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New eGFR equation ‘less biased’ by age, kidney function; some disagree
The European Kidney Function Consortium (EKFC) equation surpasses existing equations by “resulting in generally lower bias across the spectrum of age and kidney function,” its developers wrote in an article published online Nov. 9 in Annals of Internal Medicine.
“The new EKFC equation may have helpful properties and perform better in estimating GFR, compared with the current KDIGO [Kidney Disease: Improving Global Outcomes]-recommended equations,” they added.
The primary KDIGO-recommended equation in its most recent guideline was the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, designed for adults, and a companion equation, the CKiD, covers children and adolescents.
“Key in our [new] equation is the adjustment for differences in serum creatinine generation between children and adults, or between men and women,” lead author Hans Pottel, PhD, KU Leuven (Belgium), said in an interview.
In an accompanying editorial, Andrew M. Levey, MD, and associates wrote: “We agree that a single eGFR equation that can be used in children and adults and performs well in the transition from adolescence to young adulthood is a worthy goal.”
“But the claim of equivalent or superior performance, compared with the CKD-EPI equation is not conclusive,” claimed Dr. Levey, who led the research team that developed the CKD-EPI equation, and coauthors.
Dr. Levey is professor of medicine at Tufts University, Boston.
What’s new is Q
Dr. Pottel and codevelopers devised what they call Q values: age- and sex-dependent median creatinine levels in normal individuals.
Q values act to “normalize or rescale creatinine before entering it into the equation, because we know that creatinine generation is different” based on factors that include age, sex, and muscle mass.
The EKFC equation extends the CKD-EPI equation and first eGFR equation by using Q values and applying across age ranges, like the full-age spectrum (FAS) equation, first reported in 2016 by a team led by Dr. Pottel.
“Although the FAS equation was designed to overcome the challenge in measuring GFR in patients transitioning from adolescence to adult nephrology care, it also underestimates GFR at low serum creatinine values and in patients with chronic kidney disease,” wrote Dr. Pottel and coauthors.
Hence, their intent to tweak the FAS equation to overcome this limitation and create the EKFC equation.
“The new equation combines the strengths of the CKD-EPI and FAS equations,” they woite.
However, “we acknowledge that lack of precision is still a major problem with all eGFR equations,” including the new EKFC, they added.
Editorialists dispute better performance of EKFC over CKD-EPI
In their editorial, Dr. Levey and coauthors noted the EKFC equations and other adapted equations in development “represent a conceptual advance over the FAS equations,” but they dispute the claims of better performance, compared with the CKD-EPI.
“We compared the performance of the EKFC and CKD-EPI equations in a different, large external validation population of Black and non-Black adults,” the external population used to validate the CKD-EPI equation, the editorialists reported.
The upshot was “our results did not confirm the author’s conclusions” about the EKFC equation.
In response, Dr. Pottel highlighted that the EKFC equation is currently not designed for use in Black patients.
“With its derivation and validation now reported in the new article, the EKFC equation is fully validated and ready for routine use in Whites,” he said. “We plan to evaluate and possibly fine tune our equation for its application in other ethnicities.”
Regarding the inferior performance, compared with the CKD-EPI equation in the non-Black population tested by the editorialists, Dr. Pottel cited “calibration issues for serum creatinine” that some experts have found in the datasets compiled by developers of the CKI-EPI equation that could limit the utility of these data.
Still room for improvement; app hopefully coming next year
Dr. Pottel and coauthors developed and validated the EKFC equation with data from 19,629 patients drawn from 13 cohorts. This included 11,251 patients from seven cohorts for development and internal validation, and 8378 from six cohorts for external validation. The EKFC effort received endorsement from the European Renal Association–European Dialysis and Transplant Association.
However, “We acknowledge that there is still room for improvement,” Dr. Pottel said.
Although the new report presents the EKFC equations (actually two slightly different equations depending on whether a patient’s serum creatinine is higher or lower than the relevant Q value), most potential users will likely find the equations easier to work with once they’re in an app form that allows someone to simply plug in age, sex, and serum creatinine level. That app currently doesn’t exist but is coming soon, promised Dr. Pottel.
“I hope to have an electronic tool by the beginning of 2021,” he said. “I have to find a programmer who can do this for me.”
The EKFC project has received no commercial funding. Dr. Pottel reported no relevant financial relationships. Dr. Levey has reported receiving research funding from AstraZeneca.
A version of this article originally appeared on Medscape.com.
The European Kidney Function Consortium (EKFC) equation surpasses existing equations by “resulting in generally lower bias across the spectrum of age and kidney function,” its developers wrote in an article published online Nov. 9 in Annals of Internal Medicine.
“The new EKFC equation may have helpful properties and perform better in estimating GFR, compared with the current KDIGO [Kidney Disease: Improving Global Outcomes]-recommended equations,” they added.
The primary KDIGO-recommended equation in its most recent guideline was the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, designed for adults, and a companion equation, the CKiD, covers children and adolescents.
“Key in our [new] equation is the adjustment for differences in serum creatinine generation between children and adults, or between men and women,” lead author Hans Pottel, PhD, KU Leuven (Belgium), said in an interview.
In an accompanying editorial, Andrew M. Levey, MD, and associates wrote: “We agree that a single eGFR equation that can be used in children and adults and performs well in the transition from adolescence to young adulthood is a worthy goal.”
“But the claim of equivalent or superior performance, compared with the CKD-EPI equation is not conclusive,” claimed Dr. Levey, who led the research team that developed the CKD-EPI equation, and coauthors.
Dr. Levey is professor of medicine at Tufts University, Boston.
What’s new is Q
Dr. Pottel and codevelopers devised what they call Q values: age- and sex-dependent median creatinine levels in normal individuals.
Q values act to “normalize or rescale creatinine before entering it into the equation, because we know that creatinine generation is different” based on factors that include age, sex, and muscle mass.
The EKFC equation extends the CKD-EPI equation and first eGFR equation by using Q values and applying across age ranges, like the full-age spectrum (FAS) equation, first reported in 2016 by a team led by Dr. Pottel.
“Although the FAS equation was designed to overcome the challenge in measuring GFR in patients transitioning from adolescence to adult nephrology care, it also underestimates GFR at low serum creatinine values and in patients with chronic kidney disease,” wrote Dr. Pottel and coauthors.
Hence, their intent to tweak the FAS equation to overcome this limitation and create the EKFC equation.
“The new equation combines the strengths of the CKD-EPI and FAS equations,” they woite.
However, “we acknowledge that lack of precision is still a major problem with all eGFR equations,” including the new EKFC, they added.
Editorialists dispute better performance of EKFC over CKD-EPI
In their editorial, Dr. Levey and coauthors noted the EKFC equations and other adapted equations in development “represent a conceptual advance over the FAS equations,” but they dispute the claims of better performance, compared with the CKD-EPI.
“We compared the performance of the EKFC and CKD-EPI equations in a different, large external validation population of Black and non-Black adults,” the external population used to validate the CKD-EPI equation, the editorialists reported.
The upshot was “our results did not confirm the author’s conclusions” about the EKFC equation.
In response, Dr. Pottel highlighted that the EKFC equation is currently not designed for use in Black patients.
“With its derivation and validation now reported in the new article, the EKFC equation is fully validated and ready for routine use in Whites,” he said. “We plan to evaluate and possibly fine tune our equation for its application in other ethnicities.”
Regarding the inferior performance, compared with the CKD-EPI equation in the non-Black population tested by the editorialists, Dr. Pottel cited “calibration issues for serum creatinine” that some experts have found in the datasets compiled by developers of the CKI-EPI equation that could limit the utility of these data.
Still room for improvement; app hopefully coming next year
Dr. Pottel and coauthors developed and validated the EKFC equation with data from 19,629 patients drawn from 13 cohorts. This included 11,251 patients from seven cohorts for development and internal validation, and 8378 from six cohorts for external validation. The EKFC effort received endorsement from the European Renal Association–European Dialysis and Transplant Association.
However, “We acknowledge that there is still room for improvement,” Dr. Pottel said.
Although the new report presents the EKFC equations (actually two slightly different equations depending on whether a patient’s serum creatinine is higher or lower than the relevant Q value), most potential users will likely find the equations easier to work with once they’re in an app form that allows someone to simply plug in age, sex, and serum creatinine level. That app currently doesn’t exist but is coming soon, promised Dr. Pottel.
“I hope to have an electronic tool by the beginning of 2021,” he said. “I have to find a programmer who can do this for me.”
The EKFC project has received no commercial funding. Dr. Pottel reported no relevant financial relationships. Dr. Levey has reported receiving research funding from AstraZeneca.
A version of this article originally appeared on Medscape.com.
The European Kidney Function Consortium (EKFC) equation surpasses existing equations by “resulting in generally lower bias across the spectrum of age and kidney function,” its developers wrote in an article published online Nov. 9 in Annals of Internal Medicine.
“The new EKFC equation may have helpful properties and perform better in estimating GFR, compared with the current KDIGO [Kidney Disease: Improving Global Outcomes]-recommended equations,” they added.
The primary KDIGO-recommended equation in its most recent guideline was the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, designed for adults, and a companion equation, the CKiD, covers children and adolescents.
“Key in our [new] equation is the adjustment for differences in serum creatinine generation between children and adults, or between men and women,” lead author Hans Pottel, PhD, KU Leuven (Belgium), said in an interview.
In an accompanying editorial, Andrew M. Levey, MD, and associates wrote: “We agree that a single eGFR equation that can be used in children and adults and performs well in the transition from adolescence to young adulthood is a worthy goal.”
“But the claim of equivalent or superior performance, compared with the CKD-EPI equation is not conclusive,” claimed Dr. Levey, who led the research team that developed the CKD-EPI equation, and coauthors.
Dr. Levey is professor of medicine at Tufts University, Boston.
What’s new is Q
Dr. Pottel and codevelopers devised what they call Q values: age- and sex-dependent median creatinine levels in normal individuals.
Q values act to “normalize or rescale creatinine before entering it into the equation, because we know that creatinine generation is different” based on factors that include age, sex, and muscle mass.
The EKFC equation extends the CKD-EPI equation and first eGFR equation by using Q values and applying across age ranges, like the full-age spectrum (FAS) equation, first reported in 2016 by a team led by Dr. Pottel.
“Although the FAS equation was designed to overcome the challenge in measuring GFR in patients transitioning from adolescence to adult nephrology care, it also underestimates GFR at low serum creatinine values and in patients with chronic kidney disease,” wrote Dr. Pottel and coauthors.
Hence, their intent to tweak the FAS equation to overcome this limitation and create the EKFC equation.
“The new equation combines the strengths of the CKD-EPI and FAS equations,” they woite.
However, “we acknowledge that lack of precision is still a major problem with all eGFR equations,” including the new EKFC, they added.
Editorialists dispute better performance of EKFC over CKD-EPI
In their editorial, Dr. Levey and coauthors noted the EKFC equations and other adapted equations in development “represent a conceptual advance over the FAS equations,” but they dispute the claims of better performance, compared with the CKD-EPI.
“We compared the performance of the EKFC and CKD-EPI equations in a different, large external validation population of Black and non-Black adults,” the external population used to validate the CKD-EPI equation, the editorialists reported.
The upshot was “our results did not confirm the author’s conclusions” about the EKFC equation.
In response, Dr. Pottel highlighted that the EKFC equation is currently not designed for use in Black patients.
“With its derivation and validation now reported in the new article, the EKFC equation is fully validated and ready for routine use in Whites,” he said. “We plan to evaluate and possibly fine tune our equation for its application in other ethnicities.”
Regarding the inferior performance, compared with the CKD-EPI equation in the non-Black population tested by the editorialists, Dr. Pottel cited “calibration issues for serum creatinine” that some experts have found in the datasets compiled by developers of the CKI-EPI equation that could limit the utility of these data.
Still room for improvement; app hopefully coming next year
Dr. Pottel and coauthors developed and validated the EKFC equation with data from 19,629 patients drawn from 13 cohorts. This included 11,251 patients from seven cohorts for development and internal validation, and 8378 from six cohorts for external validation. The EKFC effort received endorsement from the European Renal Association–European Dialysis and Transplant Association.
However, “We acknowledge that there is still room for improvement,” Dr. Pottel said.
Although the new report presents the EKFC equations (actually two slightly different equations depending on whether a patient’s serum creatinine is higher or lower than the relevant Q value), most potential users will likely find the equations easier to work with once they’re in an app form that allows someone to simply plug in age, sex, and serum creatinine level. That app currently doesn’t exist but is coming soon, promised Dr. Pottel.
“I hope to have an electronic tool by the beginning of 2021,” he said. “I have to find a programmer who can do this for me.”
The EKFC project has received no commercial funding. Dr. Pottel reported no relevant financial relationships. Dr. Levey has reported receiving research funding from AstraZeneca.
A version of this article originally appeared on Medscape.com.
Proinflammatory dietary pattern linked to higher CV risk
Dietary patterns with higher inflammatory potential were significantly associated with a higher incidence of cardiovascular disease (CVD) and stroke in a new pooled analysis of three prospective cohort studies.
The analysis included 210,145 U.S. women and men followed for up to 32 years in the Nurses’ Health Studies I and II and the Health Professionals Follow-up Study.
After adjustment for use of anti-inflammatory medications and CVD risk factors, those whose dietary pattern ranked in the highest quintile of inflammatory potential had a 38% higher risk of CVD (hazard ratio comparing highest with lowest quintiles, 1.38), a 46% higher risk of coronary heart disease (HR, 1.46), and a 28% higher risk of stroke (HR, 1.28) (all P for trend < .001).
Jun Li, MD, PhD, and colleagues at Harvard School of Public Health and Harvard Medical School, Boston, published the findings of their study in the Nov. 10 issue of the Journal of the American College of Cardiology.
The inflammatory potential of a diet was assessed using a food-based, dietary index called the “empirical dietary inflammatory pattern” or EDIP.
In an interview, Dr. Li explained that the EDIP was developed 4 years ago by many of the same authors involved with this study, including nutrition heavyweights Walter C. Willett, MD, DrPH, and Frank B. Hu, MD, PhD, both from Harvard.
“We summarized all the foods people eat into 39 defined food groups and did a reduced-rank regression analysis that looked at these 39 food groups and three inflammatory markers – interleukin-6, C-reactive protein, and tumor necrosis factor–alpha receptor 2. We found 18 food groups that are most predictive of these biomarkers, and the EDIP was calculated as the weighted sum of these 18 food groups.”
Individuals who had higher intakes of green-leafy vegetables (kale, spinach, arugula), dark-yellow vegetables (pumpkin, yellow peppers, carrots), whole grains, fruits, tea, coffee and wine had lower long-term CVD risk than those with higher intakes of red meat, processed meat, organ meat, refined carbohydrates, and sweetened beverages.
The associations were consistent across cohorts and between sexes and remained significant in multiple sensitivity analysis that adjusted for alcohol consumption, smoking pack-years, use of lipid-lowering and antihypertensive medications, sodium intake, and blood pressure.
In a secondary analysis, diets with higher inflammatory potential were also associated with significantly higher biomarker levels indicative of more systemic, vascular, and metabolic inflammation, as well as less favorable lipid profiles.
“We wanted to be able to provide guidance on dietary patterns and food combinations,” said Dr. Li. “If you tell people to eat more polyunsaturated fats instead of saturated fat or trans fat, most people don’t know what foods are higher and lower in those nutrients. Also, many foods have different nutrients – some of which are good and some of which are bad – so we wanted to help people find the foods with the higher proportion of healthy nutrients rather than point out specific nutrients to avoid.”
Researchers used prospectively gathered data from the Nurses’ Health Studies I and II starting from 1984 and from the Health Professionals Follow-up Study. After excluding participants with missing diet information or previously diagnosed heart disease, stroke or cancer, over 210,000 participants were included in the analysis. Participants completed a survey every 4 years to ascertain dietary intake.
Prevention, not treatment
In an editorial comment, Ramon Estruch, MD, PhD, from the Hospital Clinic in Barcelona, and colleagues suggested that it might be time for better dietary guidelines.
“A better knowledge of health protection provided by different foods and dietary patterns, mainly their anti-inflammatory properties, should provide the basis for designing even healthier dietary patterns to protect against heart disease,” the editorialists wrote.
They added extra-virgin olive oil, fatty fish, and tomatoes to the list of foods with “established anti-inflammatory activity.”
In a comment, Dr. Estruch said the findings of this new study are confirmatory of the PREDIMED trial, which showed a reduction in risk of major CV events in individuals at high cardiovascular risk assigned to an anti-inflammatory Mediterranean diet pattern supplemented with extra-virgin olive oil or nuts as compared with those assigned to a reduced-fat diet.
“The study of Jun Li et al. confirms that an anti-inflammatory diet is useful to prevent cardiovascular events and, more important, that healthy dietary patterns may be even healthier if subjects increase consumption of foods with the highest anti-inflammatory potential,” he said, adding that “mechanistic explanations add plausibility to the results of observational studies.”
Dr. Estruch was the principal investigator of PREDIMED. This trial was originally published in 2013 and then retracted and republished in 2018, with some required corrections, but the results had not materially changed.
Dr. Li is supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and Boston Nutrition Obesity Research Center. Dr. Estruch disclosed no financial relationships relevant to the contents of this article.
A version of this article originally appeared on Medscape.com.
Dietary patterns with higher inflammatory potential were significantly associated with a higher incidence of cardiovascular disease (CVD) and stroke in a new pooled analysis of three prospective cohort studies.
The analysis included 210,145 U.S. women and men followed for up to 32 years in the Nurses’ Health Studies I and II and the Health Professionals Follow-up Study.
After adjustment for use of anti-inflammatory medications and CVD risk factors, those whose dietary pattern ranked in the highest quintile of inflammatory potential had a 38% higher risk of CVD (hazard ratio comparing highest with lowest quintiles, 1.38), a 46% higher risk of coronary heart disease (HR, 1.46), and a 28% higher risk of stroke (HR, 1.28) (all P for trend < .001).
Jun Li, MD, PhD, and colleagues at Harvard School of Public Health and Harvard Medical School, Boston, published the findings of their study in the Nov. 10 issue of the Journal of the American College of Cardiology.
The inflammatory potential of a diet was assessed using a food-based, dietary index called the “empirical dietary inflammatory pattern” or EDIP.
In an interview, Dr. Li explained that the EDIP was developed 4 years ago by many of the same authors involved with this study, including nutrition heavyweights Walter C. Willett, MD, DrPH, and Frank B. Hu, MD, PhD, both from Harvard.
“We summarized all the foods people eat into 39 defined food groups and did a reduced-rank regression analysis that looked at these 39 food groups and three inflammatory markers – interleukin-6, C-reactive protein, and tumor necrosis factor–alpha receptor 2. We found 18 food groups that are most predictive of these biomarkers, and the EDIP was calculated as the weighted sum of these 18 food groups.”
Individuals who had higher intakes of green-leafy vegetables (kale, spinach, arugula), dark-yellow vegetables (pumpkin, yellow peppers, carrots), whole grains, fruits, tea, coffee and wine had lower long-term CVD risk than those with higher intakes of red meat, processed meat, organ meat, refined carbohydrates, and sweetened beverages.
The associations were consistent across cohorts and between sexes and remained significant in multiple sensitivity analysis that adjusted for alcohol consumption, smoking pack-years, use of lipid-lowering and antihypertensive medications, sodium intake, and blood pressure.
In a secondary analysis, diets with higher inflammatory potential were also associated with significantly higher biomarker levels indicative of more systemic, vascular, and metabolic inflammation, as well as less favorable lipid profiles.
“We wanted to be able to provide guidance on dietary patterns and food combinations,” said Dr. Li. “If you tell people to eat more polyunsaturated fats instead of saturated fat or trans fat, most people don’t know what foods are higher and lower in those nutrients. Also, many foods have different nutrients – some of which are good and some of which are bad – so we wanted to help people find the foods with the higher proportion of healthy nutrients rather than point out specific nutrients to avoid.”
Researchers used prospectively gathered data from the Nurses’ Health Studies I and II starting from 1984 and from the Health Professionals Follow-up Study. After excluding participants with missing diet information or previously diagnosed heart disease, stroke or cancer, over 210,000 participants were included in the analysis. Participants completed a survey every 4 years to ascertain dietary intake.
Prevention, not treatment
In an editorial comment, Ramon Estruch, MD, PhD, from the Hospital Clinic in Barcelona, and colleagues suggested that it might be time for better dietary guidelines.
“A better knowledge of health protection provided by different foods and dietary patterns, mainly their anti-inflammatory properties, should provide the basis for designing even healthier dietary patterns to protect against heart disease,” the editorialists wrote.
They added extra-virgin olive oil, fatty fish, and tomatoes to the list of foods with “established anti-inflammatory activity.”
In a comment, Dr. Estruch said the findings of this new study are confirmatory of the PREDIMED trial, which showed a reduction in risk of major CV events in individuals at high cardiovascular risk assigned to an anti-inflammatory Mediterranean diet pattern supplemented with extra-virgin olive oil or nuts as compared with those assigned to a reduced-fat diet.
“The study of Jun Li et al. confirms that an anti-inflammatory diet is useful to prevent cardiovascular events and, more important, that healthy dietary patterns may be even healthier if subjects increase consumption of foods with the highest anti-inflammatory potential,” he said, adding that “mechanistic explanations add plausibility to the results of observational studies.”
Dr. Estruch was the principal investigator of PREDIMED. This trial was originally published in 2013 and then retracted and republished in 2018, with some required corrections, but the results had not materially changed.
Dr. Li is supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and Boston Nutrition Obesity Research Center. Dr. Estruch disclosed no financial relationships relevant to the contents of this article.
A version of this article originally appeared on Medscape.com.
Dietary patterns with higher inflammatory potential were significantly associated with a higher incidence of cardiovascular disease (CVD) and stroke in a new pooled analysis of three prospective cohort studies.
The analysis included 210,145 U.S. women and men followed for up to 32 years in the Nurses’ Health Studies I and II and the Health Professionals Follow-up Study.
After adjustment for use of anti-inflammatory medications and CVD risk factors, those whose dietary pattern ranked in the highest quintile of inflammatory potential had a 38% higher risk of CVD (hazard ratio comparing highest with lowest quintiles, 1.38), a 46% higher risk of coronary heart disease (HR, 1.46), and a 28% higher risk of stroke (HR, 1.28) (all P for trend < .001).
Jun Li, MD, PhD, and colleagues at Harvard School of Public Health and Harvard Medical School, Boston, published the findings of their study in the Nov. 10 issue of the Journal of the American College of Cardiology.
The inflammatory potential of a diet was assessed using a food-based, dietary index called the “empirical dietary inflammatory pattern” or EDIP.
In an interview, Dr. Li explained that the EDIP was developed 4 years ago by many of the same authors involved with this study, including nutrition heavyweights Walter C. Willett, MD, DrPH, and Frank B. Hu, MD, PhD, both from Harvard.
“We summarized all the foods people eat into 39 defined food groups and did a reduced-rank regression analysis that looked at these 39 food groups and three inflammatory markers – interleukin-6, C-reactive protein, and tumor necrosis factor–alpha receptor 2. We found 18 food groups that are most predictive of these biomarkers, and the EDIP was calculated as the weighted sum of these 18 food groups.”
Individuals who had higher intakes of green-leafy vegetables (kale, spinach, arugula), dark-yellow vegetables (pumpkin, yellow peppers, carrots), whole grains, fruits, tea, coffee and wine had lower long-term CVD risk than those with higher intakes of red meat, processed meat, organ meat, refined carbohydrates, and sweetened beverages.
The associations were consistent across cohorts and between sexes and remained significant in multiple sensitivity analysis that adjusted for alcohol consumption, smoking pack-years, use of lipid-lowering and antihypertensive medications, sodium intake, and blood pressure.
In a secondary analysis, diets with higher inflammatory potential were also associated with significantly higher biomarker levels indicative of more systemic, vascular, and metabolic inflammation, as well as less favorable lipid profiles.
“We wanted to be able to provide guidance on dietary patterns and food combinations,” said Dr. Li. “If you tell people to eat more polyunsaturated fats instead of saturated fat or trans fat, most people don’t know what foods are higher and lower in those nutrients. Also, many foods have different nutrients – some of which are good and some of which are bad – so we wanted to help people find the foods with the higher proportion of healthy nutrients rather than point out specific nutrients to avoid.”
Researchers used prospectively gathered data from the Nurses’ Health Studies I and II starting from 1984 and from the Health Professionals Follow-up Study. After excluding participants with missing diet information or previously diagnosed heart disease, stroke or cancer, over 210,000 participants were included in the analysis. Participants completed a survey every 4 years to ascertain dietary intake.
Prevention, not treatment
In an editorial comment, Ramon Estruch, MD, PhD, from the Hospital Clinic in Barcelona, and colleagues suggested that it might be time for better dietary guidelines.
“A better knowledge of health protection provided by different foods and dietary patterns, mainly their anti-inflammatory properties, should provide the basis for designing even healthier dietary patterns to protect against heart disease,” the editorialists wrote.
They added extra-virgin olive oil, fatty fish, and tomatoes to the list of foods with “established anti-inflammatory activity.”
In a comment, Dr. Estruch said the findings of this new study are confirmatory of the PREDIMED trial, which showed a reduction in risk of major CV events in individuals at high cardiovascular risk assigned to an anti-inflammatory Mediterranean diet pattern supplemented with extra-virgin olive oil or nuts as compared with those assigned to a reduced-fat diet.
“The study of Jun Li et al. confirms that an anti-inflammatory diet is useful to prevent cardiovascular events and, more important, that healthy dietary patterns may be even healthier if subjects increase consumption of foods with the highest anti-inflammatory potential,” he said, adding that “mechanistic explanations add plausibility to the results of observational studies.”
Dr. Estruch was the principal investigator of PREDIMED. This trial was originally published in 2013 and then retracted and republished in 2018, with some required corrections, but the results had not materially changed.
Dr. Li is supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and Boston Nutrition Obesity Research Center. Dr. Estruch disclosed no financial relationships relevant to the contents of this article.
A version of this article originally appeared on Medscape.com.
Comment & Controversy
OBG Manag. 2020 November; 32(11).
The Fetal Pillow: A new option for delivering the deeply impacted fetal head
Robert L. Barbieri, MD
(Editorial; July 2020)
Alternative option to the Fetal Pillow
I enjoyed Dr. Barbieri’s editorial on the Fetal Pillow. I worry, however, that applying high air pressure to the upper vagina could result in an air embolism.
I have experienced good results using a vacuum cup. Like the pillow, it distributes the force more evenly than a hand. Also, the handle makes elevation of the vertex much less awkward and allows elevation to a higher station. Whatever approach is employed, using an open internal monitor catheter allows for a gentler procedure than when brute force alone is used to “break the seal” to allow ingress of air into the uterine cavity (at just 1 atmosphere of pressure).
John H. Sand, MD
Ellensburg, Washington
Cost of device must be considered
The information on the Fetal Pillow in Dr. Barbieri’s timely editorial, while limited in scope, does make the device look like a promising option.
One of my institution’s biggest issues relates to cost. We have had some interest in incorporating the Fetal Pillow into our practice, and we have been quoted a rate of about $600.00 per device. I had our Fetal Pillow representative look into reimbursement and have been informed that, at least in our region, there has been no reimbursement for the cost.
When I look at the cost of a hospital stay for a normal spontaneous vaginal delivery (NSVD), the cost of the Fetal Pillow would actually add 15% to 20% to that stay. Now, one must consider also the cost of extension of the uterine incision versus the cost of the Fetal Pillow. When we did a superficial look at when the Fetal Pillow might be used versus how many uterine extensions we experienced, the cost of the Fetal Pillow over a year far exceeded the cost of the uterine extensions. Without reimbursement, this appeared unsustainable. It has been interesting as some sites had no awareness of cost and the fact that essentially “the system” was absorbing those costs.
This issue is worthy of thought but likely one that most obstetricians will not consider.
Casey Morris, MD
Downers Grove, Illinois
Tip for dislodging the fetal head
I read Dr. Barbieri’s editorial regarding the Fetal Pillow and would like to share my experience. Over the last 30 years, I have used a simple trick. After entering the pelvic cavity, we push on the lower uterine segment toward the fundus prior to uterine incision. This helps dislodge the fetal head. Occasionally, you can feel the “pop” when the suction is broken, which sets the head free. We then proceed with the uterine incision and delivery of the head. We have had great success over the years, and the poor nurse does not have to go under the drapes.
Walter Kobasa Jr, MD
Wilmington, Delaware
Dr. Barbieri responds
I appreciate the recommendations and insights of Drs. Sand, Morris, and Kobasa. As I mentioned in the editorial on the Fetal Pillow, there are many clinical pearls about management of a second stage, deep-transverse cephalic arrest at the time of cesarean delivery, including to extend or T the uterine incision, push with a hand from below, reverse breech extraction, use a Coyne spoon, administer nitroglycerine or terbutaline, break the vaginal suction before attempting delivery, and incise a Bandl ring. Dr. Sand adds vaginal placement of a vacuum cup to our armamentarium, and Dr. Kobasa recommends dislodging the fetal head with a push on the lower uterine segment before making the hysterotomy incision. I thank Dr. Morris for correcting my failure to report the cost of the Fetal Pillow, reporting a quoted price of $600 for each Fetal Pillow. I agree with Dr. Morris that physicians have an important responsibility to be good stewards of health care resources and weigh the benefits and costs of our decisions.
Continue to: In your practice, are you planning to have a chaperone present for all intimate examinations?
In your practice, are you planning to have a chaperone present for all intimate examinations?
Robert L. Barbieri, MD
(Editorial; June 2020)
Enough is enough
I have always thought that many doctors who write opinions and pontificate about what should be done in practice live in la-la land. This editorial, for me, confirms it.
I personally am becoming tired of all this: dividing the specialty into obstetricians and gynecologists; pelvic exams are not necessary during annual visits; HPV testing by patients at home; doing away with Pap smears; Pap smears are not necessary for patients after a certain age; scribes in your footsteps to document all findings in the EMR; heaven forbid you do not ask the patient if she has a fire extinguisher in her house or some other stupid information; interpreters for people who speak Mongolian because their partner should not be used to interpret for them; and so on.
Now you want us to have a chaperone for every pelvic exam! Not any chaperone, but a specialized one! You worry about the sanctity and privacy of the patient but now have 2 additional people in the room for the patient’s exam. First, most patients prefer to have the least number of people looking at their bodies during an exam, especially a pelvic exam. Second, where do we get the money to support all of this? Does this type of policy make any sense? Are lawyers now controlling what medical care is all about? Is that what is now considered quality medical care?
By the way, I am not a burned out physician. I use common sense and consider what is best for my patients in everything that I do. If a patient requests a chaperone, my medical assistant will come to the room and provide that service. You do not need to be specialized to provide this service! Ivory tower people have lost all common sense. You consider yourselves the authorities in whatever medical field you specialize in, but let me tell you something: You really are not.
I know I will be criticized and demonized publicly by many; however, I have the courage to say what, in my opinion, I feel is right and what is wrong. Many physicians are afraid to do so, and, like sheep, will comply with your misguided opinions. I truly do not mean any disrespect to your knowledge and good intentions. I just think that enough is enough!
Gabriel G. Hakim, MD
Waterbury, Connecticut
Dr. Barbieri responds
In response to my editorial on the American College of Obstetricians and Gynecologists (ACOG) recommendation that chaperones be present for intimate examinations (ACOG Committee Opinion No. 796), Dr. Hakim outlines many concerns with the rapidly evolving practice of medicine.1 I am confident that the ACOG Committee on Ethics wisely considered the benefits, costs, and unintended consequences of the recommendation. The United States Veterans Administration, the Royal College of Obstetricians and Gynaecologists, and the American College Health Association endorse a similar recommendation. I do not think the distinguished members of the committees who issued the recommendation “live in la-la land.”
Reference
- American College of Obstetricians and Gynecologists Committee on Ethics. Sexual misconduct: ACOG Committee Opinion No. 796. Obstet Gynecol. 2020;135:e43-e50.
- American College of Obstetricians and Gynecologists Committee on Ethics. Sexual misconduct: ACOG Committee Opinion No. 796. Obstet Gynecol. 2020;135:e43-e50.
OBG Manag. 2020 November; 32(11).
The Fetal Pillow: A new option for delivering the deeply impacted fetal head
Robert L. Barbieri, MD
(Editorial; July 2020)
Alternative option to the Fetal Pillow
I enjoyed Dr. Barbieri’s editorial on the Fetal Pillow. I worry, however, that applying high air pressure to the upper vagina could result in an air embolism.
I have experienced good results using a vacuum cup. Like the pillow, it distributes the force more evenly than a hand. Also, the handle makes elevation of the vertex much less awkward and allows elevation to a higher station. Whatever approach is employed, using an open internal monitor catheter allows for a gentler procedure than when brute force alone is used to “break the seal” to allow ingress of air into the uterine cavity (at just 1 atmosphere of pressure).
John H. Sand, MD
Ellensburg, Washington
Cost of device must be considered
The information on the Fetal Pillow in Dr. Barbieri’s timely editorial, while limited in scope, does make the device look like a promising option.
One of my institution’s biggest issues relates to cost. We have had some interest in incorporating the Fetal Pillow into our practice, and we have been quoted a rate of about $600.00 per device. I had our Fetal Pillow representative look into reimbursement and have been informed that, at least in our region, there has been no reimbursement for the cost.
When I look at the cost of a hospital stay for a normal spontaneous vaginal delivery (NSVD), the cost of the Fetal Pillow would actually add 15% to 20% to that stay. Now, one must consider also the cost of extension of the uterine incision versus the cost of the Fetal Pillow. When we did a superficial look at when the Fetal Pillow might be used versus how many uterine extensions we experienced, the cost of the Fetal Pillow over a year far exceeded the cost of the uterine extensions. Without reimbursement, this appeared unsustainable. It has been interesting as some sites had no awareness of cost and the fact that essentially “the system” was absorbing those costs.
This issue is worthy of thought but likely one that most obstetricians will not consider.
Casey Morris, MD
Downers Grove, Illinois
Tip for dislodging the fetal head
I read Dr. Barbieri’s editorial regarding the Fetal Pillow and would like to share my experience. Over the last 30 years, I have used a simple trick. After entering the pelvic cavity, we push on the lower uterine segment toward the fundus prior to uterine incision. This helps dislodge the fetal head. Occasionally, you can feel the “pop” when the suction is broken, which sets the head free. We then proceed with the uterine incision and delivery of the head. We have had great success over the years, and the poor nurse does not have to go under the drapes.
Walter Kobasa Jr, MD
Wilmington, Delaware
Dr. Barbieri responds
I appreciate the recommendations and insights of Drs. Sand, Morris, and Kobasa. As I mentioned in the editorial on the Fetal Pillow, there are many clinical pearls about management of a second stage, deep-transverse cephalic arrest at the time of cesarean delivery, including to extend or T the uterine incision, push with a hand from below, reverse breech extraction, use a Coyne spoon, administer nitroglycerine or terbutaline, break the vaginal suction before attempting delivery, and incise a Bandl ring. Dr. Sand adds vaginal placement of a vacuum cup to our armamentarium, and Dr. Kobasa recommends dislodging the fetal head with a push on the lower uterine segment before making the hysterotomy incision. I thank Dr. Morris for correcting my failure to report the cost of the Fetal Pillow, reporting a quoted price of $600 for each Fetal Pillow. I agree with Dr. Morris that physicians have an important responsibility to be good stewards of health care resources and weigh the benefits and costs of our decisions.
Continue to: In your practice, are you planning to have a chaperone present for all intimate examinations?
In your practice, are you planning to have a chaperone present for all intimate examinations?
Robert L. Barbieri, MD
(Editorial; June 2020)
Enough is enough
I have always thought that many doctors who write opinions and pontificate about what should be done in practice live in la-la land. This editorial, for me, confirms it.
I personally am becoming tired of all this: dividing the specialty into obstetricians and gynecologists; pelvic exams are not necessary during annual visits; HPV testing by patients at home; doing away with Pap smears; Pap smears are not necessary for patients after a certain age; scribes in your footsteps to document all findings in the EMR; heaven forbid you do not ask the patient if she has a fire extinguisher in her house or some other stupid information; interpreters for people who speak Mongolian because their partner should not be used to interpret for them; and so on.
Now you want us to have a chaperone for every pelvic exam! Not any chaperone, but a specialized one! You worry about the sanctity and privacy of the patient but now have 2 additional people in the room for the patient’s exam. First, most patients prefer to have the least number of people looking at their bodies during an exam, especially a pelvic exam. Second, where do we get the money to support all of this? Does this type of policy make any sense? Are lawyers now controlling what medical care is all about? Is that what is now considered quality medical care?
By the way, I am not a burned out physician. I use common sense and consider what is best for my patients in everything that I do. If a patient requests a chaperone, my medical assistant will come to the room and provide that service. You do not need to be specialized to provide this service! Ivory tower people have lost all common sense. You consider yourselves the authorities in whatever medical field you specialize in, but let me tell you something: You really are not.
I know I will be criticized and demonized publicly by many; however, I have the courage to say what, in my opinion, I feel is right and what is wrong. Many physicians are afraid to do so, and, like sheep, will comply with your misguided opinions. I truly do not mean any disrespect to your knowledge and good intentions. I just think that enough is enough!
Gabriel G. Hakim, MD
Waterbury, Connecticut
Dr. Barbieri responds
In response to my editorial on the American College of Obstetricians and Gynecologists (ACOG) recommendation that chaperones be present for intimate examinations (ACOG Committee Opinion No. 796), Dr. Hakim outlines many concerns with the rapidly evolving practice of medicine.1 I am confident that the ACOG Committee on Ethics wisely considered the benefits, costs, and unintended consequences of the recommendation. The United States Veterans Administration, the Royal College of Obstetricians and Gynaecologists, and the American College Health Association endorse a similar recommendation. I do not think the distinguished members of the committees who issued the recommendation “live in la-la land.”
Reference
- American College of Obstetricians and Gynecologists Committee on Ethics. Sexual misconduct: ACOG Committee Opinion No. 796. Obstet Gynecol. 2020;135:e43-e50.
OBG Manag. 2020 November; 32(11).
The Fetal Pillow: A new option for delivering the deeply impacted fetal head
Robert L. Barbieri, MD
(Editorial; July 2020)
Alternative option to the Fetal Pillow
I enjoyed Dr. Barbieri’s editorial on the Fetal Pillow. I worry, however, that applying high air pressure to the upper vagina could result in an air embolism.
I have experienced good results using a vacuum cup. Like the pillow, it distributes the force more evenly than a hand. Also, the handle makes elevation of the vertex much less awkward and allows elevation to a higher station. Whatever approach is employed, using an open internal monitor catheter allows for a gentler procedure than when brute force alone is used to “break the seal” to allow ingress of air into the uterine cavity (at just 1 atmosphere of pressure).
John H. Sand, MD
Ellensburg, Washington
Cost of device must be considered
The information on the Fetal Pillow in Dr. Barbieri’s timely editorial, while limited in scope, does make the device look like a promising option.
One of my institution’s biggest issues relates to cost. We have had some interest in incorporating the Fetal Pillow into our practice, and we have been quoted a rate of about $600.00 per device. I had our Fetal Pillow representative look into reimbursement and have been informed that, at least in our region, there has been no reimbursement for the cost.
When I look at the cost of a hospital stay for a normal spontaneous vaginal delivery (NSVD), the cost of the Fetal Pillow would actually add 15% to 20% to that stay. Now, one must consider also the cost of extension of the uterine incision versus the cost of the Fetal Pillow. When we did a superficial look at when the Fetal Pillow might be used versus how many uterine extensions we experienced, the cost of the Fetal Pillow over a year far exceeded the cost of the uterine extensions. Without reimbursement, this appeared unsustainable. It has been interesting as some sites had no awareness of cost and the fact that essentially “the system” was absorbing those costs.
This issue is worthy of thought but likely one that most obstetricians will not consider.
Casey Morris, MD
Downers Grove, Illinois
Tip for dislodging the fetal head
I read Dr. Barbieri’s editorial regarding the Fetal Pillow and would like to share my experience. Over the last 30 years, I have used a simple trick. After entering the pelvic cavity, we push on the lower uterine segment toward the fundus prior to uterine incision. This helps dislodge the fetal head. Occasionally, you can feel the “pop” when the suction is broken, which sets the head free. We then proceed with the uterine incision and delivery of the head. We have had great success over the years, and the poor nurse does not have to go under the drapes.
Walter Kobasa Jr, MD
Wilmington, Delaware
Dr. Barbieri responds
I appreciate the recommendations and insights of Drs. Sand, Morris, and Kobasa. As I mentioned in the editorial on the Fetal Pillow, there are many clinical pearls about management of a second stage, deep-transverse cephalic arrest at the time of cesarean delivery, including to extend or T the uterine incision, push with a hand from below, reverse breech extraction, use a Coyne spoon, administer nitroglycerine or terbutaline, break the vaginal suction before attempting delivery, and incise a Bandl ring. Dr. Sand adds vaginal placement of a vacuum cup to our armamentarium, and Dr. Kobasa recommends dislodging the fetal head with a push on the lower uterine segment before making the hysterotomy incision. I thank Dr. Morris for correcting my failure to report the cost of the Fetal Pillow, reporting a quoted price of $600 for each Fetal Pillow. I agree with Dr. Morris that physicians have an important responsibility to be good stewards of health care resources and weigh the benefits and costs of our decisions.
Continue to: In your practice, are you planning to have a chaperone present for all intimate examinations?
In your practice, are you planning to have a chaperone present for all intimate examinations?
Robert L. Barbieri, MD
(Editorial; June 2020)
Enough is enough
I have always thought that many doctors who write opinions and pontificate about what should be done in practice live in la-la land. This editorial, for me, confirms it.
I personally am becoming tired of all this: dividing the specialty into obstetricians and gynecologists; pelvic exams are not necessary during annual visits; HPV testing by patients at home; doing away with Pap smears; Pap smears are not necessary for patients after a certain age; scribes in your footsteps to document all findings in the EMR; heaven forbid you do not ask the patient if she has a fire extinguisher in her house or some other stupid information; interpreters for people who speak Mongolian because their partner should not be used to interpret for them; and so on.
Now you want us to have a chaperone for every pelvic exam! Not any chaperone, but a specialized one! You worry about the sanctity and privacy of the patient but now have 2 additional people in the room for the patient’s exam. First, most patients prefer to have the least number of people looking at their bodies during an exam, especially a pelvic exam. Second, where do we get the money to support all of this? Does this type of policy make any sense? Are lawyers now controlling what medical care is all about? Is that what is now considered quality medical care?
By the way, I am not a burned out physician. I use common sense and consider what is best for my patients in everything that I do. If a patient requests a chaperone, my medical assistant will come to the room and provide that service. You do not need to be specialized to provide this service! Ivory tower people have lost all common sense. You consider yourselves the authorities in whatever medical field you specialize in, but let me tell you something: You really are not.
I know I will be criticized and demonized publicly by many; however, I have the courage to say what, in my opinion, I feel is right and what is wrong. Many physicians are afraid to do so, and, like sheep, will comply with your misguided opinions. I truly do not mean any disrespect to your knowledge and good intentions. I just think that enough is enough!
Gabriel G. Hakim, MD
Waterbury, Connecticut
Dr. Barbieri responds
In response to my editorial on the American College of Obstetricians and Gynecologists (ACOG) recommendation that chaperones be present for intimate examinations (ACOG Committee Opinion No. 796), Dr. Hakim outlines many concerns with the rapidly evolving practice of medicine.1 I am confident that the ACOG Committee on Ethics wisely considered the benefits, costs, and unintended consequences of the recommendation. The United States Veterans Administration, the Royal College of Obstetricians and Gynaecologists, and the American College Health Association endorse a similar recommendation. I do not think the distinguished members of the committees who issued the recommendation “live in la-la land.”
Reference
- American College of Obstetricians and Gynecologists Committee on Ethics. Sexual misconduct: ACOG Committee Opinion No. 796. Obstet Gynecol. 2020;135:e43-e50.
- American College of Obstetricians and Gynecologists Committee on Ethics. Sexual misconduct: ACOG Committee Opinion No. 796. Obstet Gynecol. 2020;135:e43-e50.
- American College of Obstetricians and Gynecologists Committee on Ethics. Sexual misconduct: ACOG Committee Opinion No. 796. Obstet Gynecol. 2020;135:e43-e50.
Continued Dosing of Oritavancin for Complicated Gram-Positive Infections
Oritavancin is a lipoglycopeptide antibiotic. The US Food and Drug Administration (FDA) approved oritavancin in 2014 for adults with acute bacterial skin and skin structure infections (ABSSSI).1 The antibiotic is currently FDA approved for infections caused by Gram-positive organisms, including methicillin-resistant and methicillinsusceptible Staphylococcus aureus (MRSA, MSSA), a variety of Streptococcus species, and vancomycin-susceptible Enterococcus faecalis (VSE). Oritavancin demonstrates concentrationdependent bactericidal activity and has a half-life of 245 hours. This half-life allows for treatment of ABSSSI with a single 1,200 mg IV dose, which has been shown to be noninferior to vancomycin dosed twice daily for 7 to 10 days.1-3
Proposal for Expanded Uses
Although the approved indication for oritavancin is narrow, in vitro studies have shown that oritavancin also has activity against vancomycin-resistant enterococci (VRE), and rabbit studies have demonstrated its excellent bone penetration.4,5 These findings have raised the question of whether oritavancin can be safely and effectively used for infections such as endocarditis, osteomyelitis, and bacteremia, which are often caused by invasive Grampositive organisms. These types of invasive infections, particularly when MRSA is implicated, generally require IV antibiotic therapy for several weeks, often with vancomycin.6
To avoid long hospital stays solely for antibiotic administration, health care practitioners will often use outpatient parenteral antimicrobial therapy (OPAT). However, using OPAT presents many challenges due to the need for frequent dosing, the risk of peripheral or central-line infections, and therapeutic drug monitoring when using vancomycin; additionally, administration and line care oftentimes require caregiver support, which may not be present for all patients.7 Concerns also have been raised regarding the use of OPAT in patients with a history of IV drug use due to the potential increased risk of line infections or line abuse. Few studies have explored OPAT in this population, and the Infectious Diseases Society of America OPAT guidelines recommend that the decision to use OPAT should be made on a case-by-case basis.7 Thus, patients who are deemed inappropriate for OPAT oftentimes remain hospitalized or reside briefly in nursing facilities solely for antibiotic administration
Oritavancin’s long half-life and potent activity against Gram-positive organisms has led to increased interest in off-label use of infrequent dosing intervals, such as weekly, to treat complicated and invasive infections. Weekly rather than daily dosing would allow for less burdensome antibiotic administration regimens and shorter hospital stays especially for patients who are not candidates for OPAT.
Efficacy of Continued Dosing
This proposed weekly dosing pattern, referred to as continued dosing or a multiple-dose regimen, has gained traction in the literature. To date, no randomized controlled trials have been conducted to assess oritavancin’s efficacy in off-label indications or continued dosing, but several case reports and retrospective cohort analyses show promising outcomes.8-16 In an analysis of data from the Clinical and Historic Registry and Orbactiv Medical Evaluation (CHROME) patient registry, 32 patients received multiple doses of oritavancin for complicated Gram-positive infections with a 93.8% overall clinical success rate, including success rates of 90.9% (10/11) for general bone and joint infections and 87.5% (7/8) for patients diagnosed specifically with osteomyelitis.8
Patients received between 2 and 10 doses of 1,200 mg IV given every 6 to 14 days. Johnson and colleagues report using oritavancin 1,200 mg IV every other day for 3 doses followed by 1,200 mg IV once weekly for a patient with daptomycin- and vancomycin-resistant Enterococcus endocarditis, resulting in negative blood cultures while on therapy.9 However, source control via valve replacement and postoperative oritavancin 1,200 mg IV twice weekly for 10 weeks was required to fully clear the infection.
Schulz and colleagues published a retrospective cohort analysis of 17 patients who received multiple doses of oritavancin for complicated bacterial infections, including osteomyelitis, pneumonia, and bacteremia.10 They reported 100% of patients were either successfully cured or had demonstrable improvements in their infections by using a 1,200 mg IV loading dose followed by 800 mg IV if the second dose was given within 7 days or 1,200 mg IV if the second dose was given more than 10 days later. Patients received between 2 and 18 total doses, with 6 out of 17 (35%) receiving only 2 doses. One patient who received 18 doses was an outlier, as her treatment goal was palliative suppression due to an infected endovascular graft that could not be removed.
In a published case series, 1 of 10 patients receiving oritavancin for invasive Grampositive infections received multiple doses of oritavancin for an MSSA deep tissue infection.11 The 3 total doses (strength not reported) were separated by 19 days and 14 days and resulted in cure. Several case reports and a retrospective chart review study specifically show the effectiveness of oritavancin for osteomyelitis caused by MSSA, MRSA, and VRE.12-16 However, dosing strategies varied widely after the initial 1,200 mg IV loading dose.
Drug Interactions, Safety, and Tolerability
Oritavancin has minimal drug-drug interactions, the most notable being with anticoagulants. 1 Use of IV heparin within 120 hours of oritavancin administration can falsely elevate activated partial thromboplastin time (aPTT) levels; therefore, heparin should not be monitored with aPTT during this period. Oritavancin also can artificially prolong international normalized ratio (INR) values for up to 12 hours, and dose adjustments based on INRs during this window are not recommended. Of note, factor Xa laboratory monitoring is unaffected by oritavancin, as it does not depend on phospholipid reagents as do aPTT and INR measurements.
Oritavancin has been shown to be well tolerated when dosed according to both the package insert and continued dosing strategies. The most common adverse effects (AEs) (≥ 3%), occurring at similar rates to vancomycin, are nausea, vomiting, diarrhea, headache, and limb and subcutaneous abscesses.1 Infusion reactions also have been reported, although they are usually reversible on slowing or stopping the infusion. It is worth noting that the use of oritavancin for osteomyelitis is not recommended in the product labeling, as an increased rate of osteomyelitis was observed in the oritavancin vs IV vancomycin groups for the treatment of patients with acute bacterial skin and skin structure infection (SOLO) trials (0.6% in oritavancin group vs 0.1% in vancomycin group, statistical significance not reported).17 However, it was postulated that these osteomyelitis cases were likely present, yet not recognized, at baseline and were not the result of administering oritavancin. This conclusion is further corroborated by previously presented research demonstrating successful cure of osteomyelitis with continued dosing strategies.12-16
Many patients receiving multiple doses of oritavancin did not experience AEs or laboratory abnormalities.13,15 Four of 17 patients (24%) in one retrospective review experienced AEs, including infusion reactions, anemia, and leukopenia; all were reversible on discontinuation of oritavancin, and contributions of other antibiotics in some cases could not be ruled out.10 One patient experienced taste disturbance for several hours after each infusion, and a second had documented hearing loss after 3 doses of oritavancin in a 33-day period, though she had received 6 weeks of IV vancomycin prior to oritavancin.11,12 A patient treated for daptomycin- and vancomycinresistant Enterococcus faecium prosthetic valve endocarditis experienced nausea, anorexia, and minor liver function test (LFT) abnormalities after cumulative oritavancin exposure over 18 weeks.9 On discontinuation of the drug, nausea and anorexia improved, and LFTs normalized 11 months later. Overall, AEs reported with continued dosing of oritavancin have been minimal and largely reversible, mimicking the AEs in the product labeling for traditional dosing. This suggests that using a continued dosing strategy may not result in worse or more frequent AEs, though randomized controlled trials are needed to fully ascertain these preliminary findings.
Conclusions
The literature supporting the use of oritavancin beyond single-dose administration for ABSSSI is growing. Continued dosing regimens have been well tolerated and have resulted in clinical cure for many patients with barriers to first-line treatment and complicated or invasive infections. While randomized controlled trials are needed to concretely demonstrate the efficacy and safety of continued dosing of oritavancin, it may fill an important treatment niche in this era of growing antibiotic resistance and increasing complexity of patient cases.
1. Orbactiv [package insert]. Parsippany, NJ: The Medicines Company; 2019.
2. Corey GR, Kabler H, Mehra P, et al. Single-dose oritavancin in the treatment of acute bacterial skin infections. N Engl J Med. 2014;370(23):2180-2190. doi:10.1056/NEJMoa1310422
3. Corey GR, Good S, Jiang H, et al. Single-dose oritavancin versus 7-10 days of vancomycin in the treatment of gram-positive acute bacterial skin and skin structure infections: the SOLO II noninferiority study. Clin Infect Dis. 2015;60(2):254-262. doi:10.1093/cid/ciu778
4. Sweeney D, Stoneburner A, Shinabarger DL, et al. Comparative in vitro activity of oritavancin and other agents against vancomycin-susceptible and -resistant enterococci. J Antimicrob Chemother. 2017;72(2):622-624. doi.10.1093/jac/dkw451
5. Lehoux D, Ostiguy V, Vadieux C, et al. Oritavancin pharmacokinetics and bone penetration in rabbits. Antimicrob Agents Chemother. 2015;59(10):6501-6505. doi:10.1128/AAC.00981-15
6. Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011;52(3):e18-e55. doi:10.1093/cid/ciq146
7. Norris AH, Shrestha NK, Allison GM, et al. 2018 Infectious Diseases Society of America clinical practice guideline for the management of outpatient parenteral antimicrobial therapy. Clin Infect Dis. 2019;68(1):e1-e35. doi:10.1093/cid/ciy745
8. Redell M, Seirra-Hoffman M, Assi Maha, et al. The CHROME study, a real-world experience of single- and multiple-dose oritavancin for treatment of gram-positive infections. Open Forum Infect Dis. 2019;6(11):ofz479. doi:10.1093/ofid/ofz479
9. Johnson JA, Feeney ER, Kubiak DW, Corey GR. Prolonged use of oritavancin for vancomycin-resistant Enterococcus faecium prosthetic valve endocarditis. Open Forum Infect Dis. 2015;2(4):ofv156. doi:10.1093/ofid/ofv156
10. Schulz LT, Dworkin E, Dela-Pena J, Rose WE. Multipledose oritavancin evaluation in a retrospective cohort of patients with complicated infections. Pharmacotherapy. 2018;38(1):152-159. doi:10.1002/phar.2057
11. Stewart CL, Turner MS, Frens JJ, Snider CB, Smith JR. Real-world experience with oritavancin therapy in invasive gram-positive infections. Infect Dis Ther. 2017;6(2):277-289. doi:10.1007/s40121-017-0156-z
12. Delaportas DJ, Estrada SJ, Darmelio M. Successful treatment of methicillin susceptible Staphylococcus aureus osteomyelitis with oritavancin. Pharmacotherapy. 2017;37(8):e90-e92. doi:10.1002/phar.1957
13. Chastain DB, Davis A. Treatment of chronic osteomyelitis with multidose oritavancin: a case series and literature review. Int J Antimicrob Agents. 2019;53(4):429-434. doi:10.1016/j.ijantimicag.2018.11.023
14. Dahesh S, Wong B, Nizet V, Sakoulas G, Tran TT, Aitken SL. Treatment of multidrug-resistant vancomycinresistant Enterococcus faecium hardware-associated vertebral osteomyelitis with oritavancin plus ampicillin. Antimicrob Agents Chemother. 2019;63(7):e02622-18. doi:10.1128/AAC.02622-18
15. Foster RA, Philavong KP, Weissman S, Tang X, Bookstaver PB. Oritavancin for the treatment of daptomycin nonsusceptible vancomycin-resistant Enterococci osteomyelitis. Infect Dis Clin Pract. 2018;26(2):97-99. doi:10.1097/IPC.0000000000000517
16. Ruggero M, Ziegler M, Tebas P, Binkley A, Kelly B. Successful treatment of methicillin-resistant Staphylococcus aureus vertebral osteomyelitis with outpatient oritavancin therapy. Infect Dis Clin Pract. 2018;26(3):141-144. doi:10.1097/IPC.0000000000000599
17. Corey GR, Loutit J, Moeck G, et al. Single intravenous dose of oritavancin for treatment of acute skin and skin structure infections caused by gram-positive bacteria: summary of safety analysis from the phase 3 SOLO studies. Antimicrob Agents Chemother. 2018;62(4):e01919- 17. doi:10.1128/AAC.01919-17
Oritavancin is a lipoglycopeptide antibiotic. The US Food and Drug Administration (FDA) approved oritavancin in 2014 for adults with acute bacterial skin and skin structure infections (ABSSSI).1 The antibiotic is currently FDA approved for infections caused by Gram-positive organisms, including methicillin-resistant and methicillinsusceptible Staphylococcus aureus (MRSA, MSSA), a variety of Streptococcus species, and vancomycin-susceptible Enterococcus faecalis (VSE). Oritavancin demonstrates concentrationdependent bactericidal activity and has a half-life of 245 hours. This half-life allows for treatment of ABSSSI with a single 1,200 mg IV dose, which has been shown to be noninferior to vancomycin dosed twice daily for 7 to 10 days.1-3
Proposal for Expanded Uses
Although the approved indication for oritavancin is narrow, in vitro studies have shown that oritavancin also has activity against vancomycin-resistant enterococci (VRE), and rabbit studies have demonstrated its excellent bone penetration.4,5 These findings have raised the question of whether oritavancin can be safely and effectively used for infections such as endocarditis, osteomyelitis, and bacteremia, which are often caused by invasive Grampositive organisms. These types of invasive infections, particularly when MRSA is implicated, generally require IV antibiotic therapy for several weeks, often with vancomycin.6
To avoid long hospital stays solely for antibiotic administration, health care practitioners will often use outpatient parenteral antimicrobial therapy (OPAT). However, using OPAT presents many challenges due to the need for frequent dosing, the risk of peripheral or central-line infections, and therapeutic drug monitoring when using vancomycin; additionally, administration and line care oftentimes require caregiver support, which may not be present for all patients.7 Concerns also have been raised regarding the use of OPAT in patients with a history of IV drug use due to the potential increased risk of line infections or line abuse. Few studies have explored OPAT in this population, and the Infectious Diseases Society of America OPAT guidelines recommend that the decision to use OPAT should be made on a case-by-case basis.7 Thus, patients who are deemed inappropriate for OPAT oftentimes remain hospitalized or reside briefly in nursing facilities solely for antibiotic administration
Oritavancin’s long half-life and potent activity against Gram-positive organisms has led to increased interest in off-label use of infrequent dosing intervals, such as weekly, to treat complicated and invasive infections. Weekly rather than daily dosing would allow for less burdensome antibiotic administration regimens and shorter hospital stays especially for patients who are not candidates for OPAT.
Efficacy of Continued Dosing
This proposed weekly dosing pattern, referred to as continued dosing or a multiple-dose regimen, has gained traction in the literature. To date, no randomized controlled trials have been conducted to assess oritavancin’s efficacy in off-label indications or continued dosing, but several case reports and retrospective cohort analyses show promising outcomes.8-16 In an analysis of data from the Clinical and Historic Registry and Orbactiv Medical Evaluation (CHROME) patient registry, 32 patients received multiple doses of oritavancin for complicated Gram-positive infections with a 93.8% overall clinical success rate, including success rates of 90.9% (10/11) for general bone and joint infections and 87.5% (7/8) for patients diagnosed specifically with osteomyelitis.8
Patients received between 2 and 10 doses of 1,200 mg IV given every 6 to 14 days. Johnson and colleagues report using oritavancin 1,200 mg IV every other day for 3 doses followed by 1,200 mg IV once weekly for a patient with daptomycin- and vancomycin-resistant Enterococcus endocarditis, resulting in negative blood cultures while on therapy.9 However, source control via valve replacement and postoperative oritavancin 1,200 mg IV twice weekly for 10 weeks was required to fully clear the infection.
Schulz and colleagues published a retrospective cohort analysis of 17 patients who received multiple doses of oritavancin for complicated bacterial infections, including osteomyelitis, pneumonia, and bacteremia.10 They reported 100% of patients were either successfully cured or had demonstrable improvements in their infections by using a 1,200 mg IV loading dose followed by 800 mg IV if the second dose was given within 7 days or 1,200 mg IV if the second dose was given more than 10 days later. Patients received between 2 and 18 total doses, with 6 out of 17 (35%) receiving only 2 doses. One patient who received 18 doses was an outlier, as her treatment goal was palliative suppression due to an infected endovascular graft that could not be removed.
In a published case series, 1 of 10 patients receiving oritavancin for invasive Grampositive infections received multiple doses of oritavancin for an MSSA deep tissue infection.11 The 3 total doses (strength not reported) were separated by 19 days and 14 days and resulted in cure. Several case reports and a retrospective chart review study specifically show the effectiveness of oritavancin for osteomyelitis caused by MSSA, MRSA, and VRE.12-16 However, dosing strategies varied widely after the initial 1,200 mg IV loading dose.
Drug Interactions, Safety, and Tolerability
Oritavancin has minimal drug-drug interactions, the most notable being with anticoagulants. 1 Use of IV heparin within 120 hours of oritavancin administration can falsely elevate activated partial thromboplastin time (aPTT) levels; therefore, heparin should not be monitored with aPTT during this period. Oritavancin also can artificially prolong international normalized ratio (INR) values for up to 12 hours, and dose adjustments based on INRs during this window are not recommended. Of note, factor Xa laboratory monitoring is unaffected by oritavancin, as it does not depend on phospholipid reagents as do aPTT and INR measurements.
Oritavancin has been shown to be well tolerated when dosed according to both the package insert and continued dosing strategies. The most common adverse effects (AEs) (≥ 3%), occurring at similar rates to vancomycin, are nausea, vomiting, diarrhea, headache, and limb and subcutaneous abscesses.1 Infusion reactions also have been reported, although they are usually reversible on slowing or stopping the infusion. It is worth noting that the use of oritavancin for osteomyelitis is not recommended in the product labeling, as an increased rate of osteomyelitis was observed in the oritavancin vs IV vancomycin groups for the treatment of patients with acute bacterial skin and skin structure infection (SOLO) trials (0.6% in oritavancin group vs 0.1% in vancomycin group, statistical significance not reported).17 However, it was postulated that these osteomyelitis cases were likely present, yet not recognized, at baseline and were not the result of administering oritavancin. This conclusion is further corroborated by previously presented research demonstrating successful cure of osteomyelitis with continued dosing strategies.12-16
Many patients receiving multiple doses of oritavancin did not experience AEs or laboratory abnormalities.13,15 Four of 17 patients (24%) in one retrospective review experienced AEs, including infusion reactions, anemia, and leukopenia; all were reversible on discontinuation of oritavancin, and contributions of other antibiotics in some cases could not be ruled out.10 One patient experienced taste disturbance for several hours after each infusion, and a second had documented hearing loss after 3 doses of oritavancin in a 33-day period, though she had received 6 weeks of IV vancomycin prior to oritavancin.11,12 A patient treated for daptomycin- and vancomycinresistant Enterococcus faecium prosthetic valve endocarditis experienced nausea, anorexia, and minor liver function test (LFT) abnormalities after cumulative oritavancin exposure over 18 weeks.9 On discontinuation of the drug, nausea and anorexia improved, and LFTs normalized 11 months later. Overall, AEs reported with continued dosing of oritavancin have been minimal and largely reversible, mimicking the AEs in the product labeling for traditional dosing. This suggests that using a continued dosing strategy may not result in worse or more frequent AEs, though randomized controlled trials are needed to fully ascertain these preliminary findings.
Conclusions
The literature supporting the use of oritavancin beyond single-dose administration for ABSSSI is growing. Continued dosing regimens have been well tolerated and have resulted in clinical cure for many patients with barriers to first-line treatment and complicated or invasive infections. While randomized controlled trials are needed to concretely demonstrate the efficacy and safety of continued dosing of oritavancin, it may fill an important treatment niche in this era of growing antibiotic resistance and increasing complexity of patient cases.
Oritavancin is a lipoglycopeptide antibiotic. The US Food and Drug Administration (FDA) approved oritavancin in 2014 for adults with acute bacterial skin and skin structure infections (ABSSSI).1 The antibiotic is currently FDA approved for infections caused by Gram-positive organisms, including methicillin-resistant and methicillinsusceptible Staphylococcus aureus (MRSA, MSSA), a variety of Streptococcus species, and vancomycin-susceptible Enterococcus faecalis (VSE). Oritavancin demonstrates concentrationdependent bactericidal activity and has a half-life of 245 hours. This half-life allows for treatment of ABSSSI with a single 1,200 mg IV dose, which has been shown to be noninferior to vancomycin dosed twice daily for 7 to 10 days.1-3
Proposal for Expanded Uses
Although the approved indication for oritavancin is narrow, in vitro studies have shown that oritavancin also has activity against vancomycin-resistant enterococci (VRE), and rabbit studies have demonstrated its excellent bone penetration.4,5 These findings have raised the question of whether oritavancin can be safely and effectively used for infections such as endocarditis, osteomyelitis, and bacteremia, which are often caused by invasive Grampositive organisms. These types of invasive infections, particularly when MRSA is implicated, generally require IV antibiotic therapy for several weeks, often with vancomycin.6
To avoid long hospital stays solely for antibiotic administration, health care practitioners will often use outpatient parenteral antimicrobial therapy (OPAT). However, using OPAT presents many challenges due to the need for frequent dosing, the risk of peripheral or central-line infections, and therapeutic drug monitoring when using vancomycin; additionally, administration and line care oftentimes require caregiver support, which may not be present for all patients.7 Concerns also have been raised regarding the use of OPAT in patients with a history of IV drug use due to the potential increased risk of line infections or line abuse. Few studies have explored OPAT in this population, and the Infectious Diseases Society of America OPAT guidelines recommend that the decision to use OPAT should be made on a case-by-case basis.7 Thus, patients who are deemed inappropriate for OPAT oftentimes remain hospitalized or reside briefly in nursing facilities solely for antibiotic administration
Oritavancin’s long half-life and potent activity against Gram-positive organisms has led to increased interest in off-label use of infrequent dosing intervals, such as weekly, to treat complicated and invasive infections. Weekly rather than daily dosing would allow for less burdensome antibiotic administration regimens and shorter hospital stays especially for patients who are not candidates for OPAT.
Efficacy of Continued Dosing
This proposed weekly dosing pattern, referred to as continued dosing or a multiple-dose regimen, has gained traction in the literature. To date, no randomized controlled trials have been conducted to assess oritavancin’s efficacy in off-label indications or continued dosing, but several case reports and retrospective cohort analyses show promising outcomes.8-16 In an analysis of data from the Clinical and Historic Registry and Orbactiv Medical Evaluation (CHROME) patient registry, 32 patients received multiple doses of oritavancin for complicated Gram-positive infections with a 93.8% overall clinical success rate, including success rates of 90.9% (10/11) for general bone and joint infections and 87.5% (7/8) for patients diagnosed specifically with osteomyelitis.8
Patients received between 2 and 10 doses of 1,200 mg IV given every 6 to 14 days. Johnson and colleagues report using oritavancin 1,200 mg IV every other day for 3 doses followed by 1,200 mg IV once weekly for a patient with daptomycin- and vancomycin-resistant Enterococcus endocarditis, resulting in negative blood cultures while on therapy.9 However, source control via valve replacement and postoperative oritavancin 1,200 mg IV twice weekly for 10 weeks was required to fully clear the infection.
Schulz and colleagues published a retrospective cohort analysis of 17 patients who received multiple doses of oritavancin for complicated bacterial infections, including osteomyelitis, pneumonia, and bacteremia.10 They reported 100% of patients were either successfully cured or had demonstrable improvements in their infections by using a 1,200 mg IV loading dose followed by 800 mg IV if the second dose was given within 7 days or 1,200 mg IV if the second dose was given more than 10 days later. Patients received between 2 and 18 total doses, with 6 out of 17 (35%) receiving only 2 doses. One patient who received 18 doses was an outlier, as her treatment goal was palliative suppression due to an infected endovascular graft that could not be removed.
In a published case series, 1 of 10 patients receiving oritavancin for invasive Grampositive infections received multiple doses of oritavancin for an MSSA deep tissue infection.11 The 3 total doses (strength not reported) were separated by 19 days and 14 days and resulted in cure. Several case reports and a retrospective chart review study specifically show the effectiveness of oritavancin for osteomyelitis caused by MSSA, MRSA, and VRE.12-16 However, dosing strategies varied widely after the initial 1,200 mg IV loading dose.
Drug Interactions, Safety, and Tolerability
Oritavancin has minimal drug-drug interactions, the most notable being with anticoagulants. 1 Use of IV heparin within 120 hours of oritavancin administration can falsely elevate activated partial thromboplastin time (aPTT) levels; therefore, heparin should not be monitored with aPTT during this period. Oritavancin also can artificially prolong international normalized ratio (INR) values for up to 12 hours, and dose adjustments based on INRs during this window are not recommended. Of note, factor Xa laboratory monitoring is unaffected by oritavancin, as it does not depend on phospholipid reagents as do aPTT and INR measurements.
Oritavancin has been shown to be well tolerated when dosed according to both the package insert and continued dosing strategies. The most common adverse effects (AEs) (≥ 3%), occurring at similar rates to vancomycin, are nausea, vomiting, diarrhea, headache, and limb and subcutaneous abscesses.1 Infusion reactions also have been reported, although they are usually reversible on slowing or stopping the infusion. It is worth noting that the use of oritavancin for osteomyelitis is not recommended in the product labeling, as an increased rate of osteomyelitis was observed in the oritavancin vs IV vancomycin groups for the treatment of patients with acute bacterial skin and skin structure infection (SOLO) trials (0.6% in oritavancin group vs 0.1% in vancomycin group, statistical significance not reported).17 However, it was postulated that these osteomyelitis cases were likely present, yet not recognized, at baseline and were not the result of administering oritavancin. This conclusion is further corroborated by previously presented research demonstrating successful cure of osteomyelitis with continued dosing strategies.12-16
Many patients receiving multiple doses of oritavancin did not experience AEs or laboratory abnormalities.13,15 Four of 17 patients (24%) in one retrospective review experienced AEs, including infusion reactions, anemia, and leukopenia; all were reversible on discontinuation of oritavancin, and contributions of other antibiotics in some cases could not be ruled out.10 One patient experienced taste disturbance for several hours after each infusion, and a second had documented hearing loss after 3 doses of oritavancin in a 33-day period, though she had received 6 weeks of IV vancomycin prior to oritavancin.11,12 A patient treated for daptomycin- and vancomycinresistant Enterococcus faecium prosthetic valve endocarditis experienced nausea, anorexia, and minor liver function test (LFT) abnormalities after cumulative oritavancin exposure over 18 weeks.9 On discontinuation of the drug, nausea and anorexia improved, and LFTs normalized 11 months later. Overall, AEs reported with continued dosing of oritavancin have been minimal and largely reversible, mimicking the AEs in the product labeling for traditional dosing. This suggests that using a continued dosing strategy may not result in worse or more frequent AEs, though randomized controlled trials are needed to fully ascertain these preliminary findings.
Conclusions
The literature supporting the use of oritavancin beyond single-dose administration for ABSSSI is growing. Continued dosing regimens have been well tolerated and have resulted in clinical cure for many patients with barriers to first-line treatment and complicated or invasive infections. While randomized controlled trials are needed to concretely demonstrate the efficacy and safety of continued dosing of oritavancin, it may fill an important treatment niche in this era of growing antibiotic resistance and increasing complexity of patient cases.
1. Orbactiv [package insert]. Parsippany, NJ: The Medicines Company; 2019.
2. Corey GR, Kabler H, Mehra P, et al. Single-dose oritavancin in the treatment of acute bacterial skin infections. N Engl J Med. 2014;370(23):2180-2190. doi:10.1056/NEJMoa1310422
3. Corey GR, Good S, Jiang H, et al. Single-dose oritavancin versus 7-10 days of vancomycin in the treatment of gram-positive acute bacterial skin and skin structure infections: the SOLO II noninferiority study. Clin Infect Dis. 2015;60(2):254-262. doi:10.1093/cid/ciu778
4. Sweeney D, Stoneburner A, Shinabarger DL, et al. Comparative in vitro activity of oritavancin and other agents against vancomycin-susceptible and -resistant enterococci. J Antimicrob Chemother. 2017;72(2):622-624. doi.10.1093/jac/dkw451
5. Lehoux D, Ostiguy V, Vadieux C, et al. Oritavancin pharmacokinetics and bone penetration in rabbits. Antimicrob Agents Chemother. 2015;59(10):6501-6505. doi:10.1128/AAC.00981-15
6. Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011;52(3):e18-e55. doi:10.1093/cid/ciq146
7. Norris AH, Shrestha NK, Allison GM, et al. 2018 Infectious Diseases Society of America clinical practice guideline for the management of outpatient parenteral antimicrobial therapy. Clin Infect Dis. 2019;68(1):e1-e35. doi:10.1093/cid/ciy745
8. Redell M, Seirra-Hoffman M, Assi Maha, et al. The CHROME study, a real-world experience of single- and multiple-dose oritavancin for treatment of gram-positive infections. Open Forum Infect Dis. 2019;6(11):ofz479. doi:10.1093/ofid/ofz479
9. Johnson JA, Feeney ER, Kubiak DW, Corey GR. Prolonged use of oritavancin for vancomycin-resistant Enterococcus faecium prosthetic valve endocarditis. Open Forum Infect Dis. 2015;2(4):ofv156. doi:10.1093/ofid/ofv156
10. Schulz LT, Dworkin E, Dela-Pena J, Rose WE. Multipledose oritavancin evaluation in a retrospective cohort of patients with complicated infections. Pharmacotherapy. 2018;38(1):152-159. doi:10.1002/phar.2057
11. Stewart CL, Turner MS, Frens JJ, Snider CB, Smith JR. Real-world experience with oritavancin therapy in invasive gram-positive infections. Infect Dis Ther. 2017;6(2):277-289. doi:10.1007/s40121-017-0156-z
12. Delaportas DJ, Estrada SJ, Darmelio M. Successful treatment of methicillin susceptible Staphylococcus aureus osteomyelitis with oritavancin. Pharmacotherapy. 2017;37(8):e90-e92. doi:10.1002/phar.1957
13. Chastain DB, Davis A. Treatment of chronic osteomyelitis with multidose oritavancin: a case series and literature review. Int J Antimicrob Agents. 2019;53(4):429-434. doi:10.1016/j.ijantimicag.2018.11.023
14. Dahesh S, Wong B, Nizet V, Sakoulas G, Tran TT, Aitken SL. Treatment of multidrug-resistant vancomycinresistant Enterococcus faecium hardware-associated vertebral osteomyelitis with oritavancin plus ampicillin. Antimicrob Agents Chemother. 2019;63(7):e02622-18. doi:10.1128/AAC.02622-18
15. Foster RA, Philavong KP, Weissman S, Tang X, Bookstaver PB. Oritavancin for the treatment of daptomycin nonsusceptible vancomycin-resistant Enterococci osteomyelitis. Infect Dis Clin Pract. 2018;26(2):97-99. doi:10.1097/IPC.0000000000000517
16. Ruggero M, Ziegler M, Tebas P, Binkley A, Kelly B. Successful treatment of methicillin-resistant Staphylococcus aureus vertebral osteomyelitis with outpatient oritavancin therapy. Infect Dis Clin Pract. 2018;26(3):141-144. doi:10.1097/IPC.0000000000000599
17. Corey GR, Loutit J, Moeck G, et al. Single intravenous dose of oritavancin for treatment of acute skin and skin structure infections caused by gram-positive bacteria: summary of safety analysis from the phase 3 SOLO studies. Antimicrob Agents Chemother. 2018;62(4):e01919- 17. doi:10.1128/AAC.01919-17
1. Orbactiv [package insert]. Parsippany, NJ: The Medicines Company; 2019.
2. Corey GR, Kabler H, Mehra P, et al. Single-dose oritavancin in the treatment of acute bacterial skin infections. N Engl J Med. 2014;370(23):2180-2190. doi:10.1056/NEJMoa1310422
3. Corey GR, Good S, Jiang H, et al. Single-dose oritavancin versus 7-10 days of vancomycin in the treatment of gram-positive acute bacterial skin and skin structure infections: the SOLO II noninferiority study. Clin Infect Dis. 2015;60(2):254-262. doi:10.1093/cid/ciu778
4. Sweeney D, Stoneburner A, Shinabarger DL, et al. Comparative in vitro activity of oritavancin and other agents against vancomycin-susceptible and -resistant enterococci. J Antimicrob Chemother. 2017;72(2):622-624. doi.10.1093/jac/dkw451
5. Lehoux D, Ostiguy V, Vadieux C, et al. Oritavancin pharmacokinetics and bone penetration in rabbits. Antimicrob Agents Chemother. 2015;59(10):6501-6505. doi:10.1128/AAC.00981-15
6. Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011;52(3):e18-e55. doi:10.1093/cid/ciq146
7. Norris AH, Shrestha NK, Allison GM, et al. 2018 Infectious Diseases Society of America clinical practice guideline for the management of outpatient parenteral antimicrobial therapy. Clin Infect Dis. 2019;68(1):e1-e35. doi:10.1093/cid/ciy745
8. Redell M, Seirra-Hoffman M, Assi Maha, et al. The CHROME study, a real-world experience of single- and multiple-dose oritavancin for treatment of gram-positive infections. Open Forum Infect Dis. 2019;6(11):ofz479. doi:10.1093/ofid/ofz479
9. Johnson JA, Feeney ER, Kubiak DW, Corey GR. Prolonged use of oritavancin for vancomycin-resistant Enterococcus faecium prosthetic valve endocarditis. Open Forum Infect Dis. 2015;2(4):ofv156. doi:10.1093/ofid/ofv156
10. Schulz LT, Dworkin E, Dela-Pena J, Rose WE. Multipledose oritavancin evaluation in a retrospective cohort of patients with complicated infections. Pharmacotherapy. 2018;38(1):152-159. doi:10.1002/phar.2057
11. Stewart CL, Turner MS, Frens JJ, Snider CB, Smith JR. Real-world experience with oritavancin therapy in invasive gram-positive infections. Infect Dis Ther. 2017;6(2):277-289. doi:10.1007/s40121-017-0156-z
12. Delaportas DJ, Estrada SJ, Darmelio M. Successful treatment of methicillin susceptible Staphylococcus aureus osteomyelitis with oritavancin. Pharmacotherapy. 2017;37(8):e90-e92. doi:10.1002/phar.1957
13. Chastain DB, Davis A. Treatment of chronic osteomyelitis with multidose oritavancin: a case series and literature review. Int J Antimicrob Agents. 2019;53(4):429-434. doi:10.1016/j.ijantimicag.2018.11.023
14. Dahesh S, Wong B, Nizet V, Sakoulas G, Tran TT, Aitken SL. Treatment of multidrug-resistant vancomycinresistant Enterococcus faecium hardware-associated vertebral osteomyelitis with oritavancin plus ampicillin. Antimicrob Agents Chemother. 2019;63(7):e02622-18. doi:10.1128/AAC.02622-18
15. Foster RA, Philavong KP, Weissman S, Tang X, Bookstaver PB. Oritavancin for the treatment of daptomycin nonsusceptible vancomycin-resistant Enterococci osteomyelitis. Infect Dis Clin Pract. 2018;26(2):97-99. doi:10.1097/IPC.0000000000000517
16. Ruggero M, Ziegler M, Tebas P, Binkley A, Kelly B. Successful treatment of methicillin-resistant Staphylococcus aureus vertebral osteomyelitis with outpatient oritavancin therapy. Infect Dis Clin Pract. 2018;26(3):141-144. doi:10.1097/IPC.0000000000000599
17. Corey GR, Loutit J, Moeck G, et al. Single intravenous dose of oritavancin for treatment of acute skin and skin structure infections caused by gram-positive bacteria: summary of safety analysis from the phase 3 SOLO studies. Antimicrob Agents Chemother. 2018;62(4):e01919- 17. doi:10.1128/AAC.01919-17
What to know as ACA heads to Supreme Court – again
The case, California v. Texas, is the result of a change to the health law made by Congress in 2017. As part of a major tax bill, Congress reduced to zero the penalty for not having health insurance. But it was that penalty – a tax – that the high court ruled made the law constitutional in a 2012 decision, argues a group of Republican state attorneys general. Without the tax, they say in their suit, the rest of the law must fall, too.
After originally contending that the entire law should not be struck down when the suit was filed in 2018, the Trump administration changed course in 2019 and joined the GOP officials who brought the case.
Here are some key questions and answers about the case.
What are the possibilities for how the court could rule?
There is a long list of ways this could play out.
The justices could declare the entire law unconstitutional – which is what a federal district judge in Texas ruled in December 2018. But legal experts say that’s not the most likely outcome of this case.
First, the court may avoid deciding the case on its merits entirely by ruling that the plaintiffs do not have “standing” to sue. The central issue in the case is whether the requirement in the law to have insurance – which remains even though Congress eliminated the penalty or tax – is constitutional. But states are not subject to the so-called individual mandate, so some analysts suggest the Republican officials have no standing. In addition, questions have been raised about the individual plaintiffs in the case, two consultants from Texas who argue that they felt compelled to buy insurance even without a possible penalty.
The court could also rule that, by eliminating the penalty but not the rest of the mandate (which Congress could not do in that 2017 tax bill for procedural reasons), lawmakers “didn’t mean to coerce anyone to do anything, and so there’s no constitutional problem,” University of Michigan law professor Nicholas Bagley said in a recent webinar for the NIHCM Foundation, the Commonwealth Fund, and the University of Southern California’s Center for Health Journalism.
Or, said Bagley, the court could rule that, without the tax, the requirement to have health insurance is unconstitutional, but the rest of the law is not. In that case, the justices might strike the mandate only, which would have basically no impact.
It gets more complicated if the court decides that, as the plaintiffs argue, the individual mandate language without the penalty is unconstitutional and so closely tied to other parts of the law that some of them must fall as well.
Even there the court has choices. One option would be, as the Trump administration originally argued, to strike down the mandate and just the pieces of the law most closely related to it – which happen to include the insurance protections for people with preexisting conditions, an extremely popular provision of the law. The two parts are connected because the original purpose of the mandate was to make sure enough healthy people sign up for insurance to offset the added costs to insurers of sicker people.
Another option, of course, would be for the court to follow the lead of the Texas judge and strike down the entire law.
While that’s not the most likely outcome, said Bagley, if it happens it could be “a hot mess” for the nation’s entire health care system. As just one example, he said, “every hospital is getting paid pursuant to changes made by the ACA. How do you even go about making payments if the thing that you are looking to guide what those payments ought to be is itself invalid?”
What impact will new Justice Amy Coney Barrett have?
Perhaps a lot. Before the death of Justice Ruth Bader Ginsburg, most court observers thought the case was highly unlikely to result in the entire law being struck down. That’s because Chief Justice John Roberts voted to uphold the law in 2012, and again when it was challenged in a less sweeping way in 2015.
But with Barrett replacing Ginsburg, even if Roberts joined the court’s remaining three liberals they could still be outvoted by the other five conservatives. Barrett was coy about her views on the Affordable Care Act during her confirmation hearings in October, but she has written that she thinks Roberts was wrong to uphold the law in 2012.
Could a new president and Congress make the case go away?
Many have suggested that, if Joe Biden assumes the presidency, his Justice Department could simply drop the case. But the administration did not bring the case; the GOP state officials did. And while normally the Justice Department’s job is to defend existing laws in court, in this case the ACA is being defended by a group of Democratic state attorneys general. A new administration could change that position, but that’s not the same as dropping the case.
Congress, on the other hand, could easily make the case moot. It could add back even a nominal financial penalty for not having insurance. It could eliminate the mandate altogether, although that would require 60 votes in the Senate under current rules. Congress could also pass a “severability” provision saying that, if any portion of the law is struck down, the rest should remain.
“The problem is not technical,” said Bagley. “It’s political.”
What is the timeline for a decision? Could the court delay implementation of its ruling?
The court usually hears oral arguments in a case months before it issues a decision. Unless the decision is unanimous or turns out to be very simple, Bagley said, he would expect to see an opinion “sometime in the spring.”
As to whether the court could find some or all of the law unconstitutional but delay when its decision takes effect, Bagley said that happened from time to time as recently as the 1970s. “That practice has been more or less abandoned,” he said, but in the case of a law so large, “you could imagine the Supreme Court using its discretion to say the decision wouldn’t take effect immediately.”
If the court does invalidate the entire ACA, Congress could act to fix things, but it’s unclear if it will be able to, especially if Republicans still control the Senate. If the justices strike the law, Bagley said, “I honestly think the likeliest outcome is that Congress runs around like a chicken with its head cut off, doesn’t come to a deal, and we’re back to where we were before 2010” when the ACA passed.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
The case, California v. Texas, is the result of a change to the health law made by Congress in 2017. As part of a major tax bill, Congress reduced to zero the penalty for not having health insurance. But it was that penalty – a tax – that the high court ruled made the law constitutional in a 2012 decision, argues a group of Republican state attorneys general. Without the tax, they say in their suit, the rest of the law must fall, too.
After originally contending that the entire law should not be struck down when the suit was filed in 2018, the Trump administration changed course in 2019 and joined the GOP officials who brought the case.
Here are some key questions and answers about the case.
What are the possibilities for how the court could rule?
There is a long list of ways this could play out.
The justices could declare the entire law unconstitutional – which is what a federal district judge in Texas ruled in December 2018. But legal experts say that’s not the most likely outcome of this case.
First, the court may avoid deciding the case on its merits entirely by ruling that the plaintiffs do not have “standing” to sue. The central issue in the case is whether the requirement in the law to have insurance – which remains even though Congress eliminated the penalty or tax – is constitutional. But states are not subject to the so-called individual mandate, so some analysts suggest the Republican officials have no standing. In addition, questions have been raised about the individual plaintiffs in the case, two consultants from Texas who argue that they felt compelled to buy insurance even without a possible penalty.
The court could also rule that, by eliminating the penalty but not the rest of the mandate (which Congress could not do in that 2017 tax bill for procedural reasons), lawmakers “didn’t mean to coerce anyone to do anything, and so there’s no constitutional problem,” University of Michigan law professor Nicholas Bagley said in a recent webinar for the NIHCM Foundation, the Commonwealth Fund, and the University of Southern California’s Center for Health Journalism.
Or, said Bagley, the court could rule that, without the tax, the requirement to have health insurance is unconstitutional, but the rest of the law is not. In that case, the justices might strike the mandate only, which would have basically no impact.
It gets more complicated if the court decides that, as the plaintiffs argue, the individual mandate language without the penalty is unconstitutional and so closely tied to other parts of the law that some of them must fall as well.
Even there the court has choices. One option would be, as the Trump administration originally argued, to strike down the mandate and just the pieces of the law most closely related to it – which happen to include the insurance protections for people with preexisting conditions, an extremely popular provision of the law. The two parts are connected because the original purpose of the mandate was to make sure enough healthy people sign up for insurance to offset the added costs to insurers of sicker people.
Another option, of course, would be for the court to follow the lead of the Texas judge and strike down the entire law.
While that’s not the most likely outcome, said Bagley, if it happens it could be “a hot mess” for the nation’s entire health care system. As just one example, he said, “every hospital is getting paid pursuant to changes made by the ACA. How do you even go about making payments if the thing that you are looking to guide what those payments ought to be is itself invalid?”
What impact will new Justice Amy Coney Barrett have?
Perhaps a lot. Before the death of Justice Ruth Bader Ginsburg, most court observers thought the case was highly unlikely to result in the entire law being struck down. That’s because Chief Justice John Roberts voted to uphold the law in 2012, and again when it was challenged in a less sweeping way in 2015.
But with Barrett replacing Ginsburg, even if Roberts joined the court’s remaining three liberals they could still be outvoted by the other five conservatives. Barrett was coy about her views on the Affordable Care Act during her confirmation hearings in October, but she has written that she thinks Roberts was wrong to uphold the law in 2012.
Could a new president and Congress make the case go away?
Many have suggested that, if Joe Biden assumes the presidency, his Justice Department could simply drop the case. But the administration did not bring the case; the GOP state officials did. And while normally the Justice Department’s job is to defend existing laws in court, in this case the ACA is being defended by a group of Democratic state attorneys general. A new administration could change that position, but that’s not the same as dropping the case.
Congress, on the other hand, could easily make the case moot. It could add back even a nominal financial penalty for not having insurance. It could eliminate the mandate altogether, although that would require 60 votes in the Senate under current rules. Congress could also pass a “severability” provision saying that, if any portion of the law is struck down, the rest should remain.
“The problem is not technical,” said Bagley. “It’s political.”
What is the timeline for a decision? Could the court delay implementation of its ruling?
The court usually hears oral arguments in a case months before it issues a decision. Unless the decision is unanimous or turns out to be very simple, Bagley said, he would expect to see an opinion “sometime in the spring.”
As to whether the court could find some or all of the law unconstitutional but delay when its decision takes effect, Bagley said that happened from time to time as recently as the 1970s. “That practice has been more or less abandoned,” he said, but in the case of a law so large, “you could imagine the Supreme Court using its discretion to say the decision wouldn’t take effect immediately.”
If the court does invalidate the entire ACA, Congress could act to fix things, but it’s unclear if it will be able to, especially if Republicans still control the Senate. If the justices strike the law, Bagley said, “I honestly think the likeliest outcome is that Congress runs around like a chicken with its head cut off, doesn’t come to a deal, and we’re back to where we were before 2010” when the ACA passed.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
The case, California v. Texas, is the result of a change to the health law made by Congress in 2017. As part of a major tax bill, Congress reduced to zero the penalty for not having health insurance. But it was that penalty – a tax – that the high court ruled made the law constitutional in a 2012 decision, argues a group of Republican state attorneys general. Without the tax, they say in their suit, the rest of the law must fall, too.
After originally contending that the entire law should not be struck down when the suit was filed in 2018, the Trump administration changed course in 2019 and joined the GOP officials who brought the case.
Here are some key questions and answers about the case.
What are the possibilities for how the court could rule?
There is a long list of ways this could play out.
The justices could declare the entire law unconstitutional – which is what a federal district judge in Texas ruled in December 2018. But legal experts say that’s not the most likely outcome of this case.
First, the court may avoid deciding the case on its merits entirely by ruling that the plaintiffs do not have “standing” to sue. The central issue in the case is whether the requirement in the law to have insurance – which remains even though Congress eliminated the penalty or tax – is constitutional. But states are not subject to the so-called individual mandate, so some analysts suggest the Republican officials have no standing. In addition, questions have been raised about the individual plaintiffs in the case, two consultants from Texas who argue that they felt compelled to buy insurance even without a possible penalty.
The court could also rule that, by eliminating the penalty but not the rest of the mandate (which Congress could not do in that 2017 tax bill for procedural reasons), lawmakers “didn’t mean to coerce anyone to do anything, and so there’s no constitutional problem,” University of Michigan law professor Nicholas Bagley said in a recent webinar for the NIHCM Foundation, the Commonwealth Fund, and the University of Southern California’s Center for Health Journalism.
Or, said Bagley, the court could rule that, without the tax, the requirement to have health insurance is unconstitutional, but the rest of the law is not. In that case, the justices might strike the mandate only, which would have basically no impact.
It gets more complicated if the court decides that, as the plaintiffs argue, the individual mandate language without the penalty is unconstitutional and so closely tied to other parts of the law that some of them must fall as well.
Even there the court has choices. One option would be, as the Trump administration originally argued, to strike down the mandate and just the pieces of the law most closely related to it – which happen to include the insurance protections for people with preexisting conditions, an extremely popular provision of the law. The two parts are connected because the original purpose of the mandate was to make sure enough healthy people sign up for insurance to offset the added costs to insurers of sicker people.
Another option, of course, would be for the court to follow the lead of the Texas judge and strike down the entire law.
While that’s not the most likely outcome, said Bagley, if it happens it could be “a hot mess” for the nation’s entire health care system. As just one example, he said, “every hospital is getting paid pursuant to changes made by the ACA. How do you even go about making payments if the thing that you are looking to guide what those payments ought to be is itself invalid?”
What impact will new Justice Amy Coney Barrett have?
Perhaps a lot. Before the death of Justice Ruth Bader Ginsburg, most court observers thought the case was highly unlikely to result in the entire law being struck down. That’s because Chief Justice John Roberts voted to uphold the law in 2012, and again when it was challenged in a less sweeping way in 2015.
But with Barrett replacing Ginsburg, even if Roberts joined the court’s remaining three liberals they could still be outvoted by the other five conservatives. Barrett was coy about her views on the Affordable Care Act during her confirmation hearings in October, but she has written that she thinks Roberts was wrong to uphold the law in 2012.
Could a new president and Congress make the case go away?
Many have suggested that, if Joe Biden assumes the presidency, his Justice Department could simply drop the case. But the administration did not bring the case; the GOP state officials did. And while normally the Justice Department’s job is to defend existing laws in court, in this case the ACA is being defended by a group of Democratic state attorneys general. A new administration could change that position, but that’s not the same as dropping the case.
Congress, on the other hand, could easily make the case moot. It could add back even a nominal financial penalty for not having insurance. It could eliminate the mandate altogether, although that would require 60 votes in the Senate under current rules. Congress could also pass a “severability” provision saying that, if any portion of the law is struck down, the rest should remain.
“The problem is not technical,” said Bagley. “It’s political.”
What is the timeline for a decision? Could the court delay implementation of its ruling?
The court usually hears oral arguments in a case months before it issues a decision. Unless the decision is unanimous or turns out to be very simple, Bagley said, he would expect to see an opinion “sometime in the spring.”
As to whether the court could find some or all of the law unconstitutional but delay when its decision takes effect, Bagley said that happened from time to time as recently as the 1970s. “That practice has been more or less abandoned,” he said, but in the case of a law so large, “you could imagine the Supreme Court using its discretion to say the decision wouldn’t take effect immediately.”
If the court does invalidate the entire ACA, Congress could act to fix things, but it’s unclear if it will be able to, especially if Republicans still control the Senate. If the justices strike the law, Bagley said, “I honestly think the likeliest outcome is that Congress runs around like a chicken with its head cut off, doesn’t come to a deal, and we’re back to where we were before 2010” when the ACA passed.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
COVID-19 and Venous Thromboembolism Pharmacologic Thromboprophylaxis
The novel coronavirus SARS-CoV-2 and resulting viral syndrome (COVID-19) was first reported in China during December 2019 and within weeks emerged in the US.1 Since it is a rapidly evolving situation, clinicians must remain current on best practices—a challenging institutional responsibility. According to LitCovid, a curated literature hub for tracking scientific information on COVID-19, there are > 54,000 articles on the subject in PubMed. Among these include venous thromboembolism (VTE) prophylaxis guidance from 4 respected thrombosis organizations/societies and the US National Institutes of Health.1-5
Observations
COVID-19 predisposes patients with and without a history of cardiovascular disease to thrombotic complications, occurring in either the venous or arterial circulation system.2,6 Early observational studies suggest that thrombotic rates may be in excess of 20 to 30%; however, the use of prophylactic anticoagulation was inconsistent among studies that were rushed to publication.6
Autopsy data have demonstrated the presence of fibrin thrombi within distended small vessels and capillaries and extensive extracellular fibrin deposition.6 Investigators compared the characteristics of acute pulmonary embolism in 23 cases with COVID-19 but with no clinical signs of deep vein thrombosis with 100 controls without COVID-19.7 They observed that thrombotic lesions had a greater distribution in peripheral lung segments (ie, peripheral arteries) and were less extensive for those with COVID-19 vs without COVID-19 infection. Thus, experts currently hypothesize that COVID-19 has a distinct “pathomechanism.” As a unique phenotype, thrombotic events represent a combination of thromboembolic disease influenced by components of the Virchow triad (eg, acute illness and immobility) and in situ immunothrombosis, a local inflammatory response.6,7
Well-established surgical and nonsurgical VTE thromboprophylaxis guidelines serve as the foundation for current COVID-19 thromboprophylaxis guidance.8,9 Condition specific guidance is extrapolated from small, retrospective observational studies or based on expert opinion, representing levels 2 and 3 evidence, respectively.1-5 Table 1 captures similarities and differences among COVID-19 VTE thromboprophylaxis recommendations which vary by time to publication and by society member expertise gained from practice in the field.
Three thrombosis societies recommend universal pharmacologic thromboprophylaxis for acutely ill COVID-19 patients who lack contraindications.3-5 Others recommend use of risk stratification scoring tools, such as the Padua risk assessment model (RAM) for medical patients or Caprini RAM for surgical patients, the disseminated intravascular coagulation (DIC) score, or the sepsis-induced coagulopathy score to determine therapeutic appropriateness (Tables 2 and 3).1,2 Since most patients hospitalized for COVID-19 will present with a pathognomonic pneumonia and an oxygen requirement, they will generally achieve a score of ≥ 4 when the Padua RAM is applied; thus, representing a clear indication for pharmacologic thromboprophylaxis.8,9 If the patient is pregnant, the Anticoagulation Forum recommends pharmacologic prophylaxis, consultation with an obstetrician, and use of obstetrical thromboprophylaxis guidelines.3,10,11
Most thrombosis experts prefer parenteral thromboprophylaxis, specifically low molecular-weight heparin (LMWH) or fondaparinux, for inpatients over use of direct oral anticoagulants (DOACs) in order to minimize the potential for drug interactions particularly when investigational antivirals are in use.4 Once-daily agents (eg, rivaroxaban, fondaparinux, and enoxaparin) are preferred over multiple daily doses to minimize staff contact with patients infected with COVID-19.4,5 Fondaparinux and DOACs should preferentially be used in patients with a recent history of heparin-induced thrombocytopenia with and without thrombosis (HIT/HITTS). Subcutaneous heparin is reserved for patients who are scheduled for invasive procedures or have reduced renal function (eg, creatinine clearance < 30 mL/min).1,3-5 In line with existing pharmacologic thromboprophylaxis guidance, standard prophylactic LMWH doses are recommended unless patients are obese (body mass index [BMI] > 30) or morbidly obese (BMI > 40) necessitating selection of intermediate doses.4
Since early non-US studies demonstrated high thrombotic risk without signaling a potential for harm from pharmacologic thromboprophylaxis, some organizations recommend empiric escalation of anticoagulation doses for critical illness.3,4,6 Thus, it may be reasonable to advance to either intermediate pharmacologic thromboprophylaxis dosing or therapeutic doses.3 However, observational studies question this aggressive practice unless a clear indication exists for intensification (ie, atrial fibrillation, known VTE).
A large multi-institutional registry study that included 400 subjects from 5 centers demonstrated a radiographically confirmed VTE rate of 4.8% and an arterial thrombosis rate of 2.8%.6 When limiting to the critically ill setting, VTE and arterial thrombosis occurred at slightly higher rates (7.6% and 5.6%, respectively). Patients also were at risk for nonvessel thrombotic complications (eg, CVVH circuit, central venous catheters, and arterial lines). Subsequently, the overall thrombotic complication rate was 9.5%. All thrombotic events except one arose in patients who were receiving standard doses of pharmacologic thromboprophylaxis. Unfortunately, D-dimer elevation at admission was not only predictive of thrombosis and death, but portended bleeding. The overall bleeding rate was 4.8%, with a major bleeding rate of 2.3%. In the context of observing thromboses at normally expected rates during critical illness in association with a significant bleeding risk, the authors recommended further investigation into the net clinical benefit.
Similarly, a National Institutes of Health funded, observational, single center US study evaluated 4,389 inpatients infected with COVID-19 and determined that therapeutic and prophylactic anticoagulation reduced inpatient mortality (adjusted hazard ratio [aHR], 0.53 and 0.50, respectively for the primary outcome) and intubation (aHR, 0.69 and 0.72, respectively) over no anticoagulation.12 Notably, use of inpatient therapeutic anticoagulation commonly represented a continuation of preadmission therapy or progressive COVID-19. A subanalysis demonstrated that timely use (eg, within 48 hours of admission) of prophylactic or therapeutic anticoagulation, resulted in no difference (P < .08) in the primary outcome. Bleeding rates were low overall: 3%, 1.7%, and 1.9% for therapeutic, prophylactic, and no anticoagulation groups, respectively. Furthermore, selection of DOACs seems to be associated with lower bleeding rates when compared with that of LMWH heparin (1.3% vs 2.6%, respectively). In those where site of bleeding could be ascertained, the most common sites were the gastrointestinal tract (50.7%) followed by mucocutaneous (19.4%), bronchopulmonary (14.9%), and intracranial (6%). In summary, prophylactic thromboprophylaxis doses seem to be associated with positive net clinical benefit.
As of October 30, 2020, the US Department of Veterans Affairs (VA) had reported 75,156 COVID-19 cases and 3,961 deaths.13 Since the VA Pharmacy Benefits Management (PBM) does not disseminate nationally prepared anticoagulation order sets to the field, facility anticoagulation leads should be encouraged to develop local guidance-based policies to help standardize care and minimize further variations in practice, which would likely lack evidential support. Per the VA Tennessee Valley Healthcare System (TVHS)- Nashville/Murfreesboro anticoagulation policy, we limit the ordering of parenteral anticoagulation to Computerized Patient Record System (CPRS) order sets in order to provide decision support (eFigure 1, available at doi:10.12788/fp.0063). Other facilities have shown that embedded clinical decision support tools increase adherence to guideline VTE prophylaxis recommendations within the VA.14
In April 2020, the TVHS anticoagulation clinical pharmacy leads developed a COVID-19 specific order set based on review of societal guidance and the evolving, supportive literature summarized in this review with consideration of provider familiarity (eFigure 2, available at doi:10.12788/fp.0063)). Between April and June 2020, the COVID-19 order set content consistently evolved with publication of each COVID-19 thromboprophylaxis guideline.1-5
Since TVHS is a high-complexity facility, we elected to use universal pharmacologic thromboprophylaxis for patients with COVID-19. This construct bypasses the use of scoring tools (eg, RAM), although we use Padua and Caprini RAMS for medical and surgical patients, respectively, who are not diagnosed with COVID-19. The order set displays all acceptable guideline recommended options, delineated by location of care (eg, medical ward vs intensive care unit), prior history of heparin-induced thrombocytopenia, and renal function. Subsequently, all potential agents, doses, and dosing interval options are offered so that the provider autonomously determines how to individualize the clinical care. Since TVHS has only diagnosed 932 ambulatory/inpatient COVID-19 cases combined, our plans are to complete a future observational analysis to determine the effectiveness of the inpatient COVID-19 thromboprophylaxis order set for our internal customers.
Conclusions
The COVID-19 pandemic has resulted in arguably the most challenging medical climate in the evidence-based medicine era. Until high-quality randomized controlled trials are published, the medical community is, in a sense, operating within a crucible of crisis having to navigate therapeutic policy with little certainty. This principle holds true for thromboprophylaxis in patients with COVID-19 despite the numerous advancements in this field over the past decade.
A review of societal guidance shows there is universal agreement with regards to supporting standard doses of pharmacologicalprophylaxis in acutely ill patients either when universally applied or guided by a RAM as well as the use of universal thromboprophylaxis in critically ill patients. All societies discourage the use of antiplatelet therapy for arterial thrombosis prevention and advocate for mechanical compression in patients with contraindications to pharmacologic anticoagulation. Beyond this, divergence between guidance statements begins to appear. For example, societies do not currently agree on the role and approach for extended pharmacologic prophylaxis postdischarge. The differences between societal guidance speaks to the degree of uncertainty among leading experts, which is considered to be the logical outworking of the current level of evidence. Regardless, these guidance documents should be considered the best resource currently available.
The medical community is fortunate to have robust societies that have published guidance on thromboprophylaxis in patients with COVID-19. The novelty of COVID-19 precludes these societal guidance publications from being based on high-quality evidence, but at the very least, they provide insight into how leading experts in the field of thrombosis and hemostasis are currently navigating the therapeutic landscape.
While this paper provides a summary of the current guidance, evidence is evolving at an unprecedented pace. Facilities and anticoagulation leads should be actively and frequently evaluating literature and guidance to ensure their practices and policies remain current.
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville/Murfreesboro.
1. National Institutes of Health. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/whats-new/. Updated October 9, 2020. Accessed October 15, 2020.
2. Bikdeli B, Madhavan MV, Jimenez D, et al. COVID-19 and thrombotic or thromboembolic disease: implications for prevention, antithrombotic therapy, and follow-up: JACC state-of-the-art review. J Am Coll Cardiol. 2020;75(23):2950-2973. doi:10.1016/j.jacc.2020.04.031
3. Barnes GD, Burnett A, Allen A, et al. Thromboembolism and anticoagulant therapy during the COVID-19 pandemic: interim clinical guidance from the anticoagulation forum. J Thromb Thrombolysis. 2020;50(1):72-81. doi:10.1007/s11239-020-02138-z
4. Spyropoulos AC, Levy JH, Ageno W, et al. Scientific and Standardization Committee communication: Clinical guidance on the diagnosis, prevention, and treatment of venous thromboembolism in hospitalized patients with COVID-19. J Thromb Haemost. 2020;18(8):1859-1865. doi:10.1111/jth.14929
5. Moores LK, Tritschler T, Brosnahan S, et al. Prevention, Diagnosis, and Treatment of VTE in Patients With Coronavirus Disease 2019: CHEST Guideline and Expert Panel Report. Chest. 2020;158(3):1143-1163. doi:10.1016/j.chest.2020.05.559
6. Al-Samkari H, Karp Leaf RS, Dzik WH, et al. COVID-19 and coagulation: bleeding and thrombotic manifestations of SARS-CoV-2 infection. Blood. 2020;136(4):489-500. doi:10.1182/blood.2020006520.
7. van Dam LF, Kroft LJM, van der Wal LI, et al. Clinical and computed tomography characteristics of COVID-19 associated acute pulmonary embolism: a different phenotype of thrombotic disease?. Thromb Res. 2020;193:86-89. doi:10.1016/j.thromres.2020.06.010
8. Kahn SR, Lim W, Dunn AS, et al. Prevention of VTE in nonsurgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(suppl 2):e195S-e226S. doi:10.1378/chest.11-2296
9. Gould MK, Garcia DA, Wren SM, et al. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines [published correction appears in Chest. 2012 May;141(5):1369]. Chest. 2012;141(suppl 2):e227S-e277S. doi:10.1378/chest.11-2297
10. ACOG Practice Bulletin No. 196 Summary: thromboembolism in pregnancy. Obstet Gynecol. 2018;132(1):243-248. doi:10.1097/AOG.0000000000002707
11. Royal College of Obstetricians and Gynaecologists. Reducing the risk of venous thromboembolism during pregnancy and the puerperium. Green-top Guideline. No. 37a. https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-37a.pdf. Published April 2015. Accessed October 15, 2020.
12. Nadkarni GN, Lala A, Bagiella E, et al. Anticoagulation, mortality, bleeding and pathology among patients hospitalized with COVID-19: a single health system study [published online ahead of print, 2020 Aug 24]. J Am Coll Cardiol. 2020;76(16):1815-1826. doi:10.1016/j.jacc.2020.08.041
13. US Department of Veterans Affairs. Department of Veterans Affairs COVID-19 national summary. https://www.accesstocare.va.gov/Healthcare/COVID19NationalSummary. Updated November 1, 2020. Accessed November 1, 2020.
14. George B, Gonzales S, Patel K, Petit S, Franck AJ, Bovio Franck J. Impact of a clinical decision-support tool on venous thromboembolism prophylaxis in acutely ill medical patients. J Pharm Technol. 2020;36(4):141-147. doi:10.1177/8755122520930288
The novel coronavirus SARS-CoV-2 and resulting viral syndrome (COVID-19) was first reported in China during December 2019 and within weeks emerged in the US.1 Since it is a rapidly evolving situation, clinicians must remain current on best practices—a challenging institutional responsibility. According to LitCovid, a curated literature hub for tracking scientific information on COVID-19, there are > 54,000 articles on the subject in PubMed. Among these include venous thromboembolism (VTE) prophylaxis guidance from 4 respected thrombosis organizations/societies and the US National Institutes of Health.1-5
Observations
COVID-19 predisposes patients with and without a history of cardiovascular disease to thrombotic complications, occurring in either the venous or arterial circulation system.2,6 Early observational studies suggest that thrombotic rates may be in excess of 20 to 30%; however, the use of prophylactic anticoagulation was inconsistent among studies that were rushed to publication.6
Autopsy data have demonstrated the presence of fibrin thrombi within distended small vessels and capillaries and extensive extracellular fibrin deposition.6 Investigators compared the characteristics of acute pulmonary embolism in 23 cases with COVID-19 but with no clinical signs of deep vein thrombosis with 100 controls without COVID-19.7 They observed that thrombotic lesions had a greater distribution in peripheral lung segments (ie, peripheral arteries) and were less extensive for those with COVID-19 vs without COVID-19 infection. Thus, experts currently hypothesize that COVID-19 has a distinct “pathomechanism.” As a unique phenotype, thrombotic events represent a combination of thromboembolic disease influenced by components of the Virchow triad (eg, acute illness and immobility) and in situ immunothrombosis, a local inflammatory response.6,7
Well-established surgical and nonsurgical VTE thromboprophylaxis guidelines serve as the foundation for current COVID-19 thromboprophylaxis guidance.8,9 Condition specific guidance is extrapolated from small, retrospective observational studies or based on expert opinion, representing levels 2 and 3 evidence, respectively.1-5 Table 1 captures similarities and differences among COVID-19 VTE thromboprophylaxis recommendations which vary by time to publication and by society member expertise gained from practice in the field.
Three thrombosis societies recommend universal pharmacologic thromboprophylaxis for acutely ill COVID-19 patients who lack contraindications.3-5 Others recommend use of risk stratification scoring tools, such as the Padua risk assessment model (RAM) for medical patients or Caprini RAM for surgical patients, the disseminated intravascular coagulation (DIC) score, or the sepsis-induced coagulopathy score to determine therapeutic appropriateness (Tables 2 and 3).1,2 Since most patients hospitalized for COVID-19 will present with a pathognomonic pneumonia and an oxygen requirement, they will generally achieve a score of ≥ 4 when the Padua RAM is applied; thus, representing a clear indication for pharmacologic thromboprophylaxis.8,9 If the patient is pregnant, the Anticoagulation Forum recommends pharmacologic prophylaxis, consultation with an obstetrician, and use of obstetrical thromboprophylaxis guidelines.3,10,11
Most thrombosis experts prefer parenteral thromboprophylaxis, specifically low molecular-weight heparin (LMWH) or fondaparinux, for inpatients over use of direct oral anticoagulants (DOACs) in order to minimize the potential for drug interactions particularly when investigational antivirals are in use.4 Once-daily agents (eg, rivaroxaban, fondaparinux, and enoxaparin) are preferred over multiple daily doses to minimize staff contact with patients infected with COVID-19.4,5 Fondaparinux and DOACs should preferentially be used in patients with a recent history of heparin-induced thrombocytopenia with and without thrombosis (HIT/HITTS). Subcutaneous heparin is reserved for patients who are scheduled for invasive procedures or have reduced renal function (eg, creatinine clearance < 30 mL/min).1,3-5 In line with existing pharmacologic thromboprophylaxis guidance, standard prophylactic LMWH doses are recommended unless patients are obese (body mass index [BMI] > 30) or morbidly obese (BMI > 40) necessitating selection of intermediate doses.4
Since early non-US studies demonstrated high thrombotic risk without signaling a potential for harm from pharmacologic thromboprophylaxis, some organizations recommend empiric escalation of anticoagulation doses for critical illness.3,4,6 Thus, it may be reasonable to advance to either intermediate pharmacologic thromboprophylaxis dosing or therapeutic doses.3 However, observational studies question this aggressive practice unless a clear indication exists for intensification (ie, atrial fibrillation, known VTE).
A large multi-institutional registry study that included 400 subjects from 5 centers demonstrated a radiographically confirmed VTE rate of 4.8% and an arterial thrombosis rate of 2.8%.6 When limiting to the critically ill setting, VTE and arterial thrombosis occurred at slightly higher rates (7.6% and 5.6%, respectively). Patients also were at risk for nonvessel thrombotic complications (eg, CVVH circuit, central venous catheters, and arterial lines). Subsequently, the overall thrombotic complication rate was 9.5%. All thrombotic events except one arose in patients who were receiving standard doses of pharmacologic thromboprophylaxis. Unfortunately, D-dimer elevation at admission was not only predictive of thrombosis and death, but portended bleeding. The overall bleeding rate was 4.8%, with a major bleeding rate of 2.3%. In the context of observing thromboses at normally expected rates during critical illness in association with a significant bleeding risk, the authors recommended further investigation into the net clinical benefit.
Similarly, a National Institutes of Health funded, observational, single center US study evaluated 4,389 inpatients infected with COVID-19 and determined that therapeutic and prophylactic anticoagulation reduced inpatient mortality (adjusted hazard ratio [aHR], 0.53 and 0.50, respectively for the primary outcome) and intubation (aHR, 0.69 and 0.72, respectively) over no anticoagulation.12 Notably, use of inpatient therapeutic anticoagulation commonly represented a continuation of preadmission therapy or progressive COVID-19. A subanalysis demonstrated that timely use (eg, within 48 hours of admission) of prophylactic or therapeutic anticoagulation, resulted in no difference (P < .08) in the primary outcome. Bleeding rates were low overall: 3%, 1.7%, and 1.9% for therapeutic, prophylactic, and no anticoagulation groups, respectively. Furthermore, selection of DOACs seems to be associated with lower bleeding rates when compared with that of LMWH heparin (1.3% vs 2.6%, respectively). In those where site of bleeding could be ascertained, the most common sites were the gastrointestinal tract (50.7%) followed by mucocutaneous (19.4%), bronchopulmonary (14.9%), and intracranial (6%). In summary, prophylactic thromboprophylaxis doses seem to be associated with positive net clinical benefit.
As of October 30, 2020, the US Department of Veterans Affairs (VA) had reported 75,156 COVID-19 cases and 3,961 deaths.13 Since the VA Pharmacy Benefits Management (PBM) does not disseminate nationally prepared anticoagulation order sets to the field, facility anticoagulation leads should be encouraged to develop local guidance-based policies to help standardize care and minimize further variations in practice, which would likely lack evidential support. Per the VA Tennessee Valley Healthcare System (TVHS)- Nashville/Murfreesboro anticoagulation policy, we limit the ordering of parenteral anticoagulation to Computerized Patient Record System (CPRS) order sets in order to provide decision support (eFigure 1, available at doi:10.12788/fp.0063). Other facilities have shown that embedded clinical decision support tools increase adherence to guideline VTE prophylaxis recommendations within the VA.14
In April 2020, the TVHS anticoagulation clinical pharmacy leads developed a COVID-19 specific order set based on review of societal guidance and the evolving, supportive literature summarized in this review with consideration of provider familiarity (eFigure 2, available at doi:10.12788/fp.0063)). Between April and June 2020, the COVID-19 order set content consistently evolved with publication of each COVID-19 thromboprophylaxis guideline.1-5
Since TVHS is a high-complexity facility, we elected to use universal pharmacologic thromboprophylaxis for patients with COVID-19. This construct bypasses the use of scoring tools (eg, RAM), although we use Padua and Caprini RAMS for medical and surgical patients, respectively, who are not diagnosed with COVID-19. The order set displays all acceptable guideline recommended options, delineated by location of care (eg, medical ward vs intensive care unit), prior history of heparin-induced thrombocytopenia, and renal function. Subsequently, all potential agents, doses, and dosing interval options are offered so that the provider autonomously determines how to individualize the clinical care. Since TVHS has only diagnosed 932 ambulatory/inpatient COVID-19 cases combined, our plans are to complete a future observational analysis to determine the effectiveness of the inpatient COVID-19 thromboprophylaxis order set for our internal customers.
Conclusions
The COVID-19 pandemic has resulted in arguably the most challenging medical climate in the evidence-based medicine era. Until high-quality randomized controlled trials are published, the medical community is, in a sense, operating within a crucible of crisis having to navigate therapeutic policy with little certainty. This principle holds true for thromboprophylaxis in patients with COVID-19 despite the numerous advancements in this field over the past decade.
A review of societal guidance shows there is universal agreement with regards to supporting standard doses of pharmacologicalprophylaxis in acutely ill patients either when universally applied or guided by a RAM as well as the use of universal thromboprophylaxis in critically ill patients. All societies discourage the use of antiplatelet therapy for arterial thrombosis prevention and advocate for mechanical compression in patients with contraindications to pharmacologic anticoagulation. Beyond this, divergence between guidance statements begins to appear. For example, societies do not currently agree on the role and approach for extended pharmacologic prophylaxis postdischarge. The differences between societal guidance speaks to the degree of uncertainty among leading experts, which is considered to be the logical outworking of the current level of evidence. Regardless, these guidance documents should be considered the best resource currently available.
The medical community is fortunate to have robust societies that have published guidance on thromboprophylaxis in patients with COVID-19. The novelty of COVID-19 precludes these societal guidance publications from being based on high-quality evidence, but at the very least, they provide insight into how leading experts in the field of thrombosis and hemostasis are currently navigating the therapeutic landscape.
While this paper provides a summary of the current guidance, evidence is evolving at an unprecedented pace. Facilities and anticoagulation leads should be actively and frequently evaluating literature and guidance to ensure their practices and policies remain current.
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville/Murfreesboro.
The novel coronavirus SARS-CoV-2 and resulting viral syndrome (COVID-19) was first reported in China during December 2019 and within weeks emerged in the US.1 Since it is a rapidly evolving situation, clinicians must remain current on best practices—a challenging institutional responsibility. According to LitCovid, a curated literature hub for tracking scientific information on COVID-19, there are > 54,000 articles on the subject in PubMed. Among these include venous thromboembolism (VTE) prophylaxis guidance from 4 respected thrombosis organizations/societies and the US National Institutes of Health.1-5
Observations
COVID-19 predisposes patients with and without a history of cardiovascular disease to thrombotic complications, occurring in either the venous or arterial circulation system.2,6 Early observational studies suggest that thrombotic rates may be in excess of 20 to 30%; however, the use of prophylactic anticoagulation was inconsistent among studies that were rushed to publication.6
Autopsy data have demonstrated the presence of fibrin thrombi within distended small vessels and capillaries and extensive extracellular fibrin deposition.6 Investigators compared the characteristics of acute pulmonary embolism in 23 cases with COVID-19 but with no clinical signs of deep vein thrombosis with 100 controls without COVID-19.7 They observed that thrombotic lesions had a greater distribution in peripheral lung segments (ie, peripheral arteries) and were less extensive for those with COVID-19 vs without COVID-19 infection. Thus, experts currently hypothesize that COVID-19 has a distinct “pathomechanism.” As a unique phenotype, thrombotic events represent a combination of thromboembolic disease influenced by components of the Virchow triad (eg, acute illness and immobility) and in situ immunothrombosis, a local inflammatory response.6,7
Well-established surgical and nonsurgical VTE thromboprophylaxis guidelines serve as the foundation for current COVID-19 thromboprophylaxis guidance.8,9 Condition specific guidance is extrapolated from small, retrospective observational studies or based on expert opinion, representing levels 2 and 3 evidence, respectively.1-5 Table 1 captures similarities and differences among COVID-19 VTE thromboprophylaxis recommendations which vary by time to publication and by society member expertise gained from practice in the field.
Three thrombosis societies recommend universal pharmacologic thromboprophylaxis for acutely ill COVID-19 patients who lack contraindications.3-5 Others recommend use of risk stratification scoring tools, such as the Padua risk assessment model (RAM) for medical patients or Caprini RAM for surgical patients, the disseminated intravascular coagulation (DIC) score, or the sepsis-induced coagulopathy score to determine therapeutic appropriateness (Tables 2 and 3).1,2 Since most patients hospitalized for COVID-19 will present with a pathognomonic pneumonia and an oxygen requirement, they will generally achieve a score of ≥ 4 when the Padua RAM is applied; thus, representing a clear indication for pharmacologic thromboprophylaxis.8,9 If the patient is pregnant, the Anticoagulation Forum recommends pharmacologic prophylaxis, consultation with an obstetrician, and use of obstetrical thromboprophylaxis guidelines.3,10,11
Most thrombosis experts prefer parenteral thromboprophylaxis, specifically low molecular-weight heparin (LMWH) or fondaparinux, for inpatients over use of direct oral anticoagulants (DOACs) in order to minimize the potential for drug interactions particularly when investigational antivirals are in use.4 Once-daily agents (eg, rivaroxaban, fondaparinux, and enoxaparin) are preferred over multiple daily doses to minimize staff contact with patients infected with COVID-19.4,5 Fondaparinux and DOACs should preferentially be used in patients with a recent history of heparin-induced thrombocytopenia with and without thrombosis (HIT/HITTS). Subcutaneous heparin is reserved for patients who are scheduled for invasive procedures or have reduced renal function (eg, creatinine clearance < 30 mL/min).1,3-5 In line with existing pharmacologic thromboprophylaxis guidance, standard prophylactic LMWH doses are recommended unless patients are obese (body mass index [BMI] > 30) or morbidly obese (BMI > 40) necessitating selection of intermediate doses.4
Since early non-US studies demonstrated high thrombotic risk without signaling a potential for harm from pharmacologic thromboprophylaxis, some organizations recommend empiric escalation of anticoagulation doses for critical illness.3,4,6 Thus, it may be reasonable to advance to either intermediate pharmacologic thromboprophylaxis dosing or therapeutic doses.3 However, observational studies question this aggressive practice unless a clear indication exists for intensification (ie, atrial fibrillation, known VTE).
A large multi-institutional registry study that included 400 subjects from 5 centers demonstrated a radiographically confirmed VTE rate of 4.8% and an arterial thrombosis rate of 2.8%.6 When limiting to the critically ill setting, VTE and arterial thrombosis occurred at slightly higher rates (7.6% and 5.6%, respectively). Patients also were at risk for nonvessel thrombotic complications (eg, CVVH circuit, central venous catheters, and arterial lines). Subsequently, the overall thrombotic complication rate was 9.5%. All thrombotic events except one arose in patients who were receiving standard doses of pharmacologic thromboprophylaxis. Unfortunately, D-dimer elevation at admission was not only predictive of thrombosis and death, but portended bleeding. The overall bleeding rate was 4.8%, with a major bleeding rate of 2.3%. In the context of observing thromboses at normally expected rates during critical illness in association with a significant bleeding risk, the authors recommended further investigation into the net clinical benefit.
Similarly, a National Institutes of Health funded, observational, single center US study evaluated 4,389 inpatients infected with COVID-19 and determined that therapeutic and prophylactic anticoagulation reduced inpatient mortality (adjusted hazard ratio [aHR], 0.53 and 0.50, respectively for the primary outcome) and intubation (aHR, 0.69 and 0.72, respectively) over no anticoagulation.12 Notably, use of inpatient therapeutic anticoagulation commonly represented a continuation of preadmission therapy or progressive COVID-19. A subanalysis demonstrated that timely use (eg, within 48 hours of admission) of prophylactic or therapeutic anticoagulation, resulted in no difference (P < .08) in the primary outcome. Bleeding rates were low overall: 3%, 1.7%, and 1.9% for therapeutic, prophylactic, and no anticoagulation groups, respectively. Furthermore, selection of DOACs seems to be associated with lower bleeding rates when compared with that of LMWH heparin (1.3% vs 2.6%, respectively). In those where site of bleeding could be ascertained, the most common sites were the gastrointestinal tract (50.7%) followed by mucocutaneous (19.4%), bronchopulmonary (14.9%), and intracranial (6%). In summary, prophylactic thromboprophylaxis doses seem to be associated with positive net clinical benefit.
As of October 30, 2020, the US Department of Veterans Affairs (VA) had reported 75,156 COVID-19 cases and 3,961 deaths.13 Since the VA Pharmacy Benefits Management (PBM) does not disseminate nationally prepared anticoagulation order sets to the field, facility anticoagulation leads should be encouraged to develop local guidance-based policies to help standardize care and minimize further variations in practice, which would likely lack evidential support. Per the VA Tennessee Valley Healthcare System (TVHS)- Nashville/Murfreesboro anticoagulation policy, we limit the ordering of parenteral anticoagulation to Computerized Patient Record System (CPRS) order sets in order to provide decision support (eFigure 1, available at doi:10.12788/fp.0063). Other facilities have shown that embedded clinical decision support tools increase adherence to guideline VTE prophylaxis recommendations within the VA.14
In April 2020, the TVHS anticoagulation clinical pharmacy leads developed a COVID-19 specific order set based on review of societal guidance and the evolving, supportive literature summarized in this review with consideration of provider familiarity (eFigure 2, available at doi:10.12788/fp.0063)). Between April and June 2020, the COVID-19 order set content consistently evolved with publication of each COVID-19 thromboprophylaxis guideline.1-5
Since TVHS is a high-complexity facility, we elected to use universal pharmacologic thromboprophylaxis for patients with COVID-19. This construct bypasses the use of scoring tools (eg, RAM), although we use Padua and Caprini RAMS for medical and surgical patients, respectively, who are not diagnosed with COVID-19. The order set displays all acceptable guideline recommended options, delineated by location of care (eg, medical ward vs intensive care unit), prior history of heparin-induced thrombocytopenia, and renal function. Subsequently, all potential agents, doses, and dosing interval options are offered so that the provider autonomously determines how to individualize the clinical care. Since TVHS has only diagnosed 932 ambulatory/inpatient COVID-19 cases combined, our plans are to complete a future observational analysis to determine the effectiveness of the inpatient COVID-19 thromboprophylaxis order set for our internal customers.
Conclusions
The COVID-19 pandemic has resulted in arguably the most challenging medical climate in the evidence-based medicine era. Until high-quality randomized controlled trials are published, the medical community is, in a sense, operating within a crucible of crisis having to navigate therapeutic policy with little certainty. This principle holds true for thromboprophylaxis in patients with COVID-19 despite the numerous advancements in this field over the past decade.
A review of societal guidance shows there is universal agreement with regards to supporting standard doses of pharmacologicalprophylaxis in acutely ill patients either when universally applied or guided by a RAM as well as the use of universal thromboprophylaxis in critically ill patients. All societies discourage the use of antiplatelet therapy for arterial thrombosis prevention and advocate for mechanical compression in patients with contraindications to pharmacologic anticoagulation. Beyond this, divergence between guidance statements begins to appear. For example, societies do not currently agree on the role and approach for extended pharmacologic prophylaxis postdischarge. The differences between societal guidance speaks to the degree of uncertainty among leading experts, which is considered to be the logical outworking of the current level of evidence. Regardless, these guidance documents should be considered the best resource currently available.
The medical community is fortunate to have robust societies that have published guidance on thromboprophylaxis in patients with COVID-19. The novelty of COVID-19 precludes these societal guidance publications from being based on high-quality evidence, but at the very least, they provide insight into how leading experts in the field of thrombosis and hemostasis are currently navigating the therapeutic landscape.
While this paper provides a summary of the current guidance, evidence is evolving at an unprecedented pace. Facilities and anticoagulation leads should be actively and frequently evaluating literature and guidance to ensure their practices and policies remain current.
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville/Murfreesboro.
1. National Institutes of Health. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/whats-new/. Updated October 9, 2020. Accessed October 15, 2020.
2. Bikdeli B, Madhavan MV, Jimenez D, et al. COVID-19 and thrombotic or thromboembolic disease: implications for prevention, antithrombotic therapy, and follow-up: JACC state-of-the-art review. J Am Coll Cardiol. 2020;75(23):2950-2973. doi:10.1016/j.jacc.2020.04.031
3. Barnes GD, Burnett A, Allen A, et al. Thromboembolism and anticoagulant therapy during the COVID-19 pandemic: interim clinical guidance from the anticoagulation forum. J Thromb Thrombolysis. 2020;50(1):72-81. doi:10.1007/s11239-020-02138-z
4. Spyropoulos AC, Levy JH, Ageno W, et al. Scientific and Standardization Committee communication: Clinical guidance on the diagnosis, prevention, and treatment of venous thromboembolism in hospitalized patients with COVID-19. J Thromb Haemost. 2020;18(8):1859-1865. doi:10.1111/jth.14929
5. Moores LK, Tritschler T, Brosnahan S, et al. Prevention, Diagnosis, and Treatment of VTE in Patients With Coronavirus Disease 2019: CHEST Guideline and Expert Panel Report. Chest. 2020;158(3):1143-1163. doi:10.1016/j.chest.2020.05.559
6. Al-Samkari H, Karp Leaf RS, Dzik WH, et al. COVID-19 and coagulation: bleeding and thrombotic manifestations of SARS-CoV-2 infection. Blood. 2020;136(4):489-500. doi:10.1182/blood.2020006520.
7. van Dam LF, Kroft LJM, van der Wal LI, et al. Clinical and computed tomography characteristics of COVID-19 associated acute pulmonary embolism: a different phenotype of thrombotic disease?. Thromb Res. 2020;193:86-89. doi:10.1016/j.thromres.2020.06.010
8. Kahn SR, Lim W, Dunn AS, et al. Prevention of VTE in nonsurgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(suppl 2):e195S-e226S. doi:10.1378/chest.11-2296
9. Gould MK, Garcia DA, Wren SM, et al. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines [published correction appears in Chest. 2012 May;141(5):1369]. Chest. 2012;141(suppl 2):e227S-e277S. doi:10.1378/chest.11-2297
10. ACOG Practice Bulletin No. 196 Summary: thromboembolism in pregnancy. Obstet Gynecol. 2018;132(1):243-248. doi:10.1097/AOG.0000000000002707
11. Royal College of Obstetricians and Gynaecologists. Reducing the risk of venous thromboembolism during pregnancy and the puerperium. Green-top Guideline. No. 37a. https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-37a.pdf. Published April 2015. Accessed October 15, 2020.
12. Nadkarni GN, Lala A, Bagiella E, et al. Anticoagulation, mortality, bleeding and pathology among patients hospitalized with COVID-19: a single health system study [published online ahead of print, 2020 Aug 24]. J Am Coll Cardiol. 2020;76(16):1815-1826. doi:10.1016/j.jacc.2020.08.041
13. US Department of Veterans Affairs. Department of Veterans Affairs COVID-19 national summary. https://www.accesstocare.va.gov/Healthcare/COVID19NationalSummary. Updated November 1, 2020. Accessed November 1, 2020.
14. George B, Gonzales S, Patel K, Petit S, Franck AJ, Bovio Franck J. Impact of a clinical decision-support tool on venous thromboembolism prophylaxis in acutely ill medical patients. J Pharm Technol. 2020;36(4):141-147. doi:10.1177/8755122520930288
1. National Institutes of Health. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/whats-new/. Updated October 9, 2020. Accessed October 15, 2020.
2. Bikdeli B, Madhavan MV, Jimenez D, et al. COVID-19 and thrombotic or thromboembolic disease: implications for prevention, antithrombotic therapy, and follow-up: JACC state-of-the-art review. J Am Coll Cardiol. 2020;75(23):2950-2973. doi:10.1016/j.jacc.2020.04.031
3. Barnes GD, Burnett A, Allen A, et al. Thromboembolism and anticoagulant therapy during the COVID-19 pandemic: interim clinical guidance from the anticoagulation forum. J Thromb Thrombolysis. 2020;50(1):72-81. doi:10.1007/s11239-020-02138-z
4. Spyropoulos AC, Levy JH, Ageno W, et al. Scientific and Standardization Committee communication: Clinical guidance on the diagnosis, prevention, and treatment of venous thromboembolism in hospitalized patients with COVID-19. J Thromb Haemost. 2020;18(8):1859-1865. doi:10.1111/jth.14929
5. Moores LK, Tritschler T, Brosnahan S, et al. Prevention, Diagnosis, and Treatment of VTE in Patients With Coronavirus Disease 2019: CHEST Guideline and Expert Panel Report. Chest. 2020;158(3):1143-1163. doi:10.1016/j.chest.2020.05.559
6. Al-Samkari H, Karp Leaf RS, Dzik WH, et al. COVID-19 and coagulation: bleeding and thrombotic manifestations of SARS-CoV-2 infection. Blood. 2020;136(4):489-500. doi:10.1182/blood.2020006520.
7. van Dam LF, Kroft LJM, van der Wal LI, et al. Clinical and computed tomography characteristics of COVID-19 associated acute pulmonary embolism: a different phenotype of thrombotic disease?. Thromb Res. 2020;193:86-89. doi:10.1016/j.thromres.2020.06.010
8. Kahn SR, Lim W, Dunn AS, et al. Prevention of VTE in nonsurgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(suppl 2):e195S-e226S. doi:10.1378/chest.11-2296
9. Gould MK, Garcia DA, Wren SM, et al. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines [published correction appears in Chest. 2012 May;141(5):1369]. Chest. 2012;141(suppl 2):e227S-e277S. doi:10.1378/chest.11-2297
10. ACOG Practice Bulletin No. 196 Summary: thromboembolism in pregnancy. Obstet Gynecol. 2018;132(1):243-248. doi:10.1097/AOG.0000000000002707
11. Royal College of Obstetricians and Gynaecologists. Reducing the risk of venous thromboembolism during pregnancy and the puerperium. Green-top Guideline. No. 37a. https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-37a.pdf. Published April 2015. Accessed October 15, 2020.
12. Nadkarni GN, Lala A, Bagiella E, et al. Anticoagulation, mortality, bleeding and pathology among patients hospitalized with COVID-19: a single health system study [published online ahead of print, 2020 Aug 24]. J Am Coll Cardiol. 2020;76(16):1815-1826. doi:10.1016/j.jacc.2020.08.041
13. US Department of Veterans Affairs. Department of Veterans Affairs COVID-19 national summary. https://www.accesstocare.va.gov/Healthcare/COVID19NationalSummary. Updated November 1, 2020. Accessed November 1, 2020.
14. George B, Gonzales S, Patel K, Petit S, Franck AJ, Bovio Franck J. Impact of a clinical decision-support tool on venous thromboembolism prophylaxis in acutely ill medical patients. J Pharm Technol. 2020;36(4):141-147. doi:10.1177/8755122520930288
Coaching in medicine: A perspective
Coaching is a new topic in medicine. I first heard about coaching several years ago and met the term with skepticism. I was unsure how coaching was different than mentoring or advising and I wondered about its usefulness. However, the reason that I even started to learn about coaching was because I was struggling. I had finally arrived in my career, I had my dream job with two healthy kids, a perfect house, and good marriage. I kept hearing the refrain in my head: “Is this all there is?” I had this arrival fallacy that after all this striving and straining that I would finally be content. I felt unfulfilled and was dissatisfied with where I was that was affecting all parts of my life.
As I was wrestling with these thoughts, I had an opportunity to become a coach to residents around the country through the Association of Women Surgeons. I discussed with them what fills them up, what gets them down, how to set goals, and what their goals were for the year, as well as imposter syndrome. Impostor syndrome is defined as a pattern in which an individual doubts their accomplishments or talents and has a persistent internalized fear of being exposed as a “fraud.” Despite external evidence of their competence, those experiencing this phenomenon remain convinced that they are fooling everyone around them and do not deserve all they have achieved. Individuals incorrectly attribute their success to luck or interpret it as a result of deceiving others into thinking they are more intelligent than they perceive themselves to be. Imposter syndrome is prevalent and deep in medicine. As perfectionists, we are especially vulnerable to imposter syndrome as we set unrealistic ideals for ourselves. When we fail to reach these ideals, we feel like frauds, setting up this cycle of self-doubt that is toxic. When we feel that we can’t achieve the goals that we are striving for we will always find ourselves lacking. There is a slow, insidious erosion of self over the years. Imposter syndrome is well documented in medicine and is even felt as early as medical school.1,2
When I began coaching these residents the most profound thing that came out of these sessions was that my life was getting better – I knew what filled me up, what got me down, what my goals were for the year, and how I still deal with imposter syndrome. Coaching gave me a framework for helping determine what I wanted for the rest of my life. As I began coaching, I started learning all the ways in which I could figure out my values, my personal and professional goals, and perhaps most importantly, my relationships with myself and others.
Another perspective on coaching is to look at a professional athlete such as Tom Brady, one of the greatest quarterbacks of all time. He has a quarterback coach. No coach is going to be a better quarterback than Tom Brady. A coach for him is to be there as an advocate, break his fundamentals down technically, and help him improve upon what he already knows. A coach also identifies strengths and weaknesses, and helps him capitalize on both by bringing awareness, reflection, accountability, and support. If world-class athletes still want and benefit from coaching in a sport they have already mastered, coaching for physicians is just another tool to help us improve our abilities in and out of medicine.
Coaching is more encompassing than advising or mentoring. It is about examining deeply held beliefs to see if they are really serving us, if they are in line with our values and how we want to live our lives.
Coaching has also been validated in medicine in several papers. In an article by Dyrbye et al. in JAMA Internal Medicine, measures of emotional exhaustion and burnout decreased in physicians who were coached and increased in those who were not.3 In another study from this year by McGonagle et al., a randomized, controlled trial showed that primary care physicians who had sessions (as short as 6 weeks) to address burnout, psychological capital, and job satisfaction experienced an improvement in measures which persisted for 6 months after intervention.4 Numerous other articles in medicine also exist to demonstrate the effect of coaching on mitigating burnout at an institutional level.
Physicians are inherently driven by their love of learning. As physicians, we love getting to the root cause of any problem and coming up with creative solutions. Any challenge we have, or just wanting to improve the quality of our lives, can be addressed with coaching. As perpetual students we can use coaching to truly master ourselves.
Dr. Shah is associate professor of surgery, Rush University Medical Center, Chicago. Instagram: ami.shahmdcoaching.
References
1. Gottlieb M et al. Med Educ. 2020 Feb;54(2):116-24.
2. Villwock JA et al. Int J Med Educ. 2016 Oct 31;7:364-9.
3. Dyrbye LN et al. JAMA Intern Med. 2019 Aug 5;179(10):1406-14.
4. McGonagle AK et al. J Occup Health Psychol. 2020 Apr 16. doi: 10.1037/ocp0000180.
Coaching is a new topic in medicine. I first heard about coaching several years ago and met the term with skepticism. I was unsure how coaching was different than mentoring or advising and I wondered about its usefulness. However, the reason that I even started to learn about coaching was because I was struggling. I had finally arrived in my career, I had my dream job with two healthy kids, a perfect house, and good marriage. I kept hearing the refrain in my head: “Is this all there is?” I had this arrival fallacy that after all this striving and straining that I would finally be content. I felt unfulfilled and was dissatisfied with where I was that was affecting all parts of my life.
As I was wrestling with these thoughts, I had an opportunity to become a coach to residents around the country through the Association of Women Surgeons. I discussed with them what fills them up, what gets them down, how to set goals, and what their goals were for the year, as well as imposter syndrome. Impostor syndrome is defined as a pattern in which an individual doubts their accomplishments or talents and has a persistent internalized fear of being exposed as a “fraud.” Despite external evidence of their competence, those experiencing this phenomenon remain convinced that they are fooling everyone around them and do not deserve all they have achieved. Individuals incorrectly attribute their success to luck or interpret it as a result of deceiving others into thinking they are more intelligent than they perceive themselves to be. Imposter syndrome is prevalent and deep in medicine. As perfectionists, we are especially vulnerable to imposter syndrome as we set unrealistic ideals for ourselves. When we fail to reach these ideals, we feel like frauds, setting up this cycle of self-doubt that is toxic. When we feel that we can’t achieve the goals that we are striving for we will always find ourselves lacking. There is a slow, insidious erosion of self over the years. Imposter syndrome is well documented in medicine and is even felt as early as medical school.1,2
When I began coaching these residents the most profound thing that came out of these sessions was that my life was getting better – I knew what filled me up, what got me down, what my goals were for the year, and how I still deal with imposter syndrome. Coaching gave me a framework for helping determine what I wanted for the rest of my life. As I began coaching, I started learning all the ways in which I could figure out my values, my personal and professional goals, and perhaps most importantly, my relationships with myself and others.
Another perspective on coaching is to look at a professional athlete such as Tom Brady, one of the greatest quarterbacks of all time. He has a quarterback coach. No coach is going to be a better quarterback than Tom Brady. A coach for him is to be there as an advocate, break his fundamentals down technically, and help him improve upon what he already knows. A coach also identifies strengths and weaknesses, and helps him capitalize on both by bringing awareness, reflection, accountability, and support. If world-class athletes still want and benefit from coaching in a sport they have already mastered, coaching for physicians is just another tool to help us improve our abilities in and out of medicine.
Coaching is more encompassing than advising or mentoring. It is about examining deeply held beliefs to see if they are really serving us, if they are in line with our values and how we want to live our lives.
Coaching has also been validated in medicine in several papers. In an article by Dyrbye et al. in JAMA Internal Medicine, measures of emotional exhaustion and burnout decreased in physicians who were coached and increased in those who were not.3 In another study from this year by McGonagle et al., a randomized, controlled trial showed that primary care physicians who had sessions (as short as 6 weeks) to address burnout, psychological capital, and job satisfaction experienced an improvement in measures which persisted for 6 months after intervention.4 Numerous other articles in medicine also exist to demonstrate the effect of coaching on mitigating burnout at an institutional level.
Physicians are inherently driven by their love of learning. As physicians, we love getting to the root cause of any problem and coming up with creative solutions. Any challenge we have, or just wanting to improve the quality of our lives, can be addressed with coaching. As perpetual students we can use coaching to truly master ourselves.
Dr. Shah is associate professor of surgery, Rush University Medical Center, Chicago. Instagram: ami.shahmdcoaching.
References
1. Gottlieb M et al. Med Educ. 2020 Feb;54(2):116-24.
2. Villwock JA et al. Int J Med Educ. 2016 Oct 31;7:364-9.
3. Dyrbye LN et al. JAMA Intern Med. 2019 Aug 5;179(10):1406-14.
4. McGonagle AK et al. J Occup Health Psychol. 2020 Apr 16. doi: 10.1037/ocp0000180.
Coaching is a new topic in medicine. I first heard about coaching several years ago and met the term with skepticism. I was unsure how coaching was different than mentoring or advising and I wondered about its usefulness. However, the reason that I even started to learn about coaching was because I was struggling. I had finally arrived in my career, I had my dream job with two healthy kids, a perfect house, and good marriage. I kept hearing the refrain in my head: “Is this all there is?” I had this arrival fallacy that after all this striving and straining that I would finally be content. I felt unfulfilled and was dissatisfied with where I was that was affecting all parts of my life.
As I was wrestling with these thoughts, I had an opportunity to become a coach to residents around the country through the Association of Women Surgeons. I discussed with them what fills them up, what gets them down, how to set goals, and what their goals were for the year, as well as imposter syndrome. Impostor syndrome is defined as a pattern in which an individual doubts their accomplishments or talents and has a persistent internalized fear of being exposed as a “fraud.” Despite external evidence of their competence, those experiencing this phenomenon remain convinced that they are fooling everyone around them and do not deserve all they have achieved. Individuals incorrectly attribute their success to luck or interpret it as a result of deceiving others into thinking they are more intelligent than they perceive themselves to be. Imposter syndrome is prevalent and deep in medicine. As perfectionists, we are especially vulnerable to imposter syndrome as we set unrealistic ideals for ourselves. When we fail to reach these ideals, we feel like frauds, setting up this cycle of self-doubt that is toxic. When we feel that we can’t achieve the goals that we are striving for we will always find ourselves lacking. There is a slow, insidious erosion of self over the years. Imposter syndrome is well documented in medicine and is even felt as early as medical school.1,2
When I began coaching these residents the most profound thing that came out of these sessions was that my life was getting better – I knew what filled me up, what got me down, what my goals were for the year, and how I still deal with imposter syndrome. Coaching gave me a framework for helping determine what I wanted for the rest of my life. As I began coaching, I started learning all the ways in which I could figure out my values, my personal and professional goals, and perhaps most importantly, my relationships with myself and others.
Another perspective on coaching is to look at a professional athlete such as Tom Brady, one of the greatest quarterbacks of all time. He has a quarterback coach. No coach is going to be a better quarterback than Tom Brady. A coach for him is to be there as an advocate, break his fundamentals down technically, and help him improve upon what he already knows. A coach also identifies strengths and weaknesses, and helps him capitalize on both by bringing awareness, reflection, accountability, and support. If world-class athletes still want and benefit from coaching in a sport they have already mastered, coaching for physicians is just another tool to help us improve our abilities in and out of medicine.
Coaching is more encompassing than advising or mentoring. It is about examining deeply held beliefs to see if they are really serving us, if they are in line with our values and how we want to live our lives.
Coaching has also been validated in medicine in several papers. In an article by Dyrbye et al. in JAMA Internal Medicine, measures of emotional exhaustion and burnout decreased in physicians who were coached and increased in those who were not.3 In another study from this year by McGonagle et al., a randomized, controlled trial showed that primary care physicians who had sessions (as short as 6 weeks) to address burnout, psychological capital, and job satisfaction experienced an improvement in measures which persisted for 6 months after intervention.4 Numerous other articles in medicine also exist to demonstrate the effect of coaching on mitigating burnout at an institutional level.
Physicians are inherently driven by their love of learning. As physicians, we love getting to the root cause of any problem and coming up with creative solutions. Any challenge we have, or just wanting to improve the quality of our lives, can be addressed with coaching. As perpetual students we can use coaching to truly master ourselves.
Dr. Shah is associate professor of surgery, Rush University Medical Center, Chicago. Instagram: ami.shahmdcoaching.
References
1. Gottlieb M et al. Med Educ. 2020 Feb;54(2):116-24.
2. Villwock JA et al. Int J Med Educ. 2016 Oct 31;7:364-9.
3. Dyrbye LN et al. JAMA Intern Med. 2019 Aug 5;179(10):1406-14.
4. McGonagle AK et al. J Occup Health Psychol. 2020 Apr 16. doi: 10.1037/ocp0000180.
Poor and minority children with food allergies overlooked and in danger
As Emily Brown stood in a food pantry looking at her options, she felt alone. Up to that point, she had never struggled financially. But there she was, desperate to find safe food for her young daughter with food allergies. What she found was a jar of salsa and some potatoes.
“That was all that was available,” said Ms. Brown, who lives in Kansas City, Kansas. “It was just a desperate place.”
When she became a parent, Ms. Brown left her job for lack of child care that would accommodate her daughter’s allergies to peanuts, tree nuts, milk, eggs, wheat, and soy. When she and her husband then turned to a federal food assistance program, they found few allowable allergy substitutions. The closest allergy support group she could find was an hour away. She was almost always the only Black parent, and the only poor parent, there.
Ms. Brown called national food allergy advocacy organizations to ask for guidance to help poor families find safe food and medical resources, but she said she was told that wasn’t their focus. Support groups, fundraising activities, and advocacy efforts, plus clinical and research outreach, were targeted at wealthier – and White – families. Advertising rarely reflected families that looked like hers. She felt unseen.
“In many ways, food allergy is an invisible disease. The burden of the disease, the activities and energy it takes to avoid allergens, are mostly invisible to those not impacted,” Ms. Brown said. “Black and other minority patients often lack voice and visibility in the health care system. Add the additional burden of an invisible condition and you are in a really vulnerable position.”
An estimated 6 million children in the United States have food allergies, 40% of them with more than one. Though limited research has been done on race and class breakdowns, recent studies show that poor children and some groups of minority children not only have a higher incidence of food allergies than White children, but their families also have more difficulty accessing appropriate child care, safe food, medical care, and lifesaving medicine like epinephrine for them.
Black children are 7% more likely to have food allergies than white children, according to a 2020 study by Dr. Ruchi Gupta, MD, at Northwestern University, Chicago. To be sure, the study shows that Asian children are 24% more likely than White children to have food allergies. But Black and Hispanic children are disproportionately more likely to live in poor communities, to have asthma, and to suffer from systemic racism in the delivery of medical care.
“Many times, a mother is frank and says: ‘I have $20-$40 to buy groceries for the week, and if I buy these foods that you are telling me to buy, I will not be able to feed my entire family,’” said Carla Davis, MD, director of the food allergy program at Houston’s Texas Children’s Hospital. “If you are diagnosed with a food allergy and you don’t have disposable income or disposable time, there is really no way that you will be able to alter your diet in a way that your child is going to stay away from their allergen.”
Fed up with the lack of support, Ms. Brown founded the Food Equality Initiative advocacy organization in 2014. It offers an online marketplace to income-eligible families in Kansas and Missouri who, with a doctor’s note about the allergy, can order free allergy-safe food to fit their needs.
Nationwide, though, families’ needs far outstrip what her group can offer – and the problem has gotten worse amid the economic squeeze of the COVID pandemic. Job losses and business closures have exacerbated the barriers to finding and affording nutritious food, according to a report from Feeding America, an association of food banks.
Ms. Brown said her organization more than doubled its clientele in March through August, compared with the same period in 2019. And though it currently serves only Missouri and Kansas, she said the organization has been fielding an increasing number of calls from across the country since the pandemic began.
For low-income minorities, who live disproportionately in food deserts, fresh and allergy-friendly foods can be especially expensive and difficult to find in the best of times.
Food assistance programs are heavily weighted to prepackaged and processed foods, which often include the very ingredients that are problematic. Black children are more likely to be allergic to wheat and soy than White children, and both Black and Hispanic children are more likely to be allergic to corn, shellfish, and fish, according to a 2016 study.
Some programs allow few allergy substitutions. For example, the federal Special Supplemental Nutrition Program for Women, Infants, and Children allows only canned beans as a substitute for peanut butter. While nutritionally similar, beans are not as easy to pack for a kid’s lunch. Ms. Brown questions why WIC won’t allow a seed butter, such as sunflower butter, instead. She said they are nutritionally and functionally similar and are offered as allergy substitutions in other food programs.
Making matters worse, low-income households pay more than twice as much as higher-income families for the emergency medical care their children receive for their allergies, according to a 2016 study by Dr. Gupta. The kids often arrive at the hospital in more distress because they lack safe food and allergy medications – and because asthma, which disproportionately hits Black and Puerto Rican children and low-income communities, complicates allergic reactions.
“So, in these vulnerable populations, it’s like a double whammy, and we see that reflected in the data,” said Lakiea Wright-Bello, MD, a medical director in specialty diagnostics at Thermo Fisher Scientific and an allergist at Brigham and Women’s Hospital in Boston.
Thomas and Dina Silvera, who are Black and Latina, lived this horror firsthand. After their 3-year-old son, Elijah-Alavi, died as a result of a dairy allergy when fed a grilled cheese instead of his allergen-free food at his preschool, they launched the Elijah-Alavi Foundation to address the dearth of information about food allergies and the critical lack of culturally sensitive medical care in low-income communities.
“We started it for a cause, not because we wanted to, but because we had to,” said Thomas Silvera. “Our main focus is to bring to underserved communities – especially communities of color – this information at no cost to them.”
Recently, other advocacy groups, including Food Allergy Research & Education, a national advocacy organization, also have started to turn their attention to a lack of access and support in poor and minority communities. When Lisa Gable, who is White, took over at the group known as FARE in 2018, she began to diversify the organization internally and to make it more inclusive.
“There wasn’t a big tent when I walked in the door,” said Ms. Gable. “What we have been focused on doing is trying to find partners and relationships that will allow us to diversify those engaged in the community, because it has not been a diverse community.”
FARE has funded research into the cost of food allergies. It is also expanding its patient registry, which collects data for research, as well as its clinical network of medical institutions to include more diverse communities.
Dr. Gupta is now leading one of the first studies funded by the National Institutes of Health to investigate food allergy in children by race and ethnicity. It looks at all aspects of food allergies, including family life, management, access to care, and genetics.
“That’s a big deal,” said Dr. Gupta. “Because if we really want to improve food allergy management, care and understanding, we really need to understand how it impacts different groups. And that hasn’t been done.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
As Emily Brown stood in a food pantry looking at her options, she felt alone. Up to that point, she had never struggled financially. But there she was, desperate to find safe food for her young daughter with food allergies. What she found was a jar of salsa and some potatoes.
“That was all that was available,” said Ms. Brown, who lives in Kansas City, Kansas. “It was just a desperate place.”
When she became a parent, Ms. Brown left her job for lack of child care that would accommodate her daughter’s allergies to peanuts, tree nuts, milk, eggs, wheat, and soy. When she and her husband then turned to a federal food assistance program, they found few allowable allergy substitutions. The closest allergy support group she could find was an hour away. She was almost always the only Black parent, and the only poor parent, there.
Ms. Brown called national food allergy advocacy organizations to ask for guidance to help poor families find safe food and medical resources, but she said she was told that wasn’t their focus. Support groups, fundraising activities, and advocacy efforts, plus clinical and research outreach, were targeted at wealthier – and White – families. Advertising rarely reflected families that looked like hers. She felt unseen.
“In many ways, food allergy is an invisible disease. The burden of the disease, the activities and energy it takes to avoid allergens, are mostly invisible to those not impacted,” Ms. Brown said. “Black and other minority patients often lack voice and visibility in the health care system. Add the additional burden of an invisible condition and you are in a really vulnerable position.”
An estimated 6 million children in the United States have food allergies, 40% of them with more than one. Though limited research has been done on race and class breakdowns, recent studies show that poor children and some groups of minority children not only have a higher incidence of food allergies than White children, but their families also have more difficulty accessing appropriate child care, safe food, medical care, and lifesaving medicine like epinephrine for them.
Black children are 7% more likely to have food allergies than white children, according to a 2020 study by Dr. Ruchi Gupta, MD, at Northwestern University, Chicago. To be sure, the study shows that Asian children are 24% more likely than White children to have food allergies. But Black and Hispanic children are disproportionately more likely to live in poor communities, to have asthma, and to suffer from systemic racism in the delivery of medical care.
“Many times, a mother is frank and says: ‘I have $20-$40 to buy groceries for the week, and if I buy these foods that you are telling me to buy, I will not be able to feed my entire family,’” said Carla Davis, MD, director of the food allergy program at Houston’s Texas Children’s Hospital. “If you are diagnosed with a food allergy and you don’t have disposable income or disposable time, there is really no way that you will be able to alter your diet in a way that your child is going to stay away from their allergen.”
Fed up with the lack of support, Ms. Brown founded the Food Equality Initiative advocacy organization in 2014. It offers an online marketplace to income-eligible families in Kansas and Missouri who, with a doctor’s note about the allergy, can order free allergy-safe food to fit their needs.
Nationwide, though, families’ needs far outstrip what her group can offer – and the problem has gotten worse amid the economic squeeze of the COVID pandemic. Job losses and business closures have exacerbated the barriers to finding and affording nutritious food, according to a report from Feeding America, an association of food banks.
Ms. Brown said her organization more than doubled its clientele in March through August, compared with the same period in 2019. And though it currently serves only Missouri and Kansas, she said the organization has been fielding an increasing number of calls from across the country since the pandemic began.
For low-income minorities, who live disproportionately in food deserts, fresh and allergy-friendly foods can be especially expensive and difficult to find in the best of times.
Food assistance programs are heavily weighted to prepackaged and processed foods, which often include the very ingredients that are problematic. Black children are more likely to be allergic to wheat and soy than White children, and both Black and Hispanic children are more likely to be allergic to corn, shellfish, and fish, according to a 2016 study.
Some programs allow few allergy substitutions. For example, the federal Special Supplemental Nutrition Program for Women, Infants, and Children allows only canned beans as a substitute for peanut butter. While nutritionally similar, beans are not as easy to pack for a kid’s lunch. Ms. Brown questions why WIC won’t allow a seed butter, such as sunflower butter, instead. She said they are nutritionally and functionally similar and are offered as allergy substitutions in other food programs.
Making matters worse, low-income households pay more than twice as much as higher-income families for the emergency medical care their children receive for their allergies, according to a 2016 study by Dr. Gupta. The kids often arrive at the hospital in more distress because they lack safe food and allergy medications – and because asthma, which disproportionately hits Black and Puerto Rican children and low-income communities, complicates allergic reactions.
“So, in these vulnerable populations, it’s like a double whammy, and we see that reflected in the data,” said Lakiea Wright-Bello, MD, a medical director in specialty diagnostics at Thermo Fisher Scientific and an allergist at Brigham and Women’s Hospital in Boston.
Thomas and Dina Silvera, who are Black and Latina, lived this horror firsthand. After their 3-year-old son, Elijah-Alavi, died as a result of a dairy allergy when fed a grilled cheese instead of his allergen-free food at his preschool, they launched the Elijah-Alavi Foundation to address the dearth of information about food allergies and the critical lack of culturally sensitive medical care in low-income communities.
“We started it for a cause, not because we wanted to, but because we had to,” said Thomas Silvera. “Our main focus is to bring to underserved communities – especially communities of color – this information at no cost to them.”
Recently, other advocacy groups, including Food Allergy Research & Education, a national advocacy organization, also have started to turn their attention to a lack of access and support in poor and minority communities. When Lisa Gable, who is White, took over at the group known as FARE in 2018, she began to diversify the organization internally and to make it more inclusive.
“There wasn’t a big tent when I walked in the door,” said Ms. Gable. “What we have been focused on doing is trying to find partners and relationships that will allow us to diversify those engaged in the community, because it has not been a diverse community.”
FARE has funded research into the cost of food allergies. It is also expanding its patient registry, which collects data for research, as well as its clinical network of medical institutions to include more diverse communities.
Dr. Gupta is now leading one of the first studies funded by the National Institutes of Health to investigate food allergy in children by race and ethnicity. It looks at all aspects of food allergies, including family life, management, access to care, and genetics.
“That’s a big deal,” said Dr. Gupta. “Because if we really want to improve food allergy management, care and understanding, we really need to understand how it impacts different groups. And that hasn’t been done.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
As Emily Brown stood in a food pantry looking at her options, she felt alone. Up to that point, she had never struggled financially. But there she was, desperate to find safe food for her young daughter with food allergies. What she found was a jar of salsa and some potatoes.
“That was all that was available,” said Ms. Brown, who lives in Kansas City, Kansas. “It was just a desperate place.”
When she became a parent, Ms. Brown left her job for lack of child care that would accommodate her daughter’s allergies to peanuts, tree nuts, milk, eggs, wheat, and soy. When she and her husband then turned to a federal food assistance program, they found few allowable allergy substitutions. The closest allergy support group she could find was an hour away. She was almost always the only Black parent, and the only poor parent, there.
Ms. Brown called national food allergy advocacy organizations to ask for guidance to help poor families find safe food and medical resources, but she said she was told that wasn’t their focus. Support groups, fundraising activities, and advocacy efforts, plus clinical and research outreach, were targeted at wealthier – and White – families. Advertising rarely reflected families that looked like hers. She felt unseen.
“In many ways, food allergy is an invisible disease. The burden of the disease, the activities and energy it takes to avoid allergens, are mostly invisible to those not impacted,” Ms. Brown said. “Black and other minority patients often lack voice and visibility in the health care system. Add the additional burden of an invisible condition and you are in a really vulnerable position.”
An estimated 6 million children in the United States have food allergies, 40% of them with more than one. Though limited research has been done on race and class breakdowns, recent studies show that poor children and some groups of minority children not only have a higher incidence of food allergies than White children, but their families also have more difficulty accessing appropriate child care, safe food, medical care, and lifesaving medicine like epinephrine for them.
Black children are 7% more likely to have food allergies than white children, according to a 2020 study by Dr. Ruchi Gupta, MD, at Northwestern University, Chicago. To be sure, the study shows that Asian children are 24% more likely than White children to have food allergies. But Black and Hispanic children are disproportionately more likely to live in poor communities, to have asthma, and to suffer from systemic racism in the delivery of medical care.
“Many times, a mother is frank and says: ‘I have $20-$40 to buy groceries for the week, and if I buy these foods that you are telling me to buy, I will not be able to feed my entire family,’” said Carla Davis, MD, director of the food allergy program at Houston’s Texas Children’s Hospital. “If you are diagnosed with a food allergy and you don’t have disposable income or disposable time, there is really no way that you will be able to alter your diet in a way that your child is going to stay away from their allergen.”
Fed up with the lack of support, Ms. Brown founded the Food Equality Initiative advocacy organization in 2014. It offers an online marketplace to income-eligible families in Kansas and Missouri who, with a doctor’s note about the allergy, can order free allergy-safe food to fit their needs.
Nationwide, though, families’ needs far outstrip what her group can offer – and the problem has gotten worse amid the economic squeeze of the COVID pandemic. Job losses and business closures have exacerbated the barriers to finding and affording nutritious food, according to a report from Feeding America, an association of food banks.
Ms. Brown said her organization more than doubled its clientele in March through August, compared with the same period in 2019. And though it currently serves only Missouri and Kansas, she said the organization has been fielding an increasing number of calls from across the country since the pandemic began.
For low-income minorities, who live disproportionately in food deserts, fresh and allergy-friendly foods can be especially expensive and difficult to find in the best of times.
Food assistance programs are heavily weighted to prepackaged and processed foods, which often include the very ingredients that are problematic. Black children are more likely to be allergic to wheat and soy than White children, and both Black and Hispanic children are more likely to be allergic to corn, shellfish, and fish, according to a 2016 study.
Some programs allow few allergy substitutions. For example, the federal Special Supplemental Nutrition Program for Women, Infants, and Children allows only canned beans as a substitute for peanut butter. While nutritionally similar, beans are not as easy to pack for a kid’s lunch. Ms. Brown questions why WIC won’t allow a seed butter, such as sunflower butter, instead. She said they are nutritionally and functionally similar and are offered as allergy substitutions in other food programs.
Making matters worse, low-income households pay more than twice as much as higher-income families for the emergency medical care their children receive for their allergies, according to a 2016 study by Dr. Gupta. The kids often arrive at the hospital in more distress because they lack safe food and allergy medications – and because asthma, which disproportionately hits Black and Puerto Rican children and low-income communities, complicates allergic reactions.
“So, in these vulnerable populations, it’s like a double whammy, and we see that reflected in the data,” said Lakiea Wright-Bello, MD, a medical director in specialty diagnostics at Thermo Fisher Scientific and an allergist at Brigham and Women’s Hospital in Boston.
Thomas and Dina Silvera, who are Black and Latina, lived this horror firsthand. After their 3-year-old son, Elijah-Alavi, died as a result of a dairy allergy when fed a grilled cheese instead of his allergen-free food at his preschool, they launched the Elijah-Alavi Foundation to address the dearth of information about food allergies and the critical lack of culturally sensitive medical care in low-income communities.
“We started it for a cause, not because we wanted to, but because we had to,” said Thomas Silvera. “Our main focus is to bring to underserved communities – especially communities of color – this information at no cost to them.”
Recently, other advocacy groups, including Food Allergy Research & Education, a national advocacy organization, also have started to turn their attention to a lack of access and support in poor and minority communities. When Lisa Gable, who is White, took over at the group known as FARE in 2018, she began to diversify the organization internally and to make it more inclusive.
“There wasn’t a big tent when I walked in the door,” said Ms. Gable. “What we have been focused on doing is trying to find partners and relationships that will allow us to diversify those engaged in the community, because it has not been a diverse community.”
FARE has funded research into the cost of food allergies. It is also expanding its patient registry, which collects data for research, as well as its clinical network of medical institutions to include more diverse communities.
Dr. Gupta is now leading one of the first studies funded by the National Institutes of Health to investigate food allergy in children by race and ethnicity. It looks at all aspects of food allergies, including family life, management, access to care, and genetics.
“That’s a big deal,” said Dr. Gupta. “Because if we really want to improve food allergy management, care and understanding, we really need to understand how it impacts different groups. And that hasn’t been done.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Primary care workforce expanding, but mostly in cities
researchers say.
The finding may provide some reassurance for those who have worried about a shortage of health care workers and whether they will be able to meet the nation’s growing burden of chronic diseases.
“Access to primary care doctors is critical to population health and to reduce health care disparities in this country,” said Donglan Zhang, PhD, an assistant professor of public health at the University of Georgia, Athens.
However, many counties remain underserved, Dr. Zhang said in an interview. The need for primary care in the United States is increasing not only with population growth but because the population is aging.
Dr. Zhang and colleagues published the finding in JAMA Network Open.
Many previous reports have warned of a shortage in primary care providers. To examine recent trends in the primary care workforce, Dr. Zhang and colleagues obtained data on all the primary care clinicians registered with the Centers for Medicare & Medicaid Services from 2009 to 2017.
For the study, the researchers included general practitioners, family physicians and internists without subspecialties, nurse practitioners, and physician assistants. They then compared the number of providers with the number of residents in each county as recorded by the US Census, using urban or rural classifications for each county from the Centers for Disease Control and Prevention.
Because the U.S. Health Resources and Services Administration defines a primary care “shortage” as fewer than 1 primary care practitioner per 3,500 people, the researchers focused on this ratio. They found that the number of nurse practitioners and physician assistants was increasing much faster than the number of primary care physicians. This was true especially in rural areas, but the percentage increase for both nurse practitioners and physician assistants was lower in rural areas versus urban.
The researchers also found that there were more primary care physicians per capita in counties with higher household incomes, a higher proportion of Asian residents, and a higher proportion of college graduates.
They didn’t find a significant association between the median household income and per capita number of nurse practitioners.
They found that counties with a higher proportion of Black and Asian residents had a higher number of nurse practitioners per capita. But they found an opposite association between the proportion of Black residents and the number of physician assistants per capita.
The authors hypothesized that health care reform, particularly the passage of the Affordable Care Act in 2010, may explain the recent increase in the primary care workforce. The legislation expanded the number of people with health insurance and provided incentives for primary and preventive care.
Another factor behind the increase in the primary care workforce could be state laws that have expanded the scope of practice for nurse practitioners and primary care providers, she said.
Numbers may overestimate available care
The gap between rural and urban areas could be even wider than this study suggests, Ada D. Stewart, MD, president of the American Academy of Family Physicians, said in an interview. Many nurse practitioners and physician assistants don’t actually practice primary care, but instead assist physicians in other specialties such as orthopedics or general surgery.
“They are part of a team and I don’t want to diminish that at all, but especially when we talk about infant and maternal mortality, family physicians need to be there themselves providing primary care,” she said. “We’re there in hospitals and emergency rooms, and not just taking care of diabetes and hypertension.”
In addition, the primary care workforce may have been reduced since the conclusion of the study period (Dec. 31, 2017) as a result of the COVID-19 pandemic forcing some primary care physicians into retirement, Dr. Stewart said.
Measures that could help reduce the disparity include a more robust system of teaching health centers in rural counties, higher reimbursement for primary care, a lower cost of medical education, and recruiting more people from rural areas to become physicians, Dr. Stewart said.
Telehealth can enhance health care in rural areas, but many people in rural areas lack internet or cellular service, or don’t have access to computers. “We don’t want to create another healthcare disparity,” she said.
And physicians can get to know their patients’ needs better in a face-to-face visit, she said. “Telehealth does have a place, but it does not replace that person-to-person visit.”
This study was funded by National Institute on Minority Health and Health Disparities. Dr. Zhang and Dr. Stewart disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
researchers say.
The finding may provide some reassurance for those who have worried about a shortage of health care workers and whether they will be able to meet the nation’s growing burden of chronic diseases.
“Access to primary care doctors is critical to population health and to reduce health care disparities in this country,” said Donglan Zhang, PhD, an assistant professor of public health at the University of Georgia, Athens.
However, many counties remain underserved, Dr. Zhang said in an interview. The need for primary care in the United States is increasing not only with population growth but because the population is aging.
Dr. Zhang and colleagues published the finding in JAMA Network Open.
Many previous reports have warned of a shortage in primary care providers. To examine recent trends in the primary care workforce, Dr. Zhang and colleagues obtained data on all the primary care clinicians registered with the Centers for Medicare & Medicaid Services from 2009 to 2017.
For the study, the researchers included general practitioners, family physicians and internists without subspecialties, nurse practitioners, and physician assistants. They then compared the number of providers with the number of residents in each county as recorded by the US Census, using urban or rural classifications for each county from the Centers for Disease Control and Prevention.
Because the U.S. Health Resources and Services Administration defines a primary care “shortage” as fewer than 1 primary care practitioner per 3,500 people, the researchers focused on this ratio. They found that the number of nurse practitioners and physician assistants was increasing much faster than the number of primary care physicians. This was true especially in rural areas, but the percentage increase for both nurse practitioners and physician assistants was lower in rural areas versus urban.
The researchers also found that there were more primary care physicians per capita in counties with higher household incomes, a higher proportion of Asian residents, and a higher proportion of college graduates.
They didn’t find a significant association between the median household income and per capita number of nurse practitioners.
They found that counties with a higher proportion of Black and Asian residents had a higher number of nurse practitioners per capita. But they found an opposite association between the proportion of Black residents and the number of physician assistants per capita.
The authors hypothesized that health care reform, particularly the passage of the Affordable Care Act in 2010, may explain the recent increase in the primary care workforce. The legislation expanded the number of people with health insurance and provided incentives for primary and preventive care.
Another factor behind the increase in the primary care workforce could be state laws that have expanded the scope of practice for nurse practitioners and primary care providers, she said.
Numbers may overestimate available care
The gap between rural and urban areas could be even wider than this study suggests, Ada D. Stewart, MD, president of the American Academy of Family Physicians, said in an interview. Many nurse practitioners and physician assistants don’t actually practice primary care, but instead assist physicians in other specialties such as orthopedics or general surgery.
“They are part of a team and I don’t want to diminish that at all, but especially when we talk about infant and maternal mortality, family physicians need to be there themselves providing primary care,” she said. “We’re there in hospitals and emergency rooms, and not just taking care of diabetes and hypertension.”
In addition, the primary care workforce may have been reduced since the conclusion of the study period (Dec. 31, 2017) as a result of the COVID-19 pandemic forcing some primary care physicians into retirement, Dr. Stewart said.
Measures that could help reduce the disparity include a more robust system of teaching health centers in rural counties, higher reimbursement for primary care, a lower cost of medical education, and recruiting more people from rural areas to become physicians, Dr. Stewart said.
Telehealth can enhance health care in rural areas, but many people in rural areas lack internet or cellular service, or don’t have access to computers. “We don’t want to create another healthcare disparity,” she said.
And physicians can get to know their patients’ needs better in a face-to-face visit, she said. “Telehealth does have a place, but it does not replace that person-to-person visit.”
This study was funded by National Institute on Minority Health and Health Disparities. Dr. Zhang and Dr. Stewart disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
researchers say.
The finding may provide some reassurance for those who have worried about a shortage of health care workers and whether they will be able to meet the nation’s growing burden of chronic diseases.
“Access to primary care doctors is critical to population health and to reduce health care disparities in this country,” said Donglan Zhang, PhD, an assistant professor of public health at the University of Georgia, Athens.
However, many counties remain underserved, Dr. Zhang said in an interview. The need for primary care in the United States is increasing not only with population growth but because the population is aging.
Dr. Zhang and colleagues published the finding in JAMA Network Open.
Many previous reports have warned of a shortage in primary care providers. To examine recent trends in the primary care workforce, Dr. Zhang and colleagues obtained data on all the primary care clinicians registered with the Centers for Medicare & Medicaid Services from 2009 to 2017.
For the study, the researchers included general practitioners, family physicians and internists without subspecialties, nurse practitioners, and physician assistants. They then compared the number of providers with the number of residents in each county as recorded by the US Census, using urban or rural classifications for each county from the Centers for Disease Control and Prevention.
Because the U.S. Health Resources and Services Administration defines a primary care “shortage” as fewer than 1 primary care practitioner per 3,500 people, the researchers focused on this ratio. They found that the number of nurse practitioners and physician assistants was increasing much faster than the number of primary care physicians. This was true especially in rural areas, but the percentage increase for both nurse practitioners and physician assistants was lower in rural areas versus urban.
The researchers also found that there were more primary care physicians per capita in counties with higher household incomes, a higher proportion of Asian residents, and a higher proportion of college graduates.
They didn’t find a significant association between the median household income and per capita number of nurse practitioners.
They found that counties with a higher proportion of Black and Asian residents had a higher number of nurse practitioners per capita. But they found an opposite association between the proportion of Black residents and the number of physician assistants per capita.
The authors hypothesized that health care reform, particularly the passage of the Affordable Care Act in 2010, may explain the recent increase in the primary care workforce. The legislation expanded the number of people with health insurance and provided incentives for primary and preventive care.
Another factor behind the increase in the primary care workforce could be state laws that have expanded the scope of practice for nurse practitioners and primary care providers, she said.
Numbers may overestimate available care
The gap between rural and urban areas could be even wider than this study suggests, Ada D. Stewart, MD, president of the American Academy of Family Physicians, said in an interview. Many nurse practitioners and physician assistants don’t actually practice primary care, but instead assist physicians in other specialties such as orthopedics or general surgery.
“They are part of a team and I don’t want to diminish that at all, but especially when we talk about infant and maternal mortality, family physicians need to be there themselves providing primary care,” she said. “We’re there in hospitals and emergency rooms, and not just taking care of diabetes and hypertension.”
In addition, the primary care workforce may have been reduced since the conclusion of the study period (Dec. 31, 2017) as a result of the COVID-19 pandemic forcing some primary care physicians into retirement, Dr. Stewart said.
Measures that could help reduce the disparity include a more robust system of teaching health centers in rural counties, higher reimbursement for primary care, a lower cost of medical education, and recruiting more people from rural areas to become physicians, Dr. Stewart said.
Telehealth can enhance health care in rural areas, but many people in rural areas lack internet or cellular service, or don’t have access to computers. “We don’t want to create another healthcare disparity,” she said.
And physicians can get to know their patients’ needs better in a face-to-face visit, she said. “Telehealth does have a place, but it does not replace that person-to-person visit.”
This study was funded by National Institute on Minority Health and Health Disparities. Dr. Zhang and Dr. Stewart disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Burnout risk may be exacerbated by COVID crisis
New kinds of job stress multiply in unusual times
Clarissa Barnes, MD, a hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and until recently medical director of Avera’s LIGHT Program, a wellness-oriented service for doctors, nurse practitioners, and physician assistants, watched the COVID-19 crisis unfold up close in her community and her hospital. Sioux Falls traced its surge of COVID patients to an outbreak at a local meatpacking plant.
“In the beginning, we didn’t know much about the virus and its communicability, although we have since gotten a better handle on that,” she said. “We had questions: Should we give patients more fluids – or less? Steroids or not? In my experience as a hospitalist I never had patients die every day on my shift, but that was happening with COVID.” The crisis imposed serious stresses on frontline providers, and hospitalists were concerned about personal safety and exposure risk – not just for themselves but for their families.
“The first time I worked on the COVID unit, I moved into the guest room in our home, apart from my husband and our young children,” Dr. Barnes said. “Ultimately I caught the virus, although I have since recovered.” Her experience has highlighted how existing issues of job stress and burnout in hospital medicine have been exacerbated by COVID-19. Even physicians who consider themselves healthy may have little emotional reserve to draw upon in a crisis of this magnitude.
“We are social distancing at work, wearing masks, not eating together with our colleagues – with less camaraderie and social support than we used to have,” she said. “I feel exhausted and there’s no question that my colleagues and I have sacrificed a lot to deal with the pandemic.” Add to that the second front of the COVID-19 crisis, Dr. Barnes said, which is “fighting the medical information wars, trying to correct misinformation put out there by people. Physicians who have been on the front lines of the pandemic know how demoralizing it can be to have people negate your first-hand experience.”
The situation has gotten better in Sioux Falls, Dr. Barnes said, although cases have started rising in the state again. The stress, while not gone, is reduced. For some doctors, “COVID reminded us of why we do what we do. Some of the usual bureaucratic requirements were set aside and we could focus on what our patients needed and how to take care of them.”
Taking job stress seriously
Tiffani Panek, MA, SFHM, CLHM, administrator of the division of hospital medicine at Johns Hopkins Bayview Medical Center in Baltimore, said job stress is a major issue for hospitalist groups.
“We take it seriously here, and use a survey tool to measure morale in our group annually,” she said. “So far, knock on wood, Baltimore has not been one of the big hot spots, but we’ve definitely had waves of COVID patients.”
The Bayview hospitalist group has a diversified set of leaders, including a wellness director. “They’re always checking up on our people, keeping an eye on those who are most vulnerable. One of the stressors we hadn’t thought about before was for our people who live alone. With the isolation and lockdown, they haven’t been able to socialize, so we’ve made direct outreach, asking people how they were doing,” Ms. Panek said. “People know we’ve got their back – professionally and personally. They know, if there’s something we can do to help, we will do it.”
Bayview Medical Center has COVID-specific units and non-COVID units, and has tried to rotate hospitalist assignments because more than a couple days in a row spent wearing full personal protective equipment (PPE) is exhausting, Ms. Panek said. The group also allocated a respite room just outside the biocontainment unit, with a computer and opportunities for providers to just sit and take a breather – with appropriate social distancing. “It’s not fancy, but you just have to wear a mask, not full PPE.”
The Hopkins hospitalist group’s wellness director, Catherine Washburn, MD, also a working hospitalist, said providers are exhausted, and trying to transition to the new normal is a moving target.
“It’s hard for anyone to say what our lives will look like in 6 months,” she said. “People in our group have lost family members to COVID, or postponed major life events, like weddings. We acknowledge losses together as a group, and celebrate things worth celebrating, like babies or birthdays.”
Greatest COVID caseload
Joshua Case, MD, hospitalist medical director for 16 acute care hospitals of Northwell Health serving metropolitan New York City and Long Island, said his group’s hospitalists and other staff worked incredibly hard during the surge of COVID-19 patients in New York. “Northwell likely cared for more COVID patients than any other health care system in the U.S., if not the world.
“It’s vastly different now. We went from a peak of thousands of cases per day down to about 70-90 new cases a day across our system. We’re lucky our system recognized that COVID could be an issue early on, with all of the multifaceted stressors on patient care,” Dr. Case said. “We’ve done whatever we could to give people time off, especially as the census started to come down. We freed up as many supportive mental health services as we could, working with the health system’s employee assistance program.”
Northwell gave out numbers for the psychiatry department, with clinicians available 24/7 for a confidential call, along with outside volunteers and a network of trauma psychologists. “Our system also provided emergency child care for staff, including hospitalists, wherever we could, drawing upon community resources,” Dr. Case added.
“We recognize that we’re all in the same foxhole. That’s been a helpful attitude – recognizing that it’s okay to be upset in a crisis and to have trouble dealing with what’s going on,” he said. “We need to acknowledge that some of us are suffering and try to encourage people to face it head on. For a lot of physicians, especially those who were redeployed here from other departments, it was important just to have us ask if they were doing okay.”
Brian Schroeder, MHA, FACHE, FHM, assistant vice president for hospital and emergency medicine for Atrium Health, based in Charlotte, N.C., said one of the biggest sources of stress on his staff has been the constant pace of change – whether local hospital protocols, state policies, or guidelines from the Centers for Disease Control and Prevention. “The updating is difficult to keep up with. A lot of our physicians get worried and anxious that they’re not following the latest guidelines or correctly doing what they should be doing to care for COVID patients. One thing we’ve done to alleviate some of that fear and anxiety is through weekly huddles with our hospital teams, focusing on changes relevant to their work. We also have weekly ‘all-hands’ meetings for our 250 providers across 13 acute and four postacute facilities.”
Before COVID, it was difficult to get everyone together as one big group from hospitals up to 5 hours apart, but with the Microsoft Teams platform, they can all meet together.
“At the height of the pandemic, we’d convene weekly and share national statistics, organizational statistics, testing updates, changes to protocols,” Mr. Schroeder said. As the pace of change has slowed, these meetings were cut back to monthly. “Our physicians feel we are passing on information as soon as we get it. They know we’ll always tell them what we know.”
Sarah Richards, MD, assistant professor of internal medicine at the University of Nebraska, Omaha, who heads the Society of Hospital Medicine’s Well-Being Task Force, formed to address staff stress in the COVID environment, said there are things that health care systems can do to help mitigate job stress and burnout. But broader issues may need to be addressed at a national level. “SHM is trying to understand work-related stress – and to identify resources that could support doctors, so they can spend more of their time doing what they enjoy most, which is taking care of patients,” she said.
“We also recognize that people have had very different experiences, depending on geography, and at the individual level stressors are experienced very differently,” Dr. Richard noted. “One of the most common stressors we’ve heard from doctors is the challenge of caring for patients who are lonely and isolated in their hospital rooms, suffering and dying in new ways. In low-incidence areas, doctors are expressing guilt because they aren’t under as much stress as their colleagues. In high-incidence areas, doctors are already experiencing posttraumatic stress disorder.”
SHM’s Well-Being Task Force is working on a tool to help normalize these stressors and encourage open conversations about mental health issues. A guide called “HM COVID Check-in Guide for Self & Peers” is designed to help hospitalists break the culture of silence around well-being and burnout during COVID-19 and how people are handling and processing the pandemic experience. It is expected to be completed later this year, Dr. Richards said. Other SHM projects and resources for staff support are also in the works.
The impact on women doctors
In a recent Journal of Hospital Medicine article entitled “Collateral Damage: How COVID-19 is Adversely Impacting Women Physicians,” hospitalist Yemisi Jones, MD, medical director of continuing medical education at Cincinnati Children’s Hospital Medical Center, and colleagues argue that preexisting gender inequities in compensation, academic rank and leadership positions for physicians have made the COVID-19 crisis even more burdensome on female hospitalists.1
“Increased childcare and schooling obligations, coupled with disproportionate household responsibilities and an inability to work from home, will likely result in female hospitalists struggling to meet family needs while pandemic-related work responsibilities are ramping up,” they write. COVID may intensify workplace inequalities, with a lack of recognition of the undue strain that group policies place on women.
“Often women suffer in silence,” said coauthor Jennifer O’Toole, MD, MEd, director of education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center and program director of the internal medicine–pediatrics residency. “We are not always the best self-advocates, although many of us are working on that.”
When women in hospital medicine take leadership roles, these often tend to involve mutual support activities, taking care of colleagues, and promoting collaborative work environments, Dr. Jones added. The stereotypical example is the committee that organizes celebrations when group members get married or have babies.
These activities can take a lot of time, she said. “We need to pay attention to that kind of role in our groups, because it’s important to the cohesiveness of the group. But it often goes unrecognized and doesn’t translate into the currency of promotion and leadership in medicine. When women go for promotions in the future, how will what happened during the COVID crisis impact their opportunities?”
What is the answer to overcoming these systemic inequities? Start with making sure women are part of the leadership team, with responsibilities for group policies, schedules, and other important decisions. “Look at your group’s leadership – particularly the higher positions. If it’s not diverse, ask why. ‘What is it about the structure of our group?’ Make a more concerted effort in your recruitment and retention,” Dr. Jones said.
The JHM article also recommends closely monitoring the direct and indirect effects of COVID-19 on female hospitalists, inquiring specifically about the needs of women in the organization, and ensuring that diversity, inclusion, and equity efforts are not suspended during the pandemic. Gender-based disparities in pay also need a closer look, and not just one time but reviewed periodically and adjusted accordingly.
Mentoring for early career women is important, but more so is sponsorship – someone in a high-level leadership role in the group sponsoring women who are rising up the career ladder, Dr. O’Toole said. “Professional women tend to be overmentored and undersponsored.”
What are the answers?
Ultimately, listening is key to try to help people get through the pandemic, Dr. Washburn said. “People become burned out when they feel leadership doesn’t understand their needs or doesn’t hear their concerns. Our group leaders all do clinical work, so they are seen as one of us. They try very hard; they have listening ears. But listening is just the first step. Next step is to work creatively to get the identified needs met.”
A few years ago, Johns Hopkins developed training in enhanced communication in health care for all hospital providers, including nurses and doctors, encouraging them to get trained in how to actively listen and address their patients’ emotional and social experiences as well as disease, Dr. Washburn explained. Learning how to listen better to patients can enhance skills at listening to colleagues, and vice versa. “We recognize the importance of better communication – for reducing sentinel events in the hospital and also for preventing staff burnout.”
Dr. Barnes also does physician coaching, and says a lot of that work is helping people achieve clarity on their core values. “Healing patients is a core identify for physicians; we want to take care of people. But other things can get in the way of that, and hospitalist groups can work at minimizing those barriers. We also need to learn, as hospitalists, that we work in a group. You need to be creative in how you do your team building, especially now, when you can no longer get together for dinner. Whatever it is, how do we bring our team back together? The biggest source of support for many hospitalists, beyond their family, is the group.”
Dr. Case said there is a longer-term need to study the root causes of burnout in hospitalists and to identify the issues that cause job stress. “What is modifiable? How can we tackle it? I see that as big part of my job every day. Being a physician is hard enough as it is. Let’s work to resolve those issues that add needlessly to the stress.”
“I think the pandemic brought a magnifying glass to how important a concern staff stress is,” Ms. Panek said. Resilience is important.
“We were working in our group on creating a culture that values trust and transparency, and then the COVID crisis hit,” she said. “But you can still keep working on those things. We would not have been as good or as positive as we were in managing this crisis without that preexisting culture to draw upon. We always said it was important. Now we know that’s true.”
Reference
1. Jones Y et al. Collateral Damage: How COVID-19 Is Adversely Impacting Women Physicians. J Hosp Med. 2020 August;15(8):507-9.
New kinds of job stress multiply in unusual times
New kinds of job stress multiply in unusual times
Clarissa Barnes, MD, a hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and until recently medical director of Avera’s LIGHT Program, a wellness-oriented service for doctors, nurse practitioners, and physician assistants, watched the COVID-19 crisis unfold up close in her community and her hospital. Sioux Falls traced its surge of COVID patients to an outbreak at a local meatpacking plant.
“In the beginning, we didn’t know much about the virus and its communicability, although we have since gotten a better handle on that,” she said. “We had questions: Should we give patients more fluids – or less? Steroids or not? In my experience as a hospitalist I never had patients die every day on my shift, but that was happening with COVID.” The crisis imposed serious stresses on frontline providers, and hospitalists were concerned about personal safety and exposure risk – not just for themselves but for their families.
“The first time I worked on the COVID unit, I moved into the guest room in our home, apart from my husband and our young children,” Dr. Barnes said. “Ultimately I caught the virus, although I have since recovered.” Her experience has highlighted how existing issues of job stress and burnout in hospital medicine have been exacerbated by COVID-19. Even physicians who consider themselves healthy may have little emotional reserve to draw upon in a crisis of this magnitude.
“We are social distancing at work, wearing masks, not eating together with our colleagues – with less camaraderie and social support than we used to have,” she said. “I feel exhausted and there’s no question that my colleagues and I have sacrificed a lot to deal with the pandemic.” Add to that the second front of the COVID-19 crisis, Dr. Barnes said, which is “fighting the medical information wars, trying to correct misinformation put out there by people. Physicians who have been on the front lines of the pandemic know how demoralizing it can be to have people negate your first-hand experience.”
The situation has gotten better in Sioux Falls, Dr. Barnes said, although cases have started rising in the state again. The stress, while not gone, is reduced. For some doctors, “COVID reminded us of why we do what we do. Some of the usual bureaucratic requirements were set aside and we could focus on what our patients needed and how to take care of them.”
Taking job stress seriously
Tiffani Panek, MA, SFHM, CLHM, administrator of the division of hospital medicine at Johns Hopkins Bayview Medical Center in Baltimore, said job stress is a major issue for hospitalist groups.
“We take it seriously here, and use a survey tool to measure morale in our group annually,” she said. “So far, knock on wood, Baltimore has not been one of the big hot spots, but we’ve definitely had waves of COVID patients.”
The Bayview hospitalist group has a diversified set of leaders, including a wellness director. “They’re always checking up on our people, keeping an eye on those who are most vulnerable. One of the stressors we hadn’t thought about before was for our people who live alone. With the isolation and lockdown, they haven’t been able to socialize, so we’ve made direct outreach, asking people how they were doing,” Ms. Panek said. “People know we’ve got their back – professionally and personally. They know, if there’s something we can do to help, we will do it.”
Bayview Medical Center has COVID-specific units and non-COVID units, and has tried to rotate hospitalist assignments because more than a couple days in a row spent wearing full personal protective equipment (PPE) is exhausting, Ms. Panek said. The group also allocated a respite room just outside the biocontainment unit, with a computer and opportunities for providers to just sit and take a breather – with appropriate social distancing. “It’s not fancy, but you just have to wear a mask, not full PPE.”
The Hopkins hospitalist group’s wellness director, Catherine Washburn, MD, also a working hospitalist, said providers are exhausted, and trying to transition to the new normal is a moving target.
“It’s hard for anyone to say what our lives will look like in 6 months,” she said. “People in our group have lost family members to COVID, or postponed major life events, like weddings. We acknowledge losses together as a group, and celebrate things worth celebrating, like babies or birthdays.”
Greatest COVID caseload
Joshua Case, MD, hospitalist medical director for 16 acute care hospitals of Northwell Health serving metropolitan New York City and Long Island, said his group’s hospitalists and other staff worked incredibly hard during the surge of COVID-19 patients in New York. “Northwell likely cared for more COVID patients than any other health care system in the U.S., if not the world.
“It’s vastly different now. We went from a peak of thousands of cases per day down to about 70-90 new cases a day across our system. We’re lucky our system recognized that COVID could be an issue early on, with all of the multifaceted stressors on patient care,” Dr. Case said. “We’ve done whatever we could to give people time off, especially as the census started to come down. We freed up as many supportive mental health services as we could, working with the health system’s employee assistance program.”
Northwell gave out numbers for the psychiatry department, with clinicians available 24/7 for a confidential call, along with outside volunteers and a network of trauma psychologists. “Our system also provided emergency child care for staff, including hospitalists, wherever we could, drawing upon community resources,” Dr. Case added.
“We recognize that we’re all in the same foxhole. That’s been a helpful attitude – recognizing that it’s okay to be upset in a crisis and to have trouble dealing with what’s going on,” he said. “We need to acknowledge that some of us are suffering and try to encourage people to face it head on. For a lot of physicians, especially those who were redeployed here from other departments, it was important just to have us ask if they were doing okay.”
Brian Schroeder, MHA, FACHE, FHM, assistant vice president for hospital and emergency medicine for Atrium Health, based in Charlotte, N.C., said one of the biggest sources of stress on his staff has been the constant pace of change – whether local hospital protocols, state policies, or guidelines from the Centers for Disease Control and Prevention. “The updating is difficult to keep up with. A lot of our physicians get worried and anxious that they’re not following the latest guidelines or correctly doing what they should be doing to care for COVID patients. One thing we’ve done to alleviate some of that fear and anxiety is through weekly huddles with our hospital teams, focusing on changes relevant to their work. We also have weekly ‘all-hands’ meetings for our 250 providers across 13 acute and four postacute facilities.”
Before COVID, it was difficult to get everyone together as one big group from hospitals up to 5 hours apart, but with the Microsoft Teams platform, they can all meet together.
“At the height of the pandemic, we’d convene weekly and share national statistics, organizational statistics, testing updates, changes to protocols,” Mr. Schroeder said. As the pace of change has slowed, these meetings were cut back to monthly. “Our physicians feel we are passing on information as soon as we get it. They know we’ll always tell them what we know.”
Sarah Richards, MD, assistant professor of internal medicine at the University of Nebraska, Omaha, who heads the Society of Hospital Medicine’s Well-Being Task Force, formed to address staff stress in the COVID environment, said there are things that health care systems can do to help mitigate job stress and burnout. But broader issues may need to be addressed at a national level. “SHM is trying to understand work-related stress – and to identify resources that could support doctors, so they can spend more of their time doing what they enjoy most, which is taking care of patients,” she said.
“We also recognize that people have had very different experiences, depending on geography, and at the individual level stressors are experienced very differently,” Dr. Richard noted. “One of the most common stressors we’ve heard from doctors is the challenge of caring for patients who are lonely and isolated in their hospital rooms, suffering and dying in new ways. In low-incidence areas, doctors are expressing guilt because they aren’t under as much stress as their colleagues. In high-incidence areas, doctors are already experiencing posttraumatic stress disorder.”
SHM’s Well-Being Task Force is working on a tool to help normalize these stressors and encourage open conversations about mental health issues. A guide called “HM COVID Check-in Guide for Self & Peers” is designed to help hospitalists break the culture of silence around well-being and burnout during COVID-19 and how people are handling and processing the pandemic experience. It is expected to be completed later this year, Dr. Richards said. Other SHM projects and resources for staff support are also in the works.
The impact on women doctors
In a recent Journal of Hospital Medicine article entitled “Collateral Damage: How COVID-19 is Adversely Impacting Women Physicians,” hospitalist Yemisi Jones, MD, medical director of continuing medical education at Cincinnati Children’s Hospital Medical Center, and colleagues argue that preexisting gender inequities in compensation, academic rank and leadership positions for physicians have made the COVID-19 crisis even more burdensome on female hospitalists.1
“Increased childcare and schooling obligations, coupled with disproportionate household responsibilities and an inability to work from home, will likely result in female hospitalists struggling to meet family needs while pandemic-related work responsibilities are ramping up,” they write. COVID may intensify workplace inequalities, with a lack of recognition of the undue strain that group policies place on women.
“Often women suffer in silence,” said coauthor Jennifer O’Toole, MD, MEd, director of education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center and program director of the internal medicine–pediatrics residency. “We are not always the best self-advocates, although many of us are working on that.”
When women in hospital medicine take leadership roles, these often tend to involve mutual support activities, taking care of colleagues, and promoting collaborative work environments, Dr. Jones added. The stereotypical example is the committee that organizes celebrations when group members get married or have babies.
These activities can take a lot of time, she said. “We need to pay attention to that kind of role in our groups, because it’s important to the cohesiveness of the group. But it often goes unrecognized and doesn’t translate into the currency of promotion and leadership in medicine. When women go for promotions in the future, how will what happened during the COVID crisis impact their opportunities?”
What is the answer to overcoming these systemic inequities? Start with making sure women are part of the leadership team, with responsibilities for group policies, schedules, and other important decisions. “Look at your group’s leadership – particularly the higher positions. If it’s not diverse, ask why. ‘What is it about the structure of our group?’ Make a more concerted effort in your recruitment and retention,” Dr. Jones said.
The JHM article also recommends closely monitoring the direct and indirect effects of COVID-19 on female hospitalists, inquiring specifically about the needs of women in the organization, and ensuring that diversity, inclusion, and equity efforts are not suspended during the pandemic. Gender-based disparities in pay also need a closer look, and not just one time but reviewed periodically and adjusted accordingly.
Mentoring for early career women is important, but more so is sponsorship – someone in a high-level leadership role in the group sponsoring women who are rising up the career ladder, Dr. O’Toole said. “Professional women tend to be overmentored and undersponsored.”
What are the answers?
Ultimately, listening is key to try to help people get through the pandemic, Dr. Washburn said. “People become burned out when they feel leadership doesn’t understand their needs or doesn’t hear their concerns. Our group leaders all do clinical work, so they are seen as one of us. They try very hard; they have listening ears. But listening is just the first step. Next step is to work creatively to get the identified needs met.”
A few years ago, Johns Hopkins developed training in enhanced communication in health care for all hospital providers, including nurses and doctors, encouraging them to get trained in how to actively listen and address their patients’ emotional and social experiences as well as disease, Dr. Washburn explained. Learning how to listen better to patients can enhance skills at listening to colleagues, and vice versa. “We recognize the importance of better communication – for reducing sentinel events in the hospital and also for preventing staff burnout.”
Dr. Barnes also does physician coaching, and says a lot of that work is helping people achieve clarity on their core values. “Healing patients is a core identify for physicians; we want to take care of people. But other things can get in the way of that, and hospitalist groups can work at minimizing those barriers. We also need to learn, as hospitalists, that we work in a group. You need to be creative in how you do your team building, especially now, when you can no longer get together for dinner. Whatever it is, how do we bring our team back together? The biggest source of support for many hospitalists, beyond their family, is the group.”
Dr. Case said there is a longer-term need to study the root causes of burnout in hospitalists and to identify the issues that cause job stress. “What is modifiable? How can we tackle it? I see that as big part of my job every day. Being a physician is hard enough as it is. Let’s work to resolve those issues that add needlessly to the stress.”
“I think the pandemic brought a magnifying glass to how important a concern staff stress is,” Ms. Panek said. Resilience is important.
“We were working in our group on creating a culture that values trust and transparency, and then the COVID crisis hit,” she said. “But you can still keep working on those things. We would not have been as good or as positive as we were in managing this crisis without that preexisting culture to draw upon. We always said it was important. Now we know that’s true.”
Reference
1. Jones Y et al. Collateral Damage: How COVID-19 Is Adversely Impacting Women Physicians. J Hosp Med. 2020 August;15(8):507-9.
Clarissa Barnes, MD, a hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and until recently medical director of Avera’s LIGHT Program, a wellness-oriented service for doctors, nurse practitioners, and physician assistants, watched the COVID-19 crisis unfold up close in her community and her hospital. Sioux Falls traced its surge of COVID patients to an outbreak at a local meatpacking plant.
“In the beginning, we didn’t know much about the virus and its communicability, although we have since gotten a better handle on that,” she said. “We had questions: Should we give patients more fluids – or less? Steroids or not? In my experience as a hospitalist I never had patients die every day on my shift, but that was happening with COVID.” The crisis imposed serious stresses on frontline providers, and hospitalists were concerned about personal safety and exposure risk – not just for themselves but for their families.
“The first time I worked on the COVID unit, I moved into the guest room in our home, apart from my husband and our young children,” Dr. Barnes said. “Ultimately I caught the virus, although I have since recovered.” Her experience has highlighted how existing issues of job stress and burnout in hospital medicine have been exacerbated by COVID-19. Even physicians who consider themselves healthy may have little emotional reserve to draw upon in a crisis of this magnitude.
“We are social distancing at work, wearing masks, not eating together with our colleagues – with less camaraderie and social support than we used to have,” she said. “I feel exhausted and there’s no question that my colleagues and I have sacrificed a lot to deal with the pandemic.” Add to that the second front of the COVID-19 crisis, Dr. Barnes said, which is “fighting the medical information wars, trying to correct misinformation put out there by people. Physicians who have been on the front lines of the pandemic know how demoralizing it can be to have people negate your first-hand experience.”
The situation has gotten better in Sioux Falls, Dr. Barnes said, although cases have started rising in the state again. The stress, while not gone, is reduced. For some doctors, “COVID reminded us of why we do what we do. Some of the usual bureaucratic requirements were set aside and we could focus on what our patients needed and how to take care of them.”
Taking job stress seriously
Tiffani Panek, MA, SFHM, CLHM, administrator of the division of hospital medicine at Johns Hopkins Bayview Medical Center in Baltimore, said job stress is a major issue for hospitalist groups.
“We take it seriously here, and use a survey tool to measure morale in our group annually,” she said. “So far, knock on wood, Baltimore has not been one of the big hot spots, but we’ve definitely had waves of COVID patients.”
The Bayview hospitalist group has a diversified set of leaders, including a wellness director. “They’re always checking up on our people, keeping an eye on those who are most vulnerable. One of the stressors we hadn’t thought about before was for our people who live alone. With the isolation and lockdown, they haven’t been able to socialize, so we’ve made direct outreach, asking people how they were doing,” Ms. Panek said. “People know we’ve got their back – professionally and personally. They know, if there’s something we can do to help, we will do it.”
Bayview Medical Center has COVID-specific units and non-COVID units, and has tried to rotate hospitalist assignments because more than a couple days in a row spent wearing full personal protective equipment (PPE) is exhausting, Ms. Panek said. The group also allocated a respite room just outside the biocontainment unit, with a computer and opportunities for providers to just sit and take a breather – with appropriate social distancing. “It’s not fancy, but you just have to wear a mask, not full PPE.”
The Hopkins hospitalist group’s wellness director, Catherine Washburn, MD, also a working hospitalist, said providers are exhausted, and trying to transition to the new normal is a moving target.
“It’s hard for anyone to say what our lives will look like in 6 months,” she said. “People in our group have lost family members to COVID, or postponed major life events, like weddings. We acknowledge losses together as a group, and celebrate things worth celebrating, like babies or birthdays.”
Greatest COVID caseload
Joshua Case, MD, hospitalist medical director for 16 acute care hospitals of Northwell Health serving metropolitan New York City and Long Island, said his group’s hospitalists and other staff worked incredibly hard during the surge of COVID-19 patients in New York. “Northwell likely cared for more COVID patients than any other health care system in the U.S., if not the world.
“It’s vastly different now. We went from a peak of thousands of cases per day down to about 70-90 new cases a day across our system. We’re lucky our system recognized that COVID could be an issue early on, with all of the multifaceted stressors on patient care,” Dr. Case said. “We’ve done whatever we could to give people time off, especially as the census started to come down. We freed up as many supportive mental health services as we could, working with the health system’s employee assistance program.”
Northwell gave out numbers for the psychiatry department, with clinicians available 24/7 for a confidential call, along with outside volunteers and a network of trauma psychologists. “Our system also provided emergency child care for staff, including hospitalists, wherever we could, drawing upon community resources,” Dr. Case added.
“We recognize that we’re all in the same foxhole. That’s been a helpful attitude – recognizing that it’s okay to be upset in a crisis and to have trouble dealing with what’s going on,” he said. “We need to acknowledge that some of us are suffering and try to encourage people to face it head on. For a lot of physicians, especially those who were redeployed here from other departments, it was important just to have us ask if they were doing okay.”
Brian Schroeder, MHA, FACHE, FHM, assistant vice president for hospital and emergency medicine for Atrium Health, based in Charlotte, N.C., said one of the biggest sources of stress on his staff has been the constant pace of change – whether local hospital protocols, state policies, or guidelines from the Centers for Disease Control and Prevention. “The updating is difficult to keep up with. A lot of our physicians get worried and anxious that they’re not following the latest guidelines or correctly doing what they should be doing to care for COVID patients. One thing we’ve done to alleviate some of that fear and anxiety is through weekly huddles with our hospital teams, focusing on changes relevant to their work. We also have weekly ‘all-hands’ meetings for our 250 providers across 13 acute and four postacute facilities.”
Before COVID, it was difficult to get everyone together as one big group from hospitals up to 5 hours apart, but with the Microsoft Teams platform, they can all meet together.
“At the height of the pandemic, we’d convene weekly and share national statistics, organizational statistics, testing updates, changes to protocols,” Mr. Schroeder said. As the pace of change has slowed, these meetings were cut back to monthly. “Our physicians feel we are passing on information as soon as we get it. They know we’ll always tell them what we know.”
Sarah Richards, MD, assistant professor of internal medicine at the University of Nebraska, Omaha, who heads the Society of Hospital Medicine’s Well-Being Task Force, formed to address staff stress in the COVID environment, said there are things that health care systems can do to help mitigate job stress and burnout. But broader issues may need to be addressed at a national level. “SHM is trying to understand work-related stress – and to identify resources that could support doctors, so they can spend more of their time doing what they enjoy most, which is taking care of patients,” she said.
“We also recognize that people have had very different experiences, depending on geography, and at the individual level stressors are experienced very differently,” Dr. Richard noted. “One of the most common stressors we’ve heard from doctors is the challenge of caring for patients who are lonely and isolated in their hospital rooms, suffering and dying in new ways. In low-incidence areas, doctors are expressing guilt because they aren’t under as much stress as their colleagues. In high-incidence areas, doctors are already experiencing posttraumatic stress disorder.”
SHM’s Well-Being Task Force is working on a tool to help normalize these stressors and encourage open conversations about mental health issues. A guide called “HM COVID Check-in Guide for Self & Peers” is designed to help hospitalists break the culture of silence around well-being and burnout during COVID-19 and how people are handling and processing the pandemic experience. It is expected to be completed later this year, Dr. Richards said. Other SHM projects and resources for staff support are also in the works.
The impact on women doctors
In a recent Journal of Hospital Medicine article entitled “Collateral Damage: How COVID-19 is Adversely Impacting Women Physicians,” hospitalist Yemisi Jones, MD, medical director of continuing medical education at Cincinnati Children’s Hospital Medical Center, and colleagues argue that preexisting gender inequities in compensation, academic rank and leadership positions for physicians have made the COVID-19 crisis even more burdensome on female hospitalists.1
“Increased childcare and schooling obligations, coupled with disproportionate household responsibilities and an inability to work from home, will likely result in female hospitalists struggling to meet family needs while pandemic-related work responsibilities are ramping up,” they write. COVID may intensify workplace inequalities, with a lack of recognition of the undue strain that group policies place on women.
“Often women suffer in silence,” said coauthor Jennifer O’Toole, MD, MEd, director of education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center and program director of the internal medicine–pediatrics residency. “We are not always the best self-advocates, although many of us are working on that.”
When women in hospital medicine take leadership roles, these often tend to involve mutual support activities, taking care of colleagues, and promoting collaborative work environments, Dr. Jones added. The stereotypical example is the committee that organizes celebrations when group members get married or have babies.
These activities can take a lot of time, she said. “We need to pay attention to that kind of role in our groups, because it’s important to the cohesiveness of the group. But it often goes unrecognized and doesn’t translate into the currency of promotion and leadership in medicine. When women go for promotions in the future, how will what happened during the COVID crisis impact their opportunities?”
What is the answer to overcoming these systemic inequities? Start with making sure women are part of the leadership team, with responsibilities for group policies, schedules, and other important decisions. “Look at your group’s leadership – particularly the higher positions. If it’s not diverse, ask why. ‘What is it about the structure of our group?’ Make a more concerted effort in your recruitment and retention,” Dr. Jones said.
The JHM article also recommends closely monitoring the direct and indirect effects of COVID-19 on female hospitalists, inquiring specifically about the needs of women in the organization, and ensuring that diversity, inclusion, and equity efforts are not suspended during the pandemic. Gender-based disparities in pay also need a closer look, and not just one time but reviewed periodically and adjusted accordingly.
Mentoring for early career women is important, but more so is sponsorship – someone in a high-level leadership role in the group sponsoring women who are rising up the career ladder, Dr. O’Toole said. “Professional women tend to be overmentored and undersponsored.”
What are the answers?
Ultimately, listening is key to try to help people get through the pandemic, Dr. Washburn said. “People become burned out when they feel leadership doesn’t understand their needs or doesn’t hear their concerns. Our group leaders all do clinical work, so they are seen as one of us. They try very hard; they have listening ears. But listening is just the first step. Next step is to work creatively to get the identified needs met.”
A few years ago, Johns Hopkins developed training in enhanced communication in health care for all hospital providers, including nurses and doctors, encouraging them to get trained in how to actively listen and address their patients’ emotional and social experiences as well as disease, Dr. Washburn explained. Learning how to listen better to patients can enhance skills at listening to colleagues, and vice versa. “We recognize the importance of better communication – for reducing sentinel events in the hospital and also for preventing staff burnout.”
Dr. Barnes also does physician coaching, and says a lot of that work is helping people achieve clarity on their core values. “Healing patients is a core identify for physicians; we want to take care of people. But other things can get in the way of that, and hospitalist groups can work at minimizing those barriers. We also need to learn, as hospitalists, that we work in a group. You need to be creative in how you do your team building, especially now, when you can no longer get together for dinner. Whatever it is, how do we bring our team back together? The biggest source of support for many hospitalists, beyond their family, is the group.”
Dr. Case said there is a longer-term need to study the root causes of burnout in hospitalists and to identify the issues that cause job stress. “What is modifiable? How can we tackle it? I see that as big part of my job every day. Being a physician is hard enough as it is. Let’s work to resolve those issues that add needlessly to the stress.”
“I think the pandemic brought a magnifying glass to how important a concern staff stress is,” Ms. Panek said. Resilience is important.
“We were working in our group on creating a culture that values trust and transparency, and then the COVID crisis hit,” she said. “But you can still keep working on those things. We would not have been as good or as positive as we were in managing this crisis without that preexisting culture to draw upon. We always said it was important. Now we know that’s true.”
Reference
1. Jones Y et al. Collateral Damage: How COVID-19 Is Adversely Impacting Women Physicians. J Hosp Med. 2020 August;15(8):507-9.