Proposed changes to federal mammography regulations aim to provide more information for doctors and patients, as well as standardize patient information on breast density’s impact on screening.

The Food and Drug Administration posted a new proposed rule online March 27 that would “expand the information mammography facilities must provide to patients and health care professionals, allowing for more informed medical decision making,” the agency said in a statement. “It would also modernize mammography quality standards and better position the FDA to enforce regulations that apply to the safety and quality of mammography services.”

Key among the proposed changes is the addition of breast density information to the summary letter provided to patients and to the medical report provided to referring health care professionals.

“The FDA is proposing specific language that would explain how breast density can influence the accuracy of mammography and would recommend patients with dense breasts talk to their health care provider about high breast density and how it relates to breast cancer risk and their individual situation,” the agency said in a statement.

Laurie Margolies, MD, section chief of breast imaging at Mount Sinai Health System in New York, said the regulations would bring some uniformity to the communication process.

“It builds on the experience of the 37 states and the District of Columbia, all of whom have passed dense breast notification laws, and can serve to unify those disparate regulations into one that would be uniform throughout the country to give one clear message to women and health care providers,” Dr. Margolies said in an interview.

She noted that dense breasts are very common and communicating issues that are related to them, including the potential need for supplemental screening, are important.

“Almost half of American women have dense breasts and why that is significant is because the dense breast issue not only increases one’s risk of getting breast cancer, but it also can hide small breast cancers on the mammogram,” she said.

If you take 1,000 women with dense breasts and then do a breast ultrasound as a supplemental screening measure, “you will find three more small node-negative breast cancers that would not have come to light if you didn’t do the extra supplemental screening,” underscoring the importance of communicating dense breast information, she continued.

FDA also is seeking to enhance information provided to health care professionals by codifying three additional categories for mammogram assessments, including the addition of the “known biopsy proven malignancy” category, which the agency says would help identify which scans were being used to evaluate treatment of already diagnosed cancers.

Both patients and health care professionals would receive more detailed information about the mammography facility under the proposed rule.

FDA is proposing modernization of quality standards to help the agency enforce regulations, including giving the agency the authority to notify patients and health care professionals directly if a mammography facility does not meet quality standards and that a reevaluation or repeat of the exam at a different facility may be needed. The proposed amendments also include requiring that only digital accessory components specifically FDA approved or cleared for mammography be used or that facilities use components that otherwise meet the requirements, and stronger record-keeping requirements.

Dr. Margolies did note one potential deficiency in the proposed rule – the lack of any information on health insurance coverage of supplemental screening for women with dense breasts, though she noted this may not fall under the FDA’s authority.

“It would do the most good if everybody could get the supplemental screening without regards to their ability to pay for it out of pocket,” she said.

The proposal amends regulations issued under the Mammography Quality Standards Act of 1992, which gives FDA oversight authority over mammography facilities, including accreditation, certification, annual inspection, and enforcement of standards.

Comments on the proposal are due 90 days after the proposed rule is published in the Federal Register, which is scheduled for March 28.

gtwachtman@mdedge.com

Proposed changes to federal mammography regulations aim to provide more information for doctors and patients, as well as standardize patient information on breast density’s impact on screening.

The Food and Drug Administration posted a new proposed rule online March 27 that would “expand the information mammography facilities must provide to patients and health care professionals, allowing for more informed medical decision making,” the agency said in a statement. “It would also modernize mammography quality standards and better position the FDA to enforce regulations that apply to the safety and quality of mammography services.”

Key among the proposed changes is the addition of breast density information to the summary letter provided to patients and to the medical report provided to referring health care professionals.

“The FDA is proposing specific language that would explain how breast density can influence the accuracy of mammography and would recommend patients with dense breasts talk to their health care provider about high breast density and how it relates to breast cancer risk and their individual situation,” the agency said in a statement.

Laurie Margolies, MD, section chief of breast imaging at Mount Sinai Health System in New York, said the regulations would bring some uniformity to the communication process.

“It builds on the experience of the 37 states and the District of Columbia, all of whom have passed dense breast notification laws, and can serve to unify those disparate regulations into one that would be uniform throughout the country to give one clear message to women and health care providers,” Dr. Margolies said in an interview.

She noted that dense breasts are very common and communicating issues that are related to them, including the potential need for supplemental screening, are important.

“Almost half of American women have dense breasts and why that is significant is because the dense breast issue not only increases one’s risk of getting breast cancer, but it also can hide small breast cancers on the mammogram,” she said.

If you take 1,000 women with dense breasts and then do a breast ultrasound as a supplemental screening measure, “you will find three more small node-negative breast cancers that would not have come to light if you didn’t do the extra supplemental screening,” underscoring the importance of communicating dense breast information, she continued.

FDA also is seeking to enhance information provided to health care professionals by codifying three additional categories for mammogram assessments, including the addition of the “known biopsy proven malignancy” category, which the agency says would help identify which scans were being used to evaluate treatment of already diagnosed cancers.

Both patients and health care professionals would receive more detailed information about the mammography facility under the proposed rule.

FDA is proposing modernization of quality standards to help the agency enforce regulations, including giving the agency the authority to notify patients and health care professionals directly if a mammography facility does not meet quality standards and that a reevaluation or repeat of the exam at a different facility may be needed. The proposed amendments also include requiring that only digital accessory components specifically FDA approved or cleared for mammography be used or that facilities use components that otherwise meet the requirements, and stronger record-keeping requirements.

Dr. Margolies did note one potential deficiency in the proposed rule – the lack of any information on health insurance coverage of supplemental screening for women with dense breasts, though she noted this may not fall under the FDA’s authority.

“It would do the most good if everybody could get the supplemental screening without regards to their ability to pay for it out of pocket,” she said.

The proposal amends regulations issued under the Mammography Quality Standards Act of 1992, which gives FDA oversight authority over mammography facilities, including accreditation, certification, annual inspection, and enforcement of standards.

Comments on the proposal are due 90 days after the proposed rule is published in the Federal Register, which is scheduled for March 28.

gtwachtman@mdedge.com

Proposed changes to federal mammography regulations aim to provide more information for doctors and patients, as well as standardize patient information on breast density’s impact on screening.

The Food and Drug Administration posted a new proposed rule online March 27 that would “expand the information mammography facilities must provide to patients and health care professionals, allowing for more informed medical decision making,” the agency said in a statement. “It would also modernize mammography quality standards and better position the FDA to enforce regulations that apply to the safety and quality of mammography services.”

Key among the proposed changes is the addition of breast density information to the summary letter provided to patients and to the medical report provided to referring health care professionals.

“The FDA is proposing specific language that would explain how breast density can influence the accuracy of mammography and would recommend patients with dense breasts talk to their health care provider about high breast density and how it relates to breast cancer risk and their individual situation,” the agency said in a statement.

Laurie Margolies, MD, section chief of breast imaging at Mount Sinai Health System in New York, said the regulations would bring some uniformity to the communication process.

“It builds on the experience of the 37 states and the District of Columbia, all of whom have passed dense breast notification laws, and can serve to unify those disparate regulations into one that would be uniform throughout the country to give one clear message to women and health care providers,” Dr. Margolies said in an interview.

She noted that dense breasts are very common and communicating issues that are related to them, including the potential need for supplemental screening, are important.

“Almost half of American women have dense breasts and why that is significant is because the dense breast issue not only increases one’s risk of getting breast cancer, but it also can hide small breast cancers on the mammogram,” she said.

If you take 1,000 women with dense breasts and then do a breast ultrasound as a supplemental screening measure, “you will find three more small node-negative breast cancers that would not have come to light if you didn’t do the extra supplemental screening,” underscoring the importance of communicating dense breast information, she continued.

FDA also is seeking to enhance information provided to health care professionals by codifying three additional categories for mammogram assessments, including the addition of the “known biopsy proven malignancy” category, which the agency says would help identify which scans were being used to evaluate treatment of already diagnosed cancers.

Both patients and health care professionals would receive more detailed information about the mammography facility under the proposed rule.

FDA is proposing modernization of quality standards to help the agency enforce regulations, including giving the agency the authority to notify patients and health care professionals directly if a mammography facility does not meet quality standards and that a reevaluation or repeat of the exam at a different facility may be needed. The proposed amendments also include requiring that only digital accessory components specifically FDA approved or cleared for mammography be used or that facilities use components that otherwise meet the requirements, and stronger record-keeping requirements.

Dr. Margolies did note one potential deficiency in the proposed rule – the lack of any information on health insurance coverage of supplemental screening for women with dense breasts, though she noted this may not fall under the FDA’s authority.

“It would do the most good if everybody could get the supplemental screening without regards to their ability to pay for it out of pocket,” she said.

The proposal amends regulations issued under the Mammography Quality Standards Act of 1992, which gives FDA oversight authority over mammography facilities, including accreditation, certification, annual inspection, and enforcement of standards.

Comments on the proposal are due 90 days after the proposed rule is published in the Federal Register, which is scheduled for March 28.

gtwachtman@mdedge.com

This year’s race for “best state to practice medicine” came down to the proverbial photo finish, with Montana edging out Wisconsin by 0.02 points, according to personal finance website WalletHub.

Montana had a total score of 69.15 out of 100 in the ranking of the best and worst states for doctors for 2019, with Wisconsin coming in at 69.13. The small degree of separation didn’t stop there, though, as third-place Idaho (68.55) and fourth-place Minnesota (68.32) both finished within a single point of the top, with Iowa a bit further behind at 67.58, WalletHub reported. In last year’s ranking, South Dakota won by more than 5 points over Nebraska, and in 2017 Iowa finished more than 2 points ahead of Minnesota.

The lowest-ranked state in 2019 was New York, with a score of 34.01 that was well below the 41.55 earned by 50th-place Washington, D.C. The rest of the bottom five was occupied by Rhode Island, New Jersey, and Connecticut, WalletHub said. New Jersey was the worst state in which to practice medicine in 2018, and New York finished last in 2017.

The rankings are based on 18 metrics across two broad categories: “opportunity and competition” (11 metrics worth 70 points) and “medical environment” (7 metrics worth 30 points). One metric in the opportunity and competition category, physicians’ average annual wage (adjusted for cost of living), was given double weight; other metrics included employer-based insurance rate, projected share of elderly population, punitiveness of state medical board, and malpractice award payout amount per capita.

Montana posted top-five scores in such areas as average physician monthly starting salary, share of medical residents retained, and presence of nationally accredited health departments. New York took big hits with bottom-five scores in adjusted average annual wage, projected competition, and annual cost of malpractice insurance, according to WalletHub.

rfranki@mdedge.com

This year’s race for “best state to practice medicine” came down to the proverbial photo finish, with Montana edging out Wisconsin by 0.02 points, according to personal finance website WalletHub.

Montana had a total score of 69.15 out of 100 in the ranking of the best and worst states for doctors for 2019, with Wisconsin coming in at 69.13. The small degree of separation didn’t stop there, though, as third-place Idaho (68.55) and fourth-place Minnesota (68.32) both finished within a single point of the top, with Iowa a bit further behind at 67.58, WalletHub reported. In last year’s ranking, South Dakota won by more than 5 points over Nebraska, and in 2017 Iowa finished more than 2 points ahead of Minnesota.

The lowest-ranked state in 2019 was New York, with a score of 34.01 that was well below the 41.55 earned by 50th-place Washington, D.C. The rest of the bottom five was occupied by Rhode Island, New Jersey, and Connecticut, WalletHub said. New Jersey was the worst state in which to practice medicine in 2018, and New York finished last in 2017.

The rankings are based on 18 metrics across two broad categories: “opportunity and competition” (11 metrics worth 70 points) and “medical environment” (7 metrics worth 30 points). One metric in the opportunity and competition category, physicians’ average annual wage (adjusted for cost of living), was given double weight; other metrics included employer-based insurance rate, projected share of elderly population, punitiveness of state medical board, and malpractice award payout amount per capita.

Montana posted top-five scores in such areas as average physician monthly starting salary, share of medical residents retained, and presence of nationally accredited health departments. New York took big hits with bottom-five scores in adjusted average annual wage, projected competition, and annual cost of malpractice insurance, according to WalletHub.

rfranki@mdedge.com

This year’s race for “best state to practice medicine” came down to the proverbial photo finish, with Montana edging out Wisconsin by 0.02 points, according to personal finance website WalletHub.

Montana had a total score of 69.15 out of 100 in the ranking of the best and worst states for doctors for 2019, with Wisconsin coming in at 69.13. The small degree of separation didn’t stop there, though, as third-place Idaho (68.55) and fourth-place Minnesota (68.32) both finished within a single point of the top, with Iowa a bit further behind at 67.58, WalletHub reported. In last year’s ranking, South Dakota won by more than 5 points over Nebraska, and in 2017 Iowa finished more than 2 points ahead of Minnesota.

The lowest-ranked state in 2019 was New York, with a score of 34.01 that was well below the 41.55 earned by 50th-place Washington, D.C. The rest of the bottom five was occupied by Rhode Island, New Jersey, and Connecticut, WalletHub said. New Jersey was the worst state in which to practice medicine in 2018, and New York finished last in 2017.

The rankings are based on 18 metrics across two broad categories: “opportunity and competition” (11 metrics worth 70 points) and “medical environment” (7 metrics worth 30 points). One metric in the opportunity and competition category, physicians’ average annual wage (adjusted for cost of living), was given double weight; other metrics included employer-based insurance rate, projected share of elderly population, punitiveness of state medical board, and malpractice award payout amount per capita.

Montana posted top-five scores in such areas as average physician monthly starting salary, share of medical residents retained, and presence of nationally accredited health departments. New York took big hits with bottom-five scores in adjusted average annual wage, projected competition, and annual cost of malpractice insurance, according to WalletHub.

rfranki@mdedge.com

SEATTLE – Once HIV positive men who have sex with men contract the hepatitis C virus, they are more likely to get it again, according a study of 305 men in New York.

Wikimedia Commons/BruceBlaus

Overall, 38 men (12%) picked up another HCV infection a median of 1.9 years after clearance of their first, yielding a reinfection rate was 4.4/100 person-years, “a solid seven times higher than the primary infection rate” among HIV-positive men who have sex with men (MSM), said senior investigator Daniel Fierer, MD, an associate professor of infectious diseases at Mount Sinai Hospital, New York.

Thirty-three men cleared their second infection. Of those, six picked up a third infection at a median of 1.1 years, yielding an overall third infection incidence of 8.7/100 person-years.

The results held no matter how the men cleared HCV, whether spontaneously, as in about 10%, or by interferon before 2013, and direct-acting antivirals (DAAs) after.

Most reinfections occurred within 2 years of initial clearance, but some occurred more than a decade later.

The results suggest that there’s a particular need for HCV prevention efforts among men who have previously cleared the infection. For those patients, testing for HCV at an annual HIV checkup might not be frequent enough, Dr. Fierer said at the Conference on Retroviruses and Opportunistic Infections.

“Long-term surveillance is warranted for all HIV-infected MSM after clearance of HCV infection. Further, strategies to reduce HCV reinfections are needed to meet the goal of eliminating HCV in these men,” he said.

Also, “the large difference between primary” and secondary infection “rates suggests HCV risk is not distributed evenly between HIV-infected MSM, but concentrated among a small subpopulation. By definition, this subpopulation would have a higher prevalence” of risky behavior, such as condomless receptive anal sex and sexualized injection methamphetamine use, he said.

The high reinfection rate “tells us basically that we have not done a good job of” preventing infection and reinfection among at risk, HIV-positive men. There’s an “inadequate level of HCV treatment ... we need to eliminate restrictions on DAA” access, Dr. Fierer said.

As far as prevention goes, “I believe we just don’t know what to do. I tell all of my patients about the body fluids that have HCV in them,” which is a good start, he said.

The median age at first clearance was about 45 years, 82% of the men were white, and there was about a 50-50 split between people with private and public insurance.

The work was funded by Gilead. Dr. Fierer did not mention any disclosures.

aotto@mdedge.com

SOURCE: Carollo JR et al. CROI 2019, Abstract 86

SEATTLE – Once HIV positive men who have sex with men contract the hepatitis C virus, they are more likely to get it again, according a study of 305 men in New York.

Wikimedia Commons/BruceBlaus

Overall, 38 men (12%) picked up another HCV infection a median of 1.9 years after clearance of their first, yielding a reinfection rate was 4.4/100 person-years, “a solid seven times higher than the primary infection rate” among HIV-positive men who have sex with men (MSM), said senior investigator Daniel Fierer, MD, an associate professor of infectious diseases at Mount Sinai Hospital, New York.

Thirty-three men cleared their second infection. Of those, six picked up a third infection at a median of 1.1 years, yielding an overall third infection incidence of 8.7/100 person-years.

The results held no matter how the men cleared HCV, whether spontaneously, as in about 10%, or by interferon before 2013, and direct-acting antivirals (DAAs) after.

Most reinfections occurred within 2 years of initial clearance, but some occurred more than a decade later.

The results suggest that there’s a particular need for HCV prevention efforts among men who have previously cleared the infection. For those patients, testing for HCV at an annual HIV checkup might not be frequent enough, Dr. Fierer said at the Conference on Retroviruses and Opportunistic Infections.

“Long-term surveillance is warranted for all HIV-infected MSM after clearance of HCV infection. Further, strategies to reduce HCV reinfections are needed to meet the goal of eliminating HCV in these men,” he said.

Also, “the large difference between primary” and secondary infection “rates suggests HCV risk is not distributed evenly between HIV-infected MSM, but concentrated among a small subpopulation. By definition, this subpopulation would have a higher prevalence” of risky behavior, such as condomless receptive anal sex and sexualized injection methamphetamine use, he said.

The high reinfection rate “tells us basically that we have not done a good job of” preventing infection and reinfection among at risk, HIV-positive men. There’s an “inadequate level of HCV treatment ... we need to eliminate restrictions on DAA” access, Dr. Fierer said.

As far as prevention goes, “I believe we just don’t know what to do. I tell all of my patients about the body fluids that have HCV in them,” which is a good start, he said.

The median age at first clearance was about 45 years, 82% of the men were white, and there was about a 50-50 split between people with private and public insurance.

The work was funded by Gilead. Dr. Fierer did not mention any disclosures.

aotto@mdedge.com

SOURCE: Carollo JR et al. CROI 2019, Abstract 86

SEATTLE – Once HIV positive men who have sex with men contract the hepatitis C virus, they are more likely to get it again, according a study of 305 men in New York.

Wikimedia Commons/BruceBlaus

Overall, 38 men (12%) picked up another HCV infection a median of 1.9 years after clearance of their first, yielding a reinfection rate was 4.4/100 person-years, “a solid seven times higher than the primary infection rate” among HIV-positive men who have sex with men (MSM), said senior investigator Daniel Fierer, MD, an associate professor of infectious diseases at Mount Sinai Hospital, New York.

Thirty-three men cleared their second infection. Of those, six picked up a third infection at a median of 1.1 years, yielding an overall third infection incidence of 8.7/100 person-years.

The results held no matter how the men cleared HCV, whether spontaneously, as in about 10%, or by interferon before 2013, and direct-acting antivirals (DAAs) after.

Most reinfections occurred within 2 years of initial clearance, but some occurred more than a decade later.

The results suggest that there’s a particular need for HCV prevention efforts among men who have previously cleared the infection. For those patients, testing for HCV at an annual HIV checkup might not be frequent enough, Dr. Fierer said at the Conference on Retroviruses and Opportunistic Infections.

“Long-term surveillance is warranted for all HIV-infected MSM after clearance of HCV infection. Further, strategies to reduce HCV reinfections are needed to meet the goal of eliminating HCV in these men,” he said.

Also, “the large difference between primary” and secondary infection “rates suggests HCV risk is not distributed evenly between HIV-infected MSM, but concentrated among a small subpopulation. By definition, this subpopulation would have a higher prevalence” of risky behavior, such as condomless receptive anal sex and sexualized injection methamphetamine use, he said.

The high reinfection rate “tells us basically that we have not done a good job of” preventing infection and reinfection among at risk, HIV-positive men. There’s an “inadequate level of HCV treatment ... we need to eliminate restrictions on DAA” access, Dr. Fierer said.

As far as prevention goes, “I believe we just don’t know what to do. I tell all of my patients about the body fluids that have HCV in them,” which is a good start, he said.

The median age at first clearance was about 45 years, 82% of the men were white, and there was about a 50-50 split between people with private and public insurance.

The work was funded by Gilead. Dr. Fierer did not mention any disclosures.

aotto@mdedge.com

SOURCE: Carollo JR et al. CROI 2019, Abstract 86

Collaborative chronic care models (CCMs) are effective in serious mental illnesses, which has been shown in extensive randomized clinical trials. Much of their effectiveness comes from the emphasis on flexibility: They are implemented according to local needs, capabilities, and priorities. Collaborative chronic care models also provide support: for redesigned work roles that promote “anticipatory” continuous care, for self-management, and for clinical decision making at a local level.

In 2013, the VA Office of Mental Health and Suicide Prevention (OMHSP) began an initiative to enhance care coordination in general mental health clinics with mixed-diagnosis populations. It established interdisciplinary teams in each VA medical center throughout the US. Although providing centrally developed guidance, VAOMHSP gave facilities “broad latitude” to develop their team processes. In 2015, VAOMHSP adopted the CCM.

But most of the data on how well CCMs work for mental health conditions come from depression treatment in primary care—and the effects seem to be inconsistent. So researchers from Veterans Affairs Boston Healthcare System and others partnered with VAOMHSP to find out whether the CCM model would be effective in a general clinical setting.

They recruited 9 VA facilities for a 2-year study conducted in 3 waves. The implementation strategy was based on the premise that “health care is a complex adaptive system rather than a highly controlled machine.” That is, it would work best if local solutions for local challenges could be developed in accordance with evidence-based guidance. The multifaceted approach included an external facilitator who provided guidance and quality improvement expertise and an on-site internal facilitator to direct the implementation.

In the study, 5,596 veterans treated by outpatient general mental health teams were included in hospitalization analyses. A randomly selected sample of 1,050 (including 210 women) was identified for health status interviews.

The researchers found a “robust” and sustained reduction in mental health hospitalization. However, the effects on self-reported health outcomes were “limited,” the researchers say. The mental component score (the primary intervention outcome) did not change statistically significantly with implementation support in adjusted or unadjusted models, nor did other interview measures. The researchers say they saw no difference in the way veterans were treated between higher and lower implementing teams.

In post hoc analyses, though, patients with more complex problems, defined as receiving treatment for ≥ 3 mental health diagnoses in the previous year, did show statistically significant improvements in the facilitation year (by a magnitude of 0.31 SD). By contrast, those with ≤ 2 diagnoses declined nonsignificantly during the same time. The researchers note that other studies have found that CCM-based teams in patient-centered medical homes have also shown more benefit among higher morbidity patients.

Overall, the model was shown to be effectively implemented with “practical, scalable support” for clinicians. Another benefit was that teams performed better, the researchers found. They assessed team function at baseline and during the second 6 months on measures, including communication, cohesion, role clarity, and team primacy (prioritizing team over individual goals). The subscales showed high ratings for cohesion and communication at baseline, which did not change with implementation support. However, role clarity and team primacy improved significantly. The researchers conclude that under typical practice conditions CCMs can help the clinicians help the sickest patients.

Collaborative chronic care models (CCMs) are effective in serious mental illnesses, which has been shown in extensive randomized clinical trials. Much of their effectiveness comes from the emphasis on flexibility: They are implemented according to local needs, capabilities, and priorities. Collaborative chronic care models also provide support: for redesigned work roles that promote “anticipatory” continuous care, for self-management, and for clinical decision making at a local level.

In 2013, the VA Office of Mental Health and Suicide Prevention (OMHSP) began an initiative to enhance care coordination in general mental health clinics with mixed-diagnosis populations. It established interdisciplinary teams in each VA medical center throughout the US. Although providing centrally developed guidance, VAOMHSP gave facilities “broad latitude” to develop their team processes. In 2015, VAOMHSP adopted the CCM.

But most of the data on how well CCMs work for mental health conditions come from depression treatment in primary care—and the effects seem to be inconsistent. So researchers from Veterans Affairs Boston Healthcare System and others partnered with VAOMHSP to find out whether the CCM model would be effective in a general clinical setting.

They recruited 9 VA facilities for a 2-year study conducted in 3 waves. The implementation strategy was based on the premise that “health care is a complex adaptive system rather than a highly controlled machine.” That is, it would work best if local solutions for local challenges could be developed in accordance with evidence-based guidance. The multifaceted approach included an external facilitator who provided guidance and quality improvement expertise and an on-site internal facilitator to direct the implementation.

In the study, 5,596 veterans treated by outpatient general mental health teams were included in hospitalization analyses. A randomly selected sample of 1,050 (including 210 women) was identified for health status interviews.

The researchers found a “robust” and sustained reduction in mental health hospitalization. However, the effects on self-reported health outcomes were “limited,” the researchers say. The mental component score (the primary intervention outcome) did not change statistically significantly with implementation support in adjusted or unadjusted models, nor did other interview measures. The researchers say they saw no difference in the way veterans were treated between higher and lower implementing teams.

In post hoc analyses, though, patients with more complex problems, defined as receiving treatment for ≥ 3 mental health diagnoses in the previous year, did show statistically significant improvements in the facilitation year (by a magnitude of 0.31 SD). By contrast, those with ≤ 2 diagnoses declined nonsignificantly during the same time. The researchers note that other studies have found that CCM-based teams in patient-centered medical homes have also shown more benefit among higher morbidity patients.

Overall, the model was shown to be effectively implemented with “practical, scalable support” for clinicians. Another benefit was that teams performed better, the researchers found. They assessed team function at baseline and during the second 6 months on measures, including communication, cohesion, role clarity, and team primacy (prioritizing team over individual goals). The subscales showed high ratings for cohesion and communication at baseline, which did not change with implementation support. However, role clarity and team primacy improved significantly. The researchers conclude that under typical practice conditions CCMs can help the clinicians help the sickest patients.

Collaborative chronic care models (CCMs) are effective in serious mental illnesses, which has been shown in extensive randomized clinical trials. Much of their effectiveness comes from the emphasis on flexibility: They are implemented according to local needs, capabilities, and priorities. Collaborative chronic care models also provide support: for redesigned work roles that promote “anticipatory” continuous care, for self-management, and for clinical decision making at a local level.

In 2013, the VA Office of Mental Health and Suicide Prevention (OMHSP) began an initiative to enhance care coordination in general mental health clinics with mixed-diagnosis populations. It established interdisciplinary teams in each VA medical center throughout the US. Although providing centrally developed guidance, VAOMHSP gave facilities “broad latitude” to develop their team processes. In 2015, VAOMHSP adopted the CCM.

But most of the data on how well CCMs work for mental health conditions come from depression treatment in primary care—and the effects seem to be inconsistent. So researchers from Veterans Affairs Boston Healthcare System and others partnered with VAOMHSP to find out whether the CCM model would be effective in a general clinical setting.

They recruited 9 VA facilities for a 2-year study conducted in 3 waves. The implementation strategy was based on the premise that “health care is a complex adaptive system rather than a highly controlled machine.” That is, it would work best if local solutions for local challenges could be developed in accordance with evidence-based guidance. The multifaceted approach included an external facilitator who provided guidance and quality improvement expertise and an on-site internal facilitator to direct the implementation.

In the study, 5,596 veterans treated by outpatient general mental health teams were included in hospitalization analyses. A randomly selected sample of 1,050 (including 210 women) was identified for health status interviews.

The researchers found a “robust” and sustained reduction in mental health hospitalization. However, the effects on self-reported health outcomes were “limited,” the researchers say. The mental component score (the primary intervention outcome) did not change statistically significantly with implementation support in adjusted or unadjusted models, nor did other interview measures. The researchers say they saw no difference in the way veterans were treated between higher and lower implementing teams.

In post hoc analyses, though, patients with more complex problems, defined as receiving treatment for ≥ 3 mental health diagnoses in the previous year, did show statistically significant improvements in the facilitation year (by a magnitude of 0.31 SD). By contrast, those with ≤ 2 diagnoses declined nonsignificantly during the same time. The researchers note that other studies have found that CCM-based teams in patient-centered medical homes have also shown more benefit among higher morbidity patients.

Overall, the model was shown to be effectively implemented with “practical, scalable support” for clinicians. Another benefit was that teams performed better, the researchers found. They assessed team function at baseline and during the second 6 months on measures, including communication, cohesion, role clarity, and team primacy (prioritizing team over individual goals). The subscales showed high ratings for cohesion and communication at baseline, which did not change with implementation support. However, role clarity and team primacy improved significantly. The researchers conclude that under typical practice conditions CCMs can help the clinicians help the sickest patients.

DALLAS – Imaging mass cytometry is helping researchers to better understand how meningeal inflammation relates to cortical pathology in a subset of multiple sclerosis patients.

This technique for examining multiple proteins within intact tissue and distinguishing cell types based on complex combinations of markers has helped to spot evidence of meningeal inflammation in areas of patient brain samples with cortical gray matter lesions, confirming demyelination and meningeal inflammation observed in experimental allergic encephalomyelitis mouse models.

Imaging mass cytometry “allows us to potentially discriminate microglia from macrophages within brain lesions,” Jennifer Gommerman, PhD, said at a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “We can look at lymphocytes as well. There’s a lot of potential with this technique, and we’re excited to apply it to the meningeal inflammatory sections of the brain.”

Dr. Gommerman, professor of immunology at the University of Toronto, noted that multiple sclerosis (MS) begins often with a relapsing form of the disease, which tracks with deep white matter lesions that clinicians can image with MRI. “But as the disease progresses, we know that pathology can change, and we can see more pathology in the cortex, including varied bands of demyelination that are adjacent to the meninges,” she said. “This phase of the disease is not effectively treated by therapeutics.”

In this later phase of the disease, she continued, “it’s thought perhaps that the immune system isn’t playing such a big role, but there has been a fair bit of evidence in the literature in recent years that there are in fact immune cells in the brains of people with progressive MS. You can find them in the meninges. They can form clusters of cells within the meninges and they tend to be adjacent to areas of cortical demyelination, suggesting they might be involved in this pathology.”

Dr. Gommerman and her colleagues developed an animal model to evaluate meningeal inflammation in an effort to determine if they can model cortical injury and disease progression. They used an adoptive transfer form of experimental allergic encephalomyelitis in which they prime T cells in SJL mice, remove them, polarize them toward a Th17 phenotype, and transfer them into naive recipients. “When we do this we can see clusters of immune cells forming in the meninges,” Dr. Gommerman said. “They start with T cells but then become overwhelmingly populated by B cells.” Adjacent to these clusters they noted disruption of the glia limitans and demyelination in the cortex. “There’s clearly something going on in the cortex of these animals.”

Mindful that age is one of the most significant predictors of disease progression, the researchers transferred young T cells into mice that were 6-8 months old in addition to animals that were 6-8 weeks old. “Upon sacrifice, the younger mice that got the young T cells had largely resolved their cortical pathology, while the old mice that got the young T cells still showed evidence of demyelination, very angry microglia, and a continual disruption of the glial limitans,” Dr. Gommerman said. “We were able to see axonal stress in comparison to the young mice. We also saw some evidence of synapse loss. It seems that these animals not only have demyelination in the cortex, but there are problems with the axons and the synapses.”

To apply this model in humans, she and her colleagues collaborated with Netherlands Brain Bank in order to obtain brain samples for analysis with imaging mass cytometry, which provides a time-of-flight mass spectrometry readout of the staining pattern of heavy metal ion–tagged antibodies on a single slide-mounted tissue section.

“We really have to be careful which [brain] samples we choose, because not all samples from progressive MS patients have evidence of meningeal inflammation,” she noted. So far, they have observed that meningeal inflammation is associated with gray matter lesions, rather than with normal-appearing gray matter.

“We also need to look at appropriate controls, so our plan is to look at patients who have meningeal inflammation but do not have MS,” she said.

Dr. Gommerman reported having received grants from Novartis, Roche, and Merck, as well as a consulting agreement with Roche.

dbrunk@mdedge.com

DALLAS – Imaging mass cytometry is helping researchers to better understand how meningeal inflammation relates to cortical pathology in a subset of multiple sclerosis patients.

This technique for examining multiple proteins within intact tissue and distinguishing cell types based on complex combinations of markers has helped to spot evidence of meningeal inflammation in areas of patient brain samples with cortical gray matter lesions, confirming demyelination and meningeal inflammation observed in experimental allergic encephalomyelitis mouse models.

Imaging mass cytometry “allows us to potentially discriminate microglia from macrophages within brain lesions,” Jennifer Gommerman, PhD, said at a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “We can look at lymphocytes as well. There’s a lot of potential with this technique, and we’re excited to apply it to the meningeal inflammatory sections of the brain.”

Dr. Gommerman, professor of immunology at the University of Toronto, noted that multiple sclerosis (MS) begins often with a relapsing form of the disease, which tracks with deep white matter lesions that clinicians can image with MRI. “But as the disease progresses, we know that pathology can change, and we can see more pathology in the cortex, including varied bands of demyelination that are adjacent to the meninges,” she said. “This phase of the disease is not effectively treated by therapeutics.”

In this later phase of the disease, she continued, “it’s thought perhaps that the immune system isn’t playing such a big role, but there has been a fair bit of evidence in the literature in recent years that there are in fact immune cells in the brains of people with progressive MS. You can find them in the meninges. They can form clusters of cells within the meninges and they tend to be adjacent to areas of cortical demyelination, suggesting they might be involved in this pathology.”

Dr. Gommerman and her colleagues developed an animal model to evaluate meningeal inflammation in an effort to determine if they can model cortical injury and disease progression. They used an adoptive transfer form of experimental allergic encephalomyelitis in which they prime T cells in SJL mice, remove them, polarize them toward a Th17 phenotype, and transfer them into naive recipients. “When we do this we can see clusters of immune cells forming in the meninges,” Dr. Gommerman said. “They start with T cells but then become overwhelmingly populated by B cells.” Adjacent to these clusters they noted disruption of the glia limitans and demyelination in the cortex. “There’s clearly something going on in the cortex of these animals.”

Mindful that age is one of the most significant predictors of disease progression, the researchers transferred young T cells into mice that were 6-8 months old in addition to animals that were 6-8 weeks old. “Upon sacrifice, the younger mice that got the young T cells had largely resolved their cortical pathology, while the old mice that got the young T cells still showed evidence of demyelination, very angry microglia, and a continual disruption of the glial limitans,” Dr. Gommerman said. “We were able to see axonal stress in comparison to the young mice. We also saw some evidence of synapse loss. It seems that these animals not only have demyelination in the cortex, but there are problems with the axons and the synapses.”

To apply this model in humans, she and her colleagues collaborated with Netherlands Brain Bank in order to obtain brain samples for analysis with imaging mass cytometry, which provides a time-of-flight mass spectrometry readout of the staining pattern of heavy metal ion–tagged antibodies on a single slide-mounted tissue section.

“We really have to be careful which [brain] samples we choose, because not all samples from progressive MS patients have evidence of meningeal inflammation,” she noted. So far, they have observed that meningeal inflammation is associated with gray matter lesions, rather than with normal-appearing gray matter.

“We also need to look at appropriate controls, so our plan is to look at patients who have meningeal inflammation but do not have MS,” she said.

Dr. Gommerman reported having received grants from Novartis, Roche, and Merck, as well as a consulting agreement with Roche.

dbrunk@mdedge.com

DALLAS – Imaging mass cytometry is helping researchers to better understand how meningeal inflammation relates to cortical pathology in a subset of multiple sclerosis patients.

This technique for examining multiple proteins within intact tissue and distinguishing cell types based on complex combinations of markers has helped to spot evidence of meningeal inflammation in areas of patient brain samples with cortical gray matter lesions, confirming demyelination and meningeal inflammation observed in experimental allergic encephalomyelitis mouse models.

Imaging mass cytometry “allows us to potentially discriminate microglia from macrophages within brain lesions,” Jennifer Gommerman, PhD, said at a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “We can look at lymphocytes as well. There’s a lot of potential with this technique, and we’re excited to apply it to the meningeal inflammatory sections of the brain.”

Dr. Gommerman, professor of immunology at the University of Toronto, noted that multiple sclerosis (MS) begins often with a relapsing form of the disease, which tracks with deep white matter lesions that clinicians can image with MRI. “But as the disease progresses, we know that pathology can change, and we can see more pathology in the cortex, including varied bands of demyelination that are adjacent to the meninges,” she said. “This phase of the disease is not effectively treated by therapeutics.”

In this later phase of the disease, she continued, “it’s thought perhaps that the immune system isn’t playing such a big role, but there has been a fair bit of evidence in the literature in recent years that there are in fact immune cells in the brains of people with progressive MS. You can find them in the meninges. They can form clusters of cells within the meninges and they tend to be adjacent to areas of cortical demyelination, suggesting they might be involved in this pathology.”

Dr. Gommerman and her colleagues developed an animal model to evaluate meningeal inflammation in an effort to determine if they can model cortical injury and disease progression. They used an adoptive transfer form of experimental allergic encephalomyelitis in which they prime T cells in SJL mice, remove them, polarize them toward a Th17 phenotype, and transfer them into naive recipients. “When we do this we can see clusters of immune cells forming in the meninges,” Dr. Gommerman said. “They start with T cells but then become overwhelmingly populated by B cells.” Adjacent to these clusters they noted disruption of the glia limitans and demyelination in the cortex. “There’s clearly something going on in the cortex of these animals.”

Mindful that age is one of the most significant predictors of disease progression, the researchers transferred young T cells into mice that were 6-8 months old in addition to animals that were 6-8 weeks old. “Upon sacrifice, the younger mice that got the young T cells had largely resolved their cortical pathology, while the old mice that got the young T cells still showed evidence of demyelination, very angry microglia, and a continual disruption of the glial limitans,” Dr. Gommerman said. “We were able to see axonal stress in comparison to the young mice. We also saw some evidence of synapse loss. It seems that these animals not only have demyelination in the cortex, but there are problems with the axons and the synapses.”

To apply this model in humans, she and her colleagues collaborated with Netherlands Brain Bank in order to obtain brain samples for analysis with imaging mass cytometry, which provides a time-of-flight mass spectrometry readout of the staining pattern of heavy metal ion–tagged antibodies on a single slide-mounted tissue section.

“We really have to be careful which [brain] samples we choose, because not all samples from progressive MS patients have evidence of meningeal inflammation,” she noted. So far, they have observed that meningeal inflammation is associated with gray matter lesions, rather than with normal-appearing gray matter.

“We also need to look at appropriate controls, so our plan is to look at patients who have meningeal inflammation but do not have MS,” she said.

Dr. Gommerman reported having received grants from Novartis, Roche, and Merck, as well as a consulting agreement with Roche.

dbrunk@mdedge.com

A novel whole blood assay was unable to predict clinical severity in patients with type 1 von Willebrand disease (VWD).

The whole blood ristocetin-induced platelet agglutination (WB-RIPA) assay has shown potential for use as a diagnostic test for patients with type 1 VWD. However, the ability of the assay to predict clinical severity of the disease is unknown.

Yuto Nakajima, MD, of the Nara (Japan) Medical University and his colleagues studied the diagnostic and clinical capabilities of the assay in 55 patients with type 1 VWD and 20 healthy controls. The results of the study were published in Haemophilia.

The team examined relationships between WB-RIPA levels, VWF-associated measurements, and bleeding scores using whole blood samples. Bleeding severity was assessed using scores from a standardized assessment tool.

After analysis, the team found that assay values were significantly lower in patients with type 1 VWD versus healthy controls (P less than .0001), which validated the detection abilities of the test.

However, correlations between WB-RIPA levels and specific VWF-associated measurements were found to be weak. Similar results were reported with assay levels and bleeding scores. There were no significant differences seen in WB-RIPA between patients with a bleeding score of 4 or greater (abnormal bleeding tendency) and less than 4 (no abnormal bleeding tendency).

“Our study indicated that the WB-RIPA assay would not be useful for assessing and predicting the clinical severity in type 1 VWD,” they wrote.

The authors acknowledged that a key limitation was that the definition of type 1 VWD used in the study was not based on the most current classification.

The study was supported by grant funding from the Ministry of Education, Culture, Sports, Science and Technology (Japan). The authors reported having no conflicts of interest.

SOURCE: Nakajima Y et al. Haemophilia. 2019 Mar 13. doi: 10.1111/hae.13725.

A novel whole blood assay was unable to predict clinical severity in patients with type 1 von Willebrand disease (VWD).

The whole blood ristocetin-induced platelet agglutination (WB-RIPA) assay has shown potential for use as a diagnostic test for patients with type 1 VWD. However, the ability of the assay to predict clinical severity of the disease is unknown.

Yuto Nakajima, MD, of the Nara (Japan) Medical University and his colleagues studied the diagnostic and clinical capabilities of the assay in 55 patients with type 1 VWD and 20 healthy controls. The results of the study were published in Haemophilia.

The team examined relationships between WB-RIPA levels, VWF-associated measurements, and bleeding scores using whole blood samples. Bleeding severity was assessed using scores from a standardized assessment tool.

After analysis, the team found that assay values were significantly lower in patients with type 1 VWD versus healthy controls (P less than .0001), which validated the detection abilities of the test.

However, correlations between WB-RIPA levels and specific VWF-associated measurements were found to be weak. Similar results were reported with assay levels and bleeding scores. There were no significant differences seen in WB-RIPA between patients with a bleeding score of 4 or greater (abnormal bleeding tendency) and less than 4 (no abnormal bleeding tendency).

“Our study indicated that the WB-RIPA assay would not be useful for assessing and predicting the clinical severity in type 1 VWD,” they wrote.

The authors acknowledged that a key limitation was that the definition of type 1 VWD used in the study was not based on the most current classification.

The study was supported by grant funding from the Ministry of Education, Culture, Sports, Science and Technology (Japan). The authors reported having no conflicts of interest.

SOURCE: Nakajima Y et al. Haemophilia. 2019 Mar 13. doi: 10.1111/hae.13725.

A novel whole blood assay was unable to predict clinical severity in patients with type 1 von Willebrand disease (VWD).

The whole blood ristocetin-induced platelet agglutination (WB-RIPA) assay has shown potential for use as a diagnostic test for patients with type 1 VWD. However, the ability of the assay to predict clinical severity of the disease is unknown.

Yuto Nakajima, MD, of the Nara (Japan) Medical University and his colleagues studied the diagnostic and clinical capabilities of the assay in 55 patients with type 1 VWD and 20 healthy controls. The results of the study were published in Haemophilia.

The team examined relationships between WB-RIPA levels, VWF-associated measurements, and bleeding scores using whole blood samples. Bleeding severity was assessed using scores from a standardized assessment tool.

After analysis, the team found that assay values were significantly lower in patients with type 1 VWD versus healthy controls (P less than .0001), which validated the detection abilities of the test.

However, correlations between WB-RIPA levels and specific VWF-associated measurements were found to be weak. Similar results were reported with assay levels and bleeding scores. There were no significant differences seen in WB-RIPA between patients with a bleeding score of 4 or greater (abnormal bleeding tendency) and less than 4 (no abnormal bleeding tendency).

“Our study indicated that the WB-RIPA assay would not be useful for assessing and predicting the clinical severity in type 1 VWD,” they wrote.

The authors acknowledged that a key limitation was that the definition of type 1 VWD used in the study was not based on the most current classification.

The study was supported by grant funding from the Ministry of Education, Culture, Sports, Science and Technology (Japan). The authors reported having no conflicts of interest.

SOURCE: Nakajima Y et al. Haemophilia. 2019 Mar 13. doi: 10.1111/hae.13725.

The Food and Drug Administration has approved testosterone undecanoate (Jatenzo), an oral capsule for the treatment of male hypogonadism caused by certain conditions, such as genetic disorders or tumors that have damaged the pituitary gland.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The approval is based on results from a 4-month clinical trial involving 166 men with hypogonadism. Patients received 237 mg testosterone undecanoate twice a day initially, a dosage that was adjusted downward or upward to a maximum of 396 mg twice a day, based on testosterone levels. At the end of the trial, 87% of men had achieved testosterone levels within the normal range.

The label for testosterone undecanoate contains a warning that the drug can cause an increase in blood pressure, raising the risk of heart attack, stroke, and cardiovascular death. Other common adverse events associated with testosterone undecanoate include headache, an increase in hematocrit, a decrease in HDL cholesterol, and nausea.

“[The] oral route of administration provides an important addition to current treatment options available for men with certain hypogonadal conditions who, until now, have most commonly been treated with testosterone products that are applied to the skin or injected,” said Hylton V. Joffe, MD, MMSc, director of the division of bone, reproductive, and urologic products at the FDA’s Center for Drug Evaluation and Research, in the press release.

Testosterone undecanoate is not approved to treat age-related hypogonadism, even in cases in which men have symptoms caused by low testosterone. The drug’s benefits do not outweigh its risks in those cases, the agency noted.

Find the full press release on the FDA website.

lfranki@mdedge.com

The Food and Drug Administration has approved testosterone undecanoate (Jatenzo), an oral capsule for the treatment of male hypogonadism caused by certain conditions, such as genetic disorders or tumors that have damaged the pituitary gland.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The approval is based on results from a 4-month clinical trial involving 166 men with hypogonadism. Patients received 237 mg testosterone undecanoate twice a day initially, a dosage that was adjusted downward or upward to a maximum of 396 mg twice a day, based on testosterone levels. At the end of the trial, 87% of men had achieved testosterone levels within the normal range.

The label for testosterone undecanoate contains a warning that the drug can cause an increase in blood pressure, raising the risk of heart attack, stroke, and cardiovascular death. Other common adverse events associated with testosterone undecanoate include headache, an increase in hematocrit, a decrease in HDL cholesterol, and nausea.

“[The] oral route of administration provides an important addition to current treatment options available for men with certain hypogonadal conditions who, until now, have most commonly been treated with testosterone products that are applied to the skin or injected,” said Hylton V. Joffe, MD, MMSc, director of the division of bone, reproductive, and urologic products at the FDA’s Center for Drug Evaluation and Research, in the press release.

Testosterone undecanoate is not approved to treat age-related hypogonadism, even in cases in which men have symptoms caused by low testosterone. The drug’s benefits do not outweigh its risks in those cases, the agency noted.

Find the full press release on the FDA website.

lfranki@mdedge.com

The Food and Drug Administration has approved testosterone undecanoate (Jatenzo), an oral capsule for the treatment of male hypogonadism caused by certain conditions, such as genetic disorders or tumors that have damaged the pituitary gland.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The approval is based on results from a 4-month clinical trial involving 166 men with hypogonadism. Patients received 237 mg testosterone undecanoate twice a day initially, a dosage that was adjusted downward or upward to a maximum of 396 mg twice a day, based on testosterone levels. At the end of the trial, 87% of men had achieved testosterone levels within the normal range.

The label for testosterone undecanoate contains a warning that the drug can cause an increase in blood pressure, raising the risk of heart attack, stroke, and cardiovascular death. Other common adverse events associated with testosterone undecanoate include headache, an increase in hematocrit, a decrease in HDL cholesterol, and nausea.

“[The] oral route of administration provides an important addition to current treatment options available for men with certain hypogonadal conditions who, until now, have most commonly been treated with testosterone products that are applied to the skin or injected,” said Hylton V. Joffe, MD, MMSc, director of the division of bone, reproductive, and urologic products at the FDA’s Center for Drug Evaluation and Research, in the press release.

Testosterone undecanoate is not approved to treat age-related hypogonadism, even in cases in which men have symptoms caused by low testosterone. The drug’s benefits do not outweigh its risks in those cases, the agency noted.

Find the full press release on the FDA website.

lfranki@mdedge.com

In patients with multiple sclerosis (MS), the risk of acute myocardial infarction (AMI) is elevated but may not be accounted for by traditional vascular risk factors, a new study found. Researchers conducted a retrospective matched cohort study using population-based administrative data in 2 Canadian provinces. Incident MS cases were identified and for each case, up to 5 controls without MS were matched on age, sex, and region. The incidence of AMI between cohorts was compared using incidence rate ratios (IRRs). Among the findings:

• 14,565 persons with MS and 72,825 matched controls were identified.
• The crude incidence of AMI per 100,000 population was 146.2 in the MS population vs 128.8 in the matched population.
• After age standardization, the incidence of AMI was higher in the MS population vs the matched population (IRR 1.18).
• After adjustment, the hazard of AMI was 60% higher in the MS population vs the matched population (hazard ratio 1.63).

Marrie RA, Garland A, Schaffer SA. Traditional risk factors may not explain increased incidence of myocardial infarction in MS. [Published online ahead of print March 6, 2019]. Neurology. doi:10.1212/WNL.0000000000007251.

In patients with multiple sclerosis (MS), the risk of acute myocardial infarction (AMI) is elevated but may not be accounted for by traditional vascular risk factors, a new study found. Researchers conducted a retrospective matched cohort study using population-based administrative data in 2 Canadian provinces. Incident MS cases were identified and for each case, up to 5 controls without MS were matched on age, sex, and region. The incidence of AMI between cohorts was compared using incidence rate ratios (IRRs). Among the findings:

• 14,565 persons with MS and 72,825 matched controls were identified.
• The crude incidence of AMI per 100,000 population was 146.2 in the MS population vs 128.8 in the matched population.
• After age standardization, the incidence of AMI was higher in the MS population vs the matched population (IRR 1.18).
• After adjustment, the hazard of AMI was 60% higher in the MS population vs the matched population (hazard ratio 1.63).

Marrie RA, Garland A, Schaffer SA. Traditional risk factors may not explain increased incidence of myocardial infarction in MS. [Published online ahead of print March 6, 2019]. Neurology. doi:10.1212/WNL.0000000000007251.

In patients with multiple sclerosis (MS), the risk of acute myocardial infarction (AMI) is elevated but may not be accounted for by traditional vascular risk factors, a new study found. Researchers conducted a retrospective matched cohort study using population-based administrative data in 2 Canadian provinces. Incident MS cases were identified and for each case, up to 5 controls without MS were matched on age, sex, and region. The incidence of AMI between cohorts was compared using incidence rate ratios (IRRs). Among the findings:

• 14,565 persons with MS and 72,825 matched controls were identified.
• The crude incidence of AMI per 100,000 population was 146.2 in the MS population vs 128.8 in the matched population.
• After age standardization, the incidence of AMI was higher in the MS population vs the matched population (IRR 1.18).
• After adjustment, the hazard of AMI was 60% higher in the MS population vs the matched population (hazard ratio 1.63).

Marrie RA, Garland A, Schaffer SA. Traditional risk factors may not explain increased incidence of myocardial infarction in MS. [Published online ahead of print March 6, 2019]. Neurology. doi:10.1212/WNL.0000000000007251.

In a recent survey, patients with multiple sclerosis (MS) displayed a wide range of risk tolerance (RT) to MS therapies. People with MS from the North American Research Committee on Multiple Sclerosis Registry’s online cohort and the National Multiple Sclerosis Society were invited to complete a questionnaire on tolerance to real-world risks associated with a hypothetical therapy. Multiple risk levels were presented, including skin rash, infection, kidney injury, thyroid injury, liver injury, and progressive multifocal leukoencephalopathy (PML). Researchers found:

• Both PML and kidney injury had the lowest RT; thyroid and infection risk had the highest tolerance.
• Men, younger individuals, and those with greater disability reported a higher tolerance to all risk scenarios.
• Participants currently taking an MS therapy reported higher tolerance vs those not taking any therapy.

Fox RJ, Cosenza C, Cripps L, et al. A survey of risk tolerance to multiple sclerosis therapies. [Published online ahead of print March 13, 2019]. Neurology. doi:10.1212/WNL.0000000000007245.

In a recent survey, patients with multiple sclerosis (MS) displayed a wide range of risk tolerance (RT) to MS therapies. People with MS from the North American Research Committee on Multiple Sclerosis Registry’s online cohort and the National Multiple Sclerosis Society were invited to complete a questionnaire on tolerance to real-world risks associated with a hypothetical therapy. Multiple risk levels were presented, including skin rash, infection, kidney injury, thyroid injury, liver injury, and progressive multifocal leukoencephalopathy (PML). Researchers found:

• Both PML and kidney injury had the lowest RT; thyroid and infection risk had the highest tolerance.
• Men, younger individuals, and those with greater disability reported a higher tolerance to all risk scenarios.
• Participants currently taking an MS therapy reported higher tolerance vs those not taking any therapy.

Fox RJ, Cosenza C, Cripps L, et al. A survey of risk tolerance to multiple sclerosis therapies. [Published online ahead of print March 13, 2019]. Neurology. doi:10.1212/WNL.0000000000007245.

In a recent survey, patients with multiple sclerosis (MS) displayed a wide range of risk tolerance (RT) to MS therapies. People with MS from the North American Research Committee on Multiple Sclerosis Registry’s online cohort and the National Multiple Sclerosis Society were invited to complete a questionnaire on tolerance to real-world risks associated with a hypothetical therapy. Multiple risk levels were presented, including skin rash, infection, kidney injury, thyroid injury, liver injury, and progressive multifocal leukoencephalopathy (PML). Researchers found:

• Both PML and kidney injury had the lowest RT; thyroid and infection risk had the highest tolerance.
• Men, younger individuals, and those with greater disability reported a higher tolerance to all risk scenarios.
• Participants currently taking an MS therapy reported higher tolerance vs those not taking any therapy.

Fox RJ, Cosenza C, Cripps L, et al. A survey of risk tolerance to multiple sclerosis therapies. [Published online ahead of print March 13, 2019]. Neurology. doi:10.1212/WNL.0000000000007245.

In an age and gender-based US national retrospective analysis, overall 30-day readmission in multiple sclerosis (MS) was ∼10%, with higher readmission rates observed in older patients. The retrospective observational cohort study included patients hospitalized with primary discharge diagnosis of MS using 2013 Nationwide Readmission Database (NRD). Age (<40 vs >40 years) and gender-based analyses were performed using multivariable logistic regression adjusting co-variables to identify the patient/system-specific factors associated with 30-day readmission. Researchers found:

• 30-day readmission rate in MS was 10.2% in the cohort.
• Higher 30-day readmission was observed in patients aged >40 years due to burden of comorbidities.
• Readmission causes were MS exacerbations, sepsis, and respiratory complications.
• Readmission was associated with higher cost of care and longer length of stay compared to index admissions.

Patel S, SirDeshpande P, Desai R, et al. Thirty-day readmissions in multiple sclerosis: An age and gender-based US national retrospective analysis. [Published online ahead of print March 20, 2019]. Mult Scler Relat Disord. doi:10.1016/j.msard.2019.03.012.

In an age and gender-based US national retrospective analysis, overall 30-day readmission in multiple sclerosis (MS) was ∼10%, with higher readmission rates observed in older patients. The retrospective observational cohort study included patients hospitalized with primary discharge diagnosis of MS using 2013 Nationwide Readmission Database (NRD). Age (<40 vs >40 years) and gender-based analyses were performed using multivariable logistic regression adjusting co-variables to identify the patient/system-specific factors associated with 30-day readmission. Researchers found:

• 30-day readmission rate in MS was 10.2% in the cohort.
• Higher 30-day readmission was observed in patients aged >40 years due to burden of comorbidities.
• Readmission causes were MS exacerbations, sepsis, and respiratory complications.
• Readmission was associated with higher cost of care and longer length of stay compared to index admissions.

Patel S, SirDeshpande P, Desai R, et al. Thirty-day readmissions in multiple sclerosis: An age and gender-based US national retrospective analysis. [Published online ahead of print March 20, 2019]. Mult Scler Relat Disord. doi:10.1016/j.msard.2019.03.012.

In an age and gender-based US national retrospective analysis, overall 30-day readmission in multiple sclerosis (MS) was ∼10%, with higher readmission rates observed in older patients. The retrospective observational cohort study included patients hospitalized with primary discharge diagnosis of MS using 2013 Nationwide Readmission Database (NRD). Age (<40 vs >40 years) and gender-based analyses were performed using multivariable logistic regression adjusting co-variables to identify the patient/system-specific factors associated with 30-day readmission. Researchers found:

• 30-day readmission rate in MS was 10.2% in the cohort.
• Higher 30-day readmission was observed in patients aged >40 years due to burden of comorbidities.
• Readmission causes were MS exacerbations, sepsis, and respiratory complications.
• Readmission was associated with higher cost of care and longer length of stay compared to index admissions.

Patel S, SirDeshpande P, Desai R, et al. Thirty-day readmissions in multiple sclerosis: An age and gender-based US national retrospective analysis. [Published online ahead of print March 20, 2019]. Mult Scler Relat Disord. doi:10.1016/j.msard.2019.03.012.