Journal of Clinical Outcomes Management

LONG BEACH, CALIF. – Ms. S had recently arrived home after a stay at a skilled nursing facility to recover from a hip fracture resulting from osteoporosis. For many patients, follow-up care would have included a DEXA scan or a prescription for a bisphosphonate from a primary care clinician not trained in geriatrics.

But the 85-year-old received care that went further and that is considered best practice for the management of geriatric fractures: A physical therapist visited her after discharge and provided education on the importance of maintaining mobility. Ms. S also underwent assessment for fall risk and gait balance, and a team of multidisciplinary clinicians managed other factors, from postural hypotension to footwear and foot problems.

Sonja Rosen, MD, professor of medicine and chief of geriatric medicine at Cedars-Sinai Medical Center, Los Angeles, talked about Ms. S as part of a panel discussion on applying the “Geriatric 5Ms” for patients with osteoporosis at the annual meeting of the American Geriatrics Society.

“You have to figure out why they are falling and help them not fall again,” Dr. Rosen said.

Approximately 10 million Americans have osteoporosis, and another 44 million have low bone density. One in two women and up to one in four men will experience a bone fracture as a result of osteoporosis, according to the Bone Health and Osteoporosis Foundation.

Geriatric health care providers view the 5Ms as core principles to be mindful of as their patients age – mobility, medications, mind, multicomplexity, and matters most, which involves considering the care preferences and goals for health care outcomes of individuals.

Ms. S eventually visited a geriatrician through the Cedars-Sinai Geriatric Fracture Program, which has been shown to lower costs and shorten hospital stays. In the program, she was advised to use a walker. Initially, she saw the aid as a hindrance – she felt she should be able to walk without it, like before. But with education, she learned that it is impossible to predict falls and that the walking aid could reduce her risk of a stumble.

Dr. Rosen said clinicians should address any vision problems, prescriptions for psychotropic drugs,which can affect balance, and heart rate and rhythm abnormalities, and they should suggest modifications to the home environment, such as installing grab bars in showers and removing rugs that can easily be tripped over.

The program at Cedars-Sinai, like similar initiatives, offers a team with resources that some clinicians may not have access to, such as a care coordinator and bone-health coach. But health care providers can utilize aspects, such as making referrals to community exercise classes.

Dr. Rosen and her colleagues studied the effects of such exercise programs and found that the programs lessen loneliness and social isolation. Fear of falling decreased in 75% of participants, “which is so key to these postfracture patients in getting back out into the world and engaging in their prior level of functional status,” Dr. Rosen said.
 

The second ‘M’: Medication management

The second “M,” medications, can help clinicians sequence osteoporosis drugs, depending on patient characteristics and scenarios.

Cathleen Colon-Emeric, MD, MHS, chief of geriatrics at Duke University, in Durham, N.C., dived into the case history of Ms. S, who had hypertension and insomnia in addition to osteoporosis.

First-line treatment for Ms. S – and for most patients – was an oral bisphosphonate, Dr. Colon-Emeric said. Compared with placebo, the drugs decrease the risk of overall osteoporotic fractures by nearly 40% (odds ratio, 0.62). But the medications are linked to injury of the esophageal mucosa. This risk is decreased when a patient stays upright for 30 minutes after taking oral bisphosphonates. Dr. Colon-Emeric displayed a slide of a woman receiving a pedicure at a nail salon.

“The picture of the pedicure is to share the wonderful idea I got from one skilled nursing facility I was working with, who makes sure they do safe administration to prevent esophagitis in their patients by having them all go to a spa day, where they all sit up and get their nails done while they wait their 30 minutes [after taking the pill] sitting up safely,” Dr. Colon-Emeric said.

This strategy drew applause from the audience.

Dr. Colon-Emeric advised that clinicians use judgment in the interpretation of results from the Fracture Risk Assessment Tool (FRAX). Incorporating race into estimates of fracture risk has pros and cons. While there are racial and ethnic differences in average bone density, the data for race calibrations to estimate risk are dated, she said. Clinicians should compare FRAX estimates with and without race input to help patients understand a range of risks.

Some patients may be reluctant to begin taking osteoporosis drugs because of misinformation originating from inaccurate news reports or anecdotes from friends. Dr. Colon-Emeric advised clinicians to remind patients that one in five who experience a fracture will have another injury in the following 2 years.

“A major osteoporotic fracture is akin to a heart attack; it has a very similar 1-year mortality rate and a very similar rate of a subsequent secondary event,” Dr. Colon-Emeric said. “We have a class of medications that decrease both those risks by nearly a third.”

Shared decision-making can help patients understand the risks and benefits of treatment, she said.

“People are really scared about the side effects,” Michelle Keller, PhD, MPH, a research scientist at Cedars-Sinai who attended the session, said. “The idea that a “bone attack” is like a heart attack gets the message across.”
 

Mind and multicomplexity

Medical complexity of a patient must be considered when making decisions on treatment, according to Joshua Niznik, PharmD, PhD, assistant professor of medicine in the Center for Aging and Health at the University of North Carolina at Chapel Hill.

“Medical complexity is an acknowledgment of the entire person, the burden of their multiple chronic conditions, advanced illnesses, and also their biopsychosocial needs and how those together might augment treatment selection and decision-making,” Dr. Niznik said.

Studies by Dr. Niznik and others have shown that swallowing difficulties, severe dementia, and being older than 90 are linked with a lower likelihood of receiving treatment for osteoporosis.

But therapies for fracture prevention, especially bisphosphonates, appear to be at least as effective for adults with medical complexity as they are for people without such conditions, Dr. Niznik said. Physicians must consider the potential treatment burden and the likelihood of benefit, he said.

Dr. Niznik’s research has shown a lack of strong evidence on how clinicians can manage patients in nursing homes. In some cases, deprescribing is reasonable, such as for patients who have undergone treatment for several years and whose life expectancy is less than 2 years.

“In the absence of any of those, if they are not already treated for osteoporosis, it makes sense to initiate treatment at that time,” Dr. Niznik said.
 

Matters most: Patient input

Clinicians need to educate patients on how long they must undergo a treatment before they experience benefits, according to Sarah D. Berry, MD, MPH, associate professor of medicine at Harvard Medical School, in Boston.

A meta-analysis of studies that included more than 20,000 women who were randomly assigned to receive bisphosphonate or placebo found that one nonvertebral fracture was avoided during a 12-month period for every 100 persons treated. One hip fracture was avoided during a 20-month period for every 200 patients treated.

“In general, in persons with a 2-year life expectancy, time to benefit favors bisphosphonate use,” Dr. Berry said. “Anabolics may have an even quicker time to benefit.”

Dr. Berry said a shared a decision-making model can help clinicians facilitate discussions that help patients prioritize goals and compare options while considering results, benefits, and harms. And she offered a final tip: Use tools with absolute risk reduction to convey risks and benefits, as the relative risk calculations overestimate how effective treatment will be.

Dr. Rosen has disclosed no relevant financial relationships. Dr. Colon-Emeric has received grants from the National Institutes of Health and VA Health Services Research and Development Funding; has served as endpoint adjudication chair for UCB Pharma; and has received royalties from Wolters Kluwer. Dr. Niznik has received funding from the National Institute of Aging and the Centers for Disease Control and Prevention. Dr. Berry has received funding from the NIH and royalties from Wolters Kluwer.

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

LONG BEACH, CALIF. – Ms. S had recently arrived home after a stay at a skilled nursing facility to recover from a hip fracture resulting from osteoporosis. For many patients, follow-up care would have included a DEXA scan or a prescription for a bisphosphonate from a primary care clinician not trained in geriatrics.

But the 85-year-old received care that went further and that is considered best practice for the management of geriatric fractures: A physical therapist visited her after discharge and provided education on the importance of maintaining mobility. Ms. S also underwent assessment for fall risk and gait balance, and a team of multidisciplinary clinicians managed other factors, from postural hypotension to footwear and foot problems.

Sonja Rosen, MD, professor of medicine and chief of geriatric medicine at Cedars-Sinai Medical Center, Los Angeles, talked about Ms. S as part of a panel discussion on applying the “Geriatric 5Ms” for patients with osteoporosis at the annual meeting of the American Geriatrics Society.

“You have to figure out why they are falling and help them not fall again,” Dr. Rosen said.

Approximately 10 million Americans have osteoporosis, and another 44 million have low bone density. One in two women and up to one in four men will experience a bone fracture as a result of osteoporosis, according to the Bone Health and Osteoporosis Foundation.

Geriatric health care providers view the 5Ms as core principles to be mindful of as their patients age – mobility, medications, mind, multicomplexity, and matters most, which involves considering the care preferences and goals for health care outcomes of individuals.

Ms. S eventually visited a geriatrician through the Cedars-Sinai Geriatric Fracture Program, which has been shown to lower costs and shorten hospital stays. In the program, she was advised to use a walker. Initially, she saw the aid as a hindrance – she felt she should be able to walk without it, like before. But with education, she learned that it is impossible to predict falls and that the walking aid could reduce her risk of a stumble.

Dr. Rosen said clinicians should address any vision problems, prescriptions for psychotropic drugs,which can affect balance, and heart rate and rhythm abnormalities, and they should suggest modifications to the home environment, such as installing grab bars in showers and removing rugs that can easily be tripped over.

The program at Cedars-Sinai, like similar initiatives, offers a team with resources that some clinicians may not have access to, such as a care coordinator and bone-health coach. But health care providers can utilize aspects, such as making referrals to community exercise classes.

Dr. Rosen and her colleagues studied the effects of such exercise programs and found that the programs lessen loneliness and social isolation. Fear of falling decreased in 75% of participants, “which is so key to these postfracture patients in getting back out into the world and engaging in their prior level of functional status,” Dr. Rosen said.
 

The second ‘M’: Medication management

The second “M,” medications, can help clinicians sequence osteoporosis drugs, depending on patient characteristics and scenarios.

Cathleen Colon-Emeric, MD, MHS, chief of geriatrics at Duke University, in Durham, N.C., dived into the case history of Ms. S, who had hypertension and insomnia in addition to osteoporosis.

First-line treatment for Ms. S – and for most patients – was an oral bisphosphonate, Dr. Colon-Emeric said. Compared with placebo, the drugs decrease the risk of overall osteoporotic fractures by nearly 40% (odds ratio, 0.62). But the medications are linked to injury of the esophageal mucosa. This risk is decreased when a patient stays upright for 30 minutes after taking oral bisphosphonates. Dr. Colon-Emeric displayed a slide of a woman receiving a pedicure at a nail salon.

“The picture of the pedicure is to share the wonderful idea I got from one skilled nursing facility I was working with, who makes sure they do safe administration to prevent esophagitis in their patients by having them all go to a spa day, where they all sit up and get their nails done while they wait their 30 minutes [after taking the pill] sitting up safely,” Dr. Colon-Emeric said.

This strategy drew applause from the audience.

Dr. Colon-Emeric advised that clinicians use judgment in the interpretation of results from the Fracture Risk Assessment Tool (FRAX). Incorporating race into estimates of fracture risk has pros and cons. While there are racial and ethnic differences in average bone density, the data for race calibrations to estimate risk are dated, she said. Clinicians should compare FRAX estimates with and without race input to help patients understand a range of risks.

Some patients may be reluctant to begin taking osteoporosis drugs because of misinformation originating from inaccurate news reports or anecdotes from friends. Dr. Colon-Emeric advised clinicians to remind patients that one in five who experience a fracture will have another injury in the following 2 years.

“A major osteoporotic fracture is akin to a heart attack; it has a very similar 1-year mortality rate and a very similar rate of a subsequent secondary event,” Dr. Colon-Emeric said. “We have a class of medications that decrease both those risks by nearly a third.”

Shared decision-making can help patients understand the risks and benefits of treatment, she said.

“People are really scared about the side effects,” Michelle Keller, PhD, MPH, a research scientist at Cedars-Sinai who attended the session, said. “The idea that a “bone attack” is like a heart attack gets the message across.”
 

Mind and multicomplexity

Medical complexity of a patient must be considered when making decisions on treatment, according to Joshua Niznik, PharmD, PhD, assistant professor of medicine in the Center for Aging and Health at the University of North Carolina at Chapel Hill.

“Medical complexity is an acknowledgment of the entire person, the burden of their multiple chronic conditions, advanced illnesses, and also their biopsychosocial needs and how those together might augment treatment selection and decision-making,” Dr. Niznik said.

Studies by Dr. Niznik and others have shown that swallowing difficulties, severe dementia, and being older than 90 are linked with a lower likelihood of receiving treatment for osteoporosis.

But therapies for fracture prevention, especially bisphosphonates, appear to be at least as effective for adults with medical complexity as they are for people without such conditions, Dr. Niznik said. Physicians must consider the potential treatment burden and the likelihood of benefit, he said.

Dr. Niznik’s research has shown a lack of strong evidence on how clinicians can manage patients in nursing homes. In some cases, deprescribing is reasonable, such as for patients who have undergone treatment for several years and whose life expectancy is less than 2 years.

“In the absence of any of those, if they are not already treated for osteoporosis, it makes sense to initiate treatment at that time,” Dr. Niznik said.
 

Matters most: Patient input

Clinicians need to educate patients on how long they must undergo a treatment before they experience benefits, according to Sarah D. Berry, MD, MPH, associate professor of medicine at Harvard Medical School, in Boston.

A meta-analysis of studies that included more than 20,000 women who were randomly assigned to receive bisphosphonate or placebo found that one nonvertebral fracture was avoided during a 12-month period for every 100 persons treated. One hip fracture was avoided during a 20-month period for every 200 patients treated.

“In general, in persons with a 2-year life expectancy, time to benefit favors bisphosphonate use,” Dr. Berry said. “Anabolics may have an even quicker time to benefit.”

Dr. Berry said a shared a decision-making model can help clinicians facilitate discussions that help patients prioritize goals and compare options while considering results, benefits, and harms. And she offered a final tip: Use tools with absolute risk reduction to convey risks and benefits, as the relative risk calculations overestimate how effective treatment will be.

Dr. Rosen has disclosed no relevant financial relationships. Dr. Colon-Emeric has received grants from the National Institutes of Health and VA Health Services Research and Development Funding; has served as endpoint adjudication chair for UCB Pharma; and has received royalties from Wolters Kluwer. Dr. Niznik has received funding from the National Institute of Aging and the Centers for Disease Control and Prevention. Dr. Berry has received funding from the NIH and royalties from Wolters Kluwer.

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

LONG BEACH, CALIF. – Ms. S had recently arrived home after a stay at a skilled nursing facility to recover from a hip fracture resulting from osteoporosis. For many patients, follow-up care would have included a DEXA scan or a prescription for a bisphosphonate from a primary care clinician not trained in geriatrics.

But the 85-year-old received care that went further and that is considered best practice for the management of geriatric fractures: A physical therapist visited her after discharge and provided education on the importance of maintaining mobility. Ms. S also underwent assessment for fall risk and gait balance, and a team of multidisciplinary clinicians managed other factors, from postural hypotension to footwear and foot problems.

Sonja Rosen, MD, professor of medicine and chief of geriatric medicine at Cedars-Sinai Medical Center, Los Angeles, talked about Ms. S as part of a panel discussion on applying the “Geriatric 5Ms” for patients with osteoporosis at the annual meeting of the American Geriatrics Society.

“You have to figure out why they are falling and help them not fall again,” Dr. Rosen said.

Approximately 10 million Americans have osteoporosis, and another 44 million have low bone density. One in two women and up to one in four men will experience a bone fracture as a result of osteoporosis, according to the Bone Health and Osteoporosis Foundation.

Geriatric health care providers view the 5Ms as core principles to be mindful of as their patients age – mobility, medications, mind, multicomplexity, and matters most, which involves considering the care preferences and goals for health care outcomes of individuals.

Ms. S eventually visited a geriatrician through the Cedars-Sinai Geriatric Fracture Program, which has been shown to lower costs and shorten hospital stays. In the program, she was advised to use a walker. Initially, she saw the aid as a hindrance – she felt she should be able to walk without it, like before. But with education, she learned that it is impossible to predict falls and that the walking aid could reduce her risk of a stumble.

Dr. Rosen said clinicians should address any vision problems, prescriptions for psychotropic drugs,which can affect balance, and heart rate and rhythm abnormalities, and they should suggest modifications to the home environment, such as installing grab bars in showers and removing rugs that can easily be tripped over.

The program at Cedars-Sinai, like similar initiatives, offers a team with resources that some clinicians may not have access to, such as a care coordinator and bone-health coach. But health care providers can utilize aspects, such as making referrals to community exercise classes.

Dr. Rosen and her colleagues studied the effects of such exercise programs and found that the programs lessen loneliness and social isolation. Fear of falling decreased in 75% of participants, “which is so key to these postfracture patients in getting back out into the world and engaging in their prior level of functional status,” Dr. Rosen said.
 

The second ‘M’: Medication management

The second “M,” medications, can help clinicians sequence osteoporosis drugs, depending on patient characteristics and scenarios.

Cathleen Colon-Emeric, MD, MHS, chief of geriatrics at Duke University, in Durham, N.C., dived into the case history of Ms. S, who had hypertension and insomnia in addition to osteoporosis.

First-line treatment for Ms. S – and for most patients – was an oral bisphosphonate, Dr. Colon-Emeric said. Compared with placebo, the drugs decrease the risk of overall osteoporotic fractures by nearly 40% (odds ratio, 0.62). But the medications are linked to injury of the esophageal mucosa. This risk is decreased when a patient stays upright for 30 minutes after taking oral bisphosphonates. Dr. Colon-Emeric displayed a slide of a woman receiving a pedicure at a nail salon.

“The picture of the pedicure is to share the wonderful idea I got from one skilled nursing facility I was working with, who makes sure they do safe administration to prevent esophagitis in their patients by having them all go to a spa day, where they all sit up and get their nails done while they wait their 30 minutes [after taking the pill] sitting up safely,” Dr. Colon-Emeric said.

This strategy drew applause from the audience.

Dr. Colon-Emeric advised that clinicians use judgment in the interpretation of results from the Fracture Risk Assessment Tool (FRAX). Incorporating race into estimates of fracture risk has pros and cons. While there are racial and ethnic differences in average bone density, the data for race calibrations to estimate risk are dated, she said. Clinicians should compare FRAX estimates with and without race input to help patients understand a range of risks.

Some patients may be reluctant to begin taking osteoporosis drugs because of misinformation originating from inaccurate news reports or anecdotes from friends. Dr. Colon-Emeric advised clinicians to remind patients that one in five who experience a fracture will have another injury in the following 2 years.

“A major osteoporotic fracture is akin to a heart attack; it has a very similar 1-year mortality rate and a very similar rate of a subsequent secondary event,” Dr. Colon-Emeric said. “We have a class of medications that decrease both those risks by nearly a third.”

Shared decision-making can help patients understand the risks and benefits of treatment, she said.

“People are really scared about the side effects,” Michelle Keller, PhD, MPH, a research scientist at Cedars-Sinai who attended the session, said. “The idea that a “bone attack” is like a heart attack gets the message across.”
 

Mind and multicomplexity

Medical complexity of a patient must be considered when making decisions on treatment, according to Joshua Niznik, PharmD, PhD, assistant professor of medicine in the Center for Aging and Health at the University of North Carolina at Chapel Hill.

“Medical complexity is an acknowledgment of the entire person, the burden of their multiple chronic conditions, advanced illnesses, and also their biopsychosocial needs and how those together might augment treatment selection and decision-making,” Dr. Niznik said.

Studies by Dr. Niznik and others have shown that swallowing difficulties, severe dementia, and being older than 90 are linked with a lower likelihood of receiving treatment for osteoporosis.

But therapies for fracture prevention, especially bisphosphonates, appear to be at least as effective for adults with medical complexity as they are for people without such conditions, Dr. Niznik said. Physicians must consider the potential treatment burden and the likelihood of benefit, he said.

Dr. Niznik’s research has shown a lack of strong evidence on how clinicians can manage patients in nursing homes. In some cases, deprescribing is reasonable, such as for patients who have undergone treatment for several years and whose life expectancy is less than 2 years.

“In the absence of any of those, if they are not already treated for osteoporosis, it makes sense to initiate treatment at that time,” Dr. Niznik said.
 

Matters most: Patient input

Clinicians need to educate patients on how long they must undergo a treatment before they experience benefits, according to Sarah D. Berry, MD, MPH, associate professor of medicine at Harvard Medical School, in Boston.

A meta-analysis of studies that included more than 20,000 women who were randomly assigned to receive bisphosphonate or placebo found that one nonvertebral fracture was avoided during a 12-month period for every 100 persons treated. One hip fracture was avoided during a 20-month period for every 200 patients treated.

“In general, in persons with a 2-year life expectancy, time to benefit favors bisphosphonate use,” Dr. Berry said. “Anabolics may have an even quicker time to benefit.”

Dr. Berry said a shared a decision-making model can help clinicians facilitate discussions that help patients prioritize goals and compare options while considering results, benefits, and harms. And she offered a final tip: Use tools with absolute risk reduction to convey risks and benefits, as the relative risk calculations overestimate how effective treatment will be.

Dr. Rosen has disclosed no relevant financial relationships. Dr. Colon-Emeric has received grants from the National Institutes of Health and VA Health Services Research and Development Funding; has served as endpoint adjudication chair for UCB Pharma; and has received royalties from Wolters Kluwer. Dr. Niznik has received funding from the National Institute of Aging and the Centers for Disease Control and Prevention. Dr. Berry has received funding from the NIH and royalties from Wolters Kluwer.

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

BY ALICIA AULT

The Centers for Disease Control and Prevention is alerting clinicians to be on the lookout for a severe antifungal-resistant form of tinea, as it was recently detected in two patients in New York.

Tinea, or ringworm, one of the most common fungal infections, is responsible for almost 5 million outpatient visits and 690 hospitalizations annually, according to the CDC.

Over the past 10 years, severe, antifungal-resistant tinea has spread in South Asia, in part because of the rise of a new dermatophyte species known as Trichophyton indotineae, wrote the authors of a report on the two patients with the drug-resistant strain. This epidemic “has likely been driven by misuse and overuse of topical antifungals and corticosteroids,” added the authors, in Morbidity and Mortality Weekly Report.

The cases were detected by a New York City dermatologist. In the first case, a 28-year-old woman developed a widespread pruritic eruption in the summer of 2021. She did not consult a dermatologist until December, when she was in the third trimester of pregnancy. She had large, annular, scaly, pruritic plaques on her neck, abdomen, pubic region, and buttocks, but had no underlying medical conditions, no known exposures to someone with a similar rash, and no recent international travel history.

After she gave birth in January, she started oral terbinafine therapy but had no improvement after 2 weeks. Clinicians administered a 4-week course of itraconazole, which resolved the infection.

The second patient, a 47-year-old woman with no medical conditions, developed a rash while in Bangladesh in the summer of 2022. Other family members had a similar rash. She was treated with topical antifungal and steroid combination creams but had no resolution. Back in the United States, she was prescribed hydrocortisone 2.5% ointment and diphenhydramine, clotrimazole cream, and terbinafine cream in three successive emergency department visits. In December 2022, dermatologists, observing widespread, discrete, scaly, annular, pruritic plaques on the thighs and buttocks, prescribed a 4-week course of oral terbinafine. When the rash did not resolve, she was given 4 weeks of griseofulvin. The rash persisted, although there was 80% improvement. Clinicians are now considering itraconazole. The woman’s son and husband are also being evaluated, as they have similar rashes.

In both cases, skin culture isolates were initially identified as Trichophyton mentagrophytes. Further analysis at the New York State Department of Health’s lab, using Sanger sequencing of the internal transcribed spacer region of the ribosomal gene, followed by phylogenetic analysis, identified the isolates as T. indotineae.

The authors note that culture-based techniques used by most clinical laboratories typically misidentify T. indotineae as T. mentagrophytes or T. interdigitale. Genomic sequencing must be used to properly identify T. indotineae, they wrote.

Clinicians should consider T. indotineae in patients with widespread ringworm, especially if they do not improve with topical antifungals or oral terbinafine, said the authors. If T. indotineae is suspected, state or local public health departments can direct clinicians to testing.

The authors report no relevant financial relationships.

BY ALICIA AULT

The Centers for Disease Control and Prevention is alerting clinicians to be on the lookout for a severe antifungal-resistant form of tinea, as it was recently detected in two patients in New York.

Tinea, or ringworm, one of the most common fungal infections, is responsible for almost 5 million outpatient visits and 690 hospitalizations annually, according to the CDC.

Over the past 10 years, severe, antifungal-resistant tinea has spread in South Asia, in part because of the rise of a new dermatophyte species known as Trichophyton indotineae, wrote the authors of a report on the two patients with the drug-resistant strain. This epidemic “has likely been driven by misuse and overuse of topical antifungals and corticosteroids,” added the authors, in Morbidity and Mortality Weekly Report.

The cases were detected by a New York City dermatologist. In the first case, a 28-year-old woman developed a widespread pruritic eruption in the summer of 2021. She did not consult a dermatologist until December, when she was in the third trimester of pregnancy. She had large, annular, scaly, pruritic plaques on her neck, abdomen, pubic region, and buttocks, but had no underlying medical conditions, no known exposures to someone with a similar rash, and no recent international travel history.

After she gave birth in January, she started oral terbinafine therapy but had no improvement after 2 weeks. Clinicians administered a 4-week course of itraconazole, which resolved the infection.

The second patient, a 47-year-old woman with no medical conditions, developed a rash while in Bangladesh in the summer of 2022. Other family members had a similar rash. She was treated with topical antifungal and steroid combination creams but had no resolution. Back in the United States, she was prescribed hydrocortisone 2.5% ointment and diphenhydramine, clotrimazole cream, and terbinafine cream in three successive emergency department visits. In December 2022, dermatologists, observing widespread, discrete, scaly, annular, pruritic plaques on the thighs and buttocks, prescribed a 4-week course of oral terbinafine. When the rash did not resolve, she was given 4 weeks of griseofulvin. The rash persisted, although there was 80% improvement. Clinicians are now considering itraconazole. The woman’s son and husband are also being evaluated, as they have similar rashes.

In both cases, skin culture isolates were initially identified as Trichophyton mentagrophytes. Further analysis at the New York State Department of Health’s lab, using Sanger sequencing of the internal transcribed spacer region of the ribosomal gene, followed by phylogenetic analysis, identified the isolates as T. indotineae.

The authors note that culture-based techniques used by most clinical laboratories typically misidentify T. indotineae as T. mentagrophytes or T. interdigitale. Genomic sequencing must be used to properly identify T. indotineae, they wrote.

Clinicians should consider T. indotineae in patients with widespread ringworm, especially if they do not improve with topical antifungals or oral terbinafine, said the authors. If T. indotineae is suspected, state or local public health departments can direct clinicians to testing.

The authors report no relevant financial relationships.

BY ALICIA AULT

The Centers for Disease Control and Prevention is alerting clinicians to be on the lookout for a severe antifungal-resistant form of tinea, as it was recently detected in two patients in New York.

Tinea, or ringworm, one of the most common fungal infections, is responsible for almost 5 million outpatient visits and 690 hospitalizations annually, according to the CDC.

Over the past 10 years, severe, antifungal-resistant tinea has spread in South Asia, in part because of the rise of a new dermatophyte species known as Trichophyton indotineae, wrote the authors of a report on the two patients with the drug-resistant strain. This epidemic “has likely been driven by misuse and overuse of topical antifungals and corticosteroids,” added the authors, in Morbidity and Mortality Weekly Report.

The cases were detected by a New York City dermatologist. In the first case, a 28-year-old woman developed a widespread pruritic eruption in the summer of 2021. She did not consult a dermatologist until December, when she was in the third trimester of pregnancy. She had large, annular, scaly, pruritic plaques on her neck, abdomen, pubic region, and buttocks, but had no underlying medical conditions, no known exposures to someone with a similar rash, and no recent international travel history.

After she gave birth in January, she started oral terbinafine therapy but had no improvement after 2 weeks. Clinicians administered a 4-week course of itraconazole, which resolved the infection.

The second patient, a 47-year-old woman with no medical conditions, developed a rash while in Bangladesh in the summer of 2022. Other family members had a similar rash. She was treated with topical antifungal and steroid combination creams but had no resolution. Back in the United States, she was prescribed hydrocortisone 2.5% ointment and diphenhydramine, clotrimazole cream, and terbinafine cream in three successive emergency department visits. In December 2022, dermatologists, observing widespread, discrete, scaly, annular, pruritic plaques on the thighs and buttocks, prescribed a 4-week course of oral terbinafine. When the rash did not resolve, she was given 4 weeks of griseofulvin. The rash persisted, although there was 80% improvement. Clinicians are now considering itraconazole. The woman’s son and husband are also being evaluated, as they have similar rashes.

In both cases, skin culture isolates were initially identified as Trichophyton mentagrophytes. Further analysis at the New York State Department of Health’s lab, using Sanger sequencing of the internal transcribed spacer region of the ribosomal gene, followed by phylogenetic analysis, identified the isolates as T. indotineae.

The authors note that culture-based techniques used by most clinical laboratories typically misidentify T. indotineae as T. mentagrophytes or T. interdigitale. Genomic sequencing must be used to properly identify T. indotineae, they wrote.

Clinicians should consider T. indotineae in patients with widespread ringworm, especially if they do not improve with topical antifungals or oral terbinafine, said the authors. If T. indotineae is suspected, state or local public health departments can direct clinicians to testing.

The authors report no relevant financial relationships.

Bariatric surgery for obesity is associated with a reduced risk of developing breast cancer, new data suggest.

In a matched cohort study of more than 69,000 Canadian women, risk for incident breast cancer at 1 year was 40% higher among women who had not undergone bariatric surgery, compared with those who had. The risk remained elevated through 5 years of follow-up.

The findings were “definitely a bit surprising,” study author Aristithes G. Doumouras, MD, MPH, assistant professor of surgery at McMaster University, Hamilton, Ont., said in an interview. “The patients that underwent bariatric surgery had better cancer outcomes than patients who weighed less than they did, so it showed that there was more at play than just weight loss. This effect was durable [and] shows how powerful the surgery is, [as well as] the fact that we haven’t even explored all of its effects.”

The study was published online in JAMA Surgery.
 

Protective association

To determine whether there is a residual risk for breast cancer following bariatric surgery for obesity, the investigators analyzed clinical and administrative data collected between 2010 and 2016 in Ontario. They retrospectively matched women with obesity who underwent bariatric surgery with women without a history of bariatric surgery. Participants were matched by age and breast cancer screening status. Covariates included diabetes status, neighborhood income quintile, and measures of health care use. The population included 69,260 women (mean age, 45 years).

Among participants who underwent bariatric surgery for obesity, baseline body mass index was greater than 35 for those with related comorbid conditions, and BMI was greater than 40 for those without comorbid conditions. The investigators categorized nonsurgical control patients in accordance with the following four BMI categories: less than 25, 25-29, 30-34, and greater than or equal to 35. Each control group, as well as the surgical group, included 13,852 women.

Participants in the surgical group were followed for 5 years after bariatric surgery. Those in the nonsurgical group were followed for 5 years after the index date (that is, the date of BMI measurement).

In the overall population, 659 cases of breast cancer were diagnosed in the overall population (0.95%) during the study period. This total included 103 (0.74%) cancers in the surgical cohort; 128 (0.92%) in the group with BMI less than 25; 143 (1.03%) among those with BMI 25-29; 150 (1.08%) in the group with BMI 30-34; and 135 (0.97%) among those with BMI greater than or equal to 35.

Most cancers were stage I. There were 65 cases among those with BMI less than 25; 76 for those with BMI of 25-29; 65 for BMI of 30-34; 67 for BMI greater than or equal to 35, and 60 for the surgery group.

Most tumors were of medium grade and were estrogen receptor positive, progesterone receptor positive, and ERBB2 negative. No significant differences were observed across the groups for stage, grade, or hormone status.

There was an increased hazard for incident breast cancer in the nonsurgical group, compared with the postsurgical group after washout periods of 1 year (hazard ratio, 1.40), 2 years (HR, 1.31), and 5 years (HR, 1.38).

In a comparison of the postsurgical cohort with the nonsurgical cohort with BMI less than 25, the hazard of incident breast cancer was not significantly different for any of the washout periods, but there was a reduced hazard for incident breast cancer among postsurgical patients than among nonsurgical patients in all high BMI categories (BMI ≥ 25).

“Taken together, these results demonstrate that the protective association between substantial weight loss via bariatric surgery and breast cancer risk is sustained after 5 years following surgery and that it is associated with a baseline risk similar to that of women with BMI less than 25,” the investigators write.

Nevertheless, Dr. Doumouras said “the interaction between the surgery and individuals is poorly studied, and this level of personalized medicine is simply not there yet. We are working on developing a prospective cohort that has genetic, protein, and microbiome [data] to help answer these questions.”

There are not enough women in subpopulations such as BRCA carriers to study at this point, he added. “This is where more patients and time will really help the research process.”
 

A universal benefit?

“Although these findings are important overall for the general population at risk for breast cancer, we raise an important caveat: The benefit of surgical weight loss may not be universal,” write Justin B. Dimick, MD, MPH, surgical innovation editor for JAMA Surgery, and Melissa L. Pilewskie, MD, both of the University of Michigan, Ann Arbor, in an accompanying commentary.

“In addition to lifestyle factors, several nonmodifiable risk factors, such as a genetic predisposition, strong family history, personal history of a high-risk breast lesion, or history of chest wall radiation, impart significant elevation in risk, and the data remain mixed on the impact of weight loss for individuals in these high-risk cohorts,” they add.

“Further study to elucidate the underlying mechanism associated with obesity, weight loss, and breast cancer risk should help guide strategies for risk reduction that are specific to unique high-risk cohorts, because modifiable risk factors may not portend the same benefit among all groups.”

Commenting on the findings, Stephen Edge, MD, breast surgeon and vice president for system quality and outcomes at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., said, “The importance of this study is that it shows that weight loss in midlife can reduce breast cancer risk back to or even below the risk of similar people who were not obese. This has major implications for counseling women.”

The investigators did not have information on the extent of weight loss with surgery or on which participants maintained the lower weight, Dr. Edge noted; “However, overall, most people who have weight reduction surgery have major weight loss.”

At this point, he said, “we can now tell women with obesity that in addition to the many other advantages of weight loss, their risk of getting breast cancer will also be reduced.”

The study was supported by the Ontario Bariatric Registry and ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ontario Ministry of Long-Term Care. Dr. Doumouras, Dr. Dimick, Dr. Pilewskie, and Dr. Edge reported no relevant financial relationships.

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

Bariatric surgery for obesity is associated with a reduced risk of developing breast cancer, new data suggest.

In a matched cohort study of more than 69,000 Canadian women, risk for incident breast cancer at 1 year was 40% higher among women who had not undergone bariatric surgery, compared with those who had. The risk remained elevated through 5 years of follow-up.

The findings were “definitely a bit surprising,” study author Aristithes G. Doumouras, MD, MPH, assistant professor of surgery at McMaster University, Hamilton, Ont., said in an interview. “The patients that underwent bariatric surgery had better cancer outcomes than patients who weighed less than they did, so it showed that there was more at play than just weight loss. This effect was durable [and] shows how powerful the surgery is, [as well as] the fact that we haven’t even explored all of its effects.”

The study was published online in JAMA Surgery.
 

Protective association

To determine whether there is a residual risk for breast cancer following bariatric surgery for obesity, the investigators analyzed clinical and administrative data collected between 2010 and 2016 in Ontario. They retrospectively matched women with obesity who underwent bariatric surgery with women without a history of bariatric surgery. Participants were matched by age and breast cancer screening status. Covariates included diabetes status, neighborhood income quintile, and measures of health care use. The population included 69,260 women (mean age, 45 years).

Among participants who underwent bariatric surgery for obesity, baseline body mass index was greater than 35 for those with related comorbid conditions, and BMI was greater than 40 for those without comorbid conditions. The investigators categorized nonsurgical control patients in accordance with the following four BMI categories: less than 25, 25-29, 30-34, and greater than or equal to 35. Each control group, as well as the surgical group, included 13,852 women.

Participants in the surgical group were followed for 5 years after bariatric surgery. Those in the nonsurgical group were followed for 5 years after the index date (that is, the date of BMI measurement).

In the overall population, 659 cases of breast cancer were diagnosed in the overall population (0.95%) during the study period. This total included 103 (0.74%) cancers in the surgical cohort; 128 (0.92%) in the group with BMI less than 25; 143 (1.03%) among those with BMI 25-29; 150 (1.08%) in the group with BMI 30-34; and 135 (0.97%) among those with BMI greater than or equal to 35.

Most cancers were stage I. There were 65 cases among those with BMI less than 25; 76 for those with BMI of 25-29; 65 for BMI of 30-34; 67 for BMI greater than or equal to 35, and 60 for the surgery group.

Most tumors were of medium grade and were estrogen receptor positive, progesterone receptor positive, and ERBB2 negative. No significant differences were observed across the groups for stage, grade, or hormone status.

There was an increased hazard for incident breast cancer in the nonsurgical group, compared with the postsurgical group after washout periods of 1 year (hazard ratio, 1.40), 2 years (HR, 1.31), and 5 years (HR, 1.38).

In a comparison of the postsurgical cohort with the nonsurgical cohort with BMI less than 25, the hazard of incident breast cancer was not significantly different for any of the washout periods, but there was a reduced hazard for incident breast cancer among postsurgical patients than among nonsurgical patients in all high BMI categories (BMI ≥ 25).

“Taken together, these results demonstrate that the protective association between substantial weight loss via bariatric surgery and breast cancer risk is sustained after 5 years following surgery and that it is associated with a baseline risk similar to that of women with BMI less than 25,” the investigators write.

Nevertheless, Dr. Doumouras said “the interaction between the surgery and individuals is poorly studied, and this level of personalized medicine is simply not there yet. We are working on developing a prospective cohort that has genetic, protein, and microbiome [data] to help answer these questions.”

There are not enough women in subpopulations such as BRCA carriers to study at this point, he added. “This is where more patients and time will really help the research process.”
 

A universal benefit?

“Although these findings are important overall for the general population at risk for breast cancer, we raise an important caveat: The benefit of surgical weight loss may not be universal,” write Justin B. Dimick, MD, MPH, surgical innovation editor for JAMA Surgery, and Melissa L. Pilewskie, MD, both of the University of Michigan, Ann Arbor, in an accompanying commentary.

“In addition to lifestyle factors, several nonmodifiable risk factors, such as a genetic predisposition, strong family history, personal history of a high-risk breast lesion, or history of chest wall radiation, impart significant elevation in risk, and the data remain mixed on the impact of weight loss for individuals in these high-risk cohorts,” they add.

“Further study to elucidate the underlying mechanism associated with obesity, weight loss, and breast cancer risk should help guide strategies for risk reduction that are specific to unique high-risk cohorts, because modifiable risk factors may not portend the same benefit among all groups.”

Commenting on the findings, Stephen Edge, MD, breast surgeon and vice president for system quality and outcomes at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., said, “The importance of this study is that it shows that weight loss in midlife can reduce breast cancer risk back to or even below the risk of similar people who were not obese. This has major implications for counseling women.”

The investigators did not have information on the extent of weight loss with surgery or on which participants maintained the lower weight, Dr. Edge noted; “However, overall, most people who have weight reduction surgery have major weight loss.”

At this point, he said, “we can now tell women with obesity that in addition to the many other advantages of weight loss, their risk of getting breast cancer will also be reduced.”

The study was supported by the Ontario Bariatric Registry and ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ontario Ministry of Long-Term Care. Dr. Doumouras, Dr. Dimick, Dr. Pilewskie, and Dr. Edge reported no relevant financial relationships.

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

Bariatric surgery for obesity is associated with a reduced risk of developing breast cancer, new data suggest.

In a matched cohort study of more than 69,000 Canadian women, risk for incident breast cancer at 1 year was 40% higher among women who had not undergone bariatric surgery, compared with those who had. The risk remained elevated through 5 years of follow-up.

The findings were “definitely a bit surprising,” study author Aristithes G. Doumouras, MD, MPH, assistant professor of surgery at McMaster University, Hamilton, Ont., said in an interview. “The patients that underwent bariatric surgery had better cancer outcomes than patients who weighed less than they did, so it showed that there was more at play than just weight loss. This effect was durable [and] shows how powerful the surgery is, [as well as] the fact that we haven’t even explored all of its effects.”

The study was published online in JAMA Surgery.
 

Protective association

To determine whether there is a residual risk for breast cancer following bariatric surgery for obesity, the investigators analyzed clinical and administrative data collected between 2010 and 2016 in Ontario. They retrospectively matched women with obesity who underwent bariatric surgery with women without a history of bariatric surgery. Participants were matched by age and breast cancer screening status. Covariates included diabetes status, neighborhood income quintile, and measures of health care use. The population included 69,260 women (mean age, 45 years).

Among participants who underwent bariatric surgery for obesity, baseline body mass index was greater than 35 for those with related comorbid conditions, and BMI was greater than 40 for those without comorbid conditions. The investigators categorized nonsurgical control patients in accordance with the following four BMI categories: less than 25, 25-29, 30-34, and greater than or equal to 35. Each control group, as well as the surgical group, included 13,852 women.

Participants in the surgical group were followed for 5 years after bariatric surgery. Those in the nonsurgical group were followed for 5 years after the index date (that is, the date of BMI measurement).

In the overall population, 659 cases of breast cancer were diagnosed in the overall population (0.95%) during the study period. This total included 103 (0.74%) cancers in the surgical cohort; 128 (0.92%) in the group with BMI less than 25; 143 (1.03%) among those with BMI 25-29; 150 (1.08%) in the group with BMI 30-34; and 135 (0.97%) among those with BMI greater than or equal to 35.

Most cancers were stage I. There were 65 cases among those with BMI less than 25; 76 for those with BMI of 25-29; 65 for BMI of 30-34; 67 for BMI greater than or equal to 35, and 60 for the surgery group.

Most tumors were of medium grade and were estrogen receptor positive, progesterone receptor positive, and ERBB2 negative. No significant differences were observed across the groups for stage, grade, or hormone status.

There was an increased hazard for incident breast cancer in the nonsurgical group, compared with the postsurgical group after washout periods of 1 year (hazard ratio, 1.40), 2 years (HR, 1.31), and 5 years (HR, 1.38).

In a comparison of the postsurgical cohort with the nonsurgical cohort with BMI less than 25, the hazard of incident breast cancer was not significantly different for any of the washout periods, but there was a reduced hazard for incident breast cancer among postsurgical patients than among nonsurgical patients in all high BMI categories (BMI ≥ 25).

“Taken together, these results demonstrate that the protective association between substantial weight loss via bariatric surgery and breast cancer risk is sustained after 5 years following surgery and that it is associated with a baseline risk similar to that of women with BMI less than 25,” the investigators write.

Nevertheless, Dr. Doumouras said “the interaction between the surgery and individuals is poorly studied, and this level of personalized medicine is simply not there yet. We are working on developing a prospective cohort that has genetic, protein, and microbiome [data] to help answer these questions.”

There are not enough women in subpopulations such as BRCA carriers to study at this point, he added. “This is where more patients and time will really help the research process.”
 

A universal benefit?

“Although these findings are important overall for the general population at risk for breast cancer, we raise an important caveat: The benefit of surgical weight loss may not be universal,” write Justin B. Dimick, MD, MPH, surgical innovation editor for JAMA Surgery, and Melissa L. Pilewskie, MD, both of the University of Michigan, Ann Arbor, in an accompanying commentary.

“In addition to lifestyle factors, several nonmodifiable risk factors, such as a genetic predisposition, strong family history, personal history of a high-risk breast lesion, or history of chest wall radiation, impart significant elevation in risk, and the data remain mixed on the impact of weight loss for individuals in these high-risk cohorts,” they add.

“Further study to elucidate the underlying mechanism associated with obesity, weight loss, and breast cancer risk should help guide strategies for risk reduction that are specific to unique high-risk cohorts, because modifiable risk factors may not portend the same benefit among all groups.”

Commenting on the findings, Stephen Edge, MD, breast surgeon and vice president for system quality and outcomes at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., said, “The importance of this study is that it shows that weight loss in midlife can reduce breast cancer risk back to or even below the risk of similar people who were not obese. This has major implications for counseling women.”

The investigators did not have information on the extent of weight loss with surgery or on which participants maintained the lower weight, Dr. Edge noted; “However, overall, most people who have weight reduction surgery have major weight loss.”

At this point, he said, “we can now tell women with obesity that in addition to the many other advantages of weight loss, their risk of getting breast cancer will also be reduced.”

The study was supported by the Ontario Bariatric Registry and ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ontario Ministry of Long-Term Care. Dr. Doumouras, Dr. Dimick, Dr. Pilewskie, and Dr. Edge reported no relevant financial relationships.

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

The Food and Drug Administration has announced new action to address ongoing concerns about misuse, abuse, addiction, and overdose of prescription stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).

“The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA said in a drug safety communication.

Going forward, updated drug labels will clearly state that patients should never share their prescription stimulants with anyone, and the boxed warning will describe the risks of misuse, abuse, addiction, and overdose consistently for all medicines in the class, the FDA said.

The boxed warning will also advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.

Patient medication guides will be updated to educate patients and caregivers about these risks.

The FDA encourages prescribers to assess patient risk of misuse, abuse, and addiction before prescribing a stimulant and to counsel patients not to share the medication.
 

Friends and family

A recent literature review by the FDA found that friends and family members are the most common source of prescription stimulant misuse and abuse (nonmedical use). Estimates of such use range from 56% to 80%.

Misuse/abuse of a patient’s own prescription make up 10%-20% of people who report nonmedical stimulant use.

Less commonly reported sources include drug dealers or strangers (4%-7% of people who report nonmedical use) and the Internet (1%-2%).

The groups at highest risk for misuse/abuse of prescription stimulants are young adults aged 18-25 years, college students, and adolescents and young adults who have been diagnosed with ADHD, the FDA said.

Recent data from the Centers for Disease Control and Prevention show that during the first year of the COVID-19 pandemic, prescriptions for stimulants increased 10% among older children and adults.
 

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

The Food and Drug Administration has announced new action to address ongoing concerns about misuse, abuse, addiction, and overdose of prescription stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).

“The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA said in a drug safety communication.

Going forward, updated drug labels will clearly state that patients should never share their prescription stimulants with anyone, and the boxed warning will describe the risks of misuse, abuse, addiction, and overdose consistently for all medicines in the class, the FDA said.

The boxed warning will also advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.

Patient medication guides will be updated to educate patients and caregivers about these risks.

The FDA encourages prescribers to assess patient risk of misuse, abuse, and addiction before prescribing a stimulant and to counsel patients not to share the medication.
 

Friends and family

A recent literature review by the FDA found that friends and family members are the most common source of prescription stimulant misuse and abuse (nonmedical use). Estimates of such use range from 56% to 80%.

Misuse/abuse of a patient’s own prescription make up 10%-20% of people who report nonmedical stimulant use.

Less commonly reported sources include drug dealers or strangers (4%-7% of people who report nonmedical use) and the Internet (1%-2%).

The groups at highest risk for misuse/abuse of prescription stimulants are young adults aged 18-25 years, college students, and adolescents and young adults who have been diagnosed with ADHD, the FDA said.

Recent data from the Centers for Disease Control and Prevention show that during the first year of the COVID-19 pandemic, prescriptions for stimulants increased 10% among older children and adults.
 

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

The Food and Drug Administration has announced new action to address ongoing concerns about misuse, abuse, addiction, and overdose of prescription stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).

“The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA said in a drug safety communication.

Going forward, updated drug labels will clearly state that patients should never share their prescription stimulants with anyone, and the boxed warning will describe the risks of misuse, abuse, addiction, and overdose consistently for all medicines in the class, the FDA said.

The boxed warning will also advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.

Patient medication guides will be updated to educate patients and caregivers about these risks.

The FDA encourages prescribers to assess patient risk of misuse, abuse, and addiction before prescribing a stimulant and to counsel patients not to share the medication.
 

Friends and family

A recent literature review by the FDA found that friends and family members are the most common source of prescription stimulant misuse and abuse (nonmedical use). Estimates of such use range from 56% to 80%.

Misuse/abuse of a patient’s own prescription make up 10%-20% of people who report nonmedical stimulant use.

Less commonly reported sources include drug dealers or strangers (4%-7% of people who report nonmedical use) and the Internet (1%-2%).

The groups at highest risk for misuse/abuse of prescription stimulants are young adults aged 18-25 years, college students, and adolescents and young adults who have been diagnosed with ADHD, the FDA said.

Recent data from the Centers for Disease Control and Prevention show that during the first year of the COVID-19 pandemic, prescriptions for stimulants increased 10% among older children and adults.
 

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

Statins have disease-modifying potential in people with noncirrhotic chronic liver disease (CLD) by reducing the risk for progression to severe liver disease, new research shows.

The Swedish population-based study found that adults with noncirrhotic CLD who were on statin therapy had a statistically significant 40% lower risk of developing severe liver disease, compared with matched patients who were not on statin therapy.

©rogerashford/Thinkstock

The statin users were also less apt to progress to cirrhosis or hepatocellular carcinoma (HCC) and to die of liver disease, Rajani Sharma, MD, MSc, division of digestive and liver diseases, Columbia University Irving Medical Center, New York, and colleagues reported.

Their study was published online in Clinical Gastroenterology and Hepatology.
 

More than just cholesterol lowering

The study “continues the theme that cholesterol-lowering statins are good for a lot more things than just lowering cholesterol,” William Carey, MD, who wasn’t involved with the study, said in an interview.

The results are “very consistent with other trials that show that people with liver disease on statins do better in many respects than those who are not on statins,” said Dr. Carey, acting head of the hepatology section, department of gastroenterology, hepatology, and nutrition, Cleveland Clinic.

“The effects are not trivial,” Dr. Carey added. “It’s a very significant advantage in terms of fibrosis progression and survival.”

Statins have been shown to inhibit inflammatory pathways, promote endothelial cell function, and reduce hepatic stellate cell activity, suggesting that statins could lessen the progression of liver fibrosis, Dr. Sharma and coauthors wrote.

A few prior studies have looked at the effects of statins in noncirrhotic CLD specifically, but most only included patients with viral hepatitis, and the identification of precirrhotic liver disease was largely based on fibrosis scores or ICD coding, leading to a risk for misclassification and heterogeneity in results, they wrote.

Using histopathology data in a nationwide Swedish cohort, Dr. Sharma and colleagues identified 3862 adults with noncirrhotic CLD who were statin users and a like number of propensity score–matched nonstatin users with noncirrhotic CLD. The adults with CLD included in the study were required to have a liver biopsy showing fibrosis or inflammation between the years 1969 and 2017 and at least one ICD code for CLD.

In both groups, 45% of patients had nonalcoholic fatty liver disease (NAFLD), 22% had alcohol-related liver disease (ALD), 18% had viral hepatitis, and 15% had autoimmune hepatitis (AIH).

The analysis found 234 (6.1%) statin users developed severe liver disease versus 276 (7.1%) nonusers, with incidence rates of 10.5 versus 18.1 per 1,000 person-years, respectively.

Statin use was associated with a statistically significant 40% lower rate of severe liver disease (hazard ratio, 0.60; 95% confidence interval, 0.48-0.74).

This was the case in ALD (HR, 0.30; 95% CI, 0.19-0.49) and NAFLD (HR, 0.68; 95% CI 0.45-1.00), but the results were not statistically significant for individuals with viral hepatitis (HR, 0.76; 95% CI, 0.51-1.14) or AIH (HR, 0.88; 0.48-1.58).

Statin use had a protective association in both prefibrosis and fibrosis stages at diagnosis, the researchers reported.

Statin use was also associated with lower rates of progression to cirrhosis (HR, 0.62; 95% CI, 0.49-0.78), HCC (HR, 0.44; 95% CI, 0.27-0.71) and liver-related death or liver transplant (HR, 0.55; 95% CI, 0.36-0.82).

The authors noted that their “study provides the most robust estimates available thus far.” However, they cautioned that “prospective randomized controlled trials are necessary in order to recommend statin use in clinical practice.”
 

‘Reassuring and pleasantly surprising’

The study is “very interesting, reassuring, and pleasantly surprising,” Scott L. Friedman, MD, chief of the division of liver diseases and dean for therapeutic discovery at the Icahn School of Medicine at Mount Sinai. New York, said in an interview.

“Statins have been around for a long time, and in earlier days, there was fear of using them because they might induce liver injury. But ample and consistent data exclude the possibility that they are more toxic in patients with liver disease,” said Dr. Friedman, who was not associated with this research.

“What’s interesting and new about this paper is that those studies that have looked at the effects of statins on liver disease have primarily focused on patients who have cirrhosis because there’s some scientific evidence [that] statins can lead to vasodilation and reduce the elevated liver blood flow that occurs in cirrhosis,” he explained.

“Instead, this study, which is quite sizable, includes patients who do not have evidence of cirrhosis based on biopsies. The results suggest that statins have a significant protective effect in these patients,” Dr. Friedman said.

The study was supported by the Karolinska Institute in Stockholm, the Columbia University Irving Medical Center, the Swedish Research Council, the Swedish Cancer Society, and the U.S. National Institutes of Health. Dr. Sharma is a consultant for Takeda and Volv. Other coauthors reported current or past relationships with Bristol-Myers Squibb, Gilead, Salix, and GlaxoSmithKline. Dr. Carey and Dr. Friedman reported no relevant financial relationships.

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

Statins have disease-modifying potential in people with noncirrhotic chronic liver disease (CLD) by reducing the risk for progression to severe liver disease, new research shows.

The Swedish population-based study found that adults with noncirrhotic CLD who were on statin therapy had a statistically significant 40% lower risk of developing severe liver disease, compared with matched patients who were not on statin therapy.

©rogerashford/Thinkstock

The statin users were also less apt to progress to cirrhosis or hepatocellular carcinoma (HCC) and to die of liver disease, Rajani Sharma, MD, MSc, division of digestive and liver diseases, Columbia University Irving Medical Center, New York, and colleagues reported.

Their study was published online in Clinical Gastroenterology and Hepatology.
 

More than just cholesterol lowering

The study “continues the theme that cholesterol-lowering statins are good for a lot more things than just lowering cholesterol,” William Carey, MD, who wasn’t involved with the study, said in an interview.

The results are “very consistent with other trials that show that people with liver disease on statins do better in many respects than those who are not on statins,” said Dr. Carey, acting head of the hepatology section, department of gastroenterology, hepatology, and nutrition, Cleveland Clinic.

“The effects are not trivial,” Dr. Carey added. “It’s a very significant advantage in terms of fibrosis progression and survival.”

Statins have been shown to inhibit inflammatory pathways, promote endothelial cell function, and reduce hepatic stellate cell activity, suggesting that statins could lessen the progression of liver fibrosis, Dr. Sharma and coauthors wrote.

A few prior studies have looked at the effects of statins in noncirrhotic CLD specifically, but most only included patients with viral hepatitis, and the identification of precirrhotic liver disease was largely based on fibrosis scores or ICD coding, leading to a risk for misclassification and heterogeneity in results, they wrote.

Using histopathology data in a nationwide Swedish cohort, Dr. Sharma and colleagues identified 3862 adults with noncirrhotic CLD who were statin users and a like number of propensity score–matched nonstatin users with noncirrhotic CLD. The adults with CLD included in the study were required to have a liver biopsy showing fibrosis or inflammation between the years 1969 and 2017 and at least one ICD code for CLD.

In both groups, 45% of patients had nonalcoholic fatty liver disease (NAFLD), 22% had alcohol-related liver disease (ALD), 18% had viral hepatitis, and 15% had autoimmune hepatitis (AIH).

The analysis found 234 (6.1%) statin users developed severe liver disease versus 276 (7.1%) nonusers, with incidence rates of 10.5 versus 18.1 per 1,000 person-years, respectively.

Statin use was associated with a statistically significant 40% lower rate of severe liver disease (hazard ratio, 0.60; 95% confidence interval, 0.48-0.74).

This was the case in ALD (HR, 0.30; 95% CI, 0.19-0.49) and NAFLD (HR, 0.68; 95% CI 0.45-1.00), but the results were not statistically significant for individuals with viral hepatitis (HR, 0.76; 95% CI, 0.51-1.14) or AIH (HR, 0.88; 0.48-1.58).

Statin use had a protective association in both prefibrosis and fibrosis stages at diagnosis, the researchers reported.

Statin use was also associated with lower rates of progression to cirrhosis (HR, 0.62; 95% CI, 0.49-0.78), HCC (HR, 0.44; 95% CI, 0.27-0.71) and liver-related death or liver transplant (HR, 0.55; 95% CI, 0.36-0.82).

The authors noted that their “study provides the most robust estimates available thus far.” However, they cautioned that “prospective randomized controlled trials are necessary in order to recommend statin use in clinical practice.”
 

‘Reassuring and pleasantly surprising’

The study is “very interesting, reassuring, and pleasantly surprising,” Scott L. Friedman, MD, chief of the division of liver diseases and dean for therapeutic discovery at the Icahn School of Medicine at Mount Sinai. New York, said in an interview.

“Statins have been around for a long time, and in earlier days, there was fear of using them because they might induce liver injury. But ample and consistent data exclude the possibility that they are more toxic in patients with liver disease,” said Dr. Friedman, who was not associated with this research.

“What’s interesting and new about this paper is that those studies that have looked at the effects of statins on liver disease have primarily focused on patients who have cirrhosis because there’s some scientific evidence [that] statins can lead to vasodilation and reduce the elevated liver blood flow that occurs in cirrhosis,” he explained.

“Instead, this study, which is quite sizable, includes patients who do not have evidence of cirrhosis based on biopsies. The results suggest that statins have a significant protective effect in these patients,” Dr. Friedman said.

The study was supported by the Karolinska Institute in Stockholm, the Columbia University Irving Medical Center, the Swedish Research Council, the Swedish Cancer Society, and the U.S. National Institutes of Health. Dr. Sharma is a consultant for Takeda and Volv. Other coauthors reported current or past relationships with Bristol-Myers Squibb, Gilead, Salix, and GlaxoSmithKline. Dr. Carey and Dr. Friedman reported no relevant financial relationships.

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

Statins have disease-modifying potential in people with noncirrhotic chronic liver disease (CLD) by reducing the risk for progression to severe liver disease, new research shows.

The Swedish population-based study found that adults with noncirrhotic CLD who were on statin therapy had a statistically significant 40% lower risk of developing severe liver disease, compared with matched patients who were not on statin therapy.

©rogerashford/Thinkstock

The statin users were also less apt to progress to cirrhosis or hepatocellular carcinoma (HCC) and to die of liver disease, Rajani Sharma, MD, MSc, division of digestive and liver diseases, Columbia University Irving Medical Center, New York, and colleagues reported.

Their study was published online in Clinical Gastroenterology and Hepatology.
 

More than just cholesterol lowering

The study “continues the theme that cholesterol-lowering statins are good for a lot more things than just lowering cholesterol,” William Carey, MD, who wasn’t involved with the study, said in an interview.

The results are “very consistent with other trials that show that people with liver disease on statins do better in many respects than those who are not on statins,” said Dr. Carey, acting head of the hepatology section, department of gastroenterology, hepatology, and nutrition, Cleveland Clinic.

“The effects are not trivial,” Dr. Carey added. “It’s a very significant advantage in terms of fibrosis progression and survival.”

Statins have been shown to inhibit inflammatory pathways, promote endothelial cell function, and reduce hepatic stellate cell activity, suggesting that statins could lessen the progression of liver fibrosis, Dr. Sharma and coauthors wrote.

A few prior studies have looked at the effects of statins in noncirrhotic CLD specifically, but most only included patients with viral hepatitis, and the identification of precirrhotic liver disease was largely based on fibrosis scores or ICD coding, leading to a risk for misclassification and heterogeneity in results, they wrote.

Using histopathology data in a nationwide Swedish cohort, Dr. Sharma and colleagues identified 3862 adults with noncirrhotic CLD who were statin users and a like number of propensity score–matched nonstatin users with noncirrhotic CLD. The adults with CLD included in the study were required to have a liver biopsy showing fibrosis or inflammation between the years 1969 and 2017 and at least one ICD code for CLD.

In both groups, 45% of patients had nonalcoholic fatty liver disease (NAFLD), 22% had alcohol-related liver disease (ALD), 18% had viral hepatitis, and 15% had autoimmune hepatitis (AIH).

The analysis found 234 (6.1%) statin users developed severe liver disease versus 276 (7.1%) nonusers, with incidence rates of 10.5 versus 18.1 per 1,000 person-years, respectively.

Statin use was associated with a statistically significant 40% lower rate of severe liver disease (hazard ratio, 0.60; 95% confidence interval, 0.48-0.74).

This was the case in ALD (HR, 0.30; 95% CI, 0.19-0.49) and NAFLD (HR, 0.68; 95% CI 0.45-1.00), but the results were not statistically significant for individuals with viral hepatitis (HR, 0.76; 95% CI, 0.51-1.14) or AIH (HR, 0.88; 0.48-1.58).

Statin use had a protective association in both prefibrosis and fibrosis stages at diagnosis, the researchers reported.

Statin use was also associated with lower rates of progression to cirrhosis (HR, 0.62; 95% CI, 0.49-0.78), HCC (HR, 0.44; 95% CI, 0.27-0.71) and liver-related death or liver transplant (HR, 0.55; 95% CI, 0.36-0.82).

The authors noted that their “study provides the most robust estimates available thus far.” However, they cautioned that “prospective randomized controlled trials are necessary in order to recommend statin use in clinical practice.”
 

‘Reassuring and pleasantly surprising’

The study is “very interesting, reassuring, and pleasantly surprising,” Scott L. Friedman, MD, chief of the division of liver diseases and dean for therapeutic discovery at the Icahn School of Medicine at Mount Sinai. New York, said in an interview.

“Statins have been around for a long time, and in earlier days, there was fear of using them because they might induce liver injury. But ample and consistent data exclude the possibility that they are more toxic in patients with liver disease,” said Dr. Friedman, who was not associated with this research.

“What’s interesting and new about this paper is that those studies that have looked at the effects of statins on liver disease have primarily focused on patients who have cirrhosis because there’s some scientific evidence [that] statins can lead to vasodilation and reduce the elevated liver blood flow that occurs in cirrhosis,” he explained.

“Instead, this study, which is quite sizable, includes patients who do not have evidence of cirrhosis based on biopsies. The results suggest that statins have a significant protective effect in these patients,” Dr. Friedman said.

The study was supported by the Karolinska Institute in Stockholm, the Columbia University Irving Medical Center, the Swedish Research Council, the Swedish Cancer Society, and the U.S. National Institutes of Health. Dr. Sharma is a consultant for Takeda and Volv. Other coauthors reported current or past relationships with Bristol-Myers Squibb, Gilead, Salix, and GlaxoSmithKline. Dr. Carey and Dr. Friedman reported no relevant financial relationships.

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

As the number of cases of early-onset colorectal cancer (CRC) diagnosed before age 50 continues to rise, early detection has become increasingly important.

A new study has identified four signs and symptoms that can serve as red flags to facilitate earlier detection of early-onset CRC. The signs and symptoms are abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia.

Two symptoms in particular – rectal bleeding and iron-deficiency anemia – point to the need for timely endoscopy and follow-up, the researchers say.

“Colorectal cancer is not simply a disease affecting older people; we want younger adults to be aware of and act on these potentially very telling signs and symptoms – particularly because people under 50 are considered to be at low risk, and they don’t receive routine colorectal cancer screening,” senior investigator Yin Cao, ScD, with Washington University School of Medicine, St. Louis, said in a news release.

“It’s also crucial to spread awareness among primary care doctors, gastroenterologists, and emergency medicine doctors,” Dr. Cao added. “To date, many early-onset colorectal cancers are detected in emergency rooms, and there often are significant diagnostic delays with this cancer.”

The study was published online  in the Journal of the National Cancer Institute.

Although previous research has identified rectal bleeding, iron-deficiency anemia, and rectal/abdominal pain as symptoms of early-onset CRC, most studies “have aggregated symptoms till the time of diagnosis,” which limits their use for early detection, the authors explain.

In the current study, the researchers analyzed data from more than 5,000 cases of early-onset CRC and from more than 22,000 control patients using the IBM MarketScan commercial database.

Dr. Cao and colleagues found that between 3 months and 2 years before diagnosis, abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia each indicated an increased risk for early-onset CRC.

Among patients with early-onset CRC, 19.3% presented with one or more of the four red flags between 3 months and 2 years prior to the index date; 15.6% had one symptom, and 3.7% had two or more.

After multivariable adjustment, having one symptom almost doubled the risk for early-onset CRC (odds ratio, 1.94); having two symptoms increased risk by more than threefold (OR, 3.59); and having three or more boosted the risk by more than 6.5-fold (OR, 6.52).

Abdominal pain was associated with a 34% higher risk of early-onset CRC (11.6% among case patients vs. 7.7% among controls; OR, 1.34).

Although not as common, rectal bleeding was associated with the highest odds for early-onset CRC (7.2% case patients vs. 1.3% controls; OR, 5.13).

The other predictive signs and symptoms included diarrhea (2.8% case patients vs. 1.4% controls; OR, 1.43) and iron-deficiency anemia (2.3% case patients vs. 0.9% controls; OR, 2.07).

No differences were observed by gender for each sign or symptom.

Among patients with a red-flag symptom who presented between 3 months and 2 years before diagnosis, for those with early-onset CRC, the median diagnostic interval was 8.7 months.

The researchers suggest that clinicians prioritize prompt diagnostic workups for patients younger than 50 who present with rectal bleeding and/or iron-deficiency anemia and that they also keep abdominal pain and diarrhea in mind as early symptoms.

Dr. Cao noted that since most early-onset CRC cases “have been and will continue to be diagnosed after symptom presentation, it is crucial to recognize these red-flag signs and symptoms promptly and conduct a diagnostic workup as soon as possible.

“By doing so, we can diagnose the disease earlier, which in turn can reduce the need for more aggressive treatment and improve patients’ quality of life and survival rates,” said Dr. Cao.

The study was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

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

As the number of cases of early-onset colorectal cancer (CRC) diagnosed before age 50 continues to rise, early detection has become increasingly important.

A new study has identified four signs and symptoms that can serve as red flags to facilitate earlier detection of early-onset CRC. The signs and symptoms are abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia.

Two symptoms in particular – rectal bleeding and iron-deficiency anemia – point to the need for timely endoscopy and follow-up, the researchers say.

“Colorectal cancer is not simply a disease affecting older people; we want younger adults to be aware of and act on these potentially very telling signs and symptoms – particularly because people under 50 are considered to be at low risk, and they don’t receive routine colorectal cancer screening,” senior investigator Yin Cao, ScD, with Washington University School of Medicine, St. Louis, said in a news release.

“It’s also crucial to spread awareness among primary care doctors, gastroenterologists, and emergency medicine doctors,” Dr. Cao added. “To date, many early-onset colorectal cancers are detected in emergency rooms, and there often are significant diagnostic delays with this cancer.”

The study was published online  in the Journal of the National Cancer Institute.

Although previous research has identified rectal bleeding, iron-deficiency anemia, and rectal/abdominal pain as symptoms of early-onset CRC, most studies “have aggregated symptoms till the time of diagnosis,” which limits their use for early detection, the authors explain.

In the current study, the researchers analyzed data from more than 5,000 cases of early-onset CRC and from more than 22,000 control patients using the IBM MarketScan commercial database.

Dr. Cao and colleagues found that between 3 months and 2 years before diagnosis, abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia each indicated an increased risk for early-onset CRC.

Among patients with early-onset CRC, 19.3% presented with one or more of the four red flags between 3 months and 2 years prior to the index date; 15.6% had one symptom, and 3.7% had two or more.

After multivariable adjustment, having one symptom almost doubled the risk for early-onset CRC (odds ratio, 1.94); having two symptoms increased risk by more than threefold (OR, 3.59); and having three or more boosted the risk by more than 6.5-fold (OR, 6.52).

Abdominal pain was associated with a 34% higher risk of early-onset CRC (11.6% among case patients vs. 7.7% among controls; OR, 1.34).

Although not as common, rectal bleeding was associated with the highest odds for early-onset CRC (7.2% case patients vs. 1.3% controls; OR, 5.13).

The other predictive signs and symptoms included diarrhea (2.8% case patients vs. 1.4% controls; OR, 1.43) and iron-deficiency anemia (2.3% case patients vs. 0.9% controls; OR, 2.07).

No differences were observed by gender for each sign or symptom.

Among patients with a red-flag symptom who presented between 3 months and 2 years before diagnosis, for those with early-onset CRC, the median diagnostic interval was 8.7 months.

The researchers suggest that clinicians prioritize prompt diagnostic workups for patients younger than 50 who present with rectal bleeding and/or iron-deficiency anemia and that they also keep abdominal pain and diarrhea in mind as early symptoms.

Dr. Cao noted that since most early-onset CRC cases “have been and will continue to be diagnosed after symptom presentation, it is crucial to recognize these red-flag signs and symptoms promptly and conduct a diagnostic workup as soon as possible.

“By doing so, we can diagnose the disease earlier, which in turn can reduce the need for more aggressive treatment and improve patients’ quality of life and survival rates,” said Dr. Cao.

The study was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

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

As the number of cases of early-onset colorectal cancer (CRC) diagnosed before age 50 continues to rise, early detection has become increasingly important.

A new study has identified four signs and symptoms that can serve as red flags to facilitate earlier detection of early-onset CRC. The signs and symptoms are abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia.

Two symptoms in particular – rectal bleeding and iron-deficiency anemia – point to the need for timely endoscopy and follow-up, the researchers say.

“Colorectal cancer is not simply a disease affecting older people; we want younger adults to be aware of and act on these potentially very telling signs and symptoms – particularly because people under 50 are considered to be at low risk, and they don’t receive routine colorectal cancer screening,” senior investigator Yin Cao, ScD, with Washington University School of Medicine, St. Louis, said in a news release.

“It’s also crucial to spread awareness among primary care doctors, gastroenterologists, and emergency medicine doctors,” Dr. Cao added. “To date, many early-onset colorectal cancers are detected in emergency rooms, and there often are significant diagnostic delays with this cancer.”

The study was published online  in the Journal of the National Cancer Institute.

Although previous research has identified rectal bleeding, iron-deficiency anemia, and rectal/abdominal pain as symptoms of early-onset CRC, most studies “have aggregated symptoms till the time of diagnosis,” which limits their use for early detection, the authors explain.

In the current study, the researchers analyzed data from more than 5,000 cases of early-onset CRC and from more than 22,000 control patients using the IBM MarketScan commercial database.

Dr. Cao and colleagues found that between 3 months and 2 years before diagnosis, abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia each indicated an increased risk for early-onset CRC.

Among patients with early-onset CRC, 19.3% presented with one or more of the four red flags between 3 months and 2 years prior to the index date; 15.6% had one symptom, and 3.7% had two or more.

After multivariable adjustment, having one symptom almost doubled the risk for early-onset CRC (odds ratio, 1.94); having two symptoms increased risk by more than threefold (OR, 3.59); and having three or more boosted the risk by more than 6.5-fold (OR, 6.52).

Abdominal pain was associated with a 34% higher risk of early-onset CRC (11.6% among case patients vs. 7.7% among controls; OR, 1.34).

Although not as common, rectal bleeding was associated with the highest odds for early-onset CRC (7.2% case patients vs. 1.3% controls; OR, 5.13).

The other predictive signs and symptoms included diarrhea (2.8% case patients vs. 1.4% controls; OR, 1.43) and iron-deficiency anemia (2.3% case patients vs. 0.9% controls; OR, 2.07).

No differences were observed by gender for each sign or symptom.

Among patients with a red-flag symptom who presented between 3 months and 2 years before diagnosis, for those with early-onset CRC, the median diagnostic interval was 8.7 months.

The researchers suggest that clinicians prioritize prompt diagnostic workups for patients younger than 50 who present with rectal bleeding and/or iron-deficiency anemia and that they also keep abdominal pain and diarrhea in mind as early symptoms.

Dr. Cao noted that since most early-onset CRC cases “have been and will continue to be diagnosed after symptom presentation, it is crucial to recognize these red-flag signs and symptoms promptly and conduct a diagnostic workup as soon as possible.

“By doing so, we can diagnose the disease earlier, which in turn can reduce the need for more aggressive treatment and improve patients’ quality of life and survival rates,” said Dr. Cao.

The study was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

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

CHICAGO – Antiobesity medications and endoscopic sleeve gastroplasty (ESG) are popular strategies for weight loss on their own. Now researchers are looking at what happens when you combine them.

In a study presented at the annual Digestive Disease Week® (DDW), they found ESG followed by an antiobesity medication led to more total weight loss than ESG alone.

Starting medication within 6 months of ESG was more ideal than other timing intervals. Initiating medical therapy more than 6 months before ESG was associated with less weight loss.

In the single-center, retrospective study, 224 patients were enrolled, of whom 34% were on monotherapy (ESG alone), 31% had combination therapy (medication prescribed within 6 months prior to or after ESG), and 35% had sequential therapy (medication more than 6 months prior to or after ESG).

Most patients were female, ranging from 74% to 95% of each group, and baseline BMI ranged from a mean 37.5 kg/m² to 40.1 kg/m².

The medications involved in the study were phentermine, phentermine/topiramate extended release (Qsymia), orlistat (Xenical, Alli), bupropion/naltrexone ER (Contrave), or the glucagonlike peptide–1 receptor agonist (GLP-1RA) liraglutide (Saxenda, Victoza) or semaglutide (Ozempic, Wegovy, Rybelsus). Of the patients who underwent combination therapy, 30% were prescribed a regimen that included a GLP-1RA. Of the patients who underwent sequential therapy, 81% were prescribed a medication first and 19% underwent ESG first.

At 1 year, the greatest total weight loss was a mean 23.7% with the combination of ESG and a GLP-1RA. Total weight loss was 18% with ESG plus a non–GLP-1RA medication. ESG alone led to 17.3%. Sequential therapy that began with ESG yielded 14.7% total weight loss, whereas sequential therapy that began with medication first resulted in 12% weight loss.

Different study, similar result

In a second study, also presented at DDW 2023, investigators looked at timing of liraglutide for weight loss in a randomized controlled trial. They found that administration of GLP-1RA right after transoral outlet reduction endoscopy (TORe) in people with a history of Roux-en-Y gastric bypass extended weight loss longer than a placebo injection. This strategy was also favorable versus waiting to give liraglutide 1 year later.

The researchers randomly assigned 51 people to get weekly subcutaneous liraglutide injections following TORe for 12 months, then placebo injections for 12 months. They assigned 58 patients to receive weekly placebo injections following TORe for 12 months, then liraglutide injections for 12 months.

At 12 months following the procedure, total body weight loss (TBWL) among participants receiving liraglutide was about 22%, compared with about 14% among patients receiving placebo. At 24 months following the procedure (12 months after crossover), TBWL among patients in the liraglutide-first group was almost 35%, compared with about 24% in the placebo-first/liraglutide-second group.

There was a durable effect associated with liraglutide even after switching to placebo, said Ali Lahooti, lead study author and second-year medical student at Weill Cornell Medicine, New York.

“There did seem to be a better benefit of starting on it for the first year and then stopping it,” Dr. Austin noted.

These two studies come at a time when the debate over the timing of different obesity interventions continues. Some experts believe weight loss medications can help with the rebound in weight that some people experience months after bariatric surgery, for example.
 

‘Wave of the future’

The study by Dr. Jirapinyo and colleagues is “really exciting and interesting,” said Linda S. Lee, MD, medical director of endoscopy, Brigham and Women’s Hospital, Boston, when asked to comment.

Medication begun within 6 months of the endoscopic procedure “led to superior outcomes, compared to just endoscopy alone,” Dr. Lee said. “I think that’s really the wave of the future as far as treating patients with obesity issues. We clearly know that diet and exercise alone for most people is not good enough. Of course, we have surgery, but we also realize that with surgery sometimes the weight starts to creep back up over time.”

Dr. Lee noted that the study was limited because it was retrospective. Ideally, it would be good if future, prospective research randomly assigns people to endoscopy alone or endoscopy plus medication.

Dr. Lee also noted there is a limited number of bariatric endoscopists. By the time people with obesity get to a specialist, they’ve likely tried diet and exercise and “probably have seen all the commercials for these different medications. I think the reality is that most people will ask their primary care physicians about antiobesity medication.

“From my point of view, as long as the medicine is safe and not harming them, then let’s do both of them together,” Dr. Lee added.

Dr. Lee also mentioned another study (Abstract Mo1898) presented at DDW 2023 that showed total weight loss with endoscopic sleeve gastroplasty was durable over 10 years. Follow-up was with only seven patients, however.

Larger numbers are needed to confirm the finding, but it’s “exciting,” she said.

Dr. Jirapinyo receives grant/research support from Apollo Endosurgery, Fractyl, and USGI Medical, and is a consultant for ERBE, GI Dynamics, and Spatz Medical. Dr. Lahooti, Dr. Austin, and Dr. Lee reported no relevant financial relationships.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

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

CHICAGO – Antiobesity medications and endoscopic sleeve gastroplasty (ESG) are popular strategies for weight loss on their own. Now researchers are looking at what happens when you combine them.

In a study presented at the annual Digestive Disease Week® (DDW), they found ESG followed by an antiobesity medication led to more total weight loss than ESG alone.

Starting medication within 6 months of ESG was more ideal than other timing intervals. Initiating medical therapy more than 6 months before ESG was associated with less weight loss.

In the single-center, retrospective study, 224 patients were enrolled, of whom 34% were on monotherapy (ESG alone), 31% had combination therapy (medication prescribed within 6 months prior to or after ESG), and 35% had sequential therapy (medication more than 6 months prior to or after ESG).

Most patients were female, ranging from 74% to 95% of each group, and baseline BMI ranged from a mean 37.5 kg/m² to 40.1 kg/m².

The medications involved in the study were phentermine, phentermine/topiramate extended release (Qsymia), orlistat (Xenical, Alli), bupropion/naltrexone ER (Contrave), or the glucagonlike peptide–1 receptor agonist (GLP-1RA) liraglutide (Saxenda, Victoza) or semaglutide (Ozempic, Wegovy, Rybelsus). Of the patients who underwent combination therapy, 30% were prescribed a regimen that included a GLP-1RA. Of the patients who underwent sequential therapy, 81% were prescribed a medication first and 19% underwent ESG first.

At 1 year, the greatest total weight loss was a mean 23.7% with the combination of ESG and a GLP-1RA. Total weight loss was 18% with ESG plus a non–GLP-1RA medication. ESG alone led to 17.3%. Sequential therapy that began with ESG yielded 14.7% total weight loss, whereas sequential therapy that began with medication first resulted in 12% weight loss.

Different study, similar result

In a second study, also presented at DDW 2023, investigators looked at timing of liraglutide for weight loss in a randomized controlled trial. They found that administration of GLP-1RA right after transoral outlet reduction endoscopy (TORe) in people with a history of Roux-en-Y gastric bypass extended weight loss longer than a placebo injection. This strategy was also favorable versus waiting to give liraglutide 1 year later.

The researchers randomly assigned 51 people to get weekly subcutaneous liraglutide injections following TORe for 12 months, then placebo injections for 12 months. They assigned 58 patients to receive weekly placebo injections following TORe for 12 months, then liraglutide injections for 12 months.

At 12 months following the procedure, total body weight loss (TBWL) among participants receiving liraglutide was about 22%, compared with about 14% among patients receiving placebo. At 24 months following the procedure (12 months after crossover), TBWL among patients in the liraglutide-first group was almost 35%, compared with about 24% in the placebo-first/liraglutide-second group.

There was a durable effect associated with liraglutide even after switching to placebo, said Ali Lahooti, lead study author and second-year medical student at Weill Cornell Medicine, New York.

“There did seem to be a better benefit of starting on it for the first year and then stopping it,” Dr. Austin noted.

These two studies come at a time when the debate over the timing of different obesity interventions continues. Some experts believe weight loss medications can help with the rebound in weight that some people experience months after bariatric surgery, for example.
 

‘Wave of the future’

The study by Dr. Jirapinyo and colleagues is “really exciting and interesting,” said Linda S. Lee, MD, medical director of endoscopy, Brigham and Women’s Hospital, Boston, when asked to comment.

Medication begun within 6 months of the endoscopic procedure “led to superior outcomes, compared to just endoscopy alone,” Dr. Lee said. “I think that’s really the wave of the future as far as treating patients with obesity issues. We clearly know that diet and exercise alone for most people is not good enough. Of course, we have surgery, but we also realize that with surgery sometimes the weight starts to creep back up over time.”

Dr. Lee noted that the study was limited because it was retrospective. Ideally, it would be good if future, prospective research randomly assigns people to endoscopy alone or endoscopy plus medication.

Dr. Lee also noted there is a limited number of bariatric endoscopists. By the time people with obesity get to a specialist, they’ve likely tried diet and exercise and “probably have seen all the commercials for these different medications. I think the reality is that most people will ask their primary care physicians about antiobesity medication.

“From my point of view, as long as the medicine is safe and not harming them, then let’s do both of them together,” Dr. Lee added.

Dr. Lee also mentioned another study (Abstract Mo1898) presented at DDW 2023 that showed total weight loss with endoscopic sleeve gastroplasty was durable over 10 years. Follow-up was with only seven patients, however.

Larger numbers are needed to confirm the finding, but it’s “exciting,” she said.

Dr. Jirapinyo receives grant/research support from Apollo Endosurgery, Fractyl, and USGI Medical, and is a consultant for ERBE, GI Dynamics, and Spatz Medical. Dr. Lahooti, Dr. Austin, and Dr. Lee reported no relevant financial relationships.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

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

CHICAGO – Antiobesity medications and endoscopic sleeve gastroplasty (ESG) are popular strategies for weight loss on their own. Now researchers are looking at what happens when you combine them.

In a study presented at the annual Digestive Disease Week® (DDW), they found ESG followed by an antiobesity medication led to more total weight loss than ESG alone.

Starting medication within 6 months of ESG was more ideal than other timing intervals. Initiating medical therapy more than 6 months before ESG was associated with less weight loss.

In the single-center, retrospective study, 224 patients were enrolled, of whom 34% were on monotherapy (ESG alone), 31% had combination therapy (medication prescribed within 6 months prior to or after ESG), and 35% had sequential therapy (medication more than 6 months prior to or after ESG).

Most patients were female, ranging from 74% to 95% of each group, and baseline BMI ranged from a mean 37.5 kg/m² to 40.1 kg/m².

The medications involved in the study were phentermine, phentermine/topiramate extended release (Qsymia), orlistat (Xenical, Alli), bupropion/naltrexone ER (Contrave), or the glucagonlike peptide–1 receptor agonist (GLP-1RA) liraglutide (Saxenda, Victoza) or semaglutide (Ozempic, Wegovy, Rybelsus). Of the patients who underwent combination therapy, 30% were prescribed a regimen that included a GLP-1RA. Of the patients who underwent sequential therapy, 81% were prescribed a medication first and 19% underwent ESG first.

At 1 year, the greatest total weight loss was a mean 23.7% with the combination of ESG and a GLP-1RA. Total weight loss was 18% with ESG plus a non–GLP-1RA medication. ESG alone led to 17.3%. Sequential therapy that began with ESG yielded 14.7% total weight loss, whereas sequential therapy that began with medication first resulted in 12% weight loss.

Different study, similar result

In a second study, also presented at DDW 2023, investigators looked at timing of liraglutide for weight loss in a randomized controlled trial. They found that administration of GLP-1RA right after transoral outlet reduction endoscopy (TORe) in people with a history of Roux-en-Y gastric bypass extended weight loss longer than a placebo injection. This strategy was also favorable versus waiting to give liraglutide 1 year later.

The researchers randomly assigned 51 people to get weekly subcutaneous liraglutide injections following TORe for 12 months, then placebo injections for 12 months. They assigned 58 patients to receive weekly placebo injections following TORe for 12 months, then liraglutide injections for 12 months.

At 12 months following the procedure, total body weight loss (TBWL) among participants receiving liraglutide was about 22%, compared with about 14% among patients receiving placebo. At 24 months following the procedure (12 months after crossover), TBWL among patients in the liraglutide-first group was almost 35%, compared with about 24% in the placebo-first/liraglutide-second group.

There was a durable effect associated with liraglutide even after switching to placebo, said Ali Lahooti, lead study author and second-year medical student at Weill Cornell Medicine, New York.

“There did seem to be a better benefit of starting on it for the first year and then stopping it,” Dr. Austin noted.

These two studies come at a time when the debate over the timing of different obesity interventions continues. Some experts believe weight loss medications can help with the rebound in weight that some people experience months after bariatric surgery, for example.
 

‘Wave of the future’

The study by Dr. Jirapinyo and colleagues is “really exciting and interesting,” said Linda S. Lee, MD, medical director of endoscopy, Brigham and Women’s Hospital, Boston, when asked to comment.

Medication begun within 6 months of the endoscopic procedure “led to superior outcomes, compared to just endoscopy alone,” Dr. Lee said. “I think that’s really the wave of the future as far as treating patients with obesity issues. We clearly know that diet and exercise alone for most people is not good enough. Of course, we have surgery, but we also realize that with surgery sometimes the weight starts to creep back up over time.”

Dr. Lee noted that the study was limited because it was retrospective. Ideally, it would be good if future, prospective research randomly assigns people to endoscopy alone or endoscopy plus medication.

Dr. Lee also noted there is a limited number of bariatric endoscopists. By the time people with obesity get to a specialist, they’ve likely tried diet and exercise and “probably have seen all the commercials for these different medications. I think the reality is that most people will ask their primary care physicians about antiobesity medication.

“From my point of view, as long as the medicine is safe and not harming them, then let’s do both of them together,” Dr. Lee added.

Dr. Lee also mentioned another study (Abstract Mo1898) presented at DDW 2023 that showed total weight loss with endoscopic sleeve gastroplasty was durable over 10 years. Follow-up was with only seven patients, however.

Larger numbers are needed to confirm the finding, but it’s “exciting,” she said.

Dr. Jirapinyo receives grant/research support from Apollo Endosurgery, Fractyl, and USGI Medical, and is a consultant for ERBE, GI Dynamics, and Spatz Medical. Dr. Lahooti, Dr. Austin, and Dr. Lee reported no relevant financial relationships.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

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

When people ask Paul Offit, MD, what worries him the most about the COVID-19 pandemic, he names two concerns. “One is the lack of socialization and education that came from keeping kids out of school for so long,” Dr. Offit said in a recent interview. “And I think vaccines have suffered.”

Dr. Offit is director of the Vaccine Education Center and a professor of pediatrics at Children’s Hospital of Philadelphia. He has watched with alarm as the American public appears to be losing faith in the lifesaving vaccines the public health community has worked hard to promote. The Centers for Disease Control and Prevention estimates that the proportion of kids entering kindergarten who have received state-required vaccines dipped to 94% in the 2020-2021 school year – a full point less than the year before the pandemic – then dropped by another percentage point, to 93%, the following year.

Although a couple of percentage points may sound trivial, were only 93% of kindergarteners to receive the vaccine against measles, mumps, and rubella (MMR), approximately 250,000 vulnerable 5-year-olds could spark the next big outbreak, such as the recent measles outbreaks in Ohio and Minnesota.

Dr. Offit is one of many public health officials and clinicians who are working to reverse the concerning trends in pediatric vaccinations. Their efforts combine conventional approaches, such as community outreach, with newer strategies, including using social media and even lending a sympathetic ear to parents voicing anti-science imaginings.

“I just don’t want to see an outbreak of something that we could have avoided because we were not protected enough,” Judith Shlay, MD, associate director of the Public Health Institute at Denver Health, said.
 

Official stumbles in part to blame

Disruptions in health care from the COVID-19 pandemic certainly played a role in the decline. Parents were afraid to expose their children to other sick kids, providers shifted to a telehealth model, and routine preventive care was difficult to access.

But Dr. Offit also blamed erosion of trust on mistakes made by government and public health institutions for the alarming trend. “I think that health care professionals have lost some level of trust in the Food and Drug Administration and CDC.”

He cited as an example poor messaging during a large outbreak in Massachusetts in summer 2021, when the CDC published a report that highlighted the high proportion of COVID-19 cases among vaccinated people. Health officials called those cases “breakthrough” infections, although most were mild or asymptomatic.

Dr. Offit said the CDC should have focused the message instead on the low rate (1%) of hospitalizations and the low number of deaths from the infections. Instead, they had to walk back their promise that vaccinated people didn’t need to wear masks. At other times, the Biden administration pressured public health officials by promising to make booster shots available to the American public when the FDA and CDC felt they lacked evidence to recommend the injections.

Rupali Limaye, PhD, an associate professor of international health at the Bloomberg School of Public Health at Johns Hopkins University, Baltimore, studies vaccine behavior and decision-making. She would go a step further in characterizing the roots of worsening vaccine hesitancy.

“In the last 20 years, we’ve seen there’s less and less trust in health care providers in general,” Dr. Limaye said. “More people are turning to their social networks or social contacts for that kind of information.” In the maelstrom of the COVID-19 pandemic, digital social networks facilitated the spread of misinformation about COVID-19 faster than scientists could unravel the mysteries of the disease.

“There’s always been this underlying hesitancy for some people about vaccines,” Dr. Shlay said. But she has noticed more resistance to the COVID-19 vaccine from parents nervous about the new mRNA technology. “There was a lot of politicization of the vaccine, even though the mRNA vaccine technology has been around for a long time,” she said.
 

Multipronged approaches

Dr. Shlay is committed to restoring childhood vaccination uptake to prepandemic levels now that clinics are open again. To do so, she is relying on a combination of quality improvement strategies and outreach to undervaccinated populations.

Denver Health, for instance, offers vaccinations at any inpatient or outpatient visit – not just well-child visits – with the help of alerts built into their electronic health records that notify clinicians if a patient is due for a vaccine.

COVID-19 revealed marked health inequities in underserved communities as Black, Hispanic, and people from other minority communities experienced higher rates of COVID-19 cases and deaths, compared with White people. The Public Health Institute, which is part of Denver Health, has responded with vaccine outreach teams that go to schools, shelters, churches, and community-based organizations to vaccinate children. They focus their efforts on areas where immunization rates are low. Health centers in schools throughout Colorado vaccinate students, and the Public Health Institute partners with Denver-area public schools to provide vaccines to students in schools that don’t have such centers. (They also provide dental care and behavioral health services.)

But it is unlikely that restoring clinic operations and making vaccines more accessible will fill the gap. After 3 years of fear and mistrust, parents are still nervous about routine shots. To help clinicians facilitate conversations about vaccination, Denver Health trains providers in communication techniques using motivational interviewing (MI), a collaborative goal-oriented approach that encourages changes in health behaviors.

Dr. Shlay, who stressed the value of persistence, advised, “Through motivational interviewing, discussing things, talking about it, you can actually address most of the concerns.”
 

Giving parents a boost in the right direction

That spirit drives the work of Boost Oregon, a parent-led nonprofit organization founded in 2015 that helps parents make science-based decisions for themselves and their families. Even before the pandemic, primary care providers needed better strategies for addressing parents who had concerns about vaccines and found themselves failing in the effort while trying to see 20 patients a day.

For families that have questions about vaccines, Boost Oregon holds community meetings in which parents meet with clinicians, share their concerns with other parents, and get answers to their questions in a nonjudgmental way. The 1- to 2-hour sessions enable deeper discussions of the issues than many clinicians can manage in a 20-minute patient visit.

Boost Oregon also trains providers in communication techniques using MI. Ryan Hassan, MD, a pediatrician in private practice who serves as the medical director for the organization, has made the approach an integral part of his day. A key realization for him about the use of MI is that if providers want to build trust with parents, they need to accept that their role is not simply to educate but also to listen.

“Even if it’s the wildest conspiracy theory I’ve ever heard, that is my opportunity to show them that I’m listening and to empathize,” Dr. Hassan said.

His next step, a central tenet of MI, is to make reflective statements that summarize the parent’s concerns, demonstrate empathy, and help him get to the heart of their concerns. He then tailors his message to their issues.

Dr. Hassan tells people who are learning the technique to acknowledge that patients have the autonomy to make their own decisions. Coercing them into a decision is unhelpful and potentially counterproductive. “You can’t change anyone else’s mind,” he said. “You have to help them change their own mind.”

Dr. Limaye reinforced that message. Overwhelmed by conflicting messages on the internet, people are just trying to find answers. She trains providers not to dismiss patients’ concerns, because dismissal erodes trust.

“When you’re dealing with misinformation and conspiracy, to me, one thing to keep in mind is that it’s the long game,” Dr. Limaye said, “You’re not going to be able to sway them in one conversation.”

Can the powers of social media be harnessed for pro-vaccine messaging? Dr. Limaye has studied social media strategies to promote vaccine acceptance and has identified several elements that can be useful for swaying opinions about vaccine.

One is the messenger – as people trust their physicians less, “it’s important to find influencers that people might trust to actually spread a message,” she said. Another factor is that as society has become more polarized, interaction with the leadership of groups that hold influence has become key. To promote vaccine acceptance, for example, leaders of moms’ groups on Facebook could be equipped with evidence-based information.

“It’s important for us to reach out and engage with those that are leaders in those groups, because they kind of hold the power,” Dr. Limaye said.

Framing the message is critical. Dr. Limaye has found that personal narratives can be persuasive and that to influence vaccine behavior, it is necessary to tailor the approach to the specific audience. Danish researchers, for example, in 2017 launched a campaign to increase uptake of HPV vaccinations among teenagers. The researchers provided facts about the safety and effectiveness of the vaccine, cited posts by clinicians about the importance of immunization against the virus, and relayed personal stories, such as one about a father who chose to vaccinate his daughter and another about a blogger’s encounter with a woman with cervical cancer. The researchers found that the highest engagement rates were achieved through personal content and that such content generated the highest proportion of positive comments.

According to Dr. Limaye, to change behavior, social media messaging must address the issues of risk perception and self-efficacy. For risk perception regarding vaccines, a successful message needs to address the parents’ questions about whether their child is at risk for catching a disease, such as measles or pertussis, and if they are, whether the child will wind up in the hospital.

Self-efficacy is the belief that one can accomplish a task. An effective message would provide information on where to find free or low-cost vaccines and would identify locations that are easy to reach and that have expanded hours for working parents, Dr. Limaye said.

What’s the best approach for boosting vaccination rates in the post-pandemic era? In the 1850s, Massachusetts enacted the first vaccine mandate in the United States to prevent smallpox, and by the 1900s, similar laws had been passed in almost half of states. But recent polls suggest that support for vaccine mandates is dwindling. In a poll by the Kaiser Family Foundation last fall, 71% of adults said that healthy children should be required to be vaccinated against measles before entering school, which was down from 82% in a similar poll in 2019.

So perhaps a better approach for promoting vaccine confidence in the 21st century would involve wider use of MI by clinicians and more focus by public health agencies taking advantage of the potential power of social media. As Dr. Offit put it, “I think trust is the key thing.”

Dr. Offit, Dr. Limaye, Dr. Shlay, and Dr. Hassan report no relevant financial relationships.

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

When people ask Paul Offit, MD, what worries him the most about the COVID-19 pandemic, he names two concerns. “One is the lack of socialization and education that came from keeping kids out of school for so long,” Dr. Offit said in a recent interview. “And I think vaccines have suffered.”

Dr. Offit is director of the Vaccine Education Center and a professor of pediatrics at Children’s Hospital of Philadelphia. He has watched with alarm as the American public appears to be losing faith in the lifesaving vaccines the public health community has worked hard to promote. The Centers for Disease Control and Prevention estimates that the proportion of kids entering kindergarten who have received state-required vaccines dipped to 94% in the 2020-2021 school year – a full point less than the year before the pandemic – then dropped by another percentage point, to 93%, the following year.

Although a couple of percentage points may sound trivial, were only 93% of kindergarteners to receive the vaccine against measles, mumps, and rubella (MMR), approximately 250,000 vulnerable 5-year-olds could spark the next big outbreak, such as the recent measles outbreaks in Ohio and Minnesota.

Dr. Offit is one of many public health officials and clinicians who are working to reverse the concerning trends in pediatric vaccinations. Their efforts combine conventional approaches, such as community outreach, with newer strategies, including using social media and even lending a sympathetic ear to parents voicing anti-science imaginings.

“I just don’t want to see an outbreak of something that we could have avoided because we were not protected enough,” Judith Shlay, MD, associate director of the Public Health Institute at Denver Health, said.
 

Official stumbles in part to blame

Disruptions in health care from the COVID-19 pandemic certainly played a role in the decline. Parents were afraid to expose their children to other sick kids, providers shifted to a telehealth model, and routine preventive care was difficult to access.

But Dr. Offit also blamed erosion of trust on mistakes made by government and public health institutions for the alarming trend. “I think that health care professionals have lost some level of trust in the Food and Drug Administration and CDC.”

He cited as an example poor messaging during a large outbreak in Massachusetts in summer 2021, when the CDC published a report that highlighted the high proportion of COVID-19 cases among vaccinated people. Health officials called those cases “breakthrough” infections, although most were mild or asymptomatic.

Dr. Offit said the CDC should have focused the message instead on the low rate (1%) of hospitalizations and the low number of deaths from the infections. Instead, they had to walk back their promise that vaccinated people didn’t need to wear masks. At other times, the Biden administration pressured public health officials by promising to make booster shots available to the American public when the FDA and CDC felt they lacked evidence to recommend the injections.

Rupali Limaye, PhD, an associate professor of international health at the Bloomberg School of Public Health at Johns Hopkins University, Baltimore, studies vaccine behavior and decision-making. She would go a step further in characterizing the roots of worsening vaccine hesitancy.

“In the last 20 years, we’ve seen there’s less and less trust in health care providers in general,” Dr. Limaye said. “More people are turning to their social networks or social contacts for that kind of information.” In the maelstrom of the COVID-19 pandemic, digital social networks facilitated the spread of misinformation about COVID-19 faster than scientists could unravel the mysteries of the disease.

“There’s always been this underlying hesitancy for some people about vaccines,” Dr. Shlay said. But she has noticed more resistance to the COVID-19 vaccine from parents nervous about the new mRNA technology. “There was a lot of politicization of the vaccine, even though the mRNA vaccine technology has been around for a long time,” she said.
 

Multipronged approaches

Dr. Shlay is committed to restoring childhood vaccination uptake to prepandemic levels now that clinics are open again. To do so, she is relying on a combination of quality improvement strategies and outreach to undervaccinated populations.

Denver Health, for instance, offers vaccinations at any inpatient or outpatient visit – not just well-child visits – with the help of alerts built into their electronic health records that notify clinicians if a patient is due for a vaccine.

COVID-19 revealed marked health inequities in underserved communities as Black, Hispanic, and people from other minority communities experienced higher rates of COVID-19 cases and deaths, compared with White people. The Public Health Institute, which is part of Denver Health, has responded with vaccine outreach teams that go to schools, shelters, churches, and community-based organizations to vaccinate children. They focus their efforts on areas where immunization rates are low. Health centers in schools throughout Colorado vaccinate students, and the Public Health Institute partners with Denver-area public schools to provide vaccines to students in schools that don’t have such centers. (They also provide dental care and behavioral health services.)

But it is unlikely that restoring clinic operations and making vaccines more accessible will fill the gap. After 3 years of fear and mistrust, parents are still nervous about routine shots. To help clinicians facilitate conversations about vaccination, Denver Health trains providers in communication techniques using motivational interviewing (MI), a collaborative goal-oriented approach that encourages changes in health behaviors.

Dr. Shlay, who stressed the value of persistence, advised, “Through motivational interviewing, discussing things, talking about it, you can actually address most of the concerns.”
 

Giving parents a boost in the right direction

That spirit drives the work of Boost Oregon, a parent-led nonprofit organization founded in 2015 that helps parents make science-based decisions for themselves and their families. Even before the pandemic, primary care providers needed better strategies for addressing parents who had concerns about vaccines and found themselves failing in the effort while trying to see 20 patients a day.

For families that have questions about vaccines, Boost Oregon holds community meetings in which parents meet with clinicians, share their concerns with other parents, and get answers to their questions in a nonjudgmental way. The 1- to 2-hour sessions enable deeper discussions of the issues than many clinicians can manage in a 20-minute patient visit.

Boost Oregon also trains providers in communication techniques using MI. Ryan Hassan, MD, a pediatrician in private practice who serves as the medical director for the organization, has made the approach an integral part of his day. A key realization for him about the use of MI is that if providers want to build trust with parents, they need to accept that their role is not simply to educate but also to listen.

“Even if it’s the wildest conspiracy theory I’ve ever heard, that is my opportunity to show them that I’m listening and to empathize,” Dr. Hassan said.

His next step, a central tenet of MI, is to make reflective statements that summarize the parent’s concerns, demonstrate empathy, and help him get to the heart of their concerns. He then tailors his message to their issues.

Dr. Hassan tells people who are learning the technique to acknowledge that patients have the autonomy to make their own decisions. Coercing them into a decision is unhelpful and potentially counterproductive. “You can’t change anyone else’s mind,” he said. “You have to help them change their own mind.”

Dr. Limaye reinforced that message. Overwhelmed by conflicting messages on the internet, people are just trying to find answers. She trains providers not to dismiss patients’ concerns, because dismissal erodes trust.

“When you’re dealing with misinformation and conspiracy, to me, one thing to keep in mind is that it’s the long game,” Dr. Limaye said, “You’re not going to be able to sway them in one conversation.”

Can the powers of social media be harnessed for pro-vaccine messaging? Dr. Limaye has studied social media strategies to promote vaccine acceptance and has identified several elements that can be useful for swaying opinions about vaccine.

One is the messenger – as people trust their physicians less, “it’s important to find influencers that people might trust to actually spread a message,” she said. Another factor is that as society has become more polarized, interaction with the leadership of groups that hold influence has become key. To promote vaccine acceptance, for example, leaders of moms’ groups on Facebook could be equipped with evidence-based information.

“It’s important for us to reach out and engage with those that are leaders in those groups, because they kind of hold the power,” Dr. Limaye said.

Framing the message is critical. Dr. Limaye has found that personal narratives can be persuasive and that to influence vaccine behavior, it is necessary to tailor the approach to the specific audience. Danish researchers, for example, in 2017 launched a campaign to increase uptake of HPV vaccinations among teenagers. The researchers provided facts about the safety and effectiveness of the vaccine, cited posts by clinicians about the importance of immunization against the virus, and relayed personal stories, such as one about a father who chose to vaccinate his daughter and another about a blogger’s encounter with a woman with cervical cancer. The researchers found that the highest engagement rates were achieved through personal content and that such content generated the highest proportion of positive comments.

According to Dr. Limaye, to change behavior, social media messaging must address the issues of risk perception and self-efficacy. For risk perception regarding vaccines, a successful message needs to address the parents’ questions about whether their child is at risk for catching a disease, such as measles or pertussis, and if they are, whether the child will wind up in the hospital.

Self-efficacy is the belief that one can accomplish a task. An effective message would provide information on where to find free or low-cost vaccines and would identify locations that are easy to reach and that have expanded hours for working parents, Dr. Limaye said.

What’s the best approach for boosting vaccination rates in the post-pandemic era? In the 1850s, Massachusetts enacted the first vaccine mandate in the United States to prevent smallpox, and by the 1900s, similar laws had been passed in almost half of states. But recent polls suggest that support for vaccine mandates is dwindling. In a poll by the Kaiser Family Foundation last fall, 71% of adults said that healthy children should be required to be vaccinated against measles before entering school, which was down from 82% in a similar poll in 2019.

So perhaps a better approach for promoting vaccine confidence in the 21st century would involve wider use of MI by clinicians and more focus by public health agencies taking advantage of the potential power of social media. As Dr. Offit put it, “I think trust is the key thing.”

Dr. Offit, Dr. Limaye, Dr. Shlay, and Dr. Hassan report no relevant financial relationships.

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

When people ask Paul Offit, MD, what worries him the most about the COVID-19 pandemic, he names two concerns. “One is the lack of socialization and education that came from keeping kids out of school for so long,” Dr. Offit said in a recent interview. “And I think vaccines have suffered.”

Dr. Offit is director of the Vaccine Education Center and a professor of pediatrics at Children’s Hospital of Philadelphia. He has watched with alarm as the American public appears to be losing faith in the lifesaving vaccines the public health community has worked hard to promote. The Centers for Disease Control and Prevention estimates that the proportion of kids entering kindergarten who have received state-required vaccines dipped to 94% in the 2020-2021 school year – a full point less than the year before the pandemic – then dropped by another percentage point, to 93%, the following year.

Although a couple of percentage points may sound trivial, were only 93% of kindergarteners to receive the vaccine against measles, mumps, and rubella (MMR), approximately 250,000 vulnerable 5-year-olds could spark the next big outbreak, such as the recent measles outbreaks in Ohio and Minnesota.

Dr. Offit is one of many public health officials and clinicians who are working to reverse the concerning trends in pediatric vaccinations. Their efforts combine conventional approaches, such as community outreach, with newer strategies, including using social media and even lending a sympathetic ear to parents voicing anti-science imaginings.

“I just don’t want to see an outbreak of something that we could have avoided because we were not protected enough,” Judith Shlay, MD, associate director of the Public Health Institute at Denver Health, said.
 

Official stumbles in part to blame

Disruptions in health care from the COVID-19 pandemic certainly played a role in the decline. Parents were afraid to expose their children to other sick kids, providers shifted to a telehealth model, and routine preventive care was difficult to access.

But Dr. Offit also blamed erosion of trust on mistakes made by government and public health institutions for the alarming trend. “I think that health care professionals have lost some level of trust in the Food and Drug Administration and CDC.”

He cited as an example poor messaging during a large outbreak in Massachusetts in summer 2021, when the CDC published a report that highlighted the high proportion of COVID-19 cases among vaccinated people. Health officials called those cases “breakthrough” infections, although most were mild or asymptomatic.

Dr. Offit said the CDC should have focused the message instead on the low rate (1%) of hospitalizations and the low number of deaths from the infections. Instead, they had to walk back their promise that vaccinated people didn’t need to wear masks. At other times, the Biden administration pressured public health officials by promising to make booster shots available to the American public when the FDA and CDC felt they lacked evidence to recommend the injections.

Rupali Limaye, PhD, an associate professor of international health at the Bloomberg School of Public Health at Johns Hopkins University, Baltimore, studies vaccine behavior and decision-making. She would go a step further in characterizing the roots of worsening vaccine hesitancy.

“In the last 20 years, we’ve seen there’s less and less trust in health care providers in general,” Dr. Limaye said. “More people are turning to their social networks or social contacts for that kind of information.” In the maelstrom of the COVID-19 pandemic, digital social networks facilitated the spread of misinformation about COVID-19 faster than scientists could unravel the mysteries of the disease.

“There’s always been this underlying hesitancy for some people about vaccines,” Dr. Shlay said. But she has noticed more resistance to the COVID-19 vaccine from parents nervous about the new mRNA technology. “There was a lot of politicization of the vaccine, even though the mRNA vaccine technology has been around for a long time,” she said.
 

Multipronged approaches

Dr. Shlay is committed to restoring childhood vaccination uptake to prepandemic levels now that clinics are open again. To do so, she is relying on a combination of quality improvement strategies and outreach to undervaccinated populations.

Denver Health, for instance, offers vaccinations at any inpatient or outpatient visit – not just well-child visits – with the help of alerts built into their electronic health records that notify clinicians if a patient is due for a vaccine.

COVID-19 revealed marked health inequities in underserved communities as Black, Hispanic, and people from other minority communities experienced higher rates of COVID-19 cases and deaths, compared with White people. The Public Health Institute, which is part of Denver Health, has responded with vaccine outreach teams that go to schools, shelters, churches, and community-based organizations to vaccinate children. They focus their efforts on areas where immunization rates are low. Health centers in schools throughout Colorado vaccinate students, and the Public Health Institute partners with Denver-area public schools to provide vaccines to students in schools that don’t have such centers. (They also provide dental care and behavioral health services.)

But it is unlikely that restoring clinic operations and making vaccines more accessible will fill the gap. After 3 years of fear and mistrust, parents are still nervous about routine shots. To help clinicians facilitate conversations about vaccination, Denver Health trains providers in communication techniques using motivational interviewing (MI), a collaborative goal-oriented approach that encourages changes in health behaviors.

Dr. Shlay, who stressed the value of persistence, advised, “Through motivational interviewing, discussing things, talking about it, you can actually address most of the concerns.”
 

Giving parents a boost in the right direction

That spirit drives the work of Boost Oregon, a parent-led nonprofit organization founded in 2015 that helps parents make science-based decisions for themselves and their families. Even before the pandemic, primary care providers needed better strategies for addressing parents who had concerns about vaccines and found themselves failing in the effort while trying to see 20 patients a day.

For families that have questions about vaccines, Boost Oregon holds community meetings in which parents meet with clinicians, share their concerns with other parents, and get answers to their questions in a nonjudgmental way. The 1- to 2-hour sessions enable deeper discussions of the issues than many clinicians can manage in a 20-minute patient visit.

Boost Oregon also trains providers in communication techniques using MI. Ryan Hassan, MD, a pediatrician in private practice who serves as the medical director for the organization, has made the approach an integral part of his day. A key realization for him about the use of MI is that if providers want to build trust with parents, they need to accept that their role is not simply to educate but also to listen.

“Even if it’s the wildest conspiracy theory I’ve ever heard, that is my opportunity to show them that I’m listening and to empathize,” Dr. Hassan said.

His next step, a central tenet of MI, is to make reflective statements that summarize the parent’s concerns, demonstrate empathy, and help him get to the heart of their concerns. He then tailors his message to their issues.

Dr. Hassan tells people who are learning the technique to acknowledge that patients have the autonomy to make their own decisions. Coercing them into a decision is unhelpful and potentially counterproductive. “You can’t change anyone else’s mind,” he said. “You have to help them change their own mind.”

Dr. Limaye reinforced that message. Overwhelmed by conflicting messages on the internet, people are just trying to find answers. She trains providers not to dismiss patients’ concerns, because dismissal erodes trust.

“When you’re dealing with misinformation and conspiracy, to me, one thing to keep in mind is that it’s the long game,” Dr. Limaye said, “You’re not going to be able to sway them in one conversation.”

Can the powers of social media be harnessed for pro-vaccine messaging? Dr. Limaye has studied social media strategies to promote vaccine acceptance and has identified several elements that can be useful for swaying opinions about vaccine.

One is the messenger – as people trust their physicians less, “it’s important to find influencers that people might trust to actually spread a message,” she said. Another factor is that as society has become more polarized, interaction with the leadership of groups that hold influence has become key. To promote vaccine acceptance, for example, leaders of moms’ groups on Facebook could be equipped with evidence-based information.

“It’s important for us to reach out and engage with those that are leaders in those groups, because they kind of hold the power,” Dr. Limaye said.

Framing the message is critical. Dr. Limaye has found that personal narratives can be persuasive and that to influence vaccine behavior, it is necessary to tailor the approach to the specific audience. Danish researchers, for example, in 2017 launched a campaign to increase uptake of HPV vaccinations among teenagers. The researchers provided facts about the safety and effectiveness of the vaccine, cited posts by clinicians about the importance of immunization against the virus, and relayed personal stories, such as one about a father who chose to vaccinate his daughter and another about a blogger’s encounter with a woman with cervical cancer. The researchers found that the highest engagement rates were achieved through personal content and that such content generated the highest proportion of positive comments.

According to Dr. Limaye, to change behavior, social media messaging must address the issues of risk perception and self-efficacy. For risk perception regarding vaccines, a successful message needs to address the parents’ questions about whether their child is at risk for catching a disease, such as measles or pertussis, and if they are, whether the child will wind up in the hospital.

Self-efficacy is the belief that one can accomplish a task. An effective message would provide information on where to find free or low-cost vaccines and would identify locations that are easy to reach and that have expanded hours for working parents, Dr. Limaye said.

What’s the best approach for boosting vaccination rates in the post-pandemic era? In the 1850s, Massachusetts enacted the first vaccine mandate in the United States to prevent smallpox, and by the 1900s, similar laws had been passed in almost half of states. But recent polls suggest that support for vaccine mandates is dwindling. In a poll by the Kaiser Family Foundation last fall, 71% of adults said that healthy children should be required to be vaccinated against measles before entering school, which was down from 82% in a similar poll in 2019.

So perhaps a better approach for promoting vaccine confidence in the 21st century would involve wider use of MI by clinicians and more focus by public health agencies taking advantage of the potential power of social media. As Dr. Offit put it, “I think trust is the key thing.”

Dr. Offit, Dr. Limaye, Dr. Shlay, and Dr. Hassan report no relevant financial relationships.

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.

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.