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Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).

Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).

“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.

Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.

NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.

The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.

Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.

The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.

COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).

They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.

Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.

Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).

But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).

Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.

“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”

Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.

During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.

“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”

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

Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).

Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).

“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.

Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.

NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.

The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.

Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.

The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.

COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).

They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.

Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.

Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).

But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).

Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.

“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”

Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.

During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.

“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”

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

Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).

Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).

“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.

Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.

NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.

The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.

Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.

The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.

COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).

They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.

Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.

Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).

But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).

Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.

“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”

Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.

During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.

“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”

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

What seems like a usual day to a seasoned hospitalist can be a daunting task for a new hospitalist. A routine day as a hospitalist begins with prerounding, organizing, familiarizing, and gathering data on the list of patients, and most importantly prioritizing the tasks for the day. I have experienced both traditional and unit-based rounding models, and the geographic (unit-based) rounding model stands out for me.

The push for geographic rounding comes from the need to achieve excellence in patient care, coordination with nursing staff, higher HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores, better provider satisfaction, and efficiency in work flow and in documentation. The goal is typically to use this well-established tool to provide quality care to acutely ill patients admitted to the hospital, creating an environment of improved communication with the staff. It’s a “patient-centered care” model – if the patient wants to see a physician, it’s quicker to get to the patient and provides more visibility for the physician. These encounters result in improved patient-provider relationships, which in turn influences HCAHPS scores. Proximity encourages empathy, better work flow, and productivity.

The American health care system is intense and complex, and effective hospital medicine groups (HMGs) strive to provide quality care. Performance of an effective HMG is often scored on a “balanced score card.” The “balanced score” evaluates performance on domains such as clinical quality and safety, financial stability, HCAHPS, and operational effectiveness (length of stay and readmission rates). In my experience, effective unit-based rounding positively influences all the measures of the balanced score card.

Multidisciplinary roundings (MDRs) provide a platform where “the team” meets every morning to discuss the daily plan of care, everyone gets on the same page, and unit-based assignments facilitate hospitalist participation in MDRs. MDRs typically are a collaborative effort between care team members, such as a case manager, nurse, and hospitalist, physical therapist, and pharmacist. Each team member provides a precise input. Team members feel accountable and are better prepared for the day. It’s easier to develop a rapport with your patient when the same organized, comprehensive plan of care gets communicated to the patient.

Dr. Puri is a hospitalist at Lahey Hospital and Medical Center in Burlington, Mass.

What seems like a usual day to a seasoned hospitalist can be a daunting task for a new hospitalist. A routine day as a hospitalist begins with prerounding, organizing, familiarizing, and gathering data on the list of patients, and most importantly prioritizing the tasks for the day. I have experienced both traditional and unit-based rounding models, and the geographic (unit-based) rounding model stands out for me.

The push for geographic rounding comes from the need to achieve excellence in patient care, coordination with nursing staff, higher HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores, better provider satisfaction, and efficiency in work flow and in documentation. The goal is typically to use this well-established tool to provide quality care to acutely ill patients admitted to the hospital, creating an environment of improved communication with the staff. It’s a “patient-centered care” model – if the patient wants to see a physician, it’s quicker to get to the patient and provides more visibility for the physician. These encounters result in improved patient-provider relationships, which in turn influences HCAHPS scores. Proximity encourages empathy, better work flow, and productivity.

The American health care system is intense and complex, and effective hospital medicine groups (HMGs) strive to provide quality care. Performance of an effective HMG is often scored on a “balanced score card.” The “balanced score” evaluates performance on domains such as clinical quality and safety, financial stability, HCAHPS, and operational effectiveness (length of stay and readmission rates). In my experience, effective unit-based rounding positively influences all the measures of the balanced score card.

Multidisciplinary roundings (MDRs) provide a platform where “the team” meets every morning to discuss the daily plan of care, everyone gets on the same page, and unit-based assignments facilitate hospitalist participation in MDRs. MDRs typically are a collaborative effort between care team members, such as a case manager, nurse, and hospitalist, physical therapist, and pharmacist. Each team member provides a precise input. Team members feel accountable and are better prepared for the day. It’s easier to develop a rapport with your patient when the same organized, comprehensive plan of care gets communicated to the patient.

Dr. Puri is a hospitalist at Lahey Hospital and Medical Center in Burlington, Mass.

What seems like a usual day to a seasoned hospitalist can be a daunting task for a new hospitalist. A routine day as a hospitalist begins with prerounding, organizing, familiarizing, and gathering data on the list of patients, and most importantly prioritizing the tasks for the day. I have experienced both traditional and unit-based rounding models, and the geographic (unit-based) rounding model stands out for me.

The push for geographic rounding comes from the need to achieve excellence in patient care, coordination with nursing staff, higher HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores, better provider satisfaction, and efficiency in work flow and in documentation. The goal is typically to use this well-established tool to provide quality care to acutely ill patients admitted to the hospital, creating an environment of improved communication with the staff. It’s a “patient-centered care” model – if the patient wants to see a physician, it’s quicker to get to the patient and provides more visibility for the physician. These encounters result in improved patient-provider relationships, which in turn influences HCAHPS scores. Proximity encourages empathy, better work flow, and productivity.

The American health care system is intense and complex, and effective hospital medicine groups (HMGs) strive to provide quality care. Performance of an effective HMG is often scored on a “balanced score card.” The “balanced score” evaluates performance on domains such as clinical quality and safety, financial stability, HCAHPS, and operational effectiveness (length of stay and readmission rates). In my experience, effective unit-based rounding positively influences all the measures of the balanced score card.

Multidisciplinary roundings (MDRs) provide a platform where “the team” meets every morning to discuss the daily plan of care, everyone gets on the same page, and unit-based assignments facilitate hospitalist participation in MDRs. MDRs typically are a collaborative effort between care team members, such as a case manager, nurse, and hospitalist, physical therapist, and pharmacist. Each team member provides a precise input. Team members feel accountable and are better prepared for the day. It’s easier to develop a rapport with your patient when the same organized, comprehensive plan of care gets communicated to the patient.

Dr. Puri is a hospitalist at Lahey Hospital and Medical Center in Burlington, Mass.

Diarrhea affected one in every five patients with inflammatory bowel disease (IBD) and COVID-19, compared with only 7%-10% of all patients with COVID-19 in prior studies, researchers reported in Clinical Gastroenterology and Hepatology.

In a systematic review and meta-analysis of 23 studies incorporating data from 449 patients with IBD and COVID-19, their most common symptoms were fever (affecting 48.3% of patients), cough (46.5%), and diarrhea (20.5%), and diarrhea was approximately twice as prevalent as dyspnea, nausea, abdominal pain, and fatigue, wrote Ferdinando D’Amico of Humanitas University in Milan and his associates. “[S]ymptoms experienced by IBD patients with COVID-19 are similar to those occurring in the general population, except for a higher percentage of diarrhea,” they wrote. This increased prevalence might result from IBD itself or from inflammatory effects of viral gut tropism, they noted. “Currently, the diagnostic–therapeutic approach does not differ between IBD and non-IBD patients, but further studies are needed to evaluate whether fecal research of viral RNA and treatment with IBD drugs may play a role in the management of COVID-19 patients.”

To characterize the clinical presentation and course of patients with IBD and COVID-19, the researchers searched PubMed, Embase, Web of Science, and MedRxiv through July 29, 2020, for keywords related to COVID-19, Crohn’s disease, ulcerative colitis, and IBD. They identified 23 studies presenting clinical data from adults or children with a confirmed IBD diagnosis and least one case of COVID-19. Among 243,760 patients with IBD, 1,028 patients had COVID-19 infection, including 509 patients with Crohn’s disease, 428 patients with ulcerative colitis, 49 patients with indeterminate colitis, and 42 patients for whom the IBD subtype was not recorded.

In all, 0.4% of patients with IBD had COVID-19. Nearly all had been diagnosed by polymerase chain reaction of nasopharyngeal swabs, and approximately 40% also had received chest CT scans. Most were male (56.5%), and 43.5% were older than 65 years. Patients were receiving a wide range of IBD therapies, most commonly anti–tumor necrosis factor (TNF) agents, mesalamine, thiopurine (alone or in combination with biologics), vedolizumab, ustekinumab, steroids, methotrexate, and tofacitinib. Results from six studies indicated that patients with IBD were significantly more likely to be diagnosed with COVID-19 if they were older than 66 years (odds ratio, 21.3) or had other comorbidities (OR, 1.24). The most commonly used drugs for managing COVID-19 were hydroxychloroquine, lopinavir/ritonavir, steroids, antibiotics, chloroquine, tofacitinib, and infliximab.

A total of 30.6% of patients with IBD and COVID-19 were hospitalized, 11.4% stayed in the ICU, 3.7% required mechanical ventilation, and 3.8% died from COVID-19. Significant risk factors for death from COVID-19 included older age, active IBD, and a Charlson Comorbidity Index score above 1. Similarly, risk factors for severe COVID-19 included older age, having two or more comorbidities, receiving systemic steroids, and receiving mesalamine/sulfasalazine. In one study, a recent (3-month) history of corticosteroid treatment was associated with a 60% increase in the risk for severe COVID-19. Other immune-mediated therapies did not show this association. Patients with ulcerative colitis were significantly more likely to be seen in the ED or hospitalized, compared with patients with other forms of IBD (adjusted OR, 12.7).

No funding sources were disclosed. Dr. D’Amico reported having no conflicts of interest. Two coinvestigators disclosed ties to AbbVie, MSD, Schering-Plough, UCB Pharma, and several other pharmaceutical companies.

SOURCE: D’Amico F et al. Clin Gastroenterol Hepatol. 2020 Aug 7. doi: 10.1016/j.cgh.2020.08.003.
 

Diarrhea affected one in every five patients with inflammatory bowel disease (IBD) and COVID-19, compared with only 7%-10% of all patients with COVID-19 in prior studies, researchers reported in Clinical Gastroenterology and Hepatology.

In a systematic review and meta-analysis of 23 studies incorporating data from 449 patients with IBD and COVID-19, their most common symptoms were fever (affecting 48.3% of patients), cough (46.5%), and diarrhea (20.5%), and diarrhea was approximately twice as prevalent as dyspnea, nausea, abdominal pain, and fatigue, wrote Ferdinando D’Amico of Humanitas University in Milan and his associates. “[S]ymptoms experienced by IBD patients with COVID-19 are similar to those occurring in the general population, except for a higher percentage of diarrhea,” they wrote. This increased prevalence might result from IBD itself or from inflammatory effects of viral gut tropism, they noted. “Currently, the diagnostic–therapeutic approach does not differ between IBD and non-IBD patients, but further studies are needed to evaluate whether fecal research of viral RNA and treatment with IBD drugs may play a role in the management of COVID-19 patients.”

To characterize the clinical presentation and course of patients with IBD and COVID-19, the researchers searched PubMed, Embase, Web of Science, and MedRxiv through July 29, 2020, for keywords related to COVID-19, Crohn’s disease, ulcerative colitis, and IBD. They identified 23 studies presenting clinical data from adults or children with a confirmed IBD diagnosis and least one case of COVID-19. Among 243,760 patients with IBD, 1,028 patients had COVID-19 infection, including 509 patients with Crohn’s disease, 428 patients with ulcerative colitis, 49 patients with indeterminate colitis, and 42 patients for whom the IBD subtype was not recorded.

In all, 0.4% of patients with IBD had COVID-19. Nearly all had been diagnosed by polymerase chain reaction of nasopharyngeal swabs, and approximately 40% also had received chest CT scans. Most were male (56.5%), and 43.5% were older than 65 years. Patients were receiving a wide range of IBD therapies, most commonly anti–tumor necrosis factor (TNF) agents, mesalamine, thiopurine (alone or in combination with biologics), vedolizumab, ustekinumab, steroids, methotrexate, and tofacitinib. Results from six studies indicated that patients with IBD were significantly more likely to be diagnosed with COVID-19 if they were older than 66 years (odds ratio, 21.3) or had other comorbidities (OR, 1.24). The most commonly used drugs for managing COVID-19 were hydroxychloroquine, lopinavir/ritonavir, steroids, antibiotics, chloroquine, tofacitinib, and infliximab.

A total of 30.6% of patients with IBD and COVID-19 were hospitalized, 11.4% stayed in the ICU, 3.7% required mechanical ventilation, and 3.8% died from COVID-19. Significant risk factors for death from COVID-19 included older age, active IBD, and a Charlson Comorbidity Index score above 1. Similarly, risk factors for severe COVID-19 included older age, having two or more comorbidities, receiving systemic steroids, and receiving mesalamine/sulfasalazine. In one study, a recent (3-month) history of corticosteroid treatment was associated with a 60% increase in the risk for severe COVID-19. Other immune-mediated therapies did not show this association. Patients with ulcerative colitis were significantly more likely to be seen in the ED or hospitalized, compared with patients with other forms of IBD (adjusted OR, 12.7).

No funding sources were disclosed. Dr. D’Amico reported having no conflicts of interest. Two coinvestigators disclosed ties to AbbVie, MSD, Schering-Plough, UCB Pharma, and several other pharmaceutical companies.

SOURCE: D’Amico F et al. Clin Gastroenterol Hepatol. 2020 Aug 7. doi: 10.1016/j.cgh.2020.08.003.
 

Diarrhea affected one in every five patients with inflammatory bowel disease (IBD) and COVID-19, compared with only 7%-10% of all patients with COVID-19 in prior studies, researchers reported in Clinical Gastroenterology and Hepatology.

In a systematic review and meta-analysis of 23 studies incorporating data from 449 patients with IBD and COVID-19, their most common symptoms were fever (affecting 48.3% of patients), cough (46.5%), and diarrhea (20.5%), and diarrhea was approximately twice as prevalent as dyspnea, nausea, abdominal pain, and fatigue, wrote Ferdinando D’Amico of Humanitas University in Milan and his associates. “[S]ymptoms experienced by IBD patients with COVID-19 are similar to those occurring in the general population, except for a higher percentage of diarrhea,” they wrote. This increased prevalence might result from IBD itself or from inflammatory effects of viral gut tropism, they noted. “Currently, the diagnostic–therapeutic approach does not differ between IBD and non-IBD patients, but further studies are needed to evaluate whether fecal research of viral RNA and treatment with IBD drugs may play a role in the management of COVID-19 patients.”

To characterize the clinical presentation and course of patients with IBD and COVID-19, the researchers searched PubMed, Embase, Web of Science, and MedRxiv through July 29, 2020, for keywords related to COVID-19, Crohn’s disease, ulcerative colitis, and IBD. They identified 23 studies presenting clinical data from adults or children with a confirmed IBD diagnosis and least one case of COVID-19. Among 243,760 patients with IBD, 1,028 patients had COVID-19 infection, including 509 patients with Crohn’s disease, 428 patients with ulcerative colitis, 49 patients with indeterminate colitis, and 42 patients for whom the IBD subtype was not recorded.

In all, 0.4% of patients with IBD had COVID-19. Nearly all had been diagnosed by polymerase chain reaction of nasopharyngeal swabs, and approximately 40% also had received chest CT scans. Most were male (56.5%), and 43.5% were older than 65 years. Patients were receiving a wide range of IBD therapies, most commonly anti–tumor necrosis factor (TNF) agents, mesalamine, thiopurine (alone or in combination with biologics), vedolizumab, ustekinumab, steroids, methotrexate, and tofacitinib. Results from six studies indicated that patients with IBD were significantly more likely to be diagnosed with COVID-19 if they were older than 66 years (odds ratio, 21.3) or had other comorbidities (OR, 1.24). The most commonly used drugs for managing COVID-19 were hydroxychloroquine, lopinavir/ritonavir, steroids, antibiotics, chloroquine, tofacitinib, and infliximab.

A total of 30.6% of patients with IBD and COVID-19 were hospitalized, 11.4% stayed in the ICU, 3.7% required mechanical ventilation, and 3.8% died from COVID-19. Significant risk factors for death from COVID-19 included older age, active IBD, and a Charlson Comorbidity Index score above 1. Similarly, risk factors for severe COVID-19 included older age, having two or more comorbidities, receiving systemic steroids, and receiving mesalamine/sulfasalazine. In one study, a recent (3-month) history of corticosteroid treatment was associated with a 60% increase in the risk for severe COVID-19. Other immune-mediated therapies did not show this association. Patients with ulcerative colitis were significantly more likely to be seen in the ED or hospitalized, compared with patients with other forms of IBD (adjusted OR, 12.7).

No funding sources were disclosed. Dr. D’Amico reported having no conflicts of interest. Two coinvestigators disclosed ties to AbbVie, MSD, Schering-Plough, UCB Pharma, and several other pharmaceutical companies.

SOURCE: D’Amico F et al. Clin Gastroenterol Hepatol. 2020 Aug 7. doi: 10.1016/j.cgh.2020.08.003.
 

The mental health consequences of COVID-19 deaths are likely to overwhelm an already tattered U.S. mental health system, leading to a lack of access, particularly for the most vulnerable, experts warn.

“A second wave of devastation is imminent, attributable to mental health consequences of COVID-19,” write Naomi Simon, MD, and coauthors with the department of psychiatry, New York University.

In a Viewpoint article published in JAMA on Oct. 12, physicians offer some sobering statistics.

Since February 2020, COVID-19 has taken the lives of more than 214,000 Americans. The number of deaths currently attributed to the virus is nearly four times the number of Americans killed during the Vietnam War. The magnitude of death over a short period is a tragedy on a “historic scale,” wrote Dr. Simon and colleagues.

The surge in mental health problems related to COVID-19 deaths will bring further challenges to individuals, families, and communities, including a spike in deaths from suicide and drug overdoses, they warned.

It’s important to consider, they noted, that each COVID-19 death leaves an estimated nine family members bereaved, which is projected to lead to an estimated 2 million bereaved individuals in the United States.

“This interpersonal loss on a massive scale is compounded by societal disruption,” they wrote. The necessary social distancing and quarantine measures implemented to fight the virus have amplified emotional turmoil and have disrupted the ability of personal support networks and communities to come together and grieve.

“Of central concern is the transformation of normal grief and distress into prolonged grief and major depressive disorder and symptoms of posttraumatic stress disorder,” Simon and colleagues said.

“Once established, these conditions can become chronic with additional comorbidities such as substance use disorders. Prolonged grief affects approximately 10% of bereaved individuals, but this is likely an underestimate for grief related to deaths from COVID-19,” they wrote.

As with the first COVID-19 wave, the mental health wave will disproportionately affect Black persons, Hispanic persons, older adults, persons in lower socioeconomic groups of all races and ethnicities, and healthcare workers, they note.

The psychological risks for health care and other essential workers are of particular concern, they say. “Supporting the mental health of these and other essential workforce is critical to readiness for managing recurrent waves of the pandemic,” they stated.

How will the United States manage this impending wave of mental health problems?

“The solution will require increased funding for mental health; widespread screening to identify individuals at highest risk including suicide risk; availability of primary care clinicians and mental health professionals trained to treat those with prolonged grief, depression, traumatic stress, and substance abuse; and a diligent focus on families and communities to creatively restore the approaches by which they have managed tragedy and loss over generations,” the authors wrote.

“History has shown that societies recover from such devastation when leaders and members are joined by a shared purpose, acting in a unified way to facilitate recovery. In such societies, there is a shared understanding that its members must care for one another because the loss of one is a loss for all. Above all, this shared understanding must be restored,” they concluded.

Dr. Simon has received personal fees from Vanda Pharmaceuticals Inc, MGH Psychiatry Academy, Axovant Sciences, Springworks, Praxis Therapeutics, Aptinyx, Genomind, and Wiley (deputy editor, Depression and Anxiety). Saxe has received royalties from Guilford Press for the book Trauma Systems Therapy for Children and Teens (2016). Marmar serves on the scientific advisory board and owns equity in Receptor Life Sciences and serves on the PTSD advisory board for Otsuka Pharmaceutical.
 

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

The mental health consequences of COVID-19 deaths are likely to overwhelm an already tattered U.S. mental health system, leading to a lack of access, particularly for the most vulnerable, experts warn.

“A second wave of devastation is imminent, attributable to mental health consequences of COVID-19,” write Naomi Simon, MD, and coauthors with the department of psychiatry, New York University.

In a Viewpoint article published in JAMA on Oct. 12, physicians offer some sobering statistics.

Since February 2020, COVID-19 has taken the lives of more than 214,000 Americans. The number of deaths currently attributed to the virus is nearly four times the number of Americans killed during the Vietnam War. The magnitude of death over a short period is a tragedy on a “historic scale,” wrote Dr. Simon and colleagues.

The surge in mental health problems related to COVID-19 deaths will bring further challenges to individuals, families, and communities, including a spike in deaths from suicide and drug overdoses, they warned.

It’s important to consider, they noted, that each COVID-19 death leaves an estimated nine family members bereaved, which is projected to lead to an estimated 2 million bereaved individuals in the United States.

“This interpersonal loss on a massive scale is compounded by societal disruption,” they wrote. The necessary social distancing and quarantine measures implemented to fight the virus have amplified emotional turmoil and have disrupted the ability of personal support networks and communities to come together and grieve.

“Of central concern is the transformation of normal grief and distress into prolonged grief and major depressive disorder and symptoms of posttraumatic stress disorder,” Simon and colleagues said.

“Once established, these conditions can become chronic with additional comorbidities such as substance use disorders. Prolonged grief affects approximately 10% of bereaved individuals, but this is likely an underestimate for grief related to deaths from COVID-19,” they wrote.

As with the first COVID-19 wave, the mental health wave will disproportionately affect Black persons, Hispanic persons, older adults, persons in lower socioeconomic groups of all races and ethnicities, and healthcare workers, they note.

The psychological risks for health care and other essential workers are of particular concern, they say. “Supporting the mental health of these and other essential workforce is critical to readiness for managing recurrent waves of the pandemic,” they stated.

How will the United States manage this impending wave of mental health problems?

“The solution will require increased funding for mental health; widespread screening to identify individuals at highest risk including suicide risk; availability of primary care clinicians and mental health professionals trained to treat those with prolonged grief, depression, traumatic stress, and substance abuse; and a diligent focus on families and communities to creatively restore the approaches by which they have managed tragedy and loss over generations,” the authors wrote.

“History has shown that societies recover from such devastation when leaders and members are joined by a shared purpose, acting in a unified way to facilitate recovery. In such societies, there is a shared understanding that its members must care for one another because the loss of one is a loss for all. Above all, this shared understanding must be restored,” they concluded.

Dr. Simon has received personal fees from Vanda Pharmaceuticals Inc, MGH Psychiatry Academy, Axovant Sciences, Springworks, Praxis Therapeutics, Aptinyx, Genomind, and Wiley (deputy editor, Depression and Anxiety). Saxe has received royalties from Guilford Press for the book Trauma Systems Therapy for Children and Teens (2016). Marmar serves on the scientific advisory board and owns equity in Receptor Life Sciences and serves on the PTSD advisory board for Otsuka Pharmaceutical.
 

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

The mental health consequences of COVID-19 deaths are likely to overwhelm an already tattered U.S. mental health system, leading to a lack of access, particularly for the most vulnerable, experts warn.

“A second wave of devastation is imminent, attributable to mental health consequences of COVID-19,” write Naomi Simon, MD, and coauthors with the department of psychiatry, New York University.

In a Viewpoint article published in JAMA on Oct. 12, physicians offer some sobering statistics.

Since February 2020, COVID-19 has taken the lives of more than 214,000 Americans. The number of deaths currently attributed to the virus is nearly four times the number of Americans killed during the Vietnam War. The magnitude of death over a short period is a tragedy on a “historic scale,” wrote Dr. Simon and colleagues.

The surge in mental health problems related to COVID-19 deaths will bring further challenges to individuals, families, and communities, including a spike in deaths from suicide and drug overdoses, they warned.

It’s important to consider, they noted, that each COVID-19 death leaves an estimated nine family members bereaved, which is projected to lead to an estimated 2 million bereaved individuals in the United States.

“This interpersonal loss on a massive scale is compounded by societal disruption,” they wrote. The necessary social distancing and quarantine measures implemented to fight the virus have amplified emotional turmoil and have disrupted the ability of personal support networks and communities to come together and grieve.

“Of central concern is the transformation of normal grief and distress into prolonged grief and major depressive disorder and symptoms of posttraumatic stress disorder,” Simon and colleagues said.

“Once established, these conditions can become chronic with additional comorbidities such as substance use disorders. Prolonged grief affects approximately 10% of bereaved individuals, but this is likely an underestimate for grief related to deaths from COVID-19,” they wrote.

As with the first COVID-19 wave, the mental health wave will disproportionately affect Black persons, Hispanic persons, older adults, persons in lower socioeconomic groups of all races and ethnicities, and healthcare workers, they note.

The psychological risks for health care and other essential workers are of particular concern, they say. “Supporting the mental health of these and other essential workforce is critical to readiness for managing recurrent waves of the pandemic,” they stated.

How will the United States manage this impending wave of mental health problems?

“The solution will require increased funding for mental health; widespread screening to identify individuals at highest risk including suicide risk; availability of primary care clinicians and mental health professionals trained to treat those with prolonged grief, depression, traumatic stress, and substance abuse; and a diligent focus on families and communities to creatively restore the approaches by which they have managed tragedy and loss over generations,” the authors wrote.

“History has shown that societies recover from such devastation when leaders and members are joined by a shared purpose, acting in a unified way to facilitate recovery. In such societies, there is a shared understanding that its members must care for one another because the loss of one is a loss for all. Above all, this shared understanding must be restored,” they concluded.

Dr. Simon has received personal fees from Vanda Pharmaceuticals Inc, MGH Psychiatry Academy, Axovant Sciences, Springworks, Praxis Therapeutics, Aptinyx, Genomind, and Wiley (deputy editor, Depression and Anxiety). Saxe has received royalties from Guilford Press for the book Trauma Systems Therapy for Children and Teens (2016). Marmar serves on the scientific advisory board and owns equity in Receptor Life Sciences and serves on the PTSD advisory board for Otsuka Pharmaceutical.
 

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

Patients with heart failure with preserved ejection fraction (HFpEF) who received sacubitril/valsartan in the PARAGON-HF trial had significant protection against progression of renal dysfunction in a prespecified secondary analysis.

The 2,419 patients with HFpEF who received sacubitril/valsartan (Entresto) had half the rate of the primary adverse renal outcome, compared with the 2,403 patients randomized to valsartan alone in the comparator group, a significant difference, according to the results published online Sept. 29 in Circulation by Finnian R. McCausland, MBBCh, and colleagues.

In absolute terms, sacubitril/valsartan treatment, an angiotensin-receptor/neprilysin inhibitor (ARNI), cut the incidence of the combined renal endpoint – renal death, end-stage renal disease, or at least a 50% drop in estimated glomerular filtration rate (eGFR) – from 2.7% in the control group to 1.4% in the sacubitril/valsartan group during a median follow-up of 35 months.

The absolute difference of 1.3% equated to a number needed to treat of 51 to prevent one of these events.

Also notable was that renal protection from sacubitril/valsartan was equally robust across the range of baseline kidney function.
 

‘An important therapeutic option’

The efficacy “across the spectrum of baseline renal function” indicates treatment with sacubitril/valsartan is “an important therapeutic option to slow renal-function decline in patients with heart failure,” wrote Dr. McCausland, a nephrologist at Brigham and Women’s Hospital in Boston, and colleagues.

The authors’ conclusion is striking because currently no drug class has produced clear evidence for efficacy in HFpEF.

On the other hand, the PARAGON-HF trial that provided the data for this new analysis was statistically neutral for its primary endpoint – a reduction in the combined rate of cardiovascular death and hospitalizations for heart failure – with a P value of .06 and 95% confidence interval of 0.75-1.01.

“Because this difference [in the primary endpoint incidence between the two study group] did not meet the predetermined level of statistical significance, subsequent analyses were considered to be exploratory,” noted the authors of the primary analysis of PARAGON-HF, as reported by Medscape Medical News.

Despite this limitation in interpreting secondary outcomes from the trial, the new report of a significant renal benefit “opens the potential to provide evidence-based treatment for patients with HFpEF,” commented Sheldon W. Tobe, MD, and Stephanie Poon, MD, in an editorial accompanying the latest analysis.

“At the very least, these results are certainly intriguing and suggest that there may be important patient subgroups with HFpEF who might benefit from using sacubitril/valsartan,” they emphasized.
 

First large trial to show renal improvement in HFpEF

The editorialists’ enthusiasm for the implications of the new findings relate in part to the fact that “PARAGON-HF is the first large trial to demonstrate improvement in renal parameters in HFpEF,” they noted.

“The finding that the composite renal outcome did not differ according to baseline eGFR is significant and suggests that the beneficial effect on renal function was indirect, possibly linked to improved cardiac function,” say Dr. Tobe, a nephrologist, and Dr. Poon, a cardiologist, both at Sunnybrook Health Sciences Centre in Toronto.

PARAGON-HF enrolled 4,822 HFpEF patients at 848 centers in 43 countries, and the efficacy analysis included 4,796 patients.

The composite renal outcome was mainly driven by the incidence of a 50% or greater drop from baseline in eGFR, which occurred in 27 patients (1.1%) in the sacubitril/valsartan group and 60 patients (2.5%) who received valsartan alone.

The annual average drop in eGFR during the study was 2.0 mL/min per 1.73m² in the sacubitril/valsartan group and 2.7 mL/min per 1.73m² in the control group.

Although the heart failure community was disappointed that sacubitril/valsartan failed to show a significant benefit for the study’s primary outcome in HFpEF, the combination has become a mainstay of treatment for patients with HFpEF based on its performance in the PARADIGM-HF trial.

And despite the unqualified support sacubitril/valsartan now receives in guidelines and its label as a foundational treatment for HFpEF, the formulation has had a hard time gaining traction in U.S. practice, often because of barriers placed by third-party payers.

PARAGON-HF was sponsored by Novartis, which markets sacubitril/valsartan (Entresto). Dr. McCausland has reported no relevant financial relationships. Dr. Tobe has reported participating on a steering committee for Bayer Fidelio/Figaro studies and being a speaker on behalf of Pfizer and Servier. Dr. Poon has reported being an adviser to Novartis, Boehringer Ingelheim, and Servier.
 

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

Patients with heart failure with preserved ejection fraction (HFpEF) who received sacubitril/valsartan in the PARAGON-HF trial had significant protection against progression of renal dysfunction in a prespecified secondary analysis.

The 2,419 patients with HFpEF who received sacubitril/valsartan (Entresto) had half the rate of the primary adverse renal outcome, compared with the 2,403 patients randomized to valsartan alone in the comparator group, a significant difference, according to the results published online Sept. 29 in Circulation by Finnian R. McCausland, MBBCh, and colleagues.

In absolute terms, sacubitril/valsartan treatment, an angiotensin-receptor/neprilysin inhibitor (ARNI), cut the incidence of the combined renal endpoint – renal death, end-stage renal disease, or at least a 50% drop in estimated glomerular filtration rate (eGFR) – from 2.7% in the control group to 1.4% in the sacubitril/valsartan group during a median follow-up of 35 months.

The absolute difference of 1.3% equated to a number needed to treat of 51 to prevent one of these events.

Also notable was that renal protection from sacubitril/valsartan was equally robust across the range of baseline kidney function.
 

‘An important therapeutic option’

The efficacy “across the spectrum of baseline renal function” indicates treatment with sacubitril/valsartan is “an important therapeutic option to slow renal-function decline in patients with heart failure,” wrote Dr. McCausland, a nephrologist at Brigham and Women’s Hospital in Boston, and colleagues.

The authors’ conclusion is striking because currently no drug class has produced clear evidence for efficacy in HFpEF.

On the other hand, the PARAGON-HF trial that provided the data for this new analysis was statistically neutral for its primary endpoint – a reduction in the combined rate of cardiovascular death and hospitalizations for heart failure – with a P value of .06 and 95% confidence interval of 0.75-1.01.

“Because this difference [in the primary endpoint incidence between the two study group] did not meet the predetermined level of statistical significance, subsequent analyses were considered to be exploratory,” noted the authors of the primary analysis of PARAGON-HF, as reported by Medscape Medical News.

Despite this limitation in interpreting secondary outcomes from the trial, the new report of a significant renal benefit “opens the potential to provide evidence-based treatment for patients with HFpEF,” commented Sheldon W. Tobe, MD, and Stephanie Poon, MD, in an editorial accompanying the latest analysis.

“At the very least, these results are certainly intriguing and suggest that there may be important patient subgroups with HFpEF who might benefit from using sacubitril/valsartan,” they emphasized.
 

First large trial to show renal improvement in HFpEF

The editorialists’ enthusiasm for the implications of the new findings relate in part to the fact that “PARAGON-HF is the first large trial to demonstrate improvement in renal parameters in HFpEF,” they noted.

“The finding that the composite renal outcome did not differ according to baseline eGFR is significant and suggests that the beneficial effect on renal function was indirect, possibly linked to improved cardiac function,” say Dr. Tobe, a nephrologist, and Dr. Poon, a cardiologist, both at Sunnybrook Health Sciences Centre in Toronto.

PARAGON-HF enrolled 4,822 HFpEF patients at 848 centers in 43 countries, and the efficacy analysis included 4,796 patients.

The composite renal outcome was mainly driven by the incidence of a 50% or greater drop from baseline in eGFR, which occurred in 27 patients (1.1%) in the sacubitril/valsartan group and 60 patients (2.5%) who received valsartan alone.

The annual average drop in eGFR during the study was 2.0 mL/min per 1.73m² in the sacubitril/valsartan group and 2.7 mL/min per 1.73m² in the control group.

Although the heart failure community was disappointed that sacubitril/valsartan failed to show a significant benefit for the study’s primary outcome in HFpEF, the combination has become a mainstay of treatment for patients with HFpEF based on its performance in the PARADIGM-HF trial.

And despite the unqualified support sacubitril/valsartan now receives in guidelines and its label as a foundational treatment for HFpEF, the formulation has had a hard time gaining traction in U.S. practice, often because of barriers placed by third-party payers.

PARAGON-HF was sponsored by Novartis, which markets sacubitril/valsartan (Entresto). Dr. McCausland has reported no relevant financial relationships. Dr. Tobe has reported participating on a steering committee for Bayer Fidelio/Figaro studies and being a speaker on behalf of Pfizer and Servier. Dr. Poon has reported being an adviser to Novartis, Boehringer Ingelheim, and Servier.
 

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

Patients with heart failure with preserved ejection fraction (HFpEF) who received sacubitril/valsartan in the PARAGON-HF trial had significant protection against progression of renal dysfunction in a prespecified secondary analysis.

The 2,419 patients with HFpEF who received sacubitril/valsartan (Entresto) had half the rate of the primary adverse renal outcome, compared with the 2,403 patients randomized to valsartan alone in the comparator group, a significant difference, according to the results published online Sept. 29 in Circulation by Finnian R. McCausland, MBBCh, and colleagues.

In absolute terms, sacubitril/valsartan treatment, an angiotensin-receptor/neprilysin inhibitor (ARNI), cut the incidence of the combined renal endpoint – renal death, end-stage renal disease, or at least a 50% drop in estimated glomerular filtration rate (eGFR) – from 2.7% in the control group to 1.4% in the sacubitril/valsartan group during a median follow-up of 35 months.

The absolute difference of 1.3% equated to a number needed to treat of 51 to prevent one of these events.

Also notable was that renal protection from sacubitril/valsartan was equally robust across the range of baseline kidney function.
 

‘An important therapeutic option’

The efficacy “across the spectrum of baseline renal function” indicates treatment with sacubitril/valsartan is “an important therapeutic option to slow renal-function decline in patients with heart failure,” wrote Dr. McCausland, a nephrologist at Brigham and Women’s Hospital in Boston, and colleagues.

The authors’ conclusion is striking because currently no drug class has produced clear evidence for efficacy in HFpEF.

On the other hand, the PARAGON-HF trial that provided the data for this new analysis was statistically neutral for its primary endpoint – a reduction in the combined rate of cardiovascular death and hospitalizations for heart failure – with a P value of .06 and 95% confidence interval of 0.75-1.01.

“Because this difference [in the primary endpoint incidence between the two study group] did not meet the predetermined level of statistical significance, subsequent analyses were considered to be exploratory,” noted the authors of the primary analysis of PARAGON-HF, as reported by Medscape Medical News.

Despite this limitation in interpreting secondary outcomes from the trial, the new report of a significant renal benefit “opens the potential to provide evidence-based treatment for patients with HFpEF,” commented Sheldon W. Tobe, MD, and Stephanie Poon, MD, in an editorial accompanying the latest analysis.

“At the very least, these results are certainly intriguing and suggest that there may be important patient subgroups with HFpEF who might benefit from using sacubitril/valsartan,” they emphasized.
 

First large trial to show renal improvement in HFpEF

The editorialists’ enthusiasm for the implications of the new findings relate in part to the fact that “PARAGON-HF is the first large trial to demonstrate improvement in renal parameters in HFpEF,” they noted.

“The finding that the composite renal outcome did not differ according to baseline eGFR is significant and suggests that the beneficial effect on renal function was indirect, possibly linked to improved cardiac function,” say Dr. Tobe, a nephrologist, and Dr. Poon, a cardiologist, both at Sunnybrook Health Sciences Centre in Toronto.

PARAGON-HF enrolled 4,822 HFpEF patients at 848 centers in 43 countries, and the efficacy analysis included 4,796 patients.

The composite renal outcome was mainly driven by the incidence of a 50% or greater drop from baseline in eGFR, which occurred in 27 patients (1.1%) in the sacubitril/valsartan group and 60 patients (2.5%) who received valsartan alone.

The annual average drop in eGFR during the study was 2.0 mL/min per 1.73m² in the sacubitril/valsartan group and 2.7 mL/min per 1.73m² in the control group.

Although the heart failure community was disappointed that sacubitril/valsartan failed to show a significant benefit for the study’s primary outcome in HFpEF, the combination has become a mainstay of treatment for patients with HFpEF based on its performance in the PARADIGM-HF trial.

And despite the unqualified support sacubitril/valsartan now receives in guidelines and its label as a foundational treatment for HFpEF, the formulation has had a hard time gaining traction in U.S. practice, often because of barriers placed by third-party payers.

PARAGON-HF was sponsored by Novartis, which markets sacubitril/valsartan (Entresto). Dr. McCausland has reported no relevant financial relationships. Dr. Tobe has reported participating on a steering committee for Bayer Fidelio/Figaro studies and being a speaker on behalf of Pfizer and Servier. Dr. Poon has reported being an adviser to Novartis, Boehringer Ingelheim, and Servier.
 

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

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

[email protected]

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

[email protected]

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

[email protected]

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

The SHM Annual Conference is more than an educational event. It also provides an opportunity to collaborate, network and create innovative ideas to improve the quality of inpatient care.

During the 2019 Annual Conference (HM19) – the last “in-person” Annual Conference before the COVID pandemic – SHM chapter leaders from the New Mexico chapter (Krystle Apodaca) and the Wiregrass chapter (Amith Skandhan), which covers the counties of Southern Alabama and the Panhandle of Florida, met during a networking event.

As we talked, we realized the unique differences and similarities our practice settings shared. We debated the role of clinician wellbeing, quality of medical education, and faculty development on individual hospital medicine group (HMG) practice styles.

Clinician well-being is the prerequisite to the Triple Aim of improving the health of populations, enhancing the patient experience, and reducing the cost of care. Engagement in local SHM chapter activities promotes the efficiency of practice, a culture of wellness, and personal resilience. Each HMG faces similar challenges but approaches to solving them vary. Professional challenges can affect the well-being of individual clinicians. During our discussion we realized that an interinstitutional exchange programs could provide a platform to exchange ideas and establish mentors.

The quality of medical education is directly linked to the quality of faculty development. Improving the quality of medical education requires a multifaceted approach by highly developed faculty. The complex factors affecting medical education and faculty development are further complicated by geographic location, patient characteristics, and professional growth opportunities.

Overcoming these obstacles requires an innovative and collaborative approach. Although faculty exchanges are common in academic medicine, they are not commonly attempted with HMGs. Hospitalists are responsible for a significant part of inpatient training for residents, medical students, and nurse practitioners/physician assistants (NPs/PAs) but their faculty training can vary based on location.

As a young specialty, hospital medicine is still evolving and incorporating NPs/PAs and physician hospitalists in varied practice models. Each HMG addresses common obstacles differently based on their culture and practice styles. As chapter leaders we determined that an exchange program would afford the opportunity for visiting faculty members to experience these differences.

We shared the idea of a chapter-level exchange with SHM’s Chapter Development Committee and obtained chapter development funds to execute the event. We also requested that an SHM national board member visit during the exchange to provide insight and feedback. We researched the characteristics of individual academic HMGs and structured a faculty exchange involving physicians and NPs/PAs. During the exchange program planning, the visiting faculty itinerary was tailored to a well-planned agenda for one week, with separate tracks for physicians and NPs/PAs, giving increased access to their individual peer practice styles. Additionally, the visiting faculty had meetings and discussions with the HMG and hospital leadership, to specifically address the visiting faculty’s institutional challenges.

The overall goal of the exchange program was to promote cross-institutional collaboration, increase engagement, improve medical education through faculty development and improve the quality of care. The focus of the exchange program was to share ideas and innovation, and learn the approaches to unique challenges at each institution. Out of this also grew collaboration and mentoring opportunities.

Dr. Apodaca is assistant professor and nurse practitioner hospitalist at the University of New Mexico. She serves as codirector of the UNM APP Hospital Medicine Fellowship and director of the APP Hospital Medicine Team. Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization.

The SHM Annual Conference is more than an educational event. It also provides an opportunity to collaborate, network and create innovative ideas to improve the quality of inpatient care.

During the 2019 Annual Conference (HM19) – the last “in-person” Annual Conference before the COVID pandemic – SHM chapter leaders from the New Mexico chapter (Krystle Apodaca) and the Wiregrass chapter (Amith Skandhan), which covers the counties of Southern Alabama and the Panhandle of Florida, met during a networking event.

As we talked, we realized the unique differences and similarities our practice settings shared. We debated the role of clinician wellbeing, quality of medical education, and faculty development on individual hospital medicine group (HMG) practice styles.

Clinician well-being is the prerequisite to the Triple Aim of improving the health of populations, enhancing the patient experience, and reducing the cost of care. Engagement in local SHM chapter activities promotes the efficiency of practice, a culture of wellness, and personal resilience. Each HMG faces similar challenges but approaches to solving them vary. Professional challenges can affect the well-being of individual clinicians. During our discussion we realized that an interinstitutional exchange programs could provide a platform to exchange ideas and establish mentors.

The quality of medical education is directly linked to the quality of faculty development. Improving the quality of medical education requires a multifaceted approach by highly developed faculty. The complex factors affecting medical education and faculty development are further complicated by geographic location, patient characteristics, and professional growth opportunities.

Overcoming these obstacles requires an innovative and collaborative approach. Although faculty exchanges are common in academic medicine, they are not commonly attempted with HMGs. Hospitalists are responsible for a significant part of inpatient training for residents, medical students, and nurse practitioners/physician assistants (NPs/PAs) but their faculty training can vary based on location.

As a young specialty, hospital medicine is still evolving and incorporating NPs/PAs and physician hospitalists in varied practice models. Each HMG addresses common obstacles differently based on their culture and practice styles. As chapter leaders we determined that an exchange program would afford the opportunity for visiting faculty members to experience these differences.

We shared the idea of a chapter-level exchange with SHM’s Chapter Development Committee and obtained chapter development funds to execute the event. We also requested that an SHM national board member visit during the exchange to provide insight and feedback. We researched the characteristics of individual academic HMGs and structured a faculty exchange involving physicians and NPs/PAs. During the exchange program planning, the visiting faculty itinerary was tailored to a well-planned agenda for one week, with separate tracks for physicians and NPs/PAs, giving increased access to their individual peer practice styles. Additionally, the visiting faculty had meetings and discussions with the HMG and hospital leadership, to specifically address the visiting faculty’s institutional challenges.

The overall goal of the exchange program was to promote cross-institutional collaboration, increase engagement, improve medical education through faculty development and improve the quality of care. The focus of the exchange program was to share ideas and innovation, and learn the approaches to unique challenges at each institution. Out of this also grew collaboration and mentoring opportunities.

Dr. Apodaca is assistant professor and nurse practitioner hospitalist at the University of New Mexico. She serves as codirector of the UNM APP Hospital Medicine Fellowship and director of the APP Hospital Medicine Team. Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization.

The SHM Annual Conference is more than an educational event. It also provides an opportunity to collaborate, network and create innovative ideas to improve the quality of inpatient care.

During the 2019 Annual Conference (HM19) – the last “in-person” Annual Conference before the COVID pandemic – SHM chapter leaders from the New Mexico chapter (Krystle Apodaca) and the Wiregrass chapter (Amith Skandhan), which covers the counties of Southern Alabama and the Panhandle of Florida, met during a networking event.

As we talked, we realized the unique differences and similarities our practice settings shared. We debated the role of clinician wellbeing, quality of medical education, and faculty development on individual hospital medicine group (HMG) practice styles.

Clinician well-being is the prerequisite to the Triple Aim of improving the health of populations, enhancing the patient experience, and reducing the cost of care. Engagement in local SHM chapter activities promotes the efficiency of practice, a culture of wellness, and personal resilience. Each HMG faces similar challenges but approaches to solving them vary. Professional challenges can affect the well-being of individual clinicians. During our discussion we realized that an interinstitutional exchange programs could provide a platform to exchange ideas and establish mentors.

The quality of medical education is directly linked to the quality of faculty development. Improving the quality of medical education requires a multifaceted approach by highly developed faculty. The complex factors affecting medical education and faculty development are further complicated by geographic location, patient characteristics, and professional growth opportunities.

Overcoming these obstacles requires an innovative and collaborative approach. Although faculty exchanges are common in academic medicine, they are not commonly attempted with HMGs. Hospitalists are responsible for a significant part of inpatient training for residents, medical students, and nurse practitioners/physician assistants (NPs/PAs) but their faculty training can vary based on location.

As a young specialty, hospital medicine is still evolving and incorporating NPs/PAs and physician hospitalists in varied practice models. Each HMG addresses common obstacles differently based on their culture and practice styles. As chapter leaders we determined that an exchange program would afford the opportunity for visiting faculty members to experience these differences.

We shared the idea of a chapter-level exchange with SHM’s Chapter Development Committee and obtained chapter development funds to execute the event. We also requested that an SHM national board member visit during the exchange to provide insight and feedback. We researched the characteristics of individual academic HMGs and structured a faculty exchange involving physicians and NPs/PAs. During the exchange program planning, the visiting faculty itinerary was tailored to a well-planned agenda for one week, with separate tracks for physicians and NPs/PAs, giving increased access to their individual peer practice styles. Additionally, the visiting faculty had meetings and discussions with the HMG and hospital leadership, to specifically address the visiting faculty’s institutional challenges.

The overall goal of the exchange program was to promote cross-institutional collaboration, increase engagement, improve medical education through faculty development and improve the quality of care. The focus of the exchange program was to share ideas and innovation, and learn the approaches to unique challenges at each institution. Out of this also grew collaboration and mentoring opportunities.

Dr. Apodaca is assistant professor and nurse practitioner hospitalist at the University of New Mexico. She serves as codirector of the UNM APP Hospital Medicine Fellowship and director of the APP Hospital Medicine Team. Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization.

In pediatric Crohn’s disease, a Clostridioides difficile infection detected within the first year after diagnosis is associated with a shorter time to first bowel resection surgery, according to a study that included both a retrospective and prospective analysis. The researchers also found evidence that changes in methionine biosynthesis and depletion of beneficial bacteria may contribute to risk of surgery.

C. difficile infection (CDI) disproportionately affects individuals with inflammatory bowel disease (IBD). Pediatric IBD patients have a 34% risk of recurrent CDI infection, compared with 7.5% in the general population. Previous research found that adults with ulcerative colitis and CDI are at more risk of colectomy, but the finding has not been replicated in children.

In a study published in Inflammatory Bowel Diseases, researchers led by Jennifer Hellmann and Lee Denson of the University of Cincinnati conducted a single-center retrospective analysis of 75 pediatric Crohn’s disease patients. They also conducted a prospective study of 70 pediatric Crohn’s disease patients, using shotgun metagenome sequencing to examine the relationship between microbiota composition and C. difficile carriage or surgery history.

Nineteen percent of patients tested positive for C. difficile. Use of antibiotics was associated with C. difficile (odds ratio, 7.9; P = .02). Of patients who underwent C. difficile testing in the first year, 23 went on to have surgery: 21% who were C. difficile negative required surgery, compared with 67% of those who were positive (hazard ratio, 4.4; P = .0003). The mean time to surgery was 527 days for C. difficile–positive patients and 1,268 days for those who were negative.

A multivariate regression analysis on 54 patients with complete data sets showed that the presence of C. difficile was associated with increased risk of surgery (OR, 16.2; P = .0006). When the analysis was run on all 73 patients, using null value for missing data, the results were similar (OR, 9.17; P = .008).

Shotgun sequencing found that 47 of 114 bacterial species that were associated with the presence of C. difficile were also associated with prior surgery for Crohn’s disease. Species included some that may play a role in mucosal homeostasis, such as Bifidobacterium breve and several Alistipes and Ruminococcus species. That suggests that a reduction in the numbers of these taxa may be associated with C. difficile presence and surgical risk.

The researchers also found that methionine synthesis pathways were depressed in C. difficile–positive and surgery patients. Methionine may bolster antioxidant capacity and improve villus morphology. IBD patients with dysbiosis and those experiencing Crohn’s disease exacerbations have been shown to have decreased methionine pathway activity, suggesting methionine biosynthesis changes have clinical relevance.

The study was funded by the National Institutes of Health.

SOURCE: Hellmann J et al. Inflamm Bowel Dis. 2020. doi: 10.1093/ibd/izz263.

In pediatric Crohn’s disease, a Clostridioides difficile infection detected within the first year after diagnosis is associated with a shorter time to first bowel resection surgery, according to a study that included both a retrospective and prospective analysis. The researchers also found evidence that changes in methionine biosynthesis and depletion of beneficial bacteria may contribute to risk of surgery.

C. difficile infection (CDI) disproportionately affects individuals with inflammatory bowel disease (IBD). Pediatric IBD patients have a 34% risk of recurrent CDI infection, compared with 7.5% in the general population. Previous research found that adults with ulcerative colitis and CDI are at more risk of colectomy, but the finding has not been replicated in children.

In a study published in Inflammatory Bowel Diseases, researchers led by Jennifer Hellmann and Lee Denson of the University of Cincinnati conducted a single-center retrospective analysis of 75 pediatric Crohn’s disease patients. They also conducted a prospective study of 70 pediatric Crohn’s disease patients, using shotgun metagenome sequencing to examine the relationship between microbiota composition and C. difficile carriage or surgery history.

Nineteen percent of patients tested positive for C. difficile. Use of antibiotics was associated with C. difficile (odds ratio, 7.9; P = .02). Of patients who underwent C. difficile testing in the first year, 23 went on to have surgery: 21% who were C. difficile negative required surgery, compared with 67% of those who were positive (hazard ratio, 4.4; P = .0003). The mean time to surgery was 527 days for C. difficile–positive patients and 1,268 days for those who were negative.

A multivariate regression analysis on 54 patients with complete data sets showed that the presence of C. difficile was associated with increased risk of surgery (OR, 16.2; P = .0006). When the analysis was run on all 73 patients, using null value for missing data, the results were similar (OR, 9.17; P = .008).

Shotgun sequencing found that 47 of 114 bacterial species that were associated with the presence of C. difficile were also associated with prior surgery for Crohn’s disease. Species included some that may play a role in mucosal homeostasis, such as Bifidobacterium breve and several Alistipes and Ruminococcus species. That suggests that a reduction in the numbers of these taxa may be associated with C. difficile presence and surgical risk.

The researchers also found that methionine synthesis pathways were depressed in C. difficile–positive and surgery patients. Methionine may bolster antioxidant capacity and improve villus morphology. IBD patients with dysbiosis and those experiencing Crohn’s disease exacerbations have been shown to have decreased methionine pathway activity, suggesting methionine biosynthesis changes have clinical relevance.

The study was funded by the National Institutes of Health.

SOURCE: Hellmann J et al. Inflamm Bowel Dis. 2020. doi: 10.1093/ibd/izz263.

In pediatric Crohn’s disease, a Clostridioides difficile infection detected within the first year after diagnosis is associated with a shorter time to first bowel resection surgery, according to a study that included both a retrospective and prospective analysis. The researchers also found evidence that changes in methionine biosynthesis and depletion of beneficial bacteria may contribute to risk of surgery.

C. difficile infection (CDI) disproportionately affects individuals with inflammatory bowel disease (IBD). Pediatric IBD patients have a 34% risk of recurrent CDI infection, compared with 7.5% in the general population. Previous research found that adults with ulcerative colitis and CDI are at more risk of colectomy, but the finding has not been replicated in children.

In a study published in Inflammatory Bowel Diseases, researchers led by Jennifer Hellmann and Lee Denson of the University of Cincinnati conducted a single-center retrospective analysis of 75 pediatric Crohn’s disease patients. They also conducted a prospective study of 70 pediatric Crohn’s disease patients, using shotgun metagenome sequencing to examine the relationship between microbiota composition and C. difficile carriage or surgery history.

Nineteen percent of patients tested positive for C. difficile. Use of antibiotics was associated with C. difficile (odds ratio, 7.9; P = .02). Of patients who underwent C. difficile testing in the first year, 23 went on to have surgery: 21% who were C. difficile negative required surgery, compared with 67% of those who were positive (hazard ratio, 4.4; P = .0003). The mean time to surgery was 527 days for C. difficile–positive patients and 1,268 days for those who were negative.

A multivariate regression analysis on 54 patients with complete data sets showed that the presence of C. difficile was associated with increased risk of surgery (OR, 16.2; P = .0006). When the analysis was run on all 73 patients, using null value for missing data, the results were similar (OR, 9.17; P = .008).

Shotgun sequencing found that 47 of 114 bacterial species that were associated with the presence of C. difficile were also associated with prior surgery for Crohn’s disease. Species included some that may play a role in mucosal homeostasis, such as Bifidobacterium breve and several Alistipes and Ruminococcus species. That suggests that a reduction in the numbers of these taxa may be associated with C. difficile presence and surgical risk.

The researchers also found that methionine synthesis pathways were depressed in C. difficile–positive and surgery patients. Methionine may bolster antioxidant capacity and improve villus morphology. IBD patients with dysbiosis and those experiencing Crohn’s disease exacerbations have been shown to have decreased methionine pathway activity, suggesting methionine biosynthesis changes have clinical relevance.

The study was funded by the National Institutes of Health.

SOURCE: Hellmann J et al. Inflamm Bowel Dis. 2020. doi: 10.1093/ibd/izz263.

Vancomycin followed by fecal microbiota transplant (FMT) was associated with reduced Clostridioides difficile (C. diff)-related mortality in patients hospitalized with refractory severe or fulminant C. diff infection (CDI) at a single center. The improvements came after Indiana University implemented an FMT option in 2013.

About 8% of C. diff patients develop severe or fulminant CDI (SFCDI), which can lead to toxic colon and multiorgan failure. Surgery is the current recommended treatment for these patients if they are refractory to vancomycin, but 30-day mortality is above 40%. FMT is recommended for recurrent CDI, and it achieves cure rates greater than 80%, along with fewer relapses compared with anti-CDI antibiotic therapy.

FMT has been shown to be effective for SFCDI, with a 91% cure rate for serious CDI and 66% for fulminant CDI.

In the study published in the September issue of Clinical Gastroenterology and Hepatology, researchers led by Yao-Wen Cheng, MD, and Monika Fischer, MD, of Indiana University, assessed the effect of FMT on SFCDI after their institution adopted it as a treatment protocol for SFCDI. Patients could receive FMT if there was evidence that their SFCDI was refractory, or if they had two or more CDI recurrences. The treatment includes oral vancomycin and pseudomembrane-driven sequential FMT.

Two hundred five patients were admitted before FMT implementation, 225 after. Fifty patients received FMT because of refractory SFCDI. A median of two FMTs was conducted per patient. 21 other patients received FMT for nonrefractory SFCDI or other conditions, including 18 patients with multiple recurrent CDI.

Thirty-day CDI-related mortality dropped after FMT implementation (4.4% versus 10.2%; P =.02). This was true in both the fulminant subset (9.1% versus 21.3%; P =.015) and the refractory group (12.1% versus 43.2%; P < .001).

The researchers used segmented logistic regression to determine if the improved outcomes could be due to nontreatment factors that varied over time, and found that the difference in CDI-related mortality was eliminated except for refractory SFCDI patients (odds of mortality after FMT implementation, 0.09; P =.023). There was no significant difference between those receiving non-CDI antibiotics (4.8%) and those who did not (6.9%; P =.75).

FMT was associated with lower frequency of CDI-related colectomy overall (2.7% versus 6.8%; P =.041), as well as in the fulminant (5.5% versus 15.7%; P =.017) and refractory subgroups (7.6% versus 31.8%; P =.001).

The findings follow another study that showed improved 3-month mortality for FMT among patients hospitalized with severe CDI (12.1% versus 42.2%; P < .003).

The results underscore the utility of FMT for SFCDI, and suggest it might have the most benefit in refractory SFCDI. The authors believe that FMT should be an alternative to colectomy when first-line anti-CDI antibiotics are partially or completely ineffective. In the absence of FMT, patients who go on to fail vancomycin or fidaxomicin will likely continue to be managed medically, with up to 80% mortality, or through salvage colectomy, with postsurgical morality rates of 30-40%.

Although a randomized trial could answer the question of FMT efficacy more definitively, it is unlikely to be conducted for ethical reasons.

“Further investigation is required to clearly define FMT’s role and timing in the clinical course of severe and fulminant CDI. However, our study suggests that FMT should be offered to patients with severe and fulminant CDI who do not respond to a 5-day course of anti-CDI antibiotics and may be considered in lieu of or before colectomy,” the researchers wrote.

No source of funding was disclosed.

SOURCE: Cheng YW et al. Clin Gastroenterol Hepatol. 2020;18:2234-43. doi: 10.1016/j.cgh.2019.12.029.

Vancomycin followed by fecal microbiota transplant (FMT) was associated with reduced Clostridioides difficile (C. diff)-related mortality in patients hospitalized with refractory severe or fulminant C. diff infection (CDI) at a single center. The improvements came after Indiana University implemented an FMT option in 2013.

About 8% of C. diff patients develop severe or fulminant CDI (SFCDI), which can lead to toxic colon and multiorgan failure. Surgery is the current recommended treatment for these patients if they are refractory to vancomycin, but 30-day mortality is above 40%. FMT is recommended for recurrent CDI, and it achieves cure rates greater than 80%, along with fewer relapses compared with anti-CDI antibiotic therapy.

FMT has been shown to be effective for SFCDI, with a 91% cure rate for serious CDI and 66% for fulminant CDI.

In the study published in the September issue of Clinical Gastroenterology and Hepatology, researchers led by Yao-Wen Cheng, MD, and Monika Fischer, MD, of Indiana University, assessed the effect of FMT on SFCDI after their institution adopted it as a treatment protocol for SFCDI. Patients could receive FMT if there was evidence that their SFCDI was refractory, or if they had two or more CDI recurrences. The treatment includes oral vancomycin and pseudomembrane-driven sequential FMT.

Two hundred five patients were admitted before FMT implementation, 225 after. Fifty patients received FMT because of refractory SFCDI. A median of two FMTs was conducted per patient. 21 other patients received FMT for nonrefractory SFCDI or other conditions, including 18 patients with multiple recurrent CDI.

Thirty-day CDI-related mortality dropped after FMT implementation (4.4% versus 10.2%; P =.02). This was true in both the fulminant subset (9.1% versus 21.3%; P =.015) and the refractory group (12.1% versus 43.2%; P < .001).

The researchers used segmented logistic regression to determine if the improved outcomes could be due to nontreatment factors that varied over time, and found that the difference in CDI-related mortality was eliminated except for refractory SFCDI patients (odds of mortality after FMT implementation, 0.09; P =.023). There was no significant difference between those receiving non-CDI antibiotics (4.8%) and those who did not (6.9%; P =.75).

FMT was associated with lower frequency of CDI-related colectomy overall (2.7% versus 6.8%; P =.041), as well as in the fulminant (5.5% versus 15.7%; P =.017) and refractory subgroups (7.6% versus 31.8%; P =.001).

The findings follow another study that showed improved 3-month mortality for FMT among patients hospitalized with severe CDI (12.1% versus 42.2%; P < .003).

The results underscore the utility of FMT for SFCDI, and suggest it might have the most benefit in refractory SFCDI. The authors believe that FMT should be an alternative to colectomy when first-line anti-CDI antibiotics are partially or completely ineffective. In the absence of FMT, patients who go on to fail vancomycin or fidaxomicin will likely continue to be managed medically, with up to 80% mortality, or through salvage colectomy, with postsurgical morality rates of 30-40%.

Although a randomized trial could answer the question of FMT efficacy more definitively, it is unlikely to be conducted for ethical reasons.

“Further investigation is required to clearly define FMT’s role and timing in the clinical course of severe and fulminant CDI. However, our study suggests that FMT should be offered to patients with severe and fulminant CDI who do not respond to a 5-day course of anti-CDI antibiotics and may be considered in lieu of or before colectomy,” the researchers wrote.

No source of funding was disclosed.

SOURCE: Cheng YW et al. Clin Gastroenterol Hepatol. 2020;18:2234-43. doi: 10.1016/j.cgh.2019.12.029.

Vancomycin followed by fecal microbiota transplant (FMT) was associated with reduced Clostridioides difficile (C. diff)-related mortality in patients hospitalized with refractory severe or fulminant C. diff infection (CDI) at a single center. The improvements came after Indiana University implemented an FMT option in 2013.

About 8% of C. diff patients develop severe or fulminant CDI (SFCDI), which can lead to toxic colon and multiorgan failure. Surgery is the current recommended treatment for these patients if they are refractory to vancomycin, but 30-day mortality is above 40%. FMT is recommended for recurrent CDI, and it achieves cure rates greater than 80%, along with fewer relapses compared with anti-CDI antibiotic therapy.

FMT has been shown to be effective for SFCDI, with a 91% cure rate for serious CDI and 66% for fulminant CDI.

In the study published in the September issue of Clinical Gastroenterology and Hepatology, researchers led by Yao-Wen Cheng, MD, and Monika Fischer, MD, of Indiana University, assessed the effect of FMT on SFCDI after their institution adopted it as a treatment protocol for SFCDI. Patients could receive FMT if there was evidence that their SFCDI was refractory, or if they had two or more CDI recurrences. The treatment includes oral vancomycin and pseudomembrane-driven sequential FMT.

Two hundred five patients were admitted before FMT implementation, 225 after. Fifty patients received FMT because of refractory SFCDI. A median of two FMTs was conducted per patient. 21 other patients received FMT for nonrefractory SFCDI or other conditions, including 18 patients with multiple recurrent CDI.

Thirty-day CDI-related mortality dropped after FMT implementation (4.4% versus 10.2%; P =.02). This was true in both the fulminant subset (9.1% versus 21.3%; P =.015) and the refractory group (12.1% versus 43.2%; P < .001).

The researchers used segmented logistic regression to determine if the improved outcomes could be due to nontreatment factors that varied over time, and found that the difference in CDI-related mortality was eliminated except for refractory SFCDI patients (odds of mortality after FMT implementation, 0.09; P =.023). There was no significant difference between those receiving non-CDI antibiotics (4.8%) and those who did not (6.9%; P =.75).

FMT was associated with lower frequency of CDI-related colectomy overall (2.7% versus 6.8%; P =.041), as well as in the fulminant (5.5% versus 15.7%; P =.017) and refractory subgroups (7.6% versus 31.8%; P =.001).

The findings follow another study that showed improved 3-month mortality for FMT among patients hospitalized with severe CDI (12.1% versus 42.2%; P < .003).

The results underscore the utility of FMT for SFCDI, and suggest it might have the most benefit in refractory SFCDI. The authors believe that FMT should be an alternative to colectomy when first-line anti-CDI antibiotics are partially or completely ineffective. In the absence of FMT, patients who go on to fail vancomycin or fidaxomicin will likely continue to be managed medically, with up to 80% mortality, or through salvage colectomy, with postsurgical morality rates of 30-40%.

Although a randomized trial could answer the question of FMT efficacy more definitively, it is unlikely to be conducted for ethical reasons.

“Further investigation is required to clearly define FMT’s role and timing in the clinical course of severe and fulminant CDI. However, our study suggests that FMT should be offered to patients with severe and fulminant CDI who do not respond to a 5-day course of anti-CDI antibiotics and may be considered in lieu of or before colectomy,” the researchers wrote.

No source of funding was disclosed.

SOURCE: Cheng YW et al. Clin Gastroenterol Hepatol. 2020;18:2234-43. doi: 10.1016/j.cgh.2019.12.029.

There are many challenges facing modern medicine today. Recent events have highlighted important issues affecting our society as a whole – systemic racism, sexism, and implicit bias. In medicine, we have seen a renewed focus on health equity, health disparities and the implicit systemic bias that affect those who work in the field. It is truly troubling that it has taken the continued loss of black lives to police brutality and a pandemic for this conversation to happen at every level in society.

Systemic bias is present throughout corporate America, and it is no different within the physician workforce. Overall, there has been gradual interest in promoting and teaching diversity. Institutions have been slowly creating policies and administrative positions focused on inclusion and diversity over the last decade. So has diversity training objectively increased representation and advancement of women and minority groups? Do traditionally marginalized groups have better access to health? And are women and people of color (POC) represented equally in leadership positions in medicine?

Clearly, the answers are not straightforward.
 

Diving into the data

A guilty pleasure of mine is to assess how diverse and inclusive an institution is by looking at the wall of pictures recognizing top leadership in hospitals. Despite women accounting for 47.9% of graduates from medical school in 2018-2019, I still see very few women or POC elevated to this level. Of the total women graduates, 22.6% were Asian, 8% were Black and 5.4% were Hispanic.

Being of Indian descent, I am a woman of color (albeit one who may not be as profoundly affected by racism in medicine as my less represented colleagues). It is especially rare for me to see someone I can identify with in the ranks of top leadership. I find encouragement in seeing any woman on any leadership board because to me, it means that there is hope. The literature seems to support this degree of disparity as well. For example, a recent analysis shows that presidential leadership in medical societies are predominantly held by men (82.6% male vs. 17.4% female). Other datasets demonstrate that only 15% of deans and interim deans are women and AAMC’s report shows that women account for only 18% of all department chairs.

Growing up, my parents fueled my interest to pursue medicine. They described it as a noble profession that rewarded true merit and dedication to the cause. However, those that have been traditionally elevated in medicine are men. If merit knows no gender, why does a gender gap exist? If merit is blind to race, why are minorities so poorly represented in the workforce (much less in leadership)? My view of the wall leaves me wondering about the role of both sexism and racism in medicine.

These visual representations of the medical culture reinforce the acceptable norms and values – white and masculine – in medicine. The feminist movement over the last several decades has increased awareness about the need for equality of the sexes. However, it was not until the concept of intersectionality was introduced by Black feminist Professor Kimberle Crenshaw, that feminism become a more inclusive term. Professor Crenshaw’s paper details how every individual has intersecting factors – race, gender, sexual identity, socioeconomic status – that create the sum of their experience be it privilege, oppression, or discrimination.

For example, a White woman has privileges that a woman of color does not. Among non-white women, race and sexual identity are confounding factors – a Black woman, a Black LGBTQ woman, and an Asian woman, for example, will not experience discrimination in the same way. The farther you deviate from the accepted norms and values, the harder it is for you to obtain support and achieve recognition.
 

Addressing the patriarchal structure and systemic bias in medicine

Why do patriarchal structures still exist in medicine? How do we resolve systemic bias? Addressing them in isolation – race or gender or sexual identity – is unlikely to create long-lasting change. For change to occur, organizations and individuals need to be intrinsically motivated. Creating awareness and challenging the status quo is the first step.

Over the last decade, implicit bias training and diversity training have become mandatory in various industries and states. Diversity training has grown to be a multi-billion-dollar industry that corporate America has embraced over the last several years. And yet, research shows that mandating such training may not be the most effective. To get results, organizations need to implement programs that “spark engagement, increase contact between different groups and draw on people’s desire to look good to others.”

Historically, the medical curriculum has not included a discourse on feminist theories and the advancement of women in medicine. Cultural competency training is typically offered on an annual basis once we are in the workforce, but in my experience, it focuses more on our interactions with patients and other health care colleagues, and less with regards to our physician peers and leadership. Is this enough to change deep rooted beliefs and traditions?

We can take our cue from non-medical organizations and consider changing this culture of no culture in medicine – introducing diversity task forces that hold departments accountable for recruiting and promoting women and minorities; employing diversity managers; voluntary training; cross-training to increase contact among different groups and mentoring programs that match senior leadership to women and POC. While some medical institutions have implemented some of these principles, changing century-old traditions will require embracing concepts of organizational change and every available effective tool.
 

Committing to change

Change is especially hard when the target outcome is not accurately quantifiable – even if you can measure attitudes, values, and beliefs, these are subject to reporting bias and tokenism. At the organizational level, change management involves employing a systematic approach to change organizational values, goals, policies, and processes.

Individual change, self-reflection, and personal growth are key components in changing culture. Reflexivity is being aware of your own values, norms, position, and power – an important concept to understand and apply in our everyday interactions. Believing that one’s class, gender, race and sexual orientation are irrelevant to their practice of medicine would not foster the change that we direly need in medicine. Rather, identifying how your own values and professional identity are shaped by your medical training, your organization and the broader cultural context are critically important to developing a greater empathic sense to motivate systemic change.

There has been valuable discussion on bottom-up changes to ensure women and POC have support, encouragement and a pathway to advance in an organization. Some of these include policy and process changes including providing flexible working conditions for women and sponsorship of women and minorities to help them navigate the barriers and microaggressions they encounter at work. While technical (policy) changes form the foundation for any organizational change, it is important to remember that the people side of change – the resistance that you encounter for any change effort in an organization – is equally important to address at the organizational level. A top-down approach is also vital to ensure that change is permanent in an organization and does not end when the individuals responsible for the change leave the organization.

Lewin’s three-stage change management model provides a framework for structural and organizational change in hospital systems. The three-stages of this model are: unfreezing, changing, and refreezing. Unfreezing is the process of determining what needs to change and obtaining leadership support. The actual change process involves getting people on board, empowering them to change and communicating with them frequently. Refreezing cements this change into the organization’s culture by providing support and training to sustain changes. Research has shown that Lewin’s change management model has applicability in the hospital setting.

Industry research in change management methodologies in the business sector has identified sponsorship by CEOs/senior management of an organization and having a structured implementation model for change management as two important factors for ensuring that change efforts are successful and sustainable.

This can be extrapolated to health care organizations – top leadership committed to changing the status quo should solidify organizational commitment by incorporating new attainable and measurable goals into their vision for the organization. Designing a phased implementation of change management methodologies should follow an open discussion to identify an organization’s weaknesses, strengths, capacity, and readiness for change. Lastly, helping busy professionals adapt to change requires innovative and continuous improvement strategies using formal, systematic tools for organization-wide strategic deployment.

Without a concrete commitment at the organizational level, programs such as diversity training may end up being band-aids on wounds that run deep.

I believe that the combination of both individual and organizational commitment to change systemic bias in medicine can be quite powerful. One without the other will fail to permanently change the system. The work to true equality – regardless of the intersecting factors of discrimination – starts with a commitment to change. We may all have different opportunities because of the inequality that is apparent in our systems today, but if we unite around the goal of a bias-free, merit-based equality, it gives us the strength we need to overcome challenges that we once thought insurmountable.

Each one of us is a leader in our own right. Speaking up for those with less power or opportunity than us and supporting talent and hard work solidifies medicine as a meritocracy. Even if the magnitude of change that we fight for may not be realized during our time in medical practice, our commitment to eradicate sexism, racism and discrimination will shape the future of medicine.

Just as our children are a legacy that we leave behind, our work in correcting bias in medicine will pave the path for a better future for the doctors of tomorrow. After all, when I think that my young daughter will be affected by what I do or do not do to address the discrimination, there is no better motivation for me to break down every barrier for her success.

Dr. Kanikkannan is a practicing hospitalist and assistant professor of medicine at Albany Medical College in Albany, NY. This article first appeared on The Hospital Leader, the official blog of SHM.

There are many challenges facing modern medicine today. Recent events have highlighted important issues affecting our society as a whole – systemic racism, sexism, and implicit bias. In medicine, we have seen a renewed focus on health equity, health disparities and the implicit systemic bias that affect those who work in the field. It is truly troubling that it has taken the continued loss of black lives to police brutality and a pandemic for this conversation to happen at every level in society.

Systemic bias is present throughout corporate America, and it is no different within the physician workforce. Overall, there has been gradual interest in promoting and teaching diversity. Institutions have been slowly creating policies and administrative positions focused on inclusion and diversity over the last decade. So has diversity training objectively increased representation and advancement of women and minority groups? Do traditionally marginalized groups have better access to health? And are women and people of color (POC) represented equally in leadership positions in medicine?

Clearly, the answers are not straightforward.
 

Diving into the data

A guilty pleasure of mine is to assess how diverse and inclusive an institution is by looking at the wall of pictures recognizing top leadership in hospitals. Despite women accounting for 47.9% of graduates from medical school in 2018-2019, I still see very few women or POC elevated to this level. Of the total women graduates, 22.6% were Asian, 8% were Black and 5.4% were Hispanic.

Being of Indian descent, I am a woman of color (albeit one who may not be as profoundly affected by racism in medicine as my less represented colleagues). It is especially rare for me to see someone I can identify with in the ranks of top leadership. I find encouragement in seeing any woman on any leadership board because to me, it means that there is hope. The literature seems to support this degree of disparity as well. For example, a recent analysis shows that presidential leadership in medical societies are predominantly held by men (82.6% male vs. 17.4% female). Other datasets demonstrate that only 15% of deans and interim deans are women and AAMC’s report shows that women account for only 18% of all department chairs.

Growing up, my parents fueled my interest to pursue medicine. They described it as a noble profession that rewarded true merit and dedication to the cause. However, those that have been traditionally elevated in medicine are men. If merit knows no gender, why does a gender gap exist? If merit is blind to race, why are minorities so poorly represented in the workforce (much less in leadership)? My view of the wall leaves me wondering about the role of both sexism and racism in medicine.

These visual representations of the medical culture reinforce the acceptable norms and values – white and masculine – in medicine. The feminist movement over the last several decades has increased awareness about the need for equality of the sexes. However, it was not until the concept of intersectionality was introduced by Black feminist Professor Kimberle Crenshaw, that feminism become a more inclusive term. Professor Crenshaw’s paper details how every individual has intersecting factors – race, gender, sexual identity, socioeconomic status – that create the sum of their experience be it privilege, oppression, or discrimination.

For example, a White woman has privileges that a woman of color does not. Among non-white women, race and sexual identity are confounding factors – a Black woman, a Black LGBTQ woman, and an Asian woman, for example, will not experience discrimination in the same way. The farther you deviate from the accepted norms and values, the harder it is for you to obtain support and achieve recognition.
 

Addressing the patriarchal structure and systemic bias in medicine

Why do patriarchal structures still exist in medicine? How do we resolve systemic bias? Addressing them in isolation – race or gender or sexual identity – is unlikely to create long-lasting change. For change to occur, organizations and individuals need to be intrinsically motivated. Creating awareness and challenging the status quo is the first step.

Over the last decade, implicit bias training and diversity training have become mandatory in various industries and states. Diversity training has grown to be a multi-billion-dollar industry that corporate America has embraced over the last several years. And yet, research shows that mandating such training may not be the most effective. To get results, organizations need to implement programs that “spark engagement, increase contact between different groups and draw on people’s desire to look good to others.”

Historically, the medical curriculum has not included a discourse on feminist theories and the advancement of women in medicine. Cultural competency training is typically offered on an annual basis once we are in the workforce, but in my experience, it focuses more on our interactions with patients and other health care colleagues, and less with regards to our physician peers and leadership. Is this enough to change deep rooted beliefs and traditions?

We can take our cue from non-medical organizations and consider changing this culture of no culture in medicine – introducing diversity task forces that hold departments accountable for recruiting and promoting women and minorities; employing diversity managers; voluntary training; cross-training to increase contact among different groups and mentoring programs that match senior leadership to women and POC. While some medical institutions have implemented some of these principles, changing century-old traditions will require embracing concepts of organizational change and every available effective tool.
 

Committing to change

Change is especially hard when the target outcome is not accurately quantifiable – even if you can measure attitudes, values, and beliefs, these are subject to reporting bias and tokenism. At the organizational level, change management involves employing a systematic approach to change organizational values, goals, policies, and processes.

Individual change, self-reflection, and personal growth are key components in changing culture. Reflexivity is being aware of your own values, norms, position, and power – an important concept to understand and apply in our everyday interactions. Believing that one’s class, gender, race and sexual orientation are irrelevant to their practice of medicine would not foster the change that we direly need in medicine. Rather, identifying how your own values and professional identity are shaped by your medical training, your organization and the broader cultural context are critically important to developing a greater empathic sense to motivate systemic change.

There has been valuable discussion on bottom-up changes to ensure women and POC have support, encouragement and a pathway to advance in an organization. Some of these include policy and process changes including providing flexible working conditions for women and sponsorship of women and minorities to help them navigate the barriers and microaggressions they encounter at work. While technical (policy) changes form the foundation for any organizational change, it is important to remember that the people side of change – the resistance that you encounter for any change effort in an organization – is equally important to address at the organizational level. A top-down approach is also vital to ensure that change is permanent in an organization and does not end when the individuals responsible for the change leave the organization.

Lewin’s three-stage change management model provides a framework for structural and organizational change in hospital systems. The three-stages of this model are: unfreezing, changing, and refreezing. Unfreezing is the process of determining what needs to change and obtaining leadership support. The actual change process involves getting people on board, empowering them to change and communicating with them frequently. Refreezing cements this change into the organization’s culture by providing support and training to sustain changes. Research has shown that Lewin’s change management model has applicability in the hospital setting.

Industry research in change management methodologies in the business sector has identified sponsorship by CEOs/senior management of an organization and having a structured implementation model for change management as two important factors for ensuring that change efforts are successful and sustainable.

This can be extrapolated to health care organizations – top leadership committed to changing the status quo should solidify organizational commitment by incorporating new attainable and measurable goals into their vision for the organization. Designing a phased implementation of change management methodologies should follow an open discussion to identify an organization’s weaknesses, strengths, capacity, and readiness for change. Lastly, helping busy professionals adapt to change requires innovative and continuous improvement strategies using formal, systematic tools for organization-wide strategic deployment.

Without a concrete commitment at the organizational level, programs such as diversity training may end up being band-aids on wounds that run deep.

I believe that the combination of both individual and organizational commitment to change systemic bias in medicine can be quite powerful. One without the other will fail to permanently change the system. The work to true equality – regardless of the intersecting factors of discrimination – starts with a commitment to change. We may all have different opportunities because of the inequality that is apparent in our systems today, but if we unite around the goal of a bias-free, merit-based equality, it gives us the strength we need to overcome challenges that we once thought insurmountable.

Each one of us is a leader in our own right. Speaking up for those with less power or opportunity than us and supporting talent and hard work solidifies medicine as a meritocracy. Even if the magnitude of change that we fight for may not be realized during our time in medical practice, our commitment to eradicate sexism, racism and discrimination will shape the future of medicine.

Just as our children are a legacy that we leave behind, our work in correcting bias in medicine will pave the path for a better future for the doctors of tomorrow. After all, when I think that my young daughter will be affected by what I do or do not do to address the discrimination, there is no better motivation for me to break down every barrier for her success.

Dr. Kanikkannan is a practicing hospitalist and assistant professor of medicine at Albany Medical College in Albany, NY. This article first appeared on The Hospital Leader, the official blog of SHM.

There are many challenges facing modern medicine today. Recent events have highlighted important issues affecting our society as a whole – systemic racism, sexism, and implicit bias. In medicine, we have seen a renewed focus on health equity, health disparities and the implicit systemic bias that affect those who work in the field. It is truly troubling that it has taken the continued loss of black lives to police brutality and a pandemic for this conversation to happen at every level in society.

Systemic bias is present throughout corporate America, and it is no different within the physician workforce. Overall, there has been gradual interest in promoting and teaching diversity. Institutions have been slowly creating policies and administrative positions focused on inclusion and diversity over the last decade. So has diversity training objectively increased representation and advancement of women and minority groups? Do traditionally marginalized groups have better access to health? And are women and people of color (POC) represented equally in leadership positions in medicine?

Clearly, the answers are not straightforward.
 

Diving into the data

A guilty pleasure of mine is to assess how diverse and inclusive an institution is by looking at the wall of pictures recognizing top leadership in hospitals. Despite women accounting for 47.9% of graduates from medical school in 2018-2019, I still see very few women or POC elevated to this level. Of the total women graduates, 22.6% were Asian, 8% were Black and 5.4% were Hispanic.

Being of Indian descent, I am a woman of color (albeit one who may not be as profoundly affected by racism in medicine as my less represented colleagues). It is especially rare for me to see someone I can identify with in the ranks of top leadership. I find encouragement in seeing any woman on any leadership board because to me, it means that there is hope. The literature seems to support this degree of disparity as well. For example, a recent analysis shows that presidential leadership in medical societies are predominantly held by men (82.6% male vs. 17.4% female). Other datasets demonstrate that only 15% of deans and interim deans are women and AAMC’s report shows that women account for only 18% of all department chairs.

Growing up, my parents fueled my interest to pursue medicine. They described it as a noble profession that rewarded true merit and dedication to the cause. However, those that have been traditionally elevated in medicine are men. If merit knows no gender, why does a gender gap exist? If merit is blind to race, why are minorities so poorly represented in the workforce (much less in leadership)? My view of the wall leaves me wondering about the role of both sexism and racism in medicine.

These visual representations of the medical culture reinforce the acceptable norms and values – white and masculine – in medicine. The feminist movement over the last several decades has increased awareness about the need for equality of the sexes. However, it was not until the concept of intersectionality was introduced by Black feminist Professor Kimberle Crenshaw, that feminism become a more inclusive term. Professor Crenshaw’s paper details how every individual has intersecting factors – race, gender, sexual identity, socioeconomic status – that create the sum of their experience be it privilege, oppression, or discrimination.

For example, a White woman has privileges that a woman of color does not. Among non-white women, race and sexual identity are confounding factors – a Black woman, a Black LGBTQ woman, and an Asian woman, for example, will not experience discrimination in the same way. The farther you deviate from the accepted norms and values, the harder it is for you to obtain support and achieve recognition.
 

Addressing the patriarchal structure and systemic bias in medicine

Why do patriarchal structures still exist in medicine? How do we resolve systemic bias? Addressing them in isolation – race or gender or sexual identity – is unlikely to create long-lasting change. For change to occur, organizations and individuals need to be intrinsically motivated. Creating awareness and challenging the status quo is the first step.

Over the last decade, implicit bias training and diversity training have become mandatory in various industries and states. Diversity training has grown to be a multi-billion-dollar industry that corporate America has embraced over the last several years. And yet, research shows that mandating such training may not be the most effective. To get results, organizations need to implement programs that “spark engagement, increase contact between different groups and draw on people’s desire to look good to others.”

Historically, the medical curriculum has not included a discourse on feminist theories and the advancement of women in medicine. Cultural competency training is typically offered on an annual basis once we are in the workforce, but in my experience, it focuses more on our interactions with patients and other health care colleagues, and less with regards to our physician peers and leadership. Is this enough to change deep rooted beliefs and traditions?

We can take our cue from non-medical organizations and consider changing this culture of no culture in medicine – introducing diversity task forces that hold departments accountable for recruiting and promoting women and minorities; employing diversity managers; voluntary training; cross-training to increase contact among different groups and mentoring programs that match senior leadership to women and POC. While some medical institutions have implemented some of these principles, changing century-old traditions will require embracing concepts of organizational change and every available effective tool.
 

Committing to change

Change is especially hard when the target outcome is not accurately quantifiable – even if you can measure attitudes, values, and beliefs, these are subject to reporting bias and tokenism. At the organizational level, change management involves employing a systematic approach to change organizational values, goals, policies, and processes.

Individual change, self-reflection, and personal growth are key components in changing culture. Reflexivity is being aware of your own values, norms, position, and power – an important concept to understand and apply in our everyday interactions. Believing that one’s class, gender, race and sexual orientation are irrelevant to their practice of medicine would not foster the change that we direly need in medicine. Rather, identifying how your own values and professional identity are shaped by your medical training, your organization and the broader cultural context are critically important to developing a greater empathic sense to motivate systemic change.

There has been valuable discussion on bottom-up changes to ensure women and POC have support, encouragement and a pathway to advance in an organization. Some of these include policy and process changes including providing flexible working conditions for women and sponsorship of women and minorities to help them navigate the barriers and microaggressions they encounter at work. While technical (policy) changes form the foundation for any organizational change, it is important to remember that the people side of change – the resistance that you encounter for any change effort in an organization – is equally important to address at the organizational level. A top-down approach is also vital to ensure that change is permanent in an organization and does not end when the individuals responsible for the change leave the organization.

Lewin’s three-stage change management model provides a framework for structural and organizational change in hospital systems. The three-stages of this model are: unfreezing, changing, and refreezing. Unfreezing is the process of determining what needs to change and obtaining leadership support. The actual change process involves getting people on board, empowering them to change and communicating with them frequently. Refreezing cements this change into the organization’s culture by providing support and training to sustain changes. Research has shown that Lewin’s change management model has applicability in the hospital setting.

Industry research in change management methodologies in the business sector has identified sponsorship by CEOs/senior management of an organization and having a structured implementation model for change management as two important factors for ensuring that change efforts are successful and sustainable.

This can be extrapolated to health care organizations – top leadership committed to changing the status quo should solidify organizational commitment by incorporating new attainable and measurable goals into their vision for the organization. Designing a phased implementation of change management methodologies should follow an open discussion to identify an organization’s weaknesses, strengths, capacity, and readiness for change. Lastly, helping busy professionals adapt to change requires innovative and continuous improvement strategies using formal, systematic tools for organization-wide strategic deployment.

Without a concrete commitment at the organizational level, programs such as diversity training may end up being band-aids on wounds that run deep.

I believe that the combination of both individual and organizational commitment to change systemic bias in medicine can be quite powerful. One without the other will fail to permanently change the system. The work to true equality – regardless of the intersecting factors of discrimination – starts with a commitment to change. We may all have different opportunities because of the inequality that is apparent in our systems today, but if we unite around the goal of a bias-free, merit-based equality, it gives us the strength we need to overcome challenges that we once thought insurmountable.

Each one of us is a leader in our own right. Speaking up for those with less power or opportunity than us and supporting talent and hard work solidifies medicine as a meritocracy. Even if the magnitude of change that we fight for may not be realized during our time in medical practice, our commitment to eradicate sexism, racism and discrimination will shape the future of medicine.

Just as our children are a legacy that we leave behind, our work in correcting bias in medicine will pave the path for a better future for the doctors of tomorrow. After all, when I think that my young daughter will be affected by what I do or do not do to address the discrimination, there is no better motivation for me to break down every barrier for her success.

Dr. Kanikkannan is a practicing hospitalist and assistant professor of medicine at Albany Medical College in Albany, NY. This article first appeared on The Hospital Leader, the official blog of SHM.