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New screening test validated for cognitive impairment in lupus
new research suggests.
In a paper published in Arthritis Care & Research, researchers assessed the validity of the Automated Neuropsychological Assessment Metrics (ANAM) test in 211 adult patients with systemic lupus erythematosus (SLE).
First author Oshrat E. Tayer-Shifman, MD, of the University of Toronto Lupus Clinic and coauthors wrote that current assessment of cognitive impairment in adults with SLE is done using the American College of Rheumatology neuropsychological battery (ACR-NB). However, this approach involves protected tests that require specialized personnel and takes around 1 hour to administer, as well as time for scoring and interpretation.
“For many clinics, these are notable barriers to accessing CI [cognitive impairment] assessment, as health care payers do not cover these costs,” the investigators wrote. And although briefer cognitive screening tools, such as the Montreal Cognitive Assessment, the Controlled Oral Word Association Test, and the Hopkins Verbal Learning Test–Revised, have been examined in studies of patients with SLE, “they also require specialized personnel for administration and interpretation and cannot be self-administered. In addition, their validity for the screening for CI in SLE has not been well established. Thus, there is an unmet need for a screening assessment for CI that is validated for SLE and that can be applied in an ambulatory clinic setting without specialized personnel.”
The full ANAM battery requires about 40 minutes and has been used to screen cognitive performance in a range of clinical contexts.
A total of 96 patients (46%) had CI and 52 (25%) did not, according to the ACR-NB, while the results were indeterminate in the remaining 63 (30%).
The study showed that patients without CI performed significantly better on the majority of the ANAM subtests in comparison with patients who have cognitive impairment. This was particularly evident on mean reaction time and the number of correct responses per minute (a measure of cognitive efficiency), but less so for percentage of correct responses and consistency of response speed.
“Three of the most affected cognitive domains in the CI patients in this cohort, as well as in previous studies, were learning and memory, visual spatial construction, and simple attention and speed of processing,” the researchers wrote.
The investigators created testing models using the subtests that were most discriminative for CI. The two best models included one encompassing the percentage of correct responses, consistency of response speed, and mean reaction time, as well as one encompassing these three factors as well as the number of correct responses per minute. The investigators then derived candidate ANAM composite indices from these two models. For one composite index that used 8 of the 15 ANAM subtests and included five of the six cognitive domains tested on the ACR-NB, a high and a low cutoff value gave an area under the curve of 79%, sensitivity of 80%-89%, specificity of 54%-70%, positive predictive value of 78%-83%, and negative predictive value of 65%-74%.
The composite index performed similarly well among patients with or without neuropsychiatric lupus.
“This approach not only enables us to use a cost-effective screening approach without specialized personnel, but we have reduced the duration of the ANAM battery itself. The ANAM [version 4 General Neuropsychological Screening] full battery requires approximately 40 minutes to administer, while our analyses enable us to limit the number of ANAM subtests used, shortening the testing duration to 20 minutes,” they wrote.
The investigators noted that the study included only individuals with sufficient English language ability to complete the tests, and they also excluded patients with indeterminate cognitive status. “We reasoned that they represented a nonhomogeneous group, and without a clear consensus on the definition of CI in SLE patients, we chose to concentrate on the more clearly defined CI SLE patients.”
The study was supported by grants from the Arthritis Society of Canada, Physician’s Services, the Kathi and Peter Kaiser Family, and the Lou and Marissa Rocca Family. One author was supported by the Arthritis Society and the Canadian Rheumatology Association. No conflicts of interest were declared.
SOURCE: Tayer-Shifman OE et al. Arthritis Care Res. 2019 Oct 18. doi: 10.1002/acr.24096.
new research suggests.
In a paper published in Arthritis Care & Research, researchers assessed the validity of the Automated Neuropsychological Assessment Metrics (ANAM) test in 211 adult patients with systemic lupus erythematosus (SLE).
First author Oshrat E. Tayer-Shifman, MD, of the University of Toronto Lupus Clinic and coauthors wrote that current assessment of cognitive impairment in adults with SLE is done using the American College of Rheumatology neuropsychological battery (ACR-NB). However, this approach involves protected tests that require specialized personnel and takes around 1 hour to administer, as well as time for scoring and interpretation.
“For many clinics, these are notable barriers to accessing CI [cognitive impairment] assessment, as health care payers do not cover these costs,” the investigators wrote. And although briefer cognitive screening tools, such as the Montreal Cognitive Assessment, the Controlled Oral Word Association Test, and the Hopkins Verbal Learning Test–Revised, have been examined in studies of patients with SLE, “they also require specialized personnel for administration and interpretation and cannot be self-administered. In addition, their validity for the screening for CI in SLE has not been well established. Thus, there is an unmet need for a screening assessment for CI that is validated for SLE and that can be applied in an ambulatory clinic setting without specialized personnel.”
The full ANAM battery requires about 40 minutes and has been used to screen cognitive performance in a range of clinical contexts.
A total of 96 patients (46%) had CI and 52 (25%) did not, according to the ACR-NB, while the results were indeterminate in the remaining 63 (30%).
The study showed that patients without CI performed significantly better on the majority of the ANAM subtests in comparison with patients who have cognitive impairment. This was particularly evident on mean reaction time and the number of correct responses per minute (a measure of cognitive efficiency), but less so for percentage of correct responses and consistency of response speed.
“Three of the most affected cognitive domains in the CI patients in this cohort, as well as in previous studies, were learning and memory, visual spatial construction, and simple attention and speed of processing,” the researchers wrote.
The investigators created testing models using the subtests that were most discriminative for CI. The two best models included one encompassing the percentage of correct responses, consistency of response speed, and mean reaction time, as well as one encompassing these three factors as well as the number of correct responses per minute. The investigators then derived candidate ANAM composite indices from these two models. For one composite index that used 8 of the 15 ANAM subtests and included five of the six cognitive domains tested on the ACR-NB, a high and a low cutoff value gave an area under the curve of 79%, sensitivity of 80%-89%, specificity of 54%-70%, positive predictive value of 78%-83%, and negative predictive value of 65%-74%.
The composite index performed similarly well among patients with or without neuropsychiatric lupus.
“This approach not only enables us to use a cost-effective screening approach without specialized personnel, but we have reduced the duration of the ANAM battery itself. The ANAM [version 4 General Neuropsychological Screening] full battery requires approximately 40 minutes to administer, while our analyses enable us to limit the number of ANAM subtests used, shortening the testing duration to 20 minutes,” they wrote.
The investigators noted that the study included only individuals with sufficient English language ability to complete the tests, and they also excluded patients with indeterminate cognitive status. “We reasoned that they represented a nonhomogeneous group, and without a clear consensus on the definition of CI in SLE patients, we chose to concentrate on the more clearly defined CI SLE patients.”
The study was supported by grants from the Arthritis Society of Canada, Physician’s Services, the Kathi and Peter Kaiser Family, and the Lou and Marissa Rocca Family. One author was supported by the Arthritis Society and the Canadian Rheumatology Association. No conflicts of interest were declared.
SOURCE: Tayer-Shifman OE et al. Arthritis Care Res. 2019 Oct 18. doi: 10.1002/acr.24096.
new research suggests.
In a paper published in Arthritis Care & Research, researchers assessed the validity of the Automated Neuropsychological Assessment Metrics (ANAM) test in 211 adult patients with systemic lupus erythematosus (SLE).
First author Oshrat E. Tayer-Shifman, MD, of the University of Toronto Lupus Clinic and coauthors wrote that current assessment of cognitive impairment in adults with SLE is done using the American College of Rheumatology neuropsychological battery (ACR-NB). However, this approach involves protected tests that require specialized personnel and takes around 1 hour to administer, as well as time for scoring and interpretation.
“For many clinics, these are notable barriers to accessing CI [cognitive impairment] assessment, as health care payers do not cover these costs,” the investigators wrote. And although briefer cognitive screening tools, such as the Montreal Cognitive Assessment, the Controlled Oral Word Association Test, and the Hopkins Verbal Learning Test–Revised, have been examined in studies of patients with SLE, “they also require specialized personnel for administration and interpretation and cannot be self-administered. In addition, their validity for the screening for CI in SLE has not been well established. Thus, there is an unmet need for a screening assessment for CI that is validated for SLE and that can be applied in an ambulatory clinic setting without specialized personnel.”
The full ANAM battery requires about 40 minutes and has been used to screen cognitive performance in a range of clinical contexts.
A total of 96 patients (46%) had CI and 52 (25%) did not, according to the ACR-NB, while the results were indeterminate in the remaining 63 (30%).
The study showed that patients without CI performed significantly better on the majority of the ANAM subtests in comparison with patients who have cognitive impairment. This was particularly evident on mean reaction time and the number of correct responses per minute (a measure of cognitive efficiency), but less so for percentage of correct responses and consistency of response speed.
“Three of the most affected cognitive domains in the CI patients in this cohort, as well as in previous studies, were learning and memory, visual spatial construction, and simple attention and speed of processing,” the researchers wrote.
The investigators created testing models using the subtests that were most discriminative for CI. The two best models included one encompassing the percentage of correct responses, consistency of response speed, and mean reaction time, as well as one encompassing these three factors as well as the number of correct responses per minute. The investigators then derived candidate ANAM composite indices from these two models. For one composite index that used 8 of the 15 ANAM subtests and included five of the six cognitive domains tested on the ACR-NB, a high and a low cutoff value gave an area under the curve of 79%, sensitivity of 80%-89%, specificity of 54%-70%, positive predictive value of 78%-83%, and negative predictive value of 65%-74%.
The composite index performed similarly well among patients with or without neuropsychiatric lupus.
“This approach not only enables us to use a cost-effective screening approach without specialized personnel, but we have reduced the duration of the ANAM battery itself. The ANAM [version 4 General Neuropsychological Screening] full battery requires approximately 40 minutes to administer, while our analyses enable us to limit the number of ANAM subtests used, shortening the testing duration to 20 minutes,” they wrote.
The investigators noted that the study included only individuals with sufficient English language ability to complete the tests, and they also excluded patients with indeterminate cognitive status. “We reasoned that they represented a nonhomogeneous group, and without a clear consensus on the definition of CI in SLE patients, we chose to concentrate on the more clearly defined CI SLE patients.”
The study was supported by grants from the Arthritis Society of Canada, Physician’s Services, the Kathi and Peter Kaiser Family, and the Lou and Marissa Rocca Family. One author was supported by the Arthritis Society and the Canadian Rheumatology Association. No conflicts of interest were declared.
SOURCE: Tayer-Shifman OE et al. Arthritis Care Res. 2019 Oct 18. doi: 10.1002/acr.24096.
FROM ARTHRITIS CARE & RESEARCH
Fewer bloodstream infections with FMT for C. difficile
Treating Clostridioides difficile infection with fecal microbiota transplantation is associated with a lower risk of bloodstream infection and recurrence than treatment with antibiotics, new research has found.
A paper published in Annals of Internal Medicine presents outcomes of a prospective cohort study in 290 inpatients with recurrent C. difficile infection, 109 of whom were treated with fecal microbiota transplantation (FMT); the remainder were treated with antibiotics including metronidazole, vancomycin, and fidaxomicin.
While the FMT group had a higher mean number of previous C. difficile infections than the antibiotics group (2.82 vs. 1.23, respectively), a sustained cure was achieved in 97% of the FMT group, compared with 38% in the antibiotics group.
Blood cultures were done if patients developed a temperature above 30° C or showed symptoms that might be attributable to sepsis. Bloodstream infections were diagnosed in 5% (5 patients) of those treated with FMT, and 22% (40 patients) in the antibiotics group.
The patients in the FMT group with bloodstream infections all had bacterial infections – one of which was polymicrobial – and there were no cases of fungal bloodstream infections. In the antibiotics group, 28 patients (15%) had bacterial bloodstream infections – 11 of which were polymicrobial – and 12 (7%) had fungal bloodstream infections.
Bloodstream infections were particularly evident among the 11 patients whose C. difficile infection was treated with fidaxomicin, 4 of whom developed a bloodstream infection.
Overall, 27% of patients died during the 90-day follow-up, with 7% dying because of bloodstream infections, all of whom were in the antibiotic-treated cohort. Three patients in the FMT group died because of overwhelming C. difficile infection, compared with 12 in the antibiotic cohort.
Nearly three-quarters of deaths occurred within 30 days of the end of treatment; 5 of these deaths were in the FMT group, and 53 were in the antibiotics group.
“These findings suggest that the longer 90-day [overall survival] of patients in the FMT group is attributable to cure of [C. difficile infection] leading to an improvement in clinical condition,” wrote Gianluca Ianiro, MD, from the Catholic University of the Sacred Heart in Rome, and coauthors.
The 90-day overall survival rate was 92% in the FMT group and 61% in the antibiotic group. Patients treated with FMT also showed significantly shorter mean duration of hospital stay at 13.3 days, compared with 29.7 days in patients treated with antibiotics.
The authors noted the results should be interpreted with caution because of baseline differences between the two groups that were not entirely accounted for by using propensity matching. However, even in the propensity-matched cohort of 57 patients from each group, there was still a significantly higher overall survival at 90 days among patients treated with FMT.
One author declared grants from the pharmaceutical sector outside the submitted work. No funding or other conflicts of interest were reported.
SOURCE: Ianiro G et al. Ann Intern Med. 2019 Nov 4. doi: 10.7326/M18-3635.
Treating Clostridioides difficile infection with fecal microbiota transplantation is associated with a lower risk of bloodstream infection and recurrence than treatment with antibiotics, new research has found.
A paper published in Annals of Internal Medicine presents outcomes of a prospective cohort study in 290 inpatients with recurrent C. difficile infection, 109 of whom were treated with fecal microbiota transplantation (FMT); the remainder were treated with antibiotics including metronidazole, vancomycin, and fidaxomicin.
While the FMT group had a higher mean number of previous C. difficile infections than the antibiotics group (2.82 vs. 1.23, respectively), a sustained cure was achieved in 97% of the FMT group, compared with 38% in the antibiotics group.
Blood cultures were done if patients developed a temperature above 30° C or showed symptoms that might be attributable to sepsis. Bloodstream infections were diagnosed in 5% (5 patients) of those treated with FMT, and 22% (40 patients) in the antibiotics group.
The patients in the FMT group with bloodstream infections all had bacterial infections – one of which was polymicrobial – and there were no cases of fungal bloodstream infections. In the antibiotics group, 28 patients (15%) had bacterial bloodstream infections – 11 of which were polymicrobial – and 12 (7%) had fungal bloodstream infections.
Bloodstream infections were particularly evident among the 11 patients whose C. difficile infection was treated with fidaxomicin, 4 of whom developed a bloodstream infection.
Overall, 27% of patients died during the 90-day follow-up, with 7% dying because of bloodstream infections, all of whom were in the antibiotic-treated cohort. Three patients in the FMT group died because of overwhelming C. difficile infection, compared with 12 in the antibiotic cohort.
Nearly three-quarters of deaths occurred within 30 days of the end of treatment; 5 of these deaths were in the FMT group, and 53 were in the antibiotics group.
“These findings suggest that the longer 90-day [overall survival] of patients in the FMT group is attributable to cure of [C. difficile infection] leading to an improvement in clinical condition,” wrote Gianluca Ianiro, MD, from the Catholic University of the Sacred Heart in Rome, and coauthors.
The 90-day overall survival rate was 92% in the FMT group and 61% in the antibiotic group. Patients treated with FMT also showed significantly shorter mean duration of hospital stay at 13.3 days, compared with 29.7 days in patients treated with antibiotics.
The authors noted the results should be interpreted with caution because of baseline differences between the two groups that were not entirely accounted for by using propensity matching. However, even in the propensity-matched cohort of 57 patients from each group, there was still a significantly higher overall survival at 90 days among patients treated with FMT.
One author declared grants from the pharmaceutical sector outside the submitted work. No funding or other conflicts of interest were reported.
SOURCE: Ianiro G et al. Ann Intern Med. 2019 Nov 4. doi: 10.7326/M18-3635.
Treating Clostridioides difficile infection with fecal microbiota transplantation is associated with a lower risk of bloodstream infection and recurrence than treatment with antibiotics, new research has found.
A paper published in Annals of Internal Medicine presents outcomes of a prospective cohort study in 290 inpatients with recurrent C. difficile infection, 109 of whom were treated with fecal microbiota transplantation (FMT); the remainder were treated with antibiotics including metronidazole, vancomycin, and fidaxomicin.
While the FMT group had a higher mean number of previous C. difficile infections than the antibiotics group (2.82 vs. 1.23, respectively), a sustained cure was achieved in 97% of the FMT group, compared with 38% in the antibiotics group.
Blood cultures were done if patients developed a temperature above 30° C or showed symptoms that might be attributable to sepsis. Bloodstream infections were diagnosed in 5% (5 patients) of those treated with FMT, and 22% (40 patients) in the antibiotics group.
The patients in the FMT group with bloodstream infections all had bacterial infections – one of which was polymicrobial – and there were no cases of fungal bloodstream infections. In the antibiotics group, 28 patients (15%) had bacterial bloodstream infections – 11 of which were polymicrobial – and 12 (7%) had fungal bloodstream infections.
Bloodstream infections were particularly evident among the 11 patients whose C. difficile infection was treated with fidaxomicin, 4 of whom developed a bloodstream infection.
Overall, 27% of patients died during the 90-day follow-up, with 7% dying because of bloodstream infections, all of whom were in the antibiotic-treated cohort. Three patients in the FMT group died because of overwhelming C. difficile infection, compared with 12 in the antibiotic cohort.
Nearly three-quarters of deaths occurred within 30 days of the end of treatment; 5 of these deaths were in the FMT group, and 53 were in the antibiotics group.
“These findings suggest that the longer 90-day [overall survival] of patients in the FMT group is attributable to cure of [C. difficile infection] leading to an improvement in clinical condition,” wrote Gianluca Ianiro, MD, from the Catholic University of the Sacred Heart in Rome, and coauthors.
The 90-day overall survival rate was 92% in the FMT group and 61% in the antibiotic group. Patients treated with FMT also showed significantly shorter mean duration of hospital stay at 13.3 days, compared with 29.7 days in patients treated with antibiotics.
The authors noted the results should be interpreted with caution because of baseline differences between the two groups that were not entirely accounted for by using propensity matching. However, even in the propensity-matched cohort of 57 patients from each group, there was still a significantly higher overall survival at 90 days among patients treated with FMT.
One author declared grants from the pharmaceutical sector outside the submitted work. No funding or other conflicts of interest were reported.
SOURCE: Ianiro G et al. Ann Intern Med. 2019 Nov 4. doi: 10.7326/M18-3635.
FROM ANNALS OF INTERNAL MEDICINE
A sepsis death linked to fecal microbiota transplantation
Two cases of bacteremia have been described in two patients who received fecal microbiota transplants from the same donor.
Writing in the New England Journal of Medicine, researchers reported the two case studies of extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli bacteremia, one of which ended in the death of the patient. These cases were previously announced by the Food and Drug Administration in a June 2019 safety alert.
Zachariah DeFilipp, MD, from Massachusetts General Hospital at Harvard Medical School, Boston, and coauthors wrote that fecal microbiota transplantation is rarely associated with complications. Placebo-controlled trials and a systematic review have found similar rates of complications in immunocompromised and immunocompetent recipients. Only four cases of gram-negative bacteremia previously have been reported, and in three of these, there was a plausible alternative explanation for the bacteremia.
In this paper, both patients received fecal microbiota transplantation via frozen oral capsules containing donor stool. These capsules were prepared prior to the implementation of screening for ESBL-producing organisms at the institution, and were not retrospectively tested since this expanded donor screening.
The first patient was a 69-year-old man with liver cirrhosis attributed to hepatitis C infection who was enrolled in a trial of fecal microbiota transplantation via oral capsules to treat hepatic encephalopathy. The first sign of the adverse event was a fever and cough, which developed 17 days after the final dose of 15 capsules. He was treated for pneumonia but failed to improve after 2 days, at which time gram-negative rods were discovered in blood cultures taken at the initial presentation.
After admission and further treatment, blood cultures were found to have ESBL-producing E. coli, and after further treatment, the patient was clinically stable. A stool sample taken after treatment was negative for ESBL-producing E. coli.
The second case study was a 73-year-old man with therapy-related myelodysplastic syndrome who was undergoing allogeneic hematopoietic stem cell transplantation and was receiving fecal microbiota transplantation via oral capsule as part of a phase 2 trial.
Eight days after the last dose of oral capsules, and 5 days after the stem-cell infusion, the man developed a fever, chills, febrile neutropenia and showed altered mental status. He was treated with cefepime but developed hypoxia and labored breathing later that evening, which prompted clinicians to intubate and begin mechanical ventilation.
His blood culture results showed gram-negative rods, and meropenem was added to his antibiotic regimen. However, the patient’s condition worsened, and he died of severe sepsis 2 days later with blood cultures confirmed as positive for ESBL-producing E. coli.
A follow-up investigation revealed that both patients received stool from the same donor. Each lot of three capsules from that donor was found to contain ESBL-producing E. coli with a resistance pattern similar to that seen in the two recipients.
Twenty-two patients had received capsules from this donor. Researchers contacted all the recipients and offered them stool screening for ESBL-producing E. coli. Twelve underwent testing, which found that five had samples that grew on ESBL-producing E. coli–selective medium.
The remaining seven patients who had follow-up testing were receiving treatment for recurrent or refractory Clostridioides difficile infection, and four of these grew samples on the selective medium.
“When FMT is successful, the recipient’s metagenomic burden of antimicrobial resistance genes mimics that of the donor,” the authors wrote. “Although we cannot conclusively attribute positive screening results for ESBL-producing organisms in other asymptomatic recipients to FMT, the rates of positive tests are, in our opinion, unexpectedly high and probably represent transmission through FMT.”
The authors said the donor had no risk factors for carriage of multidrug-resistant organism and had previously donated fecal material before the introduction of routine screening for ESBL-producing organisms.
However, they noted that both patients had risk factors for bacteremia, namely advanced cirrhosis and allogeneic hematopoietic stem cell transplantation and they also received oral antibiotics around the time of the fecal microbiota transplantation.
“Despite the infectious complications reported here, the benefits of FMT should be balanced with the associated risks when considering treatment options for patients with recurrent or refractory C. difficile infection,” the authors wrote. “Ongoing assessment of the risks and benefit of FMT research is needed, as are continuing efforts to improve donor screening to limit transmission of microorganisms that could lead to adverse infectious events.”
The American Gastroenterological Association FMT National Registry is a critical effort to track short- and long-term patient outcomes and potential risks associated with FMT. The registry's goal is to track 4,000 patients for 10 years. If you perform FMT, please contribute to this important initiative. Learn more at www.gastro.org/FMTRegistry.
The study was supported by a grant from the American College of Gastroenterology. Three authors declared personal fees and grants from the medical sector outside the submitted work, and two were attached to a diagnostics company involved in the study.
SOURCE: DeFilipp Z et al. N Engl J Med. 2019 Oct 30. doi: 10.1056/NEJMoa1910437.
* This story was updated on Oct. 31, 2019.
Fecal microbiota transplantation could have therapeutic utility in a range of conditions in which primary dysbiosis is suspected, but this study shows the procedure may carry risks that only become apparent after treatment. Improved screening of donors and fecal material could reduce the risks of infections by known agents. However, new pathogens may not be recognized until after they have been transplanted into a new host.
The benefits and risks of fecal microbiota transplantation must be balanced, but up to now the complications have been infrequent and the benefits have clearly outweighed the risks.
Martin J. Blaser, MD, is from Rutgers University in New Brunswick, N.J. These comments are adapted from an accompanying editorial (N Engl J Med. 2019 Oct 30. doi: 10.1056/NEJMe1913807). Dr. Blaser declared personal fees and stock options from the medical sector unrelated to the work.
Fecal microbiota transplantation could have therapeutic utility in a range of conditions in which primary dysbiosis is suspected, but this study shows the procedure may carry risks that only become apparent after treatment. Improved screening of donors and fecal material could reduce the risks of infections by known agents. However, new pathogens may not be recognized until after they have been transplanted into a new host.
The benefits and risks of fecal microbiota transplantation must be balanced, but up to now the complications have been infrequent and the benefits have clearly outweighed the risks.
Martin J. Blaser, MD, is from Rutgers University in New Brunswick, N.J. These comments are adapted from an accompanying editorial (N Engl J Med. 2019 Oct 30. doi: 10.1056/NEJMe1913807). Dr. Blaser declared personal fees and stock options from the medical sector unrelated to the work.
Fecal microbiota transplantation could have therapeutic utility in a range of conditions in which primary dysbiosis is suspected, but this study shows the procedure may carry risks that only become apparent after treatment. Improved screening of donors and fecal material could reduce the risks of infections by known agents. However, new pathogens may not be recognized until after they have been transplanted into a new host.
The benefits and risks of fecal microbiota transplantation must be balanced, but up to now the complications have been infrequent and the benefits have clearly outweighed the risks.
Martin J. Blaser, MD, is from Rutgers University in New Brunswick, N.J. These comments are adapted from an accompanying editorial (N Engl J Med. 2019 Oct 30. doi: 10.1056/NEJMe1913807). Dr. Blaser declared personal fees and stock options from the medical sector unrelated to the work.
Two cases of bacteremia have been described in two patients who received fecal microbiota transplants from the same donor.
Writing in the New England Journal of Medicine, researchers reported the two case studies of extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli bacteremia, one of which ended in the death of the patient. These cases were previously announced by the Food and Drug Administration in a June 2019 safety alert.
Zachariah DeFilipp, MD, from Massachusetts General Hospital at Harvard Medical School, Boston, and coauthors wrote that fecal microbiota transplantation is rarely associated with complications. Placebo-controlled trials and a systematic review have found similar rates of complications in immunocompromised and immunocompetent recipients. Only four cases of gram-negative bacteremia previously have been reported, and in three of these, there was a plausible alternative explanation for the bacteremia.
In this paper, both patients received fecal microbiota transplantation via frozen oral capsules containing donor stool. These capsules were prepared prior to the implementation of screening for ESBL-producing organisms at the institution, and were not retrospectively tested since this expanded donor screening.
The first patient was a 69-year-old man with liver cirrhosis attributed to hepatitis C infection who was enrolled in a trial of fecal microbiota transplantation via oral capsules to treat hepatic encephalopathy. The first sign of the adverse event was a fever and cough, which developed 17 days after the final dose of 15 capsules. He was treated for pneumonia but failed to improve after 2 days, at which time gram-negative rods were discovered in blood cultures taken at the initial presentation.
After admission and further treatment, blood cultures were found to have ESBL-producing E. coli, and after further treatment, the patient was clinically stable. A stool sample taken after treatment was negative for ESBL-producing E. coli.
The second case study was a 73-year-old man with therapy-related myelodysplastic syndrome who was undergoing allogeneic hematopoietic stem cell transplantation and was receiving fecal microbiota transplantation via oral capsule as part of a phase 2 trial.
Eight days after the last dose of oral capsules, and 5 days after the stem-cell infusion, the man developed a fever, chills, febrile neutropenia and showed altered mental status. He was treated with cefepime but developed hypoxia and labored breathing later that evening, which prompted clinicians to intubate and begin mechanical ventilation.
His blood culture results showed gram-negative rods, and meropenem was added to his antibiotic regimen. However, the patient’s condition worsened, and he died of severe sepsis 2 days later with blood cultures confirmed as positive for ESBL-producing E. coli.
A follow-up investigation revealed that both patients received stool from the same donor. Each lot of three capsules from that donor was found to contain ESBL-producing E. coli with a resistance pattern similar to that seen in the two recipients.
Twenty-two patients had received capsules from this donor. Researchers contacted all the recipients and offered them stool screening for ESBL-producing E. coli. Twelve underwent testing, which found that five had samples that grew on ESBL-producing E. coli–selective medium.
The remaining seven patients who had follow-up testing were receiving treatment for recurrent or refractory Clostridioides difficile infection, and four of these grew samples on the selective medium.
“When FMT is successful, the recipient’s metagenomic burden of antimicrobial resistance genes mimics that of the donor,” the authors wrote. “Although we cannot conclusively attribute positive screening results for ESBL-producing organisms in other asymptomatic recipients to FMT, the rates of positive tests are, in our opinion, unexpectedly high and probably represent transmission through FMT.”
The authors said the donor had no risk factors for carriage of multidrug-resistant organism and had previously donated fecal material before the introduction of routine screening for ESBL-producing organisms.
However, they noted that both patients had risk factors for bacteremia, namely advanced cirrhosis and allogeneic hematopoietic stem cell transplantation and they also received oral antibiotics around the time of the fecal microbiota transplantation.
“Despite the infectious complications reported here, the benefits of FMT should be balanced with the associated risks when considering treatment options for patients with recurrent or refractory C. difficile infection,” the authors wrote. “Ongoing assessment of the risks and benefit of FMT research is needed, as are continuing efforts to improve donor screening to limit transmission of microorganisms that could lead to adverse infectious events.”
The American Gastroenterological Association FMT National Registry is a critical effort to track short- and long-term patient outcomes and potential risks associated with FMT. The registry's goal is to track 4,000 patients for 10 years. If you perform FMT, please contribute to this important initiative. Learn more at www.gastro.org/FMTRegistry.
The study was supported by a grant from the American College of Gastroenterology. Three authors declared personal fees and grants from the medical sector outside the submitted work, and two were attached to a diagnostics company involved in the study.
SOURCE: DeFilipp Z et al. N Engl J Med. 2019 Oct 30. doi: 10.1056/NEJMoa1910437.
* This story was updated on Oct. 31, 2019.
Two cases of bacteremia have been described in two patients who received fecal microbiota transplants from the same donor.
Writing in the New England Journal of Medicine, researchers reported the two case studies of extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli bacteremia, one of which ended in the death of the patient. These cases were previously announced by the Food and Drug Administration in a June 2019 safety alert.
Zachariah DeFilipp, MD, from Massachusetts General Hospital at Harvard Medical School, Boston, and coauthors wrote that fecal microbiota transplantation is rarely associated with complications. Placebo-controlled trials and a systematic review have found similar rates of complications in immunocompromised and immunocompetent recipients. Only four cases of gram-negative bacteremia previously have been reported, and in three of these, there was a plausible alternative explanation for the bacteremia.
In this paper, both patients received fecal microbiota transplantation via frozen oral capsules containing donor stool. These capsules were prepared prior to the implementation of screening for ESBL-producing organisms at the institution, and were not retrospectively tested since this expanded donor screening.
The first patient was a 69-year-old man with liver cirrhosis attributed to hepatitis C infection who was enrolled in a trial of fecal microbiota transplantation via oral capsules to treat hepatic encephalopathy. The first sign of the adverse event was a fever and cough, which developed 17 days after the final dose of 15 capsules. He was treated for pneumonia but failed to improve after 2 days, at which time gram-negative rods were discovered in blood cultures taken at the initial presentation.
After admission and further treatment, blood cultures were found to have ESBL-producing E. coli, and after further treatment, the patient was clinically stable. A stool sample taken after treatment was negative for ESBL-producing E. coli.
The second case study was a 73-year-old man with therapy-related myelodysplastic syndrome who was undergoing allogeneic hematopoietic stem cell transplantation and was receiving fecal microbiota transplantation via oral capsule as part of a phase 2 trial.
Eight days after the last dose of oral capsules, and 5 days after the stem-cell infusion, the man developed a fever, chills, febrile neutropenia and showed altered mental status. He was treated with cefepime but developed hypoxia and labored breathing later that evening, which prompted clinicians to intubate and begin mechanical ventilation.
His blood culture results showed gram-negative rods, and meropenem was added to his antibiotic regimen. However, the patient’s condition worsened, and he died of severe sepsis 2 days later with blood cultures confirmed as positive for ESBL-producing E. coli.
A follow-up investigation revealed that both patients received stool from the same donor. Each lot of three capsules from that donor was found to contain ESBL-producing E. coli with a resistance pattern similar to that seen in the two recipients.
Twenty-two patients had received capsules from this donor. Researchers contacted all the recipients and offered them stool screening for ESBL-producing E. coli. Twelve underwent testing, which found that five had samples that grew on ESBL-producing E. coli–selective medium.
The remaining seven patients who had follow-up testing were receiving treatment for recurrent or refractory Clostridioides difficile infection, and four of these grew samples on the selective medium.
“When FMT is successful, the recipient’s metagenomic burden of antimicrobial resistance genes mimics that of the donor,” the authors wrote. “Although we cannot conclusively attribute positive screening results for ESBL-producing organisms in other asymptomatic recipients to FMT, the rates of positive tests are, in our opinion, unexpectedly high and probably represent transmission through FMT.”
The authors said the donor had no risk factors for carriage of multidrug-resistant organism and had previously donated fecal material before the introduction of routine screening for ESBL-producing organisms.
However, they noted that both patients had risk factors for bacteremia, namely advanced cirrhosis and allogeneic hematopoietic stem cell transplantation and they also received oral antibiotics around the time of the fecal microbiota transplantation.
“Despite the infectious complications reported here, the benefits of FMT should be balanced with the associated risks when considering treatment options for patients with recurrent or refractory C. difficile infection,” the authors wrote. “Ongoing assessment of the risks and benefit of FMT research is needed, as are continuing efforts to improve donor screening to limit transmission of microorganisms that could lead to adverse infectious events.”
The American Gastroenterological Association FMT National Registry is a critical effort to track short- and long-term patient outcomes and potential risks associated with FMT. The registry's goal is to track 4,000 patients for 10 years. If you perform FMT, please contribute to this important initiative. Learn more at www.gastro.org/FMTRegistry.
The study was supported by a grant from the American College of Gastroenterology. Three authors declared personal fees and grants from the medical sector outside the submitted work, and two were attached to a diagnostics company involved in the study.
SOURCE: DeFilipp Z et al. N Engl J Med. 2019 Oct 30. doi: 10.1056/NEJMoa1910437.
* This story was updated on Oct. 31, 2019.
FROM NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Two cases of bacteremia – one fatal – have been linked to a fecal microbiota transplant.
Major finding: Two patients developed bacteremia after receiving a fecal microbiota transplant from the same donor.
Study details: Case studies.
Disclosures: The study was supported by a grant from the American College of Gastroenterology. Three authors declared personal fees and grants from the medical sector outside the submitted work, and two authors were attached to a diagnostics company involved in the study.
Source: DeFillip Z et al. N Engl J Med. 2019 Oct 30. doi: 10.1056/NEJMoa1910437.
Greater weight loss with sleeve gastroplasty than with diet therapy
Endoscopic sleeve gastroplasty achieves significantly greater weight loss than that of a high-intensity diet and lifestyle therapy program, according to a study published in Gastrointestinal Endoscopy.
In the retrospective case-matched study, 105 patients who underwent endoscopic sleeve gastroplasty, in combination with a low-intensity diet and lifestyle therapy, were compared with 281 patients who participated in a high-intensity diet and lifestyle therapy program.
“As ESG [endoscopic sleeve gastroplasty] continues to gain traction worldwide, a comprehensive understanding of its outcomes and relative place among the battery of weight loss treatments is important,” wrote Lawrence J. Cheskin, MD, of Johns Hopkins Bloomberg School of Public Health, Baltimore, and coauthors, noting that only two studies have compared endoscopic sleeve gastroscopy with another weight loss therapy.
The high-intensity program involved patients being prescribed a low-calorie, high-protein diet of 800-1,200 calories a day, and taking part in behavioral, nutritional, and exercise counseling as well as optional support from psychotherapy, support groups, and meal replacements.
The study found that patients who underwent the gastroplasty lost significantly greater mean percentage of body weight compared with those who participated in the therapy program.
At 1 month, mean percentage body weight loss was 9.3% in the gastroplasty group compared with 7% in the therapy group. At 3 months it was 14% compared with 11.3%, at 6 months it was 17.7% compared with 14.7%, and at 12 months it was 20.6% compared with 14.3%. Significantly more patients in the gastroplasty group reached 5%, 10%, and 20% weight loss compared with the therapy group.
The authors noted that high-intensity diet and lifestyle therapy programs had “notoriously” high rates of noncompliance and withdrawal from treatment; adherence rates of 63.1% and 59.6% had been seen in previous observational studies.
“Therefore, ESG may be a valuable alternative for patients who have had trouble adhering to HIDLT [high-intensity diet and lifestyle therapy],” they wrote. “Given the diversity of the obese population, ESG may begin to fill some gaps in the obesity treatment arsenal.”
A subgroup analysis looked at patients with a baseline body mass index below or above 40 kg/m2, and found even after adjustment for age and sex, both groups showed significantly more weight loss at 1 and 3 months for patients who underwent gastroplasty. However, at 6 and 12 months, the study saw no significant difference between gastroplasty and the therapy program for patients with a baseline BMI above 40 kg/m2.
While the cause of this difference in effect in higher BMI patients was unknown, it may be that sleeve gastroplasty is less effective because it is counteracted by neurohormonal effects that are altered with bariatric surgery, the authors wrote.
“This is worth exploring in future randomized control trials because it will give us insight into which patients are superior candidates for endoscopic bariatric therapy,” they wrote.
There were five moderate to severe adverse events in the gastroplasty cohort and none in the therapy group. There were three cases of upper gastrointestinal bleeding caused by gastric ulceration. In one case, the patient underwent diagnostic endoscopy, admission, and 48-hour monitoring. Another patient developed perigastric fluid collection, and one was admitted for intravenous hydration after experiencing dehydration. Despite this, the authors suggested the adverse event rate associated with the procedure may be acceptable to patients because of the superior weight loss effect compared with therapy programs.
No funding was declared. Three authors declared consultancies, advisory board positions, and personal fees from medical device companies including those in the endoscopy space. No other conflicts of interest were declared.
SOURCE: Cheskin L et al. Gastrointest Endosc. 2019 Sep 27. doi: 10.1016/j.gie.2019.09.029.
Endoscopic sleeve gastroplasty achieves significantly greater weight loss than that of a high-intensity diet and lifestyle therapy program, according to a study published in Gastrointestinal Endoscopy.
In the retrospective case-matched study, 105 patients who underwent endoscopic sleeve gastroplasty, in combination with a low-intensity diet and lifestyle therapy, were compared with 281 patients who participated in a high-intensity diet and lifestyle therapy program.
“As ESG [endoscopic sleeve gastroplasty] continues to gain traction worldwide, a comprehensive understanding of its outcomes and relative place among the battery of weight loss treatments is important,” wrote Lawrence J. Cheskin, MD, of Johns Hopkins Bloomberg School of Public Health, Baltimore, and coauthors, noting that only two studies have compared endoscopic sleeve gastroscopy with another weight loss therapy.
The high-intensity program involved patients being prescribed a low-calorie, high-protein diet of 800-1,200 calories a day, and taking part in behavioral, nutritional, and exercise counseling as well as optional support from psychotherapy, support groups, and meal replacements.
The study found that patients who underwent the gastroplasty lost significantly greater mean percentage of body weight compared with those who participated in the therapy program.
At 1 month, mean percentage body weight loss was 9.3% in the gastroplasty group compared with 7% in the therapy group. At 3 months it was 14% compared with 11.3%, at 6 months it was 17.7% compared with 14.7%, and at 12 months it was 20.6% compared with 14.3%. Significantly more patients in the gastroplasty group reached 5%, 10%, and 20% weight loss compared with the therapy group.
The authors noted that high-intensity diet and lifestyle therapy programs had “notoriously” high rates of noncompliance and withdrawal from treatment; adherence rates of 63.1% and 59.6% had been seen in previous observational studies.
“Therefore, ESG may be a valuable alternative for patients who have had trouble adhering to HIDLT [high-intensity diet and lifestyle therapy],” they wrote. “Given the diversity of the obese population, ESG may begin to fill some gaps in the obesity treatment arsenal.”
A subgroup analysis looked at patients with a baseline body mass index below or above 40 kg/m2, and found even after adjustment for age and sex, both groups showed significantly more weight loss at 1 and 3 months for patients who underwent gastroplasty. However, at 6 and 12 months, the study saw no significant difference between gastroplasty and the therapy program for patients with a baseline BMI above 40 kg/m2.
While the cause of this difference in effect in higher BMI patients was unknown, it may be that sleeve gastroplasty is less effective because it is counteracted by neurohormonal effects that are altered with bariatric surgery, the authors wrote.
“This is worth exploring in future randomized control trials because it will give us insight into which patients are superior candidates for endoscopic bariatric therapy,” they wrote.
There were five moderate to severe adverse events in the gastroplasty cohort and none in the therapy group. There were three cases of upper gastrointestinal bleeding caused by gastric ulceration. In one case, the patient underwent diagnostic endoscopy, admission, and 48-hour monitoring. Another patient developed perigastric fluid collection, and one was admitted for intravenous hydration after experiencing dehydration. Despite this, the authors suggested the adverse event rate associated with the procedure may be acceptable to patients because of the superior weight loss effect compared with therapy programs.
No funding was declared. Three authors declared consultancies, advisory board positions, and personal fees from medical device companies including those in the endoscopy space. No other conflicts of interest were declared.
SOURCE: Cheskin L et al. Gastrointest Endosc. 2019 Sep 27. doi: 10.1016/j.gie.2019.09.029.
Endoscopic sleeve gastroplasty achieves significantly greater weight loss than that of a high-intensity diet and lifestyle therapy program, according to a study published in Gastrointestinal Endoscopy.
In the retrospective case-matched study, 105 patients who underwent endoscopic sleeve gastroplasty, in combination with a low-intensity diet and lifestyle therapy, were compared with 281 patients who participated in a high-intensity diet and lifestyle therapy program.
“As ESG [endoscopic sleeve gastroplasty] continues to gain traction worldwide, a comprehensive understanding of its outcomes and relative place among the battery of weight loss treatments is important,” wrote Lawrence J. Cheskin, MD, of Johns Hopkins Bloomberg School of Public Health, Baltimore, and coauthors, noting that only two studies have compared endoscopic sleeve gastroscopy with another weight loss therapy.
The high-intensity program involved patients being prescribed a low-calorie, high-protein diet of 800-1,200 calories a day, and taking part in behavioral, nutritional, and exercise counseling as well as optional support from psychotherapy, support groups, and meal replacements.
The study found that patients who underwent the gastroplasty lost significantly greater mean percentage of body weight compared with those who participated in the therapy program.
At 1 month, mean percentage body weight loss was 9.3% in the gastroplasty group compared with 7% in the therapy group. At 3 months it was 14% compared with 11.3%, at 6 months it was 17.7% compared with 14.7%, and at 12 months it was 20.6% compared with 14.3%. Significantly more patients in the gastroplasty group reached 5%, 10%, and 20% weight loss compared with the therapy group.
The authors noted that high-intensity diet and lifestyle therapy programs had “notoriously” high rates of noncompliance and withdrawal from treatment; adherence rates of 63.1% and 59.6% had been seen in previous observational studies.
“Therefore, ESG may be a valuable alternative for patients who have had trouble adhering to HIDLT [high-intensity diet and lifestyle therapy],” they wrote. “Given the diversity of the obese population, ESG may begin to fill some gaps in the obesity treatment arsenal.”
A subgroup analysis looked at patients with a baseline body mass index below or above 40 kg/m2, and found even after adjustment for age and sex, both groups showed significantly more weight loss at 1 and 3 months for patients who underwent gastroplasty. However, at 6 and 12 months, the study saw no significant difference between gastroplasty and the therapy program for patients with a baseline BMI above 40 kg/m2.
While the cause of this difference in effect in higher BMI patients was unknown, it may be that sleeve gastroplasty is less effective because it is counteracted by neurohormonal effects that are altered with bariatric surgery, the authors wrote.
“This is worth exploring in future randomized control trials because it will give us insight into which patients are superior candidates for endoscopic bariatric therapy,” they wrote.
There were five moderate to severe adverse events in the gastroplasty cohort and none in the therapy group. There were three cases of upper gastrointestinal bleeding caused by gastric ulceration. In one case, the patient underwent diagnostic endoscopy, admission, and 48-hour monitoring. Another patient developed perigastric fluid collection, and one was admitted for intravenous hydration after experiencing dehydration. Despite this, the authors suggested the adverse event rate associated with the procedure may be acceptable to patients because of the superior weight loss effect compared with therapy programs.
No funding was declared. Three authors declared consultancies, advisory board positions, and personal fees from medical device companies including those in the endoscopy space. No other conflicts of interest were declared.
SOURCE: Cheskin L et al. Gastrointest Endosc. 2019 Sep 27. doi: 10.1016/j.gie.2019.09.029.
FROM GASTROINTESTINAL ENDOSCOPY
Mistreatment of surgical residents linked to burnout
SAN FRANCISCO – according to data presented at the annual clinical congress of the American College of Surgeons.
Published simultaneously in the New England Journal of Medicine, the cross-sectional national survey of 7,409 residents across all 262 surgical residency programs investigated the impact of mistreatment on burnout rates and suicidal thoughts. The sample included 99.3% of all eligible U.S. trainees.
The survey found that 31.9% of all respondents – 65.1% of women and 10% of men – said they had experienced discrimination because of their self-reported gender, and 16.6% had experienced racial discrimination. In the case of both gender-based and racial discrimination, nearly half of respondents who had experienced these identified patients and patients’ families as the source.
One-third of female respondents (33%) had been on the receiving end of verbal emotional abuse, as had 28.3% of male respondents. Most of the abuse came from other surgeons.
Around 1 in 10 residents – 19.9% of women and 3.9% of men – had experienced sexual harassment. In around one-third of cases, the source was other surgeons, and in one-third the source was patients and their families.
Nearly half of all the residents said they had experienced some form of mistreatment, 19% said they experienced it a few times a month, and 30.9% said it happened a few times a year.
The survey found that 38.5% of residents experienced the symptoms of burnout – such as emotional exhaustion and depersonalization – at least once a week. The incidence was higher in women than in men (42.4% vs. 35.9%), with women reporting a higher prevalence of emotional exhaustion than men. Nearly 1 in 20 (4.5%) reported having suicidal thoughts (5.3% of women and 3.9% of men).
Researchers found that the more mistreatment a resident experienced, the greater the frequency of burnout symptoms. Those who reported experiencing mistreatment a few times a year had a twofold greater odds of burnout, compared with those who had not experienced any mistreatment. Those who experienced mistreatment a few times a month or more had nearly threefold higher odds of burnout. Similarly, increasing exposure to mistreatment was also associated with stepwise increases in the odds of suicidal thoughts.
“Mistreatment is a frequent experience for general surgery residents in the United States, and is associated with burnout and suicidal thoughts,” wrote Yue-Yung Hu, MD, from the Surgical Outcomes and Quality Improvement Center at Northwestern University, Chicago, and coauthors. “Our results provide initial insights on how we may build safer, more equitable and more effective education environments for trainees.”
The study was supported by the American College of Surgeons, the Accreditation Council for Graduate Medical Education, and the American Board of Surgery. Two authors were supported by grants from the Agency for Healthcare Research and Quality, and one by a grant from the National Institutes of Health. One author was an employee of the Accreditation Council for Graduate Medical Education.
SOURCE: Hu Y-Y et al. N Engl J Med. 2019 Oct 28. doi: 10.1056/NEJMsa1903759.
SAN FRANCISCO – according to data presented at the annual clinical congress of the American College of Surgeons.
Published simultaneously in the New England Journal of Medicine, the cross-sectional national survey of 7,409 residents across all 262 surgical residency programs investigated the impact of mistreatment on burnout rates and suicidal thoughts. The sample included 99.3% of all eligible U.S. trainees.
The survey found that 31.9% of all respondents – 65.1% of women and 10% of men – said they had experienced discrimination because of their self-reported gender, and 16.6% had experienced racial discrimination. In the case of both gender-based and racial discrimination, nearly half of respondents who had experienced these identified patients and patients’ families as the source.
One-third of female respondents (33%) had been on the receiving end of verbal emotional abuse, as had 28.3% of male respondents. Most of the abuse came from other surgeons.
Around 1 in 10 residents – 19.9% of women and 3.9% of men – had experienced sexual harassment. In around one-third of cases, the source was other surgeons, and in one-third the source was patients and their families.
Nearly half of all the residents said they had experienced some form of mistreatment, 19% said they experienced it a few times a month, and 30.9% said it happened a few times a year.
The survey found that 38.5% of residents experienced the symptoms of burnout – such as emotional exhaustion and depersonalization – at least once a week. The incidence was higher in women than in men (42.4% vs. 35.9%), with women reporting a higher prevalence of emotional exhaustion than men. Nearly 1 in 20 (4.5%) reported having suicidal thoughts (5.3% of women and 3.9% of men).
Researchers found that the more mistreatment a resident experienced, the greater the frequency of burnout symptoms. Those who reported experiencing mistreatment a few times a year had a twofold greater odds of burnout, compared with those who had not experienced any mistreatment. Those who experienced mistreatment a few times a month or more had nearly threefold higher odds of burnout. Similarly, increasing exposure to mistreatment was also associated with stepwise increases in the odds of suicidal thoughts.
“Mistreatment is a frequent experience for general surgery residents in the United States, and is associated with burnout and suicidal thoughts,” wrote Yue-Yung Hu, MD, from the Surgical Outcomes and Quality Improvement Center at Northwestern University, Chicago, and coauthors. “Our results provide initial insights on how we may build safer, more equitable and more effective education environments for trainees.”
The study was supported by the American College of Surgeons, the Accreditation Council for Graduate Medical Education, and the American Board of Surgery. Two authors were supported by grants from the Agency for Healthcare Research and Quality, and one by a grant from the National Institutes of Health. One author was an employee of the Accreditation Council for Graduate Medical Education.
SOURCE: Hu Y-Y et al. N Engl J Med. 2019 Oct 28. doi: 10.1056/NEJMsa1903759.
SAN FRANCISCO – according to data presented at the annual clinical congress of the American College of Surgeons.
Published simultaneously in the New England Journal of Medicine, the cross-sectional national survey of 7,409 residents across all 262 surgical residency programs investigated the impact of mistreatment on burnout rates and suicidal thoughts. The sample included 99.3% of all eligible U.S. trainees.
The survey found that 31.9% of all respondents – 65.1% of women and 10% of men – said they had experienced discrimination because of their self-reported gender, and 16.6% had experienced racial discrimination. In the case of both gender-based and racial discrimination, nearly half of respondents who had experienced these identified patients and patients’ families as the source.
One-third of female respondents (33%) had been on the receiving end of verbal emotional abuse, as had 28.3% of male respondents. Most of the abuse came from other surgeons.
Around 1 in 10 residents – 19.9% of women and 3.9% of men – had experienced sexual harassment. In around one-third of cases, the source was other surgeons, and in one-third the source was patients and their families.
Nearly half of all the residents said they had experienced some form of mistreatment, 19% said they experienced it a few times a month, and 30.9% said it happened a few times a year.
The survey found that 38.5% of residents experienced the symptoms of burnout – such as emotional exhaustion and depersonalization – at least once a week. The incidence was higher in women than in men (42.4% vs. 35.9%), with women reporting a higher prevalence of emotional exhaustion than men. Nearly 1 in 20 (4.5%) reported having suicidal thoughts (5.3% of women and 3.9% of men).
Researchers found that the more mistreatment a resident experienced, the greater the frequency of burnout symptoms. Those who reported experiencing mistreatment a few times a year had a twofold greater odds of burnout, compared with those who had not experienced any mistreatment. Those who experienced mistreatment a few times a month or more had nearly threefold higher odds of burnout. Similarly, increasing exposure to mistreatment was also associated with stepwise increases in the odds of suicidal thoughts.
“Mistreatment is a frequent experience for general surgery residents in the United States, and is associated with burnout and suicidal thoughts,” wrote Yue-Yung Hu, MD, from the Surgical Outcomes and Quality Improvement Center at Northwestern University, Chicago, and coauthors. “Our results provide initial insights on how we may build safer, more equitable and more effective education environments for trainees.”
The study was supported by the American College of Surgeons, the Accreditation Council for Graduate Medical Education, and the American Board of Surgery. Two authors were supported by grants from the Agency for Healthcare Research and Quality, and one by a grant from the National Institutes of Health. One author was an employee of the Accreditation Council for Graduate Medical Education.
SOURCE: Hu Y-Y et al. N Engl J Med. 2019 Oct 28. doi: 10.1056/NEJMsa1903759.
REPORTING FROM CLINICAL CONGRESS 2019
Clinical interventions for global drug use need updating
Public health approach requires greater emphasis on harms, benefits of substance use.
Strategies aimed at reducing drug-related harm should be informed by evidence, and recognize the contribution of social and economic factors to drug use, report the authors of a series of four papers published in The Lancet.
Louisa Degenhardt, PhD, and coauthors wrote in the first paper that, although the availability and use of drugs have been transformed over recent decades – including the emergence of hundreds of new psychoactive substances – professional and public policy has not yet adapted to those new realities (Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32229-9).
, in a way that you don’t see in other areas of public health,” Dr. Degenhardt, of the National Drug and Alcohol Research Centre at the University of New South Wales in Sydney, said in an interview. “There has been an increasing level of awareness of issues but also level of recognition that we need to have hard evidence to work out the best ways to respond.”
The paper by Dr. Degenhardt and coauthors addressed the issue of opioid use and dependence around the world, citing evidence that in 2017, 40.5 million people were dependent on opioids and 109,500 deaths were attributable to opioid overdose. An effective treatment exists in the form of opioid agonists methadone and buprenorphine, both of which are recognized as World Health Organization essential medicines.
While the best evidence for positive outcomes from opioid agonist treatment is in people using illicit opioids such as heroin, there is also evidence for their effectiveness in people with pharmaceutical opioid dependence. A study in Kentucky suggested that scaling up the use and retention of opioid agonist treatment, including in prison, could prevent 57% of overdose deaths among injecting drug users.
“Despite strong evidence for the effectiveness of a range of interventions to improve the health and well-being of people who are dependent on opioids, coverage is low, even in high-income countries,” the authors wrote. They also called for international efforts to eliminate marketing strategies that have contributed to the increase in opioid prescription and harms in North America.
The second paper examined the public health implications of legalizing cannabis for medicinal and recreational use (Hall W et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)31789-1). Cannabis has been considered an illicit drug for more than 50 years but recently has been decriminalized or legalized in many parts of the world in recognition of the lower levels of harm, compared with other illicit substances.
Cannabis is used to treat a range of medical conditions, including muscle spasticity in multiple sclerosis. It also is used to treat pain, nausea, and vomiting in palliative care, and to reduce seizures in epilepsy. However, the authors noted that the evidence for many medical applications was absent, and that weakly regulated medical cannabis programs in some U.S. states were blurring the boundaries between medicinal and nonmedicinal use.
They also wrote that the public health effects of legalization could not be assessed, because legalization had happened only in the last 5 years.
“A major determinant of the public health effect of cannabis legalization will be the effect that it has on alcohol use,” they wrote. “The substitution of cannabis for alcohol would produce substantial public health gains, but any increase in the combined use of alcohol and cannabis could increase harm.”
The authors also looked at the effect of use of stimulants such as cocaine and amphetamines. While their use is associated with higher mortality, increased incidence of HIV and hepatitis C infection, poor mental health, and increased risk of cardiovascular events, no effective pharmacotherapies are available, and psychosocial interventions such as cognitive-behavioral therapy have only a weak effect.
“Many governments rely on punitive responses, such as involuntary detention in drug centers, despite the absence of evidence for their effectiveness and their potential to increase harm,” the authors wrote. “Substantial research investment is needed to develop more effective, innovative, and impactful prevention and treatment” (Farrell M et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32230-5).
They focused on interventions to prevent the transmission of blood-borne and sexually transmitted infections – such as the provision of safe injecting equipment, condoms or pre-exposure prophylaxis against HIV – and improve treatment of these, and interventions to prevent and treat overdose, injury, and other harms.
The final paper in the series explored new psychoactive substances, such as synthetic cannabinoids, stimulants, hallucinogens, and dissociative and depressant substances (Peacock A et al. Lancet 2019 Oct 23. doi: 10.1016/S0140-6736(19)32231-7).
There really needs to be massive change in systems in terms of the way monitoring occurs and the speed with which new drugs are identified, Dr. Degenhardt said in the interview. She also said the risks that are identified need to be communicated more effectively.
“At the moment, the way that drug surveillance works in most countries, things come and then particular drugs may spread in use, cause massive harm, and all of our systems of detecting and responding are not fit to detect those things in a timely way and disseminate information to reduce those risks.”
The papers were supported by European Monitoring Centre on Drugs and Drug Addiction, and the Australian National Drug and Alcohol Research Centre. The authors declared support from a range of institutions and funding bodies, and several also declared unrelated grants, funding, and other support from the pharmaceutical sector.
SOURCES: Degenhardt L et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32229-9; Hall W et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)31789-1; Farrell M et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32230-5; and Peacock A et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32231-7.
Public health approach requires greater emphasis on harms, benefits of substance use.
Public health approach requires greater emphasis on harms, benefits of substance use.
Strategies aimed at reducing drug-related harm should be informed by evidence, and recognize the contribution of social and economic factors to drug use, report the authors of a series of four papers published in The Lancet.
Louisa Degenhardt, PhD, and coauthors wrote in the first paper that, although the availability and use of drugs have been transformed over recent decades – including the emergence of hundreds of new psychoactive substances – professional and public policy has not yet adapted to those new realities (Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32229-9).
, in a way that you don’t see in other areas of public health,” Dr. Degenhardt, of the National Drug and Alcohol Research Centre at the University of New South Wales in Sydney, said in an interview. “There has been an increasing level of awareness of issues but also level of recognition that we need to have hard evidence to work out the best ways to respond.”
The paper by Dr. Degenhardt and coauthors addressed the issue of opioid use and dependence around the world, citing evidence that in 2017, 40.5 million people were dependent on opioids and 109,500 deaths were attributable to opioid overdose. An effective treatment exists in the form of opioid agonists methadone and buprenorphine, both of which are recognized as World Health Organization essential medicines.
While the best evidence for positive outcomes from opioid agonist treatment is in people using illicit opioids such as heroin, there is also evidence for their effectiveness in people with pharmaceutical opioid dependence. A study in Kentucky suggested that scaling up the use and retention of opioid agonist treatment, including in prison, could prevent 57% of overdose deaths among injecting drug users.
“Despite strong evidence for the effectiveness of a range of interventions to improve the health and well-being of people who are dependent on opioids, coverage is low, even in high-income countries,” the authors wrote. They also called for international efforts to eliminate marketing strategies that have contributed to the increase in opioid prescription and harms in North America.
The second paper examined the public health implications of legalizing cannabis for medicinal and recreational use (Hall W et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)31789-1). Cannabis has been considered an illicit drug for more than 50 years but recently has been decriminalized or legalized in many parts of the world in recognition of the lower levels of harm, compared with other illicit substances.
Cannabis is used to treat a range of medical conditions, including muscle spasticity in multiple sclerosis. It also is used to treat pain, nausea, and vomiting in palliative care, and to reduce seizures in epilepsy. However, the authors noted that the evidence for many medical applications was absent, and that weakly regulated medical cannabis programs in some U.S. states were blurring the boundaries between medicinal and nonmedicinal use.
They also wrote that the public health effects of legalization could not be assessed, because legalization had happened only in the last 5 years.
“A major determinant of the public health effect of cannabis legalization will be the effect that it has on alcohol use,” they wrote. “The substitution of cannabis for alcohol would produce substantial public health gains, but any increase in the combined use of alcohol and cannabis could increase harm.”
The authors also looked at the effect of use of stimulants such as cocaine and amphetamines. While their use is associated with higher mortality, increased incidence of HIV and hepatitis C infection, poor mental health, and increased risk of cardiovascular events, no effective pharmacotherapies are available, and psychosocial interventions such as cognitive-behavioral therapy have only a weak effect.
“Many governments rely on punitive responses, such as involuntary detention in drug centers, despite the absence of evidence for their effectiveness and their potential to increase harm,” the authors wrote. “Substantial research investment is needed to develop more effective, innovative, and impactful prevention and treatment” (Farrell M et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32230-5).
They focused on interventions to prevent the transmission of blood-borne and sexually transmitted infections – such as the provision of safe injecting equipment, condoms or pre-exposure prophylaxis against HIV – and improve treatment of these, and interventions to prevent and treat overdose, injury, and other harms.
The final paper in the series explored new psychoactive substances, such as synthetic cannabinoids, stimulants, hallucinogens, and dissociative and depressant substances (Peacock A et al. Lancet 2019 Oct 23. doi: 10.1016/S0140-6736(19)32231-7).
There really needs to be massive change in systems in terms of the way monitoring occurs and the speed with which new drugs are identified, Dr. Degenhardt said in the interview. She also said the risks that are identified need to be communicated more effectively.
“At the moment, the way that drug surveillance works in most countries, things come and then particular drugs may spread in use, cause massive harm, and all of our systems of detecting and responding are not fit to detect those things in a timely way and disseminate information to reduce those risks.”
The papers were supported by European Monitoring Centre on Drugs and Drug Addiction, and the Australian National Drug and Alcohol Research Centre. The authors declared support from a range of institutions and funding bodies, and several also declared unrelated grants, funding, and other support from the pharmaceutical sector.
SOURCES: Degenhardt L et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32229-9; Hall W et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)31789-1; Farrell M et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32230-5; and Peacock A et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32231-7.
Strategies aimed at reducing drug-related harm should be informed by evidence, and recognize the contribution of social and economic factors to drug use, report the authors of a series of four papers published in The Lancet.
Louisa Degenhardt, PhD, and coauthors wrote in the first paper that, although the availability and use of drugs have been transformed over recent decades – including the emergence of hundreds of new psychoactive substances – professional and public policy has not yet adapted to those new realities (Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32229-9).
, in a way that you don’t see in other areas of public health,” Dr. Degenhardt, of the National Drug and Alcohol Research Centre at the University of New South Wales in Sydney, said in an interview. “There has been an increasing level of awareness of issues but also level of recognition that we need to have hard evidence to work out the best ways to respond.”
The paper by Dr. Degenhardt and coauthors addressed the issue of opioid use and dependence around the world, citing evidence that in 2017, 40.5 million people were dependent on opioids and 109,500 deaths were attributable to opioid overdose. An effective treatment exists in the form of opioid agonists methadone and buprenorphine, both of which are recognized as World Health Organization essential medicines.
While the best evidence for positive outcomes from opioid agonist treatment is in people using illicit opioids such as heroin, there is also evidence for their effectiveness in people with pharmaceutical opioid dependence. A study in Kentucky suggested that scaling up the use and retention of opioid agonist treatment, including in prison, could prevent 57% of overdose deaths among injecting drug users.
“Despite strong evidence for the effectiveness of a range of interventions to improve the health and well-being of people who are dependent on opioids, coverage is low, even in high-income countries,” the authors wrote. They also called for international efforts to eliminate marketing strategies that have contributed to the increase in opioid prescription and harms in North America.
The second paper examined the public health implications of legalizing cannabis for medicinal and recreational use (Hall W et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)31789-1). Cannabis has been considered an illicit drug for more than 50 years but recently has been decriminalized or legalized in many parts of the world in recognition of the lower levels of harm, compared with other illicit substances.
Cannabis is used to treat a range of medical conditions, including muscle spasticity in multiple sclerosis. It also is used to treat pain, nausea, and vomiting in palliative care, and to reduce seizures in epilepsy. However, the authors noted that the evidence for many medical applications was absent, and that weakly regulated medical cannabis programs in some U.S. states were blurring the boundaries between medicinal and nonmedicinal use.
They also wrote that the public health effects of legalization could not be assessed, because legalization had happened only in the last 5 years.
“A major determinant of the public health effect of cannabis legalization will be the effect that it has on alcohol use,” they wrote. “The substitution of cannabis for alcohol would produce substantial public health gains, but any increase in the combined use of alcohol and cannabis could increase harm.”
The authors also looked at the effect of use of stimulants such as cocaine and amphetamines. While their use is associated with higher mortality, increased incidence of HIV and hepatitis C infection, poor mental health, and increased risk of cardiovascular events, no effective pharmacotherapies are available, and psychosocial interventions such as cognitive-behavioral therapy have only a weak effect.
“Many governments rely on punitive responses, such as involuntary detention in drug centers, despite the absence of evidence for their effectiveness and their potential to increase harm,” the authors wrote. “Substantial research investment is needed to develop more effective, innovative, and impactful prevention and treatment” (Farrell M et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32230-5).
They focused on interventions to prevent the transmission of blood-borne and sexually transmitted infections – such as the provision of safe injecting equipment, condoms or pre-exposure prophylaxis against HIV – and improve treatment of these, and interventions to prevent and treat overdose, injury, and other harms.
The final paper in the series explored new psychoactive substances, such as synthetic cannabinoids, stimulants, hallucinogens, and dissociative and depressant substances (Peacock A et al. Lancet 2019 Oct 23. doi: 10.1016/S0140-6736(19)32231-7).
There really needs to be massive change in systems in terms of the way monitoring occurs and the speed with which new drugs are identified, Dr. Degenhardt said in the interview. She also said the risks that are identified need to be communicated more effectively.
“At the moment, the way that drug surveillance works in most countries, things come and then particular drugs may spread in use, cause massive harm, and all of our systems of detecting and responding are not fit to detect those things in a timely way and disseminate information to reduce those risks.”
The papers were supported by European Monitoring Centre on Drugs and Drug Addiction, and the Australian National Drug and Alcohol Research Centre. The authors declared support from a range of institutions and funding bodies, and several also declared unrelated grants, funding, and other support from the pharmaceutical sector.
SOURCES: Degenhardt L et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32229-9; Hall W et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)31789-1; Farrell M et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32230-5; and Peacock A et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32231-7.
FROM THE LANCET
Key clinical point: People with drug use disorders around the world need evidence-based and nonjudgmental clinical care.
Major finding: Many interventions aimed at reducing the harm of illicit drug use are not informed by evidence.
Study details: Series of four papers reviewing the evidence on cannabinoids, opioids, new psychoactive substances, and stimulants.
Disclosures: The papers were supported by European Monitoring Centre on Drugs and Drug Addiction, and the Australian National Drug and Alcohol Research Centre. The authors declared support from a range of institutions and funding bodies, and several also declared unrelated grants, funding, and other support from the pharmaceutical sector.
Sources: Degenhardt L et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32229-9; Hall W et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)31789-1; Farrell M et al. Lancet. 2019 Oct 23. doi: 10.1016/S0140-6736(19)32230-5; and Peacock A et al. Lancet 2019 Oct 23. doi: 10.1016/S0140-6736(19)32231-7.
How to overcome barriers to exercise for cancer patients
There is increasing evidence that exercise lowers the risk of developing cancer, improves survival after a cancer diagnosis, and helps ease related health outcomes. However, relatively few cancer patients meet current physical activity guidelines – often because it wasn’t recommended by their oncologist.
“Observed barriers to clinicians referring patients to exercise programming include lack of awareness of the potential value of exercise in cancer populations, uncertainty regarding the safety or suitability of exercise for a particular patient, lack of awareness regarding available programs to help facilitate exercise in cancer populations, need for education and skills development for making referrals, and a belief that referrals to exercise programming are not within the scope of practice for oncology clinicians,” Kathryn H. Schmitz, PhD, from Penn State University in Hershey and coauthors from the American College of Sports Medicine International Multidisciplinary Roundtable wrote in CA: A Cancer Journal for Clinicians.
Dr. Schmitz and colleagues proposed using the American College of Sports Medicine’s Exercise Is Medicine initiative to address this gap, with a focus on asking physicians to take an assess, revise, and refer approach to recommending exercise.
Noting that there is clear evidence that patients are more likely to exercise if their oncologist recommends that they do so, the authors said a clinician’s silence on the subject of exercise could be interpreted as “tacit approval to maintain inactivity.”
To assess a patient’s level of physical activity, the authors suggested asking patients how many days during the past week they had undertaken physical activity during which their heart beat faster or they breathed harder than normal for more than 30 minutes or how often they had undertaken activity to increase muscle strength.
If the patient can safely exercise without medical supervision, the authors recommend that clinicians advise patients to increase their physical activity to achieve current recommended levels. Clinicians can refer patients to community programs to help ramp up their activity.
However, for patients who may not be able to exercise safely on their own, the authors recommend referring them to an outpatient rehabiliation professional.
“Referral to appropriate and effective programs and follow-up with an assessment of progress (or lack thereof) at subsequent visits can serve as key transition points to change a patient’s behavior and affect their tolerance of or recovery from treatment,” they wrote.
The authors stressed that oncology clinicians were not expected to prescribe specific levels of exercise or to perform extensive screening and triage of patients based on their fitness.
“Oncology clinicians, however, play a vital role in telling the patient that it is important to exercise and pointing patients in the right direction to make that happen,” they wrote.
The American College of Sports Medicine International Multidisciplinary Roundtable was funded by the American College of Sports Medicine, the American Cancer Society, and other groups. Four authors declared grant support for participating in the study. One declared private industry funding unrelated to the study. No other conflicts of interest were declared.
SOURCE: Schmitz K et al. CA Cancer J Clin. 2019 Oct 16. doi: 10.3322/caac.21579.
There is increasing evidence that exercise lowers the risk of developing cancer, improves survival after a cancer diagnosis, and helps ease related health outcomes. However, relatively few cancer patients meet current physical activity guidelines – often because it wasn’t recommended by their oncologist.
“Observed barriers to clinicians referring patients to exercise programming include lack of awareness of the potential value of exercise in cancer populations, uncertainty regarding the safety or suitability of exercise for a particular patient, lack of awareness regarding available programs to help facilitate exercise in cancer populations, need for education and skills development for making referrals, and a belief that referrals to exercise programming are not within the scope of practice for oncology clinicians,” Kathryn H. Schmitz, PhD, from Penn State University in Hershey and coauthors from the American College of Sports Medicine International Multidisciplinary Roundtable wrote in CA: A Cancer Journal for Clinicians.
Dr. Schmitz and colleagues proposed using the American College of Sports Medicine’s Exercise Is Medicine initiative to address this gap, with a focus on asking physicians to take an assess, revise, and refer approach to recommending exercise.
Noting that there is clear evidence that patients are more likely to exercise if their oncologist recommends that they do so, the authors said a clinician’s silence on the subject of exercise could be interpreted as “tacit approval to maintain inactivity.”
To assess a patient’s level of physical activity, the authors suggested asking patients how many days during the past week they had undertaken physical activity during which their heart beat faster or they breathed harder than normal for more than 30 minutes or how often they had undertaken activity to increase muscle strength.
If the patient can safely exercise without medical supervision, the authors recommend that clinicians advise patients to increase their physical activity to achieve current recommended levels. Clinicians can refer patients to community programs to help ramp up their activity.
However, for patients who may not be able to exercise safely on their own, the authors recommend referring them to an outpatient rehabiliation professional.
“Referral to appropriate and effective programs and follow-up with an assessment of progress (or lack thereof) at subsequent visits can serve as key transition points to change a patient’s behavior and affect their tolerance of or recovery from treatment,” they wrote.
The authors stressed that oncology clinicians were not expected to prescribe specific levels of exercise or to perform extensive screening and triage of patients based on their fitness.
“Oncology clinicians, however, play a vital role in telling the patient that it is important to exercise and pointing patients in the right direction to make that happen,” they wrote.
The American College of Sports Medicine International Multidisciplinary Roundtable was funded by the American College of Sports Medicine, the American Cancer Society, and other groups. Four authors declared grant support for participating in the study. One declared private industry funding unrelated to the study. No other conflicts of interest were declared.
SOURCE: Schmitz K et al. CA Cancer J Clin. 2019 Oct 16. doi: 10.3322/caac.21579.
There is increasing evidence that exercise lowers the risk of developing cancer, improves survival after a cancer diagnosis, and helps ease related health outcomes. However, relatively few cancer patients meet current physical activity guidelines – often because it wasn’t recommended by their oncologist.
“Observed barriers to clinicians referring patients to exercise programming include lack of awareness of the potential value of exercise in cancer populations, uncertainty regarding the safety or suitability of exercise for a particular patient, lack of awareness regarding available programs to help facilitate exercise in cancer populations, need for education and skills development for making referrals, and a belief that referrals to exercise programming are not within the scope of practice for oncology clinicians,” Kathryn H. Schmitz, PhD, from Penn State University in Hershey and coauthors from the American College of Sports Medicine International Multidisciplinary Roundtable wrote in CA: A Cancer Journal for Clinicians.
Dr. Schmitz and colleagues proposed using the American College of Sports Medicine’s Exercise Is Medicine initiative to address this gap, with a focus on asking physicians to take an assess, revise, and refer approach to recommending exercise.
Noting that there is clear evidence that patients are more likely to exercise if their oncologist recommends that they do so, the authors said a clinician’s silence on the subject of exercise could be interpreted as “tacit approval to maintain inactivity.”
To assess a patient’s level of physical activity, the authors suggested asking patients how many days during the past week they had undertaken physical activity during which their heart beat faster or they breathed harder than normal for more than 30 minutes or how often they had undertaken activity to increase muscle strength.
If the patient can safely exercise without medical supervision, the authors recommend that clinicians advise patients to increase their physical activity to achieve current recommended levels. Clinicians can refer patients to community programs to help ramp up their activity.
However, for patients who may not be able to exercise safely on their own, the authors recommend referring them to an outpatient rehabiliation professional.
“Referral to appropriate and effective programs and follow-up with an assessment of progress (or lack thereof) at subsequent visits can serve as key transition points to change a patient’s behavior and affect their tolerance of or recovery from treatment,” they wrote.
The authors stressed that oncology clinicians were not expected to prescribe specific levels of exercise or to perform extensive screening and triage of patients based on their fitness.
“Oncology clinicians, however, play a vital role in telling the patient that it is important to exercise and pointing patients in the right direction to make that happen,” they wrote.
The American College of Sports Medicine International Multidisciplinary Roundtable was funded by the American College of Sports Medicine, the American Cancer Society, and other groups. Four authors declared grant support for participating in the study. One declared private industry funding unrelated to the study. No other conflicts of interest were declared.
SOURCE: Schmitz K et al. CA Cancer J Clin. 2019 Oct 16. doi: 10.3322/caac.21579.
FROM CA: A CANCER JOURNAL FOR CLINICIANS
Updated international consensus recommendations on management of acute upper GI bleeding
Guidelines on the management of acute upper gastrointestinal bleeding have been updated, including recommendations on managing patients on antiplatelet or anticoagulant therapy and on use of endoscopy and new therapeutic approaches.
Writing in Annals of Internal Medicine, an international group of experts published an update to the 2010 International Consensus Recommendations on the Management of Patients With Nonvariceal Upper Gastrointestinal Bleeding, with a focus on resuscitation and risk assessment; pre-endoscopic, endoscopic, and pharmacologic management; and secondary prophylaxis.
Alan N. Barkun, MDCM, MSc, from McGill University, Montreal, and coauthors first recommended that fluid resuscitation should be initiated in patients with acute upper gastrointestinal bleeding and hemodynamic instability to avoid hemorrhagic shock and restore end-organ perfusion and tissue oxygenation while the bleeding is brought under control.
They acknowledged the uncertainty around whether colloid or crystalloid fluid should be used, but suggested routine use of colloids was not justified because they were more expensive and did not appear to increase survival.
On the question of whether the resuscitation should be aggressive or restrictive in its timing and rate, the group said there was not enough evidence to support a recommendation on this. “The important issue in patients with hemorrhagic shock due to trauma or UGIB [upper gastrointestinal bleeding] is to stop the bleeding while minimizing hemodynamic compromise,” they wrote.
They also advised blood transfusions in patients with a hemoglobin level below 80 g/L who did not have underlying cardiovascular disease, but suggested a higher hemoglobin threshold for those with underlying cardiovascular disease.
The second recommendation was that patients with a Glasgow Blatchford score of 1 or less were at very low risk for rebleeding and mortality, and these patients may therefore not need hospitalization or inpatient endoscopy. They advised against using the AIMS65 prognostic score for this purpose because it was designed to identify patients at high risk of death, not those at low risk for safe discharge.
In regard to endoscopic management, they advocated that all patients with acute upper gastrointestinal bleeding – whether low or high risk – undergo endoscopy within 24 hours of presentation. This was even more urgent in patients being treated with anticoagulants. “Because of the recognized benefits of early endoscopy, coagulopathy should be treated as necessary but endoscopy should not be delayed,” they wrote.
Patients with acutely bleeding ulcers with high-risk stigmata should undergo endoscopic therapy preferably with thermocoagulation or sclerosant injection, or with hemoclips depending on the bleeding location and patient characteristics.
The group also included two conditional recommendations, based on very-low-quality evidence, that patients with actively bleeding ulcers receive TC-325 hemostatic powder as temporizing therapy to stop the bleeding if conventional endoscopic therapies aren’t available or fail. However, they stressed that TC-325 should not be used as a single therapeutic strategy.
Because of a lack of efficacy data and low availability of expertise in the technology, the authors said they could not make a recommendation for or against using a Doppler endoscopic probe (DEP) to assess the need for further endoscopic therapy.
“The group generally agreed that although making a recommendation for or against using DEP to manage UGIB is premature, DEP has the potential to alter the usual approach to visually assessing bleeding lesion risk when evaluating the need for, and adequacy of, endoscopic hemostasis.”
The guidelines also addressed the issue of pharmacologic management of acute upper gastrointestinal bleeding. They strongly recommended that patients with bleeding ulcers and high-risk stigmata who have undergone successful endoscopic therapy should then receive an intravenous loading dose of proton pump inhibitor (PPI) therapy, followed by continuous intravenous infusion.
“Cost-effectiveness studies have suggested that high-dose intravenous PPIs after successful endoscopic hemostasis improve outcomes at a modest cost increase relative to non–high-dose intravenous or oral PPI strategies,” they wrote.
A second conditional recommendation, based on very-low-quality evidence, was that patients with a bleeding ulcer who were at high risk for rebleeding be also treated twice-daily with oral PPIs for 2 weeks, then once-daily. They also recommended patients on cardiovascular prophylaxis with single or dual antiplatelet therapy or anticoagulant therapy be given PPIs.
“The consensus group concluded that, for high-risk patients with an ongoing need for anticoagulants, the evidence suggests that the benefits of secondary prophylaxis outweigh the risks.”
The group was supported by a grant from CIHR Institute of Nutrition, Metabolism and Diabetes and from the Saudi Gastroenterology Association. Nine authors declared grants, personal fees, honoraria and other funding from the pharmaceutical and medical device sector outside the submitted work. No other conflicts of interest were declared.
SOURCE: Barkun A et al. Ann Intern Med 2019, October 22. doi: 10.7326/M19-1795.
These updated consensus guidelines provide a rigorous review of evidence on managing nonvariceal upper gastrointestinal bleeding. The recommendations for patients on anticoagulant or antiplatelet therapy will be particularly helpful because of increasing use of these medications. The advice on proton pump inhibitor therapy in patients on these drugs who have had previous ulcer bleeding can help allay concerns about possible integrations between PPIs and clopidogrel.
While the guidelines recommend using the Glasgow Blatchford scale to guide hospitalization decisions, prognostic scores are not commonly used in the emergency department, and many patients present with a Glasgow Blatchford score greater than 1, so this tool may have little impact on hospitalization rates. More studies are needed to compare clinical judgment with these prognostic scores.
Angel Lanas, MD, is from the University Clinic Hospital at the University of Zaragoza (Spain). These comments are adapted from an accompanying editorial (Ann Intern Med 2019, October 22. doi: 10.7326/M19-2789). Dr. Lanas declared unrelated personal fees from the pharmaceutical sector.
These updated consensus guidelines provide a rigorous review of evidence on managing nonvariceal upper gastrointestinal bleeding. The recommendations for patients on anticoagulant or antiplatelet therapy will be particularly helpful because of increasing use of these medications. The advice on proton pump inhibitor therapy in patients on these drugs who have had previous ulcer bleeding can help allay concerns about possible integrations between PPIs and clopidogrel.
While the guidelines recommend using the Glasgow Blatchford scale to guide hospitalization decisions, prognostic scores are not commonly used in the emergency department, and many patients present with a Glasgow Blatchford score greater than 1, so this tool may have little impact on hospitalization rates. More studies are needed to compare clinical judgment with these prognostic scores.
Angel Lanas, MD, is from the University Clinic Hospital at the University of Zaragoza (Spain). These comments are adapted from an accompanying editorial (Ann Intern Med 2019, October 22. doi: 10.7326/M19-2789). Dr. Lanas declared unrelated personal fees from the pharmaceutical sector.
These updated consensus guidelines provide a rigorous review of evidence on managing nonvariceal upper gastrointestinal bleeding. The recommendations for patients on anticoagulant or antiplatelet therapy will be particularly helpful because of increasing use of these medications. The advice on proton pump inhibitor therapy in patients on these drugs who have had previous ulcer bleeding can help allay concerns about possible integrations between PPIs and clopidogrel.
While the guidelines recommend using the Glasgow Blatchford scale to guide hospitalization decisions, prognostic scores are not commonly used in the emergency department, and many patients present with a Glasgow Blatchford score greater than 1, so this tool may have little impact on hospitalization rates. More studies are needed to compare clinical judgment with these prognostic scores.
Angel Lanas, MD, is from the University Clinic Hospital at the University of Zaragoza (Spain). These comments are adapted from an accompanying editorial (Ann Intern Med 2019, October 22. doi: 10.7326/M19-2789). Dr. Lanas declared unrelated personal fees from the pharmaceutical sector.
Guidelines on the management of acute upper gastrointestinal bleeding have been updated, including recommendations on managing patients on antiplatelet or anticoagulant therapy and on use of endoscopy and new therapeutic approaches.
Writing in Annals of Internal Medicine, an international group of experts published an update to the 2010 International Consensus Recommendations on the Management of Patients With Nonvariceal Upper Gastrointestinal Bleeding, with a focus on resuscitation and risk assessment; pre-endoscopic, endoscopic, and pharmacologic management; and secondary prophylaxis.
Alan N. Barkun, MDCM, MSc, from McGill University, Montreal, and coauthors first recommended that fluid resuscitation should be initiated in patients with acute upper gastrointestinal bleeding and hemodynamic instability to avoid hemorrhagic shock and restore end-organ perfusion and tissue oxygenation while the bleeding is brought under control.
They acknowledged the uncertainty around whether colloid or crystalloid fluid should be used, but suggested routine use of colloids was not justified because they were more expensive and did not appear to increase survival.
On the question of whether the resuscitation should be aggressive or restrictive in its timing and rate, the group said there was not enough evidence to support a recommendation on this. “The important issue in patients with hemorrhagic shock due to trauma or UGIB [upper gastrointestinal bleeding] is to stop the bleeding while minimizing hemodynamic compromise,” they wrote.
They also advised blood transfusions in patients with a hemoglobin level below 80 g/L who did not have underlying cardiovascular disease, but suggested a higher hemoglobin threshold for those with underlying cardiovascular disease.
The second recommendation was that patients with a Glasgow Blatchford score of 1 or less were at very low risk for rebleeding and mortality, and these patients may therefore not need hospitalization or inpatient endoscopy. They advised against using the AIMS65 prognostic score for this purpose because it was designed to identify patients at high risk of death, not those at low risk for safe discharge.
In regard to endoscopic management, they advocated that all patients with acute upper gastrointestinal bleeding – whether low or high risk – undergo endoscopy within 24 hours of presentation. This was even more urgent in patients being treated with anticoagulants. “Because of the recognized benefits of early endoscopy, coagulopathy should be treated as necessary but endoscopy should not be delayed,” they wrote.
Patients with acutely bleeding ulcers with high-risk stigmata should undergo endoscopic therapy preferably with thermocoagulation or sclerosant injection, or with hemoclips depending on the bleeding location and patient characteristics.
The group also included two conditional recommendations, based on very-low-quality evidence, that patients with actively bleeding ulcers receive TC-325 hemostatic powder as temporizing therapy to stop the bleeding if conventional endoscopic therapies aren’t available or fail. However, they stressed that TC-325 should not be used as a single therapeutic strategy.
Because of a lack of efficacy data and low availability of expertise in the technology, the authors said they could not make a recommendation for or against using a Doppler endoscopic probe (DEP) to assess the need for further endoscopic therapy.
“The group generally agreed that although making a recommendation for or against using DEP to manage UGIB is premature, DEP has the potential to alter the usual approach to visually assessing bleeding lesion risk when evaluating the need for, and adequacy of, endoscopic hemostasis.”
The guidelines also addressed the issue of pharmacologic management of acute upper gastrointestinal bleeding. They strongly recommended that patients with bleeding ulcers and high-risk stigmata who have undergone successful endoscopic therapy should then receive an intravenous loading dose of proton pump inhibitor (PPI) therapy, followed by continuous intravenous infusion.
“Cost-effectiveness studies have suggested that high-dose intravenous PPIs after successful endoscopic hemostasis improve outcomes at a modest cost increase relative to non–high-dose intravenous or oral PPI strategies,” they wrote.
A second conditional recommendation, based on very-low-quality evidence, was that patients with a bleeding ulcer who were at high risk for rebleeding be also treated twice-daily with oral PPIs for 2 weeks, then once-daily. They also recommended patients on cardiovascular prophylaxis with single or dual antiplatelet therapy or anticoagulant therapy be given PPIs.
“The consensus group concluded that, for high-risk patients with an ongoing need for anticoagulants, the evidence suggests that the benefits of secondary prophylaxis outweigh the risks.”
The group was supported by a grant from CIHR Institute of Nutrition, Metabolism and Diabetes and from the Saudi Gastroenterology Association. Nine authors declared grants, personal fees, honoraria and other funding from the pharmaceutical and medical device sector outside the submitted work. No other conflicts of interest were declared.
SOURCE: Barkun A et al. Ann Intern Med 2019, October 22. doi: 10.7326/M19-1795.
Guidelines on the management of acute upper gastrointestinal bleeding have been updated, including recommendations on managing patients on antiplatelet or anticoagulant therapy and on use of endoscopy and new therapeutic approaches.
Writing in Annals of Internal Medicine, an international group of experts published an update to the 2010 International Consensus Recommendations on the Management of Patients With Nonvariceal Upper Gastrointestinal Bleeding, with a focus on resuscitation and risk assessment; pre-endoscopic, endoscopic, and pharmacologic management; and secondary prophylaxis.
Alan N. Barkun, MDCM, MSc, from McGill University, Montreal, and coauthors first recommended that fluid resuscitation should be initiated in patients with acute upper gastrointestinal bleeding and hemodynamic instability to avoid hemorrhagic shock and restore end-organ perfusion and tissue oxygenation while the bleeding is brought under control.
They acknowledged the uncertainty around whether colloid or crystalloid fluid should be used, but suggested routine use of colloids was not justified because they were more expensive and did not appear to increase survival.
On the question of whether the resuscitation should be aggressive or restrictive in its timing and rate, the group said there was not enough evidence to support a recommendation on this. “The important issue in patients with hemorrhagic shock due to trauma or UGIB [upper gastrointestinal bleeding] is to stop the bleeding while minimizing hemodynamic compromise,” they wrote.
They also advised blood transfusions in patients with a hemoglobin level below 80 g/L who did not have underlying cardiovascular disease, but suggested a higher hemoglobin threshold for those with underlying cardiovascular disease.
The second recommendation was that patients with a Glasgow Blatchford score of 1 or less were at very low risk for rebleeding and mortality, and these patients may therefore not need hospitalization or inpatient endoscopy. They advised against using the AIMS65 prognostic score for this purpose because it was designed to identify patients at high risk of death, not those at low risk for safe discharge.
In regard to endoscopic management, they advocated that all patients with acute upper gastrointestinal bleeding – whether low or high risk – undergo endoscopy within 24 hours of presentation. This was even more urgent in patients being treated with anticoagulants. “Because of the recognized benefits of early endoscopy, coagulopathy should be treated as necessary but endoscopy should not be delayed,” they wrote.
Patients with acutely bleeding ulcers with high-risk stigmata should undergo endoscopic therapy preferably with thermocoagulation or sclerosant injection, or with hemoclips depending on the bleeding location and patient characteristics.
The group also included two conditional recommendations, based on very-low-quality evidence, that patients with actively bleeding ulcers receive TC-325 hemostatic powder as temporizing therapy to stop the bleeding if conventional endoscopic therapies aren’t available or fail. However, they stressed that TC-325 should not be used as a single therapeutic strategy.
Because of a lack of efficacy data and low availability of expertise in the technology, the authors said they could not make a recommendation for or against using a Doppler endoscopic probe (DEP) to assess the need for further endoscopic therapy.
“The group generally agreed that although making a recommendation for or against using DEP to manage UGIB is premature, DEP has the potential to alter the usual approach to visually assessing bleeding lesion risk when evaluating the need for, and adequacy of, endoscopic hemostasis.”
The guidelines also addressed the issue of pharmacologic management of acute upper gastrointestinal bleeding. They strongly recommended that patients with bleeding ulcers and high-risk stigmata who have undergone successful endoscopic therapy should then receive an intravenous loading dose of proton pump inhibitor (PPI) therapy, followed by continuous intravenous infusion.
“Cost-effectiveness studies have suggested that high-dose intravenous PPIs after successful endoscopic hemostasis improve outcomes at a modest cost increase relative to non–high-dose intravenous or oral PPI strategies,” they wrote.
A second conditional recommendation, based on very-low-quality evidence, was that patients with a bleeding ulcer who were at high risk for rebleeding be also treated twice-daily with oral PPIs for 2 weeks, then once-daily. They also recommended patients on cardiovascular prophylaxis with single or dual antiplatelet therapy or anticoagulant therapy be given PPIs.
“The consensus group concluded that, for high-risk patients with an ongoing need for anticoagulants, the evidence suggests that the benefits of secondary prophylaxis outweigh the risks.”
The group was supported by a grant from CIHR Institute of Nutrition, Metabolism and Diabetes and from the Saudi Gastroenterology Association. Nine authors declared grants, personal fees, honoraria and other funding from the pharmaceutical and medical device sector outside the submitted work. No other conflicts of interest were declared.
SOURCE: Barkun A et al. Ann Intern Med 2019, October 22. doi: 10.7326/M19-1795.
FROM ANNALS OF INTERNAL MEDICINE
Regular drinking a greater AFib risk than binge drinking
Regular low-level alcohol consumption may be a bigger risk factor for new-onset atrial fibrillation than binge drinking, according to a paper published online in EP Europace.
Alcohol consumption is known to have a dose-dependent association with the risk of new-onset atrial fibrillation (AFib), but the mechanism underlying this association was not clear, according to Yun Gi Kim, MD, from the Seoul National University (South Korea), and coauthors.
They analyzed data from the Korean National Health Insurance Service database for 9,776,956 individuals without atrial fibrillation at baseline, including health survey information about their alcohol consumption.
Overall, 51.3% of the study population were classified as nondrinkers, 32.1% were mild drinkers – defined as up to 105 g of alcohol consumed per week – 9.7% were moderate drinkers consuming 105-210 g/week, and 6.9% were heavy drinkers consuming 210 g or more per week.
The analysis revealed that heavy drinkers had the highest risk for new-onset AFib – 21.5% higher than mild drinkers – while nondrinkers had an 8.6% higher risk and moderate drinkers had a 7.7% higher risk, compared with mild drinkers.
It also showed an association between the number of drinking sessions per week and the development of new-onset atrial fibrillation. Individuals who only drank once per week had the lowest risk of AFib while those who drank every day had the highest.
“Although weekly alcohol intake was associated with the risk of new-onset [AFib], such association was lost when drinking frequency was included in the multivariate model,” the authors wrote.
They found a significant inverse relationship between the amount of alcohol consumed per drinking session, and the risk of new-onset AFib, such that individuals who consumed low amounts of alcohol per session had a higher risk, and the risk decreased as higher amounts were consumed.
“Regardless of whether weekly alcohol intake exceeded 210 g, the frequency of drinking was significantly associated with risk of new-onset [AFib],” they reported. “Patients who drink everyday represented the highest-risk group and those who drink once per week were the lowest-risk group for new-onset [AFib] in this investigation, respectively.”
The authors speculated that if alcohol consumption can trigger AFib, then multiple drinking episodes per week, regardless of amount, might trigger more episodes of AFib and potentially lead to the development of overt, new-onset disease. They also suggested that frequent drinking could lead to regular sleep disturbance, which might also contribute to the link with atrial fibrillation.
The study was supported by Korea University, Korea University Anam Hospital, Republic of Korea, the National Research Foundation of Korea, the Ministry of Education and the Ministry of Science, ICT, and Future Planning. No conflicts of interest were declared.
SOURCE: Kim YG et al. EP Europace. 2019 Oct 17. doi: 10.1093/europace/euz256.
Regular low-level alcohol consumption may be a bigger risk factor for new-onset atrial fibrillation than binge drinking, according to a paper published online in EP Europace.
Alcohol consumption is known to have a dose-dependent association with the risk of new-onset atrial fibrillation (AFib), but the mechanism underlying this association was not clear, according to Yun Gi Kim, MD, from the Seoul National University (South Korea), and coauthors.
They analyzed data from the Korean National Health Insurance Service database for 9,776,956 individuals without atrial fibrillation at baseline, including health survey information about their alcohol consumption.
Overall, 51.3% of the study population were classified as nondrinkers, 32.1% were mild drinkers – defined as up to 105 g of alcohol consumed per week – 9.7% were moderate drinkers consuming 105-210 g/week, and 6.9% were heavy drinkers consuming 210 g or more per week.
The analysis revealed that heavy drinkers had the highest risk for new-onset AFib – 21.5% higher than mild drinkers – while nondrinkers had an 8.6% higher risk and moderate drinkers had a 7.7% higher risk, compared with mild drinkers.
It also showed an association between the number of drinking sessions per week and the development of new-onset atrial fibrillation. Individuals who only drank once per week had the lowest risk of AFib while those who drank every day had the highest.
“Although weekly alcohol intake was associated with the risk of new-onset [AFib], such association was lost when drinking frequency was included in the multivariate model,” the authors wrote.
They found a significant inverse relationship between the amount of alcohol consumed per drinking session, and the risk of new-onset AFib, such that individuals who consumed low amounts of alcohol per session had a higher risk, and the risk decreased as higher amounts were consumed.
“Regardless of whether weekly alcohol intake exceeded 210 g, the frequency of drinking was significantly associated with risk of new-onset [AFib],” they reported. “Patients who drink everyday represented the highest-risk group and those who drink once per week were the lowest-risk group for new-onset [AFib] in this investigation, respectively.”
The authors speculated that if alcohol consumption can trigger AFib, then multiple drinking episodes per week, regardless of amount, might trigger more episodes of AFib and potentially lead to the development of overt, new-onset disease. They also suggested that frequent drinking could lead to regular sleep disturbance, which might also contribute to the link with atrial fibrillation.
The study was supported by Korea University, Korea University Anam Hospital, Republic of Korea, the National Research Foundation of Korea, the Ministry of Education and the Ministry of Science, ICT, and Future Planning. No conflicts of interest were declared.
SOURCE: Kim YG et al. EP Europace. 2019 Oct 17. doi: 10.1093/europace/euz256.
Regular low-level alcohol consumption may be a bigger risk factor for new-onset atrial fibrillation than binge drinking, according to a paper published online in EP Europace.
Alcohol consumption is known to have a dose-dependent association with the risk of new-onset atrial fibrillation (AFib), but the mechanism underlying this association was not clear, according to Yun Gi Kim, MD, from the Seoul National University (South Korea), and coauthors.
They analyzed data from the Korean National Health Insurance Service database for 9,776,956 individuals without atrial fibrillation at baseline, including health survey information about their alcohol consumption.
Overall, 51.3% of the study population were classified as nondrinkers, 32.1% were mild drinkers – defined as up to 105 g of alcohol consumed per week – 9.7% were moderate drinkers consuming 105-210 g/week, and 6.9% were heavy drinkers consuming 210 g or more per week.
The analysis revealed that heavy drinkers had the highest risk for new-onset AFib – 21.5% higher than mild drinkers – while nondrinkers had an 8.6% higher risk and moderate drinkers had a 7.7% higher risk, compared with mild drinkers.
It also showed an association between the number of drinking sessions per week and the development of new-onset atrial fibrillation. Individuals who only drank once per week had the lowest risk of AFib while those who drank every day had the highest.
“Although weekly alcohol intake was associated with the risk of new-onset [AFib], such association was lost when drinking frequency was included in the multivariate model,” the authors wrote.
They found a significant inverse relationship between the amount of alcohol consumed per drinking session, and the risk of new-onset AFib, such that individuals who consumed low amounts of alcohol per session had a higher risk, and the risk decreased as higher amounts were consumed.
“Regardless of whether weekly alcohol intake exceeded 210 g, the frequency of drinking was significantly associated with risk of new-onset [AFib],” they reported. “Patients who drink everyday represented the highest-risk group and those who drink once per week were the lowest-risk group for new-onset [AFib] in this investigation, respectively.”
The authors speculated that if alcohol consumption can trigger AFib, then multiple drinking episodes per week, regardless of amount, might trigger more episodes of AFib and potentially lead to the development of overt, new-onset disease. They also suggested that frequent drinking could lead to regular sleep disturbance, which might also contribute to the link with atrial fibrillation.
The study was supported by Korea University, Korea University Anam Hospital, Republic of Korea, the National Research Foundation of Korea, the Ministry of Education and the Ministry of Science, ICT, and Future Planning. No conflicts of interest were declared.
SOURCE: Kim YG et al. EP Europace. 2019 Oct 17. doi: 10.1093/europace/euz256.
FROM EP EUROPACE
Vitamin D deficiency appears to worsen survival in Hodgkin lymphoma
Vitamin D deficiency is associated with worse progression-free and overall survival among patients with Hodgkin lymphoma, according to new study findings.
Sven Borchmann, MD, of the University of Cologne (Germany) and German Hodgkin Study Group and coauthors conducted a case-control study of 351 patients enrolled in the German Hodgkin Study Group trials who had available baseline serum samples. Pretreatment vitamin D levels were assessed and categorized as deficient (less than 30 nmol/L), insufficient (30-49 nmol/L), or sufficient (50 nmol/L or greater). The findings were published in the Journal of Clinical Oncology.
The researchers found that before starting treatment, 50% of patients were vitamin D deficient.
Patients with baseline vitamin D deficiency had significantly lower progression-free survival – 10.2% lower at 5 years and 17.6% lower at 10 years – compared with patients with either sufficient or insufficient vitamin D levels (P less than .001). They also had 2% lower overall survival at 5 years and 11.1% lower overall survival at 10 years (P less than .001).
The researchers also conducted preclinical studies in effort to understand the effect of vitamin D on Hodgkin lymphoma cells and in Hodgkin lymphoma tumor models.
They explored the effect of vitamin D on cultured Hodgkin lymphoma cell lines and saw a dose-response effect of calcitriol in reducing cell proliferation rates. They then looked at the effect of calcitriol on cell lines that were also exposed to doxorubicin or etoposide, and found calcitriol improved the cytotoxicity of these chemotherapy agents, especially at lower doses.
Finally, they conducted an in-vivo mouse study using Hodgkin lymphoma xenografts, and looked at whether vitamin D supplementation increased the effect of doxorubicin or etoposide. This revealed that chemotherapy and vitamin D supplementation together were significantly better at controlling tumor growth, compared with monotherapy with either vitamin D or doxorubicin and compared with placebo.
“On the basis of our study results and the limited toxicity of vitamin D replacement therapy, we would advocate for vitamin D deficiency screening and replacement to be incorporated into future randomized clinical trials to properly clarify the role of vitamin D replacement in HL [Hodgkin lymphoma],” the researchers wrote. “The goal of these trials should be to determine whether vitamin D replacement in HL improves outcome.”
No study funding information was reported. Dr. Borchmann reported honoraria and research funding from Takeda. Other authors reported financial disclosures related to Takeda, Roche, Bristol-Myers Squibb, and other companies.
SOURCE: Borchmann S et al. J Clin Oncol. 2019 Oct 17. doi:10.1200/JCO.19.00985.
Vitamin D deficiency is associated with worse progression-free and overall survival among patients with Hodgkin lymphoma, according to new study findings.
Sven Borchmann, MD, of the University of Cologne (Germany) and German Hodgkin Study Group and coauthors conducted a case-control study of 351 patients enrolled in the German Hodgkin Study Group trials who had available baseline serum samples. Pretreatment vitamin D levels were assessed and categorized as deficient (less than 30 nmol/L), insufficient (30-49 nmol/L), or sufficient (50 nmol/L or greater). The findings were published in the Journal of Clinical Oncology.
The researchers found that before starting treatment, 50% of patients were vitamin D deficient.
Patients with baseline vitamin D deficiency had significantly lower progression-free survival – 10.2% lower at 5 years and 17.6% lower at 10 years – compared with patients with either sufficient or insufficient vitamin D levels (P less than .001). They also had 2% lower overall survival at 5 years and 11.1% lower overall survival at 10 years (P less than .001).
The researchers also conducted preclinical studies in effort to understand the effect of vitamin D on Hodgkin lymphoma cells and in Hodgkin lymphoma tumor models.
They explored the effect of vitamin D on cultured Hodgkin lymphoma cell lines and saw a dose-response effect of calcitriol in reducing cell proliferation rates. They then looked at the effect of calcitriol on cell lines that were also exposed to doxorubicin or etoposide, and found calcitriol improved the cytotoxicity of these chemotherapy agents, especially at lower doses.
Finally, they conducted an in-vivo mouse study using Hodgkin lymphoma xenografts, and looked at whether vitamin D supplementation increased the effect of doxorubicin or etoposide. This revealed that chemotherapy and vitamin D supplementation together were significantly better at controlling tumor growth, compared with monotherapy with either vitamin D or doxorubicin and compared with placebo.
“On the basis of our study results and the limited toxicity of vitamin D replacement therapy, we would advocate for vitamin D deficiency screening and replacement to be incorporated into future randomized clinical trials to properly clarify the role of vitamin D replacement in HL [Hodgkin lymphoma],” the researchers wrote. “The goal of these trials should be to determine whether vitamin D replacement in HL improves outcome.”
No study funding information was reported. Dr. Borchmann reported honoraria and research funding from Takeda. Other authors reported financial disclosures related to Takeda, Roche, Bristol-Myers Squibb, and other companies.
SOURCE: Borchmann S et al. J Clin Oncol. 2019 Oct 17. doi:10.1200/JCO.19.00985.
Vitamin D deficiency is associated with worse progression-free and overall survival among patients with Hodgkin lymphoma, according to new study findings.
Sven Borchmann, MD, of the University of Cologne (Germany) and German Hodgkin Study Group and coauthors conducted a case-control study of 351 patients enrolled in the German Hodgkin Study Group trials who had available baseline serum samples. Pretreatment vitamin D levels were assessed and categorized as deficient (less than 30 nmol/L), insufficient (30-49 nmol/L), or sufficient (50 nmol/L or greater). The findings were published in the Journal of Clinical Oncology.
The researchers found that before starting treatment, 50% of patients were vitamin D deficient.
Patients with baseline vitamin D deficiency had significantly lower progression-free survival – 10.2% lower at 5 years and 17.6% lower at 10 years – compared with patients with either sufficient or insufficient vitamin D levels (P less than .001). They also had 2% lower overall survival at 5 years and 11.1% lower overall survival at 10 years (P less than .001).
The researchers also conducted preclinical studies in effort to understand the effect of vitamin D on Hodgkin lymphoma cells and in Hodgkin lymphoma tumor models.
They explored the effect of vitamin D on cultured Hodgkin lymphoma cell lines and saw a dose-response effect of calcitriol in reducing cell proliferation rates. They then looked at the effect of calcitriol on cell lines that were also exposed to doxorubicin or etoposide, and found calcitriol improved the cytotoxicity of these chemotherapy agents, especially at lower doses.
Finally, they conducted an in-vivo mouse study using Hodgkin lymphoma xenografts, and looked at whether vitamin D supplementation increased the effect of doxorubicin or etoposide. This revealed that chemotherapy and vitamin D supplementation together were significantly better at controlling tumor growth, compared with monotherapy with either vitamin D or doxorubicin and compared with placebo.
“On the basis of our study results and the limited toxicity of vitamin D replacement therapy, we would advocate for vitamin D deficiency screening and replacement to be incorporated into future randomized clinical trials to properly clarify the role of vitamin D replacement in HL [Hodgkin lymphoma],” the researchers wrote. “The goal of these trials should be to determine whether vitamin D replacement in HL improves outcome.”
No study funding information was reported. Dr. Borchmann reported honoraria and research funding from Takeda. Other authors reported financial disclosures related to Takeda, Roche, Bristol-Myers Squibb, and other companies.
SOURCE: Borchmann S et al. J Clin Oncol. 2019 Oct 17. doi:10.1200/JCO.19.00985.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point:
Major finding: Patients with Hodgkin lymphoma and vitamin D deficiency had a 17.6% lower progression-free survival at 10 years, compared with patients who were not vitamin D deficient (P less than .001).
Study details: A case-control study in 351 patients with Hodgkin lymphoma.
Disclosures: No study funding information was reported. Dr. Borchmann reported honoraria and research funding from Takeda. Other authors reported financial disclosures related to Takeda, Roche, Bristol-Myers Squibb, and other companies.
Source: Borchmann S et al. J Clin Oncol. 2019 Oct 17. doi: 10.1200/JCO.19.00985.
