The SARS-CoV-2 pandemic has given added impetus for metagenomic testing using nanopore sequencing to progress from a research tool to routine clinical application. A study led by researchers from Guy’s and St. Thomas’ NHS Foundation Trust has shown the potential for clinical metagenomics to become a same-day test for identifying secondary infection in ventilated ICU patients. Getting results in hours rather than days would help to ensure rapid treatment with the correct antibiotic, minimize unnecessary prescriptions, and thus reduce the growing menace of antimicrobial resistance.

‘SARS-CoV-2 has put considerable strain on ICUs’

The researchers point out that the setting of an intensive care unit involves frequent staff-patient contact that imparts a risk of secondary or nosocomial infection. In addition, invasive ventilation may introduce organisms into the lungs and lead to ventilator-acquired pneumonia. This carries a high mortality and is responsible for up to 70% of antimicrobial prescribing, with current guidelines requiring empiric antibiotics pending culture results, which typically takes 2-4 days.

Many of these infection problems worsened during SARS-CoV-2. Expanded critical care capacity raised the risk of nosocomial infections, with attendant increased antimicrobial prescriptions and the threat of antimicrobial resistance. In addition, treatment of COVID-19 patients with steroid therapy potentially exacerbates bacterial or fungal infections.

The researchers, from the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London, in collaboration with the Quadram Institute in Norwich, Oxford Nanopore Technologies, and Viapath, the U.K.’s largest independent pathology service provider, noted that the pandemic thus reinforced “a need for rapid comprehensive diagnostics to improve antimicrobial stewardship and help prevent emergence and transmission of multi-drug-resistant organisms.”

“As soon as the pandemic started, our scientists realized there would be a benefit to sequencing genomes of all bacteria and fungi causing infection in COVID-19 patients while on ICU,” said Professor Jonathan Edgeworth, who led the research team.

“Within a few weeks we showed it can diagnose secondary infection, target antibiotic treatment, and detect outbreaks much earlier than current technologies – all from a single sample.”
 

Proof-of-concept study

The team performed a proof-of-concept study of nanopore metagenomics sequencing – a type of DNA sequencing that allows direct rapid unbiased detection of all organisms present in a clinical sample – on 43 surplus respiratory samples from 34 intubated COVID-19 patients with suspected secondary bacterial or fungal pneumonia. Patients were drawn from seven ICUs at St. Thomas’ Hospital, London over a 9-week period between April 11 and June 15 2020, during the first wave of COVID-19.

Their median age was 52, 70% were male, 47% White, and 44% Black or minority ethnicities. Median length of stay was 32 days and mortality 24%. Samples sent for metagenomic analysis and culture included 10 bronchoalveolar lavages, 6 tracheal aspirates, and 27 non-direct bronchoalveolar lavages.

The study, published in Genome Medicine, showed that an 8-hour metagenomics workflow was 92% sensitive (95% CI, 75% to 99%) and 82% specific (95% CI, 57% to 96%) for bacterial identification, based on culture-positive and culture-negative samples, respectively.

The main Gram-negative bacteria identified were Klebsiella spp. (53%), Citrobacter spp. (15%), and E coli (9%). The main Gram-positive bacteria were S aureus (9%), C striatum (24%) and Enterococcus spp. (12%). In addition, C albicans, other Candida spp. and Aspergillus spp. were cultured from 38%, 15%, and 9% of patients, respectively.

In every case, the initial antibiotics prescribed according to prevailing guideline recommendations would have been modified by metagenomic sequencing demonstrating the presence or absence of β-lactam-resistant genes carried by Enterobacterales.

Next day results of sequencing also detected Aspergillus fumigatus in four samples, with results 100% concordant with quantitative PCR for both the four positive and 39 negative samples. It identified two multi-drug–resistant outbreaks, one involving K pneumoniae ST307 affecting four patients and one a C striatum outbreak involving 14 patients across three ICUs.

Thus, a single sample can provide enough genetic sequence data to compare pathogen genomes with a database and accurately identify patients carrying the same strain, enabling early detection of outbreaks. This is the first time this combined benefit of a single test has been demonstrated, the team say.

Gordon Sanghera, CEO of Oxford Nanopore commented that “rapidly characterizing co-infections for precision prescribing is a vital next step for both COVID-19 patients and respiratory disease in general.”

Dr. Andrew Page of the Quadram Institute said: “We have been working on metagenomics technology for the last 7 years. It is great to see it applied to patient care during the COVID-19 pandemic.”

He said in an interview: “The pandemic has accelerated the transition from using sequencing purely in research labs to using it in the clinic to rapidly provide clinicians with information they can use to improve outcomes for patients.”
 

Potential to inform antimicrobial prescribing and infection control

“Clinical metagenomic testing provides accurate pathogen detection and antibiotic resistance prediction in a same-day laboratory workflow, with assembled genomes available the next day for genomic surveillance,” the researchers say.

The technology “could fundamentally change the multi-disciplinary team approach to managing ICU infections.” It has the potential to improve initial targeted antimicrobial treatment and infection control decisions, as well as help rapidly detect unsuspected outbreaks of multi-drug–resistant pathogens.

Professor Edgeworth told this news organization that since the study, “secondary bacterial and fungal infections have increased, perhaps due to immunomodulatory treatments or just the length of time patients spend on ICU recovering from COVID-19. This makes rapid diagnosis even more important to ensure patients get more targeted antibiotics earlier, rather than relying on generic guidelines.”

The team “are planning to move respiratory metagenomics into pilot service under our Trust’s quality improvement framework,” he revealed. This will enable them to gather data on patient benefits.  

“We also need to see how clinicians use these tests to improve antibiotic treatment, to stop antibiotics when not needed or to identify outbreaks earlier, and then how that translates into tangible benefits for individual patients and the wider NHS.”

He predicts that the technique will revolutionize the approach to prevention and treatment of serious infection in ICUs, and it is now planned to offer it as a clinical service for COVID-19 and influenza patients during the coming winter.

In addition, he said: “It can be equally applied to other samples such as tissue fluids and biopsies, including those removed at operation. It therefore has potential to impact on diagnostics for many clinical services, particularly if the progress is maintained at the current pace.”

This article first appeared on Medscape UK/Univadis.

The SARS-CoV-2 pandemic has given added impetus for metagenomic testing using nanopore sequencing to progress from a research tool to routine clinical application. A study led by researchers from Guy’s and St. Thomas’ NHS Foundation Trust has shown the potential for clinical metagenomics to become a same-day test for identifying secondary infection in ventilated ICU patients. Getting results in hours rather than days would help to ensure rapid treatment with the correct antibiotic, minimize unnecessary prescriptions, and thus reduce the growing menace of antimicrobial resistance.

‘SARS-CoV-2 has put considerable strain on ICUs’

The researchers point out that the setting of an intensive care unit involves frequent staff-patient contact that imparts a risk of secondary or nosocomial infection. In addition, invasive ventilation may introduce organisms into the lungs and lead to ventilator-acquired pneumonia. This carries a high mortality and is responsible for up to 70% of antimicrobial prescribing, with current guidelines requiring empiric antibiotics pending culture results, which typically takes 2-4 days.

Many of these infection problems worsened during SARS-CoV-2. Expanded critical care capacity raised the risk of nosocomial infections, with attendant increased antimicrobial prescriptions and the threat of antimicrobial resistance. In addition, treatment of COVID-19 patients with steroid therapy potentially exacerbates bacterial or fungal infections.

The researchers, from the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London, in collaboration with the Quadram Institute in Norwich, Oxford Nanopore Technologies, and Viapath, the U.K.’s largest independent pathology service provider, noted that the pandemic thus reinforced “a need for rapid comprehensive diagnostics to improve antimicrobial stewardship and help prevent emergence and transmission of multi-drug-resistant organisms.”

“As soon as the pandemic started, our scientists realized there would be a benefit to sequencing genomes of all bacteria and fungi causing infection in COVID-19 patients while on ICU,” said Professor Jonathan Edgeworth, who led the research team.

“Within a few weeks we showed it can diagnose secondary infection, target antibiotic treatment, and detect outbreaks much earlier than current technologies – all from a single sample.”
 

Proof-of-concept study

The team performed a proof-of-concept study of nanopore metagenomics sequencing – a type of DNA sequencing that allows direct rapid unbiased detection of all organisms present in a clinical sample – on 43 surplus respiratory samples from 34 intubated COVID-19 patients with suspected secondary bacterial or fungal pneumonia. Patients were drawn from seven ICUs at St. Thomas’ Hospital, London over a 9-week period between April 11 and June 15 2020, during the first wave of COVID-19.

Their median age was 52, 70% were male, 47% White, and 44% Black or minority ethnicities. Median length of stay was 32 days and mortality 24%. Samples sent for metagenomic analysis and culture included 10 bronchoalveolar lavages, 6 tracheal aspirates, and 27 non-direct bronchoalveolar lavages.

The study, published in Genome Medicine, showed that an 8-hour metagenomics workflow was 92% sensitive (95% CI, 75% to 99%) and 82% specific (95% CI, 57% to 96%) for bacterial identification, based on culture-positive and culture-negative samples, respectively.

The main Gram-negative bacteria identified were Klebsiella spp. (53%), Citrobacter spp. (15%), and E coli (9%). The main Gram-positive bacteria were S aureus (9%), C striatum (24%) and Enterococcus spp. (12%). In addition, C albicans, other Candida spp. and Aspergillus spp. were cultured from 38%, 15%, and 9% of patients, respectively.

In every case, the initial antibiotics prescribed according to prevailing guideline recommendations would have been modified by metagenomic sequencing demonstrating the presence or absence of β-lactam-resistant genes carried by Enterobacterales.

Next day results of sequencing also detected Aspergillus fumigatus in four samples, with results 100% concordant with quantitative PCR for both the four positive and 39 negative samples. It identified two multi-drug–resistant outbreaks, one involving K pneumoniae ST307 affecting four patients and one a C striatum outbreak involving 14 patients across three ICUs.

Thus, a single sample can provide enough genetic sequence data to compare pathogen genomes with a database and accurately identify patients carrying the same strain, enabling early detection of outbreaks. This is the first time this combined benefit of a single test has been demonstrated, the team say.

Gordon Sanghera, CEO of Oxford Nanopore commented that “rapidly characterizing co-infections for precision prescribing is a vital next step for both COVID-19 patients and respiratory disease in general.”

Dr. Andrew Page of the Quadram Institute said: “We have been working on metagenomics technology for the last 7 years. It is great to see it applied to patient care during the COVID-19 pandemic.”

He said in an interview: “The pandemic has accelerated the transition from using sequencing purely in research labs to using it in the clinic to rapidly provide clinicians with information they can use to improve outcomes for patients.”
 

Potential to inform antimicrobial prescribing and infection control

“Clinical metagenomic testing provides accurate pathogen detection and antibiotic resistance prediction in a same-day laboratory workflow, with assembled genomes available the next day for genomic surveillance,” the researchers say.

The technology “could fundamentally change the multi-disciplinary team approach to managing ICU infections.” It has the potential to improve initial targeted antimicrobial treatment and infection control decisions, as well as help rapidly detect unsuspected outbreaks of multi-drug–resistant pathogens.

Professor Edgeworth told this news organization that since the study, “secondary bacterial and fungal infections have increased, perhaps due to immunomodulatory treatments or just the length of time patients spend on ICU recovering from COVID-19. This makes rapid diagnosis even more important to ensure patients get more targeted antibiotics earlier, rather than relying on generic guidelines.”

The team “are planning to move respiratory metagenomics into pilot service under our Trust’s quality improvement framework,” he revealed. This will enable them to gather data on patient benefits.  

“We also need to see how clinicians use these tests to improve antibiotic treatment, to stop antibiotics when not needed or to identify outbreaks earlier, and then how that translates into tangible benefits for individual patients and the wider NHS.”

He predicts that the technique will revolutionize the approach to prevention and treatment of serious infection in ICUs, and it is now planned to offer it as a clinical service for COVID-19 and influenza patients during the coming winter.

In addition, he said: “It can be equally applied to other samples such as tissue fluids and biopsies, including those removed at operation. It therefore has potential to impact on diagnostics for many clinical services, particularly if the progress is maintained at the current pace.”

This article first appeared on Medscape UK/Univadis.

The SARS-CoV-2 pandemic has given added impetus for metagenomic testing using nanopore sequencing to progress from a research tool to routine clinical application. A study led by researchers from Guy’s and St. Thomas’ NHS Foundation Trust has shown the potential for clinical metagenomics to become a same-day test for identifying secondary infection in ventilated ICU patients. Getting results in hours rather than days would help to ensure rapid treatment with the correct antibiotic, minimize unnecessary prescriptions, and thus reduce the growing menace of antimicrobial resistance.

‘SARS-CoV-2 has put considerable strain on ICUs’

The researchers point out that the setting of an intensive care unit involves frequent staff-patient contact that imparts a risk of secondary or nosocomial infection. In addition, invasive ventilation may introduce organisms into the lungs and lead to ventilator-acquired pneumonia. This carries a high mortality and is responsible for up to 70% of antimicrobial prescribing, with current guidelines requiring empiric antibiotics pending culture results, which typically takes 2-4 days.

Many of these infection problems worsened during SARS-CoV-2. Expanded critical care capacity raised the risk of nosocomial infections, with attendant increased antimicrobial prescriptions and the threat of antimicrobial resistance. In addition, treatment of COVID-19 patients with steroid therapy potentially exacerbates bacterial or fungal infections.

The researchers, from the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London, in collaboration with the Quadram Institute in Norwich, Oxford Nanopore Technologies, and Viapath, the U.K.’s largest independent pathology service provider, noted that the pandemic thus reinforced “a need for rapid comprehensive diagnostics to improve antimicrobial stewardship and help prevent emergence and transmission of multi-drug-resistant organisms.”

“As soon as the pandemic started, our scientists realized there would be a benefit to sequencing genomes of all bacteria and fungi causing infection in COVID-19 patients while on ICU,” said Professor Jonathan Edgeworth, who led the research team.

“Within a few weeks we showed it can diagnose secondary infection, target antibiotic treatment, and detect outbreaks much earlier than current technologies – all from a single sample.”
 

Proof-of-concept study

The team performed a proof-of-concept study of nanopore metagenomics sequencing – a type of DNA sequencing that allows direct rapid unbiased detection of all organisms present in a clinical sample – on 43 surplus respiratory samples from 34 intubated COVID-19 patients with suspected secondary bacterial or fungal pneumonia. Patients were drawn from seven ICUs at St. Thomas’ Hospital, London over a 9-week period between April 11 and June 15 2020, during the first wave of COVID-19.

Their median age was 52, 70% were male, 47% White, and 44% Black or minority ethnicities. Median length of stay was 32 days and mortality 24%. Samples sent for metagenomic analysis and culture included 10 bronchoalveolar lavages, 6 tracheal aspirates, and 27 non-direct bronchoalveolar lavages.

The study, published in Genome Medicine, showed that an 8-hour metagenomics workflow was 92% sensitive (95% CI, 75% to 99%) and 82% specific (95% CI, 57% to 96%) for bacterial identification, based on culture-positive and culture-negative samples, respectively.

The main Gram-negative bacteria identified were Klebsiella spp. (53%), Citrobacter spp. (15%), and E coli (9%). The main Gram-positive bacteria were S aureus (9%), C striatum (24%) and Enterococcus spp. (12%). In addition, C albicans, other Candida spp. and Aspergillus spp. were cultured from 38%, 15%, and 9% of patients, respectively.

In every case, the initial antibiotics prescribed according to prevailing guideline recommendations would have been modified by metagenomic sequencing demonstrating the presence or absence of β-lactam-resistant genes carried by Enterobacterales.

Next day results of sequencing also detected Aspergillus fumigatus in four samples, with results 100% concordant with quantitative PCR for both the four positive and 39 negative samples. It identified two multi-drug–resistant outbreaks, one involving K pneumoniae ST307 affecting four patients and one a C striatum outbreak involving 14 patients across three ICUs.

Thus, a single sample can provide enough genetic sequence data to compare pathogen genomes with a database and accurately identify patients carrying the same strain, enabling early detection of outbreaks. This is the first time this combined benefit of a single test has been demonstrated, the team say.

Gordon Sanghera, CEO of Oxford Nanopore commented that “rapidly characterizing co-infections for precision prescribing is a vital next step for both COVID-19 patients and respiratory disease in general.”

Dr. Andrew Page of the Quadram Institute said: “We have been working on metagenomics technology for the last 7 years. It is great to see it applied to patient care during the COVID-19 pandemic.”

He said in an interview: “The pandemic has accelerated the transition from using sequencing purely in research labs to using it in the clinic to rapidly provide clinicians with information they can use to improve outcomes for patients.”
 

Potential to inform antimicrobial prescribing and infection control

“Clinical metagenomic testing provides accurate pathogen detection and antibiotic resistance prediction in a same-day laboratory workflow, with assembled genomes available the next day for genomic surveillance,” the researchers say.

The technology “could fundamentally change the multi-disciplinary team approach to managing ICU infections.” It has the potential to improve initial targeted antimicrobial treatment and infection control decisions, as well as help rapidly detect unsuspected outbreaks of multi-drug–resistant pathogens.

Professor Edgeworth told this news organization that since the study, “secondary bacterial and fungal infections have increased, perhaps due to immunomodulatory treatments or just the length of time patients spend on ICU recovering from COVID-19. This makes rapid diagnosis even more important to ensure patients get more targeted antibiotics earlier, rather than relying on generic guidelines.”

The team “are planning to move respiratory metagenomics into pilot service under our Trust’s quality improvement framework,” he revealed. This will enable them to gather data on patient benefits.  

“We also need to see how clinicians use these tests to improve antibiotic treatment, to stop antibiotics when not needed or to identify outbreaks earlier, and then how that translates into tangible benefits for individual patients and the wider NHS.”

He predicts that the technique will revolutionize the approach to prevention and treatment of serious infection in ICUs, and it is now planned to offer it as a clinical service for COVID-19 and influenza patients during the coming winter.

In addition, he said: “It can be equally applied to other samples such as tissue fluids and biopsies, including those removed at operation. It therefore has potential to impact on diagnostics for many clinical services, particularly if the progress is maintained at the current pace.”

This article first appeared on Medscape UK/Univadis.

LAS VEGAS – Although endoscopic resection of T1 esophageal adenocarcinoma (EAC) is associated with excellent overall survival, recurrence can occur years later, emphasizing the need for long-term surveillance, according to investigators.

Recurrence was about twice as common among patients lacking complete remission of intestinal metaplasia (CRIM) upon follow-up, reported lead author Kevin Song, MD, of the Mayo Clinic, Scottsdale, Ariz., and colleagues.

“Endoscopic resection of early-stage EAC has gained acceptance in recent years,” Dr. Song said during his presentation at the annual meeting of the American College of Gastroenterology. “While studies have demonstrated promising outcomes for short-term remission and recurrence, little is known about long-term recurrence and EAC-related mortality beyond 5 years.”

To address this knowledge gap, Dr. Song and colleagues reviewed data from 98 patients who had undergone endoscopic resection of T1 EAC at four tertiary academic centers with follow-up of at least 5 years. CRIM was defined by negative biopsies from the tubular esophagus and the gastroesophageal junction at one posttreatment surveillance endoscopy. Early recurrence was defined by a 2-year limit.

After a median follow-up of 8.76 years, 93 out of 98 patients (95%) experienced remission, while 82 patients (84%) demonstrated CRIM. Fourteen patients (14%) had recurrence of EAC, among whom eight (57%) had early recurrence at a median of 0.75 years (interquartile range, 0.43-0.80 years), while the other six (43%) had late recurrence at a median of 7.7 years (IQR, 5.20-8.77 years). Among the 93 patients entering remission, five (5.38%) had recurrence after 5 years.

CRIM was associated with a significantly lower rate of recurrence (11% vs. 46%; P = .01), generating an odds ratio of 6.55 (95% confidence interval, 1.71-26.71). Patients with CRIM also had later recurrence, at a median of 5.20 years, compared with 0.81 years for patients without CRIM. Moreover, the overall EAC-related mortality rate was 6.45%.

Dr. Song noted excellent overall survival and concluded his presentation by emphasizing the predictive value of CRIM and the need for long-term surveillance.

“CRIM should be considered the most significant endpoint for endotherapy of T1 EAC,” he said. “Surveillance is important even when early recurrence is not observed.”

Rishindra M. Reddy, MD, professor of thoracic surgery at the University of Michigan Health, Ann Arbor, agreed “100%” with Dr. Song and colleagues’ conclusion about the need for long-term surveillance.

“We struggle, in our patient population, to get people to do regular surveillance,” he said. “I think you have to have patients who have regular access to their gastroenterologist or surgeons and are willing to come in every 3 months to 6 months for surveillance endoscopies as well as CT scans.”

Dr. Reddy recommended that endoscopic resection of EAC be handled at high-volume centers.

“This really needs to be done in a multidisciplinary setting where you have both experienced endoscopists and thoracic surgeons and/or surgical oncologists who do esophagectomies to make these decisions about optimal treatment,” he said, “as well as pathologists who are more experienced in what to look for in terms of depth or lateral margins.”

The present work is a “great first study,” Dr. Reddy said. He suggested that larger real-world trials are needed to confirm findings and compare outcomes between tumor subtypes.

“I think for T1a tumors, there’s a good consensus on endoscopic mucosal resection,” he said. “I think T1b is an area where we would suggest more often doing surgery… and there’s even some nuance at a T1a level about the depth. It would be helpful to understand the risks of recurrence after [resecting] different levels of T1 tumors.”

The investigators disclosed relationships with CDX, Interpace, Lucid, and others. Dr. Reddy disclosed no relevant conflicts of interest.

LAS VEGAS – Although endoscopic resection of T1 esophageal adenocarcinoma (EAC) is associated with excellent overall survival, recurrence can occur years later, emphasizing the need for long-term surveillance, according to investigators.

Recurrence was about twice as common among patients lacking complete remission of intestinal metaplasia (CRIM) upon follow-up, reported lead author Kevin Song, MD, of the Mayo Clinic, Scottsdale, Ariz., and colleagues.

“Endoscopic resection of early-stage EAC has gained acceptance in recent years,” Dr. Song said during his presentation at the annual meeting of the American College of Gastroenterology. “While studies have demonstrated promising outcomes for short-term remission and recurrence, little is known about long-term recurrence and EAC-related mortality beyond 5 years.”

To address this knowledge gap, Dr. Song and colleagues reviewed data from 98 patients who had undergone endoscopic resection of T1 EAC at four tertiary academic centers with follow-up of at least 5 years. CRIM was defined by negative biopsies from the tubular esophagus and the gastroesophageal junction at one posttreatment surveillance endoscopy. Early recurrence was defined by a 2-year limit.

After a median follow-up of 8.76 years, 93 out of 98 patients (95%) experienced remission, while 82 patients (84%) demonstrated CRIM. Fourteen patients (14%) had recurrence of EAC, among whom eight (57%) had early recurrence at a median of 0.75 years (interquartile range, 0.43-0.80 years), while the other six (43%) had late recurrence at a median of 7.7 years (IQR, 5.20-8.77 years). Among the 93 patients entering remission, five (5.38%) had recurrence after 5 years.

CRIM was associated with a significantly lower rate of recurrence (11% vs. 46%; P = .01), generating an odds ratio of 6.55 (95% confidence interval, 1.71-26.71). Patients with CRIM also had later recurrence, at a median of 5.20 years, compared with 0.81 years for patients without CRIM. Moreover, the overall EAC-related mortality rate was 6.45%.

Dr. Song noted excellent overall survival and concluded his presentation by emphasizing the predictive value of CRIM and the need for long-term surveillance.

“CRIM should be considered the most significant endpoint for endotherapy of T1 EAC,” he said. “Surveillance is important even when early recurrence is not observed.”

Rishindra M. Reddy, MD, professor of thoracic surgery at the University of Michigan Health, Ann Arbor, agreed “100%” with Dr. Song and colleagues’ conclusion about the need for long-term surveillance.

“We struggle, in our patient population, to get people to do regular surveillance,” he said. “I think you have to have patients who have regular access to their gastroenterologist or surgeons and are willing to come in every 3 months to 6 months for surveillance endoscopies as well as CT scans.”

Dr. Reddy recommended that endoscopic resection of EAC be handled at high-volume centers.

“This really needs to be done in a multidisciplinary setting where you have both experienced endoscopists and thoracic surgeons and/or surgical oncologists who do esophagectomies to make these decisions about optimal treatment,” he said, “as well as pathologists who are more experienced in what to look for in terms of depth or lateral margins.”

The present work is a “great first study,” Dr. Reddy said. He suggested that larger real-world trials are needed to confirm findings and compare outcomes between tumor subtypes.

“I think for T1a tumors, there’s a good consensus on endoscopic mucosal resection,” he said. “I think T1b is an area where we would suggest more often doing surgery… and there’s even some nuance at a T1a level about the depth. It would be helpful to understand the risks of recurrence after [resecting] different levels of T1 tumors.”

The investigators disclosed relationships with CDX, Interpace, Lucid, and others. Dr. Reddy disclosed no relevant conflicts of interest.

LAS VEGAS – Although endoscopic resection of T1 esophageal adenocarcinoma (EAC) is associated with excellent overall survival, recurrence can occur years later, emphasizing the need for long-term surveillance, according to investigators.

Recurrence was about twice as common among patients lacking complete remission of intestinal metaplasia (CRIM) upon follow-up, reported lead author Kevin Song, MD, of the Mayo Clinic, Scottsdale, Ariz., and colleagues.

“Endoscopic resection of early-stage EAC has gained acceptance in recent years,” Dr. Song said during his presentation at the annual meeting of the American College of Gastroenterology. “While studies have demonstrated promising outcomes for short-term remission and recurrence, little is known about long-term recurrence and EAC-related mortality beyond 5 years.”

To address this knowledge gap, Dr. Song and colleagues reviewed data from 98 patients who had undergone endoscopic resection of T1 EAC at four tertiary academic centers with follow-up of at least 5 years. CRIM was defined by negative biopsies from the tubular esophagus and the gastroesophageal junction at one posttreatment surveillance endoscopy. Early recurrence was defined by a 2-year limit.

After a median follow-up of 8.76 years, 93 out of 98 patients (95%) experienced remission, while 82 patients (84%) demonstrated CRIM. Fourteen patients (14%) had recurrence of EAC, among whom eight (57%) had early recurrence at a median of 0.75 years (interquartile range, 0.43-0.80 years), while the other six (43%) had late recurrence at a median of 7.7 years (IQR, 5.20-8.77 years). Among the 93 patients entering remission, five (5.38%) had recurrence after 5 years.

CRIM was associated with a significantly lower rate of recurrence (11% vs. 46%; P = .01), generating an odds ratio of 6.55 (95% confidence interval, 1.71-26.71). Patients with CRIM also had later recurrence, at a median of 5.20 years, compared with 0.81 years for patients without CRIM. Moreover, the overall EAC-related mortality rate was 6.45%.

Dr. Song noted excellent overall survival and concluded his presentation by emphasizing the predictive value of CRIM and the need for long-term surveillance.

“CRIM should be considered the most significant endpoint for endotherapy of T1 EAC,” he said. “Surveillance is important even when early recurrence is not observed.”

Rishindra M. Reddy, MD, professor of thoracic surgery at the University of Michigan Health, Ann Arbor, agreed “100%” with Dr. Song and colleagues’ conclusion about the need for long-term surveillance.

“We struggle, in our patient population, to get people to do regular surveillance,” he said. “I think you have to have patients who have regular access to their gastroenterologist or surgeons and are willing to come in every 3 months to 6 months for surveillance endoscopies as well as CT scans.”

Dr. Reddy recommended that endoscopic resection of EAC be handled at high-volume centers.

“This really needs to be done in a multidisciplinary setting where you have both experienced endoscopists and thoracic surgeons and/or surgical oncologists who do esophagectomies to make these decisions about optimal treatment,” he said, “as well as pathologists who are more experienced in what to look for in terms of depth or lateral margins.”

The present work is a “great first study,” Dr. Reddy said. He suggested that larger real-world trials are needed to confirm findings and compare outcomes between tumor subtypes.

“I think for T1a tumors, there’s a good consensus on endoscopic mucosal resection,” he said. “I think T1b is an area where we would suggest more often doing surgery… and there’s even some nuance at a T1a level about the depth. It would be helpful to understand the risks of recurrence after [resecting] different levels of T1 tumors.”

The investigators disclosed relationships with CDX, Interpace, Lucid, and others. Dr. Reddy disclosed no relevant conflicts of interest.

As I sit down to write this article, I cannot help but reflect on the significance of today and the upcoming week – Transgender Awareness Week. While it may seem that the transgender community has made great strides in political, social, and health care forums, this week serves as a cold and grave reality check for members of the community and its allies. We still have a long way to go.

This annual tradition began in 1998 in response to the murder of a transgender woman, Rita Hester. Now Transgender Awareness Week, which occurs from Nov. 13th through the 19th is a week dedicated to help raise awareness and improve visibility of transgender people and the issues they face.¹ The week culminates on Nov. 20 with The Transgender Day of Remembrance (TDOR). The day is an annual observance to honor the memory of the transgender people who lost their lives to acts of antitransgender violence during that year.¹

Unfortunately, 2021 marks the worst year in recent history for transgender violence and anti-LGBT legislation. Over this past year, 375 transgender people were killed – 96% of whom were black and migrant trans women of color and over half (58%) of whom were sex workers.² What is even more shocking is that one in four of these victims were murdered in their own homes.² Compared with 2015, which previously held the title of “worst year,” 250 anti-LGBT bills have been introduced in state legislatures in 2021; 17 of which have been already enacted into law.³ The recently passed laws involve antitrans sports bans, religious refusal, anti-LGBTQ education, antitrans medical care, antitrans birth certificates, and an anti–all comers bill.³ In evaluating the 250 anti-LGBT bills introduced into state legislatures, at least 35 of these would prohibit transgender youth from accessing gender-affirming medical care and an additional 43 bills would allow people to deny or not provide services (including all medical care) by asserting religious freedom.³ The current bills exhibit a flagrant disregard for current best practices, which have demonstrated the benefits of gender-affirming medical care. Furthermore, they can increase the already high death toll for transgender patients by allowing providers and institutions to deny care to patients seeking services unrelated to their gender identity or sexual orientation.

Even if providers are not directly prescribing hormone therapy or performing gender-affirming procedures, all providers have encountered and will treat an LGBTQ patient at some point during their career. It is necessary for all obstetrician-gynecologists to be aware of the systemic damages and threats that LGBTQ patients face, as well as pending legislation that can significantly affect and harm patient care. As a result, we need to screen these patients for depression and history of self-harm, and to assess social support, as well as challenge legislation that can negatively affect LGBTQ care. The American College of Obstetricians and Gynecologists has not only issued formal statements condemning discrimination on the basis of gender identity and sexual orientation, but also advocates for inclusive, thoughtful, and affirming care for transgender individuals.⁴ In a time when our patients may not feel as though they can advocate for themselves, we as providers must use our voices and medical knowledge to enact these changes to encourage equitable and safe health care for all.
 

Dr. Brandt is an an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Transgender awareness month 2021. Fenway Health. 2021 Nov 1.

2. Wareham J. 375 transgender people murdered in 2021 – ‘Deadliest year’ since records began. Forbes. 2021 Nov 11..

3. Ronan R. 2021 officially becomes worst year in recent history for LGBTQ state legislative attacks as unprecedented number of states enact record-shattering number of anti-LGBTQ measures into law. Human Rights Campaign Press Release. 2021 May 7..

4. Practice Guideline. Health care for transgender and gender diverse individuals: ACOG Committee Opinion, No. 823. American College of Obstetricians and Gynecologists.

As I sit down to write this article, I cannot help but reflect on the significance of today and the upcoming week – Transgender Awareness Week. While it may seem that the transgender community has made great strides in political, social, and health care forums, this week serves as a cold and grave reality check for members of the community and its allies. We still have a long way to go.

This annual tradition began in 1998 in response to the murder of a transgender woman, Rita Hester. Now Transgender Awareness Week, which occurs from Nov. 13th through the 19th is a week dedicated to help raise awareness and improve visibility of transgender people and the issues they face.¹ The week culminates on Nov. 20 with The Transgender Day of Remembrance (TDOR). The day is an annual observance to honor the memory of the transgender people who lost their lives to acts of antitransgender violence during that year.¹

Unfortunately, 2021 marks the worst year in recent history for transgender violence and anti-LGBT legislation. Over this past year, 375 transgender people were killed – 96% of whom were black and migrant trans women of color and over half (58%) of whom were sex workers.² What is even more shocking is that one in four of these victims were murdered in their own homes.² Compared with 2015, which previously held the title of “worst year,” 250 anti-LGBT bills have been introduced in state legislatures in 2021; 17 of which have been already enacted into law.³ The recently passed laws involve antitrans sports bans, religious refusal, anti-LGBTQ education, antitrans medical care, antitrans birth certificates, and an anti–all comers bill.³ In evaluating the 250 anti-LGBT bills introduced into state legislatures, at least 35 of these would prohibit transgender youth from accessing gender-affirming medical care and an additional 43 bills would allow people to deny or not provide services (including all medical care) by asserting religious freedom.³ The current bills exhibit a flagrant disregard for current best practices, which have demonstrated the benefits of gender-affirming medical care. Furthermore, they can increase the already high death toll for transgender patients by allowing providers and institutions to deny care to patients seeking services unrelated to their gender identity or sexual orientation.

Even if providers are not directly prescribing hormone therapy or performing gender-affirming procedures, all providers have encountered and will treat an LGBTQ patient at some point during their career. It is necessary for all obstetrician-gynecologists to be aware of the systemic damages and threats that LGBTQ patients face, as well as pending legislation that can significantly affect and harm patient care. As a result, we need to screen these patients for depression and history of self-harm, and to assess social support, as well as challenge legislation that can negatively affect LGBTQ care. The American College of Obstetricians and Gynecologists has not only issued formal statements condemning discrimination on the basis of gender identity and sexual orientation, but also advocates for inclusive, thoughtful, and affirming care for transgender individuals.⁴ In a time when our patients may not feel as though they can advocate for themselves, we as providers must use our voices and medical knowledge to enact these changes to encourage equitable and safe health care for all.
 

Dr. Brandt is an an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Transgender awareness month 2021. Fenway Health. 2021 Nov 1.

2. Wareham J. 375 transgender people murdered in 2021 – ‘Deadliest year’ since records began. Forbes. 2021 Nov 11..

3. Ronan R. 2021 officially becomes worst year in recent history for LGBTQ state legislative attacks as unprecedented number of states enact record-shattering number of anti-LGBTQ measures into law. Human Rights Campaign Press Release. 2021 May 7..

4. Practice Guideline. Health care for transgender and gender diverse individuals: ACOG Committee Opinion, No. 823. American College of Obstetricians and Gynecologists.

As I sit down to write this article, I cannot help but reflect on the significance of today and the upcoming week – Transgender Awareness Week. While it may seem that the transgender community has made great strides in political, social, and health care forums, this week serves as a cold and grave reality check for members of the community and its allies. We still have a long way to go.

This annual tradition began in 1998 in response to the murder of a transgender woman, Rita Hester. Now Transgender Awareness Week, which occurs from Nov. 13th through the 19th is a week dedicated to help raise awareness and improve visibility of transgender people and the issues they face.¹ The week culminates on Nov. 20 with The Transgender Day of Remembrance (TDOR). The day is an annual observance to honor the memory of the transgender people who lost their lives to acts of antitransgender violence during that year.¹

Unfortunately, 2021 marks the worst year in recent history for transgender violence and anti-LGBT legislation. Over this past year, 375 transgender people were killed – 96% of whom were black and migrant trans women of color and over half (58%) of whom were sex workers.² What is even more shocking is that one in four of these victims were murdered in their own homes.² Compared with 2015, which previously held the title of “worst year,” 250 anti-LGBT bills have been introduced in state legislatures in 2021; 17 of which have been already enacted into law.³ The recently passed laws involve antitrans sports bans, religious refusal, anti-LGBTQ education, antitrans medical care, antitrans birth certificates, and an anti–all comers bill.³ In evaluating the 250 anti-LGBT bills introduced into state legislatures, at least 35 of these would prohibit transgender youth from accessing gender-affirming medical care and an additional 43 bills would allow people to deny or not provide services (including all medical care) by asserting religious freedom.³ The current bills exhibit a flagrant disregard for current best practices, which have demonstrated the benefits of gender-affirming medical care. Furthermore, they can increase the already high death toll for transgender patients by allowing providers and institutions to deny care to patients seeking services unrelated to their gender identity or sexual orientation.

Even if providers are not directly prescribing hormone therapy or performing gender-affirming procedures, all providers have encountered and will treat an LGBTQ patient at some point during their career. It is necessary for all obstetrician-gynecologists to be aware of the systemic damages and threats that LGBTQ patients face, as well as pending legislation that can significantly affect and harm patient care. As a result, we need to screen these patients for depression and history of self-harm, and to assess social support, as well as challenge legislation that can negatively affect LGBTQ care. The American College of Obstetricians and Gynecologists has not only issued formal statements condemning discrimination on the basis of gender identity and sexual orientation, but also advocates for inclusive, thoughtful, and affirming care for transgender individuals.⁴ In a time when our patients may not feel as though they can advocate for themselves, we as providers must use our voices and medical knowledge to enact these changes to encourage equitable and safe health care for all.
 

Dr. Brandt is an an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Transgender awareness month 2021. Fenway Health. 2021 Nov 1.

2. Wareham J. 375 transgender people murdered in 2021 – ‘Deadliest year’ since records began. Forbes. 2021 Nov 11..

3. Ronan R. 2021 officially becomes worst year in recent history for LGBTQ state legislative attacks as unprecedented number of states enact record-shattering number of anti-LGBTQ measures into law. Human Rights Campaign Press Release. 2021 May 7..

4. Practice Guideline. Health care for transgender and gender diverse individuals: ACOG Committee Opinion, No. 823. American College of Obstetricians and Gynecologists.

Treatment with endoscopic submucosal dissection (ESD) is associated with higher rates of complete remission of dysplasia at 2 years compared with cap-assisted endoscopic mucosal resection (cEMR) in patients with Barrett’s esophagus with dysplasia or early-stage intramucosal esophageal adenocarcinoma (EAC), according to study findings.

Despite the seeming advantage of ESD over cEMR, the study found similar rates of complete remission of intestinal metaplasia (CRIM) between the treatment groups at 2 years.

The study authors explained that ESD, a recent development in endoscopic resection, allows for en bloc resection of larger lesions in dysplastic Barrett’s and EAC and features less diagnostic uncertainty compared with cEMR. Findings from the study highlight the importance of this newer technique but also emphasize the utility of both treatments. “In expert hands both sets of procedures appear to be safe and well tolerated,” wrote study authors Don Codipilly, MD, of the Mayo Clinic in Rochester, Minn., and colleagues in Clinical Gastroenterology and Hepatology.

Given the lack of comparative data on the long-term outcomes of cEMR versus ESD in patients with neoplasia associated with Barrett’s esophagus, Dr. Codipilly and colleagues examined histologic outcomes in a prospectively maintained database of 537 patients who underwent endoscopic eradication therapy for Barrett’s esophagus or EAC at the Mayo Clinic between 2006 and 2020. Only patients who had undergone either cEMR (n = 456) or ESD (n = 81) followed by endoscopic ablation were included in the analysis.

The primary endpoint of the study was the rate and time to complete remission of dysplasia (CRD), which was defined by the absence of dysplasia on biopsy from the gastroesophageal junction and tubular esophagus during ≥1 surveillance endoscopy. Researchers also examined the rates of complications, such as clinically significant intraprocedural or post-procedural bleeding that required hospitalization, perforation, receipt of red blood cells within 30 days of the initial procedure, and stricture formation that required dilation within 120 days of the index procedure.

Patients in the ESD group had a longer mean length of resected specimens (23.9 vs. 10.9 mm; P <.01) as well as higher rates of en bloc (97.5% vs. 41.9%; P <.01) and R0 resection (58% vs. 20.2%; P <.01). Patients were generally balanced on other basic baseline demographics, including age, sex distribution, and smoking status.

Over a median 11.2-year follow-up period, a total of 420 patients in the cEMR group achieved CRD. In the ESD group, 48 patients achieved CRD over a median 1.4-year follow-up period. The 2-year cumulative probability of CRD was lower in patients who received cEMR versus those who received ESD (75.8% vs. 85.6%, respectively). In a univariate analysis, the odds of achieving CRD were lower in cEMR versus ESD (hazard ratio, 0.41; 95% CI, 0.31-0.54; P <.01).

According to multivariate analysis, 2 independent predictors of CRD included ESD (hazard ratio, 2.38; P <.01) and shorter Barrett’s segment length (HR, 1.11; P <.01).

The investigators also assessed whether advancements made in cEMR technique have contributed to the findings in an analysis of patients who underwent cEMR (n = 48) with ESD (n = 80) from 2015 to 2019. In this analysis, the researchers found that the odds of CRD were lower than that of ESD (HR, 0.67; 95% CI, 0.45-0.99). Additionally, higher odds of achieving CRD in the cEMR group were observed in years between 2013 and 2019 (n = 129) compared with years 2006 and 2012 (n = 112) (HR, 2.09; 95% CI, 1.59-2.75; P <.01).

Demographic and clinical variables were incorporated into a Cox proportional hazard model to identify factors associated with decreased odds of CRD. This analysis found that decreased odds of CRD were associated with longer Barrett’s esophagus segment length (HR, 0.90; P <.01) and treatment with cEMR versus ESD (HR, 0.42; P <.01).

Over median follow-up periods of 7.8 years in the cEMR group and 1.1 years in the ESD group, approximately 78.5% and 40.7% of patients, respectively, achieved CRIM. While those in the ESD group achieved CRIM earlier, the cumulative probabilities of CRIM were similar by 2 years (59.3% vs. 50.6%; HR, 0.74; 95% CI, 0.52-1.07; P =.11). Shorter Barrett’s esophagus segment was the only independent predictor of CRIM (HR, 1.16; P <.01).

The researchers noted that the study population may have included patients with more severe disease than that in the general population, which may limit the generalizability of the findings. Additionally, the lack of a randomized design was cited as an additional study limitation.

In spite of their findings, the researchers explained that “continued monitoring for additional outcomes such as recurrence are required for further elucidation of the optimal role of these procedures in the management of” neoplasia associated with Barrett’s esophagus.”

The study was funded by the National Cancer Institute and the Freeman Foundation. The researchers reported no conflicts of interest with any pharmaceutical companies.

Treatment with endoscopic submucosal dissection (ESD) is associated with higher rates of complete remission of dysplasia at 2 years compared with cap-assisted endoscopic mucosal resection (cEMR) in patients with Barrett’s esophagus with dysplasia or early-stage intramucosal esophageal adenocarcinoma (EAC), according to study findings.

Despite the seeming advantage of ESD over cEMR, the study found similar rates of complete remission of intestinal metaplasia (CRIM) between the treatment groups at 2 years.

The study authors explained that ESD, a recent development in endoscopic resection, allows for en bloc resection of larger lesions in dysplastic Barrett’s and EAC and features less diagnostic uncertainty compared with cEMR. Findings from the study highlight the importance of this newer technique but also emphasize the utility of both treatments. “In expert hands both sets of procedures appear to be safe and well tolerated,” wrote study authors Don Codipilly, MD, of the Mayo Clinic in Rochester, Minn., and colleagues in Clinical Gastroenterology and Hepatology.

Given the lack of comparative data on the long-term outcomes of cEMR versus ESD in patients with neoplasia associated with Barrett’s esophagus, Dr. Codipilly and colleagues examined histologic outcomes in a prospectively maintained database of 537 patients who underwent endoscopic eradication therapy for Barrett’s esophagus or EAC at the Mayo Clinic between 2006 and 2020. Only patients who had undergone either cEMR (n = 456) or ESD (n = 81) followed by endoscopic ablation were included in the analysis.

The primary endpoint of the study was the rate and time to complete remission of dysplasia (CRD), which was defined by the absence of dysplasia on biopsy from the gastroesophageal junction and tubular esophagus during ≥1 surveillance endoscopy. Researchers also examined the rates of complications, such as clinically significant intraprocedural or post-procedural bleeding that required hospitalization, perforation, receipt of red blood cells within 30 days of the initial procedure, and stricture formation that required dilation within 120 days of the index procedure.

Patients in the ESD group had a longer mean length of resected specimens (23.9 vs. 10.9 mm; P <.01) as well as higher rates of en bloc (97.5% vs. 41.9%; P <.01) and R0 resection (58% vs. 20.2%; P <.01). Patients were generally balanced on other basic baseline demographics, including age, sex distribution, and smoking status.

Over a median 11.2-year follow-up period, a total of 420 patients in the cEMR group achieved CRD. In the ESD group, 48 patients achieved CRD over a median 1.4-year follow-up period. The 2-year cumulative probability of CRD was lower in patients who received cEMR versus those who received ESD (75.8% vs. 85.6%, respectively). In a univariate analysis, the odds of achieving CRD were lower in cEMR versus ESD (hazard ratio, 0.41; 95% CI, 0.31-0.54; P <.01).

According to multivariate analysis, 2 independent predictors of CRD included ESD (hazard ratio, 2.38; P <.01) and shorter Barrett’s segment length (HR, 1.11; P <.01).

The investigators also assessed whether advancements made in cEMR technique have contributed to the findings in an analysis of patients who underwent cEMR (n = 48) with ESD (n = 80) from 2015 to 2019. In this analysis, the researchers found that the odds of CRD were lower than that of ESD (HR, 0.67; 95% CI, 0.45-0.99). Additionally, higher odds of achieving CRD in the cEMR group were observed in years between 2013 and 2019 (n = 129) compared with years 2006 and 2012 (n = 112) (HR, 2.09; 95% CI, 1.59-2.75; P <.01).

Demographic and clinical variables were incorporated into a Cox proportional hazard model to identify factors associated with decreased odds of CRD. This analysis found that decreased odds of CRD were associated with longer Barrett’s esophagus segment length (HR, 0.90; P <.01) and treatment with cEMR versus ESD (HR, 0.42; P <.01).

Over median follow-up periods of 7.8 years in the cEMR group and 1.1 years in the ESD group, approximately 78.5% and 40.7% of patients, respectively, achieved CRIM. While those in the ESD group achieved CRIM earlier, the cumulative probabilities of CRIM were similar by 2 years (59.3% vs. 50.6%; HR, 0.74; 95% CI, 0.52-1.07; P =.11). Shorter Barrett’s esophagus segment was the only independent predictor of CRIM (HR, 1.16; P <.01).

The researchers noted that the study population may have included patients with more severe disease than that in the general population, which may limit the generalizability of the findings. Additionally, the lack of a randomized design was cited as an additional study limitation.

In spite of their findings, the researchers explained that “continued monitoring for additional outcomes such as recurrence are required for further elucidation of the optimal role of these procedures in the management of” neoplasia associated with Barrett’s esophagus.”

The study was funded by the National Cancer Institute and the Freeman Foundation. The researchers reported no conflicts of interest with any pharmaceutical companies.

Treatment with endoscopic submucosal dissection (ESD) is associated with higher rates of complete remission of dysplasia at 2 years compared with cap-assisted endoscopic mucosal resection (cEMR) in patients with Barrett’s esophagus with dysplasia or early-stage intramucosal esophageal adenocarcinoma (EAC), according to study findings.

Despite the seeming advantage of ESD over cEMR, the study found similar rates of complete remission of intestinal metaplasia (CRIM) between the treatment groups at 2 years.

The study authors explained that ESD, a recent development in endoscopic resection, allows for en bloc resection of larger lesions in dysplastic Barrett’s and EAC and features less diagnostic uncertainty compared with cEMR. Findings from the study highlight the importance of this newer technique but also emphasize the utility of both treatments. “In expert hands both sets of procedures appear to be safe and well tolerated,” wrote study authors Don Codipilly, MD, of the Mayo Clinic in Rochester, Minn., and colleagues in Clinical Gastroenterology and Hepatology.

Given the lack of comparative data on the long-term outcomes of cEMR versus ESD in patients with neoplasia associated with Barrett’s esophagus, Dr. Codipilly and colleagues examined histologic outcomes in a prospectively maintained database of 537 patients who underwent endoscopic eradication therapy for Barrett’s esophagus or EAC at the Mayo Clinic between 2006 and 2020. Only patients who had undergone either cEMR (n = 456) or ESD (n = 81) followed by endoscopic ablation were included in the analysis.

The primary endpoint of the study was the rate and time to complete remission of dysplasia (CRD), which was defined by the absence of dysplasia on biopsy from the gastroesophageal junction and tubular esophagus during ≥1 surveillance endoscopy. Researchers also examined the rates of complications, such as clinically significant intraprocedural or post-procedural bleeding that required hospitalization, perforation, receipt of red blood cells within 30 days of the initial procedure, and stricture formation that required dilation within 120 days of the index procedure.

Patients in the ESD group had a longer mean length of resected specimens (23.9 vs. 10.9 mm; P <.01) as well as higher rates of en bloc (97.5% vs. 41.9%; P <.01) and R0 resection (58% vs. 20.2%; P <.01). Patients were generally balanced on other basic baseline demographics, including age, sex distribution, and smoking status.

Over a median 11.2-year follow-up period, a total of 420 patients in the cEMR group achieved CRD. In the ESD group, 48 patients achieved CRD over a median 1.4-year follow-up period. The 2-year cumulative probability of CRD was lower in patients who received cEMR versus those who received ESD (75.8% vs. 85.6%, respectively). In a univariate analysis, the odds of achieving CRD were lower in cEMR versus ESD (hazard ratio, 0.41; 95% CI, 0.31-0.54; P <.01).

According to multivariate analysis, 2 independent predictors of CRD included ESD (hazard ratio, 2.38; P <.01) and shorter Barrett’s segment length (HR, 1.11; P <.01).

The investigators also assessed whether advancements made in cEMR technique have contributed to the findings in an analysis of patients who underwent cEMR (n = 48) with ESD (n = 80) from 2015 to 2019. In this analysis, the researchers found that the odds of CRD were lower than that of ESD (HR, 0.67; 95% CI, 0.45-0.99). Additionally, higher odds of achieving CRD in the cEMR group were observed in years between 2013 and 2019 (n = 129) compared with years 2006 and 2012 (n = 112) (HR, 2.09; 95% CI, 1.59-2.75; P <.01).

Demographic and clinical variables were incorporated into a Cox proportional hazard model to identify factors associated with decreased odds of CRD. This analysis found that decreased odds of CRD were associated with longer Barrett’s esophagus segment length (HR, 0.90; P <.01) and treatment with cEMR versus ESD (HR, 0.42; P <.01).

Over median follow-up periods of 7.8 years in the cEMR group and 1.1 years in the ESD group, approximately 78.5% and 40.7% of patients, respectively, achieved CRIM. While those in the ESD group achieved CRIM earlier, the cumulative probabilities of CRIM were similar by 2 years (59.3% vs. 50.6%; HR, 0.74; 95% CI, 0.52-1.07; P =.11). Shorter Barrett’s esophagus segment was the only independent predictor of CRIM (HR, 1.16; P <.01).

The researchers noted that the study population may have included patients with more severe disease than that in the general population, which may limit the generalizability of the findings. Additionally, the lack of a randomized design was cited as an additional study limitation.

In spite of their findings, the researchers explained that “continued monitoring for additional outcomes such as recurrence are required for further elucidation of the optimal role of these procedures in the management of” neoplasia associated with Barrett’s esophagus.”

The study was funded by the National Cancer Institute and the Freeman Foundation. The researchers reported no conflicts of interest with any pharmaceutical companies.

While often linked to deleterious outcomes in certain disease states, the hepatocyte-produced inflammatory marker C-reactive protein (CRP) may be a checkpoint that protects against acetaminophen-induced acute liver injury, according to research findings.

Based on the study findings, researchers believe long-term suppression of CRP function or expression may increase an individual’s susceptibility to acetaminophen-induced liver injury. In contrast, CRP “could be exploited as a promising therapeutic approach to treat hepatotoxicity caused by drug overdose” wrote study authors Hai-Yun Li, MD, of the Xi’an Jiaotong University in Shaanxi, China, and colleagues in Cellular and Molecular Gastroenterology and Hepatology.

According to Dr. Li and colleagues, a major cause of acute liver failure is acetaminophen-induced liver injury, but despite this risk, very few treatment options for this condition exist. The only approved treatment for this complication is N-acetyl cysteine (NAC).

Although CRP represents a marker for inflammation following tissue injury, a study from 2020 and one from 2018 suggest the protein regulates complement activation and may modulate responses of immune cells. The authors of the current study noted that few studies have explored what roles complement activation and modulated immune cell responses via CRP play in acetaminophen-induced acute liver injury.

To further elucidate the role of CRP in this setting, Dr. Li and researchers assessed the mechanisms of CRP action both in vitro as well as in CRP mice with Fcy receptor 2B knockout. The researchers suggested CRP may modulate immune cell responses via these receptors. Additionally, the investigators assessed CRP action in mice with C3 knockout, given previous studies suggesting C3 knockout may alleviate acetaminophen-induced liver injury in mice. The researchers also investigated hepatic expression of CRP mutants that were defective in complement interaction. Finally, the researchers sought to understand the therapeutic potential of the inflammatory marker by performing intraperitoneal administration of human CRP at 2 or 6 hours after induction of acetaminophen-induced acute liver injury in wild-type mice.

Injection of 300 mg/kg acetaminophen over 24 hours led to overt liver injury in wild-type mice, which was characterized by increased levels of circulating alanine transaminase (ALT) and aspartate transaminase (AST) as well as massive necrosis of hepatocytes. The researchers noted that these manifestations were exacerbated significantly in the CRP knockout mice.

The intravenous administration of human CRP in the mice with the drug-induced liver injury rescued defects caused by mouse CRP knockout. Additionally, human CRP administration alleviated acetaminophen-induced acute liver injury in the wild-type mice. The researchers wrote that these findings demonstrate that endogenous and human CRP “are both protective,” at least in mouse models of acetaminophen-induced liver injury.

In a second experiment, the researchers examined the mechanisms involved in CRP protection in early phases of drug-induced liver injury. Based on the experiment, the researchers found that the knockout of an inhibitory Fcy receptor mediating the anti-inflammatory activities of CRP demonstrated only “marginal effects” on the protection of the protein in acetaminophen-induced liver injury. Overall, the investigators suggested that the inflammatory marker does not likely act via the cellular Fcy receptor 2B to inhibit early phases of acetaminophen-induced hepatocyte injury. Rather, the investigators explained that CRP may act via factor H, which is recruited by CRP in regulating complement activation, to inhibit overactivation of complement on injured hepatocytes. Ultimately, the researchers explained, this results in suppression of the late phase amplification of inflammation that is mediated by neutrophils’ C3a-dependent actions.

Finally, the researchers found that intraperitoneal administration of human CRP at 2.5 mg/kg in wild-type mice at 2 hours following induction of acetaminophen-induced liver injury led to “markedly reduced liver injury,” with an efficacy that was similar to that of 500 mg/kg N-acetylcysteine, the only available treatment approved for acetaminophen-induced liver injury.

The researchers noted that N-acetylcysteine is only effective during the early phases of the acetaminophen-induced liver injury and loses effectiveness at 6 hours following injury. In contrast, human CRP in this study was still highly effective at this time point. “Given that people can tolerate high levels of circulating CRP, the administration of this protein might be a promising option to treat [acetaminophen-induced liver injury] with minimal side effects,” the researchers wrote.

The study was funded by the National Natural Science Foundation of China. The researchers reported no conflicts of interest with any pharmaceutical companies.

This article was updated on Sep. 20, 2022.

While often linked to deleterious outcomes in certain disease states, the hepatocyte-produced inflammatory marker C-reactive protein (CRP) may be a checkpoint that protects against acetaminophen-induced acute liver injury, according to research findings.

Based on the study findings, researchers believe long-term suppression of CRP function or expression may increase an individual’s susceptibility to acetaminophen-induced liver injury. In contrast, CRP “could be exploited as a promising therapeutic approach to treat hepatotoxicity caused by drug overdose” wrote study authors Hai-Yun Li, MD, of the Xi’an Jiaotong University in Shaanxi, China, and colleagues in Cellular and Molecular Gastroenterology and Hepatology.

According to Dr. Li and colleagues, a major cause of acute liver failure is acetaminophen-induced liver injury, but despite this risk, very few treatment options for this condition exist. The only approved treatment for this complication is N-acetyl cysteine (NAC).

Although CRP represents a marker for inflammation following tissue injury, a study from 2020 and one from 2018 suggest the protein regulates complement activation and may modulate responses of immune cells. The authors of the current study noted that few studies have explored what roles complement activation and modulated immune cell responses via CRP play in acetaminophen-induced acute liver injury.

To further elucidate the role of CRP in this setting, Dr. Li and researchers assessed the mechanisms of CRP action both in vitro as well as in CRP mice with Fcy receptor 2B knockout. The researchers suggested CRP may modulate immune cell responses via these receptors. Additionally, the investigators assessed CRP action in mice with C3 knockout, given previous studies suggesting C3 knockout may alleviate acetaminophen-induced liver injury in mice. The researchers also investigated hepatic expression of CRP mutants that were defective in complement interaction. Finally, the researchers sought to understand the therapeutic potential of the inflammatory marker by performing intraperitoneal administration of human CRP at 2 or 6 hours after induction of acetaminophen-induced acute liver injury in wild-type mice.

Injection of 300 mg/kg acetaminophen over 24 hours led to overt liver injury in wild-type mice, which was characterized by increased levels of circulating alanine transaminase (ALT) and aspartate transaminase (AST) as well as massive necrosis of hepatocytes. The researchers noted that these manifestations were exacerbated significantly in the CRP knockout mice.

The intravenous administration of human CRP in the mice with the drug-induced liver injury rescued defects caused by mouse CRP knockout. Additionally, human CRP administration alleviated acetaminophen-induced acute liver injury in the wild-type mice. The researchers wrote that these findings demonstrate that endogenous and human CRP “are both protective,” at least in mouse models of acetaminophen-induced liver injury.

In a second experiment, the researchers examined the mechanisms involved in CRP protection in early phases of drug-induced liver injury. Based on the experiment, the researchers found that the knockout of an inhibitory Fcy receptor mediating the anti-inflammatory activities of CRP demonstrated only “marginal effects” on the protection of the protein in acetaminophen-induced liver injury. Overall, the investigators suggested that the inflammatory marker does not likely act via the cellular Fcy receptor 2B to inhibit early phases of acetaminophen-induced hepatocyte injury. Rather, the investigators explained that CRP may act via factor H, which is recruited by CRP in regulating complement activation, to inhibit overactivation of complement on injured hepatocytes. Ultimately, the researchers explained, this results in suppression of the late phase amplification of inflammation that is mediated by neutrophils’ C3a-dependent actions.

Finally, the researchers found that intraperitoneal administration of human CRP at 2.5 mg/kg in wild-type mice at 2 hours following induction of acetaminophen-induced liver injury led to “markedly reduced liver injury,” with an efficacy that was similar to that of 500 mg/kg N-acetylcysteine, the only available treatment approved for acetaminophen-induced liver injury.

The researchers noted that N-acetylcysteine is only effective during the early phases of the acetaminophen-induced liver injury and loses effectiveness at 6 hours following injury. In contrast, human CRP in this study was still highly effective at this time point. “Given that people can tolerate high levels of circulating CRP, the administration of this protein might be a promising option to treat [acetaminophen-induced liver injury] with minimal side effects,” the researchers wrote.

The study was funded by the National Natural Science Foundation of China. The researchers reported no conflicts of interest with any pharmaceutical companies.

This article was updated on Sep. 20, 2022.

While often linked to deleterious outcomes in certain disease states, the hepatocyte-produced inflammatory marker C-reactive protein (CRP) may be a checkpoint that protects against acetaminophen-induced acute liver injury, according to research findings.

Based on the study findings, researchers believe long-term suppression of CRP function or expression may increase an individual’s susceptibility to acetaminophen-induced liver injury. In contrast, CRP “could be exploited as a promising therapeutic approach to treat hepatotoxicity caused by drug overdose” wrote study authors Hai-Yun Li, MD, of the Xi’an Jiaotong University in Shaanxi, China, and colleagues in Cellular and Molecular Gastroenterology and Hepatology.

According to Dr. Li and colleagues, a major cause of acute liver failure is acetaminophen-induced liver injury, but despite this risk, very few treatment options for this condition exist. The only approved treatment for this complication is N-acetyl cysteine (NAC).

Although CRP represents a marker for inflammation following tissue injury, a study from 2020 and one from 2018 suggest the protein regulates complement activation and may modulate responses of immune cells. The authors of the current study noted that few studies have explored what roles complement activation and modulated immune cell responses via CRP play in acetaminophen-induced acute liver injury.

To further elucidate the role of CRP in this setting, Dr. Li and researchers assessed the mechanisms of CRP action both in vitro as well as in CRP mice with Fcy receptor 2B knockout. The researchers suggested CRP may modulate immune cell responses via these receptors. Additionally, the investigators assessed CRP action in mice with C3 knockout, given previous studies suggesting C3 knockout may alleviate acetaminophen-induced liver injury in mice. The researchers also investigated hepatic expression of CRP mutants that were defective in complement interaction. Finally, the researchers sought to understand the therapeutic potential of the inflammatory marker by performing intraperitoneal administration of human CRP at 2 or 6 hours after induction of acetaminophen-induced acute liver injury in wild-type mice.

Injection of 300 mg/kg acetaminophen over 24 hours led to overt liver injury in wild-type mice, which was characterized by increased levels of circulating alanine transaminase (ALT) and aspartate transaminase (AST) as well as massive necrosis of hepatocytes. The researchers noted that these manifestations were exacerbated significantly in the CRP knockout mice.

The intravenous administration of human CRP in the mice with the drug-induced liver injury rescued defects caused by mouse CRP knockout. Additionally, human CRP administration alleviated acetaminophen-induced acute liver injury in the wild-type mice. The researchers wrote that these findings demonstrate that endogenous and human CRP “are both protective,” at least in mouse models of acetaminophen-induced liver injury.

In a second experiment, the researchers examined the mechanisms involved in CRP protection in early phases of drug-induced liver injury. Based on the experiment, the researchers found that the knockout of an inhibitory Fcy receptor mediating the anti-inflammatory activities of CRP demonstrated only “marginal effects” on the protection of the protein in acetaminophen-induced liver injury. Overall, the investigators suggested that the inflammatory marker does not likely act via the cellular Fcy receptor 2B to inhibit early phases of acetaminophen-induced hepatocyte injury. Rather, the investigators explained that CRP may act via factor H, which is recruited by CRP in regulating complement activation, to inhibit overactivation of complement on injured hepatocytes. Ultimately, the researchers explained, this results in suppression of the late phase amplification of inflammation that is mediated by neutrophils’ C3a-dependent actions.

Finally, the researchers found that intraperitoneal administration of human CRP at 2.5 mg/kg in wild-type mice at 2 hours following induction of acetaminophen-induced liver injury led to “markedly reduced liver injury,” with an efficacy that was similar to that of 500 mg/kg N-acetylcysteine, the only available treatment approved for acetaminophen-induced liver injury.

The researchers noted that N-acetylcysteine is only effective during the early phases of the acetaminophen-induced liver injury and loses effectiveness at 6 hours following injury. In contrast, human CRP in this study was still highly effective at this time point. “Given that people can tolerate high levels of circulating CRP, the administration of this protein might be a promising option to treat [acetaminophen-induced liver injury] with minimal side effects,” the researchers wrote.

The study was funded by the National Natural Science Foundation of China. The researchers reported no conflicts of interest with any pharmaceutical companies.

This article was updated on Sep. 20, 2022.

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

A new survey of U.S. patients with breast cancer found that 42% were using cannabis, primarily to relieve side effects associated with treatment, such as pain, anxiety, nausea, and insomnia.

Most (75%) of the patients who reported using cannabis said it was extremely helpful or very helpful in alleviating symptoms.

The authors warn of potential safety concerns with cannabis, especially with the use of unregulated products.

In addition, the survey found that physicians were not highly regarded as a source of information about cannabis use. Only 39% of patients said that they discussed cannabis with their physicians; 28% reported feeling uncomfortable when broaching the topic. Only 4% indicated that physicians were the most helpful source of information about cannabis.

The survey involved 612 patients with breast cancer. The results were published online Oct. 12 in Cancer.

“Our study highlights an important opportunity for providers to initiate informed conversations about medical cannabis with their patients, as the evidence shows that many are using medical cannabis without our knowledge or guidance,” said lead author Marisa Weiss, MD, of Breastcancer.org and the Lankenau Medical Center, near Philadelphia. “Not knowing whether or not our cancer patients are using cannabis is a major blind spot in our ability to provide optimal care,” she said.

Cannabis in one form or another has been legalized in many states across America, and even in states where it hasn’t been legalized, people are using it.

“Even though many states have relaxed their laws on cannabis, it remains a Schedule I drug on the federal level and is essentially still considered illegal,” commented Donald I. Abrams, MD, professor of medicine at the University of California, San Francisco, and an integrative oncologist at the UCSF Osher Center for Integrative Medicine. “This is why many physicians are uncomfortable discussing it with patients,” he said.

“Cannabis use isn’t taught in medical school, and until that changes, I don’t know how physicians are going to be advisers for this,” said Dr. Abrams, who was approached by this news organization for comment.

This “is a really nice study in that it looks at a large group of breast cancer patients from the community ... It’s not from a single institution [such as this previous study] and so a more representative mix,” Dr. Abrams said.

However, he also commented that the article had a “scent of ‘reefer madness’” about it, given its emphasis on potential harms and safety concerns.

“It’s interesting how alcohol is considered mainstream but cannabis has been demonized,” he said. “Especially for women with breast cancer, it’s so clear that alcohol is related to the development of postmenopausal breast cancer. As a recreational intervention, cannabis in my mind appears to be much safer for women for relaxation.”

“The one thing I worry about are patients who take highly concentrated CBD [cannabidiol] oil, as it can block the metabolism of prescription drugs and allow them to build up in the blood,” Dr. Abrams said. “I advise people against using these products.”
 

Cannabis to relieve symptoms

Previous studies have noted widespread use of cannabis among patients with cancer. For example, a large study from Israel that included nearly 3,000 participants found that cannabis use improved a variety of cancer-related symptoms, including nausea and vomiting, sleep disorders, pain, anxiety, and depression. Among those with cancer who survived to 6 months and who finished the study protocol, 60% achieved “treatment success.” Of note, at 6 months, 36% of patients had stopped taking opioids, and for 9.9%, the dose of opioids had decreased.

In the current study, dubbed the Coala-T-Cannabis study, the investigators approached U.S. members of the Breastcancer.org and Healthline.com communities who self-reported that they had been diagnosed with breast cancer within the past 5 years; 612 surveys were completed.

Half of all respondents said they had looked for information on medical cannabis, but most were unsatisfied with the information that they had received. Only 6% were extremely satisfied; 25% were very satisfied with the information.

Most patients (39%) did not discuss cannabis use with their physicians. Of those who did, 28% reported feeling uncomfortable discussing the topic. Only 4% of survey respondents indicated that physicians were the most helpful source of cannabis information.

Regarding which source of information was most helpful, 22% said websites, 18% said family members or friends, 12% said staffers and pharmacists in dispensaries, and 7% said other patients with breast cancer.

Forty-two percent of the survey respondents said they used cannabis for medical purposes and for relief of symptoms, which included pain (78%), insomnia (70%), anxiety (57%), stress (51%), and nausea/vomiting (46%).

In addition, 49% believed that medical cannabis could be used to treat the cancer itself.

A fair number were also using cannabis for recreational purposes. Of those who used cannabis, only 23% reported that they used it for medical purposes only.

Participants used cannabis in a variety of forms. The most popular form of consumption was as edibles (70%), followed by liquids/tinctures (65%), smoking (51%), topicals (46%), and vape pens (45%). Participants reported using an average of 3.7 different products.
 

Safety concerns?

The authors caution about the use of cannabis while receiving anticancer therapies because such use “raises important efficacy and safety concerns.”

“Many chemotherapy agents as well as cannabinoids are metabolized in the liver’s p450 cytochrome system,” Dr. Weiss and colleagues note, and the mechanism by which cannabinoids interact with particular CYP450 isoenzymes “has the potential to alter the metabolism of other medications and lead to adverse side effects.”

They also question the safety of some of the cannabis products that are being used. Participants reported receiving cannabis from a variety of sources, which included state-regulated dispensaries, “dealers,” and family/friends.

Three-quarters of respondents believed that cannabis was better than “chemicals” and that the benefits outweighed the risks. But many of the products used are unregulated, the authors point out.

“Providers should communicate clearly about the health and safety concerns associated with certain cannabis products and methods of delivery,” they conclude. “Without these measures, patients may make these decisions without qualified medical guidance, obtain poor-quality cannabis products, and consume them through potentially hazardous delivery methods during various types of cancer therapies.”

The study was supported by research grants from Ananda Health/Ecofibre and the Dr. Philip Reeves Legacy Fund. Several coauthors reported relationships with industry, as noted in the article. Dr. Abrams owns stock in Cannformatics and Lumen; he has received honorarium from Clever Leaves and Maui Grown Therapies and speaker honorarium from GW Pharmaceuticals.

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

A new survey of U.S. patients with breast cancer found that 42% were using cannabis, primarily to relieve side effects associated with treatment, such as pain, anxiety, nausea, and insomnia.

Most (75%) of the patients who reported using cannabis said it was extremely helpful or very helpful in alleviating symptoms.

The authors warn of potential safety concerns with cannabis, especially with the use of unregulated products.

In addition, the survey found that physicians were not highly regarded as a source of information about cannabis use. Only 39% of patients said that they discussed cannabis with their physicians; 28% reported feeling uncomfortable when broaching the topic. Only 4% indicated that physicians were the most helpful source of information about cannabis.

The survey involved 612 patients with breast cancer. The results were published online Oct. 12 in Cancer.

“Our study highlights an important opportunity for providers to initiate informed conversations about medical cannabis with their patients, as the evidence shows that many are using medical cannabis without our knowledge or guidance,” said lead author Marisa Weiss, MD, of Breastcancer.org and the Lankenau Medical Center, near Philadelphia. “Not knowing whether or not our cancer patients are using cannabis is a major blind spot in our ability to provide optimal care,” she said.

Cannabis in one form or another has been legalized in many states across America, and even in states where it hasn’t been legalized, people are using it.

“Even though many states have relaxed their laws on cannabis, it remains a Schedule I drug on the federal level and is essentially still considered illegal,” commented Donald I. Abrams, MD, professor of medicine at the University of California, San Francisco, and an integrative oncologist at the UCSF Osher Center for Integrative Medicine. “This is why many physicians are uncomfortable discussing it with patients,” he said.

“Cannabis use isn’t taught in medical school, and until that changes, I don’t know how physicians are going to be advisers for this,” said Dr. Abrams, who was approached by this news organization for comment.

This “is a really nice study in that it looks at a large group of breast cancer patients from the community ... It’s not from a single institution [such as this previous study] and so a more representative mix,” Dr. Abrams said.

However, he also commented that the article had a “scent of ‘reefer madness’” about it, given its emphasis on potential harms and safety concerns.

“It’s interesting how alcohol is considered mainstream but cannabis has been demonized,” he said. “Especially for women with breast cancer, it’s so clear that alcohol is related to the development of postmenopausal breast cancer. As a recreational intervention, cannabis in my mind appears to be much safer for women for relaxation.”

“The one thing I worry about are patients who take highly concentrated CBD [cannabidiol] oil, as it can block the metabolism of prescription drugs and allow them to build up in the blood,” Dr. Abrams said. “I advise people against using these products.”
 

Cannabis to relieve symptoms

Previous studies have noted widespread use of cannabis among patients with cancer. For example, a large study from Israel that included nearly 3,000 participants found that cannabis use improved a variety of cancer-related symptoms, including nausea and vomiting, sleep disorders, pain, anxiety, and depression. Among those with cancer who survived to 6 months and who finished the study protocol, 60% achieved “treatment success.” Of note, at 6 months, 36% of patients had stopped taking opioids, and for 9.9%, the dose of opioids had decreased.

In the current study, dubbed the Coala-T-Cannabis study, the investigators approached U.S. members of the Breastcancer.org and Healthline.com communities who self-reported that they had been diagnosed with breast cancer within the past 5 years; 612 surveys were completed.

Half of all respondents said they had looked for information on medical cannabis, but most were unsatisfied with the information that they had received. Only 6% were extremely satisfied; 25% were very satisfied with the information.

Most patients (39%) did not discuss cannabis use with their physicians. Of those who did, 28% reported feeling uncomfortable discussing the topic. Only 4% of survey respondents indicated that physicians were the most helpful source of cannabis information.

Regarding which source of information was most helpful, 22% said websites, 18% said family members or friends, 12% said staffers and pharmacists in dispensaries, and 7% said other patients with breast cancer.

Forty-two percent of the survey respondents said they used cannabis for medical purposes and for relief of symptoms, which included pain (78%), insomnia (70%), anxiety (57%), stress (51%), and nausea/vomiting (46%).

In addition, 49% believed that medical cannabis could be used to treat the cancer itself.

A fair number were also using cannabis for recreational purposes. Of those who used cannabis, only 23% reported that they used it for medical purposes only.

Participants used cannabis in a variety of forms. The most popular form of consumption was as edibles (70%), followed by liquids/tinctures (65%), smoking (51%), topicals (46%), and vape pens (45%). Participants reported using an average of 3.7 different products.
 

Safety concerns?

The authors caution about the use of cannabis while receiving anticancer therapies because such use “raises important efficacy and safety concerns.”

“Many chemotherapy agents as well as cannabinoids are metabolized in the liver’s p450 cytochrome system,” Dr. Weiss and colleagues note, and the mechanism by which cannabinoids interact with particular CYP450 isoenzymes “has the potential to alter the metabolism of other medications and lead to adverse side effects.”

They also question the safety of some of the cannabis products that are being used. Participants reported receiving cannabis from a variety of sources, which included state-regulated dispensaries, “dealers,” and family/friends.

Three-quarters of respondents believed that cannabis was better than “chemicals” and that the benefits outweighed the risks. But many of the products used are unregulated, the authors point out.

“Providers should communicate clearly about the health and safety concerns associated with certain cannabis products and methods of delivery,” they conclude. “Without these measures, patients may make these decisions without qualified medical guidance, obtain poor-quality cannabis products, and consume them through potentially hazardous delivery methods during various types of cancer therapies.”

The study was supported by research grants from Ananda Health/Ecofibre and the Dr. Philip Reeves Legacy Fund. Several coauthors reported relationships with industry, as noted in the article. Dr. Abrams owns stock in Cannformatics and Lumen; he has received honorarium from Clever Leaves and Maui Grown Therapies and speaker honorarium from GW Pharmaceuticals.

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

A new survey of U.S. patients with breast cancer found that 42% were using cannabis, primarily to relieve side effects associated with treatment, such as pain, anxiety, nausea, and insomnia.

Most (75%) of the patients who reported using cannabis said it was extremely helpful or very helpful in alleviating symptoms.

The authors warn of potential safety concerns with cannabis, especially with the use of unregulated products.

In addition, the survey found that physicians were not highly regarded as a source of information about cannabis use. Only 39% of patients said that they discussed cannabis with their physicians; 28% reported feeling uncomfortable when broaching the topic. Only 4% indicated that physicians were the most helpful source of information about cannabis.

The survey involved 612 patients with breast cancer. The results were published online Oct. 12 in Cancer.

“Our study highlights an important opportunity for providers to initiate informed conversations about medical cannabis with their patients, as the evidence shows that many are using medical cannabis without our knowledge or guidance,” said lead author Marisa Weiss, MD, of Breastcancer.org and the Lankenau Medical Center, near Philadelphia. “Not knowing whether or not our cancer patients are using cannabis is a major blind spot in our ability to provide optimal care,” she said.

Cannabis in one form or another has been legalized in many states across America, and even in states where it hasn’t been legalized, people are using it.

“Even though many states have relaxed their laws on cannabis, it remains a Schedule I drug on the federal level and is essentially still considered illegal,” commented Donald I. Abrams, MD, professor of medicine at the University of California, San Francisco, and an integrative oncologist at the UCSF Osher Center for Integrative Medicine. “This is why many physicians are uncomfortable discussing it with patients,” he said.

“Cannabis use isn’t taught in medical school, and until that changes, I don’t know how physicians are going to be advisers for this,” said Dr. Abrams, who was approached by this news organization for comment.

This “is a really nice study in that it looks at a large group of breast cancer patients from the community ... It’s not from a single institution [such as this previous study] and so a more representative mix,” Dr. Abrams said.

However, he also commented that the article had a “scent of ‘reefer madness’” about it, given its emphasis on potential harms and safety concerns.

“It’s interesting how alcohol is considered mainstream but cannabis has been demonized,” he said. “Especially for women with breast cancer, it’s so clear that alcohol is related to the development of postmenopausal breast cancer. As a recreational intervention, cannabis in my mind appears to be much safer for women for relaxation.”

“The one thing I worry about are patients who take highly concentrated CBD [cannabidiol] oil, as it can block the metabolism of prescription drugs and allow them to build up in the blood,” Dr. Abrams said. “I advise people against using these products.”
 

Cannabis to relieve symptoms

Previous studies have noted widespread use of cannabis among patients with cancer. For example, a large study from Israel that included nearly 3,000 participants found that cannabis use improved a variety of cancer-related symptoms, including nausea and vomiting, sleep disorders, pain, anxiety, and depression. Among those with cancer who survived to 6 months and who finished the study protocol, 60% achieved “treatment success.” Of note, at 6 months, 36% of patients had stopped taking opioids, and for 9.9%, the dose of opioids had decreased.

In the current study, dubbed the Coala-T-Cannabis study, the investigators approached U.S. members of the Breastcancer.org and Healthline.com communities who self-reported that they had been diagnosed with breast cancer within the past 5 years; 612 surveys were completed.

Half of all respondents said they had looked for information on medical cannabis, but most were unsatisfied with the information that they had received. Only 6% were extremely satisfied; 25% were very satisfied with the information.

Most patients (39%) did not discuss cannabis use with their physicians. Of those who did, 28% reported feeling uncomfortable discussing the topic. Only 4% of survey respondents indicated that physicians were the most helpful source of cannabis information.

Regarding which source of information was most helpful, 22% said websites, 18% said family members or friends, 12% said staffers and pharmacists in dispensaries, and 7% said other patients with breast cancer.

Forty-two percent of the survey respondents said they used cannabis for medical purposes and for relief of symptoms, which included pain (78%), insomnia (70%), anxiety (57%), stress (51%), and nausea/vomiting (46%).

In addition, 49% believed that medical cannabis could be used to treat the cancer itself.

A fair number were also using cannabis for recreational purposes. Of those who used cannabis, only 23% reported that they used it for medical purposes only.

Participants used cannabis in a variety of forms. The most popular form of consumption was as edibles (70%), followed by liquids/tinctures (65%), smoking (51%), topicals (46%), and vape pens (45%). Participants reported using an average of 3.7 different products.
 

Safety concerns?

The authors caution about the use of cannabis while receiving anticancer therapies because such use “raises important efficacy and safety concerns.”

“Many chemotherapy agents as well as cannabinoids are metabolized in the liver’s p450 cytochrome system,” Dr. Weiss and colleagues note, and the mechanism by which cannabinoids interact with particular CYP450 isoenzymes “has the potential to alter the metabolism of other medications and lead to adverse side effects.”

They also question the safety of some of the cannabis products that are being used. Participants reported receiving cannabis from a variety of sources, which included state-regulated dispensaries, “dealers,” and family/friends.

Three-quarters of respondents believed that cannabis was better than “chemicals” and that the benefits outweighed the risks. But many of the products used are unregulated, the authors point out.

“Providers should communicate clearly about the health and safety concerns associated with certain cannabis products and methods of delivery,” they conclude. “Without these measures, patients may make these decisions without qualified medical guidance, obtain poor-quality cannabis products, and consume them through potentially hazardous delivery methods during various types of cancer therapies.”

The study was supported by research grants from Ananda Health/Ecofibre and the Dr. Philip Reeves Legacy Fund. Several coauthors reported relationships with industry, as noted in the article. Dr. Abrams owns stock in Cannformatics and Lumen; he has received honorarium from Clever Leaves and Maui Grown Therapies and speaker honorarium from GW Pharmaceuticals.

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

Mothers who use cannabis during pregnancy risk disrupting immune gene networks in the placenta and potentially increasing the risk of anxiety and hyperactivity in their children.

These findings emerged from a study led by Yasmin Hurd, PhD, a professor of psychiatry and director of the Addiction Institute at the Icahn School of Medicine at Mount Sinai, New York, and Yoko Nomura, PhD, a professor of behavioral neuroscience at Queen’s College, City University of New York, that was published online in Proceedings of the National Academy of Sciences.

The analysis assessed the effects of gestational maternal cannabis use on psychosocial and physiological measures in young children as well as its potentially immunomodulatory effect on the in utero environment as reflected in the placental transcriptome.

Participants were drawn from a larger cohort in a study launched in 2012; the investigators evaluated offspring aged 3-6 years for hair hormone levels, neurobehavioral traits on the Behavioral Assessment System for Children survey, and heart rate variability (HRV) at rest and during auditory startle.

The cohort consisted of 322 mother-child dyads and children with prenatal exposure to cannabis were compared with those having no exposure. The cohort consisted of 251 non–cannabis-using mothers and 71 cannabis-using mothers, with mean maternal ages in the two groups of 28.46 years and 25.91 years, respectively, The mothers gave birth at Mount Sinai and they and their children were assessed annually at affiliated medical centers in Mount Sinai’s catchment area.

For a subset of children with behavioral assessments, placental specimens collected at birth were processed for RNA sequencing.

Among the findings:

• Maternal cannabis use was associated with reduced maternal and paternal age, more single-mother pregnancies, state anxiety, trait anxiety, depression, cigarette smoking, and African American race.
• Hair hormone analysis revealed increased cortisol levels in the children of cannabis-using mothers, and was associated with greater anxiety, aggression, and hyperactivity.
• Affected children showed a reduction in the high-frequency component of HRV at baseline, reflecting reduced vagal tone.
• In the placenta, there was reduced expression of many genes involved in immune system function. These included genes for type I interferon, neutrophil, and cytokine-signaling pathways.

Several of these genes organized into coexpression networks that correlated with child anxiety and hyperactivity.

The principal active component of cannabis, tetrahydrocannabinol (THC), targets the endocannabinoid system in placental tissue and the developing brain, the authors noted. Exposure during pregnancy is associated with a range of adverse outcomes from fetal growth restriction to low birth weight and preterm birth.

“There are cannabinoid receptors on immune cells, and it is known that cannabinoids can alter immune function, which is important for maintaining maternal tolerance and protecting the fetus,” Dr. Hurd said. “It’s not surprising that something that affects the immune cells can have an impact on the developing fetus.”

“Overall, our findings reveal a relationship between [maternal cannabis use] and immune response gene networks in the placenta as a potential mediator of risk for anxiety-related problems in early childhood,” Dr. Hurd and colleagues wrote, adding that the results have significant implications for defining mental health issues in the children gestated by cannabis-smoking mothers.

Their results align with previous research indicating a greater risk for psychiatric illness in children with prenatal cannabis exposure from maternal use.

“While data are pretty limited in this realm, there are other studies that demonstrate a relationship between early child developmental and behavioral measures and cannabis use during pregnancy,” Camille Hoffman, MD, MSc, a high-risk obstetrics specialist and an associate professor at the University of Colorado at Denver, Aurora, said in an interview. “Our research group found children exposed to cannabis in utero at 10 weeks’ gestation and beyond were less interactive and more withdrawn than children who were not exposed.”

And THC remains in maternal breast milk even 6 weeks after usage stops.

The long-term effects of prenatal cannabis exposure remain to be determined and it is unknown whether the effects of gestational THC might attenuate as a child grows older. “We use early childhood measures in research as a proxy for the later development of diagnosed mental health conditions or behavioral problems,” Dr. Hoffman explained. “We know when we do this that not every child with an abnormal score early will go on to develop an actual condition. Fortunately, or unfortunately, other factors and exposures during childhood can change the trajectory for the better or worse.”

According to Dr. Hurd, child development is a dynamic process and epigenetic events in utero need not be deterministic. “The important thing is to identify children at risk early and to be able to go in and try to improve the environment they’re being raised in – not in terms of impoverishment but in terms of positive nurturing and giving the mother and family support.”

At the prenatal level, what’s the best advice for cannabis-using mothers-to-be? “If a woman doesn’t know she’s pregnant and has been using cannabis, taking extra choline for the remainder of the pregnancy can help buffer the potential negative impact of the cannabis exposure,” Dr. Hoffman said. The Food and Drug Administration and the American Medical Association recommend a dose of 550 mg daily. “The same is true for alcohol, which we know is also very bad for fetal brain development. This is not to say go ahead and use these substances and just take choline. The choline is more to try and salvage damage to the fetal brain that may have already occurred.”

This study was supported by the National Institute of Mental Health and the National Institute on Drug Abuse. The authors declared no competing interests. Dr. Hoffman disclosed no conflicts of interest with respect to her comments.

Mothers who use cannabis during pregnancy risk disrupting immune gene networks in the placenta and potentially increasing the risk of anxiety and hyperactivity in their children.

These findings emerged from a study led by Yasmin Hurd, PhD, a professor of psychiatry and director of the Addiction Institute at the Icahn School of Medicine at Mount Sinai, New York, and Yoko Nomura, PhD, a professor of behavioral neuroscience at Queen’s College, City University of New York, that was published online in Proceedings of the National Academy of Sciences.

The analysis assessed the effects of gestational maternal cannabis use on psychosocial and physiological measures in young children as well as its potentially immunomodulatory effect on the in utero environment as reflected in the placental transcriptome.

Participants were drawn from a larger cohort in a study launched in 2012; the investigators evaluated offspring aged 3-6 years for hair hormone levels, neurobehavioral traits on the Behavioral Assessment System for Children survey, and heart rate variability (HRV) at rest and during auditory startle.

The cohort consisted of 322 mother-child dyads and children with prenatal exposure to cannabis were compared with those having no exposure. The cohort consisted of 251 non–cannabis-using mothers and 71 cannabis-using mothers, with mean maternal ages in the two groups of 28.46 years and 25.91 years, respectively, The mothers gave birth at Mount Sinai and they and their children were assessed annually at affiliated medical centers in Mount Sinai’s catchment area.

For a subset of children with behavioral assessments, placental specimens collected at birth were processed for RNA sequencing.

Among the findings:

• Maternal cannabis use was associated with reduced maternal and paternal age, more single-mother pregnancies, state anxiety, trait anxiety, depression, cigarette smoking, and African American race.
• Hair hormone analysis revealed increased cortisol levels in the children of cannabis-using mothers, and was associated with greater anxiety, aggression, and hyperactivity.
• Affected children showed a reduction in the high-frequency component of HRV at baseline, reflecting reduced vagal tone.
• In the placenta, there was reduced expression of many genes involved in immune system function. These included genes for type I interferon, neutrophil, and cytokine-signaling pathways.

Several of these genes organized into coexpression networks that correlated with child anxiety and hyperactivity.

The principal active component of cannabis, tetrahydrocannabinol (THC), targets the endocannabinoid system in placental tissue and the developing brain, the authors noted. Exposure during pregnancy is associated with a range of adverse outcomes from fetal growth restriction to low birth weight and preterm birth.

“There are cannabinoid receptors on immune cells, and it is known that cannabinoids can alter immune function, which is important for maintaining maternal tolerance and protecting the fetus,” Dr. Hurd said. “It’s not surprising that something that affects the immune cells can have an impact on the developing fetus.”

“Overall, our findings reveal a relationship between [maternal cannabis use] and immune response gene networks in the placenta as a potential mediator of risk for anxiety-related problems in early childhood,” Dr. Hurd and colleagues wrote, adding that the results have significant implications for defining mental health issues in the children gestated by cannabis-smoking mothers.

Their results align with previous research indicating a greater risk for psychiatric illness in children with prenatal cannabis exposure from maternal use.

“While data are pretty limited in this realm, there are other studies that demonstrate a relationship between early child developmental and behavioral measures and cannabis use during pregnancy,” Camille Hoffman, MD, MSc, a high-risk obstetrics specialist and an associate professor at the University of Colorado at Denver, Aurora, said in an interview. “Our research group found children exposed to cannabis in utero at 10 weeks’ gestation and beyond were less interactive and more withdrawn than children who were not exposed.”

And THC remains in maternal breast milk even 6 weeks after usage stops.

The long-term effects of prenatal cannabis exposure remain to be determined and it is unknown whether the effects of gestational THC might attenuate as a child grows older. “We use early childhood measures in research as a proxy for the later development of diagnosed mental health conditions or behavioral problems,” Dr. Hoffman explained. “We know when we do this that not every child with an abnormal score early will go on to develop an actual condition. Fortunately, or unfortunately, other factors and exposures during childhood can change the trajectory for the better or worse.”

According to Dr. Hurd, child development is a dynamic process and epigenetic events in utero need not be deterministic. “The important thing is to identify children at risk early and to be able to go in and try to improve the environment they’re being raised in – not in terms of impoverishment but in terms of positive nurturing and giving the mother and family support.”

At the prenatal level, what’s the best advice for cannabis-using mothers-to-be? “If a woman doesn’t know she’s pregnant and has been using cannabis, taking extra choline for the remainder of the pregnancy can help buffer the potential negative impact of the cannabis exposure,” Dr. Hoffman said. The Food and Drug Administration and the American Medical Association recommend a dose of 550 mg daily. “The same is true for alcohol, which we know is also very bad for fetal brain development. This is not to say go ahead and use these substances and just take choline. The choline is more to try and salvage damage to the fetal brain that may have already occurred.”

This study was supported by the National Institute of Mental Health and the National Institute on Drug Abuse. The authors declared no competing interests. Dr. Hoffman disclosed no conflicts of interest with respect to her comments.

Mothers who use cannabis during pregnancy risk disrupting immune gene networks in the placenta and potentially increasing the risk of anxiety and hyperactivity in their children.

These findings emerged from a study led by Yasmin Hurd, PhD, a professor of psychiatry and director of the Addiction Institute at the Icahn School of Medicine at Mount Sinai, New York, and Yoko Nomura, PhD, a professor of behavioral neuroscience at Queen’s College, City University of New York, that was published online in Proceedings of the National Academy of Sciences.

The analysis assessed the effects of gestational maternal cannabis use on psychosocial and physiological measures in young children as well as its potentially immunomodulatory effect on the in utero environment as reflected in the placental transcriptome.

Participants were drawn from a larger cohort in a study launched in 2012; the investigators evaluated offspring aged 3-6 years for hair hormone levels, neurobehavioral traits on the Behavioral Assessment System for Children survey, and heart rate variability (HRV) at rest and during auditory startle.

The cohort consisted of 322 mother-child dyads and children with prenatal exposure to cannabis were compared with those having no exposure. The cohort consisted of 251 non–cannabis-using mothers and 71 cannabis-using mothers, with mean maternal ages in the two groups of 28.46 years and 25.91 years, respectively, The mothers gave birth at Mount Sinai and they and their children were assessed annually at affiliated medical centers in Mount Sinai’s catchment area.

For a subset of children with behavioral assessments, placental specimens collected at birth were processed for RNA sequencing.

Among the findings:

• Maternal cannabis use was associated with reduced maternal and paternal age, more single-mother pregnancies, state anxiety, trait anxiety, depression, cigarette smoking, and African American race.
• Hair hormone analysis revealed increased cortisol levels in the children of cannabis-using mothers, and was associated with greater anxiety, aggression, and hyperactivity.
• Affected children showed a reduction in the high-frequency component of HRV at baseline, reflecting reduced vagal tone.
• In the placenta, there was reduced expression of many genes involved in immune system function. These included genes for type I interferon, neutrophil, and cytokine-signaling pathways.

Several of these genes organized into coexpression networks that correlated with child anxiety and hyperactivity.

The principal active component of cannabis, tetrahydrocannabinol (THC), targets the endocannabinoid system in placental tissue and the developing brain, the authors noted. Exposure during pregnancy is associated with a range of adverse outcomes from fetal growth restriction to low birth weight and preterm birth.

“There are cannabinoid receptors on immune cells, and it is known that cannabinoids can alter immune function, which is important for maintaining maternal tolerance and protecting the fetus,” Dr. Hurd said. “It’s not surprising that something that affects the immune cells can have an impact on the developing fetus.”

“Overall, our findings reveal a relationship between [maternal cannabis use] and immune response gene networks in the placenta as a potential mediator of risk for anxiety-related problems in early childhood,” Dr. Hurd and colleagues wrote, adding that the results have significant implications for defining mental health issues in the children gestated by cannabis-smoking mothers.

Their results align with previous research indicating a greater risk for psychiatric illness in children with prenatal cannabis exposure from maternal use.

“While data are pretty limited in this realm, there are other studies that demonstrate a relationship between early child developmental and behavioral measures and cannabis use during pregnancy,” Camille Hoffman, MD, MSc, a high-risk obstetrics specialist and an associate professor at the University of Colorado at Denver, Aurora, said in an interview. “Our research group found children exposed to cannabis in utero at 10 weeks’ gestation and beyond were less interactive and more withdrawn than children who were not exposed.”

And THC remains in maternal breast milk even 6 weeks after usage stops.

The long-term effects of prenatal cannabis exposure remain to be determined and it is unknown whether the effects of gestational THC might attenuate as a child grows older. “We use early childhood measures in research as a proxy for the later development of diagnosed mental health conditions or behavioral problems,” Dr. Hoffman explained. “We know when we do this that not every child with an abnormal score early will go on to develop an actual condition. Fortunately, or unfortunately, other factors and exposures during childhood can change the trajectory for the better or worse.”

According to Dr. Hurd, child development is a dynamic process and epigenetic events in utero need not be deterministic. “The important thing is to identify children at risk early and to be able to go in and try to improve the environment they’re being raised in – not in terms of impoverishment but in terms of positive nurturing and giving the mother and family support.”

At the prenatal level, what’s the best advice for cannabis-using mothers-to-be? “If a woman doesn’t know she’s pregnant and has been using cannabis, taking extra choline for the remainder of the pregnancy can help buffer the potential negative impact of the cannabis exposure,” Dr. Hoffman said. The Food and Drug Administration and the American Medical Association recommend a dose of 550 mg daily. “The same is true for alcohol, which we know is also very bad for fetal brain development. This is not to say go ahead and use these substances and just take choline. The choline is more to try and salvage damage to the fetal brain that may have already occurred.”

This study was supported by the National Institute of Mental Health and the National Institute on Drug Abuse. The authors declared no competing interests. Dr. Hoffman disclosed no conflicts of interest with respect to her comments.

Erenumab, a calcitonin-gene related peptide receptor (CGRP) inhibitor, is more tolerable and effective than topiramate for treating patients with migraine, according to data from almost 800 patients in the first head-to-head trial of its kind.

The findings suggest that erenumab may help overcome longstanding issues with migraine medication adherence, and additional supportive data may alter treatment sequencing, reported lead author Uwe Reuter, MD, professor at Charité Universitätsmedizin Berlin, and colleagues.

“So far, no study has been done in order to compare the efficacy of a monoclonal antibody targeting the CGRP pathway to that of a standard of care oral preventive drug,” the investigators wrote in Cephalalgia.

The phase 4 HER-MES trial aimed to address this knowledge gap by enrolling 777 adult patients with a history of migraine. All patients reported migraine with or without aura for at least 1 year prior to screening. At baseline, most patients (65%) reported 8-14 migraine days per months, followed by 4-7 days (24.0%), and at least 15 days (11.0%). No patients had previously received topiramate or a CGRP-targeting agent.

“HER-MES includes a broad migraine population with two-thirds of the patients in the high-frequency migraine spectrum,” the investigators noted. “Despite a mean disease duration of about 20 years, almost 60% of the patients had not received previous prophylactic treatment, which underlines the long-standing problem of undertreatment in migraine.”

The trial had a double-dummy design; patients were randomized in a 1:1 ratio to receive either subcutaneous erenumab (70 or 140 mg/month) plus oral placebo, or oral topiramate (50-100 mg/day) plus subcutaneous placebo. The topiramate dose was uptitrated over the first 6 weeks. Treatments were given for a total of 24 weeks or until discontinuation due to adverse events, which was the primary endpoint. The secondary endpoint was efficacy over months 4-6, defined as at least 50% reduction in monthly migraine days, compared with baseline. Other patient-reported outcomes were also evaluated.

After 24 weeks, 95.1% of patients were still enrolled in the trial. Discontinuations due to adverse events were almost four times as common in the topiramate group than the erenumab group (38.9% vs. 10.6%; odds ratio [OR], 0.19; confidence interval, 0.13-0.27; P less than .001). Efficacy findings followed suit, with 55.4% of patients in the erenumab group reporting at least 50% reduction in monthly migraine days, compared with 31.2% of patients in the topiramate group (OR, 2.76; 95% CI, 2.06-3.71; P less than.001).

Erenumab significantly improved monthly migraine days, headache impact test (HIT-6) scores, and short form health survey version (SF-35v2) scores, including physical and mental components (P less than .001 for all).

Safety profiles aligned with previous findings.

“Compared to topiramate, treatment with erenumab has a superior tolerability profile and a significantly higher efficacy,” the investigators concluded. “HER-MES supports the potential of erenumab in overcoming issues of low adherence in clinical practice observed with topiramate, lessening migraine burden, and improving quality of life in a broad migraine population.”
 

Superior tolerability

Commenting on the study, Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and editor-in-chief of Neurology Reviews, said this is “a very important, very well conducted trial that documents what many of us already suspected; erenumab clearly has better tolerability than topiramate as well as better efficacy.”

Dr. Rapoport, a past president of the International Headache Society, said the study highlights an area of unmet need in neurology practice.

“Despite most patients in the trial having chronic headaches for 20 years, 60% of them had never received preventive treatment,” he said, noting that this reflects current practice in the United States.

Dr. Rapoport said primary care providers in the United States prescribe preventive migraine medications to 10%-15% of eligible patients. Prescribing rates for general neurologists are slightly higher, he said, ranging from 35% to 40%, while headache specialists prescribe 70%-90% of the time.

“How can we improve this situation?” Dr. Rapoport asked. “For years we have tried to improve it with education, but we need to do a better job. We need to educate our primary care physicians in more practical ways. We have to teach them how to make a diagnosis of high frequency migraine and chronic migraine and strongly suggest that those patients be put on appropriate preventive medications.”

Barriers to care may be systemic, according to Dr. Rapoport.

“One issue in the U.S. is that patients with commercial insurance are almost always required to fail two or three categories of older oral preventive migraine medications before they can get a monoclonal antibody or gepants for prevention,” he said. “It would be good if we could change that system so that patients that absolutely need the better tolerated, more effective preventive medications could get them sooner rather than later. This will help them feel and function better, with less pain, and eventually bring down the cost of migraine therapy.”

While Dr. Reuter and colleagues concluded that revised treatment sequencing may be warranted after more trials show similar results, Dr. Rapoport suggested that “this was such a large, well-performed, 6-month study with few dropouts, that further trials to confirm these findings are unnecessary, in my opinion.”

The HER-MES trial was funded by Novartis. Dr. Reuter and colleagues disclosed additional relationships with Eli Lilly, Teva Pharmaceutical, Allergan, and others. Dr. Rapoport was involved in early topiramate trials for prevention and migraine, and is a speaker for Amgen.

Erenumab, a calcitonin-gene related peptide receptor (CGRP) inhibitor, is more tolerable and effective than topiramate for treating patients with migraine, according to data from almost 800 patients in the first head-to-head trial of its kind.

The findings suggest that erenumab may help overcome longstanding issues with migraine medication adherence, and additional supportive data may alter treatment sequencing, reported lead author Uwe Reuter, MD, professor at Charité Universitätsmedizin Berlin, and colleagues.

“So far, no study has been done in order to compare the efficacy of a monoclonal antibody targeting the CGRP pathway to that of a standard of care oral preventive drug,” the investigators wrote in Cephalalgia.

The phase 4 HER-MES trial aimed to address this knowledge gap by enrolling 777 adult patients with a history of migraine. All patients reported migraine with or without aura for at least 1 year prior to screening. At baseline, most patients (65%) reported 8-14 migraine days per months, followed by 4-7 days (24.0%), and at least 15 days (11.0%). No patients had previously received topiramate or a CGRP-targeting agent.

“HER-MES includes a broad migraine population with two-thirds of the patients in the high-frequency migraine spectrum,” the investigators noted. “Despite a mean disease duration of about 20 years, almost 60% of the patients had not received previous prophylactic treatment, which underlines the long-standing problem of undertreatment in migraine.”

The trial had a double-dummy design; patients were randomized in a 1:1 ratio to receive either subcutaneous erenumab (70 or 140 mg/month) plus oral placebo, or oral topiramate (50-100 mg/day) plus subcutaneous placebo. The topiramate dose was uptitrated over the first 6 weeks. Treatments were given for a total of 24 weeks or until discontinuation due to adverse events, which was the primary endpoint. The secondary endpoint was efficacy over months 4-6, defined as at least 50% reduction in monthly migraine days, compared with baseline. Other patient-reported outcomes were also evaluated.

After 24 weeks, 95.1% of patients were still enrolled in the trial. Discontinuations due to adverse events were almost four times as common in the topiramate group than the erenumab group (38.9% vs. 10.6%; odds ratio [OR], 0.19; confidence interval, 0.13-0.27; P less than .001). Efficacy findings followed suit, with 55.4% of patients in the erenumab group reporting at least 50% reduction in monthly migraine days, compared with 31.2% of patients in the topiramate group (OR, 2.76; 95% CI, 2.06-3.71; P less than.001).

Erenumab significantly improved monthly migraine days, headache impact test (HIT-6) scores, and short form health survey version (SF-35v2) scores, including physical and mental components (P less than .001 for all).

Safety profiles aligned with previous findings.

“Compared to topiramate, treatment with erenumab has a superior tolerability profile and a significantly higher efficacy,” the investigators concluded. “HER-MES supports the potential of erenumab in overcoming issues of low adherence in clinical practice observed with topiramate, lessening migraine burden, and improving quality of life in a broad migraine population.”
 

Superior tolerability

Commenting on the study, Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and editor-in-chief of Neurology Reviews, said this is “a very important, very well conducted trial that documents what many of us already suspected; erenumab clearly has better tolerability than topiramate as well as better efficacy.”

Dr. Rapoport, a past president of the International Headache Society, said the study highlights an area of unmet need in neurology practice.

“Despite most patients in the trial having chronic headaches for 20 years, 60% of them had never received preventive treatment,” he said, noting that this reflects current practice in the United States.

Dr. Rapoport said primary care providers in the United States prescribe preventive migraine medications to 10%-15% of eligible patients. Prescribing rates for general neurologists are slightly higher, he said, ranging from 35% to 40%, while headache specialists prescribe 70%-90% of the time.

“How can we improve this situation?” Dr. Rapoport asked. “For years we have tried to improve it with education, but we need to do a better job. We need to educate our primary care physicians in more practical ways. We have to teach them how to make a diagnosis of high frequency migraine and chronic migraine and strongly suggest that those patients be put on appropriate preventive medications.”

Barriers to care may be systemic, according to Dr. Rapoport.

“One issue in the U.S. is that patients with commercial insurance are almost always required to fail two or three categories of older oral preventive migraine medications before they can get a monoclonal antibody or gepants for prevention,” he said. “It would be good if we could change that system so that patients that absolutely need the better tolerated, more effective preventive medications could get them sooner rather than later. This will help them feel and function better, with less pain, and eventually bring down the cost of migraine therapy.”

While Dr. Reuter and colleagues concluded that revised treatment sequencing may be warranted after more trials show similar results, Dr. Rapoport suggested that “this was such a large, well-performed, 6-month study with few dropouts, that further trials to confirm these findings are unnecessary, in my opinion.”

The HER-MES trial was funded by Novartis. Dr. Reuter and colleagues disclosed additional relationships with Eli Lilly, Teva Pharmaceutical, Allergan, and others. Dr. Rapoport was involved in early topiramate trials for prevention and migraine, and is a speaker for Amgen.

Erenumab, a calcitonin-gene related peptide receptor (CGRP) inhibitor, is more tolerable and effective than topiramate for treating patients with migraine, according to data from almost 800 patients in the first head-to-head trial of its kind.

The findings suggest that erenumab may help overcome longstanding issues with migraine medication adherence, and additional supportive data may alter treatment sequencing, reported lead author Uwe Reuter, MD, professor at Charité Universitätsmedizin Berlin, and colleagues.

“So far, no study has been done in order to compare the efficacy of a monoclonal antibody targeting the CGRP pathway to that of a standard of care oral preventive drug,” the investigators wrote in Cephalalgia.

The phase 4 HER-MES trial aimed to address this knowledge gap by enrolling 777 adult patients with a history of migraine. All patients reported migraine with or without aura for at least 1 year prior to screening. At baseline, most patients (65%) reported 8-14 migraine days per months, followed by 4-7 days (24.0%), and at least 15 days (11.0%). No patients had previously received topiramate or a CGRP-targeting agent.

“HER-MES includes a broad migraine population with two-thirds of the patients in the high-frequency migraine spectrum,” the investigators noted. “Despite a mean disease duration of about 20 years, almost 60% of the patients had not received previous prophylactic treatment, which underlines the long-standing problem of undertreatment in migraine.”

The trial had a double-dummy design; patients were randomized in a 1:1 ratio to receive either subcutaneous erenumab (70 or 140 mg/month) plus oral placebo, or oral topiramate (50-100 mg/day) plus subcutaneous placebo. The topiramate dose was uptitrated over the first 6 weeks. Treatments were given for a total of 24 weeks or until discontinuation due to adverse events, which was the primary endpoint. The secondary endpoint was efficacy over months 4-6, defined as at least 50% reduction in monthly migraine days, compared with baseline. Other patient-reported outcomes were also evaluated.

After 24 weeks, 95.1% of patients were still enrolled in the trial. Discontinuations due to adverse events were almost four times as common in the topiramate group than the erenumab group (38.9% vs. 10.6%; odds ratio [OR], 0.19; confidence interval, 0.13-0.27; P less than .001). Efficacy findings followed suit, with 55.4% of patients in the erenumab group reporting at least 50% reduction in monthly migraine days, compared with 31.2% of patients in the topiramate group (OR, 2.76; 95% CI, 2.06-3.71; P less than.001).

Erenumab significantly improved monthly migraine days, headache impact test (HIT-6) scores, and short form health survey version (SF-35v2) scores, including physical and mental components (P less than .001 for all).

Safety profiles aligned with previous findings.

“Compared to topiramate, treatment with erenumab has a superior tolerability profile and a significantly higher efficacy,” the investigators concluded. “HER-MES supports the potential of erenumab in overcoming issues of low adherence in clinical practice observed with topiramate, lessening migraine burden, and improving quality of life in a broad migraine population.”
 

Superior tolerability

Commenting on the study, Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and editor-in-chief of Neurology Reviews, said this is “a very important, very well conducted trial that documents what many of us already suspected; erenumab clearly has better tolerability than topiramate as well as better efficacy.”

Dr. Rapoport, a past president of the International Headache Society, said the study highlights an area of unmet need in neurology practice.

“Despite most patients in the trial having chronic headaches for 20 years, 60% of them had never received preventive treatment,” he said, noting that this reflects current practice in the United States.

Dr. Rapoport said primary care providers in the United States prescribe preventive migraine medications to 10%-15% of eligible patients. Prescribing rates for general neurologists are slightly higher, he said, ranging from 35% to 40%, while headache specialists prescribe 70%-90% of the time.

“How can we improve this situation?” Dr. Rapoport asked. “For years we have tried to improve it with education, but we need to do a better job. We need to educate our primary care physicians in more practical ways. We have to teach them how to make a diagnosis of high frequency migraine and chronic migraine and strongly suggest that those patients be put on appropriate preventive medications.”

Barriers to care may be systemic, according to Dr. Rapoport.

“One issue in the U.S. is that patients with commercial insurance are almost always required to fail two or three categories of older oral preventive migraine medications before they can get a monoclonal antibody or gepants for prevention,” he said. “It would be good if we could change that system so that patients that absolutely need the better tolerated, more effective preventive medications could get them sooner rather than later. This will help them feel and function better, with less pain, and eventually bring down the cost of migraine therapy.”

While Dr. Reuter and colleagues concluded that revised treatment sequencing may be warranted after more trials show similar results, Dr. Rapoport suggested that “this was such a large, well-performed, 6-month study with few dropouts, that further trials to confirm these findings are unnecessary, in my opinion.”

The HER-MES trial was funded by Novartis. Dr. Reuter and colleagues disclosed additional relationships with Eli Lilly, Teva Pharmaceutical, Allergan, and others. Dr. Rapoport was involved in early topiramate trials for prevention and migraine, and is a speaker for Amgen.

At the height of the COVID-19 pandemic’s terrifying first wave in the spring of 2020, dozens of hospitals in high-incidence areas either planned or opened temporary, emergency field hospitals to cover anticipated demand for beds beyond the capacity of local permanent hospitals.

Chastened by images of overwhelmed health care systems in Northern Italy and other hard-hit areas,¹ the planners used available modeling tools and estimates for projecting maximum potential need in worst-case scenarios. Some of these temporary hospitals never opened. Others opened in convention centers, parking garages, or parking lot tents, and ended up being used to a lesser degree than the worst-case scenarios.

But those who participated in the planning – including, in many cases, hospitalists – believe they created alternate care site manuals that could be quickly revived in the event of future COVID surges or other, similar crises. Better to plan for too much, they say, than not plan for enough.

Field hospitals or alternate care sites are defined in a recent journal article in Prehospital Disaster Medicine as “locations that can be converted to provide either inpatient and/or outpatient health services when existing facilities are compromised by a hazard impact or the volume of patients exceeds available capacity and/or capabilities.”²

University of Michigan Institute for Healthcare Policy and Innovation

The lead author of that report, Sue Anne Bell, PhD, FNP-BC, a disaster expert and assistant professor of nursing at the University of Michigan (UM), was one of five members of the leadership team for planning UM’s field hospital. They used an organizational unit structure based on the U.S. military’s staffing structure, with their work organized around six units of planning: personnel and labor, security, clinical operations, logistics and supply, planning and training, and communications. This team planned a 519-bed step-down care facility, the Michigan Medicine Field Hospital, for a 73,000-foot indoor track and performance facility at the university, three miles from UM’s main hospital. The aim was to provide safe care in a resource-limited environment.

“We were prepared, but the need never materialized as the peak of COVID cases started to subside,” Dr. Bell said. The team was ready to open within days using a “T-Minus” framework of days remaining on an official countdown clock. But when the need and deadlines kept getting pushed back, that gave them more time to develop clearer procedures.

Two Michigan Medicine hospitalists, Christopher Smith, MD, and David Paje, MD, MPH, both professors at UM’s medical school, were intimately involved in the process. “I was the medical director for the respiratory care unit that was opened for COVID patients, so I was pulled in to assist in the field hospital planning,” said Dr. Smith.

Baltimore builds a convention center hospital

A COVID-19 field hospital was planned and executed at an exhibit hall in the Baltimore Convention Center, starting in March 2020 under the leadership of Johns Hopkins Bayview hospitalist Eric Howell, MD, MHM, who eventually handed over responsibilities as chief medical officer when he assumed the position of CEO for the Society of Hospital Medicine in July of that year.

Courtesy Dr. Eric Howell

Hopkins collaborated with the University of Maryland health system and state leaders, including the Secretary of Health, to open a 252-bed temporary facility, which at its peak carried a census of 48 patients, with no on-site mortality or cardiac arrests, before it was closed in June 2021 – ready to reopen if necessary. It also served as Baltimore’s major site for polymerase chain reaction COVID-19 testing, vaccinations, and monoclonal antibody infusions, along with medical research.

“My belief at the time we started was that my entire 20-year career as a hospitalist had prepared me for the challenge of opening a COVID field hospital,” Dr. Howell said. “I had learned how to build clinical programs. The difference was that instead of months and years to build a program, we only had a few weeks.”

His first request was to bring on an associate medical director for the field hospital, Melinda E. Kantsiper, MD, a hospitalist and director of clinical operations in the Division of Hospital Medicine at Johns Hopkins Bayview. She became the field hospital’s CMO when Dr. Howell moved to SHM. “As hospitalists, we are trained to care for the patient in front of us while at the same time creating systems that can adjust to rapidly changing circumstances,” Dr. Kantsiper said. “We did what was asked and set up a field hospital that cared for a total of 1,500 COVID patients.”

Courtesy Johns Hopkins Medicine

“They gave us a lot of autonomy and helped us break down barriers. They gave us the political capital to say proper PPE was absolutely essential. As hard and devastating as the pandemic has been, one take-away is that we showed that we can be more flexible and elastic in response to actual needs than we used to think.”

Range of challenges

Among the questions that need to be answered by a field hospital’s planners, the first is ‘where to put it?’ The answer is, hopefully, someplace not too far away, large enough, with ready access to supplies and intake. The next question is ‘who is the patient?’ Clinicians must determine who goes to the field hospital versus who stays at the standing hospital. How sick should these patients be? And when do they need to go back to the permanent hospital? Can staff be trained to recognize when patients in the field hospital are starting to decompensate? The EPIC Deterioration Index³ is a proprietary prediction model that was used by more than a hundred hospitals during the pandemic.

The hospitalist team may develop specific inclusion and exclusion criteria – for example, don’t admit patients who are receiving oxygen therapy above a certain threshold or who are hemodynamically unstable. These criteria should reflect the capacity of the field hospital and the needs of the permanent hospital. At Michigan, as at other field hospital sites, the goal was to offer a step-down or postacute setting for patients with COVID-19 who were too sick to return home but didn’t need acute or ICU-level care, thereby freeing up beds at the permanent hospital for patients who were sicker.

Other questions: What is the process for admissions and discharges? How will patients be transported? What kind of staffing is needed, and what levels of care will be provided? What about rehabilitation services, or palliative care? What about patients with substance abuse or psychiatric comorbidities?

“Are we going to do paper charting? How will that work out for long-term documentation and billing?” Dr. Bell said. A clear reporting structure and communication pathways are essential. Among the other operational processes to address, outlined in Dr. Bell’s article, are orientation and training, PPE donning and doffing procedures, the code or rapid response team, patient and staff food and nutrition, infection control protocols, pharmacy services, access to radiology, rounding procedures, staff support, and the morgue.

One other issue that shouldn’t be overlooked is health equity in the field hospital. “Providing safe and equitable care should be the focus. Thinking who goes to the field hospital should be done within a health equity framework,” Dr. Bell said.⁴ She also wonders if field hospital planners are sharing their experience with colleagues across the country and developing more collaborative relationships with other hospitals in their communities.

“Field hospitals can be different things,” Dr. Bell said. “The important take-home is it doesn’t have to be in a tent or a parking garage, which can be suboptimal.” In many cases, it may be better to focus on finding unused space within the hospital – whether a lobby, staff lounge, or unoccupied unit – closer to personnel, supplies, pharmacy, and the like. “I think the pandemic showed us how unprepared we were as a health care system, and how much more we need to do in preparation for future crises.”

Limits to the temporary hospital

In New York City, which had the country’s worst COVID-19 outbreak during the first surge in the spring of 2020, a 1,000-bed field hospital was opened at the Jacob Javits Center in March 2020 and closed that June. “I was in the field hospital early, in March and April, when our hospitals were temporarily overrun,” said hospitalist Mona Krouss, MD, FACP, CPPS, NYC Health + Hospitals’ director of patient safety. “My role was to figure out how to get patients on our medical floors into these field hospitals, with responsibility for helping to revise admission criteria,” she said.

“No one knew how horrible it would become. This was so unanticipated, so difficult to operationalize. What they were able to create was amazing, but there were just too many barriers to have it work smoothly,” Dr. Krouss said.

Courtesy of Renown Regional Medical Center

Replicating hospital work flows

“We ensured that everybody who needed to be within the walls of the permanent hospitals was able to stay there,” said Dr. Lee’s colleague, hospitalist Adnan (Eddy) Akbar, MD. “The postacute system we ordinarily rely on was no longer accepting patients. Other hospitals in the area were able to manage within their capacity because Renown’s field hospital could admit excess patients. We tried to replicate in the field hospital, as much as possible, the work flows and systems of our main hospital.”

When the field hospital finally opened, Dr. Akbar said, “we had a good feeling. We were ready. If something more catastrophic had come down, we were ready to care for more patients. In the field hospital you have to keep monitoring your work flow – almost on a daily basis. But we felt privileged to be working for a system where you knew you can go and care for everyone who needed care.”

One upside of the field hospital experience for participating clinicians, Dr. Lee added, is the opportunity to practice creatively. “The downside is it’s extremely expensive, and has consequences for the mental health of staff. Like so many of these things, it wore on people over time – such as all the time spent donning and doffing protective equipment. And recently the patients have become a lot less gracious.”

Amy Baughman, MD, a hospitalist at Massachusetts General Hospital in Boston, was co-medical director of the postacute care section of a 1,000-bed field hospital, Boston Hope Medical Center, opened in April 2020 at the Boston Convention and Exhibition Center. The other half of the facility was dedicated to undomiciled COVID-19 patients who had no place else to go. Peak census was around 100 patients, housed on four units, each with a clinical team led by a physician.

Partners HealthCare

References

1. Horowitz J. Italy’s health care system groans under coronavirus – a warning to the world. New York Times. 2020 Mar 12.

2. Bell SA et al. T-Minus 10 days: The role of an academic medical institution in field hospital planning. Prehosp Disaster Med. 2021 Feb 18:1-6. doi: 10.1017/S1049023X21000224.

3. Singh K et al. Evaluating a widely implemented proprietary deterioration index model among hospitalized patients with COVID-19. Ann Am Thorac Soc. 2021 Jul;18(7):1129-37. doi: 10.1513/AnnalsATS.202006-698OC.

4. Bell SA et al. Alternate care sites during COVID-19 pandemic: Policy implications for pandemic surge planning. Disaster Med Public Health Prep. 2021 Jul 23;1-3. doi: 10.1017/dmp.2021.241.

At the height of the COVID-19 pandemic’s terrifying first wave in the spring of 2020, dozens of hospitals in high-incidence areas either planned or opened temporary, emergency field hospitals to cover anticipated demand for beds beyond the capacity of local permanent hospitals.

Chastened by images of overwhelmed health care systems in Northern Italy and other hard-hit areas,¹ the planners used available modeling tools and estimates for projecting maximum potential need in worst-case scenarios. Some of these temporary hospitals never opened. Others opened in convention centers, parking garages, or parking lot tents, and ended up being used to a lesser degree than the worst-case scenarios.

But those who participated in the planning – including, in many cases, hospitalists – believe they created alternate care site manuals that could be quickly revived in the event of future COVID surges or other, similar crises. Better to plan for too much, they say, than not plan for enough.

Field hospitals or alternate care sites are defined in a recent journal article in Prehospital Disaster Medicine as “locations that can be converted to provide either inpatient and/or outpatient health services when existing facilities are compromised by a hazard impact or the volume of patients exceeds available capacity and/or capabilities.”²

University of Michigan Institute for Healthcare Policy and Innovation

The lead author of that report, Sue Anne Bell, PhD, FNP-BC, a disaster expert and assistant professor of nursing at the University of Michigan (UM), was one of five members of the leadership team for planning UM’s field hospital. They used an organizational unit structure based on the U.S. military’s staffing structure, with their work organized around six units of planning: personnel and labor, security, clinical operations, logistics and supply, planning and training, and communications. This team planned a 519-bed step-down care facility, the Michigan Medicine Field Hospital, for a 73,000-foot indoor track and performance facility at the university, three miles from UM’s main hospital. The aim was to provide safe care in a resource-limited environment.

“We were prepared, but the need never materialized as the peak of COVID cases started to subside,” Dr. Bell said. The team was ready to open within days using a “T-Minus” framework of days remaining on an official countdown clock. But when the need and deadlines kept getting pushed back, that gave them more time to develop clearer procedures.

Two Michigan Medicine hospitalists, Christopher Smith, MD, and David Paje, MD, MPH, both professors at UM’s medical school, were intimately involved in the process. “I was the medical director for the respiratory care unit that was opened for COVID patients, so I was pulled in to assist in the field hospital planning,” said Dr. Smith.

Baltimore builds a convention center hospital

A COVID-19 field hospital was planned and executed at an exhibit hall in the Baltimore Convention Center, starting in March 2020 under the leadership of Johns Hopkins Bayview hospitalist Eric Howell, MD, MHM, who eventually handed over responsibilities as chief medical officer when he assumed the position of CEO for the Society of Hospital Medicine in July of that year.

Courtesy Dr. Eric Howell

Hopkins collaborated with the University of Maryland health system and state leaders, including the Secretary of Health, to open a 252-bed temporary facility, which at its peak carried a census of 48 patients, with no on-site mortality or cardiac arrests, before it was closed in June 2021 – ready to reopen if necessary. It also served as Baltimore’s major site for polymerase chain reaction COVID-19 testing, vaccinations, and monoclonal antibody infusions, along with medical research.

“My belief at the time we started was that my entire 20-year career as a hospitalist had prepared me for the challenge of opening a COVID field hospital,” Dr. Howell said. “I had learned how to build clinical programs. The difference was that instead of months and years to build a program, we only had a few weeks.”

His first request was to bring on an associate medical director for the field hospital, Melinda E. Kantsiper, MD, a hospitalist and director of clinical operations in the Division of Hospital Medicine at Johns Hopkins Bayview. She became the field hospital’s CMO when Dr. Howell moved to SHM. “As hospitalists, we are trained to care for the patient in front of us while at the same time creating systems that can adjust to rapidly changing circumstances,” Dr. Kantsiper said. “We did what was asked and set up a field hospital that cared for a total of 1,500 COVID patients.”

Courtesy Johns Hopkins Medicine

“They gave us a lot of autonomy and helped us break down barriers. They gave us the political capital to say proper PPE was absolutely essential. As hard and devastating as the pandemic has been, one take-away is that we showed that we can be more flexible and elastic in response to actual needs than we used to think.”

Range of challenges

Among the questions that need to be answered by a field hospital’s planners, the first is ‘where to put it?’ The answer is, hopefully, someplace not too far away, large enough, with ready access to supplies and intake. The next question is ‘who is the patient?’ Clinicians must determine who goes to the field hospital versus who stays at the standing hospital. How sick should these patients be? And when do they need to go back to the permanent hospital? Can staff be trained to recognize when patients in the field hospital are starting to decompensate? The EPIC Deterioration Index³ is a proprietary prediction model that was used by more than a hundred hospitals during the pandemic.

The hospitalist team may develop specific inclusion and exclusion criteria – for example, don’t admit patients who are receiving oxygen therapy above a certain threshold or who are hemodynamically unstable. These criteria should reflect the capacity of the field hospital and the needs of the permanent hospital. At Michigan, as at other field hospital sites, the goal was to offer a step-down or postacute setting for patients with COVID-19 who were too sick to return home but didn’t need acute or ICU-level care, thereby freeing up beds at the permanent hospital for patients who were sicker.

Other questions: What is the process for admissions and discharges? How will patients be transported? What kind of staffing is needed, and what levels of care will be provided? What about rehabilitation services, or palliative care? What about patients with substance abuse or psychiatric comorbidities?

“Are we going to do paper charting? How will that work out for long-term documentation and billing?” Dr. Bell said. A clear reporting structure and communication pathways are essential. Among the other operational processes to address, outlined in Dr. Bell’s article, are orientation and training, PPE donning and doffing procedures, the code or rapid response team, patient and staff food and nutrition, infection control protocols, pharmacy services, access to radiology, rounding procedures, staff support, and the morgue.

One other issue that shouldn’t be overlooked is health equity in the field hospital. “Providing safe and equitable care should be the focus. Thinking who goes to the field hospital should be done within a health equity framework,” Dr. Bell said.⁴ She also wonders if field hospital planners are sharing their experience with colleagues across the country and developing more collaborative relationships with other hospitals in their communities.

“Field hospitals can be different things,” Dr. Bell said. “The important take-home is it doesn’t have to be in a tent or a parking garage, which can be suboptimal.” In many cases, it may be better to focus on finding unused space within the hospital – whether a lobby, staff lounge, or unoccupied unit – closer to personnel, supplies, pharmacy, and the like. “I think the pandemic showed us how unprepared we were as a health care system, and how much more we need to do in preparation for future crises.”

Limits to the temporary hospital

In New York City, which had the country’s worst COVID-19 outbreak during the first surge in the spring of 2020, a 1,000-bed field hospital was opened at the Jacob Javits Center in March 2020 and closed that June. “I was in the field hospital early, in March and April, when our hospitals were temporarily overrun,” said hospitalist Mona Krouss, MD, FACP, CPPS, NYC Health + Hospitals’ director of patient safety. “My role was to figure out how to get patients on our medical floors into these field hospitals, with responsibility for helping to revise admission criteria,” she said.

“No one knew how horrible it would become. This was so unanticipated, so difficult to operationalize. What they were able to create was amazing, but there were just too many barriers to have it work smoothly,” Dr. Krouss said.

Courtesy of Renown Regional Medical Center

Replicating hospital work flows

“We ensured that everybody who needed to be within the walls of the permanent hospitals was able to stay there,” said Dr. Lee’s colleague, hospitalist Adnan (Eddy) Akbar, MD. “The postacute system we ordinarily rely on was no longer accepting patients. Other hospitals in the area were able to manage within their capacity because Renown’s field hospital could admit excess patients. We tried to replicate in the field hospital, as much as possible, the work flows and systems of our main hospital.”

When the field hospital finally opened, Dr. Akbar said, “we had a good feeling. We were ready. If something more catastrophic had come down, we were ready to care for more patients. In the field hospital you have to keep monitoring your work flow – almost on a daily basis. But we felt privileged to be working for a system where you knew you can go and care for everyone who needed care.”

One upside of the field hospital experience for participating clinicians, Dr. Lee added, is the opportunity to practice creatively. “The downside is it’s extremely expensive, and has consequences for the mental health of staff. Like so many of these things, it wore on people over time – such as all the time spent donning and doffing protective equipment. And recently the patients have become a lot less gracious.”

Amy Baughman, MD, a hospitalist at Massachusetts General Hospital in Boston, was co-medical director of the postacute care section of a 1,000-bed field hospital, Boston Hope Medical Center, opened in April 2020 at the Boston Convention and Exhibition Center. The other half of the facility was dedicated to undomiciled COVID-19 patients who had no place else to go. Peak census was around 100 patients, housed on four units, each with a clinical team led by a physician.

Partners HealthCare

References

1. Horowitz J. Italy’s health care system groans under coronavirus – a warning to the world. New York Times. 2020 Mar 12.

2. Bell SA et al. T-Minus 10 days: The role of an academic medical institution in field hospital planning. Prehosp Disaster Med. 2021 Feb 18:1-6. doi: 10.1017/S1049023X21000224.

3. Singh K et al. Evaluating a widely implemented proprietary deterioration index model among hospitalized patients with COVID-19. Ann Am Thorac Soc. 2021 Jul;18(7):1129-37. doi: 10.1513/AnnalsATS.202006-698OC.

4. Bell SA et al. Alternate care sites during COVID-19 pandemic: Policy implications for pandemic surge planning. Disaster Med Public Health Prep. 2021 Jul 23;1-3. doi: 10.1017/dmp.2021.241.

At the height of the COVID-19 pandemic’s terrifying first wave in the spring of 2020, dozens of hospitals in high-incidence areas either planned or opened temporary, emergency field hospitals to cover anticipated demand for beds beyond the capacity of local permanent hospitals.

Chastened by images of overwhelmed health care systems in Northern Italy and other hard-hit areas,¹ the planners used available modeling tools and estimates for projecting maximum potential need in worst-case scenarios. Some of these temporary hospitals never opened. Others opened in convention centers, parking garages, or parking lot tents, and ended up being used to a lesser degree than the worst-case scenarios.

But those who participated in the planning – including, in many cases, hospitalists – believe they created alternate care site manuals that could be quickly revived in the event of future COVID surges or other, similar crises. Better to plan for too much, they say, than not plan for enough.

Field hospitals or alternate care sites are defined in a recent journal article in Prehospital Disaster Medicine as “locations that can be converted to provide either inpatient and/or outpatient health services when existing facilities are compromised by a hazard impact or the volume of patients exceeds available capacity and/or capabilities.”²

University of Michigan Institute for Healthcare Policy and Innovation

The lead author of that report, Sue Anne Bell, PhD, FNP-BC, a disaster expert and assistant professor of nursing at the University of Michigan (UM), was one of five members of the leadership team for planning UM’s field hospital. They used an organizational unit structure based on the U.S. military’s staffing structure, with their work organized around six units of planning: personnel and labor, security, clinical operations, logistics and supply, planning and training, and communications. This team planned a 519-bed step-down care facility, the Michigan Medicine Field Hospital, for a 73,000-foot indoor track and performance facility at the university, three miles from UM’s main hospital. The aim was to provide safe care in a resource-limited environment.

“We were prepared, but the need never materialized as the peak of COVID cases started to subside,” Dr. Bell said. The team was ready to open within days using a “T-Minus” framework of days remaining on an official countdown clock. But when the need and deadlines kept getting pushed back, that gave them more time to develop clearer procedures.

Two Michigan Medicine hospitalists, Christopher Smith, MD, and David Paje, MD, MPH, both professors at UM’s medical school, were intimately involved in the process. “I was the medical director for the respiratory care unit that was opened for COVID patients, so I was pulled in to assist in the field hospital planning,” said Dr. Smith.

Baltimore builds a convention center hospital

A COVID-19 field hospital was planned and executed at an exhibit hall in the Baltimore Convention Center, starting in March 2020 under the leadership of Johns Hopkins Bayview hospitalist Eric Howell, MD, MHM, who eventually handed over responsibilities as chief medical officer when he assumed the position of CEO for the Society of Hospital Medicine in July of that year.

Courtesy Dr. Eric Howell

Hopkins collaborated with the University of Maryland health system and state leaders, including the Secretary of Health, to open a 252-bed temporary facility, which at its peak carried a census of 48 patients, with no on-site mortality or cardiac arrests, before it was closed in June 2021 – ready to reopen if necessary. It also served as Baltimore’s major site for polymerase chain reaction COVID-19 testing, vaccinations, and monoclonal antibody infusions, along with medical research.

“My belief at the time we started was that my entire 20-year career as a hospitalist had prepared me for the challenge of opening a COVID field hospital,” Dr. Howell said. “I had learned how to build clinical programs. The difference was that instead of months and years to build a program, we only had a few weeks.”

His first request was to bring on an associate medical director for the field hospital, Melinda E. Kantsiper, MD, a hospitalist and director of clinical operations in the Division of Hospital Medicine at Johns Hopkins Bayview. She became the field hospital’s CMO when Dr. Howell moved to SHM. “As hospitalists, we are trained to care for the patient in front of us while at the same time creating systems that can adjust to rapidly changing circumstances,” Dr. Kantsiper said. “We did what was asked and set up a field hospital that cared for a total of 1,500 COVID patients.”

Courtesy Johns Hopkins Medicine

“They gave us a lot of autonomy and helped us break down barriers. They gave us the political capital to say proper PPE was absolutely essential. As hard and devastating as the pandemic has been, one take-away is that we showed that we can be more flexible and elastic in response to actual needs than we used to think.”

Range of challenges

Among the questions that need to be answered by a field hospital’s planners, the first is ‘where to put it?’ The answer is, hopefully, someplace not too far away, large enough, with ready access to supplies and intake. The next question is ‘who is the patient?’ Clinicians must determine who goes to the field hospital versus who stays at the standing hospital. How sick should these patients be? And when do they need to go back to the permanent hospital? Can staff be trained to recognize when patients in the field hospital are starting to decompensate? The EPIC Deterioration Index³ is a proprietary prediction model that was used by more than a hundred hospitals during the pandemic.

The hospitalist team may develop specific inclusion and exclusion criteria – for example, don’t admit patients who are receiving oxygen therapy above a certain threshold or who are hemodynamically unstable. These criteria should reflect the capacity of the field hospital and the needs of the permanent hospital. At Michigan, as at other field hospital sites, the goal was to offer a step-down or postacute setting for patients with COVID-19 who were too sick to return home but didn’t need acute or ICU-level care, thereby freeing up beds at the permanent hospital for patients who were sicker.

Other questions: What is the process for admissions and discharges? How will patients be transported? What kind of staffing is needed, and what levels of care will be provided? What about rehabilitation services, or palliative care? What about patients with substance abuse or psychiatric comorbidities?

“Are we going to do paper charting? How will that work out for long-term documentation and billing?” Dr. Bell said. A clear reporting structure and communication pathways are essential. Among the other operational processes to address, outlined in Dr. Bell’s article, are orientation and training, PPE donning and doffing procedures, the code or rapid response team, patient and staff food and nutrition, infection control protocols, pharmacy services, access to radiology, rounding procedures, staff support, and the morgue.

One other issue that shouldn’t be overlooked is health equity in the field hospital. “Providing safe and equitable care should be the focus. Thinking who goes to the field hospital should be done within a health equity framework,” Dr. Bell said.⁴ She also wonders if field hospital planners are sharing their experience with colleagues across the country and developing more collaborative relationships with other hospitals in their communities.

“Field hospitals can be different things,” Dr. Bell said. “The important take-home is it doesn’t have to be in a tent or a parking garage, which can be suboptimal.” In many cases, it may be better to focus on finding unused space within the hospital – whether a lobby, staff lounge, or unoccupied unit – closer to personnel, supplies, pharmacy, and the like. “I think the pandemic showed us how unprepared we were as a health care system, and how much more we need to do in preparation for future crises.”

Limits to the temporary hospital

In New York City, which had the country’s worst COVID-19 outbreak during the first surge in the spring of 2020, a 1,000-bed field hospital was opened at the Jacob Javits Center in March 2020 and closed that June. “I was in the field hospital early, in March and April, when our hospitals were temporarily overrun,” said hospitalist Mona Krouss, MD, FACP, CPPS, NYC Health + Hospitals’ director of patient safety. “My role was to figure out how to get patients on our medical floors into these field hospitals, with responsibility for helping to revise admission criteria,” she said.

“No one knew how horrible it would become. This was so unanticipated, so difficult to operationalize. What they were able to create was amazing, but there were just too many barriers to have it work smoothly,” Dr. Krouss said.

Courtesy of Renown Regional Medical Center

Replicating hospital work flows

“We ensured that everybody who needed to be within the walls of the permanent hospitals was able to stay there,” said Dr. Lee’s colleague, hospitalist Adnan (Eddy) Akbar, MD. “The postacute system we ordinarily rely on was no longer accepting patients. Other hospitals in the area were able to manage within their capacity because Renown’s field hospital could admit excess patients. We tried to replicate in the field hospital, as much as possible, the work flows and systems of our main hospital.”

When the field hospital finally opened, Dr. Akbar said, “we had a good feeling. We were ready. If something more catastrophic had come down, we were ready to care for more patients. In the field hospital you have to keep monitoring your work flow – almost on a daily basis. But we felt privileged to be working for a system where you knew you can go and care for everyone who needed care.”

One upside of the field hospital experience for participating clinicians, Dr. Lee added, is the opportunity to practice creatively. “The downside is it’s extremely expensive, and has consequences for the mental health of staff. Like so many of these things, it wore on people over time – such as all the time spent donning and doffing protective equipment. And recently the patients have become a lot less gracious.”

Amy Baughman, MD, a hospitalist at Massachusetts General Hospital in Boston, was co-medical director of the postacute care section of a 1,000-bed field hospital, Boston Hope Medical Center, opened in April 2020 at the Boston Convention and Exhibition Center. The other half of the facility was dedicated to undomiciled COVID-19 patients who had no place else to go. Peak census was around 100 patients, housed on four units, each with a clinical team led by a physician.

Partners HealthCare

References

1. Horowitz J. Italy’s health care system groans under coronavirus – a warning to the world. New York Times. 2020 Mar 12.

2. Bell SA et al. T-Minus 10 days: The role of an academic medical institution in field hospital planning. Prehosp Disaster Med. 2021 Feb 18:1-6. doi: 10.1017/S1049023X21000224.

3. Singh K et al. Evaluating a widely implemented proprietary deterioration index model among hospitalized patients with COVID-19. Ann Am Thorac Soc. 2021 Jul;18(7):1129-37. doi: 10.1513/AnnalsATS.202006-698OC.

4. Bell SA et al. Alternate care sites during COVID-19 pandemic: Policy implications for pandemic surge planning. Disaster Med Public Health Prep. 2021 Jul 23;1-3. doi: 10.1017/dmp.2021.241.