Pancreatitis remains the third most common gastroenterological cause of hospital admission, and staying on top of the latest quality indicators is important for the care and safety of patients, said Jamie S. Barkin, MD, professor of medicine in the division of gastroenterology at the University of Miami, in a virtual presentation at the annual Digestive Diseases: New Advances conference jointly provided by Rutgers and Global Academy for Medical Education.

The basics of treatment have changed, said Dr. Barkin. “A large volume of ringers lactate intravenous fluids given within the first 24 hours of admission, as opposed to normal saline, may decrease the inflammatory response in patients with acute pancreatitis.” The preferred diagnostic method remains clinical evaluation along with use of serum lipase, which is more sensitive than serum amylase (97%) but with similar specificity (99%), and current wisdom does not support the need for an early CT for diagnosis unless there is a diagnostic dilemma.

Early establishment of disease etiology and its therapy is imperative to attempt to prevent recurrent episodes and progression to chronic pancreatitis, Dr. Barkin said. Genetic testing studies suggest that approximately 10% of acute pancreatitis cases are the result of genetic factors, and Dr. Barkin recommended performing genetic testing after a first attack of idiopathic acute pancreatitis, especially in younger patients.

There is an extensive list of medications that may cause acute pancreatitis, according to a recent study published in PLOS One, the most common of which include acetaminophen, amiodarone, azathioprine, and angiotensin-converting enzyme inhibitors, Dr. Barkin said. In addition, acute pancreatitis can be caused by isonicotinic acid hydrazide (INH), cannabis, L-asparaginase, metronidazole, mesalamine, simvastatin, sulindac, sitagliptin, thiazides, tigecycline, trans-retinoic acid, and valproic acid, among others.

Current recommendations for hospital treatment of acute pancreatitis include early large volume fluid replacement and initiation of per-oral nutrition as soon as able to be tolerated, as well as pain control, Dr. Barkin said. In addition, management includes strict glycemic and triglyceride control and performance of cholecystectomy for mild and or moderate biliary pancreatitis or endoscopic retrograde cholangiopancreatography (ERCP) if the patient is not an operative candidate during the same hospital stay.

Current recommendations for the prevention of acute pancreatitis include avoidance of irritants such as alcohol, nicotine, and drugs known to cause acute pancreatitis, including marijuana, said Dr. Barkin. In addition, controlling metabolic factors such as obesity, diabetes, and triglycerides can help reduce risk of recurrent episodes in susceptible patients. Several of these factors are also linked to increased risk for progression of acute pancreatitis to chronic pancreatitis.

For patients with biliary pancreatitis, Dr. Barkin noted that cholecystectomy should be performed prior to discharge during the index hospitalization. “In patients who cannot undergo surgery, endoscopic sphincterotomy should be performed to allow spontaneous passage of any stones still in the gallbladder,” he noted.

In addition, patients who have experienced an attack of acute pancreatitis should be screened long-term for development of pancreatic exocrine insufficiency, which may be present in approximately one-quarter of patients following an acute pancreatitis episode, and diabetes, Dr. Barkin said. He cited a population-based study published in the American Journal of Gastroenterology in 2019 in which individuals with postpancreatitis diabetes had significantly higher rates of all-cause mortality, as well as hospitalization for conditions including chronic pulmonary disease, severe renal disease, and infectious disease.

Finally, at the time of discharge, it is essential to evaluate acute pancreatitis patients for risk of readmission, Dr. Barkin said. In addition to severe disease and systemic inflammatory response syndrome at the time of patient discharge, several factors increase the likelihood of readmission including ongoing abdominal pain requiring use of pain medicine, obesity, and inability to tolerate solid food, he noted.

Global Academy for Medical Education and this news organization are owned by the same parent company.

Dr. Barkin had no relevant financial conflicts to disclose.

Share AGA GI Patient Center education on pancreatitis to help your patients understand testing and treatment options and possible complications at http://ow.ly/nsdn30rcz5A.

Pancreatitis remains the third most common gastroenterological cause of hospital admission, and staying on top of the latest quality indicators is important for the care and safety of patients, said Jamie S. Barkin, MD, professor of medicine in the division of gastroenterology at the University of Miami, in a virtual presentation at the annual Digestive Diseases: New Advances conference jointly provided by Rutgers and Global Academy for Medical Education.

The basics of treatment have changed, said Dr. Barkin. “A large volume of ringers lactate intravenous fluids given within the first 24 hours of admission, as opposed to normal saline, may decrease the inflammatory response in patients with acute pancreatitis.” The preferred diagnostic method remains clinical evaluation along with use of serum lipase, which is more sensitive than serum amylase (97%) but with similar specificity (99%), and current wisdom does not support the need for an early CT for diagnosis unless there is a diagnostic dilemma.

Early establishment of disease etiology and its therapy is imperative to attempt to prevent recurrent episodes and progression to chronic pancreatitis, Dr. Barkin said. Genetic testing studies suggest that approximately 10% of acute pancreatitis cases are the result of genetic factors, and Dr. Barkin recommended performing genetic testing after a first attack of idiopathic acute pancreatitis, especially in younger patients.

There is an extensive list of medications that may cause acute pancreatitis, according to a recent study published in PLOS One, the most common of which include acetaminophen, amiodarone, azathioprine, and angiotensin-converting enzyme inhibitors, Dr. Barkin said. In addition, acute pancreatitis can be caused by isonicotinic acid hydrazide (INH), cannabis, L-asparaginase, metronidazole, mesalamine, simvastatin, sulindac, sitagliptin, thiazides, tigecycline, trans-retinoic acid, and valproic acid, among others.

Current recommendations for hospital treatment of acute pancreatitis include early large volume fluid replacement and initiation of per-oral nutrition as soon as able to be tolerated, as well as pain control, Dr. Barkin said. In addition, management includes strict glycemic and triglyceride control and performance of cholecystectomy for mild and or moderate biliary pancreatitis or endoscopic retrograde cholangiopancreatography (ERCP) if the patient is not an operative candidate during the same hospital stay.

Current recommendations for the prevention of acute pancreatitis include avoidance of irritants such as alcohol, nicotine, and drugs known to cause acute pancreatitis, including marijuana, said Dr. Barkin. In addition, controlling metabolic factors such as obesity, diabetes, and triglycerides can help reduce risk of recurrent episodes in susceptible patients. Several of these factors are also linked to increased risk for progression of acute pancreatitis to chronic pancreatitis.

For patients with biliary pancreatitis, Dr. Barkin noted that cholecystectomy should be performed prior to discharge during the index hospitalization. “In patients who cannot undergo surgery, endoscopic sphincterotomy should be performed to allow spontaneous passage of any stones still in the gallbladder,” he noted.

In addition, patients who have experienced an attack of acute pancreatitis should be screened long-term for development of pancreatic exocrine insufficiency, which may be present in approximately one-quarter of patients following an acute pancreatitis episode, and diabetes, Dr. Barkin said. He cited a population-based study published in the American Journal of Gastroenterology in 2019 in which individuals with postpancreatitis diabetes had significantly higher rates of all-cause mortality, as well as hospitalization for conditions including chronic pulmonary disease, severe renal disease, and infectious disease.

Finally, at the time of discharge, it is essential to evaluate acute pancreatitis patients for risk of readmission, Dr. Barkin said. In addition to severe disease and systemic inflammatory response syndrome at the time of patient discharge, several factors increase the likelihood of readmission including ongoing abdominal pain requiring use of pain medicine, obesity, and inability to tolerate solid food, he noted.

Global Academy for Medical Education and this news organization are owned by the same parent company.

Dr. Barkin had no relevant financial conflicts to disclose.

Share AGA GI Patient Center education on pancreatitis to help your patients understand testing and treatment options and possible complications at http://ow.ly/nsdn30rcz5A.

Pancreatitis remains the third most common gastroenterological cause of hospital admission, and staying on top of the latest quality indicators is important for the care and safety of patients, said Jamie S. Barkin, MD, professor of medicine in the division of gastroenterology at the University of Miami, in a virtual presentation at the annual Digestive Diseases: New Advances conference jointly provided by Rutgers and Global Academy for Medical Education.

The basics of treatment have changed, said Dr. Barkin. “A large volume of ringers lactate intravenous fluids given within the first 24 hours of admission, as opposed to normal saline, may decrease the inflammatory response in patients with acute pancreatitis.” The preferred diagnostic method remains clinical evaluation along with use of serum lipase, which is more sensitive than serum amylase (97%) but with similar specificity (99%), and current wisdom does not support the need for an early CT for diagnosis unless there is a diagnostic dilemma.

Early establishment of disease etiology and its therapy is imperative to attempt to prevent recurrent episodes and progression to chronic pancreatitis, Dr. Barkin said. Genetic testing studies suggest that approximately 10% of acute pancreatitis cases are the result of genetic factors, and Dr. Barkin recommended performing genetic testing after a first attack of idiopathic acute pancreatitis, especially in younger patients.

There is an extensive list of medications that may cause acute pancreatitis, according to a recent study published in PLOS One, the most common of which include acetaminophen, amiodarone, azathioprine, and angiotensin-converting enzyme inhibitors, Dr. Barkin said. In addition, acute pancreatitis can be caused by isonicotinic acid hydrazide (INH), cannabis, L-asparaginase, metronidazole, mesalamine, simvastatin, sulindac, sitagliptin, thiazides, tigecycline, trans-retinoic acid, and valproic acid, among others.

Current recommendations for hospital treatment of acute pancreatitis include early large volume fluid replacement and initiation of per-oral nutrition as soon as able to be tolerated, as well as pain control, Dr. Barkin said. In addition, management includes strict glycemic and triglyceride control and performance of cholecystectomy for mild and or moderate biliary pancreatitis or endoscopic retrograde cholangiopancreatography (ERCP) if the patient is not an operative candidate during the same hospital stay.

Current recommendations for the prevention of acute pancreatitis include avoidance of irritants such as alcohol, nicotine, and drugs known to cause acute pancreatitis, including marijuana, said Dr. Barkin. In addition, controlling metabolic factors such as obesity, diabetes, and triglycerides can help reduce risk of recurrent episodes in susceptible patients. Several of these factors are also linked to increased risk for progression of acute pancreatitis to chronic pancreatitis.

For patients with biliary pancreatitis, Dr. Barkin noted that cholecystectomy should be performed prior to discharge during the index hospitalization. “In patients who cannot undergo surgery, endoscopic sphincterotomy should be performed to allow spontaneous passage of any stones still in the gallbladder,” he noted.

In addition, patients who have experienced an attack of acute pancreatitis should be screened long-term for development of pancreatic exocrine insufficiency, which may be present in approximately one-quarter of patients following an acute pancreatitis episode, and diabetes, Dr. Barkin said. He cited a population-based study published in the American Journal of Gastroenterology in 2019 in which individuals with postpancreatitis diabetes had significantly higher rates of all-cause mortality, as well as hospitalization for conditions including chronic pulmonary disease, severe renal disease, and infectious disease.

Finally, at the time of discharge, it is essential to evaluate acute pancreatitis patients for risk of readmission, Dr. Barkin said. In addition to severe disease and systemic inflammatory response syndrome at the time of patient discharge, several factors increase the likelihood of readmission including ongoing abdominal pain requiring use of pain medicine, obesity, and inability to tolerate solid food, he noted.

Global Academy for Medical Education and this news organization are owned by the same parent company.

Dr. Barkin had no relevant financial conflicts to disclose.

Share AGA GI Patient Center education on pancreatitis to help your patients understand testing and treatment options and possible complications at http://ow.ly/nsdn30rcz5A.

When COVID-19 hit, the AGA Research Foundation quickly announced the AGA-Takeda COVID-19 Rapid Response Research Awards to provide funding to kick-start research into the virus’ impact on the digestive tract. We’re excited to share our three award recipients with you. Read about their research projects below.

David A. Drew, PhD, and Long H. Nguyen, MD, MS, from Massachusetts General Hospital and Harvard Medical School will test their hypothesis that gut microbial communities mediate the relationship between GI symptoms and the varied clinical presentations and outcomes in patients with COVID-19. To accomplish this goal, they will jointly develop and rapidly deploy a multinational digital infrastructure for large-scale epidemiologic studies during the current global pandemic. By characterizing the GI symptoms most predictive of COVID-19 infection risk and severity, their work will offer timely insights into the ongoing pandemic and offer a foundation for further study on the effects of COVID-19 on human gut microbial communities.

Jeffrey Wade Brown from Washington University is evaluating the infective potential of the metaplastic GI foregut. For this project Dr. Brown and his team will use a novel, unique, and unpublished organoid system that propagates the features of upper GI human metaplasia in vitro to study a potential role for metaplasia in the predisposition to COVID-19. Dr. Brown hopes this research will directly help by making a previously naive population know that they are potentially at higher risk. Further, the high-throughput screening technology they are developing will not only be useful here but also could quickly be adapted to other pandemics.

Congratulations to Drs. David A. Drew, Long H. Nguyen, and Jeffrey Wade Brown — recipients of our AGA-Takeda COVID-19 Rapid Response Research Awards from the AGA Research Foundation.

[email protected]

When COVID-19 hit, the AGA Research Foundation quickly announced the AGA-Takeda COVID-19 Rapid Response Research Awards to provide funding to kick-start research into the virus’ impact on the digestive tract. We’re excited to share our three award recipients with you. Read about their research projects below.

David A. Drew, PhD, and Long H. Nguyen, MD, MS, from Massachusetts General Hospital and Harvard Medical School will test their hypothesis that gut microbial communities mediate the relationship between GI symptoms and the varied clinical presentations and outcomes in patients with COVID-19. To accomplish this goal, they will jointly develop and rapidly deploy a multinational digital infrastructure for large-scale epidemiologic studies during the current global pandemic. By characterizing the GI symptoms most predictive of COVID-19 infection risk and severity, their work will offer timely insights into the ongoing pandemic and offer a foundation for further study on the effects of COVID-19 on human gut microbial communities.

Jeffrey Wade Brown from Washington University is evaluating the infective potential of the metaplastic GI foregut. For this project Dr. Brown and his team will use a novel, unique, and unpublished organoid system that propagates the features of upper GI human metaplasia in vitro to study a potential role for metaplasia in the predisposition to COVID-19. Dr. Brown hopes this research will directly help by making a previously naive population know that they are potentially at higher risk. Further, the high-throughput screening technology they are developing will not only be useful here but also could quickly be adapted to other pandemics.

Congratulations to Drs. David A. Drew, Long H. Nguyen, and Jeffrey Wade Brown — recipients of our AGA-Takeda COVID-19 Rapid Response Research Awards from the AGA Research Foundation.

[email protected]

When COVID-19 hit, the AGA Research Foundation quickly announced the AGA-Takeda COVID-19 Rapid Response Research Awards to provide funding to kick-start research into the virus’ impact on the digestive tract. We’re excited to share our three award recipients with you. Read about their research projects below.

David A. Drew, PhD, and Long H. Nguyen, MD, MS, from Massachusetts General Hospital and Harvard Medical School will test their hypothesis that gut microbial communities mediate the relationship between GI symptoms and the varied clinical presentations and outcomes in patients with COVID-19. To accomplish this goal, they will jointly develop and rapidly deploy a multinational digital infrastructure for large-scale epidemiologic studies during the current global pandemic. By characterizing the GI symptoms most predictive of COVID-19 infection risk and severity, their work will offer timely insights into the ongoing pandemic and offer a foundation for further study on the effects of COVID-19 on human gut microbial communities.

Jeffrey Wade Brown from Washington University is evaluating the infective potential of the metaplastic GI foregut. For this project Dr. Brown and his team will use a novel, unique, and unpublished organoid system that propagates the features of upper GI human metaplasia in vitro to study a potential role for metaplasia in the predisposition to COVID-19. Dr. Brown hopes this research will directly help by making a previously naive population know that they are potentially at higher risk. Further, the high-throughput screening technology they are developing will not only be useful here but also could quickly be adapted to other pandemics.

Congratulations to Drs. David A. Drew, Long H. Nguyen, and Jeffrey Wade Brown — recipients of our AGA-Takeda COVID-19 Rapid Response Research Awards from the AGA Research Foundation.

[email protected]

Adding neoadjuvant chemotherapy to standard treatment of locally advanced rectal cancer more than doubled the pathologic complete response rate and significantly improved 3-year disease-free survival (DFS) in a multicenter, phase 3 trial.

The pathologic complete response rate was 12.1% in the standard therapy arm and 27.8% with the addition of neoadjuvant chemotherapy – modified FOLFIRINOX (oxaliplatin, irinotecan, folinic acid, and 5-fluorouracil). The 3-year DFS rates were 68.5% and 75.7%, respectively.

It’s not clear if the response and DFS benefits of modified FOLFIRINOX will translate to improved overall survival (OS). Nevertheless, neoadjuvant therapy with modified FOLFIRINOX “should now be considered as a new option” for T3-T4 rectal cancer, said investigator Christophe Borg, MD, PhD, of the University of Besancon (France).

Dr. Borg presented this research at the European Society for Medical Oncology Virtual Congress 2020.

Study discussant David Sebag-Montefiore, MBBS, of the University of Leeds (England), was more cautious about these findings. Although the results were “clear” in this trial, “we have not seen any overall survival data,” Dr. Sebag-Montefiore stressed.
 

Study details

In explaining the trial, dubbed PRODIGE 23, Dr. Borg noted that local recurrence is minimal with modern standard treatment – chemoradiation followed by total mesorectal excision (TME) – but distant metastases occur in up to 30% of patients and remain a significant problem despite years of research. Adjuvant chemotherapy after surgery might help, but it “is still not proven” to reduce the risk, so compliance is poor, Dr. Borg said.

He and his colleagues conducted the PRODIGE 23 trial to see if neoadjuvant chemotherapy could reduce the risk of metastases.

The study enrolled 461 patients, 18-75 years old, with cT3-4 rectal cancer. Patients were randomized to receive:

• Standard therapy, consisting of chemoradiation (50.4 gy/5 weeks plus capecitabine), followed 7 weeks later by TME, then 6 months of adjuvant chemotherapy with FOLFOX (folinic acid, fluorouracil, and oxaliplatin) or XELOX (capecitabine and oxaliplatin, also known as CAPOX).
• Six cycles of modified FOLFIRINOX, followed by chemoradiation (50.4 gy/5 weeks plus capecitabine), TME, and FOLFOX/XELOX adjuvant therapy for 3 months instead of 6 months.

Overall, 119 patients in the standard therapy arm and 130 in the neoadjuvant arm completed their assigned protocol.
 

Results

The median follow-up was 46.5 months. The 3-year DFS, the primary endpoint, was significantly higher in the neoadjuvant arm than in the standard therapy arm (75.7% vs. 68.5%; hazard ratio = 0.69; P = .034). This correlated with a significant improvement in 3-year metastasis-free survival (78.8% vs. 71.7%; HR = 0.64; P < .02).

The rate of palliative surgery was significantly higher in the standard therapy arm (3.7% vs. 0%; P = .007), but there were no significant differences in other surgical outcomes.

A difference in 60-day postoperative mortality favored neoadjuvant therapy (0% vs. 2.8%, P = .03).

Grade 3 or 4 adverse events during adjuvant therapy were less common when subjects had neoadjuvant chemotherapy (44.4% vs. 74.1%, P < .001).

Quality of life outcomes were similar between the treatment arms, except that men in the neoadjuvant arm were significantly less likely to suffer from impotence (P = .03).

Dr. Sebag-Montefiore said these findings are “very important,” but PRODIGE 23 is not “a practice-defining or practice-changing study,” especially without OS data.

He noted that the RAPIDO trial had similar outcomes with a different neoadjuvant regimen.

RAPIDO had a standard treatment arm with capecitabine-based chemoradiotherapy followed by TME and optional CAPOX/FOLFOX, and the experimental arm consisted of short-course radiotherapy followed by CAPOX/FOLFOX then TME. The experimental arm had superior 3-year disease-related treatment failure (30.4% vs. 23.7%, P = .019) but no better OS (89.1% vs. 88.8%, P = .59).

PRODIGE 23 was funded by the French National Cancer Institute and the French National League Against Cancer. Dr. Borg disclosed relationships with Roche, Servier, Pierre Fabre, and Merck Sharp & Dohme. Dr. Sebag-Montefiore didn’t have any disclosures.

[email protected]

SOURCE: Borg C et al. ESMO 2020. Abstract LBA21.

Adding neoadjuvant chemotherapy to standard treatment of locally advanced rectal cancer more than doubled the pathologic complete response rate and significantly improved 3-year disease-free survival (DFS) in a multicenter, phase 3 trial.

The pathologic complete response rate was 12.1% in the standard therapy arm and 27.8% with the addition of neoadjuvant chemotherapy – modified FOLFIRINOX (oxaliplatin, irinotecan, folinic acid, and 5-fluorouracil). The 3-year DFS rates were 68.5% and 75.7%, respectively.

It’s not clear if the response and DFS benefits of modified FOLFIRINOX will translate to improved overall survival (OS). Nevertheless, neoadjuvant therapy with modified FOLFIRINOX “should now be considered as a new option” for T3-T4 rectal cancer, said investigator Christophe Borg, MD, PhD, of the University of Besancon (France).

Dr. Borg presented this research at the European Society for Medical Oncology Virtual Congress 2020.

Study discussant David Sebag-Montefiore, MBBS, of the University of Leeds (England), was more cautious about these findings. Although the results were “clear” in this trial, “we have not seen any overall survival data,” Dr. Sebag-Montefiore stressed.
 

Study details

In explaining the trial, dubbed PRODIGE 23, Dr. Borg noted that local recurrence is minimal with modern standard treatment – chemoradiation followed by total mesorectal excision (TME) – but distant metastases occur in up to 30% of patients and remain a significant problem despite years of research. Adjuvant chemotherapy after surgery might help, but it “is still not proven” to reduce the risk, so compliance is poor, Dr. Borg said.

He and his colleagues conducted the PRODIGE 23 trial to see if neoadjuvant chemotherapy could reduce the risk of metastases.

The study enrolled 461 patients, 18-75 years old, with cT3-4 rectal cancer. Patients were randomized to receive:

• Standard therapy, consisting of chemoradiation (50.4 gy/5 weeks plus capecitabine), followed 7 weeks later by TME, then 6 months of adjuvant chemotherapy with FOLFOX (folinic acid, fluorouracil, and oxaliplatin) or XELOX (capecitabine and oxaliplatin, also known as CAPOX).
• Six cycles of modified FOLFIRINOX, followed by chemoradiation (50.4 gy/5 weeks plus capecitabine), TME, and FOLFOX/XELOX adjuvant therapy for 3 months instead of 6 months.

Overall, 119 patients in the standard therapy arm and 130 in the neoadjuvant arm completed their assigned protocol.
 

Results

The median follow-up was 46.5 months. The 3-year DFS, the primary endpoint, was significantly higher in the neoadjuvant arm than in the standard therapy arm (75.7% vs. 68.5%; hazard ratio = 0.69; P = .034). This correlated with a significant improvement in 3-year metastasis-free survival (78.8% vs. 71.7%; HR = 0.64; P < .02).

The rate of palliative surgery was significantly higher in the standard therapy arm (3.7% vs. 0%; P = .007), but there were no significant differences in other surgical outcomes.

A difference in 60-day postoperative mortality favored neoadjuvant therapy (0% vs. 2.8%, P = .03).

Grade 3 or 4 adverse events during adjuvant therapy were less common when subjects had neoadjuvant chemotherapy (44.4% vs. 74.1%, P < .001).

Quality of life outcomes were similar between the treatment arms, except that men in the neoadjuvant arm were significantly less likely to suffer from impotence (P = .03).

Dr. Sebag-Montefiore said these findings are “very important,” but PRODIGE 23 is not “a practice-defining or practice-changing study,” especially without OS data.

He noted that the RAPIDO trial had similar outcomes with a different neoadjuvant regimen.

RAPIDO had a standard treatment arm with capecitabine-based chemoradiotherapy followed by TME and optional CAPOX/FOLFOX, and the experimental arm consisted of short-course radiotherapy followed by CAPOX/FOLFOX then TME. The experimental arm had superior 3-year disease-related treatment failure (30.4% vs. 23.7%, P = .019) but no better OS (89.1% vs. 88.8%, P = .59).

PRODIGE 23 was funded by the French National Cancer Institute and the French National League Against Cancer. Dr. Borg disclosed relationships with Roche, Servier, Pierre Fabre, and Merck Sharp & Dohme. Dr. Sebag-Montefiore didn’t have any disclosures.

[email protected]

SOURCE: Borg C et al. ESMO 2020. Abstract LBA21.

Adding neoadjuvant chemotherapy to standard treatment of locally advanced rectal cancer more than doubled the pathologic complete response rate and significantly improved 3-year disease-free survival (DFS) in a multicenter, phase 3 trial.

The pathologic complete response rate was 12.1% in the standard therapy arm and 27.8% with the addition of neoadjuvant chemotherapy – modified FOLFIRINOX (oxaliplatin, irinotecan, folinic acid, and 5-fluorouracil). The 3-year DFS rates were 68.5% and 75.7%, respectively.

It’s not clear if the response and DFS benefits of modified FOLFIRINOX will translate to improved overall survival (OS). Nevertheless, neoadjuvant therapy with modified FOLFIRINOX “should now be considered as a new option” for T3-T4 rectal cancer, said investigator Christophe Borg, MD, PhD, of the University of Besancon (France).

Dr. Borg presented this research at the European Society for Medical Oncology Virtual Congress 2020.

Study discussant David Sebag-Montefiore, MBBS, of the University of Leeds (England), was more cautious about these findings. Although the results were “clear” in this trial, “we have not seen any overall survival data,” Dr. Sebag-Montefiore stressed.
 

Study details

In explaining the trial, dubbed PRODIGE 23, Dr. Borg noted that local recurrence is minimal with modern standard treatment – chemoradiation followed by total mesorectal excision (TME) – but distant metastases occur in up to 30% of patients and remain a significant problem despite years of research. Adjuvant chemotherapy after surgery might help, but it “is still not proven” to reduce the risk, so compliance is poor, Dr. Borg said.

He and his colleagues conducted the PRODIGE 23 trial to see if neoadjuvant chemotherapy could reduce the risk of metastases.

The study enrolled 461 patients, 18-75 years old, with cT3-4 rectal cancer. Patients were randomized to receive:

• Standard therapy, consisting of chemoradiation (50.4 gy/5 weeks plus capecitabine), followed 7 weeks later by TME, then 6 months of adjuvant chemotherapy with FOLFOX (folinic acid, fluorouracil, and oxaliplatin) or XELOX (capecitabine and oxaliplatin, also known as CAPOX).
• Six cycles of modified FOLFIRINOX, followed by chemoradiation (50.4 gy/5 weeks plus capecitabine), TME, and FOLFOX/XELOX adjuvant therapy for 3 months instead of 6 months.

Overall, 119 patients in the standard therapy arm and 130 in the neoadjuvant arm completed their assigned protocol.
 

Results

The median follow-up was 46.5 months. The 3-year DFS, the primary endpoint, was significantly higher in the neoadjuvant arm than in the standard therapy arm (75.7% vs. 68.5%; hazard ratio = 0.69; P = .034). This correlated with a significant improvement in 3-year metastasis-free survival (78.8% vs. 71.7%; HR = 0.64; P < .02).

The rate of palliative surgery was significantly higher in the standard therapy arm (3.7% vs. 0%; P = .007), but there were no significant differences in other surgical outcomes.

A difference in 60-day postoperative mortality favored neoadjuvant therapy (0% vs. 2.8%, P = .03).

Grade 3 or 4 adverse events during adjuvant therapy were less common when subjects had neoadjuvant chemotherapy (44.4% vs. 74.1%, P < .001).

Quality of life outcomes were similar between the treatment arms, except that men in the neoadjuvant arm were significantly less likely to suffer from impotence (P = .03).

Dr. Sebag-Montefiore said these findings are “very important,” but PRODIGE 23 is not “a practice-defining or practice-changing study,” especially without OS data.

He noted that the RAPIDO trial had similar outcomes with a different neoadjuvant regimen.

RAPIDO had a standard treatment arm with capecitabine-based chemoradiotherapy followed by TME and optional CAPOX/FOLFOX, and the experimental arm consisted of short-course radiotherapy followed by CAPOX/FOLFOX then TME. The experimental arm had superior 3-year disease-related treatment failure (30.4% vs. 23.7%, P = .019) but no better OS (89.1% vs. 88.8%, P = .59).

PRODIGE 23 was funded by the French National Cancer Institute and the French National League Against Cancer. Dr. Borg disclosed relationships with Roche, Servier, Pierre Fabre, and Merck Sharp & Dohme. Dr. Sebag-Montefiore didn’t have any disclosures.

[email protected]

SOURCE: Borg C et al. ESMO 2020. Abstract LBA21.

Machine-based learning of genetic and epigenetic characteristics of patients with rheumatoid arthritis could help to predict who is likely to benefit from the biologic drugs adalimumab and etanercept, according to results from a longitudinal, observational cohort study.

In the study, machine learning models created by researchers from Utrecht University in the Netherlands using different parameters predicted true-positive rates for response to adalimumab ranging from 76% to 90% and true-negative rates ranging from 70% to 89%, while for etanercept true-positive rates ranged from about 60% to 80% and true-negative rates ranged from about 82% to 98%.

“These results suggest that we can accurately predict the clinical response before adalimumab and etanercept treatment using molecular signatures-based machine learning models, although the prediction accuracy of these molecular signatures differs between cell types and treatments, underlining the need to study more than one drug, cell type, or epigenetic layers,” first author Weiyang Tao and colleagues wrote in Arthritis & Rheumatology. The ability to predict which tumor necrosis factor inhibitor (TNFi) is the first choice for treatment would be highly beneficial in reducing the time to effective treatment, which has been extensively proven to be a paramount factor for achieving long-sustained disease remission, they noted.

The researchers analyzed gene expression and epigenetic signatures in 80 patients with rheumatoid arthritis prior to treatment with adalimumab or etanercept and then examined patients’ response to treatment at 6 months. They then used that information to build a machine learning model to try to predict treatment response.

Overall, 47.5% of patients were treated with adalimumab, and 52.5% were treated with etanercept. Among the adalimumab group, 53% had a good or moderate response to treatment at 6 months, and among those treated with etanercept, 45% had a good or moderate response.

While there were no differences in baseline clinical parameters between responders and nonresponders, the study found significant genetic and epigenetic differences between patients.

They identified 549 genes that showed significantly different levels of expression between responders and nonresponders treated with adalimumab – in particular, genes involved in DNA and nucleotide binding – and 460 genes that were differentially expressed between etanercept responders and nonresponders, including genes involved in TNF-receptor signaling. However, only 2% of these differentially expressed genes were common in both the adalimumab and etanercept groups, suggesting treatment responses for these two medications have distinct gene signatures.

Looking at DNA methylation, researchers found 16,141 CpG positions – sites of DNA methylation – that were differentially methylated between adalimumab responders and nonresponders, 46% of which were hypermethylated among responders but not nonresponders. In the etanercept group, there were 17,026 differentially methylated sites in responders and nonresponders, 76.3% of which were hypermethylated among responders.

The researchers also noted that among the adalimumab responders, the hypermethylated sites were more likely to be found in the upstream and promoter regions of genes, and on CpG islands.

“Thus, on epigenetic level, we observed a distinct hypermethylation pattern between adalimumab and etanercept responders, suggesting the role of epigenetics in defining response towards adalimumab and to etanercept in PBMCs [peripheral blood mononuclear cells],” the authors wrote.

Given the differences in gene signatures seen in the adalimumab responders and etanercept responders, researchers speculated that different cell types might be involved in the responses to these two treatments. They undertook RNA sequencing on the variety of immune cell types known to be involved in rheumatoid arthritis, which revealed gene-expression differences between adalimumab responders and nonresponders in their CD4+ T cells but not in monocytes. However, the gene-expression differences between etanercept responders and nonresponders were seen in both CD4+ T cells and monocytes.

The study was supported by AbbVie, which manufactures adalimumab, and two authors were supported by the China Scholarship Council and the Netherlands Organization for Scientific Research. No conflicts of interest were declared.

SOURCE: Tao W et al. Arthritis Rheumatol. 2020 Sep 10. doi: 10.1002/art.41516.

Machine-based learning of genetic and epigenetic characteristics of patients with rheumatoid arthritis could help to predict who is likely to benefit from the biologic drugs adalimumab and etanercept, according to results from a longitudinal, observational cohort study.

In the study, machine learning models created by researchers from Utrecht University in the Netherlands using different parameters predicted true-positive rates for response to adalimumab ranging from 76% to 90% and true-negative rates ranging from 70% to 89%, while for etanercept true-positive rates ranged from about 60% to 80% and true-negative rates ranged from about 82% to 98%.

“These results suggest that we can accurately predict the clinical response before adalimumab and etanercept treatment using molecular signatures-based machine learning models, although the prediction accuracy of these molecular signatures differs between cell types and treatments, underlining the need to study more than one drug, cell type, or epigenetic layers,” first author Weiyang Tao and colleagues wrote in Arthritis & Rheumatology. The ability to predict which tumor necrosis factor inhibitor (TNFi) is the first choice for treatment would be highly beneficial in reducing the time to effective treatment, which has been extensively proven to be a paramount factor for achieving long-sustained disease remission, they noted.

The researchers analyzed gene expression and epigenetic signatures in 80 patients with rheumatoid arthritis prior to treatment with adalimumab or etanercept and then examined patients’ response to treatment at 6 months. They then used that information to build a machine learning model to try to predict treatment response.

Overall, 47.5% of patients were treated with adalimumab, and 52.5% were treated with etanercept. Among the adalimumab group, 53% had a good or moderate response to treatment at 6 months, and among those treated with etanercept, 45% had a good or moderate response.

While there were no differences in baseline clinical parameters between responders and nonresponders, the study found significant genetic and epigenetic differences between patients.

They identified 549 genes that showed significantly different levels of expression between responders and nonresponders treated with adalimumab – in particular, genes involved in DNA and nucleotide binding – and 460 genes that were differentially expressed between etanercept responders and nonresponders, including genes involved in TNF-receptor signaling. However, only 2% of these differentially expressed genes were common in both the adalimumab and etanercept groups, suggesting treatment responses for these two medications have distinct gene signatures.

Looking at DNA methylation, researchers found 16,141 CpG positions – sites of DNA methylation – that were differentially methylated between adalimumab responders and nonresponders, 46% of which were hypermethylated among responders but not nonresponders. In the etanercept group, there were 17,026 differentially methylated sites in responders and nonresponders, 76.3% of which were hypermethylated among responders.

The researchers also noted that among the adalimumab responders, the hypermethylated sites were more likely to be found in the upstream and promoter regions of genes, and on CpG islands.

“Thus, on epigenetic level, we observed a distinct hypermethylation pattern between adalimumab and etanercept responders, suggesting the role of epigenetics in defining response towards adalimumab and to etanercept in PBMCs [peripheral blood mononuclear cells],” the authors wrote.

Given the differences in gene signatures seen in the adalimumab responders and etanercept responders, researchers speculated that different cell types might be involved in the responses to these two treatments. They undertook RNA sequencing on the variety of immune cell types known to be involved in rheumatoid arthritis, which revealed gene-expression differences between adalimumab responders and nonresponders in their CD4+ T cells but not in monocytes. However, the gene-expression differences between etanercept responders and nonresponders were seen in both CD4+ T cells and monocytes.

The study was supported by AbbVie, which manufactures adalimumab, and two authors were supported by the China Scholarship Council and the Netherlands Organization for Scientific Research. No conflicts of interest were declared.

SOURCE: Tao W et al. Arthritis Rheumatol. 2020 Sep 10. doi: 10.1002/art.41516.

Machine-based learning of genetic and epigenetic characteristics of patients with rheumatoid arthritis could help to predict who is likely to benefit from the biologic drugs adalimumab and etanercept, according to results from a longitudinal, observational cohort study.

In the study, machine learning models created by researchers from Utrecht University in the Netherlands using different parameters predicted true-positive rates for response to adalimumab ranging from 76% to 90% and true-negative rates ranging from 70% to 89%, while for etanercept true-positive rates ranged from about 60% to 80% and true-negative rates ranged from about 82% to 98%.

“These results suggest that we can accurately predict the clinical response before adalimumab and etanercept treatment using molecular signatures-based machine learning models, although the prediction accuracy of these molecular signatures differs between cell types and treatments, underlining the need to study more than one drug, cell type, or epigenetic layers,” first author Weiyang Tao and colleagues wrote in Arthritis & Rheumatology. The ability to predict which tumor necrosis factor inhibitor (TNFi) is the first choice for treatment would be highly beneficial in reducing the time to effective treatment, which has been extensively proven to be a paramount factor for achieving long-sustained disease remission, they noted.

The researchers analyzed gene expression and epigenetic signatures in 80 patients with rheumatoid arthritis prior to treatment with adalimumab or etanercept and then examined patients’ response to treatment at 6 months. They then used that information to build a machine learning model to try to predict treatment response.

Overall, 47.5% of patients were treated with adalimumab, and 52.5% were treated with etanercept. Among the adalimumab group, 53% had a good or moderate response to treatment at 6 months, and among those treated with etanercept, 45% had a good or moderate response.

While there were no differences in baseline clinical parameters between responders and nonresponders, the study found significant genetic and epigenetic differences between patients.

They identified 549 genes that showed significantly different levels of expression between responders and nonresponders treated with adalimumab – in particular, genes involved in DNA and nucleotide binding – and 460 genes that were differentially expressed between etanercept responders and nonresponders, including genes involved in TNF-receptor signaling. However, only 2% of these differentially expressed genes were common in both the adalimumab and etanercept groups, suggesting treatment responses for these two medications have distinct gene signatures.

Looking at DNA methylation, researchers found 16,141 CpG positions – sites of DNA methylation – that were differentially methylated between adalimumab responders and nonresponders, 46% of which were hypermethylated among responders but not nonresponders. In the etanercept group, there were 17,026 differentially methylated sites in responders and nonresponders, 76.3% of which were hypermethylated among responders.

The researchers also noted that among the adalimumab responders, the hypermethylated sites were more likely to be found in the upstream and promoter regions of genes, and on CpG islands.

“Thus, on epigenetic level, we observed a distinct hypermethylation pattern between adalimumab and etanercept responders, suggesting the role of epigenetics in defining response towards adalimumab and to etanercept in PBMCs [peripheral blood mononuclear cells],” the authors wrote.

Given the differences in gene signatures seen in the adalimumab responders and etanercept responders, researchers speculated that different cell types might be involved in the responses to these two treatments. They undertook RNA sequencing on the variety of immune cell types known to be involved in rheumatoid arthritis, which revealed gene-expression differences between adalimumab responders and nonresponders in their CD4+ T cells but not in monocytes. However, the gene-expression differences between etanercept responders and nonresponders were seen in both CD4+ T cells and monocytes.

The study was supported by AbbVie, which manufactures adalimumab, and two authors were supported by the China Scholarship Council and the Netherlands Organization for Scientific Research. No conflicts of interest were declared.

SOURCE: Tao W et al. Arthritis Rheumatol. 2020 Sep 10. doi: 10.1002/art.41516.

The Food and Drug Administration has approved tablet and oral solution formulations of the Janus kinase (JAK) inhibitor tofactinib (Xeljanz) for the treatment of children and adolescents 2 years and older with active polyarticular-course juvenile idiopathic arthritis (pJIA).

The approval, announced Sept. 28 by tofacitinib’s manufacturer, Pfizer, marks the first JAK inhibitor to be approved for the condition in the United States and is the fourth indication to be approved for the drug after approvals in adult patients with moderate to severe rheumatoid arthritis following methotrexate failure, active psoriatic arthritis after disease-modifying antirheumatic drug failure, and moderate to severe ulcerative colitis after failure on a tumor necrosis factor inhibitor.

The agency based its approval on a phase 3, multinational, randomized, double-blind, controlled withdrawal study that had an 18-week, open-label, run-in phase involving 225 patients who twice daily took either a 5-mg tablet or, in patients under 40 kg, a weight-based lower dose in the form of a 1 mg/mL oral solution, according to the company press release. A total of 173 patients from this phase met JIA American College of Rheumatology 30 response criteria, defined as 30% or greater improvement in three of six JIA core set variables and worsening in no more than one of the core set variables; they were then randomized in part 2 of the study to continue the same dose of tofacitinib or receive placebo until 44 weeks. By the end of this period, 31% who received tofacitinib had a disease flare, compared with 55% on placebo (P = .0007). Disease flare was defined as a 30% or greater worsening in at least three of the six variables of the JIA core set, with no more than one of the remaining JIA core response variables improving by 30% or more after randomization.

The types of adverse drug reactions in patients with pJIA were consistent with those seen in adult rheumatoid arthritis patients, according to Pfizer. Serious adverse drug reactions have most commonly been serious infections that may lead to hospitalization or death, and most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. Common adverse drug reactions reported in 2% or more of patients during the first 3 months in controlled clinical trials in patients with rheumatoid arthritis taking tofacitinib at 5 mg twice daily were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension.

While the 5-mg tablet formulation is already available, Pfizer said it expects the oral solution to be available by the end of the first quarter in 2021.

Prescribing information can be found on the FDA website.

[email protected]

The Food and Drug Administration has approved tablet and oral solution formulations of the Janus kinase (JAK) inhibitor tofactinib (Xeljanz) for the treatment of children and adolescents 2 years and older with active polyarticular-course juvenile idiopathic arthritis (pJIA).

The approval, announced Sept. 28 by tofacitinib’s manufacturer, Pfizer, marks the first JAK inhibitor to be approved for the condition in the United States and is the fourth indication to be approved for the drug after approvals in adult patients with moderate to severe rheumatoid arthritis following methotrexate failure, active psoriatic arthritis after disease-modifying antirheumatic drug failure, and moderate to severe ulcerative colitis after failure on a tumor necrosis factor inhibitor.

The agency based its approval on a phase 3, multinational, randomized, double-blind, controlled withdrawal study that had an 18-week, open-label, run-in phase involving 225 patients who twice daily took either a 5-mg tablet or, in patients under 40 kg, a weight-based lower dose in the form of a 1 mg/mL oral solution, according to the company press release. A total of 173 patients from this phase met JIA American College of Rheumatology 30 response criteria, defined as 30% or greater improvement in three of six JIA core set variables and worsening in no more than one of the core set variables; they were then randomized in part 2 of the study to continue the same dose of tofacitinib or receive placebo until 44 weeks. By the end of this period, 31% who received tofacitinib had a disease flare, compared with 55% on placebo (P = .0007). Disease flare was defined as a 30% or greater worsening in at least three of the six variables of the JIA core set, with no more than one of the remaining JIA core response variables improving by 30% or more after randomization.

The types of adverse drug reactions in patients with pJIA were consistent with those seen in adult rheumatoid arthritis patients, according to Pfizer. Serious adverse drug reactions have most commonly been serious infections that may lead to hospitalization or death, and most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. Common adverse drug reactions reported in 2% or more of patients during the first 3 months in controlled clinical trials in patients with rheumatoid arthritis taking tofacitinib at 5 mg twice daily were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension.

While the 5-mg tablet formulation is already available, Pfizer said it expects the oral solution to be available by the end of the first quarter in 2021.

Prescribing information can be found on the FDA website.

[email protected]

The Food and Drug Administration has approved tablet and oral solution formulations of the Janus kinase (JAK) inhibitor tofactinib (Xeljanz) for the treatment of children and adolescents 2 years and older with active polyarticular-course juvenile idiopathic arthritis (pJIA).

The approval, announced Sept. 28 by tofacitinib’s manufacturer, Pfizer, marks the first JAK inhibitor to be approved for the condition in the United States and is the fourth indication to be approved for the drug after approvals in adult patients with moderate to severe rheumatoid arthritis following methotrexate failure, active psoriatic arthritis after disease-modifying antirheumatic drug failure, and moderate to severe ulcerative colitis after failure on a tumor necrosis factor inhibitor.

The agency based its approval on a phase 3, multinational, randomized, double-blind, controlled withdrawal study that had an 18-week, open-label, run-in phase involving 225 patients who twice daily took either a 5-mg tablet or, in patients under 40 kg, a weight-based lower dose in the form of a 1 mg/mL oral solution, according to the company press release. A total of 173 patients from this phase met JIA American College of Rheumatology 30 response criteria, defined as 30% or greater improvement in three of six JIA core set variables and worsening in no more than one of the core set variables; they were then randomized in part 2 of the study to continue the same dose of tofacitinib or receive placebo until 44 weeks. By the end of this period, 31% who received tofacitinib had a disease flare, compared with 55% on placebo (P = .0007). Disease flare was defined as a 30% or greater worsening in at least three of the six variables of the JIA core set, with no more than one of the remaining JIA core response variables improving by 30% or more after randomization.

The types of adverse drug reactions in patients with pJIA were consistent with those seen in adult rheumatoid arthritis patients, according to Pfizer. Serious adverse drug reactions have most commonly been serious infections that may lead to hospitalization or death, and most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. Common adverse drug reactions reported in 2% or more of patients during the first 3 months in controlled clinical trials in patients with rheumatoid arthritis taking tofacitinib at 5 mg twice daily were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension.

While the 5-mg tablet formulation is already available, Pfizer said it expects the oral solution to be available by the end of the first quarter in 2021.

Prescribing information can be found on the FDA website.

[email protected]

Recently I was in a minor car accident. No injuries, just some bent metal and scratched paint from a low-speed parking lot mishap.

The other driver and I got out of our cars, made sure we were both okay, and then I said “Let’s exchange insurance information.” We got our insurance cards out; I took a picture of her card, and she wrote down my info. Then we drove off and went on with our days. The whole thing took a few minutes.

Why am I writing about this?

Because it was all handled very politely. There were no angry words, name calling, or heated exchanges. We checked the damage, made sure the other was okay, and exchanged insurance cards ... without a single impolite phrase or gesture.

To me this is a good thing. In a world in which people yell (and sometimes brandish weapons) over imagined and minor offenses, in which political candidates exchange crude insults rather then debate policy, and in which an opposing viewpoint is treated as blasphemy rather than an honest difference of opinion, it was nice to have a polite, adult, exchange under unpleasant circumstances.

Perhaps it’s sad to find relief in such a minor event, but it’s also reassuring. In medicine (especially hospital work) we often see people at their very worst, and dealing with them can be a challenge. We live in a world of at-times seemingly endless rudeness, one-upping, and “problem-solving” with yelling, threats, and intimidation.

So I was glad the minor incident resulted in nothing more serious at the time than a brief, polite, conversation. It’s nice to know many people out there still subscribe to civil ideas and polite behavior, even when the circumstances are difficult.

Dr. Block has a solo neurology practice in Scottsdale, Arizona. He has nothing to disclose.

Recently I was in a minor car accident. No injuries, just some bent metal and scratched paint from a low-speed parking lot mishap.

The other driver and I got out of our cars, made sure we were both okay, and then I said “Let’s exchange insurance information.” We got our insurance cards out; I took a picture of her card, and she wrote down my info. Then we drove off and went on with our days. The whole thing took a few minutes.

Why am I writing about this?

Because it was all handled very politely. There were no angry words, name calling, or heated exchanges. We checked the damage, made sure the other was okay, and exchanged insurance cards ... without a single impolite phrase or gesture.

To me this is a good thing. In a world in which people yell (and sometimes brandish weapons) over imagined and minor offenses, in which political candidates exchange crude insults rather then debate policy, and in which an opposing viewpoint is treated as blasphemy rather than an honest difference of opinion, it was nice to have a polite, adult, exchange under unpleasant circumstances.

Perhaps it’s sad to find relief in such a minor event, but it’s also reassuring. In medicine (especially hospital work) we often see people at their very worst, and dealing with them can be a challenge. We live in a world of at-times seemingly endless rudeness, one-upping, and “problem-solving” with yelling, threats, and intimidation.

So I was glad the minor incident resulted in nothing more serious at the time than a brief, polite, conversation. It’s nice to know many people out there still subscribe to civil ideas and polite behavior, even when the circumstances are difficult.

Dr. Block has a solo neurology practice in Scottsdale, Arizona. He has nothing to disclose.

Recently I was in a minor car accident. No injuries, just some bent metal and scratched paint from a low-speed parking lot mishap.

The other driver and I got out of our cars, made sure we were both okay, and then I said “Let’s exchange insurance information.” We got our insurance cards out; I took a picture of her card, and she wrote down my info. Then we drove off and went on with our days. The whole thing took a few minutes.

Why am I writing about this?

Because it was all handled very politely. There were no angry words, name calling, or heated exchanges. We checked the damage, made sure the other was okay, and exchanged insurance cards ... without a single impolite phrase or gesture.

To me this is a good thing. In a world in which people yell (and sometimes brandish weapons) over imagined and minor offenses, in which political candidates exchange crude insults rather then debate policy, and in which an opposing viewpoint is treated as blasphemy rather than an honest difference of opinion, it was nice to have a polite, adult, exchange under unpleasant circumstances.

Perhaps it’s sad to find relief in such a minor event, but it’s also reassuring. In medicine (especially hospital work) we often see people at their very worst, and dealing with them can be a challenge. We live in a world of at-times seemingly endless rudeness, one-upping, and “problem-solving” with yelling, threats, and intimidation.

So I was glad the minor incident resulted in nothing more serious at the time than a brief, polite, conversation. It’s nice to know many people out there still subscribe to civil ideas and polite behavior, even when the circumstances are difficult.

Dr. Block has a solo neurology practice in Scottsdale, Arizona. He has nothing to disclose.

The American Gastroenterological Association (AGA) has issued guidance for pre-endoscopy coronavirus testing based on a review of existing literature and a survey of endoscopist risk tolerance.

While serologic antibody testing is not recommended for any patients, use of nucleic acid amplification testing (NAAT) for viral RNA should be informed by local prevalence of asymptomatic individuals, reported lead guideline panelist Shahnaz Sultan, MD, of the University of Minnesota in Minneapolis and colleagues.

“The two main concerns with a pretesting strategy are the false positives and false negatives,” the panelists wrote in Gastroenterology. When performing endoscopy in a false-negative patient, health care providers who wear a surgical mask instead of an N95/N99 respirator may have an increased risk of infection, and the patient undergoing the procedure may be falsely reassured that they are not contagious, the panelists wrote.

Among false-positive individuals, “implications for the patient include cancellation of the procedure, self-quarantine for 14 days, apprehension, and loss of work.”

Because of these concerns, the panelists concluded that pretesting strategies should be tailored to the local prevalence of asymptomatic infection because this rate is associated with likelihood of encountering false-positive and false-negative patients.

To determine appropriate prevalence thresholds, Dr. Sultan and colleagues first conducted a meta-analysis of 12 studies comparing the accuracy of various NAAT tests. This revealed a pooled sensitivity of 0.941 and a pooled specificity of 0.971. These figures remained consistent when only studies with low risk bias were considered; pooled sensitivity and specificity were 0.929 and 0.968, respectively.

“An important caveat of these studies is that tests were validated in samples from symptomatic individuals and it is likely that in asymptomatic individuals the tests may not perform as well and have lower sensitivity and specificity,” the panelists noted.

Next, Dr. Sultan and colleagues conducted an online survey of U.S. endoscopists to determine their tolerance for risk of coronavirus transmission, with proposed risk thresholds ranging from 1/40,000 to 1/1,000. Out of 74 respondents, 28 (37.8%) said that they would be willing to accept a risk level of 1/40,000, whereas 27 (36.5%) would accept risks between 1/10,000 and 1/2,500, and 19 (25.7%) would accept a risk level of 1/1,000. Among clinicians expressing the highest risk tolerance (1/1,000), almost two-thirds (63.2%) were private practitioners.

Drawing on these findings, the panelists issued three tiered recommendations for pretesting based on local prevalence of asymptomatic infection.

• Low prevalence (less than 0.5%): Pretesting is not recommended.
• Intermediate prevalence (0.5-2%): Pretesting is recommended.
• High prevalence (greater than 2%): Pretesting is not recommended.

The panelists recommended against pretesting in low and high prevalence settings because of the likelihood of false positives and false negatives, respectively. For “hotspot” areas, in which hospital capacity is acutely burdened, the panelists noted that “resumption of outpatient endoscopy may depend on availability of PPE.”

In areas of intermediate prevalence, the pretesting recommendation stands only if “testing is feasible and there is less perceived burden on patients, and when the benefits outweigh the downsides (e.g., false positives do not significantly outnumber the true positives).” According to the guidance, when performing upper and lower endoscopies on negative patients in areas of intermediate prevalence, surgical masks are appropriate for endoscopists and staff, with the caveat that those unwilling to accept any increased risk may still wear an N95/N99 respirator or a powered air-purifying respirator (PAPR).

Finally, the panelists made a recommendation against pretesting for antibodies in all areas, regardless of asymptomatic infection prevalence.

“Evidence supporting the role of seroconversion for return to work or hospital staffing policies is also lacking,” they added.

All recommendations were based on low or very low certainty evidence.

To help endoscopy centers determine an appropriate pretesting strategy, the AGA has created an online interactive tool that allows for input of diagnostic test accuracy and local prevalence rate.The investigators reported no conflicts of interest. 

Instructions for using the tool, along with additional COVID-19 guidance, can be found on the AGA website: www.gastro.org/COVID. 

The investigators reported no conflicts of interest.

This story was updated on 10/13/2020 and on 11/6/2020.

SOURCE: Sultan S et al. Gastroenterology. 2020 Jul 28. doi: 10.1053/j.gastro.2020.07.043.

The American Gastroenterological Association (AGA) has issued guidance for pre-endoscopy coronavirus testing based on a review of existing literature and a survey of endoscopist risk tolerance.

While serologic antibody testing is not recommended for any patients, use of nucleic acid amplification testing (NAAT) for viral RNA should be informed by local prevalence of asymptomatic individuals, reported lead guideline panelist Shahnaz Sultan, MD, of the University of Minnesota in Minneapolis and colleagues.

“The two main concerns with a pretesting strategy are the false positives and false negatives,” the panelists wrote in Gastroenterology. When performing endoscopy in a false-negative patient, health care providers who wear a surgical mask instead of an N95/N99 respirator may have an increased risk of infection, and the patient undergoing the procedure may be falsely reassured that they are not contagious, the panelists wrote.

Among false-positive individuals, “implications for the patient include cancellation of the procedure, self-quarantine for 14 days, apprehension, and loss of work.”

Because of these concerns, the panelists concluded that pretesting strategies should be tailored to the local prevalence of asymptomatic infection because this rate is associated with likelihood of encountering false-positive and false-negative patients.

To determine appropriate prevalence thresholds, Dr. Sultan and colleagues first conducted a meta-analysis of 12 studies comparing the accuracy of various NAAT tests. This revealed a pooled sensitivity of 0.941 and a pooled specificity of 0.971. These figures remained consistent when only studies with low risk bias were considered; pooled sensitivity and specificity were 0.929 and 0.968, respectively.

“An important caveat of these studies is that tests were validated in samples from symptomatic individuals and it is likely that in asymptomatic individuals the tests may not perform as well and have lower sensitivity and specificity,” the panelists noted.

Next, Dr. Sultan and colleagues conducted an online survey of U.S. endoscopists to determine their tolerance for risk of coronavirus transmission, with proposed risk thresholds ranging from 1/40,000 to 1/1,000. Out of 74 respondents, 28 (37.8%) said that they would be willing to accept a risk level of 1/40,000, whereas 27 (36.5%) would accept risks between 1/10,000 and 1/2,500, and 19 (25.7%) would accept a risk level of 1/1,000. Among clinicians expressing the highest risk tolerance (1/1,000), almost two-thirds (63.2%) were private practitioners.

Drawing on these findings, the panelists issued three tiered recommendations for pretesting based on local prevalence of asymptomatic infection.

• Low prevalence (less than 0.5%): Pretesting is not recommended.
• Intermediate prevalence (0.5-2%): Pretesting is recommended.
• High prevalence (greater than 2%): Pretesting is not recommended.

The panelists recommended against pretesting in low and high prevalence settings because of the likelihood of false positives and false negatives, respectively. For “hotspot” areas, in which hospital capacity is acutely burdened, the panelists noted that “resumption of outpatient endoscopy may depend on availability of PPE.”

In areas of intermediate prevalence, the pretesting recommendation stands only if “testing is feasible and there is less perceived burden on patients, and when the benefits outweigh the downsides (e.g., false positives do not significantly outnumber the true positives).” According to the guidance, when performing upper and lower endoscopies on negative patients in areas of intermediate prevalence, surgical masks are appropriate for endoscopists and staff, with the caveat that those unwilling to accept any increased risk may still wear an N95/N99 respirator or a powered air-purifying respirator (PAPR).

Finally, the panelists made a recommendation against pretesting for antibodies in all areas, regardless of asymptomatic infection prevalence.

“Evidence supporting the role of seroconversion for return to work or hospital staffing policies is also lacking,” they added.

All recommendations were based on low or very low certainty evidence.

To help endoscopy centers determine an appropriate pretesting strategy, the AGA has created an online interactive tool that allows for input of diagnostic test accuracy and local prevalence rate.The investigators reported no conflicts of interest. 

Instructions for using the tool, along with additional COVID-19 guidance, can be found on the AGA website: www.gastro.org/COVID. 

The investigators reported no conflicts of interest.

This story was updated on 10/13/2020 and on 11/6/2020.

SOURCE: Sultan S et al. Gastroenterology. 2020 Jul 28. doi: 10.1053/j.gastro.2020.07.043.

The American Gastroenterological Association (AGA) has issued guidance for pre-endoscopy coronavirus testing based on a review of existing literature and a survey of endoscopist risk tolerance.

While serologic antibody testing is not recommended for any patients, use of nucleic acid amplification testing (NAAT) for viral RNA should be informed by local prevalence of asymptomatic individuals, reported lead guideline panelist Shahnaz Sultan, MD, of the University of Minnesota in Minneapolis and colleagues.

“The two main concerns with a pretesting strategy are the false positives and false negatives,” the panelists wrote in Gastroenterology. When performing endoscopy in a false-negative patient, health care providers who wear a surgical mask instead of an N95/N99 respirator may have an increased risk of infection, and the patient undergoing the procedure may be falsely reassured that they are not contagious, the panelists wrote.

Among false-positive individuals, “implications for the patient include cancellation of the procedure, self-quarantine for 14 days, apprehension, and loss of work.”

Because of these concerns, the panelists concluded that pretesting strategies should be tailored to the local prevalence of asymptomatic infection because this rate is associated with likelihood of encountering false-positive and false-negative patients.

To determine appropriate prevalence thresholds, Dr. Sultan and colleagues first conducted a meta-analysis of 12 studies comparing the accuracy of various NAAT tests. This revealed a pooled sensitivity of 0.941 and a pooled specificity of 0.971. These figures remained consistent when only studies with low risk bias were considered; pooled sensitivity and specificity were 0.929 and 0.968, respectively.

“An important caveat of these studies is that tests were validated in samples from symptomatic individuals and it is likely that in asymptomatic individuals the tests may not perform as well and have lower sensitivity and specificity,” the panelists noted.

Next, Dr. Sultan and colleagues conducted an online survey of U.S. endoscopists to determine their tolerance for risk of coronavirus transmission, with proposed risk thresholds ranging from 1/40,000 to 1/1,000. Out of 74 respondents, 28 (37.8%) said that they would be willing to accept a risk level of 1/40,000, whereas 27 (36.5%) would accept risks between 1/10,000 and 1/2,500, and 19 (25.7%) would accept a risk level of 1/1,000. Among clinicians expressing the highest risk tolerance (1/1,000), almost two-thirds (63.2%) were private practitioners.

Drawing on these findings, the panelists issued three tiered recommendations for pretesting based on local prevalence of asymptomatic infection.

• Low prevalence (less than 0.5%): Pretesting is not recommended.
• Intermediate prevalence (0.5-2%): Pretesting is recommended.
• High prevalence (greater than 2%): Pretesting is not recommended.

The panelists recommended against pretesting in low and high prevalence settings because of the likelihood of false positives and false negatives, respectively. For “hotspot” areas, in which hospital capacity is acutely burdened, the panelists noted that “resumption of outpatient endoscopy may depend on availability of PPE.”

In areas of intermediate prevalence, the pretesting recommendation stands only if “testing is feasible and there is less perceived burden on patients, and when the benefits outweigh the downsides (e.g., false positives do not significantly outnumber the true positives).” According to the guidance, when performing upper and lower endoscopies on negative patients in areas of intermediate prevalence, surgical masks are appropriate for endoscopists and staff, with the caveat that those unwilling to accept any increased risk may still wear an N95/N99 respirator or a powered air-purifying respirator (PAPR).

Finally, the panelists made a recommendation against pretesting for antibodies in all areas, regardless of asymptomatic infection prevalence.

“Evidence supporting the role of seroconversion for return to work or hospital staffing policies is also lacking,” they added.

All recommendations were based on low or very low certainty evidence.

To help endoscopy centers determine an appropriate pretesting strategy, the AGA has created an online interactive tool that allows for input of diagnostic test accuracy and local prevalence rate.The investigators reported no conflicts of interest. 

Instructions for using the tool, along with additional COVID-19 guidance, can be found on the AGA website: www.gastro.org/COVID. 

The investigators reported no conflicts of interest.

This story was updated on 10/13/2020 and on 11/6/2020.

SOURCE: Sultan S et al. Gastroenterology. 2020 Jul 28. doi: 10.1053/j.gastro.2020.07.043.

Brachial plexus injury often is thought to co-occur with shoulder dystocia, but the two complications appear to be unrelated, according to research published in Obstetrics & Gynecology.

dimarik/iStock/Getty Images

Grace J. Johnson, MD, and colleagues at Baylor College of Medicine in Houston performed a medical review of 41,525 deliveries at Texas Children’s Hospital between March 2012 and July 2019, identifying cases of brachial plexus injury, with and without shoulder dystocia, occurring and persisting. The researchers also evaluated whether clinical experience (5 years or fewer, 6-15 years, or more than 15 years since training) and education impacted the risk of children developing shoulder dystocia or brachial plexus injury.

There were 547 cases of shoulder dystocia in 26,163 vaginal births (2.1%) and 9 cases in 15,362 cesarean births (0.06%), while 33 cases of brachial plexus injury occurred overall. Nearly all brachial plexus injuries were in vaginal deliveries (30 cases; 0.1%), while 3 cases occurred in cesarean deliveries (0.02%). Of these, 14 cases (42%) of brachial plexus injury did not co-occur with shoulder dystocia. Brachial plexus injury that persisted to discharge was similar for children with shoulder dystocia (17 of 19 cases; 89%) and without shoulder dystocia (10 of 14 cases; 71%). In the 27 children with persistent brachial plexus injury, 2 of 23 children who received follow-up care continued to experience persistent brachial plexus injury at 9 months (1 case with shoulder dystocia) and 12 months (1 case without shoulder dystocia).

“The frequent co-occurrence of shoulder dystocia and brachial plexus injury coupled with the equally frequent occurrence of isolated brachial plexus injury suggests that both brachial plexus injury and shoulder dystocia often reflect two causally unrelated complications of uterine forces driving a fetus through the birth canal in the presence of disproportion between the passage and the shoulder girdle of the passenger,” Dr. Johnson and colleagues wrote.
 

Results unchanged by clinician experience

Factors that impacted the risk of brachial plexus injury in children without shoulder dystocia were lack of maternal diabetes (0 women vs. 6 women; P = .03) and second-stage labor length (mean 103 minutes vs. 53 minutes; P = .08). Dr. Johnson and colleagues found no significant between-group differences regarding operative delivery, maternal age, or gestational age.

The researchers also examined the experience of the clinician who delivered children with brachial plexus injuries, and discovered there were no significant differences in children who had transient as opposed to persistent brachial plexus injury based on the number of years a clinician had been in practice (P = .97). There also were no significant changes in the “ratios of brachial plexus injury per total deliveries, brachial plexus injury per vaginal deliveries, and brachial plexus injury per shoulder dystocia” despite the presence of education and training for shoulder dystocia.
 

Questions require further study

Torri Metz, MD, MS, a maternal-fetal medicine subspecialist and associate professor of obstetrics and gynecology at University of Utah Health in Salt Lake City, said in an interview that the review by Johnson and colleagues was able to address limitations in previous studies by looking at the medical records of shoulder dystocia cases at a single tertiary care center.

“Brachial plexus injury occurs both with and without a diagnosis of shoulder dystocia. The finding that the non–shoulder dystocia brachial plexus injuries were associated with a longer second stage of labor suggests that these injuries can occur even prior to delivery of the fetal head and are often not related to maneuvers employed by an obstetrician during delivery,” Dr. Metz said.

The findings that brachial plexus injury severity was unrelated to clinician experience suggests “the occurrence, severity, and persistence of brachial plexus injury may be unrelated to maneuvers by the practitioner at the time of delivery,” she said.

Although Johnson et al. found education and training initiatives did not significantly impact the ratio of brachial plexus injury cases, “importantly, there are likely many other benefits to shoulder dystocia simulation including team communication and comfort of the practitioner in an obstetrical emergency. Thus, the conclusion should not be that simulation training should be abandoned,” Dr. Metz explained.

The results of the study should be confirmed in future research, she noted. “Despite looking at all cases of shoulder dystocia at a tertiary center over a 7-year period, the incidence of brachial plexus injury is low enough that only 33 cases were evaluated. As such, many questions about obstetrical management and the risk of brachial plexus injury still require further study,” said Dr. Metz, who was asked to comment on the study.

The authors reported no relevant financial disclosures. Dr. Metz is an editorial board member for Obstetrics and Gynecology. She was not involved in the review of this manuscript or the decision to publish it.

SOURCE: Johnson GJ et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004013.

Brachial plexus injury often is thought to co-occur with shoulder dystocia, but the two complications appear to be unrelated, according to research published in Obstetrics & Gynecology.

dimarik/iStock/Getty Images

Grace J. Johnson, MD, and colleagues at Baylor College of Medicine in Houston performed a medical review of 41,525 deliveries at Texas Children’s Hospital between March 2012 and July 2019, identifying cases of brachial plexus injury, with and without shoulder dystocia, occurring and persisting. The researchers also evaluated whether clinical experience (5 years or fewer, 6-15 years, or more than 15 years since training) and education impacted the risk of children developing shoulder dystocia or brachial plexus injury.

There were 547 cases of shoulder dystocia in 26,163 vaginal births (2.1%) and 9 cases in 15,362 cesarean births (0.06%), while 33 cases of brachial plexus injury occurred overall. Nearly all brachial plexus injuries were in vaginal deliveries (30 cases; 0.1%), while 3 cases occurred in cesarean deliveries (0.02%). Of these, 14 cases (42%) of brachial plexus injury did not co-occur with shoulder dystocia. Brachial plexus injury that persisted to discharge was similar for children with shoulder dystocia (17 of 19 cases; 89%) and without shoulder dystocia (10 of 14 cases; 71%). In the 27 children with persistent brachial plexus injury, 2 of 23 children who received follow-up care continued to experience persistent brachial plexus injury at 9 months (1 case with shoulder dystocia) and 12 months (1 case without shoulder dystocia).

“The frequent co-occurrence of shoulder dystocia and brachial plexus injury coupled with the equally frequent occurrence of isolated brachial plexus injury suggests that both brachial plexus injury and shoulder dystocia often reflect two causally unrelated complications of uterine forces driving a fetus through the birth canal in the presence of disproportion between the passage and the shoulder girdle of the passenger,” Dr. Johnson and colleagues wrote.
 

Results unchanged by clinician experience

Factors that impacted the risk of brachial plexus injury in children without shoulder dystocia were lack of maternal diabetes (0 women vs. 6 women; P = .03) and second-stage labor length (mean 103 minutes vs. 53 minutes; P = .08). Dr. Johnson and colleagues found no significant between-group differences regarding operative delivery, maternal age, or gestational age.

The researchers also examined the experience of the clinician who delivered children with brachial plexus injuries, and discovered there were no significant differences in children who had transient as opposed to persistent brachial plexus injury based on the number of years a clinician had been in practice (P = .97). There also were no significant changes in the “ratios of brachial plexus injury per total deliveries, brachial plexus injury per vaginal deliveries, and brachial plexus injury per shoulder dystocia” despite the presence of education and training for shoulder dystocia.
 

Questions require further study

Torri Metz, MD, MS, a maternal-fetal medicine subspecialist and associate professor of obstetrics and gynecology at University of Utah Health in Salt Lake City, said in an interview that the review by Johnson and colleagues was able to address limitations in previous studies by looking at the medical records of shoulder dystocia cases at a single tertiary care center.

“Brachial plexus injury occurs both with and without a diagnosis of shoulder dystocia. The finding that the non–shoulder dystocia brachial plexus injuries were associated with a longer second stage of labor suggests that these injuries can occur even prior to delivery of the fetal head and are often not related to maneuvers employed by an obstetrician during delivery,” Dr. Metz said.

The findings that brachial plexus injury severity was unrelated to clinician experience suggests “the occurrence, severity, and persistence of brachial plexus injury may be unrelated to maneuvers by the practitioner at the time of delivery,” she said.

Although Johnson et al. found education and training initiatives did not significantly impact the ratio of brachial plexus injury cases, “importantly, there are likely many other benefits to shoulder dystocia simulation including team communication and comfort of the practitioner in an obstetrical emergency. Thus, the conclusion should not be that simulation training should be abandoned,” Dr. Metz explained.

The results of the study should be confirmed in future research, she noted. “Despite looking at all cases of shoulder dystocia at a tertiary center over a 7-year period, the incidence of brachial plexus injury is low enough that only 33 cases were evaluated. As such, many questions about obstetrical management and the risk of brachial plexus injury still require further study,” said Dr. Metz, who was asked to comment on the study.

The authors reported no relevant financial disclosures. Dr. Metz is an editorial board member for Obstetrics and Gynecology. She was not involved in the review of this manuscript or the decision to publish it.

SOURCE: Johnson GJ et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004013.

Brachial plexus injury often is thought to co-occur with shoulder dystocia, but the two complications appear to be unrelated, according to research published in Obstetrics & Gynecology.

dimarik/iStock/Getty Images

Grace J. Johnson, MD, and colleagues at Baylor College of Medicine in Houston performed a medical review of 41,525 deliveries at Texas Children’s Hospital between March 2012 and July 2019, identifying cases of brachial plexus injury, with and without shoulder dystocia, occurring and persisting. The researchers also evaluated whether clinical experience (5 years or fewer, 6-15 years, or more than 15 years since training) and education impacted the risk of children developing shoulder dystocia or brachial plexus injury.

There were 547 cases of shoulder dystocia in 26,163 vaginal births (2.1%) and 9 cases in 15,362 cesarean births (0.06%), while 33 cases of brachial plexus injury occurred overall. Nearly all brachial plexus injuries were in vaginal deliveries (30 cases; 0.1%), while 3 cases occurred in cesarean deliveries (0.02%). Of these, 14 cases (42%) of brachial plexus injury did not co-occur with shoulder dystocia. Brachial plexus injury that persisted to discharge was similar for children with shoulder dystocia (17 of 19 cases; 89%) and without shoulder dystocia (10 of 14 cases; 71%). In the 27 children with persistent brachial plexus injury, 2 of 23 children who received follow-up care continued to experience persistent brachial plexus injury at 9 months (1 case with shoulder dystocia) and 12 months (1 case without shoulder dystocia).

“The frequent co-occurrence of shoulder dystocia and brachial plexus injury coupled with the equally frequent occurrence of isolated brachial plexus injury suggests that both brachial plexus injury and shoulder dystocia often reflect two causally unrelated complications of uterine forces driving a fetus through the birth canal in the presence of disproportion between the passage and the shoulder girdle of the passenger,” Dr. Johnson and colleagues wrote.
 

Results unchanged by clinician experience

Factors that impacted the risk of brachial plexus injury in children without shoulder dystocia were lack of maternal diabetes (0 women vs. 6 women; P = .03) and second-stage labor length (mean 103 minutes vs. 53 minutes; P = .08). Dr. Johnson and colleagues found no significant between-group differences regarding operative delivery, maternal age, or gestational age.

The researchers also examined the experience of the clinician who delivered children with brachial plexus injuries, and discovered there were no significant differences in children who had transient as opposed to persistent brachial plexus injury based on the number of years a clinician had been in practice (P = .97). There also were no significant changes in the “ratios of brachial plexus injury per total deliveries, brachial plexus injury per vaginal deliveries, and brachial plexus injury per shoulder dystocia” despite the presence of education and training for shoulder dystocia.
 

Questions require further study

Torri Metz, MD, MS, a maternal-fetal medicine subspecialist and associate professor of obstetrics and gynecology at University of Utah Health in Salt Lake City, said in an interview that the review by Johnson and colleagues was able to address limitations in previous studies by looking at the medical records of shoulder dystocia cases at a single tertiary care center.

“Brachial plexus injury occurs both with and without a diagnosis of shoulder dystocia. The finding that the non–shoulder dystocia brachial plexus injuries were associated with a longer second stage of labor suggests that these injuries can occur even prior to delivery of the fetal head and are often not related to maneuvers employed by an obstetrician during delivery,” Dr. Metz said.

The findings that brachial plexus injury severity was unrelated to clinician experience suggests “the occurrence, severity, and persistence of brachial plexus injury may be unrelated to maneuvers by the practitioner at the time of delivery,” she said.

Although Johnson et al. found education and training initiatives did not significantly impact the ratio of brachial plexus injury cases, “importantly, there are likely many other benefits to shoulder dystocia simulation including team communication and comfort of the practitioner in an obstetrical emergency. Thus, the conclusion should not be that simulation training should be abandoned,” Dr. Metz explained.

The results of the study should be confirmed in future research, she noted. “Despite looking at all cases of shoulder dystocia at a tertiary center over a 7-year period, the incidence of brachial plexus injury is low enough that only 33 cases were evaluated. As such, many questions about obstetrical management and the risk of brachial plexus injury still require further study,” said Dr. Metz, who was asked to comment on the study.

The authors reported no relevant financial disclosures. Dr. Metz is an editorial board member for Obstetrics and Gynecology. She was not involved in the review of this manuscript or the decision to publish it.

SOURCE: Johnson GJ et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004013.

As a GI fellow, I never would have imagined I would be writing an article on GI fellowship procedure logs. At the time, in my naiveté, I looked at the procedure log as a necessary evil and part of the “red tape” imposed on fellowship programs by the Accreditation Council for Graduate Medical Education (ACGME). While the importance of keeping a log was highlighted and enforced by my program, the large majority of the recommended numbers were easily achievable. As a result, even my sporadic tracking of completed procedures was sufficient to meet the requirements. My poor compliance wasn’t because I was lazy or careless, but rather because of the absence of a formal system, which resulted in homegrown methods that were highly inaccurate. I wasn’t alone in my follies. As I discussed this issue with fellows across the nation, I learned that these sentiments were universally shared. It seemed that everyone had come up with their own unique way of keeping a log – from Word and Excel documents, to a binder of patient stickers, to a daily folded sheet of paper with scribbled technical notes – all of which were an inconvenience to trainees already stretched thin. However, when the time came for employee credentialing, I came to realize the importance of keeping an accurate record. This once-neglected document would become the ultimate record of my capabilities for independent practice. The pitfalls and shortcomings of how we currently log procedures is why it was the first thing I worked on improving once I was an academic faculty member. There had to be a better way!

I started by reviewing what ACGME actually mandates trainees in GI to track, and to my surprise, they no longer set minimum procedure requirements, but rather competencies. The current requirements state that “Fellows must demonstrate competence in performance of ... procedures”¹ and specifically state that competence should “not be based solely on a minimum number of procedures performed.” So, where does the need for a procedure log and minimum numbers come from? Your fellowship programs’ review committee. Programs recognize that, in order to approve requests for independent practice privileges, they need to substantiate the competency of the fellow, which ultimately is best evidenced through procedure logs. Therefore, the committee sets the minimum number of cases they believe is necessary for trainees to practice safely and independently.² Our program leadership at UConn Health in Farmington, Conn., annually assesses our procedure activity and, over the years, has settled on the procedure guideline numbers provided to fellows at orientation and reviewed with them semiannually.

Once I understood exactly why we need procedure logs, I started looking at how other specialties handle them, particularly surgical programs in which accurate procedure logs are vitally important. It turns out that they universally use, and look favorably on, the ACGME Case Log System - an online, all encompassing, tracking software. This system is provided to surgical programs despite ACGME’s focus on competencies rather than numbers. Why this system is not offered for GI programs is unclear. However, in my endeavor, I was able to find the American Gastroenterological Association (AGA) Procedure Log system. When we reviewed the system in 2015 for use in our program, it was more of a concept than an all-encompassing tool. Fortunately, the AGA Information Technology (IT) and Training departments were kind enough to work with us to develop a complete online tracking tool that could be used nationally by all trainees in GI. Finally, we had a system to keep an accurate, secure log online and in real time.
 

A plea to fellows

With this, understand that in today’s document driven and litigious world, your procedure log is as vital to endoscopy as the scope itself. Without it, you may not be granted permission to do x, y, or z procedure. Indirectly, it can lead to delays in patient care and may prevent you from performing certain tasks and ultimately lead to repetitive training. Treat it as an official legal document of what you’ve done and what you are capable of doing. Recognize that it will be used by your mentors as supporting evidence regarding your competency for independent practice. Ask your training program to provide a clear list of expectations and requirements for graduation and a method for you to accurately track them, such as the AGA Procedure Log. An online, mobile system will allow you to document cases immediately after you finish while the procedure is fresh in your mind. Taking an extra minute after each case will prevent headaches down the road. The faculty and your cofellows all know of the end of the year “procedure scavenger” (i.e., the fellow who searches for procedures and takes them from others to make sure they meet their numbers for graduation). Please don’t be that person.
 

A request for program directors

As GI educators, we all know the mention of procedure logs to fellows is typically accompanied by eye rolls. It doesn’t have to be that way. Provide your fellows with clear expectations and a quick, easy, and accurate way to track their accomplishments. Help them recognize the importance of an accurate and complete procedure log. Consider an online tracking system such as the AGA Procedure Log. Studies have demonstrated that a computer-based system increases compliance and accuracy.³ Not providing one will surely lead to difficulties in the long run and is a disservice to those we work to empower, educate, and prepare for success.
 

References

1. ACGME Program Requirements for Graduate Medical Education in Gastroenterology. Accreditation Council for Graduate Medical Education. 2020 Jul 1. pp 21, 28. Accessed Sept. 13, 2020. https://www.acgme.org/Portals/0/PFAssets/ProgramRequirements/144_Gastroenterology_2020.pdf.

2. Steven J et al. J Grad Med Educat. 2012;4(2):257-60.

3. Rowe BH et al. Can Fam Physician. 1995;41:2113–20.

Dr. Rezaizadeh is an assistant professor of medicine, associate program director, gastroenterology fellowship program, UConn Health, Farmington, Conn.

As a GI fellow, I never would have imagined I would be writing an article on GI fellowship procedure logs. At the time, in my naiveté, I looked at the procedure log as a necessary evil and part of the “red tape” imposed on fellowship programs by the Accreditation Council for Graduate Medical Education (ACGME). While the importance of keeping a log was highlighted and enforced by my program, the large majority of the recommended numbers were easily achievable. As a result, even my sporadic tracking of completed procedures was sufficient to meet the requirements. My poor compliance wasn’t because I was lazy or careless, but rather because of the absence of a formal system, which resulted in homegrown methods that were highly inaccurate. I wasn’t alone in my follies. As I discussed this issue with fellows across the nation, I learned that these sentiments were universally shared. It seemed that everyone had come up with their own unique way of keeping a log – from Word and Excel documents, to a binder of patient stickers, to a daily folded sheet of paper with scribbled technical notes – all of which were an inconvenience to trainees already stretched thin. However, when the time came for employee credentialing, I came to realize the importance of keeping an accurate record. This once-neglected document would become the ultimate record of my capabilities for independent practice. The pitfalls and shortcomings of how we currently log procedures is why it was the first thing I worked on improving once I was an academic faculty member. There had to be a better way!

I started by reviewing what ACGME actually mandates trainees in GI to track, and to my surprise, they no longer set minimum procedure requirements, but rather competencies. The current requirements state that “Fellows must demonstrate competence in performance of ... procedures”¹ and specifically state that competence should “not be based solely on a minimum number of procedures performed.” So, where does the need for a procedure log and minimum numbers come from? Your fellowship programs’ review committee. Programs recognize that, in order to approve requests for independent practice privileges, they need to substantiate the competency of the fellow, which ultimately is best evidenced through procedure logs. Therefore, the committee sets the minimum number of cases they believe is necessary for trainees to practice safely and independently.² Our program leadership at UConn Health in Farmington, Conn., annually assesses our procedure activity and, over the years, has settled on the procedure guideline numbers provided to fellows at orientation and reviewed with them semiannually.

Once I understood exactly why we need procedure logs, I started looking at how other specialties handle them, particularly surgical programs in which accurate procedure logs are vitally important. It turns out that they universally use, and look favorably on, the ACGME Case Log System - an online, all encompassing, tracking software. This system is provided to surgical programs despite ACGME’s focus on competencies rather than numbers. Why this system is not offered for GI programs is unclear. However, in my endeavor, I was able to find the American Gastroenterological Association (AGA) Procedure Log system. When we reviewed the system in 2015 for use in our program, it was more of a concept than an all-encompassing tool. Fortunately, the AGA Information Technology (IT) and Training departments were kind enough to work with us to develop a complete online tracking tool that could be used nationally by all trainees in GI. Finally, we had a system to keep an accurate, secure log online and in real time.
 

A plea to fellows

With this, understand that in today’s document driven and litigious world, your procedure log is as vital to endoscopy as the scope itself. Without it, you may not be granted permission to do x, y, or z procedure. Indirectly, it can lead to delays in patient care and may prevent you from performing certain tasks and ultimately lead to repetitive training. Treat it as an official legal document of what you’ve done and what you are capable of doing. Recognize that it will be used by your mentors as supporting evidence regarding your competency for independent practice. Ask your training program to provide a clear list of expectations and requirements for graduation and a method for you to accurately track them, such as the AGA Procedure Log. An online, mobile system will allow you to document cases immediately after you finish while the procedure is fresh in your mind. Taking an extra minute after each case will prevent headaches down the road. The faculty and your cofellows all know of the end of the year “procedure scavenger” (i.e., the fellow who searches for procedures and takes them from others to make sure they meet their numbers for graduation). Please don’t be that person.
 

A request for program directors

As GI educators, we all know the mention of procedure logs to fellows is typically accompanied by eye rolls. It doesn’t have to be that way. Provide your fellows with clear expectations and a quick, easy, and accurate way to track their accomplishments. Help them recognize the importance of an accurate and complete procedure log. Consider an online tracking system such as the AGA Procedure Log. Studies have demonstrated that a computer-based system increases compliance and accuracy.³ Not providing one will surely lead to difficulties in the long run and is a disservice to those we work to empower, educate, and prepare for success.
 

References

1. ACGME Program Requirements for Graduate Medical Education in Gastroenterology. Accreditation Council for Graduate Medical Education. 2020 Jul 1. pp 21, 28. Accessed Sept. 13, 2020. https://www.acgme.org/Portals/0/PFAssets/ProgramRequirements/144_Gastroenterology_2020.pdf.

2. Steven J et al. J Grad Med Educat. 2012;4(2):257-60.

3. Rowe BH et al. Can Fam Physician. 1995;41:2113–20.

Dr. Rezaizadeh is an assistant professor of medicine, associate program director, gastroenterology fellowship program, UConn Health, Farmington, Conn.

As a GI fellow, I never would have imagined I would be writing an article on GI fellowship procedure logs. At the time, in my naiveté, I looked at the procedure log as a necessary evil and part of the “red tape” imposed on fellowship programs by the Accreditation Council for Graduate Medical Education (ACGME). While the importance of keeping a log was highlighted and enforced by my program, the large majority of the recommended numbers were easily achievable. As a result, even my sporadic tracking of completed procedures was sufficient to meet the requirements. My poor compliance wasn’t because I was lazy or careless, but rather because of the absence of a formal system, which resulted in homegrown methods that were highly inaccurate. I wasn’t alone in my follies. As I discussed this issue with fellows across the nation, I learned that these sentiments were universally shared. It seemed that everyone had come up with their own unique way of keeping a log – from Word and Excel documents, to a binder of patient stickers, to a daily folded sheet of paper with scribbled technical notes – all of which were an inconvenience to trainees already stretched thin. However, when the time came for employee credentialing, I came to realize the importance of keeping an accurate record. This once-neglected document would become the ultimate record of my capabilities for independent practice. The pitfalls and shortcomings of how we currently log procedures is why it was the first thing I worked on improving once I was an academic faculty member. There had to be a better way!

I started by reviewing what ACGME actually mandates trainees in GI to track, and to my surprise, they no longer set minimum procedure requirements, but rather competencies. The current requirements state that “Fellows must demonstrate competence in performance of ... procedures”¹ and specifically state that competence should “not be based solely on a minimum number of procedures performed.” So, where does the need for a procedure log and minimum numbers come from? Your fellowship programs’ review committee. Programs recognize that, in order to approve requests for independent practice privileges, they need to substantiate the competency of the fellow, which ultimately is best evidenced through procedure logs. Therefore, the committee sets the minimum number of cases they believe is necessary for trainees to practice safely and independently.² Our program leadership at UConn Health in Farmington, Conn., annually assesses our procedure activity and, over the years, has settled on the procedure guideline numbers provided to fellows at orientation and reviewed with them semiannually.

Once I understood exactly why we need procedure logs, I started looking at how other specialties handle them, particularly surgical programs in which accurate procedure logs are vitally important. It turns out that they universally use, and look favorably on, the ACGME Case Log System - an online, all encompassing, tracking software. This system is provided to surgical programs despite ACGME’s focus on competencies rather than numbers. Why this system is not offered for GI programs is unclear. However, in my endeavor, I was able to find the American Gastroenterological Association (AGA) Procedure Log system. When we reviewed the system in 2015 for use in our program, it was more of a concept than an all-encompassing tool. Fortunately, the AGA Information Technology (IT) and Training departments were kind enough to work with us to develop a complete online tracking tool that could be used nationally by all trainees in GI. Finally, we had a system to keep an accurate, secure log online and in real time.
 

A plea to fellows

With this, understand that in today’s document driven and litigious world, your procedure log is as vital to endoscopy as the scope itself. Without it, you may not be granted permission to do x, y, or z procedure. Indirectly, it can lead to delays in patient care and may prevent you from performing certain tasks and ultimately lead to repetitive training. Treat it as an official legal document of what you’ve done and what you are capable of doing. Recognize that it will be used by your mentors as supporting evidence regarding your competency for independent practice. Ask your training program to provide a clear list of expectations and requirements for graduation and a method for you to accurately track them, such as the AGA Procedure Log. An online, mobile system will allow you to document cases immediately after you finish while the procedure is fresh in your mind. Taking an extra minute after each case will prevent headaches down the road. The faculty and your cofellows all know of the end of the year “procedure scavenger” (i.e., the fellow who searches for procedures and takes them from others to make sure they meet their numbers for graduation). Please don’t be that person.
 

A request for program directors

As GI educators, we all know the mention of procedure logs to fellows is typically accompanied by eye rolls. It doesn’t have to be that way. Provide your fellows with clear expectations and a quick, easy, and accurate way to track their accomplishments. Help them recognize the importance of an accurate and complete procedure log. Consider an online tracking system such as the AGA Procedure Log. Studies have demonstrated that a computer-based system increases compliance and accuracy.³ Not providing one will surely lead to difficulties in the long run and is a disservice to those we work to empower, educate, and prepare for success.
 

References

1. ACGME Program Requirements for Graduate Medical Education in Gastroenterology. Accreditation Council for Graduate Medical Education. 2020 Jul 1. pp 21, 28. Accessed Sept. 13, 2020. https://www.acgme.org/Portals/0/PFAssets/ProgramRequirements/144_Gastroenterology_2020.pdf.

2. Steven J et al. J Grad Med Educat. 2012;4(2):257-60.

3. Rowe BH et al. Can Fam Physician. 1995;41:2113–20.

Dr. Rezaizadeh is an assistant professor of medicine, associate program director, gastroenterology fellowship program, UConn Health, Farmington, Conn.

The cumulative percentage of COVID-19 cases reported in children continues to climb, but “the history behind that cumulative number shows substantial change,” according to a new analysis of state health department data.

As of Sept. 10, the 549,432 cases in children represented 10.0% of all reported COVID-19 cases in the United States following a substantial rise over the course of the pandemic – the figure was 7.7% on July 16 and 3.2% on May 7, Blake Sisk, PhD, of the American Academy of Pediatrics and associates reported Sept. 29 in Pediatrics.

Unlike the cumulative number, the weekly proportion of cases in children fell early in the summer but then started climbing again in late July. “In the last 8 weeks, children represented between 12%-15.9% of new weekly reported cases,” Dr. Sisk and associates wrote.

Despite the increase, however, the proportion of pediatric COVID-19 cases is still well below children’s share of the overall population (22.6%). Also, “it is unclear how much of the increase in child cases is due to increased testing capacity, although CDC data from public and commercial laboratories show the share of all tests administered to children ages 0-17 has remained stable at 5%-7% since late April,” they said.

Data for the current report were drawn from 49 state health department websites (New York state does not report ages for COVID-19 cases), along with New York City, the District of Columbia, Puerto Rico, and Guam. Alabama changed its definition of a child case in August and was not included in the trend analysis (see graph), the investigators explained.

Those data show “substantial variation in case growth by region: in April, a preponderance of cases was in the Northeast. In June, cases surged in the South and West, followed by mid-July increases in the Midwest,” Dr. Sisk and associates said.

The increase among children in Midwest states is ongoing with the number of new cases reaching its highest level yet during the week ending Sept. 10, they reported.

[email protected]

SOURCE: Sisk B et al. Pediatrics. 2020 Sep 29. doi: 10.1542/peds.2020-027425.

The cumulative percentage of COVID-19 cases reported in children continues to climb, but “the history behind that cumulative number shows substantial change,” according to a new analysis of state health department data.

As of Sept. 10, the 549,432 cases in children represented 10.0% of all reported COVID-19 cases in the United States following a substantial rise over the course of the pandemic – the figure was 7.7% on July 16 and 3.2% on May 7, Blake Sisk, PhD, of the American Academy of Pediatrics and associates reported Sept. 29 in Pediatrics.

Unlike the cumulative number, the weekly proportion of cases in children fell early in the summer but then started climbing again in late July. “In the last 8 weeks, children represented between 12%-15.9% of new weekly reported cases,” Dr. Sisk and associates wrote.

Despite the increase, however, the proportion of pediatric COVID-19 cases is still well below children’s share of the overall population (22.6%). Also, “it is unclear how much of the increase in child cases is due to increased testing capacity, although CDC data from public and commercial laboratories show the share of all tests administered to children ages 0-17 has remained stable at 5%-7% since late April,” they said.

Data for the current report were drawn from 49 state health department websites (New York state does not report ages for COVID-19 cases), along with New York City, the District of Columbia, Puerto Rico, and Guam. Alabama changed its definition of a child case in August and was not included in the trend analysis (see graph), the investigators explained.

Those data show “substantial variation in case growth by region: in April, a preponderance of cases was in the Northeast. In June, cases surged in the South and West, followed by mid-July increases in the Midwest,” Dr. Sisk and associates said.

The increase among children in Midwest states is ongoing with the number of new cases reaching its highest level yet during the week ending Sept. 10, they reported.

[email protected]

SOURCE: Sisk B et al. Pediatrics. 2020 Sep 29. doi: 10.1542/peds.2020-027425.

The cumulative percentage of COVID-19 cases reported in children continues to climb, but “the history behind that cumulative number shows substantial change,” according to a new analysis of state health department data.

As of Sept. 10, the 549,432 cases in children represented 10.0% of all reported COVID-19 cases in the United States following a substantial rise over the course of the pandemic – the figure was 7.7% on July 16 and 3.2% on May 7, Blake Sisk, PhD, of the American Academy of Pediatrics and associates reported Sept. 29 in Pediatrics.

Unlike the cumulative number, the weekly proportion of cases in children fell early in the summer but then started climbing again in late July. “In the last 8 weeks, children represented between 12%-15.9% of new weekly reported cases,” Dr. Sisk and associates wrote.

Despite the increase, however, the proportion of pediatric COVID-19 cases is still well below children’s share of the overall population (22.6%). Also, “it is unclear how much of the increase in child cases is due to increased testing capacity, although CDC data from public and commercial laboratories show the share of all tests administered to children ages 0-17 has remained stable at 5%-7% since late April,” they said.

Data for the current report were drawn from 49 state health department websites (New York state does not report ages for COVID-19 cases), along with New York City, the District of Columbia, Puerto Rico, and Guam. Alabama changed its definition of a child case in August and was not included in the trend analysis (see graph), the investigators explained.

Those data show “substantial variation in case growth by region: in April, a preponderance of cases was in the Northeast. In June, cases surged in the South and West, followed by mid-July increases in the Midwest,” Dr. Sisk and associates said.

The increase among children in Midwest states is ongoing with the number of new cases reaching its highest level yet during the week ending Sept. 10, they reported.

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SOURCE: Sisk B et al. Pediatrics. 2020 Sep 29. doi: 10.1542/peds.2020-027425.