Journal of Clinical Outcomes Management

SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.

The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.

Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.

“The algorithm takes from the larger clinical practice guideline and distills down those management principles in a much more digestible way, and a way that can be used every day in the clinic,” lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.

Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
 

Eleven separate algorithms with text and graphics

Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”

Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.

Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.

Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”

And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.

Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.

Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.

“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.

The end of the document includes a full page of each graphic, meant for wall posting.

Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.

“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.

Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”

“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.

Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.

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

SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.

The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.

Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.

“The algorithm takes from the larger clinical practice guideline and distills down those management principles in a much more digestible way, and a way that can be used every day in the clinic,” lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.

Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
 

Eleven separate algorithms with text and graphics

Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”

Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.

Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.

Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”

And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.

Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.

Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.

“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.

The end of the document includes a full page of each graphic, meant for wall posting.

Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.

“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.

Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”

“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.

Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.

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

SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.

The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.

Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.

“The algorithm takes from the larger clinical practice guideline and distills down those management principles in a much more digestible way, and a way that can be used every day in the clinic,” lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.

Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
 

Eleven separate algorithms with text and graphics

Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”

Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.

Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.

Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”

And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.

Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.

Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.

“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.

The end of the document includes a full page of each graphic, meant for wall posting.

Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.

“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.

Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”

“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.

Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.

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

Treating Helicobacter pylori infection markedly reduces the risk for stomach cancer, a large study from Kaiser Permanente Northern California demonstrates.

People with H. pylori who were treated had about a 63% lower risk of developing noncardia gastric adenocarcinoma (NCGA) after 8 years of follow-up, compared with peers with H. pylori who were not treated.

The U.S. data align with previous studies, conducted mostly in Asia, that found that treating the infection can reduce stomach cancer incidence.

The KPNC study shows the “potential for stomach cancer prevention in U.S. populations through H. pylori screening and treatment,” study investigator Dan Li, MD, gastroenterologist with the Kaiser Permanente Medical Group and Kaiser Permanente Division of Research in Oakland, Calif., said in an interview.

Judith Kim, MD, a gastroenterologist at NYU Langone Health in New York, who wasn’t involved in the research, said that the study is significant because “it is the first to show this effect in a large, diverse population in the U.S., where gastric cancer incidence is lower.”

The study was published online in Gastroenterology.
 

Top risk factor

About 30% of people in the United States are infected with H. pylori, which is the No. 1 known risk factor for stomach cancer, Dr. Li said.

The study cohort included 716,567 KPNC members who underwent H. pylori testing and/or treatment between 1997 and 2015.

Among H. pylori–infected individuals (based on positive nonserology test results), the subdistribution hazard ratio was 6.07 for untreated individuals and 2.68 for treated individuals, compared with H. pylori–negative individuals.

It’s not surprising that people who were treated for the infection still had a higher risk of NCGA than people who had never had the infection, Dr. Li said.

“This is likely because many people with chronic H. pylori infection had already developed some precancerous changes in their stomach before they were treated. This finding suggests that H. pylori ideally should be treated before precancerous changes develop,” he said.

When compared directly with H. pylori–positive/untreated individuals, the risk for NCGA in H. pylori–positive/treated individuals was somewhat lower at less than 8 years follow-up (sHR, 0.95) and significantly lower at 8+ years of follow-up (sHR, 0.37).

“After 7-10 years of follow-up, people with H. pylori who received treatment had nearly half the risk of developing stomach cancer as the general population,” Dr. Li said. “This is likely because most people infected with H. pylori in the general population are not screened nor treated. This highlights the impact screening and treatment can have.”

The data also show that cumulative incidence curves for H. pylori–positive/untreated and H. pylori–positive/treated largely overlapped during the first 7 years of follow-up and started to separate after 8 years.

At 10 years, cumulative NCGA incidence rates for H. pylori–positive/untreated, H. pylori–positive/treated, and H. pylori negative were 31.0, 19.7, and 3.5 per 10,000 persons, respectively (P < .0001).

This study shows that treating H. pylori reduces stomach cancer incidence in the United States, thus “filling an important research and knowledge gap,” Dr. Li said.

In the United States, Asian, Black, and Hispanic adults are much more likely to be infected with H. pylori, and they have a two- to threefold higher risk of developing stomach cancer, he noted.

“This suggests it may be reasonable to consider targeted screening and treatment in these high-risk groups. However, the optimal strategy for population-based H. pylori screening has not been established, and more research is needed to determine who should be screened for H. pylori and at what age screening should begin,” Dr. Li said.
 

Strong data, jury out on universal screening

For additional comment, this news organization reached out to Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America and chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y.

The study shows that the treatment of H. pylori “absolutely will decrease your risk of certain types of gastric carcinoma down the line. It does take a while to show that, 7 years, but this study shows that very clearly,” Dr. Glatt said.

“People who have definitely been shown to have H. pylori should be treated,” Dr. Glatt said.

“I don’t think this study yet supports that everybody should be screened, but it does make sense that people who have upper GI symptoms consistent with H. pylori should be checked for H. pylori and then appropriately treated, he noted.

Routine screening for H. pylori is recommended in countries with high incidence of gastric cancer, but not in the United States, Dr. Kim noted.

“Given the risk reduction of cancer with H. pylori treatment, consideration should be made in the U.S. for asymptomatic individuals with a family history of gastric cancer or immigrants from high-incidence countries,” she added.

The study was funded by the Kaiser Permanente Northern California Community Health Research Grants Program, the Permanente Medical Group Delivery Science & Applied Research Program, and the Permanente Medical Group. Dr. Li, Dr. Glatt, and Dr. Kim have declared no relevant financial relationships.

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

Treating Helicobacter pylori infection markedly reduces the risk for stomach cancer, a large study from Kaiser Permanente Northern California demonstrates.

People with H. pylori who were treated had about a 63% lower risk of developing noncardia gastric adenocarcinoma (NCGA) after 8 years of follow-up, compared with peers with H. pylori who were not treated.

The U.S. data align with previous studies, conducted mostly in Asia, that found that treating the infection can reduce stomach cancer incidence.

The KPNC study shows the “potential for stomach cancer prevention in U.S. populations through H. pylori screening and treatment,” study investigator Dan Li, MD, gastroenterologist with the Kaiser Permanente Medical Group and Kaiser Permanente Division of Research in Oakland, Calif., said in an interview.

Judith Kim, MD, a gastroenterologist at NYU Langone Health in New York, who wasn’t involved in the research, said that the study is significant because “it is the first to show this effect in a large, diverse population in the U.S., where gastric cancer incidence is lower.”

The study was published online in Gastroenterology.
 

Top risk factor

About 30% of people in the United States are infected with H. pylori, which is the No. 1 known risk factor for stomach cancer, Dr. Li said.

The study cohort included 716,567 KPNC members who underwent H. pylori testing and/or treatment between 1997 and 2015.

Among H. pylori–infected individuals (based on positive nonserology test results), the subdistribution hazard ratio was 6.07 for untreated individuals and 2.68 for treated individuals, compared with H. pylori–negative individuals.

It’s not surprising that people who were treated for the infection still had a higher risk of NCGA than people who had never had the infection, Dr. Li said.

“This is likely because many people with chronic H. pylori infection had already developed some precancerous changes in their stomach before they were treated. This finding suggests that H. pylori ideally should be treated before precancerous changes develop,” he said.

When compared directly with H. pylori–positive/untreated individuals, the risk for NCGA in H. pylori–positive/treated individuals was somewhat lower at less than 8 years follow-up (sHR, 0.95) and significantly lower at 8+ years of follow-up (sHR, 0.37).

“After 7-10 years of follow-up, people with H. pylori who received treatment had nearly half the risk of developing stomach cancer as the general population,” Dr. Li said. “This is likely because most people infected with H. pylori in the general population are not screened nor treated. This highlights the impact screening and treatment can have.”

The data also show that cumulative incidence curves for H. pylori–positive/untreated and H. pylori–positive/treated largely overlapped during the first 7 years of follow-up and started to separate after 8 years.

At 10 years, cumulative NCGA incidence rates for H. pylori–positive/untreated, H. pylori–positive/treated, and H. pylori negative were 31.0, 19.7, and 3.5 per 10,000 persons, respectively (P < .0001).

This study shows that treating H. pylori reduces stomach cancer incidence in the United States, thus “filling an important research and knowledge gap,” Dr. Li said.

In the United States, Asian, Black, and Hispanic adults are much more likely to be infected with H. pylori, and they have a two- to threefold higher risk of developing stomach cancer, he noted.

“This suggests it may be reasonable to consider targeted screening and treatment in these high-risk groups. However, the optimal strategy for population-based H. pylori screening has not been established, and more research is needed to determine who should be screened for H. pylori and at what age screening should begin,” Dr. Li said.
 

Strong data, jury out on universal screening

For additional comment, this news organization reached out to Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America and chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y.

The study shows that the treatment of H. pylori “absolutely will decrease your risk of certain types of gastric carcinoma down the line. It does take a while to show that, 7 years, but this study shows that very clearly,” Dr. Glatt said.

“People who have definitely been shown to have H. pylori should be treated,” Dr. Glatt said.

“I don’t think this study yet supports that everybody should be screened, but it does make sense that people who have upper GI symptoms consistent with H. pylori should be checked for H. pylori and then appropriately treated, he noted.

Routine screening for H. pylori is recommended in countries with high incidence of gastric cancer, but not in the United States, Dr. Kim noted.

“Given the risk reduction of cancer with H. pylori treatment, consideration should be made in the U.S. for asymptomatic individuals with a family history of gastric cancer or immigrants from high-incidence countries,” she added.

The study was funded by the Kaiser Permanente Northern California Community Health Research Grants Program, the Permanente Medical Group Delivery Science & Applied Research Program, and the Permanente Medical Group. Dr. Li, Dr. Glatt, and Dr. Kim have declared no relevant financial relationships.

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

Treating Helicobacter pylori infection markedly reduces the risk for stomach cancer, a large study from Kaiser Permanente Northern California demonstrates.

People with H. pylori who were treated had about a 63% lower risk of developing noncardia gastric adenocarcinoma (NCGA) after 8 years of follow-up, compared with peers with H. pylori who were not treated.

The U.S. data align with previous studies, conducted mostly in Asia, that found that treating the infection can reduce stomach cancer incidence.

The KPNC study shows the “potential for stomach cancer prevention in U.S. populations through H. pylori screening and treatment,” study investigator Dan Li, MD, gastroenterologist with the Kaiser Permanente Medical Group and Kaiser Permanente Division of Research in Oakland, Calif., said in an interview.

Judith Kim, MD, a gastroenterologist at NYU Langone Health in New York, who wasn’t involved in the research, said that the study is significant because “it is the first to show this effect in a large, diverse population in the U.S., where gastric cancer incidence is lower.”

The study was published online in Gastroenterology.
 

Top risk factor

About 30% of people in the United States are infected with H. pylori, which is the No. 1 known risk factor for stomach cancer, Dr. Li said.

The study cohort included 716,567 KPNC members who underwent H. pylori testing and/or treatment between 1997 and 2015.

Among H. pylori–infected individuals (based on positive nonserology test results), the subdistribution hazard ratio was 6.07 for untreated individuals and 2.68 for treated individuals, compared with H. pylori–negative individuals.

It’s not surprising that people who were treated for the infection still had a higher risk of NCGA than people who had never had the infection, Dr. Li said.

“This is likely because many people with chronic H. pylori infection had already developed some precancerous changes in their stomach before they were treated. This finding suggests that H. pylori ideally should be treated before precancerous changes develop,” he said.

When compared directly with H. pylori–positive/untreated individuals, the risk for NCGA in H. pylori–positive/treated individuals was somewhat lower at less than 8 years follow-up (sHR, 0.95) and significantly lower at 8+ years of follow-up (sHR, 0.37).

“After 7-10 years of follow-up, people with H. pylori who received treatment had nearly half the risk of developing stomach cancer as the general population,” Dr. Li said. “This is likely because most people infected with H. pylori in the general population are not screened nor treated. This highlights the impact screening and treatment can have.”

The data also show that cumulative incidence curves for H. pylori–positive/untreated and H. pylori–positive/treated largely overlapped during the first 7 years of follow-up and started to separate after 8 years.

At 10 years, cumulative NCGA incidence rates for H. pylori–positive/untreated, H. pylori–positive/treated, and H. pylori negative were 31.0, 19.7, and 3.5 per 10,000 persons, respectively (P < .0001).

This study shows that treating H. pylori reduces stomach cancer incidence in the United States, thus “filling an important research and knowledge gap,” Dr. Li said.

In the United States, Asian, Black, and Hispanic adults are much more likely to be infected with H. pylori, and they have a two- to threefold higher risk of developing stomach cancer, he noted.

“This suggests it may be reasonable to consider targeted screening and treatment in these high-risk groups. However, the optimal strategy for population-based H. pylori screening has not been established, and more research is needed to determine who should be screened for H. pylori and at what age screening should begin,” Dr. Li said.
 

Strong data, jury out on universal screening

For additional comment, this news organization reached out to Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America and chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y.

The study shows that the treatment of H. pylori “absolutely will decrease your risk of certain types of gastric carcinoma down the line. It does take a while to show that, 7 years, but this study shows that very clearly,” Dr. Glatt said.

“People who have definitely been shown to have H. pylori should be treated,” Dr. Glatt said.

“I don’t think this study yet supports that everybody should be screened, but it does make sense that people who have upper GI symptoms consistent with H. pylori should be checked for H. pylori and then appropriately treated, he noted.

Routine screening for H. pylori is recommended in countries with high incidence of gastric cancer, but not in the United States, Dr. Kim noted.

“Given the risk reduction of cancer with H. pylori treatment, consideration should be made in the U.S. for asymptomatic individuals with a family history of gastric cancer or immigrants from high-incidence countries,” she added.

The study was funded by the Kaiser Permanente Northern California Community Health Research Grants Program, the Permanente Medical Group Delivery Science & Applied Research Program, and the Permanente Medical Group. Dr. Li, Dr. Glatt, and Dr. Kim have declared no relevant financial relationships.

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

Untreated hearing loss increases dementia risk in middle-aged and older adults, new research confirms. A large observational study from the United Kingdom showed a 42% increased risk for dementia in people with hearing loss compared with their peers with no hearing trouble. In addition, there was no increased risk in those with hearing loss who used hearing aids.

“The evidence is building that hearing loss may be the most impactful modifiable risk factor for dementia in mid-life, but the effectiveness of hearing aid use on reducing the risk of dementia in the real world has remained unclear,” Dongshan Zhu, PhD, with Shandong University, Jinan, China, said in a news release.

“Our study provides the best evidence to date to suggest that hearing aids could be a minimally invasive, cost-effective treatment to mitigate the potential impact of hearing loss on dementia,” Dr. Zhu said.

The study, which was published online in Lancet Public Health, comes on the heels of the 2020 Lancet Commission report on dementia, which suggested hearing loss may be linked to approximately 8% of worldwide dementia cases.
 

‘Compelling’ evidence

For the study, investigators analyzed longitudinal data on 437,704 individuals, most of whom were White, from the UK Biobank (54% female; mean age at baseline, 56 years). Roughly three quarters of the cohort had no hearing loss and one quarter had some level of hearing loss, with 12% of these individuals using hearing aids.

After the researchers controlled for relevant cofactors, compared with people without hearing loss, those with hearing loss who were not using hearing aids had an increased risk for all-cause dementia (hazard ratio [HR], 1.42; 95% confidence interval [CI], 1.29-1.56).

No increased risk was seen in people with hearing loss who were using hearing aids (HR, 1.04; 95% CI, 0.98-1.10).

The positive association of hearing aid use was observed in all-cause dementia and cause-specific dementia subtypes, including Alzheimer’s disease, vascular dementia, and non–Alzheimer’s disease nonvascular dementia.

The data also suggest that the protection against dementia conferred by hearing aid use most likely stems from direct effects from hearing aids rather than indirect mediators, such as social isolation, loneliness, and low mood.

Dr. Zhu said the findings highlight the “urgent need” for the early use of hearing aids when an individual starts having trouble hearing.

“A group effort from across society is necessary, including raising awareness of hearing loss and the potential links with dementia; increasing accessibility to hearing aids by reducing cost; and more support for primary care workers to screen for hearing impairment, raise awareness, and deliver treatment such as fitting hearing aids,” Dr. Zhu said.

Writing in a linked comment, Gill Livingston, MD, and Sergi Costafreda, MD, PhD, with University College London, noted that with addition of this study, “the evidence that hearing aids are a powerful tool to reduce the risk of dementia in people with hearing loss, is as good as possible without randomized controlled trials, which might not be practically possible or ethical because people with hearing loss should not be stopped from using effective treatments.”

“The evidence is compelling that treating hearing loss is a promising way of reducing dementia risk. This is the time to increase awareness of and detection of hearing loss, as well as the acceptability and usability of hearing aids,” Dr. Livingston and Dr. Costafreda added.
 

High-quality evidence – with caveats

Several experts offered perspective on the analysis in a statement from the U.K.-based nonprofit Science Media Centre, which was not involved with the conduct of this study. Charles Marshall, MRCP, PhD, with Queen Mary University of London, said that the study provides “high-quality evidence” that those with hearing loss who use hearing aids are at lower risk for dementia than are those with hearing loss who do not use hearing aids.

“This raises the possibility that a proportion of dementia cases could be prevented by using hearing aids to correct hearing loss. However, the observational nature of this study makes it difficult to be sure that hearing aids are actually causing the reduced risk of dementia,” Dr. Marshall added.

“Hearing aids produce slightly distorted sound, and the brain has to adapt to this in order for hearing aids to be helpful,” he said. “People who are at risk of developing dementia in the future may have early changes in their brain that impair this adaptation, and this may lead to them choosing to not use hearing aids. This would confound the association, creating the appearance that hearing aids were reducing dementia risk, when actually their use was just identifying people with relatively healthy brains,” Dr. Marshall added.

Tara Spires-Jones, PhD, with the University of Edinburgh, said this “well-conducted” study confirms previous similar studies showing an association between hearing loss and dementia risk.

Echoing Dr. Marshall, Dr. Spires-Jones noted that this type of study cannot prove conclusively that hearing loss causes dementia.

“For example,” she said, “it is possible that people who are already in the very early stages of disease are less likely to seek help for hearing loss. However, on balance, this study and the rest of the data in the field indicate that keeping your brain healthy and engaged reduces dementia risk.”

Dr. Spires-Jones said that she agrees with the investigators that it’s “important to help people with hearing loss to get effective hearing aids to help keep their brains engaged through allowing richer social interactions.”

This study was funded by the National Natural Science Foundation of China and Shandong Province, Taishan Scholars Project, China Medical Board, and China Postdoctoral Science Foundation. Dr. Zhu, Dr. Livingston, Dr. Costafreda, Dr. Marshall, and Dr. Spires-Jones have no relevant disclosures.
 

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

Untreated hearing loss increases dementia risk in middle-aged and older adults, new research confirms. A large observational study from the United Kingdom showed a 42% increased risk for dementia in people with hearing loss compared with their peers with no hearing trouble. In addition, there was no increased risk in those with hearing loss who used hearing aids.

“The evidence is building that hearing loss may be the most impactful modifiable risk factor for dementia in mid-life, but the effectiveness of hearing aid use on reducing the risk of dementia in the real world has remained unclear,” Dongshan Zhu, PhD, with Shandong University, Jinan, China, said in a news release.

“Our study provides the best evidence to date to suggest that hearing aids could be a minimally invasive, cost-effective treatment to mitigate the potential impact of hearing loss on dementia,” Dr. Zhu said.

The study, which was published online in Lancet Public Health, comes on the heels of the 2020 Lancet Commission report on dementia, which suggested hearing loss may be linked to approximately 8% of worldwide dementia cases.
 

‘Compelling’ evidence

For the study, investigators analyzed longitudinal data on 437,704 individuals, most of whom were White, from the UK Biobank (54% female; mean age at baseline, 56 years). Roughly three quarters of the cohort had no hearing loss and one quarter had some level of hearing loss, with 12% of these individuals using hearing aids.

After the researchers controlled for relevant cofactors, compared with people without hearing loss, those with hearing loss who were not using hearing aids had an increased risk for all-cause dementia (hazard ratio [HR], 1.42; 95% confidence interval [CI], 1.29-1.56).

No increased risk was seen in people with hearing loss who were using hearing aids (HR, 1.04; 95% CI, 0.98-1.10).

The positive association of hearing aid use was observed in all-cause dementia and cause-specific dementia subtypes, including Alzheimer’s disease, vascular dementia, and non–Alzheimer’s disease nonvascular dementia.

The data also suggest that the protection against dementia conferred by hearing aid use most likely stems from direct effects from hearing aids rather than indirect mediators, such as social isolation, loneliness, and low mood.

Dr. Zhu said the findings highlight the “urgent need” for the early use of hearing aids when an individual starts having trouble hearing.

“A group effort from across society is necessary, including raising awareness of hearing loss and the potential links with dementia; increasing accessibility to hearing aids by reducing cost; and more support for primary care workers to screen for hearing impairment, raise awareness, and deliver treatment such as fitting hearing aids,” Dr. Zhu said.

Writing in a linked comment, Gill Livingston, MD, and Sergi Costafreda, MD, PhD, with University College London, noted that with addition of this study, “the evidence that hearing aids are a powerful tool to reduce the risk of dementia in people with hearing loss, is as good as possible without randomized controlled trials, which might not be practically possible or ethical because people with hearing loss should not be stopped from using effective treatments.”

“The evidence is compelling that treating hearing loss is a promising way of reducing dementia risk. This is the time to increase awareness of and detection of hearing loss, as well as the acceptability and usability of hearing aids,” Dr. Livingston and Dr. Costafreda added.
 

High-quality evidence – with caveats

Several experts offered perspective on the analysis in a statement from the U.K.-based nonprofit Science Media Centre, which was not involved with the conduct of this study. Charles Marshall, MRCP, PhD, with Queen Mary University of London, said that the study provides “high-quality evidence” that those with hearing loss who use hearing aids are at lower risk for dementia than are those with hearing loss who do not use hearing aids.

“This raises the possibility that a proportion of dementia cases could be prevented by using hearing aids to correct hearing loss. However, the observational nature of this study makes it difficult to be sure that hearing aids are actually causing the reduced risk of dementia,” Dr. Marshall added.

“Hearing aids produce slightly distorted sound, and the brain has to adapt to this in order for hearing aids to be helpful,” he said. “People who are at risk of developing dementia in the future may have early changes in their brain that impair this adaptation, and this may lead to them choosing to not use hearing aids. This would confound the association, creating the appearance that hearing aids were reducing dementia risk, when actually their use was just identifying people with relatively healthy brains,” Dr. Marshall added.

Tara Spires-Jones, PhD, with the University of Edinburgh, said this “well-conducted” study confirms previous similar studies showing an association between hearing loss and dementia risk.

Echoing Dr. Marshall, Dr. Spires-Jones noted that this type of study cannot prove conclusively that hearing loss causes dementia.

“For example,” she said, “it is possible that people who are already in the very early stages of disease are less likely to seek help for hearing loss. However, on balance, this study and the rest of the data in the field indicate that keeping your brain healthy and engaged reduces dementia risk.”

Dr. Spires-Jones said that she agrees with the investigators that it’s “important to help people with hearing loss to get effective hearing aids to help keep their brains engaged through allowing richer social interactions.”

This study was funded by the National Natural Science Foundation of China and Shandong Province, Taishan Scholars Project, China Medical Board, and China Postdoctoral Science Foundation. Dr. Zhu, Dr. Livingston, Dr. Costafreda, Dr. Marshall, and Dr. Spires-Jones have no relevant disclosures.
 

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

Untreated hearing loss increases dementia risk in middle-aged and older adults, new research confirms. A large observational study from the United Kingdom showed a 42% increased risk for dementia in people with hearing loss compared with their peers with no hearing trouble. In addition, there was no increased risk in those with hearing loss who used hearing aids.

“The evidence is building that hearing loss may be the most impactful modifiable risk factor for dementia in mid-life, but the effectiveness of hearing aid use on reducing the risk of dementia in the real world has remained unclear,” Dongshan Zhu, PhD, with Shandong University, Jinan, China, said in a news release.

“Our study provides the best evidence to date to suggest that hearing aids could be a minimally invasive, cost-effective treatment to mitigate the potential impact of hearing loss on dementia,” Dr. Zhu said.

The study, which was published online in Lancet Public Health, comes on the heels of the 2020 Lancet Commission report on dementia, which suggested hearing loss may be linked to approximately 8% of worldwide dementia cases.
 

‘Compelling’ evidence

For the study, investigators analyzed longitudinal data on 437,704 individuals, most of whom were White, from the UK Biobank (54% female; mean age at baseline, 56 years). Roughly three quarters of the cohort had no hearing loss and one quarter had some level of hearing loss, with 12% of these individuals using hearing aids.

After the researchers controlled for relevant cofactors, compared with people without hearing loss, those with hearing loss who were not using hearing aids had an increased risk for all-cause dementia (hazard ratio [HR], 1.42; 95% confidence interval [CI], 1.29-1.56).

No increased risk was seen in people with hearing loss who were using hearing aids (HR, 1.04; 95% CI, 0.98-1.10).

The positive association of hearing aid use was observed in all-cause dementia and cause-specific dementia subtypes, including Alzheimer’s disease, vascular dementia, and non–Alzheimer’s disease nonvascular dementia.

The data also suggest that the protection against dementia conferred by hearing aid use most likely stems from direct effects from hearing aids rather than indirect mediators, such as social isolation, loneliness, and low mood.

Dr. Zhu said the findings highlight the “urgent need” for the early use of hearing aids when an individual starts having trouble hearing.

“A group effort from across society is necessary, including raising awareness of hearing loss and the potential links with dementia; increasing accessibility to hearing aids by reducing cost; and more support for primary care workers to screen for hearing impairment, raise awareness, and deliver treatment such as fitting hearing aids,” Dr. Zhu said.

Writing in a linked comment, Gill Livingston, MD, and Sergi Costafreda, MD, PhD, with University College London, noted that with addition of this study, “the evidence that hearing aids are a powerful tool to reduce the risk of dementia in people with hearing loss, is as good as possible without randomized controlled trials, which might not be practically possible or ethical because people with hearing loss should not be stopped from using effective treatments.”

“The evidence is compelling that treating hearing loss is a promising way of reducing dementia risk. This is the time to increase awareness of and detection of hearing loss, as well as the acceptability and usability of hearing aids,” Dr. Livingston and Dr. Costafreda added.
 

High-quality evidence – with caveats

Several experts offered perspective on the analysis in a statement from the U.K.-based nonprofit Science Media Centre, which was not involved with the conduct of this study. Charles Marshall, MRCP, PhD, with Queen Mary University of London, said that the study provides “high-quality evidence” that those with hearing loss who use hearing aids are at lower risk for dementia than are those with hearing loss who do not use hearing aids.

“This raises the possibility that a proportion of dementia cases could be prevented by using hearing aids to correct hearing loss. However, the observational nature of this study makes it difficult to be sure that hearing aids are actually causing the reduced risk of dementia,” Dr. Marshall added.

“Hearing aids produce slightly distorted sound, and the brain has to adapt to this in order for hearing aids to be helpful,” he said. “People who are at risk of developing dementia in the future may have early changes in their brain that impair this adaptation, and this may lead to them choosing to not use hearing aids. This would confound the association, creating the appearance that hearing aids were reducing dementia risk, when actually their use was just identifying people with relatively healthy brains,” Dr. Marshall added.

Tara Spires-Jones, PhD, with the University of Edinburgh, said this “well-conducted” study confirms previous similar studies showing an association between hearing loss and dementia risk.

Echoing Dr. Marshall, Dr. Spires-Jones noted that this type of study cannot prove conclusively that hearing loss causes dementia.

“For example,” she said, “it is possible that people who are already in the very early stages of disease are less likely to seek help for hearing loss. However, on balance, this study and the rest of the data in the field indicate that keeping your brain healthy and engaged reduces dementia risk.”

Dr. Spires-Jones said that she agrees with the investigators that it’s “important to help people with hearing loss to get effective hearing aids to help keep their brains engaged through allowing richer social interactions.”

This study was funded by the National Natural Science Foundation of China and Shandong Province, Taishan Scholars Project, China Medical Board, and China Postdoctoral Science Foundation. Dr. Zhu, Dr. Livingston, Dr. Costafreda, Dr. Marshall, and Dr. Spires-Jones have no relevant disclosures.
 

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

BOSTON – Having a preoperative MRI scan does not help surgeons to reduce the likelihood of positive surgical margins when they are performing lumpectomy for early stage breast cancer, a new study concludes.

The current results suggest that MRI is “not useful to achieve this goal and not a productive use of health care resources,” said senior author Marissa Howard-McNatt, MD, director of the Breast Care Center, Wake Forest University, Winston-Salem, N.C.

“Researchers continue to look for better ways to assess margin status while the patient is still on the operating table,” she said, as a re-operation “can be traumatic.”

The study was presented at the annual meeting of the American Society of Breast Surgeons and was highlighted in a press briefing.

In the study, more than 630 patients with early stage breast cancer were randomly assigned to partial mastectomy with or without cavity shaving of the tumor margins, of whom 193 underwent MRI before their operation.

Although there was a difference in the rate of positive surgical margins before cavity shaving between patients who did and did not undergo MRI, the difference did not reach statistical significance.

“MRI exams are costly and potentially stressful for patients,” Dr. Howard-McNatt commented in a press statement. “The thought is that they will help physicians achieve negative margins during the initial surgery. However, our study shows this is simply not the case.”

Approached for comment, Mediget Teshome, MD, MPH, said, “In my practice, I primarily utilize MRI preoperatively to evaluate the extent of disease in cases where the information is not clear from mammogram and ultrasound.”

This may be when there is “discordance between the size of the malignancy or concern for chest wall or muscle involvement,” Dr. Teshome said in an interview.

MRI is also useful when there may be occult disease, such as in patients “with high suspicion for extensive intraductal component not evident on mammography and those who present with axillary metastasis and unknown breast primary,” as well as in high-risk patients with a genetic predisposition for breast cancer, she explained.

However, Dr. Teshome, an associate professor in the department of breast surgical oncology at the University of Texas MD Anderson Cancer Center, Houston, stressed that, “as with any test, it is important that preoperative MRI is performed with the specific intent to inform clinical decision-making in a meaningful way.”

“While it can provide a benefit in selected cases given its high sensitivity, MRI is associated with false positives and can also contribute to increased patient anxiety and additional procedures,” she cautioned.
 

Study details

Lumpectomy has become “a mainstay of breast cancer management, with safe and reliable outcomes as compared to mastectomy,” said Dr. Howard-McNatt, but it is associated with a higher rate of positive margins, of up to 27%.

She underlined that “re-excision surgery can contribute to greater morbidity, patient anxiety, poor cosmetic outcomes, and health care system overload,” and the desire to reduce re-operations has led to “much attention” being paid to preoperative imaging.

Their study set out to investigate the value of preoperative MRI in this regard, and for this they analyzed data on 631 women who had participated in two prior randomized trials (SHAVE1 and SHAVE2).

These women were randomly assigned to standard partial mastectomy with or without resection of cavity shave margins, with preoperative MRI performed prior to randomization in both trials at the surgeon’s discretion.

The median tumor size was 1.3 cm. An extensive intraductal component was identified in 32.8% of patients, 26.1% had palpable tumors, and 7% had invasive lobular histology. Neoadjuvant chemotherapy was administered in 6.5% of patients.

In all, 193 individuals underwent MRI. These women were less likely to have a positive surgical margin before resection of cavity shave margins, at 31.1% vs. 38.8% in those who did not have MRI, although the difference was not statistically significant (P = .073).

Multivariate analysis taking into account patient age, race, receipt of neoadjuvant chemotherapy, the presence of an extensive intraductal component, as well as histologic subtype and tumor size, revealed that MRI was not associated with a higher rate of negative surgical margins (P = .110).

However, it was shown that both tumor size (P = .040) and age (P = .032) were predictive of margin status.

It was notable that MRI use was associated with younger patient age, at a median of 63 years vs. 66 years, and smaller tumor size, at a median of 2.0 cm vs. 2.1 cm.

This latter finding “may be attributable to an inaccurate initial assessment of the extent of the actual tumor size for a variety of reasons,” Dr. Howard-McNatt commented. “For example, tumors may be discontinuous or have satellite lesions which may touch the edge of a specimen.”

The study was funded in part by the David and Katie Burke Fund for Breast Cancer Research, the Connecticut Breast Health Initiative, the Troy Cancer Program, Cleveland Clinic Akron General Operations, the Cleveland Clinic Akron General Foundation, the Lineberger Comprehensive Cancer Center, the Watson Clinic Center for Research, and LifeCycle. The study authors report no relevant financial relationships.

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

BOSTON – Having a preoperative MRI scan does not help surgeons to reduce the likelihood of positive surgical margins when they are performing lumpectomy for early stage breast cancer, a new study concludes.

The current results suggest that MRI is “not useful to achieve this goal and not a productive use of health care resources,” said senior author Marissa Howard-McNatt, MD, director of the Breast Care Center, Wake Forest University, Winston-Salem, N.C.

“Researchers continue to look for better ways to assess margin status while the patient is still on the operating table,” she said, as a re-operation “can be traumatic.”

The study was presented at the annual meeting of the American Society of Breast Surgeons and was highlighted in a press briefing.

In the study, more than 630 patients with early stage breast cancer were randomly assigned to partial mastectomy with or without cavity shaving of the tumor margins, of whom 193 underwent MRI before their operation.

Although there was a difference in the rate of positive surgical margins before cavity shaving between patients who did and did not undergo MRI, the difference did not reach statistical significance.

“MRI exams are costly and potentially stressful for patients,” Dr. Howard-McNatt commented in a press statement. “The thought is that they will help physicians achieve negative margins during the initial surgery. However, our study shows this is simply not the case.”

Approached for comment, Mediget Teshome, MD, MPH, said, “In my practice, I primarily utilize MRI preoperatively to evaluate the extent of disease in cases where the information is not clear from mammogram and ultrasound.”

This may be when there is “discordance between the size of the malignancy or concern for chest wall or muscle involvement,” Dr. Teshome said in an interview.

MRI is also useful when there may be occult disease, such as in patients “with high suspicion for extensive intraductal component not evident on mammography and those who present with axillary metastasis and unknown breast primary,” as well as in high-risk patients with a genetic predisposition for breast cancer, she explained.

However, Dr. Teshome, an associate professor in the department of breast surgical oncology at the University of Texas MD Anderson Cancer Center, Houston, stressed that, “as with any test, it is important that preoperative MRI is performed with the specific intent to inform clinical decision-making in a meaningful way.”

“While it can provide a benefit in selected cases given its high sensitivity, MRI is associated with false positives and can also contribute to increased patient anxiety and additional procedures,” she cautioned.
 

Study details

Lumpectomy has become “a mainstay of breast cancer management, with safe and reliable outcomes as compared to mastectomy,” said Dr. Howard-McNatt, but it is associated with a higher rate of positive margins, of up to 27%.

She underlined that “re-excision surgery can contribute to greater morbidity, patient anxiety, poor cosmetic outcomes, and health care system overload,” and the desire to reduce re-operations has led to “much attention” being paid to preoperative imaging.

Their study set out to investigate the value of preoperative MRI in this regard, and for this they analyzed data on 631 women who had participated in two prior randomized trials (SHAVE1 and SHAVE2).

These women were randomly assigned to standard partial mastectomy with or without resection of cavity shave margins, with preoperative MRI performed prior to randomization in both trials at the surgeon’s discretion.

The median tumor size was 1.3 cm. An extensive intraductal component was identified in 32.8% of patients, 26.1% had palpable tumors, and 7% had invasive lobular histology. Neoadjuvant chemotherapy was administered in 6.5% of patients.

In all, 193 individuals underwent MRI. These women were less likely to have a positive surgical margin before resection of cavity shave margins, at 31.1% vs. 38.8% in those who did not have MRI, although the difference was not statistically significant (P = .073).

Multivariate analysis taking into account patient age, race, receipt of neoadjuvant chemotherapy, the presence of an extensive intraductal component, as well as histologic subtype and tumor size, revealed that MRI was not associated with a higher rate of negative surgical margins (P = .110).

However, it was shown that both tumor size (P = .040) and age (P = .032) were predictive of margin status.

It was notable that MRI use was associated with younger patient age, at a median of 63 years vs. 66 years, and smaller tumor size, at a median of 2.0 cm vs. 2.1 cm.

This latter finding “may be attributable to an inaccurate initial assessment of the extent of the actual tumor size for a variety of reasons,” Dr. Howard-McNatt commented. “For example, tumors may be discontinuous or have satellite lesions which may touch the edge of a specimen.”

The study was funded in part by the David and Katie Burke Fund for Breast Cancer Research, the Connecticut Breast Health Initiative, the Troy Cancer Program, Cleveland Clinic Akron General Operations, the Cleveland Clinic Akron General Foundation, the Lineberger Comprehensive Cancer Center, the Watson Clinic Center for Research, and LifeCycle. The study authors report no relevant financial relationships.

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

BOSTON – Having a preoperative MRI scan does not help surgeons to reduce the likelihood of positive surgical margins when they are performing lumpectomy for early stage breast cancer, a new study concludes.

The current results suggest that MRI is “not useful to achieve this goal and not a productive use of health care resources,” said senior author Marissa Howard-McNatt, MD, director of the Breast Care Center, Wake Forest University, Winston-Salem, N.C.

“Researchers continue to look for better ways to assess margin status while the patient is still on the operating table,” she said, as a re-operation “can be traumatic.”

The study was presented at the annual meeting of the American Society of Breast Surgeons and was highlighted in a press briefing.

In the study, more than 630 patients with early stage breast cancer were randomly assigned to partial mastectomy with or without cavity shaving of the tumor margins, of whom 193 underwent MRI before their operation.

Although there was a difference in the rate of positive surgical margins before cavity shaving between patients who did and did not undergo MRI, the difference did not reach statistical significance.

“MRI exams are costly and potentially stressful for patients,” Dr. Howard-McNatt commented in a press statement. “The thought is that they will help physicians achieve negative margins during the initial surgery. However, our study shows this is simply not the case.”

Approached for comment, Mediget Teshome, MD, MPH, said, “In my practice, I primarily utilize MRI preoperatively to evaluate the extent of disease in cases where the information is not clear from mammogram and ultrasound.”

This may be when there is “discordance between the size of the malignancy or concern for chest wall or muscle involvement,” Dr. Teshome said in an interview.

MRI is also useful when there may be occult disease, such as in patients “with high suspicion for extensive intraductal component not evident on mammography and those who present with axillary metastasis and unknown breast primary,” as well as in high-risk patients with a genetic predisposition for breast cancer, she explained.

However, Dr. Teshome, an associate professor in the department of breast surgical oncology at the University of Texas MD Anderson Cancer Center, Houston, stressed that, “as with any test, it is important that preoperative MRI is performed with the specific intent to inform clinical decision-making in a meaningful way.”

“While it can provide a benefit in selected cases given its high sensitivity, MRI is associated with false positives and can also contribute to increased patient anxiety and additional procedures,” she cautioned.
 

Study details

Lumpectomy has become “a mainstay of breast cancer management, with safe and reliable outcomes as compared to mastectomy,” said Dr. Howard-McNatt, but it is associated with a higher rate of positive margins, of up to 27%.

She underlined that “re-excision surgery can contribute to greater morbidity, patient anxiety, poor cosmetic outcomes, and health care system overload,” and the desire to reduce re-operations has led to “much attention” being paid to preoperative imaging.

Their study set out to investigate the value of preoperative MRI in this regard, and for this they analyzed data on 631 women who had participated in two prior randomized trials (SHAVE1 and SHAVE2).

These women were randomly assigned to standard partial mastectomy with or without resection of cavity shave margins, with preoperative MRI performed prior to randomization in both trials at the surgeon’s discretion.

The median tumor size was 1.3 cm. An extensive intraductal component was identified in 32.8% of patients, 26.1% had palpable tumors, and 7% had invasive lobular histology. Neoadjuvant chemotherapy was administered in 6.5% of patients.

In all, 193 individuals underwent MRI. These women were less likely to have a positive surgical margin before resection of cavity shave margins, at 31.1% vs. 38.8% in those who did not have MRI, although the difference was not statistically significant (P = .073).

Multivariate analysis taking into account patient age, race, receipt of neoadjuvant chemotherapy, the presence of an extensive intraductal component, as well as histologic subtype and tumor size, revealed that MRI was not associated with a higher rate of negative surgical margins (P = .110).

However, it was shown that both tumor size (P = .040) and age (P = .032) were predictive of margin status.

It was notable that MRI use was associated with younger patient age, at a median of 63 years vs. 66 years, and smaller tumor size, at a median of 2.0 cm vs. 2.1 cm.

This latter finding “may be attributable to an inaccurate initial assessment of the extent of the actual tumor size for a variety of reasons,” Dr. Howard-McNatt commented. “For example, tumors may be discontinuous or have satellite lesions which may touch the edge of a specimen.”

The study was funded in part by the David and Katie Burke Fund for Breast Cancer Research, the Connecticut Breast Health Initiative, the Troy Cancer Program, Cleveland Clinic Akron General Operations, the Cleveland Clinic Akron General Foundation, the Lineberger Comprehensive Cancer Center, the Watson Clinic Center for Research, and LifeCycle. The study authors report no relevant financial relationships.

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

BOSTON – Older women who have had breast cancer frequently undergo annual surveillance mammography, even if there is only a small risk of their developing a second cancer or if they have other mortality risks associated with age and comorbidities. This ongoing annual surveillance with mammography may be doing more harm than good, warn researchers.

In a study that included almost 45,000 women who were aged 67 years or older when they were diagnosed with breast cancer, investigators found that patients commonly underwent annual mammographies.

“Even 10 years after their initial diagnosis ... about 40% of them were still getting surveillance mammography well into their 80s and 90s,” noted lead investigator Elizabeth Berger, MD, assistant professor of breast surgical oncology, Yale University, New Haven, Conn.

“Ongoing surveillance mammography in these patients may lead to overdiagnosis and overtreatment of cancers that potentially would not harm patients if left untreated,” Dr. Berger said.

“A positive or false positive finding may unnecessarily erode patient quality of life and incur costs to the patient and health care system without benefit,” she said. She added: “If an elderly woman is in poor health and has significant competing mortality risks compared to breast cancer, annual mammography may not be necessary.”

The research was presented at the annual meeting of the American Society of Breast Surgeons (ASBrS). The study was highlighted in a preview press briefing.

Speaking at the press briefing, Dr. Berger said that the “risks and benefits of surveillance mammography, including its downstream effects, should be considered by both patients and their doctors together to create a shared decision plan.” She acknowledged that the idea of skipping mammograms may be a sensitive one for patients.

She also shared what she described as “exciting news”: “We have just recently received funding from our geriatric group here at Yale to start to evaluate the potential benefits and harms of these surveillance mammographies.”

The aim is to evaluate false positive rates and the potential for overdiagnosis and overtreatment, “so stay tuned,” she added.

Approached for comment, Mediget Teshome, MD, MPH, said it was “not surprising to see the high rates of surveillance mammography, especially in the short term after treatment.”

She said in an interview that the results suggest that it “may be being overused,” given the low rates of second primary breast cancer and the “competing health concerns” of these women.

Overuse can, on the other hand, “definitely be a complex issue,” said Dr. Teshome, associate professor, department of breast surgical oncology, University of Texas MD Anderson Cancer Center, Houston.

“The goal of mammography screening is to identify breast cancer at an early stage,” she explained. She noted that because of the “competing mortality risk from other challenging and life-threatening health problems,” early-stage breast cancer “may not contribute significantly” to the overall mortality risk.

“In general, in this patient population, consideration should be given to stratifying based on an individual patient’s risk of breast cancer recurrence or new breast cancer, estimated life expectancy, as well as shared decision-making with the patient based on their goals of care.”
 

Study details

To examine the use of surveillance mammography and the risk of subsequent cancers among older women, Dr. Berger and her team used data from the Surveillance, Epidemiology, and End Results (SEER) registry to identify women aged 67 years or older who were diagnosed with a first nonmetastatic beast cancer between 2003 and 2007.

The patients were followed beginning 1 year after diagnosis until the occurrence of a second primary breast cancer, death, or the end of follow-up in 2017.

Data on 44,475 women were analyzed. Of those patients, 30% were older than 80 years. The majority (74%) of breast cancers were of stage I or II, and 72% were hormone receptor–positive (HR+).

Comorbid conditions were common; 55% of women had at least one, and 16% had three or more.

Life expectancy, determined on the basis of age, sex, and comorbidities, was estimated at less than 5 years for 26% of women. For 36% of patients, life expectancy was 6-10 years, and for 38%, it was longer than 10 years.

The cumulative incidence of developing a second primary breast cancer varied by life expectancy and the tumor’s molecular subtype.

The incidence was 3.7% among women with a life expectancy of less than 5 years, 4.9% among those expected to live 6-10 years, and 7.6% among those predicted to live more than 10 years.

Among women with a life expectancy of less than 5 years, the cumulative incidence of a second primary tumor was 4.0% among those with triple-negative breast cancer, vs. 3.0% among those with HR+ breast cancer.

Among patients whose life expectancy was more than 10 years, the cumulative incidence of a second primary tumor was 9.2% among women with triple-negative disease, vs. 7.0% among those with HR+ cancers.

The team found that it was common for women across all the groups to undergo mammography.

Among women with a life expectancy of 6-10 years, 82% underwent at least one mammogram, and 65% underwent five mammograms. Even among women with a life expectancy of less than 1 year, 51% underwent at least one mammogram within 12 months of death.

Among women with a life expectancy of less than 5 years, 68% of women had received a mammogram 1 year after treatment; 53% underwent three mammograms within 3 years after treatment.

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

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

BOSTON – Older women who have had breast cancer frequently undergo annual surveillance mammography, even if there is only a small risk of their developing a second cancer or if they have other mortality risks associated with age and comorbidities. This ongoing annual surveillance with mammography may be doing more harm than good, warn researchers.

In a study that included almost 45,000 women who were aged 67 years or older when they were diagnosed with breast cancer, investigators found that patients commonly underwent annual mammographies.

“Even 10 years after their initial diagnosis ... about 40% of them were still getting surveillance mammography well into their 80s and 90s,” noted lead investigator Elizabeth Berger, MD, assistant professor of breast surgical oncology, Yale University, New Haven, Conn.

“Ongoing surveillance mammography in these patients may lead to overdiagnosis and overtreatment of cancers that potentially would not harm patients if left untreated,” Dr. Berger said.

“A positive or false positive finding may unnecessarily erode patient quality of life and incur costs to the patient and health care system without benefit,” she said. She added: “If an elderly woman is in poor health and has significant competing mortality risks compared to breast cancer, annual mammography may not be necessary.”

The research was presented at the annual meeting of the American Society of Breast Surgeons (ASBrS). The study was highlighted in a preview press briefing.

Speaking at the press briefing, Dr. Berger said that the “risks and benefits of surveillance mammography, including its downstream effects, should be considered by both patients and their doctors together to create a shared decision plan.” She acknowledged that the idea of skipping mammograms may be a sensitive one for patients.

She also shared what she described as “exciting news”: “We have just recently received funding from our geriatric group here at Yale to start to evaluate the potential benefits and harms of these surveillance mammographies.”

The aim is to evaluate false positive rates and the potential for overdiagnosis and overtreatment, “so stay tuned,” she added.

Approached for comment, Mediget Teshome, MD, MPH, said it was “not surprising to see the high rates of surveillance mammography, especially in the short term after treatment.”

She said in an interview that the results suggest that it “may be being overused,” given the low rates of second primary breast cancer and the “competing health concerns” of these women.

Overuse can, on the other hand, “definitely be a complex issue,” said Dr. Teshome, associate professor, department of breast surgical oncology, University of Texas MD Anderson Cancer Center, Houston.

“The goal of mammography screening is to identify breast cancer at an early stage,” she explained. She noted that because of the “competing mortality risk from other challenging and life-threatening health problems,” early-stage breast cancer “may not contribute significantly” to the overall mortality risk.

“In general, in this patient population, consideration should be given to stratifying based on an individual patient’s risk of breast cancer recurrence or new breast cancer, estimated life expectancy, as well as shared decision-making with the patient based on their goals of care.”
 

Study details

To examine the use of surveillance mammography and the risk of subsequent cancers among older women, Dr. Berger and her team used data from the Surveillance, Epidemiology, and End Results (SEER) registry to identify women aged 67 years or older who were diagnosed with a first nonmetastatic beast cancer between 2003 and 2007.

The patients were followed beginning 1 year after diagnosis until the occurrence of a second primary breast cancer, death, or the end of follow-up in 2017.

Data on 44,475 women were analyzed. Of those patients, 30% were older than 80 years. The majority (74%) of breast cancers were of stage I or II, and 72% were hormone receptor–positive (HR+).

Comorbid conditions were common; 55% of women had at least one, and 16% had three or more.

Life expectancy, determined on the basis of age, sex, and comorbidities, was estimated at less than 5 years for 26% of women. For 36% of patients, life expectancy was 6-10 years, and for 38%, it was longer than 10 years.

The cumulative incidence of developing a second primary breast cancer varied by life expectancy and the tumor’s molecular subtype.

The incidence was 3.7% among women with a life expectancy of less than 5 years, 4.9% among those expected to live 6-10 years, and 7.6% among those predicted to live more than 10 years.

Among women with a life expectancy of less than 5 years, the cumulative incidence of a second primary tumor was 4.0% among those with triple-negative breast cancer, vs. 3.0% among those with HR+ breast cancer.

Among patients whose life expectancy was more than 10 years, the cumulative incidence of a second primary tumor was 9.2% among women with triple-negative disease, vs. 7.0% among those with HR+ cancers.

The team found that it was common for women across all the groups to undergo mammography.

Among women with a life expectancy of 6-10 years, 82% underwent at least one mammogram, and 65% underwent five mammograms. Even among women with a life expectancy of less than 1 year, 51% underwent at least one mammogram within 12 months of death.

Among women with a life expectancy of less than 5 years, 68% of women had received a mammogram 1 year after treatment; 53% underwent three mammograms within 3 years after treatment.

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

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

BOSTON – Older women who have had breast cancer frequently undergo annual surveillance mammography, even if there is only a small risk of their developing a second cancer or if they have other mortality risks associated with age and comorbidities. This ongoing annual surveillance with mammography may be doing more harm than good, warn researchers.

In a study that included almost 45,000 women who were aged 67 years or older when they were diagnosed with breast cancer, investigators found that patients commonly underwent annual mammographies.

“Even 10 years after their initial diagnosis ... about 40% of them were still getting surveillance mammography well into their 80s and 90s,” noted lead investigator Elizabeth Berger, MD, assistant professor of breast surgical oncology, Yale University, New Haven, Conn.

“Ongoing surveillance mammography in these patients may lead to overdiagnosis and overtreatment of cancers that potentially would not harm patients if left untreated,” Dr. Berger said.

“A positive or false positive finding may unnecessarily erode patient quality of life and incur costs to the patient and health care system without benefit,” she said. She added: “If an elderly woman is in poor health and has significant competing mortality risks compared to breast cancer, annual mammography may not be necessary.”

The research was presented at the annual meeting of the American Society of Breast Surgeons (ASBrS). The study was highlighted in a preview press briefing.

Speaking at the press briefing, Dr. Berger said that the “risks and benefits of surveillance mammography, including its downstream effects, should be considered by both patients and their doctors together to create a shared decision plan.” She acknowledged that the idea of skipping mammograms may be a sensitive one for patients.

She also shared what she described as “exciting news”: “We have just recently received funding from our geriatric group here at Yale to start to evaluate the potential benefits and harms of these surveillance mammographies.”

The aim is to evaluate false positive rates and the potential for overdiagnosis and overtreatment, “so stay tuned,” she added.

Approached for comment, Mediget Teshome, MD, MPH, said it was “not surprising to see the high rates of surveillance mammography, especially in the short term after treatment.”

She said in an interview that the results suggest that it “may be being overused,” given the low rates of second primary breast cancer and the “competing health concerns” of these women.

Overuse can, on the other hand, “definitely be a complex issue,” said Dr. Teshome, associate professor, department of breast surgical oncology, University of Texas MD Anderson Cancer Center, Houston.

“The goal of mammography screening is to identify breast cancer at an early stage,” she explained. She noted that because of the “competing mortality risk from other challenging and life-threatening health problems,” early-stage breast cancer “may not contribute significantly” to the overall mortality risk.

“In general, in this patient population, consideration should be given to stratifying based on an individual patient’s risk of breast cancer recurrence or new breast cancer, estimated life expectancy, as well as shared decision-making with the patient based on their goals of care.”
 

Study details

To examine the use of surveillance mammography and the risk of subsequent cancers among older women, Dr. Berger and her team used data from the Surveillance, Epidemiology, and End Results (SEER) registry to identify women aged 67 years or older who were diagnosed with a first nonmetastatic beast cancer between 2003 and 2007.

The patients were followed beginning 1 year after diagnosis until the occurrence of a second primary breast cancer, death, or the end of follow-up in 2017.

Data on 44,475 women were analyzed. Of those patients, 30% were older than 80 years. The majority (74%) of breast cancers were of stage I or II, and 72% were hormone receptor–positive (HR+).

Comorbid conditions were common; 55% of women had at least one, and 16% had three or more.

Life expectancy, determined on the basis of age, sex, and comorbidities, was estimated at less than 5 years for 26% of women. For 36% of patients, life expectancy was 6-10 years, and for 38%, it was longer than 10 years.

The cumulative incidence of developing a second primary breast cancer varied by life expectancy and the tumor’s molecular subtype.

The incidence was 3.7% among women with a life expectancy of less than 5 years, 4.9% among those expected to live 6-10 years, and 7.6% among those predicted to live more than 10 years.

Among women with a life expectancy of less than 5 years, the cumulative incidence of a second primary tumor was 4.0% among those with triple-negative breast cancer, vs. 3.0% among those with HR+ breast cancer.

Among patients whose life expectancy was more than 10 years, the cumulative incidence of a second primary tumor was 9.2% among women with triple-negative disease, vs. 7.0% among those with HR+ cancers.

The team found that it was common for women across all the groups to undergo mammography.

Among women with a life expectancy of 6-10 years, 82% underwent at least one mammogram, and 65% underwent five mammograms. Even among women with a life expectancy of less than 1 year, 51% underwent at least one mammogram within 12 months of death.

Among women with a life expectancy of less than 5 years, 68% of women had received a mammogram 1 year after treatment; 53% underwent three mammograms within 3 years after treatment.

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

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

Early-stage breast cancer patients who undergo a mastectomy and have a pathological analysis of their sentinel lymph nodes (SLN) performed during surgery are more likely to be overtreated with both axillary lymph node dissection (ALND) and axillary radiation (AxRT), warned U.S. investigators.

The team studied data on more than 40,000 clinically node-negative women who underwent upfront mastectomy. Just over 8,000 patients were found to have one to two SLN, with intraoperative pathology performed in approximately one-third.

Intraoperative pathology was associated with a more than eightfold increase in the likelihood of performing both ALND and AxRT, far more than any other factor.

These results provide “evidence that a significant percentage of the mastectomy patients with limited disease in up to two SLNs may be overtreated. … simply because their pathology results are read and acted on while they are on the operating table,” said senior author Olga Kantor, MD, MS, associate program director, Breast Surgical Oncology Fellowship Program, Brigham and Women’s Hospital and Dana-Farber Cancer Institute, Boston.

“Notably, postsurgical decisions typically involve a multidisciplinary team, including radiation oncologists, which will likely result in a more integrated overall treatment plan,” she commented in a statement.

“This study suggests that surgeons should delay ALND decision-making until a later time to avoid overtreating patients,” Dr. Kantor emphasized.

The research was presented at the annual meeting of the American Society of Breast Surgeons, and was highlighted in a premeeting press briefing.

Approached for comment on the new findings, Sarah L. Blair, MD, professor and vice chair, department of surgery, University of California San Diego Health, noted that “there is a great deal of data on deescalation in axillary surgery in patients undergoing breast conservation with radiation.”

Dr. Blair, who was not involved in the study, noted that, while there are some studies in mastectomy patients with equal oncologic results, “the topic remains more controversial.”

“This study highlights that surgeons strongly consider deescalating axillary surgery in mastectomy patients to reduce long-term complications,” she said in an interview.

“If possible, these patients should be discussed in a multidisciplinary fashion ahead of time,” she emphasized.

“If surgeons send the lymph nodes for frozen section then, as this paper demonstrates, they will act on the information and perform axillary dissection for early-stage disease.”
 

Study details

At the press briefing for the study, Dr. Kantor explained that several clinical trials, including AMAROS, have already “established the safety of axillary observation or AxRT as an alternative to ALND” in clinically node-negative breast cancer patients found to have one to two positive SLN.

She noted that “mastectomy patients were included in these trials, but they made up a minority” of the populations, ranging from 9% to 18%, “and so controversy remains over the optimal axillary management” in this patient population.

Dr. Kantor said that intraoperative pathology assessment “can help avoid the need to return to the operating room for additional axillary surgery” by checking the SLN at the time.

However, acting on the results during the procedure “does not allow for multidisciplinary discussion” and can mean that patients end up having both ALND and postoperative AxRT.

“This dual approach may result in axillary overtreatment in patients who may otherwise have been eligible for axillary radiation alone,” she underlined.

Moreover, a recent survey of 680 surgeons by the ASBrS found that 52% were performing routine intraoperative pathology assessment of SLN, and 78% of those said they would perform ALND if the results came back positive.

To investigate the impact of intraoperative pathology assessment on axillary management in mastectomy patients who would have been eligible for the AMAROS trial, the team examined data from the U.S. National Cancer Database.

They included cT1-2N0 breast cancer patients who had upfront mastectomy in 2018-2019 and were found to have one to two positive SLN.

They defined intraoperative pathology assessment as:

• “Not done/not acted on” if ALND was either not performed or performed at a later date than the pathology assessment.
• “Done/acted on” if both ALND and the pathology assessment were carried out on the same day.

In addition, AxRT was defined as postmastectomy radiation to the chest wall that included radiation to the draining lymph nodes.

The researchers identified 40,467 patients, of whom 20.3% had one to two positive SLN. Among those, axillary management consisted of observation in 33.2%, ALND in 26.6%, AxRT in 22.2%, and ALND plus AxRT in 18.0%.

Overall, 37.2% of the patients underwent intraoperative pathology and 62.8% did not, 11.8% of whom later returned to the operating room for ALND.

Patients who underwent intraoperative pathology were more likely than those who did not to have cT2 disease (48.0% vs. 44.1%), lympho-vascular invasion (43.4% vs. 37.1%), two positive SLN (26.5% vs. 19.2%), and macrometastasis (87.6% vs. 64.2%, P < .001 for all).

Rates of ALND plus AxRT were significantly higher in patients who had intraoperative pathology done/acted on than in those whom intraoperative pathology was not done/not acted on, at 41.0% vs. 4.9% (P < .001).

Adjusted multivariate analysis indicated that receipt of ALND plus AxRT was significantly associated with intraoperative pathology being done/acted on vs. being not done/acted on, at an odds ratio of 8.99 (P < .001).

There were also significant associations between having both procedures and macrometastasis in the SLN, at an odds ratio vs. micrometastasis of 3.38 (P < .001), and the number of total positive SLN, at odds ratio vs. 1 of 2.14 for two nodes, 3.92 for three nodes, and 5.32 for > three nodes (P < .001 for all).

The researchers also found that lobular tumors on histologic analysis were associated with having ALND plus AxRT, at an odds ratio vs. ductal histology of 1.40 (P < .001).

No funding was declared. Dr. Kantor and Dr. Blair report no relevant financial relationships.

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

Early-stage breast cancer patients who undergo a mastectomy and have a pathological analysis of their sentinel lymph nodes (SLN) performed during surgery are more likely to be overtreated with both axillary lymph node dissection (ALND) and axillary radiation (AxRT), warned U.S. investigators.

The team studied data on more than 40,000 clinically node-negative women who underwent upfront mastectomy. Just over 8,000 patients were found to have one to two SLN, with intraoperative pathology performed in approximately one-third.

Intraoperative pathology was associated with a more than eightfold increase in the likelihood of performing both ALND and AxRT, far more than any other factor.

These results provide “evidence that a significant percentage of the mastectomy patients with limited disease in up to two SLNs may be overtreated. … simply because their pathology results are read and acted on while they are on the operating table,” said senior author Olga Kantor, MD, MS, associate program director, Breast Surgical Oncology Fellowship Program, Brigham and Women’s Hospital and Dana-Farber Cancer Institute, Boston.

“Notably, postsurgical decisions typically involve a multidisciplinary team, including radiation oncologists, which will likely result in a more integrated overall treatment plan,” she commented in a statement.

“This study suggests that surgeons should delay ALND decision-making until a later time to avoid overtreating patients,” Dr. Kantor emphasized.

The research was presented at the annual meeting of the American Society of Breast Surgeons, and was highlighted in a premeeting press briefing.

Approached for comment on the new findings, Sarah L. Blair, MD, professor and vice chair, department of surgery, University of California San Diego Health, noted that “there is a great deal of data on deescalation in axillary surgery in patients undergoing breast conservation with radiation.”

Dr. Blair, who was not involved in the study, noted that, while there are some studies in mastectomy patients with equal oncologic results, “the topic remains more controversial.”

“This study highlights that surgeons strongly consider deescalating axillary surgery in mastectomy patients to reduce long-term complications,” she said in an interview.

“If possible, these patients should be discussed in a multidisciplinary fashion ahead of time,” she emphasized.

“If surgeons send the lymph nodes for frozen section then, as this paper demonstrates, they will act on the information and perform axillary dissection for early-stage disease.”
 

Study details

At the press briefing for the study, Dr. Kantor explained that several clinical trials, including AMAROS, have already “established the safety of axillary observation or AxRT as an alternative to ALND” in clinically node-negative breast cancer patients found to have one to two positive SLN.

She noted that “mastectomy patients were included in these trials, but they made up a minority” of the populations, ranging from 9% to 18%, “and so controversy remains over the optimal axillary management” in this patient population.

Dr. Kantor said that intraoperative pathology assessment “can help avoid the need to return to the operating room for additional axillary surgery” by checking the SLN at the time.

However, acting on the results during the procedure “does not allow for multidisciplinary discussion” and can mean that patients end up having both ALND and postoperative AxRT.

“This dual approach may result in axillary overtreatment in patients who may otherwise have been eligible for axillary radiation alone,” she underlined.

Moreover, a recent survey of 680 surgeons by the ASBrS found that 52% were performing routine intraoperative pathology assessment of SLN, and 78% of those said they would perform ALND if the results came back positive.

To investigate the impact of intraoperative pathology assessment on axillary management in mastectomy patients who would have been eligible for the AMAROS trial, the team examined data from the U.S. National Cancer Database.

They included cT1-2N0 breast cancer patients who had upfront mastectomy in 2018-2019 and were found to have one to two positive SLN.

They defined intraoperative pathology assessment as:

• “Not done/not acted on” if ALND was either not performed or performed at a later date than the pathology assessment.
• “Done/acted on” if both ALND and the pathology assessment were carried out on the same day.

In addition, AxRT was defined as postmastectomy radiation to the chest wall that included radiation to the draining lymph nodes.

The researchers identified 40,467 patients, of whom 20.3% had one to two positive SLN. Among those, axillary management consisted of observation in 33.2%, ALND in 26.6%, AxRT in 22.2%, and ALND plus AxRT in 18.0%.

Overall, 37.2% of the patients underwent intraoperative pathology and 62.8% did not, 11.8% of whom later returned to the operating room for ALND.

Patients who underwent intraoperative pathology were more likely than those who did not to have cT2 disease (48.0% vs. 44.1%), lympho-vascular invasion (43.4% vs. 37.1%), two positive SLN (26.5% vs. 19.2%), and macrometastasis (87.6% vs. 64.2%, P < .001 for all).

Rates of ALND plus AxRT were significantly higher in patients who had intraoperative pathology done/acted on than in those whom intraoperative pathology was not done/not acted on, at 41.0% vs. 4.9% (P < .001).

Adjusted multivariate analysis indicated that receipt of ALND plus AxRT was significantly associated with intraoperative pathology being done/acted on vs. being not done/acted on, at an odds ratio of 8.99 (P < .001).

There were also significant associations between having both procedures and macrometastasis in the SLN, at an odds ratio vs. micrometastasis of 3.38 (P < .001), and the number of total positive SLN, at odds ratio vs. 1 of 2.14 for two nodes, 3.92 for three nodes, and 5.32 for > three nodes (P < .001 for all).

The researchers also found that lobular tumors on histologic analysis were associated with having ALND plus AxRT, at an odds ratio vs. ductal histology of 1.40 (P < .001).

No funding was declared. Dr. Kantor and Dr. Blair report no relevant financial relationships.

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

Early-stage breast cancer patients who undergo a mastectomy and have a pathological analysis of their sentinel lymph nodes (SLN) performed during surgery are more likely to be overtreated with both axillary lymph node dissection (ALND) and axillary radiation (AxRT), warned U.S. investigators.

The team studied data on more than 40,000 clinically node-negative women who underwent upfront mastectomy. Just over 8,000 patients were found to have one to two SLN, with intraoperative pathology performed in approximately one-third.

Intraoperative pathology was associated with a more than eightfold increase in the likelihood of performing both ALND and AxRT, far more than any other factor.

These results provide “evidence that a significant percentage of the mastectomy patients with limited disease in up to two SLNs may be overtreated. … simply because their pathology results are read and acted on while they are on the operating table,” said senior author Olga Kantor, MD, MS, associate program director, Breast Surgical Oncology Fellowship Program, Brigham and Women’s Hospital and Dana-Farber Cancer Institute, Boston.

“Notably, postsurgical decisions typically involve a multidisciplinary team, including radiation oncologists, which will likely result in a more integrated overall treatment plan,” she commented in a statement.

“This study suggests that surgeons should delay ALND decision-making until a later time to avoid overtreating patients,” Dr. Kantor emphasized.

The research was presented at the annual meeting of the American Society of Breast Surgeons, and was highlighted in a premeeting press briefing.

Approached for comment on the new findings, Sarah L. Blair, MD, professor and vice chair, department of surgery, University of California San Diego Health, noted that “there is a great deal of data on deescalation in axillary surgery in patients undergoing breast conservation with radiation.”

Dr. Blair, who was not involved in the study, noted that, while there are some studies in mastectomy patients with equal oncologic results, “the topic remains more controversial.”

“This study highlights that surgeons strongly consider deescalating axillary surgery in mastectomy patients to reduce long-term complications,” she said in an interview.

“If possible, these patients should be discussed in a multidisciplinary fashion ahead of time,” she emphasized.

“If surgeons send the lymph nodes for frozen section then, as this paper demonstrates, they will act on the information and perform axillary dissection for early-stage disease.”
 

Study details

At the press briefing for the study, Dr. Kantor explained that several clinical trials, including AMAROS, have already “established the safety of axillary observation or AxRT as an alternative to ALND” in clinically node-negative breast cancer patients found to have one to two positive SLN.

She noted that “mastectomy patients were included in these trials, but they made up a minority” of the populations, ranging from 9% to 18%, “and so controversy remains over the optimal axillary management” in this patient population.

Dr. Kantor said that intraoperative pathology assessment “can help avoid the need to return to the operating room for additional axillary surgery” by checking the SLN at the time.

However, acting on the results during the procedure “does not allow for multidisciplinary discussion” and can mean that patients end up having both ALND and postoperative AxRT.

“This dual approach may result in axillary overtreatment in patients who may otherwise have been eligible for axillary radiation alone,” she underlined.

Moreover, a recent survey of 680 surgeons by the ASBrS found that 52% were performing routine intraoperative pathology assessment of SLN, and 78% of those said they would perform ALND if the results came back positive.

To investigate the impact of intraoperative pathology assessment on axillary management in mastectomy patients who would have been eligible for the AMAROS trial, the team examined data from the U.S. National Cancer Database.

They included cT1-2N0 breast cancer patients who had upfront mastectomy in 2018-2019 and were found to have one to two positive SLN.

They defined intraoperative pathology assessment as:

• “Not done/not acted on” if ALND was either not performed or performed at a later date than the pathology assessment.
• “Done/acted on” if both ALND and the pathology assessment were carried out on the same day.

In addition, AxRT was defined as postmastectomy radiation to the chest wall that included radiation to the draining lymph nodes.

The researchers identified 40,467 patients, of whom 20.3% had one to two positive SLN. Among those, axillary management consisted of observation in 33.2%, ALND in 26.6%, AxRT in 22.2%, and ALND plus AxRT in 18.0%.

Overall, 37.2% of the patients underwent intraoperative pathology and 62.8% did not, 11.8% of whom later returned to the operating room for ALND.

Patients who underwent intraoperative pathology were more likely than those who did not to have cT2 disease (48.0% vs. 44.1%), lympho-vascular invasion (43.4% vs. 37.1%), two positive SLN (26.5% vs. 19.2%), and macrometastasis (87.6% vs. 64.2%, P < .001 for all).

Rates of ALND plus AxRT were significantly higher in patients who had intraoperative pathology done/acted on than in those whom intraoperative pathology was not done/not acted on, at 41.0% vs. 4.9% (P < .001).

Adjusted multivariate analysis indicated that receipt of ALND plus AxRT was significantly associated with intraoperative pathology being done/acted on vs. being not done/acted on, at an odds ratio of 8.99 (P < .001).

There were also significant associations between having both procedures and macrometastasis in the SLN, at an odds ratio vs. micrometastasis of 3.38 (P < .001), and the number of total positive SLN, at odds ratio vs. 1 of 2.14 for two nodes, 3.92 for three nodes, and 5.32 for > three nodes (P < .001 for all).

The researchers also found that lobular tumors on histologic analysis were associated with having ALND plus AxRT, at an odds ratio vs. ductal histology of 1.40 (P < .001).

No funding was declared. Dr. Kantor and Dr. Blair report no relevant financial relationships.

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

The time has come to rethink the conventional primary endpoints investigators use in coronary revascularization trials – a composite of major adverse cardiovascular events (MACE), death or MI, and other endpoints – and shift toward greater emphasis on quality of life, two clinical trial investigators say.

Gregg Stone, MD, and Mario Gaudino, MD, MSCE, PhD, made their case in the Journal of the American College of Cardiology, writing: “The classic academic exercise of comparing revascularization modalities in an elusive search for a clear ‘winner’ has failed.” Dr. Stone was the principal investigator of the landmark EXCEL trial and an investigator for the ISCHEMIA trial, the latter of which Dr. Gaudino was also an investigator. Both trials evaluated percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) as treatments for coronary artery disease.

In an interview, Dr. Stone, a cardiologist at the Icahn School of Medicine at Mount Sinai, New York, said: “We’re proposing a new endpoint called a composite endpoint measured in a hierarchical fashion of death or quality of life [QOL].” Dr. Gaudino is a cardiac surgeon at Weill Cornell Medicine, New York.
 

Quality of life as a validation tool

As a measure of revascularization after PCI or CABG, Dr. Stone said, QOL is ready for prime time. “Over the last 20 years there’s been a very rich literature of science developed linking certain quality of life instruments to improved outcomes, in particularly health but also heart failure.”

Those instruments include the Seattle Angina Questionnaire, the Minnesota Living with Heart Failure Questionnaire and the Kansas City Cardiomyopathy questionnaire. “All of these are sufficiently validated that the [Food and Drug Administration] considers them ‘validated tools’ for use in clinical trials.” Dr. Stone also noted that substudies of three landmark trials comparing PCI and CABG – EXCEL, SYNTAX, and FREEDOM – used those instruments to evaluate QOL as an endpoint alongside “hard” outcomes such as death, MI or stroke. “So quality of life already is being used and it is already widely accepted. What we’re saying is, when you think about the information you need for medical studies, we believe it’s time to elevate that from secondary supportive information to primary.”

He and Dr. Gaudino are putting their money where their mouths are. They’ve applied for a grant through the Patient-Centered Outcomes Research Institute to use QOL as an outcomes measure in a trial of revascularization strategies in women and minority patients.
 

Shortcomings with traditional endpoints

Dr. Stone explained some of the shortcomings with the traditional endpoints revascularization studies have used. “Everybody agrees that mortality or survival is the most important endpoint, but studies can never be large enough to be powered for that. So we always end up combining them with myocardial infarction, stroke, and often with repeat revascularization” into one MACE endpoint.

But those four types of events are “very, very different,” Dr. Stone said. The severity of MIs and strokes can range from minor, almost inconsequential events to major, debilitating events. “Some strokes resolve in a few days but we count them all the same.”

He ticked off a list of the other outcomes the traditional endpoints don’t account for: atrial fibrillation, kidney dysfunction, musculoskeletal disorders, depression, cognitive changes, and vascular complications. They all can all have a significant impact on a patient’s QOL, Dr. Stone said.

“We’ve now entered an era that is much more patient centered,” Dr. Stone said. “My goal as a physician is to try to impart my knowledge of the evidence that’s out there so that the patient can make the decision that gives them the best chance of meeting their life goals and objectives. When you ask patients what they want, they all want to live longer and they want to live better.”

Mass General

MACE as a composite endpoint has its shortcomings, but using QOL can also be fraught with problems, said Suzanne Baron, MD, director of interventional cardiology research at Massachusetts General Hospital, Boston.

With regards to MACE, she echoed some of Dr. Stone’s concerns. “Patients and clinicians likely would not consider a repeat stenting procedure to be the same as having a stroke, and so weighting these two outcomes equally within a composite endpoint can potentially result in a skewed trial conclusion.”

One potential issue with QOL as an endpoint is that it can vary from day to day. “If quality of life is only measured at a few time points, such as annually, it is possible that those measurements may only reflect a small portion of the patient’s overall quality of life,” she said. “Accordingly, I think that it will be important to incorporate frequent assessments of a patient’s quality of life if these measures will be used as a primary endpoint in cardiac revascularization trials.”

And, in a cost-conscious health care system, quantity (length) of life tends to carry more weight than QOL, she said. “So it will be important that a trial using quality-of-life improvement as a primary endpoint mandates that the degree of improvement be large enough to ensure that the treatment remains high-value from a health economics standpoint.”

Dr. Stone disclosed financial relationships with numerous pharmaceutical companies. Dr. Baron reported financial relationships with Abiomed, Acarix, Boston Scientific, Medtronic, Zoll Medical, Biotronik, Edwards Lifesciences, and Janssen.
 

The time has come to rethink the conventional primary endpoints investigators use in coronary revascularization trials – a composite of major adverse cardiovascular events (MACE), death or MI, and other endpoints – and shift toward greater emphasis on quality of life, two clinical trial investigators say.

Gregg Stone, MD, and Mario Gaudino, MD, MSCE, PhD, made their case in the Journal of the American College of Cardiology, writing: “The classic academic exercise of comparing revascularization modalities in an elusive search for a clear ‘winner’ has failed.” Dr. Stone was the principal investigator of the landmark EXCEL trial and an investigator for the ISCHEMIA trial, the latter of which Dr. Gaudino was also an investigator. Both trials evaluated percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) as treatments for coronary artery disease.

In an interview, Dr. Stone, a cardiologist at the Icahn School of Medicine at Mount Sinai, New York, said: “We’re proposing a new endpoint called a composite endpoint measured in a hierarchical fashion of death or quality of life [QOL].” Dr. Gaudino is a cardiac surgeon at Weill Cornell Medicine, New York.
 

Quality of life as a validation tool

As a measure of revascularization after PCI or CABG, Dr. Stone said, QOL is ready for prime time. “Over the last 20 years there’s been a very rich literature of science developed linking certain quality of life instruments to improved outcomes, in particularly health but also heart failure.”

Those instruments include the Seattle Angina Questionnaire, the Minnesota Living with Heart Failure Questionnaire and the Kansas City Cardiomyopathy questionnaire. “All of these are sufficiently validated that the [Food and Drug Administration] considers them ‘validated tools’ for use in clinical trials.” Dr. Stone also noted that substudies of three landmark trials comparing PCI and CABG – EXCEL, SYNTAX, and FREEDOM – used those instruments to evaluate QOL as an endpoint alongside “hard” outcomes such as death, MI or stroke. “So quality of life already is being used and it is already widely accepted. What we’re saying is, when you think about the information you need for medical studies, we believe it’s time to elevate that from secondary supportive information to primary.”

He and Dr. Gaudino are putting their money where their mouths are. They’ve applied for a grant through the Patient-Centered Outcomes Research Institute to use QOL as an outcomes measure in a trial of revascularization strategies in women and minority patients.
 

Shortcomings with traditional endpoints

Dr. Stone explained some of the shortcomings with the traditional endpoints revascularization studies have used. “Everybody agrees that mortality or survival is the most important endpoint, but studies can never be large enough to be powered for that. So we always end up combining them with myocardial infarction, stroke, and often with repeat revascularization” into one MACE endpoint.

But those four types of events are “very, very different,” Dr. Stone said. The severity of MIs and strokes can range from minor, almost inconsequential events to major, debilitating events. “Some strokes resolve in a few days but we count them all the same.”

He ticked off a list of the other outcomes the traditional endpoints don’t account for: atrial fibrillation, kidney dysfunction, musculoskeletal disorders, depression, cognitive changes, and vascular complications. They all can all have a significant impact on a patient’s QOL, Dr. Stone said.

“We’ve now entered an era that is much more patient centered,” Dr. Stone said. “My goal as a physician is to try to impart my knowledge of the evidence that’s out there so that the patient can make the decision that gives them the best chance of meeting their life goals and objectives. When you ask patients what they want, they all want to live longer and they want to live better.”

Mass General

MACE as a composite endpoint has its shortcomings, but using QOL can also be fraught with problems, said Suzanne Baron, MD, director of interventional cardiology research at Massachusetts General Hospital, Boston.

With regards to MACE, she echoed some of Dr. Stone’s concerns. “Patients and clinicians likely would not consider a repeat stenting procedure to be the same as having a stroke, and so weighting these two outcomes equally within a composite endpoint can potentially result in a skewed trial conclusion.”

One potential issue with QOL as an endpoint is that it can vary from day to day. “If quality of life is only measured at a few time points, such as annually, it is possible that those measurements may only reflect a small portion of the patient’s overall quality of life,” she said. “Accordingly, I think that it will be important to incorporate frequent assessments of a patient’s quality of life if these measures will be used as a primary endpoint in cardiac revascularization trials.”

And, in a cost-conscious health care system, quantity (length) of life tends to carry more weight than QOL, she said. “So it will be important that a trial using quality-of-life improvement as a primary endpoint mandates that the degree of improvement be large enough to ensure that the treatment remains high-value from a health economics standpoint.”

Dr. Stone disclosed financial relationships with numerous pharmaceutical companies. Dr. Baron reported financial relationships with Abiomed, Acarix, Boston Scientific, Medtronic, Zoll Medical, Biotronik, Edwards Lifesciences, and Janssen.
 

The time has come to rethink the conventional primary endpoints investigators use in coronary revascularization trials – a composite of major adverse cardiovascular events (MACE), death or MI, and other endpoints – and shift toward greater emphasis on quality of life, two clinical trial investigators say.

Gregg Stone, MD, and Mario Gaudino, MD, MSCE, PhD, made their case in the Journal of the American College of Cardiology, writing: “The classic academic exercise of comparing revascularization modalities in an elusive search for a clear ‘winner’ has failed.” Dr. Stone was the principal investigator of the landmark EXCEL trial and an investigator for the ISCHEMIA trial, the latter of which Dr. Gaudino was also an investigator. Both trials evaluated percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) as treatments for coronary artery disease.

In an interview, Dr. Stone, a cardiologist at the Icahn School of Medicine at Mount Sinai, New York, said: “We’re proposing a new endpoint called a composite endpoint measured in a hierarchical fashion of death or quality of life [QOL].” Dr. Gaudino is a cardiac surgeon at Weill Cornell Medicine, New York.
 

Quality of life as a validation tool

As a measure of revascularization after PCI or CABG, Dr. Stone said, QOL is ready for prime time. “Over the last 20 years there’s been a very rich literature of science developed linking certain quality of life instruments to improved outcomes, in particularly health but also heart failure.”

Those instruments include the Seattle Angina Questionnaire, the Minnesota Living with Heart Failure Questionnaire and the Kansas City Cardiomyopathy questionnaire. “All of these are sufficiently validated that the [Food and Drug Administration] considers them ‘validated tools’ for use in clinical trials.” Dr. Stone also noted that substudies of three landmark trials comparing PCI and CABG – EXCEL, SYNTAX, and FREEDOM – used those instruments to evaluate QOL as an endpoint alongside “hard” outcomes such as death, MI or stroke. “So quality of life already is being used and it is already widely accepted. What we’re saying is, when you think about the information you need for medical studies, we believe it’s time to elevate that from secondary supportive information to primary.”

He and Dr. Gaudino are putting their money where their mouths are. They’ve applied for a grant through the Patient-Centered Outcomes Research Institute to use QOL as an outcomes measure in a trial of revascularization strategies in women and minority patients.
 

Shortcomings with traditional endpoints

Dr. Stone explained some of the shortcomings with the traditional endpoints revascularization studies have used. “Everybody agrees that mortality or survival is the most important endpoint, but studies can never be large enough to be powered for that. So we always end up combining them with myocardial infarction, stroke, and often with repeat revascularization” into one MACE endpoint.

But those four types of events are “very, very different,” Dr. Stone said. The severity of MIs and strokes can range from minor, almost inconsequential events to major, debilitating events. “Some strokes resolve in a few days but we count them all the same.”

He ticked off a list of the other outcomes the traditional endpoints don’t account for: atrial fibrillation, kidney dysfunction, musculoskeletal disorders, depression, cognitive changes, and vascular complications. They all can all have a significant impact on a patient’s QOL, Dr. Stone said.

“We’ve now entered an era that is much more patient centered,” Dr. Stone said. “My goal as a physician is to try to impart my knowledge of the evidence that’s out there so that the patient can make the decision that gives them the best chance of meeting their life goals and objectives. When you ask patients what they want, they all want to live longer and they want to live better.”

Mass General

MACE as a composite endpoint has its shortcomings, but using QOL can also be fraught with problems, said Suzanne Baron, MD, director of interventional cardiology research at Massachusetts General Hospital, Boston.

With regards to MACE, she echoed some of Dr. Stone’s concerns. “Patients and clinicians likely would not consider a repeat stenting procedure to be the same as having a stroke, and so weighting these two outcomes equally within a composite endpoint can potentially result in a skewed trial conclusion.”

One potential issue with QOL as an endpoint is that it can vary from day to day. “If quality of life is only measured at a few time points, such as annually, it is possible that those measurements may only reflect a small portion of the patient’s overall quality of life,” she said. “Accordingly, I think that it will be important to incorporate frequent assessments of a patient’s quality of life if these measures will be used as a primary endpoint in cardiac revascularization trials.”

And, in a cost-conscious health care system, quantity (length) of life tends to carry more weight than QOL, she said. “So it will be important that a trial using quality-of-life improvement as a primary endpoint mandates that the degree of improvement be large enough to ensure that the treatment remains high-value from a health economics standpoint.”

Dr. Stone disclosed financial relationships with numerous pharmaceutical companies. Dr. Baron reported financial relationships with Abiomed, Acarix, Boston Scientific, Medtronic, Zoll Medical, Biotronik, Edwards Lifesciences, and Janssen.
 

BOSTON – In emergency department stroke consultations, the National Institute of Health Stroke Scale (NIHSS) alone does not appear to be a reliable guide for ordering diagnostic tests for a large vessel occlusion (LVO), according to large body of data presented at the 2023 annual meeting of the American Academy of Neurology.

If the goal is not to miss any LVOs, there is no NIHSS score below which these do not occur, according to Theresa Sevilis, DO, regional medical director, TeleSpecialists, Fort Myers, Fla.

For example, her evaluation of a large and nationally representative dataset shows that more than 10% of the LVOs eventually identified and accepted for intervention would be missed with a cutoff of NIHSS score of 6 or higher. Moving the cutoff NIHSS score to 4 or greater, 6% of LVOs among the 23,166 strokes evaluated would have gone undetected.

“The current guidelines do not address low NIHSS score largely due to a paucity of data,” according to Dr. Sevilis, who showed data indicating that there is great variation among institutions in regard to ordering computed tomography angiography (CTA). She indicated that CTA is the current imaging standard for detecting LVO.
 

Large prospective dataset

The data for this study were derived from the TeleCare database, which captures acute stroke consultations in the emergency departments in 227 facilities in 27 states. Stroke consultations over a 6-month period from July through December 2021 were evaluated. The prospectively collected data were subjected to a multivariate analysis to determine the odds ratio for a CTA performed and LVO found at each NIHSS score of 0 to 5. Scores 6 or above served as the reference.

“Only consults performed within 24 hours [of presentation] were included,” Dr. Sevilis said.

After excluding cases in which no NIHSS score was captured, which represented less than 1% of cases, more than 10,500 cases underwent CTA, providing a rate of 45.5%. The rate of CTA for the whole dataset was 45.5%. Of the study population, 24.6% had a NIHSS score of 6 or above.

“When you are discussing when to perform CTA in patients with a low NIHSS score, you are discussing the majority of patients,” Dr. Sevilis said.

Of those with a NIHSS stroke of 6 or below, 28.2% had a score of 0. Not surprisingly, these were the least likely to have a CTA performed on the basis of an odds ratio of 0.14 and the least likely to have a LVO detected (OR, 0.1). With the exception of a NIHSS stroke score of 1, the likelihood of CTA and LVO climbed incrementally with higher stroke scores. These odds ratios were, respectively, 0.16 and 0.09 for a score of 1; 0.27 and 0.16 for a score of 2; 0.33 and 0.14 for a score of 3; 0.49 and 0.24 for a score of 4; and 0.71 and 0.27 for a score of 5.

In the group with NIHSS score of 6 or above, 24.1% were found to have an LVO. Of these, the proportion accepted for a mechanical thrombectomy was less than half. The intervention acceptance rate for mechanical intervention among LVOs in patients with lower NIHSS scores again fell incrementally by score. The acceptance rate was about 35% among LVO patients with a NIHSS score of 3 or 4 and 25% for those with a score of 0-2.

The interpretation of these data “depends on goals,” Dr. Sevilis said. “If the goal is to not miss a single LVO, then it is important to consider the balance between benefits and risks.”
 

No consistent cutoff

In participating facilities, the protocol for considering CTA to detect and treat LVOs ranges from neurologist choice to cutoffs of NIHSS scores of 2, 4, and 6, according to Dr. Sevilis. Where the data suggest that a cutoff of 4 or above might be reasonable, she said that NIHSS scoring is not a useful tool for those “who do not want to miss any LVOs.”

These data are based on emergency room stroke consultations and not on confirmed strokes,” Dr. Sevilis emphasized. Indeed, she noted that the final discharge diagnosis was not available. Recognizing that the analysis was not performed on a population with confirmed strokes is particularly important for understanding the limited rate of CTAs performed even in those with relatively high NIHSS scores. She noted this could be explained by many different reasons, including suspicion of hemorrhage or clinical features that took the workup in a different direction.
 

Reconsidering protocols

Based on the large sample size, Dr. Sevilis contended that it is likely that these data are representative, but she considers this study a first step toward considering protocols and developing guidelines for addressing stroke alerts in the emergency department.

A more important step will be ongoing trials designed specifically to generate data to answer this question. Pascal Jabbour, MD, chief of the division of neurovascular and endovascular neurosurgery, Thomas Jefferson University Hospitals, Philadelphia, is participating in one of these trials. He agreed with the premise that better evidence-based criteria are needed when evaluating acute stroke patients with a potential LVO.

The trial in which he is a coinvestigator, called ENDOLOW, is testing the hypothesis that outcomes will be better if acute stroke patients with a LVO and a low baseline NIHSS score (< 5) are treated with immediate thrombectomy rather than medical management. If this hypothesis is confirmed in the randomized ENDOLOW, it will provide an evidence basis for an approach already being practiced at some centers.

“There should be a very low threshold for CTA,” said Dr. Jabbour in an interview. This imaging “takes less than 2 minutes and it can provide the basis for a life-saving endovascular thrombectomy if a LVO is found.”

It is already well known that LVO is not restricted only to patients with an elevated NIHSS score, he said.

For determining whether to order a CTA, “I do not agree with NIHSS score of 6 or above. There is no absolute number below which risk of missing a LVO is eliminated,” Dr. Jabbour said. He also argued against relying on NIHSS score without considering other clinical features, particularly cortical signs, which should raise suspicion of a LVO regardless of NIHSS score.

One problem is that NIHSS scores are not static. Decompensation can be rapid with the NIHSS score quickly climbing. When this happens, the delay in treatment might lead to a preventable adverse outcome.

“There is a change in the paradigm now that we have more evidence of a benefit from aggressive treatment in the right candidates,” according to Dr. Jabbour, referring to the recently published SELECT2 trial. In that trial, on which Dr. Jabbour served as a coauthor, patients with LVO and large territory infarct were randomized to thrombectomy or medical care within 24 hours of a stroke. It was stopped early for efficacy because of the increased functional independence (20% vs. 7%) in the surgical intervention group.

If the ongoing trials establish better criteria for ruling in or out the presence of LVO in patients with acute stroke, Dr. Jabbour predicted that guidelines will be written to standardize practice.

Dr. Sevilis reports no potential conflicts of interest. Dr. Jabbour has financial relationships with Cerenovus, Medtronic, and Microvention.
 

BOSTON – In emergency department stroke consultations, the National Institute of Health Stroke Scale (NIHSS) alone does not appear to be a reliable guide for ordering diagnostic tests for a large vessel occlusion (LVO), according to large body of data presented at the 2023 annual meeting of the American Academy of Neurology.

If the goal is not to miss any LVOs, there is no NIHSS score below which these do not occur, according to Theresa Sevilis, DO, regional medical director, TeleSpecialists, Fort Myers, Fla.

For example, her evaluation of a large and nationally representative dataset shows that more than 10% of the LVOs eventually identified and accepted for intervention would be missed with a cutoff of NIHSS score of 6 or higher. Moving the cutoff NIHSS score to 4 or greater, 6% of LVOs among the 23,166 strokes evaluated would have gone undetected.

“The current guidelines do not address low NIHSS score largely due to a paucity of data,” according to Dr. Sevilis, who showed data indicating that there is great variation among institutions in regard to ordering computed tomography angiography (CTA). She indicated that CTA is the current imaging standard for detecting LVO.
 

Large prospective dataset

The data for this study were derived from the TeleCare database, which captures acute stroke consultations in the emergency departments in 227 facilities in 27 states. Stroke consultations over a 6-month period from July through December 2021 were evaluated. The prospectively collected data were subjected to a multivariate analysis to determine the odds ratio for a CTA performed and LVO found at each NIHSS score of 0 to 5. Scores 6 or above served as the reference.

“Only consults performed within 24 hours [of presentation] were included,” Dr. Sevilis said.

After excluding cases in which no NIHSS score was captured, which represented less than 1% of cases, more than 10,500 cases underwent CTA, providing a rate of 45.5%. The rate of CTA for the whole dataset was 45.5%. Of the study population, 24.6% had a NIHSS score of 6 or above.

“When you are discussing when to perform CTA in patients with a low NIHSS score, you are discussing the majority of patients,” Dr. Sevilis said.

Of those with a NIHSS stroke of 6 or below, 28.2% had a score of 0. Not surprisingly, these were the least likely to have a CTA performed on the basis of an odds ratio of 0.14 and the least likely to have a LVO detected (OR, 0.1). With the exception of a NIHSS stroke score of 1, the likelihood of CTA and LVO climbed incrementally with higher stroke scores. These odds ratios were, respectively, 0.16 and 0.09 for a score of 1; 0.27 and 0.16 for a score of 2; 0.33 and 0.14 for a score of 3; 0.49 and 0.24 for a score of 4; and 0.71 and 0.27 for a score of 5.

In the group with NIHSS score of 6 or above, 24.1% were found to have an LVO. Of these, the proportion accepted for a mechanical thrombectomy was less than half. The intervention acceptance rate for mechanical intervention among LVOs in patients with lower NIHSS scores again fell incrementally by score. The acceptance rate was about 35% among LVO patients with a NIHSS score of 3 or 4 and 25% for those with a score of 0-2.

The interpretation of these data “depends on goals,” Dr. Sevilis said. “If the goal is to not miss a single LVO, then it is important to consider the balance between benefits and risks.”
 

No consistent cutoff

In participating facilities, the protocol for considering CTA to detect and treat LVOs ranges from neurologist choice to cutoffs of NIHSS scores of 2, 4, and 6, according to Dr. Sevilis. Where the data suggest that a cutoff of 4 or above might be reasonable, she said that NIHSS scoring is not a useful tool for those “who do not want to miss any LVOs.”

These data are based on emergency room stroke consultations and not on confirmed strokes,” Dr. Sevilis emphasized. Indeed, she noted that the final discharge diagnosis was not available. Recognizing that the analysis was not performed on a population with confirmed strokes is particularly important for understanding the limited rate of CTAs performed even in those with relatively high NIHSS scores. She noted this could be explained by many different reasons, including suspicion of hemorrhage or clinical features that took the workup in a different direction.
 

Reconsidering protocols

Based on the large sample size, Dr. Sevilis contended that it is likely that these data are representative, but she considers this study a first step toward considering protocols and developing guidelines for addressing stroke alerts in the emergency department.

A more important step will be ongoing trials designed specifically to generate data to answer this question. Pascal Jabbour, MD, chief of the division of neurovascular and endovascular neurosurgery, Thomas Jefferson University Hospitals, Philadelphia, is participating in one of these trials. He agreed with the premise that better evidence-based criteria are needed when evaluating acute stroke patients with a potential LVO.

The trial in which he is a coinvestigator, called ENDOLOW, is testing the hypothesis that outcomes will be better if acute stroke patients with a LVO and a low baseline NIHSS score (< 5) are treated with immediate thrombectomy rather than medical management. If this hypothesis is confirmed in the randomized ENDOLOW, it will provide an evidence basis for an approach already being practiced at some centers.

“There should be a very low threshold for CTA,” said Dr. Jabbour in an interview. This imaging “takes less than 2 minutes and it can provide the basis for a life-saving endovascular thrombectomy if a LVO is found.”

It is already well known that LVO is not restricted only to patients with an elevated NIHSS score, he said.

For determining whether to order a CTA, “I do not agree with NIHSS score of 6 or above. There is no absolute number below which risk of missing a LVO is eliminated,” Dr. Jabbour said. He also argued against relying on NIHSS score without considering other clinical features, particularly cortical signs, which should raise suspicion of a LVO regardless of NIHSS score.

One problem is that NIHSS scores are not static. Decompensation can be rapid with the NIHSS score quickly climbing. When this happens, the delay in treatment might lead to a preventable adverse outcome.

“There is a change in the paradigm now that we have more evidence of a benefit from aggressive treatment in the right candidates,” according to Dr. Jabbour, referring to the recently published SELECT2 trial. In that trial, on which Dr. Jabbour served as a coauthor, patients with LVO and large territory infarct were randomized to thrombectomy or medical care within 24 hours of a stroke. It was stopped early for efficacy because of the increased functional independence (20% vs. 7%) in the surgical intervention group.

If the ongoing trials establish better criteria for ruling in or out the presence of LVO in patients with acute stroke, Dr. Jabbour predicted that guidelines will be written to standardize practice.

Dr. Sevilis reports no potential conflicts of interest. Dr. Jabbour has financial relationships with Cerenovus, Medtronic, and Microvention.
 

BOSTON – In emergency department stroke consultations, the National Institute of Health Stroke Scale (NIHSS) alone does not appear to be a reliable guide for ordering diagnostic tests for a large vessel occlusion (LVO), according to large body of data presented at the 2023 annual meeting of the American Academy of Neurology.

If the goal is not to miss any LVOs, there is no NIHSS score below which these do not occur, according to Theresa Sevilis, DO, regional medical director, TeleSpecialists, Fort Myers, Fla.

For example, her evaluation of a large and nationally representative dataset shows that more than 10% of the LVOs eventually identified and accepted for intervention would be missed with a cutoff of NIHSS score of 6 or higher. Moving the cutoff NIHSS score to 4 or greater, 6% of LVOs among the 23,166 strokes evaluated would have gone undetected.

“The current guidelines do not address low NIHSS score largely due to a paucity of data,” according to Dr. Sevilis, who showed data indicating that there is great variation among institutions in regard to ordering computed tomography angiography (CTA). She indicated that CTA is the current imaging standard for detecting LVO.
 

Large prospective dataset

The data for this study were derived from the TeleCare database, which captures acute stroke consultations in the emergency departments in 227 facilities in 27 states. Stroke consultations over a 6-month period from July through December 2021 were evaluated. The prospectively collected data were subjected to a multivariate analysis to determine the odds ratio for a CTA performed and LVO found at each NIHSS score of 0 to 5. Scores 6 or above served as the reference.

“Only consults performed within 24 hours [of presentation] were included,” Dr. Sevilis said.

After excluding cases in which no NIHSS score was captured, which represented less than 1% of cases, more than 10,500 cases underwent CTA, providing a rate of 45.5%. The rate of CTA for the whole dataset was 45.5%. Of the study population, 24.6% had a NIHSS score of 6 or above.

“When you are discussing when to perform CTA in patients with a low NIHSS score, you are discussing the majority of patients,” Dr. Sevilis said.

Of those with a NIHSS stroke of 6 or below, 28.2% had a score of 0. Not surprisingly, these were the least likely to have a CTA performed on the basis of an odds ratio of 0.14 and the least likely to have a LVO detected (OR, 0.1). With the exception of a NIHSS stroke score of 1, the likelihood of CTA and LVO climbed incrementally with higher stroke scores. These odds ratios were, respectively, 0.16 and 0.09 for a score of 1; 0.27 and 0.16 for a score of 2; 0.33 and 0.14 for a score of 3; 0.49 and 0.24 for a score of 4; and 0.71 and 0.27 for a score of 5.

In the group with NIHSS score of 6 or above, 24.1% were found to have an LVO. Of these, the proportion accepted for a mechanical thrombectomy was less than half. The intervention acceptance rate for mechanical intervention among LVOs in patients with lower NIHSS scores again fell incrementally by score. The acceptance rate was about 35% among LVO patients with a NIHSS score of 3 or 4 and 25% for those with a score of 0-2.

The interpretation of these data “depends on goals,” Dr. Sevilis said. “If the goal is to not miss a single LVO, then it is important to consider the balance between benefits and risks.”
 

No consistent cutoff

In participating facilities, the protocol for considering CTA to detect and treat LVOs ranges from neurologist choice to cutoffs of NIHSS scores of 2, 4, and 6, according to Dr. Sevilis. Where the data suggest that a cutoff of 4 or above might be reasonable, she said that NIHSS scoring is not a useful tool for those “who do not want to miss any LVOs.”

These data are based on emergency room stroke consultations and not on confirmed strokes,” Dr. Sevilis emphasized. Indeed, she noted that the final discharge diagnosis was not available. Recognizing that the analysis was not performed on a population with confirmed strokes is particularly important for understanding the limited rate of CTAs performed even in those with relatively high NIHSS scores. She noted this could be explained by many different reasons, including suspicion of hemorrhage or clinical features that took the workup in a different direction.
 

Reconsidering protocols

Based on the large sample size, Dr. Sevilis contended that it is likely that these data are representative, but she considers this study a first step toward considering protocols and developing guidelines for addressing stroke alerts in the emergency department.

A more important step will be ongoing trials designed specifically to generate data to answer this question. Pascal Jabbour, MD, chief of the division of neurovascular and endovascular neurosurgery, Thomas Jefferson University Hospitals, Philadelphia, is participating in one of these trials. He agreed with the premise that better evidence-based criteria are needed when evaluating acute stroke patients with a potential LVO.

The trial in which he is a coinvestigator, called ENDOLOW, is testing the hypothesis that outcomes will be better if acute stroke patients with a LVO and a low baseline NIHSS score (< 5) are treated with immediate thrombectomy rather than medical management. If this hypothesis is confirmed in the randomized ENDOLOW, it will provide an evidence basis for an approach already being practiced at some centers.

“There should be a very low threshold for CTA,” said Dr. Jabbour in an interview. This imaging “takes less than 2 minutes and it can provide the basis for a life-saving endovascular thrombectomy if a LVO is found.”

It is already well known that LVO is not restricted only to patients with an elevated NIHSS score, he said.

For determining whether to order a CTA, “I do not agree with NIHSS score of 6 or above. There is no absolute number below which risk of missing a LVO is eliminated,” Dr. Jabbour said. He also argued against relying on NIHSS score without considering other clinical features, particularly cortical signs, which should raise suspicion of a LVO regardless of NIHSS score.

One problem is that NIHSS scores are not static. Decompensation can be rapid with the NIHSS score quickly climbing. When this happens, the delay in treatment might lead to a preventable adverse outcome.

“There is a change in the paradigm now that we have more evidence of a benefit from aggressive treatment in the right candidates,” according to Dr. Jabbour, referring to the recently published SELECT2 trial. In that trial, on which Dr. Jabbour served as a coauthor, patients with LVO and large territory infarct were randomized to thrombectomy or medical care within 24 hours of a stroke. It was stopped early for efficacy because of the increased functional independence (20% vs. 7%) in the surgical intervention group.

If the ongoing trials establish better criteria for ruling in or out the presence of LVO in patients with acute stroke, Dr. Jabbour predicted that guidelines will be written to standardize practice.

Dr. Sevilis reports no potential conflicts of interest. Dr. Jabbour has financial relationships with Cerenovus, Medtronic, and Microvention.
 

The U.S. federal government wrote duplicate checks to private doctors who treated veterans, costing taxpayers up to $128 million in extra payments over 5 years, a new report by a federal watchdog revealed in April.
 

Private doctors were paid twice in nearly 300,000 cases from 2017 to 2021 involving veterans who were eligible for Veterans Health Administration and Medicare benefits, according to the report by the Health & Human Services Office of Inspector General.

The doctors were paid by Medicare for medical services that the VHA had authorized and already paid for, the OIG reported after it conducted a 5-year audit.

Duplicate Medicare payments have doubled from $22 million in 2019 when the Veterans Community Care Program was implemented to $45 million in 2021, according to the OIG report. The program allows veterans to seek care from private doctors when the VHA can’t provide the care they need.

Roughly 1.9 million veterans every year receive government-paid health care from private doctors.

The OIG said it decided to audit Medicare’s claims because “duplicate payments were a long-standing issue.”

The problem dates back to a 1979 General Accounting Office (now the Government Accountability Office) report that found Medicare and the Department of Veterans Affairs VHA made duplicate payments of more than $72,000 for certain medical services provided to veterans, the OIG reported.

The HHS OIG’s audit examined $19.2 billion in Medicare payments for 36 million claims for individuals who enrolled in Medicare and were eligible for VA services. About 90% of those claims were for doctor evaluations and visits, according to the OIG report.

The OIG found “these duplicate payments occurred because CMS did not implement controls to address duplicate payments for services provided to individuals with Medicare and VHA benefits.”

Specifically, the OIG found that the CMS and the VHA were not sharing enrollment, claims, and payment data with each other, as required by federal law.

If CMS had access to that information, the agency could have compared the VHA claims data with existing Medicare claims data to identify duplicate claims, the OIG claimed.

The OIG recommended that CMS take the following four steps to fix the problem, which CMS has agreed to do, according to the report:

• Integrate VHA enrollment, claims, and payment data into the CMS centralized claims data system so it can identify potential fraud, waste, and abuse under the Medicare program.
• Issue guidance to medical professionals on not billing Medicare for a medical service that was authorized by the VHA.
• Establish a comprehensive data-sharing agreement with the VHA.
• Establish an internal process (such as system edits) to address duplicate payments.

“CMS previously informed [the OIG] that establishing a long-term solution to address duplicate payments will take time,” the OIG reported.

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

The U.S. federal government wrote duplicate checks to private doctors who treated veterans, costing taxpayers up to $128 million in extra payments over 5 years, a new report by a federal watchdog revealed in April.
 

Private doctors were paid twice in nearly 300,000 cases from 2017 to 2021 involving veterans who were eligible for Veterans Health Administration and Medicare benefits, according to the report by the Health & Human Services Office of Inspector General.

The doctors were paid by Medicare for medical services that the VHA had authorized and already paid for, the OIG reported after it conducted a 5-year audit.

Duplicate Medicare payments have doubled from $22 million in 2019 when the Veterans Community Care Program was implemented to $45 million in 2021, according to the OIG report. The program allows veterans to seek care from private doctors when the VHA can’t provide the care they need.

Roughly 1.9 million veterans every year receive government-paid health care from private doctors.

The OIG said it decided to audit Medicare’s claims because “duplicate payments were a long-standing issue.”

The problem dates back to a 1979 General Accounting Office (now the Government Accountability Office) report that found Medicare and the Department of Veterans Affairs VHA made duplicate payments of more than $72,000 for certain medical services provided to veterans, the OIG reported.

The HHS OIG’s audit examined $19.2 billion in Medicare payments for 36 million claims for individuals who enrolled in Medicare and were eligible for VA services. About 90% of those claims were for doctor evaluations and visits, according to the OIG report.

The OIG found “these duplicate payments occurred because CMS did not implement controls to address duplicate payments for services provided to individuals with Medicare and VHA benefits.”

Specifically, the OIG found that the CMS and the VHA were not sharing enrollment, claims, and payment data with each other, as required by federal law.

If CMS had access to that information, the agency could have compared the VHA claims data with existing Medicare claims data to identify duplicate claims, the OIG claimed.

The OIG recommended that CMS take the following four steps to fix the problem, which CMS has agreed to do, according to the report:

• Integrate VHA enrollment, claims, and payment data into the CMS centralized claims data system so it can identify potential fraud, waste, and abuse under the Medicare program.
• Issue guidance to medical professionals on not billing Medicare for a medical service that was authorized by the VHA.
• Establish a comprehensive data-sharing agreement with the VHA.
• Establish an internal process (such as system edits) to address duplicate payments.

“CMS previously informed [the OIG] that establishing a long-term solution to address duplicate payments will take time,” the OIG reported.

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

The U.S. federal government wrote duplicate checks to private doctors who treated veterans, costing taxpayers up to $128 million in extra payments over 5 years, a new report by a federal watchdog revealed in April.
 

Private doctors were paid twice in nearly 300,000 cases from 2017 to 2021 involving veterans who were eligible for Veterans Health Administration and Medicare benefits, according to the report by the Health & Human Services Office of Inspector General.

The doctors were paid by Medicare for medical services that the VHA had authorized and already paid for, the OIG reported after it conducted a 5-year audit.

Duplicate Medicare payments have doubled from $22 million in 2019 when the Veterans Community Care Program was implemented to $45 million in 2021, according to the OIG report. The program allows veterans to seek care from private doctors when the VHA can’t provide the care they need.

Roughly 1.9 million veterans every year receive government-paid health care from private doctors.

The OIG said it decided to audit Medicare’s claims because “duplicate payments were a long-standing issue.”

The problem dates back to a 1979 General Accounting Office (now the Government Accountability Office) report that found Medicare and the Department of Veterans Affairs VHA made duplicate payments of more than $72,000 for certain medical services provided to veterans, the OIG reported.

The HHS OIG’s audit examined $19.2 billion in Medicare payments for 36 million claims for individuals who enrolled in Medicare and were eligible for VA services. About 90% of those claims were for doctor evaluations and visits, according to the OIG report.

The OIG found “these duplicate payments occurred because CMS did not implement controls to address duplicate payments for services provided to individuals with Medicare and VHA benefits.”

Specifically, the OIG found that the CMS and the VHA were not sharing enrollment, claims, and payment data with each other, as required by federal law.

If CMS had access to that information, the agency could have compared the VHA claims data with existing Medicare claims data to identify duplicate claims, the OIG claimed.

The OIG recommended that CMS take the following four steps to fix the problem, which CMS has agreed to do, according to the report:

• Integrate VHA enrollment, claims, and payment data into the CMS centralized claims data system so it can identify potential fraud, waste, and abuse under the Medicare program.
• Issue guidance to medical professionals on not billing Medicare for a medical service that was authorized by the VHA.
• Establish a comprehensive data-sharing agreement with the VHA.
• Establish an internal process (such as system edits) to address duplicate payments.

“CMS previously informed [the OIG] that establishing a long-term solution to address duplicate payments will take time,” the OIG reported.

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

SAN DIEGO – Primary care providers can draw from a wide range of diets to give patients evidence-based advice on how to lose weight, prevent diabetes, and achieve other health goals, according to a speaker at the annual meeting of the American College of Physicians.

“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
 

Predominantly plant‐based diets

Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).

The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.

“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.

A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.

“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.

For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
 

Time‐restricted feeding

There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.

Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.

These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
 

Low‐carbohydrate and ketogenic diets

Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.

The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
 

Rating the level of scientific evidence behind different diet options

Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.

In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
 

Getting to know patients is essential to help them maintain diet modifications

When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”

In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.

“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.

When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.

Dr. Hauser and Dr. Bittleman report no relevant financial relationships.

SAN DIEGO – Primary care providers can draw from a wide range of diets to give patients evidence-based advice on how to lose weight, prevent diabetes, and achieve other health goals, according to a speaker at the annual meeting of the American College of Physicians.

“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
 

Predominantly plant‐based diets

Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).

The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.

“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.

A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.

“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.

For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
 

Time‐restricted feeding

There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.

Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.

These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
 

Low‐carbohydrate and ketogenic diets

Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.

The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
 

Rating the level of scientific evidence behind different diet options

Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.

In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
 

Getting to know patients is essential to help them maintain diet modifications

When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”

In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.

“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.

When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.

Dr. Hauser and Dr. Bittleman report no relevant financial relationships.

SAN DIEGO – Primary care providers can draw from a wide range of diets to give patients evidence-based advice on how to lose weight, prevent diabetes, and achieve other health goals, according to a speaker at the annual meeting of the American College of Physicians.

“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
 

Predominantly plant‐based diets

Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).

The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.

“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.

A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.

“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.

For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
 

Time‐restricted feeding

There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.

Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.

These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
 

Low‐carbohydrate and ketogenic diets

Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.

The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
 

Rating the level of scientific evidence behind different diet options

Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.

In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
 

Getting to know patients is essential to help them maintain diet modifications

When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”

In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.

“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.

When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.

Dr. Hauser and Dr. Bittleman report no relevant financial relationships.