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Leflunomide-hydroxychloroquine combination for Sjögren’s shows potential
according to results from a phase 2a, randomized clinical trial published in Lancet Rheumatology.
The combination’s statistically significant effect on the European League Against Rheumatism (EULAR) Sjögren’s syndrome disease activity index (ESSDAI) score at 24 weeks, the primary endpoint of the small, double-blind, placebo-controlled trial, suggests that the combination should be studied further in larger trials, according to first author Eefje Hanna Martine van der Heijden, MD, a rheumatologist at University Medical Center Utrecht (the Netherlands), and colleagues.
The investigators decided to study leflunomide and hydroxychloroquine, which target overlapping and distinct immunopathologic pathways, because data support the safety of each drug individually, and a previous in vitro study by the authors indicated that they have complementary effects when administered together.
“To our knowledge, this is the first randomized, placebo-controlled clinical trial in patients with primary Sjögren’s syndrome that shows significant clinical efficacy, as measured by ESSDAI, and is associated with significant improvements in other clinical parameters, including dryness and fatigue,” the investigators wrote.
Dr. van der Heijden and colleagues screened 37 patients from the outpatient clinic of their medical center and enrolled 29 (28 women) who met American-European Consensus Criteria into their study. They had moderate to active disease, defined as an ESSDAI score of 5 or higher, and a lymphocytic focus score of 1 or higher in labial salivary gland biopsy specimens that were obtained before inclusion. The population’s average age was approximately 54 years. They had an average disease duration of about 8 years, a mean ESSDAI score of about 9, and mean EULAR Sjögren’s syndrome patient reported index (ESSPRI) score of 6.7. A total of 21 patients were randomized to leflunomide 20 mg and hydroxychloroquine 400 mg daily, and 8 patients were randomized to placebos. Baseline characteristics were similar between groups, but mean serum IgG level was 19.4 g/L in the treatment group and 13.8 g/L in the placebo group. One patient in the placebo group developed polymyalgia rheumatica and required high-dose prednisone treatment. The investigators excluded this patient from the primary analysis.
At 24 weeks, the mean difference in ESSDAI score in the leflunomide-hydroxychloroquine group, compared with the placebo group, was –4.35 points after adjustment for baseline values. This difference was statistically significant.
Secondary endpoints in the study showed inconsistent statistically significant differences between the treatment groups at 8, 16, and 24 weeks. The total ESSPRI score at 16 weeks was 1.66 points lower in the treatment group than in the placebo group. Stimulated whole saliva production was increased in the leflunomide-hydroxychloroquine group at 16 weeks, compared with the placebo group. Unstimulated whole saliva production at 24 weeks was higher in the leflunomide-hydroxychloroquine group than in controls. The investigators found no differences between groups in visual analog scores for ocular or oral dryness.
No patient in the leflunomide-hydroxychloroquine group had a serious adverse event. Two serious adverse events (hospital admission for pancreatitis and hospital admission for nephrolithiasis) occurred in the placebo group. The most common adverse events in the leflunomide-hydroxychloroquine group were GI discomfort (52% vs. 25% in the placebo group), modest transient increases in ALT (48% vs. 13%), and short episodes of general malaise and shivering (43% vs. 13%).
In an accompanying editorial, Astrid Rasmussen, MD, PhD, of the Oklahoma Sjögren’s Syndrome Center of Research Translation at the Oklahoma Medical Research Foundation in Oklahoma City, wrote that the trial by Dr. van der Heijden and colleagues was limited by a small sample size and short duration. In addition, some of the findings were unexplained, such as modest changes in secondary endpoints and a concomitant decrease in ESSDAI scores at 8 weeks for both study groups.
Nevertheless, the study provides reason to think in new ways about old drugs, wrote Dr. Rasmussen. “Combination or sequential use of existing agents that target different aspects of immune dysregulation, while having acceptable safety profiles and cost-benefit ratios, should represent an avenue of further exploration. Just as importantly, subphenotyping patients on the basis of their underlying pathogenic processes and identifying sensitive outcome measures could transform the current enthusiasm for identifying effective treatments for Sjögren’s syndrome into a reality for the patients that need them the most.”
The study was funded by ZonMw. The authors of the study reported no conflicts of interest. Dr. Rasmussen reported having no conflicts of interest.
SOURCE: van der Heijden EHM et al. Lancet Rheumatol. 2020 Mar 26. doi: 10.1016/S2665-9913(20)30057-6.
according to results from a phase 2a, randomized clinical trial published in Lancet Rheumatology.
The combination’s statistically significant effect on the European League Against Rheumatism (EULAR) Sjögren’s syndrome disease activity index (ESSDAI) score at 24 weeks, the primary endpoint of the small, double-blind, placebo-controlled trial, suggests that the combination should be studied further in larger trials, according to first author Eefje Hanna Martine van der Heijden, MD, a rheumatologist at University Medical Center Utrecht (the Netherlands), and colleagues.
The investigators decided to study leflunomide and hydroxychloroquine, which target overlapping and distinct immunopathologic pathways, because data support the safety of each drug individually, and a previous in vitro study by the authors indicated that they have complementary effects when administered together.
“To our knowledge, this is the first randomized, placebo-controlled clinical trial in patients with primary Sjögren’s syndrome that shows significant clinical efficacy, as measured by ESSDAI, and is associated with significant improvements in other clinical parameters, including dryness and fatigue,” the investigators wrote.
Dr. van der Heijden and colleagues screened 37 patients from the outpatient clinic of their medical center and enrolled 29 (28 women) who met American-European Consensus Criteria into their study. They had moderate to active disease, defined as an ESSDAI score of 5 or higher, and a lymphocytic focus score of 1 or higher in labial salivary gland biopsy specimens that were obtained before inclusion. The population’s average age was approximately 54 years. They had an average disease duration of about 8 years, a mean ESSDAI score of about 9, and mean EULAR Sjögren’s syndrome patient reported index (ESSPRI) score of 6.7. A total of 21 patients were randomized to leflunomide 20 mg and hydroxychloroquine 400 mg daily, and 8 patients were randomized to placebos. Baseline characteristics were similar between groups, but mean serum IgG level was 19.4 g/L in the treatment group and 13.8 g/L in the placebo group. One patient in the placebo group developed polymyalgia rheumatica and required high-dose prednisone treatment. The investigators excluded this patient from the primary analysis.
At 24 weeks, the mean difference in ESSDAI score in the leflunomide-hydroxychloroquine group, compared with the placebo group, was –4.35 points after adjustment for baseline values. This difference was statistically significant.
Secondary endpoints in the study showed inconsistent statistically significant differences between the treatment groups at 8, 16, and 24 weeks. The total ESSPRI score at 16 weeks was 1.66 points lower in the treatment group than in the placebo group. Stimulated whole saliva production was increased in the leflunomide-hydroxychloroquine group at 16 weeks, compared with the placebo group. Unstimulated whole saliva production at 24 weeks was higher in the leflunomide-hydroxychloroquine group than in controls. The investigators found no differences between groups in visual analog scores for ocular or oral dryness.
No patient in the leflunomide-hydroxychloroquine group had a serious adverse event. Two serious adverse events (hospital admission for pancreatitis and hospital admission for nephrolithiasis) occurred in the placebo group. The most common adverse events in the leflunomide-hydroxychloroquine group were GI discomfort (52% vs. 25% in the placebo group), modest transient increases in ALT (48% vs. 13%), and short episodes of general malaise and shivering (43% vs. 13%).
In an accompanying editorial, Astrid Rasmussen, MD, PhD, of the Oklahoma Sjögren’s Syndrome Center of Research Translation at the Oklahoma Medical Research Foundation in Oklahoma City, wrote that the trial by Dr. van der Heijden and colleagues was limited by a small sample size and short duration. In addition, some of the findings were unexplained, such as modest changes in secondary endpoints and a concomitant decrease in ESSDAI scores at 8 weeks for both study groups.
Nevertheless, the study provides reason to think in new ways about old drugs, wrote Dr. Rasmussen. “Combination or sequential use of existing agents that target different aspects of immune dysregulation, while having acceptable safety profiles and cost-benefit ratios, should represent an avenue of further exploration. Just as importantly, subphenotyping patients on the basis of their underlying pathogenic processes and identifying sensitive outcome measures could transform the current enthusiasm for identifying effective treatments for Sjögren’s syndrome into a reality for the patients that need them the most.”
The study was funded by ZonMw. The authors of the study reported no conflicts of interest. Dr. Rasmussen reported having no conflicts of interest.
SOURCE: van der Heijden EHM et al. Lancet Rheumatol. 2020 Mar 26. doi: 10.1016/S2665-9913(20)30057-6.
according to results from a phase 2a, randomized clinical trial published in Lancet Rheumatology.
The combination’s statistically significant effect on the European League Against Rheumatism (EULAR) Sjögren’s syndrome disease activity index (ESSDAI) score at 24 weeks, the primary endpoint of the small, double-blind, placebo-controlled trial, suggests that the combination should be studied further in larger trials, according to first author Eefje Hanna Martine van der Heijden, MD, a rheumatologist at University Medical Center Utrecht (the Netherlands), and colleagues.
The investigators decided to study leflunomide and hydroxychloroquine, which target overlapping and distinct immunopathologic pathways, because data support the safety of each drug individually, and a previous in vitro study by the authors indicated that they have complementary effects when administered together.
“To our knowledge, this is the first randomized, placebo-controlled clinical trial in patients with primary Sjögren’s syndrome that shows significant clinical efficacy, as measured by ESSDAI, and is associated with significant improvements in other clinical parameters, including dryness and fatigue,” the investigators wrote.
Dr. van der Heijden and colleagues screened 37 patients from the outpatient clinic of their medical center and enrolled 29 (28 women) who met American-European Consensus Criteria into their study. They had moderate to active disease, defined as an ESSDAI score of 5 or higher, and a lymphocytic focus score of 1 or higher in labial salivary gland biopsy specimens that were obtained before inclusion. The population’s average age was approximately 54 years. They had an average disease duration of about 8 years, a mean ESSDAI score of about 9, and mean EULAR Sjögren’s syndrome patient reported index (ESSPRI) score of 6.7. A total of 21 patients were randomized to leflunomide 20 mg and hydroxychloroquine 400 mg daily, and 8 patients were randomized to placebos. Baseline characteristics were similar between groups, but mean serum IgG level was 19.4 g/L in the treatment group and 13.8 g/L in the placebo group. One patient in the placebo group developed polymyalgia rheumatica and required high-dose prednisone treatment. The investigators excluded this patient from the primary analysis.
At 24 weeks, the mean difference in ESSDAI score in the leflunomide-hydroxychloroquine group, compared with the placebo group, was –4.35 points after adjustment for baseline values. This difference was statistically significant.
Secondary endpoints in the study showed inconsistent statistically significant differences between the treatment groups at 8, 16, and 24 weeks. The total ESSPRI score at 16 weeks was 1.66 points lower in the treatment group than in the placebo group. Stimulated whole saliva production was increased in the leflunomide-hydroxychloroquine group at 16 weeks, compared with the placebo group. Unstimulated whole saliva production at 24 weeks was higher in the leflunomide-hydroxychloroquine group than in controls. The investigators found no differences between groups in visual analog scores for ocular or oral dryness.
No patient in the leflunomide-hydroxychloroquine group had a serious adverse event. Two serious adverse events (hospital admission for pancreatitis and hospital admission for nephrolithiasis) occurred in the placebo group. The most common adverse events in the leflunomide-hydroxychloroquine group were GI discomfort (52% vs. 25% in the placebo group), modest transient increases in ALT (48% vs. 13%), and short episodes of general malaise and shivering (43% vs. 13%).
In an accompanying editorial, Astrid Rasmussen, MD, PhD, of the Oklahoma Sjögren’s Syndrome Center of Research Translation at the Oklahoma Medical Research Foundation in Oklahoma City, wrote that the trial by Dr. van der Heijden and colleagues was limited by a small sample size and short duration. In addition, some of the findings were unexplained, such as modest changes in secondary endpoints and a concomitant decrease in ESSDAI scores at 8 weeks for both study groups.
Nevertheless, the study provides reason to think in new ways about old drugs, wrote Dr. Rasmussen. “Combination or sequential use of existing agents that target different aspects of immune dysregulation, while having acceptable safety profiles and cost-benefit ratios, should represent an avenue of further exploration. Just as importantly, subphenotyping patients on the basis of their underlying pathogenic processes and identifying sensitive outcome measures could transform the current enthusiasm for identifying effective treatments for Sjögren’s syndrome into a reality for the patients that need them the most.”
The study was funded by ZonMw. The authors of the study reported no conflicts of interest. Dr. Rasmussen reported having no conflicts of interest.
SOURCE: van der Heijden EHM et al. Lancet Rheumatol. 2020 Mar 26. doi: 10.1016/S2665-9913(20)30057-6.
FROM LANCET RHEUMATOLOGY
Cardiovascular disease is implicated in link between air pollution and dementia
Virtually all of the association between air pollution and dementia seemed to occur through the presence or the development of cardiovascular disease, which suggests a need to optimize treatment of concurrent cardiovascular disease and risk-factor control in older adults at higher risk for dementia and living in polluted urban areas, said lead author Giulia Grande, MD, a researcher at the Aging Research Center, Karolinska Institutet and Stockholm University, in Solna, Sweden.
In the longitudinal, population-based cohort study, investigators studied 2,927 randomly selected residents in a district of Stockholm who were aged 60 years or older (mean, 74.1 years), lived at home or in institutions, and were free of dementia at baseline (March 2001 through August 2004).
The investigators assessed the participants’ exposure to two major air pollutants – particulate matter ≤2.5 mcm and nitrogen oxide – yearly starting in 1990, from outdoor levels at their residential addresses. Both pollutants are generated by road traffic, among other sources.
Results reported in JAMA Neurology showed that, with a mean follow-up of 6.01 years, 12.4% of the older adults received a dementia diagnosis.
Dementia risk increased with the level of air pollutants at their residential address in the past, with strongest associations seen for exposure in the preceding 5 years: The hazard ratio (HR) for dementia was 1.54 for an interquartile range difference of 0.88 mcg/m3 in particulate matter ≤2.5 mcm and 1.14 for an interquartile range difference of 8.35 mcg/m3 in nitrogen oxide during that time period.
Of note, the study cohort lived in an area having “comparatively good ambient air quality” in which restrictions on air pollution have increased in recent decades, Dr. Grande and coinvestigators noted. “Interestingly, the higher limit reported herein is not only below the current European limit for fine particulate matter but also below the US standard. In other words, we were able to establish harmful effects at levels below current standards,” they wrote.
In analyses of effect modification, the elevation of risk related to particulate matter ≤2.5 mcm exposure and nitrogen oxide exposure was significantly greater among older adults who had heart failure (HRs, 1.93 and 1.43, respectively). Risk was marginally greater among those with ischemic heart disease (HRs, 1.67 and 1.36, respectively).
Analyses of potential mediators showed that preceding stroke accounted for the largest share of all dementia cases related to particulate matter ≤2.5 mcm exposure, at 49.4%.
The stronger association for exposure in the past 5 years is noteworthy for the big picture, they added. “From a policy point of view, this result is encouraging because it might imply that reducing air pollutant levels today could yield better outcomes already in the shorter term, reinforcing the need for appropriately set air quality standards,” they said.
Dr. Grande disclosed no relevant conflicts of interest. The study was funded by the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K); the Swedish Ministry of Health and Social Affairs; the participating County Councils and Municipalities; the Swedish Research Council; funding for doctoral education from the Karolinska Institutet; and the Swedish Research Council for Health, Working Life and Welfare.
SOURCE: Grande G et al. JAMA Neurol. 2020. doi:10.1001/jamaneurol.2019.4914.
Virtually all of the association between air pollution and dementia seemed to occur through the presence or the development of cardiovascular disease, which suggests a need to optimize treatment of concurrent cardiovascular disease and risk-factor control in older adults at higher risk for dementia and living in polluted urban areas, said lead author Giulia Grande, MD, a researcher at the Aging Research Center, Karolinska Institutet and Stockholm University, in Solna, Sweden.
In the longitudinal, population-based cohort study, investigators studied 2,927 randomly selected residents in a district of Stockholm who were aged 60 years or older (mean, 74.1 years), lived at home or in institutions, and were free of dementia at baseline (March 2001 through August 2004).
The investigators assessed the participants’ exposure to two major air pollutants – particulate matter ≤2.5 mcm and nitrogen oxide – yearly starting in 1990, from outdoor levels at their residential addresses. Both pollutants are generated by road traffic, among other sources.
Results reported in JAMA Neurology showed that, with a mean follow-up of 6.01 years, 12.4% of the older adults received a dementia diagnosis.
Dementia risk increased with the level of air pollutants at their residential address in the past, with strongest associations seen for exposure in the preceding 5 years: The hazard ratio (HR) for dementia was 1.54 for an interquartile range difference of 0.88 mcg/m3 in particulate matter ≤2.5 mcm and 1.14 for an interquartile range difference of 8.35 mcg/m3 in nitrogen oxide during that time period.
Of note, the study cohort lived in an area having “comparatively good ambient air quality” in which restrictions on air pollution have increased in recent decades, Dr. Grande and coinvestigators noted. “Interestingly, the higher limit reported herein is not only below the current European limit for fine particulate matter but also below the US standard. In other words, we were able to establish harmful effects at levels below current standards,” they wrote.
In analyses of effect modification, the elevation of risk related to particulate matter ≤2.5 mcm exposure and nitrogen oxide exposure was significantly greater among older adults who had heart failure (HRs, 1.93 and 1.43, respectively). Risk was marginally greater among those with ischemic heart disease (HRs, 1.67 and 1.36, respectively).
Analyses of potential mediators showed that preceding stroke accounted for the largest share of all dementia cases related to particulate matter ≤2.5 mcm exposure, at 49.4%.
The stronger association for exposure in the past 5 years is noteworthy for the big picture, they added. “From a policy point of view, this result is encouraging because it might imply that reducing air pollutant levels today could yield better outcomes already in the shorter term, reinforcing the need for appropriately set air quality standards,” they said.
Dr. Grande disclosed no relevant conflicts of interest. The study was funded by the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K); the Swedish Ministry of Health and Social Affairs; the participating County Councils and Municipalities; the Swedish Research Council; funding for doctoral education from the Karolinska Institutet; and the Swedish Research Council for Health, Working Life and Welfare.
SOURCE: Grande G et al. JAMA Neurol. 2020. doi:10.1001/jamaneurol.2019.4914.
Virtually all of the association between air pollution and dementia seemed to occur through the presence or the development of cardiovascular disease, which suggests a need to optimize treatment of concurrent cardiovascular disease and risk-factor control in older adults at higher risk for dementia and living in polluted urban areas, said lead author Giulia Grande, MD, a researcher at the Aging Research Center, Karolinska Institutet and Stockholm University, in Solna, Sweden.
In the longitudinal, population-based cohort study, investigators studied 2,927 randomly selected residents in a district of Stockholm who were aged 60 years or older (mean, 74.1 years), lived at home or in institutions, and were free of dementia at baseline (March 2001 through August 2004).
The investigators assessed the participants’ exposure to two major air pollutants – particulate matter ≤2.5 mcm and nitrogen oxide – yearly starting in 1990, from outdoor levels at their residential addresses. Both pollutants are generated by road traffic, among other sources.
Results reported in JAMA Neurology showed that, with a mean follow-up of 6.01 years, 12.4% of the older adults received a dementia diagnosis.
Dementia risk increased with the level of air pollutants at their residential address in the past, with strongest associations seen for exposure in the preceding 5 years: The hazard ratio (HR) for dementia was 1.54 for an interquartile range difference of 0.88 mcg/m3 in particulate matter ≤2.5 mcm and 1.14 for an interquartile range difference of 8.35 mcg/m3 in nitrogen oxide during that time period.
Of note, the study cohort lived in an area having “comparatively good ambient air quality” in which restrictions on air pollution have increased in recent decades, Dr. Grande and coinvestigators noted. “Interestingly, the higher limit reported herein is not only below the current European limit for fine particulate matter but also below the US standard. In other words, we were able to establish harmful effects at levels below current standards,” they wrote.
In analyses of effect modification, the elevation of risk related to particulate matter ≤2.5 mcm exposure and nitrogen oxide exposure was significantly greater among older adults who had heart failure (HRs, 1.93 and 1.43, respectively). Risk was marginally greater among those with ischemic heart disease (HRs, 1.67 and 1.36, respectively).
Analyses of potential mediators showed that preceding stroke accounted for the largest share of all dementia cases related to particulate matter ≤2.5 mcm exposure, at 49.4%.
The stronger association for exposure in the past 5 years is noteworthy for the big picture, they added. “From a policy point of view, this result is encouraging because it might imply that reducing air pollutant levels today could yield better outcomes already in the shorter term, reinforcing the need for appropriately set air quality standards,” they said.
Dr. Grande disclosed no relevant conflicts of interest. The study was funded by the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K); the Swedish Ministry of Health and Social Affairs; the participating County Councils and Municipalities; the Swedish Research Council; funding for doctoral education from the Karolinska Institutet; and the Swedish Research Council for Health, Working Life and Welfare.
SOURCE: Grande G et al. JAMA Neurol. 2020. doi:10.1001/jamaneurol.2019.4914.
FROM JAMA NEUROLOGY
Innovation in colorectal cancer screening
Disregard what is currently accepted as state of the art, reimagine the present as an imperfect stepping stone, and envision a future in which colorectal cancer (CRC) screening and surveillance are optimized. This was the direction for attendees of AGA’s consensus conference — Colorectal Cancer Screening and Surveillance: Role of Emerging Technology and Innovation to Improve Outcomes.
The AGA Center for GI Innovation and Technology invited leading academic and industry experts to a working meeting to identify barriers to the optimization of CRC screening and surveillance, and to define a roadmap for overcoming these barriers.
Meeting conclusions
Although colonoscopy is widely considered to be an excellent tool for CRC screening and surveillance, barriers to optimal effectiveness exist. Barriers include lack of access to health care, financial cost, suboptimal uptake even among individuals with health insurance and financial resources, imperfect adherence to guidelines, and development of early-age, and interval cancers despite adherence to guidelines.
Novel cost-effective, sensitive, specific, and personalized strategies are needed to address these barriers.
To read about the emerging technologies discussed at the meeting, review the meeting summary in Gastroenterology.
Disregard what is currently accepted as state of the art, reimagine the present as an imperfect stepping stone, and envision a future in which colorectal cancer (CRC) screening and surveillance are optimized. This was the direction for attendees of AGA’s consensus conference — Colorectal Cancer Screening and Surveillance: Role of Emerging Technology and Innovation to Improve Outcomes.
The AGA Center for GI Innovation and Technology invited leading academic and industry experts to a working meeting to identify barriers to the optimization of CRC screening and surveillance, and to define a roadmap for overcoming these barriers.
Meeting conclusions
Although colonoscopy is widely considered to be an excellent tool for CRC screening and surveillance, barriers to optimal effectiveness exist. Barriers include lack of access to health care, financial cost, suboptimal uptake even among individuals with health insurance and financial resources, imperfect adherence to guidelines, and development of early-age, and interval cancers despite adherence to guidelines.
Novel cost-effective, sensitive, specific, and personalized strategies are needed to address these barriers.
To read about the emerging technologies discussed at the meeting, review the meeting summary in Gastroenterology.
Disregard what is currently accepted as state of the art, reimagine the present as an imperfect stepping stone, and envision a future in which colorectal cancer (CRC) screening and surveillance are optimized. This was the direction for attendees of AGA’s consensus conference — Colorectal Cancer Screening and Surveillance: Role of Emerging Technology and Innovation to Improve Outcomes.
The AGA Center for GI Innovation and Technology invited leading academic and industry experts to a working meeting to identify barriers to the optimization of CRC screening and surveillance, and to define a roadmap for overcoming these barriers.
Meeting conclusions
Although colonoscopy is widely considered to be an excellent tool for CRC screening and surveillance, barriers to optimal effectiveness exist. Barriers include lack of access to health care, financial cost, suboptimal uptake even among individuals with health insurance and financial resources, imperfect adherence to guidelines, and development of early-age, and interval cancers despite adherence to guidelines.
Novel cost-effective, sensitive, specific, and personalized strategies are needed to address these barriers.
To read about the emerging technologies discussed at the meeting, review the meeting summary in Gastroenterology.
Top AGA Community patient cases
Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.
Here are some recent clinical discussions in the forum regarding the coronavirus and your patients:
1. Biologic treatment for IBD in the COVID-19 era (http://ow.ly/9akD50yKW8E)
A GI colleague from Italy asks how others are managing IBD patients on ongoing biologic treatment during the coronavirus pandemic.
2. COVID-19 and colonoscopy (http://ow.ly/uYUD50yKWfS)
AGA members discuss recommendations for infection control in endoscopy centers.
3. IBD patients concerned about visiting infusion centers (http://ow.ly/gKED50yKWVZ)
How would you address patient concerns about picking up coronavirus from asymptomatic carriers at bustling infusion centers?
Join these discussions and more at https://community.gastro.org/discussions.
Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.
Here are some recent clinical discussions in the forum regarding the coronavirus and your patients:
1. Biologic treatment for IBD in the COVID-19 era (http://ow.ly/9akD50yKW8E)
A GI colleague from Italy asks how others are managing IBD patients on ongoing biologic treatment during the coronavirus pandemic.
2. COVID-19 and colonoscopy (http://ow.ly/uYUD50yKWfS)
AGA members discuss recommendations for infection control in endoscopy centers.
3. IBD patients concerned about visiting infusion centers (http://ow.ly/gKED50yKWVZ)
How would you address patient concerns about picking up coronavirus from asymptomatic carriers at bustling infusion centers?
Join these discussions and more at https://community.gastro.org/discussions.
Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.
Here are some recent clinical discussions in the forum regarding the coronavirus and your patients:
1. Biologic treatment for IBD in the COVID-19 era (http://ow.ly/9akD50yKW8E)
A GI colleague from Italy asks how others are managing IBD patients on ongoing biologic treatment during the coronavirus pandemic.
2. COVID-19 and colonoscopy (http://ow.ly/uYUD50yKWfS)
AGA members discuss recommendations for infection control in endoscopy centers.
3. IBD patients concerned about visiting infusion centers (http://ow.ly/gKED50yKWVZ)
How would you address patient concerns about picking up coronavirus from asymptomatic carriers at bustling infusion centers?
Join these discussions and more at https://community.gastro.org/discussions.
AGA app improves your patient’s health and bottom line
AGA has partnered with Rx.Health, a digital health company, to create a colorectal cancer (CRC) preparatory app.
You want to find ways to improve your patient outcomes and reduce your practice costs? Now, there is an app for that. The CRC preparatory app can reduce expenses you lose from aborted or incomplete colonoscopies.
Launched in 2019, the CRC app is already generating remarkable results. The Arizona Center for Digestive Health used the CRC app and recorded a 24% improvement in bowel preparation by colonoscopy patients, a 50% reduction in aborted procedures and a 93% patient satisfaction rate. Research conducted by Rx.Health also determined patients were using the CRC app two to four times longer than competing apps, and the CRC app was saving gastroenterologists between $20,000 and $40,000 annually.
Plans are underway between AGA and Rx.Health to expand the partnership to build apps for colorectal cancer surveillance, an inflammatory bowel disease (IBD) registry, fecal microbiota transplantation (FMT), and other GI disorders.
Interested in learning more? Visit rx.health/gi.
AGA has partnered with Rx.Health, a digital health company, to create a colorectal cancer (CRC) preparatory app.
You want to find ways to improve your patient outcomes and reduce your practice costs? Now, there is an app for that. The CRC preparatory app can reduce expenses you lose from aborted or incomplete colonoscopies.
Launched in 2019, the CRC app is already generating remarkable results. The Arizona Center for Digestive Health used the CRC app and recorded a 24% improvement in bowel preparation by colonoscopy patients, a 50% reduction in aborted procedures and a 93% patient satisfaction rate. Research conducted by Rx.Health also determined patients were using the CRC app two to four times longer than competing apps, and the CRC app was saving gastroenterologists between $20,000 and $40,000 annually.
Plans are underway between AGA and Rx.Health to expand the partnership to build apps for colorectal cancer surveillance, an inflammatory bowel disease (IBD) registry, fecal microbiota transplantation (FMT), and other GI disorders.
Interested in learning more? Visit rx.health/gi.
AGA has partnered with Rx.Health, a digital health company, to create a colorectal cancer (CRC) preparatory app.
You want to find ways to improve your patient outcomes and reduce your practice costs? Now, there is an app for that. The CRC preparatory app can reduce expenses you lose from aborted or incomplete colonoscopies.
Launched in 2019, the CRC app is already generating remarkable results. The Arizona Center for Digestive Health used the CRC app and recorded a 24% improvement in bowel preparation by colonoscopy patients, a 50% reduction in aborted procedures and a 93% patient satisfaction rate. Research conducted by Rx.Health also determined patients were using the CRC app two to four times longer than competing apps, and the CRC app was saving gastroenterologists between $20,000 and $40,000 annually.
Plans are underway between AGA and Rx.Health to expand the partnership to build apps for colorectal cancer surveillance, an inflammatory bowel disease (IBD) registry, fecal microbiota transplantation (FMT), and other GI disorders.
Interested in learning more? Visit rx.health/gi.
The Return of the Plague: A Primer on Pandemic Ethics
I am writing this editorial on a beautiful day in the high desert of the Southwest: a bright blue clear sky such as you see only in the mountain air, a sun warm and comforting, and birds singing as if they had not a care in the world. Spring has come early as if to dramatize the cognitive dissonance between this idyllic scene and a seemingly invincible winter of disease and death that has gripped the globe.
For now, my editorials will focus on the most threatening infectious disease outbreak since, perhaps, 1918. I have been teaching public health and pandemic ethics to health care professionals and trainees for more than a decade. I always tell the medical students, “it is not if but when” the next viral wave overwhelms society. It is human nature to disbelieve this inevitability and to ignore, dismiss, or even attack the infectious disease experts and science journalists who, like Cassandra, warn us of the return of the plague.1
In the early 2000s, virologists were concerned that Avian influenza with a mortality rate of > 60% would mutate into a virus capable of jumping the species barrier with sustained human transmission; however, that threat has not materialized (yet).2 Instead, in 2009 the H1N1 influenza pandemic struck viciously. The always capricious genetic mutations of viral combinations outwitted vaccine manufacturers, offering little protection, resulting in an estimated 12,469 deaths, tragically many of them children, young, and middle-aged people.3 In between, there were periodic eruptions of the deadly Ebola virus in Africa. In 2014, 11 Americans who had either served as health care workers or traveled in the region were treated in the US.4
This much abridged survey of recent pandemics reminds us of how wrong were those who returning victorious from World War II with newly developed antibiotics and at the zenith of American military medicine argued that we would also beat infectious disease.5 As my Army pediatrician father would tell me, “the bugs will always be smarter than the drugs.” For now, COVID-19 is outwitting those in science and medicine who are engaged in a desperate race to discover a vaccine or a drug to “stop the virus in its tracks” as the media is so fond of saying.6 Irresponsible news outlets are giving a panicked citizenry false hope. Experts recently testified before the US House of Representatives that according to the most optimistic estimates, a vaccine is a year away.7 Yet information is a double-edged sword, as the Internet also is able to communicate accurate lifesaving information from the Centers of Disease Control and Prevention and state health departments with unprecedented speed and reach.
The best chance for civilization to “flatten the curve” of the pandemic is, as it has been so many times before, through precautionary measures and preventive public health efforts. There is a reason that in 2007, readers of the prestigious British Journal of Medicine ranked public health interventions as the most important advances in medical history.8
The initial installment of this pandemic series will offer a primer in public health ethics. Just as almost everything else in daily life has rapidly and radically changed, from cancelled church services to school closures, so too public health ethics is significantly different in many important aspects from the clinical health ethics we are accustomed to in our practice.
The first difference is focus. In clinical health ethics the focus of the individual health care practitioner is the individual patient, but public health ethics focuses on “what we as a society do to keep people healthy.”9 In a pandemic when decisions must be made (to paraphrase Mr. Spock) “for the good of the many” this creates an intrinsic ethical tension for the health care practitioner whose ethos is to advocate for his or her patient.
The second difference is that in order to accomplish these communitarian aims, the law and political and cultural factors have much more influence in medical decision making than within the ideal dyad of a health care practitioner and the patient engaged in shared decision making about the patient’s health. This is nowhere more evident than in the President’s recent declaration of a public health emergency. “The Federal Government, along with State and Local governments, has taken preventive and proactive measures to slow the spread of the virus and treat those affected. . .”10 Federal and state governments can exercise wide-ranging powers that can restrict individual liberties in ways that would never be legal or ethically justifiable in the course of routine clinical care.
The third difference relates to the ethical principles that guide public health care decision making in comparison with those of clinical ethics. The primacy of autonomy in modern American medical ethics must for the health of the public sometimes yield to the overarching goal of preventing serious harm to the public and mitigating the transmission of the infection. Values such as nonmaleficence and justice become even more important than individual self-determination especially as the pandemic worsens and the demand for scarce ventilators and other life-saving resources outstrips the supply.11
The fourth difference is that in nonemergent care, whether in the clinic or the hospital, the health care provider bears the primary responsibility for making decisions. Practitioners bring their knowledge and experience and patients their values and preferences to arrive at a mutually acceptable treatment plan. In stark contrast the profound and tragic life and death decisions made in a pandemic should not be left to the individual clinician who to the degree possible should remain faithful to the individual patient’s interests to preserve his or her professional integrity. Instead, decisions should be in the hands of highly trained and respected committees with diverse membership and expertise in accordance with evidence-based scientific protocols that are in response to changing pandemic conditions and the best available evidence. This process ensures that the values of consistency, transparency, and fairness which take center place in a public health emergency are the moral basis of decisions rather than ad hoc decisions that risk bias and inequity especially regarding vulnerable populations.11
There is one characteristic of medical decision making that does not change whether in a routine checkup or resource allocation in an intensive care unit in a pandemic: the need to respect individual human dignity and to show compassion for the suffering of those who will not survive. In the Star Trek episode “Wrath of Khan,” Spock sacrificed himself to save his ship, his comrades, and his friends who mourned his death and honored his life.
1. Garrett L. The Coming Plague: Newly Emerging Diseases in a World Out of Balance. New York: Penguin Books, 1995.
2. World Health Organization. FAQS: H5N1 influenza. https://www.who.int/influenza/human_animal_interface/avian_influenza/h5n1_research/faqs/en/. Accessed March 20, 2020.
3. Centers for Disease Control and Prevention. 2009 H1N1 pandemic. https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html. Updated June 11, 2019. Accessed March 20, 2020.
4. Centers for Disease Control and Prevention. 2014-2016 Ebola outbreak in West Africa. https://www.cdc.gov/vhf/ebola/history/2014-2016-outbreak/index.html. Updated March 8, 2019. March 20, 2020.
5. Pier GB. On the greatly exaggerated reports of the death of infectious diseases. Clin Infect Dis. 2008;47(8):1113-1114.
6. Digital staff. Coronavirus Australia: researchers say they are close to a cure. https://7news.com.au/sunrise/on-the-show/coronavirus-australia-researchers-say-theyre-close-to-a-cure-c-746508. Published March 15, 2020. Accessed March 20, 2020.
7. Hoetz P. Testimony of Peter Hoetz, M.D, Ph.D. Before the House Committee on Space, Science and Technology of the United States House of Representatives, March 5, 2020. https://science.house.gov/imo/media/doc/Hotez%20Testimony.pdf. Accessed March 15, 2020.
8. Ferriman A. BMJ readers choose the “sanitary revolution” as greatest medical advance since 1840. BMJ. 2007;334(7585):111.
9. Institute of Medicine (US) Committee on Assuring the Health of the Public in the 21st Century. The Future of the Public’s Health in the 21st Century. Washington, DC: National Academies Press; 2002.
10. Trump DJ. Proclamation on declaring a national emergency concerning the novel coronavirus (COVID-19) disease outbreak. https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. Published March 13, 2020. Accessed March 20, 2020.
11. US Department of Veterans Affairs, Veterans Health Administration, National Center for Ethics in Health Care. Meeting the challenge of pandemic influenza: ethical guidance for leaders and health care professionals in the Veterans Health Administration. https://www.ethics.va.gov/activities/pandemic_influenza_preparedness.asp. Published July 2010. Accessed March 20, 2020.
I am writing this editorial on a beautiful day in the high desert of the Southwest: a bright blue clear sky such as you see only in the mountain air, a sun warm and comforting, and birds singing as if they had not a care in the world. Spring has come early as if to dramatize the cognitive dissonance between this idyllic scene and a seemingly invincible winter of disease and death that has gripped the globe.
For now, my editorials will focus on the most threatening infectious disease outbreak since, perhaps, 1918. I have been teaching public health and pandemic ethics to health care professionals and trainees for more than a decade. I always tell the medical students, “it is not if but when” the next viral wave overwhelms society. It is human nature to disbelieve this inevitability and to ignore, dismiss, or even attack the infectious disease experts and science journalists who, like Cassandra, warn us of the return of the plague.1
In the early 2000s, virologists were concerned that Avian influenza with a mortality rate of > 60% would mutate into a virus capable of jumping the species barrier with sustained human transmission; however, that threat has not materialized (yet).2 Instead, in 2009 the H1N1 influenza pandemic struck viciously. The always capricious genetic mutations of viral combinations outwitted vaccine manufacturers, offering little protection, resulting in an estimated 12,469 deaths, tragically many of them children, young, and middle-aged people.3 In between, there were periodic eruptions of the deadly Ebola virus in Africa. In 2014, 11 Americans who had either served as health care workers or traveled in the region were treated in the US.4
This much abridged survey of recent pandemics reminds us of how wrong were those who returning victorious from World War II with newly developed antibiotics and at the zenith of American military medicine argued that we would also beat infectious disease.5 As my Army pediatrician father would tell me, “the bugs will always be smarter than the drugs.” For now, COVID-19 is outwitting those in science and medicine who are engaged in a desperate race to discover a vaccine or a drug to “stop the virus in its tracks” as the media is so fond of saying.6 Irresponsible news outlets are giving a panicked citizenry false hope. Experts recently testified before the US House of Representatives that according to the most optimistic estimates, a vaccine is a year away.7 Yet information is a double-edged sword, as the Internet also is able to communicate accurate lifesaving information from the Centers of Disease Control and Prevention and state health departments with unprecedented speed and reach.
The best chance for civilization to “flatten the curve” of the pandemic is, as it has been so many times before, through precautionary measures and preventive public health efforts. There is a reason that in 2007, readers of the prestigious British Journal of Medicine ranked public health interventions as the most important advances in medical history.8
The initial installment of this pandemic series will offer a primer in public health ethics. Just as almost everything else in daily life has rapidly and radically changed, from cancelled church services to school closures, so too public health ethics is significantly different in many important aspects from the clinical health ethics we are accustomed to in our practice.
The first difference is focus. In clinical health ethics the focus of the individual health care practitioner is the individual patient, but public health ethics focuses on “what we as a society do to keep people healthy.”9 In a pandemic when decisions must be made (to paraphrase Mr. Spock) “for the good of the many” this creates an intrinsic ethical tension for the health care practitioner whose ethos is to advocate for his or her patient.
The second difference is that in order to accomplish these communitarian aims, the law and political and cultural factors have much more influence in medical decision making than within the ideal dyad of a health care practitioner and the patient engaged in shared decision making about the patient’s health. This is nowhere more evident than in the President’s recent declaration of a public health emergency. “The Federal Government, along with State and Local governments, has taken preventive and proactive measures to slow the spread of the virus and treat those affected. . .”10 Federal and state governments can exercise wide-ranging powers that can restrict individual liberties in ways that would never be legal or ethically justifiable in the course of routine clinical care.
The third difference relates to the ethical principles that guide public health care decision making in comparison with those of clinical ethics. The primacy of autonomy in modern American medical ethics must for the health of the public sometimes yield to the overarching goal of preventing serious harm to the public and mitigating the transmission of the infection. Values such as nonmaleficence and justice become even more important than individual self-determination especially as the pandemic worsens and the demand for scarce ventilators and other life-saving resources outstrips the supply.11
The fourth difference is that in nonemergent care, whether in the clinic or the hospital, the health care provider bears the primary responsibility for making decisions. Practitioners bring their knowledge and experience and patients their values and preferences to arrive at a mutually acceptable treatment plan. In stark contrast the profound and tragic life and death decisions made in a pandemic should not be left to the individual clinician who to the degree possible should remain faithful to the individual patient’s interests to preserve his or her professional integrity. Instead, decisions should be in the hands of highly trained and respected committees with diverse membership and expertise in accordance with evidence-based scientific protocols that are in response to changing pandemic conditions and the best available evidence. This process ensures that the values of consistency, transparency, and fairness which take center place in a public health emergency are the moral basis of decisions rather than ad hoc decisions that risk bias and inequity especially regarding vulnerable populations.11
There is one characteristic of medical decision making that does not change whether in a routine checkup or resource allocation in an intensive care unit in a pandemic: the need to respect individual human dignity and to show compassion for the suffering of those who will not survive. In the Star Trek episode “Wrath of Khan,” Spock sacrificed himself to save his ship, his comrades, and his friends who mourned his death and honored his life.
I am writing this editorial on a beautiful day in the high desert of the Southwest: a bright blue clear sky such as you see only in the mountain air, a sun warm and comforting, and birds singing as if they had not a care in the world. Spring has come early as if to dramatize the cognitive dissonance between this idyllic scene and a seemingly invincible winter of disease and death that has gripped the globe.
For now, my editorials will focus on the most threatening infectious disease outbreak since, perhaps, 1918. I have been teaching public health and pandemic ethics to health care professionals and trainees for more than a decade. I always tell the medical students, “it is not if but when” the next viral wave overwhelms society. It is human nature to disbelieve this inevitability and to ignore, dismiss, or even attack the infectious disease experts and science journalists who, like Cassandra, warn us of the return of the plague.1
In the early 2000s, virologists were concerned that Avian influenza with a mortality rate of > 60% would mutate into a virus capable of jumping the species barrier with sustained human transmission; however, that threat has not materialized (yet).2 Instead, in 2009 the H1N1 influenza pandemic struck viciously. The always capricious genetic mutations of viral combinations outwitted vaccine manufacturers, offering little protection, resulting in an estimated 12,469 deaths, tragically many of them children, young, and middle-aged people.3 In between, there were periodic eruptions of the deadly Ebola virus in Africa. In 2014, 11 Americans who had either served as health care workers or traveled in the region were treated in the US.4
This much abridged survey of recent pandemics reminds us of how wrong were those who returning victorious from World War II with newly developed antibiotics and at the zenith of American military medicine argued that we would also beat infectious disease.5 As my Army pediatrician father would tell me, “the bugs will always be smarter than the drugs.” For now, COVID-19 is outwitting those in science and medicine who are engaged in a desperate race to discover a vaccine or a drug to “stop the virus in its tracks” as the media is so fond of saying.6 Irresponsible news outlets are giving a panicked citizenry false hope. Experts recently testified before the US House of Representatives that according to the most optimistic estimates, a vaccine is a year away.7 Yet information is a double-edged sword, as the Internet also is able to communicate accurate lifesaving information from the Centers of Disease Control and Prevention and state health departments with unprecedented speed and reach.
The best chance for civilization to “flatten the curve” of the pandemic is, as it has been so many times before, through precautionary measures and preventive public health efforts. There is a reason that in 2007, readers of the prestigious British Journal of Medicine ranked public health interventions as the most important advances in medical history.8
The initial installment of this pandemic series will offer a primer in public health ethics. Just as almost everything else in daily life has rapidly and radically changed, from cancelled church services to school closures, so too public health ethics is significantly different in many important aspects from the clinical health ethics we are accustomed to in our practice.
The first difference is focus. In clinical health ethics the focus of the individual health care practitioner is the individual patient, but public health ethics focuses on “what we as a society do to keep people healthy.”9 In a pandemic when decisions must be made (to paraphrase Mr. Spock) “for the good of the many” this creates an intrinsic ethical tension for the health care practitioner whose ethos is to advocate for his or her patient.
The second difference is that in order to accomplish these communitarian aims, the law and political and cultural factors have much more influence in medical decision making than within the ideal dyad of a health care practitioner and the patient engaged in shared decision making about the patient’s health. This is nowhere more evident than in the President’s recent declaration of a public health emergency. “The Federal Government, along with State and Local governments, has taken preventive and proactive measures to slow the spread of the virus and treat those affected. . .”10 Federal and state governments can exercise wide-ranging powers that can restrict individual liberties in ways that would never be legal or ethically justifiable in the course of routine clinical care.
The third difference relates to the ethical principles that guide public health care decision making in comparison with those of clinical ethics. The primacy of autonomy in modern American medical ethics must for the health of the public sometimes yield to the overarching goal of preventing serious harm to the public and mitigating the transmission of the infection. Values such as nonmaleficence and justice become even more important than individual self-determination especially as the pandemic worsens and the demand for scarce ventilators and other life-saving resources outstrips the supply.11
The fourth difference is that in nonemergent care, whether in the clinic or the hospital, the health care provider bears the primary responsibility for making decisions. Practitioners bring their knowledge and experience and patients their values and preferences to arrive at a mutually acceptable treatment plan. In stark contrast the profound and tragic life and death decisions made in a pandemic should not be left to the individual clinician who to the degree possible should remain faithful to the individual patient’s interests to preserve his or her professional integrity. Instead, decisions should be in the hands of highly trained and respected committees with diverse membership and expertise in accordance with evidence-based scientific protocols that are in response to changing pandemic conditions and the best available evidence. This process ensures that the values of consistency, transparency, and fairness which take center place in a public health emergency are the moral basis of decisions rather than ad hoc decisions that risk bias and inequity especially regarding vulnerable populations.11
There is one characteristic of medical decision making that does not change whether in a routine checkup or resource allocation in an intensive care unit in a pandemic: the need to respect individual human dignity and to show compassion for the suffering of those who will not survive. In the Star Trek episode “Wrath of Khan,” Spock sacrificed himself to save his ship, his comrades, and his friends who mourned his death and honored his life.
1. Garrett L. The Coming Plague: Newly Emerging Diseases in a World Out of Balance. New York: Penguin Books, 1995.
2. World Health Organization. FAQS: H5N1 influenza. https://www.who.int/influenza/human_animal_interface/avian_influenza/h5n1_research/faqs/en/. Accessed March 20, 2020.
3. Centers for Disease Control and Prevention. 2009 H1N1 pandemic. https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html. Updated June 11, 2019. Accessed March 20, 2020.
4. Centers for Disease Control and Prevention. 2014-2016 Ebola outbreak in West Africa. https://www.cdc.gov/vhf/ebola/history/2014-2016-outbreak/index.html. Updated March 8, 2019. March 20, 2020.
5. Pier GB. On the greatly exaggerated reports of the death of infectious diseases. Clin Infect Dis. 2008;47(8):1113-1114.
6. Digital staff. Coronavirus Australia: researchers say they are close to a cure. https://7news.com.au/sunrise/on-the-show/coronavirus-australia-researchers-say-theyre-close-to-a-cure-c-746508. Published March 15, 2020. Accessed March 20, 2020.
7. Hoetz P. Testimony of Peter Hoetz, M.D, Ph.D. Before the House Committee on Space, Science and Technology of the United States House of Representatives, March 5, 2020. https://science.house.gov/imo/media/doc/Hotez%20Testimony.pdf. Accessed March 15, 2020.
8. Ferriman A. BMJ readers choose the “sanitary revolution” as greatest medical advance since 1840. BMJ. 2007;334(7585):111.
9. Institute of Medicine (US) Committee on Assuring the Health of the Public in the 21st Century. The Future of the Public’s Health in the 21st Century. Washington, DC: National Academies Press; 2002.
10. Trump DJ. Proclamation on declaring a national emergency concerning the novel coronavirus (COVID-19) disease outbreak. https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. Published March 13, 2020. Accessed March 20, 2020.
11. US Department of Veterans Affairs, Veterans Health Administration, National Center for Ethics in Health Care. Meeting the challenge of pandemic influenza: ethical guidance for leaders and health care professionals in the Veterans Health Administration. https://www.ethics.va.gov/activities/pandemic_influenza_preparedness.asp. Published July 2010. Accessed March 20, 2020.
1. Garrett L. The Coming Plague: Newly Emerging Diseases in a World Out of Balance. New York: Penguin Books, 1995.
2. World Health Organization. FAQS: H5N1 influenza. https://www.who.int/influenza/human_animal_interface/avian_influenza/h5n1_research/faqs/en/. Accessed March 20, 2020.
3. Centers for Disease Control and Prevention. 2009 H1N1 pandemic. https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html. Updated June 11, 2019. Accessed March 20, 2020.
4. Centers for Disease Control and Prevention. 2014-2016 Ebola outbreak in West Africa. https://www.cdc.gov/vhf/ebola/history/2014-2016-outbreak/index.html. Updated March 8, 2019. March 20, 2020.
5. Pier GB. On the greatly exaggerated reports of the death of infectious diseases. Clin Infect Dis. 2008;47(8):1113-1114.
6. Digital staff. Coronavirus Australia: researchers say they are close to a cure. https://7news.com.au/sunrise/on-the-show/coronavirus-australia-researchers-say-theyre-close-to-a-cure-c-746508. Published March 15, 2020. Accessed March 20, 2020.
7. Hoetz P. Testimony of Peter Hoetz, M.D, Ph.D. Before the House Committee on Space, Science and Technology of the United States House of Representatives, March 5, 2020. https://science.house.gov/imo/media/doc/Hotez%20Testimony.pdf. Accessed March 15, 2020.
8. Ferriman A. BMJ readers choose the “sanitary revolution” as greatest medical advance since 1840. BMJ. 2007;334(7585):111.
9. Institute of Medicine (US) Committee on Assuring the Health of the Public in the 21st Century. The Future of the Public’s Health in the 21st Century. Washington, DC: National Academies Press; 2002.
10. Trump DJ. Proclamation on declaring a national emergency concerning the novel coronavirus (COVID-19) disease outbreak. https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. Published March 13, 2020. Accessed March 20, 2020.
11. US Department of Veterans Affairs, Veterans Health Administration, National Center for Ethics in Health Care. Meeting the challenge of pandemic influenza: ethical guidance for leaders and health care professionals in the Veterans Health Administration. https://www.ethics.va.gov/activities/pandemic_influenza_preparedness.asp. Published July 2010. Accessed March 20, 2020.
‘We will get through this’: Advice for lessening your pandemic anxiety
The COVID-19 pandemic is an experience that is unprecedented in our lifetime. It is having a pervasive effect due to how mysterious, potentially dangerous, and sustained it is. We don’t know how bad it’s going to get or how long it’s going to last. We have natural disasters like hurricanes and earthquakes, but they are limited in time and scope. But this global pandemic is something we can’t put our arms around just yet, breeding uncertainty, worry, and fear. This is where mental health professionals need to come in.
The populations being affected by this pandemic can be placed into different groups on the basis of their mental health consequences and needs. First you have, for lack of a better term, “the worried well.” These are people with no preexisting mental disorder who are naturally worried by this and are trying to take appropriate actions to protect themselves and prepare. For such individuals, the equivalent of mental health first-aid should be useful (we’ll come back to that in a moment). Given the proper guidance and sources of information, most such people should be able to manage the anxiety, worry, and dysphoria associated with this critical pandemic.
Then there are those who have preexisting mental conditions related to mood, anxiety, stress, or obsessive tendencies. They are probably going to have an increase in their symptoms, and as such, a corresponding need for adjusting treatment. This may require an increase in their existing medications or the addition of an ad hoc medication, or perhaps more frequent contact with their doctor or therapist.
Because travel and direct visitation is discouraged at the moment, virtual methods of communication should be used to speak with these patients. Such methods have long existed but haven’t been adopted in large numbers; this may be the impetus to finally make it happen. Using the telephone, FaceTime, Skype, WebEx, Zoom, and other means of videoconferencing should be feasible. As billing procedures are being adapted for this moment, there’s no reason why individuals shouldn’t be able to contact their mental health provider.
Substance abuse is also a condition vulnerable to the stress effects of this pandemic. This will prompt or tempt those to use substances that they’ve abused or turned to in the past as a way of self-medicating and assuaging their anxiety and worry.
It’s possible that the pandemic could find its way into delusions or exacerbate symptoms, but somewhat paradoxically, people with serious mental illnesses often respond more calmly to crises than do individuals without them. As a result, the number of these patients requiring emergency room admission for possible exacerbation of symptoms is probably not going to be that much greater than normal.
How to Cope With an Unprecedented Situation
For the worried well and for the clinicians who have understandable fears about exposure, there are several things you can try to manage your anxiety. There are concentric circles of concern that you have to maintain. Think of it like the instructions on an airplane when, if there’s a drop in cabin pressure, you’re asked to apply your own oxygen mask first before placing one on your child. In the same way, you must first think about protecting yourself by limiting your exposure and monitoring your own physical state for any symptoms. But then you must be concerned about your family, your friends, and also society. This is a situation where the impulse and the ethos of worrying about your fellow persons—being your brother’s keeper—is imperative.
The epidemic has been successfully managed in some countries, like Singapore and China, which, once they got on top of it, were able to limit contagion in a very dramatic way. But these are authoritarian governments. The United States doesn’t work that way, which is what makes appealing to the principle of caring for others so crucial. You can protect yourself, but if other people aren’t also protected, it may not matter. You have to worry not just about yourself but about everyone else.
When it comes to stress management, I recommend not catastrophizing or watching the news media 24/7. Distract yourself with other work or recreational activities. Reach out and communicate—virtually, of course—with friends, family, and healthcare providers as needed. Staying in touch acts not just as a diversion but also as an outlet for assuaging your feelings, your sense of being in this alone, feeling isolated.
There are also cognitive reframing mechanisms you can employ. Consider that although this is bad, some countries have already gone through it. And we’ll get through it too. You’ll understandably ask yourself what it would mean if you were to be exposed. In most cases you can say, “I’m going to have the flu and symptoms that are not going to be pleasant, but I’ve had the flu or serious sickness before.”
Remember that there are already antiretroviral treatments being tested in clinical trials and showing efficacy. It’s good to know that before this pandemic ends, some of these treatments will probably be clinically applied, mostly to those who are severely affected and in intensive care.
Diagnose yourself. Monitor your state. Determine whether the stress is really having an impact on you. Is it affecting your sleep, appetite, concentration, mood? And if you do have a preexisting psychiatric condition, don’t feel afraid to reach out to your mental health provider. Understand that you’re going to be anxious, which may aggravate your symptoms and require an adjustment in your treatment. That’s okay. It’s to be expected and your provider should be available to help you.
Controlling this outbreak via the same epidemiologic infectious disease prevention guidance that works in authoritarian societies is not going to be applicable here because of the liberties that we experience in American society. What will determine our success is the belief that we’re in this together, that we’re going to help each other. We should be proud of that, as it shows how Americans and people around the world stand up in situations like this.
Let’s also note that even though everybody is affected and undergoing previously unimaginable levels of anticipated stress and dislocation, it’s the healthcare providers who are really on the frontlines. They’re under tremendous pressure to continue to perform heroically, at great risk to themselves. They deserve a real debt of gratitude.
We will get through this, but as we do, it will not end until we’ve undergone an extreme test of our character. I certainly hope and trust that we will be up to it.
Dr. Jeffrey A. Lieberman is chairman of the Department of Psychiatry at Columbia University. He is a former president of the American Psychiatric Association.
Disclosure: Jeffrey A. Lieberman, MD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Clintara; Intracellular Therapies. Received research grant from Alkermes; Biomarin; EnVivo/Forum; Genentech; Novartis/Novation; Sunovion. Patent: Repligen.
This article first appeared on Medscape.com.
The COVID-19 pandemic is an experience that is unprecedented in our lifetime. It is having a pervasive effect due to how mysterious, potentially dangerous, and sustained it is. We don’t know how bad it’s going to get or how long it’s going to last. We have natural disasters like hurricanes and earthquakes, but they are limited in time and scope. But this global pandemic is something we can’t put our arms around just yet, breeding uncertainty, worry, and fear. This is where mental health professionals need to come in.
The populations being affected by this pandemic can be placed into different groups on the basis of their mental health consequences and needs. First you have, for lack of a better term, “the worried well.” These are people with no preexisting mental disorder who are naturally worried by this and are trying to take appropriate actions to protect themselves and prepare. For such individuals, the equivalent of mental health first-aid should be useful (we’ll come back to that in a moment). Given the proper guidance and sources of information, most such people should be able to manage the anxiety, worry, and dysphoria associated with this critical pandemic.
Then there are those who have preexisting mental conditions related to mood, anxiety, stress, or obsessive tendencies. They are probably going to have an increase in their symptoms, and as such, a corresponding need for adjusting treatment. This may require an increase in their existing medications or the addition of an ad hoc medication, or perhaps more frequent contact with their doctor or therapist.
Because travel and direct visitation is discouraged at the moment, virtual methods of communication should be used to speak with these patients. Such methods have long existed but haven’t been adopted in large numbers; this may be the impetus to finally make it happen. Using the telephone, FaceTime, Skype, WebEx, Zoom, and other means of videoconferencing should be feasible. As billing procedures are being adapted for this moment, there’s no reason why individuals shouldn’t be able to contact their mental health provider.
Substance abuse is also a condition vulnerable to the stress effects of this pandemic. This will prompt or tempt those to use substances that they’ve abused or turned to in the past as a way of self-medicating and assuaging their anxiety and worry.
It’s possible that the pandemic could find its way into delusions or exacerbate symptoms, but somewhat paradoxically, people with serious mental illnesses often respond more calmly to crises than do individuals without them. As a result, the number of these patients requiring emergency room admission for possible exacerbation of symptoms is probably not going to be that much greater than normal.
How to Cope With an Unprecedented Situation
For the worried well and for the clinicians who have understandable fears about exposure, there are several things you can try to manage your anxiety. There are concentric circles of concern that you have to maintain. Think of it like the instructions on an airplane when, if there’s a drop in cabin pressure, you’re asked to apply your own oxygen mask first before placing one on your child. In the same way, you must first think about protecting yourself by limiting your exposure and monitoring your own physical state for any symptoms. But then you must be concerned about your family, your friends, and also society. This is a situation where the impulse and the ethos of worrying about your fellow persons—being your brother’s keeper—is imperative.
The epidemic has been successfully managed in some countries, like Singapore and China, which, once they got on top of it, were able to limit contagion in a very dramatic way. But these are authoritarian governments. The United States doesn’t work that way, which is what makes appealing to the principle of caring for others so crucial. You can protect yourself, but if other people aren’t also protected, it may not matter. You have to worry not just about yourself but about everyone else.
When it comes to stress management, I recommend not catastrophizing or watching the news media 24/7. Distract yourself with other work or recreational activities. Reach out and communicate—virtually, of course—with friends, family, and healthcare providers as needed. Staying in touch acts not just as a diversion but also as an outlet for assuaging your feelings, your sense of being in this alone, feeling isolated.
There are also cognitive reframing mechanisms you can employ. Consider that although this is bad, some countries have already gone through it. And we’ll get through it too. You’ll understandably ask yourself what it would mean if you were to be exposed. In most cases you can say, “I’m going to have the flu and symptoms that are not going to be pleasant, but I’ve had the flu or serious sickness before.”
Remember that there are already antiretroviral treatments being tested in clinical trials and showing efficacy. It’s good to know that before this pandemic ends, some of these treatments will probably be clinically applied, mostly to those who are severely affected and in intensive care.
Diagnose yourself. Monitor your state. Determine whether the stress is really having an impact on you. Is it affecting your sleep, appetite, concentration, mood? And if you do have a preexisting psychiatric condition, don’t feel afraid to reach out to your mental health provider. Understand that you’re going to be anxious, which may aggravate your symptoms and require an adjustment in your treatment. That’s okay. It’s to be expected and your provider should be available to help you.
Controlling this outbreak via the same epidemiologic infectious disease prevention guidance that works in authoritarian societies is not going to be applicable here because of the liberties that we experience in American society. What will determine our success is the belief that we’re in this together, that we’re going to help each other. We should be proud of that, as it shows how Americans and people around the world stand up in situations like this.
Let’s also note that even though everybody is affected and undergoing previously unimaginable levels of anticipated stress and dislocation, it’s the healthcare providers who are really on the frontlines. They’re under tremendous pressure to continue to perform heroically, at great risk to themselves. They deserve a real debt of gratitude.
We will get through this, but as we do, it will not end until we’ve undergone an extreme test of our character. I certainly hope and trust that we will be up to it.
Dr. Jeffrey A. Lieberman is chairman of the Department of Psychiatry at Columbia University. He is a former president of the American Psychiatric Association.
Disclosure: Jeffrey A. Lieberman, MD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Clintara; Intracellular Therapies. Received research grant from Alkermes; Biomarin; EnVivo/Forum; Genentech; Novartis/Novation; Sunovion. Patent: Repligen.
This article first appeared on Medscape.com.
The COVID-19 pandemic is an experience that is unprecedented in our lifetime. It is having a pervasive effect due to how mysterious, potentially dangerous, and sustained it is. We don’t know how bad it’s going to get or how long it’s going to last. We have natural disasters like hurricanes and earthquakes, but they are limited in time and scope. But this global pandemic is something we can’t put our arms around just yet, breeding uncertainty, worry, and fear. This is where mental health professionals need to come in.
The populations being affected by this pandemic can be placed into different groups on the basis of their mental health consequences and needs. First you have, for lack of a better term, “the worried well.” These are people with no preexisting mental disorder who are naturally worried by this and are trying to take appropriate actions to protect themselves and prepare. For such individuals, the equivalent of mental health first-aid should be useful (we’ll come back to that in a moment). Given the proper guidance and sources of information, most such people should be able to manage the anxiety, worry, and dysphoria associated with this critical pandemic.
Then there are those who have preexisting mental conditions related to mood, anxiety, stress, or obsessive tendencies. They are probably going to have an increase in their symptoms, and as such, a corresponding need for adjusting treatment. This may require an increase in their existing medications or the addition of an ad hoc medication, or perhaps more frequent contact with their doctor or therapist.
Because travel and direct visitation is discouraged at the moment, virtual methods of communication should be used to speak with these patients. Such methods have long existed but haven’t been adopted in large numbers; this may be the impetus to finally make it happen. Using the telephone, FaceTime, Skype, WebEx, Zoom, and other means of videoconferencing should be feasible. As billing procedures are being adapted for this moment, there’s no reason why individuals shouldn’t be able to contact their mental health provider.
Substance abuse is also a condition vulnerable to the stress effects of this pandemic. This will prompt or tempt those to use substances that they’ve abused or turned to in the past as a way of self-medicating and assuaging their anxiety and worry.
It’s possible that the pandemic could find its way into delusions or exacerbate symptoms, but somewhat paradoxically, people with serious mental illnesses often respond more calmly to crises than do individuals without them. As a result, the number of these patients requiring emergency room admission for possible exacerbation of symptoms is probably not going to be that much greater than normal.
How to Cope With an Unprecedented Situation
For the worried well and for the clinicians who have understandable fears about exposure, there are several things you can try to manage your anxiety. There are concentric circles of concern that you have to maintain. Think of it like the instructions on an airplane when, if there’s a drop in cabin pressure, you’re asked to apply your own oxygen mask first before placing one on your child. In the same way, you must first think about protecting yourself by limiting your exposure and monitoring your own physical state for any symptoms. But then you must be concerned about your family, your friends, and also society. This is a situation where the impulse and the ethos of worrying about your fellow persons—being your brother’s keeper—is imperative.
The epidemic has been successfully managed in some countries, like Singapore and China, which, once they got on top of it, were able to limit contagion in a very dramatic way. But these are authoritarian governments. The United States doesn’t work that way, which is what makes appealing to the principle of caring for others so crucial. You can protect yourself, but if other people aren’t also protected, it may not matter. You have to worry not just about yourself but about everyone else.
When it comes to stress management, I recommend not catastrophizing or watching the news media 24/7. Distract yourself with other work or recreational activities. Reach out and communicate—virtually, of course—with friends, family, and healthcare providers as needed. Staying in touch acts not just as a diversion but also as an outlet for assuaging your feelings, your sense of being in this alone, feeling isolated.
There are also cognitive reframing mechanisms you can employ. Consider that although this is bad, some countries have already gone through it. And we’ll get through it too. You’ll understandably ask yourself what it would mean if you were to be exposed. In most cases you can say, “I’m going to have the flu and symptoms that are not going to be pleasant, but I’ve had the flu or serious sickness before.”
Remember that there are already antiretroviral treatments being tested in clinical trials and showing efficacy. It’s good to know that before this pandemic ends, some of these treatments will probably be clinically applied, mostly to those who are severely affected and in intensive care.
Diagnose yourself. Monitor your state. Determine whether the stress is really having an impact on you. Is it affecting your sleep, appetite, concentration, mood? And if you do have a preexisting psychiatric condition, don’t feel afraid to reach out to your mental health provider. Understand that you’re going to be anxious, which may aggravate your symptoms and require an adjustment in your treatment. That’s okay. It’s to be expected and your provider should be available to help you.
Controlling this outbreak via the same epidemiologic infectious disease prevention guidance that works in authoritarian societies is not going to be applicable here because of the liberties that we experience in American society. What will determine our success is the belief that we’re in this together, that we’re going to help each other. We should be proud of that, as it shows how Americans and people around the world stand up in situations like this.
Let’s also note that even though everybody is affected and undergoing previously unimaginable levels of anticipated stress and dislocation, it’s the healthcare providers who are really on the frontlines. They’re under tremendous pressure to continue to perform heroically, at great risk to themselves. They deserve a real debt of gratitude.
We will get through this, but as we do, it will not end until we’ve undergone an extreme test of our character. I certainly hope and trust that we will be up to it.
Dr. Jeffrey A. Lieberman is chairman of the Department of Psychiatry at Columbia University. He is a former president of the American Psychiatric Association.
Disclosure: Jeffrey A. Lieberman, MD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Clintara; Intracellular Therapies. Received research grant from Alkermes; Biomarin; EnVivo/Forum; Genentech; Novartis/Novation; Sunovion. Patent: Repligen.
This article first appeared on Medscape.com.
Announcing AGA’s new endoscopy journal
The recent explosion of innovations for the diagnosis and treatment of GI diseases makes it difficult to identify what will affect you today and what has implications for tomorrow.
Techniques and Innovations in Gastrointestinal Endoscopy (TIGE) cuts through the noise with quarterly updates featuring groundbreaking advances in GI endoscopy. Previously known as Techniques in Gastrointestinal Endoscopy, TIGE is the newest member of the AGA journal family and illuminates the next generation of technologies in an easily accessible, online-only format. TIGE will continue to be led by Co-Editors-in-Chief Vinay Chandrasekhara, MD, Mayo Clinic, Rochester, Minn., and Michael Kochman, MD, AGAF, University of Pennsylvania School of Medicine, Philadelphia, and a hand-selected editorial board of leaders in GI endoscopy.
Check out the current issue of TIGE focused on how lumen apposing metal stents (LAMS) are changing GI endoscopy. The issue provides a comprehensive review on the current state of LAMS and best practices for using LAMS to optimize patient outcomes.
Discover TIGE at tigejournal.org.
The recent explosion of innovations for the diagnosis and treatment of GI diseases makes it difficult to identify what will affect you today and what has implications for tomorrow.
Techniques and Innovations in Gastrointestinal Endoscopy (TIGE) cuts through the noise with quarterly updates featuring groundbreaking advances in GI endoscopy. Previously known as Techniques in Gastrointestinal Endoscopy, TIGE is the newest member of the AGA journal family and illuminates the next generation of technologies in an easily accessible, online-only format. TIGE will continue to be led by Co-Editors-in-Chief Vinay Chandrasekhara, MD, Mayo Clinic, Rochester, Minn., and Michael Kochman, MD, AGAF, University of Pennsylvania School of Medicine, Philadelphia, and a hand-selected editorial board of leaders in GI endoscopy.
Check out the current issue of TIGE focused on how lumen apposing metal stents (LAMS) are changing GI endoscopy. The issue provides a comprehensive review on the current state of LAMS and best practices for using LAMS to optimize patient outcomes.
Discover TIGE at tigejournal.org.
The recent explosion of innovations for the diagnosis and treatment of GI diseases makes it difficult to identify what will affect you today and what has implications for tomorrow.
Techniques and Innovations in Gastrointestinal Endoscopy (TIGE) cuts through the noise with quarterly updates featuring groundbreaking advances in GI endoscopy. Previously known as Techniques in Gastrointestinal Endoscopy, TIGE is the newest member of the AGA journal family and illuminates the next generation of technologies in an easily accessible, online-only format. TIGE will continue to be led by Co-Editors-in-Chief Vinay Chandrasekhara, MD, Mayo Clinic, Rochester, Minn., and Michael Kochman, MD, AGAF, University of Pennsylvania School of Medicine, Philadelphia, and a hand-selected editorial board of leaders in GI endoscopy.
Check out the current issue of TIGE focused on how lumen apposing metal stents (LAMS) are changing GI endoscopy. The issue provides a comprehensive review on the current state of LAMS and best practices for using LAMS to optimize patient outcomes.
Discover TIGE at tigejournal.org.
AI algorithm predicts treatment success in lung cancer patients
Radiomics signatures developed by artificial intelligence can predict sensitivity to treatment in adults with non–small cell lung cancer (NSCLC), according to a study published in Clinical Cancer Research.
“Radiomics features are calculated by algorithmic analysis of tumor images and have been linked to characteristics of NSCLC,” wrote Laurent Dercle, MD, of Columbia University, New York, and colleagues.
With their study, the researchers found that “radiomic signatures, derived from quantitative, artificial intelligence–based analysis of standard-of-care CT images, offer the potential to enhance clinical decision-making as on-treatment markers of efficacy.”
The researchers identified 188 adults with NSCLC: 92 receiving nivolumab, 50 receiving docetaxel, and 46 receiving gefitinib.
The team extracted 1,160 radiomics features from the largest measurable lung lesion in each patient. The researchers used CT images from baseline and the patients’ first treatment assessment (3 weeks for gefitinib and 8 weeks for nivolumab and docetaxel) to develop a model that would predict treatment sensitivity based on changes to the largest lung lesion.
In validation sets following training sets, the prediction models for nivolumab, docetaxel, and gefitinib yielded area under the curve results of 0.77, 0.67, and 0.82, respectively.
“Machine-learning techniques successfully performed a specific complex task: identifying a pattern of baseline and treatment-induced changes on CT images associated with sensitivity to systemic nivolumab, docetaxel, and gefitinib therapy in patients with a diagnosis of NSCLC,” the researchers wrote.
They noted that this study was limited by several factors, including the small sample size and the inability to evaluate the impact of various time intervals on feature selection and classification.
However, the researchers concluded that “this study is a proof of concept that AI [artificial intelligence] support could provide clinicians an early indication of the likelihood of success of treatment with the new generation of systemic anticancer therapies using conventional imaging techniques.”
This study was supported by Bristol-Myers Squibb, the National Institutes of Health, Fondation Philanthropia, and Fondation Nuovo-Soldati. The authors disclosed relationships, including employment, with Bristol-Myers Squibb. They also disclosed relationships with Roche, Novartis, Merck, and Boehringer Ingelheim.
SOURCE: Dercle L et al. Clin Cancer Res. 2020 Mar 20. doi: 10.1158/1078-0432.CCR-19-2942.
Radiomics signatures developed by artificial intelligence can predict sensitivity to treatment in adults with non–small cell lung cancer (NSCLC), according to a study published in Clinical Cancer Research.
“Radiomics features are calculated by algorithmic analysis of tumor images and have been linked to characteristics of NSCLC,” wrote Laurent Dercle, MD, of Columbia University, New York, and colleagues.
With their study, the researchers found that “radiomic signatures, derived from quantitative, artificial intelligence–based analysis of standard-of-care CT images, offer the potential to enhance clinical decision-making as on-treatment markers of efficacy.”
The researchers identified 188 adults with NSCLC: 92 receiving nivolumab, 50 receiving docetaxel, and 46 receiving gefitinib.
The team extracted 1,160 radiomics features from the largest measurable lung lesion in each patient. The researchers used CT images from baseline and the patients’ first treatment assessment (3 weeks for gefitinib and 8 weeks for nivolumab and docetaxel) to develop a model that would predict treatment sensitivity based on changes to the largest lung lesion.
In validation sets following training sets, the prediction models for nivolumab, docetaxel, and gefitinib yielded area under the curve results of 0.77, 0.67, and 0.82, respectively.
“Machine-learning techniques successfully performed a specific complex task: identifying a pattern of baseline and treatment-induced changes on CT images associated with sensitivity to systemic nivolumab, docetaxel, and gefitinib therapy in patients with a diagnosis of NSCLC,” the researchers wrote.
They noted that this study was limited by several factors, including the small sample size and the inability to evaluate the impact of various time intervals on feature selection and classification.
However, the researchers concluded that “this study is a proof of concept that AI [artificial intelligence] support could provide clinicians an early indication of the likelihood of success of treatment with the new generation of systemic anticancer therapies using conventional imaging techniques.”
This study was supported by Bristol-Myers Squibb, the National Institutes of Health, Fondation Philanthropia, and Fondation Nuovo-Soldati. The authors disclosed relationships, including employment, with Bristol-Myers Squibb. They also disclosed relationships with Roche, Novartis, Merck, and Boehringer Ingelheim.
SOURCE: Dercle L et al. Clin Cancer Res. 2020 Mar 20. doi: 10.1158/1078-0432.CCR-19-2942.
Radiomics signatures developed by artificial intelligence can predict sensitivity to treatment in adults with non–small cell lung cancer (NSCLC), according to a study published in Clinical Cancer Research.
“Radiomics features are calculated by algorithmic analysis of tumor images and have been linked to characteristics of NSCLC,” wrote Laurent Dercle, MD, of Columbia University, New York, and colleagues.
With their study, the researchers found that “radiomic signatures, derived from quantitative, artificial intelligence–based analysis of standard-of-care CT images, offer the potential to enhance clinical decision-making as on-treatment markers of efficacy.”
The researchers identified 188 adults with NSCLC: 92 receiving nivolumab, 50 receiving docetaxel, and 46 receiving gefitinib.
The team extracted 1,160 radiomics features from the largest measurable lung lesion in each patient. The researchers used CT images from baseline and the patients’ first treatment assessment (3 weeks for gefitinib and 8 weeks for nivolumab and docetaxel) to develop a model that would predict treatment sensitivity based on changes to the largest lung lesion.
In validation sets following training sets, the prediction models for nivolumab, docetaxel, and gefitinib yielded area under the curve results of 0.77, 0.67, and 0.82, respectively.
“Machine-learning techniques successfully performed a specific complex task: identifying a pattern of baseline and treatment-induced changes on CT images associated with sensitivity to systemic nivolumab, docetaxel, and gefitinib therapy in patients with a diagnosis of NSCLC,” the researchers wrote.
They noted that this study was limited by several factors, including the small sample size and the inability to evaluate the impact of various time intervals on feature selection and classification.
However, the researchers concluded that “this study is a proof of concept that AI [artificial intelligence] support could provide clinicians an early indication of the likelihood of success of treatment with the new generation of systemic anticancer therapies using conventional imaging techniques.”
This study was supported by Bristol-Myers Squibb, the National Institutes of Health, Fondation Philanthropia, and Fondation Nuovo-Soldati. The authors disclosed relationships, including employment, with Bristol-Myers Squibb. They also disclosed relationships with Roche, Novartis, Merck, and Boehringer Ingelheim.
SOURCE: Dercle L et al. Clin Cancer Res. 2020 Mar 20. doi: 10.1158/1078-0432.CCR-19-2942.
FROM CLINICAL CANCER RESEARCH
U.S. lifts visa halt to boost COVID-19 physician workforce
New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.
The move may also help physicians extend their visas.
The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.
As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.
The State Department lifted the suspensions and issued this update:
“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”
The State Department also issued guidance for foreign medical professionals already in the United States:
“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.
“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.
“Those who need to extend their stay or adjust their visa status must apply with USCIS (US Citizenship and Immigration Services).”
Complications Still Exist
ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.
ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.
However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.
“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.
He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.
Pinsky said he did not yet know whether that would be a problem.
He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.
Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
This article first appeared on Medscape.com.
New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.
The move may also help physicians extend their visas.
The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.
As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.
The State Department lifted the suspensions and issued this update:
“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”
The State Department also issued guidance for foreign medical professionals already in the United States:
“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.
“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.
“Those who need to extend their stay or adjust their visa status must apply with USCIS (US Citizenship and Immigration Services).”
Complications Still Exist
ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.
ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.
However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.
“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.
He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.
Pinsky said he did not yet know whether that would be a problem.
He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.
Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
This article first appeared on Medscape.com.
New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.
The move may also help physicians extend their visas.
The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.
As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.
The State Department lifted the suspensions and issued this update:
“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”
The State Department also issued guidance for foreign medical professionals already in the United States:
“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.
“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.
“Those who need to extend their stay or adjust their visa status must apply with USCIS (US Citizenship and Immigration Services).”
Complications Still Exist
ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.
ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.
However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.
“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.
He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.
Pinsky said he did not yet know whether that would be a problem.
He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.
Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
This article first appeared on Medscape.com.