Patients with pediatric-onset multiple sclerosis are more likely than those with adult-onset disease to have impairment in information processing in adulthood, independent of age or disease duration, according to a study published in JAMA Neurology.

designer491/Thinkstock

Information-processing efficiency as measured by the Symbol Digit Modalities Test (SDMT) may decrease more rapidly in patients with pediatric-onset multiple sclerosis (MS).

“Children and adolescents who develop [MS] should be monitored closely for cognitive changes and helped to manage the potential challenges that early-onset multiple sclerosis poses for cognitive abilities later in life,” Kyla A. McKay, PhD, a researcher at Karolinska Institutet in Stockholm, and colleagues wrote.

Prior research has found that an SDMT score of 55 may be a point at which a person with MS is “employed but work challenged.” In the present study, patients with pediatric-onset MS reached this threshold at about age 34 years, whereas patients with adult-onset MS reached it at approximately 50 years. These findings suggest that the groups’ different cognitive outcomes “may be meaningful,” the researchers wrote.

Onset of MS before age 18 years occurs in 2%-10% of cases, but few studies have looked at cognitive outcomes of patients with pediatric-onset MS in adulthood. Cognitive impairment is common in patients with MS and may affect quality of life, social functioning, and employment.

To compare changes in cognitive function over time in adults with pediatric-onset MS versus adults with adult-onset MS, Dr. McKay and colleagues conducted a population-based, longitudinal cohort study using data from more than 5,700 patients in the Swedish Multiple Sclerosis Registry. The registry includes information from all neurology clinics in Sweden, and the researchers examined data collected between April 2006 and April 2018.

SDMT scores range from 0 to 120, and higher scores indicate greater information-processing efficiency.

The researchers classified patients with MS onset at younger than 18 years as pediatric-onset MS. The researchers excluded patients with fewer than two SDMT scores, patients younger than 18 years or older than 55 years at the time of testing, and patients with disease duration of 30 years or more.

The researchers included 5,704 patients, 300 of whom had pediatric-onset MS (5.3%). About 70% of the patients were female, and 98% had a relapsing-onset disease course. The pediatric-onset MS group had a younger median age at baseline than the adult-onset group did (26 years vs. 38 years). The patients had more than 46,000 SDMT scores, with an average baseline SDMT of 51; the median follow-up time was 3 years.

Patients with pediatric-onset MS had significantly lower SDMT scores (beta coefficient, –3.59), after adjusting for sex, age, disease duration, disease course, total number of SDMTs completed, oral or visual SDMT form, and exposure to disease-modifying therapy. Their scores also declined faster than those of patients with adult-onset MS (beta coefficient, –0.30; 95% confidence interval, –5.56 to –1.54), and they were more likely to ever have cognitive impairment (odds ratio, 1.44).

“At younger than 30 years, SDMT scores between the ... groups were comparable; but after 30 years of age the trajectories began to diverge,” Dr. McKay and associates wrote. At age 35 years, the mean SDMT score for patients with adult-onset MS was 61, whereas for patients with pediatric-onset MS it was 51. By age 40 years, the mean score was 58 for adult-onset MS versus 46 for pediatric-onset MS.

The study was supported by the Swedish Research Council and the Swedish Brain Foundation and by postdoctoral awards from the Canadian Institutes of Health Research to Dr. McKay and European Committee for Treatment and Research in Multiple Sclerosis to Dr. McKay. Coauthors reported receiving honoraria for speaking and serving on advisory boards for various pharmaceutical companies, as well as receiving research funding from agencies, foundations, and pharmaceutical companies.

[email protected]

SOURCE: McKay KA et al. JAMA Neurol. 2019 Jun 17. doi: 10.1001/jamaneurol.2019.1546.
 

Patients with pediatric-onset multiple sclerosis are more likely than those with adult-onset disease to have impairment in information processing in adulthood, independent of age or disease duration, according to a study published in JAMA Neurology.

designer491/Thinkstock

Information-processing efficiency as measured by the Symbol Digit Modalities Test (SDMT) may decrease more rapidly in patients with pediatric-onset multiple sclerosis (MS).

“Children and adolescents who develop [MS] should be monitored closely for cognitive changes and helped to manage the potential challenges that early-onset multiple sclerosis poses for cognitive abilities later in life,” Kyla A. McKay, PhD, a researcher at Karolinska Institutet in Stockholm, and colleagues wrote.

Prior research has found that an SDMT score of 55 may be a point at which a person with MS is “employed but work challenged.” In the present study, patients with pediatric-onset MS reached this threshold at about age 34 years, whereas patients with adult-onset MS reached it at approximately 50 years. These findings suggest that the groups’ different cognitive outcomes “may be meaningful,” the researchers wrote.

Onset of MS before age 18 years occurs in 2%-10% of cases, but few studies have looked at cognitive outcomes of patients with pediatric-onset MS in adulthood. Cognitive impairment is common in patients with MS and may affect quality of life, social functioning, and employment.

To compare changes in cognitive function over time in adults with pediatric-onset MS versus adults with adult-onset MS, Dr. McKay and colleagues conducted a population-based, longitudinal cohort study using data from more than 5,700 patients in the Swedish Multiple Sclerosis Registry. The registry includes information from all neurology clinics in Sweden, and the researchers examined data collected between April 2006 and April 2018.

SDMT scores range from 0 to 120, and higher scores indicate greater information-processing efficiency.

The researchers classified patients with MS onset at younger than 18 years as pediatric-onset MS. The researchers excluded patients with fewer than two SDMT scores, patients younger than 18 years or older than 55 years at the time of testing, and patients with disease duration of 30 years or more.

The researchers included 5,704 patients, 300 of whom had pediatric-onset MS (5.3%). About 70% of the patients were female, and 98% had a relapsing-onset disease course. The pediatric-onset MS group had a younger median age at baseline than the adult-onset group did (26 years vs. 38 years). The patients had more than 46,000 SDMT scores, with an average baseline SDMT of 51; the median follow-up time was 3 years.

Patients with pediatric-onset MS had significantly lower SDMT scores (beta coefficient, –3.59), after adjusting for sex, age, disease duration, disease course, total number of SDMTs completed, oral or visual SDMT form, and exposure to disease-modifying therapy. Their scores also declined faster than those of patients with adult-onset MS (beta coefficient, –0.30; 95% confidence interval, –5.56 to –1.54), and they were more likely to ever have cognitive impairment (odds ratio, 1.44).

“At younger than 30 years, SDMT scores between the ... groups were comparable; but after 30 years of age the trajectories began to diverge,” Dr. McKay and associates wrote. At age 35 years, the mean SDMT score for patients with adult-onset MS was 61, whereas for patients with pediatric-onset MS it was 51. By age 40 years, the mean score was 58 for adult-onset MS versus 46 for pediatric-onset MS.

The study was supported by the Swedish Research Council and the Swedish Brain Foundation and by postdoctoral awards from the Canadian Institutes of Health Research to Dr. McKay and European Committee for Treatment and Research in Multiple Sclerosis to Dr. McKay. Coauthors reported receiving honoraria for speaking and serving on advisory boards for various pharmaceutical companies, as well as receiving research funding from agencies, foundations, and pharmaceutical companies.

[email protected]

SOURCE: McKay KA et al. JAMA Neurol. 2019 Jun 17. doi: 10.1001/jamaneurol.2019.1546.
 

Patients with pediatric-onset multiple sclerosis are more likely than those with adult-onset disease to have impairment in information processing in adulthood, independent of age or disease duration, according to a study published in JAMA Neurology.

designer491/Thinkstock

Information-processing efficiency as measured by the Symbol Digit Modalities Test (SDMT) may decrease more rapidly in patients with pediatric-onset multiple sclerosis (MS).

“Children and adolescents who develop [MS] should be monitored closely for cognitive changes and helped to manage the potential challenges that early-onset multiple sclerosis poses for cognitive abilities later in life,” Kyla A. McKay, PhD, a researcher at Karolinska Institutet in Stockholm, and colleagues wrote.

Prior research has found that an SDMT score of 55 may be a point at which a person with MS is “employed but work challenged.” In the present study, patients with pediatric-onset MS reached this threshold at about age 34 years, whereas patients with adult-onset MS reached it at approximately 50 years. These findings suggest that the groups’ different cognitive outcomes “may be meaningful,” the researchers wrote.

Onset of MS before age 18 years occurs in 2%-10% of cases, but few studies have looked at cognitive outcomes of patients with pediatric-onset MS in adulthood. Cognitive impairment is common in patients with MS and may affect quality of life, social functioning, and employment.

To compare changes in cognitive function over time in adults with pediatric-onset MS versus adults with adult-onset MS, Dr. McKay and colleagues conducted a population-based, longitudinal cohort study using data from more than 5,700 patients in the Swedish Multiple Sclerosis Registry. The registry includes information from all neurology clinics in Sweden, and the researchers examined data collected between April 2006 and April 2018.

SDMT scores range from 0 to 120, and higher scores indicate greater information-processing efficiency.

The researchers classified patients with MS onset at younger than 18 years as pediatric-onset MS. The researchers excluded patients with fewer than two SDMT scores, patients younger than 18 years or older than 55 years at the time of testing, and patients with disease duration of 30 years or more.

The researchers included 5,704 patients, 300 of whom had pediatric-onset MS (5.3%). About 70% of the patients were female, and 98% had a relapsing-onset disease course. The pediatric-onset MS group had a younger median age at baseline than the adult-onset group did (26 years vs. 38 years). The patients had more than 46,000 SDMT scores, with an average baseline SDMT of 51; the median follow-up time was 3 years.

Patients with pediatric-onset MS had significantly lower SDMT scores (beta coefficient, –3.59), after adjusting for sex, age, disease duration, disease course, total number of SDMTs completed, oral or visual SDMT form, and exposure to disease-modifying therapy. Their scores also declined faster than those of patients with adult-onset MS (beta coefficient, –0.30; 95% confidence interval, –5.56 to –1.54), and they were more likely to ever have cognitive impairment (odds ratio, 1.44).

“At younger than 30 years, SDMT scores between the ... groups were comparable; but after 30 years of age the trajectories began to diverge,” Dr. McKay and associates wrote. At age 35 years, the mean SDMT score for patients with adult-onset MS was 61, whereas for patients with pediatric-onset MS it was 51. By age 40 years, the mean score was 58 for adult-onset MS versus 46 for pediatric-onset MS.

The study was supported by the Swedish Research Council and the Swedish Brain Foundation and by postdoctoral awards from the Canadian Institutes of Health Research to Dr. McKay and European Committee for Treatment and Research in Multiple Sclerosis to Dr. McKay. Coauthors reported receiving honoraria for speaking and serving on advisory boards for various pharmaceutical companies, as well as receiving research funding from agencies, foundations, and pharmaceutical companies.

[email protected]

SOURCE: McKay KA et al. JAMA Neurol. 2019 Jun 17. doi: 10.1001/jamaneurol.2019.1546.
 

Women in their 80s who have osteoporosis are at greater risk of fracture than their counterparts without the disease and therefore have more to gain from osteoporosis treatment, regardless of the presence of any comorbidities, according to a new study.

To determine how and when to treat older women for osteoporosis, Kristine E. Ensrud, MD, of the University of Minnesota, Minneapolis, and coauthors studied active surviving participants in the Study of Osteoporotic Fractures. The cohort comprised 1,528 women who met criteria for either osteoporosis (n = 761) or without osteoporosis but at high fracture risk (n = 767). Mean age at the time of examination was 84 years and mean femoral neck bone mineral density (BMD) T-score was −2.24.

During an average follow-up period of 4.4 years after initial examination, 125 women (9%) experienced a hip fracture and 287 (19%) died without experiencing that outcome. The 5-year absolute probability of mortality was 25% (95% confidence interval, 21.8%-28.1%) in women with osteoporosis and 19% (95% CI, 16.6%-22.3%) in women without osteoporosis but at high fracture risk. Although both groups saw mortality probability increase with more comorbidities and poorer prognosis, 5-year hip fracture probability was 13% (95% CI, 10.7%-15.5%) among women with osteoporosis and 4% (95% CI, 2.8%-5.6%) among women without osteoporosis but at high fracture risk.

Bojan89/iStock/Getty Images Plus

This probability of the women with osteoporosis experiencing a hip fracture, “even after considering their competing mortality risk” suggests that “initiation of drug treatment in late-life women with osteoporosis may still be effective in the prevention of subsequent hip fracture,” the researchers wrote in JAMA Internal Medicine.

Dr. Ensrud and associates acknowledged their study’s limitations, including the cohort being made up of community-dwelling white women and thus the results not being generalizable to men or women of other racial or ethnic groups. But the researchers noted that the mean femoral neck BMD of women in the study “was essentially identical to that of a nationally representative sample of community-dwelling women 80 years and older enrolled in the 2005 to 2008 NHANES [National Health and Nutrition Examination Survey].”

Dr. Cynthia M. Boyd reported receiving royalties from UpToDate and a grant from the National Institutes of Aging Dr. Katie L. Stone reported receiving grant support from Merck, and Dr. Lisa Langsetmo reported receiving grants from the National Institutes of Health and Merck. No other authors reported any relevant financial disclosures. The Study of Osteoporotic Fractures was supported by NIH and grants from NIA.

SOURCE: Ensrud KE et al. JAMA Intern Med. 2019 Jun 17. doi: 10.1001/jamainternmed.2019.0682.

Women in their 80s who have osteoporosis are at greater risk of fracture than their counterparts without the disease and therefore have more to gain from osteoporosis treatment, regardless of the presence of any comorbidities, according to a new study.

To determine how and when to treat older women for osteoporosis, Kristine E. Ensrud, MD, of the University of Minnesota, Minneapolis, and coauthors studied active surviving participants in the Study of Osteoporotic Fractures. The cohort comprised 1,528 women who met criteria for either osteoporosis (n = 761) or without osteoporosis but at high fracture risk (n = 767). Mean age at the time of examination was 84 years and mean femoral neck bone mineral density (BMD) T-score was −2.24.

During an average follow-up period of 4.4 years after initial examination, 125 women (9%) experienced a hip fracture and 287 (19%) died without experiencing that outcome. The 5-year absolute probability of mortality was 25% (95% confidence interval, 21.8%-28.1%) in women with osteoporosis and 19% (95% CI, 16.6%-22.3%) in women without osteoporosis but at high fracture risk. Although both groups saw mortality probability increase with more comorbidities and poorer prognosis, 5-year hip fracture probability was 13% (95% CI, 10.7%-15.5%) among women with osteoporosis and 4% (95% CI, 2.8%-5.6%) among women without osteoporosis but at high fracture risk.

Bojan89/iStock/Getty Images Plus

This probability of the women with osteoporosis experiencing a hip fracture, “even after considering their competing mortality risk” suggests that “initiation of drug treatment in late-life women with osteoporosis may still be effective in the prevention of subsequent hip fracture,” the researchers wrote in JAMA Internal Medicine.

Dr. Ensrud and associates acknowledged their study’s limitations, including the cohort being made up of community-dwelling white women and thus the results not being generalizable to men or women of other racial or ethnic groups. But the researchers noted that the mean femoral neck BMD of women in the study “was essentially identical to that of a nationally representative sample of community-dwelling women 80 years and older enrolled in the 2005 to 2008 NHANES [National Health and Nutrition Examination Survey].”

Dr. Cynthia M. Boyd reported receiving royalties from UpToDate and a grant from the National Institutes of Aging Dr. Katie L. Stone reported receiving grant support from Merck, and Dr. Lisa Langsetmo reported receiving grants from the National Institutes of Health and Merck. No other authors reported any relevant financial disclosures. The Study of Osteoporotic Fractures was supported by NIH and grants from NIA.

SOURCE: Ensrud KE et al. JAMA Intern Med. 2019 Jun 17. doi: 10.1001/jamainternmed.2019.0682.

Women in their 80s who have osteoporosis are at greater risk of fracture than their counterparts without the disease and therefore have more to gain from osteoporosis treatment, regardless of the presence of any comorbidities, according to a new study.

To determine how and when to treat older women for osteoporosis, Kristine E. Ensrud, MD, of the University of Minnesota, Minneapolis, and coauthors studied active surviving participants in the Study of Osteoporotic Fractures. The cohort comprised 1,528 women who met criteria for either osteoporosis (n = 761) or without osteoporosis but at high fracture risk (n = 767). Mean age at the time of examination was 84 years and mean femoral neck bone mineral density (BMD) T-score was −2.24.

During an average follow-up period of 4.4 years after initial examination, 125 women (9%) experienced a hip fracture and 287 (19%) died without experiencing that outcome. The 5-year absolute probability of mortality was 25% (95% confidence interval, 21.8%-28.1%) in women with osteoporosis and 19% (95% CI, 16.6%-22.3%) in women without osteoporosis but at high fracture risk. Although both groups saw mortality probability increase with more comorbidities and poorer prognosis, 5-year hip fracture probability was 13% (95% CI, 10.7%-15.5%) among women with osteoporosis and 4% (95% CI, 2.8%-5.6%) among women without osteoporosis but at high fracture risk.

Bojan89/iStock/Getty Images Plus

This probability of the women with osteoporosis experiencing a hip fracture, “even after considering their competing mortality risk” suggests that “initiation of drug treatment in late-life women with osteoporosis may still be effective in the prevention of subsequent hip fracture,” the researchers wrote in JAMA Internal Medicine.

Dr. Ensrud and associates acknowledged their study’s limitations, including the cohort being made up of community-dwelling white women and thus the results not being generalizable to men or women of other racial or ethnic groups. But the researchers noted that the mean femoral neck BMD of women in the study “was essentially identical to that of a nationally representative sample of community-dwelling women 80 years and older enrolled in the 2005 to 2008 NHANES [National Health and Nutrition Examination Survey].”

Dr. Cynthia M. Boyd reported receiving royalties from UpToDate and a grant from the National Institutes of Aging Dr. Katie L. Stone reported receiving grant support from Merck, and Dr. Lisa Langsetmo reported receiving grants from the National Institutes of Health and Merck. No other authors reported any relevant financial disclosures. The Study of Osteoporotic Fractures was supported by NIH and grants from NIA.

SOURCE: Ensrud KE et al. JAMA Intern Med. 2019 Jun 17. doi: 10.1001/jamainternmed.2019.0682.

It’s time to revisit legislation that exempts certain U.S. specialized cancer centers from the Medicare Prospective Payment System and from fully reporting measures of care and outcomes to the Centers for Medicare & Medicaid Services, a retrospective cohort study suggests.

The Prospective Payment System (PPS) exemption dates back to 1983 and allows exempted centers to be reimbursed on a reasonable cost basis rather than on a diagnosis-related group basis. Unlike centers that are a part of PPS, exempted centers are not required to report all process-of-care, outcome, and patient experience measures to CMS through its pay-for-performance programs.

In the new study, investigators working under senior author Karl Y. Bilimoria, MD, MS, director of the Surgical Outcomes and Quality Improvement Center and John B. Murphy Professor of Surgery at Northwestern University, Chicago, compared a variety of measures across hospital types. Data came from the American Hospital Association Annual Survey, U.S. News Best Hospitals rankings, and a sample of Medicare beneficiaries who underwent nine cancer operations.

Analyses were based on 15 hospitals affiliated with PPS-exempt cancer centers, 54 hospitals affiliated with National Cancer Institute–designated cancer centers, and 3,578 other U.S. hospitals providing cancer care. The results reported in JAMA Internal Medicine showed that hospitals affiliated with PPS-exempt cancer centers and hospitals affiliated with NCI cancer centers were similar on characteristics other than bed size and overall volume, which were larger for the latter, and on basic cancer-related services such as full-field digital mammography, genetic testing/counseling, chemotherapy, image-guided radiation, and hospice/palliative services.

U.S. News reputation scores averaged 17.5 for the PPS-exempt cancer center hospitals versus just 2.6 for the NCI cancer center hospitals (P less than .001). However, the two types of centers were statistically indistinguishable on oncology patient volume, patient safety ratings, comorbidity burden, nurse staffing, and U.S. News survival scores.

When it came to cancer operations, hospitals affiliated with PPS-exempt cancer centers and with NCI cancer centers had essentially the same adjusted postoperative outcomes for 15 of 18 measures, including mortality, readmission, and surgical site infections. Patients treated at the latter more often developed postoperative sepsis (3.1% vs. 1.7%; P = .002), acute renal failure (6.2% vs. 3.9%; P = .01), and urinary tract infection (6.4% vs. 4.0%; P = .002).

PPS-exempt cancer center hospitals had better outcomes than the group of other U.S. hospitals providing cancer care for 7 of the 18 oncology surgery measures, including mortality, sepsis, acute renal failure, pulmonary failure, and failure to rescue.

“Although PPS-exempt cancer centers may serve an important purpose by advancing the science and quality of cancer care, limited information is available on the selection of PPS-exempt cancer centers, their reimbursement, and how these centers compare with other hospitals with regard to quality of care,” Dr. Bilimoria and colleagues wrote.

“Our findings suggest the need for additional transparency, periodic reviews of the program by CMS, and consideration of whether the classification of PPS exemption should continue. Moreover, the requirement to publicly report cancer care–quality metrics should be uniformly applied across all types of hospitals, not just PPS-exempt cancer centers,” they concluded.

Dr. Bilimoria reported receiving support from the National Institutes of Health; Agency for Healthcare Research and Quality; American Board of Surgery; American College of Surgeons; and the Accreditation Council for Graduate Medical Education, Health Care. The study was supported by the Northwestern Institute for Comparative Effectiveness Research in Oncology of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

SOURCE: Bilimoria KY et al. JAMA Intern Med. 2019 June 17. doi: 10.1001/jamainternmed.2019.0914.

It’s time to revisit legislation that exempts certain U.S. specialized cancer centers from the Medicare Prospective Payment System and from fully reporting measures of care and outcomes to the Centers for Medicare & Medicaid Services, a retrospective cohort study suggests.

The Prospective Payment System (PPS) exemption dates back to 1983 and allows exempted centers to be reimbursed on a reasonable cost basis rather than on a diagnosis-related group basis. Unlike centers that are a part of PPS, exempted centers are not required to report all process-of-care, outcome, and patient experience measures to CMS through its pay-for-performance programs.

In the new study, investigators working under senior author Karl Y. Bilimoria, MD, MS, director of the Surgical Outcomes and Quality Improvement Center and John B. Murphy Professor of Surgery at Northwestern University, Chicago, compared a variety of measures across hospital types. Data came from the American Hospital Association Annual Survey, U.S. News Best Hospitals rankings, and a sample of Medicare beneficiaries who underwent nine cancer operations.

Analyses were based on 15 hospitals affiliated with PPS-exempt cancer centers, 54 hospitals affiliated with National Cancer Institute–designated cancer centers, and 3,578 other U.S. hospitals providing cancer care. The results reported in JAMA Internal Medicine showed that hospitals affiliated with PPS-exempt cancer centers and hospitals affiliated with NCI cancer centers were similar on characteristics other than bed size and overall volume, which were larger for the latter, and on basic cancer-related services such as full-field digital mammography, genetic testing/counseling, chemotherapy, image-guided radiation, and hospice/palliative services.

U.S. News reputation scores averaged 17.5 for the PPS-exempt cancer center hospitals versus just 2.6 for the NCI cancer center hospitals (P less than .001). However, the two types of centers were statistically indistinguishable on oncology patient volume, patient safety ratings, comorbidity burden, nurse staffing, and U.S. News survival scores.

When it came to cancer operations, hospitals affiliated with PPS-exempt cancer centers and with NCI cancer centers had essentially the same adjusted postoperative outcomes for 15 of 18 measures, including mortality, readmission, and surgical site infections. Patients treated at the latter more often developed postoperative sepsis (3.1% vs. 1.7%; P = .002), acute renal failure (6.2% vs. 3.9%; P = .01), and urinary tract infection (6.4% vs. 4.0%; P = .002).

PPS-exempt cancer center hospitals had better outcomes than the group of other U.S. hospitals providing cancer care for 7 of the 18 oncology surgery measures, including mortality, sepsis, acute renal failure, pulmonary failure, and failure to rescue.

“Although PPS-exempt cancer centers may serve an important purpose by advancing the science and quality of cancer care, limited information is available on the selection of PPS-exempt cancer centers, their reimbursement, and how these centers compare with other hospitals with regard to quality of care,” Dr. Bilimoria and colleagues wrote.

“Our findings suggest the need for additional transparency, periodic reviews of the program by CMS, and consideration of whether the classification of PPS exemption should continue. Moreover, the requirement to publicly report cancer care–quality metrics should be uniformly applied across all types of hospitals, not just PPS-exempt cancer centers,” they concluded.

Dr. Bilimoria reported receiving support from the National Institutes of Health; Agency for Healthcare Research and Quality; American Board of Surgery; American College of Surgeons; and the Accreditation Council for Graduate Medical Education, Health Care. The study was supported by the Northwestern Institute for Comparative Effectiveness Research in Oncology of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

SOURCE: Bilimoria KY et al. JAMA Intern Med. 2019 June 17. doi: 10.1001/jamainternmed.2019.0914.

It’s time to revisit legislation that exempts certain U.S. specialized cancer centers from the Medicare Prospective Payment System and from fully reporting measures of care and outcomes to the Centers for Medicare & Medicaid Services, a retrospective cohort study suggests.

The Prospective Payment System (PPS) exemption dates back to 1983 and allows exempted centers to be reimbursed on a reasonable cost basis rather than on a diagnosis-related group basis. Unlike centers that are a part of PPS, exempted centers are not required to report all process-of-care, outcome, and patient experience measures to CMS through its pay-for-performance programs.

In the new study, investigators working under senior author Karl Y. Bilimoria, MD, MS, director of the Surgical Outcomes and Quality Improvement Center and John B. Murphy Professor of Surgery at Northwestern University, Chicago, compared a variety of measures across hospital types. Data came from the American Hospital Association Annual Survey, U.S. News Best Hospitals rankings, and a sample of Medicare beneficiaries who underwent nine cancer operations.

Analyses were based on 15 hospitals affiliated with PPS-exempt cancer centers, 54 hospitals affiliated with National Cancer Institute–designated cancer centers, and 3,578 other U.S. hospitals providing cancer care. The results reported in JAMA Internal Medicine showed that hospitals affiliated with PPS-exempt cancer centers and hospitals affiliated with NCI cancer centers were similar on characteristics other than bed size and overall volume, which were larger for the latter, and on basic cancer-related services such as full-field digital mammography, genetic testing/counseling, chemotherapy, image-guided radiation, and hospice/palliative services.

U.S. News reputation scores averaged 17.5 for the PPS-exempt cancer center hospitals versus just 2.6 for the NCI cancer center hospitals (P less than .001). However, the two types of centers were statistically indistinguishable on oncology patient volume, patient safety ratings, comorbidity burden, nurse staffing, and U.S. News survival scores.

When it came to cancer operations, hospitals affiliated with PPS-exempt cancer centers and with NCI cancer centers had essentially the same adjusted postoperative outcomes for 15 of 18 measures, including mortality, readmission, and surgical site infections. Patients treated at the latter more often developed postoperative sepsis (3.1% vs. 1.7%; P = .002), acute renal failure (6.2% vs. 3.9%; P = .01), and urinary tract infection (6.4% vs. 4.0%; P = .002).

PPS-exempt cancer center hospitals had better outcomes than the group of other U.S. hospitals providing cancer care for 7 of the 18 oncology surgery measures, including mortality, sepsis, acute renal failure, pulmonary failure, and failure to rescue.

“Although PPS-exempt cancer centers may serve an important purpose by advancing the science and quality of cancer care, limited information is available on the selection of PPS-exempt cancer centers, their reimbursement, and how these centers compare with other hospitals with regard to quality of care,” Dr. Bilimoria and colleagues wrote.

“Our findings suggest the need for additional transparency, periodic reviews of the program by CMS, and consideration of whether the classification of PPS exemption should continue. Moreover, the requirement to publicly report cancer care–quality metrics should be uniformly applied across all types of hospitals, not just PPS-exempt cancer centers,” they concluded.

Dr. Bilimoria reported receiving support from the National Institutes of Health; Agency for Healthcare Research and Quality; American Board of Surgery; American College of Surgeons; and the Accreditation Council for Graduate Medical Education, Health Care. The study was supported by the Northwestern Institute for Comparative Effectiveness Research in Oncology of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

SOURCE: Bilimoria KY et al. JAMA Intern Med. 2019 June 17. doi: 10.1001/jamainternmed.2019.0914.

Many cardiac catheterization and electrophysiology laboratory directors receive significant payments from industry that could create conflicts of interest, according to a new study of payments to lab directors at top hospitals.

adventtr/iStock/Getty Images Plus

“With continued concerns about rising health care costs, it is important to ensure that physician decisions regarding choice of devices and other pharmaceutical therapies be driven by clinical and cost effectiveness, not industry influence,” Amarnath Annapureddy, MD, of the Yale School of Medicine, New Haven, Conn. and coauthors wrote in their study published in JAMA Internal Medicine.

Dr. Annapureddy and fellow researchers analyzed Open Payments Program data from 2017 to determine payments made to cardiac catheterization and electrophysiology laboratory directors the top 100 hospitals based on US News and World Report’s ranking. They compared those payments to payments made to local interventional cardiologists and electrophysiologists, along with payments to interventional cardiologists and electrophysiologists from across the country.

In 2017, the directors of the top cardiac catheterization and electrophysiology labs received $1,416,232 and $2,307,504 from industry, respectively. The median payments to cardiac catheterization lab directors were significantly higher ($3,203 [$388-$14,156]), compared with interventional cardiologists ($1,064 [$206-$4,104]). The results were similar comparing electrophysiology lab directors with electrophysiology physicians practicing in the same zip codes ($10,521 [$1,159-$35,076] versus $2,900 [$549-$13,101]).

Overall, nearly one-third of cardiac catheterization lab directors and nearly half of electrophysiology lab directors received payments of $10,000 or more, an amount the National Academy of Medicine noted as constituting “a significant conflict of interest.”

The coauthors acknowledged their study’s limitations, including the possibility that they misclassified some lab directors and the fact that Open Payments Program’s data may have been inaccurate. However, they also anticipated that “inaccuracies would not vary between laboratory directors and other clinicians.”

Dr. Nihar R. Desai reported receiving funding from the Centers for Medicare & Medicaid Services, financial support from Johnson & Johnson, and research support from the American College of Cardiology Foundation. Dr. Jeptha P. Curtis reported receiving salary support from the American College of Cardiology, funding from the Centers for Medicare & Medicaid Services, and equity interest in Medtronic. No other authors reported any relevant financial disclosures. No funding for the study was reported.

SOURCE: Annapureddy A et al. JAMA Intern Med. 2019 Jun 17. doi:10.1001/jamainternmed.2018.8775.

Many cardiac catheterization and electrophysiology laboratory directors receive significant payments from industry that could create conflicts of interest, according to a new study of payments to lab directors at top hospitals.

adventtr/iStock/Getty Images Plus

“With continued concerns about rising health care costs, it is important to ensure that physician decisions regarding choice of devices and other pharmaceutical therapies be driven by clinical and cost effectiveness, not industry influence,” Amarnath Annapureddy, MD, of the Yale School of Medicine, New Haven, Conn. and coauthors wrote in their study published in JAMA Internal Medicine.

Dr. Annapureddy and fellow researchers analyzed Open Payments Program data from 2017 to determine payments made to cardiac catheterization and electrophysiology laboratory directors the top 100 hospitals based on US News and World Report’s ranking. They compared those payments to payments made to local interventional cardiologists and electrophysiologists, along with payments to interventional cardiologists and electrophysiologists from across the country.

In 2017, the directors of the top cardiac catheterization and electrophysiology labs received $1,416,232 and $2,307,504 from industry, respectively. The median payments to cardiac catheterization lab directors were significantly higher ($3,203 [$388-$14,156]), compared with interventional cardiologists ($1,064 [$206-$4,104]). The results were similar comparing electrophysiology lab directors with electrophysiology physicians practicing in the same zip codes ($10,521 [$1,159-$35,076] versus $2,900 [$549-$13,101]).

Overall, nearly one-third of cardiac catheterization lab directors and nearly half of electrophysiology lab directors received payments of $10,000 or more, an amount the National Academy of Medicine noted as constituting “a significant conflict of interest.”

The coauthors acknowledged their study’s limitations, including the possibility that they misclassified some lab directors and the fact that Open Payments Program’s data may have been inaccurate. However, they also anticipated that “inaccuracies would not vary between laboratory directors and other clinicians.”

Dr. Nihar R. Desai reported receiving funding from the Centers for Medicare & Medicaid Services, financial support from Johnson & Johnson, and research support from the American College of Cardiology Foundation. Dr. Jeptha P. Curtis reported receiving salary support from the American College of Cardiology, funding from the Centers for Medicare & Medicaid Services, and equity interest in Medtronic. No other authors reported any relevant financial disclosures. No funding for the study was reported.

SOURCE: Annapureddy A et al. JAMA Intern Med. 2019 Jun 17. doi:10.1001/jamainternmed.2018.8775.

Many cardiac catheterization and electrophysiology laboratory directors receive significant payments from industry that could create conflicts of interest, according to a new study of payments to lab directors at top hospitals.

adventtr/iStock/Getty Images Plus

“With continued concerns about rising health care costs, it is important to ensure that physician decisions regarding choice of devices and other pharmaceutical therapies be driven by clinical and cost effectiveness, not industry influence,” Amarnath Annapureddy, MD, of the Yale School of Medicine, New Haven, Conn. and coauthors wrote in their study published in JAMA Internal Medicine.

Dr. Annapureddy and fellow researchers analyzed Open Payments Program data from 2017 to determine payments made to cardiac catheterization and electrophysiology laboratory directors the top 100 hospitals based on US News and World Report’s ranking. They compared those payments to payments made to local interventional cardiologists and electrophysiologists, along with payments to interventional cardiologists and electrophysiologists from across the country.

In 2017, the directors of the top cardiac catheterization and electrophysiology labs received $1,416,232 and $2,307,504 from industry, respectively. The median payments to cardiac catheterization lab directors were significantly higher ($3,203 [$388-$14,156]), compared with interventional cardiologists ($1,064 [$206-$4,104]). The results were similar comparing electrophysiology lab directors with electrophysiology physicians practicing in the same zip codes ($10,521 [$1,159-$35,076] versus $2,900 [$549-$13,101]).

Overall, nearly one-third of cardiac catheterization lab directors and nearly half of electrophysiology lab directors received payments of $10,000 or more, an amount the National Academy of Medicine noted as constituting “a significant conflict of interest.”

The coauthors acknowledged their study’s limitations, including the possibility that they misclassified some lab directors and the fact that Open Payments Program’s data may have been inaccurate. However, they also anticipated that “inaccuracies would not vary between laboratory directors and other clinicians.”

Dr. Nihar R. Desai reported receiving funding from the Centers for Medicare & Medicaid Services, financial support from Johnson & Johnson, and research support from the American College of Cardiology Foundation. Dr. Jeptha P. Curtis reported receiving salary support from the American College of Cardiology, funding from the Centers for Medicare & Medicaid Services, and equity interest in Medtronic. No other authors reported any relevant financial disclosures. No funding for the study was reported.

SOURCE: Annapureddy A et al. JAMA Intern Med. 2019 Jun 17. doi:10.1001/jamainternmed.2018.8775.

SAN ANTONIO – Lemborexant was effective in treating both sleep onset and maintenance variables in male and female subjects with insomnia, and it was well tolerated by both sexes, results from a pooled analysis showed.

Doug Brunk/MDedge News

A dual orexin receptor antagonist developed by Eisai, lemborexant is being studied as a treatment for insomnia disorder and irregular sleep-wake rhythm disorder. Early in 2019, the Food and Drug Administration accepted for review the New Drug Application for lemborexant for the treatment of insomnia. A target Prescription Drug User Fee Act date is set for Dec. 27, 2019.

“We evaluated early on whether exposure to lemborexant was going to be different between men and women,” lead study author Margaret Moline, PhD, said during an interview at the annual meeting of the Associated Professional Sleep Societies. “With some drugs, like zolpidem and other so-called Z drugs, because exposure is different, clinical studies could involve different dosing for different sexes. Because we knew the exposure to lemborexant wasn’t different between the sexes, we expected to see similar results in both sexes. That was the case.”

Dr. Moline, executive director of the Neurology Business Group and International Project Team Lead for the lemborexant clinical development program at Eisai, and colleagues presented pooled analyses of subject-reported sleep onset latency (sSOL) and subject-reported wake after sleep onset (sWASO) from lemborexant phase 3 studies, SUNRISE-1 and SUNRISE-2. SUNRISE-1 was a 1-month, double-blind, placebo- and active-controlled, parallel-group study in 1,006 subjects. Participants were females aged 55 years and older and males aged 65 years and older with a primary complaint of sleep maintenance difficulties and an Insomnia Severity Index (ISI) total score of 13 or higher. SUNRISE-2 was a placebo-controlled, 6-month, active treatment, double-blind, parallel-group study in 949 subjects with insomnia disorder. Participants were females and males aged 18 years and older with a primary complaint of sleep onset and/or sleep maintenance difficulties and an ISI total score of 15 or higher. Both analyses included subjects randomized to placebo, lemborexant 5 mg, or lemborexant 10 mg. Each study included a single-blind placebo run-in period prior to randomization.

The pooled analysis of 1,693 subjects included 402 (23.7%) men and 1,291 (76.3%) women. Results on sSOL and sWASO were consistent with the significant results on sleep diary in the individual studies. In both sexes, sSOL for lemborexant 5 mg and lemborexant 10 mg was significantly reduced versus that for placebo during the first 7 days and end of month 1 (P less than .05 for all comparisons). In women, the researchers observed significantly greater reductions in sWASO placebo for both lemborexant doses versus that with placebo (first 7 days and end of month 1; P less than .0001 for all comparisons). In males, sWASO decreased significantly, compared with placebo, for the first 7 days (lemborexant 5 mg and lemborexant 10 mg; P equal to or less than .0001) and at end of month 1 (lemborexant 10 mg only; P = .0032). For placebo, lemborexant 5 mg, and lemborexant 10 mg, the overall incidence of treatment-emergent adverse events was similar across sexes. Incidence of treatment-emergent serious adverse events was low for both sex subgroups; most events occurred in one subject each. Treatment-emergent adverse events leading to study drug withdrawal or interruption were few and similar across sexes for all treatments and was highest in males receiving lemborexant 10 mg. The most frequent treatment-emergent adverse events reported in males were somnolence, fatigue, and headache, while the most common in females were somnolence, headache, and urinary tract infection. About 3% of females (no males) reported a urinary tract infection; the incidence in females was similar across treatment groups.

“Overall, sleep diary outcomes in males and females were consistent with the significant results observed in the total populations of the individual studies,” Dr. Moline concluded. “A dose adjustment based on sex is not anticipated.”

The research was supported by Eisai. Dr. Moline is an employee of the company.

[email protected]

SOURCE: Moline M et al. Sleep 2019, Abstract 0368.

SAN ANTONIO – Lemborexant was effective in treating both sleep onset and maintenance variables in male and female subjects with insomnia, and it was well tolerated by both sexes, results from a pooled analysis showed.

Doug Brunk/MDedge News

A dual orexin receptor antagonist developed by Eisai, lemborexant is being studied as a treatment for insomnia disorder and irregular sleep-wake rhythm disorder. Early in 2019, the Food and Drug Administration accepted for review the New Drug Application for lemborexant for the treatment of insomnia. A target Prescription Drug User Fee Act date is set for Dec. 27, 2019.

“We evaluated early on whether exposure to lemborexant was going to be different between men and women,” lead study author Margaret Moline, PhD, said during an interview at the annual meeting of the Associated Professional Sleep Societies. “With some drugs, like zolpidem and other so-called Z drugs, because exposure is different, clinical studies could involve different dosing for different sexes. Because we knew the exposure to lemborexant wasn’t different between the sexes, we expected to see similar results in both sexes. That was the case.”

Dr. Moline, executive director of the Neurology Business Group and International Project Team Lead for the lemborexant clinical development program at Eisai, and colleagues presented pooled analyses of subject-reported sleep onset latency (sSOL) and subject-reported wake after sleep onset (sWASO) from lemborexant phase 3 studies, SUNRISE-1 and SUNRISE-2. SUNRISE-1 was a 1-month, double-blind, placebo- and active-controlled, parallel-group study in 1,006 subjects. Participants were females aged 55 years and older and males aged 65 years and older with a primary complaint of sleep maintenance difficulties and an Insomnia Severity Index (ISI) total score of 13 or higher. SUNRISE-2 was a placebo-controlled, 6-month, active treatment, double-blind, parallel-group study in 949 subjects with insomnia disorder. Participants were females and males aged 18 years and older with a primary complaint of sleep onset and/or sleep maintenance difficulties and an ISI total score of 15 or higher. Both analyses included subjects randomized to placebo, lemborexant 5 mg, or lemborexant 10 mg. Each study included a single-blind placebo run-in period prior to randomization.

The pooled analysis of 1,693 subjects included 402 (23.7%) men and 1,291 (76.3%) women. Results on sSOL and sWASO were consistent with the significant results on sleep diary in the individual studies. In both sexes, sSOL for lemborexant 5 mg and lemborexant 10 mg was significantly reduced versus that for placebo during the first 7 days and end of month 1 (P less than .05 for all comparisons). In women, the researchers observed significantly greater reductions in sWASO placebo for both lemborexant doses versus that with placebo (first 7 days and end of month 1; P less than .0001 for all comparisons). In males, sWASO decreased significantly, compared with placebo, for the first 7 days (lemborexant 5 mg and lemborexant 10 mg; P equal to or less than .0001) and at end of month 1 (lemborexant 10 mg only; P = .0032). For placebo, lemborexant 5 mg, and lemborexant 10 mg, the overall incidence of treatment-emergent adverse events was similar across sexes. Incidence of treatment-emergent serious adverse events was low for both sex subgroups; most events occurred in one subject each. Treatment-emergent adverse events leading to study drug withdrawal or interruption were few and similar across sexes for all treatments and was highest in males receiving lemborexant 10 mg. The most frequent treatment-emergent adverse events reported in males were somnolence, fatigue, and headache, while the most common in females were somnolence, headache, and urinary tract infection. About 3% of females (no males) reported a urinary tract infection; the incidence in females was similar across treatment groups.

“Overall, sleep diary outcomes in males and females were consistent with the significant results observed in the total populations of the individual studies,” Dr. Moline concluded. “A dose adjustment based on sex is not anticipated.”

The research was supported by Eisai. Dr. Moline is an employee of the company.

[email protected]

SOURCE: Moline M et al. Sleep 2019, Abstract 0368.

SAN ANTONIO – Lemborexant was effective in treating both sleep onset and maintenance variables in male and female subjects with insomnia, and it was well tolerated by both sexes, results from a pooled analysis showed.

Doug Brunk/MDedge News

A dual orexin receptor antagonist developed by Eisai, lemborexant is being studied as a treatment for insomnia disorder and irregular sleep-wake rhythm disorder. Early in 2019, the Food and Drug Administration accepted for review the New Drug Application for lemborexant for the treatment of insomnia. A target Prescription Drug User Fee Act date is set for Dec. 27, 2019.

“We evaluated early on whether exposure to lemborexant was going to be different between men and women,” lead study author Margaret Moline, PhD, said during an interview at the annual meeting of the Associated Professional Sleep Societies. “With some drugs, like zolpidem and other so-called Z drugs, because exposure is different, clinical studies could involve different dosing for different sexes. Because we knew the exposure to lemborexant wasn’t different between the sexes, we expected to see similar results in both sexes. That was the case.”

Dr. Moline, executive director of the Neurology Business Group and International Project Team Lead for the lemborexant clinical development program at Eisai, and colleagues presented pooled analyses of subject-reported sleep onset latency (sSOL) and subject-reported wake after sleep onset (sWASO) from lemborexant phase 3 studies, SUNRISE-1 and SUNRISE-2. SUNRISE-1 was a 1-month, double-blind, placebo- and active-controlled, parallel-group study in 1,006 subjects. Participants were females aged 55 years and older and males aged 65 years and older with a primary complaint of sleep maintenance difficulties and an Insomnia Severity Index (ISI) total score of 13 or higher. SUNRISE-2 was a placebo-controlled, 6-month, active treatment, double-blind, parallel-group study in 949 subjects with insomnia disorder. Participants were females and males aged 18 years and older with a primary complaint of sleep onset and/or sleep maintenance difficulties and an ISI total score of 15 or higher. Both analyses included subjects randomized to placebo, lemborexant 5 mg, or lemborexant 10 mg. Each study included a single-blind placebo run-in period prior to randomization.

The pooled analysis of 1,693 subjects included 402 (23.7%) men and 1,291 (76.3%) women. Results on sSOL and sWASO were consistent with the significant results on sleep diary in the individual studies. In both sexes, sSOL for lemborexant 5 mg and lemborexant 10 mg was significantly reduced versus that for placebo during the first 7 days and end of month 1 (P less than .05 for all comparisons). In women, the researchers observed significantly greater reductions in sWASO placebo for both lemborexant doses versus that with placebo (first 7 days and end of month 1; P less than .0001 for all comparisons). In males, sWASO decreased significantly, compared with placebo, for the first 7 days (lemborexant 5 mg and lemborexant 10 mg; P equal to or less than .0001) and at end of month 1 (lemborexant 10 mg only; P = .0032). For placebo, lemborexant 5 mg, and lemborexant 10 mg, the overall incidence of treatment-emergent adverse events was similar across sexes. Incidence of treatment-emergent serious adverse events was low for both sex subgroups; most events occurred in one subject each. Treatment-emergent adverse events leading to study drug withdrawal or interruption were few and similar across sexes for all treatments and was highest in males receiving lemborexant 10 mg. The most frequent treatment-emergent adverse events reported in males were somnolence, fatigue, and headache, while the most common in females were somnolence, headache, and urinary tract infection. About 3% of females (no males) reported a urinary tract infection; the incidence in females was similar across treatment groups.

“Overall, sleep diary outcomes in males and females were consistent with the significant results observed in the total populations of the individual studies,” Dr. Moline concluded. “A dose adjustment based on sex is not anticipated.”

The research was supported by Eisai. Dr. Moline is an employee of the company.

[email protected]

SOURCE: Moline M et al. Sleep 2019, Abstract 0368.

Osteosarcoma (OS) is a rare disease with approximately 800- 900 newly diagnosed cases each year in the United States. Of those, the majority occur about the knee. The distal femur is the most common site, followed by the proximal tibia, with the proximal humerus being a distant third. OS of the clavicle has been reported, with the earliest case report dating from 1975.1 Since then, additional case reports of high-grade OS of the clavicle have been published.^2,3 We describe the case of a 16-year-old female who presented with a mass on her right medial clavicle, which was confirmed to be a low-grade central OS.

Case Presentation

The patient is a 16-year-old female who presented to the Emergency Department (ED) for evaluation of a mass on her right clavicle, after being evaluated by her primary care physician (PCP). She noted an enlarging mass over the previous 2 months but stated that it had been asymptomatic until 4 days prior to presentation to her PCP, at which time she had developed tenderness to palpation and pain with range of motion of the right arm. X-rays were obtained at the PCP’s office and she was referred to the ED for further evaluation. She denied constitutional symptoms.

At the ED visit, she was noted to have an area of erythema and tenderness over the medial aspect of the right clavicle with increased bony prominence. A chest x-ray demonstrated medial clavicle enlargement with periosteal reaction and sclerosis (Figure 1).

MRI demonstrated a 6-cm x 3.8-cm x 4.1-cm mass arising from the right medial clavicle with cortical destruction and concomitant displacement of the right subclavian and brachiocephalic veins (Figure 2). A CT-guided biopsy was performed 1 week later and demonstrated low-grade OS. The pathologist was concerned about the possibility of sampling error and the presence of a higher-grade component, as low-grade OS of the clavicle had not been reported.

The patient was evaluated by a pediatric hematologist/oncologist 2 weeks later after having obtained the biopsy and a PET/CT scan. At that time, the PET/CT showed an FDG-avid mass at the clavicle without evidence of pulmonary metastatic disease (Figure 3). She was subsequently evaluated by orthopedic oncology, at which time a discussion was had regarding further treatment. There was essentially no literature to guide the surgical and medical teams, as low-grade clavicular OS is unknown. Based on the evidence of localized, low-grade disease, the determination was made to proceedwith surgical resection. In the event that high-grade disease was identified at the time of final pathological evaluation, the pediatric hematology/oncology team felt that administering all of the patient’s chemotherapy postoperatively would be acceptable and not affect her long-term prognosis. CT and CT angiogram were obtained for further operative planning (Figure 4).

Given the intimacy of the mass to the subclavian vessels, she was also seen preoperatively by pediatric general and cardiothoracic surgeons. The plan was formulated to have them in the operating room for mobilization of the subclavian vessels and in the event that a sternotomy was required for proximal control of the vessels. Following this visit, the case was discussed at the multidisciplinary pediatric tumor board and the consensus was to proceed with surgical resection.

Surgical Technique

General endotracheal anesthesia was administered without complication. The patient was positioned supine with a soft bump under her shoulders to place her neck in slight extension and thus facilitate access to the clavicle and great vessels. A 14-cm oblique incision was made over the subcutaneous clavicle extending to the contralateral sternoclavicular joint. Dissection was carried down to the fascia and the biopsy site was excised with the skin paddle. Dissection was carried through the sternocleidomastoid superiorly and the pectoralis major inferiorly, to 8 cm lateral from the right sternoclavicular joint. The clavicle was osteotomized well lateral of the palpable tumor and a marrow margin was sent for frozen section, which was found to be negative.

Dissection was continued circumferentially. Assistance from pediatric general and cardiothoracic surgery was required at the inferior aspect of the mass to assist with exposure and control of the subclavian vein (Figure 5A). A large branch of the subclavian vein near its junction with the internal jugular vein was found to be involved with the tumor and thus required suture ligation. The subclavian vein was noted to be intimate with the mass and somewhat friable. With the vein mobilized, a cuff of normal tissue was obtained inferiorly and superiorly to the mass. Medially, the sternoclavicular joint was disarticulated (Figure 5B). At this point, the specimen was delivered from the operative field and tagged in the usual fashion (Figure 5C). A medial soft tissue margin from the sternal side of the sternoclavicular joint was also sent and found to be negative for tumor. The wound was closed in layered fashion over a ¼” Penrose drain. A soft dressing was placed, and the patient was successfully extubated and transferred to the post-anesthesia care unit in stable condition.

Postoperative Course

The patient was found to be neurologically and vascularly intact on postoperative exam and was discharged on postoperative day 1.

She was seen 14 days postoperatively and was doing well at that time, with full range of motion of the shoulder, elbow, wrist, and hand. Final pathology confirmed a low-grade OS with extraosseous extension. All margins were negative except the medial (sternoclavicular joint) margin and the inferior margin adjacent to the subclavian vein. The intraoperative frozen section from the medial margin was negative for tumor.

The pediatric hematology/oncology team determined that, as no high-grade areas were identified, chemotherapy should be deferred. The positive margins were also discussed with the patient and her family specifically regarding further possible treatments. The findings from the pathology were discussed in a multidisciplinary tumor board and it was felt that, given the low-grade nature of the lesion as well as the high morbidity and risk of mortality with further surgery, additional surgery would be potentially more harmful than helpful. Additionally, low-grade OS is extremely resistant to radiotherapy. The plan remains to monitor her for local recurrence as well as metastases with serial imaging.

Discussion

The clavicle is one of the first bones in the body to ossify but one of the last to have final physeal closure. Its unique characteristics have led to various descriptions, such as a “short tubular bone” versus a “flat bone.”^4,5 Of note are its paucity of a true intramedullary space and scanty red marrow, which make it an unlikely site for a primarily intramedullary- based neoplasm to arise.4 However, it has also been noted that malignant lesions are more common in the clavicle than benign lesions, and special attention should be paid to aggressiveappearing lesions in the clavicle.

Radiographs can be misleading as well. Prior studies have demonstrated that low-grade central OS can be readily misdiagnosed as fibrous dysplasia, desmoplastic fibroma, nonossifying fibroma, osteoblastoma, and aneurysmal bone cyst.6 Findings found in low-grade OS can include evidence of cortical interruption, local soft tissue mass development, intramedullary involvement, cortical destruction, and poor margination; however, low-grade OS is typically sclerotic and highly trabeculated. Cross-sectional imaging can help differentiate between OS and other more benign pathologies and should be considered in the clavicle where biopsy may be perilous.⁵

In this case, wide resection was carried out with the subclavian vein as the posterior-inferior margin and the sternoclavicular joint as the medial margin. Though the intra-operative medial margin was clear of disease, final pathology demonstrated focal (microscopic) involvement of the posterior and medial margins. A study of soft tissue sarcoma evaluated positive margins and concluded that the imperative of preservation of vital structures supersedes the need for negative margins.^7,8 The rate of metastasis and overall survival was similar to surgical resections with positive margins. In the case of our patient, further resection would have carried significant morbidity and possibly mortality, including sacrifice of the major vessels to the arm below and entering into the sternum and thoracic cavity. The likely disability as well as the hazards of surgery were deemed to be too great to justify further excision. Frequent cross-sectional imaging will be necessary to evaluate the presence of recurrent or metastatic disease. To our knowledge, this is the first documented case of low-grade clavicle OS. This report demonstrates the need for multidisciplinary sarcoma care at a center of excellence, particularly in instances of unusual diagnoses.

Osteosarcoma (OS) is a rare disease with approximately 800- 900 newly diagnosed cases each year in the United States. Of those, the majority occur about the knee. The distal femur is the most common site, followed by the proximal tibia, with the proximal humerus being a distant third. OS of the clavicle has been reported, with the earliest case report dating from 1975.1 Since then, additional case reports of high-grade OS of the clavicle have been published.^2,3 We describe the case of a 16-year-old female who presented with a mass on her right medial clavicle, which was confirmed to be a low-grade central OS.

Case Presentation

The patient is a 16-year-old female who presented to the Emergency Department (ED) for evaluation of a mass on her right clavicle, after being evaluated by her primary care physician (PCP). She noted an enlarging mass over the previous 2 months but stated that it had been asymptomatic until 4 days prior to presentation to her PCP, at which time she had developed tenderness to palpation and pain with range of motion of the right arm. X-rays were obtained at the PCP’s office and she was referred to the ED for further evaluation. She denied constitutional symptoms.

At the ED visit, she was noted to have an area of erythema and tenderness over the medial aspect of the right clavicle with increased bony prominence. A chest x-ray demonstrated medial clavicle enlargement with periosteal reaction and sclerosis (Figure 1).

MRI demonstrated a 6-cm x 3.8-cm x 4.1-cm mass arising from the right medial clavicle with cortical destruction and concomitant displacement of the right subclavian and brachiocephalic veins (Figure 2). A CT-guided biopsy was performed 1 week later and demonstrated low-grade OS. The pathologist was concerned about the possibility of sampling error and the presence of a higher-grade component, as low-grade OS of the clavicle had not been reported.

The patient was evaluated by a pediatric hematologist/oncologist 2 weeks later after having obtained the biopsy and a PET/CT scan. At that time, the PET/CT showed an FDG-avid mass at the clavicle without evidence of pulmonary metastatic disease (Figure 3). She was subsequently evaluated by orthopedic oncology, at which time a discussion was had regarding further treatment. There was essentially no literature to guide the surgical and medical teams, as low-grade clavicular OS is unknown. Based on the evidence of localized, low-grade disease, the determination was made to proceedwith surgical resection. In the event that high-grade disease was identified at the time of final pathological evaluation, the pediatric hematology/oncology team felt that administering all of the patient’s chemotherapy postoperatively would be acceptable and not affect her long-term prognosis. CT and CT angiogram were obtained for further operative planning (Figure 4).

Given the intimacy of the mass to the subclavian vessels, she was also seen preoperatively by pediatric general and cardiothoracic surgeons. The plan was formulated to have them in the operating room for mobilization of the subclavian vessels and in the event that a sternotomy was required for proximal control of the vessels. Following this visit, the case was discussed at the multidisciplinary pediatric tumor board and the consensus was to proceed with surgical resection.

Surgical Technique

General endotracheal anesthesia was administered without complication. The patient was positioned supine with a soft bump under her shoulders to place her neck in slight extension and thus facilitate access to the clavicle and great vessels. A 14-cm oblique incision was made over the subcutaneous clavicle extending to the contralateral sternoclavicular joint. Dissection was carried down to the fascia and the biopsy site was excised with the skin paddle. Dissection was carried through the sternocleidomastoid superiorly and the pectoralis major inferiorly, to 8 cm lateral from the right sternoclavicular joint. The clavicle was osteotomized well lateral of the palpable tumor and a marrow margin was sent for frozen section, which was found to be negative.

Dissection was continued circumferentially. Assistance from pediatric general and cardiothoracic surgery was required at the inferior aspect of the mass to assist with exposure and control of the subclavian vein (Figure 5A). A large branch of the subclavian vein near its junction with the internal jugular vein was found to be involved with the tumor and thus required suture ligation. The subclavian vein was noted to be intimate with the mass and somewhat friable. With the vein mobilized, a cuff of normal tissue was obtained inferiorly and superiorly to the mass. Medially, the sternoclavicular joint was disarticulated (Figure 5B). At this point, the specimen was delivered from the operative field and tagged in the usual fashion (Figure 5C). A medial soft tissue margin from the sternal side of the sternoclavicular joint was also sent and found to be negative for tumor. The wound was closed in layered fashion over a ¼” Penrose drain. A soft dressing was placed, and the patient was successfully extubated and transferred to the post-anesthesia care unit in stable condition.

Postoperative Course

The patient was found to be neurologically and vascularly intact on postoperative exam and was discharged on postoperative day 1.

She was seen 14 days postoperatively and was doing well at that time, with full range of motion of the shoulder, elbow, wrist, and hand. Final pathology confirmed a low-grade OS with extraosseous extension. All margins were negative except the medial (sternoclavicular joint) margin and the inferior margin adjacent to the subclavian vein. The intraoperative frozen section from the medial margin was negative for tumor.

The pediatric hematology/oncology team determined that, as no high-grade areas were identified, chemotherapy should be deferred. The positive margins were also discussed with the patient and her family specifically regarding further possible treatments. The findings from the pathology were discussed in a multidisciplinary tumor board and it was felt that, given the low-grade nature of the lesion as well as the high morbidity and risk of mortality with further surgery, additional surgery would be potentially more harmful than helpful. Additionally, low-grade OS is extremely resistant to radiotherapy. The plan remains to monitor her for local recurrence as well as metastases with serial imaging.

Discussion

The clavicle is one of the first bones in the body to ossify but one of the last to have final physeal closure. Its unique characteristics have led to various descriptions, such as a “short tubular bone” versus a “flat bone.”^4,5 Of note are its paucity of a true intramedullary space and scanty red marrow, which make it an unlikely site for a primarily intramedullary- based neoplasm to arise.4 However, it has also been noted that malignant lesions are more common in the clavicle than benign lesions, and special attention should be paid to aggressiveappearing lesions in the clavicle.

Radiographs can be misleading as well. Prior studies have demonstrated that low-grade central OS can be readily misdiagnosed as fibrous dysplasia, desmoplastic fibroma, nonossifying fibroma, osteoblastoma, and aneurysmal bone cyst.6 Findings found in low-grade OS can include evidence of cortical interruption, local soft tissue mass development, intramedullary involvement, cortical destruction, and poor margination; however, low-grade OS is typically sclerotic and highly trabeculated. Cross-sectional imaging can help differentiate between OS and other more benign pathologies and should be considered in the clavicle where biopsy may be perilous.⁵

In this case, wide resection was carried out with the subclavian vein as the posterior-inferior margin and the sternoclavicular joint as the medial margin. Though the intra-operative medial margin was clear of disease, final pathology demonstrated focal (microscopic) involvement of the posterior and medial margins. A study of soft tissue sarcoma evaluated positive margins and concluded that the imperative of preservation of vital structures supersedes the need for negative margins.^7,8 The rate of metastasis and overall survival was similar to surgical resections with positive margins. In the case of our patient, further resection would have carried significant morbidity and possibly mortality, including sacrifice of the major vessels to the arm below and entering into the sternum and thoracic cavity. The likely disability as well as the hazards of surgery were deemed to be too great to justify further excision. Frequent cross-sectional imaging will be necessary to evaluate the presence of recurrent or metastatic disease. To our knowledge, this is the first documented case of low-grade clavicle OS. This report demonstrates the need for multidisciplinary sarcoma care at a center of excellence, particularly in instances of unusual diagnoses.

Osteosarcoma (OS) is a rare disease with approximately 800- 900 newly diagnosed cases each year in the United States. Of those, the majority occur about the knee. The distal femur is the most common site, followed by the proximal tibia, with the proximal humerus being a distant third. OS of the clavicle has been reported, with the earliest case report dating from 1975.1 Since then, additional case reports of high-grade OS of the clavicle have been published.^2,3 We describe the case of a 16-year-old female who presented with a mass on her right medial clavicle, which was confirmed to be a low-grade central OS.

Case Presentation

The patient is a 16-year-old female who presented to the Emergency Department (ED) for evaluation of a mass on her right clavicle, after being evaluated by her primary care physician (PCP). She noted an enlarging mass over the previous 2 months but stated that it had been asymptomatic until 4 days prior to presentation to her PCP, at which time she had developed tenderness to palpation and pain with range of motion of the right arm. X-rays were obtained at the PCP’s office and she was referred to the ED for further evaluation. She denied constitutional symptoms.

At the ED visit, she was noted to have an area of erythema and tenderness over the medial aspect of the right clavicle with increased bony prominence. A chest x-ray demonstrated medial clavicle enlargement with periosteal reaction and sclerosis (Figure 1).

MRI demonstrated a 6-cm x 3.8-cm x 4.1-cm mass arising from the right medial clavicle with cortical destruction and concomitant displacement of the right subclavian and brachiocephalic veins (Figure 2). A CT-guided biopsy was performed 1 week later and demonstrated low-grade OS. The pathologist was concerned about the possibility of sampling error and the presence of a higher-grade component, as low-grade OS of the clavicle had not been reported.

The patient was evaluated by a pediatric hematologist/oncologist 2 weeks later after having obtained the biopsy and a PET/CT scan. At that time, the PET/CT showed an FDG-avid mass at the clavicle without evidence of pulmonary metastatic disease (Figure 3). She was subsequently evaluated by orthopedic oncology, at which time a discussion was had regarding further treatment. There was essentially no literature to guide the surgical and medical teams, as low-grade clavicular OS is unknown. Based on the evidence of localized, low-grade disease, the determination was made to proceedwith surgical resection. In the event that high-grade disease was identified at the time of final pathological evaluation, the pediatric hematology/oncology team felt that administering all of the patient’s chemotherapy postoperatively would be acceptable and not affect her long-term prognosis. CT and CT angiogram were obtained for further operative planning (Figure 4).

Given the intimacy of the mass to the subclavian vessels, she was also seen preoperatively by pediatric general and cardiothoracic surgeons. The plan was formulated to have them in the operating room for mobilization of the subclavian vessels and in the event that a sternotomy was required for proximal control of the vessels. Following this visit, the case was discussed at the multidisciplinary pediatric tumor board and the consensus was to proceed with surgical resection.

Surgical Technique

General endotracheal anesthesia was administered without complication. The patient was positioned supine with a soft bump under her shoulders to place her neck in slight extension and thus facilitate access to the clavicle and great vessels. A 14-cm oblique incision was made over the subcutaneous clavicle extending to the contralateral sternoclavicular joint. Dissection was carried down to the fascia and the biopsy site was excised with the skin paddle. Dissection was carried through the sternocleidomastoid superiorly and the pectoralis major inferiorly, to 8 cm lateral from the right sternoclavicular joint. The clavicle was osteotomized well lateral of the palpable tumor and a marrow margin was sent for frozen section, which was found to be negative.

Dissection was continued circumferentially. Assistance from pediatric general and cardiothoracic surgery was required at the inferior aspect of the mass to assist with exposure and control of the subclavian vein (Figure 5A). A large branch of the subclavian vein near its junction with the internal jugular vein was found to be involved with the tumor and thus required suture ligation. The subclavian vein was noted to be intimate with the mass and somewhat friable. With the vein mobilized, a cuff of normal tissue was obtained inferiorly and superiorly to the mass. Medially, the sternoclavicular joint was disarticulated (Figure 5B). At this point, the specimen was delivered from the operative field and tagged in the usual fashion (Figure 5C). A medial soft tissue margin from the sternal side of the sternoclavicular joint was also sent and found to be negative for tumor. The wound was closed in layered fashion over a ¼” Penrose drain. A soft dressing was placed, and the patient was successfully extubated and transferred to the post-anesthesia care unit in stable condition.

Postoperative Course

The patient was found to be neurologically and vascularly intact on postoperative exam and was discharged on postoperative day 1.

She was seen 14 days postoperatively and was doing well at that time, with full range of motion of the shoulder, elbow, wrist, and hand. Final pathology confirmed a low-grade OS with extraosseous extension. All margins were negative except the medial (sternoclavicular joint) margin and the inferior margin adjacent to the subclavian vein. The intraoperative frozen section from the medial margin was negative for tumor.

The pediatric hematology/oncology team determined that, as no high-grade areas were identified, chemotherapy should be deferred. The positive margins were also discussed with the patient and her family specifically regarding further possible treatments. The findings from the pathology were discussed in a multidisciplinary tumor board and it was felt that, given the low-grade nature of the lesion as well as the high morbidity and risk of mortality with further surgery, additional surgery would be potentially more harmful than helpful. Additionally, low-grade OS is extremely resistant to radiotherapy. The plan remains to monitor her for local recurrence as well as metastases with serial imaging.

Discussion

The clavicle is one of the first bones in the body to ossify but one of the last to have final physeal closure. Its unique characteristics have led to various descriptions, such as a “short tubular bone” versus a “flat bone.”^4,5 Of note are its paucity of a true intramedullary space and scanty red marrow, which make it an unlikely site for a primarily intramedullary- based neoplasm to arise.4 However, it has also been noted that malignant lesions are more common in the clavicle than benign lesions, and special attention should be paid to aggressiveappearing lesions in the clavicle.

Radiographs can be misleading as well. Prior studies have demonstrated that low-grade central OS can be readily misdiagnosed as fibrous dysplasia, desmoplastic fibroma, nonossifying fibroma, osteoblastoma, and aneurysmal bone cyst.6 Findings found in low-grade OS can include evidence of cortical interruption, local soft tissue mass development, intramedullary involvement, cortical destruction, and poor margination; however, low-grade OS is typically sclerotic and highly trabeculated. Cross-sectional imaging can help differentiate between OS and other more benign pathologies and should be considered in the clavicle where biopsy may be perilous.⁵

In this case, wide resection was carried out with the subclavian vein as the posterior-inferior margin and the sternoclavicular joint as the medial margin. Though the intra-operative medial margin was clear of disease, final pathology demonstrated focal (microscopic) involvement of the posterior and medial margins. A study of soft tissue sarcoma evaluated positive margins and concluded that the imperative of preservation of vital structures supersedes the need for negative margins.^7,8 The rate of metastasis and overall survival was similar to surgical resections with positive margins. In the case of our patient, further resection would have carried significant morbidity and possibly mortality, including sacrifice of the major vessels to the arm below and entering into the sternum and thoracic cavity. The likely disability as well as the hazards of surgery were deemed to be too great to justify further excision. Frequent cross-sectional imaging will be necessary to evaluate the presence of recurrent or metastatic disease. To our knowledge, this is the first documented case of low-grade clavicle OS. This report demonstrates the need for multidisciplinary sarcoma care at a center of excellence, particularly in instances of unusual diagnoses.

How have you managed a possible infected aortitis, a severe focal stenosis or a fractured carotid stent? Give your input in discussions about these topics, and more, on your online community, SVSConnect. If you attended VAM last week, continue the discussions with other attendees. All SVS members can participate in discussions – log in here with your SVS credentials. Reach out to [email protected] or call 312-334-2300 with questions.

How have you managed a possible infected aortitis, a severe focal stenosis or a fractured carotid stent? Give your input in discussions about these topics, and more, on your online community, SVSConnect. If you attended VAM last week, continue the discussions with other attendees. All SVS members can participate in discussions – log in here with your SVS credentials. Reach out to [email protected] or call 312-334-2300 with questions.

How have you managed a possible infected aortitis, a severe focal stenosis or a fractured carotid stent? Give your input in discussions about these topics, and more, on your online community, SVSConnect. If you attended VAM last week, continue the discussions with other attendees. All SVS members can participate in discussions – log in here with your SVS credentials. Reach out to [email protected] or call 312-334-2300 with questions.

The SVS has recently re-vamped its newsletters geared towards future vascular surgeons. These provide residents, students and vascular trainees with up-to-date information on upcoming events, awards and scholarships, open positions and more. These are sent on a bi-weekly and monthly basis, depending on what content you are interested in. Learn more and subscribe here. They will also be posted on the SVS future vascular surgeon’s Twitter and Facebook.

The SVS has recently re-vamped its newsletters geared towards future vascular surgeons. These provide residents, students and vascular trainees with up-to-date information on upcoming events, awards and scholarships, open positions and more. These are sent on a bi-weekly and monthly basis, depending on what content you are interested in. Learn more and subscribe here. They will also be posted on the SVS future vascular surgeon’s Twitter and Facebook.

The SVS has recently re-vamped its newsletters geared towards future vascular surgeons. These provide residents, students and vascular trainees with up-to-date information on upcoming events, awards and scholarships, open positions and more. These are sent on a bi-weekly and monthly basis, depending on what content you are interested in. Learn more and subscribe here. They will also be posted on the SVS future vascular surgeon’s Twitter and Facebook.

The SVS Foundation developed the Research Career Development Travel Awards program to develop strong leaders in vascular surgery research. Recipients of the award will be assigned SVS research mentors who will provide guidance and discuss academic career advancement. They’ll also receive financial support to be used for travel, hotel accommodations and registration expenses for a research course. Applicants must be an SVS Candidate or Active Member who’s completed postgraduate clinical training in vascular surgery and has been in practice no more than seven years. Apply before August 15 to be considered.

The SVS Foundation developed the Research Career Development Travel Awards program to develop strong leaders in vascular surgery research. Recipients of the award will be assigned SVS research mentors who will provide guidance and discuss academic career advancement. They’ll also receive financial support to be used for travel, hotel accommodations and registration expenses for a research course. Applicants must be an SVS Candidate or Active Member who’s completed postgraduate clinical training in vascular surgery and has been in practice no more than seven years. Apply before August 15 to be considered.

The SVS Foundation developed the Research Career Development Travel Awards program to develop strong leaders in vascular surgery research. Recipients of the award will be assigned SVS research mentors who will provide guidance and discuss academic career advancement. They’ll also receive financial support to be used for travel, hotel accommodations and registration expenses for a research course. Applicants must be an SVS Candidate or Active Member who’s completed postgraduate clinical training in vascular surgery and has been in practice no more than seven years. Apply before August 15 to be considered.

CRYSTAL CITY, VA. – Some patients experience consistent suicidal ideation – but most do not, an expert said at Focus on Neuropsychiatry presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Highwaystarz-Photography/Thinkstock

“In most patients, the ideation tends to go up and down – which means you ask the patient about the most severe example of suicidal ideation … in the last week or 2,” J. John Mann, MD, said. Getting a handle on patients’ worst suicidal ideation also can provide clues into the range of suicidal behavior they might be subject to, he added.

U.S. suicide rates have increased dramatically since 2000, and most people who die by suicide had depression, said Dr. Mann, the Paul Janssen Professor of Translational Neuroscience (in psychiatry and in radiology) at Columbia University, New York. However, those patients who are depressed tend to attempt suicide early in their depression.

“Most people with a major depressive episode never attempt suicide,” said Dr. Mann, who also is affiliated with the New York State Psychiatric Institute. “Suicidal behavior is not a ‘wear and tear’ phenomenon.”

When assessing risk of suicide clinically, patients most at risk include those with past history of suicide attempts, a family history of suicide, and those who have the worst suicidal ideation.

About half of the predisposition to suicidal behavior is genetic and independent of genetic risk associated with major psychiatric disorders. This genetic risk affects the diathesis each patient has for suicidal behavior. In the stress-diathesis model for suicidal behavior, stress from major depressive episodes and life events contributes to the patient’s perception of stress, which in turn contributes to that patient’s response to stress. Rather than depression itself being a suicidal trigger, these stressors in the form of adverse life events appear to be the trigger for suicide attempts, Dr. Mann noted.

“All of the risk is pretty much accounted for by whether the patient was in or out of an episode of major depression,” said Dr. Mann. “If they were in an episode of major depression, all the risk was accounted for by the major depression, and the stressors counted for enough. When they’re out of an episode of major depression, the risk fell right away and the stressors didn’t matter much.”

In the stress-diathesis model, trait components of suicidal behavior include mood and emotion dysregulation and perception; misreading social signals; reactive or impulsive aggressive traits of decision making or delayed discounting; and altered learning, memory, and problem solving. However, clinicians should look to the patients for whom depression appears more painful in subjective scores, because going by these trait components alone will not distinguish between patients at risk for suicide and those who will not make an attempt.

According to the Columbia Classification Algorithm of Suicide Assessment, suicide is distinguished by whether a patient wished to die, if an attempt is stopped by themselves or another person before harm has begun, and whether a patient prepared for the act beyond verbalizing or thinking of suicide but before harm has begun.

In addition to prescribing antidepressants, treatments with evidence for preventing suicide include means restriction and cognitive-behavioral therapy. For patients with borderline personality disorder, dialectical behavior therapy has proven effective. School interventions that educate students about mental health also have shown effectiveness. Other strategies include educating reporters about media guidelines on writing about suicide. Internet outreach interventions are promising, he said, but more evidence is needed to determine whether they work.

Among antidepressant options for patients with suicidal ideation, fluoxetine appears best for adolescents, and data show that venlafaxine is effective in adults. The Food and Drug Administration originally put a black box warning on selective serotonin reuptake inhibitors in 2004; however, recent data have shown that the increased risk of suicidal ideation brought on by those medications tapers off after the first week on the medication. Meanwhile, in the case of ketamine, there is “rapid and robust improvement” in depressive symptoms and suicidal ideation, which targets the diathesis, Dr. Mann said at the meeting presented by Global Academy for Medical Education.

“We need to identify rapidly acting antisuicidal medications, and we now see there’s a clear path forward to do that” with treatments like ketamine, he said.

Dr. Mann’s presentation was based on research funded by the National Institute of Mental Health and the Brain & Behavior Research Foundation. He reported receiving royalties from the Research Foundation for Mental Hygiene for commercial use of the Columbia-Suicide Severity Rating Scale.

Global Academy for Medical Education, Current Psychiatry, and this publication are owned by the same company.

CRYSTAL CITY, VA. – Some patients experience consistent suicidal ideation – but most do not, an expert said at Focus on Neuropsychiatry presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Highwaystarz-Photography/Thinkstock

“In most patients, the ideation tends to go up and down – which means you ask the patient about the most severe example of suicidal ideation … in the last week or 2,” J. John Mann, MD, said. Getting a handle on patients’ worst suicidal ideation also can provide clues into the range of suicidal behavior they might be subject to, he added.

U.S. suicide rates have increased dramatically since 2000, and most people who die by suicide had depression, said Dr. Mann, the Paul Janssen Professor of Translational Neuroscience (in psychiatry and in radiology) at Columbia University, New York. However, those patients who are depressed tend to attempt suicide early in their depression.

“Most people with a major depressive episode never attempt suicide,” said Dr. Mann, who also is affiliated with the New York State Psychiatric Institute. “Suicidal behavior is not a ‘wear and tear’ phenomenon.”

When assessing risk of suicide clinically, patients most at risk include those with past history of suicide attempts, a family history of suicide, and those who have the worst suicidal ideation.

About half of the predisposition to suicidal behavior is genetic and independent of genetic risk associated with major psychiatric disorders. This genetic risk affects the diathesis each patient has for suicidal behavior. In the stress-diathesis model for suicidal behavior, stress from major depressive episodes and life events contributes to the patient’s perception of stress, which in turn contributes to that patient’s response to stress. Rather than depression itself being a suicidal trigger, these stressors in the form of adverse life events appear to be the trigger for suicide attempts, Dr. Mann noted.

“All of the risk is pretty much accounted for by whether the patient was in or out of an episode of major depression,” said Dr. Mann. “If they were in an episode of major depression, all the risk was accounted for by the major depression, and the stressors counted for enough. When they’re out of an episode of major depression, the risk fell right away and the stressors didn’t matter much.”

In the stress-diathesis model, trait components of suicidal behavior include mood and emotion dysregulation and perception; misreading social signals; reactive or impulsive aggressive traits of decision making or delayed discounting; and altered learning, memory, and problem solving. However, clinicians should look to the patients for whom depression appears more painful in subjective scores, because going by these trait components alone will not distinguish between patients at risk for suicide and those who will not make an attempt.

According to the Columbia Classification Algorithm of Suicide Assessment, suicide is distinguished by whether a patient wished to die, if an attempt is stopped by themselves or another person before harm has begun, and whether a patient prepared for the act beyond verbalizing or thinking of suicide but before harm has begun.

In addition to prescribing antidepressants, treatments with evidence for preventing suicide include means restriction and cognitive-behavioral therapy. For patients with borderline personality disorder, dialectical behavior therapy has proven effective. School interventions that educate students about mental health also have shown effectiveness. Other strategies include educating reporters about media guidelines on writing about suicide. Internet outreach interventions are promising, he said, but more evidence is needed to determine whether they work.

Among antidepressant options for patients with suicidal ideation, fluoxetine appears best for adolescents, and data show that venlafaxine is effective in adults. The Food and Drug Administration originally put a black box warning on selective serotonin reuptake inhibitors in 2004; however, recent data have shown that the increased risk of suicidal ideation brought on by those medications tapers off after the first week on the medication. Meanwhile, in the case of ketamine, there is “rapid and robust improvement” in depressive symptoms and suicidal ideation, which targets the diathesis, Dr. Mann said at the meeting presented by Global Academy for Medical Education.

“We need to identify rapidly acting antisuicidal medications, and we now see there’s a clear path forward to do that” with treatments like ketamine, he said.

Dr. Mann’s presentation was based on research funded by the National Institute of Mental Health and the Brain & Behavior Research Foundation. He reported receiving royalties from the Research Foundation for Mental Hygiene for commercial use of the Columbia-Suicide Severity Rating Scale.

Global Academy for Medical Education, Current Psychiatry, and this publication are owned by the same company.

CRYSTAL CITY, VA. – Some patients experience consistent suicidal ideation – but most do not, an expert said at Focus on Neuropsychiatry presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Highwaystarz-Photography/Thinkstock

“In most patients, the ideation tends to go up and down – which means you ask the patient about the most severe example of suicidal ideation … in the last week or 2,” J. John Mann, MD, said. Getting a handle on patients’ worst suicidal ideation also can provide clues into the range of suicidal behavior they might be subject to, he added.

U.S. suicide rates have increased dramatically since 2000, and most people who die by suicide had depression, said Dr. Mann, the Paul Janssen Professor of Translational Neuroscience (in psychiatry and in radiology) at Columbia University, New York. However, those patients who are depressed tend to attempt suicide early in their depression.

“Most people with a major depressive episode never attempt suicide,” said Dr. Mann, who also is affiliated with the New York State Psychiatric Institute. “Suicidal behavior is not a ‘wear and tear’ phenomenon.”

When assessing risk of suicide clinically, patients most at risk include those with past history of suicide attempts, a family history of suicide, and those who have the worst suicidal ideation.

About half of the predisposition to suicidal behavior is genetic and independent of genetic risk associated with major psychiatric disorders. This genetic risk affects the diathesis each patient has for suicidal behavior. In the stress-diathesis model for suicidal behavior, stress from major depressive episodes and life events contributes to the patient’s perception of stress, which in turn contributes to that patient’s response to stress. Rather than depression itself being a suicidal trigger, these stressors in the form of adverse life events appear to be the trigger for suicide attempts, Dr. Mann noted.

“All of the risk is pretty much accounted for by whether the patient was in or out of an episode of major depression,” said Dr. Mann. “If they were in an episode of major depression, all the risk was accounted for by the major depression, and the stressors counted for enough. When they’re out of an episode of major depression, the risk fell right away and the stressors didn’t matter much.”

In the stress-diathesis model, trait components of suicidal behavior include mood and emotion dysregulation and perception; misreading social signals; reactive or impulsive aggressive traits of decision making or delayed discounting; and altered learning, memory, and problem solving. However, clinicians should look to the patients for whom depression appears more painful in subjective scores, because going by these trait components alone will not distinguish between patients at risk for suicide and those who will not make an attempt.

According to the Columbia Classification Algorithm of Suicide Assessment, suicide is distinguished by whether a patient wished to die, if an attempt is stopped by themselves or another person before harm has begun, and whether a patient prepared for the act beyond verbalizing or thinking of suicide but before harm has begun.

In addition to prescribing antidepressants, treatments with evidence for preventing suicide include means restriction and cognitive-behavioral therapy. For patients with borderline personality disorder, dialectical behavior therapy has proven effective. School interventions that educate students about mental health also have shown effectiveness. Other strategies include educating reporters about media guidelines on writing about suicide. Internet outreach interventions are promising, he said, but more evidence is needed to determine whether they work.

Among antidepressant options for patients with suicidal ideation, fluoxetine appears best for adolescents, and data show that venlafaxine is effective in adults. The Food and Drug Administration originally put a black box warning on selective serotonin reuptake inhibitors in 2004; however, recent data have shown that the increased risk of suicidal ideation brought on by those medications tapers off after the first week on the medication. Meanwhile, in the case of ketamine, there is “rapid and robust improvement” in depressive symptoms and suicidal ideation, which targets the diathesis, Dr. Mann said at the meeting presented by Global Academy for Medical Education.

“We need to identify rapidly acting antisuicidal medications, and we now see there’s a clear path forward to do that” with treatments like ketamine, he said.

Dr. Mann’s presentation was based on research funded by the National Institute of Mental Health and the Brain & Behavior Research Foundation. He reported receiving royalties from the Research Foundation for Mental Hygiene for commercial use of the Columbia-Suicide Severity Rating Scale.

Global Academy for Medical Education, Current Psychiatry, and this publication are owned by the same company.