. Recognizing that morale, motivation, and burnout will be issues to deal with on the horizon, a focus on sustainability and wellness will become increasingly important as the marathon continues. To date, we’ve found the following principles to be helpful.

Delegate Responsibilities

Hospitals will not be able to survive COVID-19 through the efforts of single individuals. Instead, consider creating “operational champion” roles for frontline clinicians. These individuals can lead in specific areas (eg, PPE, updates on COVID-19 testing, discharge protocols) and act as conduits for information, updates, and resources for your group. At our institution, such operational meetings and activities take hours out of each day. By creating a breadth of leadership roles, our group has spread the operational workload while still allowing clinicians to care for patients, avoid burnout, and build autonomy and opportunities for both personal and professional growth. While for most institutions, these positions are temporary and not compensated with salary or time, the contribution to the group should be recognized both now and in the future.

Focus on Wellness

Providers are battling a laundry list of both clinical and personal stressors. The Centers for Disease Control and Prevention has already recognized that stress and mental health are going to be large hurdles for both patients and providers during this crisis.⁸ From the beginning, hospitalist leadership should be attuned to physician wellness and be aware that burnout, mental and physical exhaustion, and the possibility of contracting COVID-19 will be issues in the coming weeks and months. Volunteerism is built into the physician’s work ethic, but we must be mindful about its cost for long-term staffing demands. In addition, scarce medical resources add an additional moral strain for clinicians as they face tough allocation decisions, as we’ve seen with our Italian colleagues.⁹

As regular meetings around COVID-19 have become commonplace, we’ve made sure to set aside defined time for staff to discuss and reflect on their experiences. Doing so has allowed our clinicians to feel heard and to acknowledge the difficulties they are facing in their clinical duties. Leaders should also consider frequent check-ins with individual providers. At our institution, the first positive COVID-19 patient did not radically change any protocol that was in place, but a check-in with the hospitalist on service that day proved helpful for a debrief and processing opportunity. Individual conversations can help those on the front lines feel supported and remind them they are not operating alone in an anonymous vacuum.

Continue by celebrating small victories because this marathon is not going to end with an obvious finish line or a singular moment in which everyone can rejoice. A negative test, a patient with a good outcome, and a donation of PPE are all opportunities to celebrate. It may be what keeps us going when there is no end in sight. We have relied on these celebrations and moments of levity as an integral part of our regular group meetings.

At the end of this pandemic, just as we hope that our social distancing feels like an overreaction, we similarly hope that our sprint to build capacity ends up being unnecessary as well. As we wrote this Perspectives piece, uncertainty about the extent, length, and impact of this pandemic still existed. By the time it is published it may be that the sprint is over, and the marathon is beginning. Or, if our wildest hopes come true, there will be no marathon to run at all.

The pandemic of coronavirus disease 2019 (COVID-19) is confronting the modern world like nothing else before. With over 20 million individuals expected to require hospitalization in the US, this health crisis may become a generation-defining moment for healthcare systems and the field of hospital medicine.¹ The specific challenges facing hospital medicine are comparable to running a sprint and a marathon—at the same time. For the sprint underway, hospitalists must learn to respond to a rapidly changing environment in which critical decisions are made within hours and days. At the same time, hospitalists need to plan for the marathon of increased clinical needs over the coming months, the possibility of burnout, and concerns about staff well-­being. Although runners typically focus on either the sprint or the marathon, healthcare systems and hospital medicine providers will need to simultaneously prepare for both types of races.

Over the past several weeks, hospital medicine leaders have been rapidly responding to an evolving crisis. Leaders and clinicians are quickly learning how to restructure clinical operations, negotiate the short supply of personal protective equipment (PPE), and manage delays in COVID-19 testing. In these areas, our hospitalist group has experienced a steep learning curve. In addition to the strategies outlined in the Table, we will share here our experiences and insights on managing and preparing for the COVID-19 pandemic.

Communication Is Central

During the sprint, focused, regular communication is imperative to ameliorate anxiety and fear. A study of crisis communication after 9/11 found that, for employees, good communication from leadership was one of the most valued factors.² Communications experts also note that, in times of crisis, leaders have a special role in communication, specifically around demystifying the situation, providing hope, and maintaining transparency.³

Mental bandwidth may be limited in a stressful environment, so efforts should be taken to maximize the value of each communication. Information on hospital metrics should be provided regularly, including the number of COVID-19 cases, the status of clinical services and staffing, hospital capacity, and resource availability.⁴ Although the ubiquity and ease of email is convenient, recognize that providers are likely receiving email updates from multiple layers within your healthcare organization. To guard against losing important information, we use the same templated format for daily email updates with changes highlighted, which allows busy clinicians to digest pertinent information easily.⁵ Finally, consider having a single individual be responsible for collating COVID-19–related emails sent to your group. Although clinicians may want to share the most recent studies or their clinical experiences with a group email, instead have them send this information to a single individual who can organize these materials and share them on a regular basis.

To keep two-way communication channels open in a busy, asynchronous environment, consider having a centralized shared document in which providers can give real-time feedback to capture on-the-ground experiences or share questions they would like answered. Within our group, we found that centralizing our conversation in a shared document eliminated redundancy, focused our meetings, and kept everyone up to date. Additionally, regularly scheduled meetings may need to be adapted to a remote format (eg, Zoom, WebEx) as clinicians are asked to work from home when not on clinical service. Finally, recognize that virtual meetings require a different skill set than that required by in-person meetings, including reestablishment of social norms and technology preparation.⁶

Optimize Your Staffing

Hospital volumes could increase to as high as 270% of current hospital bed capacities during this pandemic.¹ This surge is further complicated by the effort involved in caring for these patients, given their increased medical complexity, the use of new protocols, and the extra time needed to update staff and family. As the workload intensifies, staffing models and operations will also need to adapt.

First, optimize your inpatient resources based on the changes your hospital system is making. For instance, as elective surgeries were cancelled, we dissolved our surgical comanagement and consult services to better accommodate our hospitals’ needs. Further, consider using advanced practice providers (eg, physician assistants and nurse practitioners) released from their clinical duties to help with inpatient care in the event of a surge. If your hospital has trainees (eg, residents or fellows), consider reassigning those whose rotations have been postponed to newly created inpatient teams; trainees often have strong institutional knowledge and understanding of hospital protocols and resources.

Second, use hospitalists for their most relevant skills. Hospitalists are pluripotent clinicians who are comfortable with high-­acuity patients and can fit into a myriad of clinical positions. The initial instinct at our institution was to mobilize hospitalists across all areas of increasing needs in the hospital (eg, screening clinics,⁷ advice phone lines for patients, or in the Emergency Department), but we quickly recognized that the hospitalist group is a finite resource. We focused our hospitalists’ clinical work on the expanding inpatient needs and allowed other outpatient or procedure-based specialties that have less inpatient experience to fill the broader institutional gaps.

Finally, consider long-term implications of staffing decisions. Leaders are making challenging coverage decisions that can affect the morale and autonomy of staff. Does backup staffing happen on a volunteer basis? Who fills the need—those with less clinical time or those with fewer personal obligations? When a staffing model is challenged and your group is making such decisions, engaged communication again becomes paramount.

Experts believe that we are only at the beginning of this crisis, one for which we don’t know what the end looks like or when it will come. With this in mind, hospital medicine leadership must plan for the long-term implications of the lengthy race ahead. Recognizing that morale, motivation, and burnout will be issues to deal with on the horizon, a focus on sustainability and wellness will become increasingly important as the marathon continues. To date, we’ve found the following principles to be helpful.

Delegate Responsibilities

Hospitals will not be able to survive COVID-19 through the efforts of single individuals. Instead, consider creating “operational champion” roles for frontline clinicians. These individuals can lead in specific areas (eg, PPE, updates on COVID-19 testing, discharge protocols) and act as conduits for information, updates, and resources for your group. At our institution, such operational meetings and activities take hours out of each day. By creating a breadth of leadership roles, our group has spread the operational workload while still allowing clinicians to care for patients, avoid burnout, and build autonomy and opportunities for both personal and professional growth. While for most institutions, these positions are temporary and not compensated with salary or time, the contribution to the group should be recognized both now and in the future.

Focus on Wellness

Providers are battling a laundry list of both clinical and personal stressors. The Centers for Disease Control and Prevention has already recognized that stress and mental health are going to be large hurdles for both patients and providers during this crisis.⁸ From the beginning, hospitalist leadership should be attuned to physician wellness and be aware that burnout, mental and physical exhaustion, and the possibility of contracting COVID-19 will be issues in the coming weeks and months. Volunteerism is built into the physician’s work ethic, but we must be mindful about its cost for long-term staffing demands. In addition, scarce medical resources add an additional moral strain for clinicians as they face tough allocation decisions, as we’ve seen with our Italian colleagues.⁹

As regular meetings around COVID-19 have become commonplace, we’ve made sure to set aside defined time for staff to discuss and reflect on their experiences. Doing so has allowed our clinicians to feel heard and to acknowledge the difficulties they are facing in their clinical duties. Leaders should also consider frequent check-ins with individual providers. At our institution, the first positive COVID-19 patient did not radically change any protocol that was in place, but a check-in with the hospitalist on service that day proved helpful for a debrief and processing opportunity. Individual conversations can help those on the front lines feel supported and remind them they are not operating alone in an anonymous vacuum.

Continue by celebrating small victories because this marathon is not going to end with an obvious finish line or a singular moment in which everyone can rejoice. A negative test, a patient with a good outcome, and a donation of PPE are all opportunities to celebrate. It may be what keeps us going when there is no end in sight. We have relied on these celebrations and moments of levity as an integral part of our regular group meetings.

At the end of this pandemic, just as we hope that our social distancing feels like an overreaction, we similarly hope that our sprint to build capacity ends up being unnecessary as well. As we wrote this Perspectives piece, uncertainty about the extent, length, and impact of this pandemic still existed. By the time it is published it may be that the sprint is over, and the marathon is beginning. Or, if our wildest hopes come true, there will be no marathon to run at all.

It’s becoming clear that COVID-19 infection can involve the cardiovascular system in many different ways, and this has “evolving” potential implications for treatment, say a team of cardiologists on the frontlines of the COVID-19 battle in New York City.

In an article published online April 3 in Circulation, Justin Fried, MD, Division of Cardiology, Columbia University, New York City, and colleagues present four case studies of COVID-19 patients with various cardiovascular presentations.

Case 1 is a 64-year-old woman whose predominant symptoms on admission were cardiac in nature, including chest pain and ST elevation, but without fever, cough, or other symptoms suggestive of COVID-19.

“In patients presenting with what appears to be a typical cardiac syndrome, COVID-19 infection should be in the differential during the current pandemic, even in the absence of fever or cough,” the clinicians advise.

Case 2 is a 38-year-old man with cardiogenic shock and acute respiratory distress with profound hypoxia who was rescued with veno-arterial-venous extracorporeal membrane oxygenation (VV ECMO).

The initial presentation of this patient was more characteristic of severe COVID-19 disease, and cardiac involvement only became apparent after the initiation of ECMO, Fried and colleagues report.

Based on this case, they advise a “low threshold” to assess for cardiogenic shock in patients with acute systolic heart failure related to COVID-19. If inotropic support fails in these patients, intra-aortic balloon pump should be considered first for mechanical circulatory support because it requires the least maintenance from medical support staff.

In addition, in their experience, when a patient on VV ECMO develops superimposed cardiogenic shock, adding an arterial conduit at a relatively low blood flow rate may provide the necessary circulatory support without inducing left ventricular distension, they note.

“Our experience confirms that rescue of patients even with profound cardiogenic or mixed shock may be possible with temporary hemodynamic support at centers with availability of such devices,” Fried and colleagues report.

Case 3 is a 64-year-old woman with underlying cardiac disease who developed profound decompensation with COVID-19 infection.

This case demonstrates that the infection can cause decompensation of underlying heart failure and may lead to mixed shock, the clinicians say.

“Invasive hemodynamic monitoring, if feasible, may be helpful to manage the cardiac component of shock in such cases. Medications that prolong the QT interval are being considered for COVID-19 patients and may require closer monitoring in patients with underlying structural heart disease,” they note.

Case 4 is a 51-year-old man who underwent a heart transplant in 2007 and a kidney transplant in 2010. He had COVID-19 symptoms akin to those seen in nonimmunosuppressed patients with COVID-19.

The COVID-19 pandemic presents a “unique challenge” for solid organ transplant recipients, with only “limited” data on how to adjust immunosuppression during COVID-19 infection, Fried and colleagues say.

The pandemic also creates a challenge for the management of heart failure patients on the heart transplant wait list; the risks of delaying a transplant need to be balanced against the risks of donor infection and uncertainty regarding the impact of post-transplant immunosuppression protocols, they note.

As reported by Medscape Medical News, the American Heart Association has developed a COVID-19 patient registry to collect data on cardiovascular conditions and outcomes related to COVID-19 infection.

To participate in the registry, contact [email protected].

This article first appeared on Medscape.com.

It’s becoming clear that COVID-19 infection can involve the cardiovascular system in many different ways, and this has “evolving” potential implications for treatment, say a team of cardiologists on the frontlines of the COVID-19 battle in New York City.

In an article published online April 3 in Circulation, Justin Fried, MD, Division of Cardiology, Columbia University, New York City, and colleagues present four case studies of COVID-19 patients with various cardiovascular presentations.

Case 1 is a 64-year-old woman whose predominant symptoms on admission were cardiac in nature, including chest pain and ST elevation, but without fever, cough, or other symptoms suggestive of COVID-19.

“In patients presenting with what appears to be a typical cardiac syndrome, COVID-19 infection should be in the differential during the current pandemic, even in the absence of fever or cough,” the clinicians advise.

Case 2 is a 38-year-old man with cardiogenic shock and acute respiratory distress with profound hypoxia who was rescued with veno-arterial-venous extracorporeal membrane oxygenation (VV ECMO).

The initial presentation of this patient was more characteristic of severe COVID-19 disease, and cardiac involvement only became apparent after the initiation of ECMO, Fried and colleagues report.

Based on this case, they advise a “low threshold” to assess for cardiogenic shock in patients with acute systolic heart failure related to COVID-19. If inotropic support fails in these patients, intra-aortic balloon pump should be considered first for mechanical circulatory support because it requires the least maintenance from medical support staff.

In addition, in their experience, when a patient on VV ECMO develops superimposed cardiogenic shock, adding an arterial conduit at a relatively low blood flow rate may provide the necessary circulatory support without inducing left ventricular distension, they note.

“Our experience confirms that rescue of patients even with profound cardiogenic or mixed shock may be possible with temporary hemodynamic support at centers with availability of such devices,” Fried and colleagues report.

Case 3 is a 64-year-old woman with underlying cardiac disease who developed profound decompensation with COVID-19 infection.

This case demonstrates that the infection can cause decompensation of underlying heart failure and may lead to mixed shock, the clinicians say.

“Invasive hemodynamic monitoring, if feasible, may be helpful to manage the cardiac component of shock in such cases. Medications that prolong the QT interval are being considered for COVID-19 patients and may require closer monitoring in patients with underlying structural heart disease,” they note.

Case 4 is a 51-year-old man who underwent a heart transplant in 2007 and a kidney transplant in 2010. He had COVID-19 symptoms akin to those seen in nonimmunosuppressed patients with COVID-19.

The COVID-19 pandemic presents a “unique challenge” for solid organ transplant recipients, with only “limited” data on how to adjust immunosuppression during COVID-19 infection, Fried and colleagues say.

The pandemic also creates a challenge for the management of heart failure patients on the heart transplant wait list; the risks of delaying a transplant need to be balanced against the risks of donor infection and uncertainty regarding the impact of post-transplant immunosuppression protocols, they note.

As reported by Medscape Medical News, the American Heart Association has developed a COVID-19 patient registry to collect data on cardiovascular conditions and outcomes related to COVID-19 infection.

To participate in the registry, contact [email protected].

This article first appeared on Medscape.com.

It’s becoming clear that COVID-19 infection can involve the cardiovascular system in many different ways, and this has “evolving” potential implications for treatment, say a team of cardiologists on the frontlines of the COVID-19 battle in New York City.

In an article published online April 3 in Circulation, Justin Fried, MD, Division of Cardiology, Columbia University, New York City, and colleagues present four case studies of COVID-19 patients with various cardiovascular presentations.

Case 1 is a 64-year-old woman whose predominant symptoms on admission were cardiac in nature, including chest pain and ST elevation, but without fever, cough, or other symptoms suggestive of COVID-19.

“In patients presenting with what appears to be a typical cardiac syndrome, COVID-19 infection should be in the differential during the current pandemic, even in the absence of fever or cough,” the clinicians advise.

Case 2 is a 38-year-old man with cardiogenic shock and acute respiratory distress with profound hypoxia who was rescued with veno-arterial-venous extracorporeal membrane oxygenation (VV ECMO).

The initial presentation of this patient was more characteristic of severe COVID-19 disease, and cardiac involvement only became apparent after the initiation of ECMO, Fried and colleagues report.

Based on this case, they advise a “low threshold” to assess for cardiogenic shock in patients with acute systolic heart failure related to COVID-19. If inotropic support fails in these patients, intra-aortic balloon pump should be considered first for mechanical circulatory support because it requires the least maintenance from medical support staff.

In addition, in their experience, when a patient on VV ECMO develops superimposed cardiogenic shock, adding an arterial conduit at a relatively low blood flow rate may provide the necessary circulatory support without inducing left ventricular distension, they note.

“Our experience confirms that rescue of patients even with profound cardiogenic or mixed shock may be possible with temporary hemodynamic support at centers with availability of such devices,” Fried and colleagues report.

Case 3 is a 64-year-old woman with underlying cardiac disease who developed profound decompensation with COVID-19 infection.

This case demonstrates that the infection can cause decompensation of underlying heart failure and may lead to mixed shock, the clinicians say.

“Invasive hemodynamic monitoring, if feasible, may be helpful to manage the cardiac component of shock in such cases. Medications that prolong the QT interval are being considered for COVID-19 patients and may require closer monitoring in patients with underlying structural heart disease,” they note.

Case 4 is a 51-year-old man who underwent a heart transplant in 2007 and a kidney transplant in 2010. He had COVID-19 symptoms akin to those seen in nonimmunosuppressed patients with COVID-19.

The COVID-19 pandemic presents a “unique challenge” for solid organ transplant recipients, with only “limited” data on how to adjust immunosuppression during COVID-19 infection, Fried and colleagues say.

The pandemic also creates a challenge for the management of heart failure patients on the heart transplant wait list; the risks of delaying a transplant need to be balanced against the risks of donor infection and uncertainty regarding the impact of post-transplant immunosuppression protocols, they note.

As reported by Medscape Medical News, the American Heart Association has developed a COVID-19 patient registry to collect data on cardiovascular conditions and outcomes related to COVID-19 infection.

To participate in the registry, contact [email protected].

This article first appeared on Medscape.com.

Authors of a recent Cochrane review concluded that low-dose aspirin treatment of 1,000 pregnant women at risk of developing preeclampsia resulted in 16 fewer cases of preeclampsia, 16 fewer preterm births, 7 fewer cases of small-for-gestational age newborns, and 5 fewer fetal or neonatal deaths.¹

The American College of Obstetricians and Gynecologists (ACOG) and the US Preventive Services Task Force (USPSTF) recommend treatment with 81 mg of aspirin daily, initiated before 16 weeks of pregnancy to prevent preeclampsia in women with one major risk factor (personal history of preeclampsia, multifetal gestation, chronic hypertension, type 1 or 2 diabetes, renal or autoimmune disease) or at least two moderate risk factors (nulliparity; obesity; mother or sister with preeclampsia; a sociodemographic characteristic such as African American race or low socioeconomic status; age ≥35 years; personal history factors such as prior low birth weight infant, previous adverse pregnancy outcome, or >10-year interpregnancy interval).^2,3 Healthy pregnant women with a previous uncomplicated full-term delivery do not need treatment with low-dose aspirin.^2,3

However, evolving data and expert opinion suggest that expanding the indications for aspirin treatment and increasing the recommended dose of aspirin may be warranted. 

Nulliparity

Nulliparity is the single clinical characteristic that is associated with the greatest number of cases of preeclampsia.⁴ Hence, from a public health perspective, reducing the rate of preeclampsia among nulliparous women is a top priority.

ACOG and USPSTF do not recommend aspirin treatment for all nulliparous women because risk factors help to identify those nulliparous women who benefit from aspirin treatment.

However, a recent cost-effectiveness analysis compared the health care costs and rates of preeclampsia for 4 prevention strategies among all pregnant women in the United States (nulliparous and parous)⁵:

1. no aspirin use
2. use of aspirin based on biomarker and ultrasound measurements
3. use of aspirin based on USPSTF guidelines for identifying women at risk
4. prescription of aspirin to all pregnant women.

Health care costs and rates of preeclampsia were lowest with the universal prescription of aspirin to all pregnant women in the United States. Compared with universal prescription of aspirin, the USPSTF approach, the biomarker-ultrasound approach, and the no aspirin approach were associated with 346, 308, and 762 additional cases of preeclampsia per 100,000 women. In sensitivity analyses, universal aspirin was the optimal strategy under most assumptions.

Another cost effectiveness analysis concluded that among nulliparous pregnant women, universal aspirin treatment was superior to aspirin treatment based on biomarker-ultrasound identification of women at high risk.⁶ 

In a recent clinical trial performed in India, Guatemala, Pakistan, Democratic Republic of Congo, Kenya, and Zambia, 14,361 nulliparous women were randomly assigned to placebo or 81 mg of aspirin daily between 6 and 14 weeks of gestation.⁷ Preterm birth (<37 weeks’ gestation) occurred in 13.1% and 11.6% of women treated with placebo or aspirin (relative risk [RR], 0.89; 95% confidence interval [CI], 0.81 to 0.98, P = .012). Most of the decrease in preterm birth appeared to be due to a decrease in the rate of preeclampsia in the aspirin-treated nulliparous women. The investigators also noted that aspirin treatment of nulliparous women resulted in a statistically significant decrease in perinatal mortality (RR, 0.86) and early preterm delivery, <34 weeks’ gestation (RR, 0.75). 

Universal prescription of low-dose aspirin to nulliparous women in order to prevent preeclampsia and preterm birth may become recognized as an optimal public health strategy. As a step toward universal prescription of aspirin to nulliparous women, an opt-out rather than a screen-in strategy might be considered.⁸

Continue to: Booking systolic blood pressure, 120 to 134 mm Hg...

Booking systolic blood pressure, 120 to 134 mm Hg

All obstetricians recognize that women with chronic hypertension should be treated with low-dose aspirin because they are at high risk for preeclampsia. However, there is evidence that nulliparous women with a booking systolic pressure ≥120 mm Hg might also benefit from low-dose aspirin treatment. In one US trial, 3,135 nulliparous normotensive women (booking blood pressure [BP] <135/85 mm Hg) were randomly assigned to treatment with aspirin (60 mg daily) or placebo initiated between 13 and 26 weeks’ gestation. Preeclampsia occurred in 6.3% and 4.6% of the women treated with placebo or aspirin, respectively (RR, 0.7; 95% CI, 0.6–1.0; P = .05).⁹ A secondary analysis showed that, among 519 nulliparous women with a booking systolic BP from 120 to 134 mm Hg, compared with placebo, low-dose aspirin treatment reduced the rate of preeclampsia from 11.9% to 5.6%.⁹ Aspirin did not reduce the rate of preeclampsia among nulliparous women with a booking systolic BP <120 mm Hg.⁹ A systematic review of risk factors for developing preeclampsia reported that a booking diastolic BP of ≥80 mm Hg was associated with an increased risk of developing preeclampsia (RR, 1.38).¹⁰ 

The American Heart Association (AHA) and the American College of Cardiology (ACC) recently updated the definition of hypertension.¹¹ Normal BP is now defined as a systolic pressure <120 mm Hg and diastolic pressure <80 mm Hg. Elevated BP is a systolic pressure of 120 to 129 mm Hg and diastolic pressure of <80 mm Hg. Stage I hypertension is a systolic BP from 130 to 139 mm Hg or diastolic blood pressure from 80 to 89 mm Hg. Stage II hypertension is a systolic BP of ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg.¹¹ 

A recent study reported that 90% of women at 12 weeks’ gestation have a BP of ≤130 mm Hg systolic and ≤80 mm Hg diastolic, suggesting that the AHA-ACC criteria for stage I hypertension are reasonable.¹² Obstetricians have not yet fully adopted the AHA-ACC criteria for defining stage I hypertension in pregnant women. Future research may demonstrate that a booking systolic BP 
 ≥130 mm Hg or a diastolic BP ≥80 mm Hg are major risk factors for developing preeclampsia and warrant treatment with low-dose aspirin.

Continue to: Pregnancy resulting from fertility therapy...

Pregnancy resulting from fertility therapy

Current ACOG and USPSTF guidelines do not specifically identify pregnancies resulting from assisted reproductive technology as a major or moderate risk factor for preeclampsia.^2,3 In a study comparing 83,582 births resulting from in vitro fertilization (IVF) and 1,382,311 births to fertile women, treatment with autologous cryopreserved embryos (adjusted odds ratio [aOR], 1.30), fresh donor embryos (aOR, 1.92), and cryopreserved donor embryos (aOR, 1.70) significantly increased the risk of preeclampsia.¹³ However, use of fresh autologous embryos did not increase the risk of preeclampsia (aOR, 1.04). These associations persisted after controlling for diabetes, hypertension, body mass index, and cause of infertility.¹³

Other studies also have reported that use of cryopreserved embryos is associated with a higher rate of preeclampsia than use of fresh autologous embryos. In a study of 825 infertile women undergoing IVF and randomly assigned to single embryo cryopreserved or fresh cycles, the rate of preeclampsia was 3.1% and 1.0% in the pregnancies that resulted from cryopreserved versus fresh cycles.¹⁴ 

What is the optimal dose of aspirin?

ACOG and the USPSTF recommend aspirin 81 mg daily for the prevention of preeclampsia.^2,3 The International Federation of Gynecology and Obstetrics (FIGO) recommends aspirin 150 mg daily for the prevention of preeclampsia.¹⁵ The FIGO recommendation is based, in part, on the results of a large international clinical trial that randomly assigned 1,776 women at high risk for preeclampsia as determined by clinical factors plus biomarker and ultrasound screening to receive aspirin 150 mg daily or placebo daily initiated at 11 to 14 weeks’ gestation and continued until 36 weeks’ gestation.¹⁶ Preeclampsia before 37 weeks’ gestation occurred in 4.3% and 1.6% of women in the placebo and aspirin groups (OR, 0.38; 95% CI, 0.20–0.74; P = .004).¹⁶ FIGO recommends that women at risk for preeclampsia with a body mass <40 kg take aspirin 100 mg daily and women with a body mass ≥40 kg take aspirin at a dose of 150 mg daily. For women who live in a country where aspirin is not available in a pill containing 150 mg, FIGO recommends taking two 81 mg tablets.¹⁵ FIGO recommends initiating aspirin between 11 and 14 weeks and 6 days of gestation and continuing aspirin therapy until 36 weeks of gestation.¹⁵

Aspirin is an inexpensive intervention with many possible benefits

For many nulliparous women and some parous women aspirin treatment initiated early in pregnancy will improve maternal and newborn outcomes, including reducing the risk of preeclampsia, preterm birth, and intrauterine growth restriction.¹ Obstetricians may want to begin to expand the indications for offering aspirin to prevent preeclampsia from those recommended by ACOG and the USPSTF to include nulliparous women with a booking systolic pressure of 120 to 134 mm Hg and women whose pregnancy was the result of an assisted reproduction treatment that used cryopreserved embryos. In addition, obstetricians who currently prescribe 81 mg of aspirin daily might want to consider increasing the prescribed dose to 162 mg of aspirin daily (two 81 mg tablets daily or one-half of a 325 mg tablet). Aspirin costs about less than 5 cents per 81 mg tablet (according to GoodRx website). It is an inexpensive intervention that could benefit many mothers and newborns. ●

Authors of a recent Cochrane review concluded that low-dose aspirin treatment of 1,000 pregnant women at risk of developing preeclampsia resulted in 16 fewer cases of preeclampsia, 16 fewer preterm births, 7 fewer cases of small-for-gestational age newborns, and 5 fewer fetal or neonatal deaths.¹

The American College of Obstetricians and Gynecologists (ACOG) and the US Preventive Services Task Force (USPSTF) recommend treatment with 81 mg of aspirin daily, initiated before 16 weeks of pregnancy to prevent preeclampsia in women with one major risk factor (personal history of preeclampsia, multifetal gestation, chronic hypertension, type 1 or 2 diabetes, renal or autoimmune disease) or at least two moderate risk factors (nulliparity; obesity; mother or sister with preeclampsia; a sociodemographic characteristic such as African American race or low socioeconomic status; age ≥35 years; personal history factors such as prior low birth weight infant, previous adverse pregnancy outcome, or >10-year interpregnancy interval).^2,3 Healthy pregnant women with a previous uncomplicated full-term delivery do not need treatment with low-dose aspirin.^2,3

However, evolving data and expert opinion suggest that expanding the indications for aspirin treatment and increasing the recommended dose of aspirin may be warranted. 

Nulliparity

Nulliparity is the single clinical characteristic that is associated with the greatest number of cases of preeclampsia.⁴ Hence, from a public health perspective, reducing the rate of preeclampsia among nulliparous women is a top priority.

ACOG and USPSTF do not recommend aspirin treatment for all nulliparous women because risk factors help to identify those nulliparous women who benefit from aspirin treatment.

However, a recent cost-effectiveness analysis compared the health care costs and rates of preeclampsia for 4 prevention strategies among all pregnant women in the United States (nulliparous and parous)⁵:

1. no aspirin use
2. use of aspirin based on biomarker and ultrasound measurements
3. use of aspirin based on USPSTF guidelines for identifying women at risk
4. prescription of aspirin to all pregnant women.

Health care costs and rates of preeclampsia were lowest with the universal prescription of aspirin to all pregnant women in the United States. Compared with universal prescription of aspirin, the USPSTF approach, the biomarker-ultrasound approach, and the no aspirin approach were associated with 346, 308, and 762 additional cases of preeclampsia per 100,000 women. In sensitivity analyses, universal aspirin was the optimal strategy under most assumptions.

Another cost effectiveness analysis concluded that among nulliparous pregnant women, universal aspirin treatment was superior to aspirin treatment based on biomarker-ultrasound identification of women at high risk.⁶ 

In a recent clinical trial performed in India, Guatemala, Pakistan, Democratic Republic of Congo, Kenya, and Zambia, 14,361 nulliparous women were randomly assigned to placebo or 81 mg of aspirin daily between 6 and 14 weeks of gestation.⁷ Preterm birth (<37 weeks’ gestation) occurred in 13.1% and 11.6% of women treated with placebo or aspirin (relative risk [RR], 0.89; 95% confidence interval [CI], 0.81 to 0.98, P = .012). Most of the decrease in preterm birth appeared to be due to a decrease in the rate of preeclampsia in the aspirin-treated nulliparous women. The investigators also noted that aspirin treatment of nulliparous women resulted in a statistically significant decrease in perinatal mortality (RR, 0.86) and early preterm delivery, <34 weeks’ gestation (RR, 0.75). 

Universal prescription of low-dose aspirin to nulliparous women in order to prevent preeclampsia and preterm birth may become recognized as an optimal public health strategy. As a step toward universal prescription of aspirin to nulliparous women, an opt-out rather than a screen-in strategy might be considered.⁸

Continue to: Booking systolic blood pressure, 120 to 134 mm Hg...

Booking systolic blood pressure, 120 to 134 mm Hg

All obstetricians recognize that women with chronic hypertension should be treated with low-dose aspirin because they are at high risk for preeclampsia. However, there is evidence that nulliparous women with a booking systolic pressure ≥120 mm Hg might also benefit from low-dose aspirin treatment. In one US trial, 3,135 nulliparous normotensive women (booking blood pressure [BP] <135/85 mm Hg) were randomly assigned to treatment with aspirin (60 mg daily) or placebo initiated between 13 and 26 weeks’ gestation. Preeclampsia occurred in 6.3% and 4.6% of the women treated with placebo or aspirin, respectively (RR, 0.7; 95% CI, 0.6–1.0; P = .05).⁹ A secondary analysis showed that, among 519 nulliparous women with a booking systolic BP from 120 to 134 mm Hg, compared with placebo, low-dose aspirin treatment reduced the rate of preeclampsia from 11.9% to 5.6%.⁹ Aspirin did not reduce the rate of preeclampsia among nulliparous women with a booking systolic BP <120 mm Hg.⁹ A systematic review of risk factors for developing preeclampsia reported that a booking diastolic BP of ≥80 mm Hg was associated with an increased risk of developing preeclampsia (RR, 1.38).¹⁰ 

The American Heart Association (AHA) and the American College of Cardiology (ACC) recently updated the definition of hypertension.¹¹ Normal BP is now defined as a systolic pressure <120 mm Hg and diastolic pressure <80 mm Hg. Elevated BP is a systolic pressure of 120 to 129 mm Hg and diastolic pressure of <80 mm Hg. Stage I hypertension is a systolic BP from 130 to 139 mm Hg or diastolic blood pressure from 80 to 89 mm Hg. Stage II hypertension is a systolic BP of ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg.¹¹ 

A recent study reported that 90% of women at 12 weeks’ gestation have a BP of ≤130 mm Hg systolic and ≤80 mm Hg diastolic, suggesting that the AHA-ACC criteria for stage I hypertension are reasonable.¹² Obstetricians have not yet fully adopted the AHA-ACC criteria for defining stage I hypertension in pregnant women. Future research may demonstrate that a booking systolic BP 
 ≥130 mm Hg or a diastolic BP ≥80 mm Hg are major risk factors for developing preeclampsia and warrant treatment with low-dose aspirin.

Continue to: Pregnancy resulting from fertility therapy...

Pregnancy resulting from fertility therapy

Current ACOG and USPSTF guidelines do not specifically identify pregnancies resulting from assisted reproductive technology as a major or moderate risk factor for preeclampsia.^2,3 In a study comparing 83,582 births resulting from in vitro fertilization (IVF) and 1,382,311 births to fertile women, treatment with autologous cryopreserved embryos (adjusted odds ratio [aOR], 1.30), fresh donor embryos (aOR, 1.92), and cryopreserved donor embryos (aOR, 1.70) significantly increased the risk of preeclampsia.¹³ However, use of fresh autologous embryos did not increase the risk of preeclampsia (aOR, 1.04). These associations persisted after controlling for diabetes, hypertension, body mass index, and cause of infertility.¹³

Other studies also have reported that use of cryopreserved embryos is associated with a higher rate of preeclampsia than use of fresh autologous embryos. In a study of 825 infertile women undergoing IVF and randomly assigned to single embryo cryopreserved or fresh cycles, the rate of preeclampsia was 3.1% and 1.0% in the pregnancies that resulted from cryopreserved versus fresh cycles.¹⁴ 

What is the optimal dose of aspirin?

ACOG and the USPSTF recommend aspirin 81 mg daily for the prevention of preeclampsia.^2,3 The International Federation of Gynecology and Obstetrics (FIGO) recommends aspirin 150 mg daily for the prevention of preeclampsia.¹⁵ The FIGO recommendation is based, in part, on the results of a large international clinical trial that randomly assigned 1,776 women at high risk for preeclampsia as determined by clinical factors plus biomarker and ultrasound screening to receive aspirin 150 mg daily or placebo daily initiated at 11 to 14 weeks’ gestation and continued until 36 weeks’ gestation.¹⁶ Preeclampsia before 37 weeks’ gestation occurred in 4.3% and 1.6% of women in the placebo and aspirin groups (OR, 0.38; 95% CI, 0.20–0.74; P = .004).¹⁶ FIGO recommends that women at risk for preeclampsia with a body mass <40 kg take aspirin 100 mg daily and women with a body mass ≥40 kg take aspirin at a dose of 150 mg daily. For women who live in a country where aspirin is not available in a pill containing 150 mg, FIGO recommends taking two 81 mg tablets.¹⁵ FIGO recommends initiating aspirin between 11 and 14 weeks and 6 days of gestation and continuing aspirin therapy until 36 weeks of gestation.¹⁵

Aspirin is an inexpensive intervention with many possible benefits

For many nulliparous women and some parous women aspirin treatment initiated early in pregnancy will improve maternal and newborn outcomes, including reducing the risk of preeclampsia, preterm birth, and intrauterine growth restriction.¹ Obstetricians may want to begin to expand the indications for offering aspirin to prevent preeclampsia from those recommended by ACOG and the USPSTF to include nulliparous women with a booking systolic pressure of 120 to 134 mm Hg and women whose pregnancy was the result of an assisted reproduction treatment that used cryopreserved embryos. In addition, obstetricians who currently prescribe 81 mg of aspirin daily might want to consider increasing the prescribed dose to 162 mg of aspirin daily (two 81 mg tablets daily or one-half of a 325 mg tablet). Aspirin costs about less than 5 cents per 81 mg tablet (according to GoodRx website). It is an inexpensive intervention that could benefit many mothers and newborns. ●

Authors of a recent Cochrane review concluded that low-dose aspirin treatment of 1,000 pregnant women at risk of developing preeclampsia resulted in 16 fewer cases of preeclampsia, 16 fewer preterm births, 7 fewer cases of small-for-gestational age newborns, and 5 fewer fetal or neonatal deaths.¹

The American College of Obstetricians and Gynecologists (ACOG) and the US Preventive Services Task Force (USPSTF) recommend treatment with 81 mg of aspirin daily, initiated before 16 weeks of pregnancy to prevent preeclampsia in women with one major risk factor (personal history of preeclampsia, multifetal gestation, chronic hypertension, type 1 or 2 diabetes, renal or autoimmune disease) or at least two moderate risk factors (nulliparity; obesity; mother or sister with preeclampsia; a sociodemographic characteristic such as African American race or low socioeconomic status; age ≥35 years; personal history factors such as prior low birth weight infant, previous adverse pregnancy outcome, or >10-year interpregnancy interval).^2,3 Healthy pregnant women with a previous uncomplicated full-term delivery do not need treatment with low-dose aspirin.^2,3

However, evolving data and expert opinion suggest that expanding the indications for aspirin treatment and increasing the recommended dose of aspirin may be warranted. 

Nulliparity

Nulliparity is the single clinical characteristic that is associated with the greatest number of cases of preeclampsia.⁴ Hence, from a public health perspective, reducing the rate of preeclampsia among nulliparous women is a top priority.

ACOG and USPSTF do not recommend aspirin treatment for all nulliparous women because risk factors help to identify those nulliparous women who benefit from aspirin treatment.

However, a recent cost-effectiveness analysis compared the health care costs and rates of preeclampsia for 4 prevention strategies among all pregnant women in the United States (nulliparous and parous)⁵:

1. no aspirin use
2. use of aspirin based on biomarker and ultrasound measurements
3. use of aspirin based on USPSTF guidelines for identifying women at risk
4. prescription of aspirin to all pregnant women.

Health care costs and rates of preeclampsia were lowest with the universal prescription of aspirin to all pregnant women in the United States. Compared with universal prescription of aspirin, the USPSTF approach, the biomarker-ultrasound approach, and the no aspirin approach were associated with 346, 308, and 762 additional cases of preeclampsia per 100,000 women. In sensitivity analyses, universal aspirin was the optimal strategy under most assumptions.

Another cost effectiveness analysis concluded that among nulliparous pregnant women, universal aspirin treatment was superior to aspirin treatment based on biomarker-ultrasound identification of women at high risk.⁶ 

In a recent clinical trial performed in India, Guatemala, Pakistan, Democratic Republic of Congo, Kenya, and Zambia, 14,361 nulliparous women were randomly assigned to placebo or 81 mg of aspirin daily between 6 and 14 weeks of gestation.⁷ Preterm birth (<37 weeks’ gestation) occurred in 13.1% and 11.6% of women treated with placebo or aspirin (relative risk [RR], 0.89; 95% confidence interval [CI], 0.81 to 0.98, P = .012). Most of the decrease in preterm birth appeared to be due to a decrease in the rate of preeclampsia in the aspirin-treated nulliparous women. The investigators also noted that aspirin treatment of nulliparous women resulted in a statistically significant decrease in perinatal mortality (RR, 0.86) and early preterm delivery, <34 weeks’ gestation (RR, 0.75). 

Universal prescription of low-dose aspirin to nulliparous women in order to prevent preeclampsia and preterm birth may become recognized as an optimal public health strategy. As a step toward universal prescription of aspirin to nulliparous women, an opt-out rather than a screen-in strategy might be considered.⁸

Continue to: Booking systolic blood pressure, 120 to 134 mm Hg...

Booking systolic blood pressure, 120 to 134 mm Hg

All obstetricians recognize that women with chronic hypertension should be treated with low-dose aspirin because they are at high risk for preeclampsia. However, there is evidence that nulliparous women with a booking systolic pressure ≥120 mm Hg might also benefit from low-dose aspirin treatment. In one US trial, 3,135 nulliparous normotensive women (booking blood pressure [BP] <135/85 mm Hg) were randomly assigned to treatment with aspirin (60 mg daily) or placebo initiated between 13 and 26 weeks’ gestation. Preeclampsia occurred in 6.3% and 4.6% of the women treated with placebo or aspirin, respectively (RR, 0.7; 95% CI, 0.6–1.0; P = .05).⁹ A secondary analysis showed that, among 519 nulliparous women with a booking systolic BP from 120 to 134 mm Hg, compared with placebo, low-dose aspirin treatment reduced the rate of preeclampsia from 11.9% to 5.6%.⁹ Aspirin did not reduce the rate of preeclampsia among nulliparous women with a booking systolic BP <120 mm Hg.⁹ A systematic review of risk factors for developing preeclampsia reported that a booking diastolic BP of ≥80 mm Hg was associated with an increased risk of developing preeclampsia (RR, 1.38).¹⁰ 

The American Heart Association (AHA) and the American College of Cardiology (ACC) recently updated the definition of hypertension.¹¹ Normal BP is now defined as a systolic pressure <120 mm Hg and diastolic pressure <80 mm Hg. Elevated BP is a systolic pressure of 120 to 129 mm Hg and diastolic pressure of <80 mm Hg. Stage I hypertension is a systolic BP from 130 to 139 mm Hg or diastolic blood pressure from 80 to 89 mm Hg. Stage II hypertension is a systolic BP of ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg.¹¹ 

A recent study reported that 90% of women at 12 weeks’ gestation have a BP of ≤130 mm Hg systolic and ≤80 mm Hg diastolic, suggesting that the AHA-ACC criteria for stage I hypertension are reasonable.¹² Obstetricians have not yet fully adopted the AHA-ACC criteria for defining stage I hypertension in pregnant women. Future research may demonstrate that a booking systolic BP 
 ≥130 mm Hg or a diastolic BP ≥80 mm Hg are major risk factors for developing preeclampsia and warrant treatment with low-dose aspirin.

Continue to: Pregnancy resulting from fertility therapy...

Pregnancy resulting from fertility therapy

Current ACOG and USPSTF guidelines do not specifically identify pregnancies resulting from assisted reproductive technology as a major or moderate risk factor for preeclampsia.^2,3 In a study comparing 83,582 births resulting from in vitro fertilization (IVF) and 1,382,311 births to fertile women, treatment with autologous cryopreserved embryos (adjusted odds ratio [aOR], 1.30), fresh donor embryos (aOR, 1.92), and cryopreserved donor embryos (aOR, 1.70) significantly increased the risk of preeclampsia.¹³ However, use of fresh autologous embryos did not increase the risk of preeclampsia (aOR, 1.04). These associations persisted after controlling for diabetes, hypertension, body mass index, and cause of infertility.¹³

Other studies also have reported that use of cryopreserved embryos is associated with a higher rate of preeclampsia than use of fresh autologous embryos. In a study of 825 infertile women undergoing IVF and randomly assigned to single embryo cryopreserved or fresh cycles, the rate of preeclampsia was 3.1% and 1.0% in the pregnancies that resulted from cryopreserved versus fresh cycles.¹⁴ 

What is the optimal dose of aspirin?

ACOG and the USPSTF recommend aspirin 81 mg daily for the prevention of preeclampsia.^2,3 The International Federation of Gynecology and Obstetrics (FIGO) recommends aspirin 150 mg daily for the prevention of preeclampsia.¹⁵ The FIGO recommendation is based, in part, on the results of a large international clinical trial that randomly assigned 1,776 women at high risk for preeclampsia as determined by clinical factors plus biomarker and ultrasound screening to receive aspirin 150 mg daily or placebo daily initiated at 11 to 14 weeks’ gestation and continued until 36 weeks’ gestation.¹⁶ Preeclampsia before 37 weeks’ gestation occurred in 4.3% and 1.6% of women in the placebo and aspirin groups (OR, 0.38; 95% CI, 0.20–0.74; P = .004).¹⁶ FIGO recommends that women at risk for preeclampsia with a body mass <40 kg take aspirin 100 mg daily and women with a body mass ≥40 kg take aspirin at a dose of 150 mg daily. For women who live in a country where aspirin is not available in a pill containing 150 mg, FIGO recommends taking two 81 mg tablets.¹⁵ FIGO recommends initiating aspirin between 11 and 14 weeks and 6 days of gestation and continuing aspirin therapy until 36 weeks of gestation.¹⁵

Aspirin is an inexpensive intervention with many possible benefits

For many nulliparous women and some parous women aspirin treatment initiated early in pregnancy will improve maternal and newborn outcomes, including reducing the risk of preeclampsia, preterm birth, and intrauterine growth restriction.¹ Obstetricians may want to begin to expand the indications for offering aspirin to prevent preeclampsia from those recommended by ACOG and the USPSTF to include nulliparous women with a booking systolic pressure of 120 to 134 mm Hg and women whose pregnancy was the result of an assisted reproduction treatment that used cryopreserved embryos. In addition, obstetricians who currently prescribe 81 mg of aspirin daily might want to consider increasing the prescribed dose to 162 mg of aspirin daily (two 81 mg tablets daily or one-half of a 325 mg tablet). Aspirin costs about less than 5 cents per 81 mg tablet (according to GoodRx website). It is an inexpensive intervention that could benefit many mothers and newborns. ●

I think it’s fair to say, none of us have seen anything like this before. Yet here we are, and we must lead. We are many weeks into the COVID-19 crisis. We moved our offices home and tried not to miss a beat. Our patients need us more than ever – and in different ways.

Lest we become like the shoemaker’s daughter who has no shoes, let’s make sure we take care of ourselves. The shock waves from this pandemic are going to be massive and long lasting. I am already witnessing massive psychological growth on the part of my patients, and I hope, myself and my family. We must be strong as individuals and as a group of professionals.

Now more than ever, we need to set boundaries. So many are suffering. We must take stock of our own lives. Many of us are extremely fortunate. We have homes, families, and plenty of food. We are doctors performing essential services, and we can do so without risking our lives.

The priority is to make sure you are safe, and keeping your family and loved ones safe. As physicians, we have learned to distance ourselves from illness, but the coronavirus has affected us in disproportionate numbers. As a group, we must be risk averse as we will be called upon to heal a very traumatized nation.

To be physically and mentally strong, we must get enough sleep. This is exhausting for some and energizing for others. It is definitely a marathon not a sprint, so pace yourself. Eat well. This is no time for empty calories, and that goes for alcohol as well.

Create new routines. Exercise at the same time each day or perhaps twice a day. Try to be productive during certain hours, and relax at other times. Eat at similar times each day. We must strive to quickly create a “new normal” as we spend our days at home.

Find safe alternatives to your usual workout routine. Use YouTube and Instagram to help you find ways to stay fit in your own home. Ask friends for tips and consider sharing workout time with them via Zoom or FaceTime. New options are coming on line daily.

Make sure you are getting enough information to stay safe, and follow the advice of experts. Then turn off the news. I offer the same advice for financial worries. Try not to stress too much about finances right now. Most of us are feeling the pain of lost income and lost savings. Many of us have spouses or partners who suddenly found themselves out of work. Most likely, we will have ample ability to recover financially as we move forward and find ourselves with more work than ever.

Meditate. This may be advice you have been telling your patients for years but never found the time to try yourself. You can begin very simply with an app called Headspace or Calm. Google “5-minute meditation” on YouTube or find a meditation of any length you desire. If not now, when?

Reach out to one another. We can all use a caring word, or some humor or advice about how to move our practices online.

You may find your concentration is decreased, so be realistic in your expectations of yourself. I am finding shorter sessions more often are providing more comfort to some patients. Other patients are digging deeper than ever emotionally, and the work is becoming more rewarding.

Make sure you take a break to engage in positive activities. Read a book. Listen to soft music. Dim the lights. Watch the sunset, or be in nature if you can do so safely. Watch a TedTalk. Brush up on a foreign language. Take a deep breath. Journal. Puzzles, games, cooking, magazines, and humor all provide much needed respite from the stress. If you are lucky enough to be with family, try to take advantage of this unique time.

Try to avoid or minimize conflict with others. We need one another now more than ever. If you lose your cool, forgive yourself and make amends.

Even in these most challenging times, we must focus on what we are grateful for. Express gratitude to those around you as it will lift their mood as well. I know I am extremely grateful to be able to continue meaningful work when so many are unable to do so.

The next waves of this virus will be hitting our specialty directly so be strong and be prepared. It is an honor to serve, and we must rise to the occasion.
 

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach, Fla. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018), and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.

I think it’s fair to say, none of us have seen anything like this before. Yet here we are, and we must lead. We are many weeks into the COVID-19 crisis. We moved our offices home and tried not to miss a beat. Our patients need us more than ever – and in different ways.

Lest we become like the shoemaker’s daughter who has no shoes, let’s make sure we take care of ourselves. The shock waves from this pandemic are going to be massive and long lasting. I am already witnessing massive psychological growth on the part of my patients, and I hope, myself and my family. We must be strong as individuals and as a group of professionals.

Now more than ever, we need to set boundaries. So many are suffering. We must take stock of our own lives. Many of us are extremely fortunate. We have homes, families, and plenty of food. We are doctors performing essential services, and we can do so without risking our lives.

The priority is to make sure you are safe, and keeping your family and loved ones safe. As physicians, we have learned to distance ourselves from illness, but the coronavirus has affected us in disproportionate numbers. As a group, we must be risk averse as we will be called upon to heal a very traumatized nation.

To be physically and mentally strong, we must get enough sleep. This is exhausting for some and energizing for others. It is definitely a marathon not a sprint, so pace yourself. Eat well. This is no time for empty calories, and that goes for alcohol as well.

Create new routines. Exercise at the same time each day or perhaps twice a day. Try to be productive during certain hours, and relax at other times. Eat at similar times each day. We must strive to quickly create a “new normal” as we spend our days at home.

Find safe alternatives to your usual workout routine. Use YouTube and Instagram to help you find ways to stay fit in your own home. Ask friends for tips and consider sharing workout time with them via Zoom or FaceTime. New options are coming on line daily.

Make sure you are getting enough information to stay safe, and follow the advice of experts. Then turn off the news. I offer the same advice for financial worries. Try not to stress too much about finances right now. Most of us are feeling the pain of lost income and lost savings. Many of us have spouses or partners who suddenly found themselves out of work. Most likely, we will have ample ability to recover financially as we move forward and find ourselves with more work than ever.

Meditate. This may be advice you have been telling your patients for years but never found the time to try yourself. You can begin very simply with an app called Headspace or Calm. Google “5-minute meditation” on YouTube or find a meditation of any length you desire. If not now, when?

Reach out to one another. We can all use a caring word, or some humor or advice about how to move our practices online.

You may find your concentration is decreased, so be realistic in your expectations of yourself. I am finding shorter sessions more often are providing more comfort to some patients. Other patients are digging deeper than ever emotionally, and the work is becoming more rewarding.

Make sure you take a break to engage in positive activities. Read a book. Listen to soft music. Dim the lights. Watch the sunset, or be in nature if you can do so safely. Watch a TedTalk. Brush up on a foreign language. Take a deep breath. Journal. Puzzles, games, cooking, magazines, and humor all provide much needed respite from the stress. If you are lucky enough to be with family, try to take advantage of this unique time.

Try to avoid or minimize conflict with others. We need one another now more than ever. If you lose your cool, forgive yourself and make amends.

Even in these most challenging times, we must focus on what we are grateful for. Express gratitude to those around you as it will lift their mood as well. I know I am extremely grateful to be able to continue meaningful work when so many are unable to do so.

The next waves of this virus will be hitting our specialty directly so be strong and be prepared. It is an honor to serve, and we must rise to the occasion.
 

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach, Fla. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018), and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.

I think it’s fair to say, none of us have seen anything like this before. Yet here we are, and we must lead. We are many weeks into the COVID-19 crisis. We moved our offices home and tried not to miss a beat. Our patients need us more than ever – and in different ways.

Lest we become like the shoemaker’s daughter who has no shoes, let’s make sure we take care of ourselves. The shock waves from this pandemic are going to be massive and long lasting. I am already witnessing massive psychological growth on the part of my patients, and I hope, myself and my family. We must be strong as individuals and as a group of professionals.

Now more than ever, we need to set boundaries. So many are suffering. We must take stock of our own lives. Many of us are extremely fortunate. We have homes, families, and plenty of food. We are doctors performing essential services, and we can do so without risking our lives.

The priority is to make sure you are safe, and keeping your family and loved ones safe. As physicians, we have learned to distance ourselves from illness, but the coronavirus has affected us in disproportionate numbers. As a group, we must be risk averse as we will be called upon to heal a very traumatized nation.

To be physically and mentally strong, we must get enough sleep. This is exhausting for some and energizing for others. It is definitely a marathon not a sprint, so pace yourself. Eat well. This is no time for empty calories, and that goes for alcohol as well.

Create new routines. Exercise at the same time each day or perhaps twice a day. Try to be productive during certain hours, and relax at other times. Eat at similar times each day. We must strive to quickly create a “new normal” as we spend our days at home.

Find safe alternatives to your usual workout routine. Use YouTube and Instagram to help you find ways to stay fit in your own home. Ask friends for tips and consider sharing workout time with them via Zoom or FaceTime. New options are coming on line daily.

Make sure you are getting enough information to stay safe, and follow the advice of experts. Then turn off the news. I offer the same advice for financial worries. Try not to stress too much about finances right now. Most of us are feeling the pain of lost income and lost savings. Many of us have spouses or partners who suddenly found themselves out of work. Most likely, we will have ample ability to recover financially as we move forward and find ourselves with more work than ever.

Meditate. This may be advice you have been telling your patients for years but never found the time to try yourself. You can begin very simply with an app called Headspace or Calm. Google “5-minute meditation” on YouTube or find a meditation of any length you desire. If not now, when?

Reach out to one another. We can all use a caring word, or some humor or advice about how to move our practices online.

You may find your concentration is decreased, so be realistic in your expectations of yourself. I am finding shorter sessions more often are providing more comfort to some patients. Other patients are digging deeper than ever emotionally, and the work is becoming more rewarding.

Make sure you take a break to engage in positive activities. Read a book. Listen to soft music. Dim the lights. Watch the sunset, or be in nature if you can do so safely. Watch a TedTalk. Brush up on a foreign language. Take a deep breath. Journal. Puzzles, games, cooking, magazines, and humor all provide much needed respite from the stress. If you are lucky enough to be with family, try to take advantage of this unique time.

Try to avoid or minimize conflict with others. We need one another now more than ever. If you lose your cool, forgive yourself and make amends.

Even in these most challenging times, we must focus on what we are grateful for. Express gratitude to those around you as it will lift their mood as well. I know I am extremely grateful to be able to continue meaningful work when so many are unable to do so.

The next waves of this virus will be hitting our specialty directly so be strong and be prepared. It is an honor to serve, and we must rise to the occasion.
 

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach, Fla. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018), and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.

The president of the American Medical Association is calling on politicians and the media to rely on science and evidence to help the public through the COVID-19 pandemic.

“We live in a time when misinformation, falsehoods, and outright lies spread like viruses online, through social media and even, at times, in the media at large,” Patrice A. Harris, MD, said during an April 7 address. “We have witnessed a concerning shift over the last several decades where policy decisions seem to be driven by ideology and politics instead of facts and evidence. The result is a growing mistrust in American institutions, in science, and in the counsel of leading experts whose lives are dedicated to the pursuit of evidence and reason.”

To that end, she called on everyone – from politicians to the general public – to trust the scientific evidence.

Dr. Harris noted that the scientific data on COVID-19 have already yielded important lessons about who is more likely to be affected and how easily the virus can spread. The data also point to the effectiveness of stay-at-home and shelter-in-place orders. “This is our best chance to slow the spread of the virus,” she said, adding that the enhanced emphasis on hand washing and other hygiene practices “may seem ‘simplistic,’ but they are, in fact, based in science and evidence.”

And, as the pandemic continues, Dr. Harris said that now is the time to rely on science. She said the AMA “calls on all elected officials to affirm science, evidence, and fact in their words and actions,” and she urged that the government’s scientific institutions be led by experts who are “protected from political influence.”

It is incumbent upon everyone to actively work to contain and stop the spread of misinformation related to COVID-19, she said. “We must ensure the war is against the virus and not against science,” Dr. Harris said.

[email protected]

The president of the American Medical Association is calling on politicians and the media to rely on science and evidence to help the public through the COVID-19 pandemic.

“We live in a time when misinformation, falsehoods, and outright lies spread like viruses online, through social media and even, at times, in the media at large,” Patrice A. Harris, MD, said during an April 7 address. “We have witnessed a concerning shift over the last several decades where policy decisions seem to be driven by ideology and politics instead of facts and evidence. The result is a growing mistrust in American institutions, in science, and in the counsel of leading experts whose lives are dedicated to the pursuit of evidence and reason.”

To that end, she called on everyone – from politicians to the general public – to trust the scientific evidence.

Dr. Harris noted that the scientific data on COVID-19 have already yielded important lessons about who is more likely to be affected and how easily the virus can spread. The data also point to the effectiveness of stay-at-home and shelter-in-place orders. “This is our best chance to slow the spread of the virus,” she said, adding that the enhanced emphasis on hand washing and other hygiene practices “may seem ‘simplistic,’ but they are, in fact, based in science and evidence.”

And, as the pandemic continues, Dr. Harris said that now is the time to rely on science. She said the AMA “calls on all elected officials to affirm science, evidence, and fact in their words and actions,” and she urged that the government’s scientific institutions be led by experts who are “protected from political influence.”

It is incumbent upon everyone to actively work to contain and stop the spread of misinformation related to COVID-19, she said. “We must ensure the war is against the virus and not against science,” Dr. Harris said.

[email protected]

The president of the American Medical Association is calling on politicians and the media to rely on science and evidence to help the public through the COVID-19 pandemic.

“We live in a time when misinformation, falsehoods, and outright lies spread like viruses online, through social media and even, at times, in the media at large,” Patrice A. Harris, MD, said during an April 7 address. “We have witnessed a concerning shift over the last several decades where policy decisions seem to be driven by ideology and politics instead of facts and evidence. The result is a growing mistrust in American institutions, in science, and in the counsel of leading experts whose lives are dedicated to the pursuit of evidence and reason.”

To that end, she called on everyone – from politicians to the general public – to trust the scientific evidence.

Dr. Harris noted that the scientific data on COVID-19 have already yielded important lessons about who is more likely to be affected and how easily the virus can spread. The data also point to the effectiveness of stay-at-home and shelter-in-place orders. “This is our best chance to slow the spread of the virus,” she said, adding that the enhanced emphasis on hand washing and other hygiene practices “may seem ‘simplistic,’ but they are, in fact, based in science and evidence.”

And, as the pandemic continues, Dr. Harris said that now is the time to rely on science. She said the AMA “calls on all elected officials to affirm science, evidence, and fact in their words and actions,” and she urged that the government’s scientific institutions be led by experts who are “protected from political influence.”

It is incumbent upon everyone to actively work to contain and stop the spread of misinformation related to COVID-19, she said. “We must ensure the war is against the virus and not against science,” Dr. Harris said.

[email protected]

To the early trainee, often the goal of performing a colonoscopy is to reach the cecum using whatever technique necessary. Although the recommended amount of colonoscopies for safe independent practice is 140 (with some sources stating more than 500), this only relates to the safety of the patient.¹ We receive scant education on how to form good procedural habits to preserve our own safety and efficiency over the course of our career. Here are some tips on how to prevent injury:

Maintain an appropriate stance. The optimal stance during endoscopy is an athletic stance: chest out, shoulders back to facilitate ease of neck movements, and a slight bend in the knees to facilitate good blood return and distribute weight. Feet should be hip width apart with toes pointed at the endoscopy screen to allow for easy pivoting of the hips and torque of upper body if needed. Ideally, this stance is complemented by the use of proper footwear and a cushioned mat to facilitate weight distribution while standing. An athletic stance facilitates a fluidity for movements from head to toe and an ability to use larger muscles groups to accomplish fine movements.

Handle the endoscope properly. Preserve energy by understanding your equipment and how to manipulate it. Orienting the endoscope directly in front of the endoscopist for upper endoscopy, and at a 45-degree angle for colonoscopy, places the instrument at optimal location to complete the procedure.⁵ Reviewing how to perform common techniques such as retroflexion, scope reduction, and instrumentation can also facilitate improved ergonomics and adjustment of incorrect techniques at an early stage of endoscopic training. An area of particular concern for most early trainees is the amount of rotational force placed on the right wrist with administration of torque to the endoscope. This is a foreign movement for most endoscopists and requires use of smaller muscle groups of the forearms. We suggest attempting torque with internal and external rotation of the left shoulder to utilize larger muscle groups. We can also combat fatigue during the procedure with the use of microrests intermittently to reduce prolonged muscle contraction. A common way to utilize microrests is by pinning the scope to the patient’s bed with the endoscopist’s hip to provide stability of endoscope and allow removal and relaxation of the right hand. This can be done periodically throughout the procedure to provide the ability to regroup mentally and physically.

Seek feedback. Because it is difficult to focus on ergonomics while performing a diagnostic procedure, utilize your team of observers to facilitate proper form during procedure. This includes your attending gastroenterologists, nurses, and technicians who can observe posture and technique to help detect incorrect positioning early and make corrections. A common practice is to discuss areas of desired improvement before procedures to facilitate a more vigilant observation of areas for improvement.

Assess and adjust often. As early trainees, these endoscopists perform all endoscopies under the direct supervision and often with significant assistance from a supervising gastroenterologist. This can lead to a sharp differential in psychological size; it can be hard to adjust a room to your needs when you have an intimidating and demanding attending physician who has different needs. Despite this disparity, we strongly encourage all trainees to be vigilant about adjusting the room (monitors and beds) to their own needs rather than their attendings’. A great way to head off potential conflict is to discuss the ergonomic positioning of the room before you start endoscopy with your attending, nurse, and technicians so that everyone is in agreement.
 

Conclusion

We offer this article as a guide for the novice endoscopist to make small changes early to prevent injuries later. Reaching competency with our skills is difficult, and we hope it can be achieved safely with our health in mind.

Dr. Magee, first-year fellow, NCC Gastroenterology; Dr. Singla, associate program director, NCC Gastroenterology, and gastroenterology service, department of internal medicine, Walter Reed National Military Medical Center, Bethesda, Md.

References

1. Spier B et al. Colonoscopy training in gastroenterology fellowships: determining competence. Gastrointest Endosc. 2010 Feb;71(2):319-24G.

2. Malmström EM et al. A slouched body posture decreases arm mobility and changes muscle recruitment in the neck and shoulder region. Eur J Appl Physiol. 2015;115(12):2491-503.

3. Singla M et al. Training the endo-athlete: an update in ergonomics in endoscopy. Clin Gastroenterol Hepatol. 2018 Jul;16(7):1003-6.

4. Bexander CS, et al. Effect of gaze direction on neck muscle activity during cervical rotation. Exp Brain Res. 2005 Dec;167(3):422-32.

5. Soetikno R et al. Holding and manipulating the endoscope: A user’s guide. Techn Gastrointest Endosc. 2019;21:124-32.

To the early trainee, often the goal of performing a colonoscopy is to reach the cecum using whatever technique necessary. Although the recommended amount of colonoscopies for safe independent practice is 140 (with some sources stating more than 500), this only relates to the safety of the patient.¹ We receive scant education on how to form good procedural habits to preserve our own safety and efficiency over the course of our career. Here are some tips on how to prevent injury:

Maintain an appropriate stance. The optimal stance during endoscopy is an athletic stance: chest out, shoulders back to facilitate ease of neck movements, and a slight bend in the knees to facilitate good blood return and distribute weight. Feet should be hip width apart with toes pointed at the endoscopy screen to allow for easy pivoting of the hips and torque of upper body if needed. Ideally, this stance is complemented by the use of proper footwear and a cushioned mat to facilitate weight distribution while standing. An athletic stance facilitates a fluidity for movements from head to toe and an ability to use larger muscles groups to accomplish fine movements.

Handle the endoscope properly. Preserve energy by understanding your equipment and how to manipulate it. Orienting the endoscope directly in front of the endoscopist for upper endoscopy, and at a 45-degree angle for colonoscopy, places the instrument at optimal location to complete the procedure.⁵ Reviewing how to perform common techniques such as retroflexion, scope reduction, and instrumentation can also facilitate improved ergonomics and adjustment of incorrect techniques at an early stage of endoscopic training. An area of particular concern for most early trainees is the amount of rotational force placed on the right wrist with administration of torque to the endoscope. This is a foreign movement for most endoscopists and requires use of smaller muscle groups of the forearms. We suggest attempting torque with internal and external rotation of the left shoulder to utilize larger muscle groups. We can also combat fatigue during the procedure with the use of microrests intermittently to reduce prolonged muscle contraction. A common way to utilize microrests is by pinning the scope to the patient’s bed with the endoscopist’s hip to provide stability of endoscope and allow removal and relaxation of the right hand. This can be done periodically throughout the procedure to provide the ability to regroup mentally and physically.

Seek feedback. Because it is difficult to focus on ergonomics while performing a diagnostic procedure, utilize your team of observers to facilitate proper form during procedure. This includes your attending gastroenterologists, nurses, and technicians who can observe posture and technique to help detect incorrect positioning early and make corrections. A common practice is to discuss areas of desired improvement before procedures to facilitate a more vigilant observation of areas for improvement.

Assess and adjust often. As early trainees, these endoscopists perform all endoscopies under the direct supervision and often with significant assistance from a supervising gastroenterologist. This can lead to a sharp differential in psychological size; it can be hard to adjust a room to your needs when you have an intimidating and demanding attending physician who has different needs. Despite this disparity, we strongly encourage all trainees to be vigilant about adjusting the room (monitors and beds) to their own needs rather than their attendings’. A great way to head off potential conflict is to discuss the ergonomic positioning of the room before you start endoscopy with your attending, nurse, and technicians so that everyone is in agreement.
 

Conclusion

We offer this article as a guide for the novice endoscopist to make small changes early to prevent injuries later. Reaching competency with our skills is difficult, and we hope it can be achieved safely with our health in mind.

Dr. Magee, first-year fellow, NCC Gastroenterology; Dr. Singla, associate program director, NCC Gastroenterology, and gastroenterology service, department of internal medicine, Walter Reed National Military Medical Center, Bethesda, Md.

References

1. Spier B et al. Colonoscopy training in gastroenterology fellowships: determining competence. Gastrointest Endosc. 2010 Feb;71(2):319-24G.

2. Malmström EM et al. A slouched body posture decreases arm mobility and changes muscle recruitment in the neck and shoulder region. Eur J Appl Physiol. 2015;115(12):2491-503.

3. Singla M et al. Training the endo-athlete: an update in ergonomics in endoscopy. Clin Gastroenterol Hepatol. 2018 Jul;16(7):1003-6.

4. Bexander CS, et al. Effect of gaze direction on neck muscle activity during cervical rotation. Exp Brain Res. 2005 Dec;167(3):422-32.

5. Soetikno R et al. Holding and manipulating the endoscope: A user’s guide. Techn Gastrointest Endosc. 2019;21:124-32.

To the early trainee, often the goal of performing a colonoscopy is to reach the cecum using whatever technique necessary. Although the recommended amount of colonoscopies for safe independent practice is 140 (with some sources stating more than 500), this only relates to the safety of the patient.¹ We receive scant education on how to form good procedural habits to preserve our own safety and efficiency over the course of our career. Here are some tips on how to prevent injury:

Maintain an appropriate stance. The optimal stance during endoscopy is an athletic stance: chest out, shoulders back to facilitate ease of neck movements, and a slight bend in the knees to facilitate good blood return and distribute weight. Feet should be hip width apart with toes pointed at the endoscopy screen to allow for easy pivoting of the hips and torque of upper body if needed. Ideally, this stance is complemented by the use of proper footwear and a cushioned mat to facilitate weight distribution while standing. An athletic stance facilitates a fluidity for movements from head to toe and an ability to use larger muscles groups to accomplish fine movements.

Handle the endoscope properly. Preserve energy by understanding your equipment and how to manipulate it. Orienting the endoscope directly in front of the endoscopist for upper endoscopy, and at a 45-degree angle for colonoscopy, places the instrument at optimal location to complete the procedure.⁵ Reviewing how to perform common techniques such as retroflexion, scope reduction, and instrumentation can also facilitate improved ergonomics and adjustment of incorrect techniques at an early stage of endoscopic training. An area of particular concern for most early trainees is the amount of rotational force placed on the right wrist with administration of torque to the endoscope. This is a foreign movement for most endoscopists and requires use of smaller muscle groups of the forearms. We suggest attempting torque with internal and external rotation of the left shoulder to utilize larger muscle groups. We can also combat fatigue during the procedure with the use of microrests intermittently to reduce prolonged muscle contraction. A common way to utilize microrests is by pinning the scope to the patient’s bed with the endoscopist’s hip to provide stability of endoscope and allow removal and relaxation of the right hand. This can be done periodically throughout the procedure to provide the ability to regroup mentally and physically.

Seek feedback. Because it is difficult to focus on ergonomics while performing a diagnostic procedure, utilize your team of observers to facilitate proper form during procedure. This includes your attending gastroenterologists, nurses, and technicians who can observe posture and technique to help detect incorrect positioning early and make corrections. A common practice is to discuss areas of desired improvement before procedures to facilitate a more vigilant observation of areas for improvement.

Assess and adjust often. As early trainees, these endoscopists perform all endoscopies under the direct supervision and often with significant assistance from a supervising gastroenterologist. This can lead to a sharp differential in psychological size; it can be hard to adjust a room to your needs when you have an intimidating and demanding attending physician who has different needs. Despite this disparity, we strongly encourage all trainees to be vigilant about adjusting the room (monitors and beds) to their own needs rather than their attendings’. A great way to head off potential conflict is to discuss the ergonomic positioning of the room before you start endoscopy with your attending, nurse, and technicians so that everyone is in agreement.
 

Conclusion

We offer this article as a guide for the novice endoscopist to make small changes early to prevent injuries later. Reaching competency with our skills is difficult, and we hope it can be achieved safely with our health in mind.

Dr. Magee, first-year fellow, NCC Gastroenterology; Dr. Singla, associate program director, NCC Gastroenterology, and gastroenterology service, department of internal medicine, Walter Reed National Military Medical Center, Bethesda, Md.

References

1. Spier B et al. Colonoscopy training in gastroenterology fellowships: determining competence. Gastrointest Endosc. 2010 Feb;71(2):319-24G.

2. Malmström EM et al. A slouched body posture decreases arm mobility and changes muscle recruitment in the neck and shoulder region. Eur J Appl Physiol. 2015;115(12):2491-503.

3. Singla M et al. Training the endo-athlete: an update in ergonomics in endoscopy. Clin Gastroenterol Hepatol. 2018 Jul;16(7):1003-6.

4. Bexander CS, et al. Effect of gaze direction on neck muscle activity during cervical rotation. Exp Brain Res. 2005 Dec;167(3):422-32.

5. Soetikno R et al. Holding and manipulating the endoscope: A user’s guide. Techn Gastrointest Endosc. 2019;21:124-32.

Synbiotics can alter gut microbiota in patients with nonalcoholic fatty liver disease (NAFLD), but associated liver benefits remain unseen, according to a recent phase II study.

NAFLD patients who received a year-long regimen of fructo-oligosaccharides and Bifidobacterium animalis had no significant changes in liver fat content or fibrosis, compared with those who received placebo, reported lead author Eleonora Scorletti, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

“There is recent growing interest in the role of gut microbiota in NAFLD pathogenesis, and there are several metaorganismal pathways linking altered gut microbiota ... and NAFLD,” the investigators wrote in Gastroenterology.According to the investigators, previous studies have shown that patients with NAFLD may have some characteristic alterations to their microbiota, such as increased Gram-negative bacteria or more abundant Ruminococcus species, the latter of which were associated with worse fibrosis.

“However, there is currently a lack of consistency in these findings due to the marked variance in the population studied, with differing ages, diets, and geographic locations,” the investigators wrote. “Nonetheless, despite these inconsistencies, there is the possibility that manipulation of the gut microbiota to a more favorable profile could provide a beneficial effect on liver disease in patients with NAFLD.”

To evaluate this possibility, the investigators enrolled 104 patients with NAFLD in the United Kingdom. Patients were randomly divided into a placebo (n = 49) and synbiotic group (n = 55), with the latter receiving 4 grams of fructo-oligosaccharides twice per day plus 10 billion colony-forming units of Bifidobacterium animalis subspecies lactis BB-12 on a daily basis. Treatments were given for 10-14 months.

Diagnostics were conducted across all participants at the beginning and end of the study. These included fecal microbiota analysis by 16s ribosomal DNA sequencing, liver fat measurement by proton magnetic resonance spectroscopy, biomarker-based liver fibrosis scoring, and liver stiffness assessment by vibration-controlled transient elastography.

At the end of the study, patients in the synbiotic group had increased abundance of Bifidobacterium and Faecalibacterium species and reduced proportions of Oscillibacter and Alistipes species, compared with baseline. These changes were not observed in the placebo group.

But changes in microbiota had no apparent impact on liver pathology. Although mean liver fat percentages dropped from 32.3% to 28.5% in the synbiotic group (approximately 4%), they also dropped in the placebo group, from 31.3% to 25.2% (approximately 6%), with differences between groups lacking statistical significance. Using multivariate analysis, the investigators linked these liver fat improvements, which occurred in 65% of participants, with weight loss.

“The fact that most patients had an improvement in ... liver fat, regardless of treatment allocation, is consistent with the so-called clinical trial effect, whereby participants benefit from participating in clinical trials,” the investigators wrote.

Similarly to liver fat content, no significant intergroup differences were found for liver fibrosis or stiffness, whereas, again, weight loss was linked with improvements in both disease parameters.

“Our randomized clinical trial suggests that changing the gut microbiota with this synbiotic may occur without clinically significant effects on the liver in NAFLD,” the investigators concluded.

Still, they noted that the failure of one synbiotic regimen does not discount the possibility of microbiota-based NAFLD interventions as a whole.

“Previous studies that have tested the effects of synbiotic treatment in NAFLD have also used a combination of multiple strains of probiotics as a component of the synbiotic treatment,” the investigators wrote. “Therefore, it might be possible that, because the intestine harbors trillions of bacteria, adding 1 single type of bacterium in a synbiotic may not be as effective as adding 3 or 6 different types of bacteria with the potential to influence many more bacterial species.”

The study was supported by the National Institute of Health Research, the Parnell Diabetes Trust, and Chr. Hansen Holding. One author reported funding from Chr. Hansen unrelated to this trial.

SOURCE: Scorletti E et al. Gastro. 2020 Jan 24. doi: 10.1053/j.gastro.2020.01.031.

Synbiotics can alter gut microbiota in patients with nonalcoholic fatty liver disease (NAFLD), but associated liver benefits remain unseen, according to a recent phase II study.

NAFLD patients who received a year-long regimen of fructo-oligosaccharides and Bifidobacterium animalis had no significant changes in liver fat content or fibrosis, compared with those who received placebo, reported lead author Eleonora Scorletti, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

“There is recent growing interest in the role of gut microbiota in NAFLD pathogenesis, and there are several metaorganismal pathways linking altered gut microbiota ... and NAFLD,” the investigators wrote in Gastroenterology.According to the investigators, previous studies have shown that patients with NAFLD may have some characteristic alterations to their microbiota, such as increased Gram-negative bacteria or more abundant Ruminococcus species, the latter of which were associated with worse fibrosis.

“However, there is currently a lack of consistency in these findings due to the marked variance in the population studied, with differing ages, diets, and geographic locations,” the investigators wrote. “Nonetheless, despite these inconsistencies, there is the possibility that manipulation of the gut microbiota to a more favorable profile could provide a beneficial effect on liver disease in patients with NAFLD.”

To evaluate this possibility, the investigators enrolled 104 patients with NAFLD in the United Kingdom. Patients were randomly divided into a placebo (n = 49) and synbiotic group (n = 55), with the latter receiving 4 grams of fructo-oligosaccharides twice per day plus 10 billion colony-forming units of Bifidobacterium animalis subspecies lactis BB-12 on a daily basis. Treatments were given for 10-14 months.

Diagnostics were conducted across all participants at the beginning and end of the study. These included fecal microbiota analysis by 16s ribosomal DNA sequencing, liver fat measurement by proton magnetic resonance spectroscopy, biomarker-based liver fibrosis scoring, and liver stiffness assessment by vibration-controlled transient elastography.

At the end of the study, patients in the synbiotic group had increased abundance of Bifidobacterium and Faecalibacterium species and reduced proportions of Oscillibacter and Alistipes species, compared with baseline. These changes were not observed in the placebo group.

But changes in microbiota had no apparent impact on liver pathology. Although mean liver fat percentages dropped from 32.3% to 28.5% in the synbiotic group (approximately 4%), they also dropped in the placebo group, from 31.3% to 25.2% (approximately 6%), with differences between groups lacking statistical significance. Using multivariate analysis, the investigators linked these liver fat improvements, which occurred in 65% of participants, with weight loss.

“The fact that most patients had an improvement in ... liver fat, regardless of treatment allocation, is consistent with the so-called clinical trial effect, whereby participants benefit from participating in clinical trials,” the investigators wrote.

Similarly to liver fat content, no significant intergroup differences were found for liver fibrosis or stiffness, whereas, again, weight loss was linked with improvements in both disease parameters.

“Our randomized clinical trial suggests that changing the gut microbiota with this synbiotic may occur without clinically significant effects on the liver in NAFLD,” the investigators concluded.

Still, they noted that the failure of one synbiotic regimen does not discount the possibility of microbiota-based NAFLD interventions as a whole.

“Previous studies that have tested the effects of synbiotic treatment in NAFLD have also used a combination of multiple strains of probiotics as a component of the synbiotic treatment,” the investigators wrote. “Therefore, it might be possible that, because the intestine harbors trillions of bacteria, adding 1 single type of bacterium in a synbiotic may not be as effective as adding 3 or 6 different types of bacteria with the potential to influence many more bacterial species.”

The study was supported by the National Institute of Health Research, the Parnell Diabetes Trust, and Chr. Hansen Holding. One author reported funding from Chr. Hansen unrelated to this trial.

SOURCE: Scorletti E et al. Gastro. 2020 Jan 24. doi: 10.1053/j.gastro.2020.01.031.

Synbiotics can alter gut microbiota in patients with nonalcoholic fatty liver disease (NAFLD), but associated liver benefits remain unseen, according to a recent phase II study.

NAFLD patients who received a year-long regimen of fructo-oligosaccharides and Bifidobacterium animalis had no significant changes in liver fat content or fibrosis, compared with those who received placebo, reported lead author Eleonora Scorletti, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

“There is recent growing interest in the role of gut microbiota in NAFLD pathogenesis, and there are several metaorganismal pathways linking altered gut microbiota ... and NAFLD,” the investigators wrote in Gastroenterology.According to the investigators, previous studies have shown that patients with NAFLD may have some characteristic alterations to their microbiota, such as increased Gram-negative bacteria or more abundant Ruminococcus species, the latter of which were associated with worse fibrosis.

“However, there is currently a lack of consistency in these findings due to the marked variance in the population studied, with differing ages, diets, and geographic locations,” the investigators wrote. “Nonetheless, despite these inconsistencies, there is the possibility that manipulation of the gut microbiota to a more favorable profile could provide a beneficial effect on liver disease in patients with NAFLD.”

To evaluate this possibility, the investigators enrolled 104 patients with NAFLD in the United Kingdom. Patients were randomly divided into a placebo (n = 49) and synbiotic group (n = 55), with the latter receiving 4 grams of fructo-oligosaccharides twice per day plus 10 billion colony-forming units of Bifidobacterium animalis subspecies lactis BB-12 on a daily basis. Treatments were given for 10-14 months.

Diagnostics were conducted across all participants at the beginning and end of the study. These included fecal microbiota analysis by 16s ribosomal DNA sequencing, liver fat measurement by proton magnetic resonance spectroscopy, biomarker-based liver fibrosis scoring, and liver stiffness assessment by vibration-controlled transient elastography.

At the end of the study, patients in the synbiotic group had increased abundance of Bifidobacterium and Faecalibacterium species and reduced proportions of Oscillibacter and Alistipes species, compared with baseline. These changes were not observed in the placebo group.

But changes in microbiota had no apparent impact on liver pathology. Although mean liver fat percentages dropped from 32.3% to 28.5% in the synbiotic group (approximately 4%), they also dropped in the placebo group, from 31.3% to 25.2% (approximately 6%), with differences between groups lacking statistical significance. Using multivariate analysis, the investigators linked these liver fat improvements, which occurred in 65% of participants, with weight loss.

“The fact that most patients had an improvement in ... liver fat, regardless of treatment allocation, is consistent with the so-called clinical trial effect, whereby participants benefit from participating in clinical trials,” the investigators wrote.

Similarly to liver fat content, no significant intergroup differences were found for liver fibrosis or stiffness, whereas, again, weight loss was linked with improvements in both disease parameters.

“Our randomized clinical trial suggests that changing the gut microbiota with this synbiotic may occur without clinically significant effects on the liver in NAFLD,” the investigators concluded.

Still, they noted that the failure of one synbiotic regimen does not discount the possibility of microbiota-based NAFLD interventions as a whole.

“Previous studies that have tested the effects of synbiotic treatment in NAFLD have also used a combination of multiple strains of probiotics as a component of the synbiotic treatment,” the investigators wrote. “Therefore, it might be possible that, because the intestine harbors trillions of bacteria, adding 1 single type of bacterium in a synbiotic may not be as effective as adding 3 or 6 different types of bacteria with the potential to influence many more bacterial species.”

The study was supported by the National Institute of Health Research, the Parnell Diabetes Trust, and Chr. Hansen Holding. One author reported funding from Chr. Hansen unrelated to this trial.

SOURCE: Scorletti E et al. Gastro. 2020 Jan 24. doi: 10.1053/j.gastro.2020.01.031.