Quick Byte: Global health before COVID-19

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How quickly things change. On September 23, 2019 – months before the COVID-19 pandemic struck – at a UN High-Level Meeting on Universal Health Coverage, heads of state from around the world pledged to achieve universal health coverage by 2030.

“This will be an unprecedented moment in public health: according to the declaration being negotiated by member states, this commitment is being made globally ‘for the first time.’ Whether or not the new commitment succeeds will depend on a large degree of advocacy at the national level.”
 

Reference

1. Carter M, Emmel A. The Global Community Has Pledged To Achieve Universal Health Coverage: What’s It Going To Take? Health Affairs Blog, 2019 Sept 23. doi: 10.1377/hblog20190920.827005.

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How quickly things change. On September 23, 2019 – months before the COVID-19 pandemic struck – at a UN High-Level Meeting on Universal Health Coverage, heads of state from around the world pledged to achieve universal health coverage by 2030.

“This will be an unprecedented moment in public health: according to the declaration being negotiated by member states, this commitment is being made globally ‘for the first time.’ Whether or not the new commitment succeeds will depend on a large degree of advocacy at the national level.”
 

Reference

1. Carter M, Emmel A. The Global Community Has Pledged To Achieve Universal Health Coverage: What’s It Going To Take? Health Affairs Blog, 2019 Sept 23. doi: 10.1377/hblog20190920.827005.

How quickly things change. On September 23, 2019 – months before the COVID-19 pandemic struck – at a UN High-Level Meeting on Universal Health Coverage, heads of state from around the world pledged to achieve universal health coverage by 2030.

“This will be an unprecedented moment in public health: according to the declaration being negotiated by member states, this commitment is being made globally ‘for the first time.’ Whether or not the new commitment succeeds will depend on a large degree of advocacy at the national level.”
 

Reference

1. Carter M, Emmel A. The Global Community Has Pledged To Achieve Universal Health Coverage: What’s It Going To Take? Health Affairs Blog, 2019 Sept 23. doi: 10.1377/hblog20190920.827005.

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Getting to secure text messaging in health care

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Health care teams are searching for solutions

Hospitalists and health care teams struggle with issues related to text messaging in the workplace. “It’s happening whether an institution has a secure text messaging platform or not,” said Philip Hagedorn, MD, MBI, associate chief medical information officer at Cincinnati Children’s Hospital Medical Center.

“Many places reacted to this reality by procuring a solution – take your pick of secure text messaging platforms – and implementing it, but bypassed an opportunity to think about how we tailor the use of this culturally ubiquitous medium to the health care setting,” he said.It doesn’t work to just drop a secure text messaging platform into clinical systems and expect that health care practitioners will know how to use them appropriately, Dr. Hagedorn says. “The way we use text messaging in our lives outside health care inevitably bleeds into how we use the medium at work, but it shouldn’t. The needs are different and the stakes are higher for communication in the health care setting.”

In a paper looking at the issue, Dr. Hagedorn and co-authors laid out critical areas of concern, such as text messaging becoming a form of alarm fatigue and also increasing the likelihood of communication error.

“It’s my hope that fellow hospitalists can use this as an opportunity to think deeply about how we communicate in health care,” he said. “If we don’t think critically about how and where something like text messaging should be used in medicine, we risk facing unintended consequences for our patients.”The article discusses several steps for mitigating the risks laid out, including proactive surveillance and targeted training. “These are starting points, and I’m sure there are plenty of other creative solutions out there. We wanted to get the conversation going. We’d love to hear from others who face similar issues or have come up with interesting solutions.”
 

Reference

1. Hagedorn PA, et al. Secure Text Messaging in Healthcare: Latent Threats and Opportunities to Improve Patient Safety. J Hosp Med. 2020 June;15(6):378-380. Published Online First 2019 Sept 18. doi: 10.12788/jhm.3305

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Health care teams are searching for solutions

Health care teams are searching for solutions

Hospitalists and health care teams struggle with issues related to text messaging in the workplace. “It’s happening whether an institution has a secure text messaging platform or not,” said Philip Hagedorn, MD, MBI, associate chief medical information officer at Cincinnati Children’s Hospital Medical Center.

“Many places reacted to this reality by procuring a solution – take your pick of secure text messaging platforms – and implementing it, but bypassed an opportunity to think about how we tailor the use of this culturally ubiquitous medium to the health care setting,” he said.It doesn’t work to just drop a secure text messaging platform into clinical systems and expect that health care practitioners will know how to use them appropriately, Dr. Hagedorn says. “The way we use text messaging in our lives outside health care inevitably bleeds into how we use the medium at work, but it shouldn’t. The needs are different and the stakes are higher for communication in the health care setting.”

In a paper looking at the issue, Dr. Hagedorn and co-authors laid out critical areas of concern, such as text messaging becoming a form of alarm fatigue and also increasing the likelihood of communication error.

“It’s my hope that fellow hospitalists can use this as an opportunity to think deeply about how we communicate in health care,” he said. “If we don’t think critically about how and where something like text messaging should be used in medicine, we risk facing unintended consequences for our patients.”The article discusses several steps for mitigating the risks laid out, including proactive surveillance and targeted training. “These are starting points, and I’m sure there are plenty of other creative solutions out there. We wanted to get the conversation going. We’d love to hear from others who face similar issues or have come up with interesting solutions.”
 

Reference

1. Hagedorn PA, et al. Secure Text Messaging in Healthcare: Latent Threats and Opportunities to Improve Patient Safety. J Hosp Med. 2020 June;15(6):378-380. Published Online First 2019 Sept 18. doi: 10.12788/jhm.3305

Hospitalists and health care teams struggle with issues related to text messaging in the workplace. “It’s happening whether an institution has a secure text messaging platform or not,” said Philip Hagedorn, MD, MBI, associate chief medical information officer at Cincinnati Children’s Hospital Medical Center.

“Many places reacted to this reality by procuring a solution – take your pick of secure text messaging platforms – and implementing it, but bypassed an opportunity to think about how we tailor the use of this culturally ubiquitous medium to the health care setting,” he said.It doesn’t work to just drop a secure text messaging platform into clinical systems and expect that health care practitioners will know how to use them appropriately, Dr. Hagedorn says. “The way we use text messaging in our lives outside health care inevitably bleeds into how we use the medium at work, but it shouldn’t. The needs are different and the stakes are higher for communication in the health care setting.”

In a paper looking at the issue, Dr. Hagedorn and co-authors laid out critical areas of concern, such as text messaging becoming a form of alarm fatigue and also increasing the likelihood of communication error.

“It’s my hope that fellow hospitalists can use this as an opportunity to think deeply about how we communicate in health care,” he said. “If we don’t think critically about how and where something like text messaging should be used in medicine, we risk facing unintended consequences for our patients.”The article discusses several steps for mitigating the risks laid out, including proactive surveillance and targeted training. “These are starting points, and I’m sure there are plenty of other creative solutions out there. We wanted to get the conversation going. We’d love to hear from others who face similar issues or have come up with interesting solutions.”
 

Reference

1. Hagedorn PA, et al. Secure Text Messaging in Healthcare: Latent Threats and Opportunities to Improve Patient Safety. J Hosp Med. 2020 June;15(6):378-380. Published Online First 2019 Sept 18. doi: 10.12788/jhm.3305

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Fracking sites tied to increased heart failure hospitalizations

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Living near hydraulic fracturing is associated with increased risk of hospitalization in people with heart failure (HF), a new study from Pennsylvania suggests.

The link was strongest among those with more severe heart failure but patients with either HF phenotype showed this association of increased risk with exposure to fracking activities, according to the investigators, led by Tara P. McAlexander, PhD, MPH, Drexel University Dornsife School of Public Health in Philadelphia.

“Our understanding has expanded well beyond the famous Harvard Six Cities study to know that it’s not just a short-term uptick in air pollution that›s going to send someone to the hospital a couple days later,” said Dr. McAlexander in an interview, referring to the study conducted from the mid-1970s through 1991. “We know that people who live in these environments and are exposed for long periods of time may have long-term detrimental effects.”

Although questions remain about specific mechanisms and how best to assess exposure, the evidence is mounting in a way that is consistent with the biologic hypotheses of how fracking would adversely affect health, Dr. McAlexander said. “We have many studies now on adverse pregnancy and birth outcomes, and that’s just the tip of the iceberg.”

Pennsylvania is a hot spot for fracking, also known as unconventional natural gas development (UNGD), with more than 12,000 wells drilled in the Marcellus shale since 2004. The shale extends from upstate New York in the north to northeastern Kentucky and Tennessee in the south and covers about 72,000 square miles. Last year, Pennsylvania pledged $3 million to study clusters of rare pediatric cancers and asthma near fracking operations. A recent grand jury report concluded government officials failed to protect residents from the health effects of fracking.

Fracking involves a cascade of activities that can trigger neural circuitry, sympathetic activation, and inflammation – all well-known pathways that potentiate heart failure, said Sanjay Rajagopalan, MD, who has researched the health effects of air pollution for two decades and was not involved with the study.

“If you think about it, it’s like environmental perturbation on steroids in some ways where they are pulling the trigger from a variety of different ways: noise, air pollution, social displacement, psychosocial impacts, economic disparities. So it’s not at all surprising that they saw an association,” said Dr. Rajagopalan, chief of cardiovascular medicine at University Hospitals Harrington Heart & Vascular Institute and director of the Case Western Cardiovascular Research Institute, both in Cleveland, Ohio.

As reported in the Journal of the American College of Cardiology, Dr. McAlexander and colleagues at Johns Hopkins University, Baltimore, used electronic health data from the Geisinger Health System to identify 9,054 patients with heart failure seen between 2008 and 2015. Of these, 5,839 patients had an incident HF hospitalization and 3,215 served as controls. Geisinger operates 13 hospitals and two research centers in 45 of Pennsylvania’s 67 counties, serving more than 3 million of the state’s residents.

Patients’ residential addresses were used to identify latitude and longitude coordinates that were matched with 9,669 UNGD wells in Pennsylvania and the location of major and minor roadways. The researchers also calculated a measure of community socioeconomic deprivation.

The adjusted odds of hospitalization were higher for patients in the highest quartile of exposure for three of the four UNGD phases: pad preparation (odds ratio, 1.70; 95% confidence interval, 1.35-2.13), stimulation or the actual fracking (OR, 1.80; 95% CI, 1.35-2.40), and production (OR, 1.62; 95% CI, 1.07-2.45).

Dr. McAlexander said she initially thought the lack of association with drilling (OR, 0.97; 95% CI, 0.75-1.27) was a mistake but noted that the drilling metric reflects a shorter time period than, for example, 30 days needed to clear the well pad and bring in the necessary equipment.

Stronger associations between pad preparation, fracking, and production are also consistent with the known increases in air pollution, traffic, and noise associated with these phases.

Individuals with more severe HF had greater odds of hospitalization, but the effect sizes were generally comparable between HF with preserved versus reduced ejection fraction. For those with the highest exposure to fracking, the odds ratios for hospitalization reached 2.25 (95% CI, 1.56-3.25) and 2.09 (95% CI, 1.44-3.03), respectively.

Notably, patients who could be phenotyped versus those who could not were more likely to die, to be hospitalized for HF, and to have a higher Charlson Comorbidity Index and other relevant diagnoses like myocardial infarction.

“Clinicians need to be increasingly aware that the environments their patients are in are a huge factor in their disease progression and outlook,” McAlexander said. “We know that UNGD, specifically now, is something that could be impacting a heart failure patient’s survival.”

She also suggested that the findings may also spur more advocacy work and “across-silo” collaboration between clinicians and environmental researchers.

Dr. Rajagopalan said there is increasing recognition that physicians need to be aware of environmental health links as extreme events like the California and Oregon wildfires and coastal flooding become increasingly common. “Unfortunately, unconventional is becoming the new convention.”

The problem for many physicians, however, is just having enough bandwidth to get through the day and get enough learning to keep above water, he said. Artificial intelligence could be used to seed electronic medical records with other personalized information from a bevy of sources including smartphones and the internet of things, but fundamental changes are also needed in the educational process to emphasize the environment.

“It’s going to take a huge societal shift in the way we view commodities, what we consider healthy, etc, but it can happen very quickly because all it takes is a crisis like COVID-19 to bring people to their knees and make them understand how this is going to take over our lives over the next decade,” Dr. Rajagopalan said.

The scientific community has been calling for “good” epidemiologic studies on the health effects of fracking since the early 2010s, Barrak Alahmad, MBChB, MPH, Harvard T.H. Chan School of Public Health, and Haitham Khraishah, MD, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, point out in an accompanying editorial.

The current study applied “extensive and rigorous methods” involving both the design and statistical approach, including use of a negative control analysis to assess for sources of spurious causal inference, several sensitivity analyses, and controlled for a wide range of covariates.

“Their results were consistent and robust across all these measures,” the editorialists wrote. “Most importantly, the effect size is probably too large to be explained away by an unmeasured confounder.”

Dr. Alahmad and Dr. Khraishah call for advancements in exposure assessment, citing a recent study reporting that ambient particle radioactivity near unconventional oil and gas sites could induce adverse health effects. Other unmet needs include a better understanding of racial disparities in the impacts of fracking and a fine-tuning of cause-specific cardiovascular morbidity and mortality.

The study was supported by training grants from the National Institute of Environmental Health Sciences to Dr. McAlexander and principal investigator Brian Schwartz, MD. The authors, Dr. Rajagopalan, Dr. Alahmad, and Dr. Khraishah have disclosed no relevant financial relationships.
 

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

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Living near hydraulic fracturing is associated with increased risk of hospitalization in people with heart failure (HF), a new study from Pennsylvania suggests.

The link was strongest among those with more severe heart failure but patients with either HF phenotype showed this association of increased risk with exposure to fracking activities, according to the investigators, led by Tara P. McAlexander, PhD, MPH, Drexel University Dornsife School of Public Health in Philadelphia.

“Our understanding has expanded well beyond the famous Harvard Six Cities study to know that it’s not just a short-term uptick in air pollution that›s going to send someone to the hospital a couple days later,” said Dr. McAlexander in an interview, referring to the study conducted from the mid-1970s through 1991. “We know that people who live in these environments and are exposed for long periods of time may have long-term detrimental effects.”

Although questions remain about specific mechanisms and how best to assess exposure, the evidence is mounting in a way that is consistent with the biologic hypotheses of how fracking would adversely affect health, Dr. McAlexander said. “We have many studies now on adverse pregnancy and birth outcomes, and that’s just the tip of the iceberg.”

Pennsylvania is a hot spot for fracking, also known as unconventional natural gas development (UNGD), with more than 12,000 wells drilled in the Marcellus shale since 2004. The shale extends from upstate New York in the north to northeastern Kentucky and Tennessee in the south and covers about 72,000 square miles. Last year, Pennsylvania pledged $3 million to study clusters of rare pediatric cancers and asthma near fracking operations. A recent grand jury report concluded government officials failed to protect residents from the health effects of fracking.

Fracking involves a cascade of activities that can trigger neural circuitry, sympathetic activation, and inflammation – all well-known pathways that potentiate heart failure, said Sanjay Rajagopalan, MD, who has researched the health effects of air pollution for two decades and was not involved with the study.

“If you think about it, it’s like environmental perturbation on steroids in some ways where they are pulling the trigger from a variety of different ways: noise, air pollution, social displacement, psychosocial impacts, economic disparities. So it’s not at all surprising that they saw an association,” said Dr. Rajagopalan, chief of cardiovascular medicine at University Hospitals Harrington Heart & Vascular Institute and director of the Case Western Cardiovascular Research Institute, both in Cleveland, Ohio.

As reported in the Journal of the American College of Cardiology, Dr. McAlexander and colleagues at Johns Hopkins University, Baltimore, used electronic health data from the Geisinger Health System to identify 9,054 patients with heart failure seen between 2008 and 2015. Of these, 5,839 patients had an incident HF hospitalization and 3,215 served as controls. Geisinger operates 13 hospitals and two research centers in 45 of Pennsylvania’s 67 counties, serving more than 3 million of the state’s residents.

Patients’ residential addresses were used to identify latitude and longitude coordinates that were matched with 9,669 UNGD wells in Pennsylvania and the location of major and minor roadways. The researchers also calculated a measure of community socioeconomic deprivation.

The adjusted odds of hospitalization were higher for patients in the highest quartile of exposure for three of the four UNGD phases: pad preparation (odds ratio, 1.70; 95% confidence interval, 1.35-2.13), stimulation or the actual fracking (OR, 1.80; 95% CI, 1.35-2.40), and production (OR, 1.62; 95% CI, 1.07-2.45).

Dr. McAlexander said she initially thought the lack of association with drilling (OR, 0.97; 95% CI, 0.75-1.27) was a mistake but noted that the drilling metric reflects a shorter time period than, for example, 30 days needed to clear the well pad and bring in the necessary equipment.

Stronger associations between pad preparation, fracking, and production are also consistent with the known increases in air pollution, traffic, and noise associated with these phases.

Individuals with more severe HF had greater odds of hospitalization, but the effect sizes were generally comparable between HF with preserved versus reduced ejection fraction. For those with the highest exposure to fracking, the odds ratios for hospitalization reached 2.25 (95% CI, 1.56-3.25) and 2.09 (95% CI, 1.44-3.03), respectively.

Notably, patients who could be phenotyped versus those who could not were more likely to die, to be hospitalized for HF, and to have a higher Charlson Comorbidity Index and other relevant diagnoses like myocardial infarction.

“Clinicians need to be increasingly aware that the environments their patients are in are a huge factor in their disease progression and outlook,” McAlexander said. “We know that UNGD, specifically now, is something that could be impacting a heart failure patient’s survival.”

She also suggested that the findings may also spur more advocacy work and “across-silo” collaboration between clinicians and environmental researchers.

Dr. Rajagopalan said there is increasing recognition that physicians need to be aware of environmental health links as extreme events like the California and Oregon wildfires and coastal flooding become increasingly common. “Unfortunately, unconventional is becoming the new convention.”

The problem for many physicians, however, is just having enough bandwidth to get through the day and get enough learning to keep above water, he said. Artificial intelligence could be used to seed electronic medical records with other personalized information from a bevy of sources including smartphones and the internet of things, but fundamental changes are also needed in the educational process to emphasize the environment.

“It’s going to take a huge societal shift in the way we view commodities, what we consider healthy, etc, but it can happen very quickly because all it takes is a crisis like COVID-19 to bring people to their knees and make them understand how this is going to take over our lives over the next decade,” Dr. Rajagopalan said.

The scientific community has been calling for “good” epidemiologic studies on the health effects of fracking since the early 2010s, Barrak Alahmad, MBChB, MPH, Harvard T.H. Chan School of Public Health, and Haitham Khraishah, MD, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, point out in an accompanying editorial.

The current study applied “extensive and rigorous methods” involving both the design and statistical approach, including use of a negative control analysis to assess for sources of spurious causal inference, several sensitivity analyses, and controlled for a wide range of covariates.

“Their results were consistent and robust across all these measures,” the editorialists wrote. “Most importantly, the effect size is probably too large to be explained away by an unmeasured confounder.”

Dr. Alahmad and Dr. Khraishah call for advancements in exposure assessment, citing a recent study reporting that ambient particle radioactivity near unconventional oil and gas sites could induce adverse health effects. Other unmet needs include a better understanding of racial disparities in the impacts of fracking and a fine-tuning of cause-specific cardiovascular morbidity and mortality.

The study was supported by training grants from the National Institute of Environmental Health Sciences to Dr. McAlexander and principal investigator Brian Schwartz, MD. The authors, Dr. Rajagopalan, Dr. Alahmad, and Dr. Khraishah have disclosed no relevant financial relationships.
 

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

Living near hydraulic fracturing is associated with increased risk of hospitalization in people with heart failure (HF), a new study from Pennsylvania suggests.

The link was strongest among those with more severe heart failure but patients with either HF phenotype showed this association of increased risk with exposure to fracking activities, according to the investigators, led by Tara P. McAlexander, PhD, MPH, Drexel University Dornsife School of Public Health in Philadelphia.

“Our understanding has expanded well beyond the famous Harvard Six Cities study to know that it’s not just a short-term uptick in air pollution that›s going to send someone to the hospital a couple days later,” said Dr. McAlexander in an interview, referring to the study conducted from the mid-1970s through 1991. “We know that people who live in these environments and are exposed for long periods of time may have long-term detrimental effects.”

Although questions remain about specific mechanisms and how best to assess exposure, the evidence is mounting in a way that is consistent with the biologic hypotheses of how fracking would adversely affect health, Dr. McAlexander said. “We have many studies now on adverse pregnancy and birth outcomes, and that’s just the tip of the iceberg.”

Pennsylvania is a hot spot for fracking, also known as unconventional natural gas development (UNGD), with more than 12,000 wells drilled in the Marcellus shale since 2004. The shale extends from upstate New York in the north to northeastern Kentucky and Tennessee in the south and covers about 72,000 square miles. Last year, Pennsylvania pledged $3 million to study clusters of rare pediatric cancers and asthma near fracking operations. A recent grand jury report concluded government officials failed to protect residents from the health effects of fracking.

Fracking involves a cascade of activities that can trigger neural circuitry, sympathetic activation, and inflammation – all well-known pathways that potentiate heart failure, said Sanjay Rajagopalan, MD, who has researched the health effects of air pollution for two decades and was not involved with the study.

“If you think about it, it’s like environmental perturbation on steroids in some ways where they are pulling the trigger from a variety of different ways: noise, air pollution, social displacement, psychosocial impacts, economic disparities. So it’s not at all surprising that they saw an association,” said Dr. Rajagopalan, chief of cardiovascular medicine at University Hospitals Harrington Heart & Vascular Institute and director of the Case Western Cardiovascular Research Institute, both in Cleveland, Ohio.

As reported in the Journal of the American College of Cardiology, Dr. McAlexander and colleagues at Johns Hopkins University, Baltimore, used electronic health data from the Geisinger Health System to identify 9,054 patients with heart failure seen between 2008 and 2015. Of these, 5,839 patients had an incident HF hospitalization and 3,215 served as controls. Geisinger operates 13 hospitals and two research centers in 45 of Pennsylvania’s 67 counties, serving more than 3 million of the state’s residents.

Patients’ residential addresses were used to identify latitude and longitude coordinates that were matched with 9,669 UNGD wells in Pennsylvania and the location of major and minor roadways. The researchers also calculated a measure of community socioeconomic deprivation.

The adjusted odds of hospitalization were higher for patients in the highest quartile of exposure for three of the four UNGD phases: pad preparation (odds ratio, 1.70; 95% confidence interval, 1.35-2.13), stimulation or the actual fracking (OR, 1.80; 95% CI, 1.35-2.40), and production (OR, 1.62; 95% CI, 1.07-2.45).

Dr. McAlexander said she initially thought the lack of association with drilling (OR, 0.97; 95% CI, 0.75-1.27) was a mistake but noted that the drilling metric reflects a shorter time period than, for example, 30 days needed to clear the well pad and bring in the necessary equipment.

Stronger associations between pad preparation, fracking, and production are also consistent with the known increases in air pollution, traffic, and noise associated with these phases.

Individuals with more severe HF had greater odds of hospitalization, but the effect sizes were generally comparable between HF with preserved versus reduced ejection fraction. For those with the highest exposure to fracking, the odds ratios for hospitalization reached 2.25 (95% CI, 1.56-3.25) and 2.09 (95% CI, 1.44-3.03), respectively.

Notably, patients who could be phenotyped versus those who could not were more likely to die, to be hospitalized for HF, and to have a higher Charlson Comorbidity Index and other relevant diagnoses like myocardial infarction.

“Clinicians need to be increasingly aware that the environments their patients are in are a huge factor in their disease progression and outlook,” McAlexander said. “We know that UNGD, specifically now, is something that could be impacting a heart failure patient’s survival.”

She also suggested that the findings may also spur more advocacy work and “across-silo” collaboration between clinicians and environmental researchers.

Dr. Rajagopalan said there is increasing recognition that physicians need to be aware of environmental health links as extreme events like the California and Oregon wildfires and coastal flooding become increasingly common. “Unfortunately, unconventional is becoming the new convention.”

The problem for many physicians, however, is just having enough bandwidth to get through the day and get enough learning to keep above water, he said. Artificial intelligence could be used to seed electronic medical records with other personalized information from a bevy of sources including smartphones and the internet of things, but fundamental changes are also needed in the educational process to emphasize the environment.

“It’s going to take a huge societal shift in the way we view commodities, what we consider healthy, etc, but it can happen very quickly because all it takes is a crisis like COVID-19 to bring people to their knees and make them understand how this is going to take over our lives over the next decade,” Dr. Rajagopalan said.

The scientific community has been calling for “good” epidemiologic studies on the health effects of fracking since the early 2010s, Barrak Alahmad, MBChB, MPH, Harvard T.H. Chan School of Public Health, and Haitham Khraishah, MD, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, point out in an accompanying editorial.

The current study applied “extensive and rigorous methods” involving both the design and statistical approach, including use of a negative control analysis to assess for sources of spurious causal inference, several sensitivity analyses, and controlled for a wide range of covariates.

“Their results were consistent and robust across all these measures,” the editorialists wrote. “Most importantly, the effect size is probably too large to be explained away by an unmeasured confounder.”

Dr. Alahmad and Dr. Khraishah call for advancements in exposure assessment, citing a recent study reporting that ambient particle radioactivity near unconventional oil and gas sites could induce adverse health effects. Other unmet needs include a better understanding of racial disparities in the impacts of fracking and a fine-tuning of cause-specific cardiovascular morbidity and mortality.

The study was supported by training grants from the National Institute of Environmental Health Sciences to Dr. McAlexander and principal investigator Brian Schwartz, MD. The authors, Dr. Rajagopalan, Dr. Alahmad, and Dr. Khraishah have disclosed no relevant financial relationships.
 

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

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To D or not to D? Vitamin D doesn’t reduce falls in older adults

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Higher doses of vitamin D supplementation not only show no benefit in the prevention of falls in older adults at increased risk of falling, compared with the lowest doses, but they appear to increase the risk, new research shows.

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Based on the findings, supplemental vitamin D above the minimum dose of 200 IU/day likely has little benefit, lead author Lawrence J. Appel, MD, MPH, told this news organization.

“In the absence of any benefit of 1,000 IU/day versus 2,000 IU/day [of vitamin D supplementation] on falls, along with the potential for harm from doses above 1,000 IU/day, it is hard to recommend a dose above 200 IU/day in older-aged persons, unless there is a compelling reason,” asserted Dr. Appel, director of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins Bloomberg School of Public Health in Baltimore.

“More is not always better – and it may even be worse,” when it comes to vitamin D’s role in the prevention of falls, he said.

The research, published in Annals of Internal Medicine, adds important evidence in the ongoing struggle to prevent falls, says Bruce R. Troen, MD, in an accompanying editorial.

“Falls and their deleterious consequences remain a substantial risk for older adults and a huge challenge for health care teams,” writes Dr. Troen, a physician-investigator with the Veterans Affairs Western New York Healthcare System.

However, commenting in an interview, Dr. Troen cautions: “There are many epidemiological studies that are correlative, not causative, that do show a likelihood for benefit [with vitamin D supplementation]. … Therefore, there’s no reason for clinicians to discontinue vitamin D in individuals because of this study.”

“If you’re monitoring an older adult who is frail and has multiple comorbidities, you want to know what their vitamin D level is [and] provide them an appropriate supplement if needed,” he emphasized.

Some guidelines already reflect the lack of evidence of any role of vitamin D supplementation in the prevention of falls, including those of the 2018 U.S. Preventive Services Task Force, which, in a reversal of its 2012 recommendation, now does not recommend vitamin D supplementation for fall prevention in older persons without osteoporosis or vitamin D deficiency, Dr. Appel and colleagues note.
 

No prevention of falls regardless of baseline vitamin D

As part of STURDY (Study to understand fall reduction and vitamin D in you), Dr. Appel and colleagues enrolled 688 community-dwelling participants who had an elevated risk of falling, defined as a serum 25-hydroxyvitamin D [25(OH)D] level of 25 to 72.5 nmol/L (10-29 ng/dL).

Participants were a mean age of 77.2 years and had a mean total 25(OH)D level of 55.3 nmol/L at enrollment.

They were randomized to one of four doses of vitamin D3, including 200 IU/day (the control group), or 1,000, 2,000, or 4,000 IU/day.

The highest doses were found to be associated with worse – not better – outcomes including a shorter time to hospitalization or death, compared with the 1,000-IU/day group. The higher-dose groups were therefore switched to a dose of 1,000 IU/day or lower, and all participants were followed for up to 2 years.

Overall, 63% experienced falls over the course of the study, which, though high, was consistent with the study’s criteria of participants having an elevated fall risk.

Of the 667 participants who completed the trial, no benefit in prevention of falling was seen across any of the doses, compared with the control group dose of 200 IU/day, regardless of participants’ baseline vitamin D levels.

Safety analyses showed that even in the 1,000-IU/day group, a higher risk of first serious fall and first fall with hospitalization was seen compared with the 200-IU/day group.

A limitation is that the study did not have a placebo group, however, “200 IU/day is a very small dose, probably homeopathic,” Dr. Appel said. “It was likely close to a placebo,” he said.
 

 

 

Caveats: comorbidities, subgroups

In his editorial, Dr. Troen notes other studies, including VITAL (Vitamin D and Omega-3 Trial) also found no reduction in falls with higher vitamin D doses; however, that study did not show any significant risks with the higher doses.

He adds that the current study lacks information on subsets of participants.

“We don’t have enough information about the existing comorbidities and medications that these people are on to be able to pull back the layers. Maybe there is a subgroup that should not be getting 4,000 IU, whereas another subgroup may not be harmed and you may decide that patient can benefit,” he said.

Furthermore, the trial doesn’t address groups such as nursing home residents.

“I have, for instance, 85-year-olds with vitamin D levels of maybe 20 nmol/L with multiple medical issues, but levels that low were not included in the study, so this is a tricky business, but the bottom line is first, do no harm,” he said.

“We really need trials that factor in the multiple different aspects so we can come up, hopefully, with a holistic and interdisciplinary approach, which is usually the best way to optimize care for frail older adults,” he concluded.

The study received funding from the National Institute of Aging.
 

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

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Higher doses of vitamin D supplementation not only show no benefit in the prevention of falls in older adults at increased risk of falling, compared with the lowest doses, but they appear to increase the risk, new research shows.

Zbynek Pospisil/iStock/Getty Images

Based on the findings, supplemental vitamin D above the minimum dose of 200 IU/day likely has little benefit, lead author Lawrence J. Appel, MD, MPH, told this news organization.

“In the absence of any benefit of 1,000 IU/day versus 2,000 IU/day [of vitamin D supplementation] on falls, along with the potential for harm from doses above 1,000 IU/day, it is hard to recommend a dose above 200 IU/day in older-aged persons, unless there is a compelling reason,” asserted Dr. Appel, director of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins Bloomberg School of Public Health in Baltimore.

“More is not always better – and it may even be worse,” when it comes to vitamin D’s role in the prevention of falls, he said.

The research, published in Annals of Internal Medicine, adds important evidence in the ongoing struggle to prevent falls, says Bruce R. Troen, MD, in an accompanying editorial.

“Falls and their deleterious consequences remain a substantial risk for older adults and a huge challenge for health care teams,” writes Dr. Troen, a physician-investigator with the Veterans Affairs Western New York Healthcare System.

However, commenting in an interview, Dr. Troen cautions: “There are many epidemiological studies that are correlative, not causative, that do show a likelihood for benefit [with vitamin D supplementation]. … Therefore, there’s no reason for clinicians to discontinue vitamin D in individuals because of this study.”

“If you’re monitoring an older adult who is frail and has multiple comorbidities, you want to know what their vitamin D level is [and] provide them an appropriate supplement if needed,” he emphasized.

Some guidelines already reflect the lack of evidence of any role of vitamin D supplementation in the prevention of falls, including those of the 2018 U.S. Preventive Services Task Force, which, in a reversal of its 2012 recommendation, now does not recommend vitamin D supplementation for fall prevention in older persons without osteoporosis or vitamin D deficiency, Dr. Appel and colleagues note.
 

No prevention of falls regardless of baseline vitamin D

As part of STURDY (Study to understand fall reduction and vitamin D in you), Dr. Appel and colleagues enrolled 688 community-dwelling participants who had an elevated risk of falling, defined as a serum 25-hydroxyvitamin D [25(OH)D] level of 25 to 72.5 nmol/L (10-29 ng/dL).

Participants were a mean age of 77.2 years and had a mean total 25(OH)D level of 55.3 nmol/L at enrollment.

They were randomized to one of four doses of vitamin D3, including 200 IU/day (the control group), or 1,000, 2,000, or 4,000 IU/day.

The highest doses were found to be associated with worse – not better – outcomes including a shorter time to hospitalization or death, compared with the 1,000-IU/day group. The higher-dose groups were therefore switched to a dose of 1,000 IU/day or lower, and all participants were followed for up to 2 years.

Overall, 63% experienced falls over the course of the study, which, though high, was consistent with the study’s criteria of participants having an elevated fall risk.

Of the 667 participants who completed the trial, no benefit in prevention of falling was seen across any of the doses, compared with the control group dose of 200 IU/day, regardless of participants’ baseline vitamin D levels.

Safety analyses showed that even in the 1,000-IU/day group, a higher risk of first serious fall and first fall with hospitalization was seen compared with the 200-IU/day group.

A limitation is that the study did not have a placebo group, however, “200 IU/day is a very small dose, probably homeopathic,” Dr. Appel said. “It was likely close to a placebo,” he said.
 

 

 

Caveats: comorbidities, subgroups

In his editorial, Dr. Troen notes other studies, including VITAL (Vitamin D and Omega-3 Trial) also found no reduction in falls with higher vitamin D doses; however, that study did not show any significant risks with the higher doses.

He adds that the current study lacks information on subsets of participants.

“We don’t have enough information about the existing comorbidities and medications that these people are on to be able to pull back the layers. Maybe there is a subgroup that should not be getting 4,000 IU, whereas another subgroup may not be harmed and you may decide that patient can benefit,” he said.

Furthermore, the trial doesn’t address groups such as nursing home residents.

“I have, for instance, 85-year-olds with vitamin D levels of maybe 20 nmol/L with multiple medical issues, but levels that low were not included in the study, so this is a tricky business, but the bottom line is first, do no harm,” he said.

“We really need trials that factor in the multiple different aspects so we can come up, hopefully, with a holistic and interdisciplinary approach, which is usually the best way to optimize care for frail older adults,” he concluded.

The study received funding from the National Institute of Aging.
 

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

Higher doses of vitamin D supplementation not only show no benefit in the prevention of falls in older adults at increased risk of falling, compared with the lowest doses, but they appear to increase the risk, new research shows.

Zbynek Pospisil/iStock/Getty Images

Based on the findings, supplemental vitamin D above the minimum dose of 200 IU/day likely has little benefit, lead author Lawrence J. Appel, MD, MPH, told this news organization.

“In the absence of any benefit of 1,000 IU/day versus 2,000 IU/day [of vitamin D supplementation] on falls, along with the potential for harm from doses above 1,000 IU/day, it is hard to recommend a dose above 200 IU/day in older-aged persons, unless there is a compelling reason,” asserted Dr. Appel, director of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins Bloomberg School of Public Health in Baltimore.

“More is not always better – and it may even be worse,” when it comes to vitamin D’s role in the prevention of falls, he said.

The research, published in Annals of Internal Medicine, adds important evidence in the ongoing struggle to prevent falls, says Bruce R. Troen, MD, in an accompanying editorial.

“Falls and their deleterious consequences remain a substantial risk for older adults and a huge challenge for health care teams,” writes Dr. Troen, a physician-investigator with the Veterans Affairs Western New York Healthcare System.

However, commenting in an interview, Dr. Troen cautions: “There are many epidemiological studies that are correlative, not causative, that do show a likelihood for benefit [with vitamin D supplementation]. … Therefore, there’s no reason for clinicians to discontinue vitamin D in individuals because of this study.”

“If you’re monitoring an older adult who is frail and has multiple comorbidities, you want to know what their vitamin D level is [and] provide them an appropriate supplement if needed,” he emphasized.

Some guidelines already reflect the lack of evidence of any role of vitamin D supplementation in the prevention of falls, including those of the 2018 U.S. Preventive Services Task Force, which, in a reversal of its 2012 recommendation, now does not recommend vitamin D supplementation for fall prevention in older persons without osteoporosis or vitamin D deficiency, Dr. Appel and colleagues note.
 

No prevention of falls regardless of baseline vitamin D

As part of STURDY (Study to understand fall reduction and vitamin D in you), Dr. Appel and colleagues enrolled 688 community-dwelling participants who had an elevated risk of falling, defined as a serum 25-hydroxyvitamin D [25(OH)D] level of 25 to 72.5 nmol/L (10-29 ng/dL).

Participants were a mean age of 77.2 years and had a mean total 25(OH)D level of 55.3 nmol/L at enrollment.

They were randomized to one of four doses of vitamin D3, including 200 IU/day (the control group), or 1,000, 2,000, or 4,000 IU/day.

The highest doses were found to be associated with worse – not better – outcomes including a shorter time to hospitalization or death, compared with the 1,000-IU/day group. The higher-dose groups were therefore switched to a dose of 1,000 IU/day or lower, and all participants were followed for up to 2 years.

Overall, 63% experienced falls over the course of the study, which, though high, was consistent with the study’s criteria of participants having an elevated fall risk.

Of the 667 participants who completed the trial, no benefit in prevention of falling was seen across any of the doses, compared with the control group dose of 200 IU/day, regardless of participants’ baseline vitamin D levels.

Safety analyses showed that even in the 1,000-IU/day group, a higher risk of first serious fall and first fall with hospitalization was seen compared with the 200-IU/day group.

A limitation is that the study did not have a placebo group, however, “200 IU/day is a very small dose, probably homeopathic,” Dr. Appel said. “It was likely close to a placebo,” he said.
 

 

 

Caveats: comorbidities, subgroups

In his editorial, Dr. Troen notes other studies, including VITAL (Vitamin D and Omega-3 Trial) also found no reduction in falls with higher vitamin D doses; however, that study did not show any significant risks with the higher doses.

He adds that the current study lacks information on subsets of participants.

“We don’t have enough information about the existing comorbidities and medications that these people are on to be able to pull back the layers. Maybe there is a subgroup that should not be getting 4,000 IU, whereas another subgroup may not be harmed and you may decide that patient can benefit,” he said.

Furthermore, the trial doesn’t address groups such as nursing home residents.

“I have, for instance, 85-year-olds with vitamin D levels of maybe 20 nmol/L with multiple medical issues, but levels that low were not included in the study, so this is a tricky business, but the bottom line is first, do no harm,” he said.

“We really need trials that factor in the multiple different aspects so we can come up, hopefully, with a holistic and interdisciplinary approach, which is usually the best way to optimize care for frail older adults,” he concluded.

The study received funding from the National Institute of Aging.
 

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

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Phase 1 study: Beta-blocker may improve melanoma treatment response

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Response rates were high without dose-limiting toxicities in a small phase 1 study that evaluated the addition of propranolol to pembrolizumab in treatment-naive patients with metastatic melanoma.

“To our knowledge, this effort is the first prospective clinical trial to show that the combination of propranolol with pembrolizumab is safe, and additionally suggests preliminary synergistic antitumor activity in treatment-naive metastatic melanoma,” wrote the two co-first authors, Shipra Gandhi, MD, and Manu Pandey, MBBS, from the Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and coauthors.

The need for combinations built on anti-PD1 checkpoint inhibitor therapy strategies in metastatic melanoma that safely improve outcomes is underscored by the high (59%) grade 3 or 4 treatment-related adverse event (TRAE) rates when an anti-CTLA4 agent (ipilimumab) was added to an anti-PD-1 agent (nivolumab), they noted. In contrast, a TRAE rate of only 17% has been reported with pembrolizumab monotherapy.

The phase 1b study was stimulated by preclinical, retrospective observations of improved overall survival (OS) in cancer patients treated with beta-blockers. These were preceded by murine melanoma studies showing decreased tumor growth and metastasis with the nonselective beta-blocker propranolol. “Propranolol exerts an antitumor effect,” the authors stated, “by favorably modulating the tumor microenvironment (TME) by decreasing myeloid-derived suppressor cells and increasing CD8+ T-cell and natural killer cells in the TME.” Other research in a melanoma model in chronically-stressed mice has demonstrated synergy between an anti-PD1 antibody and propranolol.

“We know that stress can have a significant negative effect on health, but the extent to which stress may impact the outcome of cancer therapy is not well understood at all,” Dr. Ghandi said in a statement provided by Roswell Park. “We set out to better understand this relationship and to explore its implications for cancer treatment.”

The investigators recruited nine White adults (median age 65 years) with treatment-naive, histologically confirmed unresectable stage III or IV melanoma and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 to the open-label, single arm, nonrandomized, single-center, dose-finding study. Patients received standard of care intravenous pembrolizumab 200 mg every 3 weeks and, in three groups, propranolol doses of 10 mg, 20 mg, or 30 mg twice a day until 2 years on study or disease progression or the development of dose-limiting toxicities (DLTs). Assessing the safety and efficacy (overall response rate [ORR] within 6 months of starting therapy) of pembrolizumab with the increasing doses of propranolol and selecting the recommended phase 2 dose were the study’s primary objectives.

Objective responses (complete or partial responses) were reported in seven of the nine patients, with partial tumor responses in two patients in the propranolol 10-mg group, two partial responses in the 20-mg group, and three partial responses in the 30-mg group.

While all patients experienced TRAEs, only one was above grade 2. The most commonly reported TRAEs were fatigue, rash and vitiligo, reported in four of the nine patients. Two patients in the 20-mg twice-a-day group discontinued therapy because of TRAEs (hemophagocytic lymphohistiocytosis and labyrinthitis). No DLTs were observed at any of the three dose levels, and no deaths occurred on study treatment.

The authors said that propranolol 30 mg twice a day was chosen as the recommended phase 2 dose, because in combination with pembrolizumab, there were no DLTs, and preliminary antitumor efficacy was observed in all three patients. Also, in all three patients, the investigators observed a trend toward higher CD8+T-cell percentage, higher ratios of CD8+T-cell/ Treg and CD8+T-cell/ polymorphonuclear myeloid-derived suppressor cells. They underscored, however, that the small size and significant heterogeneity in biomarkers made a statistically sound and meaningful interpretation of biomarkers for deciding the phase 2 dose difficult.

“In repurposing propranolol,” Dr. Pandey said in the Roswell statement, “we’ve gained important insights on how to manage stress in people with cancer – who can face dangerously elevated levels of mental and physical stress related to their diagnosis and treatment.”

In an interview, one of the two senior authors, Elizabeth Repasky, PhD, professor of oncology and immunology at Roswell Park, said, “it’s exciting that an extremely inexpensive drug like propranolol that could be used in every country around the world could have an impact on cancer by blocking stress, especially chronic stress.” Her murine research showing that adding propranolol to immunotherapy or radiotherapy or chemotherapy improved tumor growth control provided rationale for the current study.

“The breakthrough in this study is that it reveals the immune system as the best target to look at, and shows that what stress reduction is doing is improving a patient’s immune response to his or her own tumor,” Dr. Repasky said. “The mind/body connection is so important, but we have not had a handle on how to study it,” she added.

Further research funded by Herd of Hope grants at Roswell will look at tumor effects of propranolol and nonpharmacological reducers of chronic stress such as exercise, meditation, yoga, and Tai Chi, with first studies in breast cancer.

The study was funded by Roswell Park, private, and NIH grants. The authors had no disclosures.
 

SOURCE: Gandhi S et al. Clin Cancer Res. 2020 Oct 30. doi: 10.1158/1078-0432.CCR-20-2381

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Response rates were high without dose-limiting toxicities in a small phase 1 study that evaluated the addition of propranolol to pembrolizumab in treatment-naive patients with metastatic melanoma.

“To our knowledge, this effort is the first prospective clinical trial to show that the combination of propranolol with pembrolizumab is safe, and additionally suggests preliminary synergistic antitumor activity in treatment-naive metastatic melanoma,” wrote the two co-first authors, Shipra Gandhi, MD, and Manu Pandey, MBBS, from the Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and coauthors.

The need for combinations built on anti-PD1 checkpoint inhibitor therapy strategies in metastatic melanoma that safely improve outcomes is underscored by the high (59%) grade 3 or 4 treatment-related adverse event (TRAE) rates when an anti-CTLA4 agent (ipilimumab) was added to an anti-PD-1 agent (nivolumab), they noted. In contrast, a TRAE rate of only 17% has been reported with pembrolizumab monotherapy.

The phase 1b study was stimulated by preclinical, retrospective observations of improved overall survival (OS) in cancer patients treated with beta-blockers. These were preceded by murine melanoma studies showing decreased tumor growth and metastasis with the nonselective beta-blocker propranolol. “Propranolol exerts an antitumor effect,” the authors stated, “by favorably modulating the tumor microenvironment (TME) by decreasing myeloid-derived suppressor cells and increasing CD8+ T-cell and natural killer cells in the TME.” Other research in a melanoma model in chronically-stressed mice has demonstrated synergy between an anti-PD1 antibody and propranolol.

“We know that stress can have a significant negative effect on health, but the extent to which stress may impact the outcome of cancer therapy is not well understood at all,” Dr. Ghandi said in a statement provided by Roswell Park. “We set out to better understand this relationship and to explore its implications for cancer treatment.”

The investigators recruited nine White adults (median age 65 years) with treatment-naive, histologically confirmed unresectable stage III or IV melanoma and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 to the open-label, single arm, nonrandomized, single-center, dose-finding study. Patients received standard of care intravenous pembrolizumab 200 mg every 3 weeks and, in three groups, propranolol doses of 10 mg, 20 mg, or 30 mg twice a day until 2 years on study or disease progression or the development of dose-limiting toxicities (DLTs). Assessing the safety and efficacy (overall response rate [ORR] within 6 months of starting therapy) of pembrolizumab with the increasing doses of propranolol and selecting the recommended phase 2 dose were the study’s primary objectives.

Objective responses (complete or partial responses) were reported in seven of the nine patients, with partial tumor responses in two patients in the propranolol 10-mg group, two partial responses in the 20-mg group, and three partial responses in the 30-mg group.

While all patients experienced TRAEs, only one was above grade 2. The most commonly reported TRAEs were fatigue, rash and vitiligo, reported in four of the nine patients. Two patients in the 20-mg twice-a-day group discontinued therapy because of TRAEs (hemophagocytic lymphohistiocytosis and labyrinthitis). No DLTs were observed at any of the three dose levels, and no deaths occurred on study treatment.

The authors said that propranolol 30 mg twice a day was chosen as the recommended phase 2 dose, because in combination with pembrolizumab, there were no DLTs, and preliminary antitumor efficacy was observed in all three patients. Also, in all three patients, the investigators observed a trend toward higher CD8+T-cell percentage, higher ratios of CD8+T-cell/ Treg and CD8+T-cell/ polymorphonuclear myeloid-derived suppressor cells. They underscored, however, that the small size and significant heterogeneity in biomarkers made a statistically sound and meaningful interpretation of biomarkers for deciding the phase 2 dose difficult.

“In repurposing propranolol,” Dr. Pandey said in the Roswell statement, “we’ve gained important insights on how to manage stress in people with cancer – who can face dangerously elevated levels of mental and physical stress related to their diagnosis and treatment.”

In an interview, one of the two senior authors, Elizabeth Repasky, PhD, professor of oncology and immunology at Roswell Park, said, “it’s exciting that an extremely inexpensive drug like propranolol that could be used in every country around the world could have an impact on cancer by blocking stress, especially chronic stress.” Her murine research showing that adding propranolol to immunotherapy or radiotherapy or chemotherapy improved tumor growth control provided rationale for the current study.

“The breakthrough in this study is that it reveals the immune system as the best target to look at, and shows that what stress reduction is doing is improving a patient’s immune response to his or her own tumor,” Dr. Repasky said. “The mind/body connection is so important, but we have not had a handle on how to study it,” she added.

Further research funded by Herd of Hope grants at Roswell will look at tumor effects of propranolol and nonpharmacological reducers of chronic stress such as exercise, meditation, yoga, and Tai Chi, with first studies in breast cancer.

The study was funded by Roswell Park, private, and NIH grants. The authors had no disclosures.
 

SOURCE: Gandhi S et al. Clin Cancer Res. 2020 Oct 30. doi: 10.1158/1078-0432.CCR-20-2381

Response rates were high without dose-limiting toxicities in a small phase 1 study that evaluated the addition of propranolol to pembrolizumab in treatment-naive patients with metastatic melanoma.

“To our knowledge, this effort is the first prospective clinical trial to show that the combination of propranolol with pembrolizumab is safe, and additionally suggests preliminary synergistic antitumor activity in treatment-naive metastatic melanoma,” wrote the two co-first authors, Shipra Gandhi, MD, and Manu Pandey, MBBS, from the Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and coauthors.

The need for combinations built on anti-PD1 checkpoint inhibitor therapy strategies in metastatic melanoma that safely improve outcomes is underscored by the high (59%) grade 3 or 4 treatment-related adverse event (TRAE) rates when an anti-CTLA4 agent (ipilimumab) was added to an anti-PD-1 agent (nivolumab), they noted. In contrast, a TRAE rate of only 17% has been reported with pembrolizumab monotherapy.

The phase 1b study was stimulated by preclinical, retrospective observations of improved overall survival (OS) in cancer patients treated with beta-blockers. These were preceded by murine melanoma studies showing decreased tumor growth and metastasis with the nonselective beta-blocker propranolol. “Propranolol exerts an antitumor effect,” the authors stated, “by favorably modulating the tumor microenvironment (TME) by decreasing myeloid-derived suppressor cells and increasing CD8+ T-cell and natural killer cells in the TME.” Other research in a melanoma model in chronically-stressed mice has demonstrated synergy between an anti-PD1 antibody and propranolol.

“We know that stress can have a significant negative effect on health, but the extent to which stress may impact the outcome of cancer therapy is not well understood at all,” Dr. Ghandi said in a statement provided by Roswell Park. “We set out to better understand this relationship and to explore its implications for cancer treatment.”

The investigators recruited nine White adults (median age 65 years) with treatment-naive, histologically confirmed unresectable stage III or IV melanoma and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 to the open-label, single arm, nonrandomized, single-center, dose-finding study. Patients received standard of care intravenous pembrolizumab 200 mg every 3 weeks and, in three groups, propranolol doses of 10 mg, 20 mg, or 30 mg twice a day until 2 years on study or disease progression or the development of dose-limiting toxicities (DLTs). Assessing the safety and efficacy (overall response rate [ORR] within 6 months of starting therapy) of pembrolizumab with the increasing doses of propranolol and selecting the recommended phase 2 dose were the study’s primary objectives.

Objective responses (complete or partial responses) were reported in seven of the nine patients, with partial tumor responses in two patients in the propranolol 10-mg group, two partial responses in the 20-mg group, and three partial responses in the 30-mg group.

While all patients experienced TRAEs, only one was above grade 2. The most commonly reported TRAEs were fatigue, rash and vitiligo, reported in four of the nine patients. Two patients in the 20-mg twice-a-day group discontinued therapy because of TRAEs (hemophagocytic lymphohistiocytosis and labyrinthitis). No DLTs were observed at any of the three dose levels, and no deaths occurred on study treatment.

The authors said that propranolol 30 mg twice a day was chosen as the recommended phase 2 dose, because in combination with pembrolizumab, there were no DLTs, and preliminary antitumor efficacy was observed in all three patients. Also, in all three patients, the investigators observed a trend toward higher CD8+T-cell percentage, higher ratios of CD8+T-cell/ Treg and CD8+T-cell/ polymorphonuclear myeloid-derived suppressor cells. They underscored, however, that the small size and significant heterogeneity in biomarkers made a statistically sound and meaningful interpretation of biomarkers for deciding the phase 2 dose difficult.

“In repurposing propranolol,” Dr. Pandey said in the Roswell statement, “we’ve gained important insights on how to manage stress in people with cancer – who can face dangerously elevated levels of mental and physical stress related to their diagnosis and treatment.”

In an interview, one of the two senior authors, Elizabeth Repasky, PhD, professor of oncology and immunology at Roswell Park, said, “it’s exciting that an extremely inexpensive drug like propranolol that could be used in every country around the world could have an impact on cancer by blocking stress, especially chronic stress.” Her murine research showing that adding propranolol to immunotherapy or radiotherapy or chemotherapy improved tumor growth control provided rationale for the current study.

“The breakthrough in this study is that it reveals the immune system as the best target to look at, and shows that what stress reduction is doing is improving a patient’s immune response to his or her own tumor,” Dr. Repasky said. “The mind/body connection is so important, but we have not had a handle on how to study it,” she added.

Further research funded by Herd of Hope grants at Roswell will look at tumor effects of propranolol and nonpharmacological reducers of chronic stress such as exercise, meditation, yoga, and Tai Chi, with first studies in breast cancer.

The study was funded by Roswell Park, private, and NIH grants. The authors had no disclosures.
 

SOURCE: Gandhi S et al. Clin Cancer Res. 2020 Oct 30. doi: 10.1158/1078-0432.CCR-20-2381

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New residency matching sets record, says NRMP

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The 2020 Medical Specialties Matching Program (MSMP), a division of the National Resident Matching Program, matched a record number of applicants to subspecialty training programs for positions beginning in 2021, the NRMP reported.

“Specifically, the 2020 MSMP included 6,847 applicants submitting certified rank order lists (an 8.9% increase), 2042 programs submitting certified rank order lists (a 4.3% increase), 5,734 positions (a 2.8% increase), and 5,208 positions filled (a 6.1% increase),” according to a news release.

The MSMP now includes 14 internal medicine subspecialties and four sub-subspecialties. The MSMP offered 5,734 positions this year, and 5,208 (90.8%) were successfully filled. That represents an increase of almost 3 percentage points, compared with last year’s results.

Among those subspecialties that offered 30 positions or more, the most competitive were allergy and immunology, cardiovascular disease, clinical cardiac electrophysiology, gastroenterology, hematology and oncology, and pulmonary/critical care. Each of those filled at least 95% of available slots. More than half of the positions were filled by U.S. MDs.

By contrast, the least competitive subspecialties were geriatric medicine and nephrology. Programs in these two fields filled less than 75% of positions offered. Less than 45% were filled by U.S. MDs.

More than 76% of the 6,847 applicants who submitted rank order lists (5,208) matched into residency programs.

The number of U.S. MDs in this category increased nearly 7% over last year, with a total of 2,935. The number of DO graduates increased as well, with a total of 855, which was 9.6% more than the previous year.

More U.S. citizens who graduated from international medical schools matched this year as well; 1,087 placed into subspecialty residency, a 9% increase, compared with last year.

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

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The 2020 Medical Specialties Matching Program (MSMP), a division of the National Resident Matching Program, matched a record number of applicants to subspecialty training programs for positions beginning in 2021, the NRMP reported.

“Specifically, the 2020 MSMP included 6,847 applicants submitting certified rank order lists (an 8.9% increase), 2042 programs submitting certified rank order lists (a 4.3% increase), 5,734 positions (a 2.8% increase), and 5,208 positions filled (a 6.1% increase),” according to a news release.

The MSMP now includes 14 internal medicine subspecialties and four sub-subspecialties. The MSMP offered 5,734 positions this year, and 5,208 (90.8%) were successfully filled. That represents an increase of almost 3 percentage points, compared with last year’s results.

Among those subspecialties that offered 30 positions or more, the most competitive were allergy and immunology, cardiovascular disease, clinical cardiac electrophysiology, gastroenterology, hematology and oncology, and pulmonary/critical care. Each of those filled at least 95% of available slots. More than half of the positions were filled by U.S. MDs.

By contrast, the least competitive subspecialties were geriatric medicine and nephrology. Programs in these two fields filled less than 75% of positions offered. Less than 45% were filled by U.S. MDs.

More than 76% of the 6,847 applicants who submitted rank order lists (5,208) matched into residency programs.

The number of U.S. MDs in this category increased nearly 7% over last year, with a total of 2,935. The number of DO graduates increased as well, with a total of 855, which was 9.6% more than the previous year.

More U.S. citizens who graduated from international medical schools matched this year as well; 1,087 placed into subspecialty residency, a 9% increase, compared with last year.

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

The 2020 Medical Specialties Matching Program (MSMP), a division of the National Resident Matching Program, matched a record number of applicants to subspecialty training programs for positions beginning in 2021, the NRMP reported.

“Specifically, the 2020 MSMP included 6,847 applicants submitting certified rank order lists (an 8.9% increase), 2042 programs submitting certified rank order lists (a 4.3% increase), 5,734 positions (a 2.8% increase), and 5,208 positions filled (a 6.1% increase),” according to a news release.

The MSMP now includes 14 internal medicine subspecialties and four sub-subspecialties. The MSMP offered 5,734 positions this year, and 5,208 (90.8%) were successfully filled. That represents an increase of almost 3 percentage points, compared with last year’s results.

Among those subspecialties that offered 30 positions or more, the most competitive were allergy and immunology, cardiovascular disease, clinical cardiac electrophysiology, gastroenterology, hematology and oncology, and pulmonary/critical care. Each of those filled at least 95% of available slots. More than half of the positions were filled by U.S. MDs.

By contrast, the least competitive subspecialties were geriatric medicine and nephrology. Programs in these two fields filled less than 75% of positions offered. Less than 45% were filled by U.S. MDs.

More than 76% of the 6,847 applicants who submitted rank order lists (5,208) matched into residency programs.

The number of U.S. MDs in this category increased nearly 7% over last year, with a total of 2,935. The number of DO graduates increased as well, with a total of 855, which was 9.6% more than the previous year.

More U.S. citizens who graduated from international medical schools matched this year as well; 1,087 placed into subspecialty residency, a 9% increase, compared with last year.

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

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Rounding to make the hospital go ‘round

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Hospitalists and performance incentive measures

No matter how you spin it, hospitalists are key to making the world of the hospital go ‘round, making their daily work of paramount interest to both hospitals and health systems.

In an effort to drive quality, safety, and efficiency, hospitals most commonly measure hospitalist work and reward it through ties to compensation. There are several trends in performance incentive metrics highlighted by the SHM 2020 State of Hospital Medicine (SoHM) Report. As hospitals support the subsidy required for hospitalist salaries, there is an increasing ask for hospitalist groups to partner with hospital operations to achieve certain goals. The lever of compensation, when appropriately applied to meaningful metrics, is one way of promoting desired behaviors.

Hospitalists are the primary attending physicians for patients in the hospital while also bridging the patient and their needs to the services of other subspecialists, allied health professionals, and when needed, postacute services. In this way, patients are efficiently moved along the acute care experience with multiple process and outcome measures being recorded along the way.

Some of these common performance incentive measures are determined by the Centers for Medicare and Medicaid Services while others may be of interest to third party payers. Often surrogate markers of process metrics (i.e. order set usage for certain diagnoses) are measured and incentivized as a way of directionally measuring small steps that each hospitalist can reliably control toward a presumably associated improvement in mortality or readmissions, for instance. Still other measures such as length of stay or timely completion of documentation have more to do with hospital operations, regulatory governance, and finance.

There are a variety of performance incentive metrics reported in the 2020 SoHM Report. Survey respondents could choose all measures that applied as compensation measures for their group in the past year. The most common metrics reported include patient satisfaction (48.7%), citizenship (45.8%), accuracy or timeliness of documentation (32.8%), and clinical process measures (30.7%).

DjelicS/Getty Images

It is important to acknowledge that most of these metrics are objective measurements and can be measured down to the individual physician. However, some of the objective measures, such as patient satisfaction data, must rely on agreed upon methods of attribution – which can include anything from attributing based on admitting physician, discharging attending, or the attending with the greatest number of days (i.e. daily charges) seeing the patient. Because of challenges with attribution, groups may opt for group measurement of metrics for some of the compensation metrics where attribution is most muddy.

For performance incentive metrics that may be more subjective, such as citizenship, it is important for hospitalist leaders to consider having a method of determining a person’s contribution with a rubric as well as some shared decision making among a committee of leaders or team members to promote fairness in compensation.

Hospital leaders must also recognize that what is measured will lead to “performance” in that area. The perfect example here is the “early morning discharge time/orders” which is a compensation metric in 27.6% of hospitalist groups. Most agree that having some early discharges, up to maybe 25%-30% of the total number of discharges before noon, can be helpful with hospital throughput. The trick here is that if a patient can be discharged that early, it is likely that some of those patients could have gone home the evening prior. It is important for hospitalist physician leaders and administrators to think about the behaviors that are incentivized in compensation metrics to ensure that the result is indeed helpful.

Dr. Tresa Muir McNeal

Other hospitalist compensation metrics such as readmissions are most effectively addressed if there are multiple physician teams working toward the same metric. Hospitalist work does effect readmissions within the first 7 days of discharge based on available evidence.1 Preventing readmissions from days 8-30 following discharge are more amenable to outpatient and home-based interventions. Also, effective readmission work involves collaboration among the emergency physician team, surgeons, primary care, and subspecialty physicians. So while having this as a compensation metric will gain the attention of hospitalist physicians, the work will be most effective when it is shared with other teams.

Overall, performance incentive metrics for hospitalists can be effective in allowing hospitals and hospitalist groups to partner toward achieving important outcomes for patients. Easy and frequent sharing of data on meaningful metrics with hospitalists is important to effect change. Also, hospital leadership can facilitate collaboration among nursing and multiple physician groups to promote a team culture with hospitalists in achieving goals related to performance incentive metrics.

Dr. McNeal is the division director of inpatient medicine at Baylor Scott & White Medical Center in Temple, Tex.
 

Reference

1. Graham, et al. Preventability of Early Versus Late Hospital Readmissions in a National Cohort of General Medicine Patients. Ann Intern Med. 2018 Jun 5;168(11):766-74.

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Hospitalists and performance incentive measures

Hospitalists and performance incentive measures

No matter how you spin it, hospitalists are key to making the world of the hospital go ‘round, making their daily work of paramount interest to both hospitals and health systems.

In an effort to drive quality, safety, and efficiency, hospitals most commonly measure hospitalist work and reward it through ties to compensation. There are several trends in performance incentive metrics highlighted by the SHM 2020 State of Hospital Medicine (SoHM) Report. As hospitals support the subsidy required for hospitalist salaries, there is an increasing ask for hospitalist groups to partner with hospital operations to achieve certain goals. The lever of compensation, when appropriately applied to meaningful metrics, is one way of promoting desired behaviors.

Hospitalists are the primary attending physicians for patients in the hospital while also bridging the patient and their needs to the services of other subspecialists, allied health professionals, and when needed, postacute services. In this way, patients are efficiently moved along the acute care experience with multiple process and outcome measures being recorded along the way.

Some of these common performance incentive measures are determined by the Centers for Medicare and Medicaid Services while others may be of interest to third party payers. Often surrogate markers of process metrics (i.e. order set usage for certain diagnoses) are measured and incentivized as a way of directionally measuring small steps that each hospitalist can reliably control toward a presumably associated improvement in mortality or readmissions, for instance. Still other measures such as length of stay or timely completion of documentation have more to do with hospital operations, regulatory governance, and finance.

There are a variety of performance incentive metrics reported in the 2020 SoHM Report. Survey respondents could choose all measures that applied as compensation measures for their group in the past year. The most common metrics reported include patient satisfaction (48.7%), citizenship (45.8%), accuracy or timeliness of documentation (32.8%), and clinical process measures (30.7%).

DjelicS/Getty Images

It is important to acknowledge that most of these metrics are objective measurements and can be measured down to the individual physician. However, some of the objective measures, such as patient satisfaction data, must rely on agreed upon methods of attribution – which can include anything from attributing based on admitting physician, discharging attending, or the attending with the greatest number of days (i.e. daily charges) seeing the patient. Because of challenges with attribution, groups may opt for group measurement of metrics for some of the compensation metrics where attribution is most muddy.

For performance incentive metrics that may be more subjective, such as citizenship, it is important for hospitalist leaders to consider having a method of determining a person’s contribution with a rubric as well as some shared decision making among a committee of leaders or team members to promote fairness in compensation.

Hospital leaders must also recognize that what is measured will lead to “performance” in that area. The perfect example here is the “early morning discharge time/orders” which is a compensation metric in 27.6% of hospitalist groups. Most agree that having some early discharges, up to maybe 25%-30% of the total number of discharges before noon, can be helpful with hospital throughput. The trick here is that if a patient can be discharged that early, it is likely that some of those patients could have gone home the evening prior. It is important for hospitalist physician leaders and administrators to think about the behaviors that are incentivized in compensation metrics to ensure that the result is indeed helpful.

Dr. Tresa Muir McNeal

Other hospitalist compensation metrics such as readmissions are most effectively addressed if there are multiple physician teams working toward the same metric. Hospitalist work does effect readmissions within the first 7 days of discharge based on available evidence.1 Preventing readmissions from days 8-30 following discharge are more amenable to outpatient and home-based interventions. Also, effective readmission work involves collaboration among the emergency physician team, surgeons, primary care, and subspecialty physicians. So while having this as a compensation metric will gain the attention of hospitalist physicians, the work will be most effective when it is shared with other teams.

Overall, performance incentive metrics for hospitalists can be effective in allowing hospitals and hospitalist groups to partner toward achieving important outcomes for patients. Easy and frequent sharing of data on meaningful metrics with hospitalists is important to effect change. Also, hospital leadership can facilitate collaboration among nursing and multiple physician groups to promote a team culture with hospitalists in achieving goals related to performance incentive metrics.

Dr. McNeal is the division director of inpatient medicine at Baylor Scott & White Medical Center in Temple, Tex.
 

Reference

1. Graham, et al. Preventability of Early Versus Late Hospital Readmissions in a National Cohort of General Medicine Patients. Ann Intern Med. 2018 Jun 5;168(11):766-74.

No matter how you spin it, hospitalists are key to making the world of the hospital go ‘round, making their daily work of paramount interest to both hospitals and health systems.

In an effort to drive quality, safety, and efficiency, hospitals most commonly measure hospitalist work and reward it through ties to compensation. There are several trends in performance incentive metrics highlighted by the SHM 2020 State of Hospital Medicine (SoHM) Report. As hospitals support the subsidy required for hospitalist salaries, there is an increasing ask for hospitalist groups to partner with hospital operations to achieve certain goals. The lever of compensation, when appropriately applied to meaningful metrics, is one way of promoting desired behaviors.

Hospitalists are the primary attending physicians for patients in the hospital while also bridging the patient and their needs to the services of other subspecialists, allied health professionals, and when needed, postacute services. In this way, patients are efficiently moved along the acute care experience with multiple process and outcome measures being recorded along the way.

Some of these common performance incentive measures are determined by the Centers for Medicare and Medicaid Services while others may be of interest to third party payers. Often surrogate markers of process metrics (i.e. order set usage for certain diagnoses) are measured and incentivized as a way of directionally measuring small steps that each hospitalist can reliably control toward a presumably associated improvement in mortality or readmissions, for instance. Still other measures such as length of stay or timely completion of documentation have more to do with hospital operations, regulatory governance, and finance.

There are a variety of performance incentive metrics reported in the 2020 SoHM Report. Survey respondents could choose all measures that applied as compensation measures for their group in the past year. The most common metrics reported include patient satisfaction (48.7%), citizenship (45.8%), accuracy or timeliness of documentation (32.8%), and clinical process measures (30.7%).

DjelicS/Getty Images

It is important to acknowledge that most of these metrics are objective measurements and can be measured down to the individual physician. However, some of the objective measures, such as patient satisfaction data, must rely on agreed upon methods of attribution – which can include anything from attributing based on admitting physician, discharging attending, or the attending with the greatest number of days (i.e. daily charges) seeing the patient. Because of challenges with attribution, groups may opt for group measurement of metrics for some of the compensation metrics where attribution is most muddy.

For performance incentive metrics that may be more subjective, such as citizenship, it is important for hospitalist leaders to consider having a method of determining a person’s contribution with a rubric as well as some shared decision making among a committee of leaders or team members to promote fairness in compensation.

Hospital leaders must also recognize that what is measured will lead to “performance” in that area. The perfect example here is the “early morning discharge time/orders” which is a compensation metric in 27.6% of hospitalist groups. Most agree that having some early discharges, up to maybe 25%-30% of the total number of discharges before noon, can be helpful with hospital throughput. The trick here is that if a patient can be discharged that early, it is likely that some of those patients could have gone home the evening prior. It is important for hospitalist physician leaders and administrators to think about the behaviors that are incentivized in compensation metrics to ensure that the result is indeed helpful.

Dr. Tresa Muir McNeal

Other hospitalist compensation metrics such as readmissions are most effectively addressed if there are multiple physician teams working toward the same metric. Hospitalist work does effect readmissions within the first 7 days of discharge based on available evidence.1 Preventing readmissions from days 8-30 following discharge are more amenable to outpatient and home-based interventions. Also, effective readmission work involves collaboration among the emergency physician team, surgeons, primary care, and subspecialty physicians. So while having this as a compensation metric will gain the attention of hospitalist physicians, the work will be most effective when it is shared with other teams.

Overall, performance incentive metrics for hospitalists can be effective in allowing hospitals and hospitalist groups to partner toward achieving important outcomes for patients. Easy and frequent sharing of data on meaningful metrics with hospitalists is important to effect change. Also, hospital leadership can facilitate collaboration among nursing and multiple physician groups to promote a team culture with hospitalists in achieving goals related to performance incentive metrics.

Dr. McNeal is the division director of inpatient medicine at Baylor Scott & White Medical Center in Temple, Tex.
 

Reference

1. Graham, et al. Preventability of Early Versus Late Hospital Readmissions in a National Cohort of General Medicine Patients. Ann Intern Med. 2018 Jun 5;168(11):766-74.

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Biden chooses California Attorney General Xavier Becerra to head HHS

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President-elect Joe Biden has nominated California Attorney General Xavier Becerra to run the US Department of Health & Human Services (HHS) under his new administration, according to a statement from the Biden-Harris transition team.

Rich Pedroncelli/AP
Xavier Becerra

If confirmed by the US Senate, Becerra will face the challenge of overseeing the federal agency charged with protecting the health of all Americans in the midst of the COVID-19 pandemic. At the time of the announcement, nearly 15 million Americans had tested positive for COVID-19 and more than 280,000 had died.

Becerra served 12 terms in Congress, representing the Los Angeles area. Although his public health experience is limited, he served on the Congressional Ways and Means Committee overseeing health-related issues. Becerra is known as an advocate for the health and well-being of women in particular.

The American College of Physicians, American Academy of Pediatrics, American College of Obstetricians & Gynecologists, American Academy of Family Physicians, and the American Psychiatric Association wrote a letter to Biden on December 3 urging him to select leaders with medical and healthcare expertise, in particular physicians.

“We believe that your administration and the country would be well-served by the appointment of qualified physicians to serve in key positions critical to advancing the health of our nation,” they wrote. “Therefore, our organizations, which represent more than 400,000 front-line physicians practicing in the United States, write to request that you identify and appoint physicians to healthcare leadership positions within your administration.”
 

Recent advocacy

Becerra has worked with Republican attorneys general to lobby HHS to increase access to remdesivir to treat people with COVID-19.

As attorney general, Becerra filed more than 100 lawsuits against the Trump administration. In November, he also represented more than 20 states in arguments supporting the Affordable Care Act before the Supreme Court.

On December 4, Becerra joined with attorneys general from 23 states and the District of Columbia opposing a proposed rule from the outgoing Trump administration. The rule would deregulate HHS and “sunset”many agency provisions before Trump leaves office next month.

Becerra will be the first Latino appointed as HHS secretary, which furthers Biden’s goal to create a diverse cabinet. Becerra has been attorney general of California since 2017, replacing Vice President-elect Kamala Harris when she became senator.

Biden’s choice of Becerra was unexpected, according to The New York Times, and he was not the only candidate. Speculation was that Biden initially considered Vivek Murthy, MD, later chosen as the next US surgeon general, as well New Mexico Gov. Michelle Lujan Grisham and Rhode Island Gov. Gina Raimondo.
 

A huge undertaking

As HHS secretary, Becerra would oversee a wide range of federal agencies, including the US Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, and the Centers for Medicare & Medicaid Services.

The fiscal year 2021 budget proposed for HHS includes $94.5 billion in discretionary budget authority and $1.3 trillion in mandatory funding. Overall, HHS controls nearly one quarter of all federal expenditures and provides more grant money than all other federal agencies combined.

Becerra, 62, grew up in Sacramento, California. He was the first in his family to graduate from college. He received his undergraduate and law degrees from Stanford University.

This article first appeared on Medscape.com.

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President-elect Joe Biden has nominated California Attorney General Xavier Becerra to run the US Department of Health & Human Services (HHS) under his new administration, according to a statement from the Biden-Harris transition team.

Rich Pedroncelli/AP
Xavier Becerra

If confirmed by the US Senate, Becerra will face the challenge of overseeing the federal agency charged with protecting the health of all Americans in the midst of the COVID-19 pandemic. At the time of the announcement, nearly 15 million Americans had tested positive for COVID-19 and more than 280,000 had died.

Becerra served 12 terms in Congress, representing the Los Angeles area. Although his public health experience is limited, he served on the Congressional Ways and Means Committee overseeing health-related issues. Becerra is known as an advocate for the health and well-being of women in particular.

The American College of Physicians, American Academy of Pediatrics, American College of Obstetricians & Gynecologists, American Academy of Family Physicians, and the American Psychiatric Association wrote a letter to Biden on December 3 urging him to select leaders with medical and healthcare expertise, in particular physicians.

“We believe that your administration and the country would be well-served by the appointment of qualified physicians to serve in key positions critical to advancing the health of our nation,” they wrote. “Therefore, our organizations, which represent more than 400,000 front-line physicians practicing in the United States, write to request that you identify and appoint physicians to healthcare leadership positions within your administration.”
 

Recent advocacy

Becerra has worked with Republican attorneys general to lobby HHS to increase access to remdesivir to treat people with COVID-19.

As attorney general, Becerra filed more than 100 lawsuits against the Trump administration. In November, he also represented more than 20 states in arguments supporting the Affordable Care Act before the Supreme Court.

On December 4, Becerra joined with attorneys general from 23 states and the District of Columbia opposing a proposed rule from the outgoing Trump administration. The rule would deregulate HHS and “sunset”many agency provisions before Trump leaves office next month.

Becerra will be the first Latino appointed as HHS secretary, which furthers Biden’s goal to create a diverse cabinet. Becerra has been attorney general of California since 2017, replacing Vice President-elect Kamala Harris when she became senator.

Biden’s choice of Becerra was unexpected, according to The New York Times, and he was not the only candidate. Speculation was that Biden initially considered Vivek Murthy, MD, later chosen as the next US surgeon general, as well New Mexico Gov. Michelle Lujan Grisham and Rhode Island Gov. Gina Raimondo.
 

A huge undertaking

As HHS secretary, Becerra would oversee a wide range of federal agencies, including the US Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, and the Centers for Medicare & Medicaid Services.

The fiscal year 2021 budget proposed for HHS includes $94.5 billion in discretionary budget authority and $1.3 trillion in mandatory funding. Overall, HHS controls nearly one quarter of all federal expenditures and provides more grant money than all other federal agencies combined.

Becerra, 62, grew up in Sacramento, California. He was the first in his family to graduate from college. He received his undergraduate and law degrees from Stanford University.

This article first appeared on Medscape.com.

President-elect Joe Biden has nominated California Attorney General Xavier Becerra to run the US Department of Health & Human Services (HHS) under his new administration, according to a statement from the Biden-Harris transition team.

Rich Pedroncelli/AP
Xavier Becerra

If confirmed by the US Senate, Becerra will face the challenge of overseeing the federal agency charged with protecting the health of all Americans in the midst of the COVID-19 pandemic. At the time of the announcement, nearly 15 million Americans had tested positive for COVID-19 and more than 280,000 had died.

Becerra served 12 terms in Congress, representing the Los Angeles area. Although his public health experience is limited, he served on the Congressional Ways and Means Committee overseeing health-related issues. Becerra is known as an advocate for the health and well-being of women in particular.

The American College of Physicians, American Academy of Pediatrics, American College of Obstetricians & Gynecologists, American Academy of Family Physicians, and the American Psychiatric Association wrote a letter to Biden on December 3 urging him to select leaders with medical and healthcare expertise, in particular physicians.

“We believe that your administration and the country would be well-served by the appointment of qualified physicians to serve in key positions critical to advancing the health of our nation,” they wrote. “Therefore, our organizations, which represent more than 400,000 front-line physicians practicing in the United States, write to request that you identify and appoint physicians to healthcare leadership positions within your administration.”
 

Recent advocacy

Becerra has worked with Republican attorneys general to lobby HHS to increase access to remdesivir to treat people with COVID-19.

As attorney general, Becerra filed more than 100 lawsuits against the Trump administration. In November, he also represented more than 20 states in arguments supporting the Affordable Care Act before the Supreme Court.

On December 4, Becerra joined with attorneys general from 23 states and the District of Columbia opposing a proposed rule from the outgoing Trump administration. The rule would deregulate HHS and “sunset”many agency provisions before Trump leaves office next month.

Becerra will be the first Latino appointed as HHS secretary, which furthers Biden’s goal to create a diverse cabinet. Becerra has been attorney general of California since 2017, replacing Vice President-elect Kamala Harris when she became senator.

Biden’s choice of Becerra was unexpected, according to The New York Times, and he was not the only candidate. Speculation was that Biden initially considered Vivek Murthy, MD, later chosen as the next US surgeon general, as well New Mexico Gov. Michelle Lujan Grisham and Rhode Island Gov. Gina Raimondo.
 

A huge undertaking

As HHS secretary, Becerra would oversee a wide range of federal agencies, including the US Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, and the Centers for Medicare & Medicaid Services.

The fiscal year 2021 budget proposed for HHS includes $94.5 billion in discretionary budget authority and $1.3 trillion in mandatory funding. Overall, HHS controls nearly one quarter of all federal expenditures and provides more grant money than all other federal agencies combined.

Becerra, 62, grew up in Sacramento, California. He was the first in his family to graduate from college. He received his undergraduate and law degrees from Stanford University.

This article first appeared on Medscape.com.

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NHS England starts pilot trial of blood test for many cancers

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A simple blood test, claimed to detect more than 50 types of cancer, will be used in a pilot trial by National Health Service England in a bid to increase rates of early-stage diagnosis, in particular for cancers that are currently difficult to diagnose.

“Early detection, particularly for hard-to-treat conditions like ovarian and pancreatic cancer, has the potential to save many lives,” said NHS Chief Executive Sir Simon Stevens in a statement.

The pilot trial will use the Galleri blood test, developed by Grail. Sir Stevens described the blood test as “promising” and said it could “be a game changer in cancer care, helping thousands more people to get successful treatment.”

However, some clinicians have expressed concerns over the potential for false-positive results with the test.

Results of a study of the Galleri blood test, published earlier this year, showed that the test detected 50 types of cancer with a specificity of 99.3% and a false positive rate of 0.7%.

It also correctly identified the originating tissue in 90% of cases. However, the sensitivity was lower, at 67%, for the 12 most common cancers, as reported at the time.

The senior author of that study, Michael Seiden, MD, PhD, president of the U.S. Oncology Network, The Woodlands, Tex., noted that it was not a screening study: the test had been used in patients with cancer and in healthy volunteers. He said the test “is intended to be complementary to, and not replace, existing guideline-recommended screening tests and might provide new avenues of investigation for cancers that don’t currently have screening tests.”

The Galleri test uses next-generation sequencing to analyze the arrangement of methyl groups on circulating cell-free DNA in a blood sample.

Several other blood tests for cancer are under development, including the CancerSEEK test, which has been reported to be able to identify eight common cancers. It measures circulating tumor DNA from 16 genes and eight protein biomarkers and then uses machine learning to analyze the data.
 

Improving early detection rates

The pilot trial of the blood test is due to start in mid-2021 and will involve 165,000 people.

The trial will include 140,000 individuals aged 50-79 years who were identified through their health records and who have no cancer symptoms. They will undergo blood tests annually for 3 years and will be referred for investigation if a test result is positive.

A second group will include 25,000 people with potential cancer symptoms. These patients will be offered the blood test to speed up their diagnosis after referral to a hospital via the normal channels.

The results of the pilot are expected in 2023. If successful, the test will be rolled out to 1 million individuals from 2024 to 2025.

The pilot trial is part of the NHS Long Term Plan, which aims to increase early detection of cancer. At present, around half of cancers in England are diagnosed in stage I or II; the NHS aims to increase this to 75% by 2028.

“The NHS has set itself an ambitious target,” commented Peter Johnson, MD, PhD, national clinical director for cancer at NHS England and Improvement.

“Tests like this may help us get there far faster, and I am excited to see how this cutting-edge technology will work out as we test it in clinics across the NHS,” he added.

Lord David Prior, chair of NHS England, noted that almost 200,000 people die from cancer in the United Kingdom every year and that “many of these people are diagnosed too late for treatment to be effective.

“This collaboration between the NHS and Grail offers the chance for a wide range of cancers to be diagnosed much earlier and could fundamentally change the outlook for people with cancer,” he said.

However, some clinicians raised potential concerns.

Stephen Duffy, PhD, Center for Cancer Prevention, Queen Mary University of London, described the pilot as “very exciting,” but cautioned: “We will need to find out just how early the test detects cancers and whether it can it be used in a way which minimizes anxiety from false positives.”

Yong-Jie Lu, MD, PhD, also at Queen Mary University of London, said: “It is not clear how early it aims to catch cancer. For a cancer screen test, it needs very high specificity (>99%), otherwise it may end up in a similar situation as the PSA [prostate-specific antigen] test for prostate cancer, or even worse.”

Mangesh Thorat, MD, Cancer Prevention Trials Unit, King’s College London, warned: “It is likely that for every testing round ... there will be about 1,000 false-positive results, and the test may not be able to pinpoint the location of cancer in 3%-4% of those with a true positive result, necessitating a range of imaging and other investigations in these participants.”

No funding for the study has been declared. The investigators have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

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A simple blood test, claimed to detect more than 50 types of cancer, will be used in a pilot trial by National Health Service England in a bid to increase rates of early-stage diagnosis, in particular for cancers that are currently difficult to diagnose.

“Early detection, particularly for hard-to-treat conditions like ovarian and pancreatic cancer, has the potential to save many lives,” said NHS Chief Executive Sir Simon Stevens in a statement.

The pilot trial will use the Galleri blood test, developed by Grail. Sir Stevens described the blood test as “promising” and said it could “be a game changer in cancer care, helping thousands more people to get successful treatment.”

However, some clinicians have expressed concerns over the potential for false-positive results with the test.

Results of a study of the Galleri blood test, published earlier this year, showed that the test detected 50 types of cancer with a specificity of 99.3% and a false positive rate of 0.7%.

It also correctly identified the originating tissue in 90% of cases. However, the sensitivity was lower, at 67%, for the 12 most common cancers, as reported at the time.

The senior author of that study, Michael Seiden, MD, PhD, president of the U.S. Oncology Network, The Woodlands, Tex., noted that it was not a screening study: the test had been used in patients with cancer and in healthy volunteers. He said the test “is intended to be complementary to, and not replace, existing guideline-recommended screening tests and might provide new avenues of investigation for cancers that don’t currently have screening tests.”

The Galleri test uses next-generation sequencing to analyze the arrangement of methyl groups on circulating cell-free DNA in a blood sample.

Several other blood tests for cancer are under development, including the CancerSEEK test, which has been reported to be able to identify eight common cancers. It measures circulating tumor DNA from 16 genes and eight protein biomarkers and then uses machine learning to analyze the data.
 

Improving early detection rates

The pilot trial of the blood test is due to start in mid-2021 and will involve 165,000 people.

The trial will include 140,000 individuals aged 50-79 years who were identified through their health records and who have no cancer symptoms. They will undergo blood tests annually for 3 years and will be referred for investigation if a test result is positive.

A second group will include 25,000 people with potential cancer symptoms. These patients will be offered the blood test to speed up their diagnosis after referral to a hospital via the normal channels.

The results of the pilot are expected in 2023. If successful, the test will be rolled out to 1 million individuals from 2024 to 2025.

The pilot trial is part of the NHS Long Term Plan, which aims to increase early detection of cancer. At present, around half of cancers in England are diagnosed in stage I or II; the NHS aims to increase this to 75% by 2028.

“The NHS has set itself an ambitious target,” commented Peter Johnson, MD, PhD, national clinical director for cancer at NHS England and Improvement.

“Tests like this may help us get there far faster, and I am excited to see how this cutting-edge technology will work out as we test it in clinics across the NHS,” he added.

Lord David Prior, chair of NHS England, noted that almost 200,000 people die from cancer in the United Kingdom every year and that “many of these people are diagnosed too late for treatment to be effective.

“This collaboration between the NHS and Grail offers the chance for a wide range of cancers to be diagnosed much earlier and could fundamentally change the outlook for people with cancer,” he said.

However, some clinicians raised potential concerns.

Stephen Duffy, PhD, Center for Cancer Prevention, Queen Mary University of London, described the pilot as “very exciting,” but cautioned: “We will need to find out just how early the test detects cancers and whether it can it be used in a way which minimizes anxiety from false positives.”

Yong-Jie Lu, MD, PhD, also at Queen Mary University of London, said: “It is not clear how early it aims to catch cancer. For a cancer screen test, it needs very high specificity (>99%), otherwise it may end up in a similar situation as the PSA [prostate-specific antigen] test for prostate cancer, or even worse.”

Mangesh Thorat, MD, Cancer Prevention Trials Unit, King’s College London, warned: “It is likely that for every testing round ... there will be about 1,000 false-positive results, and the test may not be able to pinpoint the location of cancer in 3%-4% of those with a true positive result, necessitating a range of imaging and other investigations in these participants.”

No funding for the study has been declared. The investigators have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A simple blood test, claimed to detect more than 50 types of cancer, will be used in a pilot trial by National Health Service England in a bid to increase rates of early-stage diagnosis, in particular for cancers that are currently difficult to diagnose.

“Early detection, particularly for hard-to-treat conditions like ovarian and pancreatic cancer, has the potential to save many lives,” said NHS Chief Executive Sir Simon Stevens in a statement.

The pilot trial will use the Galleri blood test, developed by Grail. Sir Stevens described the blood test as “promising” and said it could “be a game changer in cancer care, helping thousands more people to get successful treatment.”

However, some clinicians have expressed concerns over the potential for false-positive results with the test.

Results of a study of the Galleri blood test, published earlier this year, showed that the test detected 50 types of cancer with a specificity of 99.3% and a false positive rate of 0.7%.

It also correctly identified the originating tissue in 90% of cases. However, the sensitivity was lower, at 67%, for the 12 most common cancers, as reported at the time.

The senior author of that study, Michael Seiden, MD, PhD, president of the U.S. Oncology Network, The Woodlands, Tex., noted that it was not a screening study: the test had been used in patients with cancer and in healthy volunteers. He said the test “is intended to be complementary to, and not replace, existing guideline-recommended screening tests and might provide new avenues of investigation for cancers that don’t currently have screening tests.”

The Galleri test uses next-generation sequencing to analyze the arrangement of methyl groups on circulating cell-free DNA in a blood sample.

Several other blood tests for cancer are under development, including the CancerSEEK test, which has been reported to be able to identify eight common cancers. It measures circulating tumor DNA from 16 genes and eight protein biomarkers and then uses machine learning to analyze the data.
 

Improving early detection rates

The pilot trial of the blood test is due to start in mid-2021 and will involve 165,000 people.

The trial will include 140,000 individuals aged 50-79 years who were identified through their health records and who have no cancer symptoms. They will undergo blood tests annually for 3 years and will be referred for investigation if a test result is positive.

A second group will include 25,000 people with potential cancer symptoms. These patients will be offered the blood test to speed up their diagnosis after referral to a hospital via the normal channels.

The results of the pilot are expected in 2023. If successful, the test will be rolled out to 1 million individuals from 2024 to 2025.

The pilot trial is part of the NHS Long Term Plan, which aims to increase early detection of cancer. At present, around half of cancers in England are diagnosed in stage I or II; the NHS aims to increase this to 75% by 2028.

“The NHS has set itself an ambitious target,” commented Peter Johnson, MD, PhD, national clinical director for cancer at NHS England and Improvement.

“Tests like this may help us get there far faster, and I am excited to see how this cutting-edge technology will work out as we test it in clinics across the NHS,” he added.

Lord David Prior, chair of NHS England, noted that almost 200,000 people die from cancer in the United Kingdom every year and that “many of these people are diagnosed too late for treatment to be effective.

“This collaboration between the NHS and Grail offers the chance for a wide range of cancers to be diagnosed much earlier and could fundamentally change the outlook for people with cancer,” he said.

However, some clinicians raised potential concerns.

Stephen Duffy, PhD, Center for Cancer Prevention, Queen Mary University of London, described the pilot as “very exciting,” but cautioned: “We will need to find out just how early the test detects cancers and whether it can it be used in a way which minimizes anxiety from false positives.”

Yong-Jie Lu, MD, PhD, also at Queen Mary University of London, said: “It is not clear how early it aims to catch cancer. For a cancer screen test, it needs very high specificity (>99%), otherwise it may end up in a similar situation as the PSA [prostate-specific antigen] test for prostate cancer, or even worse.”

Mangesh Thorat, MD, Cancer Prevention Trials Unit, King’s College London, warned: “It is likely that for every testing round ... there will be about 1,000 false-positive results, and the test may not be able to pinpoint the location of cancer in 3%-4% of those with a true positive result, necessitating a range of imaging and other investigations in these participants.”

No funding for the study has been declared. The investigators have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

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Impostor syndrome: Implications for medical professionals

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A few years ago, I was asked to give a talk on impostor syndrome at a national conference. My initial thought was “I am not even remotely qualified to give this talk.” Upon reflection, I think that was the first time I acknowledged that I, too, suffer from this syndrome.

Dr. Kimberly Brown

There are many definitions and designations (e.g., impostor phenomenon or fraud syndrome), but the one I use most often is high-achieving individuals who are marked by an inability to internalize their accomplishments and a persistent fear of being exposed as a fraud. People with high expressions of this syndrome believe that any success they achieve is due more to luck or error than to personal skill or accomplishment. They live in fear that their incompetence will be exposed and they will be revealed as a fraud both intellectually and within their job or role. First described by Clance and Imes in 1978,1 the original authors observed that many highly respected and accomplished women did not experience an internal sense of success despite their education and evidence of academic achievement. Based in part on previous observations regarding the differential attribution of success in men and women,2 the authors suggested that two general principles were found to be at the heart of this syndrome. The first was that an unexpected performance outcome will be attributed to a temporary cause. The second was that an expected performance outcome will be attributed to a stable cause. As such, the authors originally suggested that women tended to explain failure with lack of ability, whereas men attributed failure to luck or task difficulty. Furthermore, the authors emphasized environmental factors – such as mentorship, competition, and isolation – as the primary influence in the development of these tendencies.

Although originally described in women, this phenomenon can also affect men, as well as a wide variety of people from different occupations and cultures.3-6 Furthermore, although environmental factors were originally linked as the primary driver of these tendencies, further research has suggested that personality factors play a larger role, and that up to 70% of people may experience this phenomenon in their lifetime.7 Personality traits such as perfectionism and neuroticism may be linked to the development of this phenomenon.3,8

There are several online screening questionnaires that can be used to gauge whether individuals experience some or most of these traits. On one such questionnaire, the Clance IP Scale,9 poses such questions as: “I have often succeeded on a test or task even though I was afraid that I would not do well before I undertook the task” and “I am afraid people important to me may find out that I am not as capable as they think I am.” There are 20 questions scored from 1 to 5 and a score of 40 or below suggests few impostor tendencies, while a score of 80 or above suggests the respondent often has intense IP experiences. The higher the score, the more frequently and seriously the impostor syndrome interferes in a person’s life. What is unclear is whether this worsens, improves, or stays the same throughout one’s career. Of interest is that my personal score at this time is 43; however, it would have been 89 had I taken the test during college and medical school. What is unclear to me from the literature is what factors may play a role in a person’s perception of their abilities and their personal confidence over time.

Why is this important? Given that we are all professionals, impostor tendencies appear to have significant impact in the context of our work. This may have impact on us both as employers and as employees.10 Individuals with impostor syndrome tendencies often characterize themselves negatively and perform poorly on self-appraisals.11 In a study of 201 Belgian white-collar workers, Vergauwe and colleagues found that impostor syndrome tendencies were negatively related to job satisfaction and organizational citizenship behavior; both of which could be influenced by a high degree of social support.10 Individuals with impostor syndrome tendencies do less career planning, explore career options less frequently, and are less inclined to lead.12,13 These tendencies can be detrimental as the most qualified people for a position or opportunity may not step forward for consideration. Employers may tend to overlook these individuals for promotions or for pay raises which could negatively influence future earnings. Furthermore, a person may experience increased burnout as they continuously try to overcompensate for what they perceive as their shortcomings. They may feel concerned they are letting others down or not performing to standards. They may derive less enjoyment from life because of the constant focus on feelings of inadequacy.14 Research along these lines suggest impostor syndrome tendencies can have adverse personal and health-related consequences and may increase social anxiety, depression, and overall psychological distress.15,16

 

 


What can we do about it? In a very interesting study by Zanchetta and colleagues, the authors studied 103 young employees and randomized them to receive coaching, training, or no intervention.17 Their findings showed that coaching was an effective mindset intervention which resulted in reduced impostor syndrome scores. Furthermore, fear of negative evaluation and the effect of coaching appeared to be significantly associated with a reduction in the impostor syndrome scores. Coaching appeared to improve self-enhancing attributions and self-efficacy with a reduction in the tendency of subjects to fear negative evaluation. The authors concluded that fostering a mindset shift by reducing the fear of negative evaluations through coaching demonstrated measurable and sustained improvements in overall impostor syndrome scores for participants.17


What do I suggest? It is clear this affects a significant percentage of physicians, health care professionals, and professionals in general. Harboring these tendencies can have a negative impact on health, professional achievement, income, and happiness. It is important to self-reflect, identify if you are at risk, and if so, take the opportunity to explore solutions. My recommendations are:

 

  • Name it: Take the test and see how you score.
  • Be mindful: Self-reflection will help you identify the behaviors that are interfering with your happiness and success.
  • Write it down: Be strategic and document your plan for success to reinforce your accomplishments.
  • Create a feedback group: Friends and colleagues can help to mitigate the negative effects of impostor syndrome tendencies.
  • Speak up: Ask for help; coaching has been documented to reduce impostor syndrome scores and help lessen the burden of these tendencies.
  • Step out of your comfort zone: Develop a mantra, break bigger challenges into smaller pieces, and acknowledge little wins along the way.

In conclusion, impostor syndrome appears to be highly prevalent in professionals including those of us in medicine. The experience can adversely affect our careers and ability to secure key leadership positions. As managers, we also must keep in mind our role in mentoring others and recognizing the potential impact of impostor syndrome on those who report to us. Recognition of this phenomenon – and understanding of the effects on oneself – is the first step in overcoming the negative effects and moving toward realization of one’s potential.
 

Dr. Brown is a professor of medicine at Wayne State University, division chief of gastroenterology and hepatology at Henry Ford Hospital, and associate medical director at the Henry Ford Hospital Transplant Institute, all in Detroit.

References

1. Clance PR, Imes S. Psychother Theory Res Pract. 1978 Fall;15(3):1-7.

2. Deaux D. In J.H.Harvey, W.J.Ickes and R.F. Kidd (Eds). New directions in attribution research. Vol. 1. New York: Halsted Press Division, Wiley. 1976; p 335-42.

3. Bernard NS et al. J Pers Assess. 2002;78(2):321-33.

4. Topping ME et al. Acad Psychol Bull. 1985;(7):213-26.

5. Langford J et al. Psychotherapy. 1993;30(3):495-501.

6. Chae JH et al. J Pers Assess. 1995;65(3):468-85.

7. Harvey JC et al. If I’m successful, why do I feel like a fake? New York: Random House, 1985.

8. Ross SR et al. Pers Individ Diff. 2001;31:1347-55.

9. Clance PR. The impostor phenomenon: When success makes you feel like a fake. Toronto: Bantam Books, 1985; p 20-2.

10. Vergauwe J et al. J Bus Psychol. 2015;30:565-81.

11. Leary MR et al. J Pers. 2000;68(4):725-56.

12. Neureiter M et al. Front Psychol. 2016;7:48.

13. Neureiter M et al. J Vocat Behav. 2017;98:56-69.

14. Duhigg C. The power of habit: Why we do what we do in life and business. New York: Random House, 2012.

15. Henning K et al. Med Educ. 1998 Sep;32(5):456-64.

16. Oriel K et al. Fam Med. 2004 Apr;36(4):248-52.

17. Zanchetta M et al. Front Psychol. 2020 May 15;11:405.

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A few years ago, I was asked to give a talk on impostor syndrome at a national conference. My initial thought was “I am not even remotely qualified to give this talk.” Upon reflection, I think that was the first time I acknowledged that I, too, suffer from this syndrome.

Dr. Kimberly Brown

There are many definitions and designations (e.g., impostor phenomenon or fraud syndrome), but the one I use most often is high-achieving individuals who are marked by an inability to internalize their accomplishments and a persistent fear of being exposed as a fraud. People with high expressions of this syndrome believe that any success they achieve is due more to luck or error than to personal skill or accomplishment. They live in fear that their incompetence will be exposed and they will be revealed as a fraud both intellectually and within their job or role. First described by Clance and Imes in 1978,1 the original authors observed that many highly respected and accomplished women did not experience an internal sense of success despite their education and evidence of academic achievement. Based in part on previous observations regarding the differential attribution of success in men and women,2 the authors suggested that two general principles were found to be at the heart of this syndrome. The first was that an unexpected performance outcome will be attributed to a temporary cause. The second was that an expected performance outcome will be attributed to a stable cause. As such, the authors originally suggested that women tended to explain failure with lack of ability, whereas men attributed failure to luck or task difficulty. Furthermore, the authors emphasized environmental factors – such as mentorship, competition, and isolation – as the primary influence in the development of these tendencies.

Although originally described in women, this phenomenon can also affect men, as well as a wide variety of people from different occupations and cultures.3-6 Furthermore, although environmental factors were originally linked as the primary driver of these tendencies, further research has suggested that personality factors play a larger role, and that up to 70% of people may experience this phenomenon in their lifetime.7 Personality traits such as perfectionism and neuroticism may be linked to the development of this phenomenon.3,8

There are several online screening questionnaires that can be used to gauge whether individuals experience some or most of these traits. On one such questionnaire, the Clance IP Scale,9 poses such questions as: “I have often succeeded on a test or task even though I was afraid that I would not do well before I undertook the task” and “I am afraid people important to me may find out that I am not as capable as they think I am.” There are 20 questions scored from 1 to 5 and a score of 40 or below suggests few impostor tendencies, while a score of 80 or above suggests the respondent often has intense IP experiences. The higher the score, the more frequently and seriously the impostor syndrome interferes in a person’s life. What is unclear is whether this worsens, improves, or stays the same throughout one’s career. Of interest is that my personal score at this time is 43; however, it would have been 89 had I taken the test during college and medical school. What is unclear to me from the literature is what factors may play a role in a person’s perception of their abilities and their personal confidence over time.

Why is this important? Given that we are all professionals, impostor tendencies appear to have significant impact in the context of our work. This may have impact on us both as employers and as employees.10 Individuals with impostor syndrome tendencies often characterize themselves negatively and perform poorly on self-appraisals.11 In a study of 201 Belgian white-collar workers, Vergauwe and colleagues found that impostor syndrome tendencies were negatively related to job satisfaction and organizational citizenship behavior; both of which could be influenced by a high degree of social support.10 Individuals with impostor syndrome tendencies do less career planning, explore career options less frequently, and are less inclined to lead.12,13 These tendencies can be detrimental as the most qualified people for a position or opportunity may not step forward for consideration. Employers may tend to overlook these individuals for promotions or for pay raises which could negatively influence future earnings. Furthermore, a person may experience increased burnout as they continuously try to overcompensate for what they perceive as their shortcomings. They may feel concerned they are letting others down or not performing to standards. They may derive less enjoyment from life because of the constant focus on feelings of inadequacy.14 Research along these lines suggest impostor syndrome tendencies can have adverse personal and health-related consequences and may increase social anxiety, depression, and overall psychological distress.15,16

 

 


What can we do about it? In a very interesting study by Zanchetta and colleagues, the authors studied 103 young employees and randomized them to receive coaching, training, or no intervention.17 Their findings showed that coaching was an effective mindset intervention which resulted in reduced impostor syndrome scores. Furthermore, fear of negative evaluation and the effect of coaching appeared to be significantly associated with a reduction in the impostor syndrome scores. Coaching appeared to improve self-enhancing attributions and self-efficacy with a reduction in the tendency of subjects to fear negative evaluation. The authors concluded that fostering a mindset shift by reducing the fear of negative evaluations through coaching demonstrated measurable and sustained improvements in overall impostor syndrome scores for participants.17


What do I suggest? It is clear this affects a significant percentage of physicians, health care professionals, and professionals in general. Harboring these tendencies can have a negative impact on health, professional achievement, income, and happiness. It is important to self-reflect, identify if you are at risk, and if so, take the opportunity to explore solutions. My recommendations are:

 

  • Name it: Take the test and see how you score.
  • Be mindful: Self-reflection will help you identify the behaviors that are interfering with your happiness and success.
  • Write it down: Be strategic and document your plan for success to reinforce your accomplishments.
  • Create a feedback group: Friends and colleagues can help to mitigate the negative effects of impostor syndrome tendencies.
  • Speak up: Ask for help; coaching has been documented to reduce impostor syndrome scores and help lessen the burden of these tendencies.
  • Step out of your comfort zone: Develop a mantra, break bigger challenges into smaller pieces, and acknowledge little wins along the way.

In conclusion, impostor syndrome appears to be highly prevalent in professionals including those of us in medicine. The experience can adversely affect our careers and ability to secure key leadership positions. As managers, we also must keep in mind our role in mentoring others and recognizing the potential impact of impostor syndrome on those who report to us. Recognition of this phenomenon – and understanding of the effects on oneself – is the first step in overcoming the negative effects and moving toward realization of one’s potential.
 

Dr. Brown is a professor of medicine at Wayne State University, division chief of gastroenterology and hepatology at Henry Ford Hospital, and associate medical director at the Henry Ford Hospital Transplant Institute, all in Detroit.

References

1. Clance PR, Imes S. Psychother Theory Res Pract. 1978 Fall;15(3):1-7.

2. Deaux D. In J.H.Harvey, W.J.Ickes and R.F. Kidd (Eds). New directions in attribution research. Vol. 1. New York: Halsted Press Division, Wiley. 1976; p 335-42.

3. Bernard NS et al. J Pers Assess. 2002;78(2):321-33.

4. Topping ME et al. Acad Psychol Bull. 1985;(7):213-26.

5. Langford J et al. Psychotherapy. 1993;30(3):495-501.

6. Chae JH et al. J Pers Assess. 1995;65(3):468-85.

7. Harvey JC et al. If I’m successful, why do I feel like a fake? New York: Random House, 1985.

8. Ross SR et al. Pers Individ Diff. 2001;31:1347-55.

9. Clance PR. The impostor phenomenon: When success makes you feel like a fake. Toronto: Bantam Books, 1985; p 20-2.

10. Vergauwe J et al. J Bus Psychol. 2015;30:565-81.

11. Leary MR et al. J Pers. 2000;68(4):725-56.

12. Neureiter M et al. Front Psychol. 2016;7:48.

13. Neureiter M et al. J Vocat Behav. 2017;98:56-69.

14. Duhigg C. The power of habit: Why we do what we do in life and business. New York: Random House, 2012.

15. Henning K et al. Med Educ. 1998 Sep;32(5):456-64.

16. Oriel K et al. Fam Med. 2004 Apr;36(4):248-52.

17. Zanchetta M et al. Front Psychol. 2020 May 15;11:405.

A few years ago, I was asked to give a talk on impostor syndrome at a national conference. My initial thought was “I am not even remotely qualified to give this talk.” Upon reflection, I think that was the first time I acknowledged that I, too, suffer from this syndrome.

Dr. Kimberly Brown

There are many definitions and designations (e.g., impostor phenomenon or fraud syndrome), but the one I use most often is high-achieving individuals who are marked by an inability to internalize their accomplishments and a persistent fear of being exposed as a fraud. People with high expressions of this syndrome believe that any success they achieve is due more to luck or error than to personal skill or accomplishment. They live in fear that their incompetence will be exposed and they will be revealed as a fraud both intellectually and within their job or role. First described by Clance and Imes in 1978,1 the original authors observed that many highly respected and accomplished women did not experience an internal sense of success despite their education and evidence of academic achievement. Based in part on previous observations regarding the differential attribution of success in men and women,2 the authors suggested that two general principles were found to be at the heart of this syndrome. The first was that an unexpected performance outcome will be attributed to a temporary cause. The second was that an expected performance outcome will be attributed to a stable cause. As such, the authors originally suggested that women tended to explain failure with lack of ability, whereas men attributed failure to luck or task difficulty. Furthermore, the authors emphasized environmental factors – such as mentorship, competition, and isolation – as the primary influence in the development of these tendencies.

Although originally described in women, this phenomenon can also affect men, as well as a wide variety of people from different occupations and cultures.3-6 Furthermore, although environmental factors were originally linked as the primary driver of these tendencies, further research has suggested that personality factors play a larger role, and that up to 70% of people may experience this phenomenon in their lifetime.7 Personality traits such as perfectionism and neuroticism may be linked to the development of this phenomenon.3,8

There are several online screening questionnaires that can be used to gauge whether individuals experience some or most of these traits. On one such questionnaire, the Clance IP Scale,9 poses such questions as: “I have often succeeded on a test or task even though I was afraid that I would not do well before I undertook the task” and “I am afraid people important to me may find out that I am not as capable as they think I am.” There are 20 questions scored from 1 to 5 and a score of 40 or below suggests few impostor tendencies, while a score of 80 or above suggests the respondent often has intense IP experiences. The higher the score, the more frequently and seriously the impostor syndrome interferes in a person’s life. What is unclear is whether this worsens, improves, or stays the same throughout one’s career. Of interest is that my personal score at this time is 43; however, it would have been 89 had I taken the test during college and medical school. What is unclear to me from the literature is what factors may play a role in a person’s perception of their abilities and their personal confidence over time.

Why is this important? Given that we are all professionals, impostor tendencies appear to have significant impact in the context of our work. This may have impact on us both as employers and as employees.10 Individuals with impostor syndrome tendencies often characterize themselves negatively and perform poorly on self-appraisals.11 In a study of 201 Belgian white-collar workers, Vergauwe and colleagues found that impostor syndrome tendencies were negatively related to job satisfaction and organizational citizenship behavior; both of which could be influenced by a high degree of social support.10 Individuals with impostor syndrome tendencies do less career planning, explore career options less frequently, and are less inclined to lead.12,13 These tendencies can be detrimental as the most qualified people for a position or opportunity may not step forward for consideration. Employers may tend to overlook these individuals for promotions or for pay raises which could negatively influence future earnings. Furthermore, a person may experience increased burnout as they continuously try to overcompensate for what they perceive as their shortcomings. They may feel concerned they are letting others down or not performing to standards. They may derive less enjoyment from life because of the constant focus on feelings of inadequacy.14 Research along these lines suggest impostor syndrome tendencies can have adverse personal and health-related consequences and may increase social anxiety, depression, and overall psychological distress.15,16

 

 


What can we do about it? In a very interesting study by Zanchetta and colleagues, the authors studied 103 young employees and randomized them to receive coaching, training, or no intervention.17 Their findings showed that coaching was an effective mindset intervention which resulted in reduced impostor syndrome scores. Furthermore, fear of negative evaluation and the effect of coaching appeared to be significantly associated with a reduction in the impostor syndrome scores. Coaching appeared to improve self-enhancing attributions and self-efficacy with a reduction in the tendency of subjects to fear negative evaluation. The authors concluded that fostering a mindset shift by reducing the fear of negative evaluations through coaching demonstrated measurable and sustained improvements in overall impostor syndrome scores for participants.17


What do I suggest? It is clear this affects a significant percentage of physicians, health care professionals, and professionals in general. Harboring these tendencies can have a negative impact on health, professional achievement, income, and happiness. It is important to self-reflect, identify if you are at risk, and if so, take the opportunity to explore solutions. My recommendations are:

 

  • Name it: Take the test and see how you score.
  • Be mindful: Self-reflection will help you identify the behaviors that are interfering with your happiness and success.
  • Write it down: Be strategic and document your plan for success to reinforce your accomplishments.
  • Create a feedback group: Friends and colleagues can help to mitigate the negative effects of impostor syndrome tendencies.
  • Speak up: Ask for help; coaching has been documented to reduce impostor syndrome scores and help lessen the burden of these tendencies.
  • Step out of your comfort zone: Develop a mantra, break bigger challenges into smaller pieces, and acknowledge little wins along the way.

In conclusion, impostor syndrome appears to be highly prevalent in professionals including those of us in medicine. The experience can adversely affect our careers and ability to secure key leadership positions. As managers, we also must keep in mind our role in mentoring others and recognizing the potential impact of impostor syndrome on those who report to us. Recognition of this phenomenon – and understanding of the effects on oneself – is the first step in overcoming the negative effects and moving toward realization of one’s potential.
 

Dr. Brown is a professor of medicine at Wayne State University, division chief of gastroenterology and hepatology at Henry Ford Hospital, and associate medical director at the Henry Ford Hospital Transplant Institute, all in Detroit.

References

1. Clance PR, Imes S. Psychother Theory Res Pract. 1978 Fall;15(3):1-7.

2. Deaux D. In J.H.Harvey, W.J.Ickes and R.F. Kidd (Eds). New directions in attribution research. Vol. 1. New York: Halsted Press Division, Wiley. 1976; p 335-42.

3. Bernard NS et al. J Pers Assess. 2002;78(2):321-33.

4. Topping ME et al. Acad Psychol Bull. 1985;(7):213-26.

5. Langford J et al. Psychotherapy. 1993;30(3):495-501.

6. Chae JH et al. J Pers Assess. 1995;65(3):468-85.

7. Harvey JC et al. If I’m successful, why do I feel like a fake? New York: Random House, 1985.

8. Ross SR et al. Pers Individ Diff. 2001;31:1347-55.

9. Clance PR. The impostor phenomenon: When success makes you feel like a fake. Toronto: Bantam Books, 1985; p 20-2.

10. Vergauwe J et al. J Bus Psychol. 2015;30:565-81.

11. Leary MR et al. J Pers. 2000;68(4):725-56.

12. Neureiter M et al. Front Psychol. 2016;7:48.

13. Neureiter M et al. J Vocat Behav. 2017;98:56-69.

14. Duhigg C. The power of habit: Why we do what we do in life and business. New York: Random House, 2012.

15. Henning K et al. Med Educ. 1998 Sep;32(5):456-64.

16. Oriel K et al. Fam Med. 2004 Apr;36(4):248-52.

17. Zanchetta M et al. Front Psychol. 2020 May 15;11:405.

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