Key clinical point: Compared with denosumab, zoledronic acid (ZA) therapy for osteoporosis and possibly for malignancy-related bone disease is associated with modestly increased risk for incident atrial fibrillation (AFib) in the first year of treatment.

Major finding: In the osteoporosis cohort, the risk for AFib was higher with ZA vs. denosumab over 1 year (incidence rate [IR], 18.6 vs. 14.9 per 1,000 person-years; hazard ratio [HR], 1.25; 95% confidence interval [CI], 1.04-1.50). In the malignancy cohort, a nonsignificant trend toward an increased risk was noted with ZA vs. denosumab (IR, 46.87 vs. 39.03 per 1,000 person-years; HR, 1.19; 95% CI, 1.00-1.43).

Study details: In this new-user, active comparator study, patients (age, 50 years or more) without arrhythmia or advanced kidney disease who initiated ZA were propensity score matched (1:1) to patients initiating denosumab in separate osteoporosis (n = 16,235 pairs) and malignancy (7,732 pairs) cohorts.

Disclosures: No study sponsor was identified. SC Kim received research grants to the Brigham and Women’s Hospital from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb for unrelated studies. A close family member of SJ Cromer is employed by a Johnson & Johnson company. EW Yu received a research grant to the Massachusetts General Hospital from Amgen for unrelated studies. KM D'Silva and M Fischer reported no disclosures

Source: D'Silva KM et al. J Bone Miner Res. 2020 Nov 2. doi: 10.1002/jbmr.4174.

Key clinical point: Compared with denosumab, zoledronic acid (ZA) therapy for osteoporosis and possibly for malignancy-related bone disease is associated with modestly increased risk for incident atrial fibrillation (AFib) in the first year of treatment.

Major finding: In the osteoporosis cohort, the risk for AFib was higher with ZA vs. denosumab over 1 year (incidence rate [IR], 18.6 vs. 14.9 per 1,000 person-years; hazard ratio [HR], 1.25; 95% confidence interval [CI], 1.04-1.50). In the malignancy cohort, a nonsignificant trend toward an increased risk was noted with ZA vs. denosumab (IR, 46.87 vs. 39.03 per 1,000 person-years; HR, 1.19; 95% CI, 1.00-1.43).

Study details: In this new-user, active comparator study, patients (age, 50 years or more) without arrhythmia or advanced kidney disease who initiated ZA were propensity score matched (1:1) to patients initiating denosumab in separate osteoporosis (n = 16,235 pairs) and malignancy (7,732 pairs) cohorts.

Disclosures: No study sponsor was identified. SC Kim received research grants to the Brigham and Women’s Hospital from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb for unrelated studies. A close family member of SJ Cromer is employed by a Johnson & Johnson company. EW Yu received a research grant to the Massachusetts General Hospital from Amgen for unrelated studies. KM D'Silva and M Fischer reported no disclosures

Source: D'Silva KM et al. J Bone Miner Res. 2020 Nov 2. doi: 10.1002/jbmr.4174.

Key clinical point: Compared with denosumab, zoledronic acid (ZA) therapy for osteoporosis and possibly for malignancy-related bone disease is associated with modestly increased risk for incident atrial fibrillation (AFib) in the first year of treatment.

Major finding: In the osteoporosis cohort, the risk for AFib was higher with ZA vs. denosumab over 1 year (incidence rate [IR], 18.6 vs. 14.9 per 1,000 person-years; hazard ratio [HR], 1.25; 95% confidence interval [CI], 1.04-1.50). In the malignancy cohort, a nonsignificant trend toward an increased risk was noted with ZA vs. denosumab (IR, 46.87 vs. 39.03 per 1,000 person-years; HR, 1.19; 95% CI, 1.00-1.43).

Study details: In this new-user, active comparator study, patients (age, 50 years or more) without arrhythmia or advanced kidney disease who initiated ZA were propensity score matched (1:1) to patients initiating denosumab in separate osteoporosis (n = 16,235 pairs) and malignancy (7,732 pairs) cohorts.

Disclosures: No study sponsor was identified. SC Kim received research grants to the Brigham and Women’s Hospital from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb for unrelated studies. A close family member of SJ Cromer is employed by a Johnson & Johnson company. EW Yu received a research grant to the Massachusetts General Hospital from Amgen for unrelated studies. KM D'Silva and M Fischer reported no disclosures

Source: D'Silva KM et al. J Bone Miner Res. 2020 Nov 2. doi: 10.1002/jbmr.4174.

The issue of race and survival in patients with clear cell renal cell carcinoma (ccRCC) has been debated in the literature.

Some studies have shown worse survival for Black patients, while others have suggested that Black race is instead a stand-in for social determinants, including access to care.

New research suggests that Black race is not correlated with increased mortality from ccRCC. These results were published in Urology.

“Despite well documented racial biases and race-specific outcomes in the health care landscape, our study found race was not associated with 5-year cause-specific survival from ccRCC,” wrote investigator Dhaval Jivanji, a medical student at Florida International University, Miami, and colleagues.

In their retrospective study, the investigators examined 5-year survival in ccRCC patients, comparing results across races. The team used data from the Surveillance Epidemiology, and End Results (SEER) database, which collects cancer data from 13 states using population-based cancer registries. They extracted data on demographics, prevalence, and mortality, in relation to ccRCC.

A total of 8,421 subjects with ccRCC were included in the analysis, which covered the years 2007-2015. The primary outcome was 5-year survival, defined as cause-specific mortality up to the first 60 months from time of cancer diagnosis.

In addition to race, variables included in the statistical model were age (18-50, 51-60, 61-70,71-80, >80), sex (male/female), SEER Summary tumor staging (localized, regionalized, distant), insurance status (uninsured, insured, insured not specific, Medicaid), and marital status (single, married/partner, separated/divorced/widowed).
 

Demographic determinism

In the adjusted analysis, the researchers found no association between race and 5-year cause-specific survival in patients with ccRCC.

The hazard ratios for death were 0.96 for Black patients, 1.01 for American Indian/Alaska Native patients, and 0.99 for Asian/Pacific Islander patients, with White patients as the comparator.

In terms of the other covariates studied, the researchers found that older age (>50 years) and the presence of regional or distant tumors were associated with an increased hazard of death, while female sex and having insurance were associated with a decreased hazard of death.

“Our study found that age, tumor stage, and insurance status are significantly associated with 5-year cause-specific survival. Future studies will benefit from complete assessment of other demographic factors, including income, medical comorbidities, and access to care. These are negative predictors, and [their] potential impact on overall survival should be considered by the clinician in treatment and management plans for RCC patients,” the researchers concluded.

In an editorial commentary published within the main article, Paul Russo, MD, of Weill Cornell Medicine, New York, stated: “Investigations such as this utilizing the SEER registries provide a 30,000-foot demographic view of some disease elements but lack important granularity, such as tumor size and grade, family income, critical medical comorbidities, and patient access to hospitals with surgical and medical oncologic expertise.”

Dr. Russo said it is well known that disparate access to diagnosis, surgical intervention, and expert treatment have an impact on survival.

He went on to ask: “Could African Americans have had superior outcomes if the data was controlled for these important variables? As urologic surgeons, we must join the greater medical community in understanding the root causes leading to structural racial and economic disparities, inequities in access to care, and the profound negative impact these disparities have on health outcomes in general and cancer outcomes specifically.”

The authors did not disclose funding or conflicts of interest.

[email protected]

SOURCE: Jivanji D et al. Urology. 2020. doi: 10.1016/j.urology.2020.10.055.

The issue of race and survival in patients with clear cell renal cell carcinoma (ccRCC) has been debated in the literature.

Some studies have shown worse survival for Black patients, while others have suggested that Black race is instead a stand-in for social determinants, including access to care.

New research suggests that Black race is not correlated with increased mortality from ccRCC. These results were published in Urology.

“Despite well documented racial biases and race-specific outcomes in the health care landscape, our study found race was not associated with 5-year cause-specific survival from ccRCC,” wrote investigator Dhaval Jivanji, a medical student at Florida International University, Miami, and colleagues.

In their retrospective study, the investigators examined 5-year survival in ccRCC patients, comparing results across races. The team used data from the Surveillance Epidemiology, and End Results (SEER) database, which collects cancer data from 13 states using population-based cancer registries. They extracted data on demographics, prevalence, and mortality, in relation to ccRCC.

A total of 8,421 subjects with ccRCC were included in the analysis, which covered the years 2007-2015. The primary outcome was 5-year survival, defined as cause-specific mortality up to the first 60 months from time of cancer diagnosis.

In addition to race, variables included in the statistical model were age (18-50, 51-60, 61-70,71-80, >80), sex (male/female), SEER Summary tumor staging (localized, regionalized, distant), insurance status (uninsured, insured, insured not specific, Medicaid), and marital status (single, married/partner, separated/divorced/widowed).
 

Demographic determinism

In the adjusted analysis, the researchers found no association between race and 5-year cause-specific survival in patients with ccRCC.

The hazard ratios for death were 0.96 for Black patients, 1.01 for American Indian/Alaska Native patients, and 0.99 for Asian/Pacific Islander patients, with White patients as the comparator.

In terms of the other covariates studied, the researchers found that older age (>50 years) and the presence of regional or distant tumors were associated with an increased hazard of death, while female sex and having insurance were associated with a decreased hazard of death.

“Our study found that age, tumor stage, and insurance status are significantly associated with 5-year cause-specific survival. Future studies will benefit from complete assessment of other demographic factors, including income, medical comorbidities, and access to care. These are negative predictors, and [their] potential impact on overall survival should be considered by the clinician in treatment and management plans for RCC patients,” the researchers concluded.

In an editorial commentary published within the main article, Paul Russo, MD, of Weill Cornell Medicine, New York, stated: “Investigations such as this utilizing the SEER registries provide a 30,000-foot demographic view of some disease elements but lack important granularity, such as tumor size and grade, family income, critical medical comorbidities, and patient access to hospitals with surgical and medical oncologic expertise.”

Dr. Russo said it is well known that disparate access to diagnosis, surgical intervention, and expert treatment have an impact on survival.

He went on to ask: “Could African Americans have had superior outcomes if the data was controlled for these important variables? As urologic surgeons, we must join the greater medical community in understanding the root causes leading to structural racial and economic disparities, inequities in access to care, and the profound negative impact these disparities have on health outcomes in general and cancer outcomes specifically.”

The authors did not disclose funding or conflicts of interest.

[email protected]

SOURCE: Jivanji D et al. Urology. 2020. doi: 10.1016/j.urology.2020.10.055.

The issue of race and survival in patients with clear cell renal cell carcinoma (ccRCC) has been debated in the literature.

Some studies have shown worse survival for Black patients, while others have suggested that Black race is instead a stand-in for social determinants, including access to care.

New research suggests that Black race is not correlated with increased mortality from ccRCC. These results were published in Urology.

“Despite well documented racial biases and race-specific outcomes in the health care landscape, our study found race was not associated with 5-year cause-specific survival from ccRCC,” wrote investigator Dhaval Jivanji, a medical student at Florida International University, Miami, and colleagues.

In their retrospective study, the investigators examined 5-year survival in ccRCC patients, comparing results across races. The team used data from the Surveillance Epidemiology, and End Results (SEER) database, which collects cancer data from 13 states using population-based cancer registries. They extracted data on demographics, prevalence, and mortality, in relation to ccRCC.

A total of 8,421 subjects with ccRCC were included in the analysis, which covered the years 2007-2015. The primary outcome was 5-year survival, defined as cause-specific mortality up to the first 60 months from time of cancer diagnosis.

In addition to race, variables included in the statistical model were age (18-50, 51-60, 61-70,71-80, >80), sex (male/female), SEER Summary tumor staging (localized, regionalized, distant), insurance status (uninsured, insured, insured not specific, Medicaid), and marital status (single, married/partner, separated/divorced/widowed).
 

Demographic determinism

In the adjusted analysis, the researchers found no association between race and 5-year cause-specific survival in patients with ccRCC.

The hazard ratios for death were 0.96 for Black patients, 1.01 for American Indian/Alaska Native patients, and 0.99 for Asian/Pacific Islander patients, with White patients as the comparator.

In terms of the other covariates studied, the researchers found that older age (>50 years) and the presence of regional or distant tumors were associated with an increased hazard of death, while female sex and having insurance were associated with a decreased hazard of death.

“Our study found that age, tumor stage, and insurance status are significantly associated with 5-year cause-specific survival. Future studies will benefit from complete assessment of other demographic factors, including income, medical comorbidities, and access to care. These are negative predictors, and [their] potential impact on overall survival should be considered by the clinician in treatment and management plans for RCC patients,” the researchers concluded.

In an editorial commentary published within the main article, Paul Russo, MD, of Weill Cornell Medicine, New York, stated: “Investigations such as this utilizing the SEER registries provide a 30,000-foot demographic view of some disease elements but lack important granularity, such as tumor size and grade, family income, critical medical comorbidities, and patient access to hospitals with surgical and medical oncologic expertise.”

Dr. Russo said it is well known that disparate access to diagnosis, surgical intervention, and expert treatment have an impact on survival.

He went on to ask: “Could African Americans have had superior outcomes if the data was controlled for these important variables? As urologic surgeons, we must join the greater medical community in understanding the root causes leading to structural racial and economic disparities, inequities in access to care, and the profound negative impact these disparities have on health outcomes in general and cancer outcomes specifically.”

The authors did not disclose funding or conflicts of interest.

[email protected]

SOURCE: Jivanji D et al. Urology. 2020. doi: 10.1016/j.urology.2020.10.055.

Breast cancer now tops the list of the most commonly diagnosed cancers worldwide, surpassing lung cancer for the first time, according to the latest global cancer burden estimates from the International Agency for Research on Cancer (IARC).

Breast cancer among women accounted for 11.7% of the estimated 19.3 million new cancer cases in 2020 ― and about 25% of all cancer cases among women. Lung cancer accounted for 11.4% of new cases, reports the IARC, part of the World Health Organization.

However, lung cancer remains the leading overall cause of cancer mortality, accounting for 18.0% of 10 million cancer deaths. Breast cancer ranks fifth as a cause of cancer mortality, accounting for 1 of every 6 cancer deaths in women and 685,000 deaths overall (6.9%) in 2020, but it ranks first in incidence in 159 countries and first in mortality in 110 countries, the data show.

The increase in breast cancer cases is likely attributable to the effects of “marked changes in lifestyle, sociocultural contexts, and built environments” in many countries, says the IACR. These include delayed childbearing, having fewer children, increased rates of overweight and obesity, and decreasing levels of physical activity, the IACR explains in a press release.

These new data underscore the importance of focusing on cancer prevention, IARC Director Elisabete Weiderpass, MD, states in the press release.

“Effective interventions for prevention and early detection are available and must be integrated into cancer planning to control the predicted upsurge of this devastating disease,” she said.

Weiderpass also notes that the “overwhelming need for evidence-based and resource-stratified guidelines that support the phased implementation of breast cancer early detection and treatment into real-world practice.”

To that end, the WHO and the IARC will launch a global breast cancer initiative in 2021 to improve population-level outcomes through a focus on more timely diagnosis and comprehensive treatment, she adds.

The most common cancer diagnoses worldwide after breast cancer and lung cancer are colorectal cancer (10.0%), prostate cancer (7.3%), and stomach cancer (5.6%).

The leading causes of cancer deaths after lung cancer are colorectal cancer (9.4%), liver cancer (8.3%), stomach cancer (7.7%), and breast cancer among women.
 

One in five people will develop cancer

The IACR estimates that 1 in 5 people will develop cancer in their lifetime and that 1 in 8 men and 1 in 11 women will die from it.

Among women, breast cancer is the most common cancer type and the most common cause of cancer death. Colorectal cancer and lung cancer are the second and third most common cancer types and the third and second most common causes of cancer death, respectively.

Among men, lung cancer is the most common cancer type and the most common cause of cancer death. Prostate cancer and colorectal cancer are the second and third most common cancer types, and liver cancer and colorectal cancer are the second and third most common causes of cancer death.

“Worldwide, an estimated 28.4 million new cancer cases are projected to occur in 2040, a 47% increase from the estimated 19.3 million cases in 2020,” the IARC notes.

The agency derives its estimates from the GLOBOCAN 2020 database, which tracks 185 countries and 36 types of cancer and is accessible through the IARC Global Cancer Observatory.

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

Breast cancer now tops the list of the most commonly diagnosed cancers worldwide, surpassing lung cancer for the first time, according to the latest global cancer burden estimates from the International Agency for Research on Cancer (IARC).

Breast cancer among women accounted for 11.7% of the estimated 19.3 million new cancer cases in 2020 ― and about 25% of all cancer cases among women. Lung cancer accounted for 11.4% of new cases, reports the IARC, part of the World Health Organization.

However, lung cancer remains the leading overall cause of cancer mortality, accounting for 18.0% of 10 million cancer deaths. Breast cancer ranks fifth as a cause of cancer mortality, accounting for 1 of every 6 cancer deaths in women and 685,000 deaths overall (6.9%) in 2020, but it ranks first in incidence in 159 countries and first in mortality in 110 countries, the data show.

The increase in breast cancer cases is likely attributable to the effects of “marked changes in lifestyle, sociocultural contexts, and built environments” in many countries, says the IACR. These include delayed childbearing, having fewer children, increased rates of overweight and obesity, and decreasing levels of physical activity, the IACR explains in a press release.

These new data underscore the importance of focusing on cancer prevention, IARC Director Elisabete Weiderpass, MD, states in the press release.

“Effective interventions for prevention and early detection are available and must be integrated into cancer planning to control the predicted upsurge of this devastating disease,” she said.

Weiderpass also notes that the “overwhelming need for evidence-based and resource-stratified guidelines that support the phased implementation of breast cancer early detection and treatment into real-world practice.”

To that end, the WHO and the IARC will launch a global breast cancer initiative in 2021 to improve population-level outcomes through a focus on more timely diagnosis and comprehensive treatment, she adds.

The most common cancer diagnoses worldwide after breast cancer and lung cancer are colorectal cancer (10.0%), prostate cancer (7.3%), and stomach cancer (5.6%).

The leading causes of cancer deaths after lung cancer are colorectal cancer (9.4%), liver cancer (8.3%), stomach cancer (7.7%), and breast cancer among women.
 

One in five people will develop cancer

The IACR estimates that 1 in 5 people will develop cancer in their lifetime and that 1 in 8 men and 1 in 11 women will die from it.

Among women, breast cancer is the most common cancer type and the most common cause of cancer death. Colorectal cancer and lung cancer are the second and third most common cancer types and the third and second most common causes of cancer death, respectively.

Among men, lung cancer is the most common cancer type and the most common cause of cancer death. Prostate cancer and colorectal cancer are the second and third most common cancer types, and liver cancer and colorectal cancer are the second and third most common causes of cancer death.

“Worldwide, an estimated 28.4 million new cancer cases are projected to occur in 2040, a 47% increase from the estimated 19.3 million cases in 2020,” the IARC notes.

The agency derives its estimates from the GLOBOCAN 2020 database, which tracks 185 countries and 36 types of cancer and is accessible through the IARC Global Cancer Observatory.

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

Breast cancer now tops the list of the most commonly diagnosed cancers worldwide, surpassing lung cancer for the first time, according to the latest global cancer burden estimates from the International Agency for Research on Cancer (IARC).

Breast cancer among women accounted for 11.7% of the estimated 19.3 million new cancer cases in 2020 ― and about 25% of all cancer cases among women. Lung cancer accounted for 11.4% of new cases, reports the IARC, part of the World Health Organization.

However, lung cancer remains the leading overall cause of cancer mortality, accounting for 18.0% of 10 million cancer deaths. Breast cancer ranks fifth as a cause of cancer mortality, accounting for 1 of every 6 cancer deaths in women and 685,000 deaths overall (6.9%) in 2020, but it ranks first in incidence in 159 countries and first in mortality in 110 countries, the data show.

The increase in breast cancer cases is likely attributable to the effects of “marked changes in lifestyle, sociocultural contexts, and built environments” in many countries, says the IACR. These include delayed childbearing, having fewer children, increased rates of overweight and obesity, and decreasing levels of physical activity, the IACR explains in a press release.

These new data underscore the importance of focusing on cancer prevention, IARC Director Elisabete Weiderpass, MD, states in the press release.

“Effective interventions for prevention and early detection are available and must be integrated into cancer planning to control the predicted upsurge of this devastating disease,” she said.

Weiderpass also notes that the “overwhelming need for evidence-based and resource-stratified guidelines that support the phased implementation of breast cancer early detection and treatment into real-world practice.”

To that end, the WHO and the IARC will launch a global breast cancer initiative in 2021 to improve population-level outcomes through a focus on more timely diagnosis and comprehensive treatment, she adds.

The most common cancer diagnoses worldwide after breast cancer and lung cancer are colorectal cancer (10.0%), prostate cancer (7.3%), and stomach cancer (5.6%).

The leading causes of cancer deaths after lung cancer are colorectal cancer (9.4%), liver cancer (8.3%), stomach cancer (7.7%), and breast cancer among women.
 

One in five people will develop cancer

The IACR estimates that 1 in 5 people will develop cancer in their lifetime and that 1 in 8 men and 1 in 11 women will die from it.

Among women, breast cancer is the most common cancer type and the most common cause of cancer death. Colorectal cancer and lung cancer are the second and third most common cancer types and the third and second most common causes of cancer death, respectively.

Among men, lung cancer is the most common cancer type and the most common cause of cancer death. Prostate cancer and colorectal cancer are the second and third most common cancer types, and liver cancer and colorectal cancer are the second and third most common causes of cancer death.

“Worldwide, an estimated 28.4 million new cancer cases are projected to occur in 2040, a 47% increase from the estimated 19.3 million cases in 2020,” the IARC notes.

The agency derives its estimates from the GLOBOCAN 2020 database, which tracks 185 countries and 36 types of cancer and is accessible through the IARC Global Cancer Observatory.

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

Individuals who have hypertension at any age are more likely to experience more rapid cognitive decline compared with their counterparts with normal blood pressure, new research shows. In a retrospective study of more than 15,000 participants, hypertension during middle age was associated with memory decline, and onset at later ages was linked to worsening memory and global cognition.

The investigators found that prehypertension, defined as systolic pressure of 120-139 mm Hg or diastolic pressure of 80-89 mm Hg, was also linked to accelerated cognitive decline.

Although duration of hypertension was not associated with any marker of cognitive decline, blood pressure control “can substantially reduce hypertension’s deleterious effect on the pace of cognitive decline,” said study investigator Sandhi M. Barreto, MD, PhD, professor of medicine at Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.

The findings were published online Dec. 14 in Hypertension.
 

Unanswered questions

Hypertension is an established and highly prevalent risk factor for cognitive decline, but the age at which it begins to affect cognition is unclear. Previous research suggests that onset during middle age is associated with more harmful cognitive effects than onset in later life. One reason for this apparent difference may be that the duration of hypertension influences the magnitude of cognitive decline, the researchers noted.

Other studies have shown that prehypertension is associated with damage to certain organs, but its effects on cognition are uncertain. In addition, the effect of good blood pressure control with antihypertensive medications and the impact on cognition are also unclear.

To investigate, the researchers examined data from the ongoing, multicenter ELSA-Brasil study. ELSA-Brasil follows 15,105 civil servants between the ages of 35 and 74 years. Dr. Barreto and team assessed data from visit 1, which was conducted between 2008 and 2010, and visit 2, which was conducted between 2012 and 2014.

At each visit, participants underwent a memory test, a verbal fluency test, and the Trail Making Test Part B. The investigators calculated Z scores for these tests to derive a global cognitive score.

Blood pressure was measured on the right arm, and hypertension status, age at the time of hypertension diagnosis, duration of hypertension diagnosis, hypertension treatment, and control status were recorded. Other covariables included sex, education, race, smoking status, physical activity, body mass index, and total cholesterol level.

The researchers excluded patients who did not undergo cognitive testing at visit 2, those who had a history of stroke at baseline, and those who initiated antihypertensive medications despite having normotension. After exclusions, the analysis included 7,063 participants (approximately 55% were women, 15% were Black).

At visit 1, the mean age of the group was 58.9 years, and 53.4% of participants had 14 or more years of education. In addition, 22% had prehypertension, and 46.8% had hypertension. The median duration of hypertension was 7 years; 29.8% of participants with hypertension were diagnosed with the condition during middle age.

Of those who reported having hypertension at visit 1, 7.3% were not taking any antihypertensive medication. Among participants with hypertension who were taking antihypertensives, 31.2% had uncontrolled blood pressure.
 

Independent predictor

Results showed that prehypertension independently predicted a significantly greater decline in verbal fluency (Z score, –0.0095; P < .01) and global cognitive score (Z score, –0.0049; P < .05) compared with normal blood pressure.

At middle age, hypertension was associated with a steeper decline in memory (Z score, –0.0072; P < .05) compared with normal blood pressure. At older ages, hypertension was linked to a steeper decline in both memory (Z score, –0.0151; P < .001) and global cognitive score (Z score, –0.0080; P < .01). Duration of hypertension, however, did not significantly predict changes in cognition (P < .109).

Among those with hypertension who were taking antihypertensive medications, those with uncontrolled blood pressure experienced greater declines in rapid memory (Z score, –0.0126; P < .01) and global cognitive score (Z score, –0.0074; P < .01) than did those with controlled blood pressure.

The investigators noted that the study participants had a comparatively high level of education, which has been shown to “boost cognitive reserve and lessen the speed of age-related cognitive decline,” Dr. Barreto said. However, “our results indicate that the effect of hypertension on cognitive decline affects individuals of all educational levels similarly,” she said.

Dr. Barreto noted that the findings have two major clinical implications. First, “maintaining blood pressure below prehypertension levels is important to preserve cognitive function or delay cognitive decline,” she said. Secondly, “in hypertensive individuals, keeping blood pressure under control is essential to reduce the speed of cognitive decline.”

The researchers plan to conduct further analyses of the data to clarify the observed relationship between memory and verbal fluency. They also plan to examine how hypertension affects long-term executive function.
 

‘Continuum of risk’

Commenting on the study, Philip B. Gorelick, MD, MPH, adjunct professor of neurology (stroke and neurocritical care) at Northwestern University, Chicago, noted that, so far, research suggests that the risk for stroke associated with blood pressure levels should be understood as representing a continuum rather than as being associated with several discrete points.

“The same may hold true for cognitive decline and dementia. There may be a continuum of risk whereby persons even at so-called elevated but relatively lower levels of blood pressure based on a continuous scale are at risk,” said Dr. Gorelick, who was not involved with the current study.

The investigators relied on a large and well-studied population of civil servants. However, the population’s relative youth and high level of education may limit the generalizability of the findings, he noted. In addition, the follow-up time was relatively short.

“The hard endpoint of dementia was not studied but would be of interest to enhance our understanding of the influence of blood pressure elevation on cognitive decline or dementia during a longer follow-up of the cohort,” Dr. Gorelick said.

The findings also suggest the need to better understand mechanisms that link blood pressure elevation with cognitive decline, he added.

They indicate “the need for additional clinical trials to better elucidate blood pressure lowering targets for cognitive preservation in different groups of persons at risk,” such as those with normal cognition, those with mild cognitive impairment, and those with dementia, said Dr. Gorelick. “For example, is it safe and efficacious to lower blood pressure in persons with more advanced cognitive impairment or dementia?” he asked.

The study was funded by the Brazilian Coordination for the Improvement of Higher Education Personnel. Dr. Barreto has received support from the Research Agency of the State of Minas Gerais. Although Dr. Gorelick was not involved in the ELSA-Brasil cohort study, he serves on a data monitoring committee for a trial of a blood pressure–lowering agent in the preservation of cognition.

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

Individuals who have hypertension at any age are more likely to experience more rapid cognitive decline compared with their counterparts with normal blood pressure, new research shows. In a retrospective study of more than 15,000 participants, hypertension during middle age was associated with memory decline, and onset at later ages was linked to worsening memory and global cognition.

The investigators found that prehypertension, defined as systolic pressure of 120-139 mm Hg or diastolic pressure of 80-89 mm Hg, was also linked to accelerated cognitive decline.

Although duration of hypertension was not associated with any marker of cognitive decline, blood pressure control “can substantially reduce hypertension’s deleterious effect on the pace of cognitive decline,” said study investigator Sandhi M. Barreto, MD, PhD, professor of medicine at Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.

The findings were published online Dec. 14 in Hypertension.
 

Unanswered questions

Hypertension is an established and highly prevalent risk factor for cognitive decline, but the age at which it begins to affect cognition is unclear. Previous research suggests that onset during middle age is associated with more harmful cognitive effects than onset in later life. One reason for this apparent difference may be that the duration of hypertension influences the magnitude of cognitive decline, the researchers noted.

Other studies have shown that prehypertension is associated with damage to certain organs, but its effects on cognition are uncertain. In addition, the effect of good blood pressure control with antihypertensive medications and the impact on cognition are also unclear.

To investigate, the researchers examined data from the ongoing, multicenter ELSA-Brasil study. ELSA-Brasil follows 15,105 civil servants between the ages of 35 and 74 years. Dr. Barreto and team assessed data from visit 1, which was conducted between 2008 and 2010, and visit 2, which was conducted between 2012 and 2014.

At each visit, participants underwent a memory test, a verbal fluency test, and the Trail Making Test Part B. The investigators calculated Z scores for these tests to derive a global cognitive score.

Blood pressure was measured on the right arm, and hypertension status, age at the time of hypertension diagnosis, duration of hypertension diagnosis, hypertension treatment, and control status were recorded. Other covariables included sex, education, race, smoking status, physical activity, body mass index, and total cholesterol level.

The researchers excluded patients who did not undergo cognitive testing at visit 2, those who had a history of stroke at baseline, and those who initiated antihypertensive medications despite having normotension. After exclusions, the analysis included 7,063 participants (approximately 55% were women, 15% were Black).

At visit 1, the mean age of the group was 58.9 years, and 53.4% of participants had 14 or more years of education. In addition, 22% had prehypertension, and 46.8% had hypertension. The median duration of hypertension was 7 years; 29.8% of participants with hypertension were diagnosed with the condition during middle age.

Of those who reported having hypertension at visit 1, 7.3% were not taking any antihypertensive medication. Among participants with hypertension who were taking antihypertensives, 31.2% had uncontrolled blood pressure.
 

Independent predictor

Results showed that prehypertension independently predicted a significantly greater decline in verbal fluency (Z score, –0.0095; P < .01) and global cognitive score (Z score, –0.0049; P < .05) compared with normal blood pressure.

At middle age, hypertension was associated with a steeper decline in memory (Z score, –0.0072; P < .05) compared with normal blood pressure. At older ages, hypertension was linked to a steeper decline in both memory (Z score, –0.0151; P < .001) and global cognitive score (Z score, –0.0080; P < .01). Duration of hypertension, however, did not significantly predict changes in cognition (P < .109).

Among those with hypertension who were taking antihypertensive medications, those with uncontrolled blood pressure experienced greater declines in rapid memory (Z score, –0.0126; P < .01) and global cognitive score (Z score, –0.0074; P < .01) than did those with controlled blood pressure.

The investigators noted that the study participants had a comparatively high level of education, which has been shown to “boost cognitive reserve and lessen the speed of age-related cognitive decline,” Dr. Barreto said. However, “our results indicate that the effect of hypertension on cognitive decline affects individuals of all educational levels similarly,” she said.

Dr. Barreto noted that the findings have two major clinical implications. First, “maintaining blood pressure below prehypertension levels is important to preserve cognitive function or delay cognitive decline,” she said. Secondly, “in hypertensive individuals, keeping blood pressure under control is essential to reduce the speed of cognitive decline.”

The researchers plan to conduct further analyses of the data to clarify the observed relationship between memory and verbal fluency. They also plan to examine how hypertension affects long-term executive function.
 

‘Continuum of risk’

Commenting on the study, Philip B. Gorelick, MD, MPH, adjunct professor of neurology (stroke and neurocritical care) at Northwestern University, Chicago, noted that, so far, research suggests that the risk for stroke associated with blood pressure levels should be understood as representing a continuum rather than as being associated with several discrete points.

“The same may hold true for cognitive decline and dementia. There may be a continuum of risk whereby persons even at so-called elevated but relatively lower levels of blood pressure based on a continuous scale are at risk,” said Dr. Gorelick, who was not involved with the current study.

The investigators relied on a large and well-studied population of civil servants. However, the population’s relative youth and high level of education may limit the generalizability of the findings, he noted. In addition, the follow-up time was relatively short.

“The hard endpoint of dementia was not studied but would be of interest to enhance our understanding of the influence of blood pressure elevation on cognitive decline or dementia during a longer follow-up of the cohort,” Dr. Gorelick said.

The findings also suggest the need to better understand mechanisms that link blood pressure elevation with cognitive decline, he added.

They indicate “the need for additional clinical trials to better elucidate blood pressure lowering targets for cognitive preservation in different groups of persons at risk,” such as those with normal cognition, those with mild cognitive impairment, and those with dementia, said Dr. Gorelick. “For example, is it safe and efficacious to lower blood pressure in persons with more advanced cognitive impairment or dementia?” he asked.

The study was funded by the Brazilian Coordination for the Improvement of Higher Education Personnel. Dr. Barreto has received support from the Research Agency of the State of Minas Gerais. Although Dr. Gorelick was not involved in the ELSA-Brasil cohort study, he serves on a data monitoring committee for a trial of a blood pressure–lowering agent in the preservation of cognition.

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

Individuals who have hypertension at any age are more likely to experience more rapid cognitive decline compared with their counterparts with normal blood pressure, new research shows. In a retrospective study of more than 15,000 participants, hypertension during middle age was associated with memory decline, and onset at later ages was linked to worsening memory and global cognition.

The investigators found that prehypertension, defined as systolic pressure of 120-139 mm Hg or diastolic pressure of 80-89 mm Hg, was also linked to accelerated cognitive decline.

Although duration of hypertension was not associated with any marker of cognitive decline, blood pressure control “can substantially reduce hypertension’s deleterious effect on the pace of cognitive decline,” said study investigator Sandhi M. Barreto, MD, PhD, professor of medicine at Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.

The findings were published online Dec. 14 in Hypertension.
 

Unanswered questions

Hypertension is an established and highly prevalent risk factor for cognitive decline, but the age at which it begins to affect cognition is unclear. Previous research suggests that onset during middle age is associated with more harmful cognitive effects than onset in later life. One reason for this apparent difference may be that the duration of hypertension influences the magnitude of cognitive decline, the researchers noted.

Other studies have shown that prehypertension is associated with damage to certain organs, but its effects on cognition are uncertain. In addition, the effect of good blood pressure control with antihypertensive medications and the impact on cognition are also unclear.

To investigate, the researchers examined data from the ongoing, multicenter ELSA-Brasil study. ELSA-Brasil follows 15,105 civil servants between the ages of 35 and 74 years. Dr. Barreto and team assessed data from visit 1, which was conducted between 2008 and 2010, and visit 2, which was conducted between 2012 and 2014.

At each visit, participants underwent a memory test, a verbal fluency test, and the Trail Making Test Part B. The investigators calculated Z scores for these tests to derive a global cognitive score.

Blood pressure was measured on the right arm, and hypertension status, age at the time of hypertension diagnosis, duration of hypertension diagnosis, hypertension treatment, and control status were recorded. Other covariables included sex, education, race, smoking status, physical activity, body mass index, and total cholesterol level.

The researchers excluded patients who did not undergo cognitive testing at visit 2, those who had a history of stroke at baseline, and those who initiated antihypertensive medications despite having normotension. After exclusions, the analysis included 7,063 participants (approximately 55% were women, 15% were Black).

At visit 1, the mean age of the group was 58.9 years, and 53.4% of participants had 14 or more years of education. In addition, 22% had prehypertension, and 46.8% had hypertension. The median duration of hypertension was 7 years; 29.8% of participants with hypertension were diagnosed with the condition during middle age.

Of those who reported having hypertension at visit 1, 7.3% were not taking any antihypertensive medication. Among participants with hypertension who were taking antihypertensives, 31.2% had uncontrolled blood pressure.
 

Independent predictor

Results showed that prehypertension independently predicted a significantly greater decline in verbal fluency (Z score, –0.0095; P < .01) and global cognitive score (Z score, –0.0049; P < .05) compared with normal blood pressure.

At middle age, hypertension was associated with a steeper decline in memory (Z score, –0.0072; P < .05) compared with normal blood pressure. At older ages, hypertension was linked to a steeper decline in both memory (Z score, –0.0151; P < .001) and global cognitive score (Z score, –0.0080; P < .01). Duration of hypertension, however, did not significantly predict changes in cognition (P < .109).

Among those with hypertension who were taking antihypertensive medications, those with uncontrolled blood pressure experienced greater declines in rapid memory (Z score, –0.0126; P < .01) and global cognitive score (Z score, –0.0074; P < .01) than did those with controlled blood pressure.

The investigators noted that the study participants had a comparatively high level of education, which has been shown to “boost cognitive reserve and lessen the speed of age-related cognitive decline,” Dr. Barreto said. However, “our results indicate that the effect of hypertension on cognitive decline affects individuals of all educational levels similarly,” she said.

Dr. Barreto noted that the findings have two major clinical implications. First, “maintaining blood pressure below prehypertension levels is important to preserve cognitive function or delay cognitive decline,” she said. Secondly, “in hypertensive individuals, keeping blood pressure under control is essential to reduce the speed of cognitive decline.”

The researchers plan to conduct further analyses of the data to clarify the observed relationship between memory and verbal fluency. They also plan to examine how hypertension affects long-term executive function.
 

‘Continuum of risk’

Commenting on the study, Philip B. Gorelick, MD, MPH, adjunct professor of neurology (stroke and neurocritical care) at Northwestern University, Chicago, noted that, so far, research suggests that the risk for stroke associated with blood pressure levels should be understood as representing a continuum rather than as being associated with several discrete points.

“The same may hold true for cognitive decline and dementia. There may be a continuum of risk whereby persons even at so-called elevated but relatively lower levels of blood pressure based on a continuous scale are at risk,” said Dr. Gorelick, who was not involved with the current study.

The investigators relied on a large and well-studied population of civil servants. However, the population’s relative youth and high level of education may limit the generalizability of the findings, he noted. In addition, the follow-up time was relatively short.

“The hard endpoint of dementia was not studied but would be of interest to enhance our understanding of the influence of blood pressure elevation on cognitive decline or dementia during a longer follow-up of the cohort,” Dr. Gorelick said.

The findings also suggest the need to better understand mechanisms that link blood pressure elevation with cognitive decline, he added.

They indicate “the need for additional clinical trials to better elucidate blood pressure lowering targets for cognitive preservation in different groups of persons at risk,” such as those with normal cognition, those with mild cognitive impairment, and those with dementia, said Dr. Gorelick. “For example, is it safe and efficacious to lower blood pressure in persons with more advanced cognitive impairment or dementia?” he asked.

The study was funded by the Brazilian Coordination for the Improvement of Higher Education Personnel. Dr. Barreto has received support from the Research Agency of the State of Minas Gerais. Although Dr. Gorelick was not involved in the ELSA-Brasil cohort study, he serves on a data monitoring committee for a trial of a blood pressure–lowering agent in the preservation of cognition.

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

Children with cancer are at increased risk of potentially life-threatening Clostridioides difficile infections (CDI), and CDI should be considered early in cancer patients who develop gastrointestinal symptoms, Brianna Murphy, DO, reported at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.

CDI are characterized by diarrhea, fever, and loss of appetite. The clinical features are caused by the release of toxins A and B by this gram-positive bacterium. In pediatric groups, CDI are a leading cause of antibiotic-associated gastric illness. This in turn can lead to a protracted stay in hospital and increases risk of mortality. The rising incidence in the United States over the last 2 decades prompted Dr. Murphy, a pediatric hematology oncology fellow working at the department of pediatric research at the University of Texas MD Anderson Cancer Center, Houston, to investigate further. A search of the literature found limited information regarding CDI and pediatric oncology patients.

Recognized factors for contracting CDI include the presence of other illnesses, a weakened immune system because of drugs or disease, enteral nutrition, usage of medicines such as proton pump inhibitors which decrease gastric acid production, and classically, treatment with broad spectrum antibiotics.

Dr. Murphy’s study included patients aged 1-18 years, all of whom had a cancer diagnosis and a positive stool culture for C. difficile. Presenting symptoms were three or more loose stools per day or acute onset ileus. The study evaluated data for the years 2000-2017 and included 11,366 children; 207 CDI (0.98%) cases were identified among pediatric oncology patients during the study period. This compares with historical data showing an incidence of 0.14% among hospitalized children in general.

Malignancy data were then subdivided into three groups: hematologic, nonneural solid tumors (NNST), and neural tumors. Hematologic malignancies had a CDI prevalence higher than the average for oncologic patients at 5.4%. Inside this group those suffering with acute myeloid leukemia had a rate of 10.5%. In the NNST and neural tumor groups, CDI rates were lower and closer to the overall average.

CDC/Jennifer Hulsey

Dr. Murphy then looked at her patient population in more detail. Poor clinical outcomes (PCOs) were defined as severe, refractory, recurrent, or multiple infections. Severe CDI included features such as toxic megacolon, gastrointestinal perforation, or need for surgical intervention. Refractory CDI were defined as continuation of symptoms beyond 7 days of appropriate therapy, and recurrent CDI were classed as reinfection within 8 weeks of a previous CDI. Ultimately, 51% of patients in this study died. Patients with severe CDI experienced increased mortality (P = .02). There was no difference shown when looking at the type of cancer, age, gender, or patient ethnicity.

Next, Dr. Murphy looked for associations. Hematologic and biochemical testing identified that elevated creatinine was statistically associated with the likelihood of PCOs, compared with leukocytosis and neutropenia, particularly in the NNST group. Treatment modality also was studied. Here radiation therapy was the only treatment shown to increase PCOs in patients with CDI. One-fifth (22%) of radiation therapy recipients experienced multiple CDI, compared with 12% of the total population.

In commenting on her paper, Louis Bent, MD, from the Netherlands raised the issue of deaths in septic patients. What was the origin of the responsible organism, for example from the GI tract or from central lines, and were patients receiving appropriate antibiotic treatment?

Dr. Kelly responded that sepsis was generally believed to occur as a result of infection with mixed bacterial translocation through the bowel wall, notably Escherichia coli. Patients were usually on a cocktail of antibiotics targeting CDI, but also other infections illustrating the serious nature of the situation.

Dr. Murphy had no financial conflicts of interest to declare.

Children with cancer are at increased risk of potentially life-threatening Clostridioides difficile infections (CDI), and CDI should be considered early in cancer patients who develop gastrointestinal symptoms, Brianna Murphy, DO, reported at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.

CDI are characterized by diarrhea, fever, and loss of appetite. The clinical features are caused by the release of toxins A and B by this gram-positive bacterium. In pediatric groups, CDI are a leading cause of antibiotic-associated gastric illness. This in turn can lead to a protracted stay in hospital and increases risk of mortality. The rising incidence in the United States over the last 2 decades prompted Dr. Murphy, a pediatric hematology oncology fellow working at the department of pediatric research at the University of Texas MD Anderson Cancer Center, Houston, to investigate further. A search of the literature found limited information regarding CDI and pediatric oncology patients.

Recognized factors for contracting CDI include the presence of other illnesses, a weakened immune system because of drugs or disease, enteral nutrition, usage of medicines such as proton pump inhibitors which decrease gastric acid production, and classically, treatment with broad spectrum antibiotics.

Dr. Murphy’s study included patients aged 1-18 years, all of whom had a cancer diagnosis and a positive stool culture for C. difficile. Presenting symptoms were three or more loose stools per day or acute onset ileus. The study evaluated data for the years 2000-2017 and included 11,366 children; 207 CDI (0.98%) cases were identified among pediatric oncology patients during the study period. This compares with historical data showing an incidence of 0.14% among hospitalized children in general.

Malignancy data were then subdivided into three groups: hematologic, nonneural solid tumors (NNST), and neural tumors. Hematologic malignancies had a CDI prevalence higher than the average for oncologic patients at 5.4%. Inside this group those suffering with acute myeloid leukemia had a rate of 10.5%. In the NNST and neural tumor groups, CDI rates were lower and closer to the overall average.

CDC/Jennifer Hulsey

Dr. Murphy then looked at her patient population in more detail. Poor clinical outcomes (PCOs) were defined as severe, refractory, recurrent, or multiple infections. Severe CDI included features such as toxic megacolon, gastrointestinal perforation, or need for surgical intervention. Refractory CDI were defined as continuation of symptoms beyond 7 days of appropriate therapy, and recurrent CDI were classed as reinfection within 8 weeks of a previous CDI. Ultimately, 51% of patients in this study died. Patients with severe CDI experienced increased mortality (P = .02). There was no difference shown when looking at the type of cancer, age, gender, or patient ethnicity.

Next, Dr. Murphy looked for associations. Hematologic and biochemical testing identified that elevated creatinine was statistically associated with the likelihood of PCOs, compared with leukocytosis and neutropenia, particularly in the NNST group. Treatment modality also was studied. Here radiation therapy was the only treatment shown to increase PCOs in patients with CDI. One-fifth (22%) of radiation therapy recipients experienced multiple CDI, compared with 12% of the total population.

In commenting on her paper, Louis Bent, MD, from the Netherlands raised the issue of deaths in septic patients. What was the origin of the responsible organism, for example from the GI tract or from central lines, and were patients receiving appropriate antibiotic treatment?

Dr. Kelly responded that sepsis was generally believed to occur as a result of infection with mixed bacterial translocation through the bowel wall, notably Escherichia coli. Patients were usually on a cocktail of antibiotics targeting CDI, but also other infections illustrating the serious nature of the situation.

Dr. Murphy had no financial conflicts of interest to declare.

Children with cancer are at increased risk of potentially life-threatening Clostridioides difficile infections (CDI), and CDI should be considered early in cancer patients who develop gastrointestinal symptoms, Brianna Murphy, DO, reported at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.

CDI are characterized by diarrhea, fever, and loss of appetite. The clinical features are caused by the release of toxins A and B by this gram-positive bacterium. In pediatric groups, CDI are a leading cause of antibiotic-associated gastric illness. This in turn can lead to a protracted stay in hospital and increases risk of mortality. The rising incidence in the United States over the last 2 decades prompted Dr. Murphy, a pediatric hematology oncology fellow working at the department of pediatric research at the University of Texas MD Anderson Cancer Center, Houston, to investigate further. A search of the literature found limited information regarding CDI and pediatric oncology patients.

Recognized factors for contracting CDI include the presence of other illnesses, a weakened immune system because of drugs or disease, enteral nutrition, usage of medicines such as proton pump inhibitors which decrease gastric acid production, and classically, treatment with broad spectrum antibiotics.

Dr. Murphy’s study included patients aged 1-18 years, all of whom had a cancer diagnosis and a positive stool culture for C. difficile. Presenting symptoms were three or more loose stools per day or acute onset ileus. The study evaluated data for the years 2000-2017 and included 11,366 children; 207 CDI (0.98%) cases were identified among pediatric oncology patients during the study period. This compares with historical data showing an incidence of 0.14% among hospitalized children in general.

Malignancy data were then subdivided into three groups: hematologic, nonneural solid tumors (NNST), and neural tumors. Hematologic malignancies had a CDI prevalence higher than the average for oncologic patients at 5.4%. Inside this group those suffering with acute myeloid leukemia had a rate of 10.5%. In the NNST and neural tumor groups, CDI rates were lower and closer to the overall average.

CDC/Jennifer Hulsey

Dr. Murphy then looked at her patient population in more detail. Poor clinical outcomes (PCOs) were defined as severe, refractory, recurrent, or multiple infections. Severe CDI included features such as toxic megacolon, gastrointestinal perforation, or need for surgical intervention. Refractory CDI were defined as continuation of symptoms beyond 7 days of appropriate therapy, and recurrent CDI were classed as reinfection within 8 weeks of a previous CDI. Ultimately, 51% of patients in this study died. Patients with severe CDI experienced increased mortality (P = .02). There was no difference shown when looking at the type of cancer, age, gender, or patient ethnicity.

Next, Dr. Murphy looked for associations. Hematologic and biochemical testing identified that elevated creatinine was statistically associated with the likelihood of PCOs, compared with leukocytosis and neutropenia, particularly in the NNST group. Treatment modality also was studied. Here radiation therapy was the only treatment shown to increase PCOs in patients with CDI. One-fifth (22%) of radiation therapy recipients experienced multiple CDI, compared with 12% of the total population.

In commenting on her paper, Louis Bent, MD, from the Netherlands raised the issue of deaths in septic patients. What was the origin of the responsible organism, for example from the GI tract or from central lines, and were patients receiving appropriate antibiotic treatment?

Dr. Kelly responded that sepsis was generally believed to occur as a result of infection with mixed bacterial translocation through the bowel wall, notably Escherichia coli. Patients were usually on a cocktail of antibiotics targeting CDI, but also other infections illustrating the serious nature of the situation.

Dr. Murphy had no financial conflicts of interest to declare.

If the initial success of the Pfizer-BioNTech rollout continues, and emergency use authorization (EAU) is granted to Moderna and Johnson & Johnson vaccines in development, Operation Warp Speed officials expect to have 300 million doses of COVID-19 vaccines to distribute across the United States between now and March 31.

The initial rollout remains on track, said Alex Azar, US Department of Health and Human Services (HHS) secretary, during a media briefing today. “We continue to have good news to report. As of today, shipments of vaccine will have been delivered to every delivery site identified by public health jurisdictions for our first wave of shipments.”

Anomalies in shipments to California and Alabama arose when temperature monitors showed the Pfizer vaccine dropped lower than the recommended -80 ºC (-112 °F). These vaccine trays remained on delivery trucks and were returned to Pfizer for prompt replacement, said Operation Warp Speed Chief Operating Officer Gen. Gustave F. Perna.

Azar estimated another 2 million doses of the Pfizer vaccine will be available next week. “And if the Moderna vaccine is authorized by the FDA in the coming days, we have allocated nearly 5.9 million doses of that product.”

The Moderna vaccine data released this week look promising, said Moncef Slaoui, PhD, Operation Warp Speed chief scientific adviser. “In the short term, I expect the protection to be quite significant.”

The findings in the first 2 weeks after the first dose show up to 65% protection, he said, and predicted the second-dose efficacy data will be coming in the next few weeks.

Enrollment in the phase 3 Johnson & Johnson trial with nearly 44,000 participants is expected to end December 17. Initial efficacy results are anticipated by early January, with more complete efficacy numbers by late January, Slaoui said.

The AstraZeneca COVID-19 vaccine trial also is underway with enrollment continuing. “We expect accruement to end in late December or early next year, with first results expected probably in February,” Slaoui said.
 

Antibody treatments underutilized

The media briefing also addressed COVID-19 therapeutics. Azar reported low uptake of available antibody therapies. “I want to remind Americans that there are two authorized antibody treatments that Operation Warp Speed has supported. They can help prevent hospitalization in those patients with the highest risk for severe disease.”

The higher-risk group includes those who are 65 and older and people with comorbid conditions that put them at increased risk for COVID-19 hospitalization.

The federal government allocated more than 330,000 doses of these treatments and many states have product available, Azar said.

Slaoui agreed, saying there is a “disappointing level of usage of monoclonal antibody therapy in hospitals. We look forward to that improving.”
 

Up to 3 billion vaccine doses possible

“We now have more than 900 million doses of the vaccine we have contracted delivery for,” Azar said. The government has options to increase that to a total of 3 billion doses.

In addition to the 100 million Pfizer vaccine doses and 100 million Moderna doses already ordered, the government just took an option for another 100 million Moderna doses for the second quarter of 2021. Operation Warp Speed officials are negotiating with Pfizer for additional product as well.

Azar added that there are 100 million doses of the Johnson & Johnson vaccine in active production and expects AstraZeneca can provide 300 million doses of their product.

With the possibility of three or more vaccine products and with 330 million Americans, minus the 70 million or so children under age 16, “we believe we will actually have surplus supplies,” Azar said. Plans are to take the US surplus vaccine and surplus manufacturing capacity “and use that for the benefit of the world community.”

This article first appeared on Medscape.com.

If the initial success of the Pfizer-BioNTech rollout continues, and emergency use authorization (EAU) is granted to Moderna and Johnson & Johnson vaccines in development, Operation Warp Speed officials expect to have 300 million doses of COVID-19 vaccines to distribute across the United States between now and March 31.

The initial rollout remains on track, said Alex Azar, US Department of Health and Human Services (HHS) secretary, during a media briefing today. “We continue to have good news to report. As of today, shipments of vaccine will have been delivered to every delivery site identified by public health jurisdictions for our first wave of shipments.”

Anomalies in shipments to California and Alabama arose when temperature monitors showed the Pfizer vaccine dropped lower than the recommended -80 ºC (-112 °F). These vaccine trays remained on delivery trucks and were returned to Pfizer for prompt replacement, said Operation Warp Speed Chief Operating Officer Gen. Gustave F. Perna.

Azar estimated another 2 million doses of the Pfizer vaccine will be available next week. “And if the Moderna vaccine is authorized by the FDA in the coming days, we have allocated nearly 5.9 million doses of that product.”

The Moderna vaccine data released this week look promising, said Moncef Slaoui, PhD, Operation Warp Speed chief scientific adviser. “In the short term, I expect the protection to be quite significant.”

The findings in the first 2 weeks after the first dose show up to 65% protection, he said, and predicted the second-dose efficacy data will be coming in the next few weeks.

Enrollment in the phase 3 Johnson & Johnson trial with nearly 44,000 participants is expected to end December 17. Initial efficacy results are anticipated by early January, with more complete efficacy numbers by late January, Slaoui said.

The AstraZeneca COVID-19 vaccine trial also is underway with enrollment continuing. “We expect accruement to end in late December or early next year, with first results expected probably in February,” Slaoui said.
 

Antibody treatments underutilized

The media briefing also addressed COVID-19 therapeutics. Azar reported low uptake of available antibody therapies. “I want to remind Americans that there are two authorized antibody treatments that Operation Warp Speed has supported. They can help prevent hospitalization in those patients with the highest risk for severe disease.”

The higher-risk group includes those who are 65 and older and people with comorbid conditions that put them at increased risk for COVID-19 hospitalization.

The federal government allocated more than 330,000 doses of these treatments and many states have product available, Azar said.

Slaoui agreed, saying there is a “disappointing level of usage of monoclonal antibody therapy in hospitals. We look forward to that improving.”
 

Up to 3 billion vaccine doses possible

“We now have more than 900 million doses of the vaccine we have contracted delivery for,” Azar said. The government has options to increase that to a total of 3 billion doses.

In addition to the 100 million Pfizer vaccine doses and 100 million Moderna doses already ordered, the government just took an option for another 100 million Moderna doses for the second quarter of 2021. Operation Warp Speed officials are negotiating with Pfizer for additional product as well.

Azar added that there are 100 million doses of the Johnson & Johnson vaccine in active production and expects AstraZeneca can provide 300 million doses of their product.

With the possibility of three or more vaccine products and with 330 million Americans, minus the 70 million or so children under age 16, “we believe we will actually have surplus supplies,” Azar said. Plans are to take the US surplus vaccine and surplus manufacturing capacity “and use that for the benefit of the world community.”

This article first appeared on Medscape.com.

If the initial success of the Pfizer-BioNTech rollout continues, and emergency use authorization (EAU) is granted to Moderna and Johnson & Johnson vaccines in development, Operation Warp Speed officials expect to have 300 million doses of COVID-19 vaccines to distribute across the United States between now and March 31.

The initial rollout remains on track, said Alex Azar, US Department of Health and Human Services (HHS) secretary, during a media briefing today. “We continue to have good news to report. As of today, shipments of vaccine will have been delivered to every delivery site identified by public health jurisdictions for our first wave of shipments.”

Anomalies in shipments to California and Alabama arose when temperature monitors showed the Pfizer vaccine dropped lower than the recommended -80 ºC (-112 °F). These vaccine trays remained on delivery trucks and were returned to Pfizer for prompt replacement, said Operation Warp Speed Chief Operating Officer Gen. Gustave F. Perna.

Azar estimated another 2 million doses of the Pfizer vaccine will be available next week. “And if the Moderna vaccine is authorized by the FDA in the coming days, we have allocated nearly 5.9 million doses of that product.”

The Moderna vaccine data released this week look promising, said Moncef Slaoui, PhD, Operation Warp Speed chief scientific adviser. “In the short term, I expect the protection to be quite significant.”

The findings in the first 2 weeks after the first dose show up to 65% protection, he said, and predicted the second-dose efficacy data will be coming in the next few weeks.

Enrollment in the phase 3 Johnson & Johnson trial with nearly 44,000 participants is expected to end December 17. Initial efficacy results are anticipated by early January, with more complete efficacy numbers by late January, Slaoui said.

The AstraZeneca COVID-19 vaccine trial also is underway with enrollment continuing. “We expect accruement to end in late December or early next year, with first results expected probably in February,” Slaoui said.
 

Antibody treatments underutilized

The media briefing also addressed COVID-19 therapeutics. Azar reported low uptake of available antibody therapies. “I want to remind Americans that there are two authorized antibody treatments that Operation Warp Speed has supported. They can help prevent hospitalization in those patients with the highest risk for severe disease.”

The higher-risk group includes those who are 65 and older and people with comorbid conditions that put them at increased risk for COVID-19 hospitalization.

The federal government allocated more than 330,000 doses of these treatments and many states have product available, Azar said.

Slaoui agreed, saying there is a “disappointing level of usage of monoclonal antibody therapy in hospitals. We look forward to that improving.”
 

Up to 3 billion vaccine doses possible

“We now have more than 900 million doses of the vaccine we have contracted delivery for,” Azar said. The government has options to increase that to a total of 3 billion doses.

In addition to the 100 million Pfizer vaccine doses and 100 million Moderna doses already ordered, the government just took an option for another 100 million Moderna doses for the second quarter of 2021. Operation Warp Speed officials are negotiating with Pfizer for additional product as well.

Azar added that there are 100 million doses of the Johnson & Johnson vaccine in active production and expects AstraZeneca can provide 300 million doses of their product.

With the possibility of three or more vaccine products and with 330 million Americans, minus the 70 million or so children under age 16, “we believe we will actually have surplus supplies,” Azar said. Plans are to take the US surplus vaccine and surplus manufacturing capacity “and use that for the benefit of the world community.”

This article first appeared on Medscape.com.

Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 reperfusion catheter with Xtra Flex technology (JET 7 Xtra Flex), owing to the risk for “unexpected death or serious injury” during use for clot removal in stroke patients.

“All users should stop using this device, and facilities should remove these devices from inventory,” the recall notice, posted on the U.S. Food and Drug Administration website, advises.

The recall covers the JET 7 Xtra Flex catheter, which was cleared for use in June 2019, and the JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX delivery device), which was cleared in February of this year.

The recall does not apply to the Penumbra JET 7 reperfusion catheter with standard tip.

The FDA says it has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including reports of deaths, serious injuries, and malfunctions.

Twenty of these MDRs describe 14 unique patient deaths. Other MDRs describe serious patient injury, such as vessel damage, hemorrhage, and cerebral infarction.

Device malfunctions described in the reports include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.

According to the FDA, bench testing by the manufacturer, in which the catheter distal tip is plugged and pressurized to failure, indicates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large-bore aspiration catheters used to remove thrombus for patients with acute ischemic stroke.

Penumbra’s urgent medical device recall letter advises health care providers and facilities to remove and quarantine all unused devices covered by this recall, to complete the product identification and return form, and to return all products to Penumbra in accordance with instructions provided.

For questions regarding this recall, contact Penumbra customer service by phone at 888-272-4606 or by email at [email protected].

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

Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 reperfusion catheter with Xtra Flex technology (JET 7 Xtra Flex), owing to the risk for “unexpected death or serious injury” during use for clot removal in stroke patients.

“All users should stop using this device, and facilities should remove these devices from inventory,” the recall notice, posted on the U.S. Food and Drug Administration website, advises.

The recall covers the JET 7 Xtra Flex catheter, which was cleared for use in June 2019, and the JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX delivery device), which was cleared in February of this year.

The recall does not apply to the Penumbra JET 7 reperfusion catheter with standard tip.

The FDA says it has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including reports of deaths, serious injuries, and malfunctions.

Twenty of these MDRs describe 14 unique patient deaths. Other MDRs describe serious patient injury, such as vessel damage, hemorrhage, and cerebral infarction.

Device malfunctions described in the reports include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.

According to the FDA, bench testing by the manufacturer, in which the catheter distal tip is plugged and pressurized to failure, indicates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large-bore aspiration catheters used to remove thrombus for patients with acute ischemic stroke.

Penumbra’s urgent medical device recall letter advises health care providers and facilities to remove and quarantine all unused devices covered by this recall, to complete the product identification and return form, and to return all products to Penumbra in accordance with instructions provided.

For questions regarding this recall, contact Penumbra customer service by phone at 888-272-4606 or by email at [email protected].

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

Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 reperfusion catheter with Xtra Flex technology (JET 7 Xtra Flex), owing to the risk for “unexpected death or serious injury” during use for clot removal in stroke patients.

“All users should stop using this device, and facilities should remove these devices from inventory,” the recall notice, posted on the U.S. Food and Drug Administration website, advises.

The recall covers the JET 7 Xtra Flex catheter, which was cleared for use in June 2019, and the JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX delivery device), which was cleared in February of this year.

The recall does not apply to the Penumbra JET 7 reperfusion catheter with standard tip.

The FDA says it has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including reports of deaths, serious injuries, and malfunctions.

Twenty of these MDRs describe 14 unique patient deaths. Other MDRs describe serious patient injury, such as vessel damage, hemorrhage, and cerebral infarction.

Device malfunctions described in the reports include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.

According to the FDA, bench testing by the manufacturer, in which the catheter distal tip is plugged and pressurized to failure, indicates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large-bore aspiration catheters used to remove thrombus for patients with acute ischemic stroke.

Penumbra’s urgent medical device recall letter advises health care providers and facilities to remove and quarantine all unused devices covered by this recall, to complete the product identification and return form, and to return all products to Penumbra in accordance with instructions provided.

For questions regarding this recall, contact Penumbra customer service by phone at 888-272-4606 or by email at [email protected].

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

COVID-19 became a leading cause of death in the United States in 2020, particularly for people over age 35, according to a new report published in JAMA on Thursday.

Adults over age 45 were more likely to die from COVID-19 than car crashes, respiratory diseases, drug overdoses, and suicide. And those over age 55 faced even higher rates of dying because of the coronavirus.

“The current exponential increase in COVID-19 is reaching a calamitous scale in the U.S.,” the authors wrote. “Putting these numbers in perspective may be difficult.”

Population health researchers at Virginia Commonwealth University put COVID-19 deaths into context by comparing this year’s numbers to the leading causes of death for March through October 2018, sorting by age.

By October 2020, COVID-19 had become the third leading cause of death overall for those between the ages of 45 and 84 years, following after heart disease and cancer. For those over age 85, COVID-19 was the second leading cause of death, surpassing cancer and following behind heart disease.

For people aged 35-44 years, COVID-19 surpassed car crashes and respiratory diseases and was slightly lower than suicide, heart disease, and cancer. For those under age 35, drug overdoses, suicide, and car crashes remained the leading causes of death.

Importantly, the authors wrote, death rates for the two leading causes – heart disease and cancer – are about 1,700 and 1,600 per day, respectively. COVID-19 deaths have surpassed these numbers individually throughout December and, on Wednesday, beat them combined. More than 3,400 deaths were reported, according to the COVID Tracking Project, marking an all-time high that continues to increase. Hospitalizations were also at a new high, with more than 113,000 COVID-19 patients in hospitals across the country, and another 232,000 new cases were reported.

“With COVID-19 mortality rates now exceeding these thresholds, this infectious disease has become deadlier than heart disease and cancer,” the authors wrote. “Its lethality may increase further as transmission increases with holiday travel and gatherings and with the intensified indoor exposure that winter brings.”

The reported number of COVID-19 deaths is likely a 20% underestimate, they wrote, attributable to delays in reporting and an increase in non–COVID-19 deaths that were undetected and untreated because of pandemic-related disruptions. Since the coronavirus is communicable and spreads easily, COVID-19 deaths are particularly unique and worrying, they said.

“Individuals who die from homicide or cancer do not transmit the risk of morbidity and mortality to those nearby,” they wrote. “Every COVID-19 death signals the possibility of more deaths among close contacts.”

The fall surge in cases and deaths is widespread nationally, as compared to the spring, with hot spots on both coasts and in rural areas, according to an accompanying editorial in JAMA from public health researchers at the Harvard T.H. Chan School of Public Health, Boston. People of color have faced twice the death rate as well, with one in 875 Black people and one in 925 Indigenous people dying from COVID-19, as compared with one in 1,625 White people.

“The year 2020 ends with COVID-19 massively surging, as it was in the spring, to be the leading cause of death,” they wrote. “The accelerating numbers of deaths fall far short of fully capturing each devastating human story: Every death represents untold loss for countless families.”

Vaccines offer hope, they said, but won’t prevent the upcoming increase in COVID-19 hospitalizations and deaths this winter. In 2021, containing the pandemic will require national coordination, resources to help overwhelmed health care workers, new support for state and local public health officials, a stimulus package for schools and businesses, and financial aid for people on the brink of eviction. The country needs federal coordination of testing, contact tracing, personal protective equipment, travel precautions, and a face mask mandate, they wrote.

“Ending this crisis will require not only further advances in treatment but also unprecedented commitment to all aspects of prevention, vaccination, and public health,” they wrote. “Only by doing so can future years see this illness revert back to the unfamiliar and unknown condition it once was.”

This article first appeared on WebMD.com.

COVID-19 became a leading cause of death in the United States in 2020, particularly for people over age 35, according to a new report published in JAMA on Thursday.

Adults over age 45 were more likely to die from COVID-19 than car crashes, respiratory diseases, drug overdoses, and suicide. And those over age 55 faced even higher rates of dying because of the coronavirus.

“The current exponential increase in COVID-19 is reaching a calamitous scale in the U.S.,” the authors wrote. “Putting these numbers in perspective may be difficult.”

Population health researchers at Virginia Commonwealth University put COVID-19 deaths into context by comparing this year’s numbers to the leading causes of death for March through October 2018, sorting by age.

By October 2020, COVID-19 had become the third leading cause of death overall for those between the ages of 45 and 84 years, following after heart disease and cancer. For those over age 85, COVID-19 was the second leading cause of death, surpassing cancer and following behind heart disease.

For people aged 35-44 years, COVID-19 surpassed car crashes and respiratory diseases and was slightly lower than suicide, heart disease, and cancer. For those under age 35, drug overdoses, suicide, and car crashes remained the leading causes of death.

Importantly, the authors wrote, death rates for the two leading causes – heart disease and cancer – are about 1,700 and 1,600 per day, respectively. COVID-19 deaths have surpassed these numbers individually throughout December and, on Wednesday, beat them combined. More than 3,400 deaths were reported, according to the COVID Tracking Project, marking an all-time high that continues to increase. Hospitalizations were also at a new high, with more than 113,000 COVID-19 patients in hospitals across the country, and another 232,000 new cases were reported.

“With COVID-19 mortality rates now exceeding these thresholds, this infectious disease has become deadlier than heart disease and cancer,” the authors wrote. “Its lethality may increase further as transmission increases with holiday travel and gatherings and with the intensified indoor exposure that winter brings.”

The reported number of COVID-19 deaths is likely a 20% underestimate, they wrote, attributable to delays in reporting and an increase in non–COVID-19 deaths that were undetected and untreated because of pandemic-related disruptions. Since the coronavirus is communicable and spreads easily, COVID-19 deaths are particularly unique and worrying, they said.

“Individuals who die from homicide or cancer do not transmit the risk of morbidity and mortality to those nearby,” they wrote. “Every COVID-19 death signals the possibility of more deaths among close contacts.”

The fall surge in cases and deaths is widespread nationally, as compared to the spring, with hot spots on both coasts and in rural areas, according to an accompanying editorial in JAMA from public health researchers at the Harvard T.H. Chan School of Public Health, Boston. People of color have faced twice the death rate as well, with one in 875 Black people and one in 925 Indigenous people dying from COVID-19, as compared with one in 1,625 White people.

“The year 2020 ends with COVID-19 massively surging, as it was in the spring, to be the leading cause of death,” they wrote. “The accelerating numbers of deaths fall far short of fully capturing each devastating human story: Every death represents untold loss for countless families.”

Vaccines offer hope, they said, but won’t prevent the upcoming increase in COVID-19 hospitalizations and deaths this winter. In 2021, containing the pandemic will require national coordination, resources to help overwhelmed health care workers, new support for state and local public health officials, a stimulus package for schools and businesses, and financial aid for people on the brink of eviction. The country needs federal coordination of testing, contact tracing, personal protective equipment, travel precautions, and a face mask mandate, they wrote.

“Ending this crisis will require not only further advances in treatment but also unprecedented commitment to all aspects of prevention, vaccination, and public health,” they wrote. “Only by doing so can future years see this illness revert back to the unfamiliar and unknown condition it once was.”

This article first appeared on WebMD.com.

COVID-19 became a leading cause of death in the United States in 2020, particularly for people over age 35, according to a new report published in JAMA on Thursday.

Adults over age 45 were more likely to die from COVID-19 than car crashes, respiratory diseases, drug overdoses, and suicide. And those over age 55 faced even higher rates of dying because of the coronavirus.

“The current exponential increase in COVID-19 is reaching a calamitous scale in the U.S.,” the authors wrote. “Putting these numbers in perspective may be difficult.”

Population health researchers at Virginia Commonwealth University put COVID-19 deaths into context by comparing this year’s numbers to the leading causes of death for March through October 2018, sorting by age.

By October 2020, COVID-19 had become the third leading cause of death overall for those between the ages of 45 and 84 years, following after heart disease and cancer. For those over age 85, COVID-19 was the second leading cause of death, surpassing cancer and following behind heart disease.

For people aged 35-44 years, COVID-19 surpassed car crashes and respiratory diseases and was slightly lower than suicide, heart disease, and cancer. For those under age 35, drug overdoses, suicide, and car crashes remained the leading causes of death.

Importantly, the authors wrote, death rates for the two leading causes – heart disease and cancer – are about 1,700 and 1,600 per day, respectively. COVID-19 deaths have surpassed these numbers individually throughout December and, on Wednesday, beat them combined. More than 3,400 deaths were reported, according to the COVID Tracking Project, marking an all-time high that continues to increase. Hospitalizations were also at a new high, with more than 113,000 COVID-19 patients in hospitals across the country, and another 232,000 new cases were reported.

“With COVID-19 mortality rates now exceeding these thresholds, this infectious disease has become deadlier than heart disease and cancer,” the authors wrote. “Its lethality may increase further as transmission increases with holiday travel and gatherings and with the intensified indoor exposure that winter brings.”

The reported number of COVID-19 deaths is likely a 20% underestimate, they wrote, attributable to delays in reporting and an increase in non–COVID-19 deaths that were undetected and untreated because of pandemic-related disruptions. Since the coronavirus is communicable and spreads easily, COVID-19 deaths are particularly unique and worrying, they said.

“Individuals who die from homicide or cancer do not transmit the risk of morbidity and mortality to those nearby,” they wrote. “Every COVID-19 death signals the possibility of more deaths among close contacts.”

The fall surge in cases and deaths is widespread nationally, as compared to the spring, with hot spots on both coasts and in rural areas, according to an accompanying editorial in JAMA from public health researchers at the Harvard T.H. Chan School of Public Health, Boston. People of color have faced twice the death rate as well, with one in 875 Black people and one in 925 Indigenous people dying from COVID-19, as compared with one in 1,625 White people.

“The year 2020 ends with COVID-19 massively surging, as it was in the spring, to be the leading cause of death,” they wrote. “The accelerating numbers of deaths fall far short of fully capturing each devastating human story: Every death represents untold loss for countless families.”

Vaccines offer hope, they said, but won’t prevent the upcoming increase in COVID-19 hospitalizations and deaths this winter. In 2021, containing the pandemic will require national coordination, resources to help overwhelmed health care workers, new support for state and local public health officials, a stimulus package for schools and businesses, and financial aid for people on the brink of eviction. The country needs federal coordination of testing, contact tracing, personal protective equipment, travel precautions, and a face mask mandate, they wrote.

“Ending this crisis will require not only further advances in treatment but also unprecedented commitment to all aspects of prevention, vaccination, and public health,” they wrote. “Only by doing so can future years see this illness revert back to the unfamiliar and unknown condition it once was.”

This article first appeared on WebMD.com.

Cenobamate (Xcopri, SK Life Science), a new epilepsy drug, is safe and effective up to 1 year, new research shows. Post hoc analyses from an open-label study showed that seizure frequency was significantly reduced and the seizure-freedom rate was significantly improved among 240 adult participants who received cenobamate. The patients’ use of concomitant antiseizure medications was also reduced, with no effect on efficacy.

These results are “fascinating” and “very, very exciting,” said lead author William E. Rosenfeld, MD, director, Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, Mo. Although responder rates were impressive, at 50% or greater and 75% or greater, “what patients really want is to have seizure freedom, or at least a 90% reduction in seizures,” Dr. Rosenfeld said.

The findings were presented at the annual meeting of the American Epilepsy Society, held online this year.
 

Adverse events

Cenobamate reduces seizures by inhibiting sodium current or affecting the GABA_A channel, or potentially through a combination of these two mechanisms, said Dr. Rosenfeld. The drug was approved by the U.S. Food and Drug Administration in November 2019 for the treatment of uncontrolled partial-onset seizures in adults, which represent about 60% of all epileptic seizures. It has been on the market since May 2020.

During the drug’s development, three cases of drug reaction with eosinophilia and systemic symptoms (DRESS) occurred. This condition typically involves a skin rash, fever, swollen lymph nodes, and characteristic blood abnormalities, including a high level of eosinophils. However, an open-label study, published earlier this year in Epilepsia, that assessed safety and pharmacokinetics in 1,347 patients aged 18-70 years who received stable doses of one to three antiseizure medications showed that, with “slow and low titration” of cenobamate, there were no cases of DRESS, Dr. Rosenfeld said.

In that safety study, investigators administered increasing daily doses of cenobamate at 12.5, 25, 50, 100, 150, and 200 mg/day at 2-week intervals. If necessary, the dose could be increased to 400 mg/day via 50-mg/day increments every other week.

The researchers presented post hoc analyses regarding 240 patients from 10 U.S. sites who participated in the safety study. Dr. Rosenfeld noted, “These are all good epilepsy centers, and they all kept seizure records.” Of these participants, 177 continued taking the drug as they had at their last visit for a mean of more than 30 months; for some, it was up to 44 months.

“So we had a 73.8% retention rate over the course of the open label, which is the maintenance phase of the study,” Dr. Rosenfeld said.

Among the entire group of 240 patients, 25.8% had been seizure free for more than 12 months at their last visit. Of the 177 who continued to take cenobamate, 33.9% were seizure free for an average of 23.5 months.

“We have never seen those kinds of numbers in the past,” said Dr. Rosenfeld, adding, “it’s so important for patients to get seizure freedom.” These promising results may be related to the fact that the drug works on more than one mechanism of seizure, he speculated.

For some patients, the drug will “make a big difference” by providing them with the best quality of life and allow them to resume normal activities, Dr. Rosenfeld noted. In addition, the drug was well tolerated. The most common adverse events were dizziness/diplopia and sleepiness/drowsiness.
 

Concomitant drug reductions

Another post hoc analysis of the 240 patients showed that many patients were able to reduce use of other antiseizure medications. At study outset, about 41% were taking lacosamide, 35.7% were taking levetiracetam, and 27.7% were taking lamotrigine. Among patients who continued to take cenobamate, 22.7% of concomitant baseline antiseizure medications were discontinued. Carbamazepine was discontinued by 31.3%, oxcarbazepine by 26.7%, lacosamide by 23.4%, eslicarbazepine by 23.1%, clobazam by 26.7%, lamotrigine by 14.6%, and levetiracetam by 20.3%.

“We found that the patients who stayed in the study the longest had greater reductions in their concomitant antiepileptic mediation,” said Dr. Rosenfeld. Lowering concomitant medications did not reduce efficacy at a target dose of 200 mg/day.

The investigators hope to test the drug in children and in patients with different seizure types.
 

Promising, with caveats

Commenting on the research, Jong Woo Lee, MD, PhD, associate professor of neurology, the Edward B. Bromfield Epilepsy Program, Brigham and Women’s Hospital, Boston, said cenobamate “has certainly given new hope” to some of his patients. He noted that a few of these patients had been experiencing daily or nearly daily seizures and had been taking three or more medications for many years.

“The chances of another medication being effective for these patients is very low,” said Dr. Lee, who was not involved with the research. “But several of these patients responded to cenobamate, and some of them achieved complete seizure freedom.”

However, as with all new promising medications, there are some caveats. “The concern is for long-term efficacy for more than 5 years and, of course, unforeseen side effects,” Dr. Lee said.

The studies were funded by SK Life Science. Dr. Rosenfeld has been a consultant for SK Life Science. Dr. Lee has disclosed no relevant financial relationships.

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

Cenobamate (Xcopri, SK Life Science), a new epilepsy drug, is safe and effective up to 1 year, new research shows. Post hoc analyses from an open-label study showed that seizure frequency was significantly reduced and the seizure-freedom rate was significantly improved among 240 adult participants who received cenobamate. The patients’ use of concomitant antiseizure medications was also reduced, with no effect on efficacy.

These results are “fascinating” and “very, very exciting,” said lead author William E. Rosenfeld, MD, director, Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, Mo. Although responder rates were impressive, at 50% or greater and 75% or greater, “what patients really want is to have seizure freedom, or at least a 90% reduction in seizures,” Dr. Rosenfeld said.

The findings were presented at the annual meeting of the American Epilepsy Society, held online this year.
 

Adverse events

Cenobamate reduces seizures by inhibiting sodium current or affecting the GABA_A channel, or potentially through a combination of these two mechanisms, said Dr. Rosenfeld. The drug was approved by the U.S. Food and Drug Administration in November 2019 for the treatment of uncontrolled partial-onset seizures in adults, which represent about 60% of all epileptic seizures. It has been on the market since May 2020.

During the drug’s development, three cases of drug reaction with eosinophilia and systemic symptoms (DRESS) occurred. This condition typically involves a skin rash, fever, swollen lymph nodes, and characteristic blood abnormalities, including a high level of eosinophils. However, an open-label study, published earlier this year in Epilepsia, that assessed safety and pharmacokinetics in 1,347 patients aged 18-70 years who received stable doses of one to three antiseizure medications showed that, with “slow and low titration” of cenobamate, there were no cases of DRESS, Dr. Rosenfeld said.

In that safety study, investigators administered increasing daily doses of cenobamate at 12.5, 25, 50, 100, 150, and 200 mg/day at 2-week intervals. If necessary, the dose could be increased to 400 mg/day via 50-mg/day increments every other week.

The researchers presented post hoc analyses regarding 240 patients from 10 U.S. sites who participated in the safety study. Dr. Rosenfeld noted, “These are all good epilepsy centers, and they all kept seizure records.” Of these participants, 177 continued taking the drug as they had at their last visit for a mean of more than 30 months; for some, it was up to 44 months.

“So we had a 73.8% retention rate over the course of the open label, which is the maintenance phase of the study,” Dr. Rosenfeld said.

Among the entire group of 240 patients, 25.8% had been seizure free for more than 12 months at their last visit. Of the 177 who continued to take cenobamate, 33.9% were seizure free for an average of 23.5 months.

“We have never seen those kinds of numbers in the past,” said Dr. Rosenfeld, adding, “it’s so important for patients to get seizure freedom.” These promising results may be related to the fact that the drug works on more than one mechanism of seizure, he speculated.

For some patients, the drug will “make a big difference” by providing them with the best quality of life and allow them to resume normal activities, Dr. Rosenfeld noted. In addition, the drug was well tolerated. The most common adverse events were dizziness/diplopia and sleepiness/drowsiness.
 

Concomitant drug reductions

Another post hoc analysis of the 240 patients showed that many patients were able to reduce use of other antiseizure medications. At study outset, about 41% were taking lacosamide, 35.7% were taking levetiracetam, and 27.7% were taking lamotrigine. Among patients who continued to take cenobamate, 22.7% of concomitant baseline antiseizure medications were discontinued. Carbamazepine was discontinued by 31.3%, oxcarbazepine by 26.7%, lacosamide by 23.4%, eslicarbazepine by 23.1%, clobazam by 26.7%, lamotrigine by 14.6%, and levetiracetam by 20.3%.

“We found that the patients who stayed in the study the longest had greater reductions in their concomitant antiepileptic mediation,” said Dr. Rosenfeld. Lowering concomitant medications did not reduce efficacy at a target dose of 200 mg/day.

The investigators hope to test the drug in children and in patients with different seizure types.
 

Promising, with caveats

Commenting on the research, Jong Woo Lee, MD, PhD, associate professor of neurology, the Edward B. Bromfield Epilepsy Program, Brigham and Women’s Hospital, Boston, said cenobamate “has certainly given new hope” to some of his patients. He noted that a few of these patients had been experiencing daily or nearly daily seizures and had been taking three or more medications for many years.

“The chances of another medication being effective for these patients is very low,” said Dr. Lee, who was not involved with the research. “But several of these patients responded to cenobamate, and some of them achieved complete seizure freedom.”

However, as with all new promising medications, there are some caveats. “The concern is for long-term efficacy for more than 5 years and, of course, unforeseen side effects,” Dr. Lee said.

The studies were funded by SK Life Science. Dr. Rosenfeld has been a consultant for SK Life Science. Dr. Lee has disclosed no relevant financial relationships.

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

Cenobamate (Xcopri, SK Life Science), a new epilepsy drug, is safe and effective up to 1 year, new research shows. Post hoc analyses from an open-label study showed that seizure frequency was significantly reduced and the seizure-freedom rate was significantly improved among 240 adult participants who received cenobamate. The patients’ use of concomitant antiseizure medications was also reduced, with no effect on efficacy.

These results are “fascinating” and “very, very exciting,” said lead author William E. Rosenfeld, MD, director, Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, Mo. Although responder rates were impressive, at 50% or greater and 75% or greater, “what patients really want is to have seizure freedom, or at least a 90% reduction in seizures,” Dr. Rosenfeld said.

The findings were presented at the annual meeting of the American Epilepsy Society, held online this year.
 

Adverse events

Cenobamate reduces seizures by inhibiting sodium current or affecting the GABA_A channel, or potentially through a combination of these two mechanisms, said Dr. Rosenfeld. The drug was approved by the U.S. Food and Drug Administration in November 2019 for the treatment of uncontrolled partial-onset seizures in adults, which represent about 60% of all epileptic seizures. It has been on the market since May 2020.

During the drug’s development, three cases of drug reaction with eosinophilia and systemic symptoms (DRESS) occurred. This condition typically involves a skin rash, fever, swollen lymph nodes, and characteristic blood abnormalities, including a high level of eosinophils. However, an open-label study, published earlier this year in Epilepsia, that assessed safety and pharmacokinetics in 1,347 patients aged 18-70 years who received stable doses of one to three antiseizure medications showed that, with “slow and low titration” of cenobamate, there were no cases of DRESS, Dr. Rosenfeld said.

In that safety study, investigators administered increasing daily doses of cenobamate at 12.5, 25, 50, 100, 150, and 200 mg/day at 2-week intervals. If necessary, the dose could be increased to 400 mg/day via 50-mg/day increments every other week.

The researchers presented post hoc analyses regarding 240 patients from 10 U.S. sites who participated in the safety study. Dr. Rosenfeld noted, “These are all good epilepsy centers, and they all kept seizure records.” Of these participants, 177 continued taking the drug as they had at their last visit for a mean of more than 30 months; for some, it was up to 44 months.

“So we had a 73.8% retention rate over the course of the open label, which is the maintenance phase of the study,” Dr. Rosenfeld said.

Among the entire group of 240 patients, 25.8% had been seizure free for more than 12 months at their last visit. Of the 177 who continued to take cenobamate, 33.9% were seizure free for an average of 23.5 months.

“We have never seen those kinds of numbers in the past,” said Dr. Rosenfeld, adding, “it’s so important for patients to get seizure freedom.” These promising results may be related to the fact that the drug works on more than one mechanism of seizure, he speculated.

For some patients, the drug will “make a big difference” by providing them with the best quality of life and allow them to resume normal activities, Dr. Rosenfeld noted. In addition, the drug was well tolerated. The most common adverse events were dizziness/diplopia and sleepiness/drowsiness.
 

Concomitant drug reductions

Another post hoc analysis of the 240 patients showed that many patients were able to reduce use of other antiseizure medications. At study outset, about 41% were taking lacosamide, 35.7% were taking levetiracetam, and 27.7% were taking lamotrigine. Among patients who continued to take cenobamate, 22.7% of concomitant baseline antiseizure medications were discontinued. Carbamazepine was discontinued by 31.3%, oxcarbazepine by 26.7%, lacosamide by 23.4%, eslicarbazepine by 23.1%, clobazam by 26.7%, lamotrigine by 14.6%, and levetiracetam by 20.3%.

“We found that the patients who stayed in the study the longest had greater reductions in their concomitant antiepileptic mediation,” said Dr. Rosenfeld. Lowering concomitant medications did not reduce efficacy at a target dose of 200 mg/day.

The investigators hope to test the drug in children and in patients with different seizure types.
 

Promising, with caveats

Commenting on the research, Jong Woo Lee, MD, PhD, associate professor of neurology, the Edward B. Bromfield Epilepsy Program, Brigham and Women’s Hospital, Boston, said cenobamate “has certainly given new hope” to some of his patients. He noted that a few of these patients had been experiencing daily or nearly daily seizures and had been taking three or more medications for many years.

“The chances of another medication being effective for these patients is very low,” said Dr. Lee, who was not involved with the research. “But several of these patients responded to cenobamate, and some of them achieved complete seizure freedom.”

However, as with all new promising medications, there are some caveats. “The concern is for long-term efficacy for more than 5 years and, of course, unforeseen side effects,” Dr. Lee said.

The studies were funded by SK Life Science. Dr. Rosenfeld has been a consultant for SK Life Science. Dr. Lee has disclosed no relevant financial relationships.

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

As an aspiring physician, I like learning about how things work. Since medical students learn very little about the “business” of medicine in school, this led me to pioneer a project on missed billing by hospitalists at a medium-sized hospital in the northeastern US. Although hospitalists do a tremendous amount of work, they do not always bill for what they are doing. The question became: Why are hospitalists missing charges and what can we do to stop it?

Shortly into my study, I recognized there was little daily communication between the administrators and the hospitalists; neither the hospitalists nor administrators understood the different dynamics that the others faced in their own workplace. It became apparent that administrators needed to learn what was important to hospitalists and to address them at their level in order to bring about change.

Some trending themes emerged as I started shadowing the hospitalists. Many of them asked how this project would benefit them. They argued that administrative needs should be dealt with at the administrative level. A major point was made that current incentives, such as the bonuses given for exceeding a certain number of RVUs, were not the motivating force behind their work ethics. From my observations, the motivating factors were the quality of their patient care, the needs of their patients, and teaching. The hospitalists also were eager to teach and continually instructed me on clinical skills and how to be a better medical student.

Bonuses or notoriety didn’t seem to be the main incentives for them. However, efficiency – especially in rounding – was important, and that became the focal point of the project. I found several studies that showed that improvements in aspects of rounding led to increased quality of patient care, decreased burnout, increased patient satisfaction, and decreased workload and discussed some of those findings with the hospitalists.^1-10 When the hospitalists felt that their concerns were being heard, they became even more involved in the project, and the administrators and hospitalists started working together as a team.

One hospitalist spent two hours helping me design the platform that would be used for hospitalists to report barriers in their rounding process that may cause them to miss a charge. Once we identified those barriers, we discussed the possibility of standardizing their workflow based off these data. Many hospitalists argued that each physician has unique skills and practices that make them successful; therefore, the disruption of an already established workflow may cause a decrease in efficiency.

The hospitalists and I talked a lot about the importance of them rounding more efficiently and how that could positively affect the time that they have with their patients and themselves. We discussed that due to the additional work missed billing causes, minimizing this burden can possibly help decrease burnout. As a result, seven hospitalists, the administrative staff, and I met and created thirteen best practices, six of which they were able to get approved to use immediately. To note, hospitalists bill differently; some use a software company, fill out paper forms still or have integration within their EMR. Although these solutions were made for a program which has the ability to bill within the EMR, many of the principles will apply to your program too.

When a doctor signs a note, it opens a charge option or there is a hard stop.

Charge delinquencies are sent via email to the hospitalist.

Standardize that hospitalists charge directly after writing a note consistently as part of their workflow.*

Prioritize discharges before rounding.*

Standardize the use of the “my prof charges” column, a feature of this hospital’s EMR system that tells them if they had made a charge to a patient or not, in order to remind them to/confirm billing a patient.*

Create reports by the EMR system to provide charge data for individual providers.

Create a report for bill vs note to help providers self-audit. At this hospital, this feature was offered to the administrators as a way to audit their providers and doctors.

Ensure that when a patient is seen by a physician hospitalist as well as an NP/PA hospitalist, the appropriate charge for the physician is entered.

Notifications get sent to the physician hospitalist if a charge gets deleted by another person (e.g., NP/PA hospitalist).

Handoff of daily rounding sheets, or a paper copy of the patients assigned to a hospitalist for his/her shift, at the end of the shift to the project specialist.*

To keep the rounding sheets a complete and accurate account of the patients seen by the hospitalist.*

Hospitalists are to complete and check all billing at the end of their shift at the latest.*

Hospitalists are to participate on Provider Efficiency Training to optimize workflow, by creating more efficient note-writing behavior using Dragon.

*Indicates the practices the hospitalists were able to implement immediately. Practices 1, 2, 6, 7, and 9 request EMR changes. Practice 8 was already an established practice the hospitalists wished to continue. Practice 13 was suggested by the Lean Director for the continuation of a previous project.


Six of the best practices were easier to implement right away because they were at the discretion of the hospitalists. We found that the hospitalists who had the highest billing performances were more likely to start writing notes and charge earlier while rounding. Those who had poorer billing performances were more likely to leave all note writing and billing towards the end of their shift. The few exceptions (hospitalists who left all note writing and charging to the end of their shift yet had high billing performances) were found to have a consistent and standardized workflow. This was unlike the hospitalists who had the lowest billing performances. Having practices that help remind hospitalists to bill will surely help prevent missed billing, but because of the findings from this project, it was important to have consistent and standardized practices to additionally improve missed billing.

• Hospitalists favor solutions that benefit them or their patients.
• Hospitalists want to be part of the solution process.
• Hospitalists were more likely to accept ideas to improve their rounding if it meant they could keep their routine.

Obstacles exist in our health care system that prevent administrators and hospitalists from working together as a team. The more we are able to communicate and collaborate to fix problems in the health system, the more we can use the system to our mutual advantage. With the ongoing changes in medicine, especially during uncertain times, better communication needs be a major priority to affect positive change.

Ms. Mirabella attends the Frank H. Netter MD School of Medicine at Quinnipiac University, Hamden, Conn., in the class of 2022. She has interests in internal/hospital medicine, primary care, and health management and leadership. Dr. Rosenberg is associate professor at the Frank H. Netter MD School of Medicine at Quinnipiac University where she is director of clinical skills coaching. Dr. Kiassat is associate dean of the School of Engineering and associate clinical professor at Frank H. Netter MD School of Medicine, at Quinnipiac University. His research interests are in process improvement in health care, using Lean Six Sigma.

References

1. Burdick K, et al. Bedside interprofessional rounding. J Patient Exp. 2017;4(1):22-27. doi: 10.1177/2374373517692910.

2. Patel CR. Improving communication between hospitalists and consultants. The Hospital Leader. 2018. https://thehospitalleader.org/improving-communication-between-hospitalists-and-consultants/.

3. Adams TN, et al. Hospitalist perspective of interactions with medicine subspecialty consult services. J Hosp Med. 2018;13(5):318-323. doi: 10.12788/jhm.2882.

4. Michtalik HJ, et al. Impact of attending physician workload on patient care: A survey of hospitalists. JAMA Intern Med. 2013;173(5):375-377. doi: 10.1001/jamainternmed.2013.1864.

5. Chandra R, et al. How hospitalists can improve efficiency on inpatient wards. The Hospitalist. 2014. https://www.the-hospitalist.org/hospitalist/article/126231/how-hospitalists-can-improve-efficiency-inpatient-wards.

6. Chand DV. Observational study using the tools of lean six sigma to improve the efficiency of the resident rounding process. J Grad Med Educ. 2011;3(2):144-150. doi: 10.4300/JGME-D-10-00116.1.

7. O’Leary KJ, et al. How hospitalists spend their time: Insights on efficiency and safety. J Hosp Med. 2006;1(2):88-93. doi: 10.1002/jhm.88.

8. Wachter RM. Hospitalist workload: The search for the magic number. JAMA Intern Med. 2014;174(5):794-795. doi: 10.1001/jamainternmed.2014.18.

9. Bryson C, et al. Geographical assignment of hospitalists in an urban teaching hospital: Feasibility and impact on efficiency and provider satisfaction. Hospital Practice. 2017;45(4):135-142. doi: 10.1080/21548331.2017.1353884.

10. Calderon AS, et al. Transforming ward rounds through rounding-in-flow. J Grad Med Educ. 2014 Dec;6(4):750-5. doi: 10.4300/JGME-D-13-00324.1.

As an aspiring physician, I like learning about how things work. Since medical students learn very little about the “business” of medicine in school, this led me to pioneer a project on missed billing by hospitalists at a medium-sized hospital in the northeastern US. Although hospitalists do a tremendous amount of work, they do not always bill for what they are doing. The question became: Why are hospitalists missing charges and what can we do to stop it?

Shortly into my study, I recognized there was little daily communication between the administrators and the hospitalists; neither the hospitalists nor administrators understood the different dynamics that the others faced in their own workplace. It became apparent that administrators needed to learn what was important to hospitalists and to address them at their level in order to bring about change.

Some trending themes emerged as I started shadowing the hospitalists. Many of them asked how this project would benefit them. They argued that administrative needs should be dealt with at the administrative level. A major point was made that current incentives, such as the bonuses given for exceeding a certain number of RVUs, were not the motivating force behind their work ethics. From my observations, the motivating factors were the quality of their patient care, the needs of their patients, and teaching. The hospitalists also were eager to teach and continually instructed me on clinical skills and how to be a better medical student.

Bonuses or notoriety didn’t seem to be the main incentives for them. However, efficiency – especially in rounding – was important, and that became the focal point of the project. I found several studies that showed that improvements in aspects of rounding led to increased quality of patient care, decreased burnout, increased patient satisfaction, and decreased workload and discussed some of those findings with the hospitalists.^1-10 When the hospitalists felt that their concerns were being heard, they became even more involved in the project, and the administrators and hospitalists started working together as a team.

One hospitalist spent two hours helping me design the platform that would be used for hospitalists to report barriers in their rounding process that may cause them to miss a charge. Once we identified those barriers, we discussed the possibility of standardizing their workflow based off these data. Many hospitalists argued that each physician has unique skills and practices that make them successful; therefore, the disruption of an already established workflow may cause a decrease in efficiency.

The hospitalists and I talked a lot about the importance of them rounding more efficiently and how that could positively affect the time that they have with their patients and themselves. We discussed that due to the additional work missed billing causes, minimizing this burden can possibly help decrease burnout. As a result, seven hospitalists, the administrative staff, and I met and created thirteen best practices, six of which they were able to get approved to use immediately. To note, hospitalists bill differently; some use a software company, fill out paper forms still or have integration within their EMR. Although these solutions were made for a program which has the ability to bill within the EMR, many of the principles will apply to your program too.

When a doctor signs a note, it opens a charge option or there is a hard stop.

Charge delinquencies are sent via email to the hospitalist.

Standardize that hospitalists charge directly after writing a note consistently as part of their workflow.*

Prioritize discharges before rounding.*

Standardize the use of the “my prof charges” column, a feature of this hospital’s EMR system that tells them if they had made a charge to a patient or not, in order to remind them to/confirm billing a patient.*

Create reports by the EMR system to provide charge data for individual providers.

Create a report for bill vs note to help providers self-audit. At this hospital, this feature was offered to the administrators as a way to audit their providers and doctors.

Ensure that when a patient is seen by a physician hospitalist as well as an NP/PA hospitalist, the appropriate charge for the physician is entered.

Notifications get sent to the physician hospitalist if a charge gets deleted by another person (e.g., NP/PA hospitalist).

Handoff of daily rounding sheets, or a paper copy of the patients assigned to a hospitalist for his/her shift, at the end of the shift to the project specialist.*

To keep the rounding sheets a complete and accurate account of the patients seen by the hospitalist.*

Hospitalists are to complete and check all billing at the end of their shift at the latest.*

Hospitalists are to participate on Provider Efficiency Training to optimize workflow, by creating more efficient note-writing behavior using Dragon.

*Indicates the practices the hospitalists were able to implement immediately. Practices 1, 2, 6, 7, and 9 request EMR changes. Practice 8 was already an established practice the hospitalists wished to continue. Practice 13 was suggested by the Lean Director for the continuation of a previous project.


Six of the best practices were easier to implement right away because they were at the discretion of the hospitalists. We found that the hospitalists who had the highest billing performances were more likely to start writing notes and charge earlier while rounding. Those who had poorer billing performances were more likely to leave all note writing and billing towards the end of their shift. The few exceptions (hospitalists who left all note writing and charging to the end of their shift yet had high billing performances) were found to have a consistent and standardized workflow. This was unlike the hospitalists who had the lowest billing performances. Having practices that help remind hospitalists to bill will surely help prevent missed billing, but because of the findings from this project, it was important to have consistent and standardized practices to additionally improve missed billing.

• Hospitalists favor solutions that benefit them or their patients.
• Hospitalists want to be part of the solution process.
• Hospitalists were more likely to accept ideas to improve their rounding if it meant they could keep their routine.

Obstacles exist in our health care system that prevent administrators and hospitalists from working together as a team. The more we are able to communicate and collaborate to fix problems in the health system, the more we can use the system to our mutual advantage. With the ongoing changes in medicine, especially during uncertain times, better communication needs be a major priority to affect positive change.

Ms. Mirabella attends the Frank H. Netter MD School of Medicine at Quinnipiac University, Hamden, Conn., in the class of 2022. She has interests in internal/hospital medicine, primary care, and health management and leadership. Dr. Rosenberg is associate professor at the Frank H. Netter MD School of Medicine at Quinnipiac University where she is director of clinical skills coaching. Dr. Kiassat is associate dean of the School of Engineering and associate clinical professor at Frank H. Netter MD School of Medicine, at Quinnipiac University. His research interests are in process improvement in health care, using Lean Six Sigma.

References

1. Burdick K, et al. Bedside interprofessional rounding. J Patient Exp. 2017;4(1):22-27. doi: 10.1177/2374373517692910.

2. Patel CR. Improving communication between hospitalists and consultants. The Hospital Leader. 2018. https://thehospitalleader.org/improving-communication-between-hospitalists-and-consultants/.

3. Adams TN, et al. Hospitalist perspective of interactions with medicine subspecialty consult services. J Hosp Med. 2018;13(5):318-323. doi: 10.12788/jhm.2882.

4. Michtalik HJ, et al. Impact of attending physician workload on patient care: A survey of hospitalists. JAMA Intern Med. 2013;173(5):375-377. doi: 10.1001/jamainternmed.2013.1864.

5. Chandra R, et al. How hospitalists can improve efficiency on inpatient wards. The Hospitalist. 2014. https://www.the-hospitalist.org/hospitalist/article/126231/how-hospitalists-can-improve-efficiency-inpatient-wards.

6. Chand DV. Observational study using the tools of lean six sigma to improve the efficiency of the resident rounding process. J Grad Med Educ. 2011;3(2):144-150. doi: 10.4300/JGME-D-10-00116.1.

7. O’Leary KJ, et al. How hospitalists spend their time: Insights on efficiency and safety. J Hosp Med. 2006;1(2):88-93. doi: 10.1002/jhm.88.

8. Wachter RM. Hospitalist workload: The search for the magic number. JAMA Intern Med. 2014;174(5):794-795. doi: 10.1001/jamainternmed.2014.18.

9. Bryson C, et al. Geographical assignment of hospitalists in an urban teaching hospital: Feasibility and impact on efficiency and provider satisfaction. Hospital Practice. 2017;45(4):135-142. doi: 10.1080/21548331.2017.1353884.

10. Calderon AS, et al. Transforming ward rounds through rounding-in-flow. J Grad Med Educ. 2014 Dec;6(4):750-5. doi: 10.4300/JGME-D-13-00324.1.

As an aspiring physician, I like learning about how things work. Since medical students learn very little about the “business” of medicine in school, this led me to pioneer a project on missed billing by hospitalists at a medium-sized hospital in the northeastern US. Although hospitalists do a tremendous amount of work, they do not always bill for what they are doing. The question became: Why are hospitalists missing charges and what can we do to stop it?

Shortly into my study, I recognized there was little daily communication between the administrators and the hospitalists; neither the hospitalists nor administrators understood the different dynamics that the others faced in their own workplace. It became apparent that administrators needed to learn what was important to hospitalists and to address them at their level in order to bring about change.

Some trending themes emerged as I started shadowing the hospitalists. Many of them asked how this project would benefit them. They argued that administrative needs should be dealt with at the administrative level. A major point was made that current incentives, such as the bonuses given for exceeding a certain number of RVUs, were not the motivating force behind their work ethics. From my observations, the motivating factors were the quality of their patient care, the needs of their patients, and teaching. The hospitalists also were eager to teach and continually instructed me on clinical skills and how to be a better medical student.

Bonuses or notoriety didn’t seem to be the main incentives for them. However, efficiency – especially in rounding – was important, and that became the focal point of the project. I found several studies that showed that improvements in aspects of rounding led to increased quality of patient care, decreased burnout, increased patient satisfaction, and decreased workload and discussed some of those findings with the hospitalists.^1-10 When the hospitalists felt that their concerns were being heard, they became even more involved in the project, and the administrators and hospitalists started working together as a team.

One hospitalist spent two hours helping me design the platform that would be used for hospitalists to report barriers in their rounding process that may cause them to miss a charge. Once we identified those barriers, we discussed the possibility of standardizing their workflow based off these data. Many hospitalists argued that each physician has unique skills and practices that make them successful; therefore, the disruption of an already established workflow may cause a decrease in efficiency.

The hospitalists and I talked a lot about the importance of them rounding more efficiently and how that could positively affect the time that they have with their patients and themselves. We discussed that due to the additional work missed billing causes, minimizing this burden can possibly help decrease burnout. As a result, seven hospitalists, the administrative staff, and I met and created thirteen best practices, six of which they were able to get approved to use immediately. To note, hospitalists bill differently; some use a software company, fill out paper forms still or have integration within their EMR. Although these solutions were made for a program which has the ability to bill within the EMR, many of the principles will apply to your program too.

When a doctor signs a note, it opens a charge option or there is a hard stop.

Charge delinquencies are sent via email to the hospitalist.

Standardize that hospitalists charge directly after writing a note consistently as part of their workflow.*

Prioritize discharges before rounding.*

Standardize the use of the “my prof charges” column, a feature of this hospital’s EMR system that tells them if they had made a charge to a patient or not, in order to remind them to/confirm billing a patient.*

Create reports by the EMR system to provide charge data for individual providers.

Create a report for bill vs note to help providers self-audit. At this hospital, this feature was offered to the administrators as a way to audit their providers and doctors.

Ensure that when a patient is seen by a physician hospitalist as well as an NP/PA hospitalist, the appropriate charge for the physician is entered.

Notifications get sent to the physician hospitalist if a charge gets deleted by another person (e.g., NP/PA hospitalist).

Handoff of daily rounding sheets, or a paper copy of the patients assigned to a hospitalist for his/her shift, at the end of the shift to the project specialist.*

To keep the rounding sheets a complete and accurate account of the patients seen by the hospitalist.*

Hospitalists are to complete and check all billing at the end of their shift at the latest.*

Hospitalists are to participate on Provider Efficiency Training to optimize workflow, by creating more efficient note-writing behavior using Dragon.

*Indicates the practices the hospitalists were able to implement immediately. Practices 1, 2, 6, 7, and 9 request EMR changes. Practice 8 was already an established practice the hospitalists wished to continue. Practice 13 was suggested by the Lean Director for the continuation of a previous project.


Six of the best practices were easier to implement right away because they were at the discretion of the hospitalists. We found that the hospitalists who had the highest billing performances were more likely to start writing notes and charge earlier while rounding. Those who had poorer billing performances were more likely to leave all note writing and billing towards the end of their shift. The few exceptions (hospitalists who left all note writing and charging to the end of their shift yet had high billing performances) were found to have a consistent and standardized workflow. This was unlike the hospitalists who had the lowest billing performances. Having practices that help remind hospitalists to bill will surely help prevent missed billing, but because of the findings from this project, it was important to have consistent and standardized practices to additionally improve missed billing.

• Hospitalists favor solutions that benefit them or their patients.
• Hospitalists want to be part of the solution process.
• Hospitalists were more likely to accept ideas to improve their rounding if it meant they could keep their routine.

Obstacles exist in our health care system that prevent administrators and hospitalists from working together as a team. The more we are able to communicate and collaborate to fix problems in the health system, the more we can use the system to our mutual advantage. With the ongoing changes in medicine, especially during uncertain times, better communication needs be a major priority to affect positive change.

Ms. Mirabella attends the Frank H. Netter MD School of Medicine at Quinnipiac University, Hamden, Conn., in the class of 2022. She has interests in internal/hospital medicine, primary care, and health management and leadership. Dr. Rosenberg is associate professor at the Frank H. Netter MD School of Medicine at Quinnipiac University where she is director of clinical skills coaching. Dr. Kiassat is associate dean of the School of Engineering and associate clinical professor at Frank H. Netter MD School of Medicine, at Quinnipiac University. His research interests are in process improvement in health care, using Lean Six Sigma.

References

1. Burdick K, et al. Bedside interprofessional rounding. J Patient Exp. 2017;4(1):22-27. doi: 10.1177/2374373517692910.

2. Patel CR. Improving communication between hospitalists and consultants. The Hospital Leader. 2018. https://thehospitalleader.org/improving-communication-between-hospitalists-and-consultants/.

3. Adams TN, et al. Hospitalist perspective of interactions with medicine subspecialty consult services. J Hosp Med. 2018;13(5):318-323. doi: 10.12788/jhm.2882.

4. Michtalik HJ, et al. Impact of attending physician workload on patient care: A survey of hospitalists. JAMA Intern Med. 2013;173(5):375-377. doi: 10.1001/jamainternmed.2013.1864.

5. Chandra R, et al. How hospitalists can improve efficiency on inpatient wards. The Hospitalist. 2014. https://www.the-hospitalist.org/hospitalist/article/126231/how-hospitalists-can-improve-efficiency-inpatient-wards.

6. Chand DV. Observational study using the tools of lean six sigma to improve the efficiency of the resident rounding process. J Grad Med Educ. 2011;3(2):144-150. doi: 10.4300/JGME-D-10-00116.1.

7. O’Leary KJ, et al. How hospitalists spend their time: Insights on efficiency and safety. J Hosp Med. 2006;1(2):88-93. doi: 10.1002/jhm.88.

8. Wachter RM. Hospitalist workload: The search for the magic number. JAMA Intern Med. 2014;174(5):794-795. doi: 10.1001/jamainternmed.2014.18.

9. Bryson C, et al. Geographical assignment of hospitalists in an urban teaching hospital: Feasibility and impact on efficiency and provider satisfaction. Hospital Practice. 2017;45(4):135-142. doi: 10.1080/21548331.2017.1353884.

10. Calderon AS, et al. Transforming ward rounds through rounding-in-flow. J Grad Med Educ. 2014 Dec;6(4):750-5. doi: 10.4300/JGME-D-13-00324.1.