Researchers have developed an artificial intelligence (AI) machine-learning platform that can predict the prognosis and likely treatment response of patients with colorectal cancer (CRC) using histopathology images, according to a new study published in Nature Communications.
 

Specifically, the tool can aid doctors in identifying a “molecular diagnosis” based on a patient’s tumor and cancer characteristics, Kun-Hsing Yu, MD, PhD, the study’s senior author and an assistant professor of biomedical informatics at Harvard Medical School, Boston, said in an interview.

The Multi-omics Multi-cohort Assessment (MOMA) “successfully identified indicators of how aggressive a tumor was and how likely it was to behave in response to a particular treatment,” as well as patients’ overall and disease-free survival, noted Harvard Medical School in a press release. “Based on an image alone, the model also pinpointed characteristics associated with the presence or absence of specific genetic mutations – something that typically requires genomic sequencing of the tumor.”

The researchers designed the tool to offer “transparent reasoning,” so that if a clinician asks it why it made a certain prediction, it would be able to explain its reasoning and the variables it used, the press release noted.

“We first allow AI to explore any correlation, and then we try to explain those correlations using existing pathology terms that experts will be able to understand,” Dr. Yu said in an interview.

Although the tool is freely available to clinicians and researchers, it’s not yet ready for clinical use. When it is, the tool has the potential to provide timely, accurate decision support based on tumor imaging.

Colorectal cancer is the second most common cause of death from cancer in the United States, with more than 53,000 deaths each year, and the patient population has been gradually skewing younger over the past 2 decades.

Although clinicians already use histopathology and genetic analysis to guide treatment, the process can take several days or weeks in some areas, and these services may not be available in all parts of the world.

“Currently, a clinician has to send a [tissue] sample from the tumor specimen to genomic sequencing labs and wait for a week, sometimes up to 3 or more weeks, to get genomic sequencing results,” Dr. Yu said. That means a patient’s anxiety grows as they wait to find out which treatments might benefit them or how they might respond to a particular treatment.

Additionally, current knowledge for predicting patient survival, beyond considering the patient’s cancer stage, age, and general health status, is limited, Dr. Yu said.
 

Predictive ability

The MOMA platform was trained on information from 1,888 patients with colorectal cancer from three national cohorts: 628 patients from The Cancer Genome Atlas (TCGA) program, 927 patients from the Nurses’ Health Study with Health Professionals Follow-Up Study (NHS-HPFS), and 333 patients from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.

During the training, they fed the model information about the patients’ age, sex, cancer stage, and outcomes, as well as their tumors’ “multi-omic” information: the cancers’ genomic, epigenetic, protein, and metabolic profiles. Researchers showed the AI model digital, whole-slide histopathology images of tumor samples and asked it to look for visual markers related to tumor types, genetic mutations, epigenetic alterations, disease progression, and patient survival with the goal of enabling the platform to detect patterns that are indiscernible to the human eye.

They then tested the MOMA platform’s ability to interpret images by feeding it new tumor sample images from different patients and asking it to predict their survival and progression-free survival.

The researchers found that the tool successfully identified overall survival outcomes in patients with stage I or II cancer in the TCGA cohort, which they further validated with the NHS-HPFS and PLCO cohorts. The platform revealed that “dense clusters of adenocarcinoma cells are highly indicative of worse overall survival outcomes” and that the interaction of cancer cells with smooth muscle cells in cancerous areas predicted poorer overall survival.

MOMA was slightly more effective in predicting progression-free survival for stage I and stage II colorectal cancer across all three cohorts.

“Compared with the overall survival prediction, our progression-free survival model puts more emphasis on infiltrating lymphocytes and regions associated with extracellular mucin in its prediction,” the authors noted.

Prediction of overall survival and progression-free survival for stage III colorectal cancer showed similar levels of accuracy, they noted.

The tool also successfully assessed patients’ likely response to immunotherapy using predictions of microsatellite instability, since high MSI indicates a better response to immune checkpoint inhibitors.

MOMA outperformed a different machine-learning algorithm in predicting the copy number alterations and other features related to cancer development, and it predicted the likelihood of a BRAF mutation, which is linked to poorer prognosis.
 

Pushing the envelope?

MOMA presents an “intriguing new avenue of adding to how we think about and assess someone who has cancer,” Stacey Cohen, MD, an associate professor in the clinical research division of Fred Hutchinson Cancer Center at the University of Washington Medicine, Seattle, said in an interview.

However, the tool as it’s currently described appears primarily to duplicate what clinicians already are doing, which is considering a wide range of factors – including pathologic features, patient features and demographics, and the patient’s other medical illnesses – to develop a treatment plan within the context of current guidelines, noted Dr. Cohen, who was not involved in the project.

“I’m looking for these types of models to not just prognosticate an outcome but to really predict how someone should be treated, and to do that better than [using] standard clinical features,” Dr. Cohen said. “To some degree, they’re taking this AI model and trying to catch up to what we’re currently doing. Clearly, if they could do that, they can then push the envelope.”

Dr. Cohen acknowledged that a strength of using an AI platform is the speed at which it can provide its predictions in areas with few medical resources and few health care professionals – as long as the necessary imaging is available and physicians have a way to use the platform.

“On the one hand, I do see this as an opportunity to share the wealth of knowledge in a more rapid fashion, but I don’t think anybody is going to let a computer program dictate their treatment without a human medical oncologist being able to interpret that information,” Dr. Cohen said. “It still will require a lot of education by the users and not just by the people who are designing the study.”

Although the MOMA platform looked at multiple pathologic features in multiple cohorts, the results remain limited by the fact that the patients in those cohorts were treated decades ago, before many current treatments may have been available, Dr. Cohen said.

She also added that the cohorts did not have much ethnic diversity. In the NHS-HPFS, the largest cohort, 57% of the patients were White, and researchers lacked data on race for 42% of patients, so only about 1% of participants were of a known non-White race. Similarly, 47% of the TCGA patients were White and 41% had no data on race, leaving only 12% of patients from known, non-White racial backgrounds, including 10% Black or African American.

Additional studies that focus on specific patient populations are needed to evaluate the model’s applicability in clinical settings, the investigators note. More research is required to “identify the optimal prognostic prediction methods and enable personalized treatments and advance care planning,” they added.

These are the early days for this type of technology, Dr. Cohen noted.

“I’m very excited to see how this technology develops and how it could be potentially additive or improve upon our current treatment planning for patients,” she said.

Dr. Yu developed the invention “Quantitative Pathology Analysis and Diagnosis using Neural Networks,” whose patent is held by Harvard University, and has consulted for Curatio. One coauthor is a stakeholder and employee of Vertex Pharmaceuticals. The study’s funding sources included the National Institute of General Medical Sciences, the Google Research Scholar Award, the Blavatnik Center for Computational Biomedicine Award, the National Science and Technology Council Taiwan, and the National Center for High-performance Computing Taiwan. Dr. Cohen has advised or consulted for Natera.

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

Researchers have developed an artificial intelligence (AI) machine-learning platform that can predict the prognosis and likely treatment response of patients with colorectal cancer (CRC) using histopathology images, according to a new study published in Nature Communications.
 

Specifically, the tool can aid doctors in identifying a “molecular diagnosis” based on a patient’s tumor and cancer characteristics, Kun-Hsing Yu, MD, PhD, the study’s senior author and an assistant professor of biomedical informatics at Harvard Medical School, Boston, said in an interview.

The Multi-omics Multi-cohort Assessment (MOMA) “successfully identified indicators of how aggressive a tumor was and how likely it was to behave in response to a particular treatment,” as well as patients’ overall and disease-free survival, noted Harvard Medical School in a press release. “Based on an image alone, the model also pinpointed characteristics associated with the presence or absence of specific genetic mutations – something that typically requires genomic sequencing of the tumor.”

The researchers designed the tool to offer “transparent reasoning,” so that if a clinician asks it why it made a certain prediction, it would be able to explain its reasoning and the variables it used, the press release noted.

“We first allow AI to explore any correlation, and then we try to explain those correlations using existing pathology terms that experts will be able to understand,” Dr. Yu said in an interview.

Although the tool is freely available to clinicians and researchers, it’s not yet ready for clinical use. When it is, the tool has the potential to provide timely, accurate decision support based on tumor imaging.

Colorectal cancer is the second most common cause of death from cancer in the United States, with more than 53,000 deaths each year, and the patient population has been gradually skewing younger over the past 2 decades.

Although clinicians already use histopathology and genetic analysis to guide treatment, the process can take several days or weeks in some areas, and these services may not be available in all parts of the world.

“Currently, a clinician has to send a [tissue] sample from the tumor specimen to genomic sequencing labs and wait for a week, sometimes up to 3 or more weeks, to get genomic sequencing results,” Dr. Yu said. That means a patient’s anxiety grows as they wait to find out which treatments might benefit them or how they might respond to a particular treatment.

Additionally, current knowledge for predicting patient survival, beyond considering the patient’s cancer stage, age, and general health status, is limited, Dr. Yu said.
 

Predictive ability

The MOMA platform was trained on information from 1,888 patients with colorectal cancer from three national cohorts: 628 patients from The Cancer Genome Atlas (TCGA) program, 927 patients from the Nurses’ Health Study with Health Professionals Follow-Up Study (NHS-HPFS), and 333 patients from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.

During the training, they fed the model information about the patients’ age, sex, cancer stage, and outcomes, as well as their tumors’ “multi-omic” information: the cancers’ genomic, epigenetic, protein, and metabolic profiles. Researchers showed the AI model digital, whole-slide histopathology images of tumor samples and asked it to look for visual markers related to tumor types, genetic mutations, epigenetic alterations, disease progression, and patient survival with the goal of enabling the platform to detect patterns that are indiscernible to the human eye.

They then tested the MOMA platform’s ability to interpret images by feeding it new tumor sample images from different patients and asking it to predict their survival and progression-free survival.

The researchers found that the tool successfully identified overall survival outcomes in patients with stage I or II cancer in the TCGA cohort, which they further validated with the NHS-HPFS and PLCO cohorts. The platform revealed that “dense clusters of adenocarcinoma cells are highly indicative of worse overall survival outcomes” and that the interaction of cancer cells with smooth muscle cells in cancerous areas predicted poorer overall survival.

MOMA was slightly more effective in predicting progression-free survival for stage I and stage II colorectal cancer across all three cohorts.

“Compared with the overall survival prediction, our progression-free survival model puts more emphasis on infiltrating lymphocytes and regions associated with extracellular mucin in its prediction,” the authors noted.

Prediction of overall survival and progression-free survival for stage III colorectal cancer showed similar levels of accuracy, they noted.

The tool also successfully assessed patients’ likely response to immunotherapy using predictions of microsatellite instability, since high MSI indicates a better response to immune checkpoint inhibitors.

MOMA outperformed a different machine-learning algorithm in predicting the copy number alterations and other features related to cancer development, and it predicted the likelihood of a BRAF mutation, which is linked to poorer prognosis.
 

Pushing the envelope?

MOMA presents an “intriguing new avenue of adding to how we think about and assess someone who has cancer,” Stacey Cohen, MD, an associate professor in the clinical research division of Fred Hutchinson Cancer Center at the University of Washington Medicine, Seattle, said in an interview.

However, the tool as it’s currently described appears primarily to duplicate what clinicians already are doing, which is considering a wide range of factors – including pathologic features, patient features and demographics, and the patient’s other medical illnesses – to develop a treatment plan within the context of current guidelines, noted Dr. Cohen, who was not involved in the project.

“I’m looking for these types of models to not just prognosticate an outcome but to really predict how someone should be treated, and to do that better than [using] standard clinical features,” Dr. Cohen said. “To some degree, they’re taking this AI model and trying to catch up to what we’re currently doing. Clearly, if they could do that, they can then push the envelope.”

Dr. Cohen acknowledged that a strength of using an AI platform is the speed at which it can provide its predictions in areas with few medical resources and few health care professionals – as long as the necessary imaging is available and physicians have a way to use the platform.

“On the one hand, I do see this as an opportunity to share the wealth of knowledge in a more rapid fashion, but I don’t think anybody is going to let a computer program dictate their treatment without a human medical oncologist being able to interpret that information,” Dr. Cohen said. “It still will require a lot of education by the users and not just by the people who are designing the study.”

Although the MOMA platform looked at multiple pathologic features in multiple cohorts, the results remain limited by the fact that the patients in those cohorts were treated decades ago, before many current treatments may have been available, Dr. Cohen said.

She also added that the cohorts did not have much ethnic diversity. In the NHS-HPFS, the largest cohort, 57% of the patients were White, and researchers lacked data on race for 42% of patients, so only about 1% of participants were of a known non-White race. Similarly, 47% of the TCGA patients were White and 41% had no data on race, leaving only 12% of patients from known, non-White racial backgrounds, including 10% Black or African American.

Additional studies that focus on specific patient populations are needed to evaluate the model’s applicability in clinical settings, the investigators note. More research is required to “identify the optimal prognostic prediction methods and enable personalized treatments and advance care planning,” they added.

These are the early days for this type of technology, Dr. Cohen noted.

“I’m very excited to see how this technology develops and how it could be potentially additive or improve upon our current treatment planning for patients,” she said.

Dr. Yu developed the invention “Quantitative Pathology Analysis and Diagnosis using Neural Networks,” whose patent is held by Harvard University, and has consulted for Curatio. One coauthor is a stakeholder and employee of Vertex Pharmaceuticals. The study’s funding sources included the National Institute of General Medical Sciences, the Google Research Scholar Award, the Blavatnik Center for Computational Biomedicine Award, the National Science and Technology Council Taiwan, and the National Center for High-performance Computing Taiwan. Dr. Cohen has advised or consulted for Natera.

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

Researchers have developed an artificial intelligence (AI) machine-learning platform that can predict the prognosis and likely treatment response of patients with colorectal cancer (CRC) using histopathology images, according to a new study published in Nature Communications.
 

Specifically, the tool can aid doctors in identifying a “molecular diagnosis” based on a patient’s tumor and cancer characteristics, Kun-Hsing Yu, MD, PhD, the study’s senior author and an assistant professor of biomedical informatics at Harvard Medical School, Boston, said in an interview.

The Multi-omics Multi-cohort Assessment (MOMA) “successfully identified indicators of how aggressive a tumor was and how likely it was to behave in response to a particular treatment,” as well as patients’ overall and disease-free survival, noted Harvard Medical School in a press release. “Based on an image alone, the model also pinpointed characteristics associated with the presence or absence of specific genetic mutations – something that typically requires genomic sequencing of the tumor.”

The researchers designed the tool to offer “transparent reasoning,” so that if a clinician asks it why it made a certain prediction, it would be able to explain its reasoning and the variables it used, the press release noted.

“We first allow AI to explore any correlation, and then we try to explain those correlations using existing pathology terms that experts will be able to understand,” Dr. Yu said in an interview.

Although the tool is freely available to clinicians and researchers, it’s not yet ready for clinical use. When it is, the tool has the potential to provide timely, accurate decision support based on tumor imaging.

Colorectal cancer is the second most common cause of death from cancer in the United States, with more than 53,000 deaths each year, and the patient population has been gradually skewing younger over the past 2 decades.

Although clinicians already use histopathology and genetic analysis to guide treatment, the process can take several days or weeks in some areas, and these services may not be available in all parts of the world.

“Currently, a clinician has to send a [tissue] sample from the tumor specimen to genomic sequencing labs and wait for a week, sometimes up to 3 or more weeks, to get genomic sequencing results,” Dr. Yu said. That means a patient’s anxiety grows as they wait to find out which treatments might benefit them or how they might respond to a particular treatment.

Additionally, current knowledge for predicting patient survival, beyond considering the patient’s cancer stage, age, and general health status, is limited, Dr. Yu said.
 

Predictive ability

The MOMA platform was trained on information from 1,888 patients with colorectal cancer from three national cohorts: 628 patients from The Cancer Genome Atlas (TCGA) program, 927 patients from the Nurses’ Health Study with Health Professionals Follow-Up Study (NHS-HPFS), and 333 patients from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.

During the training, they fed the model information about the patients’ age, sex, cancer stage, and outcomes, as well as their tumors’ “multi-omic” information: the cancers’ genomic, epigenetic, protein, and metabolic profiles. Researchers showed the AI model digital, whole-slide histopathology images of tumor samples and asked it to look for visual markers related to tumor types, genetic mutations, epigenetic alterations, disease progression, and patient survival with the goal of enabling the platform to detect patterns that are indiscernible to the human eye.

They then tested the MOMA platform’s ability to interpret images by feeding it new tumor sample images from different patients and asking it to predict their survival and progression-free survival.

The researchers found that the tool successfully identified overall survival outcomes in patients with stage I or II cancer in the TCGA cohort, which they further validated with the NHS-HPFS and PLCO cohorts. The platform revealed that “dense clusters of adenocarcinoma cells are highly indicative of worse overall survival outcomes” and that the interaction of cancer cells with smooth muscle cells in cancerous areas predicted poorer overall survival.

MOMA was slightly more effective in predicting progression-free survival for stage I and stage II colorectal cancer across all three cohorts.

“Compared with the overall survival prediction, our progression-free survival model puts more emphasis on infiltrating lymphocytes and regions associated with extracellular mucin in its prediction,” the authors noted.

Prediction of overall survival and progression-free survival for stage III colorectal cancer showed similar levels of accuracy, they noted.

The tool also successfully assessed patients’ likely response to immunotherapy using predictions of microsatellite instability, since high MSI indicates a better response to immune checkpoint inhibitors.

MOMA outperformed a different machine-learning algorithm in predicting the copy number alterations and other features related to cancer development, and it predicted the likelihood of a BRAF mutation, which is linked to poorer prognosis.
 

Pushing the envelope?

MOMA presents an “intriguing new avenue of adding to how we think about and assess someone who has cancer,” Stacey Cohen, MD, an associate professor in the clinical research division of Fred Hutchinson Cancer Center at the University of Washington Medicine, Seattle, said in an interview.

However, the tool as it’s currently described appears primarily to duplicate what clinicians already are doing, which is considering a wide range of factors – including pathologic features, patient features and demographics, and the patient’s other medical illnesses – to develop a treatment plan within the context of current guidelines, noted Dr. Cohen, who was not involved in the project.

“I’m looking for these types of models to not just prognosticate an outcome but to really predict how someone should be treated, and to do that better than [using] standard clinical features,” Dr. Cohen said. “To some degree, they’re taking this AI model and trying to catch up to what we’re currently doing. Clearly, if they could do that, they can then push the envelope.”

Dr. Cohen acknowledged that a strength of using an AI platform is the speed at which it can provide its predictions in areas with few medical resources and few health care professionals – as long as the necessary imaging is available and physicians have a way to use the platform.

“On the one hand, I do see this as an opportunity to share the wealth of knowledge in a more rapid fashion, but I don’t think anybody is going to let a computer program dictate their treatment without a human medical oncologist being able to interpret that information,” Dr. Cohen said. “It still will require a lot of education by the users and not just by the people who are designing the study.”

Although the MOMA platform looked at multiple pathologic features in multiple cohorts, the results remain limited by the fact that the patients in those cohorts were treated decades ago, before many current treatments may have been available, Dr. Cohen said.

She also added that the cohorts did not have much ethnic diversity. In the NHS-HPFS, the largest cohort, 57% of the patients were White, and researchers lacked data on race for 42% of patients, so only about 1% of participants were of a known non-White race. Similarly, 47% of the TCGA patients were White and 41% had no data on race, leaving only 12% of patients from known, non-White racial backgrounds, including 10% Black or African American.

Additional studies that focus on specific patient populations are needed to evaluate the model’s applicability in clinical settings, the investigators note. More research is required to “identify the optimal prognostic prediction methods and enable personalized treatments and advance care planning,” they added.

These are the early days for this type of technology, Dr. Cohen noted.

“I’m very excited to see how this technology develops and how it could be potentially additive or improve upon our current treatment planning for patients,” she said.

Dr. Yu developed the invention “Quantitative Pathology Analysis and Diagnosis using Neural Networks,” whose patent is held by Harvard University, and has consulted for Curatio. One coauthor is a stakeholder and employee of Vertex Pharmaceuticals. The study’s funding sources included the National Institute of General Medical Sciences, the Google Research Scholar Award, the Blavatnik Center for Computational Biomedicine Award, the National Science and Technology Council Taiwan, and the National Center for High-performance Computing Taiwan. Dr. Cohen has advised or consulted for Natera.

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

The Food and Drug Administration has approved the antipsychotic brexpiprazole (Rexulti, Otsuka and Lundbeck) for agitation associated with Alzheimer’s disease (AD), making it the first FDA-approved drug for this indication.

“Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease,” Tiffany Farchione, MD, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a news release.

Olivier Le Moal/Getty Images

Agitation can include symptoms that range from pacing or restlessness to verbal and physical aggression. “These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression,” Dr. Farchione said.

Brexpiprazole was approved by the FDA in 2015 as an adjunctive therapy to antidepressants for adults with major depressive disorder and for adults with schizophrenia.

Approval of the supplemental application for brexpiprazole for agitation associated with AD dementia was based on results of two randomized, double-blind, placebo-controlled studies.

In both studies, patients who received 2 mg or 3 mg of brexpiprazole showed statistically significant and clinically meaningful improvements in agitation symptoms, as shown by total Cohen-Mansfield Agitation Inventory (CMAI) score, compared with patients who received placebo.

The recommended starting dosage for the treatment of agitation associated with AD dementia is 0.5 mg once daily on days 1-7; it was increased to 1 mg once daily on days 8-14 and then to the recommended target dose of 2 mg once daily.

The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, depending on clinical response and tolerability.

The most common side effects of brexpiprazole in patients with agitation associated with AD dementia include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances.

The drug includes a boxed warning for medications in this class that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

The supplemental application for brexpiprazole for agitation had fast-track designation.

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

The Food and Drug Administration has approved the antipsychotic brexpiprazole (Rexulti, Otsuka and Lundbeck) for agitation associated with Alzheimer’s disease (AD), making it the first FDA-approved drug for this indication.

“Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease,” Tiffany Farchione, MD, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a news release.

Olivier Le Moal/Getty Images

Agitation can include symptoms that range from pacing or restlessness to verbal and physical aggression. “These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression,” Dr. Farchione said.

Brexpiprazole was approved by the FDA in 2015 as an adjunctive therapy to antidepressants for adults with major depressive disorder and for adults with schizophrenia.

Approval of the supplemental application for brexpiprazole for agitation associated with AD dementia was based on results of two randomized, double-blind, placebo-controlled studies.

In both studies, patients who received 2 mg or 3 mg of brexpiprazole showed statistically significant and clinically meaningful improvements in agitation symptoms, as shown by total Cohen-Mansfield Agitation Inventory (CMAI) score, compared with patients who received placebo.

The recommended starting dosage for the treatment of agitation associated with AD dementia is 0.5 mg once daily on days 1-7; it was increased to 1 mg once daily on days 8-14 and then to the recommended target dose of 2 mg once daily.

The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, depending on clinical response and tolerability.

The most common side effects of brexpiprazole in patients with agitation associated with AD dementia include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances.

The drug includes a boxed warning for medications in this class that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

The supplemental application for brexpiprazole for agitation had fast-track designation.

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

The Food and Drug Administration has approved the antipsychotic brexpiprazole (Rexulti, Otsuka and Lundbeck) for agitation associated with Alzheimer’s disease (AD), making it the first FDA-approved drug for this indication.

“Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease,” Tiffany Farchione, MD, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a news release.

Olivier Le Moal/Getty Images

Agitation can include symptoms that range from pacing or restlessness to verbal and physical aggression. “These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression,” Dr. Farchione said.

Brexpiprazole was approved by the FDA in 2015 as an adjunctive therapy to antidepressants for adults with major depressive disorder and for adults with schizophrenia.

Approval of the supplemental application for brexpiprazole for agitation associated with AD dementia was based on results of two randomized, double-blind, placebo-controlled studies.

In both studies, patients who received 2 mg or 3 mg of brexpiprazole showed statistically significant and clinically meaningful improvements in agitation symptoms, as shown by total Cohen-Mansfield Agitation Inventory (CMAI) score, compared with patients who received placebo.

The recommended starting dosage for the treatment of agitation associated with AD dementia is 0.5 mg once daily on days 1-7; it was increased to 1 mg once daily on days 8-14 and then to the recommended target dose of 2 mg once daily.

The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, depending on clinical response and tolerability.

The most common side effects of brexpiprazole in patients with agitation associated with AD dementia include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances.

The drug includes a boxed warning for medications in this class that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

The supplemental application for brexpiprazole for agitation had fast-track designation.

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

Adults with cutaneous vasculitis experience a significantly diminished quality of life across physical, symptom, and emotional domains, and its measurement with an organ-specific instrument may catch important disease outcomes better than a generic health-related quality of life index, according to survey responses from participants in the Vasculitis Patient-Powered Research Network (VPPRN).

Although cutaneous vasculitis often causes itching, pain, and ulceration, the impact of the disease on specific health-related quality of life (HRQOL) outcomes has not been systematically assessed, wrote Sarah Mann, MD, of the University of Pittsburgh, and colleagues.

In a study published in JAMA Dermatology, the researchers used the VPPRN to conduct an online survey of adults aged 18 years and older with cutaneous manifestations of vasculitis. The survey was conducted between January 2020 and August 2021.

The primary outcomes of HRQOL were determined using two validated measures. One measured skin-related HRQOL (the Effects of Skin Disease on Quality-of-Life Survey [Skindex-29]), and the other measured general health and well-being (36-Item Short Form Health Survey [SF-36]).

The final analysis included 190 survey responses. The mean age of the respondents was 50.5 years, 84.1% were female, and approximately two-thirds reported a duration of vasculitis of at least 5 years. Respondents’ vasculitides included cutaneous small-vessel vasculitis (14%), IgA vasculitis (6.5%), urticarial vasculitis (8.4%), granulomatosis with polyangiitis (17.6%), microscopic polyangiitis (10.3%), eosinophilic vasculitis (15%), polyarteritis nodosa (3.7%), and other vasculitis types (24.2%).

On the Skindex-29 domains, severely or very severely diminished HRQOL was reported by 77.6% of respondents for emotions, 78.5% for symptoms, 60.7% for functioning, and 75.7% for overall HRQOL.

On the SF-36, the HRQOL was below average on six of eight domains, and approximately half of the patients had summative physical component scores (56%) and mental component scores (52%) below 50.

The HRQOL outcomes of cutaneous vasculitis were worse on the Skindex-29 than the SF-36, the researchers noted. “This discordance may reflect the value of disease or organ-specific measures, which may be able to capture important outcomes of disease even when generic measures do not,” they said.

The study findings were limited by several factors, including the potential lack of generalizability to broader populations of vasculitis patients, the researchers noted. Other limitations included the underrepresentation of male patients and the lack of a disease-specific patient-reported outcome measure, they said.

In addition, “Because half of patients reported having disease which was in remission or mildly active, the study findings may underestimate the true role of active cutaneous vasculitis on HRQOL,” the researchers said.

More studies are needed to assess how HRQOL measures respond to disease treatment and control, the researchers wrote in their discussion. However, the results suggest that cutaneous vasculitis has a significant effect on patients’ perception of their health, as well as on their well-being and symptoms, they said.

The study was supported by the Patient-Centered Outcomes Research Institute and GlaxoSmithKline. Dr. Mann had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies, including GlaxoSmithKline.

Adults with cutaneous vasculitis experience a significantly diminished quality of life across physical, symptom, and emotional domains, and its measurement with an organ-specific instrument may catch important disease outcomes better than a generic health-related quality of life index, according to survey responses from participants in the Vasculitis Patient-Powered Research Network (VPPRN).

Although cutaneous vasculitis often causes itching, pain, and ulceration, the impact of the disease on specific health-related quality of life (HRQOL) outcomes has not been systematically assessed, wrote Sarah Mann, MD, of the University of Pittsburgh, and colleagues.

In a study published in JAMA Dermatology, the researchers used the VPPRN to conduct an online survey of adults aged 18 years and older with cutaneous manifestations of vasculitis. The survey was conducted between January 2020 and August 2021.

The primary outcomes of HRQOL were determined using two validated measures. One measured skin-related HRQOL (the Effects of Skin Disease on Quality-of-Life Survey [Skindex-29]), and the other measured general health and well-being (36-Item Short Form Health Survey [SF-36]).

The final analysis included 190 survey responses. The mean age of the respondents was 50.5 years, 84.1% were female, and approximately two-thirds reported a duration of vasculitis of at least 5 years. Respondents’ vasculitides included cutaneous small-vessel vasculitis (14%), IgA vasculitis (6.5%), urticarial vasculitis (8.4%), granulomatosis with polyangiitis (17.6%), microscopic polyangiitis (10.3%), eosinophilic vasculitis (15%), polyarteritis nodosa (3.7%), and other vasculitis types (24.2%).

On the Skindex-29 domains, severely or very severely diminished HRQOL was reported by 77.6% of respondents for emotions, 78.5% for symptoms, 60.7% for functioning, and 75.7% for overall HRQOL.

On the SF-36, the HRQOL was below average on six of eight domains, and approximately half of the patients had summative physical component scores (56%) and mental component scores (52%) below 50.

The HRQOL outcomes of cutaneous vasculitis were worse on the Skindex-29 than the SF-36, the researchers noted. “This discordance may reflect the value of disease or organ-specific measures, which may be able to capture important outcomes of disease even when generic measures do not,” they said.

The study findings were limited by several factors, including the potential lack of generalizability to broader populations of vasculitis patients, the researchers noted. Other limitations included the underrepresentation of male patients and the lack of a disease-specific patient-reported outcome measure, they said.

In addition, “Because half of patients reported having disease which was in remission or mildly active, the study findings may underestimate the true role of active cutaneous vasculitis on HRQOL,” the researchers said.

More studies are needed to assess how HRQOL measures respond to disease treatment and control, the researchers wrote in their discussion. However, the results suggest that cutaneous vasculitis has a significant effect on patients’ perception of their health, as well as on their well-being and symptoms, they said.

The study was supported by the Patient-Centered Outcomes Research Institute and GlaxoSmithKline. Dr. Mann had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies, including GlaxoSmithKline.

Adults with cutaneous vasculitis experience a significantly diminished quality of life across physical, symptom, and emotional domains, and its measurement with an organ-specific instrument may catch important disease outcomes better than a generic health-related quality of life index, according to survey responses from participants in the Vasculitis Patient-Powered Research Network (VPPRN).

Although cutaneous vasculitis often causes itching, pain, and ulceration, the impact of the disease on specific health-related quality of life (HRQOL) outcomes has not been systematically assessed, wrote Sarah Mann, MD, of the University of Pittsburgh, and colleagues.

In a study published in JAMA Dermatology, the researchers used the VPPRN to conduct an online survey of adults aged 18 years and older with cutaneous manifestations of vasculitis. The survey was conducted between January 2020 and August 2021.

The primary outcomes of HRQOL were determined using two validated measures. One measured skin-related HRQOL (the Effects of Skin Disease on Quality-of-Life Survey [Skindex-29]), and the other measured general health and well-being (36-Item Short Form Health Survey [SF-36]).

The final analysis included 190 survey responses. The mean age of the respondents was 50.5 years, 84.1% were female, and approximately two-thirds reported a duration of vasculitis of at least 5 years. Respondents’ vasculitides included cutaneous small-vessel vasculitis (14%), IgA vasculitis (6.5%), urticarial vasculitis (8.4%), granulomatosis with polyangiitis (17.6%), microscopic polyangiitis (10.3%), eosinophilic vasculitis (15%), polyarteritis nodosa (3.7%), and other vasculitis types (24.2%).

On the Skindex-29 domains, severely or very severely diminished HRQOL was reported by 77.6% of respondents for emotions, 78.5% for symptoms, 60.7% for functioning, and 75.7% for overall HRQOL.

On the SF-36, the HRQOL was below average on six of eight domains, and approximately half of the patients had summative physical component scores (56%) and mental component scores (52%) below 50.

The HRQOL outcomes of cutaneous vasculitis were worse on the Skindex-29 than the SF-36, the researchers noted. “This discordance may reflect the value of disease or organ-specific measures, which may be able to capture important outcomes of disease even when generic measures do not,” they said.

The study findings were limited by several factors, including the potential lack of generalizability to broader populations of vasculitis patients, the researchers noted. Other limitations included the underrepresentation of male patients and the lack of a disease-specific patient-reported outcome measure, they said.

In addition, “Because half of patients reported having disease which was in remission or mildly active, the study findings may underestimate the true role of active cutaneous vasculitis on HRQOL,” the researchers said.

More studies are needed to assess how HRQOL measures respond to disease treatment and control, the researchers wrote in their discussion. However, the results suggest that cutaneous vasculitis has a significant effect on patients’ perception of their health, as well as on their well-being and symptoms, they said.

The study was supported by the Patient-Centered Outcomes Research Institute and GlaxoSmithKline. Dr. Mann had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies, including GlaxoSmithKline.

Use of intravenous immunoglobulin (IVIG) had no apparent effect on the risk of venous thromboembolism (VTE) in adults with dermatomyositis (DM), based on data from more than 400 individuals.

DM has been associated with an increased risk of VTE in previous studies, wrote Elizabeth T. Rotrosen, of Boston University and Brigham and Women’s Hospital, Boston, and colleagues. Although IVIG is often effective for DM patients with recalcitrant disease, it carries a boxed warning for increased thrombosis risk; however, the association between IVIG use and VTE risk in DM has not been well examined, the researchers said.

In a study published in JAMA Dermatology, the researchers identified 458 adults with DM based on the European Alliance of Associations for Reumatology/American College of Rheumatology criteria. The mean age of the participants was 51.8 years, 76% were female, and 82% were White. Of these, 178 were treated with IVIG and 280 were not. The mean duration of IVIG treatment was 32.9 months. The researchers used the chi square test to test for independence between binary variables, the Pearson chi square test to test for independence between categorical variables, and the unpaired t test to compare continuous variables in their statistical analysis.

A total of 23 patients experienced DM-associated VTEs; 6 in the IVIG group and 17 in the non-IVIG group (3.4% vs. 5.7%, P = .20), a nonsignificant difference. The patients in the IVIG group who experienced a DM-associated VTE all underwent IVIG treatment within 4 weeks before the event.

bong hyunjung/iStock/Getty Images

The study findings were limited by several factors, including the retrospective design and small number of VTEs. Prospective studies are needed for better assessment of the VTE risk in patients with DM treated with IVIG, the researchers noted. However, the study is the largest known to explore the association between IVIG use and VTE risk in patients with DM, they said, and the results suggest that clinicians may continue IVIG use in these patients with considerations of risks and benefits on an individual basis.

The study received no outside funding. Ms. Rotrosen had no financial conflicts to disclose. Two coauthors reported financial relationships with Pfizer unrelated to this study.

Use of intravenous immunoglobulin (IVIG) had no apparent effect on the risk of venous thromboembolism (VTE) in adults with dermatomyositis (DM), based on data from more than 400 individuals.

DM has been associated with an increased risk of VTE in previous studies, wrote Elizabeth T. Rotrosen, of Boston University and Brigham and Women’s Hospital, Boston, and colleagues. Although IVIG is often effective for DM patients with recalcitrant disease, it carries a boxed warning for increased thrombosis risk; however, the association between IVIG use and VTE risk in DM has not been well examined, the researchers said.

In a study published in JAMA Dermatology, the researchers identified 458 adults with DM based on the European Alliance of Associations for Reumatology/American College of Rheumatology criteria. The mean age of the participants was 51.8 years, 76% were female, and 82% were White. Of these, 178 were treated with IVIG and 280 were not. The mean duration of IVIG treatment was 32.9 months. The researchers used the chi square test to test for independence between binary variables, the Pearson chi square test to test for independence between categorical variables, and the unpaired t test to compare continuous variables in their statistical analysis.

A total of 23 patients experienced DM-associated VTEs; 6 in the IVIG group and 17 in the non-IVIG group (3.4% vs. 5.7%, P = .20), a nonsignificant difference. The patients in the IVIG group who experienced a DM-associated VTE all underwent IVIG treatment within 4 weeks before the event.

bong hyunjung/iStock/Getty Images

The study findings were limited by several factors, including the retrospective design and small number of VTEs. Prospective studies are needed for better assessment of the VTE risk in patients with DM treated with IVIG, the researchers noted. However, the study is the largest known to explore the association between IVIG use and VTE risk in patients with DM, they said, and the results suggest that clinicians may continue IVIG use in these patients with considerations of risks and benefits on an individual basis.

The study received no outside funding. Ms. Rotrosen had no financial conflicts to disclose. Two coauthors reported financial relationships with Pfizer unrelated to this study.

Use of intravenous immunoglobulin (IVIG) had no apparent effect on the risk of venous thromboembolism (VTE) in adults with dermatomyositis (DM), based on data from more than 400 individuals.

DM has been associated with an increased risk of VTE in previous studies, wrote Elizabeth T. Rotrosen, of Boston University and Brigham and Women’s Hospital, Boston, and colleagues. Although IVIG is often effective for DM patients with recalcitrant disease, it carries a boxed warning for increased thrombosis risk; however, the association between IVIG use and VTE risk in DM has not been well examined, the researchers said.

In a study published in JAMA Dermatology, the researchers identified 458 adults with DM based on the European Alliance of Associations for Reumatology/American College of Rheumatology criteria. The mean age of the participants was 51.8 years, 76% were female, and 82% were White. Of these, 178 were treated with IVIG and 280 were not. The mean duration of IVIG treatment was 32.9 months. The researchers used the chi square test to test for independence between binary variables, the Pearson chi square test to test for independence between categorical variables, and the unpaired t test to compare continuous variables in their statistical analysis.

A total of 23 patients experienced DM-associated VTEs; 6 in the IVIG group and 17 in the non-IVIG group (3.4% vs. 5.7%, P = .20), a nonsignificant difference. The patients in the IVIG group who experienced a DM-associated VTE all underwent IVIG treatment within 4 weeks before the event.

bong hyunjung/iStock/Getty Images

The study findings were limited by several factors, including the retrospective design and small number of VTEs. Prospective studies are needed for better assessment of the VTE risk in patients with DM treated with IVIG, the researchers noted. However, the study is the largest known to explore the association between IVIG use and VTE risk in patients with DM, they said, and the results suggest that clinicians may continue IVIG use in these patients with considerations of risks and benefits on an individual basis.

The study received no outside funding. Ms. Rotrosen had no financial conflicts to disclose. Two coauthors reported financial relationships with Pfizer unrelated to this study.

Individuals who are carriers of germline pathogenic variants in susceptibility genes for pancreatic ductal adenocarcinoma (PDAC), or have a strong family history of PDAC, benefit from having annual MRIs, shows a new study published in Gastroenterology.

While other studies have shown potential benefit in screening high-risk individuals, “a concern is that in absence of sufficiently large control groups with unscreened controls,” the outcomes may be influenced by lead-time bias. The current study is the first to address that important limitation.

The study, which was led by Derk C.F. Klatte, MD, of the department of gastroenterology and hepatology at Leiden University Medical Center, the Netherlands, included 43,762 patients from the Netherlands Cancer Registry who were diagnosed with PDAC between January 2000 and December 2020. Using a 1:5 ratio, researchers matched 31 patients who were diagnosed in the pancreatic cancer surveillance cohort against 155 patients in the non-surveillance group.

Leiden University Medical Center

“We show that surveillance for PDAC in high-risk individuals results in significant earlier detection, increased resectability, and improved survival as compared with average-risk individuals diagnosed with PDAC not under surveillance. This reaffirms that pancreatic surveillance for certain in high-risk individuals is beneficial and could have a meaningful impact on disease course,” the authors wrote.

PDAC has the worst outcomes all cancers and is on pace to become the second-leading cause of cancer-related mortality. By the time a tumor is detected, it is usually unresectable or has developed distant metastases. In principle, early detection could improve outcomes, but there is no test that is adequate for population-wide screening. Surveillance must therefore concentrate on individuals deemed to be at heightened risk. Prospective studies have shown a benefit of pancreatic cancer screening in patients who are at high-risk. Such studies may be misleading, however, due to the potential for lead-time bias. This can occur when a condition is detected at an earlier time than it would have been identified based on clinical signs, as usually occurs in nonscreened populations, and this asymptomatic lag time between diagnosis and initial symptoms does not get incorporated into a survival analysis. The result can be an artificially longer survival time following diagnosis in the screened population.

Guidelines from the International Cancer of the Pancreas Screening (CAPS) consortium, the American Society for Gastrointestinal Endoscopy, and American Society of Clinical Oncology recommend surveillance in high-risk cases.

In this study, researchers conducted a propensity score matched cohort analysis of patients from the general population with primary PDAC who were diagnosed outside of a screening program, with carriers of a germline CDKN2A/p16 mutation who were diagnosed after surveillance.

The surveillance group received a stage 1 diagnosis in 38.7% of cases, versus 5.8% of those outside of surveillance (odds ratio [OR], 0.09; 95% confidence interval [CI], 0.04-0.19). Surgical resection occurred in 71.0% of surveillance patients, versus 18.7% of non-surveillance patients (OR, 10.62; 95% CI, 4.56-26.63), and stage 4 diagnoses were much more common in the nonsurveillance population (61.3% versus 9.7%). Among the patients who did not undergo surveillance, 61.3% were diagnosed with stage 4 disease compared with 9.7% of those in the surveillance group.

The 5-year survival rate (unadjusted for lead-time) in the surveillance group was 32.4% and 4.3% in the nonsurveillance group. The median overall survival was 26.8 months in the surveillance group compared with 5.2 months in the nonsurveillance group, (hazard ratio, 0.22; 95% CI, 0.14-0.36). The mortality rate per 100 person-years was 114.5 (95% CI, 96.2–135.3) in nonsurveillance patients and 21.9 (95% CI, 13.4–33.8) in surveillance patients.

Despite the apparent benefit of screening, there is room for improvement. “Although the outcomes presented here are encouraging and endorse our earlier findings, a significant proportion of surveillance patients (61%) still had poor outcomes because of diagnosis in a late stage (T2–4N0M0 and nodal or distant metastatic PDAC), with a 5-year survival of 16%,” the authors wrote.

The study received no funding and the authors declared no conflicts.

Individuals who are carriers of germline pathogenic variants in susceptibility genes for pancreatic ductal adenocarcinoma (PDAC), or have a strong family history of PDAC, benefit from having annual MRIs, shows a new study published in Gastroenterology.

While other studies have shown potential benefit in screening high-risk individuals, “a concern is that in absence of sufficiently large control groups with unscreened controls,” the outcomes may be influenced by lead-time bias. The current study is the first to address that important limitation.

The study, which was led by Derk C.F. Klatte, MD, of the department of gastroenterology and hepatology at Leiden University Medical Center, the Netherlands, included 43,762 patients from the Netherlands Cancer Registry who were diagnosed with PDAC between January 2000 and December 2020. Using a 1:5 ratio, researchers matched 31 patients who were diagnosed in the pancreatic cancer surveillance cohort against 155 patients in the non-surveillance group.

Leiden University Medical Center

“We show that surveillance for PDAC in high-risk individuals results in significant earlier detection, increased resectability, and improved survival as compared with average-risk individuals diagnosed with PDAC not under surveillance. This reaffirms that pancreatic surveillance for certain in high-risk individuals is beneficial and could have a meaningful impact on disease course,” the authors wrote.

PDAC has the worst outcomes all cancers and is on pace to become the second-leading cause of cancer-related mortality. By the time a tumor is detected, it is usually unresectable or has developed distant metastases. In principle, early detection could improve outcomes, but there is no test that is adequate for population-wide screening. Surveillance must therefore concentrate on individuals deemed to be at heightened risk. Prospective studies have shown a benefit of pancreatic cancer screening in patients who are at high-risk. Such studies may be misleading, however, due to the potential for lead-time bias. This can occur when a condition is detected at an earlier time than it would have been identified based on clinical signs, as usually occurs in nonscreened populations, and this asymptomatic lag time between diagnosis and initial symptoms does not get incorporated into a survival analysis. The result can be an artificially longer survival time following diagnosis in the screened population.

Guidelines from the International Cancer of the Pancreas Screening (CAPS) consortium, the American Society for Gastrointestinal Endoscopy, and American Society of Clinical Oncology recommend surveillance in high-risk cases.

In this study, researchers conducted a propensity score matched cohort analysis of patients from the general population with primary PDAC who were diagnosed outside of a screening program, with carriers of a germline CDKN2A/p16 mutation who were diagnosed after surveillance.

The surveillance group received a stage 1 diagnosis in 38.7% of cases, versus 5.8% of those outside of surveillance (odds ratio [OR], 0.09; 95% confidence interval [CI], 0.04-0.19). Surgical resection occurred in 71.0% of surveillance patients, versus 18.7% of non-surveillance patients (OR, 10.62; 95% CI, 4.56-26.63), and stage 4 diagnoses were much more common in the nonsurveillance population (61.3% versus 9.7%). Among the patients who did not undergo surveillance, 61.3% were diagnosed with stage 4 disease compared with 9.7% of those in the surveillance group.

The 5-year survival rate (unadjusted for lead-time) in the surveillance group was 32.4% and 4.3% in the nonsurveillance group. The median overall survival was 26.8 months in the surveillance group compared with 5.2 months in the nonsurveillance group, (hazard ratio, 0.22; 95% CI, 0.14-0.36). The mortality rate per 100 person-years was 114.5 (95% CI, 96.2–135.3) in nonsurveillance patients and 21.9 (95% CI, 13.4–33.8) in surveillance patients.

Despite the apparent benefit of screening, there is room for improvement. “Although the outcomes presented here are encouraging and endorse our earlier findings, a significant proportion of surveillance patients (61%) still had poor outcomes because of diagnosis in a late stage (T2–4N0M0 and nodal or distant metastatic PDAC), with a 5-year survival of 16%,” the authors wrote.

The study received no funding and the authors declared no conflicts.

Individuals who are carriers of germline pathogenic variants in susceptibility genes for pancreatic ductal adenocarcinoma (PDAC), or have a strong family history of PDAC, benefit from having annual MRIs, shows a new study published in Gastroenterology.

While other studies have shown potential benefit in screening high-risk individuals, “a concern is that in absence of sufficiently large control groups with unscreened controls,” the outcomes may be influenced by lead-time bias. The current study is the first to address that important limitation.

The study, which was led by Derk C.F. Klatte, MD, of the department of gastroenterology and hepatology at Leiden University Medical Center, the Netherlands, included 43,762 patients from the Netherlands Cancer Registry who were diagnosed with PDAC between January 2000 and December 2020. Using a 1:5 ratio, researchers matched 31 patients who were diagnosed in the pancreatic cancer surveillance cohort against 155 patients in the non-surveillance group.

Leiden University Medical Center

“We show that surveillance for PDAC in high-risk individuals results in significant earlier detection, increased resectability, and improved survival as compared with average-risk individuals diagnosed with PDAC not under surveillance. This reaffirms that pancreatic surveillance for certain in high-risk individuals is beneficial and could have a meaningful impact on disease course,” the authors wrote.

PDAC has the worst outcomes all cancers and is on pace to become the second-leading cause of cancer-related mortality. By the time a tumor is detected, it is usually unresectable or has developed distant metastases. In principle, early detection could improve outcomes, but there is no test that is adequate for population-wide screening. Surveillance must therefore concentrate on individuals deemed to be at heightened risk. Prospective studies have shown a benefit of pancreatic cancer screening in patients who are at high-risk. Such studies may be misleading, however, due to the potential for lead-time bias. This can occur when a condition is detected at an earlier time than it would have been identified based on clinical signs, as usually occurs in nonscreened populations, and this asymptomatic lag time between diagnosis and initial symptoms does not get incorporated into a survival analysis. The result can be an artificially longer survival time following diagnosis in the screened population.

Guidelines from the International Cancer of the Pancreas Screening (CAPS) consortium, the American Society for Gastrointestinal Endoscopy, and American Society of Clinical Oncology recommend surveillance in high-risk cases.

In this study, researchers conducted a propensity score matched cohort analysis of patients from the general population with primary PDAC who were diagnosed outside of a screening program, with carriers of a germline CDKN2A/p16 mutation who were diagnosed after surveillance.

The surveillance group received a stage 1 diagnosis in 38.7% of cases, versus 5.8% of those outside of surveillance (odds ratio [OR], 0.09; 95% confidence interval [CI], 0.04-0.19). Surgical resection occurred in 71.0% of surveillance patients, versus 18.7% of non-surveillance patients (OR, 10.62; 95% CI, 4.56-26.63), and stage 4 diagnoses were much more common in the nonsurveillance population (61.3% versus 9.7%). Among the patients who did not undergo surveillance, 61.3% were diagnosed with stage 4 disease compared with 9.7% of those in the surveillance group.

The 5-year survival rate (unadjusted for lead-time) in the surveillance group was 32.4% and 4.3% in the nonsurveillance group. The median overall survival was 26.8 months in the surveillance group compared with 5.2 months in the nonsurveillance group, (hazard ratio, 0.22; 95% CI, 0.14-0.36). The mortality rate per 100 person-years was 114.5 (95% CI, 96.2–135.3) in nonsurveillance patients and 21.9 (95% CI, 13.4–33.8) in surveillance patients.

Despite the apparent benefit of screening, there is room for improvement. “Although the outcomes presented here are encouraging and endorse our earlier findings, a significant proportion of surveillance patients (61%) still had poor outcomes because of diagnosis in a late stage (T2–4N0M0 and nodal or distant metastatic PDAC), with a 5-year survival of 16%,” the authors wrote.

The study received no funding and the authors declared no conflicts.

LONG BEACH, CALIF. – For years, clinicians have debated whether prescribing statins to patients older than 75 for the prevention of cardiovascular events is appropriate.

In 2022, the U.S. Preventive Services Task Force concluded that scientific evidence was insufficient to assess the balance between the benefits and harms of the therapy for this older population.

At a session of the annual meeting of the American Geriatrics Society, experts laid out new preliminary recommendations of the AGS and the National Lipid Association on assessing risk and deciding on treatment.

The group concluded that LDL cholesterol levels are associated with incident arteriosclerotic cardiovascular disease (ASCVD), that the coronary artery calcium (CAC) score can be a valuable measure, and that statins may be reasonable to prescribe, even given the risks that have been linked to statins, such as that for muscle pain. Final recommendations are expected by fall 2023.

“This is still a work in progress,” said Daniel E. Forman, MD, professor of medicine and chair of geriatric cardiology at the University of Pittsburgh.

The AGS-NLA panel concluded that, for those aged 75 or older without established ASCVD, LDL cholesterol is associated with incident ASCVD, the only recommendation to be given a class I (strong) rating; others were classed as moderate or weak.

Dr. Forman reviewed the evidence for lowering LDL cholesterol to decrease ASCVD, citing a 2018 study that concluded, “Reverse causation may contribute to the association of lower TC with higher mortality in nonrandomized studies.”

However, research overall shows that, as LDL cholesterol levels increase, patients are more likely to experience a heart event.

Dr. Forman noted that the utility of equations for assessing 5- or 10-year risk of ASCVD is uncertain. However, he said, traditional risk factors, such as family history and ethnicity, still have value.

Assessing risk “has been enriched in the past few years by the introduction of the coronary artery calcium [CAC] score,” he said.

Lower scores predict lower rates of CVD events, Forman said. The AGS-NLA recommends measuring CAC if clinical uncertainty exists about the value of statins.

“It’s reasonable to measure CAC and to withhold statins when the CAC is zero,” Dr. Forman said. “When the CAC score is zero ... the risk of having a cardiovascular event is really next to nil. Patients are happy to know they have a CAC of zero.”

Likewise, patients appreciate knowing whether their score is high, which would indicate increased risk. He said the CAC score is underused by geriatric physicians.

The group also determined, after reviewing the research, that starting treatment is reasonable for patients with an LDL cholesterol level of 70-189 if they have no life-limiting illness and their life expectancy is over 5 years.

Other preliminary recommendations include the use of statins for those aged 75 and older, irrespective of risk for statin-associated muscle symptoms, type 2 diabetes, or impaired cognition. These associations are often weak, Dr. Forman added.
 

Focusing on person-centered decisions

Ariel Green, MD, MPH, PhD, associate professor of medicine at Johns Hopkins University, Baltimore, said statin therapy “should be individualized” to weigh benefits, noncardiac risks, and other considerations.

Clinicians can incorporate life expectancy into prevention decisions using tools such as ePrognosis, from the University of California, San Francisco, Dr. Green said.

If life expectancy is greater than the time to benefit, statin therapy may help. Dr. Green cited research that showed that 2.5 years of statin therapy was needed to prevent one major adverse cardiovascular event (MACE) per 100 patients in a population aged 50-75. Other data show reductions in MACE for those older than 75, but overall, the data are limited in this population.

The proposed recommendation is to use tools such as life tables that include comorbid conditions and functional status to guide clinical decisions.

“Another aspect of assessing net benefits of statin therapy is to consider competing health risks,” Dr. Green said.

The group recommends considering using competing risk-adjusted CVD models, though these are not widely used.

The group also recommends integrating screenings for frailty (Clinical Frailty Scale), dementia (Mini-Cog), and functional status (Vulnerable Elders Scale–13) into assessments.

“The presence of these syndromes should prompt elicitation of patient values and preferences related to prevention and medication use,” Dr. Green said.

Clinicians can use decision aids, but these are not always practical, owing to obstacles such as patients’ cognitive problems, Dr. Green said.

“Another approach is asking people to prioritize a set of universal health outcomes that apply across health conditions, such as maintaining independence, staying alive, reducing, or eliminating symptoms and focusing on comfort,” Dr. Green said.

She addressed the evidence about deprescribing statins, with a focus on those with a life expectancy of less than a year. Researchers have found an increase in quality of life and no increases in cardiovascular events or death when statins were deprescribed.
 

A welcome framework

Cory Krueger, MD, an internal medicine and geriatric physician in Cornville, Ariz., who attended the talk, said he welcomed the presentation, in which preliminary recommendations were explained.

“This has been a controversial area in geriatrics,” Dr. Krueger said. “At least this gave me a framework for discussing this with my patients in a reasonable way.”

Dr. Forman and Dr. Krueger disclosed no relevant financial relationships. Dr. Green receives funding from the National Institute of Aging and Impact Collaboratory.

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

LONG BEACH, CALIF. – For years, clinicians have debated whether prescribing statins to patients older than 75 for the prevention of cardiovascular events is appropriate.

In 2022, the U.S. Preventive Services Task Force concluded that scientific evidence was insufficient to assess the balance between the benefits and harms of the therapy for this older population.

At a session of the annual meeting of the American Geriatrics Society, experts laid out new preliminary recommendations of the AGS and the National Lipid Association on assessing risk and deciding on treatment.

The group concluded that LDL cholesterol levels are associated with incident arteriosclerotic cardiovascular disease (ASCVD), that the coronary artery calcium (CAC) score can be a valuable measure, and that statins may be reasonable to prescribe, even given the risks that have been linked to statins, such as that for muscle pain. Final recommendations are expected by fall 2023.

“This is still a work in progress,” said Daniel E. Forman, MD, professor of medicine and chair of geriatric cardiology at the University of Pittsburgh.

The AGS-NLA panel concluded that, for those aged 75 or older without established ASCVD, LDL cholesterol is associated with incident ASCVD, the only recommendation to be given a class I (strong) rating; others were classed as moderate or weak.

Dr. Forman reviewed the evidence for lowering LDL cholesterol to decrease ASCVD, citing a 2018 study that concluded, “Reverse causation may contribute to the association of lower TC with higher mortality in nonrandomized studies.”

However, research overall shows that, as LDL cholesterol levels increase, patients are more likely to experience a heart event.

Dr. Forman noted that the utility of equations for assessing 5- or 10-year risk of ASCVD is uncertain. However, he said, traditional risk factors, such as family history and ethnicity, still have value.

Assessing risk “has been enriched in the past few years by the introduction of the coronary artery calcium [CAC] score,” he said.

Lower scores predict lower rates of CVD events, Forman said. The AGS-NLA recommends measuring CAC if clinical uncertainty exists about the value of statins.

“It’s reasonable to measure CAC and to withhold statins when the CAC is zero,” Dr. Forman said. “When the CAC score is zero ... the risk of having a cardiovascular event is really next to nil. Patients are happy to know they have a CAC of zero.”

Likewise, patients appreciate knowing whether their score is high, which would indicate increased risk. He said the CAC score is underused by geriatric physicians.

The group also determined, after reviewing the research, that starting treatment is reasonable for patients with an LDL cholesterol level of 70-189 if they have no life-limiting illness and their life expectancy is over 5 years.

Other preliminary recommendations include the use of statins for those aged 75 and older, irrespective of risk for statin-associated muscle symptoms, type 2 diabetes, or impaired cognition. These associations are often weak, Dr. Forman added.
 

Focusing on person-centered decisions

Ariel Green, MD, MPH, PhD, associate professor of medicine at Johns Hopkins University, Baltimore, said statin therapy “should be individualized” to weigh benefits, noncardiac risks, and other considerations.

Clinicians can incorporate life expectancy into prevention decisions using tools such as ePrognosis, from the University of California, San Francisco, Dr. Green said.

If life expectancy is greater than the time to benefit, statin therapy may help. Dr. Green cited research that showed that 2.5 years of statin therapy was needed to prevent one major adverse cardiovascular event (MACE) per 100 patients in a population aged 50-75. Other data show reductions in MACE for those older than 75, but overall, the data are limited in this population.

The proposed recommendation is to use tools such as life tables that include comorbid conditions and functional status to guide clinical decisions.

“Another aspect of assessing net benefits of statin therapy is to consider competing health risks,” Dr. Green said.

The group recommends considering using competing risk-adjusted CVD models, though these are not widely used.

The group also recommends integrating screenings for frailty (Clinical Frailty Scale), dementia (Mini-Cog), and functional status (Vulnerable Elders Scale–13) into assessments.

“The presence of these syndromes should prompt elicitation of patient values and preferences related to prevention and medication use,” Dr. Green said.

Clinicians can use decision aids, but these are not always practical, owing to obstacles such as patients’ cognitive problems, Dr. Green said.

“Another approach is asking people to prioritize a set of universal health outcomes that apply across health conditions, such as maintaining independence, staying alive, reducing, or eliminating symptoms and focusing on comfort,” Dr. Green said.

She addressed the evidence about deprescribing statins, with a focus on those with a life expectancy of less than a year. Researchers have found an increase in quality of life and no increases in cardiovascular events or death when statins were deprescribed.
 

A welcome framework

Cory Krueger, MD, an internal medicine and geriatric physician in Cornville, Ariz., who attended the talk, said he welcomed the presentation, in which preliminary recommendations were explained.

“This has been a controversial area in geriatrics,” Dr. Krueger said. “At least this gave me a framework for discussing this with my patients in a reasonable way.”

Dr. Forman and Dr. Krueger disclosed no relevant financial relationships. Dr. Green receives funding from the National Institute of Aging and Impact Collaboratory.

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

LONG BEACH, CALIF. – For years, clinicians have debated whether prescribing statins to patients older than 75 for the prevention of cardiovascular events is appropriate.

In 2022, the U.S. Preventive Services Task Force concluded that scientific evidence was insufficient to assess the balance between the benefits and harms of the therapy for this older population.

At a session of the annual meeting of the American Geriatrics Society, experts laid out new preliminary recommendations of the AGS and the National Lipid Association on assessing risk and deciding on treatment.

The group concluded that LDL cholesterol levels are associated with incident arteriosclerotic cardiovascular disease (ASCVD), that the coronary artery calcium (CAC) score can be a valuable measure, and that statins may be reasonable to prescribe, even given the risks that have been linked to statins, such as that for muscle pain. Final recommendations are expected by fall 2023.

“This is still a work in progress,” said Daniel E. Forman, MD, professor of medicine and chair of geriatric cardiology at the University of Pittsburgh.

The AGS-NLA panel concluded that, for those aged 75 or older without established ASCVD, LDL cholesterol is associated with incident ASCVD, the only recommendation to be given a class I (strong) rating; others were classed as moderate or weak.

Dr. Forman reviewed the evidence for lowering LDL cholesterol to decrease ASCVD, citing a 2018 study that concluded, “Reverse causation may contribute to the association of lower TC with higher mortality in nonrandomized studies.”

However, research overall shows that, as LDL cholesterol levels increase, patients are more likely to experience a heart event.

Dr. Forman noted that the utility of equations for assessing 5- or 10-year risk of ASCVD is uncertain. However, he said, traditional risk factors, such as family history and ethnicity, still have value.

Assessing risk “has been enriched in the past few years by the introduction of the coronary artery calcium [CAC] score,” he said.

Lower scores predict lower rates of CVD events, Forman said. The AGS-NLA recommends measuring CAC if clinical uncertainty exists about the value of statins.

“It’s reasonable to measure CAC and to withhold statins when the CAC is zero,” Dr. Forman said. “When the CAC score is zero ... the risk of having a cardiovascular event is really next to nil. Patients are happy to know they have a CAC of zero.”

Likewise, patients appreciate knowing whether their score is high, which would indicate increased risk. He said the CAC score is underused by geriatric physicians.

The group also determined, after reviewing the research, that starting treatment is reasonable for patients with an LDL cholesterol level of 70-189 if they have no life-limiting illness and their life expectancy is over 5 years.

Other preliminary recommendations include the use of statins for those aged 75 and older, irrespective of risk for statin-associated muscle symptoms, type 2 diabetes, or impaired cognition. These associations are often weak, Dr. Forman added.
 

Focusing on person-centered decisions

Ariel Green, MD, MPH, PhD, associate professor of medicine at Johns Hopkins University, Baltimore, said statin therapy “should be individualized” to weigh benefits, noncardiac risks, and other considerations.

Clinicians can incorporate life expectancy into prevention decisions using tools such as ePrognosis, from the University of California, San Francisco, Dr. Green said.

If life expectancy is greater than the time to benefit, statin therapy may help. Dr. Green cited research that showed that 2.5 years of statin therapy was needed to prevent one major adverse cardiovascular event (MACE) per 100 patients in a population aged 50-75. Other data show reductions in MACE for those older than 75, but overall, the data are limited in this population.

The proposed recommendation is to use tools such as life tables that include comorbid conditions and functional status to guide clinical decisions.

“Another aspect of assessing net benefits of statin therapy is to consider competing health risks,” Dr. Green said.

The group recommends considering using competing risk-adjusted CVD models, though these are not widely used.

The group also recommends integrating screenings for frailty (Clinical Frailty Scale), dementia (Mini-Cog), and functional status (Vulnerable Elders Scale–13) into assessments.

“The presence of these syndromes should prompt elicitation of patient values and preferences related to prevention and medication use,” Dr. Green said.

Clinicians can use decision aids, but these are not always practical, owing to obstacles such as patients’ cognitive problems, Dr. Green said.

“Another approach is asking people to prioritize a set of universal health outcomes that apply across health conditions, such as maintaining independence, staying alive, reducing, or eliminating symptoms and focusing on comfort,” Dr. Green said.

She addressed the evidence about deprescribing statins, with a focus on those with a life expectancy of less than a year. Researchers have found an increase in quality of life and no increases in cardiovascular events or death when statins were deprescribed.
 

A welcome framework

Cory Krueger, MD, an internal medicine and geriatric physician in Cornville, Ariz., who attended the talk, said he welcomed the presentation, in which preliminary recommendations were explained.

“This has been a controversial area in geriatrics,” Dr. Krueger said. “At least this gave me a framework for discussing this with my patients in a reasonable way.”

Dr. Forman and Dr. Krueger disclosed no relevant financial relationships. Dr. Green receives funding from the National Institute of Aging and Impact Collaboratory.

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

A new Canadian guideline on screening for the primary prevention of fragility fractures recommends risk assessment first, before bone mineral density (BMD) testing, for women aged 65 and older. For younger women and men aged 40 and older, screening is not recommended.

To develop the guideline, a writing group from Canadian Task Force on Preventive Health Care commissioned systematic reviews of studies on the benefits and harms of fragility fracture screenings; the predictive accuracy of current risk-assessment tools; patient acceptability; and benefits of treatment. Treatment harms were analyzed via a rapid overview of reviews.

The guideline, published online in the Canadian Medical Association Journal, is aimed at primary care practitioners for their community-dwelling patients aged 40 and older. The recommendations do not apply to people already taking preventive drugs.

Nondrug treatments were beyond the scope of the current guideline, but guidelines on the prevention of falls and other strategies are planned, Roland Grad, MD, a guideline author and associate professor at McGill University in Montreal, told this news organization.

The new guideline says that women aged 65 and older may be able to avoid fracture through screening and preventive medication. An individual’s fracture risk can be estimated with a new Fragility Fractures Decision Aid, which uses the Canadian FRAX risk-assessment tool.

“A risk assessment–first approach promotes shared decision-making with the patient, based on best medical evidence,” Dr. Grad said.

“To help clinicians, we have created an infographic with visuals to communicate the time spent on BMD vs risk assessment first.”
 

New evidence

“At least three things motivated this new guideline,” Dr. Grad said. “When we started work on this prior to the pandemic, we saw a need for updated guidance on screening to prevent fragility fractures. We were also aware of new evidence from the publication of screening trials in females older than 65.”

To conduct the risk assessment in older women, clinicians are advised to do the following:

• Use the decision aid (which patients can also use on their own).
• Use the 10-year absolute risk of major osteoporotic fracture to facilitate shared decision-making about possible benefits and harms of preventive pharmacotherapy.
• If pharmacotherapy is being considered, request a BMD using DXA of the femoral neck, then reestimate the fracture risk by adding the BMD T-score into the FRAX.

Potential harms associated with various treatments, with varying levels of evidence, include the following: with alendronate and denosumab, nonserious gastrointestinal adverse events; with denosumab, rash, eczema, and infections; with zoledronic acid, nonserious events, such as headache and flulike symptoms; and with alendronate and bisphosphonates, rare but serious harms of atypical femoral fracture and osteonecrosis of the jaw.

“These recommendations emphasize the importance of good clinical practice, where clinicians are alert to changes in physical health and patient well-being,” the authors wrote. “Clinicians should also be aware of the importance of secondary prevention (i.e., after fracture) and manage patients accordingly.”

“This is an important topic,” Dr. Grad said. “Fragility fractures are consequential for individuals and for our publicly funded health care system. We anticipate questions from clinicians about the time needed to screen with the risk assessment–first strategy. Our modeling work suggests time savings with [this] strategy compared to a strategy of BMD testing first. Following our recommendations may lead to a reduction in BMD testing.”

To promote the guideline, the CMAJ has recorded a podcast and will use other strategies to increase awareness, Dr. Grad said. “The Canadian Task Force has a communications strategy that includes outreach to primary care, stakeholder webinars, social media, partnerships, and other tactics. The College of Family Physicians of Canada has endorsed the guideline and will help promote to its members.”
 

Other at-risk groups?

Aliya Khan, MD, FRCPC, FACP, FACE, professor in the divisions of endocrinology and metabolism and geriatrics and director of the fellowship in metabolic bone diseases at McMaster University in Hamilton, Ont., told this news organization she agrees with the strategy of evaluating women aged 65 and older for fracture risk.

“The decision aid is useful, but I would like to see it expanded to other circumstances and situations,” she said.

For example, Dr. Khan would like to see recommendations for younger women and for men of all ages regarding secondary causes of osteoporosis or medications known to have a detrimental effect on bone health. By not addressing these patients, she said, “we may miss patients who would benefit from a fracture risk assessment and potentially treatment to prevent low-trauma fractures.”

A recommendation for younger postmenopausal women was included in the most recent Society of Obstetricians and Gynaecologists Canada guideline, she noted.

Overall, she said, “I believe these recommendations will reduce the excess or inappropriate use of BMD testing and that is welcome.”

Funding for the Canadian Task Force on Preventive Health Care is provided by the Public Health Agency of Canada. The task force members report no relevant financial relationships.

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

A new Canadian guideline on screening for the primary prevention of fragility fractures recommends risk assessment first, before bone mineral density (BMD) testing, for women aged 65 and older. For younger women and men aged 40 and older, screening is not recommended.

To develop the guideline, a writing group from Canadian Task Force on Preventive Health Care commissioned systematic reviews of studies on the benefits and harms of fragility fracture screenings; the predictive accuracy of current risk-assessment tools; patient acceptability; and benefits of treatment. Treatment harms were analyzed via a rapid overview of reviews.

The guideline, published online in the Canadian Medical Association Journal, is aimed at primary care practitioners for their community-dwelling patients aged 40 and older. The recommendations do not apply to people already taking preventive drugs.

Nondrug treatments were beyond the scope of the current guideline, but guidelines on the prevention of falls and other strategies are planned, Roland Grad, MD, a guideline author and associate professor at McGill University in Montreal, told this news organization.

The new guideline says that women aged 65 and older may be able to avoid fracture through screening and preventive medication. An individual’s fracture risk can be estimated with a new Fragility Fractures Decision Aid, which uses the Canadian FRAX risk-assessment tool.

“A risk assessment–first approach promotes shared decision-making with the patient, based on best medical evidence,” Dr. Grad said.

“To help clinicians, we have created an infographic with visuals to communicate the time spent on BMD vs risk assessment first.”
 

New evidence

“At least three things motivated this new guideline,” Dr. Grad said. “When we started work on this prior to the pandemic, we saw a need for updated guidance on screening to prevent fragility fractures. We were also aware of new evidence from the publication of screening trials in females older than 65.”

To conduct the risk assessment in older women, clinicians are advised to do the following:

• Use the decision aid (which patients can also use on their own).
• Use the 10-year absolute risk of major osteoporotic fracture to facilitate shared decision-making about possible benefits and harms of preventive pharmacotherapy.
• If pharmacotherapy is being considered, request a BMD using DXA of the femoral neck, then reestimate the fracture risk by adding the BMD T-score into the FRAX.

Potential harms associated with various treatments, with varying levels of evidence, include the following: with alendronate and denosumab, nonserious gastrointestinal adverse events; with denosumab, rash, eczema, and infections; with zoledronic acid, nonserious events, such as headache and flulike symptoms; and with alendronate and bisphosphonates, rare but serious harms of atypical femoral fracture and osteonecrosis of the jaw.

“These recommendations emphasize the importance of good clinical practice, where clinicians are alert to changes in physical health and patient well-being,” the authors wrote. “Clinicians should also be aware of the importance of secondary prevention (i.e., after fracture) and manage patients accordingly.”

“This is an important topic,” Dr. Grad said. “Fragility fractures are consequential for individuals and for our publicly funded health care system. We anticipate questions from clinicians about the time needed to screen with the risk assessment–first strategy. Our modeling work suggests time savings with [this] strategy compared to a strategy of BMD testing first. Following our recommendations may lead to a reduction in BMD testing.”

To promote the guideline, the CMAJ has recorded a podcast and will use other strategies to increase awareness, Dr. Grad said. “The Canadian Task Force has a communications strategy that includes outreach to primary care, stakeholder webinars, social media, partnerships, and other tactics. The College of Family Physicians of Canada has endorsed the guideline and will help promote to its members.”
 

Other at-risk groups?

Aliya Khan, MD, FRCPC, FACP, FACE, professor in the divisions of endocrinology and metabolism and geriatrics and director of the fellowship in metabolic bone diseases at McMaster University in Hamilton, Ont., told this news organization she agrees with the strategy of evaluating women aged 65 and older for fracture risk.

“The decision aid is useful, but I would like to see it expanded to other circumstances and situations,” she said.

For example, Dr. Khan would like to see recommendations for younger women and for men of all ages regarding secondary causes of osteoporosis or medications known to have a detrimental effect on bone health. By not addressing these patients, she said, “we may miss patients who would benefit from a fracture risk assessment and potentially treatment to prevent low-trauma fractures.”

A recommendation for younger postmenopausal women was included in the most recent Society of Obstetricians and Gynaecologists Canada guideline, she noted.

Overall, she said, “I believe these recommendations will reduce the excess or inappropriate use of BMD testing and that is welcome.”

Funding for the Canadian Task Force on Preventive Health Care is provided by the Public Health Agency of Canada. The task force members report no relevant financial relationships.

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

A new Canadian guideline on screening for the primary prevention of fragility fractures recommends risk assessment first, before bone mineral density (BMD) testing, for women aged 65 and older. For younger women and men aged 40 and older, screening is not recommended.

To develop the guideline, a writing group from Canadian Task Force on Preventive Health Care commissioned systematic reviews of studies on the benefits and harms of fragility fracture screenings; the predictive accuracy of current risk-assessment tools; patient acceptability; and benefits of treatment. Treatment harms were analyzed via a rapid overview of reviews.

The guideline, published online in the Canadian Medical Association Journal, is aimed at primary care practitioners for their community-dwelling patients aged 40 and older. The recommendations do not apply to people already taking preventive drugs.

Nondrug treatments were beyond the scope of the current guideline, but guidelines on the prevention of falls and other strategies are planned, Roland Grad, MD, a guideline author and associate professor at McGill University in Montreal, told this news organization.

The new guideline says that women aged 65 and older may be able to avoid fracture through screening and preventive medication. An individual’s fracture risk can be estimated with a new Fragility Fractures Decision Aid, which uses the Canadian FRAX risk-assessment tool.

“A risk assessment–first approach promotes shared decision-making with the patient, based on best medical evidence,” Dr. Grad said.

“To help clinicians, we have created an infographic with visuals to communicate the time spent on BMD vs risk assessment first.”
 

New evidence

“At least three things motivated this new guideline,” Dr. Grad said. “When we started work on this prior to the pandemic, we saw a need for updated guidance on screening to prevent fragility fractures. We were also aware of new evidence from the publication of screening trials in females older than 65.”

To conduct the risk assessment in older women, clinicians are advised to do the following:

• Use the decision aid (which patients can also use on their own).
• Use the 10-year absolute risk of major osteoporotic fracture to facilitate shared decision-making about possible benefits and harms of preventive pharmacotherapy.
• If pharmacotherapy is being considered, request a BMD using DXA of the femoral neck, then reestimate the fracture risk by adding the BMD T-score into the FRAX.

Potential harms associated with various treatments, with varying levels of evidence, include the following: with alendronate and denosumab, nonserious gastrointestinal adverse events; with denosumab, rash, eczema, and infections; with zoledronic acid, nonserious events, such as headache and flulike symptoms; and with alendronate and bisphosphonates, rare but serious harms of atypical femoral fracture and osteonecrosis of the jaw.

“These recommendations emphasize the importance of good clinical practice, where clinicians are alert to changes in physical health and patient well-being,” the authors wrote. “Clinicians should also be aware of the importance of secondary prevention (i.e., after fracture) and manage patients accordingly.”

“This is an important topic,” Dr. Grad said. “Fragility fractures are consequential for individuals and for our publicly funded health care system. We anticipate questions from clinicians about the time needed to screen with the risk assessment–first strategy. Our modeling work suggests time savings with [this] strategy compared to a strategy of BMD testing first. Following our recommendations may lead to a reduction in BMD testing.”

To promote the guideline, the CMAJ has recorded a podcast and will use other strategies to increase awareness, Dr. Grad said. “The Canadian Task Force has a communications strategy that includes outreach to primary care, stakeholder webinars, social media, partnerships, and other tactics. The College of Family Physicians of Canada has endorsed the guideline and will help promote to its members.”
 

Other at-risk groups?

Aliya Khan, MD, FRCPC, FACP, FACE, professor in the divisions of endocrinology and metabolism and geriatrics and director of the fellowship in metabolic bone diseases at McMaster University in Hamilton, Ont., told this news organization she agrees with the strategy of evaluating women aged 65 and older for fracture risk.

“The decision aid is useful, but I would like to see it expanded to other circumstances and situations,” she said.

For example, Dr. Khan would like to see recommendations for younger women and for men of all ages regarding secondary causes of osteoporosis or medications known to have a detrimental effect on bone health. By not addressing these patients, she said, “we may miss patients who would benefit from a fracture risk assessment and potentially treatment to prevent low-trauma fractures.”

A recommendation for younger postmenopausal women was included in the most recent Society of Obstetricians and Gynaecologists Canada guideline, she noted.

Overall, she said, “I believe these recommendations will reduce the excess or inappropriate use of BMD testing and that is welcome.”

Funding for the Canadian Task Force on Preventive Health Care is provided by the Public Health Agency of Canada. The task force members report no relevant financial relationships.

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

Pediatricians may have a new aid to better predict peanut allergies among infants with atopic dermatitis.

Researchers have developed a scorecard to help pediatricians identify and assess the severity of atopic dermatitis in infants of various skin tones and to then predict risk of allergies to peanuts. Their study of the implementation of the scorecard was presented at the Pediatric Academic Societies annual meeting.

Infants with atopic dermatitis or eczema are six times more likely to have an egg allergy and eleven times more likely to have a peanut allergy at age 12 months than are infants without atopic dermatitis.

The scorecard reflects recent directives from the National Institute of Allergy and Infectious Diseases to help combat the public health problem.

“When the NIAID prevention of peanut allergy guidelines first came out, it asked pediatricians to serve as frontline practitioners in implementing them by identifying children at risk for peanut allergy and guiding families on what to do next,” said Waheeda Samady, MD, professor of pediatrics at Northwestern University, Chicago. “The impetus for the study was to further support pediatricians in this role.”

Although pediatricians are trained to identify and even treat mild to moderate cases of atopic dermatitis, little emphasis has gone to categorizing the condition on the basis of severity and to correlating peanut allergy risk.

The predictive scorecard captures 14 images from one infant of mixed race, two White infants, two Black infants, and two Hispanic infants.

To create the card, two in-house pediatric dermatologists assessed 58 images from 13 children and categorized images from 0 (no signs of atopic dermatitis) to 4 (severe signs of atopic dermatitis). After a first pass on categorization, the doctors agreed on 84% of images.

Of 189 pediatricians who used the card, fewer than half reported that they “sometimes,” “very often,” or “always” used the scorecard for atopic dermatitis evaluation. A little fewer than three-quarters reported that their ability to diagnose and categorize atopic dermatitis improved.

“Severity staging of atopic dermatitis is not something that the general pediatrician necessarily performs on a day-to-day basis,” said Kawaljit Brar, MD, professor of pediatrics in the division of allergy and immunology at Hassenfeld Children’s Hospital in New York.

Dr. Brar explained that children who are identified as being at high risk are often referred to specialists such as her, who then perform allergy screenings and can determine whether introduction of food at home is safe or whether office feedings supervised by an allergist are necessary. Researchers have found that early introduction to peanuts for children with moderate to severe atopic dermatitis could prevent peanut allergy.

“This represents a wonderful initiative to educate pediatricians so that they understand which patients require screening for peanut allergy and which patients don’t and can just get introduced to peanuts at home,” Dr. Brar said.

The atopic dermatitis scorecard reflects a growing recognition that varying skin tones show levels of severity incongruously.

“Many of us in clinical practice have recognized that our education has not always been inclusive of patients with varying skin tones,” Dr. Samady said. “When we looked for photos of patients with different skin tones, we simply could not find any that we thought were appropriate. So we decided to take some ourselves, and we’re currently continuing to take photos in order to improve the scorecard we currently have.”

The study was funded by the National Institute of Health and Food Allergy Research and Education. Dr. Samady and Dr. Brar reported no relevant financial relationships.

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

Pediatricians may have a new aid to better predict peanut allergies among infants with atopic dermatitis.

Researchers have developed a scorecard to help pediatricians identify and assess the severity of atopic dermatitis in infants of various skin tones and to then predict risk of allergies to peanuts. Their study of the implementation of the scorecard was presented at the Pediatric Academic Societies annual meeting.

Infants with atopic dermatitis or eczema are six times more likely to have an egg allergy and eleven times more likely to have a peanut allergy at age 12 months than are infants without atopic dermatitis.

The scorecard reflects recent directives from the National Institute of Allergy and Infectious Diseases to help combat the public health problem.

“When the NIAID prevention of peanut allergy guidelines first came out, it asked pediatricians to serve as frontline practitioners in implementing them by identifying children at risk for peanut allergy and guiding families on what to do next,” said Waheeda Samady, MD, professor of pediatrics at Northwestern University, Chicago. “The impetus for the study was to further support pediatricians in this role.”

Although pediatricians are trained to identify and even treat mild to moderate cases of atopic dermatitis, little emphasis has gone to categorizing the condition on the basis of severity and to correlating peanut allergy risk.

The predictive scorecard captures 14 images from one infant of mixed race, two White infants, two Black infants, and two Hispanic infants.

To create the card, two in-house pediatric dermatologists assessed 58 images from 13 children and categorized images from 0 (no signs of atopic dermatitis) to 4 (severe signs of atopic dermatitis). After a first pass on categorization, the doctors agreed on 84% of images.

Of 189 pediatricians who used the card, fewer than half reported that they “sometimes,” “very often,” or “always” used the scorecard for atopic dermatitis evaluation. A little fewer than three-quarters reported that their ability to diagnose and categorize atopic dermatitis improved.

“Severity staging of atopic dermatitis is not something that the general pediatrician necessarily performs on a day-to-day basis,” said Kawaljit Brar, MD, professor of pediatrics in the division of allergy and immunology at Hassenfeld Children’s Hospital in New York.

Dr. Brar explained that children who are identified as being at high risk are often referred to specialists such as her, who then perform allergy screenings and can determine whether introduction of food at home is safe or whether office feedings supervised by an allergist are necessary. Researchers have found that early introduction to peanuts for children with moderate to severe atopic dermatitis could prevent peanut allergy.

“This represents a wonderful initiative to educate pediatricians so that they understand which patients require screening for peanut allergy and which patients don’t and can just get introduced to peanuts at home,” Dr. Brar said.

The atopic dermatitis scorecard reflects a growing recognition that varying skin tones show levels of severity incongruously.

“Many of us in clinical practice have recognized that our education has not always been inclusive of patients with varying skin tones,” Dr. Samady said. “When we looked for photos of patients with different skin tones, we simply could not find any that we thought were appropriate. So we decided to take some ourselves, and we’re currently continuing to take photos in order to improve the scorecard we currently have.”

The study was funded by the National Institute of Health and Food Allergy Research and Education. Dr. Samady and Dr. Brar reported no relevant financial relationships.

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

Pediatricians may have a new aid to better predict peanut allergies among infants with atopic dermatitis.

Researchers have developed a scorecard to help pediatricians identify and assess the severity of atopic dermatitis in infants of various skin tones and to then predict risk of allergies to peanuts. Their study of the implementation of the scorecard was presented at the Pediatric Academic Societies annual meeting.

Infants with atopic dermatitis or eczema are six times more likely to have an egg allergy and eleven times more likely to have a peanut allergy at age 12 months than are infants without atopic dermatitis.

The scorecard reflects recent directives from the National Institute of Allergy and Infectious Diseases to help combat the public health problem.

“When the NIAID prevention of peanut allergy guidelines first came out, it asked pediatricians to serve as frontline practitioners in implementing them by identifying children at risk for peanut allergy and guiding families on what to do next,” said Waheeda Samady, MD, professor of pediatrics at Northwestern University, Chicago. “The impetus for the study was to further support pediatricians in this role.”

Although pediatricians are trained to identify and even treat mild to moderate cases of atopic dermatitis, little emphasis has gone to categorizing the condition on the basis of severity and to correlating peanut allergy risk.

The predictive scorecard captures 14 images from one infant of mixed race, two White infants, two Black infants, and two Hispanic infants.

To create the card, two in-house pediatric dermatologists assessed 58 images from 13 children and categorized images from 0 (no signs of atopic dermatitis) to 4 (severe signs of atopic dermatitis). After a first pass on categorization, the doctors agreed on 84% of images.

Of 189 pediatricians who used the card, fewer than half reported that they “sometimes,” “very often,” or “always” used the scorecard for atopic dermatitis evaluation. A little fewer than three-quarters reported that their ability to diagnose and categorize atopic dermatitis improved.

“Severity staging of atopic dermatitis is not something that the general pediatrician necessarily performs on a day-to-day basis,” said Kawaljit Brar, MD, professor of pediatrics in the division of allergy and immunology at Hassenfeld Children’s Hospital in New York.

Dr. Brar explained that children who are identified as being at high risk are often referred to specialists such as her, who then perform allergy screenings and can determine whether introduction of food at home is safe or whether office feedings supervised by an allergist are necessary. Researchers have found that early introduction to peanuts for children with moderate to severe atopic dermatitis could prevent peanut allergy.

“This represents a wonderful initiative to educate pediatricians so that they understand which patients require screening for peanut allergy and which patients don’t and can just get introduced to peanuts at home,” Dr. Brar said.

The atopic dermatitis scorecard reflects a growing recognition that varying skin tones show levels of severity incongruously.

“Many of us in clinical practice have recognized that our education has not always been inclusive of patients with varying skin tones,” Dr. Samady said. “When we looked for photos of patients with different skin tones, we simply could not find any that we thought were appropriate. So we decided to take some ourselves, and we’re currently continuing to take photos in order to improve the scorecard we currently have.”

The study was funded by the National Institute of Health and Food Allergy Research and Education. Dr. Samady and Dr. Brar reported no relevant financial relationships.

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

Leaders of medical student groups and legislators in a few states are trying to convince medical schools to end a century-old practice of legacy admissions, which they say offer preferential treatment to applicants based on their association with donors or alumni.

While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.

Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.

Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.

As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy. 

Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.

Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
 

Diversity of medical applicants

Diversity in medical schools  continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.

Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.

Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.

The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
 

Legislation may hasten legacies’ end

In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.

The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.

“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”

Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.

The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.

At schools like Harvard,  whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”

Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.   
 

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

Leaders of medical student groups and legislators in a few states are trying to convince medical schools to end a century-old practice of legacy admissions, which they say offer preferential treatment to applicants based on their association with donors or alumni.

While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.

Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.

Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.

As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy. 

Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.

Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
 

Diversity of medical applicants

Diversity in medical schools  continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.

Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.

Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.

The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
 

Legislation may hasten legacies’ end

In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.

The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.

“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”

Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.

The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.

At schools like Harvard,  whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”

Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.   
 

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

Leaders of medical student groups and legislators in a few states are trying to convince medical schools to end a century-old practice of legacy admissions, which they say offer preferential treatment to applicants based on their association with donors or alumni.

While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.

Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.

Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.

As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy. 

Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.

Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
 

Diversity of medical applicants

Diversity in medical schools  continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.

Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.

Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.

The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
 

Legislation may hasten legacies’ end

In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.

The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.

“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”

Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.

The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.

At schools like Harvard,  whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”

Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.   
 

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

PHOENIX – Ever since PicoSure became the first picosecond laser cleared by the Food and Drug Administration for the treatment of unwanted tattoos and pigmented lesions in 2012, new uses for this technology continue to expand.

Now, several different FDA-cleared picosecond devices are used for treating conditions ranging from nevus of Ota, café-au-lait macules, and lentigines to melasma, photoaging, yellow tattoos, and recalcitrant tattoos. These include PicoWay, PicoSure, Enlighten, PicoPlus, PiQo4, and Quanta Pico, among others.

“PicoWay technology has integrated nicely into my practice in Houston, the most ethnically diverse city in the country, with its ability to safely treat a number of various benign, congenital, and acquired epidermal and dermal pigmented lesions with ultrashort pulse duration and low thermal impact, which greatly reduces the risk of postinflammatory hyperpigmentation even in darker skin types,” Paul M. Friedman, MD, director of the Dermatology and Laser Surgery Center, Houston, said at the annual conference of the American Society for Laser Medicine and Surgery.

Dr. Friedman

He emphasized the importance of therapeutic clinical endpoints, noting that with q-switched lasers, “you’re looking for immediate whitening, whereas with picosecond lasers, your endpoint is slight whitening or slight darkening depending on wavelength, indication, and skin type. The ability to fractionate picosecond pulses has also allowed us to utilize this technology for photoaging as well as acne scarring.”

The PicoWay system includes a 730-nm picosecond titanium sapphire handpiece, which is FDA cleared for treatment of benign pigmented lesions and blue and green tattoo removal. Dr. Friedman said that he has seen good clinical results using the handpiece for café-au-lait macules, particularly in skin of color.

In an abstract presented at the ASLMS meeting, he and his colleagues presented a retrospective review of 12 patients with café-au-lait macules with Fitzpatrick skin types III-VI who were treated with the PicoWay 730 nm handpiece between April 2021 and January 2023. Patients received a mean of 3.1 treatments at intervals that ranged from 5 to 40 weeks. Clinical photographs were graded by three board-certified dermatologists using a 5-point visual analogue scale.

Overall, patients were rated to have a mean improvement of 26%-50%. Two patients achieved 100% clearance after four to five treatment sessions. “Café-au-lait macules with smooth borders responded less well to laser treatment, confirming prior studies at our center,” he said. “We often educate parents that café-au-lait macules may recur over time, especially with repeated sun exposure.”
 

Treating melasma

Dr. Friedman’s go-to devices for melasma include the low-density, low-energy 1,927-nm fractional diode laser; the 1,064 nm picosecond Nd:YAG, the low-fluence 1,064 nm Q-switched Nd:YAG with a nanosecond pulse duration, and the 595-nm pulsed dye laser for lesions exhibiting underlying vascularity. He said that combining therapies that target pigment and vasculature may be ideal to prevent relapses. “Melasma is a multifactorial condition so by improving patient education and expectation alongside advances in laser treatment of melasma, we have ultimately improved our ability to treat this condition,” he said.

“We’re approaching it from all angles, with ultraviolet photography and spectrocolorimetry, behavioral modifications, topical skin-lightening agents, broad spectrum sunscreens with protection against visible light, and oral tranexamic acid in advanced cases. Then, we intervene with these energy-based modalities, and the bottom line is, less energy and density is more, with lengthened treatment intervals. In 2023, we’re better than we’ve ever been in terms of our ability to safely and effectively improve melasma.”

Novel lasers

Dr. Friedman also described the UltraClear, a novel ablative fractional 2,910-nm erbium-doped glass fiber laser that delivers a customized blend of ablation and coagulation based on the patient’s condition, skin type, and tolerability for down time. He provided an overview of the versatility of what he described as highly customizable technology for conditions such as photoaging and dyschromia in patients of various skin types, making it a very versatile platform in his practice.

The AVAVA MIRIA system is a “next generation” laser “where you’re able to use a focal point. Basically, you’re treating the skin from the inside out in a 3D manner and you’re able to focus intradermally up to 1 mm with high energy 1,064 nm or 1,550 nm,” he said. “It’s a unique conical geometry that spares the epidermis, combined with sapphire tip cooling and images the skin at the same time with the potential for personalized treatments of dyschromia and photoaging in all skin types. It’s truly remarkable where the technology is heading.”

Dr. Friedman disclosed that he has received consulting fees from Allergan, Galderma, Acclaro, Merz Aesthetics, Solta Medical, and Cytrellis. He has conducted contracted research for Sofwave and is a member of the speakers bureau for Solta Medical and Candela.

PHOENIX – Ever since PicoSure became the first picosecond laser cleared by the Food and Drug Administration for the treatment of unwanted tattoos and pigmented lesions in 2012, new uses for this technology continue to expand.

Now, several different FDA-cleared picosecond devices are used for treating conditions ranging from nevus of Ota, café-au-lait macules, and lentigines to melasma, photoaging, yellow tattoos, and recalcitrant tattoos. These include PicoWay, PicoSure, Enlighten, PicoPlus, PiQo4, and Quanta Pico, among others.

“PicoWay technology has integrated nicely into my practice in Houston, the most ethnically diverse city in the country, with its ability to safely treat a number of various benign, congenital, and acquired epidermal and dermal pigmented lesions with ultrashort pulse duration and low thermal impact, which greatly reduces the risk of postinflammatory hyperpigmentation even in darker skin types,” Paul M. Friedman, MD, director of the Dermatology and Laser Surgery Center, Houston, said at the annual conference of the American Society for Laser Medicine and Surgery.

Dr. Friedman

He emphasized the importance of therapeutic clinical endpoints, noting that with q-switched lasers, “you’re looking for immediate whitening, whereas with picosecond lasers, your endpoint is slight whitening or slight darkening depending on wavelength, indication, and skin type. The ability to fractionate picosecond pulses has also allowed us to utilize this technology for photoaging as well as acne scarring.”

The PicoWay system includes a 730-nm picosecond titanium sapphire handpiece, which is FDA cleared for treatment of benign pigmented lesions and blue and green tattoo removal. Dr. Friedman said that he has seen good clinical results using the handpiece for café-au-lait macules, particularly in skin of color.

In an abstract presented at the ASLMS meeting, he and his colleagues presented a retrospective review of 12 patients with café-au-lait macules with Fitzpatrick skin types III-VI who were treated with the PicoWay 730 nm handpiece between April 2021 and January 2023. Patients received a mean of 3.1 treatments at intervals that ranged from 5 to 40 weeks. Clinical photographs were graded by three board-certified dermatologists using a 5-point visual analogue scale.

Overall, patients were rated to have a mean improvement of 26%-50%. Two patients achieved 100% clearance after four to five treatment sessions. “Café-au-lait macules with smooth borders responded less well to laser treatment, confirming prior studies at our center,” he said. “We often educate parents that café-au-lait macules may recur over time, especially with repeated sun exposure.”
 

Treating melasma

Dr. Friedman’s go-to devices for melasma include the low-density, low-energy 1,927-nm fractional diode laser; the 1,064 nm picosecond Nd:YAG, the low-fluence 1,064 nm Q-switched Nd:YAG with a nanosecond pulse duration, and the 595-nm pulsed dye laser for lesions exhibiting underlying vascularity. He said that combining therapies that target pigment and vasculature may be ideal to prevent relapses. “Melasma is a multifactorial condition so by improving patient education and expectation alongside advances in laser treatment of melasma, we have ultimately improved our ability to treat this condition,” he said.

“We’re approaching it from all angles, with ultraviolet photography and spectrocolorimetry, behavioral modifications, topical skin-lightening agents, broad spectrum sunscreens with protection against visible light, and oral tranexamic acid in advanced cases. Then, we intervene with these energy-based modalities, and the bottom line is, less energy and density is more, with lengthened treatment intervals. In 2023, we’re better than we’ve ever been in terms of our ability to safely and effectively improve melasma.”

Novel lasers

Dr. Friedman also described the UltraClear, a novel ablative fractional 2,910-nm erbium-doped glass fiber laser that delivers a customized blend of ablation and coagulation based on the patient’s condition, skin type, and tolerability for down time. He provided an overview of the versatility of what he described as highly customizable technology for conditions such as photoaging and dyschromia in patients of various skin types, making it a very versatile platform in his practice.

The AVAVA MIRIA system is a “next generation” laser “where you’re able to use a focal point. Basically, you’re treating the skin from the inside out in a 3D manner and you’re able to focus intradermally up to 1 mm with high energy 1,064 nm or 1,550 nm,” he said. “It’s a unique conical geometry that spares the epidermis, combined with sapphire tip cooling and images the skin at the same time with the potential for personalized treatments of dyschromia and photoaging in all skin types. It’s truly remarkable where the technology is heading.”

Dr. Friedman disclosed that he has received consulting fees from Allergan, Galderma, Acclaro, Merz Aesthetics, Solta Medical, and Cytrellis. He has conducted contracted research for Sofwave and is a member of the speakers bureau for Solta Medical and Candela.

PHOENIX – Ever since PicoSure became the first picosecond laser cleared by the Food and Drug Administration for the treatment of unwanted tattoos and pigmented lesions in 2012, new uses for this technology continue to expand.

Now, several different FDA-cleared picosecond devices are used for treating conditions ranging from nevus of Ota, café-au-lait macules, and lentigines to melasma, photoaging, yellow tattoos, and recalcitrant tattoos. These include PicoWay, PicoSure, Enlighten, PicoPlus, PiQo4, and Quanta Pico, among others.

“PicoWay technology has integrated nicely into my practice in Houston, the most ethnically diverse city in the country, with its ability to safely treat a number of various benign, congenital, and acquired epidermal and dermal pigmented lesions with ultrashort pulse duration and low thermal impact, which greatly reduces the risk of postinflammatory hyperpigmentation even in darker skin types,” Paul M. Friedman, MD, director of the Dermatology and Laser Surgery Center, Houston, said at the annual conference of the American Society for Laser Medicine and Surgery.

Dr. Friedman

He emphasized the importance of therapeutic clinical endpoints, noting that with q-switched lasers, “you’re looking for immediate whitening, whereas with picosecond lasers, your endpoint is slight whitening or slight darkening depending on wavelength, indication, and skin type. The ability to fractionate picosecond pulses has also allowed us to utilize this technology for photoaging as well as acne scarring.”

The PicoWay system includes a 730-nm picosecond titanium sapphire handpiece, which is FDA cleared for treatment of benign pigmented lesions and blue and green tattoo removal. Dr. Friedman said that he has seen good clinical results using the handpiece for café-au-lait macules, particularly in skin of color.

In an abstract presented at the ASLMS meeting, he and his colleagues presented a retrospective review of 12 patients with café-au-lait macules with Fitzpatrick skin types III-VI who were treated with the PicoWay 730 nm handpiece between April 2021 and January 2023. Patients received a mean of 3.1 treatments at intervals that ranged from 5 to 40 weeks. Clinical photographs were graded by three board-certified dermatologists using a 5-point visual analogue scale.

Overall, patients were rated to have a mean improvement of 26%-50%. Two patients achieved 100% clearance after four to five treatment sessions. “Café-au-lait macules with smooth borders responded less well to laser treatment, confirming prior studies at our center,” he said. “We often educate parents that café-au-lait macules may recur over time, especially with repeated sun exposure.”
 

Treating melasma

Dr. Friedman’s go-to devices for melasma include the low-density, low-energy 1,927-nm fractional diode laser; the 1,064 nm picosecond Nd:YAG, the low-fluence 1,064 nm Q-switched Nd:YAG with a nanosecond pulse duration, and the 595-nm pulsed dye laser for lesions exhibiting underlying vascularity. He said that combining therapies that target pigment and vasculature may be ideal to prevent relapses. “Melasma is a multifactorial condition so by improving patient education and expectation alongside advances in laser treatment of melasma, we have ultimately improved our ability to treat this condition,” he said.

“We’re approaching it from all angles, with ultraviolet photography and spectrocolorimetry, behavioral modifications, topical skin-lightening agents, broad spectrum sunscreens with protection against visible light, and oral tranexamic acid in advanced cases. Then, we intervene with these energy-based modalities, and the bottom line is, less energy and density is more, with lengthened treatment intervals. In 2023, we’re better than we’ve ever been in terms of our ability to safely and effectively improve melasma.”

Novel lasers

Dr. Friedman also described the UltraClear, a novel ablative fractional 2,910-nm erbium-doped glass fiber laser that delivers a customized blend of ablation and coagulation based on the patient’s condition, skin type, and tolerability for down time. He provided an overview of the versatility of what he described as highly customizable technology for conditions such as photoaging and dyschromia in patients of various skin types, making it a very versatile platform in his practice.

The AVAVA MIRIA system is a “next generation” laser “where you’re able to use a focal point. Basically, you’re treating the skin from the inside out in a 3D manner and you’re able to focus intradermally up to 1 mm with high energy 1,064 nm or 1,550 nm,” he said. “It’s a unique conical geometry that spares the epidermis, combined with sapphire tip cooling and images the skin at the same time with the potential for personalized treatments of dyschromia and photoaging in all skin types. It’s truly remarkable where the technology is heading.”

Dr. Friedman disclosed that he has received consulting fees from Allergan, Galderma, Acclaro, Merz Aesthetics, Solta Medical, and Cytrellis. He has conducted contracted research for Sofwave and is a member of the speakers bureau for Solta Medical and Candela.