Key clinical point: Higher perceived distress was associated with elevated risk of developing inflammatory arthritis (IA) in an at-risk population having either positive rheumatoid arthritis (RA)-related autoantibodies or inherent genetic risk based on family history.

Major finding: A 1-point increase in the perceived distress score was significantly associated with a 10% increase in the risk of incident IA (adjusted hazard ratio [aHR], 1.10; 95% confidence interval [CI], 1.02-1.19). Total perceived stress (aHR, 1.05; 95% CI, 0.99-1.10) and self-efficacy (aHR, 1.04; 95% CI, 0.91-1.18) scores were not significantly associated with the risk of incident IA.

Study details: This prospective cohort study evaluated 448 participants at an increased risk of developing future RA (either first-degree relatives of RA probands or positive for anti-citrullinated protein antibodies) from the Studies of the Etiologies of Rheumatoid Arthritis cohort.

Disclosures: The study was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

Source: Polinski KJ et al. Arthritis Care Res (Hoboken). 2020 Nov 6. doi: 10.1002/acr.24085.

Key clinical point: Higher perceived distress was associated with elevated risk of developing inflammatory arthritis (IA) in an at-risk population having either positive rheumatoid arthritis (RA)-related autoantibodies or inherent genetic risk based on family history.

Major finding: A 1-point increase in the perceived distress score was significantly associated with a 10% increase in the risk of incident IA (adjusted hazard ratio [aHR], 1.10; 95% confidence interval [CI], 1.02-1.19). Total perceived stress (aHR, 1.05; 95% CI, 0.99-1.10) and self-efficacy (aHR, 1.04; 95% CI, 0.91-1.18) scores were not significantly associated with the risk of incident IA.

Study details: This prospective cohort study evaluated 448 participants at an increased risk of developing future RA (either first-degree relatives of RA probands or positive for anti-citrullinated protein antibodies) from the Studies of the Etiologies of Rheumatoid Arthritis cohort.

Disclosures: The study was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

Source: Polinski KJ et al. Arthritis Care Res (Hoboken). 2020 Nov 6. doi: 10.1002/acr.24085.

Key clinical point: Higher perceived distress was associated with elevated risk of developing inflammatory arthritis (IA) in an at-risk population having either positive rheumatoid arthritis (RA)-related autoantibodies or inherent genetic risk based on family history.

Major finding: A 1-point increase in the perceived distress score was significantly associated with a 10% increase in the risk of incident IA (adjusted hazard ratio [aHR], 1.10; 95% confidence interval [CI], 1.02-1.19). Total perceived stress (aHR, 1.05; 95% CI, 0.99-1.10) and self-efficacy (aHR, 1.04; 95% CI, 0.91-1.18) scores were not significantly associated with the risk of incident IA.

Study details: This prospective cohort study evaluated 448 participants at an increased risk of developing future RA (either first-degree relatives of RA probands or positive for anti-citrullinated protein antibodies) from the Studies of the Etiologies of Rheumatoid Arthritis cohort.

Disclosures: The study was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

Source: Polinski KJ et al. Arthritis Care Res (Hoboken). 2020 Nov 6. doi: 10.1002/acr.24085.

Key clinical point: The appearance of total antinuclear antibodies (ANA) before administration of TNF-α inhibitors (TNFi) is a risk factor for the appearance of antidrug antibodies (ADrA) and treatment failure.

Major finding: ADrA appeared in 36.8% and 30.2% of patients treated with infliximab (IFX) and adalimumab (ADA), respectively; all being positive for total ANA before TNFi administration. High titers of total ANA before IFX treatment were significantly associated with inefficacy and discontinuation of treatment.

Study details: The data come from observational study of 121 patients with RA newly introduced to 3 classes of TNFi.

Disclosures: The study did not receive any funding. S Kumagai reported ties with various pharmaceutical companies. The other authors reported no conflicts of interest.

Source: Mori A et al. PLoS One. 2020 Dec 14. doi: 10.1371/journal.pone.0243729.

Key clinical point: The appearance of total antinuclear antibodies (ANA) before administration of TNF-α inhibitors (TNFi) is a risk factor for the appearance of antidrug antibodies (ADrA) and treatment failure.

Major finding: ADrA appeared in 36.8% and 30.2% of patients treated with infliximab (IFX) and adalimumab (ADA), respectively; all being positive for total ANA before TNFi administration. High titers of total ANA before IFX treatment were significantly associated with inefficacy and discontinuation of treatment.

Study details: The data come from observational study of 121 patients with RA newly introduced to 3 classes of TNFi.

Disclosures: The study did not receive any funding. S Kumagai reported ties with various pharmaceutical companies. The other authors reported no conflicts of interest.

Source: Mori A et al. PLoS One. 2020 Dec 14. doi: 10.1371/journal.pone.0243729.

Key clinical point: The appearance of total antinuclear antibodies (ANA) before administration of TNF-α inhibitors (TNFi) is a risk factor for the appearance of antidrug antibodies (ADrA) and treatment failure.

Major finding: ADrA appeared in 36.8% and 30.2% of patients treated with infliximab (IFX) and adalimumab (ADA), respectively; all being positive for total ANA before TNFi administration. High titers of total ANA before IFX treatment were significantly associated with inefficacy and discontinuation of treatment.

Study details: The data come from observational study of 121 patients with RA newly introduced to 3 classes of TNFi.

Disclosures: The study did not receive any funding. S Kumagai reported ties with various pharmaceutical companies. The other authors reported no conflicts of interest.

Source: Mori A et al. PLoS One. 2020 Dec 14. doi: 10.1371/journal.pone.0243729.

A new clinical practice update from the American Gastroenterological Association seeks to provide gastroenterologists with practical and evidence-based advice for management of colonic diverticulitis.

For example, clinicians should consider lower endoscopy and CT scans of the abdomen and pelvis with oral and intravenous contrast to rule out chronic diverticular inflammation, diverticular stricture or fistula, ischemic colitis, constipation, and inflammatory bowel disease, Anne F. Peery, MD, MSCR, of the University of North Carolina, Chapel Hill, and associates wrote in Gastroenterology.

“In our practice, patients are reassured to know that ongoing symptoms are common and often attributable to visceral hypersensitivity,” they wrote. “This conversation is particularly important after a negative workup. If needed, ongoing abdominal pain can be treated with a low to modest dose of a tricyclic antidepressant.”

The update from the AGA includes 13 other recommendations, with noteworthy advice to use antibiotics selectively, rather than routinely, in cases of acute uncomplicated diverticulitis in immunocompetent patients. In a recent large meta-analysis, antibiotics did not shorten symptom duration or reduce rates of hospitalization, complications, or surgery in this setting. The clinical practice update advises using antibiotics if patients are frail or have comorbidities, vomiting or refractory symptoms, a C-reactive protein level above 140 mg/L, a baseline white blood cell count above 15 × 10⁹ cells/L, or fluid collection or a longer segment of inflammation on CT scan. Antibiotics also are strongly advised for immunocompromised patients, who are at greater risk for complications and severe diverticulitis. Because of this risk, clinicians should have “a low threshold” for cross-sectional imaging, antibiotic treatment, and consultation with a colorectal surgeon, according to the update.

The authors recommend CT if patients have severe symptoms or have not previously been diagnosed with diverticulitis based on imaging. Clinicians also should consider imaging if patients have had multiple recurrences, are not responding to treatment, are immunocompromised, or are considering prophylactic surgery (in which case imaging is used to pinpoint areas of disease).

Colonoscopy is advised after episodes of complicated diverticulitis or after a first episode of uncomplicated diverticulitis if no high-quality colonoscopy has been performed in the past year. This colonoscopy is advised to rule out malignancy, which can be misdiagnosed as diverticulitis, and because diverticulitis (particularly complicated diverticulitis) has been associated with colon cancer in some studies, the update notes. Unless patients have “alarm symptoms” – that is, a change in stool caliber, iron deficiency anemia, bloody stools, weight loss, or abdominal pain – colonoscopy should be delayed until 6-8 weeks after the diverticulitis episode or until the acute symptoms resolve, whichever occurs later.

The decision to discuss elective segmental resection should be based on disease severity, not the prior number of episodes. Although elective surgery for diverticulitis has become increasingly common, patients should be aware that surgery often does not improve chronic gastrointestinal symptoms, such as abdominal pain, and that surgery reduces but does not eliminate the risk for recurrence. The authors recommended against surgery to prevent complicated diverticulitis in immunocompetent patients with a history of uncomplicated episodes. “In this population, complicated diverticulitis is most often the first presentation of diverticulitis and is less likely with recurrences,” the update states. For acute complicated diverticulitis that has been effectively managed without surgery, patients are at heightened risk for recurrence, but “a growing literature suggest[s] a more conservative and personalized approach” rather than the routine use of interval elective resection, the authors noted. For all patients, counseling regarding surgery should incorporate thoughtful discussions of immune status, values and preferences, and operative risks versus benefits, including effects on quality of life.

Dr. Peery and another author were supported by grants from the National Institutes of Health. The authors reported having no conflicts of interest.

SOURCE: Peery AF et al. Gastroenterology. 2020 Dec 3. doi: 10.1053/j.gastro.2020.09.059.

This article was updated Feb. 10, 2021.

A new clinical practice update from the American Gastroenterological Association seeks to provide gastroenterologists with practical and evidence-based advice for management of colonic diverticulitis.

For example, clinicians should consider lower endoscopy and CT scans of the abdomen and pelvis with oral and intravenous contrast to rule out chronic diverticular inflammation, diverticular stricture or fistula, ischemic colitis, constipation, and inflammatory bowel disease, Anne F. Peery, MD, MSCR, of the University of North Carolina, Chapel Hill, and associates wrote in Gastroenterology.

“In our practice, patients are reassured to know that ongoing symptoms are common and often attributable to visceral hypersensitivity,” they wrote. “This conversation is particularly important after a negative workup. If needed, ongoing abdominal pain can be treated with a low to modest dose of a tricyclic antidepressant.”

The update from the AGA includes 13 other recommendations, with noteworthy advice to use antibiotics selectively, rather than routinely, in cases of acute uncomplicated diverticulitis in immunocompetent patients. In a recent large meta-analysis, antibiotics did not shorten symptom duration or reduce rates of hospitalization, complications, or surgery in this setting. The clinical practice update advises using antibiotics if patients are frail or have comorbidities, vomiting or refractory symptoms, a C-reactive protein level above 140 mg/L, a baseline white blood cell count above 15 × 10⁹ cells/L, or fluid collection or a longer segment of inflammation on CT scan. Antibiotics also are strongly advised for immunocompromised patients, who are at greater risk for complications and severe diverticulitis. Because of this risk, clinicians should have “a low threshold” for cross-sectional imaging, antibiotic treatment, and consultation with a colorectal surgeon, according to the update.

The authors recommend CT if patients have severe symptoms or have not previously been diagnosed with diverticulitis based on imaging. Clinicians also should consider imaging if patients have had multiple recurrences, are not responding to treatment, are immunocompromised, or are considering prophylactic surgery (in which case imaging is used to pinpoint areas of disease).

Colonoscopy is advised after episodes of complicated diverticulitis or after a first episode of uncomplicated diverticulitis if no high-quality colonoscopy has been performed in the past year. This colonoscopy is advised to rule out malignancy, which can be misdiagnosed as diverticulitis, and because diverticulitis (particularly complicated diverticulitis) has been associated with colon cancer in some studies, the update notes. Unless patients have “alarm symptoms” – that is, a change in stool caliber, iron deficiency anemia, bloody stools, weight loss, or abdominal pain – colonoscopy should be delayed until 6-8 weeks after the diverticulitis episode or until the acute symptoms resolve, whichever occurs later.

The decision to discuss elective segmental resection should be based on disease severity, not the prior number of episodes. Although elective surgery for diverticulitis has become increasingly common, patients should be aware that surgery often does not improve chronic gastrointestinal symptoms, such as abdominal pain, and that surgery reduces but does not eliminate the risk for recurrence. The authors recommended against surgery to prevent complicated diverticulitis in immunocompetent patients with a history of uncomplicated episodes. “In this population, complicated diverticulitis is most often the first presentation of diverticulitis and is less likely with recurrences,” the update states. For acute complicated diverticulitis that has been effectively managed without surgery, patients are at heightened risk for recurrence, but “a growing literature suggest[s] a more conservative and personalized approach” rather than the routine use of interval elective resection, the authors noted. For all patients, counseling regarding surgery should incorporate thoughtful discussions of immune status, values and preferences, and operative risks versus benefits, including effects on quality of life.

Dr. Peery and another author were supported by grants from the National Institutes of Health. The authors reported having no conflicts of interest.

SOURCE: Peery AF et al. Gastroenterology. 2020 Dec 3. doi: 10.1053/j.gastro.2020.09.059.

This article was updated Feb. 10, 2021.

A new clinical practice update from the American Gastroenterological Association seeks to provide gastroenterologists with practical and evidence-based advice for management of colonic diverticulitis.

For example, clinicians should consider lower endoscopy and CT scans of the abdomen and pelvis with oral and intravenous contrast to rule out chronic diverticular inflammation, diverticular stricture or fistula, ischemic colitis, constipation, and inflammatory bowel disease, Anne F. Peery, MD, MSCR, of the University of North Carolina, Chapel Hill, and associates wrote in Gastroenterology.

“In our practice, patients are reassured to know that ongoing symptoms are common and often attributable to visceral hypersensitivity,” they wrote. “This conversation is particularly important after a negative workup. If needed, ongoing abdominal pain can be treated with a low to modest dose of a tricyclic antidepressant.”

The update from the AGA includes 13 other recommendations, with noteworthy advice to use antibiotics selectively, rather than routinely, in cases of acute uncomplicated diverticulitis in immunocompetent patients. In a recent large meta-analysis, antibiotics did not shorten symptom duration or reduce rates of hospitalization, complications, or surgery in this setting. The clinical practice update advises using antibiotics if patients are frail or have comorbidities, vomiting or refractory symptoms, a C-reactive protein level above 140 mg/L, a baseline white blood cell count above 15 × 10⁹ cells/L, or fluid collection or a longer segment of inflammation on CT scan. Antibiotics also are strongly advised for immunocompromised patients, who are at greater risk for complications and severe diverticulitis. Because of this risk, clinicians should have “a low threshold” for cross-sectional imaging, antibiotic treatment, and consultation with a colorectal surgeon, according to the update.

The authors recommend CT if patients have severe symptoms or have not previously been diagnosed with diverticulitis based on imaging. Clinicians also should consider imaging if patients have had multiple recurrences, are not responding to treatment, are immunocompromised, or are considering prophylactic surgery (in which case imaging is used to pinpoint areas of disease).

Colonoscopy is advised after episodes of complicated diverticulitis or after a first episode of uncomplicated diverticulitis if no high-quality colonoscopy has been performed in the past year. This colonoscopy is advised to rule out malignancy, which can be misdiagnosed as diverticulitis, and because diverticulitis (particularly complicated diverticulitis) has been associated with colon cancer in some studies, the update notes. Unless patients have “alarm symptoms” – that is, a change in stool caliber, iron deficiency anemia, bloody stools, weight loss, or abdominal pain – colonoscopy should be delayed until 6-8 weeks after the diverticulitis episode or until the acute symptoms resolve, whichever occurs later.

The decision to discuss elective segmental resection should be based on disease severity, not the prior number of episodes. Although elective surgery for diverticulitis has become increasingly common, patients should be aware that surgery often does not improve chronic gastrointestinal symptoms, such as abdominal pain, and that surgery reduces but does not eliminate the risk for recurrence. The authors recommended against surgery to prevent complicated diverticulitis in immunocompetent patients with a history of uncomplicated episodes. “In this population, complicated diverticulitis is most often the first presentation of diverticulitis and is less likely with recurrences,” the update states. For acute complicated diverticulitis that has been effectively managed without surgery, patients are at heightened risk for recurrence, but “a growing literature suggest[s] a more conservative and personalized approach” rather than the routine use of interval elective resection, the authors noted. For all patients, counseling regarding surgery should incorporate thoughtful discussions of immune status, values and preferences, and operative risks versus benefits, including effects on quality of life.

Dr. Peery and another author were supported by grants from the National Institutes of Health. The authors reported having no conflicts of interest.

SOURCE: Peery AF et al. Gastroenterology. 2020 Dec 3. doi: 10.1053/j.gastro.2020.09.059.

This article was updated Feb. 10, 2021.

Key clinical point: Baricitinib 4 mg may be considered for long-term treatment of patients with moderate to severe rheumatoid arthritis (RA) who were either naïve to disease-modifying antirheumatic drugs (DMARDs) or had inadequate response (IR) to methotrexate (MTX).

Major finding: At week 148, low disease activity was achieved in up to 61% of DMARD-naïve patients and 59% of MTX-IR patients initially treated with baricitinib. Baricitinib was well-tolerated.

Study details: Analysis of data from 2 completed (RA-BEGIN [n = 584] and RA-BEAM [n = 1,305]) and 1 ongoing long-term extension (RA-BEYOND) phase 3 trials involving either DMARD-naïve or MTX-IR patients.

Disclosures: The study was supported by Eli Lilly and Company. L Xie, B Jia, A Elias, A Cardoso, R Ortmann and C Walls are full-time employees of Eli Lilly and Company and may own stock or stock options in the company.

Source: Smolen JS et al. Rheumatology (Oxford). 2020 Nov 17. doi: 10.1093/rheumatology/keaa576.

Key clinical point: Baricitinib 4 mg may be considered for long-term treatment of patients with moderate to severe rheumatoid arthritis (RA) who were either naïve to disease-modifying antirheumatic drugs (DMARDs) or had inadequate response (IR) to methotrexate (MTX).

Major finding: At week 148, low disease activity was achieved in up to 61% of DMARD-naïve patients and 59% of MTX-IR patients initially treated with baricitinib. Baricitinib was well-tolerated.

Study details: Analysis of data from 2 completed (RA-BEGIN [n = 584] and RA-BEAM [n = 1,305]) and 1 ongoing long-term extension (RA-BEYOND) phase 3 trials involving either DMARD-naïve or MTX-IR patients.

Disclosures: The study was supported by Eli Lilly and Company. L Xie, B Jia, A Elias, A Cardoso, R Ortmann and C Walls are full-time employees of Eli Lilly and Company and may own stock or stock options in the company.

Source: Smolen JS et al. Rheumatology (Oxford). 2020 Nov 17. doi: 10.1093/rheumatology/keaa576.

Key clinical point: Baricitinib 4 mg may be considered for long-term treatment of patients with moderate to severe rheumatoid arthritis (RA) who were either naïve to disease-modifying antirheumatic drugs (DMARDs) or had inadequate response (IR) to methotrexate (MTX).

Major finding: At week 148, low disease activity was achieved in up to 61% of DMARD-naïve patients and 59% of MTX-IR patients initially treated with baricitinib. Baricitinib was well-tolerated.

Study details: Analysis of data from 2 completed (RA-BEGIN [n = 584] and RA-BEAM [n = 1,305]) and 1 ongoing long-term extension (RA-BEYOND) phase 3 trials involving either DMARD-naïve or MTX-IR patients.

Disclosures: The study was supported by Eli Lilly and Company. L Xie, B Jia, A Elias, A Cardoso, R Ortmann and C Walls are full-time employees of Eli Lilly and Company and may own stock or stock options in the company.

Source: Smolen JS et al. Rheumatology (Oxford). 2020 Nov 17. doi: 10.1093/rheumatology/keaa576.

Key clinical point: In anti-citrullinated protein antibodies (ACPA)-negative rheumatoid arthritis (RA), a significant decline in the disease activity score (DAS) within the first 4 months after diagnosis was associated with a higher probability of achieving sustained disease-modifying anti-rheumatic drugs (DMARDs)-free remission (SDFR).

Major finding: In patients with ACPA-negative RA, the decline in DAS within the first 4 months was stronger in the SDFR vs. non-SDFR group (−1.73 vs. −1.07 units; P less than .001). SDFR incidence was high (70.2%) and rare (7.1%) when absolute DAS level at 4 months was less than 1.6 and 3.6 or greater, respectively.

Study details: The study cohort included 772 consecutive patients with RA promptly treated with conventional DMARDs. Patients were classified into SDFR (n=149) and non-SDFR (n=623) groups.

Disclosures: The study was supported by the Dutch Arthritis Foundation and the European Research Council under the European Union’s Horizon 2020 research and innovation program. The authors declared no conflicts of interest.

Source: Verstappen M et al. Arthritis Res Ther. 2020 Nov 23. doi: 10.1186/s13075-020-02368-9.

Key clinical point: In anti-citrullinated protein antibodies (ACPA)-negative rheumatoid arthritis (RA), a significant decline in the disease activity score (DAS) within the first 4 months after diagnosis was associated with a higher probability of achieving sustained disease-modifying anti-rheumatic drugs (DMARDs)-free remission (SDFR).

Major finding: In patients with ACPA-negative RA, the decline in DAS within the first 4 months was stronger in the SDFR vs. non-SDFR group (−1.73 vs. −1.07 units; P less than .001). SDFR incidence was high (70.2%) and rare (7.1%) when absolute DAS level at 4 months was less than 1.6 and 3.6 or greater, respectively.

Study details: The study cohort included 772 consecutive patients with RA promptly treated with conventional DMARDs. Patients were classified into SDFR (n=149) and non-SDFR (n=623) groups.

Disclosures: The study was supported by the Dutch Arthritis Foundation and the European Research Council under the European Union’s Horizon 2020 research and innovation program. The authors declared no conflicts of interest.

Source: Verstappen M et al. Arthritis Res Ther. 2020 Nov 23. doi: 10.1186/s13075-020-02368-9.

Key clinical point: In anti-citrullinated protein antibodies (ACPA)-negative rheumatoid arthritis (RA), a significant decline in the disease activity score (DAS) within the first 4 months after diagnosis was associated with a higher probability of achieving sustained disease-modifying anti-rheumatic drugs (DMARDs)-free remission (SDFR).

Major finding: In patients with ACPA-negative RA, the decline in DAS within the first 4 months was stronger in the SDFR vs. non-SDFR group (−1.73 vs. −1.07 units; P less than .001). SDFR incidence was high (70.2%) and rare (7.1%) when absolute DAS level at 4 months was less than 1.6 and 3.6 or greater, respectively.

Study details: The study cohort included 772 consecutive patients with RA promptly treated with conventional DMARDs. Patients were classified into SDFR (n=149) and non-SDFR (n=623) groups.

Disclosures: The study was supported by the Dutch Arthritis Foundation and the European Research Council under the European Union’s Horizon 2020 research and innovation program. The authors declared no conflicts of interest.

Source: Verstappen M et al. Arthritis Res Ther. 2020 Nov 23. doi: 10.1186/s13075-020-02368-9.

The proportion of all COVID-19 cases occurring in children, which has been rising gradually throughout the pandemic, did not rise during the week ending Dec. 31, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Children’s share of the cumulative COVID-19 burden remained at 12.4% for a second consecutive week, the AAP and CHA said in their weekly report. The last full week of 2020 also marked the second consecutive drop in new cases, although that may be holiday related.

There were almost 128,000 new cases of COVID-19 reported in children for the week, down from 179,000 cases the week before (Dec. 24) and down from the pandemic high of 182,000 reported 2 weeks earlier (Dec.17), based on data from 49 state health departments (excluding New York), along with the District of Columbia, New York City, Puerto Rico, and Guam.

Children’s proportion of new cases for the week, 12.6%, is at its lowest point since early October after dropping for the second week in a row. The cumulative rate of COVID-19 infection, however, is now 2,828 cases per 100,000 children, up from 2,658 the previous week, the AAP and CHA said.

State-level metrics show that North Dakota has the highest cumulative rate at 7,851 per 100,000 children and Hawaii the lowest at 828. Wyoming’s cumulative proportion of child cases, 20.3%, is the highest in the country, while Florida, which uses an age range of 0-14 years for children, is the lowest at 7.1%. California’s total of 268,000 cases is almost double the number of second-place Illinois (138,000), the AAP/CHA data show.

Cumulative child deaths from COVID-19 are up to 179 in the jurisdictions reporting such data (43 states and New York City). That represents just 0.6% of all coronavirus-related deaths and has changed little over the last several months – never rising higher than 0.7% or dropping below 0.6% since early July, according to the report.

[email protected]

The proportion of all COVID-19 cases occurring in children, which has been rising gradually throughout the pandemic, did not rise during the week ending Dec. 31, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Children’s share of the cumulative COVID-19 burden remained at 12.4% for a second consecutive week, the AAP and CHA said in their weekly report. The last full week of 2020 also marked the second consecutive drop in new cases, although that may be holiday related.

There were almost 128,000 new cases of COVID-19 reported in children for the week, down from 179,000 cases the week before (Dec. 24) and down from the pandemic high of 182,000 reported 2 weeks earlier (Dec.17), based on data from 49 state health departments (excluding New York), along with the District of Columbia, New York City, Puerto Rico, and Guam.

Children’s proportion of new cases for the week, 12.6%, is at its lowest point since early October after dropping for the second week in a row. The cumulative rate of COVID-19 infection, however, is now 2,828 cases per 100,000 children, up from 2,658 the previous week, the AAP and CHA said.

State-level metrics show that North Dakota has the highest cumulative rate at 7,851 per 100,000 children and Hawaii the lowest at 828. Wyoming’s cumulative proportion of child cases, 20.3%, is the highest in the country, while Florida, which uses an age range of 0-14 years for children, is the lowest at 7.1%. California’s total of 268,000 cases is almost double the number of second-place Illinois (138,000), the AAP/CHA data show.

Cumulative child deaths from COVID-19 are up to 179 in the jurisdictions reporting such data (43 states and New York City). That represents just 0.6% of all coronavirus-related deaths and has changed little over the last several months – never rising higher than 0.7% or dropping below 0.6% since early July, according to the report.

[email protected]

The proportion of all COVID-19 cases occurring in children, which has been rising gradually throughout the pandemic, did not rise during the week ending Dec. 31, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Children’s share of the cumulative COVID-19 burden remained at 12.4% for a second consecutive week, the AAP and CHA said in their weekly report. The last full week of 2020 also marked the second consecutive drop in new cases, although that may be holiday related.

There were almost 128,000 new cases of COVID-19 reported in children for the week, down from 179,000 cases the week before (Dec. 24) and down from the pandemic high of 182,000 reported 2 weeks earlier (Dec.17), based on data from 49 state health departments (excluding New York), along with the District of Columbia, New York City, Puerto Rico, and Guam.

Children’s proportion of new cases for the week, 12.6%, is at its lowest point since early October after dropping for the second week in a row. The cumulative rate of COVID-19 infection, however, is now 2,828 cases per 100,000 children, up from 2,658 the previous week, the AAP and CHA said.

State-level metrics show that North Dakota has the highest cumulative rate at 7,851 per 100,000 children and Hawaii the lowest at 828. Wyoming’s cumulative proportion of child cases, 20.3%, is the highest in the country, while Florida, which uses an age range of 0-14 years for children, is the lowest at 7.1%. California’s total of 268,000 cases is almost double the number of second-place Illinois (138,000), the AAP/CHA data show.

Cumulative child deaths from COVID-19 are up to 179 in the jurisdictions reporting such data (43 states and New York City). That represents just 0.6% of all coronavirus-related deaths and has changed little over the last several months – never rising higher than 0.7% or dropping below 0.6% since early July, according to the report.

[email protected]

In patients who undergo resection of pancreatic ductal adenocarcinoma (PDAC) after neoadjuvant therapy, reduction in tumor size between diagnosis and surgery is associated with improved survival, according to a new single-center, retrospective analysis. The researchers compared tumor size as measured by endoscopic ultrasound (EUS) and found that a threshold of 47% or greater reduction in tumor size at resection was associated with a doubling in the 3-year survival rate.

The study, led by Rohit Das, MD, of the University of Pittsburgh Medical Center, was published in Clinical Gastroenterology and Hepatology.

The research represents only a small percentage of patients since most diagnosed with PDAC have locally advanced or metastatic disease that rules out surgery. Still, the work puts more emphasis on measuring tumor size while performing EUS, according to Robert Jay Sealock, MD, who is an assistant professor of medicine at Baylor College of Medicine, Houston.

“This is some helpful information that you can relay to the patient, saying that you have a significant decrease in the size of the tumor based on your initial EUS, and your chance of 3- to 5-year survival is going to be a lot higher, compared to somebody that didn’t have that tumor regression. Most of these patients will undergo an EUS anyway, and you’ll commonly if not always measure the tumor size while you’re in there. Now you can apply this information that you already have to give the patients some additional information if they do undergo surgery,” said Dr. Sealock, who was not involved in the research.

Previous efforts to prognosticate postsurgical survival focused on overall tumor burden using multidetector CT (MDCT), carbohydrate antigen 19-9 (CA19-9) levels, and histologic examination following surgery, but all suffer from various limitations. MDCT is not always accurate in its measurement of tumor size, other conditions can also raise CA19-9 levels, and pathologic findings are subjective because sometimes the amount of tumor before neoadjuvant therapy is uncertain.

The researchers mapped survival statistics to EUS and pathologic findings for 340 treatment-naive and 365 neoadjuvant-treated PDAC patients at the University of Pittsburgh Medical Center. They used a 200 patient cohort from the same center who had been treated with neoadjuvant therapy for validation.

Pathology examination revealed that, in the treatment-naive group, 71% of tumors were larger than the size determined during EUS. In 9% of cases there was no change in size (EUS versus pathology T-staging Pearson correlation coefficient, 0.586; P < .001). A similar analysis of MDCT showed a weaker correlation. There was no correlation between preoperative EUS/MDCT findings and postoperative pathology among patients who received neoadjuvant therapy.

In the neoadjuvant therapy group, tumor size was reduced in 31%, was unchanged in 53%, and actually grew in 16%. Three-year overall survival was highest in the reduced group (50%), and lower in the unchanged (37%) and tumor-growth (34%) groups. At 5 years, overall survival was 31%, 19%, and 16%, respectively (P = .003). Compared with those whose tumor size remained the same or grew, those with reduced tumor size had higher 3-year overall survival (50% vs. 33%) and 5-year overall survival (31% vs. 18%; P < .001).

The researchers used recursive positioning to identify the optimal threshold for tumor reduction, and found that a 47% or greater reduction was associated with 67% overall survival at 3 years and 47% at 5 years, compared with 32% and 16% for those with smaller reduction or tumors that maintained or increased in size (P < .001).

The researchers noted that, although their study is large, it remains retrospective in design. Another limitation they cited was that not all patients received the same neoadjuvant therapy. Furthermore, both EUS and pathologic evaluation can be subjective, and it can be difficult to correct for that.

“While additional studies are required, incorporating preoperative EUS and postoperative pathologic tumor size measurements into the standard evaluation of neoadjuvant-treated PDAC patients may guide subsequent management in the adjuvant setting,” the researchers concluded.

The study was funded in part by the National Pancreas Foundation, Sky Foundation, and the Pittsburgh Liver Research Center at the University of Pittsburgh. One author disclosed receiving an honorarium from Foundation Medicine, but the rest reported having nothing to disclose. Dr. Sealock has no relevant financial disclosures.

SOURCE: Das R et al. Clin Gastroenterol Hepatol. 2020 Dec 2. doi: 10.1016/j.cgh.2020.11.041.

In patients who undergo resection of pancreatic ductal adenocarcinoma (PDAC) after neoadjuvant therapy, reduction in tumor size between diagnosis and surgery is associated with improved survival, according to a new single-center, retrospective analysis. The researchers compared tumor size as measured by endoscopic ultrasound (EUS) and found that a threshold of 47% or greater reduction in tumor size at resection was associated with a doubling in the 3-year survival rate.

The study, led by Rohit Das, MD, of the University of Pittsburgh Medical Center, was published in Clinical Gastroenterology and Hepatology.

The research represents only a small percentage of patients since most diagnosed with PDAC have locally advanced or metastatic disease that rules out surgery. Still, the work puts more emphasis on measuring tumor size while performing EUS, according to Robert Jay Sealock, MD, who is an assistant professor of medicine at Baylor College of Medicine, Houston.

“This is some helpful information that you can relay to the patient, saying that you have a significant decrease in the size of the tumor based on your initial EUS, and your chance of 3- to 5-year survival is going to be a lot higher, compared to somebody that didn’t have that tumor regression. Most of these patients will undergo an EUS anyway, and you’ll commonly if not always measure the tumor size while you’re in there. Now you can apply this information that you already have to give the patients some additional information if they do undergo surgery,” said Dr. Sealock, who was not involved in the research.

Previous efforts to prognosticate postsurgical survival focused on overall tumor burden using multidetector CT (MDCT), carbohydrate antigen 19-9 (CA19-9) levels, and histologic examination following surgery, but all suffer from various limitations. MDCT is not always accurate in its measurement of tumor size, other conditions can also raise CA19-9 levels, and pathologic findings are subjective because sometimes the amount of tumor before neoadjuvant therapy is uncertain.

The researchers mapped survival statistics to EUS and pathologic findings for 340 treatment-naive and 365 neoadjuvant-treated PDAC patients at the University of Pittsburgh Medical Center. They used a 200 patient cohort from the same center who had been treated with neoadjuvant therapy for validation.

Pathology examination revealed that, in the treatment-naive group, 71% of tumors were larger than the size determined during EUS. In 9% of cases there was no change in size (EUS versus pathology T-staging Pearson correlation coefficient, 0.586; P < .001). A similar analysis of MDCT showed a weaker correlation. There was no correlation between preoperative EUS/MDCT findings and postoperative pathology among patients who received neoadjuvant therapy.

In the neoadjuvant therapy group, tumor size was reduced in 31%, was unchanged in 53%, and actually grew in 16%. Three-year overall survival was highest in the reduced group (50%), and lower in the unchanged (37%) and tumor-growth (34%) groups. At 5 years, overall survival was 31%, 19%, and 16%, respectively (P = .003). Compared with those whose tumor size remained the same or grew, those with reduced tumor size had higher 3-year overall survival (50% vs. 33%) and 5-year overall survival (31% vs. 18%; P < .001).

The researchers used recursive positioning to identify the optimal threshold for tumor reduction, and found that a 47% or greater reduction was associated with 67% overall survival at 3 years and 47% at 5 years, compared with 32% and 16% for those with smaller reduction or tumors that maintained or increased in size (P < .001).

The researchers noted that, although their study is large, it remains retrospective in design. Another limitation they cited was that not all patients received the same neoadjuvant therapy. Furthermore, both EUS and pathologic evaluation can be subjective, and it can be difficult to correct for that.

“While additional studies are required, incorporating preoperative EUS and postoperative pathologic tumor size measurements into the standard evaluation of neoadjuvant-treated PDAC patients may guide subsequent management in the adjuvant setting,” the researchers concluded.

The study was funded in part by the National Pancreas Foundation, Sky Foundation, and the Pittsburgh Liver Research Center at the University of Pittsburgh. One author disclosed receiving an honorarium from Foundation Medicine, but the rest reported having nothing to disclose. Dr. Sealock has no relevant financial disclosures.

SOURCE: Das R et al. Clin Gastroenterol Hepatol. 2020 Dec 2. doi: 10.1016/j.cgh.2020.11.041.

In patients who undergo resection of pancreatic ductal adenocarcinoma (PDAC) after neoadjuvant therapy, reduction in tumor size between diagnosis and surgery is associated with improved survival, according to a new single-center, retrospective analysis. The researchers compared tumor size as measured by endoscopic ultrasound (EUS) and found that a threshold of 47% or greater reduction in tumor size at resection was associated with a doubling in the 3-year survival rate.

The study, led by Rohit Das, MD, of the University of Pittsburgh Medical Center, was published in Clinical Gastroenterology and Hepatology.

The research represents only a small percentage of patients since most diagnosed with PDAC have locally advanced or metastatic disease that rules out surgery. Still, the work puts more emphasis on measuring tumor size while performing EUS, according to Robert Jay Sealock, MD, who is an assistant professor of medicine at Baylor College of Medicine, Houston.

“This is some helpful information that you can relay to the patient, saying that you have a significant decrease in the size of the tumor based on your initial EUS, and your chance of 3- to 5-year survival is going to be a lot higher, compared to somebody that didn’t have that tumor regression. Most of these patients will undergo an EUS anyway, and you’ll commonly if not always measure the tumor size while you’re in there. Now you can apply this information that you already have to give the patients some additional information if they do undergo surgery,” said Dr. Sealock, who was not involved in the research.

Previous efforts to prognosticate postsurgical survival focused on overall tumor burden using multidetector CT (MDCT), carbohydrate antigen 19-9 (CA19-9) levels, and histologic examination following surgery, but all suffer from various limitations. MDCT is not always accurate in its measurement of tumor size, other conditions can also raise CA19-9 levels, and pathologic findings are subjective because sometimes the amount of tumor before neoadjuvant therapy is uncertain.

The researchers mapped survival statistics to EUS and pathologic findings for 340 treatment-naive and 365 neoadjuvant-treated PDAC patients at the University of Pittsburgh Medical Center. They used a 200 patient cohort from the same center who had been treated with neoadjuvant therapy for validation.

Pathology examination revealed that, in the treatment-naive group, 71% of tumors were larger than the size determined during EUS. In 9% of cases there was no change in size (EUS versus pathology T-staging Pearson correlation coefficient, 0.586; P < .001). A similar analysis of MDCT showed a weaker correlation. There was no correlation between preoperative EUS/MDCT findings and postoperative pathology among patients who received neoadjuvant therapy.

In the neoadjuvant therapy group, tumor size was reduced in 31%, was unchanged in 53%, and actually grew in 16%. Three-year overall survival was highest in the reduced group (50%), and lower in the unchanged (37%) and tumor-growth (34%) groups. At 5 years, overall survival was 31%, 19%, and 16%, respectively (P = .003). Compared with those whose tumor size remained the same or grew, those with reduced tumor size had higher 3-year overall survival (50% vs. 33%) and 5-year overall survival (31% vs. 18%; P < .001).

The researchers used recursive positioning to identify the optimal threshold for tumor reduction, and found that a 47% or greater reduction was associated with 67% overall survival at 3 years and 47% at 5 years, compared with 32% and 16% for those with smaller reduction or tumors that maintained or increased in size (P < .001).

The researchers noted that, although their study is large, it remains retrospective in design. Another limitation they cited was that not all patients received the same neoadjuvant therapy. Furthermore, both EUS and pathologic evaluation can be subjective, and it can be difficult to correct for that.

“While additional studies are required, incorporating preoperative EUS and postoperative pathologic tumor size measurements into the standard evaluation of neoadjuvant-treated PDAC patients may guide subsequent management in the adjuvant setting,” the researchers concluded.

The study was funded in part by the National Pancreas Foundation, Sky Foundation, and the Pittsburgh Liver Research Center at the University of Pittsburgh. One author disclosed receiving an honorarium from Foundation Medicine, but the rest reported having nothing to disclose. Dr. Sealock has no relevant financial disclosures.

SOURCE: Das R et al. Clin Gastroenterol Hepatol. 2020 Dec 2. doi: 10.1016/j.cgh.2020.11.041.

Dermoscopic evaluation for detection of hypomelanotic and amelanotic melanomas is less accurate than for pigmented melanomas, but its utility can be boosted by familiarity with a handful of dermoscopic features specific to melanomas lacking significant pigment, Steven Q. Wang, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

These features emerged from a major study conducted on five continents by members of the International Dermoscopy Society. The investigators developed a simple, eight-variable model, which demonstrated a sensitivity of 70% and specificity of 56% for diagnosis of melanoma. And while that’s a markedly worse performance than when dermoscopy is used for detection of pigmented melanomas, where sensitivities in excess of 90% and specificities greater than 70% are typical, it’s nonetheless a significant improvement over naked-eye evaluation of these challenging pigment-deprived melanomas, noted Dr. Wang, director of dermatologic surgery and dermatology at Memorial Sloan Kettering Basking Ridge (N.J.)

Using the predictive model developed in the international study to evaluate lesions lacking pigment, a diagnosis of melanoma is made provided two conditions are met: The lesion can have no more than three milia-like cysts, and it has to possess one or more of seven positive dermoscopic findings. The strongest predictor of melanoma in the study was the presence of a blue-white veil, which in univariate analysis was associated with a 13-fold increased likelihood of melanoma.

The other positive predictors were irregularly shaped depigmentation, more than one shade of pink, predominant central vessels, irregularly sized or distributed brown dots or globules, multiple blue-gray dots, and dotted and linear irregular vessels.

Dr. Wang emphasized that, when dermoscopy and clinical skin examination of a featureless hypomelanotic or amelanotic lesion yield ambiguous findings, frequent vigilant follow-up is a viable strategy to detect early melanoma – provided the lesion is superficial.

“The reality is not all melanomas are the same. The superficial spreading melanomas and lentigo melanomas grow very, very slowly: less than 0.1 mm per month. Those are the types of lesions you can monitor. But there is one type of lesion you should never, ever monitor: nodular lesions. They are the type of lesions that can do your patient harm because nodular melanomas can grow really fast. So my key takeaway message is, if you see a nodule and you don’t know what it is, take it off,” the dermatologist said.

Dermoscopy in the hands of experienced users has repeatedly been shown to improve diagnostic accuracy by more than 25%. But there is an additional very important reason to embrace dermoscopy in daily clinical practice, according to Dr. Wang: “When you put the scope on an individual, you slow down the exam and patients feels like you’re paying more attention to them.”

That’s worthwhile because the No. 1 complaint voiced by patients who make their way to Sloan Kettering for a second opinion is that their prior skin examination by an outside physician wasn’t thorough. They’re often angry about it. And while it’s true that incorporating dermoscopy does make for a lengthier skin examination, the additional time involved is actually minimal. Dr. Wang cited a randomized, prospective, multicenter study which documented that the median time required to conduct a thorough complete skin examination without dermoscopy was 70 seconds versus 142 seconds with dermoscopy.

Dr. Wang reported having no financial conflicts regarding his presentation.

MedscapeLive and this news organization are owned by the same parent company.
 

[email protected]

Dermoscopic evaluation for detection of hypomelanotic and amelanotic melanomas is less accurate than for pigmented melanomas, but its utility can be boosted by familiarity with a handful of dermoscopic features specific to melanomas lacking significant pigment, Steven Q. Wang, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

These features emerged from a major study conducted on five continents by members of the International Dermoscopy Society. The investigators developed a simple, eight-variable model, which demonstrated a sensitivity of 70% and specificity of 56% for diagnosis of melanoma. And while that’s a markedly worse performance than when dermoscopy is used for detection of pigmented melanomas, where sensitivities in excess of 90% and specificities greater than 70% are typical, it’s nonetheless a significant improvement over naked-eye evaluation of these challenging pigment-deprived melanomas, noted Dr. Wang, director of dermatologic surgery and dermatology at Memorial Sloan Kettering Basking Ridge (N.J.)

Using the predictive model developed in the international study to evaluate lesions lacking pigment, a diagnosis of melanoma is made provided two conditions are met: The lesion can have no more than three milia-like cysts, and it has to possess one or more of seven positive dermoscopic findings. The strongest predictor of melanoma in the study was the presence of a blue-white veil, which in univariate analysis was associated with a 13-fold increased likelihood of melanoma.

The other positive predictors were irregularly shaped depigmentation, more than one shade of pink, predominant central vessels, irregularly sized or distributed brown dots or globules, multiple blue-gray dots, and dotted and linear irregular vessels.

Dr. Wang emphasized that, when dermoscopy and clinical skin examination of a featureless hypomelanotic or amelanotic lesion yield ambiguous findings, frequent vigilant follow-up is a viable strategy to detect early melanoma – provided the lesion is superficial.

“The reality is not all melanomas are the same. The superficial spreading melanomas and lentigo melanomas grow very, very slowly: less than 0.1 mm per month. Those are the types of lesions you can monitor. But there is one type of lesion you should never, ever monitor: nodular lesions. They are the type of lesions that can do your patient harm because nodular melanomas can grow really fast. So my key takeaway message is, if you see a nodule and you don’t know what it is, take it off,” the dermatologist said.

Dermoscopy in the hands of experienced users has repeatedly been shown to improve diagnostic accuracy by more than 25%. But there is an additional very important reason to embrace dermoscopy in daily clinical practice, according to Dr. Wang: “When you put the scope on an individual, you slow down the exam and patients feels like you’re paying more attention to them.”

That’s worthwhile because the No. 1 complaint voiced by patients who make their way to Sloan Kettering for a second opinion is that their prior skin examination by an outside physician wasn’t thorough. They’re often angry about it. And while it’s true that incorporating dermoscopy does make for a lengthier skin examination, the additional time involved is actually minimal. Dr. Wang cited a randomized, prospective, multicenter study which documented that the median time required to conduct a thorough complete skin examination without dermoscopy was 70 seconds versus 142 seconds with dermoscopy.

Dr. Wang reported having no financial conflicts regarding his presentation.

MedscapeLive and this news organization are owned by the same parent company.
 

[email protected]

Dermoscopic evaluation for detection of hypomelanotic and amelanotic melanomas is less accurate than for pigmented melanomas, but its utility can be boosted by familiarity with a handful of dermoscopic features specific to melanomas lacking significant pigment, Steven Q. Wang, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

These features emerged from a major study conducted on five continents by members of the International Dermoscopy Society. The investigators developed a simple, eight-variable model, which demonstrated a sensitivity of 70% and specificity of 56% for diagnosis of melanoma. And while that’s a markedly worse performance than when dermoscopy is used for detection of pigmented melanomas, where sensitivities in excess of 90% and specificities greater than 70% are typical, it’s nonetheless a significant improvement over naked-eye evaluation of these challenging pigment-deprived melanomas, noted Dr. Wang, director of dermatologic surgery and dermatology at Memorial Sloan Kettering Basking Ridge (N.J.)

Using the predictive model developed in the international study to evaluate lesions lacking pigment, a diagnosis of melanoma is made provided two conditions are met: The lesion can have no more than three milia-like cysts, and it has to possess one or more of seven positive dermoscopic findings. The strongest predictor of melanoma in the study was the presence of a blue-white veil, which in univariate analysis was associated with a 13-fold increased likelihood of melanoma.

The other positive predictors were irregularly shaped depigmentation, more than one shade of pink, predominant central vessels, irregularly sized or distributed brown dots or globules, multiple blue-gray dots, and dotted and linear irregular vessels.

Dr. Wang emphasized that, when dermoscopy and clinical skin examination of a featureless hypomelanotic or amelanotic lesion yield ambiguous findings, frequent vigilant follow-up is a viable strategy to detect early melanoma – provided the lesion is superficial.

“The reality is not all melanomas are the same. The superficial spreading melanomas and lentigo melanomas grow very, very slowly: less than 0.1 mm per month. Those are the types of lesions you can monitor. But there is one type of lesion you should never, ever monitor: nodular lesions. They are the type of lesions that can do your patient harm because nodular melanomas can grow really fast. So my key takeaway message is, if you see a nodule and you don’t know what it is, take it off,” the dermatologist said.

Dermoscopy in the hands of experienced users has repeatedly been shown to improve diagnostic accuracy by more than 25%. But there is an additional very important reason to embrace dermoscopy in daily clinical practice, according to Dr. Wang: “When you put the scope on an individual, you slow down the exam and patients feels like you’re paying more attention to them.”

That’s worthwhile because the No. 1 complaint voiced by patients who make their way to Sloan Kettering for a second opinion is that their prior skin examination by an outside physician wasn’t thorough. They’re often angry about it. And while it’s true that incorporating dermoscopy does make for a lengthier skin examination, the additional time involved is actually minimal. Dr. Wang cited a randomized, prospective, multicenter study which documented that the median time required to conduct a thorough complete skin examination without dermoscopy was 70 seconds versus 142 seconds with dermoscopy.

Dr. Wang reported having no financial conflicts regarding his presentation.

MedscapeLive and this news organization are owned by the same parent company.
 

[email protected]

Obese women may benefit from a higher dose of magnesium sulfate to protect against preeclampsia, based on data from a randomized trial.

Pharmacokinetic models have shown that, “in women who received a 4-g intravenous loading dose followed by a 2-g/h IV maintenance dose, obese women took approximately twice as long as women of mean body weight in the sample to achieve these previously accepted therapeutic serum magnesium concentrations,” which suggests the need for alternate dosing based on body mass index, wrote Kathleen F. Brookfield, MD, of Oregon Health & Science University, Portland, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 37 women aged 15-45 years with a BMI of 35 kg/m² or higher who were at least 32 weeks’ gestation to receive the standard Zuspan regimen of magnesium sulfate (4 g intravenous loading dose, followed by a 1-g/hour infusion) or to higher dosing (6 g IV loading dose, followed by a 2-g/hour infusion).
 

Higher dose increases effectiveness

Serum magnesium concentrations were measured at baseline, and after administration of magnesium sulfate at 1 hour, 4 hours, and delivery; the primary outcome was the proportion of women with subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration.

After 4 hours, the average magnesium sulfate concentrations were significantly higher for women in the high-dose group vs. the standard group (4.41 mg/dL vs. 3.53 mg/dL). In addition, 100% of women in the standard group had subtherapeutic serum magnesium concentrations compared with 63% of the high-dose group.

No significant differences in maternal side effects or neonatal outcomes occurred between the groups. However, rates of nausea and flushing were higher in the higher dose group, compared with the standard group (10.5% vs. 5.5% and 5.2% vs. 0%, respectively).

The study findings were limited by several factors including the lack of statistical power to evaluate clinical outcomes and lack of generalizability to extremely obese patients, as well as to settings in which the higher-dose regimen is already the standard treatment, the researchers noted. However, the results were strengthened by the use of prospective pharmacokinetic data to determine dosing.

The researchers also noted that the study was not powered to examine preeclampsia as an outcome “and there is no evidence to date to suggest women in the United States with higher BMIs are more likely to experience eclampsia,” they said. “Therefore, we caution against universally applying the study findings to obese women without also considering the potential for increased toxicity with higher dosing regimens,” they added.

Current results may not affect practice

The study objectives are unclear, as they do not change the dosing for magnesium sulfate already in use, said Baha M. Sibai, MD, of the University of Texas Health Science Center at Houston, in an interview.

Dr. Sibai said he was not surprised by the findings. “This information has been known for almost 30 years as to serum levels with different dosing irrespective of BMI,” he said. Based on current evidence, Dr. Sibai advised clinicians “not to change your practice, since there are no therapeutic levels for preventing seizures.” In fact, “the largest trial that included 10,000 women showed no difference in the rate of eclampsia between 4 grams loading with 1 g/hour [magnesium sulfate] and 6 g loading and 2 g/hour,” he explained.

Future research should focus on different outcomes, said Dr. Sibai. “The outcome should be eclampsia and not serum levels. This requires studying over 6,000 women,” he emphasized.

The study was supported by the National Institutes of Health Loan Repayment Program and a Mission Support Award from Oregon Health & Science University to Dr. Brookfield and by the Oregon Clinical & Translational Research Institute grant. Dr. Brookfield also disclosed funding from the World Health Organization. Dr. Sibai had no financial conflicts to disclose.

SOURCE: Brookfield KF et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004137.

Obese women may benefit from a higher dose of magnesium sulfate to protect against preeclampsia, based on data from a randomized trial.

Pharmacokinetic models have shown that, “in women who received a 4-g intravenous loading dose followed by a 2-g/h IV maintenance dose, obese women took approximately twice as long as women of mean body weight in the sample to achieve these previously accepted therapeutic serum magnesium concentrations,” which suggests the need for alternate dosing based on body mass index, wrote Kathleen F. Brookfield, MD, of Oregon Health & Science University, Portland, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 37 women aged 15-45 years with a BMI of 35 kg/m² or higher who were at least 32 weeks’ gestation to receive the standard Zuspan regimen of magnesium sulfate (4 g intravenous loading dose, followed by a 1-g/hour infusion) or to higher dosing (6 g IV loading dose, followed by a 2-g/hour infusion).
 

Higher dose increases effectiveness

Serum magnesium concentrations were measured at baseline, and after administration of magnesium sulfate at 1 hour, 4 hours, and delivery; the primary outcome was the proportion of women with subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration.

After 4 hours, the average magnesium sulfate concentrations were significantly higher for women in the high-dose group vs. the standard group (4.41 mg/dL vs. 3.53 mg/dL). In addition, 100% of women in the standard group had subtherapeutic serum magnesium concentrations compared with 63% of the high-dose group.

No significant differences in maternal side effects or neonatal outcomes occurred between the groups. However, rates of nausea and flushing were higher in the higher dose group, compared with the standard group (10.5% vs. 5.5% and 5.2% vs. 0%, respectively).

The study findings were limited by several factors including the lack of statistical power to evaluate clinical outcomes and lack of generalizability to extremely obese patients, as well as to settings in which the higher-dose regimen is already the standard treatment, the researchers noted. However, the results were strengthened by the use of prospective pharmacokinetic data to determine dosing.

The researchers also noted that the study was not powered to examine preeclampsia as an outcome “and there is no evidence to date to suggest women in the United States with higher BMIs are more likely to experience eclampsia,” they said. “Therefore, we caution against universally applying the study findings to obese women without also considering the potential for increased toxicity with higher dosing regimens,” they added.

Current results may not affect practice

The study objectives are unclear, as they do not change the dosing for magnesium sulfate already in use, said Baha M. Sibai, MD, of the University of Texas Health Science Center at Houston, in an interview.

Dr. Sibai said he was not surprised by the findings. “This information has been known for almost 30 years as to serum levels with different dosing irrespective of BMI,” he said. Based on current evidence, Dr. Sibai advised clinicians “not to change your practice, since there are no therapeutic levels for preventing seizures.” In fact, “the largest trial that included 10,000 women showed no difference in the rate of eclampsia between 4 grams loading with 1 g/hour [magnesium sulfate] and 6 g loading and 2 g/hour,” he explained.

Future research should focus on different outcomes, said Dr. Sibai. “The outcome should be eclampsia and not serum levels. This requires studying over 6,000 women,” he emphasized.

The study was supported by the National Institutes of Health Loan Repayment Program and a Mission Support Award from Oregon Health & Science University to Dr. Brookfield and by the Oregon Clinical & Translational Research Institute grant. Dr. Brookfield also disclosed funding from the World Health Organization. Dr. Sibai had no financial conflicts to disclose.

SOURCE: Brookfield KF et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004137.

Obese women may benefit from a higher dose of magnesium sulfate to protect against preeclampsia, based on data from a randomized trial.

Pharmacokinetic models have shown that, “in women who received a 4-g intravenous loading dose followed by a 2-g/h IV maintenance dose, obese women took approximately twice as long as women of mean body weight in the sample to achieve these previously accepted therapeutic serum magnesium concentrations,” which suggests the need for alternate dosing based on body mass index, wrote Kathleen F. Brookfield, MD, of Oregon Health & Science University, Portland, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 37 women aged 15-45 years with a BMI of 35 kg/m² or higher who were at least 32 weeks’ gestation to receive the standard Zuspan regimen of magnesium sulfate (4 g intravenous loading dose, followed by a 1-g/hour infusion) or to higher dosing (6 g IV loading dose, followed by a 2-g/hour infusion).
 

Higher dose increases effectiveness

Serum magnesium concentrations were measured at baseline, and after administration of magnesium sulfate at 1 hour, 4 hours, and delivery; the primary outcome was the proportion of women with subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration.

After 4 hours, the average magnesium sulfate concentrations were significantly higher for women in the high-dose group vs. the standard group (4.41 mg/dL vs. 3.53 mg/dL). In addition, 100% of women in the standard group had subtherapeutic serum magnesium concentrations compared with 63% of the high-dose group.

No significant differences in maternal side effects or neonatal outcomes occurred between the groups. However, rates of nausea and flushing were higher in the higher dose group, compared with the standard group (10.5% vs. 5.5% and 5.2% vs. 0%, respectively).

The study findings were limited by several factors including the lack of statistical power to evaluate clinical outcomes and lack of generalizability to extremely obese patients, as well as to settings in which the higher-dose regimen is already the standard treatment, the researchers noted. However, the results were strengthened by the use of prospective pharmacokinetic data to determine dosing.

The researchers also noted that the study was not powered to examine preeclampsia as an outcome “and there is no evidence to date to suggest women in the United States with higher BMIs are more likely to experience eclampsia,” they said. “Therefore, we caution against universally applying the study findings to obese women without also considering the potential for increased toxicity with higher dosing regimens,” they added.

Current results may not affect practice

The study objectives are unclear, as they do not change the dosing for magnesium sulfate already in use, said Baha M. Sibai, MD, of the University of Texas Health Science Center at Houston, in an interview.

Dr. Sibai said he was not surprised by the findings. “This information has been known for almost 30 years as to serum levels with different dosing irrespective of BMI,” he said. Based on current evidence, Dr. Sibai advised clinicians “not to change your practice, since there are no therapeutic levels for preventing seizures.” In fact, “the largest trial that included 10,000 women showed no difference in the rate of eclampsia between 4 grams loading with 1 g/hour [magnesium sulfate] and 6 g loading and 2 g/hour,” he explained.

Future research should focus on different outcomes, said Dr. Sibai. “The outcome should be eclampsia and not serum levels. This requires studying over 6,000 women,” he emphasized.

The study was supported by the National Institutes of Health Loan Repayment Program and a Mission Support Award from Oregon Health & Science University to Dr. Brookfield and by the Oregon Clinical & Translational Research Institute grant. Dr. Brookfield also disclosed funding from the World Health Organization. Dr. Sibai had no financial conflicts to disclose.

SOURCE: Brookfield KF et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004137.

During the initial peak of coronavirus disease 2019 (COVID-19) cases, US models suggested hospital bed shortages, hinting at the dire possibility of an overwhelmed healthcare system.^1,2 Such projections invoked widespread uncertainty and fear of massive loss of life secondary to an undersupply of treatment resources. This led many state governments to rush into a series of historically unprecedented interventions, including the rapid deployment of field hospitals. US state governments, in partnership with the Army Corps of Engineers, invested more than $660 million to transform convention halls, university campus buildings, and even abandoned industrial warehouses, into overflow hospitals for the care of COVID-19 patients.¹ Such a national scale of field hospital construction is truly historic, never before having occurred at this speed and on this scale. The only other time field hospitals were deployed nearly as widely in the United States was during the Civil War.³

The use of COVID-19 field hospital resources has been variable, with patient volumes ranging from 0 at many to more than 1,000 at the Javits Center field hospital in New York City.¹ In fact, most field hospitals did not treat any patients because early public health measures, such as stay-at-home orders, helped contain the virus in most states.¹ As of this writing, the United States has seen a dramatic surge in COVID-19 transmission and hospitalizations. This has led many states to re-introduce field hospitals into their COVID emergency response.

Our site, the Baltimore Convention Center Field Hospital (BCCFH), is one of few sites that is still operational and, to our knowledge, is the longest-running US COVID-19 field hospital. We have cared for 543 patients since opening and have had no cardiac arrests or on-site deaths. To safely offload lower-acuity COVID-19 patients from Maryland hospitals, we designed admission criteria and care processes to provide medical care on site until patients are ready for discharge. However, we anticipated that some patients would decompensate and need to return to a higher level of care. Here, we share our experience with identifying, assessing, resuscitating, and transporting unstable patients. We believe that this process has allowed us to treat about 80% of our patients in place with successful discharge to outpatient care. We have safely transferred about 20% to a higher level of care, having learned from our early cases to refine and improve our rapid response process.

Case 1

A 39-year-old man was transferred to the BCCFH on his 9th day of symptoms following a 3-day hospital admission for COVID-19. On BCCFH day 1, he developed an oxygen requirement of 2 L/min and a fever of 39.9 ^oC. Testing revealed worsening hyponatremia and new proteinuria, and a chest radiograph showed increased bilateral interstitial infiltrates. Cefdinir and fluid restriction were initiated. On BCCFH day 2, the patient developed hypotension (88/55 mm Hg), tachycardia (180 bpm), an oxygen requirement of 3 L/min, and a brief syncopal episode while sitting in bed. The charge physician and nurse were directed to the bedside. They instructed staff to bring a stretcher and intravenous (IV) supplies. Unable to locate these supplies in the triage bay, the staff found them in various locations. An IV line was inserted, and fluids administered, after which vital signs improved. Emergency medical services (EMS), which were on standby outside the field hospital, were alerted via radio; they donned personal protective equipment (PPE) and arrived at the triage bay. They were redirected to patient bedside, whence they transported the patient to the hospital.

Case 2

A 64-year-old man with a history of homelessness, myocardial infarctions, cerebrovascular accident, and paroxysmal atrial fibrillation was transferred to the BCCFH on his 6th day of symptoms after a 2-day hospitalization with COVID-19 respiratory illness. On BCCFH day 1, he had a temperature of 39.3 ^oC and atypical chest pain. A laboratory workup was unrevealing. On BCCFH day 2, he had asymptomatic hypotension and a heart rate of 60-85 bpm while receiving his usual metoprolol dose. On BCCFH day 3, he reported dizziness and was found to be hypotensive (83/41 mm Hg) and febrile (38.6 ^oC). The rapid response team (RRT) was called over radio, and they quickly assessed the patient and transported him to the triage bay. EMS, signaled through the RRT radio announcement, arrived at the triage bay and transported the patient to a traditional hospital.

The BCCFH, which opened in April 2020, is a 252-bed facility that’s spread over a single exhibit hall floor and cares for stable adult COVID-19 patients from any hospital or emergency department in Maryland (Appendix A). The site offers basic laboratory tests, radiography, a limited on-site pharmacy, and spot vital sign monitoring without telemetry. Both EMS and a certified registered nurse anesthetist are on standby in the nonclinical area and must don PPE before entering the patient care area when called. The appendices show the patient beds (Appendix B) and triage area (Appendix C) used for patient evaluation and resuscitation. Unlike conventional hospitals, the BCCFH has limited consultant access, and there are frequent changes in clinical teams. In addition to clinicians, our site has physical therapists, occupational therapists, and social work teams to assist in patient care and discharge planning. As of this writing, we have cared for 543 patients, sent to us from one-third of Maryland’s hospitals. Use during the first wave of COVID was variable, with some hospitals sending us just a few patients. One Baltimore hospital sent us 8% of its COVID-19 patients. Because the patients have an average 5-day stay, the BCCFH has offloaded 2,600 bed-days of care from acute hospitals.

COVID-19 field hospitals must be prepared to respond effectively to decompensating patients. In our experience, effective RRTs provide a standard and reproducible approach to patient emergencies. In the conventional hospital setting, these teams consist of clinicians who can be called on by any healthcare worker to quickly assess deteriorating patients and intervene with treatment. The purpose of an RRT is to provide immediate care to a patient before progression to respiratory or cardiac arrest. RRTs proliferated in US hospitals after 2004 when the Institute for Healthcare Improvement in Boston, Massachusetts, recommended such teams for improved quality of care. Though studies report conflicting findings on the impact of RRTs on mortality rates, these studies were performed in traditional hospitals with ample resources, consultants, and clinicians familiar with their patients rather than in resource-limited field hospitals.^4-13 Our field hospital has found RRTs, and the principles behind them, useful in the identification and management of decompensating COVID-19 patients.

An approach to managing decompensating patients in a COVID-19 field hospital can be considered in four phases: identification, assessment, resuscitation, and transport. Referring to these phases, the first case shows opportunities for improvement in resuscitation and transport. Although decompensation was identified, the patient was not transported to the triage bay for resuscitation, and there was confusion when trying to obtain the proper equipment. Additionally, EMS awaited the patient in the triage bay, while he remained in his cubicle, which delayed transport to an acute care hospital. The second case shows opportunities for improvement in identification and assessment. The patient had signs of impending decompensation that were not immediately recognized and treated. However, once decompensation occurred, the RRT was called and the patient was transported quickly to the triage bay, and then to the hospital via EMS.

In our experience at the BCCFH, identification is a key phase in COVID-19 care at a field hospital. Identification involves recognizing impending deterioration, as well as understanding risk factors for decompensation. For COVID-19 specifically, this requires heightened awareness of patients who are in the 2nd to 3rd week of symptoms. Data from Wuhan, China, suggest that decompensation occurs predictably around symptom day 9.^14,15 At the BCCFH, the median symptom duration for patients who decompensated and returned to a hospital was 13 days. In both introductory cases, patients were in the high-risk 2nd week of symptoms when decompensation occurred. Clinicians at the BCCFH now discuss patient symptom day during their handoffs, when rounding, and when making decisions regarding acute care transfer. Our team has also integrated clinical information from our electronic health record to create a dashboard describing those patients requiring acute care transfer to assist in identifying other trends or predictive factors (Appendix D).

Although RRTs are designed to activate when an individual patient decompensates, they should fit within a larger operational framework for patient safety. Our experience with emergencies at the BCCFH has yielded four opportunities for learning relevant to COVID-19 care in nontraditional settings (Table). These lessons include how to update staff on clinical process changes, unify communication systems, create a clinical drilling culture, and review cases to improve performance. They illustrate the importance of standardizing emergency processes, conducting frequent updates and drills, and ensuring continuous improvement. We found that, while caring for patients with an unpredictable, novel disease in a nontraditional setting and while wearing PPE and working with new colleagues during every shift, the best approach to support patients and staff is to anticipate emergencies rather than relying on individual staff to develop on-the-spot solutions.

The COVID-19 era has seen the unprecedented construction and utilization of emergency field hospital facilities. Such facilities can serve to offload some COVID-19 patients from strained healthcare infrastructure and provide essential care to these patients. We share many of the unique physical and logistical considerations specific to a nontraditional site. We optimized our space, our equipment, and our communication system. We learned how to identify, assess, resuscitate, and transport decompensating COVID-19 patients. Ultimately, our field hospital has been well utilized and successful at caring for patients because of its adaptability, accessibility, and safety record. Of the 15% of patients we transferred to a hospital for care, 81% were successfully stabilized and were willing to return to the BCCFH to complete their care. Our design included supportive care such as social work, physical and occupational therapy, and treatment of comorbidities, such as diabetes and substance use disorder. Our model demonstrates an effective nonhospital option for the care of lower-acuity, medically complex COVID-19 patients. If such facilities are used in subsequent COVID-19 outbreaks, we advise structured planning for the care of decompensating patients that takes into account the need for effective communication, drilling, and ongoing process improvement.

During the initial peak of coronavirus disease 2019 (COVID-19) cases, US models suggested hospital bed shortages, hinting at the dire possibility of an overwhelmed healthcare system.^1,2 Such projections invoked widespread uncertainty and fear of massive loss of life secondary to an undersupply of treatment resources. This led many state governments to rush into a series of historically unprecedented interventions, including the rapid deployment of field hospitals. US state governments, in partnership with the Army Corps of Engineers, invested more than $660 million to transform convention halls, university campus buildings, and even abandoned industrial warehouses, into overflow hospitals for the care of COVID-19 patients.¹ Such a national scale of field hospital construction is truly historic, never before having occurred at this speed and on this scale. The only other time field hospitals were deployed nearly as widely in the United States was during the Civil War.³

The use of COVID-19 field hospital resources has been variable, with patient volumes ranging from 0 at many to more than 1,000 at the Javits Center field hospital in New York City.¹ In fact, most field hospitals did not treat any patients because early public health measures, such as stay-at-home orders, helped contain the virus in most states.¹ As of this writing, the United States has seen a dramatic surge in COVID-19 transmission and hospitalizations. This has led many states to re-introduce field hospitals into their COVID emergency response.

Our site, the Baltimore Convention Center Field Hospital (BCCFH), is one of few sites that is still operational and, to our knowledge, is the longest-running US COVID-19 field hospital. We have cared for 543 patients since opening and have had no cardiac arrests or on-site deaths. To safely offload lower-acuity COVID-19 patients from Maryland hospitals, we designed admission criteria and care processes to provide medical care on site until patients are ready for discharge. However, we anticipated that some patients would decompensate and need to return to a higher level of care. Here, we share our experience with identifying, assessing, resuscitating, and transporting unstable patients. We believe that this process has allowed us to treat about 80% of our patients in place with successful discharge to outpatient care. We have safely transferred about 20% to a higher level of care, having learned from our early cases to refine and improve our rapid response process.

Case 1

A 39-year-old man was transferred to the BCCFH on his 9th day of symptoms following a 3-day hospital admission for COVID-19. On BCCFH day 1, he developed an oxygen requirement of 2 L/min and a fever of 39.9 ^oC. Testing revealed worsening hyponatremia and new proteinuria, and a chest radiograph showed increased bilateral interstitial infiltrates. Cefdinir and fluid restriction were initiated. On BCCFH day 2, the patient developed hypotension (88/55 mm Hg), tachycardia (180 bpm), an oxygen requirement of 3 L/min, and a brief syncopal episode while sitting in bed. The charge physician and nurse were directed to the bedside. They instructed staff to bring a stretcher and intravenous (IV) supplies. Unable to locate these supplies in the triage bay, the staff found them in various locations. An IV line was inserted, and fluids administered, after which vital signs improved. Emergency medical services (EMS), which were on standby outside the field hospital, were alerted via radio; they donned personal protective equipment (PPE) and arrived at the triage bay. They were redirected to patient bedside, whence they transported the patient to the hospital.

Case 2

A 64-year-old man with a history of homelessness, myocardial infarctions, cerebrovascular accident, and paroxysmal atrial fibrillation was transferred to the BCCFH on his 6th day of symptoms after a 2-day hospitalization with COVID-19 respiratory illness. On BCCFH day 1, he had a temperature of 39.3 ^oC and atypical chest pain. A laboratory workup was unrevealing. On BCCFH day 2, he had asymptomatic hypotension and a heart rate of 60-85 bpm while receiving his usual metoprolol dose. On BCCFH day 3, he reported dizziness and was found to be hypotensive (83/41 mm Hg) and febrile (38.6 ^oC). The rapid response team (RRT) was called over radio, and they quickly assessed the patient and transported him to the triage bay. EMS, signaled through the RRT radio announcement, arrived at the triage bay and transported the patient to a traditional hospital.

The BCCFH, which opened in April 2020, is a 252-bed facility that’s spread over a single exhibit hall floor and cares for stable adult COVID-19 patients from any hospital or emergency department in Maryland (Appendix A). The site offers basic laboratory tests, radiography, a limited on-site pharmacy, and spot vital sign monitoring without telemetry. Both EMS and a certified registered nurse anesthetist are on standby in the nonclinical area and must don PPE before entering the patient care area when called. The appendices show the patient beds (Appendix B) and triage area (Appendix C) used for patient evaluation and resuscitation. Unlike conventional hospitals, the BCCFH has limited consultant access, and there are frequent changes in clinical teams. In addition to clinicians, our site has physical therapists, occupational therapists, and social work teams to assist in patient care and discharge planning. As of this writing, we have cared for 543 patients, sent to us from one-third of Maryland’s hospitals. Use during the first wave of COVID was variable, with some hospitals sending us just a few patients. One Baltimore hospital sent us 8% of its COVID-19 patients. Because the patients have an average 5-day stay, the BCCFH has offloaded 2,600 bed-days of care from acute hospitals.

COVID-19 field hospitals must be prepared to respond effectively to decompensating patients. In our experience, effective RRTs provide a standard and reproducible approach to patient emergencies. In the conventional hospital setting, these teams consist of clinicians who can be called on by any healthcare worker to quickly assess deteriorating patients and intervene with treatment. The purpose of an RRT is to provide immediate care to a patient before progression to respiratory or cardiac arrest. RRTs proliferated in US hospitals after 2004 when the Institute for Healthcare Improvement in Boston, Massachusetts, recommended such teams for improved quality of care. Though studies report conflicting findings on the impact of RRTs on mortality rates, these studies were performed in traditional hospitals with ample resources, consultants, and clinicians familiar with their patients rather than in resource-limited field hospitals.^4-13 Our field hospital has found RRTs, and the principles behind them, useful in the identification and management of decompensating COVID-19 patients.

An approach to managing decompensating patients in a COVID-19 field hospital can be considered in four phases: identification, assessment, resuscitation, and transport. Referring to these phases, the first case shows opportunities for improvement in resuscitation and transport. Although decompensation was identified, the patient was not transported to the triage bay for resuscitation, and there was confusion when trying to obtain the proper equipment. Additionally, EMS awaited the patient in the triage bay, while he remained in his cubicle, which delayed transport to an acute care hospital. The second case shows opportunities for improvement in identification and assessment. The patient had signs of impending decompensation that were not immediately recognized and treated. However, once decompensation occurred, the RRT was called and the patient was transported quickly to the triage bay, and then to the hospital via EMS.

In our experience at the BCCFH, identification is a key phase in COVID-19 care at a field hospital. Identification involves recognizing impending deterioration, as well as understanding risk factors for decompensation. For COVID-19 specifically, this requires heightened awareness of patients who are in the 2nd to 3rd week of symptoms. Data from Wuhan, China, suggest that decompensation occurs predictably around symptom day 9.^14,15 At the BCCFH, the median symptom duration for patients who decompensated and returned to a hospital was 13 days. In both introductory cases, patients were in the high-risk 2nd week of symptoms when decompensation occurred. Clinicians at the BCCFH now discuss patient symptom day during their handoffs, when rounding, and when making decisions regarding acute care transfer. Our team has also integrated clinical information from our electronic health record to create a dashboard describing those patients requiring acute care transfer to assist in identifying other trends or predictive factors (Appendix D).

Although RRTs are designed to activate when an individual patient decompensates, they should fit within a larger operational framework for patient safety. Our experience with emergencies at the BCCFH has yielded four opportunities for learning relevant to COVID-19 care in nontraditional settings (Table). These lessons include how to update staff on clinical process changes, unify communication systems, create a clinical drilling culture, and review cases to improve performance. They illustrate the importance of standardizing emergency processes, conducting frequent updates and drills, and ensuring continuous improvement. We found that, while caring for patients with an unpredictable, novel disease in a nontraditional setting and while wearing PPE and working with new colleagues during every shift, the best approach to support patients and staff is to anticipate emergencies rather than relying on individual staff to develop on-the-spot solutions.

The COVID-19 era has seen the unprecedented construction and utilization of emergency field hospital facilities. Such facilities can serve to offload some COVID-19 patients from strained healthcare infrastructure and provide essential care to these patients. We share many of the unique physical and logistical considerations specific to a nontraditional site. We optimized our space, our equipment, and our communication system. We learned how to identify, assess, resuscitate, and transport decompensating COVID-19 patients. Ultimately, our field hospital has been well utilized and successful at caring for patients because of its adaptability, accessibility, and safety record. Of the 15% of patients we transferred to a hospital for care, 81% were successfully stabilized and were willing to return to the BCCFH to complete their care. Our design included supportive care such as social work, physical and occupational therapy, and treatment of comorbidities, such as diabetes and substance use disorder. Our model demonstrates an effective nonhospital option for the care of lower-acuity, medically complex COVID-19 patients. If such facilities are used in subsequent COVID-19 outbreaks, we advise structured planning for the care of decompensating patients that takes into account the need for effective communication, drilling, and ongoing process improvement.

During the initial peak of coronavirus disease 2019 (COVID-19) cases, US models suggested hospital bed shortages, hinting at the dire possibility of an overwhelmed healthcare system.^1,2 Such projections invoked widespread uncertainty and fear of massive loss of life secondary to an undersupply of treatment resources. This led many state governments to rush into a series of historically unprecedented interventions, including the rapid deployment of field hospitals. US state governments, in partnership with the Army Corps of Engineers, invested more than $660 million to transform convention halls, university campus buildings, and even abandoned industrial warehouses, into overflow hospitals for the care of COVID-19 patients.¹ Such a national scale of field hospital construction is truly historic, never before having occurred at this speed and on this scale. The only other time field hospitals were deployed nearly as widely in the United States was during the Civil War.³

The use of COVID-19 field hospital resources has been variable, with patient volumes ranging from 0 at many to more than 1,000 at the Javits Center field hospital in New York City.¹ In fact, most field hospitals did not treat any patients because early public health measures, such as stay-at-home orders, helped contain the virus in most states.¹ As of this writing, the United States has seen a dramatic surge in COVID-19 transmission and hospitalizations. This has led many states to re-introduce field hospitals into their COVID emergency response.

Our site, the Baltimore Convention Center Field Hospital (BCCFH), is one of few sites that is still operational and, to our knowledge, is the longest-running US COVID-19 field hospital. We have cared for 543 patients since opening and have had no cardiac arrests or on-site deaths. To safely offload lower-acuity COVID-19 patients from Maryland hospitals, we designed admission criteria and care processes to provide medical care on site until patients are ready for discharge. However, we anticipated that some patients would decompensate and need to return to a higher level of care. Here, we share our experience with identifying, assessing, resuscitating, and transporting unstable patients. We believe that this process has allowed us to treat about 80% of our patients in place with successful discharge to outpatient care. We have safely transferred about 20% to a higher level of care, having learned from our early cases to refine and improve our rapid response process.

Case 1

A 39-year-old man was transferred to the BCCFH on his 9th day of symptoms following a 3-day hospital admission for COVID-19. On BCCFH day 1, he developed an oxygen requirement of 2 L/min and a fever of 39.9 ^oC. Testing revealed worsening hyponatremia and new proteinuria, and a chest radiograph showed increased bilateral interstitial infiltrates. Cefdinir and fluid restriction were initiated. On BCCFH day 2, the patient developed hypotension (88/55 mm Hg), tachycardia (180 bpm), an oxygen requirement of 3 L/min, and a brief syncopal episode while sitting in bed. The charge physician and nurse were directed to the bedside. They instructed staff to bring a stretcher and intravenous (IV) supplies. Unable to locate these supplies in the triage bay, the staff found them in various locations. An IV line was inserted, and fluids administered, after which vital signs improved. Emergency medical services (EMS), which were on standby outside the field hospital, were alerted via radio; they donned personal protective equipment (PPE) and arrived at the triage bay. They were redirected to patient bedside, whence they transported the patient to the hospital.

Case 2

A 64-year-old man with a history of homelessness, myocardial infarctions, cerebrovascular accident, and paroxysmal atrial fibrillation was transferred to the BCCFH on his 6th day of symptoms after a 2-day hospitalization with COVID-19 respiratory illness. On BCCFH day 1, he had a temperature of 39.3 ^oC and atypical chest pain. A laboratory workup was unrevealing. On BCCFH day 2, he had asymptomatic hypotension and a heart rate of 60-85 bpm while receiving his usual metoprolol dose. On BCCFH day 3, he reported dizziness and was found to be hypotensive (83/41 mm Hg) and febrile (38.6 ^oC). The rapid response team (RRT) was called over radio, and they quickly assessed the patient and transported him to the triage bay. EMS, signaled through the RRT radio announcement, arrived at the triage bay and transported the patient to a traditional hospital.

The BCCFH, which opened in April 2020, is a 252-bed facility that’s spread over a single exhibit hall floor and cares for stable adult COVID-19 patients from any hospital or emergency department in Maryland (Appendix A). The site offers basic laboratory tests, radiography, a limited on-site pharmacy, and spot vital sign monitoring without telemetry. Both EMS and a certified registered nurse anesthetist are on standby in the nonclinical area and must don PPE before entering the patient care area when called. The appendices show the patient beds (Appendix B) and triage area (Appendix C) used for patient evaluation and resuscitation. Unlike conventional hospitals, the BCCFH has limited consultant access, and there are frequent changes in clinical teams. In addition to clinicians, our site has physical therapists, occupational therapists, and social work teams to assist in patient care and discharge planning. As of this writing, we have cared for 543 patients, sent to us from one-third of Maryland’s hospitals. Use during the first wave of COVID was variable, with some hospitals sending us just a few patients. One Baltimore hospital sent us 8% of its COVID-19 patients. Because the patients have an average 5-day stay, the BCCFH has offloaded 2,600 bed-days of care from acute hospitals.

COVID-19 field hospitals must be prepared to respond effectively to decompensating patients. In our experience, effective RRTs provide a standard and reproducible approach to patient emergencies. In the conventional hospital setting, these teams consist of clinicians who can be called on by any healthcare worker to quickly assess deteriorating patients and intervene with treatment. The purpose of an RRT is to provide immediate care to a patient before progression to respiratory or cardiac arrest. RRTs proliferated in US hospitals after 2004 when the Institute for Healthcare Improvement in Boston, Massachusetts, recommended such teams for improved quality of care. Though studies report conflicting findings on the impact of RRTs on mortality rates, these studies were performed in traditional hospitals with ample resources, consultants, and clinicians familiar with their patients rather than in resource-limited field hospitals.^4-13 Our field hospital has found RRTs, and the principles behind them, useful in the identification and management of decompensating COVID-19 patients.

An approach to managing decompensating patients in a COVID-19 field hospital can be considered in four phases: identification, assessment, resuscitation, and transport. Referring to these phases, the first case shows opportunities for improvement in resuscitation and transport. Although decompensation was identified, the patient was not transported to the triage bay for resuscitation, and there was confusion when trying to obtain the proper equipment. Additionally, EMS awaited the patient in the triage bay, while he remained in his cubicle, which delayed transport to an acute care hospital. The second case shows opportunities for improvement in identification and assessment. The patient had signs of impending decompensation that were not immediately recognized and treated. However, once decompensation occurred, the RRT was called and the patient was transported quickly to the triage bay, and then to the hospital via EMS.

In our experience at the BCCFH, identification is a key phase in COVID-19 care at a field hospital. Identification involves recognizing impending deterioration, as well as understanding risk factors for decompensation. For COVID-19 specifically, this requires heightened awareness of patients who are in the 2nd to 3rd week of symptoms. Data from Wuhan, China, suggest that decompensation occurs predictably around symptom day 9.^14,15 At the BCCFH, the median symptom duration for patients who decompensated and returned to a hospital was 13 days. In both introductory cases, patients were in the high-risk 2nd week of symptoms when decompensation occurred. Clinicians at the BCCFH now discuss patient symptom day during their handoffs, when rounding, and when making decisions regarding acute care transfer. Our team has also integrated clinical information from our electronic health record to create a dashboard describing those patients requiring acute care transfer to assist in identifying other trends or predictive factors (Appendix D).

Although RRTs are designed to activate when an individual patient decompensates, they should fit within a larger operational framework for patient safety. Our experience with emergencies at the BCCFH has yielded four opportunities for learning relevant to COVID-19 care in nontraditional settings (Table). These lessons include how to update staff on clinical process changes, unify communication systems, create a clinical drilling culture, and review cases to improve performance. They illustrate the importance of standardizing emergency processes, conducting frequent updates and drills, and ensuring continuous improvement. We found that, while caring for patients with an unpredictable, novel disease in a nontraditional setting and while wearing PPE and working with new colleagues during every shift, the best approach to support patients and staff is to anticipate emergencies rather than relying on individual staff to develop on-the-spot solutions.

The COVID-19 era has seen the unprecedented construction and utilization of emergency field hospital facilities. Such facilities can serve to offload some COVID-19 patients from strained healthcare infrastructure and provide essential care to these patients. We share many of the unique physical and logistical considerations specific to a nontraditional site. We optimized our space, our equipment, and our communication system. We learned how to identify, assess, resuscitate, and transport decompensating COVID-19 patients. Ultimately, our field hospital has been well utilized and successful at caring for patients because of its adaptability, accessibility, and safety record. Of the 15% of patients we transferred to a hospital for care, 81% were successfully stabilized and were willing to return to the BCCFH to complete their care. Our design included supportive care such as social work, physical and occupational therapy, and treatment of comorbidities, such as diabetes and substance use disorder. Our model demonstrates an effective nonhospital option for the care of lower-acuity, medically complex COVID-19 patients. If such facilities are used in subsequent COVID-19 outbreaks, we advise structured planning for the care of decompensating patients that takes into account the need for effective communication, drilling, and ongoing process improvement.